FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking more Granpidam than you should may increase the risk of known side effects.
Croatian: Uzimanje više lijeka Granpidam nego što je potrebno može povećati rizik od poznatih nuspojava.
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE03
Croatian: Farmakoterapijska skupina: Urologici; lijekovi koji se primjenjuju kod erektilne disfunkcije, ATK oznaka: G04BE03.
English: Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11%), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Croatian: Sildenafil nije imao značajan učinak na izloženost atorvastatinu (AUC povećan za 11%), što upućuje na to da sildenafil nema klinički značajan učinak na CYP3A4.
English: Peak VO2 was assessed 1 year after the start of the placebo-controlled study.
Croatian: Vršni VO2 ocijenjen je nakon godinu dana od početka placebom kontroliranog ispitivanja.
English: Patients should not take a double dose to compensate for the missed dose.
Croatian: Bolesnici ne smiju uzeti dvostruku dozu kako bi nadoknadili propuštenu dozu.
English: Physicians should advise patients what to do in the event of postural hypotensive symptoms.
Croatian: Liječnici trebaju uputiti bolesnike kako trebaju postupiti u slučaju simptoma posturalne hipotenzije.
English: Sildenafil plasma concentration half-life values were estimated to range from 4.2 to 4.4 hours for a range of 10 to 70 kg of body weight and did not show any differences that would appear as clinically relevant.
Croatian: Poluvijek koncentracije sildenafila u plazmi procjenjuje se na između 4,2 i 4,4 sata za raspon tjelesne težine od 10-70 kg te nisu uočene razlike koje bi mogle biti od kliničkog značaja.
English: The adverse reactions profile seen in this paediatric study was generally consistent with that in adults (see table above).
Croatian: Profil nuspojava opažen u ovom pedijatrijskom ispitivanju bio je uglavnom u skladu s onim zabilježenim u odraslih osoba (vidjeti prethodnu tablicu).
English: In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
Croatian: Općenito, bilo kakva prilagodba doze treba se primijeniti samo nakon pažljive procjene koristi i rizika.
English: There was a doubling of the Cmin compared to healthy volunteers.
Croatian: Vrijednosti Cmin bile su dvostruko veće nego u zdravih dobrovoljaca.
English: In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.
Croatian: U ispitivanjima na dobrovoljcima s primjenom jedne doze do 800 mg nuspojave su bile slične onima opaženima pri nižim dozama, ali se povećala stopa incidencije i težina.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake "Rok valjanosti" i "EXP".
English: In vivo studies
Croatian: Ispitivanja in vivo
English: Limited data suggest that the abrupt discontinuation of sildenafil is not associated with rebound worsening of pulmonary arterial hypertension.
Croatian: Ograničeni podaci upućuju na to da nagli prekid primjene sildenafila nije povezan s povratnim pogoršanjem plućne arterijske hipertenzije.
English: - if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines containing ritonavir (for HIV).
Croatian: - ako uzimate lijekove za liječenje gljivičnih infekcija, kao što su ketokonazol ili itrakonazol, ili lijekove koji sadrže ritonavir (za liječenje HIV infekcije).
English: If you take more Granpidam than you should
Croatian: Ako uzmete više lijeka Granpidam nego što ste trebali
English: Sildenafil has no effect on visual acuity or contrast sensitivity.
Croatian: Sildenafil nema učinka na oštrinu vida niti na osjetljivost na kontraste.
English: Sildenafil has moderate influence on the ability to drive and use machines.
Croatian: Sildenafil umjereno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Protein binding is independent of total drug concentrations.
Croatian: Vezanje za proteine ne ovisi o ukupnoj koncentraciji lijeka.
English: In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Croatian: Kako bi se smanjila mogućnost razvoja posturalne hipotenzije, bolesnici trebaju biti hemodinamički stabilni na terapiji alfa-blokatorom prije započinjanja liječenja sildenafilom.
English: Sildenafil and its major circulating N-desmethyl metabolite are approximately 96% bound to plasma proteins.
Croatian: Sildenafil i njegov glavni N-dezmetil metabolit u cirkulaciji se približno 96% vežu za proteine plazme.
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Croatian: Maksimalne opažene koncentracije u plazmi dostižu se u roku od 30 do 120 minuta (medijan 60 minuta) nakon primjene peroralne doze natašte.
English: No dose adjustment is required but the concomitant use of sildenafil and grapefruit juice is not recommended.
Croatian: Nije potrebno prilagođavati dozu, ali se istovremena primjena sildenafila i soka od grejpa ne preporučuje.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verrijama RMP-a.
English: By sildenafil treatment group, median duration of sildenafil treatment was 1696 days (excluding the 5 subjects who received placebo in double-blind and were not treated in the long-term extension study).
Croatian: U skupini liječenoj sildenafilom, medijan trajanja liječenja sildenafilom bio je 1696 dana (izuzevši 5 ispitanika koji su primali placebo u dvostruko slijepom ispitivanju i nisu liječeni u dugotrajnom produžetku ispitivanja).
English: If you are not certain, ask your doctor or pharmacist.
Croatian: Ako niste sigurni, upitajte svog liječnika ili ljekarnika.
English: If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (e.g. epoprostenol) should be considered (see section 4.2).
Croatian: Ako se klinička situacija pogoršava, treba se razmotriti primjena lijekova koji se preporučuju u teškoj fazi bolesti (npr. epoprostenol) (vidjeti dio 4.2).
English: Efficacy in adult patients with pulmonary arterial hypertension (PAH)
Croatian: Djelotvornost u odraslih bolesnika s plućnom arterijskom hipertenzijom (PAH)
English: For dose recommendations, see sections 4.2 and 4.3.
Croatian: Za preporuke o doziranju vidjeti dijelove 4.2 i 4.3.
English: For adults, the recommended dose is 20 mg three times a day (taken 6 to 8 hours apart) taken with or without food.
Croatian: Za odrasle bolesnike preporučena doza je 20 mg tri puta na dan (u razmaku od 6 do 8 sati), a može se uzimati s hranom ili bez nje.
English: Treatment with sildenafil significantly delayed the time to clinical worsening of PAH compared to placebo (p = 0.0074).
Croatian: Liječenje sildenafilom značajno je odgodilo vrijeme do kliničkog pogoršanja PAH-a u usporedbi s placebom (p = 0,0074).
English: Sildenafil (or placebo) was added to patients' background therapy which could have included a combination of anticoagulation, digoxin, calcium channel blockers, diuretics or oxygen.
Croatian: Sildenafil (ili placebo) se dodavao bolesnikovoj osnovnoj terapiji, koja je mogla uključivati kombinaciju antikoagulansa, digoksina, blokatora kalcijevih kanala, diuretika ili kisika.
English: Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.
Croatian: Stoga sildenafil u tih bolesnika treba primijeniti tek nakon pažljive procjene koristi i rizika.
English: Granpidam contains lactose
Croatian: Granpidam sadrži laktozu
English: From the analysis of the pharmacokinetic profile of sildenafil in patients involved in the paediatric clinical trials, body weight was shown to be a good predictor of drug exposure in children.
Croatian: Iz analize farmakokinetičkog profila sildenafila u bolesnika uključenih u pedijatrijska klinička ispitivanja proizlazi da je tjelesna težina dobar pokazatelj izloženosti lijeku u djece.
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 šansi bili su 2,92 (p = 0,0087), 4,32 (p = 0,0004) i 5,75 (p < 0,0001).
English: Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast fed child.
Croatian: Liječnici koji propisuju lijek trebaju pažljivo procijeniti majčinu kliničku potrebu za sildenafilom i mogući nastanak bilo kakve nuspojave u dojenčeta.
English: Sildenafil had no effect on saquinavir pharmacokinetics.
Croatian: Sildenafil nije utjecao na farmakokinetiku sakvinavira.
English: You should not take more medicine than your doctor tells you to.
Croatian: Ne smijete uzimati više lijeka nego što Vam je preporučio liječnik.
English: The mean steady state volume of distribution (Vss) for sildenafil is 105 l, indicating distribution into the tissues.
Croatian: Srednja vrijednost volumena distribucije sildenafila u stanju dinamičke ravnoteže (Vss) je 105 l, što ukazuje na to da se on raspodjeljuje u tkiva.
English: There was no significant difference in effect between sildenafil doses.
Croatian: Učinak se nije značajno razlikovao između različitih doza sildenafila.
English: Time to clinical worsening was a secondary endpoint as defined as the time from randomisation to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy).
Croatian: Sekundarni ishod bilo je vrijeme do kliničkog pogoršanja, definirano kao vrijeme od randomizacije do prve pojave događaja kliničkog pogoršanja (smrt, presađivanje pluća, uvođenje liječenja bosentanom ili kliničko pogoršanje koje je zahtijevalo promjenu terapije epoprostenolom).
English: Overall, the adverse events were generally similar between the two treatment groups (sildenafil plus bosentan vs. bosentan alone), and consistent with the known safety profile of sildenafil when used as monotherapy (see sections 4.4 and 4.5).
Croatian: Ukupno rečeno, općenito su nuspojave bile slične između dvije terapijske skupine (sildenafil plus bosentan u odnosu na sam bosentan) i sukladne poznatom sigurnosnom profilu sildenafila kada je primijenjen kao monoterapija (vidjeti dijelove 4.4 i 4.5).
English: These were the only factors with a statistically significant impact on sildenafil pharmacokinetics in patients with pulmonary arterial hypertension.
Croatian: To su bili jedini faktori sa statistički značajnim utjecajem na farmakokinetiku sildenafila u bolesnika s plućnom arterijskom hipertenzijom.
English: Granpidam is for oral use only.
Croatian: Granpidam je namijenjen samo za peroralnu primjenu.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Granpidam, before driving or using machines.
Croatian: S obzirom na to da su u kliničkim ispitivanjima sildenafila prijavljene omaglica i promjene vida, bolesnici trebaju biti svjesni kako bi Granpidam na njih mogao djelovati prije nego upravljaju vozilom ili rukuju strojevima.
English: Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
Croatian: Liječenje smije započeti i nadzirati isključivo liječnik s iskustvom u liječenju plućne arterijske hipertenzije.
English: When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
Croatian: Kada su se sildenafil i doksazosin istovremeno primjenjivali u bolesnika stabiliziranih na terapiji doksazosinom, bilo je rijetkih prijava o bolesnicima u kojih se pojavila simptomatska posturalna hipotenzija.
English: Of those sildenafil treated subjects developmentally able to perform the CPET 59/114 subjects (52%) had not shown any deterioration in Peak VO2 from start of sildenafil.
Croatian: Od ispitanika liječenih sildenafilom koji su bili razvojno sposobni za izvođenje CPET testa, u 59/114 ispitanika (52%) nije pokazao pogoršanje vršnog VO2 od početka uzimanja sildenafila.
English: Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
Croatian: Primjena jednokratne peroralne doze sildenafila do 100 mg u zdravih dobrovoljaca nije proizvela klinički značajne učinke na EKG-u.
English: In the two placebo-controlled studies adverse events were generally mild to moderate in severity.
Croatian: U ta dva placebom kontrolirana ispitivanja nuspojave su općenito bile blage do umjerene u težini.
English: Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately
Croatian: Zbog dobno uvjetovanih razlika u vezanju za proteine u plazmi, odgovarajuće povećanje koncentracije slobodnog sildenafila u plazmi iznosilo je oko 40%.
English: Subjects on active sildenafil therapy continued on the same treatment regimen, while those in the placebo group in the short-term study were randomly reassigned to sildenafil treatment.
Croatian: Ispitanici na aktivnoj terapiji sildenafilom nastavili su s istim režimom liječenja, dok su oni koji su bili u skupini koja je primala placebo u kratkotrajnom ispitivanju bili ponovno randomizirani za liječenje sildenafilom.
English: Long term extension data
Croatian: Podaci iz dugotrajnog produžetka ispitivanja
English: Nicorandil is a hybrid of potassium channel activator and nitrate.
Croatian: Nikorandil je hibrid aktivatora kalijevih kanala i nitrata.
English: Each tablet also contains 0.2 mg of lactose (as monohydrate).
Croatian: Jedna tableta sadrži također 0,2 mg laktoze (u obliku hidrata).
English: At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ml, compared to approximately 5 ng/ml when sildenafil was administered alone.
Croatian: Nakon 24 sata su plazmatske razine sildenafila još uvijek bile oko 200 ng/ml, u usporedbi s približno 5 ng/ml kada se sildenafil primjenjivao sam.
English: PDE5 inhibitors, such as sildenafil have been shown to increase the hypotensive effects of this medicine.
Croatian: PDE5 inhibitori, kao što je sildenafil su pokazali da povećavaju hipotenzivne učinke ovog lijeka.
English: Intensified monitoring is recommended during the discontinuation period.
Croatian: Preporučuje se pojačan nadzor tijekom razdoblja ukidanja lijeka.
English: Granpidam contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Croatian: Granpidam sadrži djelatnu tvar sildenafil, koji pripada skupini lijekova koji se nazivaju inhibitorima fosfodiesteraze tipa 5 (PDE5).
English: There are no data from the use of sildenafil in pregnant women.
Croatian: Nema podataka o primjeni sildenafila u trudnica.
English: The effect of sildenafil on mortality is unknown.
Croatian: Nije poznat učinak sildenafila na smrtnost.
English: Granpidam is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Croatian: Granpidam se koristi za liječenje odraslih bolesnika te djece i adolescenata u dobi od 1 do 17 godina koji imaju visok krvni tlak u krvnim žilama u plućima (plućnu arterijsku hipertenziju).
English: If you stop taking Granpidam
Croatian: Ako prestanete uzimati Granpidam
English: No interactions were observed between sildenafil (100 mg single dose) and acenocoumarol.
Croatian: Nisu zabilježene interakcije između sildenafila (jedna doza od 100 mg) i acenokumarola.
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 6MWDa u skupini koja je primala dozu od 20 mg.
English: No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Croatian: Nisu opažene značajne interakcije kada je sildenafil (50 mg) primijenjen istovremeno s tolbutamidom (250 mg) ili varfarinom (40 mg), koji se oba metaboliziraju pomoću CYP2C9.
English: Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
Croatian: Nije za očekivati da će se dijalizom ubrzati klirens jer se sildenafil u velikoj mjeri veže za proteine u plazmi i ne eliminira se mokraćom.
English: Sildenafil causes mild and transient decreases in systemic blood pressure which, in the majority of cases, do not translate into clinical effects.
Croatian: Sildenafil uzrokuje blago i prolazno sniženje sistemskog krvnog tlaka, koje u većini slučajeva ne izaziva kliničke učinke.
English: These medicines are often given for relief of chest pain (or “angina pectoris”).
Croatian: Ti se lijekovi često daju za ublažavanje boli u prsima ("angine pectoris").
English: In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered (see section 4.3).
Croatian: U slučaju iznenadnog poremećaja vida liječenje je potrebno odmah prekinuti i razmotriti alternativno liječenje (vidjeti dio 4.3).
English: In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving sildenafil 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 sildenafil nego u onih koji su primali placebo, što je dovelo do prijevremenog prekida tog ispitivanja.
English: Therefore, caution is recommended in case of co-administration.
Croatian: Stoga se u slučaju istovremene primjene preporučuje oprez.
English: The safety of sildenafil has not been studied in patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) and therefore its use is not recommended.
Croatian: Sigurnost sildenafila nije ispitivana u bolesnika s poznatim nasljednim degenerativnim poremećajima mrežnice, kakav je retinitis pigmentosa (manji dio tih bolesnika ima genetske poremećaje mrežničnih fosfodiesteraza) te se stoga njegova primjena ne preporučuje.
English: Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Croatian: Riocigvat: Pretklinička ispitivanja su pokazala dodatan učinak na sniženje sistemskog krvnog tlaka kada se PDE5 inhibitori koriste u kombinaciji sa riocigvatom.
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: Due to the nitrate component it has the potential to have serious interaction with sildenafil (see section 4.3).
Croatian: Zbog komponente nitrata moguća je ozbiljna interakcija sa sildenafilom (vidjeti dio 4.3).
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Croatian: Srednja vrijednost apsolutne bioraspoloživosti nakon peroralne primjene je 41% (raspon 25-63%).
English: Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Croatian: Sildenafil (50 mg) nije pojačao hipotenzivne učinke alkohola u zdravih dobrovoljaca sa srednjom vrijednošću najveće razine alkohola u krvi od 80 mg/dl.
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: In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease.
Croatian: U bolesnika s plućnom arterijskom hipertenzijom postoji mogućnost povećanog rizika od krvarenja kada se započinje liječenje sildenafilom u bolesnika koji već uzimaju antagonist vitamina K, osobito u onih bolesnika u kojih je plućna arterijska hipertenzija posljedica bolesti vezivnog tkiva.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 20 mg sildenafila (u obliku sildenafilcitrata).
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 6minutnoj postignutoj udaljenosti hodom.
English: In the long term paediatric extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose.
Croatian: U dugoročnom produljenju ispitivanja u pedijatrijskih bolesnika opažena je povećana smrtnost u bolesnika koji su primali veće doze od preporučenih.
English: The major circulating metabolite results from N-demethylation of sildenafil.
Croatian: Glavni metabolit u cirkulaciji nastaje N-demetilacijom sildenafila.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Učinci drugih lijekova na sildenafil
English: Galactose intolerance
Croatian: Nepodnošenje galaktoze
English: Granpidam with food and drink You should not drink grapefruit juice while you are being treated with Granpidam.
Croatian: Ne smijete piti sok od grejpa dok se liječite lijekom Granpidam.
English: The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (e.g. ambrisentan, iloprost) has not been studied in controlled clinical trials.
Croatian: Djelotvornost i sigurnost sildenafila primijenjenog istovremeno s drugim lijekovima za plućnu arterijsku hipertenziju (npr. ambrisentan, iloprost) nije ispitana u kontroliranim kliničkim ispitivanjima.
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: Of the subjects who completed the initial study, 242 entered a long-term extension study.
Croatian: Od ispitanika koji su završili prvobitno ispitivanje, 242 su ušla u dugoročno produljeno ispitivanje.
English: Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries.
Croatian: Sildenafil nije pokazao učinak na minutni volumen srca i nije ometao protok krvi kroz stenozirane koronarne arterije.