REVASC Powder and solvent for solution for injection (2014)
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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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