Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
Fibrogammin 250/1250 IU.
Powder and solvent for solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Powder and solvent for solution for injection/infusion. White powder and clear, colourless solvent. |
Active substance: Fibrogammin is a purified concentrate of blood coagulation factor XIII (FXIII). It is derived from human plasma and is presented as a white powder.
Each vial contains nominally 250 or 1250 IU human plasma coagulation factor XIII.
Fibrogammin contains approximately 62.5 IU/ml (250 IU/4 ml or 1250/20 ml) of human plasma coagulation factor XIII when reconstituted with 4 ml or 20 ml water for injections, respectively.
The specific activity of Fibrogammin is approximately 3.1–13.3 IU/mg protein.
Excipients with known effect: Sodium (as chloride and hydroxide): 2.78 to 4.36 mg/ml (120 to 189 mmol/L)
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Coagulation factor XIII |
Factor XIII connects the amino group of lysine with glutamine via its enzymatic function (transamidase activity), thereby leading to the cross-linking of fibrin molecules. This is the final stage of blood coagulation. Fibrin cross-linking and stabilisation promote the penetration of fibroblasts and support wound healing. |
| List of Excipients |
|---|
|
Powder: Human albumin * see also section 4.4 Solvent: Water for Injections |
250 IU:
Powder: injection vial of colourless glass, sealed with a bromobutyl rubber stopper, aluminium cap and plastic disc.
Solvent (Water for Injections): vial of colourless glass
1250 IU:
Powder: injection vial of colourless glass, sealed with a bromobutyl rubber stopper, aluminium cap and plastic disc.
Solvent (Water for Injections): vial of colourless glass.
Pack with 250 IU:
1 vial with powder
1 vial with 4 ml Water for Injections
1 filter transfer device 20/20 (Mix2Vial)
Administration set (inner box):
1 disposable 5 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
Pack with 1250 IU:
1 vial with powder
1 vial with 20 ml Water for Injections
1 filter transfer device 20/20 (Mix2Vial)
Administration set (inner box):
1 disposable 20 ml syringe
1 venipuncture set
2 alcohol swabs
1 non-sterile plaster
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
PL 15036/0006
22 June 1998 / 30 October 2003
| Drug | Countries | |
|---|---|---|
| FIBROGAMMIN | Austria, Brazil, France, Israel, Japan, Lithuania, United Kingdom |
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