Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
temozolomide, Quantity: 140 mg
Accord Healthcare Pty Ltd
Temozolomide
Capsule, hard
Excipient Ingredients: Gelatin; purified water; indigo carmine; colloidal anhydrous silica; stearic acid; titanium dioxide; tartaric acid; sodium starch glycollate; lactose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
20 Capsules, 15 Capsules, 5 Capsules
(S4) Prescription Only Medicine
Treatment of newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment.,Treatment of recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy.,Temozolomide is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma.
Visual Identification: Blue/White hard capsule, size 1, printed in black ink with 'TMZ' on the cap and '140' on the body.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2011-07-19
TEMACCORD CMI 1 TEMACCORD temozolomide Version 2.0 CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TEMACCORD. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking TEMACCORD against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. WHAT TEMACCORD IS USED FOR TEMACCORD contains temozolomide as the active ingredient and belongs to a group of medicines called cytotoxics or chemotherapy medicines. It works by killing cancer cells and stopping cancer cells from growing and multiplying. TEMACCORD is used to treat: patients with brain tumours adult patients with advanced metastatic malignant melanoma. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TEMACCORD HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed TEMACCORD for another reason. USE IN CHILDREN TEMACCORD can be used to treat children, 3 years of age and older, with specific forms of brain cancer (glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy). TEMACCORD is available only with a doctor's prescription. BEFORE YOU TAKE TEMACCORD WHEN YOU MUST NOT TAKE IT DO NOT TAKE TEMACCORD IF YOU ARE ALLERGIC TO MEDICINES CONTAINING TEMOZOLOMIDE, DACARBAZINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath. DO NOT TAKE TEMACCORD IF YOU HAVE VERY LOW LEVELS OF WHITE BLOOD CELLS, RED BLOOD CELLS OR PLATELETS. DO NOT TAKE TEMACCORD IF YOU ARE PREGNANT. DO NOT TAKE TEMACCORD IF YOU OR YOUR PARTNER INTEND TO BECOME PREG Прочитайте повний документ
Temaccord – Product Information Page 1 of 13 PRODUCT INFORMATION Temaccord Capsules 5/20/100/140/180/250 mg NAME OF THE MEDICINE Temozolomide. The chemical name for temozolomide is 4-methyl-5-oxo- 2,3,4,6,8-pentazabicyclo [4.3.0] nona- 2,7,9-triene- 9-carboxamide. Its structural formula is: C 6 H 6 N 6 .O 2 Molecular weight: 194.15 CAS No.: 85622-93-1 DESCRIPTION Temozolomide is a white to pale brown/pink, crystalline powder which is odourless or almost odourless and hygroscopic. It is slightly soluble in water (3.1 mg/mL), methanol (4.4 mg/mL) and ethanol (0.6 mg/mL). Temaccord capsules come in 6 strengths and contain 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg of temozolomide. The capsules also contain lactose, colloidal anhydrous silica, sodium starch glycollate, tartaric acid and stearic acid. The capsule shells contain gelatin, water, titanium dioxide, Indigo carmine (5 mg, 140 mg capsules only), iron oxide yellow CI77492 (5 mg, 20 mg, 180 mg capsules only), iron oxide red (100 mg, 180 mg capsules only) and TekPrint SW-9008 Black Ink (ARTG 2328). The capsules are gluten free. 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. Temaccord – Product Information Page 2 of 13 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 Прочитайте повний документ