IMATINIB TEVA PHARMA 400 Milligram Film Coated Tablet

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

IMATINIB MESILATE

제공처:

Teva Pharma B.V.

ATC 코드:

L01XE01

INN (International Name):

IMATINIB MESILATE

복용량:

400 Milligram

약제 형태:

Film Coated Tablet

처방전 유형:

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

치료 영역:

Protein kinase inhibitors

승인 상태:

Authorised

승인 날짜:

2014-08-22

환자 정보 전단

 
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

IMATINIB TEVA PHARMA 400 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 

WHAT IS IN THIS LEAFLET:  
1. What Imatinib Teva Pharma is and what it is used for  
2. What you need to know before you take Imatinib Teva Pharma  
3. How to take Imatinib Teva Pharma  
4. Possible side effects  
5. How to store Imatinib Teva Pharma  
6. Contents of the pack and other information 

1. 
WHAT IMATINIB TEVA PHARMA IS AND WHAT IT IS USED FOR 

Imatinib Teva Pharma  is a medicine containing an active substance
called imatinib. This medicine works by 
inhibiting the growth of abnormal cells in 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 Teva Pharma is used to treat a late
stage of Chronic Myeloid Leukaemia called 
“blast crisis.” In children however it may be used to
treat all stages of the illness. 

In the rest of this leaflet, we will use the abbreviation,
CML, when talking about this disease. 

If you have any questions about how Imatinib Teva Pharma works
or why this medicine has been prescribed 
f

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imatinib Teva Pharma 400 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 400 mg of imatinib (as mesilate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Imatinib Teva Pharma 400 mg film coated tablets are orange brown, oblong, film coated tablets debossed with 7630 on
one side and a score line on the other side. The tablet is debossed with 9 and 3 at each side of the score line.
The film coated tablets have dimensions of 20.5 mm x 10 mm.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imatinib Teva Pharma 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.
•
Adult and paediatric patients with Ph+ CML in blast crisis.
The effect of imatinib on the outcome of bone marrow transplantation has not been determined.
In adult and paediatric patients, the effectiveness of imatinb is based on overall haematological and cytogenetic
response rates and progression free survival in CML. There are no controlled trials demonstrating a clinical benefit or
increased survival for this disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the treatment of patients with haematological malignancies.
The prescribed dose should be administered orally with a meal and a large glass of water to minimise the risk of
ga