Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
vinorelbine tartrate, Quantity: 41.55 mg (Equivalent: vinorelbine, Qty 30 mg)
Luminarie Pty Ltd
Capsule, soft
Excipient Ingredients: Gelatin; partially dehydrated liquid sorbitol; polysorbate 80; macrogol 400; titanium dioxide; purified water; iron oxide red
Oral
1 capsule
(S4) Prescription Only Medicine
Non-small cell lung cancer: Velabine is indicated for the first line treatment of advanced non-small cell lung cancer, as a single agent or in combination. ,Breast cancer: Velabine is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination.
Visual Identification: oblong-shaped pink soft capsule; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Child resistant closure
Registered
2023-02-14
VELABINE 1 VELABINE 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 TAKING VELABINE CAPSULES? VELABINE contains the active ingredient vinorelbine tartrate. VELABINE is used to treat lung cancer and advanced breast cancer. For more information, see Section 1. Why am I taking VELABINE capsules? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE VELABINE CAPSULES? Do not use if you have ever had an allergic reaction to VELABINE capsules 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 take VELABINE capsules? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with VELABINE capsules 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 TAKE VELABINE CAPSULES? Swallow your VELABINE capsules whole with a full glass of water, without chewing or sucking the capsule. More instructions can be found in Section 4. How do I take VELABINE capsules? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING VELABINE CAPSULES? 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 VELABINE capsules, tell your doctor immediately. THINGS YOU SHOULD NOT DO • You should not breast-feed while you are being treated with VELABINE capsules. • Men being treated with VELABINE capsules 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 had a yell Read the complete document
AUSTRALIAN PRODUCT INFORMATION – VELABINE (VINORELBINE) SOFT CAPSULES 1 NAME OF THE MEDICINE Vinorelbine 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: oval-shaped light brown soft capsule. 30 mg soft capsule: oblong-shaped pink soft capsule. 80 mg soft capsule: oblong-shaped pale yellow soft capsule. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER VELABINE is indicated for the first line treatment of advanced non-small cell lung cancer, as a single agent or in combination. BREAST CANCER VELABINE is indicated for the treatment of advanced breast cancer after failure of standard therapy as a single agent or in combination. 4.2 D OSE 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 vinorelbine soft capsules 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 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 Read the complete document