FRAXIPARINE 2/850 or 3/800 anti-Xa IU/ml solution for injection – 0,4 ml or 0,3 ml /nadroparin calcium/ (ampoule syringe)

FRACIPIPARIN is a medicine that slows or prevents blood clots in the blood vessels (thrombosis). This type of medicine is called an antithrombotic agent.

Conditions to keep track of
FRACIPIPARIN may aggravate some pre-existing conditions or cause serious side effects. While taking FRAXIPARIN, you should monitor for certain symptoms in order to reduce the risk of any problems. See Conditions to Watch for in Section 4.

While using FRACIPIPARIN
If you are going to undergo spinal anesthesia or a sampling of the spinal cord (spinal lumbar puncture), you will be monitored closely as FRACIPARIN may cause bleeding in the spine at the injection site.

You will be given regular blood tests:
• In rare cases, FRACIPIPARIN may cause a decrease in platelet count in the blood.
• FRACIPIPARIN may increase the level of potassium in the blood. You will need blood tests if you have diabetes, severe kidney disease or if you are taking other medicines with this effect.

What FRACIPIPARIN contains
The active substance is nadroparine calcium – 9,500 anti-Xa IU / ml.
Other ingredients are calcium hydroxide solution or dilute hydrochloric acid and water for injections.

What FRACIPIPARIN looks like and contents of the pack
FRACIPIPARIN is a clear to slightly opalescent, colorless or yellowish, or brownish to dark or pale yellow solution, which is available in pre-filled glass syringes:
– 0.2 ml solution for injection equivalent to 1 900 anti-Xa IU
– 0.3 ml solution for injection equivalent to 2 850 anti-Xa IU
– 0.4 ml solution for injection equivalent to 3 800 anti-Xa IU
– 0.6 ml solution for injection equivalent to 5 700 anti-Xa IU
– 0.8 ml solution for injection equivalent to 7 600 anti-Xa IU
– 1 ml solution for injection equivalent to 9,500 anti-Xa IU

Each pack of FRACIPIPARIN contains 10 pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Aspen Pharma Trading Limited,
Ireland

Manufacturers:
Aspen Notre Dame de Bondeville,
France

or

GlaxoSmithKline Pharmaceuticals S.A.,
Poland