FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions reported below are based on pooled clinical trial data from phase II and III clinical trials involving 131 patients taking the medicinal product and on data from post-marketing surveillance.
Slovenian: in III. faze, v katere je bilo vključenih 131 bolnikov, ki so jemali zdravilo, in podatkih iz obdobja trženja.
English: • or other inhibitors of platelet aggregation, such as acetylsalicylic acid, non-steroidal anti-inflammatory medicinal products, non-selective phosphodiesterase inhibitors like pentoxifylline, selective phosphodiesterase 3 (PDE3) inhibitors like cilostazol or anagrelide, ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, like o abciximab, o eptifibatide, o tirofiban, defibrotide.
Slovenian: • ali drugimi zaviralci agregacije trombocitov, kot so acetilsalicilna kislina, nesteroidna protivnetna zdravila, neselektivni zaviralci fosfodiesteraze, kot je pentoksifilin, selektivni zaviralci fosfodiesteraze 3 (PDE 3), kot sta cilostazol ali anagrelid, tiklopidin, klopidogrel, antagonisti glikoproteina IIb/IIIa, kot so o abciksimab, o eptifibatid, o tirofiban, defibrotid.
English: It stops after the pre-set dose has been administered.
Slovenian: Oddajanje signala se ustavi po aplikaciji vnaprej določenega odmerka.
English: Patients initiating Ventavis treatment or switching from an alternative device to Breelib should be closely supervised by the treating physician to ensure that dose and speed of inhalation are well tolerated.
Slovenian: Bolnike, ki začenjajo zdravljenje z zdravilom Ventavis ali zamenjajo drug nebulator za Breelib, mora lečeči zdravnik skrbno nadzorovati in se prepričati, da odmerek in hitrost inhalacije dobro prenašajo.
English: If your doctor decides to further increase the dose up to 5 microgram, again dosing intervals of 3 - 4 hours should be chosen initially and shortened depending on how you tolerate the treatment.
Slovenian: Če se zdravnik odloči, da bo odmerek povečal do 5 mikrogramov, mora biti na začetku interval med posameznima odmerkoma ponovno 3 - 4 ure, nato pa se ga skrajša glede na to, kako dobro prenašate zdravilo.
English: The risk of bleeding may be increased in patients when potential inhibitors of platelet aggregation or anticoagulants are given concomitantly (see section 4.5).
Slovenian: Tveganje za krvavitve se lahko poveča pri bolnikih, če sočasno prejemajo potencialne zaviralce agregacije trombocitov ali antikoagulante (glejte poglavje 4.5).
English: What Ventavis is and what it is used for What Ventavis is
Slovenian: Kaj je zdravilo Ventavis in za kaj ga uporabljamo Kaj je zdravilo Ventavis
English: If you are unable to tolerate the 5 microgram dose, the dose should be reduced to 2.5 microgram.
Slovenian: Če ne prenašate odmerka 5 mikrogramov, je treba odmerek zmanjšati na 2,5 mikrogramov.
English: Cmax and AUC (0-tlast) of iloprost after inhalation with Breelib were, however, still in the range of values observed with Ventavis 10 microgram/ml using other inhalers across different studies.
Slovenian: Vendar sta bila Cmax in AUC (0tlast) iloprosta po inhalaciji z nebulatorjem Breelib še vedno znotraj vrednosti, opaženih v različnih študijah pri uporabi zdravila Ventavis 10 mikrogramov/ml z drugimi inhalatorji.
English: Limited data are available on the use of the Breelib nebuliser.
Slovenian: Podatki o uporabi nebulatorja Breelib, ki so na voljo, so omejeni.
English: For each inhalation session you should use a new ampoule of Ventavis.
Slovenian: Za vsako posamezno inhalacijo uporabite novo ampulo zdravila Ventavis.
English: Before physical exertion it might be useful to inhale.
Slovenian: Inhalacije pred telesnimi napori so lahko koristne.
English: After each inhalation session, any solution remaining in the nebuliser should be discarded.
Slovenian: Po vsaki inhalaciji je potrebno raztopino, ki je ostala v nebulatorju, zavreči.
English: You should not switch to another nebuliser without consulting the doctor who is treating you.
Slovenian: Nebulatorja ne smete zamenjati z drugim, ne da bi se pred tem posvetovali z lečečim zdravnikom.
English: For administration with the Venta-Neb.
Slovenian: Za uporabo z nebulatorjem Venta-Neb.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema krvavitve*§
English: Newborns, infants and pregnant women should not be in the same room while you are inhaling Ventavis.
Slovenian: Novorojenci, dojenčki in nosečnice ne smejo biti v istem prostoru, medtem ko inhalirate zdravilo
English: In patients with low systemic blood pressure and in patients with postural hypotension or receiving medicinal products known to reduce blood pressure levels, care should be taken to avoid further hypotension.
Slovenian: Pri bolnikih z nizkim sistemskim krvnim tlakom, bolnikih s posturalno hipotenzijo ali bolnikih, ki jemljejo zdravila, za katere je znano,
English: The risk of bleeding may be increased in patients when inhibitors of platelet aggregation or anticoagulants are given at the same time (see also section 2).
Slovenian: Tveganje za krvavitve je lahko večje pri bolnikih, ki sočasno prejemajo zaviralce agregacije trombocitov ali antikoagulante (glejte tudi poglavje 2).
English: 1 ml ampoule yellow - red ring 5 mcg golden golden
Slovenian: 1 ml ampula rumen-rdeč obroč 5 mikrogramov zlat zlat
English: For each medication chamber there is a corresponding colour coded control disc:
Slovenian: Za vsak prostor za zdravilo obstaja z ustrezno barvo označen nadzorni disk.
English: In the iloprost group, the mean change from baseline after 12 weeks of treatment in the 6-minute walking distance was an increase of 22 metres (-3.3 metres in the placebo group, no data imputation for death or missing values).
Slovenian: V skupini z iloprostom je bilo povprečno podaljšanje prehojene razdalje pri 6-minutnem testu hoje po 12 tednih zdravljenja 22 metrov glede na izhodiščne vrednosti (v placebo skupini -3,3 metre, vključeni niso podatki o smrtih ali manjkajočih vrednostih).
English: You may also experience a decrease or an increase in blood pressure, bradycardia (reduced heart rate), tachycardia (increased heart rate), vomiting, diarrhoea or limb pain.
Slovenian: Lahko se pojavijo tudi znižanje ali zvišanje krvnega tlaka, bradikardija (počasen srčni utrip), tahikardija (hiter srčni utrip), bruhanje, driska ali bolečine v okončinah.
English: The selection of the pre-set programme is made by the doctor.
Slovenian: Zdravnik izbere enega od programov, ki sta na voljo.
English: • Venta-Neb nebuliser (2 ml ampoule with white and pink rings)
Slovenian: • Nebulator Venta-Neb (2-mililitrska ampula z belim in rožnatim obročem)
English: If you stop or wish to stop treatment, discuss it with your doctor first.
Slovenian: Če ste prenehali uporabljati zdravilo Ventavis Če prenehate ali želite prenehati zdravljenje, se najprej posvetujte z zdravnikom.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi trometamol
English: Ventavis contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Slovenian: Zdravilo Ventavis vsebuje etanol Zdravilo Ventavis vsebuje majhne količine etanola (alkohola), in sicer manj kot 100 mg na odmerek.
English: To obtain the optimal droplet size for the administration of Ventavis 10 microgram/ml nebuliser solution the green baffle plate should be used.
Slovenian: Da bi dosegli optimalno velikost kapljic za aplikacijo zdravila Ventavis 10 mikrogramov/ml inhalacijska raztipina za nebulator, je treba uporabiti zeleno ploščo.
English: Hypotension, an increase of blood pressure, bradycardia or tachycardia, vomiting, diarrhoea and limb pain might also be possible.
Slovenian: Pojavijo se lahko tudi hipotenzija, povišanje krvnega tlaka, bradikardija ali tahikardija, bruhanje, driska in bolečine v okončinah.
English: Inhalation use.
Slovenian: Za inhaliranje.
English: The table below provides a summary of the user instructions of the I-Neb for Ventavis:
Slovenian: V spodnji tabeli je predstavljen povzetek navodil za uporabnika nebulatorja I-Neb za zdravilo Ventavis.
English: There is no need for dose adaptation in patients with a creatinine clearance >30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula).
Slovenian: Pri bolnikih z očistkom kreatinina > 30 ml/min (določenega po Cockroftovi in Gaultovi formuli glede na vrednosti kreatinina v serumu) prilagajanje odmerka ni potrebno.
English: If you use more Ventavis than you should
Slovenian: Če ste uporabili večji odmerek zdravila Ventavis, kot bi smeli
English: Depending on the type of device used and dose prescribed, 1 ml or 2 ml of Ventavis 10 microgram/ml are appropriate.
Slovenian: Glede na tip nebulatorja in predpisan odmerek sta ustrezna 1 ml ali 2 ml zdravila Ventavis 10 mikrogramov/ml.
English: Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion.
Slovenian: Bolniki, pri katerih se kot posledica pljučne hipertenzije pojavlja kratkotrajna izguba zavesti (sinkopa), naj se izogibajo pretiranim naporom, npr. med telesnimi obremenitvami.
English: No study has been performed with Ventavis in children with pulmonary hypertension.
Slovenian: Študij uporabe zdravila Ventavis pri otrocih s pljučno hipertenzijo niso izvedli.
English: In embryo- and foetotoxicity studies in rats continuous intravenous administration of iloprost led to anomalies of single phalanges of the forepaws in a few foetuses/pups without dose dependence.
Slovenian: V študijah embrio- in fetotoksičnosti pri podganah je neprekinjena intravenska aplikacija iloprosta pri nekaj plodih/mladičih povzročila anomalije posameznih prstnic sprednjih okončin, ne glede na odmerek.
English: 5 mcg golden golden
Slovenian: 5 mikrogramov zlat zlat
English: Ventavis lowers blood pressure and may cause dizziness or light-headedness in some people.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Ventavis znižuje krvni tlak in lahko pri nekaterih ljudeh povzroči omotico ali občutek omedlevice.
English: m. b. H. Tel: +43-(0)1-711 46-0
Slovenian: Tel: +43-(0)1-711 46-0
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC11
Slovenian: Farmakoterapevtska skupina: antitrombotiki, zaviralci agregacije trombocitov brez heparina, oznaka
English: A careful monitoring of the patients taking anticoagulants or other inhibitors of platelet aggregation according to common medical practice is recommended.
Slovenian: V skladu s splošno klinično prakso je priporočljivo skrbno spremljati bolnike, ki prejemajo antikoagulante ali druge zaviralce agregacije trombocitov.
English: You should administer the dose 6 to 9 times per day according to individual needs and tolerability.
Slovenian: Odmerek za posamezno inhalacijo aplicirajte 6- do 9-krat na dan glede na vaše potrebe in prenašanje zdravila.
English: Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol omotica
English: This is a condition where blood pressure is too high in the blood vessels between the heart and the lungs.
Slovenian: Pri pljučni hipertenziji je krvni tlak v žili med srcem in pljuči previsok.
English: If you cannot tolerate inhalation of Ventavis 20 microgram/ml talk to your doctor who may decide that you should take Ventavis 10 microgram/ml (1 ml ampoule).
Slovenian: Če ne prenašate inhaliranja z zdravilom Ventavis 20 mikrogramov/ml, se posvetujte z zdravnikom, ki se lahko odloči, da boste morali jemati zdravilo Ventavis 10 mikrogramov/ml (1-mililitrska ampula).
English: If you get any side effects talk to your doctor.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom.
English: In particular, newborns, infants and pregnant women should not be in the same room while you are inhaling Ventavis.
Slovenian: Predvsem novorojenčki, dojenčki in nosečnice ne smejo biti v istem prostoru, medtem ko inhalirate zdravilo Ventavis.
English: Cmax and AUC (0-tlast) after inhalation of 5 microgram iloprost administered as Ventavis 20 microgram/ml using the Breelib were 77% and 42%, respectively higher compared to inhalation of the same dose using Ventavis 10 microgram/ml and the I-Neb AAD system.
Slovenian: Cmax in AUC (0-tlast) po inhalaciji 5 mikrogramov iloprosta v zdravilu Ventavis 20 mikrogramov/ml z nebulatorjem Breelib sta bila 77 % oziroma 42 % večja v primerjavi z inhalcijo enakega odmerka v zdravilu Ventavis 10 mikrogramov/ml z nebulatorjem I-Neb AAD.
English: Pharmacokinetics under the specific study conditions of extended inhalation time, were investigated in a randomised, crossover study with 19 healthy adult men following inhalation of single doses of Ventavis 10 microgram/ml and Ventavis 20 microgram/ml (dose of 5 microgram iloprost at the mouthpiece) using the I-Neb.
Slovenian: Farmakokinetiko v specifičnih pogojih študije podaljšanega časa inhaliranja so preučevali v randomizirani, navzkrižni študiji z 19 zdravimi odraslimi moškimi, ki so inhalirali enkratni odmerek zdravila Ventavis 10 mikrogramov/ml in zdravila Ventavis 20 mikrogramov/ml (odmerek 5 mikrogramov iloprosta v ustniku) z nebulatorjem I-Neb.
English: Hepatic impairment Iloprost elimination is reduced in patients with hepatic dysfunction (see section 5.2).
Slovenian: Pri bolnikih z okvaro jeter je izločanje iloprosta zmanjšano (glejte poglavje 5.2).
English: • fast heartbeat (tachycardia)
Slovenian: • hiter srčni utrip (tahikardija)
English: Tachycardia Palpitations
Slovenian: Srčne bolezni tahikardija palpitacije
English: If you tolerate this dose well, your next inhalation will be with Ventavis 20 microgram/ml (ampoule with yellow and red rings).
Slovenian: Če ta odmerek dobro prenašate, boste ob naslednjem inhaliranju uporabili zdravilo Ventavis 20 mikrogramov/ml (ampula z rumenim in rdečim obročem).
English: Caution is recommended in case of co-administration of Ventavis with other antihypertensive or vasodilatating agents as dose adjustment might be required.
Slovenian: V primeru sočasne uporabe zdravila Ventavis z drugimi zdravili za zdravljenje hipertenzije ali vazodilatatorji je potrebna previdnost, ker bo morda potrebno prilagoditi odmerek.
English: An accumulation of iloprost following treatment over several days is not likely due to the overnight break in administration of the medicinal product.
Slovenian: Ker se zdravila ne uporablja ponoči, kopičenje iloprosta po več dni trajajočem zdravljenju ni verjetno.
English: In a chronic inhalation study in rats over 26 weeks, the highest achievable dose of 48.7 microgram/kg/day was identified as ‘no observed adverse effect level' (NOAEL).
Slovenian: 48,7 mikrogramov/kg/dan opredeljen kot »stopnja brez opaznih neželenih učinkov« (no observed adverse event level - NOAEL).
English: Part of a multipack containing 300 ampoules with 2 ml.
Slovenian: Del škatle večkratnega pakiranja, ki vsebuje 300 ampul z 2 ml
English: No studies to investigate the metabolism of iloprost were performed following inhalation of Ventavis.
Slovenian: Študij preučevanja presnove iloprosta po inhaliranju zdravila Ventavis niso izvedli.
English: Venta-Neb prompts the patient to inhale by an optical and an acoustic signal.
Slovenian: Nebulator Venta-Neb z optičnim in zvočnim signalom spodbudi bolnika da vdihne.
English: Very rarely, fatal cases including bleeding in the brain (cerebral and intracranial haemorrhage) have been reported.
Slovenian: Zelo redko so poročali o smrtnih primerih možganskih in znotrajlobanjskih krvavitev.
English: • stop the inhalation session
Slovenian: • prenehajte z inhalacijo,
English: This nebuliser monitors the breathing pattern to determine the aerosol pulse time required to deliver the pre-set dose of 5 micrograms iloprost of the Ventavis 20 microgram/ml nebuliser solution (1 ml ampoule with yellow and red rings).
Slovenian: Nebulator spremlja način dihanja in tako določi pulzni čas aerosola, potreben za dovajanje nastavljenega odmerka 5 mikrogramov iloprosta v zdravilu Ventavis 20 mikrogramov/ml inhalacijska raztopina za nebulator (1-mililitrska ampula z rumenim in rdečim obročem).
English: The Mass Median Aerodynamic Diameter (MMAD) of the aerosol measured using I-Neb nebulising systems equipped with power level 10 disc was similar between Ventavis 20 microgram/ml (golden programme) and Ventavis 10 microgram/ml (purple programme) nebuliser solutions (i.e.: around 2 micrometres) but with faster delivery when using Ventavis 20 microgram/ml.
Slovenian: Mediani masni aerodinamični premer (MMAD) aerosola, merjen z nebulatorjem I-Neb in opremljen z diskom s stopnjo moči 10, je bil podoben med zdraviloma Ventavis 20 mikrogramov/ml (zlat program) in Ventavis 10 mikrogramov/ml (vijoličast program) inhalacijska raztopina za nebulator (tj. približno 2 mikrometra), vendar je bilo dovajanje hitrejše pri uporabi zdravila Ventavis 20 mikrogramov/ml.
English: The dose per inhalation session should be administered 6 to 9 times per day according to the individual need and tolerability.
Slovenian: Inhalacijski odmerek je treba aplicirati šest- do devetkrat na dan, glede na potrebe posameznika in prenašanje zdravila.
English: A potential risk to the breast-feeding child cannot be excluded and it is preferable to avoid breast-feeding during Ventavis therapy.
Slovenian: Ker možnega tveganja za dojenega otroka ni mogoče izključiti, je bolje, da med zdravljenjem z zdravilom Ventavis ne dojite.
English: As you repeatedly experience extended inhalation treatment times with Ventavis 10 microgram/ml (1 ml ampoule with white and yellow rings), your doctor decided to switch to Ventavis 20 microgram/ml.
Slovenian: Ker so bile večkrat potrebne podaljšane inhalacije z zdravilom Ventavis 10 mikrogramov/ml (1mililitrska ampula z belim in rumenim obročem), se je zdravnik odločil za prehod na zdravilo
English: Part of a multipack containing 90 ampoules with 2 ml.
Slovenian: Del škatle večkratnega pakiranja, ki vsebuje 90 ampul z 2 ml.
English: What Ventavis looks like and content of the pack:
Slovenian: Izgled zdravila Ventavis in vsebina pakiranja
English: In rats, passage of low levels of iloprost and/or metabolites into the milk was observed (less than 1% of iloprost dose given intravenously).
Slovenian: Pri podganah so opazili, da iloprost in/ali presnovki prehajajo v mleko v majhnih količinah (manj kot
English: If a dose up to 5 microgram iloprost is indicated, again dosing intervals of 3-4 hours should be chosen initially and shortened according to individual tolerability.
Slovenian: Če je indiciran odmerek do 5 mikrogramov iloprosta, morajo biti na začetku intervali med posameznimi odmerki ponovno 3 - 4 ure, nato pa se krajšajo glede na to, kako bolnik prenaša zdravilo.
English: • hypersensitivity (i.e. allergy)
Slovenian: • preobčutljivost (tj. alergija) • moten občutek za okus (disgevzija)
English: Dose of iloprost at mouthpiece Estimated inhalation time
Slovenian: Odmerek iloprosta v ustniku Predviden inhalacijski čas
English: • Ventavis 10 microgram/ml nebuliser solution is inhaled using the nebulisers your doctor prescribed (either the Breelib, the Venta-Neb or the I-Neb AAD system).
Slovenian: • Zdravilo Ventavis 10 mikrogramov/ml raztopina za nebulator se inhalira z nebulatorjem, ki vam ga je predpisal zdravnik (Breelib, Venta-Neb ali I-Neb AAD).
English: • reduction in the number of blood platelets (thrombocytopenia)
Slovenian: • zmanjšano število trombocitov (trombocitopenija)
English: For each inhalation session the content of one opened ampoule of Ventavis has to be transferred completely into the medication chamber immediately before use.
Slovenian: Neposredno pred vsako inhalacijo se vsebina ene odprte ampule zdravila Ventavis v celoti prenese v prostor za zdravilo v nebulatorju.
English: To minimise accidental exposure, it is recommended to use Ventavis with nebulisers with inhalationtriggered systems (such as Breelib or I-Neb), and to keep the room well ventilated.
Slovenian: ki imajo sistem za aktivacijo ob inhalaciji (kot sta Breelib ali I-Neb), in poskrbeti za dobro zračenje prostora.
English: In inhalation studies in rats, the administration of an iloprost formulation with a concentration of 20 microgram/ml up to 26 weeks did not cause any local irritation of the upper and lower respiratory tract.
Slovenian: Lokalna toleranca, kontaktna senzibilizacija in antigensko delovanje V študijah na podganah, inhaliranje iloprosta v koncentraciji 20 mikrogramov/ml do 26 tednov, ni povzročila lokalnega draženja zgornjih ali spodnjih dihal.
English: There is no need to alter the dose in patients with mild or moderate kidney problems (patients with a creatinine clearance > 30 ml/min).
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic (bolniki z očistkom kreatinina > 30 ml/min) ni treba prilagajati odmerka.
English: Pharmacokinetics of iloprost were investigated in a randomised, crossover study with 27 patients, stable on Ventavis 10 microgram/ml inhaled with I-Neb, following inhalation of single doses of 2.5 or 5 microgram iloprost using the Breelib or the I-Neb AAD nebuliser.
Slovenian: Farmakokinetiko iloprosta so preučevali v randomizirani, navzkrižni študiji, v kateri je sodelovalo 27 bolnikov, ki so zdravilo Ventavis 10 mikrogramov/ml inhalirali z nebulatorjem I-Neb in bili stabilni, po inhalaciji enkratnega odmerka 2,5 ali 5 mikrogramov iloprosta z nebulatorjem Breelib ali I-Neb AAD.
English: Ventavis is a clear, colourless nebuliser solution for inhalation with the Breelib, the I-Neb or the Venta-Neb nebuliser.
Slovenian: Zdravilo Ventavis je bistra, brezbarvna inhalacijska raztopina za inhaliranje z nebulatorjem Breelib, INeb ali Venta-Neb.
English: Venta-Neb, a portable ultrasonic battery-powered nebuliser, has also been shown to be suitable for the administration of Ventavis 10 microgram/ml.
Slovenian: Prenosni, ultrazvočni, baterijski nebulator Venta-Neb je dokazano primeren tudi za apliciranje zdravila Ventavis 10 mikrogramov/ml.
English: Tetranor-iloprost is pharmacologically inactive as shown in animal experiments.
Slovenian: Glede na izsledke poskusov na živalih, je tetranor-iloprost farmakološko neaktiven.
English: Any Ventavis solution remaining in the nebuliser after inhalation must be thrown away.
Slovenian: Vso raztopino zdravila Ventavis, ki po inhalaciji ostane v nebulatorju, morate zavreči.
English: • chest discomfort / chest pain
Slovenian: • neprijeten občutek v prsnem košu/bolečine v prsnem košu
English: Data with intravenously administered iloprost indicated that the elimination is reduced in patients with hepatic dysfunction and in patients with renal failure requiring dialysis (see section 5.2).
Slovenian: Podatki o intravenski uporabi iloprosta so pokazali, da je izločanje iloprosta pri bolnikih z okvaro jeter kot tudi pri tistih z okvaro ledvic, ki potrebujejo zdravljenje z dializo, zmanjšano (glejte poglavje 5.2).
English: Because iloprost is extensively metabolised by the liver, the plasma levels of the active substance are influenced by changes in hepatic function.
Slovenian: Okvara jeter Ker se iloprost v glavnem presnavlja v jetrih, spremembe v delovanju jeter vplivajo na koncentracije učinkovine v plazmi.
English: • Bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing (see also section 2 “Warnings and precautions”)
Slovenian: Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) • Bronhospazem (nenaden krč mišic v steni majhnih dihalnih poti) in zasoplost (glejte tudi poglavje 2 »Opozorila in previdnostni ukrepi«).
English: Your doctor will supervise your treatment when you start using the Breelib nebuliser to ensure that you tolerate dose and speed of inhalation well.
Slovenian: Ko boste začeli uporabljati nebulator Breelib, bo zdravnik nadzoroval zdravljenje, da se bo prepričal, da dobro prenašate odmerek in hitrost inhaliranja.
English: One inhalation session will usually last about 4 to 10 minutes with I-Neb AAD depending on the prescribed dose.
Slovenian: Posamezna inhalacija z nebulatorjem I-Neb ADD traja običajno 4 do 10 minut, odvisno od predpisanega odmerka.