FrancophonIA/ELRC3.0 huggingface dataset:
English: The pooled analysis also showed fewer patients treated with Seebri Breezhaler than with placebo experienced an exacerbation requiring hospitalisation (1.7% versus 4.2%, p=0.003).
Croatian: Objedinjena analiza također je pokazala da je manje bolesnika liječenih Seebri Breezhalerom nego onih koji su primali placebo doživjelo egzacerbaciju koja je zahtijevala hospitalizaciju (1,7% u usporedbi s 4,2%, p=0,003).
English: Only use the capsules with the inhaler provided in this pack (Seebri
Croatian: Koristite kapsule samo uz inhalator priložen u ovom pakiranju (Seebri Breezhaler inhalator).
English: In patients with severe renal impairment or end-stage renal disease requiring dialysis Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk since the systemic exposure to glycopyrronium may be increased in this population (see sections 4.4 and 5.2).
Croatian: U bolesnika s teškim oštećenjem bubrega ili bolešću bubrega u završnoj fazi koja zahtijeva dijalizu Seebri Breezhaler smije se koristiti samo ako očekivane koristi premašuju potencijalni rizik obzirom da se u ovoj populaciji može povećati sistemska izloženost glikopironiju (vidjeti dijelove 4.4 i 5.2).
English: Seebri Breezhaler once daily statistically significantly reduced the use of rescue medication (salbutamol) by 0.46 puffs per day (p=0.005) over 26 weeks and by 0.37 puffs per day (p=0.039) over 52 weeks, compared to placebo for the 6- and 12-month studies, respectively.
Croatian: Seebri Breezhaler jedanput na dan statistički značajno je smanjio korištenje lijeka za hitno ublažavanje simptoma (salbutamola) za 0,46 udisaja dnevno (p=0,005) tijekom 26 tjedana, odnosno za 0,37 udisaja dnevno (p=0,039) tijekom 52 tjedna, u usporedbi s placeboom za 6-mjesečno odnosno 12-mjesečno ispitivanje.
English: What Seebri Breezhaler looks like and contents of the pack Seebri Breezhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Croatian: Kako Seebri Breezhaler izgleda i sadržaj pakiranja Seebri Breezhaler 44 mikrograma prašak inhalata, tvrde kapsule su prozirne i narančaste te sadrže bijeli prašak.
English: • Do not use the Seebri Breezhaler inhaler to take any other capsule medicine.
Croatian: • Nemojte koristiti Seebri Breezhaler inhalator za uzimanje kapsula bilo kojeg drugog lijeka.
English: Seebri Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention.
Croatian: Seebri Breezhaler treba koristiti oprezno u bolesnika s glaukomom uskog kuta ili urinarnom retencijom.
English: • One Seebri Breezhaler inhaler
Croatian: • Jedan Seebri Breezhaler inhalator
English: Excipient(s) with known effect: Each capsule contains 23.6 mg lactose (as monohydrate).
Croatian: Svaka kapsula sadrži 23,6 mg laktoze (u obliku hidrata).
English: In the 6-month study, the percentage of patients experiencing a moderate or severe exacerbation was 17.5% for Seebri Breezhaler and 24.2% for placebo (Hazard ratio: 0.69, p=0.023), and in the 12-month study it was 32.8% for Seebri Breezhaler and 40.2% for placebo (Hazard ratio: 0.66, p=0.001).
Croatian: U 6-mjesečnom ispitivanju, postotak bolesnika koji su imali umjerenu ili tešku egzacerbaciju bio je 17,5% za Seebri Breezhaler i 24,2% za placebo (omjer rizika: 0,69, p=0,023), a u 12-mjesečnom ispitivanju bio je 32,8% za Seebri Breezhaler i 40,2% za placebo (omjer rizika: 0,66, p=0,001).
English: Show the pack of Seebri Breezhaler.
Croatian: Pokažite pakiranje Seebri Breezhalera.
English: Seebri Breezhaler contains lactose
Croatian: Seebri Breezhaler sadrži laktozu
English: In the 12-month study, Seebri Breezhaler produced statistically significant improvements in FEV1 compared to tiotropium in the first 4 hours after dosing on day 1 and at week 26, and numerically greater values for FEV1 in the first 4 hours after dosing than tiotropium at week 12 and week 52.
Croatian: U 12-mjesečnom ispitivanju, Seebri Breezhaler je doveo do statistički značajna poboljšanja u FEV1 u usporedbi s tiotropijem u prva 4 sata nakon doziranja prvog dana i nakon 26 tjedana, te numerički veće vrijednosti za FEV1 od tiotropija u prva 4 sata nakon doziranja nakon 12 tjedana i nakon 52 tjedna.
English: Your Seebri Breezhaler Inhaler pack contains:
Croatian: Vaše pakiranje Seebri Breezhaler inhalatora sadrži:
English: Seebri Breezhaler 44 micrograms inhalation powder, hard capsules
Croatian: Seebri Breezhaler 44 mikrograma prašak inhalata, tvrde kapsule
English: Seebri Breezhaler is a single-dose inhaler.
Croatian: Seebri Breezhaler je jednodozni inhalator.
English: • Do not use the Seebri Breezhaler capsules with any other inhaler.
Croatian: • Nemojte koristiti Seebri Breezhaler kapsule s drugim inhalatorima.
English: What Seebri Breezhaler is and what it is used for
Croatian: Što je Seebri Breezhaler i za što se koristi
English: Seebri Breezhaler also reduced dyspnoea at rest measured using the Transitional Dyspnoea Index.
Croatian: Seebri Breezhaler je također smanjio dispneju u mirovanju, mjereno korištenjem Prijelaznog indeksa dispneje.
English: At 12 weeks (primary endpoint), Seebri Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
Croatian: Nakon 12 tjedana (primarna mjera ishoda), Seebri Breezhaler povećao je najniži FEV1 za 72 ml u bolesnika s najnižim stupnjem reverzibilnosti (<5%) te za 113 ml u onih bolesnika koji su imali viši stupanj reverzibilnosti na početku (≥5%) u usporedbi s placebom (oba p<0,05).
English: Instructions for use of Seebri Breezhaler inhaler
Croatian: Upute za primjenu Seebri Breezhaler inhalatora
English: In the 6-month study, Seebri Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p<0.001).
Croatian: 6-mjesečnom ispitivanju, Seebri Breezhaler je povećao FEV1 nakon prve doze s poboljšanjem od 93 ml u rok od 5 minuta te 144 ml u roku od 15 minuta od primjene doze, u usporedbi s placebom (oba p<0,001).
English: Seebri Breezhaler administered at 44 micrograms once daily statistically significantly reduced breathlessness as evaluated by the Transitional Dyspnoea Index (TDI).
Croatian: Seebri Breezhaler koji se primjenjivao u dozi od 44 mikrograma jedanput na dan statistički značajno je smanjio gubitak daha ocijenjen prema Prijelaznom indeksu dispneje (eng.
English: Other medicines and Seebri Breezhaler
Croatian: Drugi lijekovi i Seebri Breezhaler
English: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Seebri Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Croatian: U bolesnika s teškim oštećenjem bubrega (procijenjena glomerularna filtracija manja od 30 ml/min/1,73 m2), uključujući i one s bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Seebri Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 5.2).
English: In patients with severe renal impairment (eGFR <30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Seebri Breezhaler should only be used if the expected benefit outweighs the potential risk (see section 4.4).
Croatian: U bolesnika s teškim oštećenjem bubrega (eGFR <30 ml/min/1,73 m uključujući one s bolešću bubrega u završnoj fazi koja zahtijeva dijalizu, Seebri Breezhaler treba koristiti samo ako očekivana korist premašuje potencijalni rizik (vidjeti dio 4.4).
English: In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Seebri Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p<0.001).
Croatian: U objedinjenoj analizi prvih 6 mjeseci liječenja u 6- i 12-mjesečnom ispitivanju, u usporedbi s placebom Seebri Breezhaler statistički značajno je produljio vrijeme do prve umjerene ili teške egzacerbacije i smanjio stopu umjerenih ili teških egzacerbacija KOPB-a (0,53 egzacerbacija na godinu u usporedbi s 0,77 egzacerbacija na godinu, p<0,001).
English: At 12 weeks (primary endpoint), Seebri Breezhaler increased trough FEV1 by 108 ml in the 6-month study and by 97 ml in the 12-month study compared to placebo (both p<0.001).
Croatian: Nakon 12 tjedana (primarna mjera ishoda), Seebri Breezhaler je povećao najniži FEV1 za 108 ml u 6-mjesečnom ispitivanju te za 97 ml u 12-mjesečnom ispitivanju u usporedbi s placebom (oba p<0,001).
English: Seebri Breezhaler can be used at the recommended dose in patients with mild to moderate renal impairment.
Croatian: Seebri Breezhaler se može koristiti u preporučenoj dozi u bolesnika s blagim do umjerenim oštećenjem bubrega.
English: Seebri Breezhaler 44 micrograms inhalation powder, hard capsules glycopyrronium (as glycopyrronium bromide)
Croatian: Seebri Breezhaler 44 mikrograma prašak inhalata, tvrde kapsule glikopironij (glikopironijev bromid)
English: Seebri Breezhaler was found to decrease dyspnoea and leg discomfort when exercising as measured using Borg scales.
Croatian: Uočeno je da Seebri Breezhaler smanjuje dispneju i nelagodu u nogama kod fizičke aktivnosti mjereno korištenjem Borgove skale.
English: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Seebri Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Croatian: U objedinjenoj analizi 6- i 12-mjesečnih ključnih ispitivanja statistički značajno viši postotak bolesnika koji su primali Seebri Breezhaler odgovorio je s poboljšanjem od 1 boda ili većim u TDI-u u 26. tjednu u usporedbi s placebom (58,4% odnosno 46,4%, p<0,001).
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Seebri Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Croatian: Objedinjenom analizom 6- i 12-mjesečnih ključnih ispitivanja uočen je u bolesnika koji su primali Seebri Breezhaler statistički značajno viši postotak bolesnika koji su odgovorili s poboljšanjem od 4 boda ili više u SGRQ-u u usporedbi s placebom nakon 26 tjedana (57,8% odnosno 47,6%, p<0,001).
English: If you forget to inhale a dose, take one as soon as possible.
Croatian: Ako ste zaboravili primijeniti Seebri Breezhaler Ako zaboravite inhalirati dozu, uzmite je čim bude moguće.
English: Do not use Seebri Breezhaler - if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine
Croatian: Što morate znati prije nego počnete primjenjivati Seebri Breezhaler Nemojte primjenjivati Seebri Breezhaler - ako ste alergični na glikopironijev bromid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: 2) Reports have been received from post-approval marketing experience in association with the use of Seebri Breezhaler.
Croatian: 1) Učestalije za glikopironij nego za placebo samo u bazi 12-mjesečnih podataka 2) Dobivena su izvješća iz iskustva nakon stavljanja lijeka u promet, povezana s primjenom Seebri Breezhalera.
English: Immediate hypersensitivity reactions have been reported after administration of Seebri Breezhaler.
Croatian: Nakon primjene Seebri Breezhalera zabilježene su neposredne reakcije preosjetljivosti.
English: How much Seebri Breezhaler to use
Croatian: Koliko Seebri Breezhalera primjenjivati
English: What Seebri Breezhaler is
Croatian: Što je Seebri Breezhaler
English: What Seebri Breezhaler is used for
Croatian: Za što se koristi Seebri Breezhaler
English: Gastroenteritis
Croatian: Gastroenteritis Mučnina
English: How to store Seebri Breezhaler
Croatian: Kako primjenjivati Seebri Breezhaler
English: Musculoskeletal chest pain
Croatian: Mišićno-koštana bol u prsištu
English: • Dry mouth
Croatian: Nastavak za usta
English: This damages the bacteria and eventually kills them.
Croatian: To šteti bakterijama i naposljetku ih ubije.
English: They also presented data from the published literature.
Croatian: Podnositelj zahtjeva također je pružio podatke iz objavljene literature.
English: The trials lasted 24 weeks (three treatment cycles).
Croatian: Ispitivanja su trajala 24 tjedna (tri ciklusa liječenja).
English: The recommended dose is four capsules twice a day (as close as possible to 12 hour intervals) for four weeks, followed by four weeks without treatment.
Croatian: Preporučena doza je četiri kapsule dvaput dnevno (u razmaku od približno 12 sati, koliko je moguće) u razdoblju od četiri tjedna, nakon kojeg slijedi razdoblje od četiri tjedna bez liječenja.
English: The capsules are only to be inserted into the Podhaler and must never be swallowed.
Croatian: Kapsule su namijenjene samo umetanju u Podhaler i ni u kom se slučaju ne smiju progutati.
English: The Committee therefore recommended that it be given marketing authorisation.
Croatian: Odbor je stoga preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tobi Podhaler on 20 July 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Tobi Podhaler na snazi u Europskoj uniji od 20. srpnja 2011.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Tobi Podhaler.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Tobi Podhaler.
English: The main measure of effectiveness was the change in FEV1 at the end of the treatment period of cycle 1 in the first study and at the end of the treatment period of cycle 3 in the second study.
Croatian: Glavno mjerilo učinkovitosti bila je promjena vrijednosti FEV-a1 na kraju liječenja u okviru prvog ciklusa u prvom ispitivanju te na kraju liječenja u okviru trećeg ciklusa u drugom ispitivanju.
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls.
Croatian: Djeluje tako da ometa proizvodnju proteina koji su bakteriji P. aeruginosa potrebni za izgradnju staničnih stijenki.
English: The effect of Tobi Podhaler was similar to that of Tobi after three cycles of treatment.
Croatian: Učinak lijeka Tobi Podhaler bio je sličan učinku Tobija nakon tri ciklusa liječenja.
English: This is a summary of the European public assessment report (EPAR) for Tobi Podhaler.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Tobi Podhaler.
English: Because the number of patients with cystic fibrosis and P. aeruginosa bacterial lung infection is low, the disease is considered ‘rare' and Tobi Podhaler was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 March 2003.
Croatian: Budući da postoji mali broj bolesnika s cističnom fibrozom i plućnom infekcijom uzrokovanom bakterijom P. aeruginosa, bolest se smatra „rijetkom” te se Tobi Podhaler označava kao lijek za liječenje rijetkih bolesti od 17.ožujka 2003.
English: Tobi Podhaler tobramycin
Croatian: Tobi Podhaler tobramicin
English: It is available as capsules (28 mg) containing a dry powder for inhalation using a portable inhaler device.
Croatian: Dostupan je u obliku kapsula (28 mg) koje sadrže suhi prašak za inhaliranje uz pomoć prenosivog inhalatora.
English: The full EPAR for Tobi Podhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Tobi Podhaler nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If the patient's lung infection gets worse, the doctor should consider replacing or adding another treatment to Tobi Podhaler.
Croatian: Ako se plućna infekcija bolesnika pogorša, liječnik treba razmotriti mogućnost promjene terapije ili uvođenja dodatne terapije uz terapiju lijekom Tobi Podhaler.
English: The first trial, which involved 102 patients aged 6 to 21 years, compared Tobi Podhaler with placebo (a dummy treatment), while the second, involving 553 mostly adult patients, compared it with Tobi.
Croatian: U prvom ispitivanju, koje je uključivalo 102 bolesnika u dobi od 6 do 21 godine, lijek Tobi Podhaler uspoređivan je s placebom (prividnim liječenjem), dok je u drugom ispitivanju, koje je uključivalo 553 bolesnika, uglavnom odrasle osobe, uspoređivan s Tobijem.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Tobi Podhaler can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Tobi Podhaler nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Tobi Podhaler must not be used in people who are hypersensitive (allergic) to tobramycin, any aminoglycoside or any of the other ingredients.
Croatian: Tobi Podhaler ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na tobramicin, bilo koji aminoglikozoid ili bilo koji drugi sastojak lijeka.
English: What measures are being taken to ensure the safe and effective use of Tobi Podhaler?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tobi Podhaler?
English: For more information about treatment with Tobi Podhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Tobi Podhaler pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The most common side effects with Tobi Podhaler (seen in more than 1 patient in 10) are haemoptysis (coughing up blood), dyspnoea (difficulty breathing), dysphonia (hoarseness), cough and productive cough (producing mucus), oropharyngeal pain (affecting the mouth and throat) and pyrexia (fever).
Croatian: Najčešće nuspojave lijeka Tobi Podhaler (zabilježene u više od 1 na 10 osoba) su hemoptiza (iskašljavanje krvi), dispneja (otežano disanje), disfonija (promuklost), kašalj i produktivni kašalj (stvaranje sluzi), bol u ždrijelu (koja zahvaća usta i grlo) i pireksija (vrućica).
English: After four weeks of treatment, the patients taking Tobi Podhaler had an improvement in FEV1 of 13.2%, while patients taking placebo had a reduction in FEV1 of around 0.6%.
Croatian: Nakon četiri tjedna liječenja, kod bolesnika koji su uzimali lijek Tobi Podhaler zabilježeno je poboljšanje vrijednosti FEV-a1 od 13,2 %, dok je kod bolesnika koji su uzimali placebo zabilježeno smanjenje vrijednosti FEV-a1 za otprilike 0,6 %.
English: The applicant presented data on an existing nebuliser solution containing tobramycin called Tobi.
Croatian: Podnositelj zahtjeva pružio je podatke o postojećoj otopini za nebulizator koja sadrži tobramicin, a naziva se Tobi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tobi Podhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Tobi Podhaler nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Tobi Podhaler is inhaled using a hand-held device called Podhaler.
Croatian: Tobi Podhaler inhalira se uz pomoć ručnog aparata koji se naziva Podhaler.
English: Cystic fibrosis is an inherited disease in which there is accumulation of thick mucus in the lungs that allows bacteria to grow more easily causing infections.
Croatian: Cistična fibroza nasljedna je bolest pri kojoj dolazi do nakupljanja debelog sloja sluzi u plućima što omogućuje brži rast bakterija, rezultirajući infekcijama.
English: Tobramycin is a well-known antibiotic that has been used to treat lung infection in cystic fibrosis patients, available in the form of a solution used with a nebuliser (a machine that changes a solution into an aerosol that the patient can breathe in).
Croatian: Tobramicin je dobro poznat antibiotik koji se koristi za liječenje plućne infekcije u bolesnika s cističnom fibrozom i koji je dostupan u obliku otopine koja se koristi s nebulizatorom (aparatom koji otopinu pretvara u aerosol koju bolesnik može udisati).
English: When the patients in the placebo group were switched to Tobi Podhaler for the second and third cycles they also experienced a similar improvement in FEV1.
Croatian: Nakon što je bolesnicima iz skupine koja je uzimala placebo liječenje izmijenjeno tako da su uzimali lijek Tobi Podhaler u drugom i trećem ciklusu, kod njih je također zabilježeno poboljšanje vrijednosti FEV1-a.
English: A risk management plan has been developed to ensure that Tobi Podhaler is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Tobi Podhaler.
English: The active substance in Tobi Podhaler, tobramycin, is an antibiotic that belongs to the group ‘aminoglycosides'.
Croatian: Djelatna tvar u lijeku Tobi Podhaler, tobramicin, jest antibiotik koji pripada u skupinu „aminoglikozoida”.
English: Tobi Podhaler is a medicine that contains the active substance tobramycin.
Croatian: Tobi Podhaler je lijek koji sadrži djelatnu tvar tobramicin.
English: Other information about Tobi Podhaler
Croatian: Ostale informacije o lijeku Tobi Podhaler
English: The patient should continue with a cycle of four weeks ‘on' treatment followed by four weeks ‘off'
Croatian: Bolesnik mora nastaviti ciklus liječenja u trajanju od četiri tjedna nakon razdoblja bez liječenja od četiri tjedna, sve dok ima koristi od liječenja prema mišljenju liječnika.
English: Tobi Podhaler is intended to increase the convenience of taking tobramycin for patients.
Croatian: Tobi Podhaler je namijenjen tomu da omogući što ugodnije korištenje tobramicina za bolesnike.
English: The CHMP decided that Tobi Podhaler's benefits are greater than its risks, since it is effective at treating lung infection in cystic fibrosis patients and given its added convenience for patients.
Croatian: CHMP je odlučio da koristi od lijeka Tobi Podhaler nadmašuju s njim povezane rizike s obzirom na to da se pokazao učinkovitim u liječenju plućne infekcije u bolesnika s cističnom fibrozom te da pruža dodatnu ugodnost za bolesnike.
English: Tobi Podhaler is used to suppress chronic lung infection caused by bacteria called Pseudomonas aeruginosa in adults and children aged 6 years and over who have cystic fibrosis.
Croatian: Tobi Podhaler je indiciran za supresivno liječenje kronične plućne infekcije uzrokovane bakterijom Pseudomonas aeruginosa u odraslih i djece u dobi od 6 i više godina s cističnom fibrozom.
English: Why has Tobi Podhaler been approved?
Croatian: Zašto je Tobi Podhaler odobren?
English: What is the risk associated with Tobi Podhaler?
Croatian: Koji su rizici povezani s lijekom Tobi Podhaler?
English: For more information on how to use Tobi Podhaler, see the instructions in the package leaflet.
Croatian: Više informacija o načinu primjene lijeka Tobi Podhaler pročitajte u uputama sadržanima u uputi o lijeku.
English: P. aeruginosa is a frequent cause of infections in cystic fibrosis patients.
Croatian: P. aeruginosa učestali je uzročnik infekcija u bolesnika s cističnom fibrozom.
English: What is Tobi Podhaler?
Croatian: Što je Tobi Podhaler?