Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
vinorelbine tartrate, Quantity: 110.8 mg (Equivalent: vinorelbine, Qty 80 mg)
Pierre Fabre Australia Pty Ltd
Capsule, soft
Excipient Ingredients: ethanol; purified water; glycerol; macrogol 400; Gelatin; iron oxide yellow; titanium dioxide; medium chain triglycerides; ascorbyl palmitate; phosphatidyl choline; dl-alpha-tocopherol; sorbitol; 1,4-sorbitan; mannitol; hydrogenated starch hydrosylate; hypromellose; propylene glycol; isopropyl alcohol; aluminium chloride; sodium hydroxide; cochineal
Oral
1 tablet
(S4) Prescription Only Medicine
Non-small cell lung cancer: NAVELBINE Oral is indicated for first line treatment of advanced non-small cell lung cancer, as a single agent or in combination.,Breast cancer: NAVELBINE Oral is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.
Visual Identification: pale yellow, soft capsule printed N80.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2005-05-31
NAVELBINE ORAL N a v e l b i n e O r 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 NAVELBINE ORAL? Navelbine Oral contains the active ingredient vinorelbine tartrate. Navelbine Oral is used to treat lung cancer and advanced breast cancer. For more information, see Section 1. Why am I using Navelbine Oral? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NAVELBINE ORAL? Do not use if you have ever had an allergic reaction to 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 Navelbine Oral? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Navelbine Oral 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 NAVELBINE ORAL? • Navelbine Oral is given as a capsule. Swallow your Navelbine Oral capsule whole with a full glass of water, without chewing or sucking the capsule. More instructions can be found in Section 4. How do I use Navelbine Oral? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NAVELBINE ORAL? THINGS YOU SHOULD DO • Keep all appointments with your doctor to check on your progress and monitor side effects. • If you become pregnant while taking Navelbine Oral, tell your doctor immediately. THINGS YOU SHOULD NOT DO • You should not breast-feed while you are being treated with Navelbine Oral. • Men being treated with Navelbine Oral are advised not to father a child during and up to a minimum of 3 months after treatment. • Do not use if you have or have had an infection or high temperature in the last 2 weeks • Do not use if you are currently receiving radiation therapy. • Do not use if you ha Baca dokumen lengkapnya
Version: A05-210721 Page 1 Supersedes: A04-080620 AUSTRALIAN PRODUCT INFORMATION – NAVELBINE ® (VINORELBINE TARTRATE) SOFT CAPSULES 1 NAME OF THE MEDICINE Vinorelbine tartrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Capsules contain 20 mg, 30 mg and 80 mg vinorelbine (as tartrate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Soft capsule 20 mg soft capsule: light brown soft capsule printed N20. 30 mg soft capsule: pink soft capsule printed N30. 80 mg soft capsule*: pale yellow soft capsule printed N80. *Not marketed 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER NAVELBINE Oral is indicated for the first line treatment of advanced non-small cell lung cancer, as a single agent or in combination. BREAST CANCER NAVELBINE Oral is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination. Version: A05-210721 Page 2 Supersedes: A04-080620 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS _SINGLE AGENT _ The recommended regimen is: First three administrations: 60 mg/m 2 , administered once weekly. Subsequent administrations: Beyond the third administration, increasing the dose of NAVELBINE Oral to 80 mg/m 2 once weekly is recommended, except in those patients for whom the neutrophil count has dropped once below 500/mm 3 or more than once between 500 and 1000/mm 3 during the first 3 administrations at 60 mg/m 2 . _DOSE MODIFICATIONS ACCORDING TO HAEMATOLOGICAL STATUS _ If the neutrophil count is below 1500/mm 3 and/or the platelet count is below 100,000/mm 3 , then treatment should be delayed until recovery. TABLE 1. NEUTROPHIL COUNT DURING THE FIRST 3 ADMINISTRATIONS AT 60 MG/M 2 /WEEK NEUTROPHILS >1000 NEUTROPHILS ≥500 AND <1000 (1 EPISODE) NEUTROPHILS ≥500 AND <1000 (2 EPISODES) NEUTROPHILS <500 RECOMMENDED DOSE FOR 4 TH AND SUBSEQUENT ADMINISTRATIONS 80 80 60 60 For any administration planned at the 80 mg/m 2 /week dose, if the neutrophil count falls below 500/mm 3 or mor Baca dokumen lengkapnya