FrancophonIA/ELRC3.0 huggingface dataset:
English: One 2-week treatment pack of Bronchitol contains 28 blisters with 10 capsules each (280 capsules in total) and 2 inhalers.
Slovenian: Eno pakiranje zdravila Bronchitol za dvotedensko zdravljenje vsebuje 28 pretisnih omotov po 10 kapsul (skupno 280 kapsul) in 2 inhalatorja.
English: - If you are breast-feeding or plan to breast-feed ask your doctor for advice before using this medicine.
Slovenian: - Če dojite ali načrtujete dojenje, se posvetujte s svojim zdravnikom, preden uporabite to zdravilo.
English: These figures for study DPM-CF-302 (N=305) are as follows: 65.24 (SD:13.90) and 64.35 (SD:15.29).
Slovenian: Ti vrednosti sta bili v študiji DPM-CF-302 (n=305) 65,24 (SD:13,90) v skupini, ki je prejemala manitol, in 64,35 (SD:15,29).
English: Nonclinical toxicology studies indicate that mannitol inhaled into the lungs is absorbed into the bloodstream, with the maximum serum concentration being achieved occurring at 1 hour.
Slovenian: Neklinične toksikološke študije kažejo, da se manitol, ki je inhaliran v pljuča, absorbira v krvni obtok.
English: 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.
Slovenian: V študiji 303 je relativna sprememba (95-odstotni interval zaupanja) za uporabnike rhDNaze znašala 1,30 (-0,91; 3,51), za neuporabnike pa 4,45 (- 0,52; 8,38).
English: In female patients, the adjusted mean change in FEV1 was 27ml for Bronchitol and 44ml for the control arm, suggesting potentially inferior benefit on lung function with Bronchitol compared to the control, although the difference was not statistically significant (p=0.480).
Slovenian: Študija 303 z zdravilom Bronchitol ni pokazala boljšega terapevtskega učinka na FEV1 pri ženskah, pri katerih je lahko, iz še ne popolnoma razumljivih razlogov, potek cistične fibroze hujši kot pri moških.Pri bolnicah je bila prilagojena povprečna sprememba FEV1 27 ml za zdravilo Bronchitol in 44 ml za kontrolno roko, kar kaže na potencialno slabše koristi pri pljučni funkciji z Bronchitolom v primerjavi s kontrolo, čeprav razlika ni bila statistično pomembna (p = 0,480).
English: In study 303 13.4% subjects in the mannitol arm and 13.6% in the control had a PDPE.
Slovenian: V študiji 303 je imelo PDPE 13,4 % preiskovancev v skupini, ki je prejemala manitol in 13,6 % preiskovancev v kontrolni skupini,.
English: The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is bronchospasm.
Slovenian: Najpomembnejši neželeni učinek, povezan z uporabo zdravila Bronchitol med oceno začetnega odmerka v pediatrični populaciji, je bil bronhospazem.
English: - ≥10% fall from baseline in SpO2 at any point of the assessment; - FEV1 fall from baseline is ≥20% at 240 mg cumulative dose; - FEV1 has fallen 20-<50% (from baseline) at the end of the assessment and does not return to
Slovenian: - ≥10 % SpO2 pod izhodiščno raven kadarkoli med oceno; - ≥20 % upad FEV1 pod izhodiščno raven pri skupnem odmerku 240 mg; - upad FEV1 za 20 do <50 % pod izhodiščno raven na koncu ocene in se v 15 minutah ne vrne na raven <20 % pod izhodiščno ravnijo; - ≥50 % upad FEV1 pod izhodiščno raven na koncu ocene.
English: The most important adverse reaction associated with the use of Bronchitol is haemoptysis.
Slovenian: Najpomembnejši neželeni učinek, povezan z uporabo zdravila Bronchitol, je bila hemoptiza.
English: Nervous system
Slovenian: Organski sistem
English: Cough was commonly reported with use of Bronchitol in clinical studies (see section 4.8).
Slovenian: Pri uporabi zdravila Bronchitol v kliničnih študijah so pogosto poročali o kašlju (glejte poglavje 4.8).
English: 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.
Slovenian: 4. faza: bolnik vdihne 120 mg (3x40 mg kapsula) in izmerite FEV1 ter spremljajte SpO2; 5. faza: bolnik vdihne 160 mg (4x40 mg kapsula) in izmerite FEV1 ter spremljajte SpO2; 6. faza: 15 minut po začetnem odmerku izmerite bolnikov FEV1.
English: - Keeping the inhaler tilted downward, put the inhaler to your mouth and make sure you close your lips tightly around the mouth-piece.
Slovenian: - Inhalator obdržite v nagnjenem položaju in ga vstavite v usta, nato pa z ustnicami tesno objemite ustnik.
English: 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).
Slovenian: Najpogosteje ugotovljeni neželeni učinek, povezan z uporabo zdravila Bronchitol med oceno začetnega odmerka v pediatrični populaciji, je bil kašelj (4,8% bolnikov).
English: 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).
Slovenian: Najpogosteje ugotovljeni neželeni učinek, povezan z uporabo zdravila Bronchitol med oceno začetnega odmerka, je kašelj (2,9 % bolnikov) (glejte poglavje 4.4).
English: When you breathe in you should hear a ‘rattling' sound as the capsule spins in the inhaler.
Slovenian: Med vdihom boste slišali ropotanje kapsule, ki se vrti v inhalatorju.
English: The initiation dose carton contains 1 blister (of 10 capsules) and one inhaler device.
Slovenian: Škatla za začetni odmerek vsebuje 1 pretisni omot (10 kapsul) in en inhalator.
English: United Kingdom Chiesi Limited Tel: + 44 (0)161 488 5555
Slovenian: United Kingdom Cheisi Limited Tel: + 44 (0)161 488 5555
English: In study 302 15.2% subjects in the mannitol arm and 19% in the control had a PDPE.
Slovenian: V študiji 302 je imelo PDPE 15,2 % preiskovancev v skupini, ki je prejemala manitol, oz. 19 % v kontrolni skupini.
English: The contents of the capsules are inhaled via the inhaler device with one or two breaths.
Slovenian: Vsebina kapsul se vdihne z inhalatorjem z enim ali dvema vdihoma.
English: Chiesi Limited Tel: + 44 (0)161 488 5555
Slovenian: Cheisi Limited Tel: + 44 (0)161 488 5555
English: 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.
Slovenian: Pri mladostnikih (12-17 let) se je v 26 tednih odstotkovna vrednost napovedanega FEV1 v primerjavi s kontrolno skupino v prvi študiji relativno izboljšala za 3,31 % (95-odstotni IZ: -2,29; 8,90, n=55, p=0,245), v drugi študiji pa za 0,42 % (95-odstotni IZ: -5,45; 6,29, n=94, p=0,888).
English: In a study of 9 cystic fibrosis patients (6 adults, 3 adolescents), using 400 mg inhaled mannitol as a single dose (Day 1) then twice a day for 7 days (Days 2 - 7), pharmacokinetic parameters were similar for adults and adolescents, except for a longer average apparent terminal half life for adolescents (Day 1 = 7.29 hours, Day 7 = 6.52 hours) compared with adults (Day 1 = 6.10 hours, Day 7 = 5.42 hours).
Slovenian: Farmakokinetični parametri so bili podobni pri odraslih in mladostnikih, razen povprečne končne razpolovne dobe, ki je bila pri mladostnikih daljša (1. dan = 7,29 ur, 7. dan = 6,52 ur) kot pri odraslih (1. dan = 6,10 ur, 7. dan = 5,42 ur).
English: The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment is bronchospasm (see section 4.4).
Slovenian: Najpomembnejši neželeni učinek, povezan z uporabo zdravila Bronchitol med oceno začetnega odmerka, je bronhospazem (glejte poglavje 4.4).
English: Detailed instructions on how to use the inhaler can be found in the patient information leaflet.
Slovenian: Podrobno navodilo za uporabo inhalatorja je v priloženem navodilu za uporabo zdravila.
English: Bronchitol is a powder for inhalation that is filled into hard capsules.
Slovenian: Zdravilo Bronchitol je prašek za inhaliranje v trdih kapsulah.
English: Efficacy and safety have not been established in non-CF bronchiectasis patients.
Slovenian: Bronhiektazija, ki ni posledica cistične fibroze (CF) Varnost in učinkovitost zdravila pri bolnikih z bronhiektazijo, ki ni posledica CF, nista bili dokazani.
English: - Inhale the contents of the capsule using the inhaler, with one or two breaths in.
Slovenian: - Vsebino kapsul vdihnite z inhalatorjem z enim ali dvema vdihoma.
English: Bronchitol capsules can only be used with the inhaler provided in the pack.
Slovenian: Kapsule Bronchitol se lahko uporabljajo samo z inhalatorjem, priloženem pakiranju zdravila.
English: What Bronchitol is used for
Slovenian: Za kaj se zdravilo Bronchitol uporablja
English: The 2-week carton contains 28 blisters (of 10 capsules each) and two inhaler devices.
Slovenian: Škatla za 2-tedensko zdravljenje vsebuje 28 pretisnih omotov (vsak po 10 kapsul) in dva inhalatorja.
English: Take off the cap - Using both hands, hold the inhaler upright and take off the cap.
Slovenian: Snemite pokrovček - Z obema rokama držite inhalator pokonci in snemite pokrovček.
English: 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.
Slovenian: V preglednici 3 so prikazane primarna vnaprej določena končna točka (tj. sprememba FEV1 (ml) iz izhodiščne ravni) in absolutna ter relativna sprememba FEV1 glede na odstotkovno napovedano raven v modificirani populaciji z namenom zdravljenja (mITT) (n=269, 297 in 423v študiji DPM-CF301,DPM-CF-302 in DPM-CF-303) v primerjavi s kontrolno skupino v 26-tedenskem obdobju.
English: Cartons containing 10 or 280 capsules for initial dose and treatment use respectively.
Slovenian: Škatle po 10 kapsul za začetni odmerek ali po 280 kapsul za terapevtsko rabo.
English: This helps your lungs to clear mucus more easily.
Slovenian: To olajša odstranjevanje sluzi iz pljuč.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: - For the best results, inhale each capsule one after another, so there is as little delay as possible between capsules.
Slovenian: - Da bo zdravljenje čim bolj učinkovito, inhalirajte kapsulo za kapsulo s čim krajšim časovnim presledkom med kapsulami.
English: This was observed in 8.3% of patients compared to 4.0% of patients in the control arm.
Slovenian: Ugotovili so ga pri8,3 % bolnikov v skupini, ki je prejemala zdravilo Bronchitol, in pri 4,0 % bolnikov v kontrolni skupini.
English: 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
Slovenian: 1. faza: pred začetnim odmerkom se izmerita izhodiščni vrednosti FEV1 in SpO2; 2. faza: bolnik vdihne 40 mg (1x40 mg kapsula) in izmerite SpO2;
English: Shake it until there are no large water droplets left in the inhaler.
Slovenian: Stresajte ga, da odstranite velike kapljice iz inhalatorja.
English: However, if your inhaler does need cleaning, the steps to follow are: Ensure your inhaler is empty.
Slovenian: Če pa inhalator potrebuje čiščenje, je postopek naslednji:
English: 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.
Slovenian: Pri otrocih (6-11 let) se je v 26 tednih relativna odstotkovna vrednost napovedanega FEV1 v primerjavi s kontrolno skupino v študiji DPM-CF-301 izboljšala za 0,44 % (95-odstotni IZ: -5,90; 6,77, n=43, p=0,892), v študiji 302 pa za 6,1 % (95-odstotni IZ: -1,28; 13,54, n=59, p=0,104).
English: Pharmacotherapeutic group: Cough and cold preparations, Mucolytic.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje kašlja in prehlada, mukolitiki, oznaka ATC: R05CB16
English: For more advice on how to look after your inhaler, please see the end of the instructions.
Slovenian: Več nasvetov za vzdrževanje inhalatorja je na koncu navodil.
English: The powder is inhaled into the lungs using the inhaler provided in the pack.
Slovenian: Prašek se inhalira v pljuča z inhalatorjem, priloženim v pakiranju.
English: Inhaler device
Slovenian: Inhalator
English: 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.
Slovenian: V študiji DPM-CF-301 (varnostna populacija, n= 295) je bila napovedana povprečna (SD) izhodiščna odstotkovna raven FEV1 62,4 (SD:16,45) v skupini, ki je prejemala manitol, in 61,4 (SD:16,13) v kontrolni skupini.
English: Summary of Product Characteristics and Patient Information Leaflet Educational material for Healthcare Professionals
Slovenian: Izobraževalni paket mora vsebovati naslednje: povzetek glavnih značilnosti zdravila in navodilo za uporabo, izobraževalno gradivo za zdravnike.
English: No mutagenic or genotoxic effect has been revealed when mannitol was assayed in a standard battery of genotoxicity tests.
Slovenian: V standardnem naboru genotoksičnih testov manitol ni izkazal mutagene ali genotoksične aktivnosti.
English: Headache
Slovenian: Kašelj
English: 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).
Slovenian: Hiperodzivnim bolnikom se ne sme predpisati režima terapevtskega odmerka Bronchitol (glejte poglavje 4.3).
English: The most commonly observed adverse reaction associated with the use of Bronchitol is cough (see section 4.4).
Slovenian: Najpogosteje ugotovljeni neželeni učinek, povezan z uporabo zdravila Bronchitol, je bil kašelj (glejte poglavje 4.4).
English: - Never take your inhaler apart.
Slovenian: - Inhalatorja ne razstavljajte.
English: Store in the original blister in order to protect from moisture.
Slovenian: Hranite v originalnem pretisnem omotu, da preprečite vdor vlage.
English: Use your bronchodilator;
Slovenian: 1. bronhodilatator ;
English: Mannitol was shown not to be an irritant in an isolated bovine eye assay or when introduced into rabbit eyes.
Slovenian: V testu izoliranega govejega očesa ali pri vnosu v oči kunca se manitol ni pokazal kot dražljiva snov.
English: • recurrent bleeding ≥100 ml/day over several days The reinstitution or withholding of Bronchitol following smaller episodes of haemoptysis should be based on clinical judgement.
Slovenian: O ponovni uvedbi ali zadržanju zdravila Bronchitol po manjših epizodah hemoptize presodi zdravnik.
English: - Never place a capsule directly into the mouth-piece of your inhaler.
Slovenian: - Kapsule na vstavljajte v ustnik inhalatorja.
English: - If you do not hear the rattling, hold the inhaler with the mouth-piece facing downwards, and tap the bottom firmly.
Slovenian: - V tem primeru primite inhalator z ustnikom navzdol in po spodnji strani močno potrkajte.
English: Oropharyngeal pain, Wheezing Uncommon Productive cough, Throat irritation, Asthma, Bronchospasm, Forced expiratory volume decreased, Rhinorrhoea, Dyspnoea Dysphonia, Hyperventilation, Obstructive airways disorder, Respiratory tract congestion, Sputum discoloured, Hypoxia
Slovenian: , astma, bronhospazem, zmanjšan forsirani ekspiracijski volumen, rinoreja, dispneja disfonija, hiperventilacija, obstruktivna bolezen dihal, kongestija dihal, obarvan sputum, hipoksija bolezni prebavil pogosti bruhanje po kašljanju, bruhanje občasni navzea, driska, spahovanje, vetrovi, gastroezofagealna refluksna bolezen, glosodinija, siljenje na bruhanje, stomatitis, bolečine v zgornjem predelu trebuha, aftozni stomatitis, bolečine pri požiranju bolezni kože in podkožja občasni
English: - The powder in the capsules must only be inhaled using the inhaler included in the pack.
Slovenian: - Prašek v kapsulah je le za inhalacijo z inhalatorjem, priloženim v pakiranju zdravila.
English: Bronchitol 40 mg inhalation powder, hard capsules
Slovenian: Bronchitol 40 mg prašek za inhaliranje, trde kapsule
English: Impaired lung function
Slovenian: Okvarjeno delovanje pljuč
English: Animal reproduction studies have not been carried out with inhaled mannitol.
Slovenian: Študije učinka inhaliranega manitola na razmnoževanje živali niso bile opravljene.
English: Bronchitol should not be used by children and adolescents under the age of 18.
Slovenian: Otroci in mladostniki, mlajši od 18 let, zdravila Bronchitol ne smejo uporabljati, ker je v tej populaciji premalo informacij o zdravilu.
English: In this leaflet we call making the hole ‘piercing'.
Slovenian: V tem navodilu se za predrtje kapsule uporablja pojem „prediranje“.
English: If you think you have used too much medicine, tell your doctor or pharmacist straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Bronchitol, kot bi smeli Če menite, da ste vzeli preveč zdravila, se nemudoma posvetujte z zdravnikom ali farmacevtom.
English: - The usual dose is 10 capsules (400 mg) inhaled in the morning, and 10 capsules inhaled in the evening.
Slovenian: Odmerek za zdravljenje (pakiranje za dvotedensko zdravljenje) - Zdravilo Bronchitol morate uporabljati vsak dan. - Običajni odmerek je inhalacija 10 kapsul (400 mg) zjutraj in 10 kapsul zvečer.
English: The treatment effect of Bronchitol on FEV1 was less evident in the subgroup of patients who were receiving concomitant rhDNase.In rhDNase users in study 301 the relative change in FEV1 % predicted from baseline across 26 weeks of treatment was 2.83 (95% CI -0.62, 6.27).
Slovenian: Pri uporabnikih rhDNaze v študiji 301 je bila v 26 tednih relativna sprememba odstotkovne vrednosti FEV1, napovedane v izhodišču, 2,83 (95-odstotni IZ: -0,62; 6,27).
English: For the full list of excipients, see section 6.1.
Slovenian: Povprečni vneseni odmerek na kapsulo je 32,2 mg. Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Bronchitol is for inhalation use, using the inhaler provided in the pack.
Slovenian: Zdravilo Bronchitol se inhalira z inhalatorjem, priloženim v pakiranju.
English: Order of using this medicine
Slovenian: NAČIN IZDAJANJA ZDRAVILA
English: The following steps explain how to use the inhaler.
Slovenian: Uporaba inhalatorja je razložena po korakih v nadaljevanju.
English: Bronchitol 40 mg, inhalation powder, hard capsules mannitol
Slovenian: Bronchitol 40 mg, prašek za inhaliranje, trde kapsule manitol
English: Bronchitol 40 mg inhalation powder, hard capsules Mannitol
Slovenian: Bronchitol 40 mg prašek za inhaliranje, trde kapsule manitol
English: Patients must be monitored for bronchial hyperresponsiveness to inhaled mannitol during their initiation dose assessment before commencing the therapeutic dose regimen of Bronchitol.If the patient is unable to perform spirometry or complete the initiation dose assessment, they must not be prescribed Bronchitol.
Slovenian: Če bolnik ne more opravljati spirometrije ali dokončati oceno začetne količine odmerka, se Bronchitola ne sme predpisati.
English: Make a hole in the capsule - This lets the powder in the capsule be released when you breathe in.
Slovenian: - To omogoči izhajanje praška iz kapsule med vdihom.
English: How to store Bronchitol
Slovenian: Shranjevanje zdravila Bronchitol
English: Reproduction and developmental toxicity studies have not been carried out with inhaled mannitol.
Slovenian: Študije učinka inhaliranega manitola na sposobnost razmnoževanja in razvoj niso bile opravljene.
English: Uncommon Pyrexia
Slovenian: Furze Road
English: Talk to your doctor if the cough won't go away or worries you.
Slovenian: Če kašelj ne izzveni ali vas skrbi, se posvetujte s svojim zdravnikom.
English: Uncommon Musculoskeletal chest pain, Arthralgia, Back pain, Joint stiffness, Musculoskeletal pain Renal and urinary disorders Uncommon Urinary incontinence General disorders and administration site conditions
Slovenian: Akne, mrzel pot, srbenje, izpuščaj, srbeč izpuščaj bolezni mišično-skeletnega sistema in vezivnega tkiva občasni mišično-skeletne bolečine v prsnem košu, bolečine v sklepih, bolečina v hrbtu, otrdelost sklepov, mišično-skeletne bolečine bolezni sečil občasni urinska inkontinenca splošne težave in spremembe na mestu aplikacije pogosti stanje je poslabšano, nelagodje v prsnem košu občasni
English: The educational pack should contain the following:
Slovenian: Navodilo vsebuje:
English: - Then twist the mouth-piece into the closed position - when it is closed you will hear a ‘click'.
Slovenian: - Nato zavrtite ustnik v zaprti položaj.
English: The most commonly observed adverse reaction associated with the use of Bronchitol is cough.
Slovenian: Terapevtski režim odmerjanja (starost od 6 do 17 let) Najpogosteje ugotovljeni neželeni učinek, povezan z uporabo zdravila Bronchitol, je kašelj.
English: Dornase alfa (Pulmozyme) if this is part of your treatment routine Inhaled antibiotics if this is part of your treatment routine
Slovenian: Priporočeni vrstni red je naslednji, razen če vam zdravnik naroči drugače: uporabite bronhodilatator, počakajte 5 do 15 minut, vzemite zdravilo Bronchitol pred fizioterapijo, če je ta del vašega običajnega dnevnega zdravljenja, dornaza alfa (Pulmozyme), če je del vašega običajnega dnevnega zdravljenja, antibiotiki za inhaliranje, če so del vašega običajnega dnevnega zdravljenja.
English: Refer to enclosed leaflet for inhaler device instructions.
Slovenian: Glejte navodilo za uporabo inhalatorja v navodilu za uporabo.
English: For instructions on how to use the inhaler, see the end of the leaflet.
Slovenian: Podrobno navodilo za uporabo inhalatorja je na kocu tega navodila.
English: In study DPM-CF-303 (N=423) the baseline FEV1 percent predicted was 63.17 (SD: 15.15) and 62.98 (SD: 13.65).In study DPM-CF-301 64.4 % of the patient population were adults while in study DPM-CF302 this figure was 49.5%.
Slovenian: V teh preskušanjih ni bilo dovoljeno sočasno dajanje hipertonične fiziološke raztopineV študiji DPM-CF-303 (N = 432) je odstotkovna vrednost FEV1, napovedana v izhodišču, znašala 63,17 (SD: 15,15) in 62,98 (SD: 13,65).
English: Breastfeeding
Slovenian: Mouthpiece
English: - To get the best results from Bronchitol, inhale each capsule one after another.
Slovenian: - Da bo zdravljenje čim bolj učinkovito, inhalirajte kapsulo za kapsulo.
English: Study 303 did not show a superior treatment effect of Bronchitol on FEV1 for female patients, in whom the underlying cystic fibrosis disease course may be worse than males for reasons that are not fully understood.
Slovenian: Učinek zdravljenja z Bronchitolom na FEV1 je bil manj opazen v podskupini bolnikov, ki so prejemali sočasno rhDNase.
English: Use immediately after preparation.
Slovenian: Uporabite takoj po pripravi.
English: Proceed immediately to next step.
Slovenian: Nato takoj nadaljujte z naslednjim korakom.
English: Repeat the rinsing operation once or twice.
Slovenian: Postopek izpiranja ponovite enkrat ali dvakrat.
English: Each dose of vaccine contains:
Slovenian: Vsak odmerek cepiva vsebuje:
English: It should be used immediately after the preparation (all of the diluted vaccine should be used up within one hour).
Slovenian: Uporabiti ga je treba takoj po pripravi (celotno količino razredčenega cepiva morate porabiti v eni uri).
English: A single vaccination is sufficient to provide protection during the risk period.
Slovenian: Enkratno cepljenje zadostuje za zaščito v obdobju tveganja.
English: The instructions for use of this device should be strictly followed.
Slovenian: Strogo je treba upoštevati navodila za uporabo takih naprav.
English: Date of first authorisation: 09/08/2002 Date of last renewal: 06/07/2012
Slovenian: Datum pridobitve dovoljenja za promet: 09/08/2002 Datum zadnjega podaljšanje DzP: 06/07/2012