Temodal capsules

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

temozolomide

Verfügbar ab:

Schering-Plough Labo N.V.

ATC-Code:

L01AX03

INN (Internationale Bezeichnung):

temozolomide

Dosierung:

100mg

Darreichungsform:

capsules

Einheiten im Paket:

(5) sachets

Verschreibungstyp:

Prescription

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2021-12-07

Fachinformation

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
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.Solution for injection in a vial.
The vaccine is a clear, colourless solution.
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 phas