natgillin/translations-raw huggingface dataset:
PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic: 
Predložitev periodičnega poročila o varnosti zdravila pri uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg med pandemijo gripe:
What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg contains 
Kaj vsebuje cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
Therefore, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is not intended to be given at the same time as other vaccines. 
O sočasnem cepljenju s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in drugimi cepivi ni podatkov, zato cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg ni namenjeno za uporabo skupaj z drugimi cepivi.
Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 
Shranjevanje cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
There are no data on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg given at the same time as other vaccines. 
Podatki o spremljanju cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg po pridobitvi dovoljenja za promet niso na voljo.
Only do this once. 
To napravite enkrat.
Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017 
Datum prve odobritve: 13 April 2012 Datum zadnjega podaljšanja: 11 Januar 2017
Absolute mL 
Absolutni ml
(See Table 1). 
(glejte preglednico 1).
- Worsening of symptoms. 
- Poslabšanje simptomov.
Your doctor will tell you how long to use this medicine for. 
Zdravnik vam bo povedal, kako dolgo jemati to zdravilo.
- Breathe out, and then breathe normally again. 
- Izdihnite in spet normalno dihajte.
Adults 18 years of age and over 
Odrasli, stari 18 let in več
The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years. 
Predlagatelj mora predložiti redne analize študije CF vsakih 6 mesecev v obdobju 3 let in letno v obdobju 2 let.
Note: There were some differences in analysis methods across the 3 studies. 
Opomba: metode analiziranja v teh treh študijah so se med seboj nekoliko razlikovale.
There are no data available for children under 12 years of age. 
Za otroke, mlajše od 12 let, ni razpoložljivih podatkov.
Patients should be advised to carefully read them. 
Bolnikom je treba naročiti, naj navodilo temeljito preberejo.
The first dose is taken in 4 steps: 
Prvi odmerek se vzame v 4 fazah:
No formal interaction studies have been conducted. 
Formalnih študij medsebojnega delovanja niso izvedli.
Initiation dose (6 to 17 years of age) 
Začetni odmerek (starost od 6 do 17 let)
If the capsule has not emptied you may need to repeat steps 6 to 8. 
Če se kapsula ni izpraznila, morate ponoviti postopek od 6. do 8. točke.
It is not known if this medicine passes into the breast milk. 
Ni znano, ali to zdravilo prehaja v materino mleko.
This happens commonly, which may affect up to 1 in 10 people. 
To je pogosto in se lahko pojavi pri do 1 bolniku od 10.
• acute bleeding ≥240 ml in a 24-hour period 
• akutna krvavitev ≥240 ml v obdobju 24 ur,
Leave it to dry in the air - lay it on its side with the mouth-piece open. 
Posušite ga na zraku - položite ga na bok z odprtim ustnikom.
Inhaled antibiotics (if applicable) 
5. inhalirani antibiotiki (če je potrebno).
Absolute % predicted Relative % predicted 
Absolutna sprememba napovedane % ravni Relativna sprememba napovedane % ravni
For patients receiving several respiratory therapies, the recommended order is: 
Pri bolnikih, ki prejemajo več terapij za dihala, je priporočeni vrstni red:
However, if it is nearly time for the next dose, skip the missed dose. 
Če pa je skoraj čas za naslednji odmerek, pozabljeni odmerek preskočite.
Dornase alfa (if applicable) 5. 
4. dornaza alfa (če je potrebno);
Put in the capsule - First make sure your hands are dry. 
Vstavite kapsulo - Najprej se prepričajte, da imate suhe roke.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data). 
Opredelitev pogostnosti: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (≥1/100.000 do <1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients. 
Varnostni profil zdravila Bronchitol je bil ovrednoten v kliničnih študijah, ki so vključevale več kot 1200 bolnikov.
The Tmax after inhaled administration was 1.5 ± 0.5 hours. 
Vrednost Tmax po inhaliranju je bila 1,5 ± 0,5 ure.
The inhaler device is to be replaced after one week of use. 
Inhalator je treba zamenjati po enem tednu uporabe.
Productive cough can contribute to sputum clearance. 
Produktivni kašelj lahko prispeva k očistku sputuma.
o The need for monitoring and when to withhold treatment. 
o potreba po spremljanju in primeri, ko je treba zdravljenje prekiniti.
Cleaning the inhaler - Usually your inhaler will give you the correct dose of medicine for 7 days without needing cleaning. 
Čiščenje inhalatorja - Običajno bo inhalator zagotovil pravilni odmerek zdravila 7 dni brez potrebe po čiščenju.
Repeat steps 3 to 10 for each capsule - Perform these steps for each of the ten capsules. 
Ponovite postopek od 3. do 10. točke za vsako kapsulo - Postopek ponovite za vsako kapsulo od desetih.
All FEV1 measurements and SpO2 monitoring should be performed 60 seconds after dose inhalation. 
Vse meritve FEV1 in spremljanje SpO2 je treba začeti 60 sekund po inhalaciji odmerka.
The recommended dose of Bronchitol is 400 mg twice a day. 
Priporočeni odmerek zdravila Bronchitol je 400 mg dvakrat na dan.
You must let it fully dry, this can take up to 24 hours. 
Inhalator morate popolnoma posušiti, kar lahko traja 24 ur.
This happens commonly. 
To je pogosto.
As well as using Bronchitol you will normally keep using the other medicines you take for cystic fibrosis. 
Poleg zdravila Bronchitol boste še naprej kot običajno uporabljali druga zdravila, ki jih jemljete za cistično fibrozo.
- Have the evening dose at least 2 to 3 hours before you go to bed. 
- Večerni odmerek vzemite vsake 2 do 3 ure pred spanjem.
It also helps improve the condition of your lungs and your breathing. 
Ravno tako izboljša stanje pljuč in dihanje.
As a result you may get a ‘productive cough', which also helps to remove mucus from your lungs. 
Posledično boste lahko imeli „produktivni kašelj,“ ki pripomore k odstranjevanju sluzi iz pljuč.
- Coughing up blood or blood in your sputum. 
- Če izkašljate kri ali opazite kri v sputumu.
The mean terminal half-life in adults was approximately 4 to 5 hours from serum and approximately 3.66 hours from urine. 
Pri odraslih je bila povprečna končna razpolovna doba iz seruma približno 4 do 5 ur, iz urina pa 3,66 ure.
Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations. 
Razpoložljivi podatki iz študij DPM-CF-301 in 302 kažejo, da prilagoditev odmerka za ti populaciji bolnikov ni potrebna.
The 2-week treatment pack is for treatment use. 
Pakiranje za dvotedensko zdravljenje je namenjeno zdravljenju.
- Take a steady deep breath in, to fill your lungs - then hold your breath for 5 seconds. 
- Z enakomernim globokim vdihom napolnite pljuča, nato pa držite dih 5 sekund.
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. 
Pogoji in zahteve za predložitev z zadnjimi podatki dopolnjenih rednih poročil o varnosti zdravila so določeni na seznamu referenčnih datumov Unije (seznam EURD), člen 107c(7) Direktive 2001/83/ES in spremembah, objavljenih na evropskem spletnem portalu za zdravila.
Do not try to loosen the capsule by pressing the piercing buttons again. 
Ne poskušajte sprostiti kapsule s ponovnim pritiskanjem gumbov za prediranje.
At the end of the initiation dose you will have taken 10 capsules (400 mg) which is the same as the usual dose. 
Na koncu začetnega odmerka boste prejeli 10 kapsul (400 mg), kolikor znaša običajni odmerek.
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. 
Primerjava vrednosti AUC med 1. in 7. dnem je v splošnem kazala časovno neodvisnost farmakokinetike, kar kaže na linearnost pri odmerkih, uporabljenih v tej študiji.
When administered intravenously, mannitol is eliminated largely unchanged by glomerular filtration and 87% of the dose is excreted in the urine within 24 hours. 
Intravensko uporabljeni manitol se izloči večinoma nespremenjen z glomerulno filtracijo in 87 % odmerka se izloči v urin v 24 urah.
The doctor may give you oxygen and medicines to help you breathe. 
Zdravnik vam bo morda za lažje dihanje dal kisik in zdravila.
The safety profile of Bronchitol is based on the safety data from Phase III clinical studies (including data from the initiation dose assessment). 
Varnostni profil zdravila Bronchitol temelji na varnostnih podatkih kliničnih študij III. faze (vključno s podatki ocene začetnega odmerka).
- If your inhaler breaks, use your second inhaler and talk to your doctor. 
- Če se inhalator pokvari, uporabite drugi inhalator in se posvetujte s svojim zdravnikom.
Lung deposition studies have demonstrated a 24.7% deposition of inhaled mannitol confirming its distribution to the target organ. 
V študijah nalaganja v pljučih so dokazali 24,7-odstotno nalaganje inhaliranega manitola, kar potrjuje njegovo porazdelitev v ciljnem organu.
The limited data available in adolescents aged 12 to 17 years indicate the pharmacokinetic parameters of inhaled mannitol are similar to the adult population. 
Omejena količina podatkov v populaciji mladostnikov, starih od 12 do 17 let, nakazuje na to, da so farmakokinetični parametri inhaliranega manitola podobni kot v odrasli populaciji.
p value 
Vrednost p
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. 
V študiji pri 18 zdravih moških odraslih prostovoljcih je bila absolutna biološka uporabnost manitola v obliki praška za inhalacijo v primerjavi z intravensko uporabljenim manitolom 0,59 % ± 0,15.
o How to interpret the results of the Bronchitol initiation dose assessment as Pass, Fail or Incomplete. 
o kako interpretirati izide ocene začetnega odmerka zdravila Bronchitol kot pozitivne, negativne ali nepopolne.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements 
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
This requires the inhalation of the contents of ten capsules via the inhaler device twice a day. 
To zahteva inhalacijo vsebine desetih kapsul prek inhalatorja dvakrat na dan.
This is because piercing the capsule more than once may make it split or break-up. 
Če kapsulo predrete večkrat, se lahko prepolovi ali razpade.
All patients should be monitored until their FEV1 has returned to baseline levels. 
Vse bolnike je treba spremljati, dokler ni FEV1 nazaj na izhodiščni ravni.
The educational material for Healthcare Professionals should be a leaflet that includes information on the following key elements: 
Izobraževalno gradivo za zdravnike mora biti navodilo za uporabo, ki vsebuje naslednje ključne informacije:
A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to glycogen and carbon dioxide. 
Majhen odstotek sistemsko absorbiranega manitola se v jetrih presnovi v glikogen in ogljikov dioksid.
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. 
Povišano število limfocitov, ki je bilo v okviru zgodovinskih kontrolnih vrednosti, ni napredovalo in je v bistvu do konca študije in po ukinitvi dajanja izzvenelo.
The initiation dose pack is used during the initiation dose assessment with your doctor. 
Pakiranje za začetni odmerek se uporablja med oceno začetnega odmerka pri vašem zdravniku.
Safety and efficacy have not been demonstrated in patients with a FEV1 of less than 30% of predicted (see section 5.1). 
Varnost in učinkovitost zdravila pri bolnikih s FEV1 manj kot 30 % od napovedane vrednosti nista bili dokazani (glejte poglavje 5.1).
You may: - feel that you cannot breathe; - become wheezy; - cough a lot. 
Morda boste: - dobili občutek, da ne morete dihati, - začeli piskajoče dihati, - precej kašljali.
Studies in rats, mice and humans have demonstrated that mannitol has no toxic metabolites. 
Študije pri podganah, miših in ljudeh kažejo, da manitol nima toksičnih presnovkov.
Check the capsule - Look to see if the capsule is empty - the capsule must spin in the inhaler in order to empty. 
Preverite kapsulo - Preverite, ali je kapsula prazna - kapsula se mora vrteti v inhalatorju, da se izprazni.
If excessive coughing and bronchoconstriction occurs, a beta2 agonist should be given, and oxygen if necessary. 
Če se pojavi čezmerno kašljanje ali bronhokonstrikcija, lahko uporabite beta2 agonist in po potrebi kisik.
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. 
Zdravilo Bronhitol je indicirano za zdravljenje cistične fibroze (CF) pri odraslih, starih 18 let ali več, kot dodatno zdravljenje k najboljšemu standardu oskrbe.
- Use a new inhaler each week. 
- Inhalator zamenjajte vsak teden.
If you stop using Bronchitol your symptoms may get worse. 
Če ste prenehali jemati zdravilo Bronchitol, se lahko vaše stanje poslabša.
If you forget to use Bronchitol - If you forget a dose, use it as soon as you remember it and carry on as usual. 
Če ste pozabili vzeti zdravilo Bronchitol - Če ste pozabili vzeti odmerek, ga vzemite, ko se spomnite in nadaljujte z običajnim režimom odmerjanja.
Paediatric population (6 to 17 years of age) Frequency, type and severity of adverse reactions in children are similar to those observed in adults. 
Pediatrična populacija (starost od 6 do 17 let) Pogostnost, vrsta in resnost neželenih učinkov pri otrocih so bile podobne kot pri odraslih.
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. 
Nosečnost in dojenje - Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden uporabite to zdravilo.
If this does not happen, the capsule may be stuck. 
Če ropotanja niste slišali, se je kapsula morda zataknila.
Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Ireland. 
Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Irska.
Overall Population 
Celotna populacija
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. 
Začetni odmerek zdravila Bronchitol je treba dati pod nadzorom in spremljanjem izkušenega zdravnika ali drugega zdravstvenega delavca, ki je ustrezno usposobljen in opremljen za izvedbo spirometrije, spremljanje nasičenosti s kisikom (SpO2) in obravnavo bronhospazma (glejte poglavji 4.4 in 4.8), vključno z ustrezno uporabo opreme za oživljanje.
Always take your bronchodilator before using Bronchitol. 
Vedno vzemite svoj bronhodilatator pred uporabo zdravila Bronchitol.
The use of Bronchitol is not recommended in these patients. 
Uporaba zdravila Bronchitol pri teh bolnikih ni priporočena.
This effect was not noted in any other species and did not result in clinical signs. 
Tega učinka, ki se ni pokazal kot klinični znak, niso opazili pri nobeni drugi živalski vrsti.
Each of the capsules is loaded into the device separately. 
Vsako kapsulo je treba vstaviti v pripomoček ločeno.
Hyperresponsiveness to mannitol 
Hiperodzivnost na manitol
Discard the inhaler and its cap 1 week after first use. 
Inhalator in njegov pokrovček zavrzite 1 teden po prvi uporabi.
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. 
Čeprav natančen mehanizem delovanja ni znan, lahko inhalirani manitol spremeni viskoelastične lastnosti sluzi, poveča hidracijo periciliarne tekočinske plasti in prispeva k večjemu očistku zadržanih izločkov zaradi mukociliarne aktivnosti.
The cumulative amount of mannitol filtered into the urine over the 24 hour collection period was similar for inhaled (55%) and oral (54%) mannitol. 
Kumulativna količina manitola, ki se prefiltrira v urin v 24 urah zbiranja, je bila za inhalirani manitol (55 %) podobna kot za peroralni (54 %).
The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime. 
Te odmerke vzamete zjutraj in zvečer, večerni odmerek 2 do 3 ure pred spanjem.
Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority. 
Imetnik dovoljenja za promet z zdravilom se mora, preden da zdravilo v promet v posamezni državi članici, z nacionalnim pristojnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva.
Repeat the inhalation to get your dose. 
Ponovite inhaliranje, da prejmete odmerek.
The initiation dose assessment described in section 4.2 should be repeated if uncertainty exists. 
V primeru dvoma je treba ponoviti oceno začetnega odmerka, opisano v poglavju 4.2.
- Then open it by turning the mouth-piece in the direction of the arrow on the inhaler. 
- Nato ga odprite tako, da zavrtite ustnik v smeri puščice na inhalatorju.
Do not use Bronchitol - if you are allergic to mannitol - if you are sensitive to mannitol. 
Ne uporabljajte zdravila Bronchitol, - Če ste alergični na manitol.
There are limited data from the use of mannitol in pregnant women. 
Podatki o uporabi manitola pri nosečnicah so omejeni.
Wash your inhaler in warm water with the mouth-piece open. 
Inhalator operite v topli vodi z odprtim ustnikom.
Physiotherapy/exercise 4. 
3. fizioterapija/telesna vadba;
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. 
Vendar v študijah peroralno dajanega manitola niso ugotovili znakov teratogenih učinkov pri miših in podganah pri odmerkih do 1,6 g/kg oz. pri hrčkih pri odmerkih do 1,2 g/kg.
Bacteria sputum identified 
Prepoznane bakterije v sputumu
It must not be administered by any other route or using any other inhaler. 
Ne sme se dajati na noben drug način ali z drugim inhalatorjem.
As a consequence, these patients should be carefully monitored, and Bronchitol should be withheld in the event of massive haemoptysis. 
Posledično je treba te bolnike natančno spremljati ter uporabo zdravila Bronchitol v primeru obsežne hemoptize prekiniti.
Average inhaled dose per capsule is 32.2 milligrams mannitol. 
Povprečni inhalirani odmerek na kapsulo je 32,2 miligramov manitola.
- Do not use a double dose to make up for a forgotten dose. 
- Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Use as directed by your doctor. 
Uporaba po navodilu zdravnika.
Arvato distribution GmbH Gottlieb-Daimler Straβe 1 33428 Harsewinkel North Rhine-Westphalia Germany 
Arvato distribution GmbH Gottlieb-Daimler Straβe 1 33428 Harsewinkel North Rhine-Westphalia Nemčija
There are no data on concomitant use of hypertonic saline with Bronchitol as it was excluded from the Phase 3 studies. 
Podatkov o sočasni uporabi hipertonične fiziološke raztopine z zdravilom Bronchitol ni, ker so bili izključeni iz študije 3. faze.
Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after taking this medicine. 
Inhalacija zdravil lahko povzroči tesnobo v prsnem košu ali piskajoče dihanje, kar se lahko zgodi nemudoma po jemanju tega zdravila.
Therefore, treatment with Bronchitol is not recommended. 
Zato zdravljenje z zdravilom Bronchitol ni priporočljivo.
Bronchospasm should be treated with a bronchodilator or as medically appropriate. 
Bronhospazem je treba zdraviti z bronhodilatatorjem ali kot je ustrezno.
The initiation dose assessment must be performed according to the following steps: 
Oceno začetnega odmerka je treba opraviti v naslednjih korakih:
The safety/efficacy of Bronchitol in patients with asthma has not been formally studied. 
Varnost in učinkovitost Bronchitol pri bolnikih z astmo nista bili uradno raziskani.
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. 
Bolnik mora dobiti premedikacijo z bronhodilatatorjem 5-15 minut pred začetnim odmerkom, vendar po izhodiščni meritvi FEV1 in SpO2 (nasičenost krvi s kisikom).
If either of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using this medicine. 
Če karkoli od zgoraj naštetega velja za vas (ali ste negotovi), se pred začetkom uporabe tega zdravila posvetujte s svojim zdravnikom ali farmacevtom.
Bronchitol has no or negligible influence on the ability to drive and use machines. 
Zdravilo Bronchitol nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Clear colourless hard capsules marked with ‘PXS 40 mg' and containing white or almost white powder. 
Prozorne, brezbarvne trde kapsule z oznako „PXS 40 mg“, ki vsebujejo bel ali skoraj bel prašek.
Bronchitol helps by increasing the amount of water on the surface of your airways and in your mucus. 
Zdravilo Bronchitol pomaga tako, da se poveča količine vode na površini dihalnih poti in v sluzi.
Table 3 - Change in FEV1 from baseline over 26 weeks in the mITT and adult populations 
Preglednica 3 - Sprememba FEV1 glede na izhodiščno raven v 26 tednih v populaciji mITT in odraslih preiskovancev
Mawdsleys Clinical Services, Unit 22, Quest Park, Wheatley Hall Road, Doncaster, DN2 4LT, United Kingdom. 
Mawdsleys Clinical Services, Unit 22, Quest Park, Wheatley Hall Road, Doncaster, DN2 4LT, Velika Britanija.
D18AY29 
Dublin 18, D18AY29 Irska
Your doctor may ask you to use other medicines such as a bronchodilator before taking Bronchitol. 
Zdravnik vam bo morda naročil, da pred jemanjem zdravila Bronchitol uporabite druga zdravila, kot je bronhodilatator.
The patient must complete and pass the initiation dose assessment before starting treatment with Bronchitol. 
Bolnik mora zaključiti in opraviti oceno začetnega odmerka pred začetkom zdravljenja z Bronchitolom.