Land: Israel
Språk: engelsk
Kilde: Ministry of Health
TEMOZOLOMIDE
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
L01AX03
CAPSULES
TEMOZOLOMIDE 250 MG
PER OS
Required
HAUPT PHARMA AMAREG GMBH, GERMANY
TEMOZOLOMIDE
TEMOZOLOMIDE
Temo 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. Temo 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.
2016-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 This medicine is dispensed with a doctor’s prescription only. TEMO 5 MG, TEMO 20 MG, TEMO 100 MG, TEMO 250 MG CAPSULES EACH CAPSULE CONTAINS: Temozolomide 5 mg, 20 mg, 100 mg, 250 mg Inactive ingredients and allergens in the medicine - see section 2 " IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF TEMO " and in section 6 of this leaflet. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING 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 your treatment. Do not pass it on to others. It might harm them, even if you think that their medical condition is similar to yours. • This medicine is not intended for children under 3 years of age, since there is no information regarding use in patients under the age of 3 years. The information concerning children over 3 years of age is limited. 1. WHAT IS THE MEDICINE INTENDED FOR? TEMO contains the active ingredient temozolomide. This medicine is intended for the treatment of cancerous tumors or different types of brain tumors. TEMO belongs to the group of medicines called cytotoxic or chemotherapy medicines. TEMO capsules are intended for the treatment of: • Patients suffering from newly diagnosed glioblastoma multiforme )a unique form of brain tumor( combined with radiation treatment and subsequently as monotherapy treatment. • In patients suffering from malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma )unique forms of brain tumors(, that recur or continue to develop after standard treatment. • A first line treatment for patients suffering from advanced metastatic malignant melanoma. THERAPEUTIC GROUP: Antineoplastic preparation. 2. BEFORE USING TEMO DO NOT USE TEMO IF: • you are hypersensitive )allergic( to the active ingredient temozolomide or to any of the other ingredients this medicine contains Les hele dokumentet