Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Frosst Ibérica, S.A. Via Complutense 140, Alcalá de Henares, 28805 Madrid, Spain
Zibor 3,500 IU anti Xa/0.2 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: 3500 IU (anti Factor Xa*) per 0.2 ml pre-filled syringe (equivalent to 17500 IU (antiFactor Xa*) per millilitre solution for injection).
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 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, 6, 10, 30 and 100 syringes.
In some package sizes, the prefilled syringe may be combined to a safety device system. For syringes with safety device system the needle must be oriented away from the user and anyone else who is present. The safety system is activated by pressing firmly on the plunger rod. The protective sleeve will automatically cover the needle and will produce an audible click which confirms the activation of the device.
Immediately, the syringe must be discarded by throwing it into the nearest sharps bin (the needle in). The container lid must be closed tightly and the container placed out of the reach of children.
Not all pack sizes may be marketed.
Frosst Ibérica, S.A. Via Complutense 140, Alcalá de Henares, 28805 Madrid, Spain
PA1769/001/002
Date of first authorisation: 03 May 2002
Date of last renewal: 09 March 2010
| Drug | Countries | |
|---|---|---|
| ZIBOR | Estonia, Ireland, Lithuania, Poland, Romania, United Kingdom |
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