DASATINIB TARO 140 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DASATINIB

Available from:

TARO INTERNATIONAL LTD, ISRAEL

ATC code:

L01XE06

Pharmaceutical form:

FILM COATED TABLETS

Composition:

DASATINIB 140 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

SYNTHON HISPANIA S.L., SPAIN

Therapeutic area:

DASATINIB

Therapeutic indications:

Dasatinib Taro 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.

Authorization date:

2021-10-18

Patient Information leaflet

Page 1 of 7
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
DASATINIB TARO 20 MG
DASATINIB TARO 50 MG
DASATINIB TARO 70 MG
DASATINIB TARO 80 MG
DASATINIB TARO 100 MG
DASATINIB TARO 140 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 80 mg,
dasatinib 100 mg,
dasatinib 140 mg
Inactive ingredients and allergens: see section 2 under 'Important
information about some of
this medicine's ingredients' and section 6 'Further information'.
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.
Dasatinib Taro is not intended for use in children and adolescents
under 18 years of age. There
is limited experience with use of Dasatinib Taro in this age group.
1. WHAT IS THE MEDICINE INTENDED FOR?
Dasatinib Taro is intended for the treatment of adults:
•
Newly diagnosed patients suffering from Philadelphia
chromosome-positive chronic
myeloid leukaemia (CML), at the chronic phase.
•
Patients with chronic myeloid leukaemia (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
leukaemia (ALL)
and patients with lymphoid blast-phase chronic myeloid leukaemia (CML)
with resistance
or intolerance to prior treatment.
THERAPEUTIC GROUP: protein kinase inhibitors
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 the medicine contains, which are listed in

Summary of Product characteristics

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of
34
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DASATINIB TARO
20 mg
,
50 mg, 70 mg, 80 mg, 100 mg, 140 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg, 50 mg, 70 mg, 80 mg, 100 mg,
and 140 mg dasatinib (as
monohydrate).
Excipients with known effect
Each
DASATINIB TARO
20 mg contains 27.67 mg of lactose monohydrate.
Each
DASATINIB TARO
50 mg contains 69.18 mg of lactose monohydrate.
Each
DASATINIB TARO
70 mg contains 96.85 mg of lactose monohydrate.
Each
DASATINIB TARO
80 mg contains 110.69 mg of lactose monohydrate.
Each
DASATINIB TARO
100 mg contains 138.36 mg of lactose monohydrate.
Each
DASATINIB TARO
140 mg contains 193.7 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
DASATINIB TARO 20 mg: white to off-white, biconvex, round film-coated
tablet with a diameter of
approximately 6 mm, with "D7SB" debossed on one side and "20" on the
other side.
DASATINIB TARO 50 mg: white to off-white, biconvex, oval film-coated
tablet with a length of
approximately 11.0 mm and a width of approximately 6.0 mm, with "D7SB"
debossed on one side
and "50" on the other side.
DASATINIB TARO 70 mg: white to off-white, biconvex, round film-coated
tablet with a diameter
of approximately 9 mm, with "D7SB" debossed on one side a "70" on the
other side.
DASATINIB TARO 80 mg: white to off-white, biconvex, triangular
film-coated tablet with a length
of approximately 10 mm and a width of approximately 11 mm, with "D7SB"
debossed one side and
"80" on the other side.
DASATINIB TARO 100 mg: white to off-white, biconvex, oval film-coated
tablet with a length of
approximately 15 mm and a width of approximately 7 mm, with "D7SB"
debossed on one side and
"100" on the other side.
DASATINIB TARO 140 mg: white to off-white, biconvex, round film-coated
tablet with a diameter
of approximately 12 mm, with "D7SB" debossed on one side and "140" on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDI