FRAGMIN 10.000 IU Solution for injection (2020)
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Περιεχόμενα
1. Name of the medicinal product
Fragmin 10,000 IU/4ml.
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 intravenous or subcutaneous administration.
4.1. Therapeutic indications
Prevention of clotting in the extracorporeal circulation during haemodialysis or haemofiltration, in patients with chronic renal insufficiency or acute renal failure.
4.2. Posology and method of administration
Recommended dosage for adults Prevention of clotting during haemodialysis and haemofiltration* In chronic renal insufficiency for patients with no known additional bleeding risk, the dosage is: (a) Long-term ...
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 ...
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
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 heparin sodium. Mechanism ...
5.2. Pharmacokinetic properties
Elimination The half life following iv and sc. administration is 2 hours and 3.5-4 hours respectively, twice that of unfractionated heparin. Bioavailability The bioavailability following sc. 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
Sodium chloride (Ph Eur) Water for injections (Ph Eur)
6.2. Incompatibilities
The compatibility of Fragmin with products other than those mentioned under 6.6 has not been investigated.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 30°C.
6.5. Nature and contents of container
Clear glass ampoules (Ph Eur Type 1) containing dalteparin sodium, 10,000 IU (anti-factor Xa) in 4 ml.
6.6. Special precautions for disposal and other handling
Fragmin solution for injection is compatible with isotonic sodium chloride (9 mg/ml) or isotonic glucose (50 mg/ml) infusion solutions in glass bottles and plastic containers for up to 24 hours. Compatibility ...
7. Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, UK
8. Marketing authorization number(s)
PL 00057/0978
9. Date of first authorization / renewal of the authorization
27 March 2002 / 30 July 2007
10. Date of revision of the text
04/2020
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