Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Frosst Ibérica, S.A. Via Complutense 140, Alcalá de Henares, 28805 Madrid, Spain
Zibor 25,000 IU anti-Xa/ml solution for injection in pre-filled syringes.
| Pharmaceutical Form |
|---|
|
Solution for injection in pre-filled syringes. (Colourless or slightly yellowish, clear solution, free of visible particles). |
Bemiparin sodium: 25,000 IU (anti-Factor Xa*) per millilitre solution for injection.
Equivalent to:
5,000 IU (anti-Factor Xa) per 0.2 ml pre-filled syringe
7,500 IU (anti-Factor Xa) per 0.3 ml pre-filled syringe
10,000 IU (anti-Factor Xa) per 0.4 ml pre-filled syringe
* Potency is described in International anti-Factor Xa activity units (IU) of the 1st International Low Molecular Weight Heparin Reference Standard.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Bemiparin |
Bemiparin is a LMWH obtained by depolymerization of heparin from porcine intestinal mucosa. Bemiparin has confirmed its antithrombotic activity and, at the recommended doses, it does not significantly prolong global clotting tests. |
| List of Excipients |
|---|
|
Water for injections |
0.2 ml, 0.3 ml and 0.4 ml of solution in pre-filled syringe (Type I glass) with a plunger rod (polypropylene), rubber plunger stopper (chlorobutyl) and injection needle (stainless steel). Packs of 2, 10, 30 and 100 syringes.
Not all pack sizes may be marketed.
Frosst Ibérica, S.A. Via Complutense 140, Alcalá de Henares, 28805 Madrid, Spain
PA1769/001/003
Date of first authorisation: 26 January 2007
Date of last renewal: 09 March 2008
| Drug | Countries | |
|---|---|---|
| ZIBOR | Estonia, Ireland, Lithuania, Poland, Romania, United Kingdom |
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