Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
temozolomide
Orion Laboratories Pty Ltd T/A Perrigo Australia
Temozolomide
Registered
ORION TEMOZOLOMIDE CAPSULES CONSUMER MEDICINE INFORMATION PLEASE READ THIS INFORMATION CAREFULLY BEFORE YOU START TO TAKE YOUR MEDICINE_ _ _(Temozolomide 5mg, 20mg, 100mg, 140mg, 180mg and 250mg) _ WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about Orion Temozolomide Capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor or pharmacist has weighed the benefits against the risks of you taking this medicine. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT ORION TEMOZOLOMIDE CAPSULES IS USED FOR Orion Temozolomide Capsules is used to treat patients with brain tumours. Orion Temozolomide Capsules is also used to treat adult patients with advanced metastatic malignant melanoma. Your doctor, however, may prescribe Orion Temozolomide Capsules for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ORION TEMOZOLOMIDE CAPSULES HAS BEEN PRESCRIBED FOR YOU. Orion Temozolomide Capsules belongs to a group of medicines called cytotoxic or chemotherapy medicines. Orion Temozolomide Capsules works by killing cancer cells from growing and multiplying. This medicine is only available with a doctor’s prescription. _USE IN CHILDREN _ Orion Temozolomide 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 ORION TEMOZOLOMIDE CAPSULES _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE ORION TEMOZOLOMIDE CAPSULES IF: 1. YOU ARE ALLERGIC TO 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, dif Read the complete document
PRODUCT INFORMATION ORION TEMOZOLOMIDE CAPSULES NAME OF THE MEDICINE Temozolomide 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 and methanol and practically insoluble in ethanol. DESCRIPTION Each Orion Temozolomide Capsule contains temozolomide (5mg, 20mg, 100mg, 140mg, 180mg or 250mg). Inactive ingredients: anhydrous lactose, sodium starch glycolate, stearic acid, tartaric acid and colloidal anhydrous silica. Capsule shell: gelatine and titanium dioxide (E171). Printing ink: TekPrint SB-4020 Green Ink [ARTG No. 2652] (Orion Temozolomide 5mg Capsules); TekPrint SB-2008 Orange Ink [ARTG No. 107473] (Orion Temozolomide 20mg Capsules); Pink TekPrint SW-1105 [ARTG No. 3325] (Orion Temozolomide 100mg Capsules); TekPrint SB-6018 Blue Ink [ARTG No. 2653] ( Orion Temozolomide 140mg Capsules); TekPrint SW-1102 Red Ink [ARTG No. 107015] (Orion Temozolomide 180mg Capsules) and OPACODE monogramming ink S-1-277002 black [ARTG No. 107581] (Orion Temozolomide 250mg Capsules). PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Temozolomide is an imidazotetrazine alkylating agent with antitumor activity, which undergoes rapid chemical conversion in the systemic circulation at physiologic 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. _PRE-CLINICAL SAFETY DATA _ 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 1900mg/m 2 ) than in the mouse (approximately 1000mg/m 2 ). The minimum lethal dose in dogs was 600mg/m 2 . In the single- dose st Read the complete document