Methotrexate 25mg/ml solution for injection (20ml Vial)

Land: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

METHOTREXATE

Fáanlegur frá:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC númer:

L01BA01

INN (Alþjóðlegt nafn):

METHOTREXATE 25 mg/ml

Lyfjaform:

SOLUTION FOR INJECTION

Samsetning:

METHOTREXATE 25 mg/ml

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Leyfisstaða:

Withdrawn

Leyfisdagur:

2012-06-05

Upplýsingar fylgiseðill

1
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 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 decides the

Vara einkenni

1
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 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 methotrexate
at high and low dosages vary,
only the most commonly used gu