Land: New Zealand
Sprog: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Vemurafenib 240mg (as a co-precipitate with hypromellose acetate succinate (800 mg total)); ;
Roche Products (NZ) Ltd
Vemurafenib 240 mg (as a co-precipitate with hypromellose acetate succinate (800 mg total))
240 mg
Film coated tablet
Active: Vemurafenib 240mg (as a co-precipitate with hypromellose acetate succinate (800 mg total)) Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Iron oxide red Macrogol 3350 Magnesium stearate Polyvinyl alcohol Purified talc Titanium dioxide
Blister pack, OPA/Al/PVC, 56 tablets
Prescription
Prescription
Micro-Macinazione SA
Indicated for the treatment of unresectable stage IIIC or stage IV metastatic melanoma positive for the BRAF V600 mutation.
Package - Contents - Shelf Life: Blister pack, OPA/Al/PVC - 56 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture. Store in the original package
2011-05-20
Zelboraf 200605 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION ZELBORAF ® VEMURAFENIB 240 MG FILM-COATED TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ZELBORAF tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ZELBORAF against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ZELBORAF IS USED FOR ZELBORAF contains the active ingredient vemurafenib. ZELBORAF belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents. ZELBORAF is used to treat metastatic melanoma (a type of skin cancer that has spread to other parts of the body). It can only be used if your melanoma has a change (mutation) in the BRAF gene. Your doctor will have tested you for this gene. This change has been shown to be involved in the development of melanoma. ZELBORAF works by targeting proteins made from the BRAF gene to slow down the development of your cancer. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ZELBORAF HAS BEEN PRESCRIBED FOR YOU. ZELBORAF is not addictive. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE ZELBORAF _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ZELBORAF IF: 1. YOU ARE ALLERGIC (HYPERSENSITIVE) TO VEMURAFENIB OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing or difficulty breathing Zelboraf 200605 2 swelling of the face, lips, tongue or other parts of the body rash, itching or hives on the skin 2. THE PACKAGE IS TORN OR SHOWS SIGNS OF TAMPERING If the package is damaged, return it to your pharmacist for disposal. 3. THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED. If you take this medicine after the ex Læs hele dokumentet
1 Zelboraf 200605 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Zelboraf 240 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 240 mg of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Zelboraf film-coated 240 mg tablets are oval, biconvex, pinkish white to orange white tablets with “VEM” engraved on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zelboraf is indicated for the treatment of unresectable stage IIIC or stage IV metastatic melanoma positive for the BRAF V600 mutation. 4.2 DOSE AND METHOD OF ADMINISTRATION Before taking Zelboraf, patients must have BRAF V600 mutation-positive tumour status confirmed by a validated molecular pathology laboratory. RECOMMENDED DOSAGE The recommended dose of Zelboraf is 960 mg (four 240 mg tablets) twice daily (equivalent to a total daily dose of 1920 mg). The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Both doses of Zelboraf should be taken either 1 hour before or 2 hours after a meal. It is recommended that treatment with Zelboraf continue until disease progression or the development of unacceptable toxicity (see Table 1). MISSED DOSES If a planned dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice-daily regimen. Both doses should not be taken at the same time. VOMITING In case of vomiting after Zelboraf administration the patient should not take an additional dose of the medicine but the treatment should be continued as usual. 2 Zelboraf 200605 DOSE MODIFICATIONS Management of symptomatic adverse events or prolongation of QTc may require dose reduction, temporary interruption or treatment discontinuation of Zelboraf (see section 4.4). Dose modifications or interruptions are not recommended for cutaneous squamous cell carcinoma (cuSCC). Dose reductions resulting in a dose below 480 mg twice daily are Læs hele dokumentet