Methotrexate Strides 25mg/ml solution for injection/infusion

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

methotrexate 25 mg/ml

Inapatikana kutoka:

Strides Arcolab International Limited

ATC kanuni:

L01BA01

INN (Jina la Kimataifa):

methotrexate

Dawa fomu:

solution for infusion or injection

Idhini hali ya:

Authorised

Idhini ya tarehe:

2013-03-05

Taarifa za kipeperushi

Page 1 of 9 
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

METHOTREXATE STRIDES 25 MG/ML SOLUTION FOR INJECTION/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 signs 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.. 

WHAT IS IN THIS LEAFLET 
1. 
What Methotrexate Strides 25 mg/ml is and what it is used for 
2. 
What you need to know before you use Methotrexate Strides 25 mg/ml 
3. 
How to use Methotrexate Strides 25 mg/ml  
4. 
Possible side effects 
5. 
How to store Methotrexate Strides 25 mg/ml 
6. 
Contents of the pack and other information 

1. 
WHAT METHOTREXATE STRIDES 25 MG/ML IS AND WHAT IT IS USED FOR 

Methotrexate 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 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, trophoblastic disease - tumour
development directly 
associated with pregnancy) 
 
cancer of the lymphatic system (Non-Hodgkin´s lymphoma). 

Page 2 of 9 
2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE METHOTREXATE STRIDES 25 MG/ML 

DO NOT USE METHOTREXATE STRIDES 25 MG/ML IF: 

Tabia za bidhaa

Page 1 of 20 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Methotrexate Strides 25 mg/ml solution for injection/infusion 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

1 ml of solution contains 25 mg methotrexate. 

One vial with 2 ml contains 50 mg methotrexate. 
One vial with 4 ml contains 100 mg methotrexate. 
One vial with 10 ml contains 250 mg methotrexate. 
One vial with 40 ml contains 1000 mg methotrexate. 

For the full list of excipients, see section 6.1 

Methotrexate Strides 25 mg/ml contains 0.21 mmol (4.945 mg)
sodium per ml. 

3 PHARMACEUTICAL 
FORM 

Solution for injection/infusion 

Clear yellow solution 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Methotrexate Strides 25 mg/ml solution for injection/infusion 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 tumours (in monotherapy in
patients at low 
risk or in combination therapy in patients at high risk) 
- 
Adjuvant and neoadjuvant therapy of osteosarcoma 

Page 2 of 20 
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. 

Methotrexate can be given intramuscularly, intravenously,
intraarterially and intrathecally. 

The dose is usually calculated per m² body surface area (BSA). 

Methotrexate Strides 25 mg/ml solution for injection or infusion
should only be applied