Methotrexate Actavis

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

METHOTREXATE

متاح من:

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

ATC رمز:

L01BA01

INN (الاسم الدولي):

METHOTREXATE 25 mg/ml

الشكل الصيدلاني:

SOLUTION FOR INFUSION OR INJECTION

تركيب:

METHOTREXATE 25 mg/ml

نوع الوصفة الطبية :

POM

المجال العلاجي:

ANTINEOPLASTIC AGENTS

الوضع إذن:

Withdrawn

تاريخ الترخيص:

2013-04-02

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER 

 METHOTREXATE ACTAVIS 25 MG/ML SOLUTION FOR INJECTION OR INFUSION 

Methotrexate 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 sign of illness are the same as yours. 
- 
If  you get any side effects, talk to your doctor. This includes any
possible side effects not 
listed in this leaflet. 

IN THIS LEAFLET:  
1. 
What Methotrexate Actavis is and what it is used for 
2. 
What you need to know before you use Methotrexate Actavis 
3. 
How to use Methotrexate Actavis 
4. 
Possible side effects 
5. 
  How to store Methotrexate Actavis 
6. 
Contents of the pack and other information 

1. 
WHAT METHOTREXATE ACTAVIS IS AND WHAT IT IS USED FOR 

Methotrexate Actavis is a substance with the following properties:  
- 
it interferes with the growth of tumour cells in the body
that reproduce quickly (anti-tumour 
agent)  
- 
it reduces undesired reactions of the body’s own defence
mechanism (immunosuppressant), 
and  
- 
it has anti-inflammatory effects.  

Methotrexate Actavis is used to treat cancer, such as: 
- 
lymphatic leukaemia (disease of the blood or bone marrow with
increased number of white 
blood cells) 
- 
breast cancer 
- 
bone cancer (osteosarcoma) 
- 
head and neck cancer 
- 
gynaecologic cancer (choriocarcinoma, throphoblastic disease –
tumour development directly 
associated with pregnancy) 
- 
cancer of the lymphatic system (Non-Hodgkin’s lymphoma).  

2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE METHOTREXATE ACTAVIS 

DO NOT USE METHOTREXATE ACTAVIS IF YOU 
- 
are allergic to methotrexate or any of the other ingredients of this
medicine (listed in sect

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Methotrexate Actavis 25 mg/ml solution for injection or infusion 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 ml solution for injection or infusion contains 25 mg
methotrexate. 

2 ml vial contains 50 mg methotrexate. 
10 ml vial contains 250 mg methotrexate. 
20 ml vial contains 500 mg methotrexate. 
40 ml vial contains 1,000 mg methotrexate. 

Excipient with known effect: 
The medicinal product contains 4.425 mg/ml sodium (0.192
mmol/ml sodium). 
For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Solution for injection or infusion 
Clear, yellow solution, with pH approximately 8.5 (8.0-9.0). 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Methotrexate is used alone or in combination with other anticancer
agents in the treatment of:  

- 
Acute lymphocytic leukaemias  
- 
Intermediate or high degree Non-Hodgkin's lymphomas in adults 
- 
Non-Hodgkin's lymphomas in paediatric patients 
- 
Metastatic or recurrent head and neck cancer 
- 
Adjuvant treatment of breast cancer after tumour resection or
mastectomy 
- Advanced 
breast 
cancer 
- 
Choriocarcinoma and other trophoblastic tumors (in monotherapy in
patients at low risk or in 
combination therapy in patients at high risk) 
- 
Adjuvant and neoadjuvant therapy of osteosarcoma 

4.2  POSOLOGY AND METHOD OF ADMINISTRATION 

WARNINGS 
The DOSE MUST BE ADJUSTED CAREFULLY depending on the body surface
area if methotrexate is used 
for the treatment of TUMOUR DISEASES. Fatal cases of intoxication
have been reported after 
administration of INCORRECT CALCULATED doses.  

Page 1 of 18 
Methotrexate can be given intramuscularly, intravenously,
intraarterially and intrathecally.  

The dose is usually calculated per m
2
 body surface area (BSA). 

Methotrexate Actavis 25 mg/ml solution for injection or infusion
sho