Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
everolimus, Quantity: 5 mg
Novartis Pharmaceuticals Australia Pty Ltd
Everolimus
Tablet, uncoated
Excipient Ingredients: butylated hydroxytoluene; lactose monohydrate; hypromellose; magnesium stearate; crospovidone; lactose
Oral
60 TABLETS, 30 TABLETS, 120 TABLETS, 100 TABLETS, 50 TABLETS
(S4) Prescription Only Medicine
Afinitor is indicated for the: ? Treatment of postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ? Treatment of progressive, unresectable or metastatic, well or moderately differentiated neuroendocrine tumours (NETs) of pancreatic origin. ? Treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults. ? Treatment of advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib. ? Treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not candidates for curative surgical resection. ? Treatment of patients with tuberous sclerosis complex (TSC) who have renal angiomyolipoma not requiring immediate surgery. ? Adjunctive treatment of patients aged 2 years and older with TSC and associated refractory seizures.
Visual Identification: White to slightly yellowish, elongated tablet with a bevelled edge. One side debossed with 'NVR' and the other side with '5'.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2009-08-06
AFINITOR ® A f i n i t o r ® 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. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details. 1. WHY AM I USING AFINITOR? Afinitor contains the active ingredient everolimus. Afinitor is used to treat various types of cancer by slowing the growth of cancer- causing cells. For more information, see Section 1. Why am I using Afinitor? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE AFINITOR? Do not use if you have ever had an allergic reaction to Afinitor 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 Afinitor? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Afinitor 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 AFINITOR? • Your doctor will tell you the dose of Afinitor that you should take. More instructions can be found in Section 4. How do I use Afinitor? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING AFINITOR? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Afinitor. • Avoid becoming pregnant while using Afinitor and for up to 8 weeks after you stop using it. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not take Afinitor to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if they have the same condition as you. DRIVING OR USING MACHINES • It is not known if Afinitor will influence your ability to drive and use machines. DRINKING ALCOHOL • There are no known interactions bet Les hele dokumentet
1 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PI – AFINITOR (EVEROLIMUS) TABLETS AND DISPERSIBLE TABLETS 1 NAME OF THE MEDICINE Everolimus. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Afinitor tablet contains either 2.5 mg, 5 mg or 10 mg everolimus. Each Afinitor dispersible tablet contains either 2 mg, 3 mg or 5 mg everolimus. Excipients with known effect: tablets only - contains sugars as lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 2.5 mg tablet: White to slightly yellowish, elongated tablet with a bevelled edge and no score engraved with “LCL” on one side and “NVR” on the other. 5 mg tablet: White to slightly yellowish, elongated tablet with a bevelled edge and no score engraved with “5” on one side and “NVR” on the other. 10 mg tablet: White to slightly yellowish, elongated tablet with a bevelled edge and no score engraved with “UHE” on one side and “NVR” on the other. 2 mg dispersible tablet: White to slightly yellowish, round, flat tablets with a bevelled edge and no score. The tablets are engraved with “D2” on one side and “NVR” on the other. 3 mg dispersible tablet: White to slightly yellowish, round, flat tablets with a bevelled edge and no score. The tablets are engraved with “D3” on one side and “NVR” on the other. 5 mg dispersible tablet: White to slightly yellowish, round, flat tablets with a bevelled edge and no score. The tablets are engraved with “D5” on one side and “NVR” on the other. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Afinitor is indicated for the: • Treatment of postmenopausal women with hormone receptor-positive, HER2 negative advanced breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ▼ 2 • Tre Les hele dokumentet