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

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

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

Name of the medicinal product

SPRYCEL 20 mg film-coated tablets. SPRYCEL 50 mg film-coated tablets. SPRYCEL 80 mg film-coated tablets. SPRYCEL 100 mg film-coated tablets. SPRYCEL 140 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 with known effect: Each 20 mg tablet contains 27 mg of lactose monohydrate. Each 50 mg tablet ...

Pharmaceutical form

Film-coated tablet (tablet). 20 mg: White to off-white, biconvex, round tablet with BMS debossed on one side and 527 on the other side. 50 mg: White to off-white, biconvex, oval tablet with BMS debossed ...

Therapeutic indications

SPRYCEL is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. Chronic, accelerated or blast ...

Posology and method of administration

Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. Posology The recommended starting dose for chronic phase CML is 100 mg dasatinib once daily, ...

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. Therefore, there is a potential for interaction with other concomitantly administered medicinal ...

Interaction with other medicinal products and other forms of interaction

Active substances that may increase dasatinib plasma concentrations In vitro studies indicate that dasatinib is a CYP3A4 substrate. Concomitant use of dasatinib and medicinal products which potently inhibit ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of dasatinib in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. SPRYCEL ...

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 be advised that they may experience adverse reactions such as dizziness or blurred vision during ...

Undesirable effects

Summary of the safety profile The data described below reflect exposure to SPRYCEL in 2,440 patients in clinical studies, including 258 patients with newly diagnosed chronic phase CML and 2,182 patients ...

Overdose

Experience with overdose of SPRYCEL in clinical studies is limited to isolated cases. The highest overdose of 280 mg per day for one week was reported in two patients and both developed a significant decrease ...

Pharmacodynamic properties

Pharmacotherapeutic group: antineoplastic agent, protein kinase inhibitor ATC code: L01XE06 Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected ...

Pharmacokinetic properties

The pharmacokinetics of dasatinib were evaluated in 229 adult healthy subjects and in 84 patients. Absorption Dasatinib is rapidly absorbed in patients following oral administration, with peak concentrations ...

Preclinical safety data

The non-clinical safety profile of dasatinib was assessed in a battery of in vitro and in vivo studies in mice, rats, monkeys, and rabbits. The primary toxicities occurred in the gastrointestinal, haematopoietic, ...

List of excipients

Tablet core: Lactose monohydrate Cellulose, microcrystalline Croscarmellose sodium Hydroxypropyl cellulose Magnesium stearate Film-coating: Hypromellose Titanium dioxide Macrogol 400

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 containing 60 film-coated tablets in perforated unit dose blisters. 80 mg, 100 mg and 140 mg Film-coated ...

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 health care professionals to the active substance. However, if the tablets are unintentionally crushed ...

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 Sprycel 50 mg Film-coated tablet blister (alu/alu) 60 1 tablet (unit dose) EU/1/06/363/011 ...

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