Methotrexate 25mg/ml solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METHOTREXATE

Available from:

Accord Healthcare Limited

ATC code:

L01BA01

INN (International Name):

METHOTREXATE

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

METHOTREXATE 25 mg/ml

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Authorised

Authorization date:

2012-06-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
METHOTREXATE 25 MG/ML SOLUTION 
FOR INJECTION
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 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 
symptoms are the same as yours.
- If you get any side effects, talk to your doctor, or pharamcist 
or nurse. This includes any possible side effects not listed in 
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Methotrexate 25 mg/ml  is and what it is used for
2. What you need to know before you use Methotrexate 25 mg/ml 
3. How to use Methotrexate 25 mg/ml  
4. Possible side effects
5. How to store Methotrexate 25 mg/ml  
6. Contents of the pack and other information
  1.  WHAT METHOTREXATE 25 MG/ML IS AND WHAT IT 
     IS USED FOR
Methotrexate 25 mg/ml contains the active substance 
methotrexate.
 Methotrexate is a cytostatic that inhibits cell growth. 
Methotrexate has its greatest effect on cells which increase 
frequently like cancer cells, bone marrow cells and skin cells.
Methotrexate 25 mg/ml is used in the treatment of the 
following types of cancer: 
- acute lymphocytic leukaemia,
- prophylaxis of meningeal leukaemia,
- non-Hodgkin’s lymphomas,
- osteogenic sarcoma,
- adjuvant and in advance disease of breast cancer,
- metastatic or recurrent head and neck cancer,
- choriocarcinoma and similar trophoblastic diseases,
- advanced cancer of urinary bladder.
  2.  WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
     METHOTREXATE 25 MG/ML  
DO NOT USE METHOTREXATE 25 MG/ML  
- If you are allergic to methotrexate or any of the other 
ingredients of this medicine (listed in section 6).
- If you have significant liver disease (Your doctor decides the 
severity of y

Summary of Product characteristics

Page 1 of 17

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Methotrexate 25 mg/ml solution for injection 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

2 ml of solution contains 50 mg methotrexate. 
20 ml of solution contains 500 mg methotrexate. 
40 ml of solution contains 1000 mg methotrexate. 

Excipients with known effect:  
4.801 mg/ml (0.208 mmol/ml) sodium. 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Solution for injection. 

Clear, yellow solution. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Acute lymphocytic leukaemia, prophylaxis of meningeal leukaemia, Non-Hodgkin’s lymphomas, osteogenic 
sarcoma, adjuvant and in advance disease
of breast cancer, metastatic or recurrent head and
neck cancer, 
choriocarcinoma and similar trophoblastic diseases, advanced
cancer of urinary bladder. 

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. 
Health care professionals and patients should be fully informed
about toxic effects. 

Treatment should be initiated by or occur in consultation with a
doctor with significant experience in 
cytostatic treatment. 

Methotrexate can be administered intramuscularly,
intravenously, intra-arterial or intrathecally. The dosage 
is generally calculated per m
2
 body surface area or body weight. Doses
of over 100 mg methotrexate always 
require subsequent administration of folinic acid (See
calcium folinate rescue). 

The application and dosage recommendations for the administration
of methotrexate for different 
indications varies considerably. Some common dosages�