Imatinib Actavis Group Tablet, film coated 300mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

IMATINIB

Tilgjengelig fra:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC-kode:

L01XE01

INN (International Name):

IMATINIB 300 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

IMATINIB 300 mg

Resept typen:

POM

Terapeutisk område:

ANTINEOPLASTIC AGENTS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2016-01-19

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB ACTAVIS GROUP 300 MG FILM-COATED TABLETS
imatinib
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imatinib Actavis Group is and what it is used for
2.
What you need to know before you take Imatinib Actavis Group
3.
How to take Imatinib Actavis Group
4.
Possible side effects
5.
How to store Imatinib Actavis Group
6.
Contents of the pack and other information
1.
WHAT IMATINIB ACTAVIS GROUP IS AND WHAT IT IS USED FOR
Imatinib Actavis Group is a medicine containing an active substance
called imatinib. This medicine
works by inhibiting the growth of abnormal cells in the diseases
listed below. These include some
types of cancer.
IMATINIB ACTAVIS GROUP IS A TREATMENT FOR ADULTS AND CHILDREN FOR:
-
CHRONIC MYELOID LEUKAEMIA (CML).
Leukaemia is a cancer of white blood cells. These white
cells usually help the body to fight infection. Chronic myeloid
leukaemia is a form of leukaemia
in which certain abnormal white cells (named myeloid cells) start
growing out of control.
In adult patients, Imatinib Actavis Group is intended for use in the
most advanced phase of the
disease (blast crisis). In children and adolescents, Imatinib Actavis
Group can be used in
different phases of the disease (chronic, accelerated phase and blast
crisis).
-
PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKAEMIA
(PH-POSITIVE ALL)
.
Leukaemia is a cancer of white blood cells. These white cells usually
help the body to fight
infection. Acute lymphoblastic l

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Imatinib Actavis Group 100 mg film-coated tablets
Imatinib Actavis Group 200 mg film-coated tablets
Imatinib Actavis Group 300 mg film-coated tablets
Imatinib Actavis Group 400 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 119.5 mg imatinib mesilate
corresponding to 100 mg of imatinib.
Excipient with known effect:
Each film-coated tablet contains 76 mg lactose monohydrate (see
section 4.4).
Each film-coated tablet contains 239 mg imatinib mesilate
corresponding to 200 mg of imatinib.
Excipient with known effect:
Each film-coated tablet contains 152 mg lactose monohydrate (see
section 4.4).
Each film-coated tablet contains 358.5 mg imatinib mesilate
corresponding to 300 mg of imatinib.
Excipient with known effect:
Each film-coated tablet contains 228 mg lactose monohydrate (see
section 4.4).
Each film-coated tablet contains 478 mg imatinib mesilate
corresponding to 400 mg of imatinib.
Excipient with known effect:
Each film-coated tablet contains 304 mg lactose monohydrate (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Imatinib Actavis Group 100 mg film-coated tablets: brownish-orange,
round, 10.5 mm in diameter,
biconvex, film-coated tablets with no scoring or markings.
Imatinib Actavis Group 200 mg film-coated tablets: brownish-orange,
ovaloid, 17 mm in length and
8 mm in width, biconvex, film-coated tablets with a score line on one
side and “200” marked on the
other side.
The score line is not intended for breaking the tablet.
Imatinib Actavis Group 300 mg film-coated tablets: brownish-orange,
ovaloid, 19 mm in length and
9 mm in width, biconvex, film-coated tablets with a score line on one
side and “300” marked on the
other side.
The score line is not intended for breaking the tablet.
Imatinib Actavis Group 400 mg film-coated tablets: brownish-orange,
capsule-shape, 22 mm in length
and 10 mm in width, biconv