Λογότυπο www.galinos.gr Beta
 

Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
Όνομα χρήστη
Συνθηματικό
Εικονίδιο Είσοδος χρήστη
Εικονίδιο Δωρεάν εγγραφή
Εικονίδιο Ανανέωση συνθηματικού

Ακολουθήστε μας Λογότυπο Facebook Λογότυπο Twitter

Αναζήτηση σε 63811 καταχωρήσεις
Εικονίδιο αναζήτησης

Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Vidaza 25 mg/ml powder for suspension for injection (2012)

Εκδότης

Εκδότης Celgene Ltd
Διεύθυνση 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, UK
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

Vidaza 25 mg/ml powder for suspension for injection.

Qualitative and quantitative composition

Each vial contains 100 mg azacitidine. After reconstitution, each ml suspension contains 25 mg azacitidine. ...

Pharmaceutical form

Powder for suspension for injection. White lyophilised powder.

Therapeutic indications

Vidaza is indicated for the treatment of adult patients who are not eligible for haematopoietic stem ...

Posology and method of administration

Vidaza treatment should be initiated and monitored under the supervision of a physician experienced in ...

Contraindications

Known hypersensitivity to the active substance or to any of the excipients. Advanced malignant hepatic ...

Special warnings and precautions for use

Haematological toxicity Treatment with azacitidine is associated with anaemia, neutropenia and thrombocytopenia, ...

Interaction with other medicinal products and other forms of interaction

Based on in vitro data, azacitidine metabolism does not appear to be mediated by cytochrome P450 isoenzymes ...

Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in males and females Men and women of childbearing potential ...

Effects on ability to drive and use machines

No studies of the effects on the ability to drive and use machines have been performed. Patients should ...

Undesirable effects

Adverse reactions considered to be possibly or probably related to the administration of Vidaza have ...

Overdose

One case of overdose with azacitidine was reported during clinical trials. A patient experienced diarrhoea, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agent, Pyrimidine analogues ATC code: L01BC07 Mechanism of ...

Pharmacokinetic properties

The pharmacokinetics of azacitidine were studied following single 75 mg/m2 doses given by subcutaneous ...

Preclinical safety data

Azacitidine induces both gene mutations and chromosomal aberrations in bacterial and mammalian cell systems ...

List of excipients

Mannitol (E421)

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section ...

Shelf life

Unopened powder vial: 4 years After reconstitution: When Vidaza is reconstituted using water for injections ...

Special precautions for storage

This medicinal product does not require any special storage conditions. For storage conditions of the ...

Nature and contents of container

Colourless type I 30 ml glass vial sealed with butyl elastomeric stopper and aluminium seal with polypropylene ...

Special precautions for disposal and other handling

Recommendations for safe handling Vidaza is a cytotoxic medicinal product and, as with other potentially ...

Marketing authorization holder

Celgene Europe Ltd 1 Longwalk Road Stockley Park Uxbridge UB11 1DB United Kingdom

Marketing authorization number(s)

EU/1/08/488/001

Date of first authorization / renewal of the authorization

17/12/2008

Date of revision of the text

20/04/2012
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.