Methotrexate Mylan Solution for Inj/Inf 25mg/ml (4ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

METHOTREXATE

Available from:

Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France

ATC code:

L01BA01

INN (International Name):

METHOTREXATE 25 mg

Pharmaceutical form:

SOLUTION FOR INFUSION OR INJECTION

Composition:

METHOTREXATE 25 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Authorization status:

Withdrawn

Authorization date:

2013-03-05

Patient Information leaflet

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
METHOTREXATE MYLAN 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 Mylan 25 mg/ml is and what it is used for
2.
What you need to know before you use Methotrexate Mylan 25 mg/ml
3.
How to use Methotrexate Mylan 25 mg/ml
4.
Possible side effects
5.
How to store Methotrexate Mylan 25 mg/ml
6.
Contents of the pack and other information
1.
WHAT METHOTREXATE MYLAN 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).
Page 2 of 9
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE METHOTREXATE MYLAN 25 MG/ML
DO NOT USE METHOTREXATE MYLAN 25 MG/ML IF:
•
you are allergic to methotrexate
or any of the other ingredients of this medicine (listed in
section 6)
•
you have significant
kidney disease
•
you have significant liver disease
•
you

Summary of Product characteristics

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Methotrexate Mylan 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 Mylan 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 Mylan 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
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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 Mylan 25 mg/ml solution for injection or infusion should
only be applied by
physicians with experience in antimetabolite chemotherapy and the
other indication ranges.
It is useful to separate the treatment with methotrexate according to
the following regimen.
Low-dose therapy