ABITREXATE TEVA

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

METHOTREXATE

Tilgængelig fra:

ABIC MARKETING LTD, ISRAEL

ATC-kode:

L01BA01

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

METHOTREXATE 25 MG/ML

Indgivelsesvej:

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

Recept type:

Required

Fremstillet af:

PHARMACHEMIE B.V., (TEVA GROUP) ,THE NETHERLANDS

Terapeutisk gruppe:

METHOTREXATE

Terapeutisk område:

METHOTREXATE

Terapeutiske indikationer:

Antineoplastic chemotherapy: treatment of gestational choriocarcinoma, chorioadenoma destruents and hydatidiform mole. Palliation of acute lymphocytic leukemia. Abitrexate is also indicated 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, Abitrexate may be used for the induction of remission, but is most commonly used in maintenance of induced remissions. Abitrexate 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. Abitrexate is effective in the treatment of the advanced stages (III and IV Peter's Staging System) of lymphosarcoma, particularly in children, and in advanced cases of mycosis fungoides. Psoriasis: because of the high risk attending its use, Abitrexate is indicated only in the symptomatic control of severe recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis has been established, as by biopsy and/or after dermatological consultation. Rheumatoid Arthritis: Abitrexate can be used in the treatment of selected adults with severe rheumatoid arthritis, only when the diagnosis has been well estabished according to rheumatological standards, with inadequate response to other forms of antirheumatic therapy, including full dose NSAIDs and usually a trial of at least one or more disease-modifying antirheumatic drugs.

Autorisation dato:

2015-02-28

Indlægsseddel

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
_______
FEBRUARY 1, 2015
__
םש
רישכת
תילגנאב
רפסמו
םושירה
ABITREXATE 25 MG/ML SOLUTION FOR INJECTION
ABITREXATE 1G/10 ML (100 MG/ML) SOLUTION FOR INJECTION
ירפסמ
םושיר
25MG/ML: 048 96 23819 05
1G/10ML: 100 38 24914 05
םש
לעב
םושירה
_
SALOMON, LEVIN & ELSTEIN LTD, POBOX 3696, PETACH TIKVA
49133
ספוט
הז
דעוימ
טורפל
תורמחהה
דבלב
!
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
INDICATION
CONTRAINDICATIONS
Methotrexate
should
not
be
used
in
pregnancy, and in patients in a poor state of
nutrition.
Methotrexate
is
furthermore
contraindicated in patients with serious renal
liver disorders, bone marrow hypoplasia,
leucopenia,
thrombocytopenia,
anaemia,
alcohol abuse, methotrexate hypersensitivity
and lung toxicity due to methotrexate.
During
methotrexate
therapy
no
breastfeeding should be given.
Methotrexate should not be used in pregnancy, and in patients in a
poor state of nutrition. Methotrexate is furthermore contraindicated
in patients with serious renal (Creatinine clearance less than 20 ml/
min) severe liver disorders, bone marrow hypoplasia, leucopenia,
thrombocytopenia,
anaemia,
alcohol
abuse,
methotrexate
hypersensitivity and lung toxicity due to methotrexate.
During methotrexate therapy no breastfeeding should be given.
Serious, acute or chronic infections such as tuberculosis and HIV.
Ulcers of the oral cavity and known active gastrointestinal ulcer
disease.
Concurrent vaccination with live vaccines
POSOLOGY, DOSAGE & ADMINISTRATION
_Hepatic Function Impairment_
If the bilirubin is between 3-5, or AST
more than 180, dosage should be reduced
by 25%. If bilirubin is more than 5, omit
the dose.
WARNINGS
The dose must be adjusted carefully depending on the body
surface area if methotrexate is used

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
ABITREXATE TEVA
Solution for Injection
For I.V., Intrathecal, I.M., Intra-Arterial and Intra-Ventricular Use
NAME OF THE MEDICINAL PRODUCT
Abitrexate Teva
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 25 mg methotrexate.
Each vial of 2 ml of solution contains 50 mg methotrexate.
Each vial of 4 ml of solution contains 100 mg methotrexate.
Each vial of 8 ml of solution contains 200 mg methotrexate.
Each vial of 20 ml of solution contains 500 mg methotrexate.
Each vial of 40 ml of solution contains 1000 mg methotrexate.
PHARMACEUTICAL FORM
Solution for Injection.
Clear yellow-brown solution.
METHOD OF ADMINISTRATION
For I.V., intrathecal, I.M., intra-arterial and intra-ventricular use.
THERAPEUTIC INDICATIONS
ANTINEOPLASTIC CHEMOTHERAPY:
Treatment of gestational choriocarcinoma, chorioadenoma destruens and
hydatidiform mole.
Palliation of acute lymphocytic leukemia. Abitrexate Teva is also
indicated 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, Abitrexate Teva may be
used for
the induction of remission, but is most commonly used in the
maintenance of
induced remissions.
Abitrexate Teva may be used alone, or in combination with other
antineoplastic
drugs, 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. Abitrexate Teva is effective in the
treatment of
the advanced stages (III and IV, Peter’s Staging system) of
lymphosarcoma,
particularly in children, and in advanced cases of mycosis fungoides.
PSORIASIS:
Because of the high risk attending its use, Abitrexate Teva is
indicated only in
the symptomatic control of severe recalcitrant, disabling psoriasis
which is not
adequately responsive to other forms of therapy, and only when the
diagnosis
has been established, as by biopsy