natgillin/translations-raw huggingface dataset:
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.
The percentage of patients receiving inhaled antibiotics was 55% in study DPM-CF-301, 56% in study DPM-CF-302 and 52% in Study DPM-CF-303.
Odstotek bolnikov, ki so prejemali aerosol, je v študiji DPM-CF-301 znašal 55 %, v študiji DPM-CF-302 56 % in v študiji DPM-CF-303 52 %.
In the third study (DPM-CF-303) 423 adult patients were randomised in a 1:1 ratio to inhaled mannitol 400 mg twice daily or to control.
V tretji študiji (DPM-CF-303) je 423 bolnikov naključno razdeljenih v razmerju 1:1 v skupino, ki je prejemala 400 mg manitola v obliki aerosola dvakrat dnevno ali v kontrolno skupino.
You should avoid using this medicine if you are pregnant.
Med nosečnostjo se je uporabi tega zdravila bolje izogibati.
Adult Population
Odrasli
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.
Ocenjeni učinek zdravljenja (povprečna sprememba in 95% IZ glede na izhodišče po 26 tednih, populacija mITT) na FVC je bil 108,78 ml (95% IZ: 49,21; 168,35) v študiji 301, 71,4 ml (95% IZ: 10,57; 132,13) v študiji 302 in 40 ml (95 % IZ: -12, 92) v študiji 303.
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%).
V študiji 302 je bil najpogosteje prijavljen neželeni učinek med izvajanjem MTT kašelj pri sedmih bolnikih (2,1 %) in v študiji 303 je bil najpogosteje prijavljen neželeni učinek med izvajanjem MTT prav tako kašelj, ki se je pojavil pri osmih bolnikih
The risk of haemoptysis during treatment o That Bronchitol has not been studied in patients with a history of significant haemoptysis (>60 ml) in the previous three months.
Tveganje za hemoptizo med zdravljenjem o da zdravilo Bronchitol ni proučeno pri bolnikih z anamnezo pomembnih epizod hemoptize (>60 ml) v zadnjih treh mesecih.
What Bronchitol contains:
Kaj vsebuje zdravilo Bronchitol:
Patients must be advised to report worsening signs and symptoms of asthma during therapeutic use to their physician.
Bolnikom je treba naročiti, da zdravniku poročajo o znakih in simptomih poslabšanja astme med terapevtsko rabo.
Inhale - Tilt your head back slightly.
Inhalirajte - Glavo nagnite nekoliko vznak.
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.
V študiji 301 so bili najpogosteje prijavljeni neželeni učinki med izvajanjem MTT kašelj pri dvajsetih (5,3 %) preizkušancih, hropenje/bronhospazem pri sedmih (1,9 %) preizkušancih in nelagodje v prsnem košu pri šestih (1,6 %) preizkušancih.
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.
Neželeni učinki, ki so se pojavili samo pri oceni začetnega odmerka (MTT), so dehidracija, zmanjšanje prisilnega izdihavanja, hipoksija, diareja, bolečine v zgornjem delu trebuha, aftozni stomatitis, odinofagija, bolečine v prsih in povečana alkalna fosfataza v krvi.
- You should hold the inhaler along the bottom to make sure you don't press the piercing buttons.
- Inhalator primite za spodnji rob, pri čemer pazite, da ne pritisnete gumbov za prediranje.
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.
Zdravilo Bronchitol se vdihne v pljuča, da pomaga pri cistični fibrozi, dedni bolezni, ki prizadene žleze v pljučih, črevesju in trebušni slinavki tako, da izločajo tekočine, kot so sluz in prebavni sokovi.
How Bronchitol works
Kako zdravilo Bronchitol deluje
For mannitol no clinical data on fertility is available.
Kliničnih podatkov o vplivu manitola na plodnost ni.
Cough which led to cessation of treatment was also commonly experienced and was observed in 4.0% of patients in the Bronchitol treatment arm.
Pogosto je bil ugotovljen tudi kašelj, ki mu je sledila prekinitev zdravljenja, in sicer pri 4,0 % bolnikov v skupini, ki je prejemala zdravilo Bronchitol.
2-week treatment pack of 280 hard capsules and 2 inhalers
Pakiranje za dvotedensko zdravljenje z 280 trdimi kapsulami in 2 inhalatorjema.
Uncommon (may affect up to 1 in 100 people) - Burning or painful sensation on the tongue - CF related diabetes - Chest and abdominal pain - Change in voice - Cold sweat - Congestion - Dehydration - Decreased appetite - Diarrhoea - Ear pain - Feeling tired - Feeling dizzy - Feeling sick (nausea) - Feeling unwell - Flu and fever - Wind - Heartburn - Hernia pain - Hyperventilation - Itching, rash, acne - Joint stiffness and pain - Morbid thoughts - Mouth ulcers - Respiratory tract infection - Runny nose - Sputum infection - Throat irritation - Trouble sleeping - Yeast infection of the mouth (thrush) - Unintentional loss of urine
Občasni (se lahko pojavijo pri do 1 bolniku od 100) - pekoč ali boleč občutek na jeziku, - sladkorna bolezen v povezavi s cistično fibrozo, - bolečine v prsnem košu in trebuhu, - sprememba glasu, - mrzel pot, - kongestija, - dehidracija, - zmanjšan apetit, - driska, - bolečine v ušesu, - utrujenost, - omotica, - občutek slabosti (navzea), - slabo počutje, - gripa in zvišana telesna temperatura, - vetrovi, - zgaga, - bolečina zaradi kile, - hiperventilacija, - srbenje, izpuščaj, akne, - otrdelost sklepov in bolečine v sklepih, - morbidne misli, - razjede v ustih, - okužba dihal, - izcedek iz nosu, - okužba sputuma, - draženje grla, - moteno spanje, - kandidna okužba v ustih (sor), - nenamerno uhajanje urina.
This was observed in 7.8% of patients compared to 3.8% of patients in the control arm.
Ugotovili so ga pri 7,8 % bolnikov v skupini, ki je prejemala zdravilo Bronchitol, in pri 3,8 % bolnikov v kontrolni skupini.
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.
Če je treba inhalator očistiti, se prepričajte, da je pripomoček prazen, nato pa ga operite v topli vodi.
The metabolic pathway of inhaled mannitol was not examined in pharmacokinetic studies.
Presnovne poti inhaliranega manitola v študijah farmakokinetike niso proučili.
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.
Pri sedemindvajsetih (7,1 %) od 378 bolnikov, ki so opravljali test tolerance na manitol (MTT) v študiji 301, 18 (5,3 %) od 341 bolnikov v študiji 302 in 25 od 486 (5,1 %) bolnikov v študiji 303 je bil ugotovoljen pozitiven MTT; bolniki s pozitivnim testom so imeli ali 1) padec FEV1 > 20 % od izhodiščne vrednosti na središčni točki študije (4. korak) ali 2) znižanje od izhodiščne vrednosti > 20 % ob koncu testa, ki ni več narasla na < 20 % v 15 minutah, ali 3) zmanjšanje FEV1 > 50 % od izhodiščne vrednosti ob koncu testa (6. korak) ali 4) so imeli znižanje Sp02 na < 89 % med postopkom.
While it is drying, use your other inhaler.
Med sušenjem uporabite drugi inhalator.
In DPM-CF-303 imputation of missing data was performed using a baseline observation carried forward (BOCF) approach whereas no imputation was performed in DPM-CF-301 or DPM-CF-302.
V DPM-CF-303 so bili manjkajoči podatki nadomeščeni z vnosom izhodiščne vrednosti (BOCF); pri študijah DPM-CF-301 IN DPMCF-302 ni bilo nadomeščanja manjkajočih podatkov.
No evidence of carcinogenicity was observed when dietary mannitol (≤5%) was administered to mice and rats for 2 years.
Po dajanju manitola v prehrano (≤5 %) mišim in podganam, ki je trajalo 2 leti, niso opazili dokazov o karcinogenosti.
The therapeutic dose regimen should not be prescribed until the initiation dose assessment has been performed.
Terapevtski režim odmerjanja lahko predpišete šele po oceni začetnega odmerka.
- This allows the capsule to drop forward into the spinning chamber.
- Pri tem kapsula pade naprej v predel za vrtenje.
Carcinogenicity studies have not been carried out with inhaled mannitol.
Študije karcinogenosti inhaliranega manitola niso bile opravljene.
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.
Tveganje za bronhospazem med zdravljenjem o treba je oceniti začetni odmerek zdravila Bronchitol, da se z merjenjem stopnje bronhokonstrikcije po zaporednem dajanju manitola odkrijejo bolniki z bronhialno hiperodzivnostjo na inhalirani manitol.
In study 302 the relative change (95% CI) for rhDNase users and non-users was 3.21 (-0.61, 7.03) and 4.73 (-1.93, 11.40), respectively.
V študiji 302 je bila relativna sprememba (95-odstotni IZ) pri uporabnikih rhDNaze 3,21 (-0,61; 7,03), pri neuporabnikih pa 4,73 (-1,93; 11,40).
The active substance is mannitol.
Zdravilna učinkovina je manitol.
How to use Bronchitol
Kako uporabljati zdravilo Bronchitol
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).
Pri sedemindvajsetih (7,1 %) od 3789 bolnikov, ki so opravljali test tolerance na manitol (MTT) in so bili vključeni v študijo 301, osemnajstih (5,3 %) od 341 bolnikov, ki so bili vključeni v študijo 302, in petindvajsetih (5,1 %) od 486 bolnikov, vključenih v študijo 303, je bil ugotovljen pozitiven MTT.
Inhaling medicines can also cause cough and this can happen with Bronchitol.
Inhalacija zdravil, tudi zdravila Bronchitol, lahko povzroči tudi kašelj.
Capsules contain powder for oral inhalation using the inhaler device enclosed.
Kapsule vsebujejo prašek za peroralno inhalacijo s priloženim inhalatorjem.
Tell your doctor straight away if you notice any of the following side effects: - Severe cough.
Če opazite naslednje neželene učinke, se nemudoma posvetujte z zdravnikom: - Hud kašelj.
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 <
V populaciji z namenom zdravljenja (ITT) nerandomizirane študije odvisnosti učinka in odmerka, DPM-CF-202, je bilo povprečje (standardni odklon, SD) odstotkovne spremembe vrednosti FEV1 za odmerek 400 mg 8,75 (SD: 12,4) in -1,569 (SD: 9,0) za odmerek 40 mg (p <0,0001).
No treatment-related adverse effect occurred greater than 13 fold the maximal therapeutic dose.
Pri 13-kratniku največjega terapevtskega odmerka niso opazili z zdravljenjem povezanih neželenih učinkov.
One 2-week treatment pack of Bronchitol contains 28 blisters with 10 capsules each (280 capsules in total) and 2 inhalers.
Eno pakiranje zdravila Bronchitol za dvotedensko zdravljenje vsebuje 28 pretisnih omotov po 10 kapsul (skupno 280 kapsul) in 2 inhalatorja.
- If you are breast-feeding or plan to breast-feed ask your doctor for advice before using this medicine.
- Če dojite ali načrtujete dojenje, se posvetujte s svojim zdravnikom, preden uporabite to zdravilo.
These figures for study DPM-CF-302 (N=305) are as follows: 65.24 (SD:13.90) and 64.35 (SD:15.29).
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).