Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
temozolomide
Merck Sharp & Dohme (Australia) Pty Ltd
Temozolomide
Registered
ASTROMIDE ® _Temozolomide_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ASTROMIDE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ASTROMIDE against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ASTROMIDE IS USED FOR ASTROMIDE belongs to a group of medicines called cytotoxic or chemotherapy medicines. ASTROMIDE works by killing cancer cells and stopping cancer cells from growing and multiplying. ASTROMIDE is used to treat patients with brain tumours. ASTROMIDE is also used to treat adult patients with advanced metastatic malignant melanoma. Your doctor, however, may prescribe ASTROMIDE for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ASTROMIDE HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. _USE IN CHILDREN_ ASTROMIDE capsules are used to treat children 3 years and older, with specific forms of brain tumour (glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy). BEFORE YOU TAKE ASTROMIDE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ASTROMIDE IF: 1. YOU ARE ALLERGIC TO ASTROMIDE (TEMOZOLOMIDE), DACARBAZINE (DTIC) OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include: • hives, itching or skin rash • swelling of the face, lips or tongue. This may lead to difficulty swallowing. • shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest. 2. YOU OR YOUR PARTNER ARE PREGNANT OR INTEND TO BECOME PREGNANT. ASTROMIDE may cause birth defects if either the male or female is using ASTROMIDE at the time of conception or during pregnancy. Therefore, female patients must Perskaitykite visą dokumentą
Page 1 of 14 PRODUCT INFORMATION ASTROMIDE CAPSULES NAME OF THE MEDICINE Temozolomide Chemical Name: imidazo[5,1-_d_]-1,2,3,5-tetrazine-8-carboxamide,3,4-dihydro-3-methyl-4-oxo CAS Registry Number: 85622-93-1 Molecular Formula: C 6 H 6 N 6 O 2 Molecular Weight: 194.15 Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4 mg/mL) and ethanol (0.6 mg/mL). DESCRIPTION Each ASTROMIDE capsule contains temozolomide (5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg). Each capsule also contains lactose, sodium starch glycollate, stearic acid, tartaric acid and colloidal anhydrous silica. ASTROMIDE capsule shells contain Titanium Dioxide, Sodium Lauryl Sulfate and Gelatin. ASTROMIDE 5 mg capsule shells also contain Indigo Carmine CI73015 and Iron Oxide Yellow CI77492. ASTROMIDE 20 mg capsule shells also contain Iron Oxide Yellow CI77492. ASTROMIDE 100 mg capsule shells also contain Iron Oxide Red CI77491. ASTROMIDE 140 mg capsule shells also contain Indigo Carmine CI73015. ASTROMIDE 180 mg capsule shells also contain Iron Oxide Red CI77491 and Iron Oxide Yellow CI77492. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Temozolomide is an imidazotetrazine alkylating agent with antitumour activity. It undergoes rapid chemical conversion in the systemic circulation at physiological pH to the active compound, monomethyl triazeno imidazole carboxamide (MTIC). The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O 6 position of guanine with additional alkylation also occurring at the N 7 position. Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct. PRECLINICAL TOXICOLOGY Single-dose toxicity studies of temozolomide were conducted in mice, rats and dogs. Estimated LD 50 doses by the oral route were moderately higher in the rat (approximately 1900 mg/m 2 ) than in the mouse (approximately 1000 mg/m 2 ). The minimum lethal dose in dogs was 600 mg/m 2 . In the single-dose studies, clinical signs of toxicity and death were generally delayed, reflecting a d Perskaitykite visą dokumentą