Imatinib Actavis Group 100mg Film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Imatinib mesilate

متاح من:

Actavis Group PTC ehf

ATC رمز:

L01X

INN (الاسم الدولي):

Imatinib mesilate

جرعة:

100 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

طريقة التعاطي:

oral use

الوحدات في الحزمة:

Pack sizes: 30, 60, 90 and 120 film-coated tablets.

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المصنعة من قبل:

Actavis Group PTC ehf

المجموعة العلاجية:

antineoplastic agents, protein kinase inhibitor

المجال العلاجي:

OTHER ANTINEOPLASTIC AGENTS

الخصائص العلاجية:

Imatinib Actavis Group is indicated for the treatment of - paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment. - paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult patients with Ph+ CML in blast crisis. - adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. - adult patients with relapsed or refractory Ph+ ALL as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL) with FIP1L1-PDGFR
rearrangement.

الوضع إذن:

Marketed

تاريخ الترخيص:

2015-10-23

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMATINIB ACTAVIS GROUP 100 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 lymphoblast

خصائص المنتج

Health Products Regulatory Authority
19 August 2019
CRN008JGD
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib Actavis Group 100mg 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).
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.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib Actavis Group is indicated for the treatment of
- paediatric patients with newly diagnosed Philadelphia chromosome
(bcr‑abl) positive (Ph+) chronic myeloid leukaemia
(CML) for whom bone marrow transplantation is not considered as the
first line of treatment.
- paediatric patients with Ph+ CML in chronic phase after failure of
interferon‑alpha therapy, or in accelerated phase or blast
crisis.
- adult patients with Ph+ CML in blast crisis.
- adult and paediatric patients with newly diagnosed Philadelphia
chromosome positive acute lymphoblastic leukaemia (Ph+
ALL) integrated with chemotherapy.
- adult patients with relapsed or refractory Ph+ ALL as monotherapy.
- adult patients with myelodysplastic/myeloproliferative diseases
(MDS/MPD) associated with platelet-derived growth factor
receptor (PDGFR) gene re-arrangements.
- adult patients with advanced hypereosinophilic syndrome (HES) and/or
chronic eosinophilic leukaemia (CEL) with
FIP1L1-PDGFRα rearrangement.
The effect of imatinib on the outcome of bone marrow transplantation
has not been determined.
Imatinib Actavis Group is indicated for
- the treatment of adult patients with unresectable
dermatofibrosarcoma protuberans (DFSP) and adult patients with
recurrent
and/or metastatic DFSP who are not eligible for surgery.
In