ACTILYSE Powder and solvent for solution (2018)
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Περιεχόμενα
Name of the medicinal product
Actilyse 10 mg powder and solvent for solution for injection and infusion. Actilyse 20 mg powder and solvent for solution for injection and infusion. Actilyse 50 mg powder and solvent for solution for ...
Qualitative and quantitative composition
1 vial with powder contains: 10 mg alteplase (corresponding to 5,800,000 IU) or 20 mg alteplase (corresponding to 11,600,000 IU) or 50 mg alteplase (corresponding to 29,000,000 IU), respectively Alteplase ...
Pharmaceutical form
Powder and solvent for solution for injection and infusion. The powder is presented as a colourless to pale yellow lyophilizate cake. The reconstituted preparation is a clear and colourless to pale yellow ...
Therapeutic indications
Thrombolytic treatment in acute myocardial infarction 90 minutes (accelerated) dose regimen (see section 4.2): for patients in whom treatment can be started within 6 hours after symptom onset 3 hour dose ...
Posology and method of administration
Actilyse should be given as early as possible after symptom onset. The following dose guidelines apply. Acute myocardial infarction Posology a) 90 minutes (accelerated) dose regimen for patients with acute ...
Contraindications
Generally, in all indications Actilyse should not be administered to patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) ...
Special warnings and precautions for use
Traceability In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file. The appropriate ...
Interaction with other medicinal products and other forms of interaction
No formal interaction studies with Actilyse and medicinal products commonly administered in patients with acute myocardial infarction have been performed. Drugs affecting coagulation/platelet function ...
Fertility, pregnancy and lactation
Pregnancy There is a limited amount of data from the use of Actilyse in pregnant women. Nonclinical studies performed with alteplase in doses higher than human doses exhibited fetal immaturity and/or embryotoxicity, ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
The most frequent adverse reaction associated with Actilyse is bleeding in different forms resulting in a fall in haematocrit and/or haemoglobin values. Adverse reactions listed below are classified according ...
Overdose
Symptoms If the maximum recommended dose is exceeded the risk of intracranial bleeding increases. The relative fibrin specificity notwithstanding, a clinically significant reduction in fibrinogen and other ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antithrombotic agents ATC code: B01AD02 Mechanism of action The active ingredient of Actilyse is alteplase a recombinant human tissue-type plasminogen activator, a glycoprotein, ...
Pharmacokinetic properties
Alteplase is cleared rapidly from the circulating blood and metabolised mainly by the liver (plasma clearance 550-680 ml/min.). The relevant plasma half-life t<sub>1/2</sub> alpha is 4-5 minutes. This ...
Preclinical safety data
In subchronic toxicity studies in rats and marmosets no unexpected undesirable effects were found. No indications of a mutagenic potential were found in mutagenic tests. In pregnant animals no teratogenic ...
List of excipients
Powder: Arginine Phosphoric acid (for pH-adjustment) Polysorbate 80 Solvent: Water for injections
Incompatibilities
The reconstituted solution may be diluted with sterile sodium chloride 9 mg/ml (0.9%) solution for injection up to a minimal concentration of 0.2 mg alteplase per ml. Further dilution, the use of water ...
Shelf life
Unopened vials: 3 years. Reconstituted solution: The reconstituted solution has been demonstrated to be stable for 24 hours at 2°C–8°C and for 8 hours at 25°C. From a microbiological point of view, the ...
Special precautions for storage
Store in the original package in order to protect from light. Do not store above 25°C. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Powder: 10 ml, 20 ml or 50 ml sterilised glass vials, sealed with sterile siliconised grey butyl-type stoppers with aluminium/plastic flip-off caps. Solvent: For the 10 mg, 20 mg and 50 mg presentations, ...
Special precautions for disposal and other handling
For reconstitution to a final concentration of 1 mg alteplase per ml the full volume of solvent provided should be transferred to the vial containing the Actilyse powder. To this purpose a transfer cannula ...
Marketing authorization holder
Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS
Marketing authorization number(s)
PL 00015/0120
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 October 1988 Date of last renewal: 26 April 2009
Date of revision of the text
05/2019
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