Wednesday, 28 September 2016

Hiprex


Hiprex is a brand name of methenamine, approved by the FDA in the following formulation(s):


HIPREX (methenamine hippurate - tablet; oral)



  • Manufacturer: SANOFI AVENTIS US

    Approved Prior to Jan 1, 1982

    Strength(s): 1GM [RLD][AB]

Has a generic version of Hiprex been approved?


Yes. The following products are equivalent to Hiprex:


methenamine hippurate tablet; oral



  • Manufacturer: COREPHARMA

    Approval date: June 20, 2003

    Strength(s): 1GM [AB]

UREX (methenamine hippurate tablet; oral)



  • Manufacturer: CNTY LINE PHARMS

    Approved Prior to Jan 1, 1982

    Strength(s): 1GM [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Hiprex. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Hiprex.

See also...

  • Hiprex Consumer Information (Wolters Kluwer)
  • Hiprex Consumer Information (Cerner Multum)
  • Hiprex Advanced Consumer Information (Micromedex)
  • Methenamine Consumer Information (Wolters Kluwer)
  • Methenamine Consumer Information (Cerner Multum)
  • Urasal Advanced Consumer Information (Micromedex)
  • Methenamine Advanced Consumer Information (Micromedex)
  • Methenamine AHFS DI Monographs (ASHP)
  • Methenamine Hippurate AHFS DI Monographs (ASHP)
  • Methenamine Mandelate AHFS DI Monographs (ASHP)

Idamycin PFS


Idamycin PFS is a brand name of idarubicin, approved by the FDA in the following formulation(s):


IDAMYCIN PFS (idarubicin hydrochloride - injectable; injection)



  • Manufacturer: PHARMACIA AND UPJOHN

    Approval date: February 17, 1997

    Strength(s): 1MG/ML [RLD][AP]

Has a generic version of Idamycin PFS been approved?


Yes. The following products are equivalent to Idamycin PFS:


idarubicin hydrochloride injectable; injection



  • Manufacturer: APP PHARMS

    Approval date: August 4, 2009

    Strength(s): 1MG/ML [AP]


  • Manufacturer: BEDFORD LABS

    Approval date: December 14, 2006

    Strength(s): 1MG/ML [AP]


  • Manufacturer: BEDFORD LABS

    Approval date: May 15, 2007

    Strength(s): 1MG/ML [AP]


  • Manufacturer: SANDOZ

    Approval date: March 29, 2011

    Strength(s): 1MG/ML [AP]

IDARUBICIN HYDROCHLORIDE PFS (idarubicin hydrochloride injectable; injection)



  • Manufacturer: TEVA PARENTERAL

    Approval date: May 1, 2002

    Strength(s): 1MG/ML [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Idamycin PFS. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Idamycin PFS.

See also...

  • Idamycin PFS Consumer Information (Wolters Kluwer)
  • Idamycin PFS Consumer Information (Cerner Multum)
  • Idamycin PFS Advanced Consumer Information (Micromedex)
  • Idamycin PFS AHFS DI Monographs (ASHP)
  • Idarubicin Consumer Information (Wolters Kluwer)
  • Idarubicin Consumer Information (Cerner Multum)
  • Idarubicin Intravenous Advanced Consumer Information (Micromedex)
  • Idarubicin Hydrochloride AHFS DI Monographs (ASHP)

Axiron


Axiron is a brand name of testosterone, approved by the FDA in the following formulation(s):


AXIRON (testosterone - solution, metered; transdermal)



  • Manufacturer: ELI LILLY AND CO

    Approval date: November 23, 2010

    Strength(s): 30MG/1.5ML ACTIVATION [RLD]

Has a generic version of Axiron been approved?


No. There is currently no therapeutically equivalent version of Axiron available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Axiron. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Dermal penetration enhancers and drug delivery systems involving same
    Patent 6,299,900
    Issued: October 9, 2001
    Inventor(s): Reed; Barry Leonard & Morgan; Timothy Matthias & Finnin; Barrie Charles
    Assignee(s): Monash University
    A transdermal drug delivery system which comprises at least one physiologically active agent or prodrug thereof and at least one dermal penetration enhancer; characterized in that the dermal penetration enhancer is a safe skin-tolerant ester sunscreen. A non-occlusive, percutaneous or transdermal drug delivery system which comprises: (i) an effective amount of at least one physiologically active agent or prodrug thereof; (ii) at least one non-volatile dermal penetration enhancer; and (iii) at least one volatile liquid; characterised in that the dermal penetration enhancer is adapted to transport the physiologically active agent across a dermal surface or mucosal membrane of an animal, including a human, when the volatile liquid evaporates, to form a reservoir or depot of a mixture comprising the penetration enhancer and the physiologically active agent or prodrug within said surface or membrane; and the dermal penetration enhancer is of low toxicity to, and is tolerated by, the dermal surface or mucosal membrane of the animal.
    Patent expiration dates:

    • February 19, 2017
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
      ✓ 
      Drug product




  • Dermal penetration enhancers and drug delivery systems involving same
    Patent 6,818,226
    Issued: November 16, 2004
    Inventor(s): Barry Leonard; Reed & Timothy Matthias; Morgan & Barrie Charles; Finnin
    Assignee(s): ACRUX DDS Pty. Ltd.
    A transdermal drug delivery system which comprises at least one physiologically active agent or prodrug thereof and at least one dermal penetration enhancer; characterised in that the dermal penetration enhancer is a safe skin-tolerant ester sunscreen. A non-occlusive, percutaneous or transdermal drug delivery system which comprises: (i) an effective amount of at least one physiologically active agent or prodrug thereof; (ii) at least one non-volatile dermal penetration enhancer; and (iii) at least one volatile liquid; characterised in that the dermal penetration enhancer is adapted to transport the physiologically active agent across a dermal surface or mucosal membrane of an animal, including a human, when the volatile liquid evaporates, to form a reservoir or depot of a mixture comprising the penetration enhancer and the physiologically active agent or prodrug within said surface or membrane; and the dermal penetration enhancer is of low toxicity to, and is tolerated by, the dermal surface or mucosal membrane of the animal.
    Patent expiration dates:

    • February 19, 2017
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
      ✓ 
      Drug product




  • Transdermal delivery of hormones
    Patent 6,923,983
    Issued: August 2, 2005
    Inventor(s): Morgan; Timothy Matthias & Bakalova; Margarita Vladislavova & Klose; Karthryn Traci-Jane & Finnin; Barrie Charles & Reed; Barry Leonard
    Assignee(s): Acrux DDS PTY LTD
    The present invention provides a transdermal drug delivery system which comprises: a therapeutically effective amount of a hormone; at least one dermal penetration enhancer, which is a safe skin-tolerant ester sunscreen ester; and at least one volatile liquid. The invention also provides a method for administering at least one systemic acting hormone to an animal which comprises applying an effective amount of the hormone in the form of the drug delivery system of the present invention
    Patent expiration dates:

    • February 19, 2017
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
      ✓ 
      Drug product




  • Dermal penetration enhancers and drug delivery systems involving the same
    Patent 8,071,075
    Issued: December 6, 2011
    Inventor(s): Reed; Barry Leonard & Morgan; Timothy Matthias & Finnin; Barrie Charles
    Assignee(s): Acrux DDS Pty Ltd.
    The invention relates to a method for treatment or prophylaxis of a disease or condition in an animal comprising administering to a mucosal membrane of said animal in need of such treatment a therapeutically effective amount of a drug delivery system comprising at least one physiologically active agent or prodrug thereof and at least one penetration enhancer selected from safe ester sunscreens.
    Patent expiration dates:

    • February 19, 2017
      ✓ 
      Patent use: TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
      ✓ 
      Drug product



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • November 23, 2013 - NEW PRODUCT

See also...

  • Axiron Consumer Information (Drugs.com)
  • Axiron Solution Consumer Information (Wolters Kluwer)
  • Axiron Consumer Information (Cerner Multum)
  • Axiron Advanced Consumer Information (Micromedex)
  • Testosterone Consumer Information (Drugs.com)
  • Testosterone Consumer Information (Wolters Kluwer)
  • Testosterone Gel Consumer Information (Wolters Kluwer)
  • Testosterone Patch Consumer Information (Wolters Kluwer)
  • Testosterone Solution Consumer Information (Wolters Kluwer)
  • Testosterone buccal system Consumer Information (Cerner Multum)
  • Testosterone injection Consumer Information (Cerner Multum)
  • Testosterone topical Consumer Information (Cerner Multum)
  • Androplex Advanced Consumer Information (Micromedex)
  • Testosterone Buccal Advanced Consumer Information (Micromedex)
  • Testosterone Topical application Advanced Consumer Information (Micromedex)
  • Testosterone Transdermal Advanced Consumer Information (Micromedex)
  • Testosterone AHFS DI Monographs (ASHP)

Lido-Hyal




Lido-Hyal may be available in the countries listed below.


Ingredient matches for Lido-Hyal



Hyaluronidase

Hyaluronidase is reported as an ingredient of Lido-Hyal in the following countries:


  • Italy

Lidocaine

Lidocaine hydrochloride (a derivative of Lidocaine) is reported as an ingredient of Lido-Hyal in the following countries:


  • Italy

International Drug Name Search

Sedazine




In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Sedazine



Xylazine

Xylazine hydrochloride (a derivative of Xylazine) is reported as an ingredient of Sedazine in the following countries:


  • Netherlands

  • United States

International Drug Name Search

Saljet Rinse flush


Generic Name: sodium chloride (flush) (SOE dee um KLOR ide)

Brand Names: Saljet Rinse, Saljet Sterile


What is Saljet Rinse (sodium chloride (flush))?

Sodium chloride is the chemical name for salt. Sodium chloride can reduce some types of bacteria.


Sodium chloride flush is used to clean out an intravenous (IV) catheter, which helps prevent blockage and removes any medicine left in the catheter area after you have received an IV infusion.


Sodium chloride may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Saljet Rinse (sodium chloride (flush))?


Call your doctor or tell your caregivers if your catheter, needle, or IV tubing becomes blocked or if the flush or IV medicine is not flowing normally. Stop using sodium chloride flush and call your doctor at once if you have severe irritation, swelling, warmth, redness, oozing, or pain around your catheter while using the flush.

What should I discuss with my health care provider before using Saljet Rinse (sodium chloride (flush))?


Before using sodium chloride flush, tell your doctor if you are allergic to any drugs.


How should I use Saljet Rinse (sodium chloride (flush))?


Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or more often than recommended.


You will use sodium chloride flush each time you use your IV catheter. Follow your doctor's instructions about how many times per day to use the flush.


Before using the flush, check the solution container to make sure there are no leaks in it. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.


Call your doctor or tell your caregivers if your catheter, needle, or IV tubing becomes blocked or if the flush or IV medicine is not flowing normally.

Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


Store sodium chloride at room temperature away from moisture and heat. Keep all of your catheter flush supplies in a clean dry place when not in use.

What happens if I miss a dose?


If you use flush your catheter each time you use it, you are not likely to miss a dose.


What happens if I overdose?


An overdose of sodium chloride flush is unlikely to occur.


What should I avoid while using Saljet Rinse (sodium chloride (flush))?


Follow your doctor's instructions about any restrictions on food, beverages, or activity.


Saljet Rinse (sodium chloride (flush)) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using sodium chloride flush and call your doctor at once if you have any of these side effects while using the flush:

  • severe irritation;




  • swelling;




  • warmth;




  • redness;




  • oozing; or




  • pain.



Less serious side effects may include mild irritation around the catheter.


This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Saljet Rinse (sodium chloride (flush))?


It is not likely that other drugs you take orally or inject will have an effect on sodium chloride used to flush your catheter. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Saljet Rinse resources


  • Saljet Rinse Support Group
  • 0 Reviews · Be the first to review/rate this drug


Where can I get more information?


  • Your doctor or pharmacist can provide more information about sodium chloride flush.


Amiodaronã




Amiodaronã may be available in the countries listed below.


Ingredient matches for Amiodaronã



Amiodarone

Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Amiodaronã in the following countries:


  • Romania

International Drug Name Search

Prednisona Calox




Prednisona Calox may be available in the countries listed below.


Ingredient matches for Prednisona Calox



Prednisone

Prednisone is reported as an ingredient of Prednisona Calox in the following countries:


  • Venezuela

International Drug Name Search

Alkeran


Alkeran is a brand name of melphalan, approved by the FDA in the following formulation(s):


ALKERAN (melphalan - tablet; oral)



  • Manufacturer: GLAXOSMITHKLINE

    Approved Prior to Jan 1, 1982

    Strength(s): 2MG [RLD]

ALKERAN (melphalan hydrochloride - injectable; injection)



  • Manufacturer: GLAXOSMITHKLINE

    Approval date: November 18, 1992

    Strength(s): EQ 50MG BASE/VIAL [RLD][AP]

Has a generic version of Alkeran been approved?


Yes. The following products are equivalent to Alkeran:


melphalan hydrochloride injectable; injection



  • Manufacturer: BEDFORD LABS

    Approval date: October 28, 2010

    Strength(s): EQ 50MG BASE/VIAL [AP]


  • Manufacturer: BIONICHE PHARMA USA

    Approval date: October 27, 2009

    Strength(s): EQ 50MG BASE/VIAL [AP]


  • Manufacturer: SYNERX

    Approval date: June 9, 2009

    Strength(s): EQ 50MG BASE/VIAL [AP]

Note: No generic formulation of the following product is available.


  • melphalan - tablet; oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Alkeran. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Alkeran.

See also...

  • Alkeran Consumer Information (Wolters Kluwer)
  • Alkeran Tablets Consumer Information (Wolters Kluwer)
  • Alkeran Consumer Information (Cerner Multum)
  • Alkeran I.V. Consumer Information (Cerner Multum)
  • Alkeran Advanced Consumer Information (Micromedex)
  • Alkeran IV Advanced Consumer Information (Micromedex)
  • Alkeran AHFS DI Monographs (ASHP)
  • Melphalan Consumer Information (Wolters Kluwer)
  • Melphalan Tablets Consumer Information (Wolters Kluwer)
  • Melphalan Consumer Information (Cerner Multum)
  • Melphalan Advanced Consumer Information (Micromedex)
  • Melphalan Intravenous Advanced Consumer Information (Micromedex)
  • Melphalan AHFS DI Monographs (ASHP)

Paracoccidioidomycosis Medications


Definition of Paracoccidioidomycosis: A mycosis affecting the skin, mucous membranes, lymph nodes, and internal organs. It is caused by paracoccidioides brasiliensis. It is also called paracoccidioidal granuloma.

Drugs associated with Paracoccidioidomycosis

The following drugs and medications are in some way related to, or used in the treatment of Paracoccidioidomycosis. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.





Drug List:

AVC


AVC is a brand name of sulfanilamide topical, approved by the FDA in the following formulation(s):


AVC (sulfanilamide - cream; vaginal)



  • Manufacturer: AZUR PHARMA

    Approval date: January 27, 1987

    Strength(s): 15% [RLD]

Has a generic version of AVC been approved?


No. There is currently no therapeutically equivalent version of AVC available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of AVC. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with AVC.

See also...

  • AVC Consumer Information (Wolters Kluwer)
  • AVC Consumer Information (Cerner Multum)
  • Sulfanilamide Consumer Information (Wolters Kluwer)
  • Sulfanilamide vaginal Consumer Information (Cerner Multum)

Bonamina




Bonamina may be available in the countries listed below.


Ingredient matches for Bonamina



Meclozine

Meclozine dihydrochloride (a derivative of Meclozine) is reported as an ingredient of Bonamina in the following countries:


  • Chile

International Drug Name Search

Trelstar


Trelstar is a brand name of triptorelin, approved by the FDA in the following formulation(s):


TRELSTAR (triptorelin pamoate - injectable; intramuscular)



  • Manufacturer: WATSON LABS

    Approval date: June 15, 2000

    Strength(s): EQ 3.75MG BASE/VIAL [RLD]


  • Manufacturer: WATSON LABS

    Approval date: June 29, 2001

    Strength(s): EQ 11.25MG BASE/VIAL [RLD]


  • Manufacturer: WATSON LABS

    Approval date: March 10, 2010

    Strength(s): EQ 22.5MG BASE/VIAL [RLD]

Has a generic version of Trelstar been approved?


No. There is currently no therapeutically equivalent version of Trelstar available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Trelstar. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Sustained and controlled release of water insoluble polypeptides
    Patent 5,776,885
    Issued: July 7, 1998
    Inventor(s): Orsolini; Piero & Mauvernay; Rolland-Yves & Deghenghi; Romano
    Assignee(s): Debio Recherche Pharmaceutique SA
    A pharmaceutical composition for the sustained release of a peptide wherein the composition includes a polylactide polymer, a polymer of lactic acid and glycolic acid, or a mixture of such polymers and a therapeutically active peptide in the form of its pamoate, tannate or stearate salt. The composition when placed in an aqueous physiological environment releases the peptide in a continuous manner for a period of at least about one week.
    Patent expiration dates:

    • July 7, 2015


    • July 7, 2015
      ✓ 
      Drug product



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • March 10, 2013 - NEW PRODUCT

See also...

  • Trelstar Advanced Consumer Information (Micromedex)
  • Trelstar AHFS DI Monographs (ASHP)
  • Triptorelin Consumer Information (Wolters Kluwer)
  • Triptorelin Consumer Information (Cerner Multum)
  • Triptorelin Intramuscular, Injection Advanced Consumer Information (Micromedex)
  • Triptorelin Pamoate AHFS DI Monographs (ASHP)

Ketoprofeno




Ketoprofeno may be available in the countries listed below.


Ingredient matches for Ketoprofeno



Ketoprofen

Ketoprofen is reported as an ingredient of Ketoprofeno in the following countries:


  • Chile

  • Colombia

  • Venezuela

International Drug Name Search

Prostin VR Pediatric


Prostin VR Pediatric is a brand name of alprostadil, approved by the FDA in the following formulation(s):


PROSTIN VR PEDIATRIC (alprostadil - injectable; injection)



  • Manufacturer: PHARMACIA AND UPJOHN

    Approved Prior to Jan 1, 1982

    Strength(s): 0.5MG/ML [RLD][AP]

Has a generic version of Prostin VR Pediatric been approved?


Yes. The following products are equivalent to Prostin VR Pediatric:


alprostadil injectable; injection



  • Manufacturer: BEDFORD

    Approval date: January 20, 1998

    Strength(s): 0.5MG/ML [AP]


  • Manufacturer: TEVA PARENTERAL

    Approval date: April 30, 1999

    Strength(s): 0.5MG/ML [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Prostin VR Pediatric. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Prostin VR Pediatric.

See also...

  • Prostin VR Pediatric injectable and transurethral Consumer Information (Cerner Multum)
  • Prostin VR Pediatric Advanced Consumer Information (Micromedex)
  • Alprostadil Consumer Information (Wolters Kluwer)
  • Alprostadil Suppository Consumer Information (Wolters Kluwer)
  • Alprostadil injectable and transurethral Consumer Information (Cerner Multum)
  • Muse Micro Advanced Consumer Information (Micromedex)
  • Alprostadil Intraurethral, Intravenous, Intracavernosal Advanced Consumer Information (Micromedex)
  • Alprostadil AHFS DI Monographs (ASHP)

Besivance


Besivance is a brand name of besifloxacin ophthalmic, approved by the FDA in the following formulation(s):


BESIVANCE (besifloxacin hydrochloride - suspension/drops; ophthalmic)



  • Manufacturer: BAUSCH AND LOMB

    Approval date: May 28, 2009

    Strength(s): EQ 0.6% BASE [RLD]

Has a generic version of Besivance been approved?


No. There is currently no therapeutically equivalent version of Besivance available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Besivance. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Quinolone carboxylic acid derivatives
    Patent 5,447,926
    Issued: September 5, 1995
    Inventor(s): Konno; Fujiko & Shibata; Akihiro & Matsuda; Hideaki & Asaoka; Takemitsu & Kawahara; Ryuichi & Taido; Naokata & Kuraishi; Tasdayuki & Takeda; Sunao
    Assignee(s): SS Pharmaceutical Co., Ltd.
    A quinolone carboxylic acid derivative having the following formula (1), ##STR1## wherein R.sup.1 is a hydrogen atom, an alkyl group, an aralkyl group, an ester residual group which can be hydrolyzed in living bodies, R.sup.2 is a hydrogen atom or an amino group which may be substituted by one or two lower alkyl groups, X is a hydrogen atom or a halogen atom, Y is CH.sub.2, O, S, SO, SO.sub.2, or N--R.sup.3, wherein R.sup.3 is a hydrogen atom or a lower alkyl group, and Z is an oxygen atom or two hydrogen atoms; or a salt thereof; and an antimicrobial agent comprising the same. The compound exhibits a superior antimicrobial activity, especially against gram positive microorganisms, and is thus useful for the treatments and prevention of various infectious diseases in clinics.
    Patent expiration dates:

    • September 5, 2012
      ✓ 
      Patent use: METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Quinolone carboxylic acid compositions and related methods of treatment
    Patent 6,685,958
    Issued: February 3, 2004
    Inventor(s): Samir; Roy & Santosh Kumar; Chandrasekaran & Katsumi; Imamori & Takemitsu; Asaoka & Akihiro; Shibata & Masami; Takahashi & Lyle M.; Bowman
    Assignee(s): InSite Vision Incorporated
    SSP Co., Ltd.
    The present invention relates to the use of quinolone carboxylic acid formulations in the treatment of ocular and periocular infections. The present invention also relates to sustained release compositions comprising specific quinolone carboxylic acid compounds. The invention also relates to quinolone carboxylic acid compositions and methods of preparing the same.
    Patent expiration dates:

    • June 29, 2021
      ✓ 
      Patent use: METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
      ✓ 
      Drug product




  • Quinolone carboxylic acid compositions and related methods of treatment
    Patent 6,699,492
    Issued: March 2, 2004
    Inventor(s): Samir; Roy & Santosh Kumar; Chandrasekaran & Katsumi; Imamori & Takemitsu; Asaoka & Akihiro; Shibata & Masami; Takahashi & Lyle M.; Bowman
    Assignee(s): InSite Vision Incorporated
    SSP Co., Ltd.
    The present invention relates to the use of quinolone carboxylic acid formulations in the treatment of ocular and periocular infections. The present invention also relates to sustained release compositions comprising specific quinolone carboxylic acid compounds. The invention also relates to quinolone carboxylic acid compositions and methods of preparing the same.
    Patent expiration dates:

    • March 31, 2019
      ✓ 
      Patent use: METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
      ✓ 
      Drug product



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • May 28, 2014 - NEW CHEMICAL ENTITY

See also...

  • Besivance Consumer Information (Drugs.com)
  • Besivance Drops Consumer Information (Wolters Kluwer)
  • Besivance Consumer Information (Cerner Multum)
  • Besivance Advanced Consumer Information (Micromedex)
  • Besivance AHFS DI Monographs (ASHP)
  • Besifloxacin Drops Consumer Information (Wolters Kluwer)
  • Besifloxacin ophthalmic Consumer Information (Cerner Multum)
  • Besifloxacin Ophthalmic Advanced Consumer Information (Micromedex)
  • Besifloxacin Hydrochloride AHFS DI Monographs (ASHP)

Natacyn


Natacyn is a brand name of natamycin ophthalmic, approved by the FDA in the following formulation(s):


NATACYN (natamycin - suspension; ophthalmic)



  • Manufacturer: ALCON

    Approved Prior to Jan 1, 1982

    Strength(s): 5% [RLD]

Has a generic version of Natacyn been approved?


No. There is currently no therapeutically equivalent version of Natacyn available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Natacyn. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Natacyn.

See also...

  • Natacyn Consumer Information (Wolters Kluwer)
  • Natacyn Consumer Information (Cerner Multum)
  • Natacyn Advanced Consumer Information (Micromedex)
  • Natacyn AHFS DI Monographs (ASHP)
  • Natamycin Consumer Information (Wolters Kluwer)
  • Natamycin ophthalmic Consumer Information (Cerner Multum)
  • Natamycin Ophthalmic Advanced Consumer Information (Micromedex)
  • Natamycin AHFS DI Monographs (ASHP)

Ambramycin




Ambramycin may be available in the countries listed below.


Ingredient matches for Ambramycin



Tetracycline

Tetracycline hydrochloride (a derivative of Tetracycline) is reported as an ingredient of Ambramycin in the following countries:


  • Ethiopia

International Drug Name Search

Skopril




Skopril may be available in the countries listed below.


Ingredient matches for Skopril



Lisinopril

Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Skopril in the following countries:


  • Bosnia & Herzegowina

International Drug Name Search

Ipilimumab


Pronunciation: IP-i-LIM-ue-mab
Generic Name: Ipilimumab
Brand Name: Yervoy

Ipilimumab may cause severe and sometimes fatal reactions. In instances when these reactions occur, they most commonly involve intestinal inflammation, liver problems, severe skin problems, nerve problems, or endocrine problems. Most of these reactions occurred during treatment with Ipilimumab. However, some occurred weeks or months after treatment was stopped.


Medical assessments and lab tests, including liver and thyroid function, should be performed before you start to take Ipilimumab and before each dose. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


Tell your doctor right away if you develop any of the following:


  • Fever; stomach pain or tenderness; increased stool frequency; diarrhea; blood or mucus in the stool; black, tarry stools

  • Yellowing of the skin or eyes, persistent nausea or stomach pain, loss of appetite, dark urine, pale stools

  • Red, swollen, blistered, or peeling skin; mouth sores or inflammation

  • Burning, tingling, or numbness; unusual muscle weakness

  • Feeling of being unusually cold or hot, inability to concentrate, mental or mood changes (eg, forgetfulness, irritability), dizziness, fainting, persistent or unusual headache, unusual fatigue, change in bowel habits, unexplained weight changes

  • Vision changes (eg, blurred vision, double vision), eye pain or redness




Ipilimumab is used for:

Treating certain types of melanoma (a kind of skin cancer). It may also be used for other conditions as determined by your doctor.


Ipilimumab is a monoclonal antibody. It works by helping the immune system to recognize and kill the cancer cells.


Do NOT use Ipilimumab if:


  • you are allergic to any ingredient in Ipilimumab

Contact your doctor or health care provider right away if any of these apply to you.



Before using Ipilimumab:


Some medical conditions may interact with Ipilimumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have an autoimmune disease (eg, ulcerative colitis, Crohn disease, rheumatoid arthritis, lupus, sarcoidosis)

  • if you have liver problems

  • if you have had an organ transplant

Some MEDICINES MAY INTERACT with Ipilimumab. However, no specific interactions with Ipilimumab are known at this time.


Ask your health care provider if Ipilimumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Ipilimumab:


Use Ipilimumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Ipilimumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ipilimumab refilled.

  • Ipilimumab is usually given as an injection at your doctor's office, hospital, or clinic.

  • Do not shake Ipilimumab.

  • Do not use Ipilimumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • If you miss a dose of Ipilimumab, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Ipilimumab.



Important safety information:


  • Diarrhea may be a sign of a serious side effect that may be caused by Ipilimumab. Contact your doctor if you develop diarrhea or increased stool frequency. Do not treat diarrhea without first checking with your doctor.

  • Tell your doctor or dentist that you take Ipilimumab before you receive any medical or dental care, emergency care, or surgery.

  • Lab tests, including liver and thyroid function, may be performed while you use Ipilimumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Ipilimumab should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Ipilimumab may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Ipilimumab while you are pregnant. It is not known if Ipilimumab is found in breast milk. Do not breast-feed while you are taking Ipilimumab.


Possible side effects of Ipilimumab:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Tiredness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or mucus in the stool; burning, tingling, or numbness; chest pain; decreased sexual desire; decreased urination; diarrhea or increased stool frequency; dizziness; eye pain or redness; fainting; mental or mood changes (eg, forgetfulness, irritability); mouth sores or inflammation; muscle pain or weakness; persistent or unusual headache; red, swollen, blistered, or peeling skin; shortness of breath or trouble breathing; stiff neck; stomach pain or tenderness; symptoms of liver problems (eg, yellowing of the skin or eyes, persistent nausea or stomach pain, loss of appetite, dark urine, pale stools); symptoms of thyroid problems (eg, feeling unusually cold or hot all the time, inability to concentrate, unusual fatigue, change in bowel habits, unexplained weight changes); unusual tiredness or weakness; vision changes (eg, blurred vision, double vision).



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Ipilimumab side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Ipilimumab:

Ipilimumab is usually handled and stored by a health care provider. If you are using Ipilimumab at home, store Ipilimumab as directed by your pharmacist or health care provider. Keep Ipilimumab out of the reach of children and away from pets.


General information:


  • If you have any questions about Ipilimumab, please talk with your doctor, pharmacist, or other health care provider.

  • Ipilimumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ipilimumab. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ipilimumab resources


  • Ipilimumab Side Effects (in more detail)
  • Ipilimumab Use in Pregnancy & Breastfeeding
  • Ipilimumab Drug Interactions
  • Ipilimumab Support Group
  • 0 Reviews for Ipilimumab - Add your own review/rating


  • Ipilimumab Professional Patient Advice (Wolters Kluwer)

  • ipilimumab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Yervoy Prescribing Information (FDA)

  • Yervoy Consumer Overview



Compare Ipilimumab with other medications


  • Melanoma
  • Melanoma, Metastatic

Helminex




Helminex may be available in the countries listed below.


Ingredient matches for Helminex



Flubendazole

Flubendazole is reported as an ingredient of Helminex in the following countries:


  • Peru

International Drug Name Search

Simvachol




Simvachol may be available in the countries listed below.


Ingredient matches for Simvachol



Simvastatin

Simvastatin is reported as an ingredient of Simvachol in the following countries:


  • Poland

International Drug Name Search

Thalomid


Thalomid is a brand name of thalidomide, approved by the FDA in the following formulation(s):


THALOMID (thalidomide - capsule; oral)



  • Manufacturer: CELGENE

    Approval date: July 16, 1998

    Strength(s): 50MG


  • Manufacturer: CELGENE

    Approval date: January 17, 2003

    Strength(s): 100MG, 200MG [RLD]


  • Manufacturer: CELGENE

    Approval date: January 10, 2007

    Strength(s): 150MG

Has a generic version of Thalomid been approved?


No. There is currently no therapeutically equivalent version of Thalomid available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Thalomid. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Methods and compositions for inhibition of angiogenesis
    Patent 5,629,327
    Issued: May 13, 1997
    Inventor(s): D'Amato; Robert
    Assignee(s): Childrens Hospital Medical Center Corp.
    The present invention comprises a group of compounds that effectively inhibit angiogenesis. More specifically, thalidomide and various related compounds such as thalidomide precursors, analogs, metabolites and hydrolysis products have been shown to inhibit angiogenesis. Importantly, these compounds can be administered orally.
    Patent expiration dates:

    • May 13, 2014
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA




  • Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 6,045,501
    Issued: April 4, 2000
    Inventor(s): Elsayed; Marc & Williams; Bruce
    Assignee(s): Celgene Corporation
    Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.
    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)


    • August 28, 2018
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA




  • Methods and compositions for inhibition of angiogenesis by thalidomide
    Patent 6,235,756
    Issued: May 22, 2001
    Inventor(s): D'Amato; Robert
    Assignee(s): The Children's Medical Center Corporation
    The present invention comprises a group of compounds that effectively inhibit angiogenesis. More specifically, thalidomide and various related compounds such as thalidomide precursors, analogs, metabolites and hydrolysis products have been shown to inhibit angiogenesis. Importantly, these compounds can be administered orally.
    Patent expiration dates:

    • March 1, 2013
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA




  • Methods for delivering a drug to a patient while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug
    Patent 6,315,720
    Issued: November 13, 2001
    Inventor(s): Williams; Bruce A. & Kaminski; Joseph K.
    Assignee(s): Celgene Corporation
    Improved methods for delivering to a patient in need of the drug, while avoiding the occurrence of an adverse side effect known or suspected of being caused by the drug are disclosed. The methods are of the type in which prescriptions for the drug are filled only after a computer readable storage medium has been consulted to assure that the prescriber, pharmacy and patient have been properly registered in the medium before the patient is approved to receive the drug. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to the side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA


    • October 23, 2020
      ✓ 
      Patent use: METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG




  • Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 6,561,976
    Issued: May 13, 2003
    Inventor(s): Marc; Elsayed & Bruce; Williams
    Assignee(s): Celgene Corporation
    Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.
    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA


    • August 28, 2018
      ✓ 
      Patent use: APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)




  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 6,561,977
    Issued: May 13, 2003
    Inventor(s): Bruce A.; Williams & Joseph K.; Kaminski
    Assignee(s): Celgene Corporation
    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA


    • October 23, 2020
      ✓ 
      Patent use: APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)




  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 6,755,784
    Issued: June 29, 2004
    Inventor(s): Bruce A.; Williams & Joseph K.; Kaminski
    Assignee(s): Celgene Corporation
    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)


    • October 23, 2020
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA




  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 6,869,399
    Issued: March 22, 2005
    Inventor(s): Williams; Bruce A. & Kaminski; Joseph K.
    Assignee(s): Celgene Corporation
    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)


    • October 23, 2020
      ✓ 
      Patent use: MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE


    • October 23, 2020
      ✓ 
      Patent use: ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)


    • October 23, 2020
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA




  • Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 6,908,432
    Issued: June 21, 2005
    Inventor(s): Elsayed; Marc & Williams; Bruce
    Assignee(s): Celgene Corporation
    Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.
    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA


    • August 28, 2018
      ✓ 
      Patent use: APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)




  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 7,141,018
    Issued: November 28, 2006
    Inventor(s): Williams; Bruce A. & Kaminski; Joseph K.
    Assignee(s): Celgene Corporation
    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE


    • October 23, 2020
      ✓ 
      Patent use: ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)


    • October 23, 2020
      ✓ 
      Patent use: USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA


    • October 23, 2020
      ✓ 
      Patent use: APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)




  • Pharmaceutical compositions and dosage forms of thalidomide
    Patent 7,230,012
    Issued: June 12, 2007
    Inventor(s): D'Angio; Paul & McCarty; John
    Assignee(s): Celgene Corporation
    Pharmaceutical compositions and single unit dosage forms of thalidomide and pharmaceutically acceptable prodrugs, salts, solvates, hydrates, or clathrates are disclosed. Also disclosed are methods of treating and preventing diseases and conditions such as, but not limited to, leprosy, chronic graft-vs-host disease, rheumatoid arthritis, sarcoidosis, an inflammatory condition, inflammatory bowel disease, and cancer using the novel dosage forms disclosed herein.
    Patent expiration dates:

    • December 9, 2023
      ✓ 
      Drug product




  • Methods and compositions for inhibition of angiogenesis
    Patent 7,435,745
    Issued: October 14, 2008
    Inventor(s): D'Amato; Robert J.
    Assignee(s): Celgene Corporation
    The present invention comprises a group of compounds that effectively inhibit angiogenesis. More specifically, thalidomide and various related compounds such as thalidomide precursors, analogs, metabolites and hydrolysis products have been shown to inhibit angiogenesis and to treat disease states resulting from angiogenesis. Additionally, antiinflammatory drugs, such as steroids and NSAIDs can inhibit angiogenesis dependent diseases either alone or in combination with thalidomide and related compounds. Importantly, these compounds can be administered orally.
    Patent expiration dates:

    • November 3, 2017
      ✓ 
      Patent use: USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA




  • Methods for inhibiting undesired angiogenesis in patients having tumors with thalidomide
    Patent 7,723,361
    Issued: May 25, 2010
    Inventor(s): D'Amato; Robert
    Assignee(s): Celgene Corporation
    The present invention comprises a group of compounds that effectively inhibit angiogenesis. More specifically, thalidomide and various related compounds such as thalidomide precursors, analogs, metabolites and hydrolysis products have been shown to inhibit angiogenesis and to treat disease states resulting from angiogenesis. Importantly, these compounds can be administered orally.
    Patent expiration dates:

    • March 1, 2013
      ✓ 
      Patent use: USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA




  • Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
    Patent 7,874,984
    Issued: January 25, 2011
    Inventor(s): Elsayed; Marc & Williams; Bruce
    Assignee(s): Celgene Corporation
    Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.
    Patent expiration dates:

    • August 28, 2018
      ✓ 
      Patent use: MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS OF ENL RECURRENCE


    • August 28, 2018
      ✓ 
      Patent use: ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA NODOSUM LEPROSUM (ENL)


    • August 28, 2018
      ✓ 
      Patent use: METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE OCCURENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID DRUG


    • August 28, 2018
      ✓ 
      Patent use: APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)


    • August 28, 2018
      ✓ 
      Patent use: TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL) IN CONNECTION WITH A SPECIAL PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)




  • Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated
    Patent 7,959,566
    Issued: June 14, 2011
    Inventor(s): Williams; Bruce A. & Kaminski; Joseph K.
    Assignee(s): Celgene Corporation
    Methods for delivering a drug to a patients in need of the drug, while restricting access to the drug by patients for whom the drug may be contraindicated are disclosed. The methods are of the type in which prescriptions for the drug are filled by a pharmacy only after a computer readable storage medium has been consulted to retrieve a prescription approval code. Embodiments are provided wherein the patients are assigned to risk groups based upon the risk that taking the drug will lead to an adverse side effect, and certain additional information, such as periodic surveys and diagnostic tests probative of the ongoing risk of the side effect developing are obtained before prescriptions for the drug are approved.
    Patent expiration dates:

    • October 23, 2020
      ✓ 
      Patent use: USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL)



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • May 23, 2013 - ORPHAN DRUG EXCLUSIVITY

    • May 25, 2013 - ORPHAN DRUG EXCLUSIVITY

See also...

  • Thalomid Consumer Information (Drugs.com)
  • Thalomid Consumer Information (Wolters Kluwer)
  • Thalomid Consumer Information (Cerner Multum)
  • Thalomid Advanced Consumer Information (Micromedex)
  • Thalomid AHFS DI Monographs (ASHP)
  • Thalidomide Consumer Information (Wolters Kluwer)
  • Thalidomide Consumer Information (Cerner Multum)
  • Thalidomide Advanced Consumer Information (Micromedex)
  • Thalidomide AHFS DI Monographs (ASHP)

Amicar


Amicar is a brand name of aminocaproic acid, approved by the FDA in the following formulation(s):


AMICAR (aminocaproic acid - syrup; oral)



  • Manufacturer: XANODYNE PHARM

    Approved Prior to Jan 1, 1982

    Strength(s): 1.25GM/5ML [RLD][AA]

AMICAR (aminocaproic acid - tablet; oral)



  • Manufacturer: XANODYNE PHARM

    Approved Prior to Jan 1, 1982

    Strength(s): 500MG [AB]


  • Manufacturer: XANODYNE PHARM

    Approval date: June 24, 2004

    Strength(s): 1GM [RLD]

Has a generic version of Amicar been approved?


Yes. The following products are equivalent to Amicar:


AMINOCAPROIC (aminocaproic acid tablet; oral)



  • Manufacturer: MIKART

    Approval date: May 24, 2001

    Strength(s): 500MG [AB]

aminocaproic acid syrup; oral



  • Manufacturer: MIKART

    Approval date: September 2, 1998

    Strength(s): 1.25GM/5ML [AA]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Amicar. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Amicar.

See also...

  • Amicar Consumer Information (Wolters Kluwer)
  • Amicar Syrup Consumer Information (Wolters Kluwer)
  • Amicar Consumer Information (Cerner Multum)
  • Amicar Advanced Consumer Information (Micromedex)
  • Amicar Intravenous Advanced Consumer Information (Micromedex)
  • Amicar AHFS DI Monographs (ASHP)
  • Aminocaproic Acid Consumer Information (Wolters Kluwer)
  • Aminocaproic Acid Solution Consumer Information (Wolters Kluwer)
  • Aminocaproic Acid Syrup Consumer Information (Wolters Kluwer)
  • Aminocaproic acid Consumer Information (Cerner Multum)
  • Aminocaproic acid Advanced Consumer Information (Micromedex)
  • Aminocaproic acid Intravenous Advanced Consumer Information (Micromedex)
  • Aminocaproic Acid AHFS DI Monographs (ASHP)

C-Fenac




C-Fenac may be available in the countries listed below.


Ingredient matches for C-Fenac



Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of C-Fenac in the following countries:


  • Bangladesh

International Drug Name Search

Clindacin-V




Clindacin-V may be available in the countries listed below.


Ingredient matches for Clindacin-V



Clindamycin

Clindamycin dihydrogen phosphate (a derivative of Clindamycin) is reported as an ingredient of Clindacin-V in the following countries:


  • Peru

International Drug Name Search

Azulfidine EN-tabs


See also: Generic Azulfidine


Azulfidine EN-tabs is a brand name of sulfasalazine, approved by the FDA in the following formulation(s):


AZULFIDINE EN-TABS (sulfasalazine - tablet, delayed release; oral)



  • Manufacturer: PHARMACIA AND UPJOHN

    Approval date: April 6, 1983

    Strength(s): 500MG [RLD][AB]

Has a generic version of Azulfidine EN-tabs been approved?


Yes. The following products are equivalent to Azulfidine EN-tabs:


sulfasalazine tablet, delayed release; oral



  • Manufacturer: VINTAGE PHARMS

    Approval date: January 11, 2002

    Strength(s): 500MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Azulfidine EN-tabs. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Azulfidine EN-tabs.

See also...

  • Azulfidine EN-tabs Delayed-Release Tablets Consumer Information (Wolters Kluwer)
  • Azulfidine EN-tabs Consumer Information (Cerner Multum)
  • Azulfidine Entabs Oral, Rectal Advanced Consumer Information (Micromedex)
  • Sulfasalazine Consumer Information (Wolters Kluwer)
  • Sulfasalazine Delayed-Release Tablets Consumer Information (Wolters Kluwer)
  • Sulfasalazine Consumer Information (Cerner Multum)
  • Alti-Sulfasalazine Oral, Rectal Advanced Consumer Information (Micromedex)
  • Salazopyrin Oral, Rectal Advanced Consumer Information (Micromedex)
  • Sulfasalazine Oral, Rectal Advanced Consumer Information (Micromedex)
  • Sulfasalazine AHFS DI Monographs (ASHP)

Isovue-370


See also: Generic Isovue-200, Generic Isovue-250, Generic Isovue-300


Isovue-370 is a brand name of iopamidol, approved by the FDA in the following formulation(s):


ISOVUE-370 (iopamidol - injectable; injection)



  • Manufacturer: BRACCO

    Approval date: December 31, 1985

    Strength(s): 76% [RLD][AP]


  • Manufacturer: BRACCO

    Approval date: October 12, 1994

    Strength(s): 76% [RLD][AP]

Has a generic version of Isovue-370 been approved?


Yes. The following products are equivalent to Isovue-370:


IOPAMIDOL-370 (iopamidol injectable; injection)



  • Manufacturer: APP PHARMS

    Approval date: April 2, 1997

    Strength(s): 76% [AP]

SCANLUX-370 (iopamidol injectable; injection)



  • Manufacturer: SANOCHEMIA CORP USA

    Approval date: June 18, 2010

    Strength(s): 76% [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Isovue-370. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Isovue-370.

See also...

  • Isovue-370 Consumer Information (Cerner Multum)
  • Iopamidol Consumer Information (Cerner Multum)

Trilipix


Trilipix is a brand name of fenofibric acid, approved by the FDA in the following formulation(s):


TRILIPIX (choline fenofibrate - capsule, delayed release; oral)



  • Manufacturer: ABBOTT LABS

    Approval date: December 15, 2008

    Strength(s): EQ 135MG FENOFIBRIC ACID [RLD], EQ 45MG FENOFIBRIC ACID

Has a generic version of Trilipix been approved?


No. There is currently no therapeutically equivalent version of Trilipix available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Trilipix. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Salts of fenofibric acid and pharmaceutical formulations thereof
    Patent 7,259,186
    Issued: August 21, 2007
    Inventor(s): Cink; Russell Drew & Paterson, Jr.; Joseph B. & Gao; Yi & Zhang; Geoff G. Z. & Long; Michelle A. & Morris; John B. & Rosenberg; Joerg
    Assignee(s): Abbott Laboratories
    In one aspect, the present invention relates to a formulation in the form of molecular dispersion comprising i) fenofibric acid, a physiologically acceptable salt or derivative thereof and optionally other active substances, ii) a binder component comprising at least one enteric binder, and optionally iii) other physiologically acceptable excipients. In a second aspect, the present invention relates to novel salts of fenofibric acid that are photostable when compared to other salts of fenofibric acid.
    Patent expiration dates:

    • January 7, 2025
      ✓ 
      Drug substance



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • December 15, 2011 - NEW PRODUCT

See also...

  • Trilipix Consumer Information (Drugs.com)
  • Trilipix Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Trilipix Consumer Information (Cerner Multum)
  • Trilipix Advanced Consumer Information (Micromedex)
  • Fenofibric Acid Consumer Information (Wolters Kluwer)
  • Fenofibric Acid Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Fenofibric acid Consumer Information (Cerner Multum)
  • Fenofibric acid Advanced Consumer Information (Micromedex)

Prevenar 13 suspension for injection






Prevenar 13 suspension for injection


Pneumococcal polysaccharide conjugate vaccine (13 valent, adsorbed)



Read all of this leaflet carefully before your child receives this vaccine.


  • Keep this leaflet. You may need to read it again.

  • If you have any further questions, ask your doctor, pharmacist, or nurse.

  • This vaccine has been prescribed for your child. Do not pass it on to others.

  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.



In this leaflet:


  • 1. What Prevenar 13 is and what it is used for

  • 2. Before your child receives Prevenar 13

  • 3. How Prevenar 13 is given

  • 4. Possible side effects

  • 5. How to store Prevenar 13

  • 6. Further information




What Prevenar 13 Is And What It Is Used For


Prevenar 13 is a pneumococcal vaccine. Prevenar 13 is given to children from 6 weeks to 5 years to help protect against diseases such as: meningitis (inflammation around the brain), sepsis or bacteraemia (bacteria in the blood stream), pneumonia (lung infection) and ear infections caused by 13 types of the bacteria Streptococcus pneumoniae.


The vaccine works by helping the body to make its own antibodies, which protect your child against these diseases.




Before Your Child Receives Prevenar 13



Prevenar 13 should not be given:


  • if your child is allergic (hypersensitive) to the active substances, to any other ingredients or to any other vaccine that contains diphtheria toxoid. The active substances and other ingredients are listed under “What Prevenar 13 contains” in section 6.

  • if your child has a severe infection with a high temperature (over 38°C). If this applies to your child, then the vaccination will be postponed until your child is feeling better. A minor infection, such as a cold, should not be a problem. However, talk to your doctor, pharmacist, or nurse first.



Take special care with Prevenar 13


Tell the doctor, pharmacist, or nurse before the vaccination:


  • if your child has any present or past medical problems after any dose of Prevenar or Prevenar 13 such as an allergic reaction or problems with breathing.

  • if your child has any bleeding problems or bruises easily.

  • if your child has a weakened immune system (such as due to HIV infection), she/he may not get the full benefit from Prevenar 13.

As with any vaccine, Prevenar 13 will not protect 100 % of those who receive the vaccine.


Prevenar 13 will only protect against ear infections caused by the types of Streptococcus pneumoniae for which the vaccine has been developed. It will not protect against other infectious agents that can cause ear infections.




Using other medicines/vaccines:


Your doctor may ask you to give your child paracetamol or other medicines that lower fever before Prevenar 13 is given. This will help to lower some of the side effects of Prevenar 13.


Please tell your doctor, pharmacist or nurse if your child is taking, has recently taken any other medicines, including medicines obtained without prescription, or has recently received any other vaccine.





How Prevenar 13 Is Given


The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into your child's arm or leg muscle.



Infants aged 6 weeks to 6 months of age


Typically, your child should receive an initial course of three injections of the vaccine followed by a booster dose.


  • The first injection may be given from the age of six weeks.

  • Each injection will be given at least one month apart.

  • A fourth injection (booster) will be given between 11 and 15 months of age.

  • You will be told when your child should come back for the next injection.

According to official recommendations in your country, an alternative schedule may be used by your healthcare provider. Please speak to your doctor, pharmacist, or nurse for more information.



Unvaccinated infants and children over 7 months of age


Infants aged 7 to 11 months should receive two injections. Each injection will be given at least one month apart. A third injection will be given in the second year of life.


Children aged 12 to 23 months should receive two injections. Each injection will be given at least two months apart.


Children aged 2 to 5 years should receive one injection.



Infants and children previously vaccinated with Prevenar


Infants and children who have previously received Prevenar may receive Prevenar 13 to complete the course of injections.


For children 1 to 5 years of age previously vaccinated with Prevenar, your doctor or nurse will recommend how many injections of Prevenar 13 are required.


It is important to follow the instructions from the doctor, pharmacist, or nurse so that your child completes the course of injections.


If you forget to go back at the scheduled time, ask the doctor, pharmacist, or nurse for advice.


If you have any further questions on the use of Prevenar 13, ask your doctor, pharmacist, or nurse.




Possible Side Effects


Like all vaccines, Prevenar 13 can cause side effects; although not everybody gets them.



The following side effects include those reported for Prevenar 13:



The most common side effects (these may occur with more than 1 in 10 doses of the vaccine) are:


  • Decreased appetite

  • Fever; irritability; any pain, tenderness, redness, swelling or hardness at the injection-site;

    drowsiness; restless sleep


Common side effects (these may occur with up to 1 in 10 doses of the vaccine) are:


  • Fever of more than 39°C


Uncommon side effects (these may occur with up to 1 in 100 doses of the vaccine) are:


  • Vomiting; diarrhoea

  • Redness, swelling, or hardness at the injection-site of more than 7 cm; crying


Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:


  • Seizures (or fits), including those caused by a high temperature

  • Hypersensitivity reaction, including swelling of the face and/or lips, difficulty in breathing

  • Rash; urticaria or urticaria-like rash (hives)

  • Flushing

Prevenar 13, which provides protection against 13 types of Streptococcus pneumoniae bacteria, replaces Prevenar, which provided protection against 7 types.




The following additional side effects have been seen with Prevenar because it has been available for a longer period of time. These side effects may be reported in the future with Prevenar 13:



Rare side effects (these may occur with up to 1 in 1,000 doses of the vaccine) are:


  • Anaphylactic/anaphylactoid reaction including shock (cardiovascular collapse); angioedema (swelling of lips, face or throat)

  • Hypotonic-hyporesponsive episode (collapse or shock-like state); urticaria (hives), dermatitis (redness and irritation) and pruritus (itching) at the injection-site


Very rare side effects (these may occur with up to 1 in 10,000 doses of the vaccine) are:


  • Enlarged lymph nodes or glands (lymphadenopathy) near the injection site, such as under the arm or in the groin

  • Erythema multiforme (a rash causing itchy red blotches)

In babies born very prematurely (at or before 28 weeks of gestation), longer gaps than normal between breaths may occur for 2-3 days after vaccination.


Please speak with your doctor, pharmacist, or nurse should you have any questions or concerns. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.





How To Store Prevenar 13


Keep out of the reach and sight of children.


Do not use Prevenar 13 after the expiry date stated on the carton and label. The expiry date refers to the last day of that month.


Store in a refrigerator (2°C – 8°C).


Do not freeze.


Medicines should not be disposed of via wastewater or household waste. Ask your doctor, pharmacist, or nurse how to dispose of medicines no longer required. These measures will help to protect the environment.




Further Information



What Prevenar 13 contains


The active substances are:


  • 2.2 µg of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F

  • 4.4 µg of polysaccharide for serotype 6B

Conjugated to CRM197 carrier protein and adsorbed on aluminium phosphate (0.125 mg aluminium).


The other ingredients are sodium chloride, succinic acid, polysorbate 80 and water for injections.




What Prevenar 13 looks like and contents of the pack


The vaccine is a white suspension for injection, provided in a single-dose, pre-filled syringe (0.5 ml). Pack sizes of 1 and 10, with or without needle, and a multipack each containing 5 packs of 10 pre-filled syringes, with or without needle.




Marketing Authorisation Holder and Manufacturer


Marketing Authorisation Holder:



Wyeth Lederle Vaccines S.A.

Rue du Bosquet, 15

B-1348 Louvain-la-Neuve

Belgium


Manufacturing Authorisation Holder responsible for batch release:



Wyeth Pharmaceuticals

New Lane

Havant

Hampshire

PO9 2NG

United Kingdom



For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
































United Kingdom

Wyeth Vaccines

Tel:+44 845 367 0098

Fax:+44 845 367 0777




This leaflet was last approved in 03/2010.


Detailed information on this medicine is available on the European Medicines Agency (EMEA) website http://www.emea.europa.eu/home



Doc ID: 59628