PROHANCE- gadoteridol injection, solution

ProHance by

Drug Labeling and Warnings

ProHance by is a Prescription medication manufactured, distributed, or labeled by BRACCO DIAGNOSTICS INC, BRACCO IMAGING SPA, BIPSO GmbH, Labor LS SE & Co. KG, BioChem Labor für biologishe und chemische Analytik GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

*The syringe assembly is a HYPAK SCF® single dose syringe supplied by Becton Dickinson.

  • SPL UNCLASSIFIED SECTION

    This product is covered by one or more of:
    U.S. Patent No. 5,474,756; U.S. Patent No. 5,846,519; and U.S. Patent No. 6,143,274.

  • SPL UNCLASSIFIED SECTION

    Manufactured for
    Bracco Diagnostics Inc.
    Monroe Township, NJ 08543
    by BIPSO GmbH
    78224 Singen (Germany)

    CL6FF03

    This Medication Guide has been approved by the U.S. Food and Drug AdministrationIssued: 04/2018
    COEB503
    MEDICATION GUIDE
    PROHANCE®(prō-ˈhan(t)s)
    (Gadoteridol)
    Injection for intravenous use
    What is PROHANCE?
    • PROHANCE is a prescription medicine called a gadolinium-based contrast agent (GBCA). PROHANCE, like other GBCAs, is used with a magnetic resonance imaging (MRI) scanner.
    • An MRI exam with a GBCA, including PROHANCE, helps your doctor to see problems better than an MRI exam without a GBCA.
    • Your doctor has reviewed your medical records and has determined that you would benefit from using a GBCA with your MRI exam.
    What is the most important information I should know about PROHANCE?
    • PROHANCE contains a metal called gadolinium. Small amounts of gadolinium can stay in your body including the brain, bones, skin and other parts of your body for a long time (several months to years).
    • It is not known how gadolinium may affect you, but so far, studies have not found harmful effects in patients with normal kidneys.
    • Rarely, patients have reported pains, tiredness, and skin, muscle or bone ailments for a long time, but these symptoms have not been directly linked to gadolinium.
    • There are different GBCAs that can be used for your MRI exam. The amount of gadolinium that stays in the body is different for different gadolinium medicines. Gadolinium stays in the body more after Omniscan or Optimark than after Eovist, Magnevist, or MultiHance. Gadolinium stays in the body the least after Dotarem, Gadavist, or ProHance.
    • People who get many doses of gadolinium medicines, women who are pregnant and young children may be at increased risk from gadolinium staying in the body.
    • Some people with kidney problems who get gadolinium medicines can develop a condition with severe thickening of the skin, muscles and other organs in the body (nephrogenic systemic fibrosis). Your healthcare provider should screen you to see how well your kidneys are working before you receive PROHANCE.
    Do not receive PROHANCE if you have had a severe allergic reaction to PROHANCE.
    Before receiving PROHANCE, tell your healthcare provider about all your medical conditions, including if you:
    • have had any MRI procedures in the past where you received a GBCA. Your healthcare provider may ask you for more information including the dates of these MRI procedures.
    • are pregnant or plan to become pregnant. It is not known if PROHANCE can harm your unborn baby. Talk to your healthcare provider about the possible risks to an unborn baby if a GBCA such as PROHANCE is received during pregnancy
    • have kidney problems, diabetes, or high blood pressure
    • have had an allergic reaction to dyes (contrast agents) including GBCAs
    What are the possible side effects of PROHANCE?
    • See “What is the most important information I should know about PROHANCE?”
    • Allergic reactions. PROHANCE can cause allergic reactions that can sometimes be serious. Your healthcare provider will monitor you closely for symptoms of an allergic reaction.
    The most common side effects of PROHANCE include: nausea, taste perversion, headache, feeling hot, or burning at the injection site.
    These are not all the possible side effects of PROHANCE.
    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
    General information about the safe and effective use of PROHANCE.
    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your healthcare provider for information about PROHANCE that is written for health professionals.
    What are the ingredients in PROHANCE?
    Active ingredient: gadoteridol
    Inactive ingredients: calteridol calcium, tromethamine
    Manufactured by: BIPSO GmbH-78224 Singen (Germany)
    Manufactured for: Bracco Diagnostics Inc., Monroe Township, NJ 08831
    US Patent No. 5,474,756; 5,846,519; and 6,143,274.
    For more information, go to www.imaging.bracco.com or call 1-800-257-5181.
  • PRINCIPAL DISPLAY PANEL

     

    Prohance 5mL Vial label
    NDC: 0270-1111-04

    5 mL Vial
  • PRINCIPAL DISPLAY PANEL

    Prohance 10mL Syringe label

    10 mL Syringe
  • INGREDIENTS AND APPEARANCE
    PROHANCE 
    gadoteridol injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0270-1111
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    gadoteridol (UNII: 0199MV609F) (gadoteridol - UNII:0199MV609F) gadoteridol279.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    calteridol calcium (UNII: RPH56VWA1A) .23 mg  in 1 mL
    tromethamine (UNII: 023C2WHX2V) 1.21 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0270-1111-045 in 1 BOX11/16/1992
    15 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    2NDC: 0270-1111-015 in 1 BOX11/16/1992
    210 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    3NDC: 0270-1111-025 in 1 BOX11/16/1992
    315 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    4NDC: 0270-1111-035 in 1 BOX11/16/1992
    420 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    5NDC: 0270-1111-165 in 1 BOX11/16/1992
    510 mL in 1 SYRINGE, GLASS; Type 0: Not a Combination Product
    6NDC: 0270-1111-455 in 1 BOX11/16/1992
    617 mL in 1 SYRINGE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02013111/16/1992
    Labeler - BRACCO DIAGNOSTICS INC (849234661)
    Registrant - BRACCO DIAGNOSTICS INC (849234661)
    Establishment
    NameAddressID/FEIBusiness Operations
    BRACCO IMAGING SPA434384007API MANUFACTURE(0270-1111)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIPSO GmbH342104149MANUFACTURE(0270-1111) , ANALYSIS(0270-1111)
    Establishment
    NameAddressID/FEIBusiness Operations
    Labor LS SE & Co. KG314929072ANALYSIS(0270-1111)

  • Trademark Results [ProHance]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROHANCE
    PROHANCE
    97264281 not registered Live/Pending
    JAMOCHA TECH PRIVATE LIMITED
    2022-02-11
    PROHANCE
    PROHANCE
    97182054 not registered Live/Pending
    JAMOCHA TECH PRIVATE LIMITED
    2021-12-21
    PROHANCE
    PROHANCE
    75572308 not registered Dead/Abandoned
    United Agri Products
    1998-10-19
    PROHANCE
    PROHANCE
    74392033 1820972 Live/Registered
    BRACCO DIAGNOSTICS INC.
    1993-05-19
    PROHANCE
    PROHANCE
    74222866 not registered Dead/Abandoned
    E. R. Squibb & Sons, Inc.
    1991-11-14
    PROHANCE
    PROHANCE
    74032581 not registered Dead/Abandoned
    E. R. Squibb & Sons, Inc.
    1990-02-26
    PROHANCE
    PROHANCE
    73809193 1582205 Live/Registered
    E. R. SQUIBB & SONS, INC.
    1989-06-26

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