FrancophonIA/ELRC3.0 huggingface dataset:
English: The volume of reconstituted concentrate corresponding to the calculated individual dose, should be further diluted with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion, to a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:
Croatian: Kako bi se dobila konačna koncentracija topotekana između 25 i 50 mikrograma po ml u otopini za infuziju, potrebno je volumen rekonstituiranog koncentrata koji odgovara izračunatoj individualnoj dozi, dodatno razrijediti ili pomoću otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju ili pomoću otopine glukoze 50 mg/ml (5%) za infuziju, npr.:
English: The adverse event profile for topotecan when given in combination with cisplatin in the cervical cancer clinical trials is consistent with that seen with topotecan monotherapy.
Croatian: U kliničkim ispitivanjima kombinacije topotekana i cisplatina u liječenju raka vrata maternice profil štetnih događaja bio je isti kao i pri monoterapiji topotekanom.
English: Cervical Carcinoma
Croatian: Karcinom vrata maternice
English: How to use Topotecan Actavis
Croatian: Kako primjenjivati Topotecan Actavis
English: Topotecan Actavis; - if your blood cell counts are too low.
Croatian: Dojenje morate prekinuti prije početka liječenja lijekom Topotecan Actavis; ako imate premali broj krvnih stanica.
English: Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1 % respectively.
Croatian: Teški oblici (stupanj 3 ili 4) mučnine zabilježeni su u 4%, povraćanja u 3%, proljeva u 2% i mukozitisa u 1% bolesnika.
English: Cervical cancer
Croatian: Rak vrata maternice
English: severe bleeding (associated with thrombocytopenia) Immune system disorders
Croatian: jako krvarenje (povezano s trombocitopenijom)
English: Reconstitution will result in a concentrate containing 1 mg topotecan per ml.
Croatian: Nakon rekonstitucije, dobiveni koncentrat sadrži 1 mg topotekana po ml.
English: Guidelines for the safe handling and disposal of antineoplastic agents Reconstitution and dilution of the medicinal product must be performed by trained personnel.
Croatian: Potrebno je slijediti sljedeća pravila za ispravno rukovanje i zbrinjavanje lijekova za liječenje karcinoma, tj.: Rekonstituciju i razrjeđivanje lijeka mora provoditi educirano osoblje.
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % C.I.
Croatian: U bolesnica (n=39) s recidivom unutar 180 dana nakon kemoradioterapije cisplatinom, medijan preživljenja u skupini liječenoj kombinacijom topotekana i cisplatina iznosio je 4,6 mjeseci (95% CI: 2,6; 6,1), u usporedbi s 4,5 mjeseca (95% CI: 2,9; 9,6) u skupini liječenoj cisplatinom, uz omjer hazarda od 1,15 (0,59; 2,23).
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 4 mg powder for concentrate for solution for infusion
Croatian: NAZIV LIJEKA Topotecan Actavis 4 mg prašak za koncentrat za otopinu za infuziju
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U
English: Median survival (weeks) (95 % CI) Hazard ratio (95 % CI) Response rate (%) (95 % CI) Difference in response rate (95 % CI) Median time to progression (weeks) (95 % CI) Hazard ratio (95 % CI) N = total number of patients treated.
Croatian: Omjer hazarda (95% CI) Stopa odgovora (%) (95% CI)
English: Ask your doctor for advice.
Croatian: Zatim zatražite liječnički pregled.
English: - Decrease in the number of all blood cells (pancytopenia) - Feeling unwell.
Croatian: Simptomi mogu uključivati žutilo kože (žuticu). smanjenje broja svih krvnih stanica (pancitopenija). opće loše osjećanje. ozbiljna infekcija krvi, koja može biti fatalna. svrbež (pruritus).
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 1 mg powder for concentrate for solution for infusion
Croatian: NAZIV LIJEKA Topotecan Actavis 1 mg prašak za koncentrat za otopinu za infuziju
English: 1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml
Croatian: Dodajte 39 ml da biste dobili 40 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Topotecan Actavis 4 mg prašak za koncentrat za otopinu za infuziju topotekan i.v.
English: - Severe allergic (anaphylactic) reactions (rare; may affect up to 1 in 1,000 people), with signs such as: - swelling of the face, lips, tongue or throat, difficulty breathing, low blood pressure, dizziness and itchy rash.
Croatian: Upala pluća (rijetko; mogu se javiti u do 1 na 1000 osoba) sa znakovima poput: - otežanog disanja - kašlja - vrućice
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Topotecan Actavis 1 mg powder for concentrate for solution for infusion topotecan
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Topotecan Actavis 1 mg prašak za koncentrat za otopinu za infuziju topotekan i.v.
English: The median survival for patients treated with topotecan + BSC was 25.9 weeks (95 % C.I.
Croatian: Medijan vremena preživljenja bolesnika liječenih topotekanom + BSC-om iznosio je 25,9 tjedana (95% CI: 18,3; 31,6) u usporedbi s 13,9 tjedana (95% CI: 11,1; 18,6) u bolesnika liječenih samo BSC-om (p=0,0104).
English: febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leukopenia
Croatian: neutropenija (vidjeti dolje pod poremećaji probavnog sustava)
English: 9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Croatian: Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije ≥1 x 109/l, broj trombocita ≥100 x 109/l, a razina hemoglobina ≥9 g/dl (nakon transfuzije, ukoliko je potrebna).
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 10
Croatian: Prije primjene prvog ciklusa topotekana, bolesnici moraju imati početni broj neutrofila ≥1,5 x 109/l, broj trombocita ≥100 x 109/l i razinu hemoglobina ≥9 g/dl (nakon transfuzije, ukoliko je potrebna).
English: - Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
Croatian: Neuobičajeno mali broj neutrofilnih granulocita (vrsta bijelih krvnih stanica) u krvi, s ili bez vrućice. neuobičajena pojava modrica ili krvarenja, ponekad teške prirode, uzrokovana smanjenjem broja krvnih stanica koje omogućavaju zgrušavanje krvi (trombociti). gubitak na težini i gubitak teka (anoreksija), umor, slabost. mučnina, povraćanje, proljev, bol u trbuhu, zatvor (konstipacija).
English: pancytopenia
Croatian: mukozitis
English: Hepatobiliary disorders Common:
Croatian: Poremećaji imunološkog sustava Često:
English: Hazard ratio (95 % C.I.)
Croatian: Razlika u stopi odgovora (95% CI)
English: extravasation
Croatian: Doziranje
English: In those (n = 102) with recurrence after 180 days, the median survival in the topotecan plus cisplatin arm was 9.9 months (95 % C.I.
Croatian: U bolesnica (n=102) s recidivom nakon 180 dana, medijan preživljenja u skupini liječenoj kombinacijom topotekana i cisplatina iznosio je 9,9 mjeseci (95% CI: 7; 12,6), u odnosu na 6,3 mjeseca (95% CI: 4,9; 9,5) u skupini liječenoj cisplatinom, uz omjer hazarda od 0,75 (0,49; 1,16).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mg topotecan (as hydrochloride).
Croatian: TVARI Jedna bočica sadrži 1 mg topotekana (u obliku topotekanklorida).
English: NAME OF THE MEDICINAL PRODUCT Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan
Croatian: Topotecan Actavis 4 mg prašak za koncentrat za otopinu za infuziju topotekan
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 4 mg topotecan (as hydrochloride).
Croatian: TVARI Jedna bočica sadrži 4 mg topotekana (u obliku topotekanklorida).
English: Dosage in renally impaired patients
Croatian: Doziranje u bolesnika s oštećenjem bubrega
English: anaphylactic reaction angioedema urticaria
Croatian: hiperbilirubinemija
English: How Topotecan Actavis is given
Croatian: Kako se primjenjuje Topotecan Actavis
English: Sími: +354 550 3300
Croatian: Actavis Group PTC ehf Sími: + 354-550 3300
English: sepsis Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) Blood and lymphatic system disorders Very common:
Croatian: 1smrtni ishodi zbog sepse zabilježeni su u bolesnika koji su liječeni topotekanom (vidjeti dio 4.4).
English: Median (95 % C.I.)
Croatian: Medijan vremena preživljenja (tjedni) (95% CI)
English: Further information on Orkambi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Orkambi.
Croatian: Više informacija o lijeku Orkambi nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Orkambi.
English: The study is to evaluate how the disease progresses in the two groups of children.
Croatian: Cilj je ispitivanja ocijeniti kako bolest napreduje u te dvije skupine djece.
English: The tablets or granules are taken every 12 hours with fat-containing foods.
Croatian: Tablete ili granule uzimaju se svakih 12 sati s hranom koja sadržava masti.
English: The children's growth (measured in terms of the body mass index, weight and height) also improved.
Croatian: Rast djece (izmjeren na temelju indeksa tjelesne mase, težine i visine) također se poboljšao.
English: The recommended dose depends on the age and weight of the patient.
Croatian: Preporučena doza ovisi o dobi i težini bolesnika.
English: Overall the number of exacerbations was reduced by 39% when compared with placebo.
Croatian: Ukupno je broj egzacerbacija smanjen za 39 % u usporedbi s placebom.
English: The beneficial effects of Orkambi were smaller than expected for a medicine that treats the mechanism of the disease rather than its symptoms.
Croatian: Pozitivni učinci lijeka Orkambi bili su manji od očekivanih za lijek kojim se liječi mehanizam bolesti, a ne njezini simptomi.
English: What measures are being taken to ensure the safe and effective use of Orkambi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Orkambi?
English: Other information about Orkambi
Croatian: Ostale informacije o lijeku Orkambi
English: Orkambi (lumacaftor / ivacaftor)
Croatian: Orkambi (lumakaftor/ivakaftor)
English: All children were treated with Orkambi.
Croatian: Sva su djeca liječena lijekom Orkambi.
English: Orkambi received a marketing authorisation valid throughout the EU on 19 November 2015.
Croatian: Lijek Orkambi dobio je odobrenje za stavljanje u promet koje je na snazi na prostoru EU-a od 19. studenoga 2015.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Orkambi have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Orkambi također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency decided that Orkambi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Orkambi nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: There was improvement in CFTR protein activity as measured by a decrease in the amount of chloride in sweat after 24 weeks of treatment.
Croatian: Došlo je do poboljšanja aktivnosti bjelančevine CFTR, što je izmjereno smanjenom količinom klorida u znoju nakon 24 tjedna terapije.
English: What is Orkambi and what is it used for?
Croatian: Što je Orkambi i za što se primjenjuje?
English: Orkambi is used in patients who have inherited the mutation from both parents.
Croatian: Orkambi se primjenjuje u bolesnika koji su mutaciju naslijedili od oba roditelja.
English: However, as cystic fibrosis caused by F508del mutation is particularly severe, the observed effects were considered clinically relevant for patients with no other option.
Croatian: No, budući da je cistična fibroza uzrokovana mutacijom F508del osobito teška, zaključeno je da su uočeni učinci klinički bitni za bolesnike koji nemaju drugih mogućnosti.
English: In total, these serious side effects occurred in more than 1 in 200 people during the clinical studies.
Croatian: Te su se ozbiljne nuspojave tijekom kliničkih ispitivanja pojavile u više od 1 na 200 osoba.
English: Why is Orkambi authorised in the EU?
Croatian: Zašto je Orkambi odobren u EU-u?
English: Serious side effects include liver problems such as raised liver enzymes, cholestatic hepatitis (build-up of bile leading to inflammation of the liver) and hepatic encephalopathy (a brain disease caused by liver problems).
Croatian: Ozbiljne nuspojave uključuju probleme kao što su povišene razine jetrenih enzima u krvi, kolestatski hepatitis (nakupljanje žuči koje dovodi do upale jetre) i hepatička encefalopatija (bolest mozga uzrokovana problemima s jetrom).
English: Side effects reported with Orkambi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Orkambi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The effects of Orkambi in children aged 2 to 5 years were considered to be similar to those in older children and a long-term study will be carried out to confirm this.
Croatian: Smatralo se da su učinci lijeka Orkambi u djece u dobi od dvije do pet godina slični onima u starije djece, te će se provesti dugoročno ispitivanje kako bi se to potvrdilo.
English: Stopping treatment with Orkambi caused chloride levels to rise again.
Croatian: Prekid terapije lijekom Orkambi uzrokovao je ponovni porast razina klorida.
English: Orkambi is available as tablets and granules.
Croatian: Orkambi je dostupan u obliku tableta i granula.
English: The most common side effects with Orkambi (which may affect more than 1 in 10 people) are dyspnoea (shortness of breath), diarrhoea and nausea (feeling sick).
Croatian: Najčešće nuspojave lijeka Orkambi (koje se mogu javiti u više od 1 na 10 osoba) su dispneja (otežano disanje), proljev i mučnina.
English: What are the risks associated with Orkambi?
Croatian: Koji su rizici povezani s lijekom Orkambi?
English: As for all medicines, data on the use of Orkambi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Orkambi kontinuirano se prate.
English: Treatment with Orkambi also reduced the number of exacerbations (flares-up) requiring hospital admission or antibiotic therapy.
Croatian: Terapija lijekom Orkambi također je dovela do smanjenja broja egzacerbacija (pogoršanja) zbog kojih je potreban prijem u bolnicu ili liječenje antibioticima.
English: In the studies, Orkambi was compared with placebo (a dummy treatment), both added to patients' usual therapy.
Croatian: U ispitivanjima je lijek Orkambi uspoređen s placebom (prividnim liječenjem) te su oba dodana uobičajenom liječenju bolesnika.
English: After 24 weeks of treatment, LCI2.5 decreased by 1.01 in patients treated with Orkambi compared with an increase of 0.08 in patients treated with placebo.
Croatian: Nakon 24 tjedna terapije, LCI2.5 smanjio se za 1,01 u bolesnika liječenih lijekom Orkambi, u usporedbi s povećanjem od 0,08 u bolesnika koji su primali placebo.
English: Orkambi can only be prescribed by a doctor with experience in the treatment of cystic fibrosis.
Croatian: Lijek Orkambi može propisati samo liječnik iskusan u liječenju cistične fibroze.
English: Cystic fibrosis is an inherited disease that has severe effects on the lungs and the digestive system.
Croatian: Cistična fibroza nasljedna je bolest koja ima ozbiljne učinke na pluća i probavni sustav.
English: An overview of Orkambi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Orkambi i zašto je odobren u EU-u
English: For more information about using Orkambi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Orkambi pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: In the study in children aged 6 to 11 years, the main measure of effectiveness was a decrease in the lung clearance index (LCI2.5), which indicates an improvement in lung ventilation.
Croatian: U ispitivanju na djeci u dobi od 6 do 11 godina, glavno mjerilo djelotvornosti bilo je smanjenje indeksa klirensa pluća (LCI2,5), što ukazuje na poboljšanu plućnu ventilaciju.
English: Orkambi improved lung function in two main studies involving 1,108 cystic fibrosis patients aged 12 years and above, and one study involving 204 children aged from 6 to 11 years.
Croatian: Lijek Orkambi poboljšao je plućnu funkciju u dvama glavnim ispitivanjima koja su provedena na 1 108 bolesnika s cističnom fibrozom u dobi od 12 i više godina i u jednom ispitivanju na 204 djeteta u dobi od 6 do 11 godina.
English: Patients with cystic fibrosis have high levels of chloride in sweat due to CFTR not working properly.
Croatian: Osobe koje boluju od cistične fibroze imaju visoke razine klorida u znoju zbog nepravilnog funkcioniranja CFTR-a.
English: Orkambi is used in patients who have a genetic mutation (change) called the F508del mutation.
Croatian: Orkambi se primjenjuje u bolesnika koji imaju genetsku mutaciju (promjenu) nazvanu mutacija F508del.
English: The company that markets Orkambi is required to conduct a 5-year study in patients with cystic fibrosis to evaluate the long-term effects of the medicine.
Croatian: Tvrtka koja stavlja na tržište lijek Orkambi mora provesti petogodišnje ispitivanje na bolesnicima s cističnom fibrozom kako bi se ocijenili dugoročni učinci lijeka.
English: Cystic fibrosis is caused by mutations in the CFTR gene.
Croatian: Cističnu fibrozu uzrokuju mutacije u genu CFTR.
English: Orkambi's side effects mainly affected the gut and breathing and were generally considered mild to moderate and manageable.
Croatian: Nuspojave lijeka Orkambi uglavnom su utjecale na probavni sustav i disanje te se smatralo da su općenito blage do umjerene i da ih se može kontrolirati.
English: In the two studies in patients aged 12 years and above, the main measure of effectiveness was based on improvement in patients' predicted FEV1 which is a measure of how well the lungs work.
Croatian: U dvama ispitivanjima na bolesnicima u dobi od 12 i više godina, glavno mjerilo djelotvornosti temeljilo se na poboljšanju predviđenog FEV1 u bolesnika, odnosno mjere rada pluća.
English: Results from the first study showed that after 24 weeks of treatment patients who took Orkambi had an average improvement in FEV1 of 2.41 percentage points more than those who took placebo; this figure was 2.65 in the second study.
Croatian: Rezultati prvog ispitivanja pokazali su da su nakon 24 tjedna liječenja bolesnici koji su uzimali lijek Orkambi imali u prosjeku poboljšanje FEV1 od 2,41 posto veće od onih koji su uzimali placebo.
English: In the gut, blockage of the tubes from the pancreas slows down the digestion of food and causes poor growth.
Croatian: U crijevima, začepljenje kanala iz gušterače usporava probavu hrane i uzrokuje premali rast.
English: A further long-term study in children aged 2 to 5 years with cystic fibrosis is also required to compare those who have the F508del mutation in the CFTR gene and are treated with Orkambi with those who have not been treated with Orkambi.
Croatian: Dodatno dugoročno ispitivanje u djece s cističnom fibrozom između dvije i pet godina starosti također je potrebno za usporedbu bolesnika s mutacijom F508del u genu CFTR liječenih lijekom Orkambi s djecom koja nisu primila terapiju lijekom Orkambi.
English: How does Orkambi work?
Croatian: Kako djeluje Orkambi?
English: One of the active substances in Orkambi, lumacaftor, increases the amount of CFTR protein on the cell and the other, ivacaftor, increases the activity of the defective CFTR protein.
Croatian: Jedna od djelatnih tvari lijeka Orkambi, lumakaftor, povećava količinu bjelančevine CTFR na površini stanica, dok druga, ivakaftor, povećava djelovanje nepravilne bjelančevine CTFR.
English: The mutations reduce the amount of CFTR protein on the cell surface or affect the way the protein works.
Croatian: Mutacije smanjuju količinu bjelančevine CTFR na površini stanica ili utječu na način na koji bjelančevina djeluje.
English: All patients had the F508del mutation in the CFTR gene.
Croatian: Svi su bolesnici imali mutaciju F508del u genu CFTR.
English: Orkambi is a medicine used to treat cystic fibrosis in patients aged 2 years and above.
Croatian: Orkambi je lijek za liječenje cistične fibroze u bolesnika u dobi od dvije godine i starijih.
English: It affects the cells that produce mucus and digestive juices.
Croatian: Utječe na stanice koje proizvode sluz i probavne sokove.
English: A further study involved 60 children aged 2 to 5 years with cystic fibrosis who had the F508del mutation in the CFTR gene.
Croatian: Dodatno ispitivanje provedeno je na 60-ero djece u dobi od dvije do pet godina s cističnom fibrozom koja su imala mutaciju F508del u genu CFTR.
English: This gene makes the CFTR protein, which is involved in regulating the production of mucus and digestive juices.
Croatian: Taj gen proizvodi bjelančevinu CFTR, koja djeluje na regulaciju proizvodnje sluzi i probavnih sokova.
English: What benefits of Orkambi have been shown in studies?
Croatian: Koje su koristi od lijeka Orkambi utvrđene u ispitivanjima?
English: It should be prescribed only to patients confirmed to have the F508del mutation in both copies of the CFTR gene.
Croatian: Trebao bi se propisivati samo bolesnicima u kojih je utvrđena mutacija F508del u objema kopijama gena CFTR.
English: Orkambi has been shown to improve lung function and lung ventilation in patients with cystic fibrosis from 6 years of age.
Croatian: Utvrđeno je da lijek Orkambi poboljšava funkciju i ventilaciju pluća u bolesnika s cističnom fibrozom u dobi od šest godina i starijih.
English: This mutation affects the gene for a protein called cystic fibrosis transmembrane conductance regulator (CFTR) which is involved in regulating the production of mucus and digestive juices.
Croatian: Ta mutacija utječe na gen za bjelančevinu pod nazivom transmembranski regulator provodljivosti (engl. skraćeno CFTR), koji djeluje na regulaciju proizvodnje sluzi i probavnih tekućina.
English: In cystic fibrosis, the secretions become thick and cause blockage.
Croatian: Pri cističnoj fibrozi izlučevine postaju guste i uzrokuju začepljenja.
English: For the full list of all side effects and restrictions with Orkambi, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Orkambi potražite u uputi o lijeku.
English: These actions make mucus and digestive juices less thick.
Croatian: Ta djelovanja razrjeđuju sluz i probavne sokove.
English: How is Orkambi used?
Croatian: Kako se Orkambi primjenjuje?
English: Orkambi contains the active substances lumacaftor and ivacaftor.
Croatian: Orkambi sadrži djelatne tvari lumakaftor i ivakaftor.
English: 22 March 2013 EMA/402540/2013
Croatian: 22. ožujka 2013 EMA/402540/2013
English: Patients were followed for a median of 3.9 years.
Croatian: Bolesnici su praćeni tijekom medijana vremena od 3,9 godina.
English: Healthcare professionals should follow these recommendations:
Croatian: Zdravstveni djelatnici trebaju se pridržavati ovih preporuka:
English: Contact our press officers Monika Benstetter or Martin Harvey Allchurch
Croatian: Obratite se našim dužnosnicima za odnose s javnošću Monika Benstetter ili Martin Harvey Allchurch
English: Of those enrolled, 14,741 were from Europe and 10,932 were from China.
Croatian: Od uključenih ispitanika, njih 14 471 bilo je iz Europe, a 10 932 iz Kine.