Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
Riastap 1 g Powder for solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Powder for solution for injection/infusion. White powder. |
Riastap is presented as a powder for solution for injection or infusion containing 1 g human fibrinogen per vial.
The product reconstituted with 50 ml of water for injections contains approximately 20 mg/ml human fibrinogen.
The content of clottable fibrinogen is determined according to the European Pharmacopoeia monograph for human fibrinogen.
Excipients recognised to have a known effect: Sodium up to 164 mg (7.1 mmol) per vial.
For a 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 |
|---|
|
Human albumin |
Vial of colourless glass, Type II Ph. Eur., sealed with a latex-free stopper (bromobutyl rubber), aluminium cap and plastic disc.
Pack with 1 g (Figure 1):
1. One vial containing 1 g human fibrinogen
1. Filter: Pall Syringe Filter
2. Dispensing pin: Mini-Spike Dispensing Pin
Figure 1:
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany
PL 15036/0033
16 August 2010 / 12 June 2014
| Drug | Countries | |
|---|---|---|
| RIASTAP | Canada, Cyprus, Spain, Finland, France, Ireland, Malta, New Zealand, Poland, United Kingdom, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
