Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Dabrafenib mesilate 88.88mg equivalent to dabrafenib 75 mg; ;
Novartis New Zealand Ltd
Dabrafenib mesilate 88.88 mg (equivalent to dabrafenib 75 mg)
75 mg
Capsule
Active: Dabrafenib mesilate 88.88mg equivalent to dabrafenib 75 mg Excipient: Colloidal silicon dioxide Hypromellose Iron oxide red Magnesium stearate Microcrystalline cellulose Purified water Titanium dioxide
Prescription
Glaxo Wellcome Manufacturing Pte Ltd
TAFINLAR is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma. Tafinlar in combination with trametinib is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. TAFINLAR in combination with MEKINIST, is indicated for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
Package - Contents - Shelf Life: Bottle, plastic, HDPE with child resistant PP closure - 28 capsules - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with child resistant PP closure - 120 capsules - 36 months from date of manufacture stored at or below 30°C
2013-09-24
TAFINLAR ® 1 TAFINLAR ® _dabrafenib (as mesilate) capsules _ NZ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING TAFINLAR. This leaflet answers some common questions about TAFINLAR. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP TO DATE LEAFLET FROM WWW.MEDSAFE.GOVT.NZ. The updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you taking TAFINLAR 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 TAFINLAR IS USED FOR TAFINLAR capsules contain the active substance dabrafenib, which belongs to a group of medicines called "Selective BRAF-inhibitors". TAFINLAR can be used by itself or in combination with another medicine called MEKINIST. IF YOU ARE TAKING THESE MEDICINES TOGETHER, PLEASE READ THE MEKINIST CONSUMER MEDICINE INFORMATION AS WELL AS THIS ONE CAREFULLY. TAFINLAR is a medicine used to: • Treat types of: − Skin cancers called melanoma − Thyroid cancers called anaplastic thyroid cancer (ATC) − lung cancers called non-small cell lung cancer (NSCLC) that have spread to other parts of the body. • Prevent melanoma from coming back after the melanoma has been removed by surgery. All of these cancers have changes (mutations) in a gene called "BRAF" that may have caused the cancer to develop. TAFINLAR targets proteins made from this mutated BRAF gene and slows down or stops the development of you Leggi il documento completo
NEW ZEALAND DATA SHEET TAFINLAR CAPSULES _Dabrafenib mesilate_ Page 1 of 49 1. PRODUCT NAME TAFINLAR 50 mg hard capsules TAFINLAR 75 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION TAFINLAR 50 mg capsule Each hard capsule contains 50mg of dabrafenib (as mesilate). TAFINLAR 75 mg capsule Each hard capsule contains 75mg of dabrafenib (as mesilate). EXCIPIENTS For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. TAFINLAR 50 mg capsule Opaque, size 2, hard capsule composed of a dark red body and dark red cap containing a white to slightly coloured solid. The capsule shell is imprinted with GS TEW and 50 mg. TAFINLAR 75 mg capsule Opaque, size 1, hard capsule composed of a dark pink body and dark pink cap containing a white to slightly coloured solid. The capsule shell is imprinted with GS LHF and 75 mg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Unresectable or metastatic melanoma TAFINLAR as monotherapy is indicated for the treatment of patients with BRAF V600 mutation positive unresectable Stage III or metastatic (Stage IV) melanoma. TAFINLAR in combination with MEKINIST is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Adjuvant treatment of melanoma TAFINLAR in combination with MEKINIST, is indicated for the adjuvant treatment of patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. Anaplastic thyroid cancer (ATC) TAFINLAR in combination with MEKINIST is indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation. Non-small cell lung cancer (NSCLC) TAFINLAR in combination with MEKINIST is indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation. NEW ZEALAND DATA SHEET TAFINLAR CAPSULES _Dabrafenib mesilate_ Page 2 of 49 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment with TAFINLAR should be initiated by a physician experience Leggi il documento completo