FIBRYGA Powder and solvent for solution for injection/infusion Ref.[27529] Active ingredients: Human fibrinogen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Octapharma Ltd., The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom

Product name and form

FIBRYGA 1g. Powder and solvent for solution for injection/infusion.

Pharmaceutical Form

Powder and solvent for solution for injection/infusion.

The powder is white or pale yellow and hygroscopic, also appearing as a friable solid.

The solvent is a clear and colorless liquid.

Qualitative and quantitative composition

Human Fibrinogen.

Each bottle of FIBRYGA contains 1 g human fibrinogen. After reconstitution with 50 mL water for injections FIBRYGA contains approximately 20 mg/mL human fibrinogen.

The content of clottable protein is determined according to the European Pharmacopoeia for human fibrinogen.

Produced from the plasma of human donors.

Excipients with known effect: sodium up to 132 mg (5.8 mmol) per bottle.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Human fibrinogen

Human fibrinogen (coagulation factor I), in the presence of thrombin, activated coagulation factor XIII (F XIIIa) and calcium ions is converted into a stable and elastic three-dimensional fibrin haemostatic clot. The administration of human fibrinogen concentrate provides an increase in plasma fibrinogen level and can temporarily correct the coagulation defect of patients with fibrinogen deficiency.
List of Excipients

Powder:

L-arginine hydrochloride
Glycine
Sodium chloride
Sodium citrate dihydrate

Solvent:

Water for injections

Pack sizes and marketing

Each pack contains:

  • 1g human fibrinogen in a 100 mL colorless glass bottle, Type II Ph.Eur., sealed with an infusion stopper (bromobutyl rubber) and an aluminium flip-off cap.
  • 50 mL solvent (water for injections) in a 50 mL colorless glass vial, Type II Ph.Eur., sealed with an infusion stopper (halobutyl rubber) and an aluminium flip-off cap
  • 1 Octajet transfer device
  • 1 particle filter

Marketing authorization holder

Octapharma Ltd., The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom

Marketing authorization dates and numbers

PL 10673/0043

13/06/2017

Drugs

Drug Countries
FIBRYGA Austria, Brazil, Canada, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Lithuania, Malta, Poland, Romania, Singapore, United Kingdom
 
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