Methotrexate 100mg/ml Concentrate for solution for infusion (5ml vial)

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

METHOTREXATE

제공처:

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

ATC 코드:

L01BA01

INN (International Name):

METHOTREXATE 100 mg/ml

약제 형태:

CONCENTRATE FOR SOLUTION FOR INFUSION

구성:

METHOTREXATE 100 mg/ml

처방전 유형:

POM

치료 영역:

ANTINEOPLASTIC AGENTS

승인 상태:

Withdrawn

승인 날짜:

2014-07-15

환자 정보 전단

1
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 100 mg/ml
is and what it is used for
2.
What you need to know before you use Methotrexate 100 mg/ml
3.
How to use Methotrexate 100 mg/ml
4.
Possible side effects
5.
How to store Methotrexate 100 mg/ml
6.
Contents of the pack and other information
1.
WHAT METHOTREXATE 100 MG/ML
IS AND WHAT IT IS USED FOR
Methotrexate 100 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 100 mg/ml
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 100 MG/ML
_ _
DO NOT USE
Methotrexate 100 mg/ml
-
If you are allergic (hypersensitive) to methotrexate or any of the
other ingredients of this medicine
(listed in section 6).
-
If you have severe liver or kidney disease .
-
If you have increased alcohol consumption.
-
If you have disorders of the blood-forming system.
-
If you have severe or existin

제품 특성 요약

Page 1 of 19
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 Accord 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 Accord 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).
Page 2 of 19
The application and dosage recommendation for the administration of
methotrexate for
different indications varies considerably. Some common dosages which
have