国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Vinorelbine tartrate 13.85 mg/mL equivalent to 10 mg/mL vinorelbine
New Zealand Medical & Scientific Ltd
Vinorelbine tartrate 13.85 mg/mL (equivalent to 10 mg/mL vinorelbine)
10 mg/mL
Solution for injection
Active: Vinorelbine tartrate 13.85 mg/mL equivalent to 10 mg/mL vinorelbine Excipient: Water for injection
Vial, glass, single dose, 1 ml single dose 10mg/ml, 1 mL
Prescription
Prescription
Pierre Fabre Medicament - Plantes et Industrie
Package - Contents - Shelf Life: Vial, glass, single dose, - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at or below 30°C - Vial, glass, single dose, - 4 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at or below 30°C - Vial, glass, single dose, - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours opened stored at or below 30°C
1995-12-22
Navelbine IV 1 NAVELBINE IV 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 DO I NEED NAVELBINE®IV? Navelbine IV contains the active ingredient vinorelbine tartrate. Navelbine IV is used to treat lung cancer and advanced breast cancer. For more information, see Section 1. Why do I need Navelbine®IV? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I AM GIVEN NAVELBINE®IV? 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 am given Navelbine IV? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Navelbine IV 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 IS NAVELBINE IV GIVEN? • Navelbine IV is given as a slow infusion (drip) into your veins. Navelbine IV must only be given by a doctor or nurse. More instructions can be found in Section 4. How is Navelbine IV given? in the full CMI. 5. WHAT SHOULD I KNOW WHILE I AM GIVEN NAVELBINE IV? THINGS YOU SHOULD DO • Tell your doctor or nurse immediately if you feel any pain or discomfort during theinfusion. • Keep all appointments with your doctor to check on your progress and monitor side effects. • If you become pregnant while taking Navelbine IV, tell your doctor immediately. • THINGS YOU SHOULD NOT DO • You should not breast-feed while you are being treated with Navelbine IV. • 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 yellow fever vaccination or plan to have one. • Do not use if 完全なドキュメントを読む
Page 1 of 19 NEW ZEALAND DATA SHEET 1 NAVELBINE ® (10 MG/ML SOLUTION FOR INJECTION) NAVELBINE ® vinorelbine (as tartrate) 10 mg/mL solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 mL contains 10 mg vinorelbine (as tartrate). For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection NAVELBINE Injection is a clear colourless to pale yellow solution. The pH of NAVELBINE Injection is approximately 3.5. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NAVELBINE Injection is indicated as a single agent or in combination for 1. the treatment of non small cell lung cancer (NSCLC), and 2. the second line treatment of advanced breast cancer 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS Single agent treatment is usually given at 25-30mg/m 2 weekly. In combination chemotherapy the dose may be the same and frequency of administration reduced, i.e. day 1 and 8 or day 1 and 5 every 3 weeks. NAVELBINE Injection should be administered either by infusion over 6 to 10 minutes after dilution in 50 mL of a 0.9% sodium chloride solution or by an infusion over 20 to 30 minutes, after dilution in 125 mL of normal saline solution. Administration should always be followed by at least 250 mL normal saline infusion to flush the vein. Page 2 of 19 DOSAGE IN PATIENTS WITH HAEMATOLOGICAL TOXICITY Neutrophil counts should be ≥1000 cells/mm 3 prior to the administration of NAVELBINE Injection. Adjustments in the dosage of NAVELBINE Injection should be based on neutrophil counts obtained on the day of treatment (see Table 1). TABLE 1. NEUTROPHILS (CELLS/MM 3 ) ON DAY OF TREATMENT DOSE OF NAVELBINE (MG/M 2 ) 1500 30 1000 TO 1499 15 < 1000 Do not administer** **Repeat neutrophil count in 1 week. If three consecutive weekly doses are held because neutrophil count is <1000 cells/mm 3 , discontinue NAVELBINE ® . Note: For patients who, during treatment with NAVELBINE Injection, have experienced fever and/or sepsis while neutropenic or had 2 consecutive weekly dos 完全なドキュメントを読む