SPRYCEL 100 MG

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

DASATINIB

Prieinama:

BRISTOL, MYERS SQUIBB (ISRAEL) LIMITED, ISRAEL

ATC kodas:

L01XE06

Vaisto forma:

FILM COATED TABLETS

Sudėtis:

DASATINIB 100 MG

Vartojimo būdas:

PER OS

Recepto tipas:

Required

Pagaminta:

BRISTOL MYERS SQUIBB COMPANY, USA

Farmakoterapinė grupė:

DASATINIB

Gydymo sritis:

DASATINIB

Terapinės indikacijos:

Treatment of adult patients with : * Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase. * Chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate. * Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.

Leidimo data:

2015-06-30

Pakuotės lapelis

Sprycel-20,50,70,100 mg-tablets_PL_MoH_Dec2021
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
SPRYCEL 20 mg
Film-coated tablets
SPRYCEL 50 mg
Film-coated tablets
SPRYCEL 70 mg
Film-coated tablets
SPRYCEL 100 mg
Film-coated tablets
The active ingredient and its quantity:
Each film-coated tablet contains: dasatinib 20 mg, dasatinib 50 mg,
dasatinib 70 mg, dasatinib 100 mg
For the list of inactive ingredients, please see section 6 and
'Important information
about some of this
medicine’s ingredients
' in section 2.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information
about the medicine. If you have further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It may harm them
even if it seems to you that their ailment is similar.
SPRYCEL is not intended for use in children and adolescents under 18
years of age. There is limited
experience with use of SPRYCEL in this age group.
1.
WHAT IS THE MEDICINE INTENDED FOR?
SPRYCEL is a medicine intended for the treatment of adults:

Newly diagnosed patients suffering from Philadelphia
chromosome-positive chronic myeloid
leukemia (CML), at the chronic phase.

Patients with chronic myeloid leukemia (CML) at the chronic,
accelerated or blast phase with
resistance or intolerance to prior treatment, including prior
treatment with imatinib mesilate.

Patients with Philadelphia chromosome-positive acute lymphoblastic
leukemia (ALL) and patients
with lymphoid blast-phase chronic myeloid leukemia (CML) with
resistance or intolerance to prior
treatment.
Therapeutic group: protein kinase inhibitors.
Sprycel-20,50,70,100 mg-tablets_PL_MoH_Dec2021
2.
BEFORE USING THE MEDICINE
Do not use the medicine if:

You are sensitive (allergic) to the active ingredient (dasatinib) or
to any of the other ingredients of
the medicine (see section

Prekės savybės

1
1.
NAME OF THE MEDICINAL PRODUCT
SPRYCEL 20 mg
,
50 mg, 70 mg,100 mg
film-coated
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg , 50 mg, 70 mg, 100 mg
dasatinib (as monohydrate).
Excipients with known effect
Each Sprycel 20mg film-coated tablet contains 27 .0 mg of lactose
monohydrate.
Each Sprycel 50mg film-coated tablet contains 67.5 mg of lactose
monohydrate.
Each Sprycel 70mg film-coated tablet contains 94.5 mg of lactose
monohydrate.
Each Sprycel 100mg film-coated tablet contains 135.0 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 White to off-white, biconvex,
round film-coated tablet with
“BMS” debossed on one side and "524" on the other side.
SPRYCEL 100 mg : film coated tablets White to off-white, biconvex,
oval film-coated tablet with
“BMS 100” debossed on one side and “852” on the other side
4.
CLINICAL PARTICULARS
4.1
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 phase CML with resistance or intolerance
to prior therapy including
imatinib mesilate.

Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with
resistance or
intolerance to prior therapy.
4.2
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.
The recommended starting dose f