FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of ivacaftor is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks (see sections 4.2 and 5.2).
Croatian: Ne preporučuje se primjena ivakaftora u bolesnika s teškim oštećenjem funkcije jetre, osim ako se očekuje da će korist od liječenja biti veća od rizika (vidjeti dijelove 4.2 i 5.2).
English: Hepatobiliary disorders
Croatian: Monoterapija ivakaftorom
English: Use of ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, is not recommended in patients with severe hepatic impairment unless the benefits are expected to outweigh the risks (see sections 4.2 and 5.2).
Croatian: Ne preporučuje se primjena ivakaftora, bilo u monoterapiji bilo u kombiniranom režimu s tezakaftorom/ivakaftorom, u bolesnika s teškim oštećenjem funkcije jetre, osim ako se očekuje da će korist od liječenja biti veća od rizika (vidjeti dijelove 4.2 i 5.2).
English: Ivacaftor should be administered with fat-containing food.
Croatian: Ivakaftor treba primjenjivati s hranom koja sadrži masti.
English: Cellulose, microcrystalline Lactose monohydrate Hypromellose acetate succinate Croscarmellose sodium Sodium laurilsulfate (E487) Silica, colloidal anhydrous Magnesium stearate
Croatian: Jezgra tablete celuloza, mikrokristalična laktoza hidrat hipromelozaacetat sukcinat karmelozanatrij, umrežena natrijev laurilsulfat (E487) silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: The effect of ivacaftor in the overall population of study 5 (including the secondary endpoints absolute change in BMI at 8 weeks of treatment and absolute change in the respiratory domain score of the CFQ-R through 8 weeks of treatment) and by individual mutation (absolute change in sweat chloride and in percent predicted FEV1 at week 8) is shown in Table 5.
Croatian: Učinak ivakaftora u cjelokupnoj populaciji u ispitivanju 5 (uključujući kao mjere sekundarnih ishoda apsolutnu promjenu u indeksu tjelesne mase (BMI) u 8. tjednu liječenja i apsolutnu promjenu rezultata u respiratornoj domeni mjerenoj upitnikom CFQ-R u 8 tjedana liječenja) te na pojedinačne mutacije (apsolutna promjena u koncentraciji klorida u znoju i u postotku predviđenog FEV1 u 8. tjednu) prikazan je u tablici 5. Na temelju kliničkog (postotak predviđenog FEV1) i farmakodinamičkog (klorid u znoju) odgovora na ivakaftor, u bolesnika s mutacijom G970R nije se mogla ustanoviti djelotvornost.
English: Table 6: Effect of ivacaftor on percent predicted FEV1 in study 4 Original study and treatment group
Croatian: Tablica 6: Učinak ivakaftora na postotak predviđenog FEV1 u ispitivanju 4
English: Caution is recommended while using ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Croatian: Preporučuje se oprez za vrijeme primjene ivakaftora u bolesnika s teškim oštećenjem funkcije bubrega ili terminalnim stadijem bubrežne bolesti (vidjeti dijelove 4.2 i 5.2).
English: − Blister card pack containing 28 film-coated tablets
Croatian: − pakiranje s blister karticama koje sadrži 28 filmom obloženih tableta
English: However, caution is recommended when administering ivacaftor to patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.2 and 4.4).
Croatian: Međutim, preporučuje se oprez kad se ivakaftor primjenjuje bolesnicima s teškim oštećenjem funkcije bubrega (klirens kreatinina manji od ili jednak 30 ml/min) ili u terminalnom stadiju bubrežne bolesti (vidjeti dijelove 4.2 i 4.4).
English: During the 48-week placebo-controlled studies 1 and 2 of ivacaftor monotherapy in patients aged 6 years and older, the incidence of maximum transaminase (ALT or AST) > 8, > 5 or > 3 x ULN was 3.7%, 3.7% and 8.3% in ivacaftor-treated patients and 1.0%, 1.9% and 8.7% in placebo-treated patients, respectively.
Croatian: Tijekom placebom kontroliranih ispitivanja 1 i 2 u trajanju od 48 tjedana u bolesnika u dobi od 6 i više godina u kojima se ispitivala monoterapija ivakaftorom, incidencija najviših vrijednosti transaminaza (ALT ili AST) > 8, > 5 ili > 3 puta GGN iznosila je 3,7%, 3,7% odnosno 8,3% u bolesnika liječenih ivakaftorom i 1,0%, 1,9% odnosno 8,7% u bolesnika koji su primali placebo.
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating ivacaftor treatment.
Croatian: U pedijatrijskih bolesnika koji započinju liječenje ivakaftorom, preporučuju se oftalmološki pregledi na početku liječenja i tijekom praćenja.
English: At the follow up visit 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -7.4% (5.5%).
Croatian: Na kontrolnom pregledu 4 tjedna nakon što je završila primjena ivakaftora, srednja vrijednost (SD) apsolutne promjene u postotku predviđenog FEV1 u odnosu na 16. tjedan 2. dijela ispitivanja iznosila je -7,4% (5,5%).
English: The effect of ivacaftor in the overall population of study 5 (including the secondary endpoints absolute change in BMI at 8 weeks of treatment and absolute change in the respiratory domain score of the CFQ-R through 8 weeks of treatment) and by individual mutation (absolute change in sweat chloride and in percent predicted FEV1 at week 8) is shown in Table 4.
Croatian: Učinak ivakaftora u cjelokupnoj populaciji u ispitivanju 5 (uključujući kao mjere sekundarnih ishoda apsolutnu promjenu u indeksu tjelesne mase (BMI) u 8. tjednu liječenja i apsolutnu promjenu rezultata u respiratornoj domeni mjerenoj upitnikom CFQ-R u 8 tjedana liječenja) te na pojedinačne mutacije (apsolutna promjena u koncentraciji klorida u znoju i u postotku predviđenog FEV1 u 8. tjednu) prikazan je u tablici 4. Na temelju kliničkog (postotak predviđenog FEV1) i farmakodinamičkog (klorid u znoju) odgovora na ivakaftor, u bolesnika s mutacijom G970R nije se mogla ustanoviti djelotvornost.
English: • Increased liver enzymes in the blood have been seen in some people receiving Kalydeco.
Croatian: • Neki ljudi koji uzimaju Kalydeco mogu imati povišene jetrene enzime u krvi.
English: There was negligible urinary excretion of ivacaftor as unchanged parent.
Croatian: Mokraćom se izlučila zanemariva količina ivakaftora u neizmijenjenom izvornom obliku.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BLISTER CARD - 28-TABLET PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BLISTER KARTICA - PAKIRANJE OD 28 TABLETA
English: Transaminase elevations
Croatian: Povišene vrijednosti transaminaza
English: When used concomitantly with digoxin or other substrates of P-gp with a narrow therapeutic index, such as ciclosporin, everolimus, sirolimus or tacrolimus, caution and appropriate monitoring should be used.
Croatian: P-gp-a uskog terapijskog indeksa, kao što su ciklosporin, everolimus, sirolimus ili takrolimus.
English: Study 5: study in patients with CF with non-G551D gating mutations
Croatian: Ispitivanje 5: ispitivanje u bolesnika s cističnom fibrozom i mutacijom koja dovodi do nepravilne regulacije kanala, ali nije mutacija G551D
English: Kalydeco contains the active ingredient ivacaftor.
Croatian: Kalydeco sadrži djelatnu tvar ivakaftor.
English: • Blister pack containing 56 film-coated tablets
Croatian: • pakiranje s blisterima koje sadrži 56 filmom obloženih tableta
English: Kalydeco 150 mg film-coated tablets ivacaftor
Croatian: Kalydeco 150 mg filmom obložene tablete ivacaftorum
English: Kalydeco 75 mg granules in sachet are white to off-white granules.
Croatian: Kalydeco 75 mg granule u vrećici bijele su do gotovo bijele granule.
English: Based on these results, a modified regimen for Kalydeco in a combination regimen with tezacaftor/ivacaftor is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Croatian: Na temelju ovih rezultata, u bolesnika s umjerenim oštećenjem funkcije jetre preporučuje se modificirani režim lijeka Kalydeco u kombiniranom režimu s tezakaftorom/ivakaftorom (vidjeti tablicu 2 u dijelu 4.2).
English: Baseline and follow-up ophthalmological examinations are recommended in paediatric patients initiating ivacaftor treatment, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor (see section 5.3).
Croatian: U pedijatrijskih bolesnika koji započinju liječenje ivakaftorom bilo u monoterapiji bilo u kombiniranom režimu s tezakaftorom/ivakaftorom preporučuju se oftalmološki pregledi na početku liječenja i tijekom praćenja (vidjeti dio 5.3).
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment with Kalydeco (see section 4.2).
Croatian: Tijekom liječenja lijekom Kalydeco potrebno je izbjegavati hranu i pića koja sadrže grejp ili naranče sorte Seville (vidjeti dio 4.2).
English: Based on these results, a modified regimen of Kalydeco monotherapy is recommended for patients with moderate hepatic impairment (see section 4.2)
Croatian: Na temelju ovih rezultata, za bolesnike s umjerenim oštećenjem funkcije jetre preporučuje se modificirani režim monoterapije lijekom Kalydeco (vidjeti dio 4.2).
English: The mean absolute change from baseline through week 16 in percent predicted FEV1 (primary efficacy endpoint) was 1.5 percentage points in the ivacaftor group and -0.2 percentage points in the placebo group.
Croatian: Srednja vrijednost apsolutne promjene od početka ispitivanja do 16. tjedna u postotku predviđenog FEV1 (mjera primarnog ishoda djelotvornosti) iznosila je 1,5 postotnih bodova u skupini koja je primala ivakaftor i -0,2 postotna boda u skupini koja je primala placebo.
English: The use of Kalydeco in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see section 4.2 and section 4.4).
Croatian: Stoga se u bolesnika s teškim oštećenjem funkcije jetre ne preporučuje primjena lijeka Kalydeco, osim ako je korist od liječenja veća od rizika (vidjeti dio 4.2 i dio 4.4).
English: G1244E (5) G1349D (2) G178R (5) G551S (2) G970R# (4) S1251N (8) S1255P (2) S549N (6) S549R (4)
Croatian: S1251N (8) S1255P (2) S549N (6) S549R (4)
English: The pharmacokinetic profile, safety and efficacy of ivacaftor in 34 patients aged 2 to less than 6 years with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R mutation in the CFTR gene were assessed in a 24-week uncontrolled study with ivacaftor (patients weighing less than 14 kg received ivacaftor 50 mg and patients weighing 14 kg or more received ivacaftor 75 mg).
Croatian: G1349D, G178R, G551S, S1251N, S1255P, S549N ili S549R na genu CFTR tijekom nekontroliranog ispitivanja s ivakaftorom u trajanju od 24 tjedna (bolesnici tjelesne težine manje od 14 kg primali su ivakaftor u dozi od 50 mg, a bolesnici tjelesne težine 14 kg ili veće primali su ivakaftor u dozi od 75 mg).
English: − Blister pack containing 56 film-coated tablets
Croatian: − pakiranje s blisterima koje sadrži 56 filmom obloženih tableta
English: At the follow-up visit 4 weeks after ivacaftor dosing had ended, the mean (SD) absolute change in percent predicted FEV1 from part 2 week 16 was -5.9% (9.4%).
Croatian: Na kontrolnom pregledu 4 tjedna nakon što je završila primjena ivakaftora, srednja vrijednost (SD) apsolutne promjene u postotku predviđenog FEV1 u odnosu na 16. tjedan 2. dijela ispitivanja iznosila je -5,9% (9,4%).
English: d Hazard ratio for time to first pulmonary exacerbation e In subjects under 20 years of age (CDC growth charts)
Croatian: d Omjer hazarda (HR) za vrijeme do prvog pogoršanja plućnih simptoma.
English: Caution is recommended when administering ivacaftor, either as monotherapy or in combination with tezacaftor, to patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.2 and 4.4).
Croatian: Preporučuje se oprez kad se ivakaftor primjenjuje bilo u monoterapiji ili u kombinaciji s tezakaftorom bolesnicima s teškim oštećenjem funkcije bubrega (klirens kreatinina manji od ili jednak 30 ml/min) ili u terminalnom stadiju bubrežne bolesti (vidjeti dijelove 4.2 i 4.4).
English: Pharmacokinetic studies have not been performed with ivacaftor in patients with renal impairment, either as monotherapy or in a combination regimen with tezacaftor/ivacaftor.
Croatian: Ivakaftor nije ispitan u bolesnika s cističnom fibrozom kojima je presađen organ ni u monoterapiji niti u kombiniranom režimu s tezakaftorom/ivakaftorom.
English: • Dizziness
Croatian: • mučnina
English: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily
Croatian: Jedna tableta tezakaftora od 100 mg / ivakaftora od 150 mg jedanput dnevno
English: The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 in patients 12 to 17 years of age in study 1 was 11.9 percentage points (5.9, 17.9).
Croatian: U ispitivanju 1, terapijska razlika između ivakaftora i placeba u srednjoj vrijednosti apsolutne promjene (95% CI) u postotku predviđenog FEV1 od početne vrijednosti do 24. tjedna u bolesnika u dobi od 12 do 17 godina iznosila je 11,9 postotnih bodova (5,9; 17,9).
English: ≥ 14 kg to < 25 kg 75 mg granules taken orally every 12 hours with fat-containing food
Croatian: ≥ 14 kg do < 25 kg 75 mg granule, uzimaju se peroralno svakih 12 sati s hranom koja sadrži masti
English: Upper respiratory tract infection very common
Croatian: Infekcije i infestacije infekcija gornjih dišnih puteva vrlo često nazofaringitis vrlo često rinitis često
English: Caution is recommended in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.4 and 5.2).
Croatian: Preporučuje se oprez u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina manji ili jednak 30 ml/min) ili u terminalnom stadiju bubrežne bolesti (vidjeti dijelove 4.4 i 5.2).
English: Kalydeco 50 mg granules in sachet are white to off-white granules.
Croatian: Kalydeco 50 mg granule u vrećici bijele su do gotovo bijele granule.
English: The use of Kalydeco monotherapy or in combination with tezacaftor/ivacaftor in patients with severe hepatic impairment is therefore not recommended unless the benefits outweigh the risks (see Table 2 in section 4.2 and section 4.4).
Croatian: Stoga se u bolesnika s teškim oštećenjem funkcije jetre ne preporučuje primjena lijeka Kalydeco u monoterapiji ili u kombinaciji s tezakaftorom/ivakaftorom, osim ako je korist od liječenja veća od rizika (vidjeti tablicu 2 u dijelu 4.2 i dio 4.4).
English: The mean absolute change from baseline through week 24 in percent predicted FEV1 was -2.8 percentage points in the ivacaftor group and 3.5 percentage points in the placebo group.
Croatian: Srednja vrijednost apsolutne promjene od početka do 24. tjedna u postotku predviđenog FEV1 iznosila je -2,8 postotnih bodova u skupini koja je primala ivakaftor i 3,5 postotnih bodova u skupini koja je primala placebo.
English: Age group
Croatian: Dobna skupina
English: • Sinus congestion
Croatian: • začepljeni sinusi
English: Abdominal pain very common
Croatian: Poremećaji probavnog sustava bol u abdomenu vrlo često proljev vrlo često
English: Kalydeco 75 mg granules in sachet ivacaftor
Croatian: Kalydeco 75 mg granule u vrećici ivakaftor (ivacaftorum)
English: Moderate transaminase (alanine transaminase [ALT] or aspartate transaminase [AST]) elevations are common in subjects with CF. Transaminase elevations have been observed in some patients treated with ivacaftor monotherapy and in a combination regimen with tezacaftor/ivacaftor.
Croatian: Povišene transaminaze opažene su u nekih bolesnika liječenih ivakaftorom u monoterapiji i u kombiniranom režimu s tezakaftorom/ivakaftorom.
English: The treatment difference between ivacaftor and placebo for the mean absolute change (95% CI) in percent predicted FEV1 from baseline through week 24 in patients with baseline predicted FEV1 greater than 90% in study 2 was 6.9 percentage points (-3.8, 17.6).
Croatian: U ispitivanju 2, terapijska razlika između ivakaftora i placeba u srednjoj vrijednosti apsolutne promjene (95% CI) u postotku predviđenog FEV1 od početne vrijednosti do 24. tjedna u bolesnika s početnim predviđenim FEV1 većim od 90% iznosila je 6,9 postotnih bodova (-3,8; 17,6).
English: Ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor, has not been studied in patients with CF who have undergone organ transplantation.
Croatian: Ispitivanja farmakokinetike ivakaftora, bilo u monoterapiji ili u kombiniranom režimu s tezakaftorom/ivakaftorom, nisu provedena u bolesnika s oštećenjem funkcije bubrega.
English: • Upper respiratory tract infection (the common cold), including sore throat and nasal congestion
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) • infekcija gornjih dišnih puteva (obična prehlada), uključujući grlobolju i začepljenost nosa
English: − Bottle containing 56 film-coated tablets
Croatian: − bočica koja sadrži 56 filmom obloženih tableta.
English: Study 5 was a Phase 3, two-part, randomised, double-blind, placebo-controlled, crossover study (part 1) followed by a 16-week open-label extension period (part 2) to evaluate the efficacy and safety of ivacaftor in patients with CF aged 6 years and older who have a G970R or non-G551D gating mutation in the CFTR gene (G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P or G1349D).
Croatian: Ispitivanje 5 bilo je ispitivanje faze III u dva dijela; randomizirano, dvostruko slijepo, placebom kontrolirano križno ispitivanje (1. dio) za kojim je slijedilo razdoblje otvorenog produžetka ispitivanja od 16 tjedana (2. dio) kako bi se procijenila djelotvornost i sigurnost ivakaftora u bolesnika s cističnom fibrozom u dobi od 6 i više godina koji su imali mutaciju gena CFTR koja dovodi do nepravilne regulacije kanala, a koja je bila mutacija G970R ili nije bila mutacija G551D (G178R,
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Croatian: Ako kod svog djeteta primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika Vašeg djeteta ili ljekarnika.
English: Kalydeco 25 mg granules in sachet are white to off-white granules.
Croatian: Kalydeco 25 mg granule u vrećici bijele su do gotovo bijele granule.
English: 12 months to less than 24 months (≥ 14 kg to < 25 kg)
Croatian: 50 mg svakih 12 sati od 12 do manje od 24 mjeseca (≥ 14 kg do < 25 kg)
English: Refer to the Summary of Product Characteristics of tezacaftor/ivacaftor for additional data.
Croatian: Za dodatne podatke vidjeti sažetak opisa svojstava lijeka za tezakaftor/ivakaftor.
English: Only patients with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R gating (class III), G970R or R117H mutation in at least one allele of the CFTR gene were included in studies 1, 2, 5 and 6 (see section 5.1).
Croatian: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R zbog koje dolazi do nepravilne regulacije kanala (III. klasa mutacija), G970R ili mutaciju R117H na najmanje jednom alelu gena CFTR (vidjeti dio 5.1).
English: Only patients with CF who had a G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R gating (class III) or G970R mutation in at least one allele of the CFTR gene were included in studies 1, 2, 5 and 7 (see section 5.1).
Croatian: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N ili S549R zbog koje dolazi do nepravilne regulacije kanala (III. klasa mutacija) ili mutaciju G970R na najmanje jednom alelu gena CFTR (vidjeti dio 5.1).
English: Take with fat-containing food.
Croatian: Lijek uzimajte s hranom koja sadrži masti.
English: ≥ 7 kg to < 14 kg 50 mg granules taken orally every 12 hours with fat-containing food
Croatian: ≥ 7 kg do < 14 kg 50 mg granule, uzimaju se peroralno svakih 12 sati s hranom koja sadrži masti
English: Study 6 evaluated 69 patients who were 6 years of age or older; 53 (76.8%) patients had the F508del mutation in the second allele.
Croatian: Ispitivanje 6: ispitivanje u bolesnika s cističnom fibrozom i mutacijom R117H gena CFTR U ispitivanju 6 procijenjeno je 69 bolesnika u dobi od 6 i više godina; 53 (76,8%) bolesnika imalo je mutaciju F508del na drugom alelu.
English: 56 tablets
Croatian: OBLIK I SADRŽAJ 56 tableta
English: Kalydeco tablets are also indicated in a combination regimen with tezacaftor 100 mg/ivacaftor 150 mg tablets for the treatment of adults and adolescents aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E,
Croatian: Kalydeco tablete indicirane su također u kombiniranom režimu s tabletama tezakaftora od 100 mg / ivakaftora od 150 mg za liječenje cistične fibroze (CF) u odraslih i adolescenata u dobi od 12 i više godina koji su homozigoti za mutaciju F508del ili su heterozigoti za mutaciju F508del i imaju jednu od sljedećih mutacija u genu CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G i 3849+10kbC→T.
English: Moderate transaminase (alanine transaminase [ALT] or aspartate transaminase [AST]) elevations are common in subjects with CF. Transaminase elevations have been observed in some patients treated with ivacaftor monotherapy.
Croatian: Povišene transaminaze opažene su u nekih bolesnika liječenih ivakaftorom u monoterapiji.
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment with Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor, see section 4.2).
Croatian: Tijekom liječenja lijekom Kalydeco (bilo u monoterapiji ili u kombiniranom režimu s tezakaftorom/ivakaftorom) potrebno je izbjegavati hranu i pića koja sadrže grejp ili naranče sorte Seville (vidjeti dio 4.2).
English: 2- to 5-year-olds (≥ 14 kg to < 25 kg)
Croatian: 50 mg svakih 12 sati od 2 do 5 godina (≥ 14 kg do < 25 kg)
English: Each sachet contains 25 mg of ivacaftor.
Croatian: Jedna vrećica sadrži 25 mg ivakaftora.
English: The pharmacokinetic profile, safety, and efficacy of ivacaftor in patients with CF aged 6 months to less than 24 months were assessed in a completed cohort of patients in an on-going 24-week, open-label, Phase 3 clinical study in patients aged less than 24 months (study 8).
Croatian: U 24-tjednom, otvorenom kliničkom ispitivanju faze III u bolesnika mlađih od 24 mjeseca koje je u tijeku (ispitivanje 8), farmakokinetički profil, sigurnost primjene i djelotvornost ivakaftora procijenjeni su u kohorti bolesnika s cističnom fibrozom u dobi od 6 mjeseci do manje od 24 mjeseca koja je završila liječenje.
English: • Redness inside the ear
Croatian: • crvenilo u uhu
English: ≥5 kg to < 7 kg 25 mg granules taken orally every 12 hours with fat-containing food
Croatian: ≥ 5 kg do < 7 kg 25 mg granule, uzimaju se peroralno svakih 12 sati s hranom koja sadrži masti
English: Kalydeco 25 mg granules in sachet Each sachet contains 25 mg of ivacaftor.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Kalydeco 25 mg granule u vrećici Jedna vrećica sadrži 25 mg ivakaftora (ivacaftorum).
English: Your child must keep using all other medicines, unless your child's doctor tells him/her to stop using any.
Croatian: Osim ako djetetov liječnik ne kaže da je potrebno prestati uzimati druge lijekove, Vaše dijete mora nastaviti uzimati sve druge lijekove.
English: Kalydeco tablets are indicated for the treatment of adults, adolescents and children aged 6 years and older and weighing 25 kg or more with cystic fibrosis (CF) who have one of the following gating mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
Croatian: Kalydeco tablete namijenjene su za liječenje cistične fibroze u odraslih, adolescenata i djece u dobi od 6 i više godina i tjelesne težine od 25 kg ili više, koji u genu CFTR imaju jednu od sljedećih mutacija zbog koje dolazi do nepravilne regulacije kanala: G551D, G1244E, G1349D, G178R, G551S, S1251N,
English: Reproductive system and breast disorders
Croatian: Klasifikacija organskog sustava
English: Ivacaftor Mean (SD)
Croatian: N Srednja vrijednost (SD)