البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
COBIMETINIB AS HEMIFUMARATE
ROCHE PHARMACEUTICALS (ISRAEL) LTD
FILM COATED TABLETS
COBIMETINIB AS HEMIFUMARATE 20 MG
PER OS
Required
HOFFMANN LA ROCHE, SWITZERLAND
Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.Cotellic as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.
2021-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only Cotellic ® 20 mg Film-coated tablets Composition: Each film-coated tablet contains: Cobimetinib 20 mg For information on the inactive ingredients, see section 6 - “Further Information”. Read this leaflet carefully in its entirety before using the medicine. ∙ This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. ∙ Keep this leaflet. You may need to read it again. ∙ This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their ailment is similar. ∙ In addition to the leaflet, there is a patient safety information card for Cotellic. This card includes important safety information, that you should know, and act upon it accordingly, before starting and during treatment with Cotellic. Read the patient safety information card and the patient leaflet before starting use of this preparation. Keep the card for additional reference, if necessary. Cotellic is intended for treatment in adults over the age of 18. 1) What is the medicine intended for? Cotellic is intended for the treatment of a type of skin cancer called metastatic melanoma, or melanoma which can not be surgically removed, in combination with vemurafenib in patients with the V600 mutation in the protein called BRAF. Cotellic as a single agent, is intended for the treatment of adult patients with histiocytic neoplasms. How does the medicine work? The medicine targets a protein called “MEK” that is important in regulating the development of the cancer cell. When Cotellic is given in combination with vemurafenib )a medicine which targets the mutated “BRAF” protein(, it further slows down or stops the development of the cancer. Therapeutic group Anti-neoplastics - protein kinase inhibitors 2) Before using the medicine Do not use t اقرأ الوثيقة كاملة
1 Cotellic PI_Version 7 COTELLIC ® COBIMETINIB FILM-COATED TABLETS 20 MG PATIENT SAFETY INFORMATION CARD The marketing of Cotellic is subject to a risk management plan (RMP) including a 'Patient safety information card'. The 'Patient safety information card', emphasizes important safety information that the patient should be aware of before and during treatment. Please explain the patient the need to review the card before starting treatment. PRESCRIBER GUIDE This product is marked with prescriber guide providing important safety information. Please ensure you are familiar with this material as it contains important safety information. 1. NAME OF THE MEDICINAL PRODUCT Cotellic 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains cobimetinib hemifumarate equivalent to 20 mg cobimetinib. Excipient with known effect: Each film-coated tablet contains 36 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White, round film-coated tablets of approximately 6.6 mm diameter, with “COB” debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Unresectable or Metastatic Melanoma Cotellic is indicated for use in combination with vemurafenib for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1). Histiocytic Neoplasms Cotellic as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Cotellic in combination with vemurafenib should only be initiated and supervised by a qualified physician experienced in the use of anticancer medicinal products. 2 For Treatment of Melanoma Before starting this treatment, patients must have BRAF V600 mutation-positive melanoma tumour status confirmed by a validated test (see sections 4.4 and 5.1). Posology The recommended dose of Cotellic is 60 mg (3 tablets of 20 mg) once daily. Cotellic is ta اقرأ الوثيقة كاملة