FrancophonIA/ELRC3.0 huggingface dataset:
English: - To get the best results from Bronchitol, inhale each capsule one after another.
Croatian: - Da bi Bronchitol dao najbolje rezultate, sve kapsule udahnite jednu za drugom.
English: Each of the capsules is loaded into the device separately.
Croatian: Svaka kapsula mora se zasebno umetnuti u uređaj.
English: Therefore, treatment with Bronchitol is not recommended.
Croatian: Iz tog razloga, liječenje Bronchitolom nije preporučeno.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u
English: Patients with asthma must be carefully monitored for worsening signs and symptoms of asthma after the initiation dose of Bronchitol.
Croatian: Pacijente s astmom mora se pažljivo nadzirati kako bi se primjetili znaci i simptomi pogoršanja astme nakon uzimanja početne doze Bronchitola.
English: After inhalation, each empty capsule is discarded before inserting the next capsule into the inhaler device with as little delay as possible between capsules.
Croatian: Nakon inhalacije, praznu je kapsulu potrebno baciti prije umetanja nove kapsule u inhalator, uz što je moguće manji vremenski razmak između dviju kapsula.
English: Mean delivered dose per capsule is 32.2 mg.
Croatian: Prosječna isporučena doza po kapsuli iznosi 32,2 mg.
English: Inhaling medicines can also cause cough and this can happen with Bronchitol.
Croatian: Lijekovi za inhalaciju također mogu uzrokovati kašalj, što je slučaj i kod Bronchitola.
English: A bronchodilator must be administered 5-15 minutes before each dose of Bronchitol.
Croatian: Bronhodilator se mora uzimati 5-15 minuta prije svake doze Bronchitol.
English: Wash your inhaler in warm water with the mouth-piece open.
Croatian: Operite inhalator s otvorenim nastavkom za usta toplom vodom.
English: - Keeping the inhaler tilted downward, put the inhaler to your mouth and make sure you close your lips tightly around the mouth-piece.
Croatian: - Držeći inhalator nagnut prema dolje, stavite ga u usta i čvrsto zatvorite usne oko nastavka za usta.
English: The safety and efficacy of Bronchitol in children and adolescents aged less than 18 years has not been established (see section 4.2).
Croatian: Sigurnost i djelotvornost lijeka Bronchitol u djece i adolescenata mlađih od 18 godina nisu ustanovljene (vidi dio 4.2).
English: The therapeutic dose regimen should not be prescribed until the initiation dose assessment has been performed.
Croatian: Režim primjene terapijske doze ne smije se propisivati dok se ne provede procjena početne doze.
English: Each capsule contains 40 milligrams mannitol.
Croatian: Svaka kapsula sadrži 40 miligrama manitola.
English: Close the inhaler - Keep the inhaler in an upright position.
Croatian: Zatvorite inhalator - Držite inhalator u uspravnom položaju.
English: It is for inhalation use only and must not be administered by any other route.
Croatian: On je isključivo namijenjen za inhalaciju i ne smije se davati na bilo koji drugi način.
English: All patients should be formally reviewed after approximately six weeks of Bronchitol treatment to assess for signs and symptoms suggestive of active substance induced bronchospasm.
Croatian: Svi pacijenti moraju biti pregledani nakon približno šest tjedana terapije Bronchitolom kako bi se utvrdilo postojanje znakova i simptoma bronhospazma induciranog aktivnom supstancom.
English: Bronchitol should not be used by children and adolescents under the age of 18.
Croatian: Djeca i adolescenti Bronchitol ne smiju upotrebljavati djeca i adolescenti mlađi od 18 godina.
English: Average inhaled dose per capsule is 32.2 milligrams mannitol.
Croatian: Prosječna inhalirana doza po kapsuli iznosi 32,2 miligrama manitola.
English: It is not known if this medicine passes into the breast milk.
Croatian: Nije poznato dospijeva li lijek u u majčino mlijeko.
English: Inhalation use only.
Croatian: Samo za inhalaciju.
English: 2-week treatment pack of 280 hard capsules and 2 inhalers
Croatian: Pakiranje za 2-tjedno liječenje s 280 tvrdih kapsula i 2 inhalatora
English: o That therapeutic doses of Bronchitol should only be prescribed if the patient has passed the initiation dose assessment.
Croatian: o Terapijske doze Bronchitola smiju se propisati samo ako je pacijent prošao procjenu početne doze.
English: If you forget to use Bronchitol - If you forget a dose, use it as soon as you remember it and carry on as usual.
Croatian: - Ako ste zaboravili uzeti lijek, uzmite ga čim se sjetite i nastavite s uobičajenom terapijom.
English: The metabolic pathway of inhaled mannitol was not examined in pharmacokinetic studies.
Croatian: Metabolitički put inhaliranog manitola nije istražen u farmakokinetičkim ispitivanjima.
English: Effect size estimate
Croatian: Procjena veličine učinka
English: However, Bronchitol has been used in clinical studies in conjunction with standard cystic fibrosis therapies such as mucolytics, antibiotics (including tobramycin and colistimethate sodium), bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, and analgesics.
Croatian: Međutim, u kliničkim ispitivanjima Bronchitol je korišten zajedno sa standardnim lijekovima za liječenje cistične fibroze, kao što su mukolitici, antibiotici (uključujući tobramicin i natrijev kolistimetat), bronhodilatatori, enzimi gušterače, vitamini, inhalacijski i sistemski kortikosteroidi i analgetici.
English: The patient must complete and pass the initiation dose assessment before starting treatment with Bronchitol.
Croatian: Pacijent mora dovršiti i proći procjenu početne doze prije no što započne tretman Bronchitolom.
English: Stop using Bronchitol and see a doctor straight away if you notice the following serious side effects: - Difficulty breathing, which may be due to narrowing of the airways, worsening of asthma symptoms or wheezing.
Croatian: Ako primijetite bilo koju od sljedećih ozbiljnih nuspojava, prestanite uzimati Bronchitol i odmah se obratite liječniku: - otežano disanje, što može biti posljedica sužavanja dišnih puteva, pogoršanje simptoma astme ili piskanje (pri disanju).
English: Open the inhaler - Hold the bottom of the inhaler firmly with one hand.
Croatian: Otvorite inhalator - Čvrsto držite donji dio inhalatora jednom rukom.
English: - Put the capsule into the capsule-shaped space in the bottom of the inhaler.
Croatian: - Stavite kapsulu u oblikovani utor za kapsulu na dnu inhalatora.
English: Put in the capsule - First make sure your hands are dry.
Croatian: Umetnite kapsulu - Ruke Vam moraju biti potpuno suhe.
English: Bronchial hyperresponsiveness to inhaled mannitol (see section 4.4).
Croatian: Bronhijalna hiperreaktivnost na inhalirani manitol (vidjeti dio 4.4).
English: Use as directed by your doctor.
Croatian: Primijeniti prema uputi liječnika.
English: This was observed in 7.8% of patients compared to 3.8% of patients in the control arm.
Croatian: Kašalj je primijećen u 7,8% pacijenata u odnosu na 3,8% pacijenata iz kontrolne skupine.
English: Mawdsleys Clinical Services, Unit 22, Quest Park, Wheatley Hall Road, Doncaster, DN2 4LT, United Kingdom.
Croatian: Mawdsleys Clinical Services, Unit 22, Quest Park, Wheatley Hall Road, Doncaster, DN2 4LT, Ujedinjeno Kraljevstvo.
English: Extra information on how to look after your inhaler - Keep your inhaler dry and always make sure your hands are dry before using it. - Never breathe or cough into your inhaler.
Croatian: Dodatne informacije o održavanju inhalatora - Inhalator mora biti suh i uvijek provjerite jesu li Vam ruke suhe prije uporabe inhalatora.
English: This helps your lungs to clear mucus more easily.
Croatian: Na taj način pluća mogu lakše uklanjati sluz.
English: However, studies conducted with mannitol administered via other routes indicated no effect on foetal survival in mice, rats and hamsters and on embryo and foetal development in rats and rabbits.
Croatian: Međutim, ispitivanja koja su uključivala druge načine primjene manitola pokazala su da nema štetnih učinaka na preživljavanje fetusa u miševa, štakora i hrčaka, kao ni na razvoj embrija i fetusa u štakora i kunića.
English: Pregnancy and breast-feeding - If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete lijek.
English: Arvato distribution GmbH, Gottlieb-Daimler Straβe 1, 33428 Harsewinkel, North Rhine-Westphalia Germany
Croatian: Arvato distribution GmbH, Gottlieb-Daimler Straβe 1, 33428 Harsewinkel, North Rhine-Westphalia, Njemačka.
English: If a therapy induced hyperresponsive reaction is suspected, Bronchitol should be discontinued.
Croatian: Kod sumnje na hiperreaktivnu reakciju uzrokovanu terapijom, prestati uzimati Bronchitol.
English: There are insufficient data in this population to support a recommendation for or against dose adjustment.
Croatian: Nema dovoljno podataka za ovu populaciju koji bi ukazivali na to bi li dozu trebalo prilagoditi.
English: Arvato distribution GmbH Gottlieb-Daimler Straβe 1 33428 Harsewinkel North Rhine-Westphalia Germany
Croatian: Arvato distribution GmbH Gottlieb-Daimler Straβe 1 33428 Harsewinkel
English: The initiation dose assessment described in section 4.2 should be repeated if uncertainty exists.
Croatian: U slučaju nesigurnosti, potrebno je ponoviti procjenu početne doze opisane u dijelu 4.2.
English: Therapeutic dose regimen
Croatian: Režim primjene terapijske doze
English: However, if your inhaler does need cleaning, the steps to follow are: Ensure your inhaler is empty.
Croatian: Međutim, ako morate očistiti inhalator, postupite na sljedeći način: Potvrdite da je inhalator prazan.
English: In a study of 9 cystic fibrosis patients (6 adults, 3 adolescents), using 400 mg inhaled mannitol as a single dose (Day 1) then twice a day for 7 days (Days 2 - 7), pharmacokinetic parameters were similar for adults and adolescents, except for a longer average apparent terminal half life for adolescents (Day 1 = 7.29 hours, Day 7 = 6.52 hours) compared with adults (Day 1 = 6.10 hours, Day 7 = 5.42 hours).
Croatian: U ispitivanju provedenom na 9 pacijenata s cističnom fibrozom (6 odraslih, 3 adolescenta), primjenom jedne doze od 400 mg manitola za inhalaciju (1. dan), a potom dva puta dnevno tijekom 7 dana (2.-7. dan), farmakokinetički parametri bili su slični za odrasle i adolescente, osim dužeg prosječnog prividnog poluvijeka u adolescenata (1. dan = 7,29 sati, 7. dan = 6,52 sata) u odnosu na odrasle osobe (1. dan = 6,10 sati, 7. dan = 5,42 sata).
English: The initiation dose pack is used during the initiation dose assessment with your doctor.
Croatian: Pakiranje za početnu dozu koristi se kod liječnika tijekom procjene početne doze.
English: The proportion of patients who experienced haemoptysis including haemoptysis reported during exacerbation was 7.0% in the mannitol arm and 7.7% in the control arm (see section 4.4).
Croatian: Udio pacijenata u kojih je zabilježena hemoptiza, uključujući hemoptizu prijavljenu tijekom egzacerbacije, iznosio je 7,0 % u skupini koja je uzimala manitol i 7,7 % u kontrolnoj skupini (vidjeti dio 4.4).
English: In the third study (DPM-CF-303) 423 adult patients were randomised in a 1:1 ratio to inhaled mannitol 400 mg twice daily or to control.
Croatian: U trećoj studiji (DPM-CF-303) 423 odrasla pacijenata randomizirana u omjeru 1:1 u skupinu koja dva puta dnevno provodi inhalaciju manitolom od 400 mg ili u kontrolnu skupinu.
English: PharmaSwiss Eesti OÜ Tel: + 372 6827400
Croatian: Eesti PharmaSwiss Eesti OÜ Tel: + 372 6827400
English: Always take your bronchodilator before using Bronchitol.
Croatian: Prije uzimanja Bronchitola, uvijek uzmite bronhodilatator
English: Cough which led to cessation of treatment was also commonly experienced and was observed in 4.0% of patients in the Bronchitol treatment arm.
Croatian: Učestala pojava bio je i kašalj koji je uzrokovao prekid terapije, a primijećen je u 4,0 % pacijenata iz skupine koja je liječena Bronchitolom.
English: Patients must be advised to report worsening signs and symptoms of asthma during therapeutic use to their physician.
Croatian: Pacijente se mora savjetovati da svom liječniku prijave znakove i simptome pogoršanja astme tijekom terapije lijekom.
English: The percentage of patients receiving inhaled antibiotics was 55% in study DPM-CF-301, 56% in study DPM-CF-302 and 52% in Study DPM-CF-303.
Croatian: Postotak pacijenata koji su primali inhalacijske antibiotike iznosio je 55 % u ispitivanju DPM-CF-301, 56 % u ispitivanju DPM-CF-302 i 52 % u ispitivanju DPM-CF-303.
English: Initiation dose assessment
Croatian: Procjena početne doze
English: - If you do not hear the rattling, hold the inhaler with the mouth-piece facing downwards, and tap the bottom firmly.
Croatian: - Ako ne čujete zvečanje, držite inhalator s nastavkom za usta okrenutim prema dolje i snažno kucnite po dnu inhalatora.
English: - Never leave a used capsule in your inhaler chamber.
Croatian: Nikada ne ostavljajte iskorištenu kapsulu u komori inhalatora.
English: Bronchitol is for use in adults 18 years of age and over.
Croatian: Bronchitol je namijenjen odraslim osobama u dobi od 18 godina i starijih.
English: Bronchitol has not formally been studied in patients with impaired renal and hepatic function.
Croatian: Bronchitol nije formalno ispitan u pacijenata s oštećenjem funkcije bubrega ili jetre.
English: These figures for study DPM-CF-302 (N=305) are as follows: 65.24 (SD:13.90) and 64.35 (SD:15.29).
Croatian: Ti su podaci za ispitivanje DPM-CF-302 (N = 305) sljedeći: 65,24 (SD: 13,90) i 64,35 (SD: 15,29).
English: Bronchitol is a powder for inhalation that is filled into hard capsules.
Croatian: Bronchitol je prašak za inhalaciju smješten u tvrde kapsule.
English: - For the best results, inhale each capsule one after another, so there is as little delay as possible between capsules.
Croatian: Za najbolje rezultate kapsule inhalirajte jednu za drugom kako bi vremenski razmak između dviju kapsula bio što manji.
English: This was observed in 8.3% of patients compared to 4.0% of patients in the control arm.
Croatian: Kašalj je primijećen u 8,3 % pacijenata u odnosu na 4,0 % pacijenata iz kontrolne skupine.
English: How to use your medicine - Bronchitol is breathed in (inhaled) as a powder from the capsule using the inhaler supplied in the pack.
Croatian: Kako uzimati lijek - Bronchitol se udiše (inhalira) u obliku praška iz kapsule uz pomoć inhalatora isporučenog u paketu
English: As a consequence, these patients should be carefully monitored, and Bronchitol should be withheld in the event of massive haemoptysis.
Croatian: Stoga, te pacijente treba pažljivo nadzirati te prekinuti primjenu Bronchitola u slučaju obilne hemoptize.
English: - Then take out a capsule from the blister (only remove the capsule just before use).
Croatian: - Izvadite kapsulu iz blistera (kapsulu izvadite samo netom prije primjene).
English: Three Phase 3, 26-week double blind, randomised, parallel arm, controlled, intervention studies (DPM-CF-301,DPM-CF-302 and DPM-CF-303) have been performed in which 324 (DPM-CF-301) and 318 (DPM-CF-302) patients aged 6 years and above were randomised in a 3:2 ratio to inhaled mannitol 400 mg twice daily or to control (inhaled mannitol 50 mg twice daily).
Croatian: Provedena su tri dvostruko slijepa, randomizirana, paralelna, kontrolirana, intervencijska ispitivanja faze 3 u trajanju od 26 tjedana (DPM-CF-301, DPM-CF-302 i DPM-CF-303) u kojima su 324 (DPMCF-301) i 318 (DPM-CF-302) pacijenata u dobi od 6 godina i više randomizirana u omjeru 3 : 2 u skupinu koja dva puta dnevno provodi inhalaciju manitolom od 400 mg i kontrolnu skupinu (inhalacija manitolom od 50 mg dva puta dnevno).
English: D18AY29,
Croatian: Dublin 18, D18AY29, Irska
English: Concomitant administration with hypertonic saline was not permitted in these trials.
Croatian: Istodobna primjena hipertonične otopine natrijevog klorida nije bila dopuštena u tim ispitivanjima.
English: AB "PharmaSwiss Tel: + 370 5 279 07 62
Croatian: UAB "PharmaSwiss Tel: + 370 5 279 07 62
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i blisteru iza oznake "Rok valjanosti".
English: Patients should be trained to practice correct inhaler technique during treatment and advised to report persistent cough with the use of Bronchitol to their physician.
Croatian: Pacijente je važno naučiti ispravnoj tehnici inhalacije tijekom liječenja te ih treba savjetovati da svom liječniku prijave slučajeve trajnog kašlja tijekom primjene Bronchitola.
English: One initiation dose pack of Bronchitol contains 1 blister with 10 capsules and 1 inhaler.
Croatian: Jedno pakiranje Bronchitola za početnu dozu sadrži 1 blister s 10 kapsula i 1 inhalator.
English: Before commencing treatment with Bronchitol all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation dose (see sections 4.4 and 5.1).
Croatian: Prije početka liječenja Bronchitolom u svakog bolesnika treba procijeniti bronhijalnu hiperreaktivnost na inhalirani manitol tijekom primjene početne doze (vidjeti dijelove 4.4 i 5.1).
English: The risk of bronchospasm during treatment o The need to perform the Bronchitol initiation dose assessment to identify patients who have bronchial hyperresponsiveness in response to inhaled mannitol by measuring the degree of bronchoconstriction that occurs following sequential administrations of mannitol.
Croatian: Rizik od bronhospazma tijekom terapije o Potreba za provođenjem procjene početne doze Bronchitola radi identifikacije pacijenata koji pokazuju bronhijalnu hiperreaktivnost nakon inhalacije manitola, mjerenjem stupnja bronhokonstrikcije do kojeg dolazi nakon uzastopne primjene manitola.
English: Initiation dose
Croatian: Početna doza
English: The active substance is mannitol.
Croatian: Djelatna tvar je manitol.
English: There are limited data from the use of mannitol in pregnant women.
Croatian: Podaci o primjeni manitola u trudnica ograničeni su.
English: An additional 2.8% (n=34) of patients from the three studies had incomplete MTTs and were not randomised.
Croatian: Testovi tolerancije na manitol (MTT) za dodatnih 2,8 % (n = 34) pacijenata iz tri ispitivanja nisu bili potpuni te ti pacijenti također nisu bili randomizirani.
English: Driving and using machines Bronchitol is not likely to affect your ability to drive or use any tools or machines.
Croatian: Upravljanje vozilima i strojevima Bronchitol ne utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: Dornase alfa (if applicable) 5.
Croatian: Fizioterapija/tjelovježba 4. Dornaza alfa (ako je primjenjivo) 5. Inhalacijski antibiotici (ako je primjenjivo)
English: - Never place a capsule directly into the mouth-piece of your inhaler.
Croatian: - Nikada ne stavljajte kapsulu izravno u nastavak za usta na inhalatoru.
English: o The need of pre-medication by a bronchodilator 5-15 minutes before the Bronchitol initiation dose assessment and before each therapeutic administration of Bronchitol.
Croatian: o Potreba za premedikacijom bronhodilatatorom 5 - 15 minuta prije procjene početne doze Bronchitola te prije svake terapijske primjene Bronchitola.
English: The risk of haemoptysis during treatment o That Bronchitol has not been studied in patients with a history of significant haemoptysis (>60 ml) in the previous three months.
Croatian: Rizik od hemoptize tijekom terapije o Bronchitol nije ispitan u pacijenata s anamnezom znatne hemoptize (> 60 ml) u prethodna tri mjeseca.
English: o The risk of bronchospasm during long term treatment even if the Bronchitol initiation dose assessment was initially passed and the need to reiterate it in case of doubt.
Croatian: o Rizik od nastanka bronhospazma tijekom dugotrajne terapije čak i ako je pacijent prošao procjenu početne doze Bronchitola te potreba za ponavljanjem procjene u slučaju nedoumica.
English: Bronchitol is inhaled into the lungs to help with cystic fibrosis, an inherited disease that affects the glands in the lungs, gut and pancreas that secrete fluids such as mucus and digestive juices.
Croatian: Bronchitol se inhalira u pluća kako bi pomogao kod cistične fibroze, prirođene bolesti koja pogađa žlijezde u plućima, crijevima i gušterači koje luče tekućine poput sluzi i probavnih sokova.
English: Table 1: Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase)
Croatian: Tablica 1: Učestalost nuspojava Bronchitola u ispitivanjima faze III (procjena početne doze i/ili faza liječenja)
English: Repeat the inhalation to get your dose.
Croatian: Ponovno udahnite da biste uzeli cijelu dozu.
English: The safety and efficacy of Bronchitol in children aged less than 6 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Bronchitol u djece mlađe od 6 godina nisu ustanovljene.
English: Take out the used capsule - Turn the inhaler upside down, tap the bottom and throw the empty capsule away.
Croatian: - Preokrenite inhalator naopako, kucnite po dnu i bacite praznu kapsulu.
English: In study 301, overall the most frequently reported adverse reactions during the MTT were cough in 20 (5.3%) subjects, wheezing/bronchospasm in seven (1.9%) subjects and chest discomfort in six (1.6%) subjects.
Croatian: U ispitivanju 301, najučestalije nuspojave zabilježene tijekom MTT-a bile su kašalj u 20 (5,3 %) ispitanika, piskanje/bronhospazam u sedam (1,9 %) ispitanika i nelagoda u prsištu u šest (1,6 %) ispitanika.
English: In a study of 18 healthy male adult volunteers, the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously was 0.59% ± 0.15.
Croatian: U ispitivanju provedenom na 18 zdravih odraslih muških dobrovoljaca, apsolutna bioraspoloživost manitola u obliku praška za inhalaciju u usporedbi s manitolom koji se uzima intravenski iznosila je
English: Mannitol was shown not to be an irritant in an isolated bovine eye assay or when introduced into rabbit eyes.
Croatian: Manitol nije imao nadražujuća svojstva nakon izoliranog ispitivanja u oku goveda, kao ni nakon dospijevanja u oko kunića.
English: Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Irska.
English: You can carry on using your medicines for cystic fibrosis when you are using Bronchitol, this includes inhaled antibiotics such as tobramycin and colistimethate sodium.
Croatian: Uz Bronchitol možete nastaviti koristiti druge lijekove za cističnu fibrozu, uključujući antibiotike za inhalaciju poput tobramicina i natrijeva kolistimetata.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7.
English: The use of Bronchitol is not recommended in these patients.
Croatian: U tih pacijenata nije preporučena primjena Bronchitola.
English: Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3%) out of 341 patientsin study 302 and 25 (5.1%) out of 486 patients in Study 303 had a positive (MTT).
Croatian: Dvadeset i sedam (7,1 %) pacijenata od 378 podvrgnutih testu tolerancije na manitol (MTT) u ispitivanju 301, 18 (5,3 %) pacijenata od 341 uključenog u ispitivanje 302 i 25 (5,1 %) pacijenata od 486 uključenih u ispitivanje 303 imali su pozitivan MTT.