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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Actilyse (2012)

Εκδότης

Εκδότης Boehringer Ingelheim Limited
Διεύθυνση Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Actilyse 10 mg: Powder and solvent for solution for injection and infusion Actilyse 20 mg: Powder and ...

Qualitative and quantitative composition

1 vial with powder contains: 10 mg alteplase (corresponding to 5,800,000 IU) or 20 mg alteplase (corresponding ...

Pharmaceutical form

Powder and solvent for solution for injection and infusion. The powder is presented as a colourless to ...

Therapeutic indications

Thrombolytic treatment in acute myocardial infarction 90 minutes (accelerated) dose regimen (see section ...

Posology and method of administration

Actilyse should be given as soon as possible after symptom onset. The following dose guidelines apply. ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Additional contraindications in ...

Special warnings and precautions for use

Special warnings and precautions in acute myocardial infarction, acute pulmonary embolism and acute ischaemic ...

Interaction with other medicinal products and other forms of interaction

No formal interaction studies with Actilyse and medicinal products commonly administered in patients ...

Pregnancy and lactation

There is very limited experience with the use of alteplase during pregnancy and lactation. Studies in ...

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 ...

Overdose

The relative fibrin specificity notwithstanding, a clinical significant reduction in fibrinogen and other ...

Pharmacodynamic properties

Pharmacotherapeutic group: antithrombotic agent ATC code: B01AD02 The active ingredient of Actilyse is ...

Pharmacokinetic properties

Alteplase is cleared rapidly from the circulating blood and metabolised mainly by the liver (plasma clearance ...

Preclinical safety data

In subchronic toxicity studies in rats and marmosets no unexpected undesirable effects were found. No ...

List of excipients

Powder for solution: Arginine Phosphoric acid, dilute Polysorbate 80 Solvent: Water for injections The ...

Incompatibilities

The reconstituted solution may be diluted with sterile sodium chloride 9 mg/ml (0.9 %) solution for injection ...

Shelf life

3 years. After reconstitution, an immediate use is recommended. However, the in-use stability has been ...

Special precautions for storage

Store in the original package in order to protect from light. Do not store above 25 °C. For storage conditions ...

Nature and contents of container

Powder for solution: 10 ml, 20 ml or 50 ml sterilised glass vials, sealed with sterile siliconised grey ...

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 ...

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
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.