FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 3: Adverse reactions in patients treated with ivacaftor monotherapy or in combination with tezacaftor System organ class
Croatian: Tablica 3: Nuspojave u bolesnika liječenih ivakaftorom u monoterapiji ili u kombinaciji s tezakaftorom
English: The NOAEL for viability and growth in the offspring provides an exposure level of approximately 3 times the systemic exposure of ivacaftor and its metabolites when administered as ivacaftor monotherapy in adult humans at the MRHD.
Croatian: NOAEL za preživljenje i rast potomaka odgovara razini izloženosti oko 3 puta većoj od sistemske izloženosti ivakaftoru i njegovim metabolitima kad se ivakaftor primjenjivao kao monoterapija u odraslih osoba pri MRHD-u.
English: It is unknown whether ivacaftor is excreted in human milk.
Croatian: Nije poznato izlučuje li se ivakaftor u majčino mlijeko.
English: G1244E (5) G1349D (2) G178R (5) G551S (2) G970R# (4) S1251N (8) S1255P (2) S549N (6)
Croatian: G1244E (5) G1349D (2) G178R (5) G551S (2)
English: Kalydeco 150 mg tablets
Croatian: Kalydeco 150 mg tablete
English: For patients in the ivacaftor/ivacaftor group from study 1, the annualised rate of pulmonary exacerbations was 0.57 events/year across day 1 to week 48 when patients were on ivacaftor.
Croatian: U bolesnika iz skupine koja je u ispitivanju 1 primala ivakaftor/ivakaftor, stopa pogoršanja plućnih simptoma iskazana na godišnjoj razini bila je 0,57 događaja/godina od 1. dana do 48. tjedna kada su bolesnici primali ivakaftor.
English: Transaminase elevations very common
Croatian: Poremećaji jetre i žuči povišene transaminaze vrlo često
English: In study 7 in patients aged 2 to less than 6 years with a gating mutation on at least 1 allele of the CFTR gene administered either 50 mg or 75 mg of ivacaftor twice daily, the mean absolute change from baseline in sweat chloride was -47 mmol/L (95% CI -58, -36) at week 24.
Croatian: U ispitivanju 7 u bolesnika u dobi od 2 do manje od 6 godina koji su imali mutaciju zbog koje dolazi do nepravilne regulacije kanala na barem 1 alelu gena CFTR i primali su 50 mg ili 75 mg ivakaftora dvaput na dan, srednja vrijednost apsolutne promjene u koncentraciji klorida u znoju od početne vrijednosti iznosila je -47 mmol/l (95% CI -58; -36) u 24. tjednu.
English: In study 8 in patients with CF aged less than 24 months, the mean absolute change from baseline in sweat chloride was -67.9 mmol/L (95% CI -77.6, -58.2) at week 24.
Croatian: U ispitivanju 8 provedenom u bolesnika s cističnom fibrozom mlađih od 24 mjeseca, srednja vrijednost apsolutne promjene u koncentraciji klorida u znoju od početne vrijednosti iznosila je u 24. tjednu -67,9 mmol/l (95% CI -77,6; -58,2).
English: Pharmacokinetic studies have not been performed with ivacaftor in patients with renal impairment.
Croatian: Ispitivanja farmakokinetike ivakaftora nisu provedena u bolesnika s oštećenjem funkcije bubrega.
English: When the mean (SD) absolute change in percent predicted FEV1 is compared from study 4 baseline for patients in the ivacaftor/ivacaftor group (n = 72) who rolled over from study 1, the mean (SD) absolute change in percent predicted FEV1 was 0.0% (9.05), while for patients in the ivacaftor/ivacaftor group (n = 25) who rolled over from study 2 this figure was 0.6% (9.1).
Croatian: Usporedbom srednje vrijednosti (SD) apsolutne promjene u postotku predviđenog FEV1 i početnih vrijednosti u ispitivanju 4, u bolesnika iz skupine koja je primala ivakaftor/ivakaftor (n = 72), a koji su prebačeni iz ispitivanja 1, srednja vrijednost (SD) apsolutne promjene u postotku predviđenog FEV1 iznosila je 0,0% (9,05), dok je u bolesnika iz skupine koja je primala ivakaftor/ivakaftor (n = 25), a koji su prebačeni iz ispitivanja 2, ta vrijednost iznosila 0,6% (9,1).
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/ivacaftor.
Croatian: Slučajevi zamućenja leće koja nisu prirođena, bez utjecaja na vid, zabilježeni su u pedijatrijskih bolesnika liječenih ivakaftorom u monoterapiji ili u kombiniranom režimu s tezakaftorom/ivakaftorom.
English: When co-administered with strong inhibitors of CYP3A, the Kalydeco dose should be reduced to 150 mg twice a week (see sections 4.4 and 4.5).
Croatian: Kad se primjenjuje s jakim inhibitorima CYP3A, dozu lijeka Kalydeco treba sniziti na 150 mg dvaput na tjedan (vidjeti dijelove 4.4 i 4.5).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE VREĆICE
English: Ivacaftor has not been studied in patients with CF who have undergone organ transplantation.
Croatian: Ivakaftor nije ispitan u bolesnika s cističnom fibrozom kojima je presađen organ.
English: • Enlargement of the breast in males
Croatian: • povećanje dojki u muškaraca
English: Therefore, co-administration of Kalydeco with strong CYP3A inducers is not recommended (see section 4.5).
Croatian: Stoga se ne preporučuje istovremena primjena lijeka Kalydeco s jakim induktorima CYP3A (vidjeti dio 4.5).
English: The mean absolute change from baseline through week 8 in percent predicted FEV1 (primary efficacy endpoint) was 7.5% in the ivacaftor period and -3.2% in the placebo period.
Croatian: Srednja vrijednost apsolutne promjene od početka do 8. tjedna u postotku predviđenog FEV1 (mjera primarnog ishoda djelotvornosti) bila je 7,5% u razdoblju liječenja ivakaftorom i -3,2% u razdoblju liječenja placebom.
English: After oral administration of ivacaftor150 mg every 12 hours for 7 days in healthy volunteers in a fed state, the mean (± SD) apparent volume of distribution was 353 (122) L.
Croatian: Nakon peroralne primjene ivakaftora od 150 mg svakih 12 sati tijekom 7 dana zdravim ispitanicima u sitom stanju, srednja vrijednost (±SD) prividnog volumena distribucije iznosila je 353 (122) l.
English: One tablet of ivacaftor 150 mg once daily
Croatian: Jedna tableta ivakaftora od 150 mg jedanput dnevno
English: A reduction of the Kalydeco dose is recommended for co-administration with strong CYP3A inhibitors, such as ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin and clarithromycin (see sections 4.2 and 4.4).
Croatian: Preporučuje se smanjiti dozu lijeka Kalydeco kad se primjenjuje istovremeno s jakim inhibitorima CYP3A, kao što su ketokonazol, itrakonazol, posakonazol, vorikonazol, telitromicin i klaritromicin (vidjeti dijelove 4.2 i 4.4).
English: A fat-containing meal or snack should be consumed just before or just after dosing.
Croatian: Neposredno prije ili neposredno poslije doziranja treba pojesti obrok ili međuobrok koji sadrži masti.
English: The dose of Kalydeco (monotherapy or in combination with tezacaftor/ivacaftor) must be adjusted when used concomitantly with strong or moderate CYP3A inhibitors (see sections 4.2 and 4.5).
Croatian: Doza lijeka Kalydeco (u monoterapiji ili u kombinaciji s tezakaftorom/ivakaftorom) mora se prilagoditi kad se primjenjuje istovremeno s jakim ili umjerenim inhibitorima CYP3A (vidjeti dijelove 4.2 i 4.5).
English: Starting dose: One tablet of tezacaftor 100 mg/ivacaftor 150 mg once daily.
Croatian: Početna doza: jedna tableta tezakaftora od 100 mg / ivakaftora od 150 mg jedanput dnevno.
English: No patients had elevations in total bilirubin or discontinued ivacaftor treatment due to transaminase elevations in either cohort.
Croatian: Ni u jednoj od kohorti nijedan bolesnik nije imao povišen ukupni bilirubin i nijedan bolesnik nije prekinuo liječenje ivakaftorom zbog povišenja transaminaza.
English: Table 2: Dosing recommendations for patients with hepatic impairment for Kalydeco monotherapy and in a combination regimen with tezacaftor/ivacaftor Kalydeco monotherapy Kalydeco in a combination regimen with tezacaftor/ivacaftor
Croatian: Tablica 2: Preporuke za doziranje lijeka Kalydeco u monoterapiji i u kombiniranom režimu s tezakaftorom/ivakaftorom u bolesnika s oštećenjem funkcije jetre
English: When co-administered with moderate inhibitors of CYP3A, the Kalydeco dose is as above recommended, but administered once daily (see sections 4.4 and 4.5).
Croatian: Kad se primjenjuje istovremeno s umjerenim inhibitorima CYP3A, Kalydeco treba primijeniti u dozi kako je preporučeno gore, ali jedanput na dan (vidjeti dijelove 4.4 i 4.5).
English: Co-administration of Kalydeco with strong CYP3A inducers, such as rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort (Hypericum perforatum), is not recommended (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena lijeka Kalydeco s jakim induktorima CYP3A, kao što su rifampicin, rifabutin, fenobarbital, karbamazepin, fenitoin i gospina trava (Hypericum perforatum) (vidjeti dio 4.4).
English: Treatment with ivacaftor resulted in a mean absolute change in percent predicted FEV1 through week 24 of 4.5 percentage points in the ivacaftor group versus -0.46 percentage points in the placebo group.
Croatian: Liječenje ivakaftorom dovelo je do srednje vrijednosti apsolutne promjene postotka predviđenog FEV1 do 24. tjedna za 4,5 postotnih bodova u skupini koja je primala ivakaftor naspram -0,46 postotnih bodova u skupini koja je primala placebo.
English: In study 6 in patients aged 6 years or older with CF who had an R117H mutation in the CFTR gene, the treatment difference in mean change in sweat chloride from baseline through 24 weeks of treatment was -24 mmol/L (95% CI -28, -20).
Croatian: U ispitivanju 6 u bolesnika s cističnom fibrozom u dobi od 6 i više godina koji su imali mutaciju R117H gena CFTR, terapijska razlika srednje vrijednosti promjene u koncentraciji klorida u znoju od početne vrijednosti do 24. tjedna iznosila je -24 mmol/l (95% CI -28; -20).
English: Bacteria in sputum very common
Croatian: Pretrage bakterije u iskašljaju vrlo često
English: Titanium dioxide (E171) Macrogol (PEG 3350) Talc
Croatian: Film ovojnica tablete poli(vinilni alkohol) titanijev dioksid (E171) makrogol (PEG 3350) talk indigo carmine aluminum lake (E132)
English: During the 24-week open-label Phase 3 clinical study of ivacaftor monotherapy in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 14.7% (5/34).
Croatian: Tijekom kliničkog ispitivanja faze III otvorenog tipa u trajanju od 24 tjedna u kojem se ispitivala monoterapija ivakaftorom u 34 bolesnika u dobi od 2 do manje od 6 godina (ispitivanje 7), incidencija bolesnika s povišenim transaminazama (ALT ili AST) > 3 puta GGN iznosila je 14,7% (5/34).
English: No dose adjustment is necessary for patients with mild to moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega.
English: Co-administration of Kalydeco (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) with strong CYP3A inducers, such as rifampicin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John's wort (Hypericum perforatum), is not recommended (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena lijeka Kalydeco (bilo u monoterapiji ili u kombiniranom režimu s tezakaftorom/ivakaftorom) s jakim induktorima CYP3A, kao što su rifampicin, rifabutin, fenobarbital, karbamazepin, fenitoin i gospina trava (Hypericum perforatum) (vidjeti dio 4.4).
English: Weight-for-age z-score Length-for-age z-score Weight-for-length z-score 28
Croatian: z-vrijednost težine za dob z-vrijednost visine za dob z-vrijednost težine za visinu
English: Table 4: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1
Croatian: Tablica 4: Učinak ivakaftora prema varijablama djelotvornosti u cjelokupnoj populaciji te prema specifičnim mutacijama gena CFTR
English: A reduction of the Kalydeco dose (as monotherapy or in a combination regimen with tezacaftor/ivacaftor) is recommended for patients taking concomitant moderate CYP3A inhibitors, such as fluconazole and erythromycin (see sections 4.2 and 4.4).
Croatian: Preporučuje se smanjiti dozu lijeka Kalydeco (u monoterapiji ili u kombiniranom režimu s tezakaftorom/ivakaftorom) kod bolesnika koji istovremeno uzimaju umjerene inhibitore CYP3A, kao što su flukonazol i eritromicin (vidjeti dijelove 4.2 i 4.4).
English: During the 24-week open-label Phase 3 clinical study of ivacaftor in 34 patients aged 2 to less than 6 years (study 7), the incidence of patients experiencing transaminase elevations (ALT or AST) > 3 x ULN was 14.7% (5/34).
Croatian: Tijekom kliničkog ispitivanja faze III otvorenog tipa u trajanju od 24 tjedna u kojem se ispitivala primjena ivakaftora u 34 bolesnika u dobi od 2 do manje od 6 godina (ispitivanje 7), incidencija bolesnika s povišenim transaminazama (ALT ili AST) > 3 puta GGN iznosila je 14,7% (5/34).
English: All patients (N = 39) Results shown as mean (95% CI) change from baseline ivacaftor vs placebo-treated patients:
Croatian: Rezultati prikazani kao srednja vrijednost (95% CI) promjene od početne vrijednosti u bolesnika liječenih ivakaftorom naspram onoj u bolesnika liječenih placebom:
English: 28 tablets
Croatian: OBLIK I SADRŽAJ 28 tableta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER - 56-TABLET PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER - PAKIRANJE OD 56 TABLETA
English: For patients randomised to the placebo/ivacaftor treatment sequence in part 1 there was a further mean (SD) change of 3.3% (9.3%) in percent predicted FEV1 after the additional 16 weeks of treatment with ivacaftor.
Croatian: U bolesnika koji su u 1. dijelu ispitivanja randomizirani na slijed liječenja placebo/ivakaftor, nakon dodatnih 16 tjedana liječenja ivakaftorom došlo je do daljnje promjene srednje vrijednosti (SD) u postotku predviđenog FEV1 od 3,3% (9,3%).
English: Ensure that the mixture is completely and immediately consumed.
Croatian: Pazite da odmah uzme sav lijek.
English: Ivacaftor in a combination regimen with tezacaftor/ivacaftor In patients homozygous for the F508del mutation, the treatment difference between ivacaftor in combination with tezacaftor/ivacaftor and placebo in mean absolute change from baseline in sweat chloride through week 24, was -10.1 mmol/L (95% CI: -11.4, -8.8).
Croatian: U bolesnika homozigota za mutaciju F508del, terapijska razlika između ivakaftora u kombinaciji s tezakaftorom/ivakaftorom i placeba u srednjoj vrijednosti apsolutne promjene koncentracije klorida u znoju od početka do 24. tjedna iznosila je -10,1 mmol/l (95% CI: -11,4; -8,8).
English: Additional adverse reactions observed with ivacaftor in combination with tezacaftor/ivacaftor are also provided in Table 3.
Croatian: U tablici 3 navedene su i dodatne nuspojave opažene uz ivakaftor u kombinaciji s tezakaftorom/ivakaftorom.
English: Table 5: Effect of ivacaftor for efficacy variables in the overall population and for specific CFTR mutations Absolute change in percent predicted FEV1
Croatian: Tablica 5: Učinak ivakaftora prema varijablama djelotvornosti u cjelokupnoj populaciji te prema specifičnim mutacijama gena CFTR
English: When co-administered with moderate inhibitors of CYP3A, the Kalydeco dose should be reduced to 150 mg once daily (see sections 4.4 and 4.5).
Croatian: Kad se primjenjuje istovremeno s umjerenim inhibitorima CYP3A, dozu lijeka Kalydeco treba sniziti na 150 mg jedanput na dan (vidjeti dijelove 4.4 i 4.5).
English: The active substance is ivacaftor.
Croatian: Djelatna tvar je ivakaftor.
English: Caution is recommended for patients with severe renal impairment or end-stage renal disease (see section 5.2).
Croatian: Preporučuje se oprez u bolesnika s teškim oštećenjem funkcije bubrega ili terminalnim stadijem bubrežne bolesti (vidjeti dio 5.2).
English: Iron oxide black (E172) Propylene glycol (E1520)
Croatian: Tinta za označavanje šelak željezov oksid, crni (E172) propilenglikol (E1520) amonijak, koncentrirana otopina
English: Results were consistent in both the 12 months to less than 24 months and 6 months to less than 12 months age cohorts.
Croatian: Rezultati bolesnika u dobnoj skupini od 12 mjeseci do manje od 24 mjeseca bili su sukladni onima u dobnoj skupini od 6 mjeseci do manje od 12 mjeseci.
English: Cataracts
Croatian: Katarakte
English: Co-administration with fluconazole, a moderate inhibitor of CYP3A, increased ivacaftor exposure by 3-fold and increased M1 to a lesser extent than ivacaftor.
Croatian: Istovremena primjena s flukonazolom, umjerenim inhibitorom CYP3A, povećala je izloženost ivakaftoru 3 puta, i povećala izloženost M1 u manjoj mjeri nego ivakaftoru.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BOČICU
English: • Tablet core: cellulose microcrystalline, lactose monohydrate, hypromellose acetate succinate, croscarmellose sodium, sodium laurilsulfate (E487), silica, colloidal anhydrous, and magnesium stearate.
Croatian: • jezgra tablete: celuloza, mikrokristalična, laktoza hidrat, hipromelozaacetat sukcinat, karmelozanatrij, umrežena, natrijev laurilsulfat (E487), silicijev dioksid, koloidni, bezvodni i magnezijev stearat
English: If you have any further questions on the use of this medicine, ask your child's doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se djetetovom liječniku ili ljekarniku.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET FOR SACHET
Croatian: PODACI KOJI SE MORAJU NALAZITI NA MEĐUPAKIRANJU PRETINAC ZA VREĆICU
English: Concomitant use of CYP3A inhibitors
Croatian: Istovremena primjena s inhibitorima CYP3A
English: Each film-coated tablet contains 150 mg of ivacaftor.
Croatian: Jedna filmom obložena tableta sadrži 150 mg ivakaftora.
English: No dose adjustments are recommended for mild and moderate renal impairment.
Croatian: Ne preporučuje se prilagodba doze kod blagog i umjerenog oštećenja funkcije bubrega.
English: During the 48-week placebo-controlled studies 1 and 2 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, 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: Therefore, co-administration of Kalydeco (monotherapy or in combination with tezacaftor/ivacaftor) with strong CYP3A inducers is not recommended (see section 4.5).
Croatian: Stoga se ne preporučuje istovremena primjena lijeka Kalydeco (u monoterapiji ili u kombinaciji s tezakaftorom/ivakaftorom) s jakim induktorima CYP3A (vidjeti dio 4.5).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - 28-TABLET PACK
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI - PAKIRANJE OD 28 TABLETA
English: • Talk to your child's doctor if your child has liver problems, or has had them previously.
Croatian: • Obratite se djetetovu liječniku ako Vaše dijete ima ili je prije imalo tegobe s jetrom.
English: Study 1 and 2: studies in patients with CF with G551D gating mutations The efficacy of Kalydeco has been evaluated in two Phase 3 randomised, double-blind, placebo-controlled, multi-centre studies of clinically stable patients with CF who had the G551D mutation in the CFTR gene on at least 1 allele and had FEV1 ≥ 40% predicted.
Croatian: Djelotvornost lijeka Kalydeco procijenjena je u dva randomizirana, dvostruko slijepa, placebom kontrolirana, multicentrična ispitivanja faze III u klinički stabilnih bolesnika s cističnom fibrozom koji su imali mutaciju G551D gena CFTR na najmanje jednom alelu i FEV1 ≥ 40% predviđenog.
English: Table 5: Effect of ivacaftor on percent predicted FEV1 in study 4 Original study and treatment group
Croatian: Tablica 5: Učinak ivakaftora na postotak predviđenog FEV1 u ispitivanju 4
English: Kalydeco 50 mg granules in sachet
Croatian: Kalydeco 50 mg granule u vrećici
English: In study 5, part 1 in patients who had a non-G551D gating mutation in the CFTR gene, treatment with ivacaftor led to a rapid (15 days) and substantial mean change from baseline in sweat chloride of -49 mmol/L (95% CI -57, -41) through 8 weeks of treatment.
Croatian: U ispitivanju 5, 1. dijelu, provedenom u bolesnika s mutacijom gena CFTR koja dovodi do nepravilne regulacije kanala, ali nije mutacija G551D, liječenje ivakaftorom dovelo je u 8 tjedana liječenja do brze (15 dana) i znatne srednje vrijednosti promjene u odnosu na početne vrijednosti u koncentraciji klorida u znoju od -49 mmol/l (95% CI -57; -41).
English: Food or drink containing grapefruit or Seville oranges should be avoided during treatment (see section 4.5).
Croatian: Za vrijeme liječenja lijekom Kalydeco treba izbjegavati hranu i pića koja sadrže grejp ili naranče sorte Seville (vidjeti dio 4.5).
English: CYP3A inhibitors
Croatian: Inhibitori CYP3A
English: Based on these results, a modified regimen of Kalydeco monotherapy is recommended for patients with moderate hepatic impairment (see Table 2 in section 4.2).
Croatian: Na temelju ovih rezultata, za bolesnike s umjerenim oštećenjem funkcije jetre preporučuje se modificirani režim monoterapije lijekom Kalydeco (vidjeti tablicu 2 u dijelu 4.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR BLISTER CARD - 28-TABLET PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA BLISTER KARTICE - PAKIRANJE OD 28 TABLETA
English: • Talk to your doctor if you have liver problems, or have previously had them.
Croatian: • Obratite se svom liječniku ako imate ili ste prije imali tegobe s jetrom.
English: Tezacaftor 100 mg/ ivacaftor 150 mg tablet Ivacaftor 150 mg tablet
Croatian: Tezakaftor 100 mg / ivakaftor 150 mg tableta
English: Caution is recommended while using ivacaftor, either in monotherapy or in a combination regimen with tezacaftor/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, bilo u monoterapiji bilo u kombiniranom režimu s tezakaftorom/ivakaftorom, u bolesnika s teškim oštećenjem funkcije bubrega ili terminalnim stadijem bubrežne bolesti (vidjeti dijelove 4.2 i 5.2).
English: The mean absolute change from baseline through week 24 in percent predicted FEV1 (primary efficacy endpoint) was 2.57 percentage points in the ivacaftor group and 0.46 percentage points in the placebo group.
Croatian: Srednja vrijednost apsolutne promjene od početka do 24. tjedna u postotku predviđenog FEV1 (mjera primarnog ishoda djelotvornosti) iznosila je 2,57 postotnih bodova u skupini koja je primala ivakaftor i 0,46 postotnih bodova u skupini koja je primala placebo.
English: • Blister card pack containing 28 film-coated tablets
Croatian: • pakiranje s blister karticama koje sadrži 28 filmom obloženih tableta
English: Mean absolute change from baseline in BMI (kg/m2)
Croatian: Srednja vrijednost apsolutne promjene indeksa tjelesne mase (BMI) od početne vrijednosti (kg/m2)
English: Tell your doctor right away if you have any of these symptoms, which may be a sign of liver problems:
Croatian: Ako imate neki od sljedećih simptoma, koji mogu biti znak poremećaja jetre, odmah o tome obavijestite liječnika:
English: Placental transfer of ivacaftor was observed in pregnant rats and rabbits.
Croatian: U skotnih ženki štakora i kunića opažen je placentalni prijenos ivakaftora.
English: Mean absolute change from baseline in body weight (kg)
Croatian: Srednja vrijednost apsolutne promjene tjelesne težine od početne vrijednosti (kg) U 24. tjednu