FRAGMIN 5.000 IU Solution for injection Ref.[10843] 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 5000 IU.

Pharmaceutical Form

Solution for injection for subcutaneous administration.

Qualitative and quantitative composition

Active ingredient: Dalteparin sodium (INN).

Quality according to Ph.Eur. and in-house specification.

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

Content of active ingredient:

Fragmin 5000 IU: single dose syringe containing dalteparin sodium 5000 IU (anti-Factor Xa) in 0.2 ml solution.

Fragmin syringes do not contain preservatives.

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.)

Pack sizes and marketing

Fragmin 5,000 IU/0.2ml 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 (polypropylene) and a needle-trap as a safety feature. The needle shield may contain latex (see section 4.4).

Each pack contains 10 syringes.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/0984

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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