Land: Australien
Språk: engelska
Källa: Department of Health (Therapeutic Goods Administration)
temozolomide
Southern Cross Pharma Pty Ltd
Temozolomide
Medicine Registered
Registered
________________________________________________________________________________ August 2016 Page 1 of 4 TEMOLIDE _Temozolomide_ CONSUMER MEDICINE INFORMATION _ _ What is in this leaflet This leaflet answers some common questions about Temolide. 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 Temolide 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 Temolide is used for Temolide is used to treat patients with brain tumours. Temolide is also used to treat adult patients with advanced metastatic malignant melanoma. Your doctor, however, may prescribe Temolide for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TEMOLIDE HAS BEEN PRESCRIBED FOR YOU. Temolide belongs to a group of medicines called cytotoxic or chemotherapy medicines. Temolide works by killing cancer cells and stopping cancer cells from growing and multiplying. This medicine is only available with a doctor's prescription. _Use in children _ Temolide 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 it _When you must not take it _ DO NOT TAKE TEMOLIDE IF: 1. YOU ARE ALLERGIC TO TEMOLIDE (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. Temolide may cause birth defects if either the male or female is using Läs hela dokumentet
Temolide/PI July 16 Page 1 of 16 PRODUCT INFORMATION TEMOLIDE CAPSULES 5 MG, 20MG 100MG, 140MG, 180MG AND 250MG NAME OF THE MEDICINE Temozolomide The chemical structure of temozolomide is: CAS number: 85622-93-1. Chemical name: imidazo[5,1-d]- 1,2,3,5-tetrazine- 8-carboxamide, 3,4-dihydro-3- methyl-4-oxo. Molecular formula: C 6 H 6 N 6 O 2 MW: 194.15 DESCRIPTION PROPRIETARY NAME: Temolide Capsules 5 mg, 20mg 100mg, 140mg, 180mg and 250mg Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4 mg/mL) and ethanol (0.6 mg/mL). _INACTIVE _ Lactose (in the 5mg and 20mg capsules only), sodium starch glycollate, stearic acid, tartaric acid, microcrystalline cellulose and anhydrous colloidal silica. _CAPSULE SHELL. _ Gelatin, water, titanium dioxide (ARTG 94457), iron oxide yellow (ARTG 93287, 5 mg, 20 mg and 250 mg capsules only), indigo carmine (ARTG 54048, 5 mg and 140mg capsules only), iron oxide red (ARTG 93285, 100 mg and 250mg capsules only), iron oxide black (ARTG 93283, 100 mg and 250 mg capsules only), sunset yellow FCF (ARTG 93377,180 mg capsules only), and allura red AC (ARTG 52014, 180 mg capsules only). Capsule printing ink is Opacode monogramming ink S-1-27794, with ARTG number 12104. Temolide/PI July 16 Page 2 of 16 PHARMACOLOGY PHARMACOLOGICAL ACTIONS 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 1,900 mg/m 2 ) than in the mouse (approximately 1,000 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 delayed toxicity to tissues that normally proliferate more rapidly resulting in general deterioration of organ function; toxicity is consistent with that expected of an alkylating agent. Temozolomide is rapidly absorbed following oral administration. Systemic exposure at the therapeutic dose level in humans is similar to that of the rat and dog. Single cycle (five Läs hela dokumentet