Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
TEMOZOLOMIDE
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
L01AX03
CAPSULES
TEMOZOLOMIDE 5 MG
PER OS
Required
ORION CORPORATION, ORION PHARMA, FINLAND
TEMOZOLOMIDE
TEMOZOLOMIDE
Temodal capsules are indicated for the treatment of patients with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. Temodal capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma. Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment.
2016-02-29
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon physician prescription only TEMODAL ® 5 mg, 20 mg, 100 mg, 250 mg Capsules Each capsule contains: Temozolomide 5 mg, 20 mg, 100 mg, 250 mg For a list of inactive ingredients see section 6 “Further Information”. See also section 2.7 “Important information about some of the ingredients of TEMODAL”. Read all of this leaflet carefully before you start taking this medicine. • This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition seems similar to yours. • This medicine is not intended for children under 3 years of age, since there are no data related to the use in patients under the age of 3 years. The data about children above the age of 3 years are limited. 1. WHAT TEMODAL IS INTENDED FOR? 1.1 What is TEMODAL? TEMODAL contains a medicine called temozolomide. This medicine is an antitumour agent for the treatment of specific forms of brain tumours. TEMODAL belongs to a group of medicines called cytotoxic or chemotherapy medicines. Therapeutic group: Antineoplastic preparation. 1.2 What is TEMODAL used for? TEMODAL capsules are indicated for the treatment of: - Adult patients suffering from newly diagnosed glioblastoma multiforme (a specific form of brain tumour) in a combination treatment with radiation and subsequently as monotherapy treatment; - Children above the age of 3 years, adolescents and adults suffering from malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma (specific forms of brain tumours), showing recurrence or progression after standard therapy; - TEMODAL capsules are also indicated as first line treatment for adult patients with advanced metastatic malignant melanoma. 2. BEFORE USING TEMODAL 2.1 Do not use TEMODAL if: - you are sensitive (allergic Leggi il documento completo
1 1. NAME OF THE MEDICINAL PRODUCT Temodal ® 5, 20, 100 or 250 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5, 20, 100 or 250 mg temozolomide. Excipient(s) with known effect: Each Temodal 5 mg capsule contains 132.8 mg of anhydrous lactose. Each Temodal 20 mg capsule contains 182.2 mg of anhydrous lactose Each Temodal 100 mg capsule contains 175.7 mg of anhydrous lactose Each Temodal 250 mg capsule contains 154.3 mg of anhydrous lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. Temodal 5 mg capsules have an opaque white body, an opaque green cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with "5 mg", the Schering-Plough logo and two stripes. Temodal 20 mg capsules have an opaque white body, an opaque yellow cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with "20 mg", the Schering-Plough logo and two stripes. Temodal 100 mg capsules have an opaque white body, an opaque pink cap, and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with "100 mg", the Schering-Plough logo and two stripes. Temodal 250 mg capsules have an opaque white body and cap and are imprinted with black ink. The cap is imprinted with “TEMODAL”. The body is imprinted with "250 mg", the Schering-Plough logo and two stripes. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Temodal capsules are 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. - Temodal capsules are also indicated as first line treatment for adult patients with advanced metastatic malignant melanoma. 4.2 Posology and method Leggi il documento completo