Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
Fragmin 5000 IU.
| Pharmaceutical Form |
|---|
|
Solution for injection for subcutaneous administration. |
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.) |
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.
Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
PL 00057/0984
18 March 2002
| 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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