natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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
Mannitol was shown not to be an irritant in an isolated bovine eye assay or when introduced into rabbit eyes. 
Manitol nije imao nadražujuća svojstva nakon izoliranog ispitivanja u oku goveda, kao ni nakon dospijevanja u oko kunića.
Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland. 
Nositelj odobrenja za stavljanje lijeka u promet Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Irska.
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. 
Uz Bronchitol možete nastaviti koristiti druge lijekove za cističnu fibrozu, uključujući antibiotike za inhalaciju poput tobramicina i natrijeva kolistimetata.
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. 
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.
The use of Bronchitol is not recommended in these patients. 
U tih pacijenata nije preporučena primjena Bronchitola.
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). 
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.
Patients with asthma may experience reversible temporary mild bronchospasm after passing the initiation dose assessment and therefore all patients should be monitored until their FEV1 has returned to baseline levels. 
Nakon što prođu procjenu početne doze, pacijenti s astmom mogu doživjeti reverzibilni privremeni blagi bronhospazam, zbog čega sve pacijente treba nadzirati dok im se vrijednost FEV1 ne vrati na razinu početne vrijednosti.
If you are not sure, talk to your doctor or pharmacist before using Bronchitol. 
Ako niste sigurni, prije primjene Bronchitola posavjetujte se s liječnikom ili ljekarnikom.
Bronchitol is an inhaled hyperosmotic medicinal product. 
Bronchitol je lijek za inhalaciju s hiperosmotskim učinkom.
For mannitol no clinical data on fertility is available. 
Nema kliničkih podataka o utjecaju manitola na plodnost.
- Keep the inhaler tilted in this way and breathe out completely (away from the inhaler). 
- Držite inhalator u tom položaju i izdahnite do kraja (dalje od inhalatora).
It is unknown whether mannitol is excreted in human milk. 
Nije poznato izlučuje li se manitol u majčino mlijeko u ljudi.
The estimated effect of treatment (mean change and 95% CI from baseline over 26 weeks, mITT population) on FVC was 108.78 ml (95% CI: 49.21, 168.35) in study 301 and 71.4 ml (95% CI: 10.57, 132.13) in study 302 and 40 ml (95% CI: -12, 92) in study 303. 
Procijenjeni učinak liječenja (srednja vrijednost promjene i 95% CI u odnosu na početnu vrijednost tijekom 26 tjedana, mITT populacija) na FVC iznosio je 108,78 ml (95% CI: 49,21, 168,35) u ispitivanju 301, 71,4 ml (95 % CI: 10,57, 132,13) u ispitivanju 302 i 40 ml (95 % CI: -12,92) u ispitivanju 303.
The final report is expected in Q3 
Konačno izvješće očekuje se u prvom kvartalu 2018.
No evidence of carcinogenicity was observed when dietary mannitol (≤5%) was administered to mice and rats for 2 years. 
Nakon davanja prehrambenog manitola (≤ 5%) miševima i štakorima tijekom 2 godine nije bilo dokaza o kancerogenosti.
Dornase alfa (Pulmozyme) if this is part of your treatment routine Inhaled antibiotics if this is part of your treatment routine 
Dornaza alfa (Pulmozyme), ako je dio Vaše uobičajene terapije.
Adverse reactions that occurred only with initiation dose assessment (MTT) are bronchospasm, chest pain, odynophagia and retching 
Nuspojave koje su se pojavile samo kod procjene početne doze (MTT) jesu bronhospazam, bol u prsištu, odinofagija i dizanje želuca
If there is evidence of therapy induced bronchospasm, the physician should carefully evaluate whether the benefits of continued use of Bronchitol outweigh the risks to the patient. 
U slučaju dokaza o postojanju terapijom induciranog bronhospazma, liječnik mora pažljivo procijeniti odnos koristi i mogućih komplikacija za pacijenta u slučaju daljnje primjene Bronchitola.
The safety and efficacy of Bronchitol in children and adolescents aged 6 to 18 years has not yet been established. 
Sigurnost i djelotvornost lijeka Bronchitol u djece i adolescenata u dobi od 6 do 18 godina nisu ustanovljene.
Uncommon Decreased appetite, CF related diabetes, Dehydration 
Manje često smanjen apetit, dijabetes povezan s cističnom fibrozom, dehidracija
This happens commonly. 
To je česta pojava.
o How to perform the Bronchitol initiation dose assessment safely and how long to monitor the patient for. 
o Način sigurnog provođenja procjene početne doze Bronchitola te potrebno vrijeme nadzora pacijenta.
The 2-week carton contains 28 blisters (of 10 capsules each) and two inhaler devices. 
Kutija za 2 tjedna sadrži 28 blistera (s 10 kapsula u svakom) i dva inhalatora.
In studies DPM-CF-301 and 302 relative % predicted FEV1 compared to control in children (6-11 years) was improved by 0.44% (95% CI -5.90, 6.77, N=43) and 6.1% (95% CI -1.28, 13.54, N=59) over 26 weeks (p=0.892 and 0.104) respectively. 
U ispitivanjima DPM-CF-301 i 302, procijenjeni relativni % FEV1 u odnosu na kontrolnu skupinu u djece (u dobi od 6 do 11 godina) poboljšan je za 0,44% (95% CI -5,90, 6,77, N = 43) te 6,1% (95% CI -1,28, 13,54, N = 59) tijekom 26 tjedana (p = 0,892 i 0,104).
Tell your doctor straight away if you notice any of the following side effects: - Severe cough. 
Ako primijetite bilo koju od sljedećih nuspojava, odmah se obratite liječniku: - Teški kašalj.
- If you are breast-feeding or plan to breast-feed ask your doctor for advice before using this medicine. 
- Ako dojite ili planirate dojiti, posavjetujte se s liječnikom prije nego uzmete ovaj lijek.
The initiation dose carton contains 1 blister (of 10 capsules) and one inhaler device. 
Kutija za početnu dozu sadrži 1 blister (s 10 kapsula) i jedan inhalator.
- if you have ever coughed up blood or had blood in your sputum; - if you have severe cystic fibrosis, in particular if your lung function measured by the Forced 
- ako ste ikada iskašljavali krv ili ste imali krvi u iskašljaju;
The proportion of patients who experienced haemoptysis as an adverse reaction was 7.3%, 3.3% and 3.4% in the Bronchitol arms for studies 301, 302 and 303 respectively vs. 3.4%, 0% and 5.6% in the control arms. 
Udio pacijenata u ispitivanjima 301, 302 i 303 u kojih je kao nuspojava zabilježena hemoptiza bio je 7,3 %, 3,3 % i 3,4 % u skupini liječenoj Bronchitolom u odnosu na 3,4 %, 0 % i 5,6 % u kontrolnoj skupini.
Bronchitol 40 mg inhalation powder, hard capsules contain a white or almost white powder filled into clear, colourless, hard, capsules with “PXS 40 mg” imprinted on them. 
Bronchitol prašak za inhalaciju od 40 mg, tvrde kapsule sadrže bijeli ili gotovo bijeli prašak unutar prozirne, bezbojne, tvrde kapsule s oznakom
For non-users the relative change was 4.30 (95% CI 0.53, 8.07). 
Relativna promjena za osobe koje ne uzimaju rhDNase iznosila je 4,30 (95% CI 0,53, 8,07).
Bronchodilator 
Bronhodilatator
Fifty five % of patients were receiving rhDNase in study DPM-CF-301 while in study DPM-CF-302 this number was 75% and for DPM-CF-303 this was 67.6%. 
Pedeset pet posto (%) pacijenata u ispitivanju DPM-CF-301 primalo je rekombinantnu humanu deoksiribonukleazu I (rhDNase), dok je ta brojka u ispitivanju DPM-CF-302 bila 75 %, a u ispitivanju DPM-CF-303 iznosila je 67,6 %.
In the ITT population of an open label dose response study, DPM-CF-202, the mean (SD) percent change in FEV1 for the 400 mg dose was 8.75 (SD: 12.4) and -1.569 (SD: 9.0) for 40 mg dose (p < 
U otvorenom ispitivanju reakcije na dozu u ITT populacije (populacije predviđene za liječenje), DPMCF-202, srednja (SD) postotna promjena vrijednosti FEV1 za dozu od 400 mg iznosila je 8,75 (SD: 12,4) te -1,569 (SD: 9,0) za dozu od 40 mg (p < 0,0001).
Impaired lung function 
Oslabljena funkcija pluća
Efficacy and safety have not been established in non-CF bronchiectasis patients. 
Sigurnost i djelotvornost lijeka nisu utvrđene u pacijenata s bronhiektazijama nepovezanim s cističnom fibrozom.
In adolescents (12-17 years) relative change in % predicted FEV1 compared to control improved by 3.31% (95% CI -2.29, 8.90, N=55) and 0.42% (95% CI -5.45, 6.29, N=94) over 26 weeks (p=0.245 and 0.888) respectively. 
U usporedbi s kontrolnom skupinom, procijenjena relativna promjena % FEV1 u adolescenata (u dobi od 12 do 17 godina) poboljšala se za 3,31% (95% CI -2,29, 8,90, N = 55) i 0,42% (95% CI -5,45, 6,29, N = 94) tijekom 26 tjedana (p = 0,245 i 0,888).
Bronchospasm can occur with inhalation of medicinal product and has been reported with Bronchitol in clinical studies, even in patients who were not hyperresponsive to the initiation dose of inhaled mannitol (see section 4.8). 
Kao i pri inhalacijskoj terapiji drugim lijekovima, klinička ispitivanja pokazala su da inhalacija Bronchitola može uzrokovati bronhospazam, čak i u pacijenata u kojih nije došlo do hiperreaktivnosti na početnu dozu inhaliranog manitola (vidjeti dio 4.8).
Carcinogenicity studies have not been carried out with inhaled mannitol. 
Ispitivanja kancerogenosti inhalacijskog manitola nisu provedena.
No treatment-related adverse effect occurred greater than 13 fold the maximal therapeutic dose. 
puta veća od maksimalne terapijske doze.
The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is bronchospasm. 
Najvažnija zabilježena nuspojava povezana s primjenom Bronchitola tijekom procjene početne doze među pedijatrijskom populacijom je bronhospazam.
- Inhale the contents of the capsule using the inhaler, with one or two breaths in. 
- Udahnite sadržaj kapsule uz pomoć inhalatora u jednom ili dva udaha.
The most commonly observed adverse reaction associated with the use of Bronchitol during the initiation dose assessment is cough (2.9% of patients), (see section 4.4). 
Najčešća zabilježena nuspojava povezana s primjenom Bronchitola tijekom procjene početne doze je kašalj (2,9 % pacijenata) (vidjeti dio 4.4).
Shake it until there are no large water droplets left in the inhaler. 
Protresite ga dok iz njega ne iziđu sve veće kapi vode.
In study 302 the relative change (95% CI) for rhDNase users and non-users was 3.21 (-0.61, 7.03) and 4.73 (-1.93, 11.40), respectively. 
U ispitivanju 302, relativna promjena (95% CI) za osobe koje uzimaju rhDNase iznosila je 3,21 (-0,61, 7,03) te 4,73 (-1,93, 11,40) za osobe koje ne uzimaju rhDNase.
Bronchitol is for inhalation use, using the inhaler provided in the pack. 
Bronchitol se koristi za inhalaciju, pomoću inhalatora isporučenog u pakiranju.
The most commonly observed adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is cough (4.8% of patients). 
Najčešća zabilježena nuspojava povezana s uporabom Bronchitola tijekom procjene početne doze među pedijatrijskom populacijom je kašalj (4,8% pacijenata).
Step 5: Patient inhales 160 mg (4x40 mg capsules), FEV1 is measured and SpO2 is monitored Step 6: Patients FEV1 is measured 15 minutes post initiation dose. 
4. korak: Pacijent inhalira 120 mg (3 kapsule od 40 mg), mjeri se FEV1 i prati se SpO2 5. korak: Pacijent inhalira 160 mg (4 kapsule od 40 mg), mjeri se FEV1 i prati se SpO2 6. korak: Pacijentu se mjeri FEV1 15 minuta nakon primjene početne doze.
What Bronchitol is used for 
Za što se koristi Bronchitol
The most important adverse reaction associated with the use of Bronchitol is haemoptysis. 
Najvažnija zabilježena nuspojava povezana s uporabom Bronchitola je hemoptiza.
Mean (SD) baseline FEV1 percent predicted in study DPM-CF-301 (safety population, N= 295) was 62.4 (SD:16.45) and 61.4 (SD:16.13) in the mannitol and control groups, respectively. 
Srednja vrijednost (SD) postotka predviđenog FEV1 na početku ispitivanja DPM-CF-301 (sigurnosna populacija, N = 295) iznosila je 62,4 (SD: 16,45) za skupinu koja je uzimala manitol i 61,4 (SD: 16,3) za kontrolnu skupinu.
Use your bronchodilator; 
Uzmite bronhodilatator.
The most commonly observed adverse reaction associated with the use of Bronchitol is cough (see section 4.4). 
Najčešća zabilježena nuspojava povezana s primjenom Bronchitola je kašalj (vidjeti dio 4.4).
Twenty seven (7.1%) out of 378 patients who undertook the mannitol tolerance test (MTT) in study 301, 18 (5.3) out of 341 patients in study 302 and 25 out of 486 patients (5.1%) in study 303 had a positive MTT defined as either 1) a fall in FEV1 >20% from baseline at midpoint (step 4) or 2) fall from baseline > 20 % at end of test that did not recover to < 20% within 15 minutes or 3) who had a fall in FEV1 > 50% from baseline at end of test (step 6) or 4) who had a fall in Sp02 to < 89% during the procedure. 
Dvadeset sedam (7,1 %) od 378 pacijenata podvrgnutih testu tolerancije na manitol (MTT) u ispitivanju 301 i 18 (5,3 %) od 341 pacijenta u ispitivanju 302 i 25 (5,1 %) od 486 u studiji 303 su imali pozitivan test MTT, koja se definira kao 1) smanjenje vrijednosti FEV1 za > 20% u odnosu na početnu vrijednost u središnjoj točki (4. korak); ili 2) smanjenje početne vrijednosti za > 20 % u odnosu na početnu vrijednost na kraju testa te nemogućnost vraćanja na < 20% unutar
In study 303 13.4% subjects in the mannitol arm and 13.6% in the control had a PDPE. 
U ispitivanju 303, PDPE je imalo 13,4 % ispitanika iz skupine koja je uzimala manitol i 13,6 % ispitanika iz kontrolne skupine.
The contents of the capsules are inhaled via the inhaler device with one or two breaths. 
Sadržaj kapsule inhalira se putem inhalatora u jednom ili dva udaha.
Common (May affect up to 1 in 10 people) - Cough - Chest discomfort - Headache - Pain in the back of your mouth and throat and discomfort when swallowing - Vomiting, vomiting after coughing 
- Glavobolja - Bol u stražnjem dijelu usta i grlu te nelagoda pri gutanju - Povraćanje, povraćanje nakon kašlja
Uncommon Acne, Cold sweat, Pruritus, Rash, Rash pruritic 
Manje često akne, hladan znoj, pruritus, osip, pruritički osip
EU/1/12/760/001-002 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/760/001-002
OTHER SPECIAL WARNING(S), IF NECESSARY 
DRUGA POSEBNA UPOZORENJA, (AKO JE POTREBNO) Kapsule se ne smiju progutati.
In study 303 the relative change (95% CI) for rhDNase users and non-users was 1.30 (-0.91, 3.51) and 4.45 (0.52, 8.38), respectively. 
U ispitivanju 303, relativna promjena (95 % CI) za osobe koje uzimaju rhDNase iznosila je 1,30 (-0,91, 3,51) te 4,45 (0,52, 8,38) za osobe koje ne uzimaju rhDNase.
Training the patient to practice correct inhaler technique during the initiation dose assessment is important. 
Tijekom procjene početne doze pacijentu je važno pokazati ispravnu tehniku inhalacije.
The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment is bronchospasm (see section 4.4). 
Najvažnija zabilježena nuspojava povezana s uporabom Bronchitola tijekom procjene početne doze je bronhospazam (vidjeti dio 4.4).
A patient is defined as hyperresponsive to inhaled mannitol and must not be prescribed the therapeutic dose regimen if they experience any of the following during the initiation dose assessment: 
Smatra se da u pacijenta postoji hiperreaktivnost na inhalirani manitol te mu se ne smije propisati terapijska doza ako tijekom uzimanja početne doze u bilo kojem od sljedećih slučajeva: - smanjenje vrijednosti SpO2 za ≥ 10% u odnosu na početnu vrijednost u bilo kojem trenutku procjene
In study 302 15.2% subjects in the mannitol arm and 19% in the control had a PDPE. 
U ispitivanju 302, PDPE je imalo 15,2% ispitanika iz skupine koja je uzimala manitol i 19% ispitanika iz kontrolne skupine.
Bronchitol capsules can only be used with the inhaler provided in the pack. 
Bronchitol kapsule smiju se rabiti isključivo uz pomoć inhalatora priloženog u pakiranju.
Adverse reactions that occurred only with the initiation dose assessment (MTT) are dehydration, forced expiratory volume decreased, hypoxia, diarrhoea, abdominal pain upper, aphthous stomatitis, odynophagia, chest pain and blood alkaline phosphatase increased. 
Tolerance Test, MTT) jesu dehidracija, smanjen forsirani ekspiracijski volumen zraka, hipoksija, proljev, bol u gornjem dijelu abdomena, aftozni stomatitis, odinofagija, bol u prsištu te povišenje alkalne fosfataze u krvi.
Inhale - Tilt your head back slightly. 
Udahnite - Blago nagnite glavu prema natrag.
One 2-week treatment pack of Bronchitol contains 28 blisters with 10 capsules each (280 capsules in total) and 2 inhalers. 
Jedno pakiranje Bronchitola za 2-tjedno liječenje sadrži 28 blistera s 10 kapsula u svakom (ukupno
How to store Bronchitol 
Kako primjenjivati Bronchitol
Step 1: Patients baseline FEV1 and SpO2 is measured prior to the initiation dose Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO2 is monitored Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO2 is monitored Step 4: Patient inhales 120 mg (3x40 mg capsules), FEV1 is measured and SpO2 is monitored 
1. korak: Prije primjene početne doze pacijentu su izmjerene početne vrijednosti FEV1 i SpO2 2. korak: Pacijent inhalira 40 mg (1 kapsula od 40 mg) i prati se SpO2
The powder is inhaled into the lungs using the inhaler provided in the pack. 
Prašak se inhalira u pluća uz pomoć inhalatora priloženog u pakiranju.
Uncommon Dizziness 
- Nekontrolirano mokrenje
Hyperresponsive patients should not be prescribed the therapeutic dose regimen of Bronchitol (see section 4.3).The usual precautions regarding bronchial hyperresponsiveness monitoring apply (see section 4.2). 
Hiperreaktivnim pacijentima ne smije se propisati terapijska doza Bronchitola (vidi dio 4.3.).
If you think you have used too much medicine, tell your doctor or pharmacist straight away. 
Ako uzmete više Bronchitola nego što ste trebali Ako mislite da ste uzeli previše lijeka, odmah se obratite liječniku ili ljekarniku.
How Bronchitol works 
Način djelovanja Bronchitola
Reproduction and developmental toxicity studies have not been carried out with inhaled mannitol. 
Ispitivanja toksičnosti inhalacijskog manitola na reprodukciju i razvoj nisu provedena.
Note: There were some differences in analysis methods across the 3 studies. 
Apsolutna promjena % predviđene vrijednosti Relativna promjena % predviđene vrijednosti Napomena: postojale su neke razlike u metodama analize u 3 ispitivanja.
Condition aggravated, Chest discomfort Uncommon Pyrexia, Fatigue, Influenza like illness, Hernia pain, Malaise, Chest pain 
Često pogoršanje stanja, nelagoda u prsištu Manje često pireksija, umor, bolest nalik gripi, bol zbog hernije, malaksalost, bol u prsištu
Expiratory Volume in first second of expiration (FEV1) is usually less than 30%. 
- ako imate teški oblik cistične fibroze, posebice ako Vam je funkcija pluća izmjerena forsiranim ekspiracijskim volumenom zraka u prvoj sekundi izdisaja (FEV1) obično manja od 30%.
Pharmaxis Europe Limited Teл. 
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Pharmaxis Europe Limited
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: 
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet: België/Belgique/Belgien
Uncommon Musculoskeletal chest pain 
Manje često mišićno-koštana bol prsišta
Uncommon Pyrexia 
Manje često pireksija
Special populations 
Posebne populacije pacijenata
Prepare for inhalation - Tilt the inhaler so that the mouth-piece faces slightly downward. 
- Nagnite inhalator tako da nastavak za usta bude okrenut malo prema dolje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - PAKIRANJE ZA POČETNU DOZU
Infections and infestations Uncommon Bacterial disease carrier, Bronchitis, Bronchopneumonia, Lung infection, Oral candidiasis, Pharyngitis, Staphylococcal infection, Upper respiratory tract infection 
Manje često kliconoša bakterijskih bolesti, bronhitis, bronhopneumonija, infekcija pluća, oralna kandidijaza, faringitis, infekcija uzrokovana stafilokokom, infekcija gornjih dišnih puteva
In DPM-CF-303 imputation of missing data was performed using a baseline observation carried forward (BOCF) approach whereas no imputation was performed in DPM-CF-301 or DPM-CF-302. 
U DPM-CF-303 nedostajućih podaci imputirani su korištenjem prenošenja podataka s početka promatranja (engl. baseline observation carried forward,
Do not remove capsules from blister until immediately before use. 
Kapsule se smiju izvaditi iz blistera isključivo netom prije uporabe.
Capsules contain powder for oral inhalation using the inhaler device enclosed. 
Kapsule sadrže prašak za inhalaciju kroz usta uz pomoć priloženog inhalatora.
- The powder in the capsules must only be inhaled using the inhaler included in the pack. 
- Prašak iz kapsula smije se samo inhalirati uz pomoć inhalatora isporučenog u paketu.
- Then open it by turning the mouth-piece in the direction of the arrow on the inhaler. 
- Okrenite nastavak za usta u smjeru strelice na inhalatoru kako biste otvorili inhalator.
The primary pre-specified endpoint i.e. the change from baseline in FEV1 (ml) in the modified ITT (mITT) population (n=269, 297 and 423 in studies DPM-CF-301,DPM-CF-302 and DPM-CF-303, respectively) compared to control over the 26 weeks period is provided in Table 3 alongside FEV1 presented as absolute and relative change % predicted. 
Primarna prethodno specificirana mjera ishoda tj. promjena FEV1 (ml) u odnosu na početnu vrijednost u modificirane ITT (mITT) populacije (n = 269, 297 i 423 u ispitivanjima DPM-CF-301, DPM-CF
For more advice on how to look after your inhaler, please see the end of the instructions. 
Savjete o održavanju inhalatora potražite na kraju uputa.
Below is a diagram that shows what the inhaler looks like. 
U nastavku se nalazi dijagram inhalatora.
Cough, Condition aggravated, Haemoptysis, Oropharyngeal pain, Chest discomfort, Wheezing, Asthma, Productive cough 
Često kašalj, pogoršanje stanja, hemoptiza, orofaringealna bol, nelagoda u prsištu, piskanje, astma, produktivni kašalj
<20% within 15 minutes; - FEV1 has fallen ≥50% (from baseline) at the end of the assessment. 
- vrijednost FEV1 pala je za 20- < 50% (u odnosu na početnu vrijednost) na kraju procjene i nije se vratila na < 20% unutar 15 minuta - smanjenje vrijednosti FEV1 za ≥ 50% (u odnosu na početnu vrijednost) na kraju procjene.
Inhaler device 
Inhalator
Each hard capsule contains 40 mg mannitol. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 40 mg manitola.
The excretion of mannitol in milk has not been studied in animals. 
Nema podataka o izlučivanju manitola u mlijeko životinja.
Medicare Pharma S.L.C Tel: +34 91 848 9534 
Tel: +34 91 848 9534