מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
temozolomide, Quantity: 20 mg
Juno Pharmaceuticals Pty Ltd
Temozolomide
Capsule, hard
Excipient Ingredients: lactose; iron oxide yellow; tartaric acid; stearic acid; titanium dioxide; Gelatin; colloidal anhydrous silica; purified water; sodium starch glycollate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
20 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: Yellow/White hard capsule, size 5, printed in black ink with 'TMZ' on the cap and '20' on the body.; Container Type: Sachet; Container Material: Other composite material; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-06-14
Temozolomide Juno 1 TEMOZOLOMIDE JUNO 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 TEMOZOLOMIDE JUNO? Temozolomide Juno contains the active ingredient temozolomide. Temozolomide belongs to a group of medicines called cytotoxic or chemotherapy medicines. Temozolomide works by killing cancer cells and stopping cancer cells from growing and multiplying. For more information, see Section 1. Why am I using Temozolomide Juno? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TEMOZOLOMIDE JUNO? Do not use if you have ever had an allergic reaction to 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 Temozolomide Juno? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with temozolomide and affect how it works. 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 TEMOZOLOMIDE JUNO? • Your doctor has worked out the exact dose of Temozolomide Juno 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 Temozolomide Juno? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TEMOZOLOMIDE JUNO? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Temozolomide Juno. • Tell your doctor if you feel sick or vomit while being treated with Temozolomide Juno. THINGS YOU SHOULD NOT DO • Do not open the capsules. If a capsule is damaged, avoid contact with your skin, eyes and nose. Avoid inhaling the powder. If you touc קרא את המסמך השלם
Australian Product Information Temozolomide JUNO PI v 7.0 Page | 1 AUSTRALIAN PRODUCT INFORMATION _TEMOZOLOMIDE JUNO _ _(TEMOZOLOMIDE) _ _ _ 1 NAME OF THE MEDICINE Temozolomide. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TEMOZOLOMIDE JUNO capsules come in 6 strengths and contain 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg of temozolomide. List of excipients with known effect: contains sugars as lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM TEMOZOLOMIDE JUNO (temozolomide) 5 mg: Green and white hard capsules, printed in black ink with “TMZ” on the cap and “5” on the body. TEMOZOLOMIDE JUNO (temozolomide) 20 mg: Yellow and white hard capsules, printed in black ink with “TMZ” on the cap and “20” on the body. TEMOZOLOMIDE JUNO (temozolomide) 100 mg: Pink and white hard capsules, printed in black ink with “TMZ” on the cap and “100” on the body. TEMOZOLOMIDE JUNO (temozolomide) 140 mg: Blue and white hard capsules, printed in black ink with “TMZ” on the cap and “140” on the body. TEMOZOLOMIDE JUNO (temozolomide) 180 mg: Maroon and white hard capsules, printed in black ink with “TMZ” on the cap and “180” on the body. TEMOZOLOMIDE JUNO (temozolomide) 250 mg: White hard capsules, printed in black ink with “TMZ” on the cap and “250” on the body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 JUNO is also indicated as a first-line treatment for patients with advanced metastatic malignant melanoma. Australian Product Information Temozolomide JUNO PI v 7.0 Page | 2 4.2 DOSE AND METHOD OF ADMINISTRATION Antiemetic therapy may be administered prior to or following administration of temozolomide. Temozolomide should be administered in the fasting state at least one hour before a meal. If vom קרא את המסמך השלם