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REVASC Powder and solvent for solution for injection (2014)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Revasc 15mg/0.5ml powder and solvent for solution for injection.

Qualitative and quantitative composition

Each vial contains 15 mg desirudin. After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml. Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges. ...

Pharmaceutical form

White powder and clear, colourless solvent for solution for injection.

Therapeutic indications

Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement surgery.

Posology and method of administration

Treatment with Revasc should be initiated under the guidance of a physician with experience in coagulation disorders. Instructions for the preparation of Revasc are provided in section 6.6. Adult and elderly ...

Contraindications

Desirudin is contraindicated in patients: with hypersensitivity to the active substance or to any of the excipients with active bleeding and/or irreversible coagulation disorders with severe renal and ...

Special warnings and precautions for use

Warnings Anaphylaxis Revasc may cause allergic reactions including anaphylaxis and shock (see section 4.8). Fatal anaphylactic reactions have been reported in patients re-exposed to hirudin product therapy ...

Interaction with other medicinal products and other forms of interaction

Any agent which may enhance the risk of haemorrhage should be discontinued prior to initiation of desirudin therapy. If co-administration cannot be avoided, close clinical and laboratory monitoring should ...

Pregnancy and lactation

There are no adequate data from the use of desirudin in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Revasc is contraindicated ...

Effects on ability to drive and use machines

Revasc has no or negligible influence on the ability to drive and use machines.

Undesirable effects

In controlled clinical trials investigating desirudin 15 mg twice daily and a standard dose of unfractionated heparin, the nature of the hip surgery operation and the mode of action of the two drugs studied ...

Overdose

There is no antidote for desirudin. Overdosage of desirudin could lead to bleeding complications. In such cases desirudin should be discontinued. If necessary, plasma expanders and/or blood transfusion ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anticoagulant ATC code: B01AE01 Mechanism of action Desirudin is a highly potent and selective inhibitor of free circulating and clot-bound thrombin. A mean peak aPTT prolongation ...

Pharmacokinetic properties

Absorption Mean absorption time of subcutaneous (SC) desirudin is 4.1, 4.5 and 5.4 h for dose levels of 0.1, 0.3 and 0.5 mg/kg, respectively (overall mean = 4.6 h). Absorption is complete based on mean ...

Preclinical safety data

Reproductive toxicology studies in animals showed desirudin to be teratogenic with changes comprising spina bifida in rabbits and omphaloceles in rats. Non-clinical data reveal no special hazard for humans ...

List of excipients

Powder: Magnesium chloride Sodium hydroxide Solvent: Mannitol (E421) Water for injections

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 3 years. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the ...

Special precautions for storage

Do not store above 25°C. Keep the vial and ampoule in the outer carton in order to protect from light. For storage conditions of the reconstituted medicinal product, see section 6.3.

Nature and contents of container

15mg of powder in a vial (Type I glass) with stopper (butyl rubber) covered with a film (fluoropolymer) in the product side and 0.5ml of solvent in an ampoule (Type I glass). Pack size of 1, 2 or 10. ...

Special precautions for disposal and other handling

To prepare the reconstituted aqueous solution, 0.5ml of the accompanying mannitol solvent is added under aseptic conditions to the vial containing the powder for solution for injection. The active substance ...

Marketing authorization holder

Canyon Pharmaceuticals Limited, 7th Floor, 52-54 Gracechurch Street, London, EC3V 0EH, United Kingdom

Marketing authorization number(s)

2 vials/2 ampoules of solvent: EU/l/97/043/001 10 vials/10 ampoules of solvent: EU/1/97/043/002 1 vial/1 ampoule of solvent: EU/1/97/043/003

Date of first authorization / renewal of the authorization

Date of first authorisation: 9 July 1997 Date of latest renewal: 9 July 2007

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