Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Sorafenib tosilate 274mg equivalent to sorafenib 200 mg; Sorafenib tosilate 274mg equivalent to sorafenib 200 mg
Bayer New Zealand Limited
Sorafenib tosilate 274 mg (equivalent to sorafenib 200 mg)
200 mg
Film coated tablet
Active: Sorafenib tosilate 274mg equivalent to sorafenib 200 mg Excipient: Croscarmellose sodium Hypromellose Iron oxide red Macrogol 3350 Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate Titanium dioxide Active: Sorafenib tosilate 274mg equivalent to sorafenib 200 mg Excipient: Croscarmellose sodium Hypromellose Iron oxide red Macrogol 3350 Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate Titanium dioxide
Blister pack, Al/Al foil, 60 tablets
Prescription
Prescription
Bayer AG
· Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
Package - Contents - Shelf Life: Blister pack, Al/Al foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Al/Al foil - 112 tablets - 36 months from date of manufacture stored at or below 25°C
2006-04-18
NEXAVAR® CMI vx4.0 1 NEXAVAR ® 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 NEXAVAR? NEXAVAR contains the active ingredient sorafenib tosilate. NEXAVAR is used to treat advanced liver cancer (hepatocellular carcinoma), advanced kidney cancer (renal cell carcinoma), or thyroid cancer (differentiated thyroid carcinoma). For more information, see Section 1. Why am I using NEXAVAR? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE NEXAVAR? Do not use if you have ever had an allergic reaction to NEXAVAR 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. NEXAVAR is not recommended for use while breast-feeding because it could harm the baby. For more information, see Section 2. What should I know before I take NEXAVAR? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with NEXAVAR and affect how it works. Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. 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 NEXAVAR? • THE USUAL DOSE OF NEXAVAR IS TWO 200 MG TABLETS TWICE A DAY. This is equivalent to 800 mg total daily dose. • Your doctor may put you on a lower dose or stop NEXAVAR treatment if you get severe side effects. • Swallow the tablets whole with a full glass of water. Take NEXAVAR either without food or with a low fat or moderate fat meal. Do not take this medicine with high fat meals, as this may make your NEXAVAR less effective. More instructions can be found in Section 4. How do I take NEXAVAR? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING NEX Đọc toàn bộ tài liệu
NEXAVAR DS Vx3.0; CCDS V22.0 Page 1 of 26 NEW ZEALAND DATA SHEET 1 PRODUCT NAME NEXAVAR® Sorafenib tosilate 274 mg (equivalent to sorafenib 200 mg) film-coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION NEXAVAR is a multikinase inhibitor targeting several serine/threonine and receptor tyrosine kinases. For the full list of Excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM NEXAVAR tablets contain 200 mg of sorafenib (274 mg sorafenib tosilate). The tablets are film coated red round, faceted biconvex marked with a Bayer cross on one side and “200” on the other. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications _Hepatocellular carcinoma _ NEXAVAR is indicated for the treatment of patients with hepatocellular carcinoma (HCC). _Renal cell carcinoma _ NEXAVAR is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). _Differentiated Thyroid carcinoma _ NEXAVAR is indicated for the treatment of patients with locally advanced or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine. 4.2 Dose and method of administration _Use in Adults _ Recommended dose The recommended daily dose of NEXAVAR is 400 mg (2 x 200 mg tablets) taken twice a day, either without food or together with a moderate fat meal. Duration of treatment Treatment should be continued until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs. Dose titration, dose adjustment, special monitoring advice Management of suspected adverse medicine reactions may require temporary interruption and/or dose reduction of NEXAVAR therapy. When dose reduction is necessary during the treatment of hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), the NEXAVAR dose should be reduced to two tablets of 200 mg once daily (see Special warnings and precautions for use). NEXAVAR DS Vx3.0; CCDS V22.0 Page 2 of 26 When dose reduction is necessary during the treatment of differentiated thyroid carcinoma, the NEXAVAR dose sh Đọc toàn bộ tài liệu