Dasatinib Accordpharma

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

dasatinib

Dostupné z:

Accord Healthcare S.L.U.

ATC kód:

L01EA02

INN (Medzinárodný Name):

dasatinib (anhydrous)

Terapeutické skupiny:

Antineoplastic agents

Terapeutické oblasti:

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Terapeutické indikácie:

Dasatinib Accordpharma 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 Accordpharma 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.

Prehľad produktov:

Revision: 1

Stav Autorizácia:

Withdrawn

Dátum Autorizácia:

2022-03-24

Príbalový leták

60
B. PACKAGE LEAFLET
Medicinal product no longer authorised
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
DASATINIB ACCORDPHARMA 20 MG FILM-COATED TABLETS
DASATINIB ACCORDPHARMA 50 MG FILM-COATED TABLETS
DASATINIB ACCORDPHARMA 70 MG FILM-COATED TABLETS
DASATINIB ACCORDPHARMA 80 MG FILM-COATED TABLETS
DASATINIB ACCORDPHARMA 100 MG FILM-COATED TABLETS
DASATINIB ACCORDPHARMA 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 Accordpharma is and what it is used for
2.
What you need to know before you take Dasatinib Accordpharma
3.
How to take Dasatinib Accordpharma
4.
Possible side effects
5.
How to store Dasatinib Accordpharma
6.
Contents of the pack and other information
1.
WHAT DASATINIB ACCORDPHARMA IS AND WHAT IT IS USED FOR
Dasatinib Accordpharma 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 Accordpharma inhibits
the growth of these leukaemic cells.
Dasatinib Accordpharma 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 l

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Dasatinib Accordpharma 20 mg film-coated tablets
Dasatinib Accordpharma 50 mg film-coated tablets
Dasatinib Accordpharma 70 mg film-coated tablets
Dasatinib Accordpharma 80 mg film-coated tablets
Dasatinib Accordpharma 100 mg film-coated tablets
Dasatinib Accordpharma 140 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Dasatinib Accordpharma 20 mg film-coated tablets
Each film-coated tablet contains 20 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 27 mg of lactose (as monohydrate).
Dasatinib Accordpharma 50 mg film-coated tablets
Each film-coated tablet contains 50 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 67.5 mg of lactose (as monohydrate).
Dasatinib Accordpharma 70 mg film-coated tablets
Each film-coated tablet contains 70 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 94.5 mg of lactose (as monohydrate).
Dasatinib Accordpharma 80 mg film-coated tablets
Each film-coated tablet contains 80 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 108 mg of lactose (as monohydrate).
Dasatinib Accordpharma 100 mg film-coated tablets
Each film-coated tablet contains 100 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 135 mg of lactose (as monohydrate).
Dasatinib Accordpharma 140 mg film-coated tablets
Each film-coated tablet contains 140 mg dasatinib.
_Excipient with known effect _
Each film-coated tablet contains 189 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Dasatinib Accordpharma 20 mg film-coated tablets
Medicinal product no longer authorised
3
White to off-white, round, 5.6 mm of diameter, coated tablets debossed
on one side with "DAS" and
"20" on the other side.
Dasatinib Accordpharma 50 mg film-coated tablets
White to off-white, oval, 5