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SPC: SPRYCEL Film-coated tablet (2020)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

SPRYCEL 20 mg film-coated tablets. SPRYCEL 50 mg film-coated tablets. SPRYCEL 70 mg film-coated tablets. SPRYCEL 80 mg film-coated tablets. SPRYCEL 100 mg film-coated tablets. SPRYCEL 140 mg film-coated ...

Qualitative and quantitative composition

SPRYCEL 20 mg film-coated tablets: Each film-coated tablet contains 20 mg dasatinib (as monohydrate). Excipient with known effect: Each film-coated tablet contains 27 mg of lactose monohydrate. SPRYCEL ...

Pharmaceutical form

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

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 Adult patients The recommended starting dose for chronic phase CML is 100 mg dasatinib ...

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 or substances which ...

Pregnancy and lactation

Women of childbearing potential/contraception in males and females Both sexually active men and women of childbearing potential should use effective methods of contraception during treatment. Pregnancy ...

Effects on ability to drive and use machines

SPRYCEL has minor influence on the ability to drive and use machines. Patients should be advised that they may experience adverse reactions such as dizziness or blurred vision during treatment with dasatinib. ...

Undesirable effects

Summary of the safety profile The data described below reflect the exposure to SPRYCEL as single-agent therapy at all doses tested in clinical studies (N=2,900), including 324 adult patients with newly ...

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 agents, protein kinase inhibitors ATC code: L01XE06 Pharmacodynamics Dasatinib inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a ...

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 Microcrystalline cellulose Croscarmellose sodium Hydroxypropylcellulose Magnesium stearate Film-coating: Hypromellose Titanium dioxide (E171) Macrogol 400

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

SPRYCEL 20 mg, SPRYCEL 50 mg and SPRYCEL 70 mg film-coated tablets: Alu/Alu blisters (calendar blisters or perforated unit dose blisters). HDPE bottle with a polypropylene child-resistant closure. 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 healthcare professionals to the active substance. The use of latex or nitrile gloves for appropriate ...

Marketing authorization holder

Bristol-Myers Squibb Pharma EEIG, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland

Marketing authorization number(s)

SPRYCEL 20 mg film-coated tablets: EU/1/06/363/004 EU/1/06/363/007 EU/1/06/363/001 SPRYCEL 50 mg film-coated tablets: EU/1/06/363/005 EU/1/06/363/008 EU/1/06/363/002 SPRYCEL 70 mg film-coated tablets: ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 20 November 2006 Date of latest renewal: 15 July 2016

Πηγαίο έγγραφο

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