METALYSE Powder and solvent for solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Metalyse 10,000 units powder and solvent for solution for injection.
Qualitative and quantitative composition
Each vial contains 10,000 units (50 mg) tenecteplase. Each pre-filled syringe contains 10 ml solvent. The reconstituted solution contains 1,000 units (5 mg) tenecteplase per ml. Potency of tenecteplase ...
Pharmaceutical form
Powder and solvent for solution for injection. The powder is white to off-white. The solvent is clear and colourless. The reconstituted preparation is a clear and colourless to slightly yellow solution. ...
Therapeutic indications
Metalyse is indicated in adults for the thrombolytic treatment of suspected myocardial infarction with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute ...
Posology and method of administration
Posology Metalyse should be prescribed by physicians experienced in the use of thrombolytic treatment and with the facilities to monitor that use. Treatment with Metalyse should be initiated as soon as ...
Contraindications
Metalyse must not be administered to patients with a history of an anaphylactic (i.e. life-threatening) reaction to any of the constituents (i.e. tenecteplase or any excipient) or gentamicin (a trace residue ...
Special warnings and precautions for use
Coronary intervention If primary percutaneous coronary intervention (PCI) is scheduled according to the current relevant treatment guidelines, tenecteplase (see section 5.1 ASSENT-4 study) should not be ...
Interaction with other medicinal products and other forms of interaction
No formal interaction studies with tenecteplase and medicinal products commonly administered in patients with AMI have been performed. However, the analysis of data from more than 12,000 patients treated ...
Fertility, pregnancy and lactation
Pregnancy There is a limited amount of data from the use of Metalyse in pregnant women. Nonclinical data performed with tenecteplase have shown bleeding with secondary mortality of dams due to the known ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of the safety profile Haemorrhage is a very common undesirable effect associated with the use of tenecteplase. The type of haemorrhage is predominantly superficial at the injection site. Ecchymoses ...
Overdose
In the event of overdose there may be an increased risk of bleeding. In case of severe prolonged bleeding substitution therapy may be considered (plasma, platelets), see also section 4.4.
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic agents, enzymes ATC code: B01AD11 Mechanism of action Tenecteplase is a recombinant fibrin-specific plasminogen activator that is derived from native t-PA by modifications ...
Pharmacokinetic properties
Absorption and distribution Tenecteplase is an intravenously administered, recombinant protein that activates plasminogen. Following intravenous bolus administration of 30 mg tenecteplase in patients with ...
Preclinical safety data
Intravenous single dose administration in rats, rabbits and dogs resulted only in dose-dependent and reversible alterations of the coagulation parameters with local haemorrhage at the injection site, which ...
List of excipients
Powder: L-arginine Phosphoric acid Polysorbate 20 Trace residue from manufacturing process: Gentamicin Solvent: Water for injections
Incompatibilities
Metalyse is incompatible with glucose infusion solutions.
Shelf life
Shelf life as packaged for sale: 2 years. Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and 8 hours at 30°C. From a microbiological point of ...
Special precautions for storage
Do not store above 30°C. Keep the container 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
20 ml glass vial type I, with a coated (B2-42) grey rubber stopper and a flip-off cap filled with powder for solution for injection. Each vial 50 mg tenecteplase. 10 ml plastic pre-filled syringe with ...
Special precautions for disposal and other handling
Metalyse should be reconstituted by adding the complete volume of water for injections from the prefilled syringe to the vial containing the powder for injection. 1. Ensure that the appropriate vial size ...
Marketing authorization holder
Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany
Marketing authorization number(s)
EU/1/00/169/006
Date of first authorization / renewal of the authorization
Date of first authorisation: 23 February 2001 Date of last renewal: 23 February 2006
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