Dasatinib Teva 20 mg Film-coated Tablets

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Dasatinib

Inapatikana kutoka:

Teva B.V.

ATC kanuni:

L01XE06

INN (Jina la Kimataifa):

Dasatinib

Kipimo:

20 milligram(s)

Dawa fomu:

Film-coated tablet

Eneo la matibabu:

dasatinib

Idhini hali ya:

Marketed

Idhini ya tarehe:

2019-03-15

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
DASATINIB TEVA 20 MG FILM-COATED TABLETS
DASATINIB TEVA 50 MG FILM-COATED TABLETS
DASATINIB TEVA 70 MG FILM-COATED TABLETS DASATINIB TEVA 100 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 Teva is and what it is used for
2.
What you need to know before you take Dasatinib Teva
3.
How to take Dasatinib Teva
4.
Possible side effects
5.
How to store Dasatinib Teva
6.
Contents of the pack and other information
1.
WHAT DASATINIB TEVA IS AND WHAT IT IS USED FOR
Dasatinib Teva contains the active substance dasatinib. This medicine
is used to treat chronic myeloid
leukaemia (CML) in adults, adolescents and children at least 1 year of
age. 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.
Dasatinib Teva inhibits the growth of
these leukaemic cells.
Dasatinib Teva is also used to treat Philadelphia chromosome positive
(Ph+) acute lymphoblastic
leukaemia (ALL) in adults, adolescents and children at least 1 year of
age, 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. Dasatinib Teva
inhibits the growth of these
leukaemic cells.
If you have any questions about how Dasatinib Teva works or why this
medicine has been prescribed
for you, ask your doctor.
2.
WHAT YOU NEED TO KNO

Tabia za bidhaa

Health⎯Products⎯Regulatory⎯Authority
28⎯April⎯2023
CRN00DFXY
Page⎯1⎯of⎯30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dasatinib⎯Teva⎯20⎯mg⎯Film-coated⎯Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each⎯film-coated⎯tablet⎯contains⎯20
mg⎯dasatinib⎯(as⎯monohydrate).
Excipient with known effect
Each⎯film-coated⎯tablet⎯contains⎯26.3
mg⎯of⎯lactose⎯monohydrate⎯and⎯0.6⎯mg⎯of⎯sodium.
For⎯the⎯full⎯list⎯of⎯excipients,⎯see⎯section⎯6.1.⎯
3 PHARMACEUTICAL FORM
Film-coated⎯tablet⎯(tablet).
White⎯to⎯off-white,⎯round⎯film-coated⎯tablet⎯with⎯bevelled⎯edges⎯and⎯with⎯"20"⎯debossed⎯on⎯one⎯side⎯of⎯the⎯tablet,⎯
approximately⎯5.6 mm⎯in⎯diameter.⎯
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dasatinib⎯Teva⎯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.

Ph+⎯acute⎯lymphoblastic⎯leukaemia⎯(ALL)⎯and⎯lymphoid⎯blast⎯CML⎯with⎯resistance⎯or⎯intolerance⎯to⎯prior⎯therapy.
Dasatinib⎯Teva⎯is⎯indicated⎯for⎯the⎯treatment⎯of⎯paediatric⎯patients⎯with:

newly⎯diagnosed⎯Ph+⎯CML⎯in⎯chronic⎯phase⎯(Ph+⎯CML-CP)⎯or⎯Ph+⎯CML-CP⎯resistant⎯or⎯intolerant⎯to⎯prior⎯therapy⎯
including⎯imatinib.

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⎯chronic⎯phase⎯CML⎯is⎯100
mg⎯dasatinib⎯once⎯daily.
The⎯recommended⎯s