Země: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
IVACAFTOR
VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL
R07AX02
GRANULES
IVACAFTOR 50 MG
PER OS
Required
VERTEX PHARMACEUTICALS (EUROPE) LIMITED, UK
IVACAFTOR
Kalydeco granules are indicated for the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25 kg who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. Limitations of use:Kalydeco is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene.
2019-03-27
KALY_50_75_150-PIL-0921-V1 Page 1 of 7 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is dispensed with a doctor’s prescription only KALYDECO 50 MG GRANULES KALYDECO 75 MG GRANULES KALYDECO 150 MG FILM COATED TABLETS ACTIVE INGREDIENTS AND THEIR QUANTITIES Kalydeco 50 mg granules Each sachet of granules contains ivacaftor 50 mg Kalydeco 75 mg granules Each sachet of granules contains ivacaftor 75 mg Kalydeco 150 mg film coated tablets Each 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 THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU/YOUR CHILD 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 you/your child’s 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? Kalydeco tablets are indicated for the treatment of patients with cystic fibrosis (CF) aged 6 years and older and weighing 25 kg or more who have one of the following gating (class III) mutations in the _CFTR_ gene: _G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N _or_ _ _S549R. _ Kalydeco granules are indicated for the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25 kg who have one of the following gating (class III) mutations in the CFTR gene: _G551D_, _G1244E_, _G1349D_, _G178R_, _G551S_, _S1251N_, _S1255P_, _S549N_ or _S549R_. Kalydeco is not effective in patients with CF who are homozygous for the _F508del _mutation in the _CFTR_ gene. Kalydeco contains the active ingredient ivacaftor. Ivacaftor acts at the level of the cystic fibrosis transmembrane conductance regulator (CFTR), a protein that forms a channel at the cell surface tha Přečtěte si celý dokument
KALY_50_75_150-SPC-0921-V1 Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kalydeco 50 mg granules Kalydeco 75 mg granules Kalydeco 150 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Film-coated tablets Each film-coated tablet contains 150 mg of ivacaftor. Excipient with known effect: each film-coated tablet contains 167.2 mg of lactose monohydrate. Granules in sachet Kalydeco 50 mg granules in sachet: each sachet contains 50 mg of ivacaftor. Excipient with known effect: each sachet contains 73.2 mg of lactose monohydrate. Kalydeco 75 mg granules in sachet : each sachet contains 75 mg of ivacaftor. Excipient with known effect: each sachet contains 109.8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Light blue, capsule-shaped tablets, printed with “V 150” in black ink on one side and plain on the other. Granules in sachet White to off-white granules approximately 2 mm in diameter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kalydeco tablets are indicated for the treatment of patients with cystic fibrosis (CF) aged 6 years and older and weighing 25 kg or more who have one of the following gating (class III) mutations in the _CFTR_ gene: _G551D_ , _G1244E_ , _G1349D_ , _G178R_ , _G551S_ , _S1251N_ , _S1255P_ , _S549N_ or _ S549R_ (see sections 4.4 and 5.1). Kalydeco granules are indicated for the treatment of children with cystic fibrosis (CF) aged 2 years and older and weighing less than 25 kg who have one of the following gating (class III) mutations in the _CFTR_ gene: _G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N _ or _ S549R_ (see sections 4.4 and 5.1). Limitations of use: Kalydeco is not effective in patients with CF who are homozygous for the _F508del_ mutation in the _CFTR_ gene. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kalydeco should only be prescribed by physicians with experience in the treatment of cystic fibrosis. If the patient's genotype is unknown, Přečtěte si celý dokument