FrancophonIA/ELRC3.0 huggingface dataset:
English: • Swollen glands in the neck, armpit or groin
Slovenian: • oteklina vratnih, podpazdušnih ali dimeljskih bezgavk.
English: GlaxoSmithKline Lietuva UAB Tel. +370 5 264 90 00 info.lt@gsk.com
Slovenian: Tel. +370 5 264 90 00 info.lt@gsk.com
English: The volume of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg (5 ml) after mixing corresponds to 10 doses of vaccine.
Slovenian: Količina cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg po mešanju (5 ml) ustreza 10 odmerkom
English: After mixing, 1 dose (0.5 ml) contains:
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Po premešanju 1 odmerek (0,5 ml) vsebuje:
English: A 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in >90% of subjects after two doses regardless of the schedule.
Slovenian: Ne glede na shemo, je > 90°% preiskovancev pod dveh odmerkih imelo 4-kraten porast titra nevtralizacijskih protiteles proti A/Indonesia/5/2005.
English: Take special care with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg:
Slovenian: Bodite posebno pozorni pri cepljenju s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg:
English: Booster factor3
Slovenian: Faktor serokonverzije3
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Slovenian: Kaj je cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in za kaj ga uporabljamo Kaj morate vedeti, preden boste cepljeni s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg Kako uporabljati cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
English: One pack of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of:
Slovenian: Eno pakiranje cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg vsebuje:
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is and what it is used for
Slovenian: Kaj je cepivo Prepandemično cepivo proti gripi H5N1 (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in za kaj ga uporabljamo
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should not be given:
Slovenian: S cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg ne smete biti cepljeni:
English: Emulsion for emulsion for injection for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Slovenian: Emulzija za emulzijo za injiciranje za Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
English: No data have been generated in pregnant women with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg or with any other vaccine that contains the AS03 adjuvant.
Slovenian: O uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg ali kateregakoli drugega cepiva z adjuvansom AS03 pri nosečnicah ni podatkov.
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg suspension for emulsion for injection IM
Slovenian: Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg suspenzija za emulzijo za injiciranje i.m.
English: Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB02
Slovenian: FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB02 Imunski odziv proti A/Vietnam/1194/2004:
English: There is no information on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in pregnant or breast-feeding women.
Slovenian: O uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg med nosečnostjo in dojenjem ni podatkov.
English: The side effects listed below have occurred with Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg in clinical studies:
Slovenian: Neželeni učinki, ki so navedeni spodaj, so se pojavili v kliničnih raziskavah s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg:
English: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg consists of two containers:
Slovenian: Cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg je na voljo v dveh vsebnikih:
English: The doctor or nurse will give Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg as an injection into your upper arm muscle.
Slovenian: Cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg vam bo zdravnik ali medicinska sestra dal/dala v obliki injekcije v mišico nadlakti.
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg looks like and contents of the pack
Slovenian: Izgled cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in vsebina pakiranja
English: Anti-HA responses against A/Indonesia/5/2005 following administration of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 were as follows:
Slovenian: Po uporabi cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2994 je bil odziv anti-HA proti A/Indonesia/5/2005 naslednji:
English: How to store Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Slovenian: Kako uporabljati cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
English: There are no data regarding the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg during lactation.
Slovenian: O uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg med dojenjem ni podatkov.
English: PSUR submission when Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is used during the influenza pandemic:
Slovenian: Predložitev periodičnega poročila o varnosti zdravila pri uporabi cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg med pandemijo gripe:
English: What Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg contains
Slovenian: Kaj vsebuje cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
English: Therefore, Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg is not intended to be given at the same time as other vaccines.
Slovenian: O sočasnem cepljenju s cepivom Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg in drugimi cepivi ni podatkov, zato cepivo Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg ni namenjeno za uporabo skupaj z drugimi cepivi.
English: Before you receive Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg
Slovenian: Shranjevanje cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg
English: There are no data on the use of Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg given at the same time as other vaccines.
Slovenian: Podatki o spremljanju cepiva Prepandemično cepivo proti gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom) GlaxoSmithKline Biologicals 3,75 µg po pridobitvi dovoljenja za promet niso na voljo.
English: Only do this once.
Slovenian: To napravite enkrat.
English: Date of first authorisation: 13 April 2012 Date of latest renewal: 11 January 2017
Slovenian: Datum prve odobritve: 13 April 2012 Datum zadnjega podaljšanja: 11 Januar 2017
English: Absolute mL
Slovenian: Absolutni ml
English: (See Table 1).
Slovenian: (glejte preglednico 1).
English: - Worsening of symptoms.
Slovenian: - Poslabšanje simptomov.
English: Your doctor will tell you how long to use this medicine for.
Slovenian: Zdravnik vam bo povedal, kako dolgo jemati to zdravilo.
English: - Breathe out, and then breathe normally again.
Slovenian: - Izdihnite in spet normalno dihajte.
English: Adults 18 years of age and over
Slovenian: Odrasli, stari 18 let in več
English: The applicant is requested to submit periodic analysis of the CF study every 6 months for 3 years and annually for 2 years.
Slovenian: Predlagatelj mora predložiti redne analize študije CF vsakih 6 mesecev v obdobju 3 let in letno v obdobju 2 let.
English: Note: There were some differences in analysis methods across the 3 studies.
Slovenian: Opomba: metode analiziranja v teh treh študijah so se med seboj nekoliko razlikovale.
English: There are no data available for children under 12 years of age.
Slovenian: Za otroke, mlajše od 12 let, ni razpoložljivih podatkov.
English: Patients should be advised to carefully read them.
Slovenian: Bolnikom je treba naročiti, naj navodilo temeljito preberejo.
English: The first dose is taken in 4 steps:
Slovenian: Prvi odmerek se vzame v 4 fazah:
English: No formal interaction studies have been conducted.
Slovenian: Formalnih študij medsebojnega delovanja niso izvedli.
English: Initiation dose (6 to 17 years of age)
Slovenian: Začetni odmerek (starost od 6 do 17 let)
English: If the capsule has not emptied you may need to repeat steps 6 to 8.
Slovenian: Če se kapsula ni izpraznila, morate ponoviti postopek od 6. do 8. točke.
English: It is not known if this medicine passes into the breast milk.
Slovenian: Ni znano, ali to zdravilo prehaja v materino mleko.
English: This happens commonly, which may affect up to 1 in 10 people.
Slovenian: To je pogosto in se lahko pojavi pri do 1 bolniku od 10.
English: • acute bleeding ≥240 ml in a 24-hour period
Slovenian: • akutna krvavitev ≥240 ml v obdobju 24 ur,
English: Leave it to dry in the air - lay it on its side with the mouth-piece open.
Slovenian: Posušite ga na zraku - položite ga na bok z odprtim ustnikom.
English: Inhaled antibiotics (if applicable)
Slovenian: 5. inhalirani antibiotiki (če je potrebno).
English: Absolute % predicted Relative % predicted
Slovenian: Absolutna sprememba napovedane % ravni Relativna sprememba napovedane % ravni
English: For patients receiving several respiratory therapies, the recommended order is:
Slovenian: Pri bolnikih, ki prejemajo več terapij za dihala, je priporočeni vrstni red:
English: However, if it is nearly time for the next dose, skip the missed dose.
Slovenian: Če pa je skoraj čas za naslednji odmerek, pozabljeni odmerek preskočite.
English: Dornase alfa (if applicable) 5.
Slovenian: 4. dornaza alfa (če je potrebno);
English: Put in the capsule - First make sure your hands are dry.
Slovenian: Vstavite kapsulo - Najprej se prepričajte, da imate suhe roke.
English: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≥1/100,000 to <1/10,000); not known (cannot be estimated from the available data).
Slovenian: Opredelitev pogostnosti: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (≥1/100.000 do <1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The safety profile of Bronchitol has been evaluated in clinical studies involving more than 1200 patients.
Slovenian: Varnostni profil zdravila Bronchitol je bil ovrednoten v kliničnih študijah, ki so vključevale več kot 1200 bolnikov.
English: The Tmax after inhaled administration was 1.5 ± 0.5 hours.
Slovenian: Vrednost Tmax po inhaliranju je bila 1,5 ± 0,5 ure.
English: The inhaler device is to be replaced after one week of use.
Slovenian: Inhalator je treba zamenjati po enem tednu uporabe.
English: Productive cough can contribute to sputum clearance.
Slovenian: Produktivni kašelj lahko prispeva k očistku sputuma.
English: o The need for monitoring and when to withhold treatment.
Slovenian: o potreba po spremljanju in primeri, ko je treba zdravljenje prekiniti.
English: Cleaning the inhaler - Usually your inhaler will give you the correct dose of medicine for 7 days without needing cleaning.
Slovenian: Čiščenje inhalatorja - Običajno bo inhalator zagotovil pravilni odmerek zdravila 7 dni brez potrebe po čiščenju.
English: Repeat steps 3 to 10 for each capsule - Perform these steps for each of the ten capsules.
Slovenian: Ponovite postopek od 3. do 10. točke za vsako kapsulo - Postopek ponovite za vsako kapsulo od desetih.
English: All FEV1 measurements and SpO2 monitoring should be performed 60 seconds after dose inhalation.
Slovenian: Vse meritve FEV1 in spremljanje SpO2 je treba začeti 60 sekund po inhalaciji odmerka.
English: The recommended dose of Bronchitol is 400 mg twice a day.
Slovenian: Priporočeni odmerek zdravila Bronchitol je 400 mg dvakrat na dan.
English: You must let it fully dry, this can take up to 24 hours.
Slovenian: Inhalator morate popolnoma posušiti, kar lahko traja 24 ur.
English: This happens commonly.
Slovenian: To je pogosto.
English: As well as using Bronchitol you will normally keep using the other medicines you take for cystic fibrosis.
Slovenian: Poleg zdravila Bronchitol boste še naprej kot običajno uporabljali druga zdravila, ki jih jemljete za cistično fibrozo.
English: - Have the evening dose at least 2 to 3 hours before you go to bed.
Slovenian: - Večerni odmerek vzemite vsake 2 do 3 ure pred spanjem.
English: It also helps improve the condition of your lungs and your breathing.
Slovenian: Ravno tako izboljša stanje pljuč in dihanje.
English: As a result you may get a ‘productive cough', which also helps to remove mucus from your lungs.
Slovenian: Posledično boste lahko imeli „produktivni kašelj,“ ki pripomore k odstranjevanju sluzi iz pljuč.
English: - Coughing up blood or blood in your sputum.
Slovenian: - Če izkašljate kri ali opazite kri v sputumu.
English: The mean terminal half-life in adults was approximately 4 to 5 hours from serum and approximately 3.66 hours from urine.
Slovenian: Pri odraslih je bila povprečna končna razpolovna doba iz seruma približno 4 do 5 ur, iz urina pa 3,66 ure.
English: Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.
Slovenian: Razpoložljivi podatki iz študij DPM-CF-301 in 302 kažejo, da prilagoditev odmerka za ti populaciji bolnikov ni potrebna.
English: The 2-week treatment pack is for treatment use.
Slovenian: Pakiranje za dvotedensko zdravljenje je namenjeno zdravljenju.
English: - Take a steady deep breath in, to fill your lungs - then hold your breath for 5 seconds.
Slovenian: - Z enakomernim globokim vdihom napolnite pljuča, nato pa držite dih 5 sekund.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Pogoji in zahteve za predložitev z zadnjimi podatki dopolnjenih rednih poročil o varnosti zdravila so določeni na seznamu referenčnih datumov Unije (seznam EURD), člen 107c(7) Direktive 2001/83/ES in spremembah, objavljenih na evropskem spletnem portalu za zdravila.
English: Do not try to loosen the capsule by pressing the piercing buttons again.
Slovenian: Ne poskušajte sprostiti kapsule s ponovnim pritiskanjem gumbov za prediranje.
English: At the end of the initiation dose you will have taken 10 capsules (400 mg) which is the same as the usual dose.
Slovenian: Na koncu začetnega odmerka boste prejeli 10 kapsul (400 mg), kolikor znaša običajni odmerek.
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.
Slovenian: Primerjava vrednosti AUC med 1. in 7. dnem je v splošnem kazala časovno neodvisnost farmakokinetike, kar kaže na linearnost pri odmerkih, uporabljenih v tej študiji.
English: When administered intravenously, mannitol is eliminated largely unchanged by glomerular filtration and 87% of the dose is excreted in the urine within 24 hours.
Slovenian: Intravensko uporabljeni manitol se izloči večinoma nespremenjen z glomerulno filtracijo in 87 % odmerka se izloči v urin v 24 urah.
English: The doctor may give you oxygen and medicines to help you breathe.
Slovenian: Zdravnik vam bo morda za lažje dihanje dal kisik in zdravila.
English: The safety profile of Bronchitol is based on the safety data from Phase III clinical studies (including data from the initiation dose assessment).
Slovenian: Varnostni profil zdravila Bronchitol temelji na varnostnih podatkih kliničnih študij III. faze (vključno s podatki ocene začetnega odmerka).
English: - If your inhaler breaks, use your second inhaler and talk to your doctor.
Slovenian: - Če se inhalator pokvari, uporabite drugi inhalator in se posvetujte s svojim zdravnikom.
English: Lung deposition studies have demonstrated a 24.7% deposition of inhaled mannitol confirming its distribution to the target organ.
Slovenian: V študijah nalaganja v pljučih so dokazali 24,7-odstotno nalaganje inhaliranega manitola, kar potrjuje njegovo porazdelitev v ciljnem organu.
English: The limited data available in adolescents aged 12 to 17 years indicate the pharmacokinetic parameters of inhaled mannitol are similar to the adult population.
Slovenian: Omejena količina podatkov v populaciji mladostnikov, starih od 12 do 17 let, nakazuje na to, da so farmakokinetični parametri inhaliranega manitola podobni kot v odrasli populaciji.
English: p value
Slovenian: Vrednost p
English: In a study of 18 healthy male adult volunteers, the absolute bioavailability of mannitol powder for inhalation by comparison to mannitol administered intravenously was 0.59% ± 0.15.
Slovenian: V študiji pri 18 zdravih moških odraslih prostovoljcih je bila absolutna biološka uporabnost manitola v obliki praška za inhalacijo v primerjavi z intravensko uporabljenim manitolom 0,59 % ± 0,15.
English: o How to interpret the results of the Bronchitol initiation dose assessment as Pass, Fail or Incomplete.
Slovenian: o kako interpretirati izide ocene začetnega odmerka zdravila Bronchitol kot pozitivne, negativne ali nepopolne.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: This requires the inhalation of the contents of ten capsules via the inhaler device twice a day.
Slovenian: To zahteva inhalacijo vsebine desetih kapsul prek inhalatorja dvakrat na dan.
English: This is because piercing the capsule more than once may make it split or break-up.
Slovenian: Če kapsulo predrete večkrat, se lahko prepolovi ali razpade.
English: All patients should be monitored until their FEV1 has returned to baseline levels.
Slovenian: Vse bolnike je treba spremljati, dokler ni FEV1 nazaj na izhodiščni ravni.
English: The educational material for Healthcare Professionals should be a leaflet that includes information on the following key elements:
Slovenian: Izobraževalno gradivo za zdravnike mora biti navodilo za uporabo, ki vsebuje naslednje ključne informacije:
English: A small percentage of systemically absorbed mannitol undergoes hepatic metabolism to glycogen and carbon dioxide.
Slovenian: Majhen odstotek sistemsko absorbiranega manitola se v jetrih presnovi v glikogen in ogljikov dioksid.
English: 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.
Slovenian: 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.
English: The initiation dose pack is used during the initiation dose assessment with your doctor.
Slovenian: Pakiranje za začetni odmerek se uporablja med oceno začetnega odmerka pri vašem zdravniku.
English: Safety and efficacy have not been demonstrated in patients with a FEV1 of less than 30% of predicted (see section 5.1).
Slovenian: Varnost in učinkovitost zdravila pri bolnikih s FEV1 manj kot 30 % od napovedane vrednosti nista bili dokazani (glejte poglavje 5.1).
English: You may: - feel that you cannot breathe; - become wheezy; - cough a lot.
Slovenian: Morda boste: - dobili občutek, da ne morete dihati, - začeli piskajoče dihati, - precej kašljali.
English: Studies in rats, mice and humans have demonstrated that mannitol has no toxic metabolites.
Slovenian: Študije pri podganah, miših in ljudeh kažejo, da manitol nima toksičnih presnovkov.
English: Check the capsule - Look to see if the capsule is empty - the capsule must spin in the inhaler in order to empty.
Slovenian: Preverite kapsulo - Preverite, ali je kapsula prazna - kapsula se mora vrteti v inhalatorju, da se izprazni.
English: If excessive coughing and bronchoconstriction occurs, a beta2 agonist should be given, and oxygen if necessary.
Slovenian: Če se pojavi čezmerno kašljanje ali bronhokonstrikcija, lahko uporabite beta2 agonist in po potrebi kisik.
English: 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.
Slovenian: Zdravilo Bronhitol je indicirano za zdravljenje cistične fibroze (CF) pri odraslih, starih 18 let ali več, kot dodatno zdravljenje k najboljšemu standardu oskrbe.
English: - Use a new inhaler each week.
Slovenian: - Inhalator zamenjajte vsak teden.
English: If you stop using Bronchitol your symptoms may get worse.
Slovenian: Če ste prenehali jemati zdravilo Bronchitol, se lahko vaše stanje poslabša.
English: If you forget to use Bronchitol - If you forget a dose, use it as soon as you remember it and carry on as usual.
Slovenian: Če ste pozabili vzeti zdravilo Bronchitol - Če ste pozabili vzeti odmerek, ga vzemite, ko se spomnite in nadaljujte z običajnim režimom odmerjanja.
English: Paediatric population (6 to 17 years of age) Frequency, type and severity of adverse reactions in children are similar to those observed in adults.
Slovenian: Pediatrična populacija (starost od 6 do 17 let) Pogostnost, vrsta in resnost neželenih učinkov pri otrocih so bile podobne kot pri odraslih.