FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1: Recommended dose of Orkambi in patients aged 6 years and older Age
Croatian: Tablica 1: Preporučena doza lijeka Orkambi u bolesnika u dobi od 6 i više godina Dob
English: If lumacaftor/ivacaftor is used in these patients, they should be closely monitored after the initiation of treatment and the dose should be reduced (see sections 4.2, 4.8, and 5.2).
Croatian: Ako se u tih bolesnika primjenjuje lumakaftor/ivakaftor, mora ih se pažljivo pratiti nakon započetog liječenja, a dozu treba smanjiti (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Key Secondary Endpoints* Absolute change in BMI at Week 24 (kg/m2)
Croatian: Ključne sekundarne mjere ishoda* Apsolutna promjena u ITM-u u 24. tjednu (kg/m2)
English: • Yellowing of the skin or the white part of the eyes
Croatian: • žutu boju kože ili bjeloočnica
English: Marketing Authorisation Holder Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper Dublin 2, D02 EK84
English: In vitro studies indicate that lumacaftor is a substrate of Breast Cancer Resistance Protein (BCRP).
Croatian: Ispitivanja in vitro pokazuju da je lumakaftor supstrat proteina rezistencije raka dojke (BCRP).
English: While taking Orkambi, you may notice that your child's breathing is easier, that they do not get ill as often, and/or that it is easier to gain weight.
Croatian: Dok uzima Orkambi, možete opaziti da Vaše dijete lakše diše, da se ne razbolijeva jednako često kao prije i da lakše dobiva na težini.
English: (listed in section 6).
Croatian: (neki primjeri nalaze se u daljnjem tekstu).
English: METHOD AND ROUTE(S) OF ADMINISTRATION Instructions for use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Upute za primjenu
English: The net effect of lumacaftor/ivacaftor therapy is expected to be strong CYP3A induction.
Croatian: Očekuje se da je neto učinak terapije lumakaftorom/ivakaftorom jaka indukcija CYP3A.
English: The other ingredients are: cellulose, microcrystalline; croscarmellose sodium; hypromellose acetate succinate; povidone (K30); and sodium laurilsulfate.
Croatian: Drugi sastojci su: celuloza, mikrokristalična; karmelozanatrij, umrežena; hipromelozaacetatsukcinat; povidon (K30); natrijev laurilsulfat.
English: The Phase 3 trials of lumacaftor/ivacaftor included 81 patients with ppFEV1 < 40 at baseline.
Croatian: U ispitivanja lumakaftora/ivakaftora faze 3 bio je uključen 81 bolesnik s ppFEV1 < 40 na početku ispitivanja.
English: However, when initiating lumacaftor/ivacaftor in patients taking strong CYP3A inhibitors, the dose should be adjusted (see sections 4.2 and 4.4).
Croatian: Međutim, kada se primjena lumakaftora/ivakaftora započinje u bolesnika koji uzimaju jake inhibitore CYP3A, dozu je potrebno prilagoditi (vidjeti diijelove 4.2 i 4.4).
English: No dose adjustment is recommended when used with moderate or weak CYP3A inducers.
Croatian: Ne preporučuje se prilagodba doze kada se primjenjuju s umjerenim ili slabim induktorima CYP3A.
English: • Anti-inflammatory medicines (used for the treatment of inflammation) for example: ibuprofen
Croatian: • protuupalni lijekovi (primjenjuju se za liječenje upale), primjerice: ibuprofen
English: Anti-mycobacterials: rifabutin, rifampicin*, rifapentine
Croatian: Antimikobakterijski lijekovi: rifabutin, rifampicin*,
English: • Antidepressant medicines (used for the treatment of depression) for example: citalopram, escitalopram, sertraline, bupropion
Croatian: • antidepresivi (primjenjuju se za liječenje depresije), primjerice: citalopram, escitalopram, sertralin, bupropion
English: The exact mechanisms by which lumacaftor improves cellular processing and trafficking of F508del-CFTR and ivacaftor potentiates F508del-CFTR are not known.
Croatian: Točni mehanizmi kojima lumakaftor poboljšava staničnu obradu i prijenos F508del-CFTR-a, a ivakaftor pojačava F508del-CFTR, nisu poznati.
English: Ivacaftor was not teratogenic when dosed orally to pregnant rats and rabbits during the organogenesis stage of foetal development at doses approximately 7 times (ivacaftor and metabolite exposure) and 46 times the ivacaftor exposure in humans at the therapeutic lumacaftor/ivacaftor dose, respectively.
Croatian: Ivakaftor nije pokazao teratogene učinke peroralno primijenjen skotnim ženkama štakora i kunića tijekom faze organogeneze fetalnog razvoja u dozama koje su bile približno 7 (izloženost ivakaftoru i metabolitima), odnosno 46 puta veće od izloženosti ivakaftoru u ljudi pri terapijskoj dozi lumakaftora/ivakaftora.
English: Following multiple doses of lumacaftor/ivacaftor for 10 days, subjects with moderately impaired hepatic function (Child-Pugh Class B, score 7 to 9) had higher exposures (AUC0-12hr by approximately 50% and Cmax by approximately 30%) compared with healthy subjects matched for demographics.
Croatian: Nakon višekratnih doza lumakaftora/ivakaftora tijekom 10 dana, u ispitanika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B, rezultat od 7 do 9) izloženost je bila veća (AUC0-12h za približno 50% a Cmax za približno 30%) u usporedbi sa zdravim ispitanicima s kojima su se podudarali u demografskim podacima.
English: Name and address of the manufacturer responsible for batch release Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate
English: *Side effects seen for ivacaftor alone.
Croatian: *Nuspojave opažene samo uz ivakaftor.
English: Serious respiratory events were seen more frequently in patients with percent predicted FEV1 (ppFEV1) < 40, and may lead to discontinuation of the medicinal product.
Croatian: U bolesnika s postotkom predviđenog FEV1 (ppFEV1) < 40 češće su opaženi ozbiljni respiratorni događaji koji mogu dovesti do prekida primjene lijeka.
English: In this trial, 10 patients (homozygous for F508del-CFTR mutation) completed dosing with lumacaftor alone 400 mg q12h for 28 days followed by the addition of ivacaftor 250 mg q12h for an additional 28 days, and 25 patients (homozygous or heterozygous for F508del) completed dosing with placebo.
Croatian: U tom ispitivanju, 10 bolesnika (homozigoti za mutaciju F508del-CFTR) završilo je primjenu samo lumakaftora u dozi od 400 mg svakih 12 sati tijekom 28 dana, nakon čega je slijedio dodatak ivakaftora u dozi od 250 mg svakih 12 sati dodatnih 28 dana, a 25 bolesnika (homozigoti ili heterozigoti za F508del) završilo je s primjenom placeba.
English: Do not use this medicine after the expiry date which is stated on the carton/blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji/blisteru iza oznake „EXP“.
English: Decrease in heart rate
Croatian: Sniženje frekvencije srca
English: Your child's doctor may monitor your child's blood pressure during treatment with Orkambi.
Croatian: Liječnik Vašeg djeteta možda će pratiti vrijednosti djetetovog krvnog tlaka tijekom liječenja lijekom Orkambi.
English: The efficacy of lumacaftor/ivacaftor in patients with CF who are homozygous for the F508del mutation in the CFTR gene was evaluated in two randomised, double-blind, placebo-controlled clinical trials of 1108 clinically stable patients with CF, in which 737 patients were randomised to and dosed with lumacaftor/ivacaftor.
Croatian: Djelotvornost lumakaftora/ivakaftora u bolesnika s cističnom fibrozom koji su homozigoti za mutaciju F508del na genu CFTR procijenjena je u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja provedena na 1108 klinički stabilnih bolesnika s cističnom fibrozom, u kojima je 737 bolesnika bilo randomizirano na primjenu doze lumakaftora/ivakaftora.
English: Anticonvulsants: carbamazepine, phenobarbital, phenytoin
Croatian: Antikonvulzivi: karbamazepin, fenobarbital, fenitoin
English: If you forget to give your child Orkambi
Croatian: Ako ste zaboravili djetetu dati Orkambi
English: There are different strengths of Orkambi tablet for different age groups.
Croatian: Za različite dobne skupine postoje različite jačine tableta Orkambi.
English: For patients with a history of ALT, AST, or bilirubin elevations, more frequent monitoring should be considered.
Croatian: U bolesnika s povišenim vrijednostima ALT, AST ili bilirubina u anamnezi, potrebno je razmotriti češće praćenje testova jetrene funkcije.
English: • Anti-allergic medicines (used for the treatment of allergies and/or asthma) for example: montelukast, fexofenadine
Croatian: • antialergici (primjenjuju se za liječenje alergija i/ili astme), primjerice: montelukast, feksofenadin
English: The active substances are lumacaftor and ivacaftor.
Croatian: Djelatne tvari su lumakaftor i ivakaftor.
English: Placental transfer of ivacaftor was observed in pregnant rats and rabbits.
Croatian: Opaženo je da ivakaftor prolazi kroz placentu kod gravidnih ženki štakora i kunića.
English: Therefore, concomitant use of lumacaftor/ivacaftor with CYP3A substrates may decrease the exposure of these substrates (see section 4.4).
Croatian: Stoga istodobna primjena lumakaftora/ivakaftora sa supstratima CYP3A može smanjiti izloženost tim supstratima (vidjeti dio 4.4).
English: Orkambi 200 mg/125 mg is available in the following pack sizes:
Croatian: Orkambi 200 mg/125 mg dostupan je u sljedećim veličinama pakiranja:
English: Ivacaftor produced concentration-dependent inhibitory effect on hERG (human ether-à-go-go related gene) tail currents, with an IC15 of 5.5 µM, compared to the Cmax (1.5 µM) for ivacaftor at the therapeutic dose for lumacaftor/ivacaftor.
Croatian: Ivakaftor je uzrokovao o koncentraciji ovisan inhibicijski učinak na hERG kanalom (engl. human ether-a-go-go related gene) posredovan spori protok, uz IC15 od 5,5 µM, što je usporedivo s Cmax (1,5 µM) za ivakaftor pri terapijskoj dozi lumakaftora/ivakaftora.
English: No dose adjustment is recommended when used with moderate or weak CYP3A inhibitors.
Croatian: Ne preporučuje se prilagodba doze kada se primjenjuju s umjerenim ili slabim inhibitorima CYP3A.
English: No meaningful changes in QTc interval or blood pressure were observed in a thorough QT clinical study evaluating either lumacaftor 600 mg once daily/ivacaftor 250 mg q12h or lumacaftor 1000 mg once daily/ivacaftor 450 mg q12h, demonstrating a lack of translation of these non-clinical findings to the clinic.
Croatian: Nisu opažene značajne promjene QTc intervala ili krvnog tlaka u temeljitom kliničkom ispitivanju QT-a kojim se procjenjivao lumakaftor 600 mg jedanput na dan/ivakaftor 250 mg svakih 12 sati ili lumakaftor 1000 mg jednaput na dan/ivakaftor 450 mg svakih 12 sati, što pokazuje da se ti neklinički nalazi ne mogu prenijeti u klinički kontekst.
English: Potential for lumacaftor/ivacaftor to interact with transporters In vitro experiments show that lumacaftor is a substrate for Breast Cancer Resistance Protein (BCRP).
Croatian: Moguće interakcije lumakaftora/ivakaftora s prijenosnicima In vitro pokusi pokazuju da je lumakaftor supstrat proteina rezistencije raka dojke (engl.
English: If your child takes more Orkambi than he/she should Contact your child's doctor or pharmacist for advice.
Croatian: Ako Vaše dijete uzme više lijeka Orkambi nego što je trebalo Obratite se djetetovom liječniku ili ljekarniku za savjet.
English: In addition, the mean absolute change in sweat chloride from Week 24 at Week 26 following the 2-week washout period (to evaluate off-drug response) was an increase of 33.0 mmol/L (95% CI: 28.9, 37.1; nominal P < 0.0001), representing a return to baseline after treatment washout.
Croatian: Uz to, srednja vrijednost apsolutne promjene koncentracije klorida u znoju iz 24. tjedna u 26. je tjednu, nakon 2-tjednog razdoblja ispiranja (da bi se procijenio odgovor na prestanak primjene lijeka), pokazala povećanje od 33,0 mmol/L (95% CI: 28,9, 37,1; nominalni P < 0,0001), što predstavlja povratak na početne vrijednosti nakon ispiranja lijeka iz organizma.
English: Following resolution of transaminase elevations, the benefits and risks of resuming dosing should be considered (see sections 4.2, 4.8, and 5.2).
Croatian: Nakon što se povišene transaminaze snize, potrebno je razmotriti koristi i rizike od nastavka primjene doze (vidjeti dijelove 4.2, 4.8 i 5.2).
English: Co-administration with sensitive CYP3A substrates or CYP3A substrates with a narrow therapeutic index is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena s osjetljivim supstratima CYP3A ili supstratima CYP3A s uskim terapijskim indeksom (vidjeti dio 4.5).
English: The safety data from 1029 patients aged 12 years and older who were homozygous for the F508del mutation in the CFTR gene treated with lumacaftor/ivacaftor for up to an additional 96 weeks in the long-term safety and efficacy rollover study (Trial 3) were similar to the 24-week, placebo-controlled studies (see section 5.1).
Croatian: Sigurnosni podaci za 1029 bolesnika u dobi od 12 i više godina koji su homozigoti za mutaciju F508del gena CFTR, liječenih lumakaftorom/ivakaftorom do dodatnih 96 tjedana u dugotrajnom prijelaznom (engl. rollover) ispitivanju sigurnosti i djelotvornosti (ispitivanje 3) bili su slični onima dobivenim u placebom kontroliranim ispitivanjima u trajanju od 24 tjedna (vidjeti dio 5.1).
English: The exposure of ivacaftor when given in combination with lumacaftor increased approximately 3-fold when given with fat-containing food in healthy volunteers.
Croatian: Izloženost ivakaftoru primijenjenom u kombinaciji s lumakaftorom povećala se približno 3 puta kada se ta kombinacija davala zdravim dobrovoljcima s hranom koja sadrži masti.
English: Upper respiratory tract infection, rhinitis
Croatian: često infekcija gornjih dišnih puteva, rinitis
English: • Increase in blood pressure
Croatian: • povišenje krvnog tlaka
English: Your doctor may monitor your blood pressure during treatment with Orkambi.
Croatian: Vaš liječnik će Vam možda pratiti vrijednosti krvnog tlaka tijekom liječenja lijekom Orkambi.
English: Caution is recommended while using Orkambi in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min) or end-stage renal disease (see sections 4.4 and 5.2).
Croatian: Preporučuje se oprez kad se Orkambi primjenjuje u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina manji ili jednak 30 mL/min) ili s terminalnim stadijem bubrežne bolesti (vidjeti dijelove 4.4 i 5.2).
English: Trial 7 was a 24-week, placebo-controlled, Phase 3 clinical study in 204 patients with CF aged 6 to 11 years old (mean age 8.8 years).
Croatian: Ispitivanje 7 bilo je 24-tjedno, placebom kontrolirano kliničko ispitivanje faze 3 u 204 bolesnika s cističnom fibrozom u dobi od 6 do 11 godina (srednja vrijednost dobi: 8,8 godina).
English: ** For patients rolled over from Trials 1 and 2 (placebo-to-lumacaftor/ivacaftor group) total exposure was up to 96 weeks.
Croatian: ** U bolesnika koji su nastavili iz ispitivanja 1 i 2 (skupina koja je prebačena s placeba na lumakaftor/ivakaftor) ukupna izloženost bila je do 96 tjedana.
English: During Trials 1 and 2, adverse reactions related to increased blood pressure (e.g., hypertension, blood pressure increased) were reported in 0.9% (7/738) of patients treated with lumacaftor/ivacaftor and in no patients who received placebo.
Croatian: Tijekom ispitivanja 1 i 2 , nuspojave povezane s povišenim krvnim tlakom (npr. hipertenzija, povišen krvni tlak) bile su prijavljene u 0,9% (7/738) bolesnika liječenih lumakaftorom/ivakaftorom i ni u jednog bolesnika koji je primao placebo.
English: • Immunosuppressants (used after an organ transplantation) for example: ciclosporin, everolimus, sirolimus, tacrolimus
Croatian: • imunosupresivi (primjenjuju se nakon presađivanja organa), primjerice: ciklosporin, everolimus, sirolimus, takrolimus
English: Your child's doctor may perform some eye examinations prior to and during treatment with Orkambi.
Croatian: Liječnik će možda Vašem djetetu napraviti neke preglede očiju prije i tijekom liječenja lijekom Orkambi.
English: Patients with a history of colonisation with organisms such as Burkholderia cenocepacia, Burkholderia dolosa, or Mycobacterium abscessus or who had 3 or more abnormal liver function tests (ALT, AST, AP, GGT ≥ 3 times the ULN or total bilirubin ≥ 2 times the ULN) were excluded.
Croatian: Iz ispitivanja su isključeni bolesnici s anamnezom kolonizacije organizmima kao što su Burkholderia cenocepacia, Burkholderia dolosa ili Mycobacterium abscessus ili oni koji su imali poremećene nalaze 3 ili više testova jetrene funkcije (ALT, AST, AP, GGT ≥ 3 puta GGN ili ukupni bilirubin ≥ 2 puta GGN).
English: The proportion of patients who experienced a systolic blood pressure value > 140 mmHg or a diastolic blood pressure > 90 mmHg on at least two occasions was 3.4% and 1.5% in patients treated with lumacaftor/ivacaftor, respectively, compared with 1.6% and 0.5% in patients who received placebo (see section 4.4).
Croatian: Udio bolesnika kojima je u najmanje dva navrata izmjerena vrijednost sistoličkog krvnog tlaka > 140 mmHg ili dijastoličkog krvnog tlaka > 90 mmHg iznosio je 3,4% odnosno 1,5% u bolesnika liječenih lumakaftorom/ivakaftorom u usporedbi s 1,6% odnosno 0,5% u bolesnika koji su primali placebo (vidjeti dio 4.4).
English: Dizziness has been reported in patients receiving ivacaftor, a component of Orkambi, which could influence the ability to drive or use machines.
Croatian: U bolesnika koji primaju ivakaftor, sastojak lijeka Orkambi, zabilježena je omaglica koja može utjecati na sposobnost upravljanja vozilima ili strojevima.
English: A decline in ppFEV1 at initiation of therapy was observed during serial post dose spirometry assessments.
Croatian: Tijekom serije spirometrijskih mjerenja nakon primjene doze na početku terapije opaženo je smanjenje ppFEV1.
English: • Oral hypoglycaemics (used for the management of type 2 diabetes): repaglinide
Croatian: • oralni hipoglikemijski lijekovi (primjenjuju se za zbrinjavanje dijabetesa tipa 2), primjerice: repaglinid.
English: After oral administration of 400 mg every 12 hours in patients with CF in a fed state, the typical apparent volumes of distribution for the central and peripheral compartments (CV) were estimated to be 23.5 L (48.7%) and 33.3 L (30.5%), respectively.
Croatian: Nakon peroralne primjene doze od 400 mg svakih 12 sati u bolesnika s cističnom fibrozom u stanju sitosti, procijenjeni tipični prividni volumen distribucije (CV) bio je za središnji odjeljak 23,5 L (48,7%), a za periferni odjeljak 33,3 L (30,5%).
English: Absolute change from baseline in percent predicted FEV1 at each visit†
Croatian: Apsolutna promjena u postotku predviđenog FEV1 od početne vrijednosti na svakom pregledu u sklopu ispitivanja†
English: (μg/mL*h)
Croatian: (μg/mL*sati) ivakaftora
English: Do not use this medicine after the expiry date which is stated on the carton/sachet after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji/vrećici iza oznake „EXP“.
English: Therefore, co-administration with strong CYP3A inducers (e.g., rifampicin, St. John's wort [Hypericum perforatum]) is not recommended (see section 4.5).
Croatian: Stoga se ne preporučuje istodobna primjena s jakim induktorima CYP3A (npr. rifampicinom, gospinom travom [Hypericum perforatum]) (vidjeti dio 4.5).
English: In vitro and in vivo data indicate that lumacaftor is mainly metabolised via oxidation and glucuronidation.
Croatian: Podaci dobiveni in vitro i in vivo pokazuju da se lumakaftor metabolizira uglavnom oksidacijom i glukuronidacijom.
English: Ivacaftor is a weak inhibitor of CYP3A when given as monotherapy.
Croatian: Ivakaftor je slabi inhibitor CYP3A kada se daje kao monoterapija.
English: Otherwise, wait until your next scheduled dose as you normally would.
Croatian: Ako nije tako, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: During Trials 1 and 2, the incidence of respiratory adverse reactions (e.g., chest discomfort, dyspnoea, and respiration abnormal) was 26.3% in lumacaftor/ivacaftor-treated patients compared to 17.0% in patients who received placebo.
Croatian: Tijekom ispitivanja 1 i 2, incidencija respiratornih nuspojava (npr. nelagoda u prsištu, dispneja i poremećeno disanje) bila je 26,3% u bolesnika liječenih lumakaftorom/ivakaftorom u usporedbi sa 17,0% u bolesnika koji su primali placebo.
English: Following multiple oral dose administration of ivacaftor in combination with lumacaftor, the exposure of ivacaftor generally increased with dose from 150 mg every 12 hours to 250 mg every 12 hours.
Croatian: Nakon primjene ponovljenih peroralnih doza ivakaftora u kombinaciji s lumakaftorom, izloženost ivakaftoru obično se povećavala s dozom od 150 mg svakih 12 sati do 250 mg svakih 12 sati.
English: Co-administration of lumacaftor/ivacaftor with itraconazole, a strong CYP3A inhibitor, did not impact the exposure of lumacaftor, but increased ivacaftor exposure by 4.3-fold.
Croatian: Istodobna primjena lumakaftora/ivakaftora s itrakonazolom, jakim inhibitorom CYP3A, nije utjecala na izloženost lumakaftoru, ali je povećala izloženost ivakaftoru 4,3 puta.
English: Lumacaftor and ivacaftor are inhibitors of BCRP.
Croatian: Lumakaftor i ivakaftor su inhibitori BCRP-a.
English: Your child's doctor will do some blood tests to check your child's liver before and while she/he is taking Orkambi, particularly during the first year.
Croatian: Liječnik Vašeg djeteta napravit će mu neke krvne pretrage da provjeri funkciju jetre prije nego što dijete počne uzimati i dok uzima Orkambi, osobito tijekom prve godine liječenja.
English: Baseline CFQ-R
Croatian: CFQ-R (engl.
English: • Printing ink: shellac; iron oxide black (E172); propylene glycol; and ammonium hydroxide.
Croatian: • tinta za označivanje: šelak; željezov oksid, crni (E172); propilenglikol; amonijev hidroksid.
English: Post-Authorisation Efficacy Study (PAES) Based on an agreed protocol, the Applicant should conduct a long-term effectiveness study to compare disease progression among children with CF homozygous for F508del-CFTR and are aged 2 through 5 years at the time of Orkambi treatment initiation versus disease progression among concurrent matched cohort of children with CF who have never received Orkambi treatment, in addition to a longitudinal historical cohort.
Croatian: Na temelju dogovorenog plana ispitivanja, podnositelj zahtjeva treba provesti dugotrajno ispitivanje učinkovitosti radi usporedbe progresije bolesti u djece s cističnom fibrozom koja su homozigoti za mutaciju F508del gena CFTR i u vrijeme započinjanja terapije Orkambijem bila su u dobi između 2 i 5 godina, i progresije bolesti u podudarnoj kohorti djece s cističnom fibrozom koja nikada nisu bila liječena lijekom Orkambi, dodatno uz longitudinalnu povijesnu kohortu.
English: 400 mg lumacaftor + 500 mg ivacaftor
Croatian: 400 mg lumakaftora + 500 mg ivakaftora
English: If you have poor lung function your doctor may monitor you more closely when you start Orkambi.
Croatian: Ako Vam je slaba plućna funkcija, kada počnete uzimati Orkambi liječnik će Vas možda pomnije pratiti.
English: Ivacaftor may cause dizziness (see section 4.8).
Croatian: Ivakaftor može prouzročiti omaglicu (vidjeti dio 4.8).
English: The entire content of each sachet of granules should be mixed with one teaspoon (5 mL) of age-appropriate soft food or liquid and the mixture completely consumed.
Croatian: Sav sadržaj jedne vrećice s granulama treba pomiješati s jednom čajnom žličicom (5 mL) meke hrane ili tekućine primjerene dobi djeteta te se sva mješavina mora progutati.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from lumacaftor/ ivacaftor therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the mother.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lumakaftorom/ivakaftorom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.