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: Sprycel 20mg, 50mg, 80mg, 100mg and 140mg Film Coated Tablets (2012)

Εκδότης

Εκδότης Bristol-Myers Squibb Pharmaceutical Limited
Διεύθυνση Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH , 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

SPRYCEL® 20 mg film-coated tablets. SPRYCEL® 50 mg film-coated tablets. SPRYCEL® 80 mg film-coated tablets. ...

Qualitative and quantitative composition

Each film-coated tablet contains 20 mg, 50 mg, 80 mg, 100 mg or 140 mg dasatinib (as monohydrate). Excipients ...

Pharmaceutical form

Film-coated tablet (tablet). 20 mg: White to off-white, biconvex, round tablet with “BMS” debossed on ...

Therapeutic indications

SPRYCEL is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

Clinically relevant interactions Dasatinib is a substrate and an inhibitor of cytochrome P450 (CYP) 3A4. ...

Interaction with other medicinal products and other forms of interaction

Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of dasatinib in pregnant women. Studies in animals ...

Effects on ability to drive and use machines

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

Undesirable effects

Summary of the safety profile The data described below reflect exposure to SPRYCEL in 2,440 patients ...

Overdose

Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases. The highest overdose ...

Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor ATC code: L01XE06 Dasatinib ...

Pharmacokinetic properties

The pharmacokinetics of dasatinib were evaluated in 229 adult healthy subjects and in 84 patients. Absorption ...

Preclinical safety data

The non-clinical safety profile of dasatinib was assessed in a battery of in vitro and in vivo studies ...

List of excipients

Tablet core: Lactose monohydrate Cellulose, microcrystalline Croscarmellose sodium Hydroxypropyl cellulose ...

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

20 mg and 50 mg Film-coated tablets: Alu/Alu blisters (calendar blisters or unit dose blisters). Carton ...

Special precautions for disposal and other handling

The film-coated tablets consist of a core tablet, surrounded by a film coating to prevent exposure of ...

Marketing authorization holder

BRISTOL-MYERS SQUIBB PHARMA EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom ...

Marketing authorization number(s)

EU/1/06/363/007 Sprycel 20 mg Film-coated tablet blister (alu/alu) 60 1 tablet (unit dose) EU/1/06/363/008 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 November 2006 Date of latest renewal: 20 November 2011

Date of revision of the text

August 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.