HAEMOSOLVEX FACTOR IX (Powder for Injection)

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Nbi

Patient Information leaflet

INDICATIONS [/za_1203.html#1]
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CONTRA-INDICATIONS [/za_1203.html#1]
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DOSAGE [/za_1203.html#1]
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IDENTIFICATION [/za_1203.html#1]
  [/za_1203.html#1]    PATIENT INFORMATION
HAEMOSOLVEX FACTOR IX (POWDER FOR INJECTION)
REGISTRATION NUMBER 
W/30.3/191
PROPRIETARY NAME
(and dosage form):
HAEMOSOLVEX FACTOR IX (POWDER FOR INJECTION)
DESCRIPTIVE NAME OF MEDICINE
Human 
FACTOR IX COMPLEX
PHARMACOLOGICAL CLASSIFICATION
A 30.3 Biologicals (Blood Fractions)
SCHEDULING STATUS
S4
COMPOSITION
Factor IX complex (prothrombin complex) is a lyophilised concentrate containing the following coagulation factors:
factor II (prothrombin), factor VII (proconvertin), factor IX (Christmas factor) and factor X (Stuart-Prower factor).
HAEMOSOLVEX FACTOR IX is prepared from pooled fresh plasma donated by healthy, non-remunerated donors. Each
unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen, antibodies to the
hepatitis C virus and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
To reduce the risk of transmission of infective agents, selection of donors and donations by suitable measures is
performed and removal and/or inactivation procedures are included in the production process. The manufacturing
method includes a process of solvent detergent treatment developed to inactivate lipid-enveloped viruses. The efficacy
of this process has been tested against hepatitis B, hepatitis C and HIV.
When each vial of the product is reconstituted with the 10 mL Water for Injection provided, the solution per vial, will
contain factor IX 500 IU (50 IU