Imatinib Rowex 100mg Film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Imatinib mesilate

제공처:

Rowex Ltd

ATC 코드:

L01XE; L01XE01

INN (International Name):

Imatinib mesilate

복용량:

100 milligram(s)

약제 형태:

Film-coated tablet

관리 경로:

oral use

패키지 단위:

Pack sizes: 60 and 120 tablets

처방전 유형:

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

Manufactured by:

Lek Pharmaceuticals d.d

치료 그룹:

protein-tyrosine kinase inhibitor

치료 영역:

Protein kinase inhibitors; imatinib

치료 징후:

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-PDGFR
rearrangement. adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurre

승인 상태:

Marketed

승인 날짜:

2015-12-04

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMATINIB ROWEX 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 Rowex is and what it is used for
2. What you need to know before you take Imatinib Rowex
3. How to take Imatinib Rowex
4. Possible side effects
5. How to store Imatinib Rowex
6. Contents of the pack and other information
1. WHAT IMATINIB ROWEX IS AND WHAT IT IS USED FOR
Imatinib Rowex 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 ROWEX 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.
•
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 leukaemia is a form of leukaemia in
which certain abnormal white
cells (named lymphoblasts) start growing out of control. Imatinib
Rowex inhibits the growth of
these cells.
IMATINIB ROWEX IS ALSO A TREATMENT FOR ADULTS FOR:
•
MYELODYSPLASTIC/MYELOPROLIFERATIVE DISEASES (MDS/MPD)
. These are a group of blood diseases
in whi

제품 특성 요약

Health Products Regulatory Authority
10 February 2023
CRN00D9R5
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib Rowex 100mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of imatinib (as mesilate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Very dark yellow to brownish orange, round, biconvex with bevelled
edges, debossed with “NVR” on one side and “SA” and
score between the letters on the other side. Approximate diameter 9.2
mm.
The film-coated tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib Rowex is indicated for the treatment of

adult and 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.

adult and paediatric patients with Ph+ CML in chronic phase after
failure of interferon-alpha therapy, or in
accelerated phase or 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 Rowex is indicated for

the treatment of adult patients with Kit (CD117)-positive unresectable
and/or metastatic malignant gastrointestinal
stromal tumours (GIST).

the adjuvant treatment of adult patients who are at significant risk
of relapse following resection of Kit
(CD117)-positiv