RAPILYSIN Powder and solvent for solution for injection (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Rapilysin 10 U powder and solvent for solution for injection.
Qualitative and quantitative composition
1 vial contains 10 U* reteplase ** in 0.56 g powder. 1 prefilled syringe contains 10 ml water for injections. The reconstituted solution contains 1 U reteplase per ml. For the full list of excipients, ...
Pharmaceutical form
Powder and solvent for solution for injection. White powder and clear colourless liquid (water for injections).
Therapeutic indications
Rapilysin is indicated for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 12 hours after the onset of acute myocardial ...
Posology and method of administration
Treatment with reteplase should be initiated as soon as possible after the onset of AMI symptoms. Rapilysin should be prescribed by physicians experienced in the use of thrombolytic treatment and with ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Because thrombolytic therapy increases the risk of bleeding, reteplase is contra-indicated in the following situations: ...
Special warnings and precautions for use
Each patient being considered for therapy with reteplase should be carefully evaluated. For information on product incompatibilities see section 6.2. Bleeding The most common complication encountered during ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Retrospective analyses of clinical studies did not reveal any clinically relevant interactions with medicinal product used concomitantly with reteplase in patients ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data on the use of reteplase in pregnant women. The only relevant available animal data refer to studies performed in rabbits, which showed vaginal bleedings associated ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile The most commonly reported adverse drug reaction associated with reteplase treatment is haemorrhage, predominantly at the injection site. Local reactions at injection site ...
Overdose
In the event of overdosage one might expect depletion of fibrinogen and other blood coagulation components (e.g. coagulation factor V) with a consequent risk of bleeding. For further information see section ...
Pharmacodynamic properties
Pharmacotherapeutic group: antithrombotic agent ATC Code: B01AD07 Mechanism of action Reteplase is a recombinant plasminogen activator that catalyzes the cleavage of endogenous plasminogen to generate ...
Pharmacokinetic properties
Elimination Following intravenous bolus injection of 10 + 10 U in patients with acute myocardial infarction reteplase antigen is distributed in plasma with a dominant half-life (t½α) of 18 ± 5 min and ...
Preclinical safety data
Acute toxicity studies were performed in rats, rabbits and monkeys Subacute toxicity studies were performed in rats, dogs and monkeys. The predominant acute symptom after single high doses of reteplase ...
List of excipients
Powder: Tranexamic acid Di potassium-hydrogen phosphate Phosphoric acid Sucrose Polysorbate 80 Solvent: Water for injections
Incompatibilities
This medicinal product should not be mixed with Heparin and/or acetylsalicylic acid. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Heparin ...
Shelf life
<u>Shelf-life as package for sale:</u> 3 years. <u>Reconstituted product:</u> Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30°C after dissolving with water for ...
Special precautions for storage
Do not store above 25°C. Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Each pack contains: 2 colourless glass vials (type I) with a rubber (butyl) closure and an aluminium flip-off cap, containing 0.56 mg of powder. 2 pre-filled glass syringes (borosilicate, type I) for single ...
Special precautions for disposal and other handling
Incompatibility of some prefilled glass syringes (including Rapilysin) with certain needle free connectors has been reported. Therefore, the compatibility of the glass syringe and intravenous access should ...
Marketing authorization holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland
Marketing authorization number(s)
EU/1/96/018/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 August 1996 Date of last renewal: 29 August 2006
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