Antihemophilic Factor Human (Hemofil M)

Trade Name : HEMOFIL M

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 Human (Hemofil M) which is also known as HEMOFIL M and Manufactured by BAXALTA US Inc.. It is available in strength of per ml. Read more

Antihemophilic Factor Human (Hemofil M) 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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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
  • Antihemophilic Factor (Human), Method M, Monoclonal Purifiedu00a0n
  • HEMOFIL M, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is a sterile, nonpyrogenic, dried preparation of antihemophilic factor (Factor VIII, Factor VIII:C, AHF) in concentrated form with a specific activity range of 2 to 22 AHF International Units/mg of total protein. HEMOFIL M contains a maximum of 12.5 mg/mL Albumin, and per AHF International Unit, 0.07 mg polyethylene glycol (3350), 0.39 mg histidine as stabilizing agents, not more than 0.1 mg glycine, 0.1 ng mouse protein, 18 ng organic solvent (tri-n-butyl phosphate) and 50 ng detergent (octoxynol 9). In the absence of the added Albumin (Human), the specific activity is approximately 2,000 AHF International Units/mg of protein . tttttt
  • HEMOFIL M is prepared by the Method M process from pooled human plasma by immunoaffinity chromatography utilizing a murine monoclonal antibody to Factor VIII:C, followed by an ion exchange chromatography step for further purification. Source material may be provided by other US licensed manufacturers. HEMOFIL M also includes an organic solvent (tri-n-butyl phosphate) and detergent (octoxynol 9) virus inactivation step designed to reduce the risk of transmission of hepatitis and other viral diseases. The process further includes a nanofiltration step between immunoaffinity chromatography and ion-exchange chromatography as an additional viral clearance step to further improve the viral safety margin of the final product.
  • Use of an organic solvent (tri-n-butyl phosphate; TNBP) in the manufacture of Antihemophilic Factor (Human) has little or no effect on AHF activity, while lipid enveloped viruses, such as hepatitis B and human immunodeficiency virus (HIV) would be inactivated. The nanofiltration step integrated into the manufacture of AHF-M further enhances the safety margin with respect to adventitious viruses. Each bottle of HEMOFIL M is labeled with the AHF activity expressed in International Units (IU) per bottle. Thisu00a0potency assignment is referenced to the World Health Organization International Standard. The purity of HEMOFIL M has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand's Factor.
  • In vitro
  • Studies for nanofiltration and other process steps, summarized in , demonstrate virus clearance during the HEMOFIL M manufacturing process using HIV-1; BVDV, a generic model for lipid enveloped RNA viruses, such as hepatitis C virus (HCV); PRV, a model for lipid enveloped DNA viruses, such as hepatitis B virus (HBV); canine parvovirus (CPV), a model for non-lipid enveloped DNA viruses, such as B19V, HAV, and MMV.
  • Antihemophilic factor (AHF) is a protein found in normal plasma which is necessary for clot formation. The administration of HEMOFIL M provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect of patients with hemophilia A (classical hemophilia). The half-life of HEMOFIL M administered to Factor VIII deficient patients has been shown to be 14.8 u00b1 3.0 hours.
  • HEMOFIL M is indicated in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes.
  • HEMOFIL M is not indicated in von Willebrand's disease.
  • HEMOFIL M is contraindicated in patients with a known hypersensitivity to the active substance, to excipients, or to mouse proteins.
  • No data
  • Identification of the clotting defect as a Factor VIII deficiency is essential before the administration of HEMOFIL M is initiated.
  • No data
  • For intravenous use only.
  • The expected peak AHF level, expressed as IU/dL of plasma or % (percent) of normal, can be calculated by multiplying the dose administered per kg body weight (IU/kg) by two. This calculation is based on the clinical finding by Abildgaard, , which is supported by data from the collaborative study of recovery and survival with 15 different lots of HEMOFIL M on 56 hemophiliacs that demonstrated a mean peak recovery point above the mean pre-infusion baseline of about 2.0 IU/dL per infused IU/kg body weight.n
  • Examples:
  • Recommended Dosage Schedule
  • Physician supervision of the dosage is required. The following dosage schedule may be used as a guide.
  • If bleeding is not controlled with the prescribed dose, determine the plasma level of Factor VIII and administer a sufficient dose of HEMOFIL M to achieve a satisfactory clinical response.
  • Under certain circumstances (e.g., presence of a low titer inhibitor) doses larger than those recommended may be necessary as per standard care. In patients with high titer Factor VIII inhibitors, HEMOFIL M therapy may not be effective and other therapeutic options should be considered. The dosage and duration of treatment depend on the severity of Factor VIII deficiency, the location and extent of the bleeding, and the patient's clinical condition. Careful control of replacement therapy is especially important in cases of major surgery or life threatening hemorrhages.
  • HEMOFIL M is available as single-dose bottles that contain the following nominal potencies:
  • Each bottle is labeled with the potency in International Units, and is packaged together with 10 mL of Sterile Water for Injection, USP, a double-ended needle, and a filter needle.
  • Not made with natural rubber latex.
  • HEMOFIL M can be stored at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F) or at room temperature, not to exceed 30u00b0C (86u00b0F), until expiration date noted on the package.
  • Do not freeze.
  • Information for Patients
  • To enroll in the confidential, industry-wide Patient Notification System, call 1-888-873-2838.
  • BAXALTA and HEMOFIL 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.u00a0n
  • Revised: Jun 2018
  • 10 mL size, driedList 1502845NDC 0944-3941-01
  • Antihemophilic Factor (Human)Method M, Monoclonal PurifiedHEMOFIL MNanofiltered
  • FVIII
  • Intravenous administration only
  • Store at 2u00b0 - 8u00b0C (36u00b0 - 46u00b0F) or room temperature, notto exceed 30u00b0C (86u00b0F) until expiration date noted onpackage.
  • Dosage and Administration: read package insert.Contains no preservative.
  • Baxalta US Inc.Lexington, MA 02421 USA U.S. License No. 2020
  • Rx Only
  • Shire
  • 10 mL size, dried
  • NDC 0944-3940-02
  • Antihemophilic Factor (Human)Method M, Monoclonal PurifiedHEMOFIL MNanofiltered
  • FVIII
  • Shire
  • Intravenous administration only.
  • Administer within 3 hours after reconstitution.
  • Dosage and Administration: Read full prescribing information.
  • Warning: This product is prepared from large pools of human plasma. Human blood andits components may transmit infectious agents. The patient and the physicianshould discuss the risks and benefits of this product.
  • Contains no preservative.
  • Rx Only
  • 10 mL size, driedList 1502846NDC 0944-3943-01
  • Antihemophilic Factor (Human)Method M, Monoclonal PurifiedHEMOFIL MNanofiltered
  • FVIII
  • Intravenous administration only
  • Store at 2u00b0 - 8u00b0C (36u00b0 - 46u00b0F) or room temperature, notto exceed 30u00b0C (86u00b0F) until expiration date noted onpackage.
  • Dosage and Administration: read package insert.Contains no preservative.
  • Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
  • Rx Only
  • Shire
  • 10 mL size, dried
  • NDC 0944-3942-02
  • Antihemophilic Factor (Human)Method M, Monoclonal PurifiedHEMOFIL MNanofiltered
  • FVIII
  • Shire
  • Intravenous administration only.
  • Administer within 3 hours after reconstitution.
  • Dosage and Administration: Read full prescribing information.
  • Warning: This product is prepared from large pools of human plasma. Human blood andits components may transmit infectious agents. The patient and the physicianshould discuss the risks and benefits of this product.
  • Contains no preservative.
  • Rx Only
  • 10 mL size, driedList 1502847NDC 0944-3945-01
  • Antihemophilic Factor (Human)Method M, Monoclonal PurifiedHEMOFIL MNanofiltered
  • FVIII
  • Intravenous administration only
  • Store at 2u00b0 - 8u00b0C (36u00b0 - 46u00b0F) or room temperature, notto exceed 30u00b0C (86u00b0F) until expiration date noted onpackage.
  • Dosage and Administration: read package insert.Contains no preservative.
  • Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
  • Rx Only
  • Shire
  • 10 mL size, dried
  • NDC 0944-3944-02
  • Antihemophilic Factor (Human)Method M, Monoclonal PurifiedHEMOFIL MNanofiltered
  • FVIII
  • Shire
  • Intravenous administration only.
  • Administer within 3 hours after reconstitution.
  • Dosage and Administration: Read full prescribing information.
  • Warning: This product is prepared from large pools of human plasma. Human blood andits components may transmit infectious agents. The patient and the physicianshould discuss the risks and benefits of this product.
  • Contains no preservative.
  • Rx Only
  • 10 mL size, driedList 1502848NDC 0944-3947-01
  • Antihemophilic Factor (Human)Method M, Monoclonal PurifiedHEMOFIL MNanofiltered
  • FVIII
  • Intravenous administration only
  • Store at 2u00b0 - 8u00b0C (36u00b0 - 46u00b0F) or room temperature, notto exceed 30u00b0C (86u00b0F) until expiration date noted onpackage.
  • Dosage and Administration: read package insert.Contains no preservative.
  • Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
  • Rx Only
  • Shire
  • 10 mL size, dried
  • NDC 0944-3946-02
  • Antihemophilic Factor (Human)Method M, Monoclonal PurifiedHEMOFIL MNanofiltered
  • FVIII
  • Shire
  • Intravenous administration only.
  • Administer within 3 hours after reconstitution.
  • Dosage and Administration: Read full prescribing information.
  • Warning: This product is prepared from large pools of human plasma. Human blood andits components may transmit infectious agents. The patient and the physicianshould discuss the risks and benefits of this product.
  • Contains no preservative.
  • Rx Only
  • Sterile Water Vial Label Baxter 10 mL
  • NDC 0338-0001-68
  • Nonpyrogenic
  • Single-Dose Container
  • 10 mL
  • Sterile Water for Injection, USP
  • for reconstitution of accompanying product
  • Do not use unless clear. No antimicrobial agent or other
  • substance has been added. Do not use for intravascular
  • injection without making approximately isotonic by
  • addition of suitable solute. Discard unused portion.
  • Rx Only.
  • This Product Contains Dry Natural Rubber.
  • Manufactured by
  • Baxter Healthcare Corporation
  • Deerfield, IL 60015 USA
  • Imported by
  • Baxter CorporationToronto, Ontario

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