NADROPARIN SODIUM Solution for injection Ref.[9376] Active ingredients: Nadroparin

Source: European Medicines Agency (EU)  Publisher: Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Product name and form

Nadroparin calcium Aspen 15,200 I.U. anti-Xa/0.8ml double strength solution for injection in a pre-filled syringe.

Pharmaceutical Form

Solution for injection in pre-filled syringe. The solution is sterile and clear, pH 4.5 to 7.5.

Qualitative and quantitative composition

1 Pre-filled syringe with 0.8 ml solution for injection contains 15,200 I.U. anti-Xa nadroparin calcium derived from porcine intestinal mucosa.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nadroparin

Nadroparin is a low-molecular weight heparin. Nadroparin inhibits Factor Xa in particular and thrombin to a lesser extent. Inhibition is partially mediated via the plasma protease inhibitor antithrombin III. Nadroparin has less effect on platelet function and aggregation and only has a minor effect on primary haemostasis compared to heparin.

List of Excipients

Calcium hydroxide
or
Hydrochloric acid 10% (for pH adjustment)
Water for injections

Pack sizes and marketing

The prefilled syringe consists of a Type-I glass cylinder with stainless steel needle and needle guard made of natural and/or styrene-butadiene-rubber, a safety cylinder made of polypropylene and a piston with sealing lip made of butyl elastomer.

Packs with 2, 6, 10, 20, 30 and 50 graduated prefilled syringes, each containing 0.8 ml injection solution (0.8 ml injection solution contains 15,200 I.U. anti-Xa nadroparin calcium).

Not all pack sizes may be marketed.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

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