ZIBOR 25.000 IU Solution for injection Ref.[8450] Active ingredients: Bemiparin

Source: Health Products Regulatory Authority (IE)  Revision Year: 2021  Publisher: Frosst Ibérica, S.A. Via Complutense 140, Alcalá de Henares, 28805 Madrid, Spain

Product name and form

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).

Qualitative and quantitative composition

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

Pack sizes and marketing

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.

Marketing authorization holder

Frosst Ibérica, S.A. Via Complutense 140, Alcalá de Henares, 28805 Madrid, Spain

Marketing authorization dates and numbers

PA1769/001/003

Date of first authorisation: 26 January 2007

Date of last renewal: 09 March 2008

Drugs

Drug Countries
ZIBOR Estonia, Ireland, Lithuania, Poland, Romania, United Kingdom

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