Temodal capsules

Страна: Вірменія

мова: англійська

Джерело: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активний інгредієнт:

temozolomide

Доступна з:

Schering-Plough Labo N.V.

Код атс:

L01AX03

ІПН (Міжнародна Ім'я):

temozolomide

Дозування:

140mg

Фармацевтична форма:

capsules

Одиниць в упаковці:

(5) in sachet

Тип рецепту:

Prescription

Статус Авторизація:

Registered

Дата Авторизація:

2017-09-26

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS IN ARMENIA
1.
NAME OF THE MEDICINAL PRODUCT
TEMODAL
 140 mg, 180 mg capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains:
_Active substance:_ 140 mg or 180 mg of
temozolomide
.
_Excipients:_
anhydrous lactose, colloidal anhydrous silica, sodium starch
glycolate, tartaric
acid, stearic acid.
_Composition of 140 mg capsules_: gelatin, titanium dioxide (E171),
sodium laurilsulfate,
yellow iron oxide; _composition of 180 mg capsules_: gelatin, titanium
dioxide (E171), sodium
laurilsulfate, yellow iron oxide (E172), red iron oxide (E172).
3. PHARMACEUTICAL FORM
Capsules
The hard capsules have an opaque cap an opaque white body. Capsules
contain white to light-
pink,
light
beige-brownish
powder.
Capsules
are
imprinted
with
black
ink:
the
cap
is
imprinted with “Temodal”; the body is imprinted with two parallel
stripes, with "140 mg", or
"180 mg", respectively, and the SP logo. The color of cap is
corresponding to dosage: blue for
140 mg, orange for 180 mg.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Temodal is indicated for the treatment of:
-
adult
patients
with
newly-diagnosed
glioblastoma
multiforme
concomitantly
with
radiotherapy (RT) and subsequently as monotherapy treatment;
-
children from the age of three years, adolescents and adult patients
with malignant
glioma,
such
as
glioblastoma
multiforme
or
anaplastic
astrocytoma,
showing
recurrence or progression after standard therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Temodal hard capsules should only be prescribed by physicians
experienced in the oncological
treatment of brain tumours.
Anti-emetic therapy may be administered.
Posology
_Adult patients with newly-diagnosed glioblastoma multiforme_
Temodal hard capsules is administered in combination with focal
radiotherapy (concomitant
phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy
(monotherapy phase).
_Concomitant phase._
TMZ is administered orally at a dose of 75 mg/m
2
daily for 42 days concomitant with focal
radiother