FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the nitric oxide donor sodium nitroprusside.
Croatian: In vitro ispitivanja na ljudskim trombocitima pokazuju da vardenafil sam po sebi nema antiagregacijski učinak, ali u visokim (višim od terapijskih) koncentracijama pojačava antiagregacijski učinak natrijevog nitroprusida, koji je donor dušikovog oksida.
English: - Ketoconazole or itraconazole, anti-fungal medicines - Erythromycin or clarithromycin, macrolide antibiotics - Alpha-blockers, a type of medicine used to treat high blood pressure and enlargement of the prostate (as benign prostatic hyperplasia).
Croatian: Levitra. - ketokonazol ili itrakonazol, antifungalni lijekovi. - eritromicin ili klaritromicin, makrolidni antibiotici. - alfa blokatori, vrsta lijekova koja se primjenjuje za liječenje povišenog krvnog tlaka i povećanja prostate (kao što je benigna hiperplazija prostate).
English: About 63% of all reported sexual attempts with vardenafil 10 mg orodispersible tablets were successful in terms of erection maintenance compared to about 26% of all placebo-controlled sexual attempts.
Croatian: Približno 63% svih zabilježenih pokušaja spolnog odnosa s vardenafil 10 mg raspadljivim tabletama za usta bilo je uspješno s obzirom na održavanje erekcije u odnosu na približno 26% svih placebom kontroliranih pokušaja spolnog odnosa.
English: There is no safety information available on the administration of vardenafil to patients with bleeding disorders or active peptic ulceration.
Croatian: Nema dostupnih informacija o sigurnosti primjene vardenafila u bolesnika s poremećajima krvarenja ili aktivnim peptičkim ulkusom.
English: Concomitant use of alpha-blockers
Croatian: Istodobna primjena alfa blokatora
English: The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets.
Croatian: Tablete su dostupne u pakiranjima od 2, 4, 8, 12 ili 20 tableta.
English: Bayer Hispania S.L.
Croatian: España Bayer Hispania S.L.
English: Film coat:
Croatian: Film ovojnica:
English: The elimination half-life of the metabolite M1 is between 3 to 5 hours, similar to parent drug.
Croatian: Poluvrijeme eliminacije metabolita M1 iznosilo je između 3 do 5 sati, slično prekursoru.
English: Photosensitivity reaction
Croatian: osip fotosenzitivna reakcija
English: Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
Croatian: Znakovi alergijske reakcije uključuju osip, svrbež, otok lica ili usana i nedostatak daha.
English: On the basis of the scientific conclusions for vardenafil the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vardenafil is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za vardenafil, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) vardenafil nepromijenjen, uz predložene izmjene informacija o lijeku.
English: It activates the enzyme guanylate cyclase, resulting in an increased level of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum.
Croatian: On aktivira enzim gvanilat ciklazu, što rezultira povećanom razinom cikličkog gvanozin monofosfata (cGMP) u kavernoznom tijelu.
English: Concomitant use of CYP3A4 inhibitors
Croatian: Istodobna primjena inhibitora CYP3A4
English: Across the pivotal trials, treatment with vardenafil (film-coated tablets) resulted in an improvement of erectile function compared to placebo.
Croatian: U pivotalnim je ispitivanjima liječenje vardenafilom (filmom obložene tablete) rezultiralo poboljšanjem erektilne funkcije u usporedbi s placebom.
English: In the small number of patients who attempted intercourse up to four to five hours after dosing the success rate for penetration and maintenance of erection was consistently greater than placebo.
Croatian: U malog broja bolesnika koji su pokušali imati spolni odnos do četiri ili pet sati nakon uzimanja doze, učestalost uspješne penetracije i održavanja erekcije bila je dosljedno viša nego uz placebo.
English: If vardenafil 10 mg orodispersible tablets are taken with water, the AUC is reduced by 29%, Cmax remains unchanged and median tmax is shortened by 60 minutes compared to intake without water.
Croatian: Ako se vardenafil 10 mg raspadljive tablete uzimaju s vodom, AUC je smanjen za 29%, Cmax ostaje neizmijenjen, a medijan tmax skraćen je za 60 minuta u usporedbi s uzimanjem bez vode.
English: Although specific interaction studies have not been conducted, the concomitant use of other potent CYP3A4 inhibitors (such as itraconazole) can be expected to produce vardenafil plasma levels comparable to those produced by ketoconazole.
Croatian: Premda nisu provedena posebna ispitivanja interakcija, može se očekivati da će istodobna primjena drugih jakih inhibitora CYP3A4 (kao što je itrakonazol) proizvesti razine vardenafila u plazmi koje su usporedive s onima kakve proizvodi ketokonazol.
English: Concomitant intake of grapefruit or grapefruit juice is expected to increase the plasma concentrations of vardenafil.
Croatian: Smatra se i da istodobno uzimanje grejpa ili soka od grejpa izaziva porast koncentracije vardenafila u plazmi.
English: These include sickle cell disease, multiple myeloma and leukaemia.
Croatian: Te bolesti uključuju bolest srpastih stanica, multipli mijelom i leukemiju.
English: Infection and infestations
Croatian: Infekcije i infestacije konjunktivitis
English: No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg film-coated tablets.
Croatian: Nije primijećen učinak na krvni tlak kad se nitroglicerin uzeo 24 sata nakon primjene jednokratne doze vardenafil 20 mg filmom obloženih tableta.
English: After a meal containing 30% fat, the rate and extent of absorption of vardenafil (tmax, Cmax and AUC) are unchanged compared to administration under fasting conditions.
Croatian: Nakon obroka koji sadrži 30% masti, brzina i opseg apsorpcije vardenafila (tmax, Cmax i AUC) ostaju nepromijenjeni u usporedbi s primjenom natašte.
English: The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators.
Croatian: Istodobna primjena alfa blokatora i vardenafila može dovesti do simptomatske hipotenzije u nekih bolesnika zato što su oba vazodilatatori.
English: (≥1/100 to
Croatian: (≥ 1/100 i
English: The maximum dose for Levitra orodispersible tablet is 10 mg/day.
Croatian: Maksimalna doza Levitra raspadljive tablete za usta je 10 mg na dan.
English: Levitra orodispersible tablets are not indicated for individuals below 18 years of age.
Croatian: Levitra raspadljive tablete za usta nisu indicirane u osoba mlađih od 18 godina.
English: What you need to know before you take Levitra Do not take Levitra
Croatian: Što morate znati prije nego počnete uzimati lijek Levitra
English: Vardenafil was not found to accumulate in the plasma in patients aged 45 years and below or 65 years or over following once-daily dosing of vardenafil 10 mg orodispersible tablets over ten days.
Croatian: Nije se pronašlo da se vardenafil nakuplja u plazmi bolesnika u dobi do 45 godina ili u dobi od 65 godina i starijih nakon doziranja vardenafil 10 mg raspadljivih tableta za usta jedanput na dan tijekom deset dana.
English: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Croatian: Pretklinička ispitivanja pokazala su aditivan učinak na sniženje sistemskog krvnog tlaka kada su se inhibitori PDE5 primjenjivali u kombinaciji s riocigvatom.
English: Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to PDE5 inhibitors such as vardenafil, tadalafil and sildenafil (see section 4.8).
Croatian: Analize podataka iz opservacijskih ispitivanja upućuju na povišeni rizik od akutnog NAION-a u muškaraca s erektilnom disfunkcijom nakon izlaganja PDE5 inhibitorima, kao što su vardenafil, tadalafil i sildenafil (vidjeti dio 4.8).
English: In two interaction studies with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin to high doses, hypotension (in some cases symptomatic) was reported in a significant number of subjects after co-administration of vardenafil.
Croatian: U dva ispitivanja interakcija u zdravih normotenzivnih ispitanika nakon forsirane titracije alfa blokatorima tamsulozinom ili terazosinom do visokih doza te nakon istodobne primjene vardenafila, zabilježena je hipotenzija (u nekim slučajevima simptomatska) u značajnog broja ispitanika.
English: - If you are over 75 years of age and are taking ketoconazole or itraconazole, anti-fungal medicines.
Croatian: - ako ste stariji od 75 godina i uzimate ketokonazol ili itrakonazol, lijekove protiv gljivica.
English: In volunteers with mild to moderate renal impairment (creatinine clearance 30 - 80 ml/min), the pharmacokinetics of vardenafil were similar to that of a normal renal function control group.
Croatian: U dobrovoljaca s blagim do umjerenim oštećenjem funkcije bubrega (klirens kreatinina 30-80 ml/min) farmakokinetika vardenafila bila je slična onoj u kontrolnoj skupini s normalnom funkcijom bubrega.
English: The total body clearance of vardenafil is 56 l/h with a resultant terminal half-life of approximately 4-5 hours.
Croatian: Ukupni klirens iz tijela vardenafila je 56 l/h uz rezultirajuće terminalno poluvrijeme od približno 4-5 sati.
English: Gastrointestinal and abdominal pain
Croatian: gastrointestinalna bol i bolovi u trbuhu,
English: The level of cGMP is regulated by the rate of synthesis via guanylate cyclase and by the rate of degradation via cGMP hydrolysing phosphodiesterases (PDEs).
Croatian: Razinu cGMP regulira brzina sinteze putem gvanilat ciklaze i brzina razgradnje putem cGMP hidrolizirajućih fosfodiesteraza (PDE).
English: - You can take Levitra with or without food but preferably not after a heavy or high-fat meal as this may delay the effect.
Croatian: Levitra s hranom, pićem i alkoholom - Lijek Levitra možete uzimati s hranom ili bez nje - ali po mogućnosti ne nakon obilnog ili mastima bogatog obroka, jer to može odgoditi djelovanje.
English: Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
Croatian: Vardenafil (10 mg) nije potencirao produljenje vremena krvarenja izazvano acetilsalicilnom kiselinom (2 x 81 mg).
English: The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity.
Croatian: Preporučena doza je 10 mg koja se uzima po potrebi približno 25 do 60 minuta prije spolnog odnosa.
English: These effects are consistent with the vasodilatory effects of PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells.
Croatian: Ovi su učinci u skladu s vazodilatacijskim učincima inhibitora PDE5 i vjerojatno su posljedica povišenih razina cGMP u glatkim mišićnim stanicama krvnih žila.
English: When nitric oxide is released in response to sexual stimulation, inhibition of PDE5 by vardenafil results in increased corpus cavernosum levels of cGMP.
Croatian: Kad se, kao odgovor na seksualnu stimulaciju, oslobodi dušikov oksid, inhibicija PDE5 vardenafilom rezultira povećanim razinama cGMP u kavernoznom tijelu.
English: The primary objective of this study was to rule out a greater than 10 msec effect (i.e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point.
Croatian: Primarni cilj ovog ispitivanja bio je isključiti učinak veći od 10 ms (tj., pokazati nedostatak učinka) jednokratne oralne doze vardenafila od 80 mg na QTc (korigirani QT) interval u usporedbi s placebom, što se mjerilo promjenom QTc intervala korigiranog prema Fridericijinoj formuli (QTcF=QT/RR1/3) od početne vrijednosti do vremenske točke 1 sata nakon primjene doze.
English: - If you have a physical condition affecting the shape of the penis.
Croatian: Vaš elektrokardiogram. - ako imate zdravstveno stanje koje utječe na oblik penisa.
English: The interaction is a consequence of blocking hepatic metabolism of vardenafil by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9.
Croatian: Ta je interakcija posljedica blokiranja jetrenog metabolizma vardenafila ritonavirom, vrlo jakim inhibitorom CYP3A4, koji također inhibira CYP2C9.
English: The following patient groups were represented: elderly (22%), patients with hypertension (35%), diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic pulmonary disease (5%), hyperlipidaemia (22%), depression (5%), radical prostatectomy (9%).
Croatian: Zastupljene su bile sljedeće skupine bolesnika: stariji (22%), bolesnici s hipertenzijom (35%), šećernom bolešću (29%), ishemijskom bolešću srca i drugim kardiovaskularnim bolestima (7%), kroničnom plućnom bolešću (5%), hiperlipidemijom (22%), depresijom (5%) i radikalnom prostatektomijom (9%).
English: Vardenafil is rapidly absorbed after administration of Levitra 10 mg orodispersible tablets without water.
Croatian: Vardenafil se brzo apsorbira nakon primjene Levitra 10 mg raspadljivih tableta za usta bez vode.
English: Based on these results vardenafil 10 mg orodispersible tablets can be taken with or without food.
Croatian: Na temelju ovih rezultata, vardenafil 10 mg raspadljive tablete za usta mogu se uzimati sa ili bez hrane.
English: If you feel dizzy, or if your vision is affected after taking Levitra don't drive or operate any tools or machines.
Croatian: Ako nakon uzimanja lijeka Levitra osjetite omaglicu ili imate problema s vidom, nemojte voziti niti koristi alate niti strojeve.
English: Hypotension was not observed when vardenafil 5 mg and terazosin administration was separated by 6 hours.
Croatian: Hipotenzija nije bila primijećena kad su se vardenafil 5 mg i terazosin primijenili u razmaku od 6 sati.
English: - Riociguat.
Croatian: - riocigvat.
English: Vardenafil AUC and Cmax in elderly patients (65 years or over) taking vardenafil orodispersible tablets were increased by 31 to 39% and 16 to 21%, respectively, in comparison to patients aged 45 years and below.
Croatian: AUC and Cmax vardenafila u starijih bolesnika (u dobi od 65 ili više godina) koji su uzimali vardenafil raspadljive tablete za usta bili su povećani za 31 do 39% odnosno 16 do 21% u usporedbi s onima u bolesnika u dobi do 45 godina.
English: Levitra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4).
Croatian: Levitra je kontraindicirana u bolesnika koji su izgubili vid na jedno oko zbog nearteritičke prednje ishemijske optičke neuropatije (NAION), bez obzira na to je li ta epizoda bila povezana s prethodnom izloženosti inhibitoru fosfodiesteraze tipa 5 (PDE5) (vidjeti dio 4.4).
English: After oral dosing of vardenafil AUC and Cmax increase almost dose proportionally over the recommended dose range (5 - 20 mg).
Croatian: Nakon peroralne primjene, AUC i Cmax vardenafila povećavaju se gotovo proporcionalno primijenjenoj dozi unutar raspona preporučenih doza (5-20 mg).
English: In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly higher in patients with a history of hypertension.
Croatian: Općenito se pokazalo da je incidencija nuspojava (osobito “omaglica”) blago viša u bolesnika s hipertenzijom u anamnezi.
English: After oral administration, vardenafil is excreted as metabolites predominantly in the faeces (approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately 2-6% of the administered dose).
Croatian: Nakon peroralne primjene, vardenafil se izlučuje kao metabolit pretežno u stolici (približno 91-95% primijenjene doze) i u manjoj mjeri u mokraći (približno 2-6% primijenjene doze).
English: In vardenafil film-coated tablets, vardenafil is rapidly absorbed with maximum observed plasma concentrations reached in some men as early as 15 minutes after oral administration.
Croatian: Vardenafil se iz vardenafil filmom obloženih tableta brzo apsorbira i postiže maksimalne koncentracije u plazmi kod nekih muškaraca već 15 minuta nakon peroralne primjene.
English: Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
Croatian: Postupno povećanje doze alfa-blokatora može biti povezano s dodatnim sniženjem krvnog tlaka u bolesnika koji uzimaju vardenafil.
English: In the predefined subgroups 57% (elderly patients), 56% (patients with history of diabetes mellitus), 59% (patients with history of dyslipidemia) and 60% (patients with history of hypertension) of all reported attempts with vardenafil 10 mg orodispersible tablets were successful in terms of maintenance of erection.
Croatian: U unaprijed definiranim podskupinama, 57% (stariji bolesnici), 56% (bolesnici sa šećernom bolešću), 59% (bolesnici s dislipidemijom) i 60% (bolesnici s hipertenzijom u anamnezi) svih zabilježenih pokušaja uz vardenafil 10 mg raspadljive tablete za usta bilo je uspješno u smislu održavanja erekcije.
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 20 film-coated tablets
Croatian: 2 filmom obložene tablete 4 filmom obložene tablete 8 filmom obloženih tableta 12 filmom obloženih tableta 20 filmom obloženih tableta
English: Visual defects and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in connection with the intake of Levitra and other PDE5 inhibitors.
Croatian: Oslabljen vid i slučajevi nearteritičke ishemijske optičke neuropatije (NAION) zabilježeni su u vezi s uzimanjem lijeka Levitra i drugih inhibitora PDE5.
English: See section 2 “Levitra 10 mg orodispersible tablets contain Aspartame and Sorbitol”.
Croatian: Vidjeti dio 2 „Levitra 10 mg raspadljive tablete za usta sadrže aspartam i sorbitol“.
English: If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati lijek Levitra - ako ste alergični na vardenafil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Levitra is not intended for use by children or adolescents under 18.
Croatian: Djeca i adolescenti Levitra nije namijenjena za primjenu u djece i adolescenata mlađih od 18 godina.
English: Levitra orodispersible tablets must be taken without liquid and immediately upon release from the blister.
Croatian: Levitra raspadljive tablete za usta moraju se uzeti bez tekućine i odmah nakon vađenja iz blistera.
English: In men older than 75 years the concomitant use of vardenafil with itraconazole or ketoconazole is contraindicated (see section 4.3).
Croatian: U muškaraca starijih od 75 godina, istodobna primjena vardenafila s itrakonazolom ili ketokonazolom je kontraindicirana (vidjeti dio 4.3).
English: On average elderly males taking vardenafil film-coated tablets had a 52% higher AUC, and a 34% higher Cmax than younger males (see section 4.2).
Croatian: U prosjeku, stariji muškarci koji su uzimali vardenafil filmom obložene tablete imali su 52% veći AUC i 34% veći Cmax nego mlađi muškarci (vidjeti dio 4.2).
English: The adverse reactions reported with Levitra film-coated tablets or 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature.
Croatian: Nuspojave zabilježene uz Levitra filmom obložene tablete ili 10 mg raspadljive tablete za usta u kliničkim su ispitivanjima bile općenito prolazne i blage do umjerene naravi.
English: Among subjects treated with terazosin, hypotension was observed more frequently when vardenafil and terazosin were given simultaneously than when the dosing was separated by a time interval of 6 hours.
Croatian: Kod ispitanika liječenih terazosinom hipotenzija je bila češće primijećena kad su se vardenafil i terazosin primjenjivali istodobno nego kad su se primjenjivali u razmaku od 6 sati.
English: If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
Croatian: - ako bolujete od nepravilnog rada srca (srčane aritmije) ili nasljedne srčane bolesti koja utječe na
English: The distribution of patients in the predefined subgroups was covering elderly patients (51%), patients with history of diabetes mellitus (29%), dyslipidemia (39%) and hypertension (40%).
Croatian: Raspodjelom bolesnika u prethodno definirane podskupine pokriveni su stariji bolesnici (51%), bolesnici sa šećernom bolešću (29%), dislipidemijom (39%) i hipertenzijom (40%).
English: In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart disease (70-73%), hyperlipidaemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%).
Croatian: U objedinjenim podacima iz velikih ispitivanja djelotvornosti, udio bolesnika koji su imali uspješnu penetraciju uz vardenafil bili su sljedeći: psihogena erektilna disfunkcija (77-87%), miješana erektilna disfunkcija (69-83%), organska erektilna disfunkcija (64-75%), stariji (52-75%), ishemijska bolest srca (70-73%), hiperlipidemija (62-73%), kronična bolest pluća (74-78%), depresija (59-69%) i bolesnici istodobno liječeni antihipertenzivima (62-73%).
English: The vardenafil results showed an increase in QTc (Fridericia) of 8 msec (90% CI: 6-9) and 10 msec (90% CI: 8-11) at 10 and 80 mg doses compared to placebo and an increase in QTci of 4 msec (90% CI: 3-6) and 6 msec (90% CI: 4-7) at 10 and 80 mg doses compared to placebo, at one hour post-dose.
Croatian: Rezultati vardenafila pokazali su produženje QTc (Fridericia) za 8 ms (90% CI: 6-9) i 10 ms (90% CI: 8-11) uz doze od 10 i 80 mg u usporedbi s placebom i produženje QTci (individualno korigirani QT) za 4 ms (90% CI: 3-6) i 6 ms (90% CI: 4-7) uz doze od 10 i 80 mg u usporedbi s placebom jedan sat nakon primjene doze.
English: - If you are taking medicines containing nitrates, such as glycerol trinitrate for angina, or nitric oxide donors, such as amyl nitrite.
Croatian: - ako uzimate lijekove koji sadrže nitrate, kao što je glicerol trinitrat za anginu, ili sredstva koja otpuštaju dušikov oksid, kao što je amil nitrat.
English: Medicinal products for the treatment of erectile dysfunction 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: Lijekove za liječenje erektilne disfunkcije treba primjenjivati s oprezom u bolesnika s anatomskom deformacijom penisa (kao što su angulacija, kavernozna fibroza ili Peyronieva bolest) i u bolesnika sa stanjima zbog kojih su skloniji prijapizmu (kao što su anemija srpastih stanica, multipli mijelom ili leukemija).
English: When vardenafil film-coated tablets are taken with a high fat meal (containing 57% fat), the rate of absorption is reduced, with an increase in the median tmax of 1 hour and a mean reduction in Cmax of 20%.
Croatian: Kad se vardenafil filmom obložene tablete uzmu uz obrok bogat mastima (koji sadrži 57% masti), brzina apsorpcije se smanjuje, uz povećanje medijana tmax za 1 sat i prosječno smanjenje Cmax za 20%.