Methotrexate 100mg per ml (10ml vial)

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

METHOTREXATE

Tillgänglig från:

Accord Healthcare Limited

ATC-kod:

L01BA01

INN (International namn):

METHOTREXATE

Läkemedelsform:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sammansättning:

METHOTREXATE 100 mg/ml

Receptbelagda typ:

POM

Terapiområde:

ANTINEOPLASTIC AGENTS

Bemyndigande status:

Authorised

Tillstånd datum:

2014-07-15

Bipacksedel

Page 1 of 8

PACKAGE LEAFLET: INFORMATION FOR THE USER 
_ _
METHOTREXATE 100 MG/ML 
CONCENTRATE
 FOR SOLUTION FOR 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 or nurse. 
- 
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 
even if their sign of illness are the same as yours. 
- 
If  you  get  any  side  effects,  talk  to  your  doctor,  or  pharmacist  or  nurse.  This  includes  any 
possible side effects not listed in this leaflet. See section 4. 
_ _
WHAT IS IN THIS LEAFLET: 

1. 
What Methotrexate  is and what it is used for 
2. 
What you need to know before you use Methotrexate   
3. 
How to use Methotrexate   
4. 
Possible side effects 
5. 
How to store Methotrexate   
6. 
Contents of the pack and other information 

1. 
WHAT METHOTREXATE IS AND WHAT IT IS USED FOR 

Methotrexate 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 is used in the treatment of the
following types of cancer:  
- 
acute lymphocytic 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 
_ _
DO NOT USE Methotrexate   
- 
If you are al

Produktens egenskaper

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Methotrexate
100 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITIONS
Each ml contains 100 mg methotrexate.
5 ml of solution contains 500 mg methotrexate.
10 ml of solution contains 1000 mg methotrexate.
50 ml of solution contains 5000 mg methotrexate.
Excipients with known effect:
10.60 mg/ml (0.461 mmol/ml) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, yellow solution with pH 7.0 to 9.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acute lymphocytic 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.
Methotrexate 100mg/ml is hypertonic and must not be administered
intrathecally.
Method of administration:
Treatment should be initiated by or occur in consultation with a
doctor with significant experience in
cytostatic treatment.
Methotrexate can be administered intramuscularly, intravenously or
intra-arterial. Methotrexate
100mg/ml
is
hypertonic
and
must
not
be
administered
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 recommendation for the administration of
methotrexate for different
indications
varies
considerably.
Some
common
dosages
which
have
been
used
in
different
indi