Source: Medicines Authority (MT) Revision Year: 2019 Publisher: CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany
Beriate 250 IU Powder and solvent for solution for injection or infusion.
Beriate 500 IU Powder and solvent for solution for injection or infusion.
Beriate 1000 IU Powder and solvent for solution for injection or infusion.
Beriate 2000 IU Powder and solvent for solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection or infusion. White powder and clear, colourless solvent for solution for injection/infusion. |
One vial contains nominally: 250/500/1000/2000 IU human coagulation factor VIII (FVIII).
After reconstitution with 2.5/5/10 ml Beriate 250/500/1000 contains 100 IU/ml factor VIII.
Beriate 2000 is to be reconstituted with 10 ml of water for injections and contains approximately 200 IU/ml factor VIII.
The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The mean specific activity of Beriate is approximately 400 IU/mg protein.
Produced from the plasma of human donors.
Excipient with known effect: Sodium approximately 100 mmol/l (2.3 mg/ml).
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 |
|---|
|
Glycine Supplied solvent: Water for injections 2.5 ml, 5 ml and 10 ml respectively. |
Injection vial of colourless glass (250 IU and 500 IU: Type I; 1000 and 2000 IU: Type II)), sealed under vacuum with rubber stopper (bromobutyl), aluminium cap and plastic disc (polypropylene).
Box with 250 IU containing:
1 vial with powder
1 vial with 2.5 ml water for injections
1 filter transfer device 20/20
Administration set (inner box):
1 disposable 5 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Box with 500 IU containing:
1 vial with powder
1 vial with 5 ml water for injections
1 filter transfer device 20/20
Administration set (inner box):
1 disposable 5 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Box with 1000 IU containing:
1 vial with powder
1 vial with 10 ml water for injections
1 filter transfer device 20/20
Administration set (inner box):
1 disposable 10 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Box with 2000 IU containing:
1 vial with powder
1 vial with 10 ml water for injections
1 filter transfer device 20/20
Administration set (inner box):
1 disposable 10 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Not all pack sizes may be marketed.
CSL Behring GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany
MA665/01101 Beriate 250 IU powder and solvent for solution for injection or infusion
MA665/01102 Beriate 500 IU powder and solvent for solution for injection or infusion
MA665/01103 Beriate 1000 IU powder and solvent for solution for injection or infusion
MA665/01104 Beriate 2000 IU powder and solvent for solution for injection or infusion
Date of first authorisation: 15th May 2020
Date of renewal: 16th February 2021
| Drug | Countries | |
|---|---|---|
| BERIATE | Austria, Ecuador, Estonia, Spain, Hong Kong, Lithuania, Malta, Poland, Romania, Singapore, Tunisia, Turkey |
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