FRAGMIN 5.000 IU Solution for injection (2020)
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Περιεχόμενα
1. Name of the medicinal product
Fragmin 5000 IU.
2. 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 ...
3. Pharmaceutical form
Solution for injection for subcutaneous administration.
4.1. Therapeutic indications
Peri- and post-operative surgical thromboprophylaxis. The prophylaxis of proximal deep venous thrombosis in patients bedridden due to a medical condition, including, but not limited to; congestive cardiac ...
4.2. Posology and method of administration
Peri- and post-operative surgical thromboprophylaxis Adults <u>Surgical thromboprophylaxis in patients at high risk of thrombosis:</u> 2,500 IU is administered subcutaneously 1-2 hours before the surgical ...
4.3. Contraindications
Known hypersensitivity to Fragmin or other low molecular weight heparins and/or heparins e.g. history of confirmed or suspected immunologically mediated heparin induced thrombocytopenia (type II); acute ...
4.4. Special warnings and precautions for use
Do not administer by the intramuscular route. Due to the risk of haematoma, intramuscular injection of other medical preparations should be avoided when the twenty-four hour dose of dalteparin exceeds ...
4.5. Interaction with other medicinal products and other forms of interaction
The possibility of the following interactions with Fragmin should be considered: An enhancement of the anticoagulant effect by anticoagulant/antiplatelet agents e.g. aspirin/dipyridamole, GP IIb/IIIa receptor ...
4.6. Fertility, pregnancy and lactation
Pregnancy Dalteparin does not pass the placenta. A large amount of data on pregnant women (more than 1000 exposed outcomes) indicate no malformative nor feto/ neonatal toxicity. Fragmin can be used during ...
4.7. Effects on ability to drive and use machines
Fragmin does not affect the ability to drive or operate machinery.
4.8. Undesirable effects
About 3% of the patients having had prophylactic treatment reported side-effects. The reported adverse reactions, which may possibly be associated to dalteparin sodium, are listed in the following table ...
4.9. Overdose
The anticoagulant effect (i.e. prolongation of the APTT) induced by Fragmin is inhibited by protamine. Since protamine itself has an inhibiting effect on primary haemostasis it should be used only in an ...
5.1. Pharmacodynamic properties
ATC Code B01AB04: Antithrombotics Dalteparin sodium is a low molecular weight heparin fraction (weight average molecular weight of 6000 Daltons (range between 5,600 and 6,400 Daltons)) produced from porcine-derived ...
5.2. Pharmacokinetic properties
Elimination The half-life following i.v. and s.c. administration is 2 hours and 3.5-4 hours respectively, twice that of unfractionated heparin. Bioavailability The bioavailability following s.c. injection ...
5.3. Preclinical safety data
The acute toxicity of dalteparin sodium is considerably lower than that of heparin. The only significant finding, which occurred consistently throughout the toxicity studies after subcutaneous administration ...
6.1. List of excipients
Water for Injections (Ph. Eur.)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
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) ...
6.6. Special precautions for disposal and other handling
The Needle-Trap consists of a plastic needle catcher which is firmly attached to the syringe label. Together, these two components comprise the Needle-Trap (safety) feature. The Needle-Trap is designed ...
7. Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom
8. Marketing authorization number(s)
PL 00057/0984
9. Date of first authorization / renewal of the authorization
18 March 2002
10. Date of revision of the text
10/2020
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