FRAGMIN 12.500 IU Solution for injection Ref.[10847] Active ingredients: Dalteparin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom

Product name and form

Fragmin 12,500 IU/0.5ml solution for injection.

Pharmaceutical Form

Solution for injection.

Qualitative and quantitative composition

Fragmin 12,500 IU: single dose syringe containing dalteparin sodium 12,500 IU (anti-Factor Xa) in 0.5 ml solution for injection equivalent to 25,000 IU/ml.

For excipients see section 6.1

Fragmin does not contain preservatives.

* Potency is described in International anti-Factor Xa units (IU) of the 1st International Standard for Low Molecular Weight Heparin.

Active Ingredient Description
Dalteparin

Dalteparin is an antithrombotic agent, which acts mainly through its ability to potentiate the inhibition of Factor Xa and thrombin by antithrombin. It has a relatively higher ability to potentiate Factor Xa inhibition than to prolong plasma clotting time (APTT).

List of Excipients

Water for Injections (Ph. Eur.)
Sodium hydroxide or hydrochloric acid for pH adjustment.

Pack sizes and marketing

Fragmin 12,500 IU/0.5 ml solution for injection is supplied in a single dose pre-filled syringe (Type I glass) with a needle shield (rubber), a plunger stopper (chlorobutyl rubber), a plunger rod (polystyrene) and a needle-trap as a safety feature. The needle shield may contain latex (see section 4.4).

Each pack contains 5 syringes.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/0980

18 March 2002

Drugs

Drug Countries
FRAGMIN Austria, Brazil, Canada, Germany, Estonia, Spain, Finland, Croatia, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States, South Africa

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