natgillin/translations-raw huggingface dataset:
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.
• 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.
• 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.
Your doctor may change the dosage.
Liječnik će možda promijeniti doziranje.
Prolonged oral treatment with iloprost clathrate in dogs up to one year was associated with slightly increased fasted serum glucose levels.
Dugotrajna peroralna primjena iloprost klatrata na psima u trajanju do jedne godine, bila je povezana s malim povišenjem razina koncentracije glukoze u serumu natašte.
• 42 ampoules.
• 42 ampule.
Before physical exertion it might be useful to inhale.
Inhaliranje prije fizičkog naprezanja može biti korisno.
Ventavis inhalation might entail the risk of inducing bronchospasm, especially in patients with bronchial hyperactivity (see section 4.8).
Inhalacija lijeka Ventavis može dovesti do rizika od pojave bronhospazma, posebno u bolesnika s bronhijalnom hiperaktivnošću (vidjeti dio 4.8).
Each ml contains 1.62 mg ethanol 96% (equivalent to 1.50 mg ethanol).
Svaki ml sadrži 1,62 mg etanola 96% (što odgovara 1,50 mg etanola).
• 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).
• 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).
In order to ensure that you receive the prescribed dose, check the colour of the medication chamber and the colour of the control disc.
Kako biste osigurali primanje propisane doze, provjerite boju komore za lijek i boju kontrolnog diska.
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.
Metaboliti se iz plazme i urina eliminiraju u 2 faze, uz izračunati poluvijek od približno 2 i 5 sati
The increased occurrence of syncope can be related to the deterioration of the disease or insufficient effectiveness of the product (see section 4.4).
Povećana učestalost sinkope može biti povezana s napredovanjem bolesti ili nedovoljnom učinkovitošću lijeka (vidjeti dio 4.4).
Ventavis contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Ventavis sadrži malu količinu etanola (alkohola), manje od 100 mg po dozi.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Ovaj lijek sadrži malu količinu etanola (alkohola), manje od 100 mg po dozi.
− Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
- Prirođena ili stečena valvularna oštećenja s klinički značajnim poremećajima u funkciji miokarda koji nisu povezani s plućnom hipertenzijom.
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).
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).
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).
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).
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.
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.
Patients who experience syncope in association with pulmonary hypertension should avoid any exceptional straining, for example during physical exertion.
Bolesnici u kojih se sinkopa pojavljuje povezana s plućnom hipertenzijom moraju izbjegavati bilo kakvo jače naprezanje, primjerice tijekom tjelesne aktivnosti.
• If you have liver problems or very severe kidney problems, requiring dialysis, tell your doctor.
• Ako imate probleme s jetrom ili vrlo teške probleme s bubrezima koji zahtijevaju dijalizu, obavijestite svog liječnika.
• 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.
• 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.
Nervous system disorders Headache
Poremećaji živčanog sustava glavobolja omaglica
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.
Osim lokalnih učinaka koji su rezultat primjene iloprosta inhalacijom, kao što je kašalj, nuspojave na iloprost povezane su s farmakološkim svojstvima prostaciklina.
(e.g. active peptic ulcers, trauma, intracranial haemorrhage).
aktivni peptički ulkusi, trauma, intrakranijalno krvarenje).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svake grupe učestalosti, nuspojave su prikazane u nizu, od ozbiljnijih prema manje ozbiljnima.
Ventavis inhibits unwanted blocking or narrowing of blood vessels and allows more blood to flow through the vessels.
Ventavis sprječava neželjeno začepljenje ili sužavanje krvnih žila te omogućuje veći protok krvi kroz žile.
• throat irritation
• iritacija grla
The Mass Median Aerodynamic Diameter (MMAD) of the aerosol is between 1 and 5 micrometers.
Medijan mase aerodinamičkog promjera (MMAD) kapljice aerosola je između 1 i 5 mikrometara.
In an intravenous study, results were obtained involving 8 patients suffering from liver cirrhosis.
U ispitivanju intravenske primjene dobiveni su rezultati od 8 bolesnika s cirozom jetre.
Undesirable exposure to Ventavis
Nepoželjna izloženost lijeku Ventavis
One inhalation session will usually last about 4 to 10 minutes with I-Neb AAD depending on the prescribed dose.
Jedna inhalacija obično traje između 4 i 10 minuta s uređajem I-Neb AAD, ovisno o propisanoj dozi.
If you have kidney or liver problems
Ako imate probleme s bubrezima ili jetrom
Fatal cases included cerebral and intracranial haemorrhage.
Smrtni slučajevi uključivali su cerebralno i intrakranijalno krvarenje.
What you need to know before you use Ventavis Do not use Ventavis
Što morate znati prije nego počnete primjenjivati Ventavis Nemojte primjenjivati Ventavis
The total clearance of iloprost is about 20 ml/kg/min, which indicates extrahepatic contribution to the metabolism of iloprost.
Ukupni klirens iloprosta iznosi oko 20 ml/kg/min, što ukazuje na doprinos metabolizmu iloprosta izvan jetre.
Contact of Ventavis with skin or swallowing Ventavis
Kontakt s kožom ili gutanje lijeka Ventavis
The most serious adverse reactions were hypotension, bleeding events, and bronchospasm.
Najteže nuspojave bile su hipotenzija, krvarenja i bronhospazam.
The frequencies of adverse reactions are defined as very common (≥1/10) and common (≥1/100 to <1/10).
Učestalosti nuspojava definirane su kao vrlo česte (≥1/10) i česte (≥1/100 i <1/10).