Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
temozolomide
Schering-Plough Labo N.V.
L01AX03
temozolomide
250mg
capsules
(5) sachets
Prescription
Registered
2021-12-07
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 Прочитать полный документ