FrancophonIA/ELRC3.0 huggingface dataset:
English: It imitates a natural substance in the body called prostacyclin.
Croatian: On oponaša prirodnu tvar u tijelu koja se zove prostaciklin.
English: Ventavis should only be used during pregnancy if your doctor decides that the potential benefit outweighs the potential risk to you and the foetus.
Croatian: Ventavis se smije koristiti u trudnoći samo ako Vaš liječnik utvrdi da je moguća korist veća od mogućeg rizika za Vas i fetus.
English: However, you should avoid taking food or drink during inhalation.
Croatian: Međutim, tijekom inhalacije trebate izbjegavati uzimanje hrane ili pića.
English: Tetranor-iloprost is pharmacologically inactive as shown in animal experiments.
Croatian: Tetranoriloprost je farmakološki neaktivan, što je dokazano u pokusima na životinjama.
English: • If you suffer from a weak heart condition such as right heart failure, and feel that your disease is worsening, tell your doctor.
Croatian: • Ako imate stanje oslabljenog rada srca, kao što je zatajenje desne strane srca, i osjećate da Vam se bolest pogoršava, obavijestite svog liječnika.
English: Control disc
Croatian: Kontrolni disk
English: Follow carefully the instructions that come with the nebuliser especially the instructions on hygiene and cleaning of the nebuliser.
Croatian: Pažljivo slijedite sve upute koje ste dobili s nebulizatorom, a osobito upute o higijeni i čišćenju nebulizatora.
English: Systemic toxicity
Croatian: Sistemska toksičnost
English: • if you have had a stroke within the last 3 months, or any other occurrence that reduced the blood supply to the brain (e.g. transient ischaemic attack),
Croatian: • ako ste imali moždani udar unutar posljednja 3 mjeseca, ili bilo koje drugo stanje koje smanjuje opskrbu mozga krvlju (npr. tranzitorna ishemijska ataka),
English: Ventavis contains ethanol
Croatian: Ventavis sadrži etanol
English: Suitable inhalation device (nebuliser) to be used
Croatian: Odgovarajući uređaj za inhalaciju (nebulizator) koji treba koristiti
English: • The active substance is iloprost.
Croatian: • Djelatna tvar je iloprost.
English: Ask your doctor to have someone help you become thoroughly familiar with the use of the nebuliser.
Croatian: Od liječnika zatražite da angažira osobu koja će Vam pomoći da se temeljito upoznate s korištenjem nebulizatora.
English: • mouth and tongue irritation including pain
Croatian: • iritacija usta i jezika, uključujući i bol
English: Do not change the recommended dose without consulting your doctor first.
Croatian: Ne smijete mijenjati preporučenu dozu bez prethodnog savjetovanja sa svojim liječnikom.
English: Genotoxic potential, tumourigenicity
Croatian: Genotoksični potencijal, tumorogenost
English: Other people might accidentally be exposed to Ventavis through the room air.
Croatian: Druge bi osobe mogle biti slučajno izložene lijeku Ventavis putem zraka u prostoriji.
English: Animal studies have shown reproductive effects (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su učinke na reprodukciju (vidjeti dio 5.3).
English: A cautious initial dose titration using dosing intervals of 3-4 hours is recommended (see section 4.2).
Croatian: Preporučuje se oprezna početna titracija doze uz intervale od 3-4 sata (vidjeti dio 4.2).
English: • if you are allergic to iloprost or any of the other ingredients of this medicine (listed in section 6),
Croatian: • ako ste alergični na iloprost ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.),
English: − Severe arrhythmias.
Croatian: - Teške aritmije.
English: Invasive haemodynamic parameters were assessed at baseline and after 12 weeks treatment.
Croatian: Invazivni hemodinamički parametri procijenjeni su na početku i nakon tretmana od 12 tjedana.
English: Cases of overdose were reported.
Croatian: Simptomi Zabilježeni su slučajevi predoziranja.
English: Following inhalation of these doses with the Breelib the maximum plasma concentrations (Cmax) and systemic exposures (AUC (0-tlast)) increased dose-proportionally.
Croatian: Nakon inhalacije ovih doza pomoću uređaja Breelib, maksimalna koncentracija u plazmi (Cmax) i sistemska izloženost (AUC (0-tlast)) povećale su se proporcionalno dozi.
English: Ventavis is used to treat moderate cases of primary pulmonary hypertension (PPH) in adult patients.
Croatian: Ventavis se koristi za liječenje umjerenih slučajeva primarne plućne hipertenzije (PPH) u odraslih bolesnika.
English: Animal studies have not shown harmful effect of iloprost on fertility.
Croatian: Ispitivanja na životinjama nisu pokazala štetan učinak iloprosta na plodnost.
English: Thereafter, dosing intervals may be shortened cautiously based on individual tolerability.
Croatian: Nakon toga se intervali doziranja mogu pažljivo skraćivati, ovisno o pojedinačnoj podnošljivosti.
English: The most frequently observed adverse reactions (≥ 20 %) in clinical trials include vasodilatation (including hypotension), headache and cough.
Croatian: Najčešće zabilježene nuspojave (≥20%) u kliničkim ispitivanjima jesu vazodilatacija (uključujući hipotenziju), glavobolja i kašalj.
English: To avoid undesired accumulation over the day, special caution has to be exercised with these patients during initial dose titration.
Croatian: Kako bi se izbjeglo njegovo neželjeno nakupljanje tijekom dana, u ovih je bolesnika potreban poseban oprez tijekom početne titracije doze.
English: • In general, you will need to take special care to try and avoid effects of low blood pressure,
Croatian: • Općenito, trebat ćete posebno paziti kako biste pokušali izbjeći učinke sniženog krvnog tlaka kao što su nesvjestica i omaglica:
English: • Dilatation of arterioles and venules
Croatian: • dilatacija arteriola i venula
English: • Do NOT let Ventavis solution come into contact with your skin or eyes.
Croatian: • NEMOJTE dopustiti da Vam Ventavis otopina dospije u kontakt s kožom ili očima.
English: This is a condition where blood pressure is too high in the blood vessels between the heart and the lungs.
Croatian: To je stanje previsokog krvnog tlaka u krvnim žilama između srca i pluća.
English: Two programmes can be operated:
Croatian: Moguća su dva programa primjene:
English: Considering the high pharmacological potency of iloprost and the absolute doses required for therapeutic purposes the results obtained in acute toxicity studies do not indicate a risk of acute adverse effects in humans.
Croatian: S obzirom na visoku farmakološku potentnost iloprosta i apsolutne doze potrebne u svrhu liječenja, rezultati dobiveni ispitivanjima akutne toksičnosti ne ukazuju na rizik od akutnih nuspojava za ljude.
English: Improved blood flow leads to a better supply of oxygen to the body and reduced strain on the heart.
Croatian: Poboljšani protok krvi dovodi do bolje opskrbe tijela kisikom i smanjenja opterećenja srca.
English: Always take Ventavis exactly as your doctor has told you.
Croatian: Uvijek primijenite lijek Ventavis točno onako kako Vam je rekao Vaš liječnik.
English: An accumulation of iloprost following treatment over several days is not likely due to the overnight break in administration of the medicinal product.
Croatian: Nakupljanje iloprosta uslijed liječenja tijekom nekoliko dana nije vjerojatno zbog prekida primjene lijeka tijekom noći.
English: Efficacy in adult patients with pulmonary hypertension
Croatian: Djelotvornost u odraslih bolesnika s plućnom hipertenzijom
English: • Fainting episodes may be due to the underlying disease.
Croatian: • Uzrok epizodama nesvjestica može biti podležeća bolest.
English: In vitro (bacterial, mammalian cells, human lymphocytes) and in vivo studies (micronucleus test) for genotoxic effects have not produced any evidence for a mutagenic potential.
Croatian: In vitro (bakterije, stanice sisavaca, ljudski limfociti) i in vivo ispitivanjima (mikronukleus test) genotoksičnih učinaka nisu dali nikakve dokaze mutagenog potencijala.
English: Total plasma protein binding of iloprost is concentration-independent in the range of 30 to 3,000 picogram/ml and amounts to approximately 60%, of which 75% is due to albumin binding.
Croatian: Ukupno vezanje iloprosta na proteine u plazmi neovisno je o koncentraciji u rasponu od 30 do 3000 pikograma/ml i iznosi približno 60%, od čega je 75% rezultat vezanja za albumin.
English: • Increase of capillary density and reduction of increased vascular permeability caused by mediators such as serotonin or histamine in the microcirculation
Croatian: • povećanje kapilarne gustoće i smanjenje povećane propusnosti žila uzrokovane medijatorima kao što su serotonin ili histamin u mikrocirkulaciji
English: Your doctor will adjust Venta-Neb to the programme you need to receive the dose prescribed for you.
Croatian: Vaš će liječnik Venta-Neb prilagoditi programu koji je potreban kako biste primali propisanu dozu.
English: In addition, instructions for hygiene and cleaning of the nebulisers provided by the device manufacturers should be followed carefully.
Croatian: Dodatno, treba pažljivo slijediti upute za higijenu i čišćenje nebulizatora priložene od strane njegovog proizvođača.
English: There are two different colour coded medication chambers.
Croatian: Postoje dvije komore za lijek, označene različitim bojama.
English: One inhalation session with Breelib will usually last about 3 minutes.
Croatian: Jedna inhalacija s uređajem Breelib obično traje otprilike 3 minute.
English: You should continue on this dose.
Croatian: Potrebno je nastaviti s tom dozom.
English: Symptoms of overdoses are mainly related to the vasodilatory effect of iloprost.
Croatian: Simptomi predoziranja uglavnom su povezani s vazodilatacijskim učinkom iloprosta.
English: • if you are at risk of bleeding- for example, if you have an active ulcer of the stomach or of the first part of the small intestine (duodenal ulcers), if you have suffered a physical injury (trauma), if you are at risk of bleeding within the skull,
Croatian: • ako ste izloženi riziku od krvarenja - na primjer, ako imate aktivan čir na želucu ili na početnom dijelu tankog crijeva (duodenalni ulkus), ako ste pretrpjeli tjelesnu ozljedu (traumu) ili ste izloženi riziku od krvarenja unutar lubanje,
English: Gender Gender is not of clinical relevance to the pharmacokinetics of iloprost.
Croatian: Spol Spol nema klinički značaj za farmakokinetiku iloprosta.
English: Do not use this medicine after the expiry date which is stated on the carton and ampoule.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i ampuli.
English: The mean daily inhaled dose was 27 microgram and the mean number of inhalations per day was 5.6.
Croatian: Prosječna dnevna inhalirana doza iznosila je 27 mikrograma, a prosječni je broj inhalacija po danu bio 5,6.
English: • If you suffer from pulmonary hypertension, avoid getting pregnant as pregnancy may lead to a worsening of your condition and may even endanger your life.
Croatian: • Ako bolujete od plućne hipertenzije, izbjegavajte trudnoću jer u trudnoći može doći do pogoršanja Vašeg stanja te Vam čak može ugroziti život.
English: If a pregnancy occurs, taking into account the potential maternal benefit, the use of Ventavis during pregnancy may be considered, only following careful benefit-risk evaluation, in those women who choose to continue their pregnancy, despite the known risks of pulmonary hypertension during pregnancy.
Croatian: Ako nastupi trudnoća, uzimajući u obzir moguću korist za majku, može se razmotriti primjena lijeka Ventavis, samo nakon pažljive ocjene omjera koristi i rizika, u onih trudnica koje odluče zadržati trudnoću unatoč poznatim rizicima od plućne hipertenzije u trudnoći.
English: Other possible effects
Croatian: Ostale moguće nuspojave
English: Bayer AG 51368 Leverkusen Germany
Croatian: 51368 Leverkusen Njemačka
English: These alterations are not considered as teratogenic effects, but are most likely related to iloprost induced growth retardation in late organogenesis due to haemodynamic alterations in the foetoplacental unit.
Croatian: Te se promjene ne smatraju teratogenim učincima, nego su najvjerojatnije povezane s retardacijom rasta koju iloprost uzrokuje u završnoj fazi organogeneze zbog hemodinamičkih promjena u fetoplacentarnoj jedinici.
English: If you have very severe kidney problems and require dialysis or if you have liver problems, your doctor will introduce you to Ventavis gradually and possibly prescribe fewer daily inhalations.
Croatian: Ako imate vrlo teške probleme s bubrezima i potrebna Vam je dijaliza ili imate problema s jetrom, liječnik će Vam postupno uvoditi Ventavis i možda propisati manji broj inhalacija tijekom dana.
English: In comparable embryotoxicity studies in rabbits and monkeys no such digit anomalies or other gross-structural anomalies were observed even after considerably higher dose levels which exceeded the human dose multiple times.
Croatian: U usporedivim ispitivanjima embriotoksičnosti kod zečeva i majmuna nisu uočene takve anomalije na prstima, kao ni druge abnormalnosti velikih struktura čak niti nakon značajno viših doza koje višestruko premašuju dozu za čovjeka.
English: Your doctor will consider changing your treatment.
Croatian: Liječnik će razmotriti promjenu terapije.
English: However, the predictive value of these acute haemodynamic data are considered to be of limited value as acute response does not in all cases correlate with long-term benefit of treatment with inhaled iloprost.
Croatian: Međutim, smatra se da je prediktivna vrijednost tih podataka o akutnoj hemodinamici ograničena jer akutni odgovor nije u svim slučajevima povezan s dugotrajnim pozitivnim učincima liječenja inhaliranim iloprostom.
English: Before taking any medicine ask your doctor or pharmacist, who has more information on medicines to be careful with or avoid when using Ventavis.
Croatian: Prije nego uzmete bilo koji lijek obratite se svom liječniku ili ljekarniku jer oni imaju više informacija o lijekovima koje je tijekom uzimanja lijeka Ventavis potrebno uzimati s oprezom ili izbjegavati.
English: Patients with a creatinine clearance of ≤30 ml/min were not investigated in the clinical trials.
Croatian: Bolesnici s klirensom kreatinina 30 ml/min ili manjim nisu ispitivani u kliničkim ispitivanjima.
English: In clinical trials peripheral oedema was reported in 12.2% of patients on iloprost and 16.2% of patients on placebo.
Croatian: U kliničkim ispitivanjima periferni edem bio je zabilježen u 12,2% bolesnika koji su primali iloprost i u 16,2% bolesnika koji su primali placebo.
English: • The nebuliser turns Ventavis solution into a mist which you breathe in through your mouth.
Croatian: • Nebulizator pretvara Ventavis otopinu u maglicu koju udišete kroz usta.
English: Your doctor will monitor you carefully.
Croatian: Liječnik će Vas pažljivo nadzirati.
English: They should both have the same colour, either red for the 2.5 microgram dose or purple for the 5 microgram dose.
Croatian: Moraju oboje biti iste boje: bilo crvene za dozu od 2,5 mikrograma ili ljubičaste za dozu od 5 mikrograma.
English: I-Neb AAD 2.5 microgram 5 microgram
Croatian: I-Neb AAD 2,5 mikrograma 5 mikrograma
English: The selection of the pre-set programme is made by the doctor.
Croatian: Odluku o odabiru unaprijed određenog programa donosi liječnik.
English: You should administer the dose 6 to 9 times per day according to individual needs and tolerability.
Croatian: Dozu trebate primijeniti 6 do 9 puta na dan sukladno individualnim potrebama i podnošljivosti.
English: If any of these happen when you have used more Ventavis than you should:
Croatian: Ako osjetite bilo koji od tih simptoma kada ste primijenili više lijeka Ventavis nego što ste trebali:
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.
Croatian: U bolesnika s niskim sistemskim krvnim tlakom, u bolesnika s posturalnom hipotenzijom ili bolesnika koji primaju lijekove za koje je poznato da snižavaju krvni tlak, potrebno je poduzeti mjere sprječavanja dodatne hipotenzije.
English: • Medicines used to treat high blood pressure or heart disease, such as beta blockers, nitro-vasodilators,
Croatian: • lijekove za liječenje povišenog krvnog tlaka ili bolesti srca, kao što su beta-blokatori, nitratni vazodilatatori,
English: Very rarely, fatal cases including bleeding in the brain (cerebral and intracranial haemorrhage) have been reported.
Croatian: Vrlo rijetko su prijavljeni smrtni slučajevi uključujući krvarenje u mozak (cerebralno i intrakranijalno krvarenje).
English: • Do NOT drink or swallow Ventavis solution.
Croatian: • NEMOJTE piti ili progutati Ventavis otopinu.
English: • disturbed sense of taste (dysgeusia)
Croatian: • poremećen osjet okusa (disgeuzija)
English: − Severe coronary heart disease or unstable angina.
Croatian: - Teška koronarna bolest srca ili nestabilna angina.
English: Patients with concomitant acute pulmonary infections, COPD and severe asthma should be carefully monitored.
Croatian: Bolesnike s istodobnim akutnim plućnim infekcijama, KOPB i teškom astmom potrebno je pomno nadzirati.
English: During nebulisation sessions a facial mask must be avoided and only a mouthpiece should be used.
Croatian: Tijekom nebulizacije potrebno je izbjegavati korištenje maske za lice i koristiti samo nastavak za usta.
English: Breathing in the mist carries Ventavis to the lungs, where it can work most effectively in the artery between heart and lungs.
Croatian: Udisanjem maglice Ventavis se prenosi do pluća, gdje može najučinkovitije djelovati u arteriji između srca i pluća.
English: Limited data are available on the use of the Breelib nebuliser.
Croatian: Dostupni su ograničeni podaci o primjeni Breelib nebulizatora.
English: Results of in vitro studies reveal that CYP 450-dependent metabolism plays only a minor role in the biotransformation of iloprost.
Croatian: Rezultati in vitro ispitivanja otkrivaju da metabolizam koji ovisi o CYP 450 igra tek malu ulogu u biotransformaciji iloprosta.
English: In subjects with normal renal and hepatic function, the disposition of iloprost following intravenous infusion is characterised in most cases by a two-phase profile with mean half-lives of 3 to 5 minutes and 15 to 30 minutes.
Croatian: U ispitanika s normalnim funkcijama bubrega i jetre, dispoziciju iloprosta nakon intravenske infuzije u većini slučajeva karakterizira dvofazni profil s prosječnim poluvijekom od 3 do 5 minuta, odnosno od 15 do 30 minuta.
English: Not known: frequency cannot be estimated from the available data.
Croatian: Nepoznato: učestalost ne može se procijeniti iz dostupnih podataka.
English: The dose of Ventavis and the duration of treatment that is right for you depend on your individual condition.
Croatian: Doza lijeka Ventavis i trajanje liječenja koji Vam odgovaraju ovise o Vašem individualnom stanju.
English: 4.6 Fertility, pregnancy and lactation
Croatian: 4.6 Plodnost, trudnoća i dojenje Žene reproduktivne dobi
English: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease.
Croatian: Plućni vazodilatatori mogu značajno pogoršati kardiovaskularni status bolesnika s venookluzivnom bolesti pluća.
English: He/she may consider adjusting your dose or changing your treatment.
Croatian: Liječnik može razmotriti prilagodbu Vaše doze ili promjenu terapije.
English: The acute adverse effects in patients receiving concomitant bosentan and iloprost were consistent with those observed in the larger experience of the phase 3 study in patients receiving only iloprost.
Croatian: Akutne nuspojave u bolesnika koji su istodobno primali bosentan i iloprost bile su u skladu s onima ustanovljenim tijekom duljeg iskustva u ispitivanju faze 3 u bolesnika koji su primali samo iloprost.
English: • Low blood pressure (hypotension)
Croatian: • Sniženi krvni tlak (hipotenzija).
English: A subgroup analysis showed that no treatment effect was observed as compared to placebo on the 6-minute walk test in the subgroup of patients with secondary pulmonary hypertension.
Croatian: Analiza podskupina pokazala je da učinak tretmana na rezultate testa 6-minutnog hoda u odnosu na placebo nije uočen u podskupini bolesnika sa sekundarnom plućnom hipertenzijom.
English: Continuous intravenous/subcutaneous infusion of iloprost up to 26 weeks in rodents and non-rodents did not cause any organ toxicity at dose levels which exceeded the human therapeutic systemic exposure between 14 and 47 times (based on plasma levels).
Croatian: Kontinuirana intravenska/supkutana infuzija iloprosta do 26 tjedana u glodavaca i neglodavaca nije uzrokovala nikakvu toksičnost za organe pri razinama doza većim između 14 i 47 puta od terapijske sistemske izloženosti u ljudi (na temelju razina u plazmi).
English: Intravenous infusion of iloprost has no effect either on the pharmacokinetics of multiple oral doses of digoxin or on the pharmacokinetics of co-administered tissue plasminogen activator (t-PA) in patients.
Croatian: Intravenska infuzija iloprosta nema nikakav učinak ni na farmakokinetiku višestrukih peroralnih doza digoksina niti na farmakokinetiku istodobno primijenjenog tkivnog aktivatora plazminogena (t-PA) u bolesnika.
English: Ventavis lowers blood pressure and may cause dizziness or light-headedness in some people.
Croatian: Ventavis snižava krvni tlak i u nekih osoba može izazvati omaglicu ili ošamućenost.
English: Food or drink is not expected to affect Ventavis.
Croatian: Ne očekuje se učinak hrane ili pića na Ventavis.
English: Treatment of adult patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms.
Croatian: Liječenje odraslih bolesnika s primarnom plućnom hipertenzijom, svrstanom u NYHA funkcijsku klasu III, radi poboljšanja kapaciteta tjelesne aktivnosti i ublažavanja simptoma.
English: Very low levels of iloprost into milk were observed in rats (see section 5.3).
Croatian: U mlijeku štakora uočene su vrlo niske razine iloprosta (vidjeti dio 5.3).
English: • Inhibition of platelet aggregation, platelet adhesion and release reaction
Croatian: • inhibicija agregacije trombocita, adhezija i reakcija otpuštanja trombocita
English: − Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: - Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: − Pulmonary hypertension due to venous occlusive disease.
Croatian: - Plućna hipertenzija zbog venske okluzivne bolesti.
English: 2.5 mcg red red
Croatian: 2,5 µg crveni crveni
English: • Bleeding events (mostly nosebleed (epistaxis) and coughing up blood (haemoptysis)) may very commonly occur, especially if you are also taking blood-thinning medicines (anticoagulants).
Croatian: • Krvarenja (najčešće krvarenje iz nosa (epistaksa) i iskašljavanje krvi (hemoptiza)) se mogu pojaviti vrlo često, posebno ako uzimate i lijekove za razrjeđivanje krvi (antikoagulanse).
English: In case of deterioration or worsening of right heart failure transfer to other medicinal products should be considered.
Croatian: U slučaju slabljenja funkcije ili pogoršanja zatajenja desne strane srca potrebno je razmotriti prelazak na druge lijekove.
English: Tell your doctor if you have a lung infection, severe asthma, or chronic lung disease (chronic obstructive pulmonary disease).
Croatian: Obavijestite svog liječnika ako imate infekciju pluća, teži oblik astme ili kroničnu bolest pluća (kroničnu opstruktivnu bolest pluća).
English: The pulmonary vasodilatory effect of each single inhalation levels off within one to two hours.
Croatian: Vazodilatacijski učinak na plućne žile svake pojedinačne inhalacije smanjuje se u roku jednog do dva sata.
English: − Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
Croatian: - Cerebrovaskularni događaji (npr. tranzitorna ishemijska ataka, moždani udar) unutar posljednja
English: No studies performed following inhalation.
Croatian: Nakon inhalacije nisu provedena ispitivanja.
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).
Croatian: U štakora je uočeno izlučivanje niskih razina iloprosta i/ili metabolita u mlijeko (manje od 1%