Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Lumacaftor, ivacaftor
Vertex Pharmaceuticals (Ireland) Limited
R07AX30
lumacaftor, ivacaftor
Other respiratory system products
Cystic Fibrosis
Orkambi tablets are 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.Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in children aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene.
Revision: 32
Authorised
2015-11-19
90 B. PACKAGE LEAFLET 91 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ORKAMBI 100 MG/125 MG FILM-COATED TABLETS ORKAMBI 200 MG/125 MG FILM-COATED TABLETS lumacaftor/ivacaftor READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • WHAT IS IN THIS LEAFLET 1. What Orkambi is and what it is used for 2. What you need to know before you take Orkambi 3. How to take Orkambi 4. Possible side effects 5. How to store Orkambi 6. Contents of the pack and other information 1. WHAT ORKAMBI IS AND WHAT IT IS USED FOR Orkambi contains two active substances, lumacaftor and ivacaftor. It is a medicine 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 plays an important role in regulating the flow of mucus in the lungs. People with the mutation will produce an abnormal CFTR protein. Cells contain two copies of the _CFTR_ gene; Orkambi is used in patients in whom both copies are affected by the _F508del_ mutation (homozygotes). Lumacaftor and ivacaftor 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 normally. Orkambi may help your breathing by improving your lung function. You may also notice that it is easier to gain weight. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORKAMBI DO NOT TAKE ORKAMBI • if you are allergic to lumac Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 tablet (tablet) Orkambi 100 mg/125 mg film-coated tablets Pink, oval-shaped tablets (dimensions 14 × 7.6 × 4.9 mm) printed with “1V125” in black ink on one side. Orkambi 200 mg/125 mg film-coated tablets Pink, oval-shaped tablets (dimensions 14 × 8.4 × 6.8 mm) printed with “2V125” in black ink on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the _F508del_ mutation in the cystic fibrosis transmembrane conductance regulator ( _CFTR_ ) gene (see sections 4.2, 4.4, and 5.1). 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Orkambi should only be prescribed by physicians with experience in the treatment of CF. If the patient’s genotype is unknown, an accurate and validated genotyping method should be performed to confirm the presence of the _F508del_ mutation on both alleles of the _CFTR_ gene. Posology TABLE 1: DOSING RECOMMENDATIONS IN PATIENTS AGED 6 YEARS AND OLDER AGE STRENGTH DOSE (EVERY 12 HOURS) MORNING EVENING 6 to < 12 years lumacaftor 100 mg/ivacaftor 125 mg 2 tablets 2 tablets 12 years and older lumacaftor 200 mg/ivacaftor 125 mg 2 tablets 2 tablets Patients may start treatment on any day of the week. This medicinal product should be taken with fat-containing food. A fat-containing meal or snack should be consumed just before or just after dosing (see section 5.2). _Missed dose _ _ _ If less than 6 hours have passed since the m Pročitajte cijeli dokument