Methotrexate 25mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Methotrexate

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

L01BA; L01BA01

INN (International Name):

Methotrexate

Dosage:

25 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

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

Therapeutic area:

Folic acid analogues; methotrexate

Authorization status:

Not marketed

Authorization date:

2012-09-28

Patient Information leaflet

1
SE/H/1205/01-02/IB/034. Ver 02, 10/2023
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 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 your disease).
-
If you have significant kidney disease (Your doctor d

Summary of Product characteristics

Health Products Regulatory Authority
27 October 2023
CRN00DGL5
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 25mg/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 which have been used in different
indications are given below. None of these dosages
can currently be described as standard therapy. Since the application
and dosage recommendations for therapy with
meth