국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
temozolomide, Quantity: 180 mg
Arrotex Pharmaceuticals Pty Ltd
Temozolomide
Capsule, hard
Excipient Ingredients: tartaric acid; purified water; colloidal anhydrous silica; stearic acid; microcrystalline cellulose; Gelatin; sodium starch glycollate; allura red AC; sunset yellow FCF; titanium dioxide; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid
Oral
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: 180 mg capsules (medium orange opaque, size 1) marked with black imprint TMZ 180 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
2015-02-19
APO-Temozolomide 1 APO-TEMOZOLOMIDE CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING APO-TEMOZOLOMIDE? APO-Temozolomide contains the active ingredient temozolomide. APO-Temozolomide belongs to a group of medicines called cytotoxic or chemotherapy medicines. APO-Temozolomide works by killing cancer cells and stopping cancer cells from growing and multiplying. For more information, see Section 1. Why am I using APO-Temozolomide? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE APO-TEMOZOLOMIDE? Do not use if you have ever had an allergic reaction to APO-Temozolomide or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use APO-Temozolomide? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with APO-Temozolomide and affect how it works. Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE APO-TEMOZOLOMIDE? • Your doctor has worked out the exact dose of APO-Temozolomide for you according to your individual needs. • Each time you start a new treatment cycle, be sure you understand exactly how many capsules of each strength you need to take on each day of dosing. More instructions can be found in Section 4. How do I use APO-Temozolomide? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING APO-TEMOZOLOMIDE? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using APO-Temozolomide. • Tell your doctor if you feel sick or v 전체 문서 읽기
1 AUSTRALIAN PRODUCT INFORMATION APO-TEMOZOLOMIDE (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. EXCIPIENTS WITH KNOWN EFFECT Lactose. Contains trace amounts of sulfites. 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 2 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 APO-Temozolomide capsules are intended for oral administration. DOSAGE 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 capsules must not be opened or chewed, but are to be swallowed whole with a glass of water. If a capsule becomes damaged, avoid contact of the powder contents with skin or mucous membrane. NEWLY DIAGNOSED GLIOBLASTOMA MULTIFORME (ADULTS) Concomitant Phase Temozo 전체 문서 읽기