Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
IVACAFTOR
VERTEX PHARMACEUTICALS (U.K) LIMITED, ISRAEL
R07AX02
FILM COATED TABLETS
IVACAFTOR 150 MG
PER OS
Required
VERTEX PHARMACEUTICALS (EUROPE) LIMITED, UK
IVACAFTOR
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.Limitations of use:Kalydeco is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene
2020-04-30
KALY_50_75_150-PIL-0320-V1 Page 1 of 7 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon physician’s prescription only KALYDECO 150MG FILM COATED TABLETS Film- coated tablets Each film-coated tablet contains: 150 mg ivacaftor KALYDECO 50MG GRANULES, KALYDECO 75MG GRANULES Granules in sachet Each 50 mg granules in sachet contains: 50 mg ivacaftor Each 75 mg granules in sachet contains: 75 mg ivacaftor The list of the inactive ingredients in the product is shown in section 6 (“other information”) in this leaflet. READ THIS LEAFLET CAREFULLY BEFORE YOU/YOUR CHILD START USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions ask the doctor or the 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. Kalydeco tablets are intended to treat adults and children age 6 years and older weighing 25 kg or more. Kalydeco granules are intended to treat children aged 2 years and older and weighing less than 25 kg. 1. WHAT IS THIS MEDICINE USED 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 regulat Læs hele dokumentet
KALY_50_75_150-SPC-0320-V1 Page 1 of 19 PHYSICIAN PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT Kalydeco 50mg Granules (granules in sachet) Kalydeco 75mg Granules (granules in sachet) Kalydeco 150mg Film Coated Tablets (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 (as 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 (as 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 (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Light blue, capsule-shaped tablets, printed with “V 150” in black ink on one side and plain on the other (16.5 mm x 8.4 mm in modified tablet shape). 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: KALY_50_75_150-SPC-0320-V1 Page 2 of 19 Kalydeco is not effective in patients with CF who are homozygous for the _F508del_ mutation in the _CFTR_ gene. 4.2 POSOLOGY AND Læs hele dokumentet