Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com
Haemoctin 250
Haemoctin 500
Haemoctin 1000
Powder and solvent for solution for injection.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection. White powder and clear, colourless solvent for solution for injection. |
Human plasma derived coagulation factor VIII.
One vial contains nominally 250, 500 or 1000 IU human plasma derived coagulation factor VIII.
Haemoctin 250 contains approximately 250 IU (50 IU/ml) human coagulation factor VIII after reconstitution.
Haemoctin 500 contains approximately 500 IU (100 IU/ml) human coagulation factor VIII after reconstitution.
Haemoctin 1000 contains approximately 1000 IU (200 IU/ml) human coagulation factor VIII after reconstitution.
The potency (IU) is determined using the European Pharmacopoeia chromogenic factor VIII coagulation assay. The specific activity of Haemoctin is approximately 100 IU/mg protein.
Produced from the plasma of human donors.
Excipient with known effect: One vial contains up to 32.2 mg sodium (1.4 mmol).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor VIII |
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X (factor Xa). Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies. |
| List of Excipients |
|---|
|
Powder: Glycine Solvent: Water for injections |
1 package Haemoctin contains:
1 vial (20 ml) with powder out of glass type I acc. to Ph. Eur.
Freeze-drying stoppers out of halobutyl-caoutchouc, type I acc. to Ph. Eur.
1 vial with 5 ml solvent, glass type I acc. to Ph. Eur. Injection stoppers out of halobutyl-caoutchouc, type I acc. to Ph. Eur.
The pack also contains:
1 disposable syringe (5 ml), 1 transfer system with integral filter, 1 butterfly cannula
Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany
Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: mail@biotest.com
PL 04500/0009
PL 04500/0010
06/08/2008 and 04/09/2008 / 18/03/2013
| Drug | Countries | |
|---|---|---|
| HAEMOCTIN | Austria, Spain, Hong Kong, Lithuania, Malta, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom |
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