FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Estonian: Patsientidele tuleb õpetada Bronchitoliga ravi ajal kasutama õiget inhaleerimistehnikat ning paluda neil teatada arstile, kui neil on püsiv köha.
English: If the inhaler does require cleaning, it must be ensured that the device is empty, then it should be washed in warm water and before re-use,the inhaler should be allowed to thoroughly air dry.
Estonian: Seejärel tuleb seda pesta sooja veega ja lasta enne uuesti kasutamist õhu käes korralikult kuivada.
English: For non-users the relative change was 4.30 (95% CI 0.53, 8.07).
Estonian: rhDNaasi mittekasutajatel oli antud näitaja suhteline muutus 4,30% (95% usaldusvahemik: 0,53; 8,07).
English: Initiation dose (6 to 17 years of age)
Estonian: Algannus (6…17 eluaastat)
English: The metabolic pathway of inhaled mannitol was not examined in pharmacokinetic studies.
Estonian: Inhaleeritava mannitooli metabolismiteid ei ole farmakokineetilistes uuringutes uuritud.
English: 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.
Estonian: 1. ja 7. päeva kontsentratsioonikõvera aluse pindala (AUC) võrdlemine näitas, et farmakokineetika on lineaarne ja ajast sõltumatu.
English: - To get the best results from Bronchitol, inhale each capsule one after another.
Estonian: - Parema tulemuse saamiseks inhaleerige kõik Bronchitoli kapslid järjest.
English: Patients with asthma must be carefully monitored for worsening signs and symptoms of asthma after the initiation dose of Bronchitol.
Estonian: Astmaga patsiente tuleb pärast Bronchitoli algannuse manustamist astma nähtude ja sümptomite süvenemise suhtes hoolikalt jälgida.
English: How to use Bronchitol
Estonian: Kuidas Bronchitoli kasutada
English: One 2-week treatment pack of Bronchitol contains 28 blisters with 10 capsules each (280 capsules in total) and 2 inhalers.
Estonian: Üks 2-nädalase raviperioodiks Bronchitoli pakend sisaldab 28 blistrit 10 kapsliga (kokku 280 kapslit) ja 2 inhalaatorit.
English: 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.
Estonian: Kõrvaltoimed, mis leidsid aset ainult lähteannuse hindamisel (MTT), on dehüdratsioon, väiksem forsseeritud ekspiratoorne mahtuvus (FEV), hüpoksia, diarröa, ülakõhu valud, aftoosne stomatiit, odünofaagia, valud rindkeres ja vere aluselise fosfataasi aktiivsuse suurenemine.
English: Bronchitol capsules can only be used with the inhaler provided in the pack.
Estonian: Bronchitoli kapsleid tohib kasutada ainult pakendis oleva inhalaatoriga.
English: Other side effects include:
Estonian: Muud kõrvaltoimed võivad olla järgmised:
English: The contents of the capsules are inhaled via the inhaler device with one or two breaths.
Estonian: Kapsli sisu inhaleeritakse inhalaatori kaudu ühe või kahe sissehingamisega.
English: The safety and efficacy of Bronchitol in children aged less than 6 years has not been established.
Estonian: Bronchitoli ohutus ja efektiivsus alla 6-aastastel lastel ei ole tõestatud.
English: A bronchodilator must be administered 5-15 minutes before each dose of Bronchitol.
Estonian: 5-15 minutit enne iga Bronchitoli annust tuleb manustada bronhilaiendajat.
English: Order of using this medicine
Estonian: Ravimi kasutamise järjekord
English: 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.
Estonian: Hinnanguline raviefekt FVC osas (keskmine muutus võrreldes lähtetasemega ja 95% usaldusvahemik 26 nädala vältel mITT-populatsioonis) oli 108,78 ml (95% usaldusvahemik: 49,21; 168,35) uuringus 301, 71,4 ml (95% usaldusvahemik: 10,57; 132,13) uuringus 302 ja 40 ml (95% usaldusvahemik: -12; 92) uuringus 303.
English: Close the inhaler - Keep the inhaler in an upright position.
Estonian: Sulgege inhalaator - Hoidke inhalaator püstasendis.
English: 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.
Estonian: Kõiki patsiente tuleb pärast ligikaudu 6-nädalast ravi Bronchitoliga põhjalikult hinnata toimeainest tingitud bronhospasmi nähtude ja sümptomite suhtes.
English: The rate and extent of absorption of mannitol after inhaled administration was very similar to that observed after oral administration.
Estonian: Mannitooli imendumisekiirus ja -määr pärast manustamist inhalatsioonina oli väga sarnane suukaudse manustamise väärtustega.
English: Initiation dose must be used under medical supervision and include monitoring of lung function.
Estonian: Algannus tuleb manustada meditsiinilise järelevalve all ja kopsutalitlust jälgides.
English: Check the capsule - Look to see if the capsule is empty - the capsule must spin in the inhaler in order to empty.
Estonian: Kontrollige kapslit - Kontrollige, kas kapsel on tühi.
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.
Estonian: 5. etapp: patsient inhaleerib 160 mg (neli 40 mg kapslit) ning seejärel mõõdetakse tema FEV1ja jälgitakse SpO2-väärtust.
English: Inhalation use only.
Estonian: Ainult inhalatsiooniks.
English: 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.
Estonian: Uuringus 301 mannitooli taluvuse testi (MTT) läbinud patsientidest 27 (7,1%) patsiendil 378st, uuringus 302 mannitooli taluvuse testi (MTT) läbinud patsientidest 18 (5,3%) patsiendil 341st ja uuringus 303 mannitooli taluvuse testi (MTT) läbinud patsientidest 25 patsiendil 486st (5,1%) oli positiivne MTT, mis oli määratletud kas 1) FEV1 vähenemine > 20% võrreldes lähtetasemega testi keskel (4. etapp) või 2) vähenemine võrreldes lähtetasemega > 20% testi lõpus, kusjuures täheldatud väärtus ei taastunud 15 minuti vältel < 20%, või 3) FEV1 vähenemine > 50% võrreldes lähtetasemega testi lõpus (6. etapp) või 4) SpO2 vähenemine < 89%-ni testi ajal.
English: For mannitol no clinical data on fertility is available.
Estonian: Andmed mannitooli toime kohta fertiilsusele puuduvad.
English: 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.
Estonian: Uuringus 301 olid kõige sagedamini esinenud kõrvaltoimed mannitooli taluvuse testi ajal köha 20 patsiendil (5,3%), vilistav hingamine / bronhospasm 7 patsiendil (1,9%) ja ebamugavustunne rindkeres 6 patsiendil (1,6%).
English: In dogs an increased occurrence of coughing was observed both during and immediately post dose for low and high dose inhaled mannitol administration.
Estonian: Koertel täheldati nii inhaleeritava mannitooli väikeste kui ka suurte annuste manustamise ajal ja kohe pärast manustamist köha esinemissageduse suurenemist.
English: Patients must be advised to report worsening signs and symptoms of asthma during therapeutic use to their physician.
Estonian: Patsientidele tuleb öelda, et nad teataksid ravimi terapeutilise kasutamise ajal arstile, kui astma nähud või sümptomid süvenevad.
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.
Estonian: Noorukitel (12-17 a) oli FEV1 eeldatav (%) suhteline suurenemine võrreldes kontrollrühmaga 26nädalase uuringuperioodi vältel vastavalt 3,31% (95% usaldusvahemik: -2,29; 8,90; n = 55) ja 0,42% (95% usaldusvahemik: -5,45; 6,29; n = 94) (vastavalt p = 0,245 ja 0,888).
English: Inhaled antibiotics (if applicable)
Estonian: 5. inhaleeritavad antibiootikumid
English: o How to perform the Bronchitol initiation dose assessment safely and how long to monitor the patient for.
Estonian: o Bronchitoli algannuse ohutu määramine ja patsiendi jälgimise aeg.
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).
Estonian: Kõige sagedam kõrvaltoime, mida on täheldatud Bronchitoli algannuse toime hindamise ajal, on köha (2,9% patsientidest) (vt lõik 4.4).
English: - Never take your inhaler apart.
Estonian: - Ärge võtke inhalaatorit koost lahti.
English: However, if your inhaler does need cleaning, the steps to follow are: Ensure your inhaler is empty.
Estonian: Kui inhalaatorit on vaja puhastada, siis tuleb veenduda, et see on tühi.
English: No formal interaction studies have been conducted.
Estonian: Koostoimeid ei ole uuritud.
English: Inhale - Tilt your head back slightly.
Estonian: Inhaleerige ravim - Kallutage pea veidi tahapoole.
English: The capsules must only be removed immediately before use.
Estonian: Kapsli tohib blistrist välja võtta alles vahetult enne kasutamist.
English: 2-week treatment pack of 280 hard capsules and 2 inhalers
Estonian: 2-nädalase raviperioodi pakend, mis sisaldab 280 kõvakapslit ja 2 inhalaatorit.
English: Do not try to loosen the capsule by pressing the piercing buttons again.
Estonian: Ärge vajutage kapsli vabastamiseks läbistamise nuppe.
English: The 2-week carton contains 28 blisters (of 10 capsules each) and two inhaler devices.
Estonian: 2-nädalase raviperioodi karp sisaldab 28 blistrit (igas 10 kapslit) ja 2 inhalaatorit.
English: It is unknown whether mannitol is excreted in human milk.
Estonian: Ei ole teada, kas mannitool eritub rinnapiima.
English: A massive/serious haemoptysis is considered to be:
Estonian: Hemoptüüs on massiivne või raske järgmistel tingimustel:
English: Animal reproduction studies have not been carried out with inhaled mannitol.
Estonian: Reproduktsiooniuuringuid loomadel ei ole inhaleeritava mannitooliga tehtud.
English: However, if it is nearly time for the next dose, skip the missed dose.
Estonian: Kui te peate varsti manustama juba järgmise annuse, siis jätke ununenud annus lihtsalt vahele.
English: 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 <
Estonian: Annuse-toime seose avatud uuringus DPM-CF-202 oli ravikavatsuslikus (ITT) populatsioonis FEV1 keskmine (SD) protsentuaalne muutus pärast 400 mg annuse inhaleerimist 8,75% (SD 12,4%) ja pärast 40 mg annuse inhaleerimist -1,569 (SD 9,0%) (p < 0,0001).
English: - You should hold the inhaler along the bottom to make sure you don't press the piercing buttons.
Estonian: - Hoidke inhalaatorit põhjast, et te ei vajutaks kogemata kapsli läbistamise nuppudele.
English: In study 302 the most frequent adverse reaction reported during the MTT was cough in seven patients (2.1%),and in study 303 the most frequently reported adverse reaction from the MTT was also cough in eight patients (1.6%).
Estonian: Uuringus 302 oli kõige sagedam mannitooli taluvuse testi ajal täheldatud kõrvaltoime köha 7 patsiendil (2,1%) ja uuringus 303 oli kõige sagedam mannitooli taluvuse testi ajal täheldatud kõrvaltoime samuti köha 8 patsiendil (1,6%).
English: - If you are breast-feeding or plan to breast-feed ask your doctor for advice before using this medicine.
Estonian: - Kui te imetate last või plaanite last imetada, rääkige enne selle ravimi kasutamist oma arstiga.
English: - Never place a capsule directly into the mouth-piece of your inhaler.
Estonian: - Ärge asetage kapslit inhalaatori huulikusse.
English: Bronchitol helps by increasing the amount of water on the surface of your airways and in your mucus.
Estonian: Bronchitol suurendab hingamisteede pinnal ja limas oleva vee hulka.
English: United Kingdom Chiesi Limited Tel: + 44 (0)161 488 5555
Estonian: United Kingdom Cheisi Limited Tel: + 44 (0)161 488 5555
English: - Inhale the contents of the capsule using the inhaler, with one or two breaths in.
Estonian: - Inhaleerige kapsli sisu inhalaatori abil ühe või kahe sissehingamisega.
English: Inhaler device
Estonian: Inhalaator
English: One initiation dose pack of Bronchitol contains 1 blister with 10 capsules and 1 inhaler.
Estonian: Bronchitoli algannuse pakendis on üks blister 10 kapsliga ja inhalaator.
English: Chiesi Limited Tel: + 44 (0)161 488 5555
Estonian: Cheisi Limited Tel: + 44 (0)161 488 5555
English: Shake it until there are no large water droplets left in the inhaler.
Estonian: Raputage inhalaatorit nii kaua, kuni inhalaatori sees ei ole enam suuri veepiisku.
English: Each of the capsules is loaded into the device separately.
Estonian: Iga kapsel asetatakse inhalaatorisse eraldi.
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.
Estonian: Tabelis 3 on esitatud uuringu esmase tulemusnäitaja FEV1 muutus (ml) võrreldes uuringu alguses esinenud väärtusega modifitseeritud ravikavatsuslikus populatsioonis (mITT) uuringutes DPM-CF301, DPM-CF-302 ja DPM-CF-303 (vastavalt n = 269, n = 297 ja n = 423) võrreldes kontrollrühmaga 26-nädalase raviperioodi lõpus nii absoluutväärtusena kui ka suhtelise protsentuaalse muutusena lähteväärtusest.
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.
Estonian: Uuringu alguses oli keskmine (SD) FEV1 % eeldatavast uuringus DPM-CF-301 (ohutuse hindamise populatsioon, n = 295) 62,4% (SD: 16,45%) mannitoolirühmas ja 61,4% (SD: 16,13%) kontrollrühmas.
English: The therapeutic dose regimen should not be prescribed until the initiation dose assessment has been performed.
Estonian: Enne algannuse toime hindamist ei tohi terapeutilist annustamisskeemi määrata.
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.
Estonian: Uuringus 303 oli suhteline muutus (95% usaldusvahemik) rhDNaasi kasutajatel ning mittekasutajatel vastavalt 1,30 (-0,91; 3,51) ja 4,45
English: N=269
Estonian: Üldpopulatsioon n = 269
English: Productive cough can contribute to sputum clearance.
Estonian: Produktiivne köha võib aidata röga paremini eritada.
English: The most important adverse reaction associated with the use of Bronchitol is haemoptysis.
Estonian: Kõige olulisem Bronchitoli kasutamisega seotud kõrvaltoime on hemoptüüs.
English: Cough was commonly reported with use of Bronchitol in clinical studies (see section 4.8).
Estonian: Kliinilistes uuringutes on Bronchitoli kasutamisel sageli esinenud köha (vt lõik 4.8).
English: How to store Bronchitol
Estonian: Kuidas Bronchitoli säilitada
English: 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).
Estonian: Uuringus 301 mannitooli taluvuse testi (MTT) läbinud patsientidest 27 (7,1%) patsiendil 378st, uuringus 302 mannitooli taluvuse testi (MTT) läbinud patsientidest 18 (5,3%) patsiendil 341st ja uuringus 303 mannitooli taluvuse testi (MTT) läbinud patsientidest 25 (5,1%) patsiendil 486st oli positiivne MTT.
English: Therefore, treatment with Bronchitol is not recommended.
Estonian: Selle tõttu ei ole ravi Bronchitoliga sellistel patsientidel soovitatav.
English: Uncommon Decreased appetite, CF related diabetes, Dehydration
Estonian: Isutus, tsüstilise fibroosiga seotud diabeet, dehüdratsioon
English: Concomitant administration with hypertonic saline was not permitted in these trials.
Estonian: Kummaski uuringus ei olnud hüpertoonilise soolalahuse samaaegne manustamine lubatud.
English: 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%.
Estonian: Uuringus DPM-CF-301 sai 55% patsientidest ravi rhDNaasiga ja uuringus DPM-CF-302 75% ning uuringus DPM-CF-303 67,6%.
English: Bronchitol is a powder for inhalation that is filled into hard capsules.
Estonian: Bronchitol on inhalatsioonipulber, mis on pakendatud kõvakapslitesse.
English: The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment with the paediatric population is bronchospasm.
Estonian: Kõige olulisem kõrvaltoime lastel, mis on seotud Bronchitoli kasutamisega algannuse toime hindamise ajal, on bronhospasm.
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).
Estonian: Kõige sagedam kõrvaltoime lastel, mida on täheldatud Bronchitoli algannuse toime hindamise ajal, on köha (4,8% patsientidest).
English: Dornase alfa (Pulmozyme) if this is part of your treatment routine Inhaled antibiotics if this is part of your treatment routine
Estonian: - Manustage alfadornaas (Pulmozyme), kui see kuulub teie raviskeemi.
English: What Bronchitol is and what it is used for What you need to know before you use Bronchitol How to use Bronchitol
Estonian: 1. Mis ravim on Bronchitol ja milleks seda kasutatakse 2. Mida on vaja teada enne Bronchitoli kasutamist 3.
English: The most important adverse reaction associated with the use of Bronchitol during the initiation dose assessment is bronchospasm (see section 4.4).
Estonian: Kõige olulisem kõrvaltoime, mis on seotud Bronchitoli kasutamisega algannuse toime hindamiseks, on bronhospasm (vt lõik 4.4).
English: Make a hole in the capsule - This lets the powder in the capsule be released when you breathe in.
Estonian: - Kui kapsel on läbistatud, saate kapslis olevat pulbrit sisse hingata.
English: p value
Estonian: p
English: Extra information on how to look after your inhaler - Keep your inhaler dry and always make sure your hands are dry before using it. - Never breathe or cough into your inhaler.
Estonian: Lisateave inhalaatori hoolduse kohta - Hoidke inhalaator kuiv ja kasutage inhalaatorit ainult kuivade kätega.
English: Mannitol was shown not to be an irritant in an isolated bovine eye assay or when introduced into rabbit eyes.
Estonian: Isoleeritud veise silmatestis ega manustamisel küüliku silmadesse ei täheldatud mannitoolil ärritavat toimet.
English: The risk of bronchospasm during treatment o The need to perform the Bronchitol initiation dose assessment to identify patients who have bronchial hyperresponsiveness in response to inhaled mannitol by measuring the degree of bronchoconstriction that occurs following sequential administrations of mannitol.
Estonian: Raviaegse bronhospasmi risk o Vaja on määrata Bronchitoli algannus, et tuvastada patsiendid, kes on inhaleeritud mannitooli suhtes bronhiaalselt ülitundlikud.
English: Bronchitol is inhaled into the lungs to help with cystic fibrosis, an inherited disease that affects the glands in the lungs, gut and pancreas that secrete fluids such as mucus and digestive juices.
Estonian: Tsüstiline fibroos on pärilik haigus, mis mõjutab kopse, soolt ja kõhunääret ning nendes erituvaid vedelikke, näiteks lima ja seedevedelikke.
English: Haemoptysis has been commonly reported with Bronchitol in clinical studies.
Estonian: Kliinilistes uuringutes on Bronchitoli kasutamisel sageli esinenud hemoptüüsi.
English: Repeat the inhalation to get your dose.
Estonian: Korrake annuse manustamiseks inhaleerimist.
English: This was observed in 8.3% of patients compared to 4.0% of patients in the control arm.
Estonian: Köha esines Bronchitoli saavas rühmas 8,3% patsientidest ja kontrollrühmas 4,0% patsientidest.
English: In study 303 13.4% subjects in the mannitol arm and 13.6% in the control had a PDPE.
Estonian: Uuringus 303 täheldati uuringuprotokollis defineeritud pulmonaalset ägenemist 13,4%-l patsientidest mannitoolirühmas ja 13,6%-l patsientidest kontrollrühmas.
English: The most commonly observed adverse reaction associated with the use of Bronchitol is cough (see section 4.4).
Estonian: Kõige sagedamini täheldatud kõrvaltoime Bronchitoli kasutamise ajal on köha (vt lõik 4.4).
English: - The powder in the capsules must only be inhaled using the inhaler included in the pack.
Estonian: - Kapslites olev pulber tuleb inhaleerida pakendis oleva inhalaatori abil.
English: In study 302 15.2% subjects in the mannitol arm and 19% in the control had a PDPE.
Estonian: Uuringus 302 täheldati uuringuprotokollis defineeritud pulmonaalset ägenemist 15,2%-l patsientidest mannitoolirühmas ja 19%-l patsientidest kontrollrühmas.
English: This was observed in 7.8% of patients compared to 3.8% of patients in the control arm.
Estonian: Nende patsientide osakaal, kellel esines köha, oli Bronchitoli rühmas 7,8% ja kontrollrühmas 3,8%.
English: Keep this leaflet.
Estonian: Kõrvaltoimete tabel .
English: Capsules contain powder for oral inhalation using the inhaler device enclosed.
Estonian: Kapslid sisaldavad suukaudse inhalatsiooni pulbrit, mis manustatakse komplekti inhalaatori abil.
English: No mutagenic or genotoxic effect has been revealed when mannitol was assayed in a standard battery of genotoxicity tests.
Estonian: Standardsetes genotoksilisuse uuringutes ei leitud mannitoolil mutageenseid ega genotoksilisi toimeid.
English: - Then open it by turning the mouth-piece in the direction of the arrow on the inhaler.
Estonian: - Inhalaatori avamiseks keerake huulikut inhalaatoril oleva noole suunas.
English: Table 3 - Change in FEV1 from baseline over 26 weeks in the mITT and adult populations
Estonian: FEV1 muutus võrreldes lähtetasemega 26-nädalase raviperioodi lõpus kõigi patsientide ja täiskasvanud patsientide populatsioonis (mITT)
English: Bronchodilator
Estonian: 1. bronhodilataator
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%.
Estonian: Uuringus DPM-CF-302 (n = 305) olid samad tulemused vastavalt 65,24% (SD: 13,90%) ja 64,35% (SD: 15,29%).Uuringus DPM-CF-303 (n = 423) oli eeldatav FEV1 lähtetaseme % 63,17% (SD: 15,15%) ja 62,98% (SD: 13,65%).
English: FEV1 (95% CI)
Estonian: FEV1 usaldusvahemik)
English: Aluminium/polyamide/PVC/aluminium blisters.
Estonian: Pakendatud kahekordsest alumiiniumist/PVC-st/PVC-st/alumiiniumist blistritesse ja väliskarpi, mis sisaldavad alg- või raviannuseks vastavalt 10 või 280 kapslit.
English: The initiation dose carton contains 1 blister (of 10 capsules) and one inhaler device.
Estonian: Algannuse karbis on 1 blister (10 kapslit) ja inhalaator.
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
Estonian: Produktiivne köha, kurguärritus, astma, bronhospasm, forsseeritud ekspiratoorse mahu vähenemine, ninavoolus, düspnoe, düsfoonia, hüperventilatsioon, hingamisteede obstruktiivne häire, hingamisteede ummistumine, röga värvuse muutus, hüpoksia