Antihemophilic Factor (Recombinant) Pegylated (Adynovate)

Trade Name : ADYNOVATE

Baxalta US Inc.

KIT, PLASMA DERIVATIVE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Antihemophilic Factor (Recombinant) Pegylated (Adynovate) which is also known as ADYNOVATE and Manufactured by Baxalta US Inc.. It is available in strength of per ml. Read more

Antihemophilic Factor (Recombinant) Pegylated (Adynovate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:
  • Limitation of Use
  • ADYNOVATE is not indicated for the treatment of von Willebrand disease.
  • ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:
  • Limitation of Use
  • ADYNOVATE is not indicated for the treatment of von Willebrand disease. ()
  • On-demand treatment and control of bleeding episodes
  • Perioperative management
  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • For intravenous use after reconstitution only.
  • For intravenous use after reconstitution only
  • One unit per kilogram body weight will raise the factor VIII level by 2% international units per deciliter (IU per dL). Each vial of ADYNOVATE is labeled with the actual amount of recombinant factor VIII present in IU. ()
  • On-demand treatment and control of bleeding episodes and perioperative management: tttttttttn
  • Routine prophylaxis: Administer 40-50 IU per kg body weight 2 times a week (Starting dose of 55 IU per kg body weight 2 times a week patients <12 years of age with a maximum of 70 IU per kg).
  • Inject intravenously over a period of less than or equal to 5 minutes (maximum infusion rate 10 mL per min). ()
  • ADYNOVATE is a lyophilized powder in single-use vials containing nominally (approximately) 250, 500, 750, 1000, 1500, 2000, and 3000 International Units (IU, units). The 250-1500 IU strengths come with 2 mL Sterile Water for Injection (sWFI); the 2000 and 3000 IU strengths come with 5 mL of sWFI. The actual factor VIII potency/content is labeled on each ADYNOVATE vial.
  • The potency assignment employs a factor VIII concentrate standard that is referenced to a WHO (World Health Organization) international standard for factor VIII concentrates and is evaluated by appropriate methodology to ensure accuracy of the results.
  • ADYNOVATE is available as a lyophilized powder in single-use vials containing nominally (approximately) 250, 500, 750, 1000, 1500, 2000, or 3000 international units. ()
  • ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).
  • Do not use in patients who have had prior anaphylactic reaction to ADYNOVATE, the parent molecule (ADVATE), mouse or hamster protein, or excipients of ADYNOVATE. ()
  • No data
  • Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment with ADYNOVATE and administer appropriate treatment. ()
  • Development of factor VIII neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration. (, )
  • The most common adverse reactions (u22651% of subjects) reported in the clinical studies were headache and nausea.
  • The most common adverse reactions reported in u22651% of subjects in the clinical studies were headache and nausea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Baxalta US Inc. at 1-800-999-1785 or FDA at 1-800-FDA-1088 or n
  • Pediatric Use: Higher clearance, a shorter half-life and lower incremental recovery of factor VIII has been observed in children (<12 years). Dose adjustment or more frequent dosing based on per kg body weight may be needed in this population.
  • ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated, is formulated as a sterile, non-pyrogenic, white to off-white lyophilized powder for reconstitution for intravenous injection. The product is supplied in single-use vials containing nominal (approximate) potencies of 250, 500, 750, 1000, 1500, 2000, or 3000 international units (IU). Each vial of ADYNOVATE is labeled with the actual factor VIII activity in IU determined using one-stage clotting assay, using a reference material calibrated against a World Health Organization (WHO) International Standard for factor VIII concentrates. One IU, as defined by the WHO standard for blood coagulation factor VIII, human, is approximately equal to the level of factor VIII activity found in 1 mL of fresh pooled human plasma.
  • When reconstituted with 2 mL or 5 mL sterile water for injection, the final solution contains the following excipients and stabilizers in targeted amounts per mL of reconstituted product:
  • ADYNOVATE contains no preservative. The specific activity of ADYNOVATE is 2700 - 8000 IU/mg protein.
  • ADYNOVATE is a recombinant full-length human coagulation factor VIII (2,332 amino acids with a molecular weight (MW) of 280 kDa) covalently conjugated with one or more molecules of polyethylene glycol (MW 20 kDa) []. The therapeutic activity of ADYNOVATE is derived from its parent drug substance, ADVATE [Antihemophilic Factor (Recombinant)], which is produced by recombinant DNA technology from the CHO cell line. ADVATE is purified from the culture medium using a series of chromatography columns. The purification process includes an immunoaffinity chromatography step in which a monoclonal antibody directed against factor VIII is employed to selectively isolate the factor VIII from the medium. The production process includes a dedicated, viral inactivation solvent-detergent treatment step. The ADVATE molecule is then covalently conjugated with the polyethylene glycol, which mainly targets lysine residues.
  • The cell culture, pegylation, purification process and formulation used in the manufacture of ADYNOVATE do not use additives of human or animal origins.
  • No data
  • Long-term studies in animals to evaluate the carcinogenic potential of ADYNOVATE or studies to determine the effects of ADYNOVATE on genotoxicity or fertility have not been performed.
  • No data
  • No data
  • Advise patients to:
  • To enroll in the confidential, industry-wide Patient Notification System, call 1-888-873-2838.
  • BAXALTA, ADVATE, ADYNOVATE, and BAXJECT are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
  • SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
  • Patented: see https://www.shire.com/legal-notice/product-patents
  • Baxalta US Inc.
  • ADYNOVATE[Antihemophilic Factor (Recombinant), PEGylated]
  • This leaflet summarizes important information about ADYNOVATE. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about ADYNOVATE. If you have any questions after reading this, ask your healthcare provider.
  • What is the most important information I need to know about ADYNOVATE?
  • Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.
  • You must carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing ADYNOVATE so that your treatment will work best for you.
  • What is ADYNOVATE?
  • ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you ADYNOVATE when you have surgery.
  • ADYNOVATE can reduce the number of bleeding episodes when used regularly (prophylaxis).
  • ADYNOVATE is not used to treat von Willebrand disease.
  • Who should not use ADYNOVATE?
  • You should not use ADYNOVATE if you:
  • Tell your healthcare provider if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.
  • How should I use ADYNOVATE?
  • ADYNOVATE is given directly into the bloodstream.
  • You may infuse ADYNOVATE at a hemophilia treatment center, at your healthcare provider's office or in your home. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with hemophilia A learn to infuse their ADYNOVATE by themselves or with the help of a family member.
  • Your healthcare provider will tell you how much ADYNOVATE to use based on your individual weight, level of physical activity, the severity of your hemophilia A, and where you are bleeding.
  • Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated. Discard any ADYNOVATE left in the vial at the end of your infusion as directed by your healthcare professional.
  • You may have to have blood tests done after getting ADYNOVATE to be sure that your blood level of factor VIII is high enough to clot your blood.
  • Call your healthcare provider right away if your bleeding does not stop after taking ADYNOVATE.
  • What should I tell my healthcare provider before I use ADYNOVATE?
  • You should tell your healthcare provider if you:
  • What are the possible side effects of ADYNOVATE?
  • You can have an allergic reaction to ADYNOVATE.
  • Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
  • The common side effects of ADYNOVATE are headache and nausea. Tell your healthcare provider about any side effects that bother you or do not go away.
  • These are not all the possible side effects with ADYNOVATE. You can ask your healthcare provider for information that is written for healthcare professionals.
  • What are the ADYNOVATE dosage strengths?
  • ADYNOVATE with 2 mL or 5 mL Sterile Water for Injection in a BAXJECT III system comes in seven different dosage strengths: 250 International Units (IU), 500 IU, 750 IU, 1000 IU, 1500 IU, 2000 IU, and 3000 IU. The actual strength will be imprinted on the label and on the box. The seven different strengths are color coded, as follows:
  • Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider. Always check the expiration date printed on the box. Do not use the product after the expiration date printed on the box.
  • How do I store ADYNOVATE?
  • What else should I know about ADYNOVATE and Hemophilia A?
  • Your body may form inhibitors to Factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, it may stop ADYNOVATE from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
  • Medicines are sometimes prescribed for purposes other than those listed here. Do not use ADYNOVATE for a condition for which it is not prescribed. Do not share ADYNOVATE with other people, even if they have the same symptoms that you have.
  • BAXALTA, ADVATE, ADYNOVATE, and BAXJECT are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
  • SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
  • Baxalta US Inc.
  • ADYNOVATE[Antihemophilic Factor (Recombinant),PEGylated](For intravenous use only)
  • Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.
  • Step-by-step instructions for reconstituting ADYNOVATE are found at the end of this leaflet.
  • Always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using ADYNOVATE. If you are unsure of the procedures, please call your healthcare provider before using.
  • Call your healthcare provider right away if bleeding is not controlled after using ADYNOVATE.
  • Your healthcare provider will prescribe the dose that you should take.
  • Reconstituted product (after mixing dry product with wet diluent) must be used within 3 hours and cannot be stored or refrigerated.
  • Your healthcare provider may need to take blood tests from time to time.
  • Talk to your healthcare provider before traveling. Plan to bring enough ADYNOVATE for your treatment during this time.
  • Dispose of all materials, including any leftover reconstituted ADYNOVATE product, in an appropriate container.
  • Important: Contact your healthcare provider or local hemophilia treatment center if you experience any problems.
  • BAXALTA, ADVATE, ADYNOVATE, and BAXJECT are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
  • SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
  • Patented: see www.shire.com/legal-notice/productpatents.
  • Baxalta US Inc.
  • Issued 05/2018
  • ADYNOVATE[Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4622-01
  • Single use only
  • For Intravenous Administration After Reconstitution Only
  • Lyophilized powder for reconstitution
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Rx Only
  • Actual potency
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Directions for use: see package insert
  • Rx Only
  • 00309444622039
  • 0742358
  • IU:
  • LOT:
  • EXP:
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4622-02
  • Single use only
  • 0742355
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Do not open until time of use
  • Do not use if packaging is opened or damaged
  • Rx Only.
  • Shire
  • ADYNOVATE[Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4623-01
  • Single use only
  • For Intravenous Administration After Reconstitution Only
  • Lyophilized powder for reconstitution
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Rx Only
  • Actual potency
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Directions for use: see package insert
  • Rx Only
  • 00309444623036
  • 0742361
  • IU:
  • LOT:
  • EXP:
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4623-02
  • Single use only
  • 0742360
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Do not open until time of use
  • Do not use if packaging is opened or damaged
  • Rx Only.
  • Shire
  • ADYNOVATE[Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4626-01
  • Single use only
  • For Intravenous Administration After Reconstitution Only
  • Lyophilized powder for reconstitution
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Rx Only
  • Actual potency
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Directions for use: see package insert
  • Rx Only
  • 00309444626037
  • 0742364
  • IU:
  • LOT:
  • EXP:
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4626-02
  • Single use only
  • 0742363
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Do not open until time of use
  • Do not use if packaging is opened or damaged
  • Rx Only.
  • 16E033-ADY-US
  • Shire
  • ADYNOVATE[Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4624-01
  • Single use only
  • For Intravenous Administration After Reconstitution Only
  • Lyophilized powder for reconstitution
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Rx Only
  • Actual potency
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Directions for use: see package insert
  • Rx Only
  • 00309444624033
  • 0742367
  • IU:
  • LOT:
  • EXP:
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4624-02
  • Single use only
  • 0742366
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Do not open until time of use
  • Do not use if packaging is opened or damaged
  • Rx Only.
  • Shire
  • ADYNOVATE[Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4627-01
  • Single use only
  • For Intravenous Administration After Reconstitution Only
  • Lyophilized powder for reconstitution
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Rx Only
  • Actual potency
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Directions for use: see package insert
  • Rx Only
  • 00309444627034
  • 0742370
  • IU:
  • LOT:
  • EXP:
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4627-02
  • Single use only
  • 0742369
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Do not open until time of use
  • Do not use if packaging is opened or damaged
  • Rx Only.
  • 16E033-ADY-US
  • Shire
  • ADYNOVATE[Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4625-01
  • Single use only
  • Actual potency
  • For Intravenous Administration After Reconstitution Only
  • Lyophilized powder for reconstitution
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Rx Only
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Directions for use: see package insert
  • Rx Only
  • 00309444625030
  • 0742373
  • IU:
  • LOT:
  • EXP:
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4625-02
  • Single use only
  • 0742372
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Do not open until time of use
  • Do not use if packaging is opened or damaged
  • Rx Only.
  • Shire
  • ADYNOVATE[Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4628-01
  • Single use only
  • Actual potency
  • For Intravenous Administration After Reconstitution Only
  • Lyophilized powder for reconstitution
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Rx Only
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Directions for use: see package insert
  • Rx Only
  • 00309444628031
  • 0742376
  • IU:
  • LOT:
  • EXP:
  • Shire
  • ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated]
  • NDC 0944-4628-02
  • Single use only
  • 0742375
  • For Intravenous Administration Only
  • ADYNOVATE and diluent preassembled in BAXJECT III system
  • Do not open until time of use
  • Do not use if packaging is opened or damaged
  • Rx Only.
  • Shire
  • Antihemophilic Factor (Recombinant), PEGylated
  • Shire
  • 0742356
  • Lot No.:
  • Sterile Water for Injection
  • Lot No.:
  • Siegfried Hameln GmbH
  • 0742211

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