Sprice - instructions for use, dose, side effects, contraindications

Active substanceDasatinibDasatinib

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Dasatinib-native

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Spiceel®

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Bristol-Myers Squibb France

Dosage form: & nbspfilm-coated tablets

Composition:

Each tablet, coated with a shell, contains

active substance: dasatinib 20 mg, 50 mg, 70 mg or 100 mg

Excipients: lactose monohydrate, microcrystalline cellulose, giprolose, croscarmellose sodium, magnesium stearate, opadrai white (titanium dioxide, hypromellose-bsR, macrogol-400).

Description:

Tablets of 20 mg: round biconvex tablets, covered with a film coat of white. or almost white, marked "BMS"on one side and" 527 "on the other.

Tablets 50 mg: oval, biconvex tablets, film-coated white or almost white, labeled "BMS"on one side and" 528 "on the other.

Tablets 70 mg: round biconvex tablets, coated with a white or almost white film cover, marked "BMS"on one side and" 524 "on the other.

Tablets 100 mg: Oval biconvex tablets, covered with a film shell of white or almost white color, with engraving "BMS 100 "on one side and" 852 "on the other.

Pharmacotherapeutic group:antitumor agent - protein tyrosine kinase inhibitor

ATX: & nbsp

L.01.X.E.06 Dasatinib

Pharmacodynamics:

Dasatinib inhibits tyrosine kinase BCR-ABL and family tyrosine kinase SRC, as well as many other oncogenic kinases, including c-KIT, the kinase of the ephrine (EPH) receptor and PDGFJβ-receptor. Dasatinib binds to the active and inactive forms of the enzyme BCR-ABL and at subnanomolar concentrations (0.6-0.8 nmol / ml) inhibits it.

Mechanism of action
In conditions in vitro dasatinib shows activity on cellular models of leukemia, both in relation to sensitive and resistant to imatinib cells. Dasatinib overcomes the resistance to imatinib associated with overexpression BCR-ABL, domain mutations BCR-ABL kinase activation of alternative mechanisms inducing family kinases SRC (LYN, NSC), as well as overexpression of the multiple drug resistance gene.

Form release / dosage:

Film coated tablets.

Packaging:For 60 tablets (dosage 20 mg, 50 mg and 70 mg) or 30 tablets (dosage of 100 mg) in high-density polyethylene bottles with a lid not accessible to children.

Inside the vial, a container with a desiccant (silica gel) is placed on which a warning mark is placed.

The neck of the vial is closed with a cotton swab (only for 20/50/70 mg dosages) and sealed with aluminum foil. 1 bottle with instructions for use in a cardboard box.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008175/10

Date of registration:17.08.2010

The owner of the registration certificate:Bristol-Myers SquibbBristol-Myers Squibb France

Manufacturer: & nbsp

BRISTOL-MYERS SQUIBB Company USA

Representation: & nbspBRISTOL-Majers SKVIBB, LLCBRISTOL-Majers SKVIBB, LLCRussia

Illustrated instructions

Instructions

Spiceel® (Sprycel® )