Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30 mg
New Zealand Medical & Scientific Ltd
Vinorelbine tartrate 41.55 mg (equivalent to vinorelbine 30 mg)
30 mg
Soft gelatin capsule
Active: Vinorelbine tartrate 41.55mg equivalent to vinorelbine 30 mg Excipient: Edible Ink Red Ethanol Gelatin Glycerol Anidrisorb 85/70 85% Phosal 53 MCT Iron oxide red Macrogol 400 Medium-chain triglycerides Purified water Titanium dioxide
Blister pack, 1 capsule
Prescription
Prescription
Pierre Fabre Medicament - Plantes et Industrie
First line treatment of advanced non-small cell lung cancer (NSCLC) as a single agent or in combination
Package - Contents - Shelf Life: Blister pack, - 1 capsules - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2004-04-21
Navelbine Oral 1 NAVELBINE ORAL 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 NAVELBINEORAL? 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 NAVELBINEORAL? 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 have recently Đọc toàn bộ tài liệu
Page 1 of 22 NEW ZEALAND DATA SHEET 1 NAVELBINE ® (SOFT CAPSULES) NAVELBINE ® 20 mg, 30 mg Soft Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Capsules contain 20 mg or 30 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. 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. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS _SINGLE AGENT _ The recommended regimen is: First three administrations: 60 mg/m 2 , administered once weekly. Page 2 of 22 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 between 75,000 and 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 more than once between 500 and 1000/mm 3 , the dose must be delayed until recovery and reduced from 80 to 60 mg/m 2 per week during the 3 subsequent administrations. TABLE 2 NEUTROP Đọc toàn bộ tài liệu