Dasatinib Krka 70 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dasatinib

Available from:

KRKA, d.d., Novo mesto

ATC code:

L01XE06

INN (International Name):

Dasatinib

Dosage:

70 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

dasatinib

Authorization status:

Not marketed

Authorization date:

2020-04-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DASATINIB KRKA 20 MG FILM-COATED TABLETS
DASATINIB KRKA 50 MG FILM-COATED TABLETS
DASATINIB KRKA 70 MG FILM-COATED TABLETS
DASATINIB KRKA 80 MG FILM-COATED TABLETS
DASATINIB KRKA 100 MG FILM-COATED TABLETS
DASATINIB KRKA 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 Dasatinib Krka is and what it is used for
2.
What you need to know before you take Dasatinib Krka
3.
How to take Dasatinib Krka
4.
Possible side effects
5.
How to store Dasatinib Krka
6.
Contents of the pack and other information
1.
WHAT DASATINIB KRKA IS AND WHAT IT IS USED FOR
Dasatinib Krka contains the active substance dasatinib.
This medicine is used to treat Philadelphia chromosome positive (Ph+)
acute lymphoblastic leukaemia
(ALL) in adults, adolescents and children at least 1 year of age. In
people with ALL, white cells called
lymphocytes multiply too quickly and live too long. Dasatinib Krka
inhibits the growth of these
leukaemic cells.
If you have any questions about how Dasatinib Krka works or why this
medicine has been prescribed
for you, ask your doctor.
Dasatinib which is contained in Dasatinib Krka is also authorised to
treat other conditions which are
not mentioned in this leaflet. Ask your doctor or pharmacist if you
have further questions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DASATINIB KRKA
DO NOT TAKE DASATINIB KRKA
-
if you are allergic to dasatinib or any of the other ingredients of
this medicine (listed in
section 6).
IF YOU COU

Summary of Product characteristics

Health Products Regulatory Authority
23 August 2023
CRN00DMCC
Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dasatinib Krka 70 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 70 mg of dasatinib.
Excipient(s) with known effect
Each film-coated tablet contains 92 mg of lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off-white, biconvex, round film-coated tablet with a diameter
of approximately 9.1 mm, with "D7SB" debossed on one
side and "70" on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dasatinib Krka is indicated for the treatment of adult patients with:
-Ph+ acute lymphoblastic leukaemia (ALL) with resistance or
intolerance to prior therapy.
Dasatinib Krka is indicated for the treatment of paediatric patients
with:
-newly diagnosed Ph+ ALL in combination with chemotherapy.
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
_Adult patients_
The recommended starting dose for Ph+ ALL is 140 mg once daily (see
section 4.4).
_Paediatric population _
Dosing for children and adolescents is on the basis of body weight
(see Table 1). Dasatinib is administered orally once daily in
the form of either dasatinib film-coated tablets or dasatinib powder
for oral suspension. The dose should be recalculated every
3 months based on changes in body weight, or more often if necessary.
The tablet is not recommended for patients weighing
less than 10 kg; the powder for oral suspension should be used for
these patients. Dose increase or reduction is recommended
based on individual patient response and tolerability. There is no
experience with Dasatinib Krka treatment in children under 1
year of age.
Dasatinib film-coated tablets and dasatinib powder for oral suspension
are not bioequivalent. Patients who are able to swallow
tablets and who desire