FrancophonIA/ELRC3.0 huggingface dataset:
English: Should patients deteriorate on this treatment intravenous prostacyclin treatment should be considered.
Croatian: U slučaju pogoršanja stanja bolesnika tijekom ovog liječenja potrebno je razmotriti liječenje intravenskom primjenom prostaciklina.
English: Each ml contains 0.81 mg ethanol 96% (equivalent to 0.75 mg ethanol)
Croatian: Svaki ml sadrži 0,81 mg etanola 96% (što odgovara 0,75 mg etanola).
English: Further in vitro studies suggest that metabolism of iloprost in the lungs is similar after intravenous administration or inhalation.
Croatian: Dodatna in vitro ispitivanja pokazuju da je metabolizam iloprosta u plućima sličan nakon intravenske primjene ili nakon inhalacije.
English: Do not drive or operate any tools or machines if you feel these effects.
Croatian: Ako osjećate takve učinke, nemojte voziti ni rukovati nikakvim alatima ili strojevima.
English: Bleeding events (mostly epistaxis and haemoptysis) were very common as expected in this patient population with a high proportion of patients taking anticoagulant co-medication.
Croatian: Opis odabranih nuspojava Krvarenja su bila vrlo česta (najčešće epistaksa i hemoptiza), što je očekivano u ovoj populaciji bolesnika s velikim udjelom bolesnika koji istodobno uzimaju antikoagulanse.
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.
Croatian: Ako se liječnik odluči za daljnje povišenje doze do 5 mikrograma, ponovno je potrebno izabrati početne intervale doziranja od 3 - 4 sata, te ih skraćivati na temelju Vašeg podnošenja liječenja.
English: This system generates droplets by ultrasound, which forces the solution through a mesh.
Croatian: Taj sustav stvara kapljice pomoću ultrazvuka koji potiskuje otopinu kroz mrežicu.
English: When using the Breelib nebuliser please follow the instructions for use provided with the device.
Croatian: Kada koristite nebulizator Breelib, slijedite upute za uporabu priložene uz uređaj.
English: The dose per inhalation session should be administered 6 to 9 times per day according to the individual need and tolerability.
Croatian: Dozu po pojedinačnoj inhalaciji potrebno je uzimati 6 do 9 puta dnevno sukladno pojedinačnim potrebama i podnošljivosti.
English: In a small, randomised, 12-week double-blinded, placebo-controlled study (the STEP trial), 34 patients treated with bosentan 125 mg twice per day for at least 16 weeks who were in stable haemodynamic conditions before enrolment, tolerated the addition of inhaled iloprost at the concentration of 10 microgram/ml (up to 5 microgram 6 to 9 times per day during waking hours).
Croatian: U malom, randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju od 12 tjedana (ispitivanje STEP), 34 bolesnika liječena bosentanom u dozi od 125 mg dvaput na dan tijekom najmanje 16 tjedana koji su bili stabilnog hemodinamičkog stanja prije uključivanja u ispitivanje, podnosili su dodatak inhaliranog iloprosta pri koncentraciji od 10 mikrograma/ml (do 5 mikrograma 6 do 9 puta na dan s prekidom tijekom spavanja).
English: Systemic exposures exceeded human therapeutic exposures after inhalation by factors of more than 10 (Cmax, cumulative AUC).
Croatian: Sistemske izloženosti premašile su za više od 10 puta terapijske izloženosti u ljudi nakon inhalacije (Cmax,
English: Your doctor will monitor you closely.
Croatian: Liječnik će Vas pomno nadzirati.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON WITHOUT BLUE BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KARTONSKA KUTIJA BEZ PLAVOG OKVIRA
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip
English: Excipient with known effect
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom
English: Packages containing:
Croatian: Pakiranja sadrže:
English: • anticoagulants, such as heparin, oral anticoagulants (either coumarin-type or direct),
Croatian: oralni antikoagulansi (bilo kumarinski ili direktni),
English: Physicians should be alerted to the presence of concomitant conditions or medicinal products that might increase the risk of hypotension and syncope (see section 4.5).
Croatian: Liječnici moraju biti upozoreni na komorbiditet te na lijekove koji mogu povećati rizik od hipotenzije i sinkope (vidjeti dio 4.5).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: • Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: Bayer HealthCare Tél(N° vert): +33-(0)800 87 54 54
Croatian: Tél(N° vert): +33-(0)800 87 54 54
English: There is a limited amount of data from the use of iloprost in pregnant women.
Croatian: Podaci o primjeni iloprosta u trudnica su ograničeni.
English: A dermal sensitisation (maximisation test) and an antigenicity study in guinea pigs showed no sensitising potential.
Croatian: Ispitivanje senzibilizacije kože (test maksimizacije) i antigenosti na zamorcima nije pokazalo potencijal za senzibilizaciju.
English: Careful monitoring of the patient should be performed when inhaled iloprost therapy is stopped and an alternative treatment should be considered in critically ill patients.
Croatian: Prilikom prekida liječenja inhaliranjem iloprosta potrebno je pažljivo nadzirati bolesnika, a u bolesnika u kritičnom stanju potrebno je razmotriti alternativan način liječenja.
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.
Croatian: Kako bi se slučajna izloženost smanjila na najmanju moguću mjeru, preporučuje se upotreba lijeka Ventavis pomoću nebulizatora sa sustavom aktiviranja inhalacijom (kao što su Breelib ili I-Neb) te dobro prozračivanje prostorije.
English: • The other ingredients are trometamol, ethanol, sodium chloride, hydrochloric acid for pH adjustment, and water for injections.
Croatian: • Drugi sastojci su trometamol, etanol, natrijev klorid, kloridna kiselina za podešavanje pH i voda za injekcije.
English: - poor blood flow to the heart muscles (severe coronary heart disease or unstable angina).
Croatian: − slab dotok krvi u srčani mišić (teška koronarna bolest srca ili nestabilna angina pektoris).
English: The pharmacological effects after inhalation of Ventavis are:
Croatian: • stimulacija endogenog fibrinolitičkog potencijala Farmakološki učinci nakon inhalacije lijeka Ventavis su:
English: The active substance of Ventavis is iloprost.
Croatian: Djelatna tvar lijeka Ventavis je iloprost.
English: Ventavis should not be initiated in patients with systolic blood pressure less than 85 mmHg.
Croatian: Ventavis se ne smije početi davati bolesnicima sa sistoličkim krvnim tlakom nižim od
English: • breathing difficulties (dyspnoea)
Croatian: • otežano disanje (dispneja)
English: When iloprost at the concentration of 10 microgram/ml is administered via inhalation in patients with pulmonary hypertension or healthy volunteers (iloprost dose at the mouthpiece: 5 microgram: inhalation time in between 4.6 - 10.6 min), mean peak serum concentrations of about 100 to 200 picogram/ml were observed at the end of inhalation session.
Croatian: Kada se iloprost pri koncentraciji od 10 mikrograma/ml primjenjuje putem inhalacije u bolesnika s plućnom hipertenzijom ili zdravih dobrovoljaca (doza iloprosta u nastavku za usta: 5 mikrograma: vrijeme inhalacije između 4,6-10,6 min), na završetku inhalacije uočene su srednje vrijednosti vršnih serumskih koncentracija od otprilike 100 do 200 pikograma/ml.
English: No clinical trial data are available comparing directly in intra-patient observations the acute haemodynamic response after intravenous to that after inhaled iloprost.
Croatian: Nema dostupnih podataka iz kliničkih ispitivanja o izravnoj usporedbi akutnog hemodinamičkog odgovora nakon primjene iloprosta intravenskim putem i primjene iloprosta inhaliranjem u istih bolesnika.
English: 2.5 microgram 5 microgram
Croatian: 2,5 mikrograma 5 mikrograma
English: For filling please follow the instructions for use of the nebuliser.
Croatian: Za punjenje slijedite upute za uporabu nebulizatora.
English: Within 30 minutes to 2 hours after the end of inhalation, iloprost is not detectable in the central compartment (limit of quantification 25 picogram/ml).
Croatian: tragovi iloprosta u središnjem odjeljku ne mogu se otkriti (granica kvantifikacije od 25 pikograma/ml).
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.
Croatian: Ako je indicirana doza do 5 mikrograma iloprosta, isprva je ponovno potrebno odabrati intervale od 3-4 sata uz skraćivanje sukladno pojedinačnoj podnošljivosti.
English: Depending on the type of device used and dose prescribed, 1 ml or 2 ml of Ventavis 10 microgram/ml are appropriate.
Croatian: Ovisno o tipu uređaja i propisanoj dozi, prikladna je primjena 1 ml ili 2 ml lijeka Ventavis 10 mikrograma/ml.
English: Any Ventavis solution remaining in the nebuliser after inhalation must be thrown away.
Croatian: Sva Ventavis otopina koja preostane u nebulizatoru nakon inhalacije mora se baciti.
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.
Croatian: U ispitivanjima toksičnosti za embrije i fetuse štakora kontinuirana intravenska primjena iloprosta dovela je do anomalije jednog članka prsta na prednjim šapama u nekoliko fetusa/mladunčadi neovisno o dozi.
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.
Croatian: Također bi Vam se moglo javiti sniženje ili povišenje krvnog tlaka, bradikardija (usporeni ritam srca), tahikardija (ubrzani ritam srca), povraćanje, proljev ili bolovi u udovima.
English: If you tend to experience fainting episodes, avoid any exceptional straining, for example during physical exertion; it might be useful to inhale Ventavis before.
Croatian: Ako ste skloni epizodama nesvjestica, izbjegavajte bilo kakav izniman napor, primjerice tijekom tjelesne aktivnosti, a prije takvih aktivnosti može biti korisna inhalacija lijeka
English: If you forget to use Ventavis
Croatian: Ako ste zaboravili primijeniti Ventavis
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava krvarenja*§
English: • 300 ampoules.
Croatian: • 300 ampula.
English: What Ventavis is and what it is used for What Ventavis is
Croatian: Što je Ventavis i za što se koristi Što je Ventavis
English: If you stop taking Ventavis
Croatian: Ako prestanete primjenjivati Ventavis
English: Room ventilation
Croatian: Prozračivanje prostorije
English: A careful monitoring of the patients taking anticoagulants or other inhibitors of platelet aggregation according to common medical practice is recommended.
Croatian: Bolesnike koji uzimaju antikoagulanse ili druge inhibitore agregacije trombocita preporučuje se pomno nadzirati u skladu s uobičajenom medicinskom praksom.
English: 85 mmHg for the upper value) then therapy with Ventavis should not be started.
Croatian: 85 mmHg), tada ne biste trebali započeti liječenje lijekom Ventavis.
English: Frequently observed symptoms following overdose are dizziness, headache, flushing, nausea, jaw pain or back pain.
Croatian: Učestalo primijećeni simptomi nakon predoziranja su omaglica, glavobolja, naleti crvenila, mučnina, bol u čeljusti ili bol u leđima.
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).
Croatian: U skupini koja je primala iloprost prosječna promjena u udaljenosti hodanja tijekom 6 minuta u odnosu na početnu vrijednost nakon 12 tjedana liječenja bila je povećanje za 22 metra (-3,3 metra u skupini koja je primala placebo bez korekcije podataka za smrtne ishode ili nedostajuće vrijednosti).
English: First dosing with 2.5 microgram should be done even if patients had already been stable on 5 microgram inhaled with an alternative device (see section 4.2).
Croatian: Potrebno je da prva doza iloprosta bude 2,5 mikrograma čak i ako je bolesnik već stabilan na dozi od 5 mikrograma inhaliranih putem drugog uređaja (vidjeti dio
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.
Croatian: Cmax i AUC (0-tlast) iloprosta nakon inhalacije pomoću uređaja Breelib bile su ipak i dalje u rasponu vrijednosti zabilježenih uz primjenu lijeka Ventavis 10 mikrograma/ml pomoću drugih inhalatora u različitim ispitivanjima.
English: “How to use Ventavis”).
Croatian: "Kako primjenjivati Ventavis").
English: Ventavis10 microgram/ml is available in the following packs:
Croatian: Ventavis 10 mikrograma/ml je dostupan u sljedećim pakiranjima:
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).
Croatian: Nema potrebe za izmjenom doze u bolesnika s blagim ili umjerenim problemima s bubrezima (bolesnici s klirensom kreatinina > 30 ml/min).
English: Patients stabilised on one nebuliser should not switch to another nebuliser without supervision by the treating physician as different nebulisers have been shown to produce aerosols with slightly different physical characteristics and delivery of the solution that may be faster (see section 5.2).
Croatian: Bolesnici stabilizirani na jednom nebulizatoru ne smiju prelaziti na drugi nebulizator bez nadzora nadležnog liječnika jer je dokazano da različiti nebulizatori stvaraju aerosole čija se fizička svojstva blago razlikuju, a isporuka otopine može biti brža (vidjeti dio 5.2).
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excluding heparin, ATC code: B01AC11
Croatian: Farmakoterapijska skupina: Antitrombotici, inhibitori agregacije trombocita izuzev heparina,
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).
Croatian: Rizik od krvarenja može biti povećan u bolesnika kad se istodobno primjenjuju potencijalni inhibitori agregacije trombocita ili antikoagulansi (vidjeti dio 4.5).
English: • Medicines that thin the blood or inhibit blood clotting, this includes acetylsalicylic acid (ASA - a compound found in many medicines that lower fever and relieve pain), heparin, coumarin-type anticoagulants, such as warfarin or phenprocoumon, non-steroidal anti-inflammatory drugs, non-selective phosphodiesterase inhibitors, such as pentoxifylline, selective phosphodiesterase 3 (PDE 3) inhibitors, such as cilostazol or anagrelide, ticlopidine, clopidogrel, glycoprotein IIb/IIIa antagonists, such as o abciximab, o eptifibatide, o tirofiban, defibrotide.
Croatian: • lijekove koji razrjeđuju krv ili sprečavaju zgrušavanje krvi, što uključuje acetilsalicilatnu kiselinu (ASK - tvar koja se nalazi u mnogim lijekovima za snižavanje tjelesne temperature i ublažavanje boli), heparin, kumarinske antikoagulanse, kao što su varfarin ili fenprokumon, nesteroidne protuupalne lijekove, neselektivne inhibitore fosfodiesteraze, kao što je pentoksifilin, selektivne inhibitore fosfodiesteraze 3 (PDE 3), kao što su cilostazol ili anagrelid,
English: • swelling of the limbs (peripheral oedema)
Croatian: • oticanje udova (periferni edem)
English: The measured MMAD of the aerosol droplets was 2.1 micrometres.
Croatian: Izmjereni MMAD kapljica aerosola bio je 2,1 mikrometara.
English: The mean clearance of iloprost is estimated to be 10 ml/minute/kg.
Croatian: Procijenjeni prosječni klirens iloprosta iznosio je 10 ml/minuta/kg.
English: Ventavis therapy should only be initiated by a physician experienced in treatment of pulmonary hypertension.
Croatian: Terapiju lijekom Ventavis smije propisati samo liječnik s iskustvom u liječenju plućne hipertenzije.
English: For each inhalation session you should use a new ampoule of Ventavis.
Croatian: Za svaku inhalaciju potrebno je primijeniti novu ampulu lijeka Ventavis.
English: A potential risk to the breast-feeding child cannot be excluded and it is preferable to avoid breast-feeding during Ventavis therapy.
Croatian: Mogući rizik za dojenče ne može se isključiti te se preporučuje izbjegavati dojenje za vrijeme liječenja lijekom Ventavis.
English: The nebulising device delivers 5 microgram iloprost at the mouthpiece.
Croatian: Nebulizator isporučuje 5 mikrograma ilioprosta u nastavku za usta.
English: Initially, doses of 2.5 microgram iloprost should be administered using Ventavis 10 microgram/ml with dosing intervals of 3-4 hours (corresponds to administration of max. 6 times per day).
Croatian: Isprva je potrebno davati doze od 2,5 mikrograma iloprosta primjenom lijeka Ventavis 10 mikrograma/ml u intervalima od 3-4 sata (što odgovara primjeni od maksimalno 6 puta na dan).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KARTONSKA KUTIJA
English: Switching to the Breelib nebuliser
Croatian: Prelazak na nebulizator Breelib
English: Breelib is a small handheld, battery-powered, breath activated, vibrating mesh technology system.
Croatian: Breelib je mali, ručni, nebulizatorski sustav s baterijskom napajanjem s tehnologijom vibrirajuće mrežice koji se aktivira udahom.
English: − Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage
Croatian: - Stanja pri kojima učinci lijeka Ventavis na trombocite mogu povećati rizik od krvarenja (npr.
English: In the iloprost group the NYHA class was improved in 26% of patients (placebo: 15%) (p = 0.032), unchanged in 67.7% of patients (placebo: 76%) and deteriorated in 6.3% of patients (placebo: 9%).
Croatian: (p = 0,032), u 67,7% bolesnika nije bilo promjene (placebo: 76%), dok je u 6,3% bolesnika došlo do pogoršanja stanja (placebo: 9%).
English: Ventavis nebuliser solution should not come into contact with skin and eyes; oral ingestion of Ventavis solution should be avoided.
Croatian: Kontakt s kožom i očima, ingestija Ventavis otopina za nebulizator ne smije doći u kontakt s kožom ni očima; mora se izbjeći ingestija otopine Ventavis.
English: • 168 (4x42) ampoules
Croatian: • 168 (4 x 42) ampula
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).
Croatian: Podaci o intravenskoj primjeni iloprosta ukazuju na to da je eliminacija smanjena u bolesnika s jetrenom disfunkcijom i u bolesnika sa zatajenjem bubrega na dijalizi (vidjeti dio 5.2).
English: Ventavis 20 microgram/ml is double the concentration of Ventavis 10 microgram/ml.
Croatian: Ventavis 20 mikrograma/ml ima dvostruku koncentraciju u odnosu na Ventavis 10 mikrograma/ml.
English: • 90 ampoules
Croatian: • 90 ampula
English: The haemodynamics observed suggest an acute response with preferential effect of inhaled treatment on the pulmonary vessels.
Croatian: Primijećeni hemodinamički podaci upućuju na akutni odgovor uz pretežiti učinak liječenja inhaliranjem na plućne žile.
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).
Croatian: Ako ne možete podnijeti inhalaciju lijekaVentavis 20 mikrograma/ml obratite se svom liječniku koji može odlučiti da trebate uzimati Ventavis 10 mikrograma/ml (ampula od 1 ml).
English: To obtain the optimal droplet size for the administration of Ventavis 10 microgram/ml nebuliser solution the green baffle plate should be used.
Croatian: Da bi se postigla optimalna veličina kapljica za primjenu Ventavis 10 mikrograma/ml otopine za nebulizator, potrebno je koristiti zelenu ploču.
English: Part of a multipack containing 300 ampoules with 2 ml.
Croatian: Dio višestrukog pakiranja koje sadrži 300 ampula s 2 ml.
English: Part of a multipack containing 90 ampoules with 2 ml.
Croatian: Dio višestrukog pakiranja koje sadrži 90 ampula s 2 ml.
English: • Ventavis 20 microgram/ml nebuliser solution is inhaled using the nebulisers your doctor prescribed (either the Breelib or the I-Neb AAD nebuliser).
Croatian: • Ventavis 20 mikrograma/ml otopina za nebulizator inhalira se pomoću nebulizatora kojeg Vam je propisao liječnik (Breelib ili I-Neb AAD nebulizator).
English: Pulmonary veno-occlusive disease
Croatian: Venookluzivna bolest pluća
English: Patients stabilised on one nebuliser should not switch to another nebuliser without close supervision by the treating doctor as different nebulisers have been shown to produce aerosols with slightly different physical characteristics and may have faster delivery of the solution (see section 5.2 of the Summary of Product Characteristics).
Croatian: Bolesnici stabilizirani na jednom nebulizatoru ne bi smjeli prelaziti na korištenje drugog nebulizatora bez pomnog nadzora svog liječnika jer je dokazano da različiti nebulizatori stvaraju aerosole čija se fizička svojstva blago razlikuju i koji mogu brže isporučiti otopinu (vidjeti dio 5.2 sažetka opisa svojstava lijeka).
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.
Croatian: Farmakokinetika iloprosta ispitivana je u randomiziranom križnom ispitivanju na 27 bolesnika stabilnih na lijeku Ventavis 10 mikrograma/ml inhaliranom s I-Neb nebulizatorom, nakon inhalacije jednokratnih doza od 2,5 ili 5 mikrograma iloprosta pomoću nebulizatora Breelib ili I-Neb AAD.
English: Hypotension, an increase of blood pressure, bradycardia or tachycardia, vomiting, diarrhoea and limb pain might also be possible.
Croatian: Mogući su također i hipotenzija, povišeni krvni tlak, bradikardija ili tahikardija, povraćanje, proljev te bolovi u udovima.
English: Bayer Oy Puh/Tel: +358 20 785 21
Croatian: Puh/Tel: +358 20 785 21
English: Comparable systemic exposures (AUC (0-tlast)) and approximately 30% higher maximum serum concentrations (Cmax) were found following inhalation of Ventavis 20 microgram/ml compared to Ventavis 10 microgram/ml which was in line with the observed shorter inhalation time using Ventavis 20 microgram/ml.
Croatian: Zabilježene su usporedive sistemske izloženosti (AUC [0-tlast])) i približno 30% više maksimalne koncentracije u serumu (Cmax) nakon inhalacije lijeka Ventavis 20 mikrograma/ml u odnosu na Ventavis 10 mikrograma/ml, što je bilo u skladu s opaženim kraćim trajanjem inhalacije kad se primjenjivao Ventavis 20 mikrograma/ml.
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.
Croatian: Na početku korištenja nebulizatora Breelib, liječnik će nadzirati Vaše liječenje kako bi se uvjerio da dobro podnosite dozu i brzinu inhalacije.
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).
Croatian: Rizik od krvarenja može biti povećan u bolesnika koji istodobno uzimaju i inhibitore agregacije trombocita ili antikoagulanse (pogledajte i dio 2.).
English: For administration with the Breelib or the I-Neb.
Croatian: Za primjenu pomoću nebulizatora Breelib ili I-Neb.