Product Information
Registration Status: ActiveSIN15586P
KOVALTRY POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500IU/VIAL is approved to be sold in Singapore with effective from 2018-11-30. It is marketed by BAYER (SOUTH EAST ASIA) PTE LTD, with the registration number of SIN15586P.
This product contains Antihemophilic Factor 500 IU 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, andBayer AG (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
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}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.