FrancophonIA/ELRC3.0 huggingface dataset:
English: Paediatric patients had clinical improvements with aztreonamas determined by an increase in FEV1, improvement in CFQ-R respiratory symptoms scores and decline in P. aeruginosa sputum density.
Croatian: Pedijatrijski bolesnici imali su klinička poboljšanja s aztreonamom kako je to određeno povećanjem u FEV1, poboljšanjem na bodovnoj ljestvici CFQ-R dišnih simptoma te padom gustoće P. aeruginosa u iskašljaju.
English: Solvent for Cayston Sodium Chloride 0.17%
Croatian: Sodium Chloride 0.17%
English: Inhalation of nebulised solutions may induce a cough reflex.
Croatian: Udisanje atomizirane otopine može potaknuti refleks kašlja.
English: Aztreonamtherapy resulted in significant improvements in pulmonary function and respiratory symptoms at Day 28 in the 66 patients treated with one course Cayston 75 mg 3 times a day.
Croatian: Na 28. dan terapija aztreonamom dovela je do značajnih poboljšanja plućne funkcije i dišnih simptoma u 66 bolesnika liječenih jednom kurom Caystona u dozi od 75 mg 3 puta na dan.
English: All patients were treated with Tobramycin Nebuliser Solution (TNS) 300 mg, 2 times a day in the four weeks immediately prior to receiving Cayston or placebo either 2 or 3 times a day for 28 days.
Croatian: Svi su bolesnici liječeni otopinom tobramicina za atomizator (TNS-om, Tobramycin Nebuliser Solution) u dozi od 300 mg 2 puta na dan tijekom četiri tjedna neposredno prije primanja Caystona ili placeba u dozi od 2 ili 3 puta na dan tijekom 28 dana.
English: You must use the Cayston specific Altera Nebuliser Handset containing an Altera Aerosol Head.
Croatian: Morate koristiti posebni ručni atomizator Altera za Cayston koji sadrži glavu za aerosol Altera.
English: Cystic fibrosis in the lungs leads to clogging them with thick sticky mucus.
Croatian: Cistična fibroza pluća dovodi do njihova začepljenja gustom, ljepljivom sluzi.
English: Reconstitute before use.
Croatian: Pripraviti prije primjene.
English: A 104-week rat inhalation toxicology study to assess the carcinogenic potential of ascending doses of aztreonamdemonstrated no drug-related increase in malignant tumours.
Croatian: Toksikološko ispitivanje inhalacije u štakora tijekom 104 tjedna radi procjene kancerogenosti aztreonama u sve većim dozama nije pokazalo nikakvo povećanje broja zloćudnih tumora povezano s lijekom.
English: The protein binding of aztreonam in plasma is approximately 77% at clinically relevant plasma concentrations.
Croatian: Kod klinički važnih koncentracija u plazmi približno je 77% aztreonama vezano za proteine plazme.
English: Step D: When the metal seal opens, continue to slowly pull on the blue cap in a counterclockwise direction until the metal seal is completely removed.
Croatian: Korak D: Kad rastvorite metalni prsten, nastavite polako povlačiti plavu kapicu u smjeru suprotnom od kazaljke na satu sve dok potpuno ne uklonite metalni prsten.
English: Treatment-emergent intermittent isolation of MRSA occurred in 7% of aztreonam-treated patients compared to 1% of TNS-treated patients and treatment-emergent persistent isolation of MRSA occurred in 3% of aztreonam-treated patients compared to no TNS-treated patients.
Croatian: Povremene izolacije MRSA-e prouzročene liječenjem pojavile su se u 7% bolesnika liječenih aztreonamom u usporedbi s 1% bolesnika liječenih TNS-om, a trajne izolacije MRSA-e prouzročene liječenjem pojavile su se u 3% bolesnika liječenih aztreonamom u usporedbi s bolesnicima koji nisu primali TNS.
English: What you need to know before you take Cayston Do not take Cayston
Croatian: Što morate znati prije nego počnete uzimati Cayston
English: Over nine 28-day courses of therapy, measures of pulmonary function (FEV1), CFQ-R respiratory symptoms scores, and P. aeruginosa sputum density showed a trend to improvement while the patients were on treatment compared with off treatment.
Croatian: Tijekom devet 28-dnevnih kura liječenja, mjerenja plućne funkcije (FEV1), bodovi na CFQ-R ljestvici za dišne simptome i gustoća P. aeruginosa u iskašljaju pokazivali su trend poboljšanja dok su bolesnici uzimali terapiju u usporedbi s razdobljem kada nisu uzimali terapiju.
English: The known mechanism of resistance to aztreonam mediated by acquisition of genes involves acquisition of extended spectrum beta-lactam enzymes (ESBLs) that hydrolyse the fourmember, nitrogen-containing ring of aztreonam.
Croatian: Poznati mehanizam razvoja rezistencije na aztreonam posredovan preuzimanjem gena uključuje stjecanje beta-laktamaza proširenog spektra (ESBL - od engl. extended spectrum beta-lactamase) koje hidroliziraju četveročlani prsten aztreonama koji sadrži dušik.
English: Close the medicine reservoir by aligning the tabs of the medicine cap with the slots on the reservoir.
Croatian: Zatvorite spremnik za lijek tako što ćete poravnati jezičce čepa za lijek s utorima na spremniku.
English: CP-AI-007 enrolled 164 adult (predominantly) and paediatric patients randomised in a 1:1 ratio comparing Cayston 75 mg (80 patients) or placebo (84 patients) administered 3 times a day for 28 days (one course).
Croatian: Ispitivanje CP-AI-007 provedeno je u 164 (uglavnom) odrasla i pedijatrijska bolesnika randomizirana u omjeru 1:1 radi usporedbe Caystona u dozi od 75 mg (80 bolesnika) i placeba (84 bolesnika) primijenjenih 3 puta na dan tijekom 28 dana (jedna kura).
English: The Phase 2 and 3 placebo-controlled, registrational studies permitted comparison of plasma concentrations 1 hour post dose of Cayston by age (6 to 12 years, 13 to 17 years, and ≥ 18 years).
Croatian: Placebo kontrolirana ispitivanja faze 2 i faze 3 u svrhu registracije lijeka omogućile su usporedbu plazmatskih koncentracija jedan sat nakon doze Caystona po dobi (od 6 do 12 godina, od 13 do 17 godina te kod bolesnika starijih od 18 godina).
English: If any of these apply to you tell your doctor before using Cayston.
Croatian: Ako se bilo što od navedenog odnosi na Vas, prije uzimanja Caystona obavijestite svog liječnika.
English: Individual patients' plasma aztreonam concentrations exhibited considerable variability.
Croatian: Koncentracije aztreonama u plazmi pojedinih bolesnika pokazale su znatnu varijabilnost.
English: The serum half-life of aztreonam averaged 1.7 hours in subjects with normal renal function, independent of the dose and route.
Croatian: Poluvrijeme aztreonama u serumu u bolesnika s normalnom funkcijom bubrega prosječno je iznosilo 1,7 sati neovisno o dozi i putu primjene.
English: Replacing the Altera Nebuliser Handset
Croatian: Zamjena ručnog atomizatora Altera
English: In a 24-week active-controlled clinical study of Cayston therapy, increases were observed in the MIC90 for all P. aeruginosa isolates as well as in the percentages of patients with P. aeruginosa resistant (MIC above the parenteral breakpoint) to aztreonam, to at least 1 beta-lactam antibiotic, and to all 6 beta-lactam antibiotics tested (see section 5.1).
Croatian: U 24-tjednom aktivno kontroliranom kliničkom ispitivanju Caystona povećanja su primijećena u MIK90 za sve izolate P. aeruginosa kao i u postotcima bolesnika s P. aeruginosa rezistentnim (MIK iznad granice osjetljivost pri parenteralnoj primjeni) na aztreonam iz najmanje jednog do svih 6 testiranih beta-laktamskih antibiotika (vidjeti dio 5.1).
English: Genotoxicity (Chromosomal aberration and mouse lymphoma mutation assay) studies with aztreonam were negative.
Croatian: Ispitivanja genotoksičnosti aztreonama (test kromosomske aberacije i mutacije limfoma u miševa) bila su negativna.
English: The use of Cayston in paediatric CF patients has been associated with haemoptysis during treatment cycles and could have aggravated underlying conditions.
Croatian: Primjena Caystona u pedijatrijskih CF bolesnika povezana je s hemoptizom tijekom ciklusa liječenja te bi mogla pogoršati osnovnu bolest.
English: Cayston is administered by inhalation over a 2 to 3 minute period, using a Cayston specific Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit.
Croatian: Cayston se primjenjuje inhalacijom tijekom 2 do 3 minute pomoću specifičnog ručnog atomizatora Altera za Cayston i glave za aerosol Altera priključenih na kontrolnu jedinicu eBase Controller ili kontrolnu jedinicu eFlow rapid.
English: However, similar improvements in lung function were seen after treatment with Cayston among patients with aztreonam susceptible or resistant P. aeruginosa isolates.
Croatian: No, slična poboljšanja plućne funkcije primijećena su nakon liječenja Caystonom u bolesnika s izolatima P. aeruginose osjetljive ili rezistentne na aztreonam.
English: Of the 101 patients, all having a positive cultures for P. aeruginosa within 30 days of study enrolment, of whom 56 (55.4%) were free of P. aeruginosa at baseline who completed a 28-day treatment course 89.1% (n = 90) were free of P. aeruginosa at the end of treatment (Day 28) and 75.2% (n = 76) were free of P. aeruginosa 1 month after the end of treatment (Day 56).
Croatian: Od 101 bolesnika, od kojih su svi imali pozitivne kulture na P. aeruginosa unutar 30 dana od uključenja u ispitivanje (od kojih 56 (55,4%) bolesnika na početku nije imalo P. aeruginosa) i koji su završili 28-dnevnu kuru, 89,1% (n=90) više nije imalo P. aeruginosa na kraju liječenja (28. dan), a 75,2% (n=76) više nije imalo P. aeruginosa 1 mjesec nakon završetka liječenja (56. dan).
English: Known mechanisms of resistance to aztreonam mediated by mutation of chromosomal genes include: hyperexpression of the Class C beta-lactamase AmpC and up-regulation of the efflux pump MexAB-OprM.
Croatian: Poznati mehanizmi razvoja rezistencije na aztreonam posredovani mutacijom kromosomskih gena obuhvaćaju: hiperekspresiju AmpC beta-laktamaze klase C i prilagodbu efluksne pumpe MexAB-OprM naviše.
English: bronchospasm1, chest discomfort, rhinorrhoea, haemoptysis1 Skin and subcutaneous tissue disorders: Common:
Croatian: bronhospazam1, osjećaj nelagode u prsištu, rinoreja, hemoptiza1 Poremećaji kože i potkožnog tkiva:
English: Do not use this medicine if you notice that the package has been tampered with.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite bilo kakve znakove otvaranja pakiranja.
English: The reconstituted Cayston is then poured into the Altera Nebuliser Handset and the dose administered.
Croatian: Rekonstituirani Cayston potom se ulijeva u ručni atomizator Altera da bi se primijenila doza.
English: Solvent for Cayston Sodium Chloride 0.17% Inhalation use only 1 ml
Croatian: Otapalo za Cayston natrijev klorid 0,17% Samo za inhaliranje
English: Musculoskeletal and connective tissue disorders: Common:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva: Često:
English: Bronchospasm
Croatian: Bronhospazam
English: Aztreonam for injection must not be used in the Altera or other nebulisers.
Croatian: Aztreonam za injekciju ne smije se primjenjivati pomoću atomizatora Altera ili drugih atomizatora.
English: In the Phase 3 placebo-controlled studies of Cayston, local aztreonam concentrations generally exceeded aztreonam MIC values for P. aeruginosa, regardless of the level of P. aeruginosa susceptibility.
Croatian: U placebom kontroliranim ispitivanjima faze 3 Caystona lokalne koncentracije aztreonama općenito su premašivale vrijednosti minimalne inhibitorne koncentracije (MIK-a) aztreonama za bakteriju P. aeruginosa neovisno o razini njezine osjetljivosti.
English: Since the plasma concentration of aztreonam following administration of Cayston (75 mg) is approximately 0.6 µg/ml, compared to serum levels of 54 µg/ml following administration of aztreonam for injection (500 mg), no safety issues associated with aztreonam overdose are anticipated.
Croatian: Budući da je koncentracija aztreonama u plazmi nakon primjene Caystona (75 mg) približno 0,6 µg/ml nasuprot razine u serumu od 54 µg/ml nakon primjene aztreonama za injekciju (500 mg), ne očekuje se da će predoziranje aztreonamom narušiti sigurnost njegove primjene.
English: Pooled sputum concentration data from the Phase 2 and 3 registrational studies revealed some evidence of lower mean sputum concentrations in patients aged 13 to 17 years following one dose of Cayston 3 times a day.
Croatian: Udruženi podaci o koncentracijama u iskašljaju iz ispitivanja faze 2 i 3 u svrhu registracije lijeka otkrili su određene dokaze nižih koncentracija lijeka u iskašljaju u bolesnika dobi od 13 do 17 godina nakon jedne doze Caystona 3 puta dnevno.
English: Mean peak plasma levels at Days 0, 14, and 28 of a course with 75 mg inhaled aztreonam 3 times a day were 0.55 µg/ml, 0.67 µg/ml, and 0.65 µg/ml, respectively, indicating no systemic accumulation of aztreonam following 3 times a day dosing.
Croatian: Srednja vrijednost vršnih razina u plazmi na dane 0., 14. i 28. kure inhaliranog aztreonama u dozi od 75 mg 3 puta na dan iznosile su 0,55 µg/ml, 0,67 µg/ml i 0,65 µg/ml, što ne ukazuje ni na kakvu sistemsku akumulaciju aztreonama kod doziranja 3 puta na dan.
English: or i.v.
Croatian: Dodatku V.
English: The development of antibiotic-resistant P. aeruginosa and superinfection with other pathogens represent potential risks associated with antibiotic therapy.
Croatian: Razvoj P. aeruginosa rezistentne na antibiotik i razvoj superinfekcija drugim patogenima predstavlja moguće rizike povezane s antibiotskom terapijom.
English: pyrexia
Croatian: pireksija
English: Do not use this medicine after the expiry date which is stated on the vial label, solvent ampoule and the carton.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici na bočici, ampuli s otapalom i pakiranju.
English: Gently tap the vial against the side of the medicine reservoir if necessary.
Croatian: Po potrebi, lagano kucnite bočicom o rub spremnika za lijek.
English: Cayston is contained in a 2 ml amber glass vial with a grey rubber stopper and aluminium tear-off overseal with a blue cap.
Croatian: Cayston se nalazi u smeđoj staklenoj bočici volumena 2 ml sa sivim gumenim čepom i aluminijskim prstenom s plavom kapicom.
English: How to take Cayston
Croatian: Kako uzimati Cayston
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CAYSTON INNER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJE PAKIRANJE CAYSTONA
English: Cayston is indicated for use in paediatric patients aged 6 years and older with repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy based on the above clinical experience.
Croatian: Cayston je indiciran za uporabu kod pedijatrijskih bolesnika od 6 godina pa nadalje s ponavljanim ciklusima od 28 dana terapije nakon čega slijedi 28 dana bez uzimanja lijeka Cayston na temelju gore navedenog kliničkog iskustva.
English: A total of 79 patients who completed a 28-day treatment course and who did not receive an additional antipseudomonal antibiotic during the treatment period were evaluable 6 months after the end of treatment; of these, 58.2% (n = 46) remained free of P. aeruginosa throughout this time period.
Croatian: 6 mjeseci nakon završetka liječenja moglo se procijeniti ukupno 79 bolesnika koji su završili 28-dnevnu kuru i koji nisu dodatno primali antipseudomonalni antibiotik tijekom razdoblja liječenja; 58,2% (n=46) tih bolesnika nije imalo P. aeruginosa tijekom cijelog tog razdoblja.
English: Do not reconstitute or mix Cayston with any other solvent or medicinal product.
Croatian: Cayston nemojte rekonstituirati ni miješati ni s kojim drugim otapalom, odnosno lijekom.
English: If you plan to breast-feed ask your doctor for advice before taking Cayston.
Croatian: Ako planirate dojiti, prije uzimanja Caystona potražite savjet liječnika.
English: General disorders and administration site conditions: Very common:
Croatian: Opći poremećaji i reakcije na mjestu primjene: Vrlo često:
English: For the combined Phase 3 placebo-controlled studies, ten minutes following a single dose of 75 mg inhaled aztreonamon Days 0, 14, and 28, the mean sputum concentrations in 195 patients with CF were 726 µg/g, 711 µg/g, and 715 µg/g, respectively, indicating no increased accumulation of aztreonam following repeated dosing.
Croatian: U kombiniranim placebom kontroliranim ispitivanjima faze 3 srednja vrijednost koncentracije u iskašljaju 195 bolesnika s CF-om deset minuta nakon jednokratne doze od 75 mg inhaliranog aztreonama na dane 0., 14. i 28. iznosile su 726 µg/g, 711 µg/g i 715 µg/g, što ne ukazuje ni na kakvu povećanu akumulaciju aztreonama nakon ponavljanog doziranja.
English: Entry criteria included CF, baseline FEV1 between 25% and 75% predicted, and chronic P. aeruginosa lung infection.
Croatian: Kriteriji pristupanja uključivali su CF, predviđeni FEV1 između 25% i 75% na početku ispitivanja i kroničnu infekciju pluća s P. aeruginosa.
English: Cayston should only be reconstituted with the solvent provided.
Croatian: Cayston se smije rekonstituirati samo pomoću priloženog otapala.
English: Using one hand to hold the vial steady, use the other hand to slowly flip up the blue cap.
Croatian: Jednom rukom čvrsto držite bočicu, a drugom rukom polako podignite plavu kapicu.
English: Patients were randomised in a 2:2:1:1 ratio to be treated with aztreonam 75 mg 2 or 3 times a day or volume-matched placebo 2 or 3 times a day for 28 days immediately following the 28-day lead-in course of open-label TNS.
Croatian: Bolesnici su randomizirani u omjeru 2:2:1:1 u skupine liječene aztreonamom u dozi od 75 mg 2 ili 3 puta na dan, odnosno placebom istog volumena 2 ili 3 puta na dan tijekom 28 dana koji su uslijedili neposredno nakon 28-dnevne uvodne kure TNS-om otvorenog tipa.
English: Powder vial also contains L-Lysine Solvent ampoule contains sodium chloride, water for injections
Croatian: POPIS POMOĆNIH TVARI Bočica s praškom sadrži i L-lizin Ampula s otapalom sadrži natrijev klorid, vodu za injekcije
English: Peak levels of aztreonam are achieved at about one hour after i.m.
Croatian: Vršne razine aztreonama postižu se otprilike jedan sat nakon intramuskularne primjene.
English: Non-clinical data for aztreonam for injection about fertility do not indicate any adverse effects.
Croatian: Neklinički podaci vezani uz plodnost ne ukazuju ni na kakve štetne učinke aztreonama za injekciju.
English: Treatments were administered for three cycles of 28 days on therapy followed by 28 days off therapy.
Croatian: Liječenja su primijenjena tijekom tri ciklusa od 28 dana terapije nakon čega slijedi 28 dana bez terapije.
English: Powder should only be mixed with the solvent provided.
Croatian: Prašak se smije miješati samo s priloženim otapalom.
English: A total of 137 paediatric patients aged 6 to 17 years with chronic P. aeruginosa infection and FEV1 ≤ 75% predicted have received Cayston in Phase 2 and Phase 3 clinical studies.
Croatian: Ukupno 137 pedijatrijskih bolesnika u dobi od 6 do 17 godina s kroničnom infekcijom P. aeruginosa i predviđenom vrijednosti FEV1 ≤ 75% primili su Cayston u fazi 2 i fazi 3 kliničkog ispitivanja.
English: Gilead Sciences Ltd Tel: + 44 (0) 8000 113700
Croatian: United Kingdom Gilead Sciences Ltd Tel: + 44 (0) 8000 113700
English: Each 28-day pack of Cayston contains 84 vials of lyophilised aztreonam and 88 solvent ampoules.
Croatian: Svako pakiranje Caystona za 28-dnevnu primjenu sadrži 84 bočice liofiliziranog aztreonama i 88 ampula s otapalom.
English: Step C: While continuing to hold the vial steady with one hand, use the other hand to slowly pull the blue cap in a counterclockwise direction.
Croatian: Korak C: Jednom rukom i dalje čvrsto držite bočicu, a drugom polako povlačite plavu kapicu u smjeru suprotnom od kazaljke na satu.
English: Solvent: 1 ml low density polyethylene ampoule.
Croatian: Otapalo: ampula od polietilena male gustoće volumena 1 ml.
English: Cayston is a white to off-white powder and solvent for nebuliser solution.
Croatian: Cayston je bijeli do bjelkasti prašak i otapalo za otopinu za atomizator.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (Outer carton containing one 28-day pack of Cayston and one Altera Nebuliser Handset with a Blue Box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE (Vanjsko pakiranje koje sadrži jedno pakiranje Caystona za 28-dnevnu primjenu i jedan ručni atomizator Altera s plavim okvirom)
English: The survival rate during the lactation period was slightly reduced in the offspring of rats that received the highest dose.
Croatian: Među potomstvom štakora koji su primali najvišu dozu stopa preživljenja tijekom razdoblja laktacije bila je malo snižena.
English: There is a risk that P. aeruginosa isolates may develop resistance to aztreonam or other beta-lactam antibiotics in patients treated with Cayston.
Croatian: Postoji rizik da bi izolati P. aeruginosa mogli razviti rezistenciju na aztreonam ili druge beta-laktamske antibiotike u bolesnika liječenih Caystonom.
English: Do not mix Cayston with any other medicines in the Altera Nebuliser Handset.
Croatian: Nemojte miješati Cayston ni s kojim drugim lijekovima u ručnom atomizatoru Altera.
English: The Altera Nebuliser Handset is designed to last for three 28-day courses of Cayston when used as directed.
Croatian: Ručni atomizator Altera osmišljen je tako da traje tijekom tri 28-dnevne kure liječenja Caystonom ako se koristi u skladu s uputama.
English: Systemic concentration of aztreonam following inhaled administration of Cayston is approximately 1% of the concentration resulting from a standard dose of aztreonam for injection.
Croatian: Sistemska koncentracija aztreonama nakon inhaliranja Caystona približno je 1% koncentracije koja se postiže standardnom dozom aztreonama za injekciju.
English: Respiratory, thoracic and mediastinal disorders: Very common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja: Vrlo često:
English: Uncommon side effects (affects 1 to 10 users in 1000) - Joint swelling
Croatian: Manje česte nuspojave (javljaju se u 1 do 10 korisnika na 1000)
English: Cayston should only be used with the Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit.
Croatian: Cayston se smije primjenjivati samo pomoću ručnog atomizatora Altera i glave za aerosol Altera priključenih na kontrolnu jedinicu eBase Controller ili kontrolnu jedinicu eFlow rapid.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CAYSTON OUTER CARTON (No Blue Box - for use only for co-packaging with Altera Nebuliser Handset)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE CAYSTONA (Bez plavog okvira - za upotrebu samo sa zajedničkim pakiranjem s ručnim atomizatorom Altera)
English: A decrease in P. aeruginosa susceptibility to aztreonam and other beta-lactam antibiotics was observed in clinical studies of Cayston.
Croatian: Smanjenje osjetljivosti P. aeruginosa na aztreonam i druge beta-laktamske antibiotike primijećena je u kliničkim ispitivanjima Caystona.
English: Each 28-day course of Cayston was followed by a 28-day off drug period.
Croatian: Nakon svake 28-dnevne kure Caystonom slijedilo je razdoblje prekida uzimanja lijeka u trajanju od 28 dana.
English: Patients were randomised in a 1:1 ratio to receive either aztreonam (75 mg) administered by inhalation 3 times a day or TNS (300 mg) administered 2 times a day.
Croatian: Bolesnici su bili randomizirani u omjeru 1:1 kako bi primili aztreonam (75 mg) inhalacijskim putem tri puta dnevno ili TNS (300 mg)
English: An Altera Nebuliser Handset containing an Altera Aerosol Head connected to an eFlow Control Unit of the type 178 (eFlow rapid) or type 678 (eBase Controller).
Croatian: Informacija koja se nalazi na ampuli otapala dostupna je samo na engleskom jeziku (vidjeti dio 6). ručni atomizator Altera koji sadrži glavu za aerosol Altera priključenu na kontrolnu jedinicu eFlow tipa 178 (eFlow rapid) ili tip 678 (eBase Controller).
English: Do not completely tear through the metal seal.
Croatian: Nemojte povući previše kako je ne bi potpuno odvojili od metalnog prstena.
English: Follow Step A to D in Figure 1 below to open the amber vial:
Croatian: Da biste otvorili smeđu bočicu, slijedite korake od A do D u slici 1 dolje: