FrancophonIA/ELRC3.0 huggingface dataset:
English: The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime.
Croatian: Doza se mora uzeti ujutro i navečer, s tim da se večernja doza mora uzeti 2-3 sata prije spavanja.
English: If you are too sensitive to mannitol, your airways will become narrower, and you may find it harder to breathe.
Croatian: Ako ste preosjetljivi na manitol, Vaši će dišni putevi postati uži i možete otežano disati.
English: o The need for monitoring and when to withhold treatment.
Croatian: o Potreba za nadzorom i okolnosti u kojima treba ukinuti terapiju.
English: A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to glycogen and carbon dioxide.
Croatian: Mali postotak sistemski apsorbiranog manitola metabolizira se u jetri na glikogen i ugljični dioksid.
English: No formal interaction studies have been conducted.
Croatian: Nisu provedena ispitivanja interakcija.
English: The Tmax after inhaled administration was 1.5 ± 0.5 hours.
Croatian: Tmax nakon inhalacije iznosio je 1,5 ± 0,5 sati.
English: The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years.
Croatian: Sudionik je dužan predati periodičnu analizu ispitivanja cistične fibroze svakih 6 mjeseci tijekom 3 godine te jednom godišnje tijekom 2 godine.
English: While it is drying, use your other inhaler.
Croatian: Dok se suši, koristite drugi inhalator.
English: You should avoid using this medicine if you are pregnant.
Croatian: Trebali biste izbjegavati primjenu lijeka tijekom trudnoće.
English: What Bronchitol contains:
Croatian: Što Bronchitol sadrži:
English: If excessive coughing and bronchoconstriction occurs, a beta2 agonist should be given, and oxygen if necessary.
Croatian: U slučaju pretjeranog kašlja i bronhokonstrikcije treba dati beta2 agonist te kisik, po potrebi.
English: Other medicines and Bronchitol
Croatian: Drugi lijekovi i Bronchitol
English: Studies in rats, mice and humans have demonstrated that mannitol has no toxic metabolites.
Croatian: Ispitivanja provedena na štakorima, miševima i ljudima pokazala su da manitol ne sadrži toksične metabolite.
English: The elevated lymphocyte count was within historical control values, did not progress and was essentially resolved by the end of the in life phase of the study and following withdrawal of treatment.
Croatian: Povećan broj limfocita bio je unutar povijesnih kontrolnih vrijednosti, nije se povećavao te je u osnovi razriješen do završetka faze ispitivanja na živim životinjama i nakon ukidanja tretmana.
English: - This allows the capsule to drop forward into the spinning chamber.
Croatian: - To će omogućiti kapsuli da se pomakne naprijed u rotirajuću komoru.
English: • recurrent bleeding ≥100 ml/day over several days The reinstitution or withholding of Bronchitol following smaller episodes of haemoptysis should be based on clinical judgement.
Croatian: • opetovano krvarenje ≥ 100 ml/dan tijekom nekoliko dana Ponovno uvođenje ili prekid primjene Bronchitola nakon manjih epizoda hemoptize treba se temeljiti na kliničkoj procjeni.
English: This happens commonly, which may affect up to 1 in 10 people.
Croatian: To je česta pojava koja se javlja u do 1 na 10 osoba.
English: - The usual dose is 10 capsules (400 mg) inhaled in the morning, and 10 capsules inhaled in the evening.
Croatian: - Uobičajena doza je 10 kapsula (400 mg) inhaliranih ujutro i 10 kapsula inhaliranih uvečer.
English: All patients should be monitored until their FEV1 has returned to baseline levels.
Croatian: Sve pacijente treba pratiti dok im se FEV1 ne vrati na početne vrijednosti.
English: Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.
Croatian: Dostupni podaci ispitivanja DPM-CF-301 i 302 pokazuju da za te populacije pacijenata nije potrebno izvršiti prilagodbu doze.
English: The limited data available in adolescents aged 12 to 17 years indicate the pharmacokinetic parameters of inhaled mannitol are similar to the adult population.
Croatian: Ograničeni podaci dostupni za adolescente u dobi od 12 do 17 godina pokazuju da su farmakokinetička svojstva inhaliranog manitola slična onima u odraslih osoba.
English: As the effects of a possible hyperresponsive reaction on the mother and/or foetus are unknown, caution should be exercised when prescribing Bronchitol to pregnant women.
Croatian: Budući da učinci moguće hiperreaktivne reakcije na majku i/ili fetus nisu poznati, potreban je oprez pri propisivanju Bronchitola trudnicama.
English: This requires the inhalation of the contents of ten capsules via the inhaler device twice a day.
Croatian: To zahtijeva inhalaciju sadržaja deset kapsula putem inhalatora dva puta dnevno.
English: Study 303 did not show a superior treatment effect of Bronchitol on FEV1 for female patients, in whom the underlying cystic fibrosis disease course may be worse than males for reasons that are not fully understood.
Croatian: Ispitivnje 303 nije pokazalo bolji učinak liječenja Bronchitolom na FEV1 za ženske pacijente kod kojih tijek bolesti cistične fibroze može biti lošiji nego kod muškaraca iz razloga koji nisu u potpunosti razjašnjeni.
English: The following steps explain how to use the inhaler.
Croatian: U sljedećim koracima objašnjen je način uporabe inhalatora.
English: Lung deposition studies have demonstrated a 24.7% deposition of inhaled mannitol confirming its distribution to the target organ.
Croatian: Ispitivanja depozicije lijeka u plućima pokazala su depoziciju inhaliranog manitola od 24,7%, čime je potvrđena njegova distribucija do ciljnog organa.
English: 10 hard capsules and 1 inhaler
Croatian: 10 tvrdih kapsula i 1 inhalator
English: What Bronchitol looks like and contents of the pack:
Croatian: Kako Bronchitol izgleda i sadržaj pakiranja:
English: This is because piercing the capsule more than once may make it split or break-up.
Croatian: Ako probušite kapsulu više puta, mogla bi se razdvojiti ili slomiti.
English: Hyperresponsiveness to mannitol
Croatian: Hiperreaktivnost na manitol
English: The cumulative amount of mannitol filtered into the urine over the 24 hour collection period was similar for inhaled (55%) and oral (54%) mannitol.
Croatian: Kumulativna količina manitola koji se izlučuje u urin tijekom razdoblja od 24 sata bila je slična za inhalirani (55%) i oralno uzet (54%) manitol.
English: Overall, the comparison of AUCs between Day 1 and Day 7 showed a time independence of pharmacokinetics, indicating linearity at the dose level administered in this study.
Croatian: Usporedba AUC između 1. i 7. dana pokazala je neovisnost farmakokinetike o vremenu, ukazujući na linearnost pri razini doze koja je korištena u ovom ispitivanju.
English: Talk to your doctor or pharmacist before using this medicine: - if you have asthma;
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Bronchitol: - ako imate astmu;
English: As a precautionary measure, it is preferable to avoid the use of Bronchitol during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavanje primjene lijeka Bronchitol tijekom trudnoće.
English: Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Croatian: Bronchitol je indiciran za liječenje cistične fibroze (CF) u odraslih u dobi od 18 godina i više kao dodatna terapija radi postizanja najboljih standarda njege.
English: The safety profile of Bronchitol is based on the safety data from Phase III clinical studies (including data from the initiation dose assessment).
Croatian: Sigurnosni profil Bronchitola temelji se na sigurnosnim podatcima iz kliničkih ispitivanja faze III (uključujući podatke iz procjene početne doze).
English: The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients.
Croatian: Sigurnosni profil Bronchitola procijenjen je u kliničkim ispitivanjima koja uključuju više od 1200 pacijenata. (vidi tablicu 1).
English: There is no evidence that mannitol is accumulated in the body, therefore distribution of inhaled mannitol was not examined in PK studies.
Croatian: Nema dokaza da se manitol nakuplja u tijelu, zbog čega distribucija inhaliranog manitola nije istražena u PK ispitivanjima.
English: You must let it fully dry, this can take up to 24 hours.
Croatian: To može potrajati do 24 sata.
English: Bronchitol helps by increasing the amount of water on the surface of your airways and in your mucus.
Croatian: Bronchitol pomaže pri povećanju količine vode na površini dišnih puteva i u sluzi.
English: In female patients, the adjusted mean change in FEV1 was 27ml for Bronchitol and 44ml for the control arm, suggesting potentially inferior benefit on lung function with Bronchitol compared to the control, although the difference was not statistically significant (p=0.480).
Croatian: Kod ženskih pacijenata, prilagođena srednja vrijednost promjene u FEV1 bila je 27 ml za Bronchitol i 44 ml za kontrolnu skupinu, što ukazuje na potencijalno manju korist za funkciju pluća s Bronchitolom u usporedbi s kontrolom, premda razlika nije bila statistički značajna (p = 0,480).
English: Study DPM-CF-303 was all adult patients.
Croatian: U ispitivanju DPM-CF-303 bili su samo odrasli pacijenti.
English: o How to interpret the results of the Bronchitol initiation dose assessment as Pass, Fail or Incomplete.
Croatian: o Interpretacija rezultata procjene početne doze Bronchitola kao Uspjelo, Neuspjelo ili Nedovršeno.
English: The safety/efficacy of Bronchitol in patients with asthma has not been formally studied.
Croatian: Sigurnost/djelotvornost Bronchitola u pacijenata s astmom nije formalno ispitana.
English: Nonclinical toxicology studies indicate that mannitol inhaled into the lungs is absorbed into the bloodstream, with the maximum serum concentration being achieved occurring at 1 hour.
Croatian: Neklinička toksikološka ispitivanja pokazuju da se manitol inhaliran u pluća apsorbira u krvotok, uz postizanje maksimalne koncentracije seruma nakon 1 sata.
English: In this leaflet we call making the hole ‘piercing'.
Croatian: U ovoj uputi, probijanje otvora nazivamo ‘bušenje'.
English: The patient's initiation dose of Bronchitol must be used under the supervision and monitoring of an experienced physician or another health care professional appropriately trained and equipped to perform spirometry, monitor oxygen saturation (SpO2), and manage acute bronchospasm (see sections 4.4 and 4.8) including appropriate use of resuscitation equipment.
Croatian: Početna doza Bronchitola mora se pacijentu dati pod nadzorom i praćenjem iskusnog liječnika ili drugog zdravstvenog djelatnika koji je prošao odgovarajuću obuku i ima mogućnosti izvođenja spirometrije, praćenja zasićenosti kisikom (SpO2) i postupanja u slučaju akutnog bronhospazma (vidjeti dijelove 4.4 i 4.8) uključujući odgovarajuću primjenu opreme za reanimaciju.
English: Discard the inhaler and its cap 1 week after first use.
Croatian: Inhalator i njegov zatvarač baciti 1 tjedan nakon prve uporabe.
English: What Bronchitol is and what it is used for
Croatian: Što je Bronchitol i za što se koristi
English: - Each of the ten capsules is put into the inhaler one at a time.
Croatian: - Svaku od deset kapsula stavljajte u inhalator jednu po jednu.
English: If the inhaler does require cleaning, it must be ensured that the device is empty, then it should be washed in warm water and before re-use,the inhaler should be allowed to thoroughly air dry.
Croatian: Ako inhalator zahtijeva čišćenje, mora se provjeriti je li uređaj prazan, potom se treba operati toplom vodom i pustiti da se temeljito osuši na zraku prije ponovne uporabe.
English: Productive cough can contribute to sputum clearance.
Croatian: Produktivni kašalj može doprinijeti uklanjanju sputuma.
English: - If your inhaler breaks, use your second inhaler and talk to your doctor.
Croatian: - Ako se inhalator razbije, upotrijebite drugi inhalator iz paketa i obratite se liječniku.
English: As well as using Bronchitol you will normally keep using the other medicines you take for cystic fibrosis.
Croatian: Uz Bronchitol, nastavit ćete s primjenom drugih lijekova koje uzimate za cističnu fibrozu.
English: Order of using this medicine
Croatian: Redoslijed uzimanja ovog lijeka
English: Safety and efficacy have not been demonstrated in patients with a FEV1 of less than 30% of predicted (see section 5.1).
Croatian: Sigurnost i djelotvornost nisu utvrđene u pacijenata čija je vrijednost FEV1 30% niža od procijenjene (vidjeti dio 5.1).
English: Breathe out - Take the inhaler away from your mouth.
Croatian: Izdahnite - Odmaknite inhalator od usta.
English: Initiation dose must be used under medical supervision and include monitoring of lung function.
Croatian: Početna doza mora se koristiti pod nadzorom liječnika i mora uključivati praćenje funkcije pluća.
English: Detailed instructions on how to use the inhaler can be found in the patient information leaflet.
Croatian: Detaljne upute o načinu uporabe inhalatora mogu se potražiti u uputi za pacijenta.
English: Clear colourless hard capsules marked with ‘PXS 40 mg' and containing white or almost white powder.
Croatian: Prozirne, bezbojne tvrde kapsule s oznakom „PXS 40 mg” koje sadrže bijeli ili gotovo bijeli prašak.
English: - You should hold the inhaler along the bottom to make sure you don't press the piercing buttons.
Croatian: - Inhalator biste trebali držati sasvim pri dnu kako ne biste pritisnuli gumbe za bušenje.
English: In dogs an increased occurrence of coughing was observed both during and immediately post dose for low and high dose inhaled mannitol administration.
Croatian: U pasa je primijećena povećana pojava kašlja tijekom i odmah nakon primjene doze za niske i visoke inhalirane doze manitola.
English: Paediatric population (6 to 17 years of age) Frequency, type and severity of adverse reactions in children are similar to those observed in adults.
Croatian: Pedijatrijska populacija (u dobi od 6 do 17 godina) Učestalost, vrsta i intenzitet nuspojava u djece slični su onima zabilježenima u odraslih.
English: Adult Population
Croatian: Odrasla populacija
English: Bronchospasm should be treated with a bronchodilator or as medically appropriate.
Croatian: Bronhospazam je potrebno tretirati bronhodilatatorom ili na drugi medicinski prihvatljiv način.
English: Check the capsule - Look to see if the capsule is empty - the capsule must spin in the inhaler in order to empty.
Croatian: Provjerite je li kapsula prazna - kapsula se mora vrtjeti u inhalatoru kako bi se ispraznila.
English: - Hold the inhaler upright and fully press in both ‘Piercing' buttons on the sides of the inhaler at the same time, then release them.
Croatian: - Držite inhalator uspravno i istodobno pritisnite do kraja oba gumba za ‘bušenje' sa strane inhalatora, a zatim ih otpustite.
English: Table 3 - Change in FEV1 from baseline over 26 weeks in the mITT and adult populations
Croatian: Tablica 3 - Promjena vrijednosti FEV1 u odnosu na početnu vrijednost tijekom 26 tjedana u mITT i odrasle populacije
English: Summary of Product Characteristics and Patient Information Leaflet Educational material for Healthcare Professionals
Croatian: Sažetak opisa svojstava lijeka i Uputu o lijeku Edukativne materijale za zdravstvene djelatnike
English: It must not be administered by any other route or using any other inhaler.
Croatian: Ne smije se primjenjivati bilo kojim drugim putem uz pomoć bilo kojeg drugog inhalatora.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: However, studies conducted with orally administered mannitol indicated no teratogenic effects in mice or rats, at doses of up to 1.6 g/kg, or in hamsters at 1.2 g/kg.
Croatian: Međutim, ispitivanjima koja su uključivala peroralnu primjenu manitola nisu dokazani teratogeni učinci na miševe ili štakore pri dozama do 1,6 g/kg, kao ni na hrčke pri dozi od 1,2 g/kg.
English: Step 1 - 1 capsule (40 mg) Step 2 - 2 capsules (80 mg) Step 3 - 3 capsules (120 mg) Step 4 - 4 capsules (160 mg)
Croatian: 1. korak - 1 kapsula (40 mg) 2. korak - 2 kapsule (80 mg) 3. korak - 3 kapsule (120 mg) 4. korak - 4 kapsule (160 mg)
English: o The need to check that the patient knows how to correctly use the bronchodilator.
Croatian: o Potreba da se provjeri zna li pacijent ispravno koristiti bronhodilatator.
English: Your doctor may ask you to use other medicines such as a bronchodilator before taking Bronchitol.
Croatian: Liječnik može zatražiti da prije uzimanja Bronchitola uzmete druge lijekove, kao što je bronhodilatator.
English: A decision must be made whether to discontinue breast feeding or to discontinue Bronchitol therapy taking into account the benefit of breast feeding for the child and the benefit of Bronchitol therapy for the woman.
Croatian: Mora se odlučiti treba li prekinuti dojenje ili liječenje lijekom Bronchitol uzimajući u obzir korist dojenja za dijete i korist liječenja Bronchitolom za ženu.
English: When administered intravenously, mannitol is eliminated largely unchanged by glomerular filtration and 87% of the dose is excreted in the urine within 24 hours.
Croatian: Pri intravenskoj primjeni, manitol se gotovo nepromijenjen eliminira glomerularnom filtracijom te se tijekom 24 sata u urin izluči 87% doze.
English: Use your Bronchitol before physiotherapy if this is part of your treatment routine.
Croatian: Uzmite Bronchitol prije fizioterapije, ako je to dio Vaše uobičajene terapije.
English: Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after taking this medicine.
Croatian: Lijekovi za inhalaciju mogu uzrokovati stezanje u prsištu i piskanje (pri disanju), do čega može doći odmah nakon uzimanja lijeka.
English: There are no data on concomitant use of hypertonic saline with Bronchitol as it was excluded from the Phase 3 studies.
Croatian: Nema podataka o istodobnoj primjeni hipertonične otopine natrijevog klorida s Bronchitolom jer je izuzeta iz ispitivanja faze III.
English: Your doctor will help you take your first dose of Bronchitol and check your lung function before, during and after dosing.
Croatian: Liječnik će Vam pomoći da uzmete prvu dozu Bronchitola te će Vam provjeriti funkciju pluća prije, za vrijeme i nakon uzimanja lijeka.
English: The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV1 and SpO2 (Oxygen saturation in the blood) measurement.
Croatian: Pacijentu treba prethodno dati bronhodilatator 5-15 minuta prije primjene početne doze, ali tek nakon mjerenja početnog FEV1 i SpO2 (zasićenost krvi kisikom).
English: Repeat steps 3 to 10 for each capsule - Perform these steps for each of the ten capsules.
Croatian: 11. Ponovite korake od 3 do 10 za svaku kapsulu
English: Use Bronchitol as part of your normal daily treatment routine.
Croatian: Bronchitol uzimajte u sklopu svoje uobičajene dnevne terapije.
English: Before you are prescribed Bronchitol your doctor will help you take your first dose of Bronchitol and test your lung function at each step to make sure you aren't sensitive to mannitol.
Croatian: Prije nego što Vam propiše Bronchitol, liječnik će Vam pomoći da uzmete prvu dozu Bronchitola i provjerit će Vam funkciju pluća u svakom koraku kako bi bio siguran da niste osjetljivi na manitol.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Bronchitol are provided with an educational pack.
Croatian: Nositelj odobrenja mora, prilikom stavljanja lijeka u promet, osigurati edukativni paket svim zdravstvenim djelatnicima koji bi trebali primjenjivati i/ili propisivati Bronchitol.
English: However, studies with orally administered mannitol indicate no fertility effects (see section 5.3).
Croatian: Međutim, ispitivanja provedena s peroralnom primjenom manitola pokazala su da nema učinaka na plodnost (vidjeti dio 5.3).
English: While the exact mechanism of action is unknown, inhaled mannitol may change the viscoelastic properties of mucus, increase the hydration of the periciliary fluid layer and contribute to increased mucus clearance of the retained secretions through mucociliary activity.
Croatian: Iako točan mehanizam djelovanja nije poznat, inhalirani manitol može promijeniti viskoelastična svojstva sluznice, povećati hidraciju pericilijarnog tekućeg sloja te doprinijeti pojačanom uklanjanju zaostalog sekreta iz sluznice putem mukocilijarne aktivnosti.
English: In male rats after 13 weeks of inhaled mannitol dosing, elevated circulating lymphocyte numbers and mandibular lymph node plasmacytosis was observed at doses greater than 9.3 fold the maximal dose.
Croatian: Nakon 13 tjedana primjene inhalacijskog manitola na štakorima, primijećen je povećan broj cirkulirajućih limfocita i plazmocitoza mandibularnih limfnih čvorova pri dozama koje su 9,3 puta veće od maksimalne doze.
English: If either of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using this medicine.
Croatian: Ako se bilo što od navedenog odnosi na Vas (ili ako niste sigurni), prije primjene lijeka posavjetujte se s liječnikom ili ljekarnikom.
English: The number of subjects with at least one protocol defined pulmonary exacerbation (PDPE, defined by the presence of at least 4 symptoms and signs plus the use of intravenous antibiotics) was 18.1% in the mannitol arm and 28% in the control arm in study 301 (ITT population).
Croatian: Broj ispitanika s barem jednom protokolom definiranom pulmonalnom egzacerbacijom (PDPE, definiran prisustvom barem 4 simptoma i znaka te uporabom intravenskih antibiotika) iznosio je 18,1% u skupini koja je uzimala manitol te 28% u kontrolnoj skupini ispitivanja 301 (ITT populacija).
English: o The need to review the patient after approximately six weeks to assess for signs and symptoms of bronchospasm.
Croatian: o Potreba za pregledom pacijenta nakon približno šest tjedana radi procjene znakova i simptoma bronhospazma.
English: - Never take your inhaler apart.
Croatian: - Nikada ne rastavljajte inhalator.
English: If you stop using Bronchitol
Croatian: Ako prestanete uzimati Bronchitol
English: Susceptible persons may suffer bronchoconstriction in the event of an inhaled overdose.
Croatian: U osjetljivih osoba može doći do sužavanja bronhija u slučaju prekomjerne inhalacije.
English: Pharmacotherapeutic group: Cough and cold preparations, Mucolytic.
Croatian: Farmakoterapijska skupina: pripravci za liječenje kašlja i prehlade, mukolitici.
English: Table 2: Frequency of adverse reactions with Bronchitol in the phase 3 studies (initiation dose assessment and/or treatment phase) - paediatric population (6 to 17 years of age) System organ class
Croatian: Tablica 2: Učestalost nuspojava Bronchitola u ispitivanjima faze III (procjena početne doze i/ili faza liječenja) - pedijatrijska populacija (u dobi od 6 do 17 godina) Klasifikacija organskih sustava
English: What you need to know before you use Bronchitol
Croatian: Što morate znati prije nego počnete primjenjivati Bronchitol
English: The rate and extent of absorption of mannitol after inhaled administration was very similar to that observed after oral administration.
Croatian: Stopa i opseg apsorpcije manitola nakon inhalacije bili su vrlo slični onima koji su zabilježeni nakon peroralne primjene.
English: What Bronchitol is Bronchitol contains a medicine called mannitol which is a mucolytic agent.
Croatian: Što je Bronchitol Bronchitol sadrži lijek manitol koji je mukolitički agens.
English: Bronchitol has not been studied in patients with a history of significant episodes of haemoptysis (>60 ml) in the previous three months.
Croatian: Bronchitol nije ispitan u pacijenata s anamnezom značajnih epizoda hemoptize (> 60 ml) u prethodna tri mjeseca.
English: When you breathe in you should hear a ‘rattling' sound as the capsule spins in the inhaler.
Croatian: Tijekom udisanja trebali biste čuti ‘zvečanje' dok se kapsula vrti u inhalatoru.
English: Overall Population
Croatian: Ukupna populacija