FrancophonIA/ELRC3.0 huggingface dataset:
English: The exposures are similar between adults and the paediatric population based on population (PK) analyses as presented in Table 8 below:
Croatian: Na temelju populacijskih (farmakokinetičkih) analiza, izloženost u odraslih i pedijatrijske populacije je slična, kao što je prikazano u tablici 8 niže:
English: Number of events requiring intravenous antibiotics per patient-year (95% CI) (rate per 48 wks)
Croatian: Broj događaja koji su zahtijevali intravenske antibiotike po bolesnikgodini (95% CI) (stopa na 48 tjedana)
English: Antifungals: itraconazole*, ketoconazole, posaconazole, voriconazole
Croatian: Antimikotici: itrakonazol*, ketokonazol, posakonazol, vorikonazol
English: The incidence of transaminase-related adverse reactions was 5.1% and 4.6% in lumacaftor/ivacaftor-treated patients and those who received placebo, respectively.
Croatian: Incidencija nuspojava povezanih s transaminazama bila je 5,1% u bolesnika liječenih lumakaftorom/ivakaftorom, a 4,6% u onih koji su primali placebo.
English: The percentage of patients with heart rate values < 50 bpm on treatment was 11% for patients who received lumacaftor/ivacaftor, compared to 4.9% for patients who received placebo.
Croatian: Postotak bolesnika s vrijednostima frekvencije srca < 50 otkucaja po minuti tijekom liječenja iznosio je 11% za bolesnike koji su primali lumakaftor/ivakaftor, u usporedbi s 4,9% za bolesnike koji su primali placebo.
English: Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet).
Croatian: Veličina pakiranja od 56 vrećica (sadrži 4 pojedinačna ovitka s 14 vrećica po ovitku).
English: After oral administration of ivacaftor 250 mg every 12 hours in combination with lumacaftor, the typical apparent volumes of distribution for the central and peripheral compartments [coefficient of variation as a percentage (CV)] were estimated to be 95.0 L (53.9%) and 201 L (26.6%), respectively.
Croatian: Nakon peroralne primjene ivakaftora u dozi od 250 mg svakih 12 sati u kombinaciji s lumakaftorom, procijenjeni tipični prividni volumen distribucije [koeficijent varijacije kao postotak (CV)] za središnji odjeljak bio je 95,0 L (53,9%), a za periferni odjeljak 201 L (26,6%).
English: Some examples of age-appropriate soft foods and liquids include puréed fruits, flavoured yogurt, and milk or juice.
Croatian: Neki primjeri meke hrane ili tekućina su kašica od voća, jogurt s okusom, mlijeko ili sok.
English: This medicine contains less than 1 mmole sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: In the lumacaftor/ivacaftor patients, the treatment difference for absolute change in ppFEV1 from baseline through Week 24 was 2.4 (P = 0.0182).
Croatian: U bolesnika liječenih lumakaftorom/ivakaftorom, terapijska razlika prema apsolutnoj promjeni ppFEV1 od početka do 24. tjedna bila je 2,4 (P = 0,0182).
English: For dose adjustments for patients with hepatic impairment see Table 2.
Croatian: Za prilagodbu doze bolesnicima s oštećenjem funkcije jetre, vidjeti tablicu 2.
English: INFORMATION IN BRAILLE Orkambi 150 mg, 188 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Orkambi 150 mg, 188 mg
English: 12 years and older Orkambi 200 mg/125 mg
Croatian: 12 i više godina Orkambi 200 mg/125 mg
English: Lumacaftor is a CFTR corrector that acts directly on F508del-CFTR to improve its cellular processing and trafficking, thereby increasing the quantity of functional CFTR at the cell surface.
Croatian: Lumakaftor je korektor CFTR-a koji djeluje izravno na F508del-CFTR kako bi poboljšao staničnu obradu i prijenos, čime se povećava količina funkcionalnog CFTR-a na površini stanice.
English: Lumacaftor is a strong inducer of CYP3A.
Croatian: Lumakaftor je jaki induktor CYP3A.
English: Table 1: Recommended dose of Orkambi in patients aged 2 years and older
Croatian: Tablica 3: Preporučena doza lijeka Orkambi u bolesnika u dobi od 2 i više godina
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1059/001 112 film-coated tablets (4 packs of 28 tablets) EU/1/15/1059/002 56 film-coated tablets (2 packs of 28 tablets)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1059/001 112 filmom obloženih tableta (4 pakiranja po 28 tableta) EU/1/15/1059/002 56 filmom obloženih tableta (2 pakiranja po 28 tableta)
English: Ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein at the cell surface.
Croatian: Ivakaftor je pojačivač CFTR-a koji olakšava povećan prijenos klorida, povećavajući vjerojatnost otvaranja kanala CFTR proteina na površini stanice.
English: Changes in sweat chloride in response to lumacaftor alone or in combination with ivacaftor were evaluated in a double-blind, placebo-controlled, Phase 2 clinical trial in patients with CF age 18 years and older.
Croatian: Promjene u koncentraciji klorida u znoju kao odgovor na lumakaftor primijenjen sam ili u kombinaciji s ivakaftorom bile su procijenjene u dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju faze 2 u bolesnika s cističnom fibrozom u dobi od 18 i više godina.
English: Of the 1108 patients who received any treatment in Trial 1 or Trial 2, 1029 (93%) were dosed and received active treatment (lumacaftor 600 mg once daily/ivacaftor 250 mg q12h or lumacaftor 400 mg q12h/ivacaftor 250 mg q12h) in Trial 3 for up to an additional 96 weeks (i.e. up to a total of 120 weeks).
Croatian: Od 1108 bolesnika koji su u ispitivanju 1 ili ispitivanju 2 primali bilo koju terapiju, u ispitivanju 3 je 1029 (93%) bolesnika aktivno liječeno (dozom lumakaftora 600 mg jedanput na dan/ivakaftora 250 mg svakih 12 sati ili lumakaftora 400 mg/ivakaftora 250 mg svakih 12 sati) do dodatnih 96 tjedana (tj. do ukupno 120 tjedana).
English: Trial in patients with CF who are heterozygous for the F508del mutation in the CFTR gene Trial 4 was a multicentre, double-blind, randomised, placebo-controlled, Phase 2 trial in 125 patients with CF aged 18 years and older who had a ppFEV1 of 40 to 90, inclusive, and have the F508del mutation on one allele plus a second allele with a mutation predicted to result in the lack of CFTR production or a CFTR that is not responsive to ivacaftor in vitro.
Croatian: Ispitivanje u bolesnika s cističnom fibrozom koji su heterozigoti za mutaciju F508del gena CFTR Ispitivanje 4 bilo je multicentrično, dvostruko slijepo, randomizirano, placebom kontrolirano ispitivanje faze 2, provedeno u 125 bolesnika s cističnom fibrozom u dobi od 18 i više godina koji su imali vrijednost ppFEV1 od 40 do 90, uključivo, i mutaciju F508del na jednom alelu te na drugom alelu mutaciju za koju se predviđa da će za posljedicu imati nedostatnu proizvodnju CFTR-a ili CFTR koji nije osjetljiv na ivakaftor in vitro.
English: Safety data were evaluated in 60 patients aged 2 to 5 years, 161 patients aged 6 to 11 years (Trials 6, 7 and 8) and in 194 patients aged 12 to 17 years with CF who are homozygous for the F508del mutation and who received lumacaftor/ivacaftor in clinical studies.
Croatian: Podaci o sigurnosti procijenjeni su u 60 bolesnika u dobi od 2 do 5 godina,161 bolesnika u dobi od 6 do 11 godina (ispitivanja 6, 7 i 8) i 194 bolesnika u dobi od 12 do 17 godina s cističnom fibrozom koji su homozigoti za mutaciju F508del i koji su primili lumakaftor/ivakaftor u kliničkim ispitivanjima.
English: The primary endpoint was improvement in lung function as determined by the mean absolute change from baseline at Day 56 in ppFEV1.
Croatian: Primarna mjera ishoda bila je poboljšanje plućne funkcije određeno kao srednja vrijednost apsolutne promjene vrijednosti ppFEV1 izmjerena 56. dana u odnosu na početak ispitivanja.
English: • Pack size of 56 sachets (contains 4 individual wallets with 14 sachets per wallet)
Croatian: • Veličina pakiranja od 56 vrećica (sadrži 4 pojedinačna ovitka s 14 vrećica po ovitku).
English: It is a medicine used for long-term treatment of cystic fibrosis (CF) in children aged 2 years and older who have a specific change (called F508del mutation) affecting the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR), which plays an important role in regulating the flow of mucus in the lungs.
Croatian: To je lijek koji se primjenjuje za dugoročno liječenje cistične fibroze u djece u dobi od 2 i više godina sa specifičnom promjenom (zvanom mutacija F508del) koja utječe na gen za protein pod nazivom transmembranski regulator provodljivosti u cističnoj fibrozi (engl. skraćeno CFTR), koji igra važnu ulogu u regulaciji protoka sluzi u plućima.
English: • Moderate liver problems: the dose may be reduced on alternate days: two sachets on one day
Croatian: • Umjerene jetrene tegobe: doza se može smanjiti svaki drugi dan: dvije vrećice jedan dan
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - MULTIPACK - WITH BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA - VIŠESTRUKO PAKIRANJE - S PLAVIM OKVIROM
English: Taking Orkambi with fat-containing food is important to get the right levels of medicine in your body.
Croatian: Važno je da se Orkambi uzima s hranom koja sadrži masti kako bi se postigle potrebne koncentracije lijeka u Vašem tijelu.
English: Patients treated with lumacaftor/ivacaftor in Trial 1 or Trial 2 showed an effect that was maintained with respect to baseline after an additional 96 weeks through Trial 3.
Croatian: Učinak koji se pokazao u bolesnika liječenih lumakaftorom/ivakaftorom u ispitivanju 1 ili ispitivanju 2 održao se u odnosu na početne vrijednosti nakon dodatnih 96 tjedana u ispitivanju
English: ↔ LUM, IVA ↓ bupropion Due to induction of CYP2B6 by LUM
Croatian: ↔ LUM, IVA ↓ bupropion zbog indukcije CYP2B6
English: Secondary endpoints included absolute change from baseline in sweat chloride at Week 24 and absolute change in sweat chloride from Week 24 at Week 26 (see Pharmacodynamic effects) as well as the endpoints listed in Table 8.
Croatian: Sekundarne mjere ishoda uključivale su apsolutnu promjenu koncentracije klorida u znoju od početne vrijednosti do 24. tjedna i apsolutnu promjenu koncentracije klorida u znoju od 24. tjedna do 26. tjedna (vidjeti Farmakodinamičke učinke), kao i mjere ishoda navedene u tablici 8.
English: It is unknown whether lumacaftor and/or ivacaftor and metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se lumakaftor i/ili ivakaftor i metaboliti u majčino mlijeko.
English: It is a medicine used for long-term treatment of cystic fibrosis (CF) in patients aged 6 years and older who have a specific change (called F508del mutation) affecting the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR), which plays an important role in regulating the flow of mucus in the lungs.
Croatian: To je lijek koji se primjenjuje za dugoročno liječenje cistične fibroze u bolesnika u dobi od 6 i više godina sa specifičnom promjenom (zvanom mutacija F508del) koja utječe na gen za protein pod nazivom transmembranski regulator provodljivosti u cističnoj fibrozi (engl. skraćeno CFTR), koji igra važnu ulogu u regulaciji protoka sluzi u plućima.
English: What you need to know before your child takes Orkambi 3.
Croatian: Što morate znati prije nego što Vaše dijete počne uzimati Orkambi
English: Lumacaftor/ivacaftor will decrease the exposures of midazolam and triazolam, which will reduce their efficacy.
Croatian: Lumakaftor/ivakaftor će smanjiti izloženost midazolamu i triazolamu, što će oslabiti njihovu djelotvornost.
English: Relative change in ppFEV1 at Week 24 (%)
Croatian: Relativna promjena ppFEV1 u 24. tjednu (%)
English: • Severe liver problems: the dose may be reduced to one sachet per day, or less often.
Croatian: • Teške jetrene tegobe: doza se može smanjiti na jednu vrećicu na dan ili rjeđe.
English: Patients should be monitored closely for breakthrough fungal infections if such drugs are necessary.
Croatian: Ako su takvi lijekovi neophodni, bolesnike se mora pažljivo pratiti zbog mogućih izbijanja gljivičnih infekcija.
English: Liver function decompensation, including liver failure leading to death, has been reported in CF patients with preexisting cirrhosis with portal hypertension receiving lumacaftor/ivacaftor.
Croatian: Dekompenzacija jetrene funkcije, uključujući zatajenje jetre koje je dovelo do smrtnog ishoda, zabilježena je u bolesnika s cističnom fibrozom i već prisutnom cirozom s portalnom hipertenzijom koji su primali lumakaftor/ivakaftor.
English: Caution is recommended while using lumacaftor/ivacaftor in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Croatian: Preporučuje se oprez kod primjene lumakaftora/ivakaftora u bolesnika s teškim oštećenjem funkcije bubrega ili terminalnim stadijem bubrežne bolesti (vidjeti dijelove 4.2 i 5.2).
English: Ivacaftor impaired fertility and reproductive performance indices in male and female rats at 200 mg/kg/day (yielding exposures approximately 11 and 7 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 150 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the pilot embryofoetal development study in this species) when dams were dosed prior to and during early pregnancy.
Croatian: Ivakaftor je smanjio indekse plodnosti i reproduktivne sposobnosti u mužjaka i ženki štakora u dozi od 200 mg/kg na dan (pri čemu su izloženosti približno 11, odnosno 7 puta veće od onih kod najveće preporučene doze u ljudi za ivakaftor kao komponentu lijeka Orkambi na temelju zbroja AUC-a ivakaftora i njegovih metabolita, ekstrapoliranih iz izloženosti 90. dana pri 150 mg/kg na dan u 6-mjesečnom ispitivanju toksičnosti ponovljene doze i 17. dana gestacije u pilot ispitivanju embriofetalnog razvoja provedenom za tu životinjsku vrstu) kad su ženke primale tu dozu prije i tijekom rane faze skotnosti.
English: No effects on male or female fertility and reproductive performance indices were observed at ≤ 100 mg/kg/day (yielding exposures approximately 8 and 5 times, respectively, those obtained with the maximum recommended human dose of the ivacaftor component of Orkambi based on summed AUCs of ivacaftor and its metabolites extrapolated from Day 90 exposures at 100 mg/kg/day in the 6-month repeat-dose toxicity study and gestation Day 17 exposures in the embryofoetal development study in this species).
Croatian: Nisu opaženi učinci na indekse plodnosti i reproduktivne sposobnosti u mužjaka i ženki pri dozi ≤ 100 mg/kg na dan (pri čemu su izloženosti približno 8 odnosno 5 puta veće od onih kod najveće preporučene doze u ljudi za ivakaftor kao komponentu lijeka Orkambi na temelju zbroja AUC-a ivakaftora i njegovih metabolita, ekstrapoliranih iz izloženosti 90. dana pri 100 mg/kg na dan u 6-mjesečnom ispitivanju toksičnosti ponovljene doze i izloženosti 17. dana gestacije u ispitivanju embriofetalnog razvoja provedenom za tu životinjsku vrstu).
English: Number of events requiring hospitalization per patientyear (95% CI) (rate per 48
Croatian: Broj događaja koji su zahtijevali hospitalizaciju po bolesnik-godini (95% CI) (stopa na 48 tjedana)
English: • Herbal medicines, for example: St. John's wort (Hypericum perforatum)
Croatian: • biljni lijekovi, primjerice: gospina trava (Hypericum perforatum)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vertex Pharmaceuticals (Ireland) Limited
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Vertex Pharmaceuticals (Ireland) Limited
English: No dose adjustment is necessary when CYP3A inhibitors are initiated in patients currently taking lumacaftor/ivacaftor.
Croatian: Prilagodba doze nije potrebna kada se primjena inhibitora CYP3A započinje u bolesnika koji već uzimaju lumakaftor/ivakaftor.
English: Patients may start taking Orkambi on any day of the week.
Croatian: Bolesnici mogu početi uzimati Orkambi bilo koji dan u tjednu.
English: Treatment with lumacaftor/ivacaftor significantly decreased the risk for exacerbations requiring hospitalisation versus placebo by 61% (rate ratio = 0.39, P < 0.0001; event rate per 48 weeks 0.17 for lumacaftor/ivacaftor and 0.45 for placebo) and reduced exacerbations requiring treatment with intravenous antibiotics by 56% (rate ratio = 0.44, P < 0.0001; event rate per 48 weeks 0.25 for lumacaftor/ivacaftor and 0.58 for placebo).
Croatian: Liječenje lumakaftorom/ivakaftorom značajno je smanjilo rizik od egzacerbacija koje zahtijevaju hospitalizaciju naspram placebu za 61% (omjer stope = 0,39, P < 0,0001; stopa događaja u 48 tjedana od 0,17 za lumakaftor/ivakaftor i 0,45 za placebo), a broj egzacerbacija koje zahtijevaju liječenje intravenskim antibioticima smanjilo je za 56% (omjer stope = 0,44, P < 0,0001; stopa događaja u 48 tjedana bila je 0,25 za lumakaftor/ivakaftor i 0,58 za placebo).
English: Common may affect up to 1 in 10 people:
Croatian: Česte - mogu se javiti u do 1 na 10 osoba:
English: Ivacaftor did not cause developmental defects in the offspring of pregnant rats dosed orally from pregnancy through parturition and weaning at 100 mg/kg/day.
Croatian: Ivakaftor nije uzrokovao razvojne defekte u potomstva skotnih ženki štakora koje su ga primale peroralno u dozi od 100 mg/kg na dan od trudnoće, u vrijeme okota, pa do prestanka sisanja.
English: • Confusion
Croatian: • smetenost
English: Orkambi 100 mg/125 mg is available in the following pack size: • Pack containing 112 film-coated tablets (4 packs of 28 film-coated tablets).
Croatian: Orkambi 100 mg/125 mg dostupan je u sljedećim veličinama pakiranja: • Pakiranje od 112 filmom obloženih tableta (4 pakiranja po 28 filmom obloženih tableta).
English: It may harm them even if their signs of illness are the same as your child's.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki onima koje ima Vaše dijete.
English: Cases of non-congenital lens opacities without impact on vision have been reported in paediatric patients treated with lumacaftor/ivacaftor and ivacaftor monotherapy.
Croatian: Slučajevi zamućenja leće koja nisu prirođena, bez utjecaja na vid, zabilježeni su u pedijatrijskih bolesnika liječenih lumakaftorom/ivakaftorom i monoterapijom ivakaftorom.
English: In patients who received placebo (mean baseline 114 mmHg systolic and 69 mmHg diastolic), the maximum increase from baseline in mean systolic and diastolic blood pressure was 0.9 mmHg and 0.9 mmHg, respectively.
Croatian: U bolesnika koji su primali placebo (srednja početna vrijednost sistoličkog tlaka bila je 114 mmHg, a dijastoličkog 69 mmHg), maksimalno povećanje srednje vrijednosti sistoličkog tlaka u odnosu na početnu vrijednost iznosilo je 0,9 mmHg, a dijastoličkog 0,9 mmHg.
English: During Trials 1 and 2, the incidence of combined menstrual abnormality events (amenorrhoea, dysmenorrhoea, menorrhagia, menstruation irregular, metrorrhagia, oligomenorrhoea, and polymenorrhoea) was 9.9 % in lumacaftor/ivacaftor-treated female patients and 1.7% in placebo-treated females.
Croatian: Tijekom ispitivanja 1 i 2, incidencija kombiniranih događaja menstrualnih poremećaja (amenoreja, dismenoreja, menoragija, neredovita menstruacija, metroragija, oligomenoreja i polimenoreja) iznosila je 9,9% u bolesnica liječenih lumakaftorom/ivakaftorom, a 1,7% u onih liječenih placebom.
English: Your child must keep using all other medicines, unless your child's doctor tells you 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: There was negligible urinary excretion of lumacaftor as unchanged drug.
Croatian: Mokraćom se izlučila zanemariva količina lumakaftora u obliku neizmijenjenog lijeka.
English: How to store Orkambi
Croatian: Kako čuvati Orkambi
English: The most common adverse reactions experienced by patients aged 12 years and older who received lumacaftor/ivacaftor in the pooled, placebo-controlled, Phase 3 studies were dyspnoea (14.0% versus 7.8% on placebo), diarrhoea (11.0% versus 8.4% on placebo), and nausea (10.2% versus 7.6% on placebo).
Croatian: Najčešće nuspojave u bolesnika u dobi od 12 i više godina koji su primali lumakaftor/ivakaftor u objedinjenim placebom kontroliranim ispitivanjima faze III, bile su dispneja (14,0% naspram 7,8% za placebo), proljev (11,0% naspram 8,4% za placebo) i mučnina (10,2% naspram 7,6% za placebo).
English: Absolute change from baseline in body mass index (BMI)
Croatian: Apsolutna promjena od početne vrijednosti indeksa tjelesne mase (ITM)
English: You may start giving your child Orkambi on any day of the week.
Croatian: Orkambi možete početi davati svom djetetu bilo koji dan u tjednu.
English: Absolute change from baseline in weight (kg)
Croatian: Apsolutna promjena od početne vrijednosti tjelesne težine (kg)
English: povidone (K30); sodium laurilsulfate; and magnesium stearate.
Croatian: hipromelozaacetatsukcinat; povidon (K30); natrijev laurilsulfat; magnezijev stearat
English: Elevated transaminases have been commonly reported in patients with CF receiving lumacaftor/ivacaftor.
Croatian: Povišene vrijednosti transaminaza često su zabilježene u bolesnika s cističnom fibrozom koji primaju lumakaftor/ivakaftor.
English: Adverse reactions identified from the 24-week, placebo-controlled, Phase 3 studies (Trials 1 and 2) in patients aged 12 years and older and from a 24-week, placebo-controlled study in patients aged 6 to 11 years (Trial 7), who are homozygous for the F508del mutation in the CFTR gene are presented in Table 4 and are listed by system organ class, frequency, and adverse reactions.
Croatian: Nuspojave ustanovljene u placebom kontroliranim kliničkim ispitivanjima faze 3 u trajanju od 24 tjedna (ispitivanja 1 i 2) u bolesnika u dobi od 12 i više godina i u placebom kontroliranom kliničkom ispitivanju u trajanju od 24 tjedna u bolesnika u dobi od 6 do 11 godina (ispitivanje 7) koji su homozigoti za mutaciju F508del gena CFTR, navedene su u tablici 4 prema klasifikaciji organskih sustava, učestalosti i nuspojavama.
English: Proportion of patients with ≥5% relative change in ppFEV1 at Week 24
Croatian: Udio bolesnika s relativnom promjenom ppFEV1 od ≥ 5% u 24. tjednu
English: Absolute change in ppFEV1 at Week 24 (percentage points)
Croatian: Apsolutna promjena ppFEV1 u 24. tjednu (postotni bodovi)
English: No effects on male or female fertility and reproductive performance indices were observed at ≤100 mg/kg/day
Croatian: Nisu opaženi učinci na indekse plodnosti i reproduktivne sposobnosti u mužjaka i ženki pri dozi ≤ 100 mg/kg na dan (vidjeti dio 5.3).
English: The MAH shall complete, within the stated timeframe, the following measure:
Croatian: • Obveza provođenja mjera nakon davanja odobrenja: Nositelj odobrenja dužan je, unutar navedenog vremenskog roka, provesti niže navedene mjere: Opis
English: Post-marketing cases of liver function decompensation including liver failure leading to death have been reported in CF patients with pre-existing cirrhosis with portal hypertension who were treated with lumacaftor/ivacaftor (see section 4.4).
Croatian: Nakon stavljanja lijeka u promet zabilježeni su slučajevi dekompenzacije jetrene funkcije, uključujući zatajenje jetre koje je dovelo do smrtnog ishoda, u bolesnika s cističnom fibrozom i već prisutnom cirozom s portalnom hipertenzijom liječenih lumakaftorom/ivakaftorom (vidjeti dio 4.4).
English: In Trial 8 in patients homozygous for F508del-CFTR mutation aged 2 to 5 years, the mean absolute within-group change in sweat chloride from baseline at Week 24 was -31.7 mmol/L (95% CI: -35.7, -27.6).
Croatian: U ispitivanju 8 u bolesnika u dobi od 2 do 5 godina koji su bili homozigoti za mutaciju F508del gena CFTR, srednja vrijednost apsolutne promjene koncentracije klorida u znoju unutar skupine od početka ispitivanja do 24. tjedna iznosila je -31,7 mmol/L (95% CI: -35,7, -27,6).