Sprycel 20mg tablets

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Dasatinib

Prieinama:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC kodas:

L01XE06

INN (Tarptautinis Pavadinimas):

Dasatinib

Dozė:

20mg

Vaisto forma:

Tablet

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 08010500; GTIN: 5012712003984

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 TABLETS
dasatinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects , talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What SPRYCEL is and what it is used for
2.
What you need to know before you take SPRYCEL
3.
How to take SPRYCEL
4.
Possible side effects
5.
How to store SPRYCEL
6.
Contents of the pack and other information
1.
WHAT SPRYCEL IS AND WHAT IT IS USED FOR
SPRYCEL contains the active substance dasatinib. This medicine is used
to treat chronic myeloid
leukaemia (CML) in adults. Leukaemia is a cancer of white blood cells.
These white cells usually help
the body to fight infection. In people with CML, white cells called
granulocytes start growing out of
control. SPRYCEL inhibits the growth of these leukaemic cells.
SPRYCEL is also used to treat Philadelphia chromosome positive (Ph+)
acute lymphoblastic
leukaemia (ALL), and lymphoid blast CML in adults who are not
benefiting from prior therapies. In
people with ALL, white cells called lymphocytes multiply too quickly
and live too long. SPRYCEL
inhibits the growth of these leukaemic cells.
If you have any questions about how SPRYCEL works or why this medicine
has been prescribed for
you, ask your doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SPRYCEL
DO NOT TAKE SPRYCEL

if you are ALLERGIC
to dasatinib or any of the other ingredients of this med

Prekės savybės

OBJECT 1
SPRYCEL 20MG FILM COATED TABLETS
Summary of Product Characteristics Updated 14-Jun-2017 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. 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 tablets
2. 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 50 mg film-coated tablets
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
_Excipient with known effect _
Each film-coated tablet contains 67.5 mg of lactose monohydrate.
SPRYCEL 70 mg film-coated tablets
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
_Excipient with known effect _
Each film-coated tablet contains 94.5 mg of lactose monohydrate.
SPRYCEL 80 mg film-coated tablets
Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
_Excipient with known effect _
Each film-coated tablet contains 108 mg of lactose monohydrate.
SPRYCEL 100 mg film-coated tablets
Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
_Excipient with known effect _
Each film-coated tablet contains 135.0 mg of lactose monohydrate.
SPRYCEL 140 mg film-coated tablets
Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
_Excipient with known effect _
Each film-coated tablet contains 189 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. 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 tablets
White to off-white, biconvex, oval film-coated tablet with "BMS"
debossed on one side and "528" on the
other side.
SPRYCEL 70 mg film-coated tablets
Whi