Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
vemurafenib
ROCHE (MALAYSIA) SDN. BHD.
vemurafenib
56tablet Tablets
Delpharm Milano s.r.l
_ _ _Consumer Medication Information Leaflet (RiMUP) _ ZELBORAF ® 240 MG FILM-COATED TABLETS _Vemurafenib 240 mg _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What Zelboraf is used for 2. How Zelboraf works 3. Before you use Zelboraf 4. How to use Zelboraf 5. While you are using Zelboraf 6. Side effects 7. Storage and disposal of Zelboraf 8. Product Description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 12. Serial Number WHAT ZELBORAF IS USED FOR Zelboraf is an anticancer medicine that contains the active substance vemurafenib. It is used to treat adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It can only be used in patients whose cancer has a change (mutation) in the “BRAF” gene. This change may have led to the development of melanoma. A validated test is required to identify BRAF V600 mutation status. HOW ZELBORAF WORKS Zelboraf targets proteins made from this modified gene and slows down or stops the development of your cancer. BEFORE YOU USE ZELBORAF - _WHEN YOU MUST NOT USE IT_ Do not take Zelboraf: - if you are ALLERGIC to vemurafenib or any of the other ingredients of this medicine (listed at the end of this leaflet). Symptoms of allergic reactions may include swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation. - _BEFORE YOU START TO USE IT _ Talk to your doctor before taking Zelboraf. You should be careful of the following: - _Allergic reactions _ Allergic reactions can happen while taking Zelboraf and may be severe. Stop taking Zelboraf and get medical help immediately if you have any symptoms of an allergic reaction such as swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation. - _Severe skin reactions _ Severe skin reactions can happen while taking Zelboraf. Stop taking Zelboraf and talk to your doctor immediately if you get a skin rash with any of the following symptoms: blisters on your skin, blisters or sores in your mouth, peeling of your skin, fever, Lees het volledige document
PACK INSERT FOR MALAYSIA Zelboraf ® Vemurafenib 1. NAME OF THE MEDICINAL PRODUCT 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. P HARMACEUTICAL FORM Film -coated tablet (tablet). Pinkish white to orange white, oval, biconvex film -coated tablets of approximately 19 mm, with ‘VEM’ engraved on one side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Zelboraf is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation -positive unresectable or metastatic melanoma (see section 5.1). A validated test is required to identify BRAF V600 mutation status. 4.2 Posology and method of administration Treatment with Zelboraf should be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. Before taking Zelboraf , patients must have BRAF V6 00 mutation -positive tumour status confirmed by a validated test (see sections 4.4 and 5.1). Posology The recommended dose of Zelboraf is 960 mg (4 tablets of 240 mg) twice daily (equivalent to a total daily dose of 1,920 mg). Zelboraf may be taken with or without food, but consistent intake of both daily doses on an empty stomach should be avoided (see Section 5.2). Duration of treatment Treatment with Zelboraf should continue until disease progression or the develo pment of unacceptable toxicity (see tables 1 and 2 below). Missed doses If a 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 v omiting after Zelboraf administration the patient should not take an additional dose of the medicinal product but the treatment should be continued as usual. Posology adjustments Management of adverse drug reactions or QTc prolongation may require dose reduction, temporary interruption and Lees het volledige document