Country: Իսրայել
language: անգլերեն
source: Ministry of Health
IVACAFTOR; TEZACAFTOR
VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL
R07AX31
FILM COATED TABLETS
IVACAFTOR 150 MG; TEZACAFTOR 100 MG
PER OS
Required
VERTEX PHARMACEUTICALS (EUROPE) LIMITED, UK
IVACAFTOR AND TEZACAFTOR
SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.If the patient’s genotype is unknown, a health authority cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use.
2019-09-23
SYMD-PIL-0923-V1 Page 1 of 6 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only SYMDEKO 50 MG/ 75 MG & 75 MG SYMDEKO 100 MG/150 MG & 150 MG FILM-COATED TABLETS ACTIVE INGREDIENTS AND THEIR QUANTITIES SYMDEKO 50 MG/ 75 MG & 75 MG White film-coated tablets Each film coated tablet contains tezacaftor 50 mg and ivacaftor 75 mg Light blue film-coated tablets Each film coated tablet contains ivacaftor 75 mg SYMDEKO 100 MG/150 MG & 150 MG Yellow film-coated tablets Each film coated tablet contains tezacaftor 100 mg and ivacaftor 150 mg Light blue film-coated tablets Each film coated tablet contains ivacaftor 150 mg Inactive ingredients and allergens - see section 6 “ ADDITIONAL INFORMATION ” . See also “IMPORTANT INFORMATION ABOUT SOME OF THIS MEDICINE’S INGREDIENTS” in section 2. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? Symdeko contains a combination of tezacaftor and ivacaftor and is used for the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have inherited the _F508del _mutation (change) from both parents and therefore have the mutation in two copies of the CFTR gene, or who have at least one mutation in the CFTR gene that is responsive to treatment with Symdeko. THERAPEUTIC GROUP: Tezacaftor – CFTR corrector Ivacaftor – Potentiator of the CFTR protein Symdeko contains two active substances, tezacaftor and ivacaftor that work together to improve the function of the abnormal CFTR protein. Tezacaftor increases the amount of CFTR available and ivacaftor helps the abnormal protein to work more properly. 2. BEFORE USING THE MED read_full_document
SYMD-SPC-0923-V1 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SYMDEKO 50 mg/75 mg & 75 mg SYMDEKO 100 mg/150 mg & 150 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SYMDEKO 50 MG/75 MG & 75 MG TEZACAFTOR/IVACAFTOR TABLET: Each film-coated tablet contains 75 mg ivacaftor and 50 mg tezacaftor. IVACAFTOR TABLET: Each film-coated tablet contains 75 mg ivacaftor. EXCIPIENTS WITH KNOWN EFFECT: Each Ivacaftor film-coated tablet contains 83.6 mg of lactose. SYMDEKO 100 MG/150 MG & 150 MG TEZACAFTOR/IVACAFTOR TABLET: Each film-coated tablet contains 150 mg ivacaftor and 100 mg tezacaftor. IVACAFTOR TABLET: Each film-coated tablet contains 150 mg ivacaftor. EXCIPIENTS WITH KNOWN EFFECT: Each Ivacaftor film-coated tablet contains 167.2 mg of lactose. For the full list of excipients, _see Description (12)_. 3 PHARMACEUTICAL FORM Film-coated tablets SYMDEKO 50 MG/75 MG & 75 MG TEZACAFTOR/IVACAFTOR TABLET: White film-coated tablet, debossed with “V 50” on one face. IVACAFTOR TABLET: Light blue capsule- shaped tablet printed with “V 75” in black ink on one face. SYMDEKO 100 MG/150 MG & 150 MG TEZACAFTOR/IVACAFTOR TABLET: Yellow film-coated tablet, debossed with “V 100” on one face. IVACAFTOR TABLET: Light blue capsule-shaped tablet printed with “ V 150 ” in black ink on one face. 4 THERAPEUTIC INDICATION SYMDEKO is a combination of tezacaftor and ivacaftor, indicated for the treatment of patients with cystic fibrosis (CF) aged 6 years and older who are homozygous for the _F508del_ mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on _in vitro_ data and/or clinical evidence [_see Clinical Pharmacology (13.1)]._ If the patient’s genotype is unknown, a health authority cleared CF mutation test should be used to detect the presence of a CFTR mutation followed by verification with bi-directional sequencing when recommended by the mutation test instructions for use. 5 DOS read_full_document