FrancophonIA/ELRC3.0 huggingface dataset:
English: Twenty-six patients out of the 34 enrolled (76.5%) had a CFTR genotype G551D/F508del with only 2 patients with a non-G551D mutation (S549N).
Croatian: Dvadeset i šest od 34 uključena bolesnika (76,5%) imalo je CFTR genotip G551D/F508del, a samo 2 bolesnika imala su mutaciju koja nije bila mutacija G551D (S549N).
English: One patient (0.2%) on therapy and 2 patients (0.4%) on placebo permanently discontinued treatment for elevated transaminases.
Croatian: Jedan bolesnik (0,2%) koji je primao terapiju i 2 bolesnika (0,4%) koja su primala placebo, trajno su prekinuli liječenje zbog povišenih transaminaza.
English: Your doctor may need to adjust your dose.
Croatian: Liječnik će Vam možda morati prilagoditi dozu.
English: • Avocados, hummus, soy-based products (tofu)
Croatian: • avokado, humus, sojini proizvodi (tofu)
English: Each film-coated tablet contains 167.2 mg of lactose (as monohydrate)
Croatian: Jedna filmom obložena tableta sadrži 167,2 mg laktoze (u obliku hidrata).
English: A total of 36 patients continued into part 2 (18 per treatment sequence).
Croatian: U 2. dio ispitivanja bilo je uključeno ukupno 36 bolesnika (18 po slijedu liječenja).
English: Some examples of age-appropriate soft foods or liquids include puréed fruits or vegetables, yogurt, applesauce, water, milk, breast milk, infant formula, or juice.
Croatian: Neki primjeri meke hrane ili tekućina su kašica od voća ili povrća, jogurt, sok od jabuke, voda, mlijeko, majčino mlijeko, adaptirano mlijeko za dojenčad ili sok.
English: Transaminase elevations occurred in 12.8% of ivacaftor-treated patients versus 11.5% of placebo-treated patients.
Croatian: Transaminaze su bile povišene u 12,8% bolesnika liječenih ivakaftorom naspram 11,5% bolesnika koji su primali placebo.
English: • Anticoagulant medicines such as warfarin, used to prevent blood clots from forming or growing larger in blood and blood vessels
Croatian: • Antikoagulansi kao što je varfarin, koji se primjenjuju za sprječavanje stvaranja i povećavanja krvnih ugrušaka u krvi i krvnim žilama.
English: Morning Dose
Croatian: Jutarnja doza
English: • Abnormality of the eye lens (cataract) without any effect on vision has been noted in some children and adolescents during treatment.
Croatian: • Nepravilnosti očnih leća (katarakte), bez ikakvog utjecaja na vid, opažene su u neke djece i adolescenata tijekom liječenja.
English: There was negligible urinary excretion of ivacaftor as unchanged parent (less than 0.01% following a single oral dose of 500 mg).
Croatian: Zanemariva količina ivakaftora izlučila se mokraćom u neizmijenjenom izvornom obliku (manje od 0,01% nakon jednokratne peroralne doze od 500 mg).
English: # Causes a splicing defect resulting in little-to-no CFTR protein at the cell surface
Croatian: # Uzrokuje defekt u prekrajanju s posljedicom da na površini stanice gotovo ili uopće nema proteina CFTR.
English: Patients received ivacaftor 25 mg, 50 mg or 75 mg according to their weight at each study visit (see section 4.2).
Croatian: Bolesnici su primali ivakaftor u dozi od 25 mg, 50 mg ili 75 mg prema tjelesnoj težini koju su imali na pojedinom dolasku na pregled u sklopu ispitivanja (vidjeti dio 4.2).
English: In particular, tell your doctor if you are taking any of the medicines listed below.
Croatian: Osobito obavijestite svog liječnika ako uzimate neki od lijekova navedenih u nastavku.
English: In part 2, all patients received ivacaftor as indicated in part 1 for 16 additional weeks.
Croatian: U 2. dijelu ispitivanja svi bolesnici primali su ivakaftor dodatnih 16 tjedana kako je navedeno za 1. dio ispitivanja.
English: A pre-planned subgroup analysis was conducted in patients 18 years and older (26 patients on placebo and 24 on ivacaftor).
Croatian: Unaprijed planirana analiza podskupina bila je provedena u bolesnika u dobi od 18 i više godina (26 bolesnika primalo je placebo, a 24 ivakaftor).
English: Take Kalydeco for as long as your doctor recommends.
Croatian: Uzimajte Kalydeco onoliko dugo koliko Vam to preporučuje liječnik.
English: It is unknown whether ivacaftor and/or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se ivakaftor i/ili njegovi metaboliti u majčino mlijeko.
English: In ivacaftor-treated patients, most transaminase elevations up to 5 x ULN resolved without treatment interruption.
Croatian: U bolesnika liječenih ivakaftorom, povišene transaminaze do 5 puta GGN većinom su se povukle bez prekida liječenja.
English: • A fat-containing meal or snack should be given to your child just before or just after dosing (some examples are provided below).
Croatian: • Neposredno prije ili neposredno poslije doziranja, djetetu treba dati obrok ili međuobrok koji sadrži masti (neki primjeri nalaze se u daljnjem tekstu).
English: Patients continued on their prescribed standard-of-care CF therapies.
Croatian: Bolesnici su nastavili uzimati svoju propisanu terapiju standardne skrbi za cističnu fibrozu.
English: Therefore, use of Kalydeco monotherapy in these patients is not recommended.
Croatian: Stoga se ne preporučuje monoterapija lijekom Kalydeco u tih bolesnika.
English: Do not give this medicine to children under 6 months of age with gating mutations as it is not known if ivacaftor is safe and effective in these children, or in patients under 18 years of age with an R117H mutation as ivacaftor may not work in them.
Croatian: Ovaj lijek nemojte davati djeci mlađoj od 6 mjeseci s mutacijama zbog kojih dolazi do nepravilne regulacije kanala, jer nije poznato je li ivakaftor siguran i djelotvoran u te djece, ili bolesnicima mlađim od 18 godina s mutacijom R117H jer kod njih ivakaftor možda neće djelovati.
English: Exposure to ivacaftor may be reduced by the concomitant use of CYP3A inducers, potentially resulting in the loss of ivacaftor efficacy.
Croatian: Izloženost ivakaftoru može biti smanjena kod istovremene primjene induktora CYP3A, što može rezultirati gubitkom djelotvornosti ivakaftora.
English: The effect of the potentially reduced activity of CYP3A4 in patients carrying the CYP3A4*22 variant on ivacaftor exposure is not known.
Croatian: Učinak potencijalno smanjene aktivnosti CYP3A4 na izloženost ivakaftoru u bolesnika koji nose varijantu CYP3A4*22 nije poznat.
English: If you have been prescribed Kalydeco to be taken with tezacaftor/ivacaftor, read the tezacaftor/ivacaftor package leaflet.
Croatian: Ako Vam je propisano da uzimate Kalydeco s tezakaftorom/ivakaftorom, pročitajte uputu o lijeku za tezakaftor/ivakaftor.
English: These medications included dornase alfa (73.1% versus 65.1%), salbutamol (53.8% versus 42.2%), tobramycin (44.9% versus 33.7%) and salmeterol/fluticasone (41.0% versus 27.7%).
Croatian: Među tim su lijekovima bili dornaza alfa (73,1% naspram 65,1%), salbutamol (53,8% naspram 42,2%), tobramicin (44,9% naspram 33,7%) i salmeterol/flutikazon (41,0% naspram 27,7%).
English: Data on percent predicted FEV1 (exploratory endpoint) were available for 3 patients in the ivacaftor 50 mg group and 17 patients in the 75 mg dosing group.
Croatian: Podaci o postotku predviđenog FEV1 (eksplorativni ishod) bili su dostupni za 3 bolesnika u skupini liječenoj ivakaftorom u dozi od 50 mg i 17 bolesnika u skupini liječenoj dozom od 75 mg.
English: CYP2C9 substrates
Croatian: Supstrati CYP2C9
English: Peak LFT (ALT or AST) elevations were generally higher in paediatric patients than in older patients.
Croatian: Povišenja vršnih vrijednosti na testovima jetrene funkcije (ALT ili AST) uglavnom su bila veća u pedijatrijskih bolesnika nego u starijih bolesnika.
English: The AUC of ivacaftor when given in combination with tezacaftor increased approximately 3-fold when given with fat containing food.
Croatian: AUC ivakaftora davanog u kombinaciji s tezakaftorom povećao se približno 3 puta kad se primjenjivao s hranom koja sadrži masti.
English: In particular, tell your child's doctor if your child is taking any of the medicines listed below.
Croatian: Osobito obavijestite djetetovog liječnika ako Vaše dijete uzima neki od lijekova navedenih u nastavku.
English: 56 sachets
Croatian: 56 vrećica
English: Kalydeco can make your child dizzy.
Croatian: Kalydeco može izazvati omaglicu u Vašeg djeteta.
English: Your child's doctor will do some blood tests to check your child's liver before and during treatment, particularly during the first year and especially if blood tests showed high liver enzymes in the past.
Croatian: Djetetov liječnik napravit će neke krvne pretrage da provjeri funkciju jetre djeteta prije i tijekom liječenja, osobito tijekom prve godine liječenja te posebno ako je nekad prije imalo povišene jetrene enzime na krvnim pretragama.
English: Kalydeco in a combination regimen with tezacaftor/ivacaftor in adults and adolescents aged 12 years and older
Croatian: Kalydeco u kombiniranom režimu s tezakaftorom/ivakaftorom u odraslih i adolescenata u dobi od 12 i više godina
English: At the start of the study, patients in the placebo group used some medicinal products at a higher frequency than the ivacaftor group.
Croatian: Na početku ispitivanja, bolesnici u skupini koja je primala placebo češće su uzimali neke lijekove nego bolesnici u skupini liječenoj ivakaftorom.
English: In the event of significant elevations of transaminases (e.g., patients with ALT or AST > 5 x the upper limit of normal (ULN), or ALT or AST > 3 x ULN with bilirubin > 2 x ULN), dosing should be interrupted and laboratory tests closely followed until the abnormalities resolve.
Croatian: U slučaju značajnog povišenja vrijednosti transaminaza (npr. bolesnici s vrijednostima ALT ili AST > 5 puta gornje granice normale [GGN] ili ALT ili AST > 3 puta GGN s bilirubinom > 2 puta GGN), potrebno je prekinuti primjenu i pažljivo kontrolirati laboratorijske nalaze sve dok se poremećaj ne povuče.
English: The safety and efficacy of Kalydeco in children aged less than 6 months have not been established.
Croatian: Sigurnost i djelotvornost lijeka Kalydeco u djece mlađe od 6 mjeseci nisu ustanovljene.
English: There is no experience of the use of Kalydeco in patients with severe hepatic impairment; therefore, its use is not recommended unless the benefits outweigh the risks.
Croatian: Nema iskustva s primjenom lijeka Kalydeco u bolesnika s teškim oštećenjem funkcije jetre te se stoga njegova primjena ne preporučuje osim ako je korist od liječenja veća od rizika.
English: No safety data are available in infants aged 6 to less than 12 months of age who are treated with ivacaftor and moderate or strong CYP3A4 inhibitors.
Croatian: Nisu dostupni podaci o sigurnosti primjene za dojenčad u dobi od 6 do manje od 12 mjeseci liječenu ivakaftorom i umjerenim ili jakim inhibitorima CYP3A4.
English: • Cheese, whole milk, whole-milk dairy products, yogurt, chocolate
Croatian: • sir, punomasno mlijeko, mliječni proizvodi iz punomasnog mlijeka, jogurt, čokolada
English: The geometric least squares mean ratio (90% CI) for the granules relative to tablets was 0.951 (0.839, 1.08) for AUC0-∞ and 0.918 (0.750, 1.12) for Cmax.
Croatian: Omjer geometrijskog prosjeka najmanjih kvadrata (90% CI) za granule u odnosu na tablete iznosio je 0,951 (0,839; 1,08) za AUC0-∞ i 0,918 (0,750; 1,12) za Cmax.
English: If your child has liver problems, either moderate or severe, your child's doctor may need to reduce the dose of Kalydeco as your child's liver will not clear the medicine as fast as in children who have normal liver function.
Croatian: Ako Vaše dijete ima tegobe s jetrom, umjerene ili teške, djetetov će liječnik možda trebati sniziti dozu lijeka Kalydeco, budući da djetetova jetra neće ukloniti lijek tako brzo kao što se to događa u djece koja imaju normalnu funkciju jetre.
English: Co-administration of ivacaftor with grapefruit juice, which contains one or more components that moderately inhibit CYP3A, may increase exposure to ivacaftor.
Croatian: Istovremena primjena ivakaftora sa sokom od grejpa, koji sadrži jednu ili više komponenti koje umjereno inhibiraju CYP3A, može povećati izloženost ivakaftoru.
English: The safety data of ivacaftor in combination with tezacaftor/ivacaftor was evaluated in 98 patients between 12 to less than 18 years of age.
Croatian: Podaci o sigurnosti primjene ivakaftora u kombinaciji s tezakaftorom/ivakaftorom procijenjeni su u 98 bolesnika u dobi od 12 do manje od 18 godina.
English: This finding has not been observed in foetuses derived from rat dams treated with ivacaftor on gestation days 7 to 17, in rat pups exposed to ivacaftor through milk ingestion up to postnatal day 20, in 7-week old rats, nor in 3.5 to 5-month old dogs treated with ivacaftor.
Croatian: Ovaj nalaz nije bio opažen u fetusa ženki štakora liječenih ivakaftorom od 7. do 17. dana gestacije, u mladunčadi štakora izložene ivakaftoru putem ingestije mlijeka do 20. postnatalnog dana, u štakora starih 7 tjedana ili u pasa u dobi od 3,5 do 5 mjeseci liječenih ivakaftorom.
English: Efficacy was not demonstrated in patients aged 6 to 11 years with CF who have an R117H mutation while only two adolescent patients were enrolled in study 6 (see section 5.1).
Croatian: Djelotvornost nije bila dokazana u bolesnika s cističnom fibrozom u dobi od 6 do 11 godina koji imaju mutaciju R117H, dok su u ispitivanje 6 bila uključena samo dva adolescentna bolesnika (vidjeti dio 5.1).
English: Kalydeco dosing recommendations are provided in Table 1.
Croatian: Preporuke za doziranje lijeka Kalydeco nalaze se u tablici 1.
English: After every 12-hour dosing, steady-state plasma concentrations of ivacaftor were reached by days 3 to 5, with an accumulation ratio ranging from 2.2 to 2.9.
Croatian: Nakon doziranja svakih 12 sati, koncentracije ivakaftora u plazmi u stanju dinamičke ravnoteže postignute su za 3 do 5 dana, uz omjer nakupljanja lijeka u rasponu od 2,2 do 2,9.
English: Take the missed dose if less than 6 hours have passed since the time you missed the dose.
Croatian: Uzmite propuštenu dozu ako je prošlo manje od 6 sati od vremena kad ste je trebali uzeti.
English: Ivacaftor also potentiated the channel-open probability of R117H-CFTR, which has both low channel-open probability (gating) and reduced channel current amplitude (conductance).
Croatian: Ivakaftor je također povećao vjerojatnost otvaranja kanala R117-CFTR koji ima i malu vjerojatnost otvaranja i smanjenu amplitudu struje (provodljivost).
English: Six patients with initial levels below 200 µg/g achieved, at week 24, a level of ≥ 200 µg/g.
Croatian: Šest bolesnika s početnim razinama ispod 200 μg/g postiglo je u 24. tjednu razinu od ≥ 200 μg/g.
English: Ivacaftor helps certain abnormal CFTR proteins open more often to improve chloride movement in and out of the cell.
Croatian: Ivakaftor pomaže da se određeni abnormalni proteini CFTR češće otvaraju kako bi se poboljšao ulazak klorida u stanicu i njihov izlazak iz stanice.
English: Pregnancy and fertility
Croatian: Trudnoća i plodnost
English: • Tear or cut sachet open along cut line.
Croatian: • Poderite ili razrežite vrećicu duž oznake za otvaranje.
English: One tablet of tezacaftor 100 mg/ivacaftor 150 mg should be taken twice a week, taken approximately 3 to 4 days apart.
Croatian: Jednu tabletu tezakaftora od 100 mg / ivakaftora od 150 mg treba uzeti dvaput tjedno u razmaku od približno 3 do 4 dana.
English: If you have been told by your child's doctor that your child has an intolerance to some sugars, contact your child's doctor before your child takes this medicine.
Croatian: Ako Vam je djetetov liječnik rekao da Vaše dijete ne podnosi neke šećere, obratite se djetetovu liječniku prije nego što dijete uzme ovaj lijek.
English: BMI-for-age z-score at week 48e
Croatian: Z-vrijednost za BMI za dob u 48. tjednue
English: The pharmacokinetic parameters of ivacaftor in combination with tezacaftor in adolescent patients (12 to 17 year-olds) are comparable to those in adults (see Table 8).
Croatian: Farmakokinetički parametri ivakaftora u kombinaciji s tezakaftorom u adolescentnih bolesnika (u dobi od 12 do 17 godina) usporedivi su s onima u odraslih (vidjeti tablicu 8).
English: Mutation (n) Absolute change in sweat chloride (mmol/L)
Croatian: Mutacija (n) Apsolutna promjena u koncentraciji klorida u znoju (mmol/l)
English: Ivacaftor is a potentiator of the CFTR protein, i.e., in vitro ivacaftor increases CFTR channel gating to enhance chloride transport in specified gating mutations (as listed in section 4.1) with reduced channel-open probability compared to normal CFTR.
Croatian: Ivakaftor pojačava aktivnost proteina CFTR, tj. ivakaftor in vitro povećava otvaranje kanala CFTR kako bi se poboljšao transport klorida kod određenih mutacija kanala (engl. gating mutations) (navedenih u dijelu 4.1) sa smanjenom vjerojatnošću otvaranja kanala u usporedbi s normalnim CFTR-om.
English: Your child's doctor may decide to adjust your child's dose or if extra check-ups are needed.
Croatian: Liječnik Vašeg djeteta može odlučiti prilagoditi dozu ili provesti dodatne preglede ako je potrebno.
English: Lactose content
Croatian: Sadržaj laktoze
English: In vitro and in vivo data indicate that ivacaftor is primarily metabolised by CYP3A.
Croatian: Podaci dobiveni in vitro i in vivo pokazuju da ivakaftor prvenstveno metabolizira enzim CYP3A.
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 ivacaftor-treated patients experienced a transaminase elevation > 3 x ULN associated with elevated total bilirubin > 1.5 x ULN.
Croatian: Nijedan bolesnik liječen ivakaftorom nije imao povišene transaminaze > 3 puta GGN povezane s povišenjem ukupnog bilirubina za > 1,5 puta GGN.
English: The pharmacokinetics of ivacaftor are similar between healthy adult volunteers and patients with CF.
Croatian: Farmakokinetika ivakaftora slična je u zdravih odraslih ispitanika i bolesnika s CF-om.
English: The observed treatment difference (95% CI) between ivacaftor and placebo was 10.7% (7.3, 14.1) (P < 0.0001).
Croatian: Opažena terapijska razlika (95% CI) između ivakaftora i placeba iznosila je 10,7% (7,3; 14,1) (P < 0,0001).
English: • Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (PEG 3350), talc, indigo carmine aluminium lake (E132) and carnauba wax.
Croatian: • ovojnica: poli(vinilni alkohol), titanijev dioksid (E171), makrogol (PEG 3350), talk, indigo carmine aluminium lake (E132) i karnauba vosak
English: Absolute change in sweat chloride (mmol/L)
Croatian: Apsolutna promjena u koncentraciji klorida u znoju (mmol/l)
English: If you stop taking Kalydeco
Croatian: Ako prestanete uzimati Kalydeco
English: Interactions with medicinal products
Croatian: Interakcije lijekova
English: Do not give this medicine in combination with tezacaftor/ivacaftor to children under 12 years of age as it is not known if they are safe and effective for them.
Croatian: Ovaj lijek nemojte davati u kombinaciji s tezakaftorom/ivakaftorom djeci mlađoj od 12 godina jer nije poznato jesu li sigurni i djelotvorni u te djece.
English: Less evidence of a positive effect of ivacaftor has been shown for patients with an R117H-7T mutation associated with less severe disease (see section 5.1).
Croatian: Bilo je manje dokaza koji su pokazali pozitivan učinak ivakaftora u bolesnika s mutacijom R117-7T povezanom s manje teškim oblikom bolesti (vidjeti dio 5.1).
English: The film-coated tablets are packed in a thermoform (PolyChloroTriFluoroEthylene [PCTFE]/foil) blister or a High-Density PolyEthylene (HDPE) bottle with a polypropylene child-resistant closure, foil-lined induction seal and molecular sieve desiccant.
Croatian: Filmom obložene tablete pakirane su u termoformnom (poliklorotrifluoroetilen [PCTFE]/folija) blisteru ili bočici od polietilena visoke gustoće (HDPE) zatvorenoj polipropilenskim zatvaračem sigurnim za djecu, s termički zalijepljenom nepropusnom folijom i molekularnim sitom kao sredstvom za sušenje.
English: The results for clinically relevant secondary endpoints are shown in Table 4.
Croatian: Rezultati klinički relevantnih mjera sekundarnih ishoda prikazani su u tablici 4.
English: Your doctor may decide to adjust your dose or that you need extra check-ups.
Croatian: Liječnik može odlučiti da Vam je potrebno prilagoditi dozu ili provesti dodatne preglede.
English: When they rolled over into study 4, the rate of annualised pulmonary exacerbations was 0.91 events/year across day 1 to week 48 and 0.77 events/year across weeks 48 to 96.
Croatian: Kada su prebačeni u ispitivanje 4, stopa pogoršanja plućnih simptoma iskazana na godišnjoj razini iznosila je 0,91 događaja/godina od 1. dana do 48. tjedna i 0,77 događaja/godina od 48. do 96. tjedna.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip vrlo često
English: Light blue, capsule-shaped film-coated tablets, printed with “V 150” in black ink on one side and plain on the other (16.5 mm x 8.4 mm in modified tablet shape).
Croatian: Svjetloplave, filmom obložene tablete u obliku kapsula, s oznakom „V 150“ otisnutom crnom tintom na jednoj strani i bez oznaka na drugoj (16,5 mm x 8,4 mm u obliku modificirane tablete).
English: Otherwise, wait until your child's next scheduled dose as you normally would.
Croatian: U suprotnom, pričekajte do sljedeće doze koju Vaše dijete treba uzeti prema uobičajenom rasporedu.
English: Your doctor may perform some eye examinations prior to and during treatment.
Croatian: Liječnik će Vam možda provesti neke preglede očiju prije i tijekom liječenja ivakaftorom.
English: The mean (SD) overall change in stature-for-age z-score was -0.01 (0.33).
Croatian: Srednja vrijednost (SD) ukupne promjene z-vrijednosti za stas prema dobi iznosila je -0,01 (0,33).
English: The apparent clearance (CL/F) of ivacaftor was similar for healthy subjects and patients with CF.
Croatian: Prividni klirens (CL/F) ivakaftora bio je sličan u zdravih ispitanika i bolesnika s CF-om.
English: c Study 1 data were pooled from CFQ-R for adults/adolescents and CFQ-R for children 12 to 13 years of age; Study 2 data were obtained from CFQ-R for children 6 to 11 years of age.
Croatian: c U ispitivanju 1 podaci su prikupljeni pomoću upitnika CFQ-R, verzija za odrasle/adolescente i CFQ-R, verzija za djecu u dobi od 12 do 13 godina; u ispitivanju 2 podaci su prikupljeni upitnikom CFQ-R, verzija za djecu u dobi od 6 do
English: The results for clinically relevant secondary endpoints are shown in Table 3.
Croatian: Rezultati klinički relevantnih mjera sekundarnih ishoda prikazani su u tablici 3.
English: Ivacaftor and its metabolites are substrates of BCRP in vitro.
Croatian: Ivakaftor i njegovi metaboliti supstrati su proteina rezistencije raka dojke na lijekove (BCRP) in vitro.
English: If you have liver problems, either moderate or severe, your doctor may need to reduce the dose of your tablets, because your liver will not clear the medicine as fast as in people who have normal liver function.
Croatian: Ako imate tegobe s jetrom, bilo umjerene ili teške, liječnik će Vam možda trebati smanjiti dozu tableta, jer Vaša jetra neće ukloniti lijek onom brzinom kojom ga uklanja u osoba s normalnom funkcijom jetre.
English: The safety and efficacy of Kalydeco in a combination regimen with tezacaftor/ivacaftor in children aged less than 12 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Kalydeco u kombiniranom režimu s tezakaftorom/ivakaftorom u djece mlađe od 12 godina nisu ustanovljene.
English: Serious adverse reactions in patients who received ivacaftor included abdominal pain and transaminase elevations (see section 4.4).
Croatian: Ozbiljne nuspojave u bolesnika koji su primali ivakaftor uključivale su bol u abdomenu i povišene transaminaze (vidjeti dio 4.4).
English: The recommended dose of Kalydeco is one 150 mg tablet every 12 hours (in total 2 tablets: 300 mg per day).
Croatian: Preporučena doza lijeka Kalydeco je jedna tableta od 150 mg svakih 12 sati (ukupno 2 tablete: 300 mg na dan).
English: Other fat-containing foods are:
Croatian: Ostala hrana koja sadrži masti:
English: • Immunosuppressants such as ciclosporin, tacrolimus, everolimus and sirolimus used after an organ transplantation
Croatian: • Imunosupresivi kao što su ciklosporin, takrolimus, everolimus i sirolimus, koji se primjenjuju nakon presađivanja organa.