ABITREXATE 1 g INJECTION

Страна: Южна Африка

Език: английски

Източник: South African Health Products Regulatory Authority (SAHPRA)

Предлага се от:

Teva Pharmaceuticals (Pty) Ltd

дозиране:

See ingredients

Лекарствена форма:

INJECTION

Композиция:

EACH 10 ml SOLUTION CONTAINS METHOTREXATE 1,0 g

Статус Оторизация:

Registered

Дата Оторизация:

1988-02-11

Данни за продукта

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SCHEDULING STATUS:
S4
PROPRIETARY NAMES (AND DOSAGE FORMS):
ABITREXATE 50 Injection
ABITREXATE 500 Injection
ABITREXATE 1 g Injection
ABITREXATE 5 g Injection
COMPOSITION:
Abitrexate 50 and Abitrexate 500: Each 1 ml contains methotrexate 25
mg
Abitrexate 1 g: Each 10 ml contains methotrexate 1 g
Abitrexate 5 g: Each 50 ml contains methotrexate 5 g
PHARMACOLOGICAL CLASSIFICATION:
A26 Cytostatic agents
PHARMACOLOGICAL ACTION:
Methotrexate is an antineoplastic agent, which acts as an
antimetabolite of folic acid. It also has
immunosuppressant qualities.
When given in low doses, methotrexate is well absorbed from the
gastro-intestinal tract. Higher
doses are less well absorbed. It is distributed mainly in the
extracellular spaces but a proportion
penetrates cell membranes and is strongly bound to dihydrofolate
reductase. Only small amounts
of methotrexate diffuse into the cerebrospinal fluid but higher
concentrations are achieved with high
doses. About 50 % is bound to plasma proteins. Biphasic and triphasic
clearance from plasma
has been reported. The majority of a dose is excreted unchanged in the
urine within 24 hours and
up to 15 % may appear in the bile although because of re-absorption
less may be excreted in the
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faeces. Bound methotrexate may be retained in the body for many
months.
INDICATIONS:

Lymphoblastic leukaemia in children and meningeal leukemia.

Choriocarcinoma and related trophoblastic tumours of women.

Women with non-metastatic trophoblastic disease, hydatidiform mole and
chorioadenoma
destruens.

Carcinomas of the breast, tongue, pharynx and testes (in conjunction
with chlorambucil
and dactinomycin).

Carcinoma of the lung and osteogenic sarcomas (high dose ABITREXATE
with folinic
acid rescue).

Treatment of severe psoriasis (see Warnings).

Prevention of graft-versus-host reactions that result from marrow
transplantation.

Dermatomyositis,
rheumatoid
arthritis
(not
adequately
responding
to
other
therapy),
Wegene