METHOTREXATE STRIDES 25 Mg/Ml Solution for Inj/Inf

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

METHOTREXATE

Inapatikana kutoka:

Strides Arcolab International Limited

INN (Jina la Kimataifa):

METHOTREXATE

Kipimo:

25 Mg/Ml

Dawa fomu:

Solution for Inj/Inf

Dawa ya aina:

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

Idhini hali ya:

Authorised

Idhini ya tarehe:

0000-00-00

Taarifa za kipeperushi

Dimension: 380 x 310 mm
Font: Times New Roman ; Font Size: 9 Pt.
Front Side
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).
2.  WHAT YOU NEED TO KNOW BEFORE YOU USE METHOTREXATE STRIDES 25
MG/ML
DO NOT USE METHOTREXATE STRIDES 25 MG/ML IF:
•  you are allergic to methotrexate or any of the other
ingredients of this

Tabia za bidhaa

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
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 appl