Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
temozolomide, Quantity: 20 mg
Merck Sharp & Dohme (Australia) Pty Ltd
Temozolomide
Capsule, hard
Excipient Ingredients: tartaric acid; colloidal anhydrous silica; iron oxide yellow; Gelatin; lactose; sodium lauryl sulfate; stearic acid; titanium dioxide; sodium starch glycollate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; simethicone
Oral
5 capsules
(S4) Prescription Only Medicine
TEMODAL capsules are 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. TEMODAL capsules are also indicated as first line treatment for patients with advanced metastatic malignant melanoma.
Visual Identification: Size No 2 capsule with yellow cap and opaque white body containing a white to light pink, light tan powder. The cap is imprinted in black ink with "TEMODAL", the body is imprinted in black ink with two stripes; "20 mg" and the Schering-Plough logo.; Container Type: Sachet; Container Material: Other plastic laminate/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2009-11-13
TEMODAL ® T E M O D A L ® 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 TEMODAL? TEMODAL contains the active ingredient temozolomide. TEMODAL belongs to a group of medicines called cytotoxic or chemotherapy medicines. TEMODAL works by killing cancer cells and stopping cancer cells from growing and multiplying. For more information, see Section 1. Why am I using TEMODAL? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TEMODAL? Do not use if you have ever had an allergic reaction to TEMODAL 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 TEMODAL? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TEMODAL 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 TEMODAL? • Your doctor has worked out the exact dose of TEMODAL 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 TEMODAL? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TEMODAL? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using TEMODAL. • Tell your doctor if you feel sick or vomit while being treated with TEMODAL THINGS YOU SHOULD NOT DO • Do not open the capsules. If a capsule is damaged, avoid contact wi Lue koko asiakirja
Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION TEMODAL (TEMOZOLOMIDE) CAPSULES 1 NAME OF THE MEDICINE Temozolomide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4 mg/mL) and ethanol (0.6 mg/mL). Each TEMODAL capsule contains temozolomide (5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg). List of excipients with known effect: - lactose For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TEMODAL (temozolomide) 5 mg: Size No. 3 capsule with opaque, green cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, “5 mg”, and the Schering-Plough logo. TEMODAL (temozolomide) 20 mg: Size No. 2 capsule with yellow cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, “20 mg”, and the Schering-Plough logo. TEMODAL (temozolomide) 100 mg: Size No. 1 capsule with pink, opaque cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, “100 mg”, and the Schering-Plough logo. TEMODAL (temozolomide) 140 mg: Size No. 0 capsule with blue, opaque cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, “140 mg”, and the Schering-Plough logo. TEMODAL (temozolomide) 180 mg: Size No. 0 capsule with orange, opaque cap and white, opaque body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, “180 mg”, and the Schering-Plough logo. TEMODAL (temozolomide) 250 mg: Size No. 0 capsule with white, opaque cap and body. The cap is imprinted in black ink with "TEMODAL". The body is imprinted in black ink with two stripes, “250 mg”, and the Schering-Plough logo. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TEMODAL is indicated for the treatment of Page 2 of 16 • patients with n Lue koko asiakirja