natgillin/translations-raw huggingface dataset:
In men older than 75 years the concomitant use of vardenafil with itraconazole or ketoconazole is contraindicated (see section 4.3)
Pri moških, starih več kot 75 let, je sočasna uporaba vardenafila in itrakonazola ali ketokonazola kontraindicirana (glejte poglavje 4. 3).
Co-administration of erythromycin (500 mg three times a day), a CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax.
Med sočasnim jemanjem eritromicina (500 mg trikrat na dan), ki zavira CYP3A4, in vardenafila (5 mg) je bila vrednost AUC vardenafila 4- krat večja, Cmax pa 3- krat.
When used in combination with a moderate CYP 3A4 inhibitor such as erythromycin or clarithromycin, vardenafil dose adjustment might be necessary (see sections 4.2 and 4.4).
V kombinaciji z zmernim zaviralcem CYP 3A4 kot sta eritromicin ali klaritromicin je včasih treba prilagoditi odmerek vardenafila (glejte poglavji 4. 2 in 4. 4).
Grapefruit juice being a weak inhibitor of CYP3A4 gut wall metabolism, may give rise to modest increases in plasma levels of vardenafil (see section 4.4).
Ker je grenivkin sok šibak zaviralec presnove CYP3A4 v steni prebavil, lahko povzroči rahlo zvišanje plazemske ravni vardenafila (glejte poglavje 4. 4).
The pharmacokinetics of vardenafil (20 mg) was not affected by co-administration with the H2-antagonist ranitidine (150 mg twice daily), digoxin, warfarin, glibenclamide, alcohol (mean maximum blood alcohol level of 73 mg/ dl) or single doses of antacid (magnesium hydroxide/ aluminium hydroxide).
Na farmakokinetiko vardenafila (20 mg) ni vplivalo sočasno jemanje antagonista H2 ranitidina (150 mg dvakrat na dan), digoksina, varfarina, glibenklamida, alkohola (povprečna najvišja raven alkohola v krvi 73 mg/ dl) ali posamičnih odmerkov antacida (magnezijev hidroksid/ aluminijev hidroksid).
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 CYP 3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
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 CYP 3A4, diuretikov in zdravil za zdravljenje sladkorne bolezni (sulfonilsečnine in metformin).
5 Effects of vardenafil on other medicinal products
5 Učinki vardenafila na druga zdravila
No potentiation of the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) was observed when vardenafil (10 mg) was given at varying time intervals (1 h to 24 h) prior to the dose of nitroglycerin in a study in 18 healthy male subjects.
Študije in vivo V študiji, v kateri je 18 zdravih moških jemalo vardenafil (10 mg) v različnih časovnih presledkih (1 do 24 ur) pred odmerkom nitroglicerina, vardenafil ni zvečal učinka nitroglicerina (0, 4 mg sublingvalno) na znižanje krvnega tlaka.
Vardenafil 20 mg potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4mg) taken 1 and 4 hours after vardenafil administration to healthy middle aged subjects.
Toda 20- miligramski odmerek vardenafila je zvečal vpliv nitroglicerina (0, 4 mg, sublingvalno) na znižanje krvnega tlaka, ki so ga zdravi moški srednjih let vzeli eno in štiri ure po zaužitju vardenafila.
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg.
20- miligramski odmerek vardenafila ni vplival na znižanje krvnega tlaka, če so zdravi moški vzeli nitroglicerin 24 ur po zaužitju enkratnega odmerka vardenafila.
However, there is no information on the possible potentiation of the hypotensive effects of nitrates by vardenafil in patients, and concomitant use is therefore contraindicated (see section 4.3).
Ni pa podatkov o tem, ali vardenafil zveča hipotenzijski učinek nitratov, zato je sočasna uporaba kontraindicirana (glejte poglavje 4. 3).
Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic hyperplasia (BPH) on stable tamsulosin or terazosin therapy: • When vardenafil was given at doses of 5, 10 or 20 mg on a background of stable therapy with tamsulosin, there was no symptomatic reduction in blood pressure, although 3/ 21 tamsulosin treated subjects exhibited transient standing systolic blood pressures of less than 85 mmHg. • When vardenafil 5 mg was given simultaneously with terazosin 5 or 10 mg, one of 21 patients experienced symptomatic postural hypotension.
Ugotovitve študij o medsebojnem delovanju zdravil, v katerih so sodelovali bolniki z benigno hiperplazijo prostate (BHP), ki so se zdravili s tamsulozinom oziroma terazosinom in katerih zdravstveno stanje je bilo stabilno: • Pri bolnikih, ki so se zdravili s tamsulozinom in katerih zdravstveno stanje je bilo stabilno, jemanje 5 -, 10 - ali 20- miligramskih odmerkov vardenafila ni povzročilo simptomatskega znižanja krvnega tlaka, čeprav je stoje izmerjen sistolični krvni tlak pri treh bolnikih (od 21, ki so se zdravili s tamsulozinom), prehodno znašal manj kot 85 mmHg. • Med sočasnim zdravljenjem s 5 mg vardenafila in 5 mg ali 10 mg terazosina se je pri enem bolniku (od 21) pojavila simptomatska posturalna hipotenzija.
Therefore, concomitant treatment should be initiated only if the patient is stable on his alpha blocker therapy.
Zaradi tega se sočasno zdravljenje sme začeti samo pri bolniku, ki jemlje zaviralec receptorjev alfa in čigar zdravstveno stanje je stabilno.
Levitra may be administered at any time with tamsulosin.
S tamsulozinom se lahko zdravilo Levitra vzame kadarkoli.
With other alpha blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.4).
Kadar pa je predpisano sočasno zdravljenje z drugimi zaviralci receptorjev alfa in vardenafilom, se od zaužitja enega zdravila do zaužitja drugega priporoča časovni presledek (glejte poglavje 4. 4).
No significant interactions were shown when warfarin (25 mg), which is metabolised by CYP2C9, or digoxin (0.375 mg) was co-administered with vardenafil (20 mg).
Po sočasni uporabi varfarina (25 mg), ki se presnavlja s pomočjo CYP2C9, ali digoksina (0, 375 mg) z vardenafilom (20 mg) se ni pojavila nobena pomembnejša interakcija.
The relative bioavailability of glibenclamide (3.5 mg) was not affected when co-administered with vardenafil (20 mg).
Relativna biološka uporabnost glibenklamida (3, 5 mg) se med sočasnim jemanjem vardenafila (20 mg) ni spremenila.
When vardenafil (20 mg) and alcohol (mean maximum blood alcohol level of 73 mg/ dl) were taken together, vardenafil did not potentiate the effects of alcohol on blood pressure and heart rate and the pharmacokinetics of vardenafil were not altered.
Zaradi sočasne uporabe vardenafila (20 mg) in alkohola (povprečna največja vrednost alkohola v krvi 73 mg/ dl) se učinek alkohola na krvni tlak in srčno frekvenco ni zvečal, pa tudi farmakokinetika vardenafila se ni spremenila.
4.6 Pregnancy and lactation
6 4. 6 Nosečnost in dojenje
As dizziness and abnormal vision have been reported in clinical trials with vardenafil, patients should be aware of how they react to Levitra, before driving or operating machinery.
Ker so v kliničnih študijah z vardenafilom poročali o omotici in motnjah vida, morajo bolniki vedeti, kako se odzivajo na zdravilo Levitra, preden začnejo voziti ali delati s strojem.
Over 9,500 patients have received Levitra in clinical trials.
Zdravilo Levitra je v kliničnih preskušanjih jemalo več kot 9500 bolnikov.
The adverse reactions were generally transient and mild to moderate in nature.
Neželeni učinki so bili v glavnem prehodni in blagi do zmerni.
The most commonly reported adverse drug reactions occurring in ≥ 10% of patients are headache and flushing.
Neželena učinka, o katerih so najpogosteje poročali in sta se pojavila pri ≥ 10% bolnikov, sta bila glavobol in rdečica.
Very Common (≥ 1/ 10)
Zelo pogosti (≥ 1/ 10)
Common (≥ 1/ 100 and < 1/ 10)
Pogosti (≥ 1/ 100 in < 1/ 10)
Uncommon (≥ 1/ 1,000 and < 1/ 100)*
Občasni (≥ 1/ 1. 000 in < 1/ 100) ∗
Rare (≥ 1/ 10,000 and < 1/ 1,000)*
Redki (≥1/ 10. 000 in < 1/ 1. 000) ∗
Not Known (can not be estimated from the available data)
Ni znano (ni mogoče oceniti iz razpoložljivih podatkov)
Immune System Disorders Psychiatric Disorders
Bolezni imunskega sistema
Hypersensitivit y Anxiety
Psihiatrične motnje
Somnolence
zaspanost
Syncope Seizure Transient global amnesia
sinkopa epileptični napad prehodna popolna amnezija
Related Investigations
Očesne bolezni vključno s preiskavami
Visual brightness) Chromatopsia Conjunctivitis Blurred Vision
solzenje motnje vida (tudi ostrine vida) kromatopsija konjunktivitis zamegljen vid
Non-arteritic-anterior ischemic optic neuropathy Visual defects
nearteritična anteriorna ishemična optična nevropatija motnje vida
Ear and labyrinth Disorders
Ušesne bolezni, vključno z motnjami labirinta
Sudden deafness**
nenadna gluhost **
Cardiac Disorders incl. related Investigations
Srčne bolezni vključno s preiskavami
Tachycardia Palpitations
tahikardija palpitacija
Angina Pectoris Myocardial ischemia
angina pektoris miokardna ishemija
Myocardial Infarction
miokardni infarkt
Vascular Disorders incl. related Investigations
Žilne bolezni vključno s preiskavami
Flushing
rdečica
Hypertension Hypotension Orthostatic Hypotension
hipertenzija hipotenzija ortostatska hipotenzijah
7 System Organ Class
7 Organski sistem
Not Known (can not be estimated from the available data)
Bolezni dihal, prsnega koša in mediastinalnega prostora
Gastrointestinal Disorders incl. related Investigations
Bolezni prebavil vključno s preiskavami
Dyspepsia Nausea
dispepsija navzea
Abnormal liver function tests GGTP increased
nenormalne vrednosti testov jetrnih funkcij zvišana raven GGTP
Photosensitivit y reaction Face oedema Rash
fotosenzitivna reakcija oteklina obraza izpuščaji
Musculoskeletal and Connective Tissue Disorders incl.
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Related Investigations Reproductive System and Breast Disorders
zvečane vrednosti kreatin fosfokinaze v krvi mialgija bolečine v hrbtu
Blood creatine Muscle phosphokinase Rigidity increased Myalgia Back Pain Priapism Erections increased (prolonged or painful erections)
priapizem podaljšane in boleče erekcije
*For adverse reactions reported in < 1% of patients, only those which warrant special attention, because of their possible association with serious disease states or of otherwise clinical relevance are listed. **Sudden deafness or loss of hearing has been reported in a small number of postmarketing and clinical trial cases with the use of all PDE5 inhibitors, including vardenafil.
* Med neželenimi učinki, ki so se pojavili pri < 1% bolnikov, so našteti samo tisti, ki zahtevajo posebno pozornost zaradi možne povezave z resnimi bolezenskimi stanji ali zaradi drugega kliničnega pomena. ** Med uporabo zaviralcev PDE5, vključno z vardenafilom, so med pomarketinško uporabo in v kliničnih preskušanjih zabeležili maloštevilne primere nenadnega poslabšanja ali izgube sluha.
At the 20mg dose, elderly (≥ 65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (< 65 years old).
0, 7%) kot mlajši bolniki (< 65 let).
Serious cardiovascular events, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post marketing in temporal association with another medicinal product in this class.
Postmarketinška poročila za druga zdravila iste skupine - žilne bolezni: v postmarketinških študijah z drugim zdravilom iz te skupine so opazili resne kardiovaskularne dogodke, tudi cerebrovaskularno krvavitev, nenadno srčno smrt, tranzitoren ishemični napad, nestabilno angino pektoris in prekatno aritmijo, ki so bili včasih povezani s tem zdravilom.
In single dose volunteer studies, doses up to and including 80 mg per day were tolerated without exhibiting serious adverse reactions.
V študiji, v kateri so prostovoljci na dan zaužili en odmerek, manjši ali enak 80 mg, so ugotovili, da so zdravilo dobro prenašali in niso imeli resnih neželenih učinkov.
When vardenafil was administered in higher doses and more frequently than the recommended dosing regimen (40 mg twice daily) cases of severe back pain have been reported.
Pri preiskovancih, ki so jemali odmerke vardenafila, večje od priporočenih (40 mg dvakrat na dan), in pogosteje, so se pojavile hude bolečine v hrbtu.
Medicinal product used in erectile dysfunction, ATC code:
Farmakoterapevtska skupina: zdravila za zdravljenje erektilne disfunkcije, oznaka ATC:
8 Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction.
Vardenafil je peroralno zdravilo za izboljšanje erektilne funkcije pri moških z erektilno disfunkcijo.
In the natural setting, i. e. with sexual stimulation it restores impaired erectile function by increasing blood flow to the penis.
Ob spolnem vzburjenju poveča dotok krvi v penis in tako izboljša oslabljeno erektilno funkcijo.
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).
Študije in vitro so pokazale, da vardenafil močneje vpliva na PDE5 kot na druge znane fosfodiesteraze (> 15- krat v primerjavi s PDE6, > 130- krat v primerjavi s PDE1, > 300- krat v primerjavi s PDE11 in > 1. 000- krat v primerjavi s PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 in PDE10).
In a penile plesthysmography (RigiScan) study, vardenafil 20 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 15 minutes after dosing.
V študiji so s pletizmografijo penisa (RigiScan) ugotovili, da je 20- miligramski odmerek vardenafila pri nekaterih moških že v 15 minutah po odmerjanju povzročil erekcijo, ki je zadostovala za penetracijo (60- odstotna otrdelost glede na RigiScan).
The mean maximum decreases in supine systolic blood pressure following 20 mg and 40 mg vardenafil were – 6.9 mmHg under 20 mg and – 4.3 mmHg under 40 mg of vardenafil, when compared to placebo.
Po zaužitju 20 - in 40- miligramskega odmerka vardenafila je povprečno maksimalno znižanje sistoličnega krvnega tlaka v primerjavi s placebom v ležečem položaju – 6, 9 mmHg po uporabi 20 - miligramskega odmerka) in – 4, 3 mmHg (po uporabi 40- miligramskega odmerka vardenafila).
Effects on the QT interval were measured one hour post dose (average Tmax for vardenafil).
Učinke na dobo QT so merili eno uro po odmerku (povprečna vrednost Tmax za vardenafil).
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.
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.
The vardenafil results showed an increase in QTc (Fridericia) of 8 msec (90% CI:
Raziskovalci so ugotovili, da se eno uro po zaužitju 10 - ali 80 - miligramskega odmerka vardenafila QTc (Fridericia) zveča za 8 msec (90- odstotni interval zaupanja:
6-9) and 10 msec (90% CI:
6- 9) in 10 msec (90- odstotni interval zaupanja:
8-11) at 10 and 80 mg doses compared to placebo and an increase in QTci of 4 msec (90% CI:
8- 11) v primerjavi s placebom, QTci za 4 msec (90 - odstotni interval zaupanja:
4-7) at 10 and 80 mg doses compared to placebo, at one hour postdose.
4- 7).
At Tmax, only the mean change in QTcF for vardenafil 80 mg was out of the study established limit (mean 10 msec, 90% CI (8-11)).
Pri Tmax je bila samo srednja vrednost spremembe QTcF za 80- miligramski odmerek vardenafila zunaj meje, ki je bila postavljena v študiji (srednja vrednost 10 msec, 90- odstotni interval zaupanja (8- 11)).
In a separate postmarketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect.
V ločeni postmarketinški študiji, v kateri je sodelovalo 44 zdravih prostovoljcev, so uporabili enkratni odmerek 10 mg vardenafila ali 50 mg sildenafila sočasno s 400 mg gatifloksacina, zdravilom, ki ima podoben učinek na dobo QT.
Both vardenafil and sildenafil showed an increase of Fredericia QTc effect of 4 msec (vardenafil) and 5 msec (sildenafil) when compared to either drug alone.
9 (Fridericia) podaljšala; za 4 msec pri vardenafilu in 5 msec pri sildenafilu v primerjavi s posameznim zdravilom.
9 Further information on clinical trials
Dodatne informacije o kliničnih preskušanjih
In clinical trials vardenafil was administered to over 3750 men with erectile dysfunction (ED) aged 18 - 89 years, many of whom had multiple co-morbid conditions.
Veliko jih je imelo več sočasnih bolezni.
Over 1630 patients have been treated with Levitra for six months or longer.
Več kot 1630 bolnikov je jemalo zdravilo Levitra šest mesecev ali dlje.
Of these, over 730 have been treated for one year or longer.
Med njimi je 730 bolnikov prejemalo zdravilo eno leto ali dlje.
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%).
V preskušanjih so sodelovali starejši bolniki (22%), bolniki s hipertenzijo (35%), sladkorno boleznijo (29%), ishemično boleznijo srca in drugimi boleznimi srca in ožilja (7%), kronično pljučno boleznijo (5%), hiperlipidemijo (22%), depresijo (5%) in bolniki po radikalni prostatektomiji (9%).
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).
V klinična preskušanja je bilo vključenih le malo starejših bolnikov (> 75 let, 2, 4%) in bolnikov z nekaterimi boleznimi srca in ožilja (glejte poglavje 4. 3).
Across the pivotal trials, treatment with vardenafil resulted in an improvement of erectile function compared to placebo.
V vseh najpomembnejših preskušanjih se je med zdravljenjem z vardenafilom, v primerjavi s placebom, erektilna funkcija izboljšala.
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.
5 ur po odmerku vardenafila, je bila stopnja uspešnosti penetracije in ohranjanja erekcije večja kot pri tistih, ki so dobili placebo.
In fixed dose studies in a broad population of men with erectile dysfunction, 68% (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period.
V trimesečnih preskušanjih pri širši populaciji moških z erektilno disfunkcijo, ki so dobivali vedno enak odmerek, je bila penetracija uspešna pri 68% (5 mg), 76% (10 mg) in 80% (20 mg) bolnikov (SEP 2), ki so jemali vardenafil, ter pri 49% bolnikov, ki so dobivali placebo.
The ability to maintain the erection (SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) compared to 29% on placebo.
Zmožnost ohranjanja erekcije (SEP 3) v tej širši populaciji moških z ED je bila 53- odstotna (5 mg), 63 - (10 mg) in 65 - odstotna (20 mg) pri bolnikih, ki so jemali vardenafil, in 29- odstotna pri tistih, ki so dobivali placebo.
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%), hyperlipidemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%).
Na podlagi podatkov, zbranih iz najpomembnejših študij učinkovitosti, je bila penetracija po zaužitju vardenafila uspešna pri bolnikih s psihogeno erektilno disfunkcijo (77 do 87%), mešano erektilno disfunkcijo (69 do 83%), organsko erektilno disfunkcijo (64 do 75%), pri starejših bolnikih (52 do 75%), bolnikih z ishemično boleznijo srca (70 do 73%), s hiperlipidemijo (62 do 73%), kronično pljučno boleznijo (74 do 78%), depresijo (59 do 69%) ter pri bolnikih, ki so se sočasno zdravili z antihipertenzivi (62 do 73%).
In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
V kliničnem preskušanju, v katerem so sodelovali bolniki s sladkorno boleznijo in v kateri so primerjali placebo z 10 - in 20- miligramskimi odmerki vardenafila, se je zaradi uporabe vardenafila pomembno izboljšala erektilna funkcija, zmožnost doseganja in ohranjanja erekcije (omogočen je bil uspešen spolni odnos), ter otrdelost penisa.
The response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three months treatment.
23- odstotna pri tistih, ki so dobivali placebo.
In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
V kliničnem preskušanju pri bolnikih po prostatektomiji, v kateri so primerjali placebo z 10 - in 20 - miligramskimi odmerki vardenafila, je vardenafil pomembno izboljšal erektilno funkcijo, zmožnost doseganja in ohranjanja erekcije (omogočen je bil uspešen spolni odnos), ter otrdelost penisa.
The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment.
10- odstotna pri tistih, ki so dobivali placebo.
The number of patients who returned to a normal IIEF domain score (> 26) were 53% on vardenafil compared to 9% on placebo.
53- odstotkov bolnikov, ki so jemali vardenafil je ponovno imelo normalno erektilno funkcijo (> 26) v primerjavi z 9- odstotki bolnikov, ki so jemali placebo.
The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p < 0.001).
59- odstotna pri bolnikih,
The safety and efficacy of vardenafil was maintained in long term studies.
22- odstotna pri tistih, ki so dobivali placebo, kar je bilo klinično in statistično pomembno (p < 0, 001).
10 5.2 Pharmacokinetic properties
5. 2 Farmakokinetične lastnosti
Vardenafil is rapidly absorbed with maximum observed plasma concentrations reached in some men as early as 15 minutes after oral administration.
Plazemske koncentracije so pri nekaterih moških največje že v 15 minutah po zaužitju peroralnega odmerka.
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.
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).