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KOGENATE-FS FOR INJECTION 1000 IU/VIAL

Product Information

Registration Status: Active

SIN13387P

KOGENATE-FS FOR INJECTION 1000 IU/VIAL is approved to be sold in Singapore with effective from 2007-07-12. It is marketed by BAYER (SOUTH EAST ASIA) PTE LTD, with the registration number of SIN13387P.

This product contains Antihemophilic Factor 1000 IU/vial in the form of INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION. It is approved for INTRAVENOUS use.

This product is manufactured by BAYER HEALTHCARE LLC in UNITED STATES, andVetter Pharma-Fertigung GmbH & Co.KG (manufacturer of diluent) in GERMANY.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Human recombinant antihemophilic factor (AHF) or Factor VIII, 2332 residues, glycosylated, produced by CHO cells

Indication

For the treatment of hemophilia A, von Willebrand disease and Factor XIII deficiency.

Mechanism of Action

Antihemophilic factor (AHF) is a protein found in normal plasma which is necessary for clot formation. The administration of AHF provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect of patients with hemophilia A (classical hemophilia).

Clearance

* 4.1 mL/h•kg [Previously treated pediatric patients]

Active Ingredient/Synonyms

Antihemophilic factor (recombinant) | Antihemophilic factor recombinant | Antihemophilic factor, human recombinant | Antihemophilic factor, recombinant | Factor VIII (rDNA) | Factor VIII (Recombinant) | Factor VIII recombin | Factor VIII, recombinant | Human Factor VIII (Recombinant) | Human factor VIII recombinant | Octocog alfa | rAHF | Recombinant antihemophilic factor VIII | Antihemophilic factor, human recombinant |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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