METHOTREXAT EBEWE 100 MGML

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

METHOTREXATE

Saatavilla:

NOVARTIS ISRAEL LTD

ATC-koodi:

L01BA01

Lääkemuoto:

CONCENTRATE FOR SOLUTION FOR INFUSION

Koostumus:

METHOTREXATE 100 MG/ML

Antoreitti:

I.M, INTRA-ARTERIAL, I.V, INTRA VENTRICULAR, INTRATHECAL

Prescription tyyppi:

Required

Valmistaja:

EBEWE PHARMA GES.M.B.H NFG.KG, AUSTRIA

Terapeuttinen ryhmä:

METHOTREXATE

Terapeuttinen alue:

METHOTREXATE

Käyttöaiheet:

Antineoplastic Chemotherapy: Treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Palliation of acute lymphocytic leukemia. In the treatment and prophylaxis of meningeal leukemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukemias in children. In combination with other anticancer agents, methotrexate may be used for the induction of remission, but is most commonly used in maintenance of induced remissions. Methotrexate may be used alone or in combination with other antineoplastics in the management of breast cancer, epidermoid cancers of the head and neck, lung cancer (particularly squamous cell and small cell types), bladder cancer and osteogenic cancer. Methotrexate is effective in the treatment of the advanced stages (III and IV, Peters’ Staging System) of lymphosarcoma, particularly in children, and in advanced cases of mycosis fungoides.

Valtuutus päivämäärä:

2023-09-30

Valmisteyhteenveto

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Methotrexat “Ebewe” 100mg/ml - concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 mg of methotrexate in an aqueous solution.
Excipients with known effect:
1 ml contains 17.62 mg of sodium hydroxide in aqueous solution.
The solution has a pH value of 7.0–8.5.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Clear, yellow concentrate for solution for infusion.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Antineoplastic chemotherapy: Treatment of gestational choriocarcinoma,
chorioadenoma
destruens and hydatidiform mole. Palliation of acute lymphocytic
leukemia. In the treatment and
prophylaxis of meningeal leukemia. Greatest effect has been observed
in palliation of acute
lymphoblastic (stem cell) leukemias in children. In combination with
other anticancer agents,
m
ethotrexate may be used for the induction of remission, but is most
commonly used in
maintenance of induced remissions. Methotrexate may be used alone or
in combination with
other antineoplastics in the management of breast cancer, epidermoid
cancers of the head and
neck, lung cancer (particularly squamous cell and small cell types),
bladder cancer and
osteogenic cancer. Methotrexate is effective in the treatment of the
advanced stages (III and IV,
Peters’ Staging System) of lymphosarcoma, particularly in children,
and in advanced cases of
mycosis fungoides.
4.2
Posology and method of administration
Methotrexate should only be prescribed by doctors with experience in
the use of methotrexate
and who are fully familiar with the risks associated with a
methotrexate treatment.
WARNINGS
The dose must be carefully adjusted to the body surface area if
methotrexate is used to treat
tumour diseases.
Cases of intoxication with fatal outcome have been reported after the
administration of
incorrectly
calculated
doses.
The
medical
personnel
and
the
patients
must
be
comprehensively informed about the toxic effects.