Country: Израел
Језик: Енглески
Извор: Ministry of Health
TRAMETINIB AS DIMETHYL SULFOXIDE
NOVARTIS ISRAEL LTD
L01XE25
FILM COATED TABLETS
TRAMETINIB AS DIMETHYL SULFOXIDE 0.5 MG
PER OS
Required
LEK PHARMACEUTICALS D.D., SLOVENIA
TRAMETINIB
Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Non-small cell lung cancer (NSCLC) :Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.Adjuvant treatment of melanoma :Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid CancerTAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment optionsBRAF V600E Mutation-Positive Unresectable or Metastatic Solid TumorsMekinist is indicated, in combination with dabrafenib, for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Limitations of Use: Trametinib is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibitionTrametinib is indicated, in combination with dabrafenib, for the treatment of pediatric patients 6 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy
2020-10-31
MEK APL MAR22 V5 Page 2 of 14 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor's prescription only MEKINIST ® 0.5 MG, FILM-COATED TABLETS Each film-coated tablet contains trametinib (as dimethyl sulfoxide) 0.5 mg MEKINIST ® 2 MG, FILM-COATED TABLETS Each film-coated tablet contains trametinib (as dimethyl sulfoxide) 2 mg Inactive ingredients and allergens: See section 6 ‘Additional information’ and section 2 under ‘Important information about some of this medicine’s ingredients’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? Mekinist is used as monotherapy or in combination with an additional medicine containing dabrafenib for the treatment of adults with a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery. Mekinist in combination with dabrafenib is also used for the adjuvant treatment of stage III melanoma in adults, following complete removal of the lesion by surgery. Mekinist in combination with dabrafenib is also used for the treatment of adults with an advanced stage of lung cancer called non-small cell lung cancer (NSCLC). Mekinist in combination with dabrafenib is also intended for the treatment of a type of thyroid cancer called anaplastic thyroid cancer (ATC) that has a mutation in the BRAF gene (BRAF V600E mutation), which has spread to other parts of the body or is in one place and in advanced state, and after no satisfactory results have been obtained from local treatment options. Mekinist in combination with dabrafenib is intended for the treatment of solid tumours in adults and children 6 years and older whic Прочитајте комплетан документ
Page 1 of 43 MEK API MAR23 V5 MEKINIST® 0.5 MG MEKINIST® 2 MG 1. NAME OF THE MEDICINAL PRODUCT Mekinist® 0.5 mg film-coated tablets Mekinist® 2 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mekinist 0.5 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 0.5 mg of trametinib. Mekinist 2 mg film-coated tablets Each film-coated tablet contains trametinib dimethyl sulfoxide equivalent to 2 mg of trametinib. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Mekinist 0.5 mg film-coated tablets Yellow, modified oval, biconvex, film-coated tablets, with ‘GS’ debossed on one face and ‘TFC’ on the opposing face. Mekinist 2 mg film-coated tablets Pink, round, biconvex, film-coated tablets, with ‘GS’ debossed on one face and ‘HMJ’ on the opposing face. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Melanoma Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5.1). Adjuvant treatment of melanoma Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection. Non-small cell lung cancer (NSCLC) Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. Page 2 of 43 MEK API MAR23 V5 Anaplastic Thyroid Cancer (ATC) Trametinib is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options ( _see section 4.2)_ . BRAF V600E Mutation-Positi Прочитајте комплетан документ