FrancophonIA/ELRC3.0 huggingface dataset:
English: In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving Revatio than those receiving placebo leading to the premature termination of this study.
Croatian: U jednom su kliničkom ispitivanju događaji vazookluzivnih kriza koje su zahtijevale hospitalizaciju prijavljeni češće u bolesnika koji su primali Revatio nego u onih koji su primali placebo, što je dovelo do prijevremenog prekida tog ispitivanja.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Revatio, before driving or using machines.
Croatian: S obzirom na to da su u kliničkim ispitivanjima sildenafila prijavljene omaglica i promjene vida, bolesnici moraju biti svjesni kako bi Revatio na njih mogao djelovati prije nego upravljaju vozilom ili rukuju strojevima.
English: The usual dose is 10 mg (corresponding to 12.5 ml) three times a day.
Croatian: Uobičajena doza je 10 mg (što odgovara 12,5 ml) tri puta na dan.
English: The oral suspension must be shaken vigorously for a minimum of 10 seconds before use.
Croatian: Oralna suspenzija se prije uporabe mora snažno tresti najmanje 10sekundi.
English: Excipient(s) with known effect Each ml of oral suspension contains 250 mg sorbitol.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedan ml oralne suspenzije sadrži 250 mg sorbitola.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
Croatian: Liječenje mora započeti i nadzirati isključivo liječnik s iskustvom u liječenju plućne arterijske hipertenzije.
English: Revatio contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Croatian: Revatio sadrži djelatnu tvar sildenafil, koji pripada skupini lijekova koji se nazivaju inhibitorima fosfodiesteraze tipa 5 (PDE5).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Revatio in newborns with pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Revatio u novorođenčadi s plućnom arterijskom hipertenzijom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: PDE5 inhibitors, such as Revatio have been shown to increase the hypotensive effects of this medicine.
Croatian: PDE5 inhibitori, kao što je Revatio su pokazali da povećavaju hipotenzivne učinke ovog lijeka.
English: If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result (see section 4.8).
Croatian: Ako se prijapizam ne liječi odmah, može doći do oštećenja tkiva penisa i trajnog gubitka potencije (vidjeti dio 4.8).
English: Unless otherwise specified, drug interaction studies have been performed in healthy adult male subjects using oral sildenafil.
Croatian: Ako nije drugačije navedeno, ispitivanja interakcije lijekova provedena su u zdravih odraslih muških ispitanika uz primjenu peroralnog oblika sildenafila.
English: Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/min).
Croatian: Nije potrebno prilagođavati početnu dozu u bolesnika s oštećenjem bubrega, uključujući i teško oštećenje bubrega (klirens kreatinina < 30 ml/min).
English: Revatio has moderate influence on the ability to drive and use machines.
Croatian: Revatio umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The respective odds ratios were 2.92 (p=0.0087), 4.32 (p=0.0004) and 5.75 (p<0.0001).
Croatian: Odgovarajući omjeri izgleda bili su 2,92 (p = 0,0087), 4,32 (p = 0,0004) i 5,75 (p < 0,0001).
English: Excipient(s) with known effect Each tablet also contains 0.7 mg of lactose.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna tableta sadrži također 0,7 mg laktoze.
English: In healthy volunteers, the plasma levels of the N-desmethyl metabolite following intravenous dosing are significantly lower than those observed following oral dosing.
Croatian: U zdravih su dobrovoljaca razine N-dezmetil metabolita u plazmi nakon intravenske primjene značajno niže od onih opaženih nakon peroralne primjene.
English: Revatio contains lactose
Croatian: Revatio sadrži laktozu
English: To measure the dose accurately, the top edge of the plunger should be lined up with the appropriate graduated mark on the oral dosing syringe (figure 8).
Croatian: Da biste dozu točno odmjerili, gornji rub klipa treba biti poravnat s odgovarajućom oznakom na štrcaljki za usta (slika 8).
English: - Information about the Pharmacovigilance Monitoring Programme regarding the potential risk of clinically relevant hypotension and related problems to be put into place with the use of the DCF.
Croatian: • Informaciju o tome da se mora uspostaviti Program farmakovigilancijskog praćenja s obzirom na potencijalni rizik od klinički značajne hipotenzije i pridruženih joj tegoba, uz korištenje Obrasca za prikupljanje podataka
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50 % that of the parent drug.
Croatian: Ovaj metabolit ima profil selektivnosti za fosfodiesteraze sličan sildenafilu, a njegova in vitro potencija za PDE5 iznosi oko 50% potencije osnovnog spoja.
English: Mean pulmonary systolic blood pressure decreased by 9 %.
Croatian: Prosječan plućni sistolički krvni tlak snižen je za 9%.
English: Revatio solution for injection is for the treatment of adult patients (≥ 18 years) with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable.
Croatian: Revatio otopina za injekciju namijenjena je za liječenje odraslih bolesnika (≥ 18 godina) s plućnom arterijskom hipertenzijom kojima je trenutno propisan peroralni oblik lijeka Revatio, a koji privremeno nisu u stanju uzimati peroralnu terapiju, ali su inače klinički i hemodinamički stabilni.
English: One 125 ml amber glass bottle (with a polypropylene screw cap) contains 32.27 g of powder for oral suspension.
Croatian: Jedna smeđa staklena boca od 125 ml (s polipropilenskim zatvaračem s navojem) sadrži 32,27 g praška za oralnu suspenziju.
English: Revatio brings down blood pressure in the lungs by widening the blood vessels in the lungs.
Croatian: Revatio snižava krvni tlak u plućima tako što proširuje krvne žile u plućima.
English: There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance.
Croatian: Ustanovljena je statistički značajna korist primjene sildenafila u usporedbi s placebom u 6-minutnoj postignutoj udaljenosti hodom.
English: Similarly 191 of 229 subjects (83 %) who had received sildenafil had either maintained or improved their WHO Functional Class at 1 year assessment.
Croatian: Slično tomu, u 191 od 229 ispitanika (83%) koji su primali sildenafil, funkcionalni stupanj bolesti po SZO-u procijenjen nakon godine dana održao se ili poboljšao.
English: Pack size: 1 bottle
Croatian: Veličina pakiranja: 1 boca.
English: Safety and effectiveness of doses higher than 12.5 ml (10 mg) TID have not been established.
Croatian: Sigurnost i djelotvornost doza viših od 12,5 ml (10 mg) tri puta na dan (TID) nisu ustanovljene.
English: A total of 10 PAH subjects enrolled and completed the study.
Croatian: Ukupno je 10 bolesnika s PAH-om bilo uključeno i završilo ispitivanje.
English: If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (eg, epoprostenol) should be considered (see section 4.2).
Croatian: Ako se klinička situacija pogoršava, mora se razmotriti primjena lijekova koji se preporučuju u teškoj fazi bolesti (npr. epoprostenol) (vidjeti dio 4.2).
English: No symptoms of hypotension were associated with these changes.
Croatian: Te promjene nisu pratili simptomi hipotenzije.
English: Please see instructions below before using the oral suspension.
Croatian: Pročitajte upute u nastavku prije primjene oralne suspenzije.
English: Remove the cap (figure 6).
Croatian: Skinite zatvarač (slika 6).
English: If you experience any of the following side effects you should stop taking Revatio and contact a doctor immediately (see also section 2): - if you experience sudden decrease or loss of vision (frequency not known) - if you have an erection, which lasts continuously for more than 4 hours.
Croatian: Ako iskusite bilo koju od sljedećih nuspojava, morate prestati uzimati Revatio i odmah se javite liječniku (pogledajte i dio 2): - ako osjetite iznenadno smanjenje ili gubitak vida (učestalost nepoznata) - ako imate erekciju koja traje neprekidno dulje od 4 sata.
English: If you take more Revatio than you should
Croatian: Ako uzmete više lijeka Revatio nego što ste trebali
English: Studies in animals have shown toxicity with respect to postnatal development (see section 5.3).
Croatian: Istraživanja na životinjama pokazala su toksičnost za postnatalni razvoj (vidjeti dio 5.3).
English: Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Croatian: Dokazana je djelotvornost u primarnoj plućnoj hipertenziji i plućnoj hipertenziji povezanoj s bolešću vezivnog tkiva.
English: When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29 % however, the extent of absorption was not significantly affected (AUC decreased by 11 %).
Croatian: Kada se sildenafil uzima s hranom, brzina apsorpcije se smanjuje, uz srednju vrijednost odgode Tmax za 60 minuta i prosječno smanjenje Cmax za 29%; međutim, nema značajnog utjecaja na stupanj apsorpcije (AUC smanjen za 11%).
English: Co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form due to the hypotensive effects of nitrates (see section 5.1).
Croatian: Istodobna primjena s donorima dušikovog oksida (poput amil nitrita) ili nitratima u bilo kojem obliku, zbog hipotenzivnih učinaka nitrata (vidjeti dio 5.1).
English: It is recommended that a pharmacist constitutes Revatio oral suspension prior to its dispensing to the patient.
Croatian: Preporučuje se da ljekarnik pripremi Revatio oralnu suspenziju prije nego što je izda bolesniku.
English: Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B).
Croatian: Nije potrebno prilagođavati početnu dozu u bolesnika s oštećenjem jetre (Child-Pugh stadij A i B).
English: A Revatio intravenous injection will be given to you instead of your Revatio tablets.
Croatian: Intravenske injekcije lijeka Revatio ćete primati umjesto Revatio tableta.
English: It was judged to be unrelated to the study medicinal product.
Croatian: Ocijenjeno je da taj događaj nije bio povezan s ispitivanim lijekom.
English: When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group.
Croatian: Prilikom analize prema SZO funkcionalnom stupnju opaženo je statistički značajno povećanje 6MWD-a u skupini koja je primala dozu od 20 mg.
English: • At the request of the European Medicine Agency;
Croatian: Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Croatian: Bolesnici s nasljednim nepodnošenjem fruktoze ne bi smjeli uzimati/primiti ovaj lijek.
English: If the powder is not reconstituted, you should reconstitute the oral suspension by following the instructions below.
Croatian: Ako prašak nije pripremljen, morate pripremiti oralnu suspenziju prema uputama u nastavku.
English: The recommended dose of 10 mg requires a volume of 12.5 ml, to be administered as an intravenous bolus injection.
Croatian: Za preporučenu dozu od 10 mg potreban je volumen od 12,5 ml, koji se primjenjuje u obliku intravenske bolusne injekcije.
English: Revatio should not be used during pregnancy unless strictly necessary.
Croatian: Revatio se ne smije primjenjivati u trudnoći, osim ako to nije izričito nužno.
English: This medicinal product does not require dilution or reconstitution before use.
Croatian: Lijek nije potrebno razrjeđivati niti pripremati prije primjene.
English: Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse.
Croatian: Nagli prekid liječenja lijekom Revatio može dovesti do pogoršanja simptoma.
English: The tablets are provided in blister packs containing 90 tablets, 90 x 1 tablets as perforated unit dose blisters and in blister packs containing 300 tablets.
Croatian: Tablete se isporučuju u blister pakiranjima koja sadrže 90 tableta, 90x1 tableta u perforiranom blisteru s jediničnim dozama i u blister pakiranjima koja sadrže 300 tableta.
English: Once reconstituted the bottle contains 112 ml of oral suspension, of which 90 ml is intended for dosing and administration.
Croatian: Nakon rekonstitucije, boca sadrži 112 ml oralne suspenzije, od čega je 90 ml namijenjeno za doziranje i primjenu.
English: Dry the two parts.
Croatian: Osušite dijelove štrcaljke.
English: Patients with left ventricular ejection fraction < 45 % or left ventricular shortening fraction < 0.2 were not studied.
Croatian: Bolesnici s istisnom frakcijom lijeve klijetke od < 45% ili frakcijom skraćenja lijeve klijetke od < 0,2 nisu ispitivani.
English: Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Croatian: Sildenafil se mora primjenjivati uz oprez u bolesnika s anatomskim deformitetima penisa (poput angulacije, kavernozne fibroze ili Peyronijeve bolesti) i u bolesnika koji pate od nekih stanja koja mogu biti predispozicija za prijapizam (poput anemije srpastih stanica, multiplog mijeloma ili leukemije).
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 M).
Croatian: Sildenafil je slab inhibitor izoformi 1A2, 2C9, 2C19, 2D6, 2E1 i 3A4 citokroma P450 (IC50 > 150 m).
English: Special considerations for patients with kidney or liver problems You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Croatian: Posebna upozorenja za bolesnike s tegobama bubrega ili jetre Morate obavijestiti svog liječnika ako imate tegoba s bubrezima ili jetrom jer će Vam možda trebati prilagoditi dozu lijeka.
English: In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Croatian: U dobrovoljaca s blagim do umjerenim oštećenjem bubrega (klirens kreatinina = 30-80 ml/min) farmakokinetika sildenafila nije se promijenila nakon jedne peroralne doze od 50 mg.
English: Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements.
Croatian: Sekundarni ishodi obuhvaćali su praćenje hemodinamičkog statusa, procjenu simptoma, SZO funkcionalni stupanj, promjene osnovne terapije i mjerila kvalitete života.
English: PVC/Aluminium blisters of 300 tablets.
Croatian: PVC/aluminij blisteri sa 300 tableta.
English: The primary objective of the study was to assess the efficacy of 16 weeks of chronic treatment with oral sildenafil in paediatric subjects to improve exercise capacity as measured by the Cardiopulmonary Exercise Test (CPET) in subjects who were developmentally able to perform the test, n = 115).
Croatian: Primarni cilj ispitivanja bio je procijeniti djelotvornost 16-tjednog kroničnog peroralnog liječenja sildenafilom u pedijatrijskih ispitanika na poboljšanje tjelesne sposobnosti, mjereno testom srčanoplućnog opterećenja (CPET test) u ispitanika koji su s obzirom na stupanj razvoja bili sposobni izvesti taj test (n = 115).
English: Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse France
Croatian: Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse Francuska
English: The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (eg, ambrisentan, iloprost) has not been studied in controlled clinical trials.
Croatian: Djelotvornost i sigurnost sildenafila primijenjenog istodobno s drugim lijekovima za plućnu arterijsku hipertenziju (npr. ambrisentan, iloprost) nije ispitana u kontroliranim kliničkim ispitivanjima.
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n = 9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Croatian: U malom, placebom kontroliranom ispitivanju u bolesnika s dokumentiranom, ranom, dobno uvjetovanom degeneracijom makule (n = 9), sildenafil (jedna doza od 100 mg) nije pokazao značajne promjene u provedenim testovima vida (oštrina vida, Amslerova mreža, razlikovanje boja simulacijom semafora, Humphreyev perimetar i fotostres test).
English: Blood and lymphatic system disorders Common anaemia
Croatian: Poremećaji krvi i limfnog sustava često anemija
English: Other pharmaceutical forms are available for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets.
Croatian: Drugi farmaceutski oblici su dostupni za primjenu u bolesnika tjelesne težine ≤ 20 kg i drugih mlađih bolesnika koji ne mogu progutati tablete.
English: Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.
Croatian: Revatio otopina za injekciju predstavlja zamjenski oblik lijeka Revatio za bolesnike koji privremeno ne mogu uzimati Revatio tablete.
English: Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90 % higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Croatian: Zdravi stariji dobrovoljci (65 ili više godina) su imali smanjen klirens sildenafila, što je rezultiralo približno 90% višim plazmatskim koncentracijama sildenafila i aktivnog N-dezmetil metabolita u odnosu na one u zdravih mlađih dobrovoljaca (18-45 godina).
English: Revatio solution for injection is for intravenous use as a bolus injection.
Croatian: Revatio otopina za injekciju namijenjena je samo za intravensku primjenu u obliku bolusne injekcije.
English: Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.
Croatian: Sildenafil, stoga, povećava koncentracije cGMP-a u glatkim mišićnim stanicama krvnih žila u plućima, što dovodi do njihova opuštanja.
English: In study A1481262 Cmax, CL and AUC (0-8) of 248 ng/ml, 30.3 l/h and 330 ng h/ml, were observed respectively.
Croatian: U ispitivanju A1481262 zabilježeni su Cmax od 248 ng/ml, klirens od 30,3 l/h i AUC(0-8) od 330 ng.h/ml.
English: You should always add a total of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking (figure 3).
Croatian: Uvijek morate dodati ukupno 90 ml (3 x 30 ml) vode bez obzira na dozu koju uzimate. (slika 3)
English: Reconstituted oral suspension
Croatian: Pripremljena oralna suspenzija
English: The magnitude of the interaction is expected to be reduced for intravenous sildenafil, as interactions for oral sildenafil are due, at least in part, to effects on oral first pass metabolism.
Croatian: Očekuje se da će kod intravenske primjene sildenafila opseg interakcija biti manji jer su interakcije kod peroralne primjene barem djelomično posljedica učinaka metabolizma prvog prolaza kroz jetru.
English: • Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted.
Croatian: lijekove koji sadrže eritromicin, klaritromicin, telitromicin (to su antibiotici koji se koriste za liječenje nekih bakterijskih infekcija), sakvinavir (za liječenje HIV infekcije) ili nefazodon (za liječenje depresije), jer će možda trebati prilagoditi dozu.
English: The recommended dose is 10 mg (corresponding to 12.5 ml) three times a day administered as an intravenous bolus injection (see section 6.6).
Croatian: Preporučena doza je 10 mg (što odgovara 12,5 ml) tri puta na dan, a primjenjuje se u obliku intravenske bolusne injekcije (vidjeti dio 6.6).
English: PVC/Aluminium blisters of 90 tablets.
Croatian: PVC/aluminij blisteri sa 90 tableta.
English: Add a total of 90 ml of water (3 x 30 ml) strictly following the package leaflet, ensuring the bottle is shaken vigorously after adding 60 ml and the remaining 30 ml.
Croatian: Dodajte ukupno 90 ml vode (3 x 30 ml) pažljivo slijedeći uputu o lijeku te snažno protresite nakon što ste dodali 60 ml i preostalih 30 ml.
English: Any unused oral suspension should be discarded or returned to your pharmacist after this date.
Croatian: Nakon tog datuma neupotrijebljenu oralnu suspenziju treba baciti ili vratiti ljekarniku.
English: Infections and infestations Common cellulitis,influenza, bronchitis, sinusitis, rhinitis, gastroenteritis
Croatian: Infekcije i infestacije često celulitis, gripa, bronhitis, sinusitis, rinitis, gastroenteritis
English: Reconstitution instructions:
Croatian: Upute za pripremu:
English: Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were administered and after 3 years 87 % of 183 patients on study treatment were receiving Revatio 80 mg TID.
Croatian: Primjenjivale su se doze do 80 mg tri puta na dan (4 puta više od preporučene doze od 20 mg tri puta na dan), a nakon 3 godine je 87% od 183 bolesnika liječenih ispitivanim lijekom primalo Revatio u dozi od 80 mg TID.
English: Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets.
Croatian: Nuspojave koje su prijavljene u kliničkim ispitivanjima u kojima se Revatio primjenjivao intravenski bile su slične onima prijavljenima u kliničkim ispitivanjima Revatio tableta.
English: There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study.
Croatian: Zabilježena je jedna ozbiljna nuspojava u ispitanika s teškom ishemijskom kardiomiopatijom, u kojeg je 6 dana nakon ispitivanja došlo do ventrikularne fibrilacije te je nastupila smrt.
English: 90 x 1 tablets in PVC/Aluminium perforated unit dose blisters.
Croatian: 90x1 tableta u PVC/aluminij perforiranim blisterima s jediničnim dozama.
English: • Therapies for pulmonary hypertension (e.g. bosentan, iloprost).
Croatian: lijekove za liječenje plućne hipertenzije (npr. bosentan, iloprost).
English: Once reconstituted one bottle contains 1.12 g of sildenafil (as citrate) with a final volume of 112 ml.
Croatian: Nakon pripreme, jedna boca sadrži 1,12 g sildenafila (u obliku sildenafilcitrata) u konačnom volumenu od 112 ml.
English: Powder: Do not store above 30°C.
Croatian: Prašak: Ne čuvati na temperaturi iznad 30°C.
English: Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Croatian: Zbog nedostatnih podataka Revatio se ne smije primjenjivati u trudnica, osim ako to nije izričito potrebno.