Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
temozolomide, Quantity: 5 mg
Southern Cross Pharma Pty Ltd
Temozolomide
Capsule, hard
Excipient Ingredients: colloidal anhydrous silica; purified water; Gelatin; sodium starch glycollate; tartaric acid; stearic acid; lactose; microcrystalline cellulose; indigo carmine; iron oxide yellow; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
20, 5
(S4) Prescription Only Medicine
Temozolomide is indicated for the treatment of:,- patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment. - 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: 5 mg capsules (light green opaque, size 4) marked with black imprint TMZ 5 mg; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-01-07
TEMOZOLOMIDE ALPHAPHARM 1 TEMOZOLOMIDE ALPHAPHARM _Temozolomide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Temozolomide Alphapharm. 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 Temozolomide Alphapharm against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TEMOZOLOMIDE ALPHAPHARM IS USED FOR Temozolomide Alphapharm is used to treat patients with brain tumours. Temozolomide Alphapharm is also used to treat adult patients with advanced metastatic malignant melanoma. Your doctor, however, may prescribe Temozolomide Alphapharm for another purpose. This medicine belongs to a group of medicines called cytotoxic or chemotherapy medicines. It works by killing cancer cells and stopping cancer cells from growing and multiplying. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Temozolomide Alphapharm 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 TEMOZOLOMIDE ALPHAPHARM _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE TEMOZOLOMIDE ALPHAPHARM IF YOU HAVE AN ALLERGY TO: • any medicine containing temozolomide or dacarbazine (DTIC) • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing, difficulty breathing or a tight feeling in your chest • swelling of the face, lips, tongue or other parts of the body, that may lead to difficulty swallowing • rash, itching or hives on the skin DO NO Read the complete document
AUSTRALIAN PRODUCT INFORMATION TEMOZOLOMIDE ALPHAPHARM (TEMOZOLOMIDE) CAPSULES _ _ 1. NAME OF THE MEDICINE Temozolomide 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg temozolomide, as the active ingredient. Excipient with known effect: Excipients with known effect: gelatin (contains sulfites) sugars (as lactose) in the 5mg and 20 mg capsules For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM 5 mg capsules Light green opaque, size 4, marked with black imprint “TMZ 5 mg”. 20 mg capsules Rich yellow opaque, size 1, marked with black imprint “TMZ 20 mg”. 100 mg capsules Flesh opaque, size 1, marked with black imprint “TMZ 100 mg”. 140 mg capsules Powder blue opaque, size 1, marked with black imprint “TMZ 140 mg”. 180 mg capsules Medium orange opaque, size 1, marked with black imprint “TMZ 180 mg”. 250 mg capsules Buff opaque, size 0, marked with black imprint “TMZ 250 mg”. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Temozolomide is indicated for the treatment of: • patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as adjuvant treatment. • recurrence of anaplastic astrocytoma and glioblastoma multiforme following standard therapy. Temozolomide is also indicated as first line treatment for patients with advanced metastatic malignant melanoma. 4.2. DOSE AND METHOD OF ADMINISTRATION Temozolomide Alphapharm capsules are intended for oral administration. Anti-emetic therapy may be administered prior to or following administration of temozolomide. Temozolomide capsules should be administered in the fasting state at least one hour before a meal. If vomiting occurs after the dose is administered, a second dose should not be administered that day. Temozolomide Alphapharm – AUSTRALIAN PRODUCT INFORMATION 2 Temozolomide capsules must not be opened or chewed, but are to be swallowed whole with a glass of water. If a capsule becomes damaged, av Read the complete document