البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
IVACAFTOR; LUMACAFTOR
VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL
R07AX30
FILM COATED TABLETS
IVACAFTOR 125 MG; LUMACAFTOR 200 MG
PER OS
Required
VERTEX PHARMACEUTICALS (EUROPE) LIMITED, UK
IVACAFTOR AND LUMACAFTOR
Orkambi is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the CFTR gene.If the patient's genotype is unknown, CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.Limitations of UseThe efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation.
2022-01-31
ORKA_100_125-200_125-PIL-0121-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 ORKAMBI 100 MG/125 MG FILM COATED TABLETS ORKAMBI 200 MG/125 MG FILM COATED TABLETS ACTIVE INGREDIENTS AND THEIR QUANTITIES Orkambi 100mg/125mg film coated tablets Each film coated tablet contains: 100 mg lumacaftor 125 mg ivacaftor Orkambi 200mg/125mg film coated tablets Each film coated tablet contains: 200 mg lumacaftor 125 mg ivacaftor Inactive ingredients - 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 THIS MEDICINE INTENDED FOR? Orkambi (lumacaftor and ivacaftor) is used for long-term treatment of cystic fibrosis (CF) in patients aged 6 years and older who have a specific change (called _F508del _mutation) affecting the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR), which has an important role in regulating the flow of mucus in the lungs. People with the mutation will produce an abnormal CFTR protein. Orkambi is used in patients in whom both copies of the CFTR gene in the cell are affected by the _F508del_ mutation. Orkambi is a single tablet that contains two active substances, lumacaftor and ivacaftor. These two work together to improve the function of the abnormal CFTR protein. Lumacaftor increases the amount of CFTR available and ivacaftor helps the abnormal protein to work more properly. THERAPEUTIC GROUP: Lumacaftor – CFTR corrector Ivacaftor – Potentiator of the CFTR protein 2. BEFORE USING THIS MEDICINE DO اقرأ الوثيقة كاملة
ORKA_100_125-200_125-SPC-0121-V1 Page 1 of 31 PHYSICIAN PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Orkambi 100 mg/125 mg film coated tablets Orkambi 200 mg/125 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Orkambi 100 mg/125 mg film coated tablets Each film-coated tablet contains 100 mg of lumacaftor and 125 mg of ivacaftor. Orkambi 200 mg/125 mg film coated tablets Each film-coated tablet contains 200 mg of lumacaftor and 125 mg of ivacaftor. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Orkambi 100 mg/125 mg film coated tablets Pink oval-shaped tablets with “1V125” printed in black on one face and plain on the other. Orkambi 200 mg/125 mg film coated tablets Pink oval-shaped tablets with “2V125” printed in black on one face and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Orkambi is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the _F508del_ mutation in the _CFTR_ gene (see sections 4.2, 4.4 and 5.1). If the patient's genotype is unknown, CF mutation test should be used to detect the presence of the _F508del_ mutation on both alleles of the _CFTR_ gene. Limitations of Use The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Orkambi should only be prescribed by physicians with experience in the treatment of CF. Posology ORKA_100_125-200_125-SPC-0121-V1 Page 2 of 31 TABLE 1: DOSING RECOMMENDATIONS IN PATIENTS AGED 6 YEARS AND OLDER AGE DOSE TOTAL DAILY DOSE 6 to 11 years 2 tablets of lumacaftor 100 mg/ivacaftor 125 mg every 12 hours lumacaftor 400 mg/ ivacaftor 500 mg 12 years and older 2 tablets of lumacaftor 200 mg/ivacaftor 125 mg every 12 hours lumacaftor 800 mg/ ivacaftor 500 mg Patients may start treatment on any day of the week. This medicinal product should be taken with fat-containing food. A fat-containi اقرأ الوثيقة كاملة