Temodal capsules

Pays: Arménie

Langue: anglais

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingrédients actifs:

temozolomide

Disponible depuis:

Schering-Plough Labo N.V.

Code ATC:

L01AX03

DCI (Dénomination commune internationale):

temozolomide

Dosage:

100mg

forme pharmaceutique:

capsules

Unités en paquet:

(5) sachets

Type d'ordonnance:

Prescription

Statut de autorisation:

Registered

Date de l'autorisation:

2020-11-18

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS IN ARMENIA
1.
NAME OF THE MEDICINAL PRODUCT
TEMODAL
®
20mg, 100 mg, 250 mg capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule contains:
_Active substance:_ 100 mg or 250 mg of
temozolomide
.
_Excipients:_
anhydrous lactose, colloidal anhydrous silica, sodium starch
glycolate, tartaric
acid,
stearic
acid.
_Composition _
_of _
_20 _
_mg _
_capsules_:
gelatin,
titanium
dioxide,
sodium
laurilsulfate, yellow iron oxide; _ composition of 100 mg capsules_:
gelatin, titanium dioxide,
sodium laurilsulfate, red iron oxide; _ composition of 250 mg
capsules_: gelatin, titanium
dioxide, sodium laurilsulfate.
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 "20 mg",
"100 mg" or "250 mg", respectively, and the SP logo. The color of cap
is corresponding to
dosage: yellow for 20 mg, pink for 100 mg, white for 250 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 o