METHOTREXATE 25 Mg/Ml Solution for Inj/Inf

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Disponibbli minn:

Actavis Group PTC ehf

Dożaġġ:

25 Mg/Ml

Għamla farmaċewtika:

Solution for Inj/Inf

Tip ta 'preskrizzjoni:

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

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

0000-00-00

Fuljett ta 'informazzjoni

Methotrexate 25 mg/ml Solution for Injection or Infusion PIL - UK /
EIRE
item no: AAAE0054 
print proof no: 6 
origination date: 03-07-12 
originated by: BW
revision date: 15.03.13
revised by: DR
dimensions: 130x600 
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 03-07-12
supplier: Sindan
technically app. date: 03-07-12
min pt size: 9pt
TECHNICAL APPROVAL
!
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 sign 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.
•  The full name of this medicine
is Methotrexate 25mg/ml
Solution for Injection or Infusion
but within the leaflet it will be
referred to as Methotrexate
Solution.
IN THIS LEAFLET:
1
 WHAT METHOTREXATE SOLUTION 
IS AND WHAT IT IS USED FOR
2
 WHAT YOU NEED TO KNOW 
BEFORE YOU USE
3
 HOW TO USE  
4
 POSSIBLE SIDE EFFECTS
5
 HOW TO STORE  
6
 CONTENTS OF THE PACK AND 
OTHER INFORMATION
1
 WHAT METHOTREXATE SOLUTION 
IS AND WHAT IT IS USED FOR
Methotrexate Solution 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)
•   it has anti-inflammatory effects.
Methotrexate Solution 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 canc

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Methotrexate 25mg/ml Solution for Injection or Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection or infusion contains 25 mg methotrexate.
2 ml vial contains 50 mg methotrexate.
10 ml vial contains 250 mg methotrexate.
20 ml vial contains 500 mg methotrexate.
40 ml vial contains 1,000 mg methotrexate.
Excipient with known effect:
The medicinal product contains 4.425 mg/ml sodium (0.192 mmol/ml sodium).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion
Clear, yellow solution, with pH approximately 8.5 (8.0-9.0)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Methotrexate 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 tumors (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 m
2
body surface area (BSA).
Methotrexate 25 mg/ml solution for injection or infusion should only be applied by ph