TRISENOX 2 MGML

Страна: Ізраїль

мова: англійська

Джерело: Ministry of Health

Активний інгредієнт:

ARSENIC TRIOXIDE

Доступна з:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Код атс:

L01XX27

Фармацевтична форма:

CONCENTRATE FOR SOLUTION FOR INJECTION

Склад:

ARSENIC TRIOXIDE 2 MG / 1 ML

Адміністрація маршрут:

I.V

Тип рецепту:

Required

Виробник:

CEPHALON INC

Терапевтична области:

ARSENIC TRIOXIDE

Терапевтичні свідчення:

TRISENOX is indicated for induction of remission, and consolidation in adult patients with:• Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/µl) in combination with all trans retinoic acid (ATRA)• Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptor-alpha (PML/RAR-alpha) gene.The response rate of other acute myelogenous leukaemia subtypes to arsenic trioxide has not been examined.

Дата Авторизація:

2020-12-06

Характеристики продукта

1
Tresanox-ME-1/2021 New - Clean
SUMMARY OF PRODUCT CHARACTERISTICS
TRISENOX 2 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINAL PRODUCT
TRISENOX 2 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRISENOX 2 mg/ml concentrate for solution for injection
Each ml of concentrate contains 2 mg of arsenic trioxide.
Each vial of 6 ml contains 12 mg of arsenic trioxide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection
Colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRISENOX is indicated for induction of remission, and consolidation in
adult patients with:
•
Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia
(APL) (white blood cell
count,
≤
10 x 10
3
/µl) in combination with all-_trans_-retinoic acid (ATRA)
•
Relapsed/refractory acute promyelocytic leukaemia (APL) (previous
treatment should have
included a retinoid and chemotherapy)
characterised by the presence of the t(15;17) translocation and/or the
presence of the promyelocytic
leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
The response rate of other acute myelogenous leukaemia subtypes to
arsenic trioxide has not been
examined.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TRISENOX must be administered under the supervision of a physician who
is experienced in the
management of acute leukaemias, and the special monitoring procedures
described in section 4.4 must
be followed._ _
Posology
The same dose is recommended for adults and elderly_. _
2
Tresanox-ME-1/2021 New - Clean
_Newly diagnosed low-to-intermediate risk acute promyelocytic
leukaemia (APL) _
_Induction treatment schedule _
TRISENOX must be administered intravenously at a dose of 0.15
mg/kg/day, given daily until complete
remission is achieved. If complete remission has not occurred by day
60, dosing must be discontinued.
_Consolidation schedule _
TRISENOX must be administered intravenously at a dose of 0.15
mg/kg/day, 5 days per week.
Treatment should be continued