natgillin/translations-raw huggingface dataset:
All patients should be monitored until their FEV1 has returned to baseline levels.
Vse bolnike je treba spremljati, dokler ni FEV1 nazaj na izhodiščni ravni.
The educational material for Healthcare Professionals should be a leaflet that includes information on the following key elements:
Izobraževalno gradivo za zdravnike mora biti navodilo za uporabo, ki vsebuje naslednje ključne informacije:
A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to glycogen and carbon dioxide.
Majhen odstotek sistemsko absorbiranega manitola se v jetrih presnovi v glikogen in ogljikov dioksid.
The elevated lymphocyte count was within historical control values, did not progress and was essentially resolved by the end of the in life phase of the study and following withdrawal of treatment.
Povišano število limfocitov, ki je bilo v okviru zgodovinskih kontrolnih vrednosti, ni napredovalo in je v bistvu do konca študije in po ukinitvi dajanja izzvenelo.
The initiation dose pack is used during the initiation dose assessment with your doctor.
Pakiranje za začetni odmerek se uporablja med oceno začetnega odmerka pri vašem zdravniku.
Safety and efficacy have not been demonstrated in patients with a FEV1 of less than 30% of predicted (see section 5.1).
Varnost in učinkovitost zdravila pri bolnikih s FEV1 manj kot 30 % od napovedane vrednosti nista bili dokazani (glejte poglavje 5.1).
You may: - feel that you cannot breathe; - become wheezy; - cough a lot.
Morda boste: - dobili občutek, da ne morete dihati, - začeli piskajoče dihati, - precej kašljali.
Studies in rats, mice and humans have demonstrated that mannitol has no toxic metabolites.
Študije pri podganah, miših in ljudeh kažejo, da manitol nima toksičnih presnovkov.
Check the capsule - Look to see if the capsule is empty - the capsule must spin in the inhaler in order to empty.
Preverite kapsulo - Preverite, ali je kapsula prazna - kapsula se mora vrteti v inhalatorju, da se izprazni.
If excessive coughing and bronchoconstriction occurs, a beta2 agonist should be given, and oxygen if necessary.
Če se pojavi čezmerno kašljanje ali bronhokonstrikcija, lahko uporabite beta2 agonist in po potrebi kisik.
Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Zdravilo Bronhitol je indicirano za zdravljenje cistične fibroze (CF) pri odraslih, starih 18 let ali več, kot dodatno zdravljenje k najboljšemu standardu oskrbe.
- Use a new inhaler each week.
- Inhalator zamenjajte vsak teden.
If you stop using Bronchitol your symptoms may get worse.
Če ste prenehali jemati zdravilo Bronchitol, se lahko vaše stanje poslabša.
If you forget to use Bronchitol - If you forget a dose, use it as soon as you remember it and carry on as usual.
Če ste pozabili vzeti zdravilo Bronchitol - Če ste pozabili vzeti odmerek, ga vzemite, ko se spomnite in nadaljujte z običajnim režimom odmerjanja.
Paediatric population (6 to 17 years of age) Frequency, type and severity of adverse reactions in children are similar to those observed in adults.
Pediatrična populacija (starost od 6 do 17 let) Pogostnost, vrsta in resnost neželenih učinkov pri otrocih so bile podobne kot pri odraslih.
Pregnancy and breast-feeding - If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Nosečnost in dojenje - Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden uporabite to zdravilo.
If this does not happen, the capsule may be stuck.
Če ropotanja niste slišali, se je kapsula morda zataknila.
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Pharmaxis Europe Limited, 108 Q House, Furze Road, Sandyford, Dublin 18, D18AY29, Irska.
Overall Population
Celotna populacija
The patient's initiation dose of Bronchitol must be used under the supervision and monitoring of an experienced physician or another health care professional appropriately trained and equipped to perform spirometry, monitor oxygen saturation (SpO2), and manage acute bronchospasm (see sections 4.4 and 4.8) including appropriate use of resuscitation equipment.
Začetni odmerek zdravila Bronchitol je treba dati pod nadzorom in spremljanjem izkušenega zdravnika ali drugega zdravstvenega delavca, ki je ustrezno usposobljen in opremljen za izvedbo spirometrije, spremljanje nasičenosti s kisikom (SpO2) in obravnavo bronhospazma (glejte poglavji 4.4 in 4.8), vključno z ustrezno uporabo opreme za oživljanje.
Always take your bronchodilator before using Bronchitol.
Vedno vzemite svoj bronhodilatator pred uporabo zdravila Bronchitol.
The use of Bronchitol is not recommended in these patients.
Uporaba zdravila Bronchitol pri teh bolnikih ni priporočena.
This effect was not noted in any other species and did not result in clinical signs.
Tega učinka, ki se ni pokazal kot klinični znak, niso opazili pri nobeni drugi živalski vrsti.
Each of the capsules is loaded into the device separately.
Vsako kapsulo je treba vstaviti v pripomoček ločeno.
Hyperresponsiveness to mannitol
Hiperodzivnost na manitol
Discard the inhaler and its cap 1 week after first use.
Inhalator in njegov pokrovček zavrzite 1 teden po prvi uporabi.
While the exact mechanism of action is unknown, inhaled mannitol may change the viscoelastic properties of mucus, increase the hydration of the periciliary fluid layer and contribute to increased mucus clearance of the retained secretions through mucociliary activity.
Čeprav natančen mehanizem delovanja ni znan, lahko inhalirani manitol spremeni viskoelastične lastnosti sluzi, poveča hidracijo periciliarne tekočinske plasti in prispeva k večjemu očistku zadržanih izločkov zaradi mukociliarne aktivnosti.
The cumulative amount of mannitol filtered into the urine over the 24 hour collection period was similar for inhaled (55%) and oral (54%) mannitol.
Kumulativna količina manitola, ki se prefiltrira v urin v 24 urah zbiranja, je bila za inhalirani manitol (55 %) podobna kot za peroralni (54 %).
The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime.
Te odmerke vzamete zjutraj in zvečer, večerni odmerek 2 do 3 ure pred spanjem.
Prior to launch of the medicinal product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Imetnik dovoljenja za promet z zdravilom se mora, preden da zdravilo v promet v posamezni državi članici, z nacionalnim pristojnim organom dogovoriti o vsebini in obliki izobraževalnega gradiva.
Repeat the inhalation to get your dose.
Ponovite inhaliranje, da prejmete odmerek.
The initiation dose assessment described in section 4.2 should be repeated if uncertainty exists.
V primeru dvoma je treba ponoviti oceno začetnega odmerka, opisano v poglavju 4.2.
- Then open it by turning the mouth-piece in the direction of the arrow on the inhaler.
- Nato ga odprite tako, da zavrtite ustnik v smeri puščice na inhalatorju.
Do not use Bronchitol - if you are allergic to mannitol - if you are sensitive to mannitol.
Ne uporabljajte zdravila Bronchitol, - Če ste alergični na manitol.
There are limited data from the use of mannitol in pregnant women.
Podatki o uporabi manitola pri nosečnicah so omejeni.
Wash your inhaler in warm water with the mouth-piece open.
Inhalator operite v topli vodi z odprtim ustnikom.
Physiotherapy/exercise 4.
3. fizioterapija/telesna vadba;
However, studies conducted with orally administered mannitol indicated no teratogenic effects in mice or rats, at doses of up to 1.6 g/kg, or in hamsters at 1.2 g/kg.
Vendar v študijah peroralno dajanega manitola niso ugotovili znakov teratogenih učinkov pri miših in podganah pri odmerkih do 1,6 g/kg oz. pri hrčkih pri odmerkih do 1,2 g/kg.
Bacteria sputum identified
Prepoznane bakterije v sputumu
It must not be administered by any other route or using any other inhaler.
Ne sme se dajati na noben drug način ali z drugim inhalatorjem.
As a consequence, these patients should be carefully monitored, and Bronchitol should be withheld in the event of massive haemoptysis.
Posledično je treba te bolnike natančno spremljati ter uporabo zdravila Bronchitol v primeru obsežne hemoptize prekiniti.
Average inhaled dose per capsule is 32.2 milligrams mannitol.
Povprečni inhalirani odmerek na kapsulo je 32,2 miligramov manitola.
- Do not use a double dose to make up for a forgotten dose.
- Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Use as directed by your doctor.
Uporaba po navodilu zdravnika.
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There are no data on concomitant use of hypertonic saline with Bronchitol as it was excluded from the Phase 3 studies.
Podatkov o sočasni uporabi hipertonične fiziološke raztopine z zdravilom Bronchitol ni, ker so bili izključeni iz študije 3. faze.
Inhaling medicines can cause chest tightness and wheezing and this can happen immediately after taking this medicine.
Inhalacija zdravil lahko povzroči tesnobo v prsnem košu ali piskajoče dihanje, kar se lahko zgodi nemudoma po jemanju tega zdravila.
Therefore, treatment with Bronchitol is not recommended.
Zato zdravljenje z zdravilom Bronchitol ni priporočljivo.
Bronchospasm should be treated with a bronchodilator or as medically appropriate.
Bronhospazem je treba zdraviti z bronhodilatatorjem ali kot je ustrezno.
The initiation dose assessment must be performed according to the following steps:
Oceno začetnega odmerka je treba opraviti v naslednjih korakih:
The safety/efficacy of Bronchitol in patients with asthma has not been formally studied.
Varnost in učinkovitost Bronchitol pri bolnikih z astmo nista bili uradno raziskani.
The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV1 and SpO2 (Oxygen saturation in the blood) measurement.
Bolnik mora dobiti premedikacijo z bronhodilatatorjem 5-15 minut pred začetnim odmerkom, vendar po izhodiščni meritvi FEV1 in SpO2 (nasičenost krvi s kisikom).
If either of the above apply to you (or you are not sure), talk to your doctor or pharmacist before using this medicine.
Če karkoli od zgoraj naštetega velja za vas (ali ste negotovi), se pred začetkom uporabe tega zdravila posvetujte s svojim zdravnikom ali farmacevtom.
Bronchitol has no or negligible influence on the ability to drive and use machines.
Zdravilo Bronchitol nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Clear colourless hard capsules marked with ‘PXS 40 mg' and containing white or almost white powder.
Prozorne, brezbarvne trde kapsule z oznako „PXS 40 mg“, ki vsebujejo bel ali skoraj bel prašek.
Bronchitol helps by increasing the amount of water on the surface of your airways and in your mucus.
Zdravilo Bronchitol pomaga tako, da se poveča količine vode na površini dihalnih poti in v sluzi.
Table 3 - Change in FEV1 from baseline over 26 weeks in the mITT and adult populations
Preglednica 3 - Sprememba FEV1 glede na izhodiščno raven v 26 tednih v populaciji mITT in odraslih preiskovancev
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Your doctor may ask you to use other medicines such as a bronchodilator before taking Bronchitol.
Zdravnik vam bo morda naročil, da pred jemanjem zdravila Bronchitol uporabite druga zdravila, kot je bronhodilatator.
The patient must complete and pass the initiation dose assessment before starting treatment with Bronchitol.
Bolnik mora zaključiti in opraviti oceno začetnega odmerka pred začetkom zdravljenja z Bronchitolom.
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.
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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 %.