FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the tissues.
Slovenian: Povprečen porazdelitveni volumen stanja dinamičnega ravnovesja vardenafila je 208 l, kar kaže na porazdelitev v tkiva.
English: Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects.
Slovenian: Vardenafil povzroči blago in prehodno znižanje krvnega tlaka, ki v večini primerov nima kliničnih učinkov.
English: Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients.
Slovenian: Obstajajo poročila o delnem, nenadnem, začasnem ali trajnem poslabšanju vida ali oslepitvi na eno ali obe očesi.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITION OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: Date of first authorisation: 6 March 2003 Date of latest renewal: 6 March 2008
Slovenian: Datum zadnjega podaljšanja: 06.03.2008
English: Effects of other medicinal products on vardenafil
Slovenian: Učinki drugih zdravil na vardenafil
English: There are no fertility data available.
Slovenian: Podatki o vplivu vardenafila na plodnost niso na voljo.
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE09.
Slovenian: Farmakoterapevtska skupina: zdravila za bolezni sečil, zdravila za zdravljenje erektilne disfunkcije, oznaka ATC: G04BE09
English: Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
Slovenian: Znaki alergijske reakcije so izpuščaji, srbečica, otekel obraz ali ustnice in kratka sapa.
English: Vardenafil AUC is not affected.
Slovenian: Vrednost AUC vardenafila se ne spremeni.
English: This in turn results in smooth muscle relaxation, allowing increased inflow of blood into the penis.
Slovenian: To povzroči sproščanje gladkih mišic, kar omogoči večji dotok krvi v penis.
English: Read the package leaflet for further information.
Slovenian: Preberite navodilo za uporabo glede dodatnih informacij.
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
Slovenian: Na podlagi znanstvenih zaključkov za vardenafil skupina CMDh meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) vardenafil nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at any time in any given patient.
Slovenian: Klinična pomembnost te ugotovitve ni znana in se je ne da posplošiti na vse bolnike v vseh okoliščinah.
English: At 24 hours, the plasma levels of vardenafil had fallen to approximately 4% of the maximum vardenafil plasma level (Cmax).
Slovenian: Po 24 urah se plazemska raven vardenafila zniža na približno 4 % največje plazemske vrednosti vardenafila (Cmax).
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).
Slovenian: To zdravilo se uporablja za zdravljenje pljučne arterijske hipertenzije (tj. visokega krvnega tlaka v pljučih) in kronične trombembolične pljučne hipertenzije (tj. visokega krvnega tlaka v pljučih, ki nastane zaradi krvnih strdkov).
English: Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins (approximately 95% for vardenafil or M1).
Slovenian: Vardenafil in njegovi glavni presnovek (M1) se obsežno vežeta na plazemske beljakovine (približno 95 % vardenafila ali M1).
English: The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disintegrate, and then swallowed.
Slovenian: Orodisperzabilne tablete se dajo pod jezik, kjer se hitro razgradijo in nato pogoltnejo.
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).
Slovenian: Pred začetkom kakršnega koli zdravljenja erektilne disfunkcije mora zdravnik upoštevati kardiovaskularno stanje bolnika, saj obstaja v povezavi s spolno aktivnostjo določena nevarnost poslabšanja srčnih bolezni (glejte poglavje 4.3).
English: Dose adjustments are not required in elderly patients.
Slovenian: Starejšim bolnikom odmerka ni treba prilagajati.
English: The recommended dose is 10 mg.
Slovenian: Priporočeni odmerek je 10 mg.
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.
Slovenian: Vardenafil se ne kopiči v plazmi pri bolnikih starih 45 let in manj ali 65 let in več, če so deset dni enkrat na dan jemali orodisperzibilne tablete po 10 mg vardenafila.
English: Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction.
Slovenian: Vardenafil je peroralno zdravilo za izboljšanje erektilne funkcije pri moških z erektilno disfunkcijo.
English: The safety and efficacy of vardenafil was maintained in long-term studies.
Slovenian: V dolgoročnih študijah sta varnost in učinkovitost vardenafila ostali nespremenjeni.
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.
Slovenian: Med preiskovanci, ki so dobivali terazosin, se je hipotenzija pojavila pogosteje, kadar so vardenafil in terazosin jemali sočasno, kot pa takrat, ko je od zaužitja odmerka enega in drugega zdravila minilo šest ur.
English: The maximum recommended dose is 20 mg.
Slovenian: Največji priporočeni odmerek je 20 mg.
English: Further information on clinical trials with vardenafil 10 mg orodispersible tablets Efficacy and safety of vardenafil 10 mg orodispersible tablets were separately demonstrated in a broad population in two studies including 701 randomized erectile dysfunction patients who were treated up to 12 weeks.
Slovenian: Dodatne informacije o kliničnih preskušanjih z orodisperzibilnimi tabletami po 10 mg vardenafila Učinkovitost in varnost orodisperzibilnih tablet po 10 mg vardenafila so ločeno dokazali v dveh kliničnih študijah na širši populaciji bolnikov, v kateri je bilo vključenih 701 randomiziranih bolnikov z erektilno disfunkcijo, ki so bili zdravljeni do 12 tednov.
English: There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Slovenian: Podatkov o medsebojnem učinkovanju vardenafila in nespecifičnih zaviralcev fosfodiesteraze, kot sta teofilin ali dipiridamol, ni.
English: If you feel dizzy, or if your vision is affected after taking Levitra don't drive or operate any tools or machines.
Slovenian: Če imate po zaužitju zdravila Levitra vrtoglavico ali se vam je vid poslabšal, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
English: Based on measurements of vardenafil in semen of healthy subjects 90 minutes after dosing, not more than 0.00012% of the administered dose may appear in the semen of patients.
Slovenian: Meritve vardenafila v semenu zdravih preiskovancev 90 minut po odmerjanju kažejo, da se v semenu bolnikov ne more pojaviti več kot 0,00012 % zaužitega odmerka.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
Slovenian: Čeprav specifične študije medsebojnega delovanja niso bile opravljene za vsa zdravila, je analiza farmakokinetike v populaciji pokazala, da na vardenafilovo farmakokinetiko ni vplivala sočasna uporaba acetilsalicilne kisline, zaviralcev angiotenzinske konvertaze, zaviralcev receptorjev beta, šibkih zaviralcev CYP3A4, diuretikov in zdravil za zdravljenje sladkorne bolezni (sulfonilsečnine in metformin).
English: Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
Slovenian: O penilni hemoragiji, hematospermiji in hematuriji so poročali v kliničnih preskušanjih in spontanih poročilih iz obdobja trženja pri uporabi vseh zaviralcev PDE5, tudi vardenafila.
English: In volunteers with severe renal impairment (creatinine clearance <30 ml/min) the mean AUC was increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal impairment.
Slovenian: Pri prostovoljcih s hudo ledvično okvaro (kreatininski očistek < 30 ml/min) se je povprečna vrednost AUC zvečala za 21 %, povprečna Cmax pa zmanjšala za 23 % v primerjavi s prostovoljci brez motenj delovanja ledvic.
English: (≥1/10,000 to
Slovenian: (≥1/10.000 do
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Slovenian: V proučevani populaciji niso dokazali, da bi imela kombinacija zdravil ugoden klinični učinek.
English: may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data - Blood in the urine (Haematuria) - Penile bleeding (Penile Haemorrhage) - Presence of blood in the semen (Haematospermia) - Sudden death - Bleeding in the brain
Slovenian: Zelo redki ali neznana pogostnost lahko se pojavijo pri manj kot 1 od 10.000 uporabnikov ali pa pogostnosti ni mogoče oceniti iz razpoložljivih podatkov - kri v urinu (hematurija) - krvavitev iz penisa (penilna hemoragija) - kri v izlivu (hematospermija) - nenadna smrt - krvavitev v možganih
English: The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections 4.5 and 5.1).
Slovenian: Sočasno jemanje vardenafila in nitratov ali donorjev dušikovega oksida (npr. amil nitrita) v kateri koli obliki je kontraindicirano (glejte poglavji 4.5 in 5.1).
English: Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as compared to healthy younger volunteers (18 - 45 years).
Slovenian: Pri zdravih starejših prostovoljcih (starih 65 let in več) se je izločanje vardenafila skozi jetra v primerjavi z zdravimi mlajšimi prostovoljci (18 do 45 let) zmanjšalo.
English: Vardenafil is rapidly absorbed after administration of Levitra 10 mg orodispersible tablets without water.
Slovenian: Vardenafil se hitro absorbira po zaužitju zdravila Levitra 10 mg orodisperzibilne tablete brez vode.
English: Parts of M1 are in the form of the glucuronide in systemic circulation.
Slovenian: Del M1 je v sistemskem obtoku v obliki glukuronida.
English: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
Slovenian: V kliničnih študijah se je pokazalo, da riociguat povečuje hipotenzivne učinke zaviralcev PDE5.
English: Therefore, inhibitors of these isoenzymes may reduce vardenafil clearance.
Slovenian: Zaviralci teh izoencimov lahko zato zmanjšajo očistek vardenafila.
English: There is no relevant indication for use of Levitra orodispersible tablets in children and adolescents.
Slovenian: Ustreznih indikacij za uporabo zdravila Levitra orodisperzibilne tablete pri otrocih in mladostnikih ni.
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.
Slovenian: V kliničnih preskušanjih je prejemalo vardenafil več kot 17.000 moških z erektilno disfunkcijo (ED), starih 18 do 89 let.
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.
Slovenian: Ti učinki so skladni z vazodilatacijskimi učinki zaviralcev PDE5 in so verjetno posledica višjih ravni cGMP v gladkomišičnih celicah žil.
English: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Slovenian: Predklinične študije so pokazale aditiven učinek na znižanje sistemskega krvnega tlaka pri kombiniranju zaviralcev PDE5 z riociguatom.
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.
Slovenian: Glavni namen te študije je bil izključiti več kot 10 msec dolg učinek (to je, pokazati, da ni učinka) enkratnega 80-miligramskega peroralnega odmerka vardenafila na dobo QTc v primerjavi s placebom, ki so ga merili s spremembo Fridericiasove korekcijske formule (QTcF=QT/RR1/3) glede na osnovno vrednost 1 uro po odmerku.
English: България Байер България ЕООД
Slovenian: Байер България ЕООД Tел.
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.
Slovenian: Pri preiskovancih, ki so jemali večje odmerke vardenafila in pogosteje od priporočenega režima odmerjanja (40 mg filmsko obložene tablete dvakrat na dan), so se pojavile hude bolečine v hrbtu.
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).
Slovenian: Analize podatkov iz spremljanj kažejo na povečano tveganje za akutno NAION pri moških z erektilno disfunkcijo, ki so jemali zaviralce PDE5 kot so vardenafil, tadalafil in sildelafil (glejte poglavje 4.8).
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.
Slovenian: Če se orodisperzibilne tablete po 10 mg vardenafila vzame z vodo, je AUC manjši za 29 %, Cmax ostane nespremenjena, povprečni tmax pa krajši za 60 minut, kot če se vzame brez vode.
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).
Slovenian: Neželeni učinki so razvrščeni po pogostnosti glede na klasifikacijo MedDRA: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: What Levitra is and what it is used for What you need to know before you take Levitra How to take Levitra
Slovenian: Kaj je zdravilo Levitra in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Levitra Kako jemati zdravilo Levitra Možni neželeni učinki
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.
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij za vse podskupine pediatrične populacije pri zdravljenju erektilne disfunkcije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
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.
Slovenian: Če hrana vsebuje 30 % maščob, se stopnja in obseg absorpcije vardenafila (tmax, Cmax in AUC) v primerjavi z jemanjem na tešče ne spremenita.
English: Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
Slovenian: Posamični in večkratni peroralni odmerki vardenafila do 40 mg niso povzročili nobenih klinično pomembnih sprememb v EKG zdravih moških prostovoljcev.
English: Levitra orodispersible tablets can be taken with or without food.
Slovenian: Zdravilo Levitra orodisperzibilne tablete se lahko vzame z ali brez hrane.
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 20 film-coated tablets
Slovenian: 2 filmsko obloženi tableti 4 filmsko obložene tablete 8 filmsko obloženih tablet 12 filmsko obloženih tablet 20 filmsko obloženih tablet
English: With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Levitra.
Slovenian: Če ste spolno vzburjeni, lahko erekcijo dosežete že v 25 minutah oz. najkasneje v štirih do petih urah po zaužitju tablete.
English: What you need to know before you take Levitra Do not take Levitra
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Levitra
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).
Slovenian: - ketokonazol ali itrakonazol - protiglivični zdravili, - eritromicin ali klaritromicin - makrolidna antibiotika, - zaviralci adrenergičnih receptorjev alfa - vrsta zdravil za zdravljenje visokega krvnega tlaka in povečane prostate (benigne hiperplazije prostate), - riociguat.
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.
Slovenian: Študije in vitro na človeških trombocitih kažejo, da vardenafil ne deluje antiagregacijsko, vendar pa velike koncentracije vardenafila (večje od terapevtskih) zvečajo antiagregacijski učinek natrijevega nitroprusida kot donorja dušikovega oksida.
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.
Slovenian: Pri prostovoljcih z blago do zmerno ledvično okvaro (kreatininski očistek 30 do 80 ml/min) je bila farmakokinetika vardenafila podobna kot pri preiskovancih iz kontrolne skupine, pri katerih je bilo delovanje ledvic normalno.
English: If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Levitra - če ste alergični na vardenafil ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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%.
Slovenian: Presnovek M1 je selektiven za fosfodiesteraze podobno kot vardenafil, in vitro pa je afiniteta za fosfodiesterazo tipa 5 v primerjavi z vardenafilom 28-odstotna, kar pomeni, da je njegov prispevek k učinkovitosti 7-odstoten.
English: If you suffer from irregular heart beat (cardiac arrhythmia) or inherited heart diseases affecting your electrocardiogram.
Slovenian: - če imate motnje srčnega ritma (srčno aritmijo) ali prirojene srčne bolezni, ki vplivajo na elektrokardiogram,
English: The mean terminal half-life of vardenafil in patients receiving Levitra 10 mg orodispersible tablets ranged between 4 - 6 hours.
Slovenian: Povprečni končni razpolovni čas vardenafila je pri bolnikih, ki jemljejo zdravilo Levitra 10 mg orodisperzibilne tablete, 4 do 6 ur.
English: Contains aspartame (E951) and sorbitol (E420).
Slovenian: SEZNAM POMOŽNIH SNOVI Vsebuje aspartam (E951) in sorbitol (E420).
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%.
Slovenian: Če se filmsko obložene tablete, ki vsebujejo vardenafil zaužije skupaj s hrano, ki vsebuje veliko maščob (57 % maščob), se zmanjša stopnja absorpcije, srednja vrednost tmax se zveča za 1 uro in Cmax zmanjša povprečno za 20 %.
English: Take a Levitra tablet about 25 to 60 minutes before sexual activity.
Slovenian: Zdravilo Levitra vzemite približno 25 do 60 minut pred nameravanim spolnim odnosom.
English: See section 2 “Levitra 10 mg orodispersible tablets contain Aspartame and Sorbitol”.
Slovenian: Glejte poglavje 2 »Zdravilo Levitra 10 mg orodisperzibilne tablete vsebuje aspartam in sorbitol.«
English: The elimination half-life of the metabolite M1 is between 3 to 5 hours, similar to parent drug.
Slovenian: Razpolovni čas izločanja presnovka M1 je 3 do 5 ur, podobno kot pri filmsko obloženih tabletah.
English: Levitra is not indicated for use by women.
Slovenian: Uporaba zdravila Levitra ni indicirana pri ženskah.
English: Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Slovenian: Bolniki z obstrukcijo iztisa levega prekata, npr. aortno stenozo in idiopatsko hipertrofično subaortno stenozo, so lahko občutljivi za delovanje vazodilatatorjev, tudi za zaviralce fosfodiesteraze tipa 5.
English: If you take more Levitra than you should, tell your doctor.
Slovenian: Če ste vzeli večji odmerek zdravila kot bi smeli, se posvetujte z zdravnikom.
English: No statistically significant correlation was observed between creatinine clearance and vardenafil exposure (AUC and Cmax) (see section 4.2).
Slovenian: Med kreatininskim očistkom in izpostavitvijo vardenafilu (AUC in Cmax) niso opazili statistično pomembne korelacije (glejte poglavje 4.2).
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.
Slovenian: Pri manjšem številu bolnikov, ki so poskusili spolno občevati do 4 oz. 5 ur po odmerku vardenafila, je bila stopnja uspešnosti penetracije in ohranjanja erekcije večja kot pri tistih, ki so dobili placebo.
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.
Slovenian: Ne glede na to pa so po peroralnem odmerku na tešče pri 90 % primerov plazemske koncentracije največje v 30 do 120 minutah (srednja vrednost 60 minut).
English: Levitra orodispersible tablets are not indicated for individuals below 18 years of age.
Slovenian: Uporaba zdravila Levitra orodisperzibilne tablete ni indicirana pri osebah, mlajših od 18 let.
English: The overall response of these subjects to vardenafil became statistically significant, compared to placebo, 25 minutes after dosing.
Slovenian: Na splošno je odziv teh preiskovancev na vardenafil postal, v primerjavi s placebom, statistično pomemben v 25 minutah po odmerjanju.
English: The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity.
Slovenian: Priporočljiv odmerek je 10 mg, ki ga moški vzame po potrebi približno 25 do 60 minut pred spolnim odnosom.