Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
Fragmin 12,500 IU/0.5ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. |
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.) |
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.
Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
PL 00057/0980
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 |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
