Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
Fragmin 100,000 IU / 4ml Multidose Vial.
| Pharmaceutical Form |
|---|
|
Solution for injection for subcutaneous administration. |
Active ingredient: Dalteparin sodium (INN).
Quality according to Ph. Eur.
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 100,000 IU/4 ml: Multidose vial containing dalteparin sodium corresponding to 25,000 IU (anti-Factor Xa)/ml.
| 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 |
|---|
|
Benzyl alcohol (Ph Eur) |
Multidose vial (Ph Eur Type 1) with bromobutyl rubber stopper, secured with aluminium overseal with flip off cap, containing dalteparin sodium 100,000 IU (anti-Factor Xa) in 4 ml.
Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
PL 00057/979
27 March 2002/30 July 2007
| 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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