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SPC, UK: FRAGMIN 2500 IU Solution for injection (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Fragmin 2500 IU.

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 ...

Pharmaceutical form

Solution for injection for subcutaneous administration.

Therapeutic indications

Peri- and post-operative surgical thromboprophylaxis.

Posology and method of administration

Adults Surgical thromboprophylaxis in patients at moderate risk of thrombosis 2,500 IU is administered subcutaneously 1-2 hours before the surgical procedure and thereafter 2,500 IU subcutaneously each ...

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 ...

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 ...

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 ...

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 ...

Effects on ability to drive and use machines

Fragmin does not affect the ability to drive or operate machinery.

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 ...

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 ...

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 ...

Pharmacokinetic properties

Elimination The half-life following iv. 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 ...

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 ...

List of excipients

Sodium chloride (Ph. Eur.) Water for injections (Ph. Eur.)

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store below 25°C.

Nature and contents of container

Fragmin 2,500 IU/0.2ml solution for injection is supplied in 0.5ml glass Ph. Eur Type I single dose pre-filled syringes with a latex-free needle shield, chlorobutyl rubber, polypropylene rod and a needle-trap ...

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 ...

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich KENT, CT13 9NJ, United Kingdom

Marketing authorization number(s)

PL 00057/0983

Date of first authorization / renewal of the authorization

18 March 2002

Date of revision of the text

05/2016

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