natgillin/translations-raw huggingface dataset:
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. 
Učinki možne hiperodzivne reakcije na bolnico in/ali plod niso znani, zato je potrebna previdnost pri predpisovanju zdravila Bronchitol nosečnicam.
Bronchitol is for use in adults 18 years of age and over. 
Zdravilo Bronchitol se uporablja pri odraslih, starih 18 let in več.
The safety and efficacy of Bronchitol in children and adolescents aged less than 18 years has not been established (see section 4.2). 
Varnost in učinkovitost zdravila Bronchitol pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani (glejte poglavje 4.2).
Other medicines and Bronchitol 
Druga zdravila in zdravilo Bronchitol
Your doctor will help you take your first dose of Bronchitol and check your lung function before, during and after dosing. 
Zdravnik vam bo pomagal vzeti prvi odmerek zdravila Bronchitol in preveril pljučno funkcijo pred, med in po odmerku.
Initiation dose 
Začetni odmerek
Patients with asthma must be carefully monitored for worsening signs and symptoms of asthma after the initiation dose of Bronchitol. 
Bolnike z astmo je treba natančno spremljati za znake in simptome poslabšanja astme po začetnem odmerku zdravila Bronchitol.
What you need to know before you use Bronchitol 
Kaj morate vedeti, preden boste uporabili zdravilo Bronchitol
- Hold the inhaler upright and fully press in both ‘Piercing' buttons on the sides of the inhaler at the same time, then release them. 
- Inhalator držite pokonci in sočasno pritisnite oba gumba za prediranje na straneh inhalatorja do konca, nato pa ju izpustite.
o How to perform the Bronchitol initiation dose assessment safely and how long to monitor the patient for. 
o kako varno oceniti začetni odmerek zdravila Bronchitol in kako dolgo spremljati bolnika.
However, studies with orally administered mannitol indicate no fertility effects (see section 5.3). 
Vendar študije s peroralno uporabljenim manitolom ne kažejo učinka na plodnost (glejte poglavje 5.3).
Training the patient to practice correct inhaler technique during the initiation dose assessment is important. 
Pomembno je usposabljanje bolnika za izvajanje pravilne tehnike uporabe inhalatorja med oceno začetnega odmerka.
After inhalation, each empty capsule is discarded before inserting the next capsule into the inhaler device with as little delay as possible between capsules. 
Po inhalaciji je treba prazno kapsulo zavreči pred vstavljanjem naslednje kapsule v inhalator, hkrati pa mora biti časovni presledek med kapsulama čim krajši.
Study DPM-CF-303 was all adult patients. 
V študiji DPM-CF-303 so sodelovali samo odrasli bolniki.
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. 
Pri bolnikih z astmo se lahko po opravljeni oceni začetnega odmerka pojavi reverzibilen, začasen, blag bronhospazem, zato je treba vse bolnike spremljati, dokler se njihov FEV1 ne vrne na izhodiščno raven.
As a precautionary measure, it is preferable to avoid the use of Bronchitol during pregnancy. 
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Bronchitol bolje izogibati.
Take out the used capsule - Turn the inhaler upside down, tap the bottom and throw the empty capsule away. 
Odstranite uporabljeno kapsulo - Inhalator obrnite na glavo, potrkajte po spodnji strani in zavrzite prazno kapsulo.
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: 
Bolnik je opredeljen kot hiperodziven na inhalirani manitol in se mu ne sme predpisati režima terapevtskega odmerka, če med oceno začetne količine odmerka opazite katerega izmed naslednjih znakov:
o The need to check that the patient knows how to correctly use the bronchodilator. 
o treba je preveriti, ali bolnik zna pravilno uporabljati bronhodilatator.
However, Bronchitol has been used in clinical studies in conjunction with standard cystic fibrosis therapies such as mucolytics, antibiotics (including tobramycin and colistimethate sodium), bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, and analgesics. 
Vendar so zdravilo Bronchitol uporabili v kliničnih študijah skupaj s standardnimi terapijami za cistično fibrozo, kot so mukolitiki, antibiotiki (vključno s tobramicinom in natrijevim kolistimetatom), bronhodilatatorji, encimi trebušne slinavke, vitamini, inhaliranimi in sistemskimi kortikosteroidi ter analgetiki.
Patients should be trained to practice correct inhaler technique during treatment and advised to report persistent cough with the use of Bronchitol to their physician. 
Bolnike je treba usposobiti za izvajanje pravilne tehnike uporabe inhalatorja med zdravljenjem in jim naročiti, naj zdravniku poročajo o perzistentnem kašlju pri uporabi zdravila Bronchitol.
If you are too sensitive to mannitol, your airways will become narrower, and you may find it harder to breathe. 
Če so vaša dihala preobčutljiva za manitol, se lahko zožijo, kar vam oteži dihanje.
The proportion of patients who experienced haemoptysis including haemoptysis reported during exacerbation was 7.0% in the mannitol arm and 7.7% in the control arm (see section 4.4). 
Razmerje bolnikov, ki so izkusili neželene učinke hemoptize, vključujoč poročano hemoptizo, med poslabšanjem bolezni je bila 7,0 % v skupini, ki je prejemala manitol, in 7,7 % v kontrolni skupini (glejte poglavje 4.4).
It is unknown whether mannitol is excreted in human milk. 
Ni znano, ali se manitol izloča v materino mleko.
If a therapy induced hyperresponsive reaction is suspected, Bronchitol should be discontinued. 
Če sumite inducirano hiperodzivno reakcijo, morate uporabo zdravila Bronchitol prekiniti.
An additional 2.8% (n=34) of patients from the three studies had incomplete MTTs and were not randomised. 
Pri 2,84 % (N = 34) preizkušancev iz vseh treh študij je bil ugotovljen nepopolen rezultat MTT, zato niso bili vključeni v naključni izbor.
A bronchodilator must be administered 5-15 minutes before each dose of Bronchitol. 
Bronhodilatator se mora uporabiti 5-15 minut pred vsakim odmerkom zdravila Bronchitol.
What Bronchitol is Bronchitol contains a medicine called mannitol which is a mucolytic agent. 
Kaj je zdravilo Bronchitol Bronchitol vsebuje učinkovino, ki se imenuje manitol in je mukolitik.
CARTON - 2-WEEK TREATMENT PACK 
ŠKATLA - PAKIRANJE ZA DVOTEDENSKO ZDRAVLJENJE
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. 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v času dajanja zdravila v promet zdravniki, za katere se pričakuje, da bodo uporabljali oz. predpisovali zdravilo Bronchitol, prejeli izobraževalni paket.
Bronchial hyperresponsiveness to inhaled mannitol (see section 4.4). 
Bronhialna hiperodzivnost na inhalirani manitol (glejte poglavje 4.4).
The rate and extent of absorption of mannitol after inhaled administration was very similar to that observed after oral administration. 
Hitrost in obseg absorpcije manitola po inhaliranju sta bila zelo podobna kot pri peroralnem dajanju.
Each capsule contains 40 milligrams mannitol. 
Vsaka kapsula vsebuje 40 miligramov manitola.
o The risk of bronchospasm during long term treatment even if the Bronchitol initiation dose assessment was initially passed and the need to reiterate it in case of doubt. 
o tveganje za bronhospazem med dolgoročnim zdravljenjem, čeprav je bolnik prestal prvotno oceno začetnega odmerka zdravila Bronchitol, in potreba po ponovitvi ocene v primeru negotovosti.
How to use your medicine - Bronchitol is breathed in (inhaled) as a powder from the capsule using the inhaler supplied in the pack. 
Kako uporabljati zdravilo - Zdravilo Bronchitol se vdihne (inhalira) kot prašek iz kapsule, z inhalatorjem, priloženim v pakiranju.
Bronchitol has not been studied in patients with a history of significant episodes of haemoptysis (>60 ml) in the previous three months. 
Zdravilo Bronchitol ni proučeno pri bolnikih z anamnezo pomembnih epizod hemoptize (>60 ml) v zadnjih treh mesecih.
For non-users the relative change was 4.30 (95% CI 0.53, 8.07). 
Pri neuporabnikih je bila relativna sprememba 4,30 (95-odstotni IZ: 0,53, 8,07).
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
If you stop using Bronchitol 
Če ste prenehali jemati zdravilo Bronchitol
Use Bronchitol as part of your normal daily treatment routine. 
Kdaj uporabiti to zdravilo Zdravilo Bronchitol uporabljajte kot del svojega običajnega dnevnega zdravljenja.
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 40 mg prašek za inhaliranje, trde kapsule vsebujejo bel ali skoraj bel prašek, napolnjen v prozorne, brezbarvne, trde kapsule, na katerih je natisnjen napis „PXS 40 mg“.
Stop using Bronchitol and see a doctor straight away if you notice the following serious side effects: - Difficulty breathing, which may be due to narrowing of the airways, worsening of asthma symptoms or wheezing. 
Če opazite naslednje resne neželene učinke, prenehajte jemati zdravilo Bronchitol in nemudoma poiščite zdravniško pomoč: - Oteženo dihanje, ki je lahko posledica zoženja dihalnih poti, poslabšanje simptomov astme ali piskajoče dihanje.
o That therapeutic doses of Bronchitol should only be prescribed if the patient has passed the initiation dose assessment. 
o Terapevtske odmerke zdravila Bronchitol se lahko predpiše le, če je bolnik prestal oceno začetnega odmerka.
CARTON - INITIATION DOSE PACK 
ŠKATLA - PAKIRANJE ZA ZAČETNI ODMEREK
Close the inhaler - Keep the inhaler in an upright position. 
Zaprite inhalator - Inhalator držite v pokončnem položaju.
However, studies conducted with mannitol administered via other routes indicated no effect on foetal survival in mice, rats and hamsters and on embryo and foetal development in rats and rabbits. 
Vendar v študijah manitola, dajanega na druge načine, niso ugotovili učinkov na preživetje ploda pri miših, podganah in hrčkih oz. razvoj zarodka in plodu pri podganah in kuncih.
Step 1 - 1 capsule (40 mg) Step 2 - 2 capsules (80 mg) Step 3 - 3 capsules (120 mg) Step 4 - 4 capsules (160 mg) 
1. faza - 1 kapsula (40 mg) 2. faza - 2 kapsuli (80 mg) 3. faza - 3 kapsule (120 mg)
Prepare for inhalation - Tilt the inhaler so that the mouth-piece faces slightly downward. 
Pripravite se za inhaliranje - Inhalator nagnite tako, da je ustnik obrnjen nekoliko navzdol.
All patients should be formally reviewed after approximately six weeks of Bronchitol treatment to assess for signs and symptoms suggestive of active substance induced bronchospasm. 
Vse bolnike je treba pregledati po približno šestih tednih zdravljenja z zdravilom Bronchitol za znake in simptome, ki kažejo na bronhospazem, induciran z aktivno snovjo.
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. 
Delež bolnikov s hemoptizo kot neželenim učinkom je bil 7,3 %, 3,3 % in 3,4 % v skupini, ki je prejemala zdravilo Bronchitol v študiji 301, 302 in 303, ter 3,4 %, 0 % in 5,6 %v kontrolnih skupinah.
- 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 
- če imate astmo, - če ste kdaj izkašljali kri ali opazili kri v sputumu, - če imate hudo cistično fibrozo, zlasti če je pljučna funkcija, izmerjena s forsiranim ekspiracijskim volumnom v prvi sekundi izdiha (FEV1), ponavadi pod 30 %.
o The need to review the patient after approximately six weeks to assess for signs and symptoms of bronchospasm. 
o bolnika je treba pregledati po približno šestih tednih, da se ocenijo znaki in simptomi bronhospazma.
The safety and efficacy of Bronchitol in children and adolescents aged 6 to 18 years has not yet been established. 
Varnost in učinkovitost zdravila Bronchitol pri otrocih in mladostnikih, starih od 6 do 18 let, še nista bili dokazani.
Driving and using machines Bronchitol is not likely to affect your ability to drive or use any tools or machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Bronchitol verjetno ne bo vplivalo na vašo sposobnost vožnje in upravljanja s stroji.
There is no evidence that mannitol is accumulated in the body, therefore distribution of inhaled mannitol was not examined in PK studies. 
Ni bilo dokazov, da se manitol v telesu kopiči, zato v študijah farmakokinetike porazdelitve manitola niso proučili.
Open the inhaler - Hold the bottom of the inhaler firmly with one hand. 
Odprite inhalator - Z eno roko trdno primite dno inhalatorja.
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. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom Bronchitol, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja z zdravilom Bronchitol za mater.
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.
It is for inhalation use only and must not be administered by any other route. 
Namenjeno je samo uporabi z inhalatorjem in ga ni dovoljeno dati oziroma vzeti na noben drug način.
Initiation dose must be used under medical supervision and include monitoring of lung function. 
Začetni odmerek morate uporabiti pod nadzorom zdravnika in ob spremljanju pljučne funkcije.
Below is a diagram that shows what the inhaler looks like. 
Spodaj je shema izgleda inhalatorja.
- Put the capsule into the capsule-shaped space in the bottom of the inhaler. 
- Kapsulo vstavite v prostor, posebej oblikovan za kapsule, na dnu inhalatorja.
What Bronchitol is and what it is used for 
Kaj je zdravilo Bronchitol in za kaj ga uporabljamo
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. 
Zdravnik mora v primeru dokazanega bronhospazma, induciranega z zdravilom, natančno oceniti, ali koristi nadaljevanja uporabe zdravila Bronchitol odtehtajo tveganje za bolnika.
- Each of the ten capsules is put into the inhaler one at a time. 
- Deset kapsul vstavite v inhalator eno po eno.
Bronchitol is an inhaled hyperosmotic medicinal product. 
Bronchitol je hiperosmotsko zdravilo za inhaliranje.
The final report is expected in Q3 
Končno poročilo se pričakuje v 1. četrtini leta 2018.
What Bronchitol looks like and contents of the pack: 
Izgled zdravila Bronchitol in vsebina pakiranja:
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. 
Med uporabo zdravila Bronchitol lahko še naprej uporabljate svoja zdravila za cistično fibrozo, tudi antibiotike za inhaliranje, kot sta tobramicin in natrijev kolistimetat.
Breathe out - Take the inhaler away from your mouth. 
Izdih - Inhalator odmaknite od ust.
Do not stop using your Bronchitol without talking to your doctor first, even if you feel better. 
Čeprav se počutite bolje, ne prenehajte z jemanjem zdravila Bronchitol, ne da bi se prej posvetovali s svojim zdravnikom.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
o The need of pre-medication by a bronchodilator 5-15 minutes before the Bronchitol initiation dose assessment and before each therapeutic administration of Bronchitol. 
o potreba po predhodni terapiji z bronhodilatatorjem 5-15 minut pred oceno začetnega odmerka zdravila Bronchitol in pred vsakim terapevtskim odmerjanjem zdravila Bronchitol.
Before commencing treatment with Bronchitol all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation dose (see sections 4.4 and 5.1). 
Pred uvedbo zdravljenja z zdravilom Bronchitol je treba vse bolnike med dajanjem začetnega odmerka oceniti za bronhialno hiperodzivnost na inhalirani manitol (glejte poglavji 4.4 in 5.1).
Susceptible persons may suffer bronchoconstriction in the event of an inhaled overdose. 
Pri dovzetnih osebah lahko v primeru inhalacije prevelikega odmerka pride do bronhokonstrikcije.
Effect size estimate 
Ocena velikosti učinka
What Bronchitol is and what it is used for What you need to know before you use Bronchitol How to use Bronchitol 
Kaj je zdravilo Bronchitol in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Bronchitol Kako uporabljati zdravilo Bronchitol Možni neželeni učinki
If you are not sure, talk to your doctor or pharmacist before using Bronchitol. 
Če ste negotovi, se pred uporabo zdravila Bronchitol posvetujte s svojim zdravnikom ali farmacevtom.
Therapeutic dose regimen 
Terapevtski režim odmerjanja
- Then take out a capsule from the blister (only remove the capsule just before use). 
- Nato iz pretisnega omota vzemite kapsulo (kapsulo vzemite tik pred uporabo).
A massive/serious haemoptysis is considered to be: 
Za obsežno hemoptizo se šteje naslednje:
The excretion of mannitol in milk has not been studied in animals. 
Izločanje manitola v materino mleko pri živalih ni bilo proučeno.
Bronchitol has not formally been studied in patients with impaired renal and hepatic function. 
Zdravilo Bronchitol ni uradno proučeno pri bolnikih z okvarjenim delovanjem ledvic ali jeter.
There are insufficient data in this population to support a recommendation for or against dose adjustment. 
Starostniki (≥65 let) Za to populacijo je premalo podatkov v podporo prilagoditvi odmerka oz. proti njej.
- Keep the inhaler tilted in this way and breathe out completely (away from the inhaler). 
- Inhalator obdržite v nagnjenem položaju in popolnoma izdihnite (stran od inhalatorja).
Inhalation use only. 
Samo za inhaliranje.
One initiation dose pack of Bronchitol contains 1 blister with 10 capsules and 1 inhaler. 
Eno pakiranje zdravila Bronchitol za začetni odmerek vsebuje 1 pretisni omot z 10 kapsulami in en inhalator.
Haemoptysis has been commonly reported with Bronchitol in clinical studies. 
O hemoptizi so pogosto poročali pri uporabi zdravila Bronchitol v kliničnih študijah.
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. 
Pri podganah moškega spola so po 13 tednih dajanja inhaliranega manitola v odmerkih, ki so bili več kot 9,3-krat večji od največjega odmerka, ugotovili zvišano število krožečih limfocitov in plazmacitozo čeljustne bezgavke.
Each hard capsule contains 40 mg mannitol. 
Ena trda kapsula vsebuje 40 mg manitola.
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. 
Preden vam bo zdravnik predpisal zdravilo Bronchitol, boste po njegovih navodilih vzeli prvi odmerek zdravila Bronchitol, zdravnik pa bo v vsaki fazi preveril pljučno funkcijo, da se prepriča, da niste občutljivi za manitol.
In dogs an increased occurrence of coughing was observed both during and immediately post dose for low and high dose inhaled mannitol administration. 
Pri psih so opazili večjo pojavnost kašlja med odmerjanjem majhnih in velikih odmerkov inhaliranega manitola in nemudoma po odmerjanju.
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 
Pogosti (se lahko pojavijo pri do 1 bolniku od 10) - kašelj, - nelagoden občutek v prsnem košu, - glavobol, - bolečine v grlu in žrelu ter nelagoden občutek pri požiranju, -- bruhanje, bruhanje po kašljanju.
The potential risk of cough related sequelae during treatment o The need to train the patient to minimise cough during administration in using the correct inhalation technique. 
Morebitno tveganje posledic med zdravljenjem, povezanih s kašljem o potreba po tem, da se bolnik nauči čim bolj zmanjšati kašelj med odmerjanjem in da uporablja pravilno tehniko inhaliranja.
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). 
V študiji 301 (populacija ITT) je bilo preiskovancev z vsaj enim v protokolu opredeljenim poslabšanjem pulmonalnega stanja (okrajšava PDPE) (opredeljeno kot prisotnost vsaj 4 simptomov in znakov ter uporaba intravenskih antibiotikov) 18,1 % v skupini, ki je prejemala manitol, oz. 28 % v kontrolni skupini.
Before you are started on Bronchitol, your doctor will check whether your airways are too sensitive to mannitol. 
Pred začetkom zdravljenja z zdravilom Bronchitol mora zdravnik preveriti, ali so morda vaša dihala preobčutljiva za manitol.
10 hard capsules and 1 inhaler 
10 trdih kapsul in 1 inhalator
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). 
Pojav so ugotovili pri zdravilu Bronchitol v kliničnih študijah tudi pri bolnikih, ki niso bili hiperodzivni na začetni odmerek inhaliranega manitola (glejte poglavje 4.8).
Adverse reactions that occurred only with initiation dose assessment (MTT) are bronchospasm, chest pain, odynophagia and retching 
Neželeni učinki, ki so se pojavili samo pri oceni začetnega odmerka (MTT), so bronhospazem, bolečina v prsih, odinofagija in bljuvanje.
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%. 
Petinpetdeset odstotkov bolnikov je prejemalo rhDNase v študiji DPM-CF-301, v študiji DPM-CF-302 je ta delež znašal 75 %, v študiji DPM-CF301 pa 67,6 %.
- Never leave a used capsule in your inhaler chamber. 
- Uporabljene kapsule ne puščajte v inhalatorju.
Three Phase 3, 26-week double blind, randomised, parallel arm, controlled, intervention studies (DPM-CF-301,DPM-CF-302 and DPM-CF-303) have been performed in which 324 (DPM-CF-301) and 318 (DPM-CF-302) patients aged 6 years and above were randomised in a 3:2 ratio to inhaled mannitol 400 mg twice daily or to control (inhaled mannitol 50 mg twice daily). 
Opravili so tri dvojno slepe, randomizirane, kontrolirane, intervencijske študije 3. faze z vzporednima skupinama, ki so trajale 26 tednov (DPM-CF-301, DPM-CF-302 in DPM-CF-303), v katerih so v razmerju 3 : 2 randomizirali 324 (DPM-CF-301) oz. 318 (DPM-CF-302) preiskovancev, starih 6 let in več, v skupino, ki je prejemala manitol 400 mg dvakrat na dan, in kontrolno skupino (inhalirani manitol 50 mg dvakrat na dan).
The safety and efficacy of Bronchitol in children aged less than 6 years has not been established. 
Varnost in učinkovitost zdravila Bronchitol pri otrocih, mlajših od 6 let, še nista bili dokazani.
Initiation dose assessment 
Ocena začetnega odmerka
Do not remove capsules from blister until immediately before use. 
Kapsule vzemite iz pretisnega omota šele tik pred uporabo.