FrancophonIA/ELRC3.0 huggingface dataset:
English: At the 4-week follow-up visit (4 weeks after dosing with ivacaftor ended), mean sweat chloride values for each group were trending to pre-treatment levels.
Croatian: Na kontrolnom pregledu nakon 4 tjedna (4 tjedna nakon završetka primjene ivakaftora), srednje vrijednosti koncentracije klorida u znoju za svaku skupinu kretale su se prema razinama prije liječenja.
English: In vitro responses seen in single channel patch clamp experiments using membrane patches from rodent cells expressing mutant CFTR forms do not necessarily correspond to in vivo pharmacodynamic response (e.g., sweat chloride) or clinical benefit.
Croatian: Odgovori opaženi u pokusima in vitro, u kojima se na djelićima membrane stanica glodavaca s mutiranim oblicima CFTR-a metodom priklještenja (engl. patch clamp) ispitivao pojedinačni kanal, ne podudaraju se nužno s farmakodinamičkim odgovorom in vivo (npr. koncentracija klorida u znoju) ili s kliničkom koristi.
English: Very limited data are available for elderly patients treated with ivacaftor (administered as monotherapy or in a combination regimen with tezacaftor/ivacaftor).
Croatian: Dostupni su vrlo ograničeni podaci za starije bolesnike liječene ivakaftorom (primijenjenim kao monoterapija ili u kombiniranom režimu s tezakaftorom/ivakaftorom).
English: Efficacy results from a Phase 2 study in patients with CF who are homozygous for the F508del mutation in the CFTR gene showed no statistically significant difference in FEV1 over 16 weeks of ivacaftor treatment compared to placebo (see section 5.1).
Croatian: Rezultati ispitivanja faze II o djelotvornosti u bolesnika s CF-om koji su homozigoti za F508del mutaciju gena CFTR pokazali su da nije bilo statistički značajne razlike u FEV1 tijekom 16 tjedana liječenja ivakaftorom u usporedbi s placebom (vidjeti dio 5.1).
English: No dose adjustment is required when Kalydeco is co-administered with ciprofloxacin.
Croatian: Nije potrebna prilagodba doze kada se Kalydeco primjenjuje istovremeno s ciprofloksacinom.
English: Otherwise, wait until your next scheduled dose as you normally would.
Croatian: U suprotnom, pričekajte do sljedeće doze koju trebate uzeti prema uobičajenom rasporedu.
English: The pharmacokinetic parameters of ivacaftor, either as monotherapy or in combination with tezacaftor, are similar in males and females.
Croatian: Farmakokinetički parametri ivakaftora, bilo u monoterapiji ili u kombinaciji s tezakaftorom, slični su u muškaraca i žena.
English: A single ivacaftor-treated patient (2.5%) in this age range had an elevation of ALT and AST > 8 x ULN.
Croatian: Jedan bolesnik liječen ivakaftorom (2,5%) u ovom dobnom rasponu imao je povišenje ALT i AST > 8 puta GGN.
English: † Change from prior study baseline after 48 weeks of placebo treatment.
Croatian: † Promjena u odnosu na početne vrijednosti iz prethodnog ispitivanja nakon liječenja placebom od 48 tjedana.
English: Some medicines can affect how Kalydeco works, or make side effects more likely.
Croatian: Neki lijekovi mogu utjecati na djelovanje lijeka Kalydeco ili povećati vjerojatnost nastanka nuspojava.
English: Table 8: Mean (SD) of ivacaftor exposure when used in combination with tezacaftor, by age group
Croatian: Tablica 8: Srednja vrijednost (SD) izloženosti ivakaftoru kad se primjenjuje u kombinaciji s tezakaftorom, prema dobnim skupinama
English: Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet)
Croatian: Veličina pakiranja od 56 vrećica (sadrži 4 pojedinačna pretinca s 14 vrećica po pretincu).
English: No dose adjustment is necessary for patients with mild hepatic impairment (Child-Pugh Class A).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh stadij A).
English: After steady-state dosing of ivacaftor in combination with tezacaftor in CF patients, the mean (SD) terminal half-life of ivacaftor was approximately 9.3 (1.7) hours.
Croatian: Nakon doziranja ivakaftora u kombinaciji s tezakaftorom u stanju dinamičke ravnoteže u bolesnika s cističnom fibrozom, srednja vrijednost (SD) terminalnog poluvijeka ivakaftora iznosila je približno 9,3 (1,7) sati.
English: The efficacy of Kalydeco monotherapy in patients less than 18 years of age with an R117H mutation in the CFTR gene has not been established.
Croatian: Djelotvornost monoterapije lijekom Kalydeco u bolesnika mlađih od 18 godina s mutacijom R117H gena CFTR nije ustanovljena.
English: Administration of ivacaftor may increase systemic exposure of medicinal products that are sensitive substrates of CYP2C9, and/or P-gp, and/or CYP3A which may increase or prolong their therapeutic effect and adverse reactions.
Croatian: Primjena ivakaftora može povećati sistemsku izloženost lijekovima koji su osjetljivi supstrati CYP2C9 i/ili P-gp-a i/ili CYP3A, što može pojačati ili produljiti njihov terapijski učinak i nuspojave.
English: Study 8: study in paediatric patients with CF aged less than 24 months
Croatian: Ispitivanje 8: ispitivanje u pedijatrijskih bolesnika s cističnom fibrozom mlađih od 24 mjeseca
English: The pharmacokinetic parameters of ivacaftor in combination with tezacaftor in the elderly patients (65-72 years) are comparable to those in younger adults.
Croatian: Farmakokinetički parametri ivakaftora u kombinaciji s tezakaftorom u starijih bolesnika (u dobi od 62 do 72 godine) usporedivi su s onima u mlađih odraslih osoba.
English: In patients aged 2 to less than 6 years the most common adverse reactions were nasal congestion (26.5%), upper respiratory tract infection (23.5%), transaminase elevations (14.7%), rash (11.8%), and bacteria in sputum (11.8%).
Croatian: U bolesnika u dobi od 2 do manje od 6 godina, najčešće nuspojave bile su kongestija nosa (26,5%), infekcija gornjih dišnih puteva (23,5%), povišene transaminaze (14,7%), osip (11,8%) i bakterije u iskašljaju (11,8%).
English: Kalydeco 150 mg film-coated tablets are light blue, capsule-shaped, 16.5 mm x 8.4 mm, and printed with “V 150” in black ink on one side and plain on the other.
Croatian: Kalydeco 150 mg filmom obložene tablete svjetloplave su boje, oblika kapsule, veličine 16,5 mm x 8,4 mm s otisnutim „V 150“ crnom tintom na jednoj strani i neoznačene s druge strane.
English: The mean (SD) overall (both ivacaftor dosing groups combined) absolute change from baseline in BMI at week 24 was 0.32 kg/m2 (0.54) and the mean (SD) overall change in BMI-for-age z-score was 0.37 (0.42).
Croatian: Srednja vrijednost (SD) ukupne (kombinirane obje skupine koje su primale ivakaftor) apsolutne promjene od početne vrijednosti BMI-ja u 24. tjednu iznosila je 0,32 kg/m2 (0,54), a srednja vrijednost (SD) ukupne promjene z-vrijednosti BMI-ja za dob iznosila je 0,37 (0,42).
English: What you need to know before your child takes Kalydeco 3.
Croatian: Što morate znati prije nego što Vaše dijete počne uzimati Kalydeco
English: Through week 24
Croatian: Do 24. tjedna
English: Do not stop unless your child's doctor advises you to.
Croatian: Nemojte prestati davati lijek, osim ako Vam je to preporučio djetetov liječnik.
English: No dose adjustment is recommended when Kalydeco is used with moderate or weak CYP3A inducers.
Croatian: Ne preporučuje se prilagodba doze kada se Kalydeco primjenjuje s umjerenim ili slabim induktorima CYP3A.
English: Your child's doctor may perform some eye examinations prior to and during treatment with ivacaftor.
Croatian: Djetetov će liječnik možda provesti neke preglede očiju prije i tijekom liječenja ivakaftorom.
English: Simulations for predicting the steady-state exposure of ivacaftor showed that by reducing the dosage from 150 mg q12h to 150 mg once daily, adults with moderate hepatic impairment would have comparable steady-state Cmin values as those obtained with a dose of 150 mg q12h in adults without hepatic impairment.
Croatian: Simulacije za predviđanje izloženosti ivakaftoru u stanju dinamičke ravnoteže pokazale su da bi smanjenjem doze sa 150 mg svakih 12 sati na 150 mg jedanput na dan, odrasli s umjerenim oštećenjem funkcije jetre imali vrijednosti Cmin u stanju dinamičke ravnoteže slične onima koje se postižu dozom od 150 mg svakih 12 sati u odraslih bez oštećenja jetre.
English: In vitro studies showed that ivacaftor is not a substrate for P-gp.
Croatian: Ispitivanja in vitro pokazala su da ivakaftor nije supstrat P-gp-a.
English: Clinical efficacy in patients with the G970R mutation of the CFTR gene could not be established (see section 5.1).
Croatian: U bolesnika s mutacijom G970R gena CFTR nije se mogla ustanoviti klinička djelotvornost (vidjeti dio 5.1).
English: Gender The pharmacokinetic parameters of ivacaftor are similar in males and females.
Croatian: Farmakokinetički parametri ivakaftora slični su u muškaraca i žena.
English: Study 2 evaluated 52 patients who were 6 to 11 years of age at screening; mean (SD) body weight was 30.9 (8.63) kg; 42 (80.8%) patients had the F508del mutation in the second allele.
Croatian: Ispitivanje 2 uključilo je 52 bolesnika koji su na probiru bili u dobi od 6 do 11 godina; srednja vrijednost (SD) tjelesne težine bila je 30,9 (8,63) kg; 42 (80,8%) bolesnika imalo je mutaciju F508del na drugom alelu.
English: In children aged 6 to less than 12 years, the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 15.0% (6/40) in ivacaftor-treated patients and 14.6% (6/41) in patients who received placebo.
Croatian: U djece u dobi od 6 do manje od 12 godina, incidencija bolesnika s povišenim transaminazama (ALT ili AST) > 3 puta GGN iznosila je 15,0% (6/40) u skupini bolesnika liječenih ivakaftorom i 14,6% (6/41) u bolesnika koji su primali placebo.
English: In a human pharmacokinetic study, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Croatian: U ispitivanju farmakokinetike u ljudi, mokraćom se eliminirala minimalna količina ivakaftora i njegovih metabolita (samo 6,6% ukupne radioaktivnosti otkriveno je u mokraći).
English: Findings of cataracts were observed in juvenile rats dosed from postnatal day 7 through 35 at ivacaftor exposure levels of 0.22 times the MRHD based on systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy.
Croatian: Nalazi katarakte opaženi su u mladih štakora koji su od 7. do 35. postnatalnog dana bili izloženi razinama ivakaftora koje su iznosile 0,22 puta MRHD na temelju sistemske izloženosti ivakaftoru i njegovim metabolitima kad se ivakaftor primjenjivao kao monoterapija.
English: One hundred and forty-four (144) patients from study 1 were rolled over in study 4, 67 in the placebo/ivacaftor group and 77 in the ivacaftor/ivacaftor group.
Croatian: Stotinu četrdeset i četiri (144) bolesnika iz ispitivanja 1 prebačeno je u ispitivanje 4; 67 u skupinu placebo/ivakaftor i 77 u skupinu ivakaftor/ivakaftor.
English: Mild (Child-Pugh Class A)
Croatian: Blago (Child-Pugh stadij A)
English: Forty-eight (48) patients from study 2 were rolled over in study 4, 22 in the placebo/ivacaftor group and 26 in the ivacaftor/ivacaftor group.
Croatian: Četrdeset i osam (48) bolesnika iz ispitivanja 2 prebačeno je u ispitivanje 4; 22 u skupinu placebo/ivakaftor i 26 u skupinu ivakaftor/ivakaftor.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: The recommended dose of Kalydeco in combination with tezacaftor/ivacaftor is one tezacaftor/ivacaftor tablet in the morning and one Kalydeco 150 mg tablet in the evening.
Croatian: Preporučena doza lijeka Kalydeco u kombinaciji s tezakaftorom/ivakaftorom je jedna tableta tezakaftora/ivakaftora ujutro i jedna tableta lijeka Kalydeco od 150 mg navečer.
English: If the patient's genotype is unknown, an accurate and validated genotyping method should be performed before starting treatment to confirm the presence of an indicated mutation in at least one allele of the CFTR gene (see section 4.1).
Croatian: Ako genotip bolesnika nije poznat, potrebno je napraviti genotipizaciju pomoću točne i validirane metode prije početka liječenja kako bi se potvrdilo postojanje neke od navedenih mutacija najmanje jednog alela gena CFTR (vidjeti dio 4.1).
English: The estimated treatment difference for ivacaftor versus placebo was 1.7 percentage points (95% CI -0.6, 4.1); this difference was not statistically significant (P = 0.15).
Croatian: Procijenjena terapijska razlika između ivakaftora i placeba iznosila je 1,7 postotnih bodova (95% CI -0,6; 4,1); ova razlika nije bila statistički značajna (P = 0,15).
English: • Hold sachet of granules with cut line on top.
Croatian: • Držite vrećicu s granulama tako da oznaka za otvaranje bude gore.
English: PC SN NN
Croatian: SN NN
English: Ivacaftor granules (2 x 75 mg sachets) had similar bioavailability as the 150 mg tablet when given with fat-containing food to healthy adult subjects.
Croatian: Bioraspoloživost granula ivakaftora (vrećice 2 x 75 mg) slična je bioraspoloživosti tableta od 150 mg kad se zdravim odraslim ispitanicima daju s hranom koja sadrži masti.
English: • Medicines for diabetes such as glimepiride and glipizide, used to lower sugar blood levels.
Croatian: • Lijekovi za liječenje šećerne bolesti kao što su glimepirid i glipizid, koji se primjenjuju za snižavanje razine šećera u krvi.
English: Severe (Child-Pugh Class C)
Croatian: Teško (Child-Pugh stadij C)
English: Description
Croatian: OZNAČIVANJE
English: Secondary endpoints were evaluation of pharmacokinetics and the absolute change from baseline in sweat chloride through 24 weeks of treatment (see Pharmacodynamic effects).
Croatian: Mjere sekundarnih ishoda bile su procjena farmakokinetike i apsolutna promjena od početne vrijednosti u koncentraciji klorida u znoju tijekom 24 tjedna liječenja (vidjeti Farmakodinamički učinci).
English: • Mix the entire content of a sachet with 5 mL of age-appropriate soft food or liquid.
Croatian: • Pomiješajte cijeli sadržaj vrećice s 5 ml meke hrane ili tekućine primjerene djetetovoj dobi.
English: Table 6: Effect of ivacaftor on growth parameters in patients aged 6 months to less than 24 months with baseline and week 24 values
Croatian: Tablica 6: Vrijednosti za učinak ivakaftora na parametre rasta u bolesnika u dobi od 6 mjeseci do manje od 24 mjeseca na početku i u 24. tjednu
English: Kalydeco tablets can also be used in combination with tezacaftor/ivacaftor tablets for the treatment of adults and adolescents aged 12 years and older with CF who have two F508del mutations in the CFTR gene (homozygous for the F508del mutation) or who have an F508del mutation and certain other second mutations (heterozygous for the F508del mutation).
Croatian: Kalydeco tablete također se mogu primjenjivati u kombinaciji s tabletama tezakaftora/ivakaftora za liječenje cistične fibroze u odraslih i adolescenata u dobi od 12 i više godina koji imaju dvije mutacije F508del gena CFTR (homozigoti za mutaciju F508del) ili koji imaju mutaciju F508del i neke druge određene mutacije (heterozigoti za mutaciju F508del).
English: Giving Kalydeco to your child:
Croatian: Kako ćete davati lijek Kalydeco svom djetetu:
English: Sixty-two percent (24/39) of them carried the F508del-CFTR mutation in the second allele.
Croatian: Šezdeset i dva posto tih bolesnika (24/39) imalo je mutaciju F508del na drugom alelu gena CFTR.
English: Therefore, monitoring of the international normalised ratio (INR) is recommended during co-administration of warfarin with Kalydeco.
Croatian: Stoga se preporučuje praćenje međunarodnog normaliziranog omjera (INR) tijekom istovremene primjene varfarina s lijekom Kalydeco.
English: Each sachet of granules should be mixed with 5 mL of age-appropriate soft food or liquid and completely and immediately consumed.
Croatian: Jednu vrećicu s granulama treba pomiješati s 5 ml meke hrane ili tekućine primjerene dobi i odmah sve pojesti ili popiti.
English: The mean (±SD) CL/F for a single 150 mg dose was 17.3 (8.4) L/hr in healthy subjects.
Croatian: Srednja vrijednost (±SD) CL/F kod jedne doze od 150 mg bila je 17,3 (8,4) l/h u zdravih ispitanika.
English: • Nuts, fat-containing nutritional bars or drinks
Croatian: • orašasti plodovi, nutritivne pločice ili pića koja sadrže masti.
English: How to take Kalydeco
Croatian: Kako čuvati Kalydeco
English: If you forget to give your child Kalydeco
Croatian: Ako ste svom djetetu zaboravili dati Kalydeco
English: Two patients with elevations of ALT or AST > 8 x ULN interrupted treatment and subsequently resumed ivacaftor successfully (see section 4.4 for management of elevated transaminases).
Croatian: Dva su bolesnika s povišenim vrijednostima ALT-a ili AST-a za > 8 puta GGN prekinula, pa kasnije uspješno nastavila liječenje ivakaftorom (vidjeti dio 4.4 za zbrinjavanje u slučaju povišenih transaminaza).
English: For patients in the placebo/ivacaftor group from study 1, the annualised rate of pulmonary exacerbations was higher in the initial study when patients were on placebo (1.34 events/year) than during the subsequent study 4 when patients rolled over to ivacaftor (0.48 events/year across day 1 to week 48, and 0.67 events/year across weeks 48 to 96).
Croatian: U bolesnika iz skupine koja je u ispitivanju 1 primala placebo/ivakaftor, stopa pogoršanja plućnih simptoma iskazana na godišnjoj razini bila je viša u prvotnom ispitivanju kada su bolesnici primali placebo (1,34 događaja/godina) nego tijekom kasnijeg ispitivanja 4 kada se bolesnici prebačeni na ivakaftor (0,48 događaja/godina od 1. dana do 48. tjedna i 0,67 događaja/godina od 48. do 96. tjedna).
English: At week 8
Croatian: U 8. tjednu
English: No safety data are available in infants aged 6 to less than 12 months of age with moderate or severe hepatic impairment treated with ivacaftor.
Croatian: Nisu dostupni podaci o sigurnosti primjene za dojenčad u dobi od 6 do manje od 12 mjeseci s umjerenim ili teškim oštećenjem funkcije jetre, koja je liječena ivakaftorom.
English: No dose adjustment is considered necessary unless moderate hepatic impairment exists.
Croatian: Nije potrebna prilagodba doze osim ako je prisutno umjereno oštećenje funkcije jetre.
English: Two patients, one on placebo and one on ivacaftor, permanently discontinued treatment for elevated transaminases, each > 8 x ULN.
Croatian: Dva bolesnika, jedan koji je primao placebo i jedan liječen ivakaftorom, trajno su prekinula liječenje zbog povišenih transaminaza za > 8 puta GGN.
English: Study 1 evaluated 161 patients who were 12 years of age or older; 122 (75.8%) patients had the F508del mutation in the second allele.
Croatian: Ispitivanje 1 uključilo je 161 bolesnika u dobi od 12 ili više godina; 122 (75,8%) bolesnika imalo je mutaciju F508del na drugom alelu.
English: Take Kalydeco tablets with food that contains fat.
Croatian: Tablete Kalydeco uzmite s hranom koja sadrži masti.
English: If the patient's genotype is unknown, an accurate and validated genotyping method should be performed before starting treatment to confirm the presence of an indicated mutation in the CFTR gene (see section 4.1).
Croatian: Ako genotip bolesnika nije poznat, potrebno je napraviti genotipizaciju pomoću točne i validirane metode prije početka liječenja kako bi se potvrdilo postojanje neke od navedenih mutacija gena CFTR (vidjeti dio 4.1).
English: • Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents treated with Kalydeco (alone or in combination with tezacaftor/ivacaftor).
Croatian: • Nepravilnosti očnih leća (katarakte), bez ikakvog utjecaja na vid, opažene su u neke djece i adolescenata liječenih lijekom Kalydeco (samim ili u kombinaciji s tezakaftorom/ivakaftorom).
English: Table 1: Dosing recommendations for children aged 6 months and older Weight
Croatian: Tablica 1: Preporuke za doziranje u djece u dobi od 6 i više mjeseci
English: Ivacaftor has been studied with an oestrogen/progesterone oral contraceptive and was found to have no significant effect on the exposures of the oral contraceptive.
Croatian: Ispitana je primjena ivakaftora s estrogensko-progesteronskim oralnim kontraceptivom i ustanovljeno je da ivakaftor nema značajan učinak na izloženost oralnom kontraceptivu.
English: The impact of severe hepatic impairment (Child Pugh Class C, score 10 to15) on the pharmacokinetics of ivacaftor have not been studied.
Croatian: Utjecaj teškog oštećenja funkcije jetre (Child-Pugh stadij C, od 10 do 15 bodova) na farmakokinetiku ivakaftora nije ispitan.
English: Absolute change in percent predicted FEV1 (percentage points)
Croatian: Apsolutna promjena u postotku predviđenog FEV1 (postotni bodovi)
English: Kalydeco in combination with tezacaftor/ivacaftor should not be prescribed in patients with CF who are heterozygous for the F508del mutation and have a second CFTR mutation not listed in section 4.1.
Croatian: Kalydeco u kombinaciji s tezakaftorom/ivakaftorom ne smije se propisivati bolesnicima s cističnom fibrozom koji su heterozigoti za mutaciju F508del i imaju drugu mutaciju gena CFTR koja nije navedena u dijelu 4.1.
English: The mean (SD) Faecal Elastase-1 value at baseline (n = 27) was 28 µg/g (95).
Croatian: Srednja vrijednost (SD) koncentracije elastaze-1 u stolici na početku (n = 27) iznosila je 28 µg/g (95).
English: Thirty-nine patients (mean age 23 years) with baseline FEV1 ≥ 40% predicted (mean FEV1 78% predicted [range: 43% to 119%]) were enrolled.
Croatian: Uključeno je trideset i devet bolesnika (srednja vrijednost dobi 23 godine) s početnim FEV1 ≥ 40% predviđene vrijednosti (srednja vrijednost FEV1 78% od predviđenog [raspon: od 43% do 119%]).
English: Patients in both studies were randomised 1:1 to receive either 150 mg of ivacaftor or placebo every 12 hours with food containing fat for 48 weeks in addition to their prescribed CF therapies (e.g., tobramycin, dornase alfa).
Croatian: Bolesnici su u oba ispitivanja bili randomizirani u omjeru 1:1, i tijekom 48 tjedana primali su 150 mg ivakaftora ili placebo svakih 12 sati s hranom koja sadrži masti, uz terapiju za CF koja im je bila propisana (npr. tobramicin, dornaza alfa).
English: Kalydeco 25 mg granules in sachet Kalydeco 50 mg granules in sachet Kalydeco 75 mg granules in sachet
Croatian: Kalydeco 25 mg granule u vrećici Kalydeco 50 mg granule u vrećici Kalydeco 75 mg granule u vrećici
English: In a human pharmacokinetic study with ivacaftor monotherapy, there was minimal elimination of ivacaftor and its metabolites in urine (only 6.6% of total radioactivity was recovered in the urine).
Croatian: U ispitivanju farmakokinetike ivakaftora u monoterapiji u ljudi, mokraćom se eliminirala minimalna količina ivakaftora i njegovih metabolita (samo 6,6% ukupne radioaktivnosti otkriveno je u mokraći).
English: However, in patients with the G970R-CFTR mutation, the mean (SD) absolute change in sweat chloride at week 8 was -6.25 (6.55) mmol/L.
Croatian: Međutim, u bolesnika s mutacijom G970R gena CFTR, srednja vrijednost (SD) apsolutne promjene u koncentraciji klorida u znoju u 8. tjednu iznosila je -6,25 (6,55) mmol/l.
English: Do not stop unless your doctor advises you to.
Croatian: Nemojte prestati uzimati lijek osim ako Vam je tako savjetovao liječnik.
English: Ivacaftor dosing was interrupted in most patients with transaminase elevations > 5 x ULN.
Croatian: Doziranje ivakaftora bilo je prekinuto u većine bolesnika s povišenjem transaminaza za > 5 puta GGN.
English: When co-administered with strong inhibitors of CYP3A, the Kalydeco dose should be reduced to one sachet (ivacaftor 25 mg for patients 5 kg to < 7 kg; ivacaftor 50 mg for patients 7 kg to < 14 kg; ivacaftor 75 mg for patients 14 kg to < 25 kg) twice a week (see sections 4.4 and 4.5).
Croatian: Kad se primjenjuje s jakim inhibitorima CYP3A, dozu lijeka Kalydeco treba sniziti na jednu vrećicu (ivakaftor 25 mg za bolesnike težine od 5 kg do < 7 kg; ivakaftor 50 mg za bolesnike težine od 7 kg do < 14 kg; ivakaftor 75 mg za bolesnike težine od 14 kg do < 25 kg) dvaput na tjedan (vidjeti dijelove 4.4 i 4.5).
English: Therefore, its use is not recommended unless the benefits outweigh the risks (see Table 2 and sections 4.4 and 5.2).
Croatian: Stoga se njegova primjena ne preporučuje osim ako je korist od liječenja veća od rizika (vidjeti tablicu 2 i dijelove 4.4 i 5.2).