FrancophonIA/ELRC3.0 huggingface dataset:
English: Lumacaftor increases the amount of CFTR available and ivacaftor helps the abnormal protein to work more normally.
Croatian: Lumakaftor povećava količinu raspoloživog CFTR-a, a ivakaftor pomaže da taj abnormalni protein funkcionira normalnije.
English: Other concomitant medicinal products of clinical relevance Antiarrhythmics: digoxin
Croatian: Drugi klinički važni lijekovi koji se uzimaju istodobno Antiaritmici: digoksin
English: Consume it completely.
Croatian: Primijenite cijeli sadržaj.
English: 2 to 5 years and weighing 14 kg or greater
Croatian: 2-5 godina i tjelesne težine 14 kg ili više
English: The primary efficacy analysis of this extension study included data up to Week 72 of Trial 3 with a sensitivity analysis that included data up to Week 96 of Trial 3.
Croatian: U ovom nastavku ispitivanja, u primarnu analizu djelotvornosti uključeni su podaci prikupljeni do 72. tjedna u ispitivanju 3, a u analizu osjetljivosti podaci do 96. tjedna u ispitivanju
English: Three of the 48 patients who had faecal elastase-1 values < 100 µg/g at baseline achieved a level of ≥ 200 µg/g at Week 24.
Croatian: Tri od 48 bolesnika u kojih su vrijednosti fekalne elastaze-1 bile < 100 µg/g na početku, postigla su razinu od ≥ 200 µg/g u 24. tjednu.
English: Cells contain two copies of the CFTR gene; Orkambi is used in patients in whom both copies are affected by the F508del mutation.
Croatian: Stanice sadrže dvije kopije gena CFTR; Orkambi se primjenjuje u bolesnika u kojih su obje kopije zahvaćene mutacijom
English: Of the patients who were initiated lumacaftor/ivacaftor at the full dose, one patient had a serious respiratory event, three patients subsequently had their dose reduced, and three patients discontinued treatment.
Croatian: Od bolesnika koji su liječenje započeli punom dozom lumakaftora/ivakaftora jedan bolesnik imao je ozbiljan respiratorni događaj, u tri bolesnika doza je kasnije snižena, a tri bolesnika prekinula su liječenje.
English: • Irregular periods (menses) or pain with menses
Croatian: • neredovite menstruacije ili bol povezana s menstruacijom
English: Studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C, score 10 to 15), but exposure is expected to be higher than in patients with moderate hepatic impairment (see sections 4.2, 4.4, and 4.8).
Croatian: Nisu provedena ispitivanja u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C, rezultat 10 do 15), ali očekuje se da bi izloženost bila veća nego u bolesnika s umjerenim oštećenjem funkcije jetre (vidjeti dijelove 4.2, 4.4 i 4.8).
English: Instructions for Use
Croatian: Upute za primjenu
English: Worsening of liver function in patients with advanced liver disease has been reported.
Croatian: Zabilježeno je pogoršanje funkcije jetre u bolesnika s uznapredovalom bolešću jetre.
English: The exposures of ivacaftor and the anticonvulsant may be significantly decreased, which may reduce the efficacy of both active substances.
Croatian: Izloženost ivakaftoru i antikonvulzivima može biti značajno smanjena, što može oslabiti djelotvornost obiju djelatnih tvari.
English: The median (range) tmax of lumacaftor is approximately 4.0 hours (2.0; 9.0) in the fed state.
Croatian: Medijan (raspon) tmax lumakaftora iznosi približno 4,0 sata (2,0; 9,0) u stanju sitosti.
English: No specific antidote is available for overdose with lumacaftor/ivacaftor.
Croatian: Nije dostupan specifični antidot za predoziranje lumakaftorom/ivakaftorom.
English: At week 24, the proportion of patients who remained free from pulmonary exacerbations was significantly higher for patients treated with lumacaftor/ivacaftor compared with placebo.
Croatian: U 24. tjednu, udio bolesnika koji i dalje nije imao plućne egzacerbacije bio je značajno veći u bolesnika liječenih lumakaftorom/ivakaftorom u usporedbi s placebom.
English: • Upper respiratory tract infection
Croatian: • infekcija gornjih dišnih puteva
English: Do not give your child a double dose to make up for the forgotten dose.
Croatian: Nemojte djetetu dati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: The side effects reported with Orkambi and ivacaftor alone (one of the active substances of Orkambi) are listed below and may occur with the use of Orkambi.
Croatian: Nuspojave zabilježene uz primjenu lijeka Orkambi i samo ivakaftora (jedna od djelatnih tvari lijeka Orkambi), navedene su ispod i moguće su uz primjenu lijeka Orkambi.
English: Clinical experience in patients with ppFEV1 <40 is limited and additional monitoring of these patients is recommended during initiation of therapy (see section 4.8).
Croatian: Zbog ograničenog kliničkog iskustva s bolesnicima u kojih je ppFEV1 < 40, preporučuje se dodatno praćenje tih bolesnika za vrijeme započinjanja terapije (vidjeti dio 4.8).
English: Therefore, after weighing the risks and benefits of treatment, Orkambi should be used with caution at a reduced dose (see sections 4.4, 4.8, and 5.2).
Croatian: Stoga, nakon procjene rizika i koristi liječenja, Orkambi se mora oprezno primjenjivati u sniženoj dozi (vidjeti dijelove 4.4, 4.8 i 5.2).
English: Ivacaftor produced a dose-related but transient increase in the blood pressure parameters in dogs at single oral doses up to 60 mg/kg.
Croatian: Ivakaftor je u pasa proizveo o dozi ovisno, ali prolazno povišenje parametara krvnog tlaka kad se davao u obliku jednokratnih peroralnih doza do najviše 60 mg/kg.
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with Orkambi (see section 4.5).
Croatian: Na hormonsku kontracepciju, uključujući oralnu, injekcijsku, transdermalnu i kontracepcijske implantate, ne smije se oslanjati kao na učinkovitu metodu kontracepcije kada se primjenjuje istodobno s lijekom Orkambi (vidjeti dio 4.5).
English: Additional adverse reactions from Trial 6 are included in Table 4.
Croatian: Dodatne nuspojave zabilježene u ispitivanju 6 uključene su u tablicu 4.
English: Orkambi is not recommended in patients who have undergone an organ transplant.
Croatian: Orkambi se ne preporučuje bolesnicima kojima je presađen organ.
English: warfarin
Croatian: varfarin
English: Hormonal contraceptives: ethinyl estradiol, norethindrone, and other progestogens
Croatian: Hormonski kontraceptivi: etinilestradiol, noretindron i drugi progestogeni
English: Talk to your child's doctor or pharmacist before taking Orkambi.
Croatian: Obratite se djetetovom liječniku ili ljekarniku prije nego što uzme Orkambi.
English: There is potential for other medicinal products to affect lumacaftor/ivacaftor when administered concomitantly, and also for lumacaftor/ivacaftor to affect other medicinal products.
Croatian: Postoji mogućnost da drugi lijekovi utječu na lumakaftor/ivakaftor kada se istodobno primjenjuju, a isto tako i da lumakaftor/ivakaftor utječe na druge lijekove.
English: Patients who had 2 or more abnormal liver function tests (ALT, AST, AP, GGT ≥ 3 times the ULN), or ALT or AST > 5 times ULN, or total bilirubin > 2 times ULN were excluded.
Croatian: Bolesnici koji su imali 2 ili više abnormalnih nalaza testova jetrene funkcije (ALT, AST, AP, GGT ≥ 3 puta GGN), ALT ili AST > 5 puta GGN ili ukupni bilirubin > 2 puta GGN bili su isključeni.
English: Especially tell the doctor if your child takes any of the following medicines:
Croatian: Osobito obavijestite liječnika ako Vaše dijete uzima neki od ovih lijekova:
English: (see section 5.3).
Croatian: (vidjeti dio 4.4).
English: Co-administration of lumacaftor/ivacaftor with rifampicin, a strong CYP3A inducer, had minimal effect on the exposure of lumacaftor, but decreased ivacaftor exposure (AUC) by 57%.
Croatian: Istodobna primjena lumakaftora/ivakaftora s rifampicinom, jakim induktorom CYP3A, minimalno je utjecala na izloženost lumakaftoru, ali je smanjila izloženost ivakaftoru (AUC) za 57%.
English: Cataracts were not observed in foetuses derived from rat dams treated during the organogenesis stage of foetal development, in rat pups exposed to a certain extent through milk ingestion prior to weaning, or in repeated dose toxicity studies with ivacaftor.
Croatian: Katarakte nisu bile opažene u fetusa ženki štakora liječenih tijekom faze organogeneze u fetalnom razvoju, u mladunčadi štakora izloženih u određenoj mjeri putem ingestije mlijeka prije prestanka sisanja ili u ispitivanjima toksičnosti ponovljene doze s ivakaftorom.
English: There is no experience of the use of Orkambi in patients with severe hepatic impairment (Child-Pugh Class C), but exposure is expected to be higher than in patients with moderate hepatic impairment.
Croatian: Nema iskustva s primjenom lijeka Orkambi u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C), ali očekuje se da će izloženost biti veća nego u bolesnika s umjerenim oštećenjem funkcije jetre.
English: For patients who transitioned from placebo to active treatment similar changes as those observed in patients treated with lumacaftor/ivacaftor in Trial 1 or Trial 2 were seen (see Table 5).
Croatian: 3. U bolesnika koji su prebačeni s placeba na aktivno liječenje opažene su promjene slične onima u bolesnika liječenih lumakaftorom/ivakaftorom u ispitivanju 1 ili ispitivanju 2 (vidjeti tablicu 5).
English: While taking Orkambi, you may notice that your breathing is easier, that you do not get ill as often, and/or that it is easier to gain weight.
Croatian: Dok uzimate Orkambi, možete opaziti da lakše dišete, da se ne razbolijevate jednako često kao prije i da lakše dobivate na težini.
English: Talk to your doctor before taking Orkambi if you have been told you have liver or kidney disease as your doctor may need to adjust the dose of Orkambi.
Croatian: Obratite se liječniku prije nego što uzmete Orkambi ako Vam je rečeno da imate bolest jetre ili bubrega, jer Vam liječnik možda treba prilagoditi dozu lijeka Orkambi.
English: Additionally, a clinical study with ivacaftor monotherapy showed that ivacaftor is a weak inhibitor of P-gp.
Croatian: Nadalje, kliničko ispitivanje monoterapije ivakaftorom pokazalo je da je ivakaftor slabi inhibitor P-gp-a.
English: A double dose should not be taken to make up for the forgotten dose.
Croatian: Ne smije se uzeti dvostruku dozu kako bi se nadoknadilo zaboravljenu dozu.
English: Following multiple oral doses of lumacaftor, the exposure of lumacaftor generally increased proportional to dose over the range of 50 mg to 1000 mg every 24 hours.
Croatian: Nakon primjene ponovljenih peroralnih doza lumakaftora, izloženost lumakaftoru obično se povećavala proporcionalno dozi u rasponu od 50 mg do 1000 mg svaka 24 sata.
English: Among different age paediatric cohorts, in the 2 to 5 years old patients, transaminase elevations have been observed more frequently than in the 6 to 11 years old (see section 4.8).
Croatian: U pedijatrijskih bolesnika je među kohortama različite dobi, povišenje transaminaza bilo opaženo češće u bolesnika u dobi od 2 do 5 godina nego u onih u dobi od 6 do 11 godina (vidjeti dio 4.8).
English: How to take Orkambi
Croatian: Kako uzimati Orkambi
English: Among 7 patients with pre-existing cirrhosis and/or portal hypertension who received lumacaftor/ivacaftor in the placebo-controlled, Phase 3 studies, worsening liver function with increased ALT, AST, bilirubin, and hepatic encephalopathy was observed in one patient.
Croatian: Među 7 bolesnika s postojećom cirozom i/ili portalnom hipertenzijom koji su primali lumakaftor/ivakaftor u placebom kontroliranim ispitivanjima faze 3, u jednog bolesnika opaženo je pogoršanje funkcije jetre s povećanim ALT-om, AST-om, bilirubinom i hepatičkom encefalopatijom.
English: Table 4: Adverse reactions in lumacaftor/ivacaftor-treated patients and in patients treated with ivacaftor alone
Croatian: Tablica 4: Nuspojave u bolesnika liječenih lumakaftorom/ivakaftorom i u bolesnika liječenih samo ivakaftorom
English: Especially tell your doctor if you take any of the following medicines:
Croatian: Osobito obavijestite liječnika ako uzimate neki od ovih lijekova:
English: Increased blood pressure
Croatian: Povišen krvni tlak
English: Clinical comment fluconazole
Croatian: Klinička napomena flukonazol
English: In a human pharmacokinetic study with lumacaftor alone, there was minimal elimination of lumacaftor and its metabolites in urine (only 8.6% of total radioactivity was recovered in the urine with 0.18% as unchanged parent).
Croatian: U ispitivanju farmakokinetike samo lumakaftora u ljudi, mokraćom se eliminirala minimalna količina lumakaftora i njegovih metabolita (samo 8,6% ukupne radioaktivnosti otkriveno je u mokraći, s tim da je 0,18% izlučeno kao neizmijenjena ishodišna tvar).
English: In the subgroup of 28 patients who were initiated at the full dose of lumacaftor/ivacaftor (2 tablets every 12 hours), the incidence was 71.4%, and in the 18 patients who were initiated at a reduced dose of lumacaftor/ivacaftor (1 tablet every 12 hours for up to 2 weeks, and subsequently increased to the full dose), the incidence was 55.6%.
Croatian: U podskupini od 28 bolesnika koji su liječenje započeli punom dozom lumakaftora/ivakaftora (2 tablete svakih 12 sati) incidencija je iznosila 71,4%, a u 18 bolesnika u kojih je liječenje započelo sniženom dozom lumakaftora/ivakaftora (1 tableta svakih 12 sati tijekom najviše 2 tjedna, a kasnije je doza povećana do pune doze), incidencija je bila 55,6%.
English: Due to the induction effect of lumacaftor on CYP3A, at steady-state, the net exposure of ivacaftor when co-administered with a CYP3A inhibitor is not expected to exceed that when given in the absence of lumacaftor at a dose of 150 mg every 12 hours, the approved dose of ivacaftor monotherapy.
Croatian: Zbog indukcijskog učinka lumakaftora na CYP3A, u stanju dinamičke ravnoteže se ne očekuje da neto izloženost ivakaftoru, kada se primjenjuje istodobno s inhibitorom CYP3A, premaši onu postignutu kada se daje bez lumakaftora u dozi od 150 mg svakih 12 sati, što je odobrena doza monoterapije ivakaftorom.
English: (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (frequency cannot be estimated using the available data).
Croatian: Nuspojave opažene uz primjenu samo ivakaftora također su prikazane u tablici 4. Nuspojave su poredane prema MedDRA-inoj klasifikaciji učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Long-term safety and efficacy rollover trial
Croatian: Dugoročno prijelazno ispitivanje sigurnosti i djelotvornosti
English: Lumacaftor and ivacaftor work together to improve the function of the abnormal CFTR protein.
Croatian: Lumakaftor i ivakaftor zajedno djeluju kako bi poboljšali funkciju abnormalnog proteina CFTR.
English: Two patients in the lumacaftor/ivacaftor group and two patients in the placebo group discontinued treatment permanently due to transaminase elevations.
Croatian: Dva bolesnika u skupini liječenoj lumakaftorom/ivakaftorom i dva bolesnika u skupini koja je primala placebo trajno su prekinuli liječenje zbog povišenih transaminaza.
English: Some examples of soft foods include puréed fruits, flavoured yogurt, and milk or juice.
Croatian: Primjeri meke hrane su pire od voća, jogurt s okusom i mlijeko ili sok.
English: Table 8: Summary of secondary outcomes in Trial 8
Croatian: Tablica 8: Sažetak sekundarnih ishoda u ispitivanju 8 Sekundarne mjere ishoda*
English: Post-Authorization Safety Study (PASS) The applicant should conduct a 5-year long-term observational study with lumacaftor/ivacaftor in patients with cystic fibrosis, including also microbiological and clinical endpoints (e.g. exacerbations) according to an approved protocol.
Croatian: Podnositelj mora provesti dugotrajno opservacijsko ispitivanje lumakaftora/ivakaftora u trajanju od 5 godina u bolesnika s cističnom fibrozom, uključujući i mikrobiološke i kliničke ishode (npr. egzacerbacije) sukladno odobrenom planu ispitivanja.
English: P value Mean (SD)
Croatian: Srednja vrijednost (SD)
English: Immunosuppressants: ciclosporin, everolimus, sirolimus, tacrolimus (used after organ transplant)
Croatian: Imunosupresivi: ciklosporin, everolimus, sirolimus, takrolimus (primjenjuju se nakon presađivanja organa)
English: Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with lumacaftor/ivacaftor.
Croatian: Na hormonske kontraceptive uključujući oralne, injekcijske, transdermalne i kontracepcijske implantate ne smije se oslanjati kao na učinkovitu metodu kontracepcije kada se primjenjuje istodobno s lumakaftorom/ivakaftorom.
English: Table 5: Summary of primary and key secondary outcomes in Trial 1 and Trial 2*
Croatian: Tablica 5: Sažeti prikaz primarnih i ključnih sekundarnih mjera ishoda u ispitivanju 1 i ispitivanju 2*
English: The exposure of ivacaftor will be decreased, which may reduce the efficacy of lumacaftor/ivacaftor.
Croatian: Izloženost ivakaftoru će se smanjiti, što može oslabiti djelotvornost lumakaftora/ivakaftora.
English: Antidepressants: citalopram, escitalopram, sertraline
Croatian: Antidepresivi: citalopram, escitalopram, sertralin
English: A population pharmacokinetic analysis of clearance versus creatinine clearance shows no trend for subjects with mild and moderate renal impairment (see section 4.2).
Croatian: Analiza populacijske farmakokinetike klirensa naspram klirensa kreatinina ne pokazuje trend promjene u ispitanika s blagim i umjerenim oštećenjem funkcije bubrega (vidjeti dio 4.2).
English: Skin and subcutaneous tissue disorders common
Croatian: Poremećaji kože i potkožnog tkiva često osip
English: ** All patients had pancreatic insufficiency at baseline.
Croatian: ** Svi bolesnici imali su na početku insuficijenciju gušterače.
English: Clinical comment
Croatian: Klinička napomena
English: • Severe liver problems: the dose may be reduced to one tablet every 12 hours.
Croatian: • Teške jetrene tegobe: doza se može smanjiti na jednu tabletu svakih 12 sati.
English: Very common may affect more than 1 in 10 people:
Croatian: Vrlo česte - mogu se javiti u više od 1 na 10 osoba:
English: In a human pharmacokinetic study with ivacaftor alone, 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 samo ivakaftora u ljudi, mokraćom se eliminirala minimalna količina ivakaftora i njegovih metabolita (samo 6,6% ukupne radioaktivnosti otkriveno je u mokraći).
English: Your doctor will do some blood tests to check your liver before and while you are taking Orkambi, particularly during the first year.
Croatian: Liječnik će napraviti neke krvne pretrage da Vam provjeri funkciju jetre prije nego što počnete uzimati i dok uzimate Orkambi, osobito tijekom prve godine liječenja.
English: Proton pump inhibitors: esomeprazole, lansoprazole, omeprazole
Croatian: Inhibitori protonske pumpe: esomeprazol, lansoprazol, omeprazol
English: The serum concentration of digoxin should be monitored and the dose should be titrated to obtain the desired clinical effect.
Croatian: Koncentraciju digoksina u serumu mora se nadzirati i dozu titrirati kako bi se dobio željeni klinički učinak.
English: At maternally toxic doses in rats, ivacaftor produced reductions in foetal body weight; an increase in the incidence of variations in cervical ribs, hypoplastic ribs, and wavy ribs; and sternal irregularities, including fusions.
Croatian: U dozama koje su bile toksične za skotne ženke štakora, ivakaftor je prouzročio sniženje tjelesne težine fetusa, povećanu incidenciju varijacija u obliku cervikalnih rebara, hipoplastičnih rebara i valovitih rebara te nepravilnosti prsne kosti uključujući spajanja.
English: The F508del mutation impacts the CFTR protein in multiple ways, primarily by causing a defect in cellular processing and trafficking that reduces the quantity of CFTR at the cell surface.
Croatian: Mutacija F508del utječe na protein CFTR na više načina, a prvenstveno tako da uzrokuje nepravilnost u staničnoj obradi i prijenosu što smanjuje količinu CFTR-a na površini stanice.
English: The impact of mild hepatic impairment (Child-Pugh Class A, score 5 to 6) on pharmacokinetics of lumacaftor given in combination with ivacaftor has not been studied, but the increase in exposure is expected to be less than 50%.
Croatian: Utjecaj blagog oštećenja funkcije jetre (Child-Pugh stadij A, rezultat 5 do 6) na farmakokinetiku lumakaftora davanog u kombinaciji s ivakaftorom nije ispitan, ali očekuje se povećanje izloženosti manje od 50%.
English: Three patients discontinued lumacaftor/ivacaftor treatment permanently due to transaminase elevations.
Croatian: Tri su bolesnika trajno prekinula liječenje lumakaftorom/ivakaftorom zbog povišenih transaminaza.
English: The median (range) tmax of ivacaftor is approximately 4.0 hours (2.0; 6.0) in the fed state.
Croatian: Medijan (raspon) tmax ivakaftora iznosi približno 4,0 sata (2,0; 6,0) u stanju sitosti.
English: PHARMACEUTICAL FORM AND CONTENTS granules
Croatian: OBLIK I SADRŽAJ granule
English: The steady-state exposure of ivacaftor is lower than that of Day 1 due to the CYP3A induction effect of lumacaftor (see section 4.5).
Croatian: Izloženost ivakaftoru u stanju dinamičke ravnoteže niža je nego 1. dana zbog indukcijskog učinka lumakaftora na CYP3A (vidjeti dio 4.5).
English: St. John's wort (Hypericum perforatum)
Croatian: gospina trava (Hypericum perforatum)
English: If you have moderate or severe problems with liver function, your doctor may need to reduce the dose of Orkambi as your liver will not clear Orkambi as fast as in people who have normal liver function.
Croatian: Ako imate umjerene ili teške tegobe s jetrenom funkcijom, liječnik će možda morati smanjiti dozu lijeka Orkambi, jer Vam jetra neće ukloniti Orkambi onako brzo kako se to postiže u ljudi s normalnom funkcijom jetre.
English: The combined effect of lumacaftor and ivacaftor is increased quantity and function of F508del-CFTR at the cell surface, resulting in increased chloride ion transport.
Croatian: Kombinirani učinak lumakaftora i ivakaftora sastoji se u povećanju količine i funkcije F508del-CFTR-a na površini stanice, što dovodi do povećanog prijenosa iona klorida.
English: Lumacaftor had no effects on fertility and reproductive performance indices in male and female rats.
Croatian: Lumakaftor nije utjecao na indekse plodnosti i reproduktivne sposobnosti u mužjaka i ženki štakora.
English: If your child has moderate or severe problems with liver function, your child's doctor may need to reduce the dose of Orkambi as your child's liver will not clear Orkambi as fast as in children who have normal liver function.
Croatian: Ako Vaše dijete ima umjerene ili teške tegobe s jetrenom funkcijom, djetetov liječnik će možda morati smanjiti dozu lijeka Orkambi jer djetetova jetra neće ukloniti Orkambi onako brzo kako se to postiže u djece s normalnom funkcijom jetre.
English: 6 years and older
Croatian: 6 i više godina
English: Table 7: Summary of primary and key secondary outcomes in Trial 7
Croatian: Tablica 7: Sažetak primarne i ključnih sekundarnih mjera ishoda u ispitivanju 7
English: • Mix entire content of sachet with 5 mL of age-appropriate soft food or liquid that is at or below room temperature.
Croatian: • Cijeli sadržaj vrećice pomiješajte s 5 mL meke hrane ili tekućine koja je primjerena dobi djeteta i sobne ili niže temperature.
English: There is no experience of initiating treatment with lumacaftor/ivacaftor in patients having a pulmonary exacerbation and initiating treatment in patients having a pulmonary exacerbation is not advisable.
Croatian: Nema iskustva sa započinjanjem liječenja lumakaftorom/ivakaftorom u bolesnika s plućnom egzacerbacijom pa se započinjanje liječenja u bolesnika s plućnom egzacerbacijom ne preporučuje.
English: The safety and efficacy of Orkambi in patients aged 65 years or older have not been evaluated.
Croatian: Sigurnost i djelotvornost lijeka Orkambi u bolesnika u dobi od 65 i više godina nisu procijenjene.