FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on tolerability and efficacy, the dose may subsequently be increased.
Croatian: Na temelju podnošljivosti i djelotvornosti, doza se kasnije može povećati.
English: Therefore, the current information of section 4.8 should be revised to highlight the temporal association with vardenafil.
Croatian: Stoga bi trenutne podatke iz dijela 4.8 trebalo revidirati kako bi se istaknula vremenska povezanost s vardenafilom.
English: With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra.
Croatian: Uz seksualnu stimulaciju možete postići erekciju bilo kada između 25 minuta do četiri do pet sati nakon uzimanja Levitra.
English: - If you are taking riociguat.
Croatian: - ako uzimate riocigvat.
English: Treatment of erectile dysfunction in adult men.
Croatian: Liječenje erektilne disfunkcije u odraslih muškaraca.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek su u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svakim daljnjim ažuriranjima objavljenim na europskom internetskom portalu za lijekove.
English: The clinical impact of these QT changes is unknown (see section 5.1).
Croatian: Kliničko značenje ovih QT promjena nije poznato (vidjeti dio 5.1).
English: Do not crush the tablet.
Croatian: Nemojte zdrobiti tabletu.
English: In cases of overdose, standard supportive measures should be adopted as required.
Croatian: U slučaju predoziranja, nužno je primijeniti potrebne standardne mjere potpornog liječenja.
English: Levitra might make some people feel dizzy or affect their vision.
Croatian: Levitra može kod nekih ljudi izazvati omaglicu i utjecati na njihov vid.
English: There may be physical or psychological causes, or a mixture of both.
Croatian: Uzroci mogu biti fizički ili psihički ili jedni i drugi.
English: Taking these medicines with Levitra could seriously affect your blood pressure.
Croatian: Uzimanje ovih lijekova s lijekom Levitra moglo bi ozbiljno utjecati na Vaš krvni tlak.
English: The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction.
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja u svim podskupinama pedijatrijske populacije u liječenju erektilne disfunkcije.
English: Effect on bleeding
Croatian: Utjecaj na krvarenje
English: - Don't drink grapefruit juice when you use Levitra.
Croatian: - Nemojte piti sok od grejpa kad uzimate lijek Levitra.
English: Penile erection is a haemodynamic process.
Croatian: Erekcija penisa je hemodinamski proces.
English: However, it is not possible to definitively determine whether these events are related directly to these risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Croatian: Međutim, nije moguće sa sigurnošću utvrditi jesu li ovi događaji izravno povezani s navedenim čimbenicima rizika, s primjenom vardenafila, sa seksualnom aktivnošću ili s kombinacijom tih ili drugih čimbenika.
English: In order for Levitra to be effective, sexual stimulation is required.
Croatian: Da bi Levitra djelovala, potrebna je seksualna stimulacija.
English: During sexual stimulation, nitric oxide is released.
Croatian: Tijekom seksualne stimulacije oslobađa se dušikov oksid.
English: It is not possible to determine whether these events were directly related to vardenafil.
Croatian: Nije moguće utvrditi jesu li navedeni događaji bili izravno povezani s uzimanjem vardenafila.
English: Elderly (>65 years old)
Croatian: Posebne populacije Stariji (u dobi od > 65 godina)
English: He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.
Croatian: Liječnik može predložiti da uzmete alternativni oblik lijeka Levitra u drugačijoj dozi, ovisno o tome koliko Vam dobro djeluje.
English: Therefore vardenafil should be administered to these patients only after careful benefit-risk assessment.
Croatian: Stoga se vardenafil kod ovih bolesnika smije primjenjivati samo nakon pažljive procjene koristi i rizika.
English: Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients.
Croatian: Neki su bolesnici iskusili djelomično, iznenadno, privremeno ili trajno slabljenje ili gubitak vida na jednom ili oba oka.
English: There are no studies of vardenafil in pregnant women.
Croatian: Ne postoje ispitivanja vardenafila u trudnica.
English: Sexual stimulation is therefore required for vardenafil to produce its beneficial therapeutic effects.
Croatian: Seksualna stimulacija je stoga potrebna da bi vardenafil imao svoj koristan terapijski učinak.
English: The following groups were not well represented in clinical trials: elderly (>75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3).
Croatian: Sljedeće skupine nisu bile dobro zastupljene u kliničkim ispitivanjima: stariji (> 75 godina, 2,4%) i bolesnici s određenim kardiovaskularnim bolestima (vidjeti dio 4.3).
English: The onset of activity may be delayed if taken with a high fat meal (see section 5.2).
Croatian: Početak djelovanja može biti odgođen ako se uzme uz obrok bogat mastima (vidjeti dio 5.2).
English: White round tablets.
Croatian: Bijele okrugle tablete.
English: Dose adjustments are not required in elderly patients.
Croatian: U starijih bolesnika nije potrebno prilagođavati dozu.
English: A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Croatian: Potrebno je uzeti anamnezu i napraviti fizikalni pregled kako bi se dijagnosticirala erektilna disfunkcija i utvrdili mogući podležeći uzroci prije nego što se razmotri farmakološko liječenje.
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE09.
Croatian: Farmakoterapijska skupina: urologici, lijekovi koji se primjenjuju kod erektilne disfunkcije, ATK oznaka: G04BE09.
English: Ritonavir significantly prolonged the half-life of vardenafil to 25.7 hours (see section 4.3).
Croatian: Ritonavir je značajno produljio poluvijek vardenafila na 25,7 sati (vidjeti dio 4.3).
English: Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.
Croatian: Štogod bio uzrok, zbog promjena na mišićima i krvnim žilama u penisu nema dovoljno krvi da bi postao i ostao ukrućen.
English: Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Croatian: Erektilna disfunkcija je nesposobnost postizanja ili održavanja erekcije penisa dovoljne za zadovoljavajući spolni odnos.
English: If you take more Levitra than you should, tell your doctor.
Croatian: Ako uzmete više lijeka Levitra nego što ste trebali, obratite se liječniku.
English: Due to the nitrate component it has the potential to have serious interaction with vardenafil.
Croatian: Zbog nitratne sastavnice, može ući u ozbiljne interakcije s vardenafilom.
English: Levitra can be taken with or without food.
Croatian: Levitra se može uzimati s hranom ili bez nje.
English: Effects on the QT interval were measured one hour post-dose (average tmax for vardenafil).
Croatian: Učinci na QT interval mjereni su jedan sat nakon primjene doze (prosječni tmax za vardenafil).
English: Over 2,500 patients have been treated with vardenafil for 6 months or longer.
Croatian: Više od 2500 bolesnika liječilo se vardenafilom šest mjeseci ili dulje.
English: Sudden decrease or loss of hearing has been reported.
Croatian: Zabilježeno je iznenadno slabljenje ili gubitak sluha.
English: In vitro studies have shown that vardenafil is more potent on PDE5 than on other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).
Croatian: In vitro ispitivanja pokazala su da vardenafil ima jači učinak na PDE5 nego na druge poznate fosfodiesteraze (> 15-struko u odnosu na PDE6, > 130-struko u odnosu na PDE1, > 300-struko u odnosu na PDE11 i > 1000-struko u odnosu na PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 i PDE10).
English: In addition, in line with the product information of other PDE5s, a warning should also be included in section 4.4 to highlight these events, and reflect that it is not possible to definitively determine whether these events are related directly to any risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Croatian: Dodatno, u skladu s informacijama o lijeku za druge inhibitore PDE5, u dio 4.4 treba se uključiti upozorenje koje će istaknuti te događaje, zajedno s informacijom kako nije moguće sa sigurnošću odrediti jesu li ti događaji izravno povezani s bilo kojim od čimbenika rizika, s primjenom vardenafila, sa seksualnom aktivnošću ili s kombinacijom tih ili drugih čimbenika.
English: Effect on vision
Croatian: Utjecaj na vid
English: Stop taking Levitra and contact your doctor immediately.
Croatian: Prestanite uzimati lijek Levitra i odmah se javite liječniku.
English: No statistically significant correlation was observed between creatinine clearance and vardenafil exposure (AUC and Cmax) (see section 4.2).
Croatian: Nije bila primijećena statistički značajna korelacija između klirensa kreatinina i izloženosti vardenafilu (AUC i Cmax) (vidjeti dio 4.2).
English: - If you have stomach ulcers (also called gastric or peptic ulcers).
Croatian: - ako imate čir želuca (također se zove želučani ili peptički ulkus).
English: In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged 18 - 89 years, many of whom had multiple co-morbid conditions.
Croatian: Vardenafil se u kliničkim ispitivanjima primijenio u više od 17 000 muškaraca s erektilnom disfunkcijom (ED) u dobi od 18-89 godina, od kojih su mnogi imali više komorbiditetnih stanja.
English: - If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
Croatian: - ako ste ikad imali stanje u kojem dolazi do gubitka vida zbog oštećenja vidnog živca uslijed nedovoljne opskrbe krvlju, poznatog kao nearteritička ishemijska optička neuropatija (NAION).
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza “EXP”.
English: However, 90% of the time, maximum plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Croatian: Međutim, u 90% slučajeva, maksimalne koncentracije u plazmi postižu se u roku od 30 do 120 minuta (medijan 60 minuta) od primjene kroz usta natašte.
English: What Levitra is and what it is used for What you need to know before you take Levitra How to take Levitra
Croatian: Što je Levitra i za što se koristi Što morate znati prije nego počnete uzimati lijek Levitra Kako uzimati lijek Levitra
English: The following adverse reactions have been reported:
Croatian: Zabilježene su sljedeće nuspojave:
English: It reduces the action of the natural chemical in your body which makes erections go away.
Croatian: Ona smanjuje djelovanje spoja koji se prirodno nalazi u Vašem tijelu, zbog kojeg se gubi erekcija.
English: Store in the original package in order to protect from humidity and light.
Croatian: Čuvati u originalnom pakiranju radi zaštite od vlage i svjetlosti.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for vardenafil, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za vardenafil, znanstveni zaključci CHMP-a su sljedeći:
English: The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the tissues.
Croatian: Prosječni volumen distribucije u stanju dinamičke ravnoteže vardenafila je 208 l, što ukazuje na distribuciju u tkiva.
English: Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity (see section 4.3).
Croatian: Prije početka bilo kakvog liječenja erektilne disfunkcije, liječnici trebaju razmotriti kardiovaskularno stanje bolesnika, budući da je sa spolnom aktivnošću povezan određeni stupanj rizika za srce (vidjeti dio 4.3).
English: The chance of having a side effect is described by the following categories:
Croatian: Nuspojave su prema vjerojatnosti razvrstane u iduće kategorije:
English: The maximum recommended dose is 20 mg.
Croatian: Maksimalna preporučena doza je 20 mg.
English: The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disintegrate, and then swallowed.
Croatian: Raspadljivu tabletu za usta treba staviti u usta na jezik, gdje će se brzo raspasti, a potom progutati.
English: Levitra allows an erection to last long enough for you to satisfactorily complete sexual activity.
Croatian: Levitra omogućuje dovoljno dugo trajanje erekcije da možete na zadovoljavajući način dovršiti spolni odnos.
English: Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic hyperplasia (BPH) on stable tamsulosin, terazosin or alfuzosin therapy:
Croatian: Na temelju rezultata ispitivanja interakcija provedenih s vardenafilom u bolesnika s benignom hiperplazijom prostate (BHP) na stabilnoj terapiji tamsulozinom, terazosinom ili alfuzosinom:
English: Adverse reactions are listed according to the MedDRA frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (can not be estimated from available data).
Croatian: Nuspojave su navedene po učestalosti prema MedDRA konvenciji: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: An additional analysis, including data from clinical trials, post marketing experience and literature showed that some occurred with a close temporal association (the two first weeks) after the intake of vardenafil.
Croatian: Dodatna analiza, koja uključuje podatke iz kliničkih ispitivanja, iskustvo nakon stavljanja lijeka u promet i literaturu, pokazala je da su se neki od njih pojavili u bliskoj vremenskoj povezanosti (unutar prva dva tjedna) s unosom vardenafila.
English: Levitra is not indicated for use by women.
Croatian: Levitra nije indicirana za primjenu u žena.
English: The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is headache.
Croatian: Najčešće zabilježena nuspojava, koja se javila u ≥ 10% bolesnika, bila je glavobolja.
English: Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction.
Croatian: Vardenafil je oralna terapija za poboljšanje erektilne funkcije u muškaraca s erektilnom disfunkcijom.
English: The recommended dose is 10 mg.
Croatian: Preporučena doza je 10 mg.
English: Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Croatian: Vardenafil ima vazodilatacijska svojstva, što dovodi do blagog i prolaznog sniženja krvnog tlaka (vidjeti dio 5.1).
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane u silaznom redoslijedu po ozbiljnosti.
English: 7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per orodispersible tablet.
Croatian: 7,96 mg sorbitola (E420) i 1,80 mg aspartama (E951) po raspadljivoj tableti za usta.
English: When vardenafil was administered in higher doses and more frequently than the recommended dose regimen (40 mg film-coated tablets twice daily) cases of severe back pain have been reported.
Croatian: Kad se vardenafil primjenjivao u višim dozama i češće od preporučenog režima doziranja (40 mg filmom obložene tablete dvaput na dan) zabilježeni su slučajevi teških bolova u leđima.
English: There is no relevant indication for use of Levitra orodispersible tablets in children and adolescents.
Croatian: Nema relevantne indikacije za primjenu Levitra raspadljivih tableta za usta u djece i adolescenata.
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 dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: At 24 hours, the plasma levels of vardenafil had fallen to approximately 4% of the maximum vardenafil plasma level (Cmax).
Croatian: Nakon 24 sata, razina vardenafila u plazmi snizila se na približno 4% maksimalne razine vardenafila u plazmi (Cmax).
English: Vardenafil AUC is not affected.
Croatian: AUC vardenafila se ne mijenja.
English: In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is subject to further metabolism with a plasma elimination half-life of approximately 4 hours.
Croatian: U ljudi, jedini glavni cirkulirajući metabolit (M1) nastaje deetilacijom vardenafila i podliježe daljnjem metabolizmu uz poluvrijeme eliminacije iz plazme od približno 4 sata.
English: Parts of M1 are in the form of the glucuronide in systemic circulation.
Croatian: Dio M1 u sistemskoj cirkulaciji je u obliku glukuronida.
English: Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum.
Croatian: Vardenafil je jaki i selektivni inhibitor specifične fosfodiesteraze tipa 5 cGMP-a (PDE5), najzastupljenije fosfodiesteraze u kavernoznom tijelu u ljudi.
English: Effects of other medicinal products on vardenafil
Croatian: Utjecaj drugih lijekova na vardenafil
English: Metabolite M1 shows a phosphodiesterase selectivity profile similar to vardenafil and an in vitro potency for phosphodiesterase type 5 of approximately 28% compared to vardenafil, resulting in an efficacy contribution of about 7%.
Croatian: Metabolit M1 pokazuje sličan profil selektivnosti za fosfodiesterazu kao i vardenafil, a in vitro jačinu za fosfodiesterazu tipa 5 od približno 28% u usporedbi s vardenafilom, što pridonosi djelotvornosti od oko 7%.
English: Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins (approximately 95% for vardenafil or M1).
Croatian: Vardenafil i njegov glavni cirkulirajući metabolit (M1) u visokom se postotku vežu na proteine plazme (približno 95% za vardenafil ili M1).
English: This drug is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots).
Croatian: Taj se lijek koristi za liječenje plućne arterijske hipertenzije (tj. povišenog krvnog tlaka u plućima) i kronične tromboembolijske plućne hipertenzije (tj. povišenog krvnog tlaka u plućima koji je posljedica krvnih ugrušaka).
English: - If you are taking ritonavir or indinavir, medicines used to treat human immunodeficiency virus (HIV) infections.
Croatian: - ako uzimate ritonavir ili indinavir, lijekove koji se koriste za liječenje infekcije virusom humane imunodeficijencije (HIV).
English: There is no relevant indication for use of Levitra in children.
Croatian: Nema relevantne indikacije za primjenu lijeka Levitra u djece.
English: Levitra is not indicated for individuals below 18 years of age.
Croatian: Levitra nije indicirana u osoba mlađih od 18 godina.
English: For vardenafil as well as M1, protein binding is independent of total drug concentrations.
Croatian: Za vardenafil, kao i M1, vezanje na proteine ne ovisi o ukupnoj koncentraciji lijeka.
English: - If you experience sudden decrease or loss of vision, stop taking Levitra and contact your doctor immediately.
Croatian: - ako osjetite iznenadno slabljenje ili gubitak vida, prestanite uzimati lijek Levitra i odmah se javite liječniku.
English: Dissolve in the mouth
Croatian: Otopiti u ustima.
English: There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Croatian: Ne postoje podaci o interakciji vardenafila i nespecifičnih inhibitora fosfodiesteraze, kao što su teofilin i dipiridamol.
English: This in turn results in smooth muscle relaxation, allowing increased inflow of blood into the penis.
Croatian: To pak rezultira opuštanjem glatkog mišićja, što omogućuje pojačan dotok krvi u penis.
English: Although a specific interaction study has not been conducted, the co-administration of clarithromycin can be expected to result in similar effects on vardenafil AUC and Cmax.
Croatian: Premda nije provedeno posebno ispitivanje interakcije, može se očekivati da će istodobna primjena klaritromicina rezultirati sličnim učincima na AUC i Cmax vardenafila.
English: Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
Croatian: Jednokratne i višekratne oralne doze vardenafila do 40 mg nisu izazvale nikakve klinički značajne promjene u EKG nalazima zdravih muških dobrovoljaca.
English: - If you have a bleeding disorder (such as haemophilia).
Croatian: - ako imate poremećaj krvarenja (kao što je hemofilija).
English: There are no fertility data available.
Croatian: Nema dostupnih podataka o utjecaju na plodnost.
English: Since alpha-blocker monotherapy can cause marked lowering of blood pressure, especially postural hypotension and syncope, interaction studies were conducted with vardenafil.
Croatian: Budući da monoterapija alfa blokatorima može prouzročiti izrazito sniženje krvnog tlaka, osobito posturalnu hipotenziju i sinkopu, provedena su ispitivanja interakcija s vardenafilom.
English: - Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva.
Croatian: - Stavite cijelu raspadljivu tabletu za usta, na jezik, gdje će se otopini u roku od nekoliko sekundi, a zatim je progutajte zajedno sa slinom.
English: Bayer A/S Tlf: +45 45 23 50 00
Croatian: Danmark Bayer A/S Tlf: +45 45 23 50 00
English: Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects.
Croatian: Vardenafil uzrokuje blaga i prolazna smanjenja krvnog tlaka koja, u većini slučajeva, nemaju klinički značajne učinke.
English: The median time to reach Cmax varied between 45 to 90 minutes and was similar or slightly delayed (by 8 to 45 min) compared to the film-coated tablets.
Croatian: Medijan vremena postizanja Cmax varirao je između 45 i 90 minuta te bio sličan ili neznatno odgođen (za 8 do 45 minuta) u usporedbi s onim nakon primjene filmom obloženih tableta.