Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Temozolomide 5mg
Orion Laboratories (NZ) Ltd
Temozolomide 5 mg
5 mg
Capsule
Active: Temozolomide 5mg Excipient: Colloidal silicon dioxide Gelatin Lactose Sodium starch glycolate Stearic acid Tartaric acid TekPrint green SB-4020 Titanium dioxide
Prescription
Perrigo API Ltd
Treatment of: - Patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment - Patients with recurrent high grade glioma, such as glioblastoma multiforme or anaplastic astrocytoma
Package - Contents - Shelf Life: Bottle, glass, - 5 capsules - 3 years from date of manufacture stored at or below 25°C protect from moisture
2013-04-09
NEW ZEALAND DATASHEET 1 PRODUCT NAME Orion Temozolomide capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Temozolomide 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg capsules. 3 PHARMACEUTICAL FORM Orion Temozolomide 5 mg capsules have a white opaque capsule with two stripes in green ink on the cap and with “T 5 mg” in green ink on the body. Orion Temozolomide 20 mg capsules have a white opaque capsule with two stripes in orange ink on the cap and with “T 20 mg” in orange ink on the body. Orion Temozolomide 100 mg capsules have a white opaque capsule with two stripes in pink ink on the cap and with “T 100 mg” in pink ink on the body. Orion Temozolomide 140 mg capsules have a white opaque capsule with two stripes in blue ink on the cap and with “T 140 mg” in blue ink on the body. Orion Temozolomide 180 mg capsules have a white opaque capsule with two stripes in red ink on the cap and with “T 180 mg” in red ink on the body. Orion Temozolomide 250 mg capsules have a white opaque with capsule two stripes in black ink on the cap and with “T 250 mg” in black ink on the body. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Orion Temozolomide capsules are indicated for the treatment of: • patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment. • patients with recurrent high grade glioma, such as glioblastoma multiforme or anaplastic astrocytoma. Orion Temozolomide capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma. 4.2 Dosage and method of administration Anti-emetic therapy may be administered prior to or following administration of Orion Temozolomide capsules. Orion Temozolomide capsules should be administered in the fasting state at least one hour before a meal. If vomiting occurs after the dose is administered, a second dose should not be administered that day. Orion Temozolomide capsules must not be opened or chewed, but are to be swallowed whole with a glass of water. Prečítajte si celý dokument