natgillin/translations-raw huggingface dataset:
To avoid undesired accumulation over the day, special caution has to be exercised with these patients during initial dose titration. 
Kako bi se izbjeglo njegovo neželjeno nakupljanje tijekom dana, u ovih je bolesnika potreban poseban oprez tijekom početne titracije doze.
• In general, you will need to take special care to try and avoid effects of low blood pressure, 
• Općenito, trebat ćete posebno paziti kako biste pokušali izbjeći učinke sniženog krvnog tlaka kao što su nesvjestica i omaglica:
• Dilatation of arterioles and venules 
• dilatacija arteriola i venula
• Do NOT let Ventavis solution come into contact with your skin or eyes. 
• NEMOJTE dopustiti da Vam Ventavis otopina dospije u kontakt s kožom ili očima.
This is a condition where blood pressure is too high in the blood vessels between the heart and the lungs. 
To je stanje previsokog krvnog tlaka u krvnim žilama između srca i pluća.
Two programmes can be operated: 
Moguća su dva programa primjene:
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. 
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.
Improved blood flow leads to a better supply of oxygen to the body and reduced strain on the heart. 
Poboljšani protok krvi dovodi do bolje opskrbe tijela kisikom i smanjenja opterećenja srca.
Always take Ventavis exactly as your doctor has told you. 
Uvijek primijenite lijek Ventavis točno onako kako Vam je rekao Vaš liječnik.
An accumulation of iloprost following treatment over several days is not likely due to the overnight break in administration of the medicinal product. 
Nakupljanje iloprosta uslijed liječenja tijekom nekoliko dana nije vjerojatno zbog prekida primjene lijeka tijekom noći.
Efficacy in adult patients with pulmonary hypertension 
Djelotvornost u odraslih bolesnika s plućnom hipertenzijom
• Fainting episodes may be due to the underlying disease. 
• Uzrok epizodama nesvjestica može biti podležeća bolest.
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. 
In vitro (bakterije, stanice sisavaca, ljudski limfociti) i in vivo ispitivanjima (mikronukleus test) genotoksičnih učinaka nisu dali nikakve dokaze mutagenog potencijala.
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. 
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.
• Increase of capillary density and reduction of increased vascular permeability caused by mediators such as serotonin or histamine in the microcirculation 
• povećanje kapilarne gustoće i smanjenje povećane propusnosti žila uzrokovane medijatorima kao što su serotonin ili histamin u mikrocirkulaciji
Your doctor will adjust Venta-Neb to the programme you need to receive the dose prescribed for you. 
Vaš će liječnik Venta-Neb prilagoditi programu koji je potreban kako biste primali propisanu dozu.
In addition, instructions for hygiene and cleaning of the nebulisers provided by the device manufacturers should be followed carefully. 
Dodatno, treba pažljivo slijediti upute za higijenu i čišćenje nebulizatora priložene od strane njegovog proizvođača.
There are two different colour coded medication chambers. 
Postoje dvije komore za lijek, označene različitim bojama.
One inhalation session with Breelib will usually last about 3 minutes. 
Jedna inhalacija s uređajem Breelib obično traje otprilike 3 minute.
You should continue on this dose. 
Potrebno je nastaviti s tom dozom.
Symptoms of overdoses are mainly related to the vasodilatory effect of iloprost. 
Simptomi predoziranja uglavnom su povezani s vazodilatacijskim učinkom iloprosta.
• 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, 
• 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,
Gender Gender is not of clinical relevance to the pharmacokinetics of iloprost. 
Spol Spol nema klinički značaj za farmakokinetiku iloprosta.
Do not use this medicine after the expiry date which is stated on the carton and ampoule. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i ampuli.
The mean daily inhaled dose was 27 microgram and the mean number of inhalations per day was 5.6. 
Prosječna dnevna inhalirana doza iznosila je 27 mikrograma, a prosječni je broj inhalacija po danu bio 5,6.
• 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. 
• Ako bolujete od plućne hipertenzije, izbjegavajte trudnoću jer u trudnoći može doći do pogoršanja Vašeg stanja te Vam čak može ugroziti život.
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. 
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.
Other possible effects 
Ostale moguće nuspojave
Bayer AG 51368 Leverkusen Germany 
51368 Leverkusen Njemačka
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. 
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.
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. 
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.
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. 
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.
Your doctor will consider changing your treatment. 
Liječnik će razmotriti promjenu terapije.
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. 
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.
Before taking any medicine ask your doctor or pharmacist, who has more information on medicines to be careful with or avoid when using Ventavis. 
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.
Patients with a creatinine clearance of ≤30 ml/min were not investigated in the clinical trials. 
Bolesnici s klirensom kreatinina 30 ml/min ili manjim nisu ispitivani u kliničkim ispitivanjima.
In clinical trials peripheral oedema was reported in 12.2% of patients on iloprost and 16.2% of patients on placebo. 
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.
• The nebuliser turns Ventavis solution into a mist which you breathe in through your mouth. 
• Nebulizator pretvara Ventavis otopinu u maglicu koju udišete kroz usta.
Your doctor will monitor you carefully. 
Liječnik će Vas pažljivo nadzirati.
They should both have the same colour, either red for the 2.5 microgram dose or purple for the 5 microgram dose. 
Moraju oboje biti iste boje: bilo crvene za dozu od 2,5 mikrograma ili ljubičaste za dozu od 5 mikrograma.
I-Neb AAD 2.5 microgram 5 microgram 
I-Neb AAD 2,5 mikrograma 5 mikrograma
The selection of the pre-set programme is made by the doctor. 
Odluku o odabiru unaprijed određenog programa donosi liječnik.
You should administer the dose 6 to 9 times per day according to individual needs and tolerability. 
Dozu trebate primijeniti 6 do 9 puta na dan sukladno individualnim potrebama i podnošljivosti.
If any of these happen when you have used more Ventavis than you should: 
Ako osjetite bilo koji od tih simptoma kada ste primijenili više lijeka Ventavis nego što ste trebali:
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. 
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.
• Medicines used to treat high blood pressure or heart disease, such as beta blockers, nitro-vasodilators, 
• lijekove za liječenje povišenog krvnog tlaka ili bolesti srca, kao što su beta-blokatori, nitratni vazodilatatori,
Very rarely, fatal cases including bleeding in the brain (cerebral and intracranial haemorrhage) have been reported. 
Vrlo rijetko su prijavljeni smrtni slučajevi uključujući krvarenje u mozak (cerebralno i intrakranijalno krvarenje).
• Do NOT drink or swallow Ventavis solution. 
• NEMOJTE piti ili progutati Ventavis otopinu.
• disturbed sense of taste (dysgeusia) 
• poremećen osjet okusa (disgeuzija)
− Severe coronary heart disease or unstable angina. 
- Teška koronarna bolest srca ili nestabilna angina.
Patients with concomitant acute pulmonary infections, COPD and severe asthma should be carefully monitored. 
Bolesnike s istodobnim akutnim plućnim infekcijama, KOPB i teškom astmom potrebno je pomno nadzirati.
During nebulisation sessions a facial mask must be avoided and only a mouthpiece should be used. 
Tijekom nebulizacije potrebno je izbjegavati korištenje maske za lice i koristiti samo nastavak za usta.
Breathing in the mist carries Ventavis to the lungs, where it can work most effectively in the artery between heart and lungs. 
Udisanjem maglice Ventavis se prenosi do pluća, gdje može najučinkovitije djelovati u arteriji između srca i pluća.
Limited data are available on the use of the Breelib nebuliser. 
Dostupni su ograničeni podaci o primjeni Breelib nebulizatora.
Results of in vitro studies reveal that CYP 450-dependent metabolism plays only a minor role in the biotransformation of iloprost. 
Rezultati in vitro ispitivanja otkrivaju da metabolizam koji ovisi o CYP 450 igra tek malu ulogu u biotransformaciji iloprosta.
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. 
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.
Not known: frequency cannot be estimated from the available data. 
Nepoznato: učestalost ne može se procijeniti iz dostupnih podataka.
The dose of Ventavis and the duration of treatment that is right for you depend on your individual condition. 
Doza lijeka Ventavis i trajanje liječenja koji Vam odgovaraju ovise o Vašem individualnom stanju.
4.6 Fertility, pregnancy and lactation 
4.6 Plodnost, trudnoća i dojenje Žene reproduktivne dobi
Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease. 
Plućni vazodilatatori mogu značajno pogoršati kardiovaskularni status bolesnika s venookluzivnom bolesti pluća.
He/she may consider adjusting your dose or changing your treatment. 
Liječnik može razmotriti prilagodbu Vaše doze ili promjenu terapije.
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. 
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.
• Low blood pressure (hypotension) 
• Sniženi krvni tlak (hipotenzija).
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. 
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.
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). 
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).
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. 
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.
Ventavis lowers blood pressure and may cause dizziness or light-headedness in some people. 
Ventavis snižava krvni tlak i u nekih osoba može izazvati omaglicu ili ošamućenost.
Food or drink is not expected to affect Ventavis. 
Ne očekuje se učinak hrane ili pića na Ventavis.
Treatment of adult patients with primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms. 
Liječenje odraslih bolesnika s primarnom plućnom hipertenzijom, svrstanom u NYHA funkcijsku klasu III, radi poboljšanja kapaciteta tjelesne aktivnosti i ublažavanja simptoma.
Very low levels of iloprost into milk were observed in rats (see section 5.3). 
U mlijeku štakora uočene su vrlo niske razine iloprosta (vidjeti dio 5.3).
• Inhibition of platelet aggregation, platelet adhesion and release reaction 
• inhibicija agregacije trombocita, adhezija i reakcija otpuštanja trombocita
− Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
- Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
− Pulmonary hypertension due to venous occlusive disease. 
- Plućna hipertenzija zbog venske okluzivne bolesti.
2.5 mcg red red 
2,5 µg crveni crveni
• Bleeding events (mostly nosebleed (epistaxis) and coughing up blood (haemoptysis)) may very commonly occur, especially if you are also taking blood-thinning medicines (anticoagulants). 
• Krvarenja (najčešće krvarenje iz nosa (epistaksa) i iskašljavanje krvi (hemoptiza)) se mogu pojaviti vrlo često, posebno ako uzimate i lijekove za razrjeđivanje krvi (antikoagulanse).
In case of deterioration or worsening of right heart failure transfer to other medicinal products should be considered. 
U slučaju slabljenja funkcije ili pogoršanja zatajenja desne strane srca potrebno je razmotriti prelazak na druge lijekove.
Tell your doctor if you have a lung infection, severe asthma, or chronic lung disease (chronic obstructive pulmonary disease). 
Obavijestite svog liječnika ako imate infekciju pluća, teži oblik astme ili kroničnu bolest pluća (kroničnu opstruktivnu bolest pluća).
The pulmonary vasodilatory effect of each single inhalation levels off within one to two hours. 
Vazodilatacijski učinak na plućne žile svake pojedinačne inhalacije smanjuje se u roku jednog do dva sata.
− Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months. 
- Cerebrovaskularni događaji (npr. tranzitorna ishemijska ataka, moždani udar) unutar posljednja
No studies performed following inhalation. 
Nakon inhalacije nisu provedena ispitivanja.
In rats, passage of low levels of iloprost and/or metabolites into the milk was observed (less than 1% of iloprost dose given intravenously). 
U štakora je uočeno izlučivanje niskih razina iloprosta i/ili metabolita u mlijeko (manje od 1%
It stops after the pre-set dose has been administered. 
Zaustavlja se nakon primjene unaprijed određene doze.
The efficacy and tolerability of inhaled iloprost when administered with other nebulising systems, which provide different nebulisation characteristics of iloprost solution, have not been established. 
Djelotvornost i podnošljivost inhaliranog iloprosta u slučajevima primjene pomoću drugih nebulizatorskih sustava, koji stvaraju drukčija svojstva nebulizacije otopine iloprosta, nisu ustanovljene.
• Your blood pressure will be checked before treatment and if it is too low (less than 
• Prije liječenja provjerit će Vam se krvni tlak i ako je prenizak (gornja vrijednost niža od
• If you experience difficulty breathing, cough up blood, and/or sweat excessively these may be signs that you have water in the lungs (lung oedema). 
• Ako imate poteškoće s disanjem, iskašljavate krv i/ili se pojačano znojite, to mogu biti znakovi vode u plućima (edem pluća).
Other medicines and Ventavis 
Drugi lijekovi i Ventavis
Although, clinical studies have not been conducted, in vitro studies investigating the inhibitory potential of iloprost on the activity of cytochrome P450 enzymes revealed that no relevant inhibition of drug metabolism via these enzymes by iloprost is to be expected. 
Iako klinička ispitivanja nisu provedena, in vitro ispitivanja inhibicijskog potencijala iloprosta na aktivnost enzima citokroma P450 pokazala su da se ne očekuje značajna inhibicija metabolizma lijekova putem tih enzima od strane iloprosta.
In this case talk to your doctor immediately. 
U slučaju njihova pojavljivanja odmah se obratite liječniku.
The safety and efficacy of Ventavis in children aged up to 18 years have not been established. 
Sigurnost i djelotvornost lijeka Ventavis u djece do 18 godina nisu ustanovljene.
The duration of an inhalation session with Breelib nebuliser is approximately 3 minutes, which reflects the higher delivery rate of the Breelib compared to other nebulisers. 
Trajanje jedne inhalacije s Breelib nebulizatorom je otprilike 3 minute, što je odraz veće brzine isporuke lijeka uz uporabu uređaja Breelib u usporedbi s drugim nebulizatorima.
No disturbance of postnatal development and reproductive performance was seen in the offspring that were raised, indicating that the observed retardation in rats was compensated during the postnatal development. 
Nije uočen poremećaj u postnatalnom razvoju i reprodukcije u potomstvu, što upućuje na to da je uočena retardacija rasta u štakora kompenzirana tijekom postnatalnog razvoja.
The pulmonary vasodilatory effect of inhaled iloprost is of short duration (one to two hours). 
Učinak inhaliranog iloprosta na vazodilataciju plućnih žila kratkog je trajanja (jedan do dva sata).
Following intravenous infusion, the recovery of total radioactivity is 81 %, and the respective recoveries in urine and faeces are 68% and 12%. 
Nakon intravenske infuzije izlučilo se 81% ukupne radioaktivnosti, 68% u mokraći i 12% u stolici.
Should signs of pulmonary oedema occur, the possibility of associated pulmonary veno-occlusive disease should be considered and treatment with Ventavis should be discontinued. 
Ukoliko se pojave znakovi plućnog edema, mora se uzeti u obzir mogućnost povezane venookluzivne bolesti pluća, te se liječenje lijekom Ventavis mora prekinuti.
Bayer Hungária KFT Tel.:+36 14 87-41 00 
Magyarország Bayer Hungária KFT Tel.:+36 14 87-41 00
Fill the medication chamber with Ventavis immediately before use. 
Komoru za lijek napunite lijekom Ventavis neposredno prije primjene.
• widening of the blood vessels (vasodilatation). 
• proširenje krvnih žila (vazodilatacija).
After intravenous administration, iloprost is extensively metabolised via ß-oxidation of the carboxyl side chain. 
Nakon intravenske primjene, iloprost se u velikoj mjeri metabolizira putem ß-oksidacije karboksilnog bočnog lanca.
Women with pulmonary hypertension (PH) should avoid pregnancy as it may lead to life-threatening exacerbation of the disease. 
Trudnoća Žene koje boluju od plućne hipertenzije (PH) moraju izbjegavati trudnoću, jer može doći do po život opasnog pogoršanja bolesti.
5 mcg golden golden 
5 µg zlatni zlatni
The adverse reactions identified only during post-marketing surveillance, and for which a frequency could not be estimated from clinical trial data, are listed under "Frequency not known". 
Nuspojave na lijek utvrđene samo tijekom praćenja nakon stavljanja lijeka u promet, za koje se učestalost nije mogla procijeniti na temelju podataka iz kliničkih ispitivanja, navedene su pod "Učestalost nepoznata".
Patients with diseases of the respiratory tract 
Bolesnici s bolešću respiratornog trakta
Caution is recommended in case of co-administration of Ventavis with other antihypertensive or vasodilatating agents as dose adjustment might be required. 
Preporučuje se oprez u slučaju istodobne primjene lijeka Ventavis s drugim antihipertenzivima ili vazodilatatorima jer bi moglo biti potrebno prilagođavanje doze.
You should not switch to another nebuliser without consulting the doctor who is treating you. 
Ne smijete prelaziti na drugi nebulizator bez prethodnog savjetovanja s liječnikom koji
It is not known whether iloprost/metabolites are excreted in human breast milk. 
Nije poznato izlučuje li se iloprost/metaboliti u majčino mlijeko u ljudi.
• Follow carefully any instructions that come with the nebuliser. 
• Pažljivo slijedite sve upute koje ste dobili s nebulizatorom.
You may be gradually introduced to the prescribed dose or be prescribed a lower dose of Ventavis than for other patients (see section 3. 
Doza Vam se može postupno povećavati do propisane doze ili će Vam se propisati niža doza lijeka Ventavis u odnosu na druge bolesnike (pogledajte dio 3.
In acute toxicity studies, single intravenous and oral doses of iloprost caused severe symptoms of intoxication or death (intravenous) at doses about two orders of magnitude above the intravenous therapeutic dose. 
U ispitivanjima akutne toksičnosti pojedinačne intravenske i oralne doze iloprosta uzrokovale su teške simptome intoksikacije ili smrti (intravenski) u dozama oko dva reda veličine iznad intravenske terapijske doze.
medication chamber). 
1 komoru za lijek).
Thereafter, your doctor may cautiously shorten the dosing intervals depending on how you tolerate the treatment. 
Vaš liječnik može oprezno skraćivati razmake između doziranja, ovisno o Vašem podnošenju liječenja.