Κλαύδιος Γαληνός
Δωρεάν εγγραφή Αποκτήσετε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr για έναν μήνα
Γαληνός Office Χρησιμοποιήστε δωρεάν το νέο cloud πρόγραμμα διαχείρισης κάθε σύγχρονου ιατρείου
Έλεγχος συγχορήγησης Ελέγξτε την αγωγή σας για αντενδείξεις και αλληλεπιδράσεις μεταξύ των φαρμάκων
Μητρότητα και φάρμακα Ενημερωθείτε για την ασφάλεια χορήγησης ενός φαρμάκου κατά τη διάρκεια της εγκυμοσύνης ή του θηλασμού
Πρόγραμμα συνδρομητών Μάθετε περισσότερα για τα οφέλη και τις επιπλέον παροχές των συνδρομητικών προγραμμάτων
Γαληνός Mobile Κατεβάστε τη δωρεάν εφαρμογή και απολαύστε τις υπηρεσίες του Galinos.gr σε κινητό ή tablet
Γνωρίζατε οτι... Μοιραζόμαστε μαζί σας γεγονότα της πορείας του Galinos.gr από το 2011 μέχρι σήμερα
®
 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

RAPILYSIN Powder and solvent for solution for injection (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

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

Shelf-life as package for sale: 3 years. Reconstituted product: Chemical and physical in-use stability has been demonstrated for 8 hours between 2° and 30°C after dissolving with water for injection. ...

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

Πηγαίο έγγραφο

Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση: