FrancophonIA/ELRC3.0 huggingface dataset:
English: It stops after the pre-set dose has been administered.
Croatian: Zaustavlja se nakon primjene unaprijed određene doze.
English: 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.
Croatian: Djelotvornost i podnošljivost inhaliranog iloprosta u slučajevima primjene pomoću drugih nebulizatorskih sustava, koji stvaraju drukčija svojstva nebulizacije otopine iloprosta, nisu ustanovljene.
English: • Your blood pressure will be checked before treatment and if it is too low (less than
Croatian: • Prije liječenja provjerit će Vam se krvni tlak i ako je prenizak (gornja vrijednost niža od
English: • 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).
Croatian: • Ako imate poteškoće s disanjem, iskašljavate krv i/ili se pojačano znojite, to mogu biti znakovi vode u plućima (edem pluća).
English: Other medicines and Ventavis
Croatian: Drugi lijekovi i Ventavis
English: 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.
Croatian: 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.
English: In this case talk to your doctor immediately.
Croatian: U slučaju njihova pojavljivanja odmah se obratite liječniku.
English: The safety and efficacy of Ventavis in children aged up to 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Ventavis u djece do 18 godina nisu ustanovljene.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: The pulmonary vasodilatory effect of inhaled iloprost is of short duration (one to two hours).
Croatian: Učinak inhaliranog iloprosta na vazodilataciju plućnih žila kratkog je trajanja (jedan do dva sata).
English: Following intravenous infusion, the recovery of total radioactivity is 81 %, and the respective recoveries in urine and faeces are 68% and 12%.
Croatian: Nakon intravenske infuzije izlučilo se 81% ukupne radioaktivnosti, 68% u mokraći i 12% u stolici.
English: Should signs of pulmonary oedema occur, the possibility of associated pulmonary veno-occlusive disease should be considered and treatment with Ventavis should be discontinued.
Croatian: Ukoliko se pojave znakovi plućnog edema, mora se uzeti u obzir mogućnost povezane venookluzivne bolesti pluća, te se liječenje lijekom Ventavis mora prekinuti.
English: Bayer Hungária KFT Tel.:+36 14 87-41 00
Croatian: Magyarország Bayer Hungária KFT Tel.:+36 14 87-41 00
English: Fill the medication chamber with Ventavis immediately before use.
Croatian: Komoru za lijek napunite lijekom Ventavis neposredno prije primjene.
English: • widening of the blood vessels (vasodilatation).
Croatian: • proširenje krvnih žila (vazodilatacija).
English: After intravenous administration, iloprost is extensively metabolised via ß-oxidation of the carboxyl side chain.
Croatian: Nakon intravenske primjene, iloprost se u velikoj mjeri metabolizira putem ß-oksidacije karboksilnog bočnog lanca.
English: Women with pulmonary hypertension (PH) should avoid pregnancy as it may lead to life-threatening exacerbation of the disease.
Croatian: Trudnoća Žene koje boluju od plućne hipertenzije (PH) moraju izbjegavati trudnoću, jer može doći do po život opasnog pogoršanja bolesti.
English: 5 mcg golden golden
Croatian: 5 µg zlatni zlatni
English: 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".
Croatian: 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".
English: Patients with diseases of the respiratory tract
Croatian: Bolesnici s bolešću respiratornog trakta
English: Caution is recommended in case of co-administration of Ventavis with other antihypertensive or vasodilatating agents as dose adjustment might be required.
Croatian: Preporučuje se oprez u slučaju istodobne primjene lijeka Ventavis s drugim antihipertenzivima ili vazodilatatorima jer bi moglo biti potrebno prilagođavanje doze.
English: You should not switch to another nebuliser without consulting the doctor who is treating you.
Croatian: Ne smijete prelaziti na drugi nebulizator bez prethodnog savjetovanja s liječnikom koji
English: It is not known whether iloprost/metabolites are excreted in human breast milk.
Croatian: Nije poznato izlučuje li se iloprost/metaboliti u majčino mlijeko u ljudi.
English: • Follow carefully any instructions that come with the nebuliser.
Croatian: • Pažljivo slijedite sve upute koje ste dobili s nebulizatorom.
English: You may be gradually introduced to the prescribed dose or be prescribed a lower dose of Ventavis than for other patients (see section 3.
Croatian: 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.
English: 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.
Croatian: 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.
English: medication chamber).
Croatian: 1 komoru za lijek).
English: Thereafter, your doctor may cautiously shorten the dosing intervals depending on how you tolerate the treatment.
Croatian: Vaš liječnik može oprezno skraćivati razmake između doziranja, ovisno o Vašem podnošenju liječenja.
English: • Inhaling Ventavis might trigger breathing difficulties (see section 4), especially in patients with bronchospasm (sudden constriction of the muscles in the walls of the small airways) and wheezing.
Croatian: • Inhaliranje lijeka Ventavis može uzrokovati poteškoće s disanjem (pogledajte dio 4.), osobito u bolesnika s bronhospazmom (iznenadno stezanje mišića u stijenkama malih dišnih putova) i piskanjem pri disanju.
English: Your doctor may change the dosage.
Croatian: Liječnik će možda promijeniti doziranje.
English: Prolonged oral treatment with iloprost clathrate in dogs up to one year was associated with slightly increased fasted serum glucose levels.
Croatian: Dugotrajna peroralna primjena iloprost klatrata na psima u trajanju do jedne godine, bila je povezana s malim povišenjem razina koncentracije glukoze u serumu natašte.
English: • 42 ampoules.
Croatian: • 42 ampule.
English: Before physical exertion it might be useful to inhale.
Croatian: Inhaliranje prije fizičkog naprezanja može biti korisno.
English: Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8).
Croatian: Inhalacija lijeka Ventavis može dovesti do rizika od pojave bronhospazma, posebno u bolesnika s bronhijalnom hiperaktivnošću (vidjeti dio 4.8).
English: Each ml contains 1.62 mg ethanol 96% (equivalent to 1.50 mg ethanol).
Croatian: Svaki ml sadrži 1,62 mg etanola 96% (što odgovara 1,50 mg etanola).
English: • Fainting (syncope) is a symptom of the illness itself but can also occur during treatment with Ventavis (see also section 2 “Warnings and precautions”, for advice on what you can do to avoid this).
Croatian: • Nesvjestica (sinkopa) simptom je same bolesti, ali se može pojaviti i tijekom liječenja lijekom Ventavis (pogledajte također dio 2. "Upozorenja i mjere opreza", za savjet što možete učiniti kako biste ovo izbjegli).
English: In order to ensure that you receive the prescribed dose, check the colour of the medication chamber and the colour of the control disc.
Croatian: Kako biste osigurali primanje propisane doze, provjerite boju komore za lijek i boju kontrolnog diska.
English: The metabolites are eliminated from plasma and urine in 2 phases, for which half-lives of about 2 and 5 hours (plasma) and 2 and 18 hours (urine) have been calculated.
Croatian: Metaboliti se iz plazme i urina eliminiraju u 2 faze, uz izračunati poluvijek od približno 2 i 5 sati
English: The increased occurrence of syncope can be related to the deterioration of the disease or insufficient effectiveness of the product (see section 4.4).
Croatian: Povećana učestalost sinkope može biti povezana s napredovanjem bolesti ili nedovoljnom učinkovitošću lijeka (vidjeti dio 4.4).
English: Ventavis contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Croatian: Ventavis sadrži malu količinu etanola (alkohola), manje od 100 mg po dozi.
English: This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Croatian: Ovaj lijek sadrži malu količinu etanola (alkohola), manje od 100 mg po dozi.
English: − Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
Croatian: - Prirođena ili stečena valvularna oštećenja s klinički značajnim poremećajima u funkciji miokarda koji nisu povezani s plućnom hipertenzijom.
English: Inhaled iloprost (or placebo) was added to patients' current therapy, which could include a combination of anticoagulants, vasodilators (e.g. calcium channel blockers), diuretics, oxygen, and digitalis, but not PGI2 (prostacyclin or its analogues).
Croatian: Inhalirani iloprost (ili placebo) dodan je uz trenutnu terapiju bolesnika, koja je mogla uključivati kombinaciju antikoagulanata, vazodilatatora (npr. blokatore kalcijevih kanala), diuretike, kisik i digitalis, ali ne i PGI2 (prostaciklin ili njegove analoge).
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).
Croatian: U ispitivanju kronične inhalacije u štakora tijekom 26 tjedana, najviša postignuta doza od 48,7 mikrograma/kg/dan označena je kao "razina bez uočenih nuspojava" (NOAEL).
English: 108 of the patients included were diagnosed with primary pulmonary hypertension, 95 were diagnosed with secondary pulmonary hypertension of which 56 were associated with chronic thromboembolic disease, 34 with connective tissue disease (including CREST and scleroderma) and 4 were considered appetite suppressant medicinal product related.
Croatian: U 108 uključenih bolesnika dijagnosticirana je primarna plućna hipertenzija, a u 95 ih je dijagnosticirana sekundarna plućna hipertenzija, koja je u njih 56 bila povezana s kroničnom tromboembolijskom bolešću, u 34 s bolešću vezivnog tkiva (uključujući CREST i sklerodermu), dok se u 4 slučaja smatrala povezana s lijekom za smanjivanje apetita.
English: Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion.
Croatian: Bolesnici u kojih se sinkopa pojavljuje povezana s plućnom hipertenzijom moraju izbjegavati bilo kakvo jače naprezanje, primjerice tijekom tjelesne aktivnosti.
English: • If you have liver problems or very severe kidney problems, requiring dialysis, tell your doctor.
Croatian: • Ako imate probleme s jetrom ili vrlo teške probleme s bubrezima koji zahtijevaju dijalizu, obavijestite svog liječnika.
English: • Swelling, mainly of the ankles and legs, due to fluid retention (peripheral oedema) is a very common symptom of the illness itself but can also occur during treatment with Ventavis.
Croatian: • Oticanje, uglavnom gležnjeva i nogu, zbog zadržavanja tekućine (periferni edem) vrlo je čest simptom same bolesti, ali se može pojaviti i tijekom liječenja lijekom Ventavis.
English: Nervous system disorders Headache
Croatian: Poremećaji živčanog sustava glavobolja omaglica
English: In addition to local effects resulting from administration of iloprost by inhalation such as cough, adverse reactions with iloprost are related to the pharmacological properties of prostacyclins.
Croatian: Osim lokalnih učinaka koji su rezultat primjene iloprosta inhalacijom, kao što je kašalj, nuspojave na iloprost povezane su s farmakološkim svojstvima prostaciklina.
English: (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
Croatian: aktivni peptički ulkusi, trauma, intrakranijalno krvarenje).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su prikazane u nizu, od ozbiljnijih prema manje ozbiljnima.
English: Ventavis inhibits unwanted blocking or narrowing of blood vessels and allows more blood to flow through the vessels.
Croatian: Ventavis sprječava neželjeno začepljenje ili sužavanje krvnih žila te omogućuje veći protok krvi kroz žile.
English: • throat irritation
Croatian: • iritacija grla
English: The Mass Median Aerodynamic Diameter (MMAD) of the aerosol is between 1 and 5 micrometers.
Croatian: Medijan mase aerodinamičkog promjera (MMAD) kapljice aerosola je između 1 i 5 mikrometara.
English: In an intravenous study, results were obtained involving 8 patients suffering from liver cirrhosis.
Croatian: U ispitivanju intravenske primjene dobiveni su rezultati od 8 bolesnika s cirozom jetre.
English: Undesirable exposure to Ventavis
Croatian: Nepoželjna izloženost lijeku Ventavis
English: One inhalation session will usually last about 4 to 10 minutes with I-Neb AAD depending on the prescribed dose.
Croatian: Jedna inhalacija obično traje između 4 i 10 minuta s uređajem I-Neb AAD, ovisno o propisanoj dozi.
English: If you have kidney or liver problems
Croatian: Ako imate probleme s bubrezima ili jetrom
English: Fatal cases included cerebral and intracranial haemorrhage.
Croatian: Smrtni slučajevi uključivali su cerebralno i intrakranijalno krvarenje.
English: What you need to know before you use Ventavis Do not use Ventavis
Croatian: Što morate znati prije nego počnete primjenjivati Ventavis Nemojte primjenjivati Ventavis
English: The total clearance of iloprost is about 20 ml/kg/min, which indicates extrahepatic contribution to the metabolism of iloprost.
Croatian: Ukupni klirens iloprosta iznosi oko 20 ml/kg/min, što ukazuje na doprinos metabolizmu iloprosta izvan jetre.
English: Contact of Ventavis with skin or swallowing Ventavis
Croatian: Kontakt s kožom ili gutanje lijeka Ventavis
English: The most serious adverse reactions were hypotension, bleeding events, and bronchospasm.
Croatian: Najteže nuspojave bile su hipotenzija, krvarenja i bronhospazam.
English: The frequencies of adverse reactions are defined as very common (≥1/10) and common (≥1/100 to <1/10).
Croatian: Učestalosti nuspojava definirane su kao vrlo česte (≥1/10) i česte (≥1/100 i <1/10).
English: • Any Ventavis solution remaining in the nebuliser after inhalation must be thrown away (see section 5).
Croatian: • Sva Ventavis otopina koja preostane u nebulizatoru nakon inhalacije mora se baciti (vidjeti dio 5).
English: As expected for a prostacyclin, iloprost produced haemodynamic effects (vasodilatation, reddening of skin, hypotension, inhibition of platelet function, respiratory distress) and general signs of intoxication such as apathy, gait disturbances, and postural changes.
Croatian: Kao što je i očekivano kod prostaciklina, iloprost je uzrokovao hemodinamičke učinke (vazodilatacija, crvenilo kože, hipotenzija, inhibicija funkcije trombocita, respiratorni distres) i općenite znakove intoksikacije, kao što su apatija, otežano kretanje i posturalne promjene.
English: Breelib nebuliser:
Croatian: Breelib nebulizator:
English: The primary efficacy endpoint defined for this study, was a combined response criterion consisting of improvement in exercise capacity (6-minute walk test) at 12 weeks by at least 10% versus baseline, and improvement by at least one NYHA class at 12 weeks versus baseline, and no deterioration of pulmonary hypertension or death at any time before 12 weeks.
Croatian: Primarna mjera djelotvornosti definirana za ovo ispitivanje bila je kombinirani kriterij odgovora koji se sastojao od poboljšanja kapaciteta tjelesne aktivnosti (mjereno testom šestominutnog hoda) u 12 tjedana za najmanje 10% u odnosu na početnu vrijednost, i poboljšanja za najmanje jednu NYHA klasu u 12 tjedana naspram početne vrijednosti te izostanka napredovanja plućne hipertenzije ili smrti u bilo kojem trenutku prije isteka 12 tjedana.
English: Women of childbearing potential should use effective contraceptive measures during treatment with Ventavis.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja lijekom Ventavis.
English: For further details please refer to the instruction manual of the nebuliser device or ask your doctor.
Croatian: Za detaljnije upute molimo pročitajte uputu za uporabu priloženu uz nebulizator ili pitajte liječnika.
English: It is not known whether Ventavis passes into human milk.
Croatian: Nije poznato prolazi li Ventavis u majčino mlijeko.
English: The table below provides a summary of the user instructions of the I-Neb:
Croatian: Donja tablica prikazuje sažetak uputa za korisnike za I-Neb:
English: How Ventavis works
Croatian: Kako Ventavis djeluje
English: − Decompensated cardiac failure if not under close medical supervision.
Croatian: - Dekompenzirano zatajenje srca ako nije pod pomnim nadzorom liječnika.
English: The table below provides a summary of the user instructions of the I-Neb for Ventavis:
Croatian: Donja tablica prikazuje sažetak uputa za korisnike za I-Neb za Ventavis:
English: A randomised, double-blind, multi-centre, placebo-controlled phase III trial (study RRA02997) has been conducted in 203 adult patients (inhaled iloprost at the concentration of 10 microgram/ml: N=101; placebo n=102) with stable pulmonary hypertension.
Croatian: Randomizirano, dvostruko slijepo, multicentrično, placebo kontrolirano ispitivanje faze III (ispitivanje RRA02997) provedeno je na 203 odrasla bolesnika (inhalirani iloprost pri koncentraciji od 10 mikrograma/ml: N = 101; placebo n = 102) sa stabilnom plućnom hipertenzijom.
English: Talk to your doctor, pharmacist or nurse before using Ventavis:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Ventavis:
English: Therefore, the same dosing recommendations as in patients with hepatic impairment (see above) are to be applied.
Croatian: Stoga se primjenjuju iste preporuke o doziranju kao i u slučaju bolesnika s oštećenjem funkcije jetre (vidjeti gore).
English: Multipacks containing:
Croatian: Višestruka pakiranja sadrže:
English: Because iloprost is extensively metabolised by the liver, the plasma levels of the active substance are influenced by changes in hepatic function.
Croatian: Budući da se iloprost u značajnoj mjeri metabolizira u jetri, promjene u funkciji jetre utječu na razine djelatne tvari u plazmi.
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.
Croatian: U ispitivanjima inhalacije na štakorima primjena iloprosta koncentracije 20 mikrograma/ml do 26 tjedana nije uzrokovala nikakvu lokalnu nadraženost gornjeg i donjeg respiratornog trakta.
English: Symptoms can include swelling of feet and ankles, shortness of breath, palpitations, urinating more frequently at night or oedema.
Croatian: Simptomi mogu uključivati oticanje stopala i gležnjeva, nedostatak zraka, osjećaj lupanja srca, češće mokrenje tijekom noći ili oteklina.
English: The increased occurrence of syncope can reflect therapeutic gaps, insufficient effectiveness and/or deterioration of the disease.
Croatian: Povećana učestalost sinkope može biti znak prekida u liječenju, njegove nedovoljne učinkovitosti i/ili napredovanja bolesti.
English: The occurrence of peripheral oedema can be related to the deterioration of the disease or insufficient effectiveness of the product.
Croatian: Povećana učestalost perifernog edema može biti povezana s napredovanjem bolesti ili nedovoljnom učinkovitošću lijeka.
English: The rate of responders to iloprost was 16.8% (17/101) and the rate of responders in the placebo group was 4.9% (5/102) (p=0.007).
Croatian: Stopa bolesnika s odgovorom na iloprost iznosila je 16,8% (17/101), dok je stopa bolesnika s odgovorom u skupini koja je primala placebo iznosila 4,9% (5/102) (p = 0,007).
English: Ventavis is intended for inhalation use by nebulisation.
Croatian: Ventavis je namijenjen inhalacijskoj primjeni nebulizacijom.
English: • if your pulmonary hypertension is due to a blocked or narrowed vein (venous occlusive disease).
Croatian: • ako je Vaša plućna hipertenzija uzrokovana začepljenjem ili suženjem vene (venska okluzivna bolest).
English: The ready-to-use Ventavis nebuliser solution is administered with a suitable inhalation device (nebuliser) (see below and section 6.6).
Croatian: Spremna za upotrebu, otopina za nebulizator Ventavis primjenjuje se s odgovarajućim uređajem za inhalaciju (nebulizatorom) (vidjeti niže i dio 6.6).
English: Since iloprost inhibits platelet function its use with the following substances may enhance iloprostmediated platelet inhibition, thereby increasing the risk of bleeding:
Croatian: Budući da iloprost inhibira funkciju trombocita, njegova primjena sa sljedećim tvarima može pojačati inhibiciju funkcije trombocita posredovanu iloprostom i tako povećati rizik od krvarenja:
English: Direct vasodilatation of the pulmonary arterial bed occur with consecutive significant improvement of pulmonary artery pressure, pulmonary vascular resistance and cardiac output as well as mixed venous oxygen saturation.
Croatian: Dolazi do izravne vazodilatacije plućnog arterijskog korita s posljedičnim značajnim poboljšanjem arterijskog tlaka u plućima, otpornosti žila u plućima i minutnog volumena srca, kao i zasićenja miješane venske krvi kisikom.
English: Tell your doctor if you are taking any other medication because the combined effect with Ventavis may lower your blood pressure further (see below "Other medicines and Ventavis").
Croatian: Obavijestite svog liječnika ukoliko uzimate bilo koje druge lijekove jer kombinirano djelovanje s lijekom Ventavis može dodatno sniziti Vaš krvni tlak (pogledajte pod
English: Only expected pharmacological effects like hypotension, reddening of skin, dyspnoea, increased intestinal motility were observed.
Croatian: Uočeni su samo očekivani farmakološki učinci, kao što su hipotenzija, crvenilo kože, dispneja, pojačani motilitet crijeva.
English: One inhalation session with Venta-Neb will usually last about 4 to 10 minutes depending on the prescribed dose.
Croatian: Jedna inhalacija obično traje s uređajem Venta-Neb između 4 i 10 minuta, ovisno o propisanoj dozi.
English: Iloprost, the active substance of Ventavis, is a synthetic prostacyclin analogue.
Croatian: Iloprost, djelatna tvar lijeka Ventavis, sintetički je analog prostaciklina.