ACTILYSE (2012)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης	Boehringer Ingelheim Limited
Διεύθυνση	Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS

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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.

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 h after symptom onset 3 h dose regimen ...

Posology and method of administration

Actilyse should be given as soon as possible after symptom onset. The following dose guidelines apply. Under aseptic conditions the content of an injection vial of Actilyse (10 mg or 20 mg or 50 mg) is ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Additional contraindications in acute myocardial infarction, acute pulmonary embolism and acute ischaemic stroke Actilyse is contraindicated ...

Special warnings and precautions for use

Special warnings and precautions in acute myocardial infarction, acute pulmonary embolism and acute ischaemic stroke Thrombolytic/fibrinolytic treatment requires adequate monitoring. Actilyse should only ...

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. The risk of haemorrhage is increased if coumarine ...

Pregnancy and lactation

There is very limited experience with the use of alteplase during pregnancy and lactation. Studies in animals have shown reproductive toxicity (see section 5.3). In cases of an acute life-threatening disease ...

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

Adverse reactions listed below are classified according to frequency and system organ class. Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to ...

Overdose

The relative fibrin specificity notwithstanding, a clinical significant reduction in fibrinogen and other blood coagulation components may occur after overdosage. In most cases, it is sufficient to await ...

Pharmacodynamic properties

Pharmacotherapeutic group: antithrombotic agent ATC code: B01AD02 The active ingredient of Actilyse is alteplase, a recombinant human tissue-type plasminogen activator, a glycoprotein, which activates ...

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 for solution: Arginine Phosphoric acid, dilute Polysorbate 80 Solvent: Water for injections The pH of the reconstituted solution is 7.3 ± 0.5.

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

3 years. After reconstitution, an immediate use is recommended. However, the in-use stability has been demonstrated for 24 hours at 2 °C – 8 °C and for 8 hours at 25 °C.

Special precautions for storage

Store in the original package in order to protect from light. Do not store above 25 °C. For storage conditions of the reconstituted medicinal product, see section 6.3.

Nature and contents of container

Powder for solution: 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: The water for injections is filled ...

Special precautions for disposal and other handling

For reconstitution to a final concentration of 1 mg altpelase per ml the full volume of solvent provided should be transfered 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: 12th October 1988 Date of last renewal: 26th April 2004

Date of revision of the text

November 2011