natgillin/translations-raw huggingface dataset:
When a single 100 mg dose of sildenafil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg twice daily. for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Ob uporabi enega 100- mg odmerka sildenafila hkrati z eritromicinom, specifičnim zaviralcem CYP3A4, je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan 5 dni) prišlo do 182- odstotnega zvečanja sistemske izpostavljenosti (AUC) sildenafilu.
Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Cimetidin (800 mg), zaviralec citokroma P450 in nespecifičen zaviralec CYP3A4, je ob sočasni uporabi s sildenafilom (50 mg) pri zdravih prostovoljcih povzročil 56- odstotno zvečanje koncentracije sildenafila v plazmi.
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.
Sok grenivke je šibek zaviralec presnove s CYP3A4 v črevesni steni in lahko nekoliko zveča koncentracijo sildenafila v plazmi.
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Posebne študije interakcij niso bile izvedene za vsa zdravila, populacijske farmakokinetične analize niso pokazale vpliva na farmakokinetiko sildenafila pri sočasnem zdravljenju z zdravili iz skupine zaviralcev CYP2C9 (npr. tolbutamid, varfarin, fenitoin) ali zaviralcev CYP2D6 (npr. selektivni zaviralci prevzema serotonina, triciklični antidepresivi), tiazidi in sorodnimi diuretiki, diuretiki Henlejeve zanke in diuretiki, ki varčujejo s kalijem, zaviralci ACE, zaviralci kalcijevih kanalčkov, zaviralci adrenergičnih receptorjev beta ali induktorji metabolizma s CYP450 (npr. rifampicin ali barbiturati).
Due to the nitrate component it has the potential to have serious interaction with sildenafil.
Zaradi nitratne sestavine je možno resno medsebojno učinkovanje s sildenafilom.
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 µM).
Sildenafil je šibek zaviralec izoencimov 1A2, 2C9, 2C19, 2D6, 2E1 in 3A4 citokroma P450 (IC50 > 150 µM).
Given sildenafil peak plasma concentrations of approximately 1 µM after recommended doses, it is unlikely that VIAGRA will alter the clearance of substrates of these isoenzymes.
Ker je največja koncentracija sildenafila v plazmi po priporočenih odmerkih približno 1 µM, ni verjetno, da bi zdravilo VIAGRA spremenilo očistek substratov teh izoencimov.
Consistent with its known effects on the nitric oxide/ cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3).
Zato je njegova hkratna uporaba z donorji dušikovega oksida ali nitrati v kakršnikoli obliki kontraindicirana (glejte poglavje 4. 3).
5 Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals.
Sočasna uporaba sildenafila pri bolnikih, ki jemljejo zaviralce adrenergičnih receptorjev alfa, lahko pri maloštevilnih občutljivih posameznikih povzroči simptomatsko hipotenzijo.
This is most likely to occur within 4 hours post sildenafil dosing (see sections 4.2 and 4.4).
Največja verjetnost, da se to zgodi, je v 4 urah po odmerku sildenafila (glejte poglavji 4. 2 in 4. 4).
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
V treh specifičnih študijah interakcij med zdravili so bolnikom z benigno hiperplazijo prostate (BPH), pri katerih bolezen ni napredovala pri zdravljenju z doksazosinom, dali zaviralec adrenergičnih receptorjev alfa doksazosin (4 mg in 8 mg) sočasno s sildenafilom (25 mg, 50 mg oz.
In these study populations, mean additional reductions of supine blood pressure of 7/ 7 mmHg, 9/ 5 mmHg, and 8/ 4 mmHg, and mean additional reductions of standing blood pressure of 6/ 6 mmHg, 11/ 4 mmHg, and 4/ 5 mmHg, respectively, were observed.
V teh študijskih populacijah so opažali povprečno dodatno znižanje krvnega tlaka leže za 7/ 7 mmHg, 9/ 5 mmHg in 8/ 4 mmHg ter dodatno znižanje krvnega tlaka stoje za 6/ 6 mmHg, 11/ 4 mmHg in 4/ 5 mmHg.
Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/ dl.
Sildenafil (50 mg) ni stopnjeval hipotenzivnih učinkov alkohola pri zdravih prostovoljcih, ki so imeli srednjo največjo koncentracijo alkohola v krvi 80mg/ dl.
Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally- acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment.
Pri bolnikih, ki so hkrati s sildenafilom jemali zdravila iz naslednjih skupin antihipertenzivov: diuretike, zaviralce receptorjev beta, zaviralce ACE, antagoniste angiotenzina II, vazodilatacijsko in centralno delujoče antihipertenzive, zaviralce adrenergičnih nevronov, zaviralce kalcijevih kanalčkov in zaviralce adrenergičnih receptorjev alfa, se profil neželenih učinkov ni razlikoval od profila pri bolnikih, ki so dobivali placebo.
The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
V specifični študiji interakcij, v kateri so bolniki z zvišanim krvnim tlakom uporabljali sildenafil (100 mg) sočasno z amlodipinom, se je sistolični krvni tlak leže dodatno znižal za 8 mmHg, diastolični krvni tlak leže pa za 7 mmHg.
These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
To dodatno znižanje krvnega tlaka je bilo po velikosti podobno kot pri dajanju sildenafila samega zdravim prostovoljcem (glejte poglavje 5. 1).
As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to VIAGRA, before driving or operating machinery.
V kliničnih študijah s sildenafilom so poročali o omotici in spremembah vida, zato se morajo bolniki zavedati, kako se odzovejo na zdravilo VIAGRA, preden vozijo ali upravljajo s stroji.
The safety profile of VIAGRA is based on 8691 patients who received the recommended dosing regimen in 67 placebo-controlled clinical studies.
Varnostni profil zdravila VIAGRA temelji na 8691 bolnikih, ki so prejemali priporočene odmerke sildenafila v 67 s placebom nadzorovanih kliničnih študijah.
The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, visual disorders, nasal congestion, dizziness and visual colour distortion.
6 v kliničnih študijah najpogosteje poročali o naslednjih neželenih učinkih: glavobol, zardevanje, dispepsija, motnje vida, zamašenost nosu, omotica in motnje zaznavanja barv.
6 Adverse reactions from post-marketing surveillance has been gathered covering an estimated period > 9 years.
Poročila o neželenih učinkih iz obdobja trženja pokrivajo obdobje več kot 9 let.
Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Ker imetniku dovoljenja za promet z zdravilom ne poročajo o vseh neželenih učinkih in le- ti niso zajeti v podatkovni bazi o varnosti, pogostnost neželenih učinkov ne moremo zanesljivo določiti.
In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (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).
Pogostnosti so opredeljene na naslednji način: zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1. 000, < 1/ 100) in redki (> 1/ 10. 000, < 1/ 1. 000).
In addition, the frequency of medically important adverse reactions reported from post-marketing experience is included as not known.
Pogostnost medicinsko pomembnih neželenih učinkov, o katerih so poročali v obdobju trženja, je navedena kot neznana.
Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post- marketing surveillance
Medicinsko pomembni neželeni učinki, o katerih so v kontroliranih kliničnih študijah poročali z večjo pogostnostjo kot pri placebu in medicinsko pomembni neželeni učinki, o katerih so poročali v obdobju trženja.
Rare Nervous system disorders
redko Bolezni živčnega sistema
Very common Common Uncommon Rare Not known Eye disorders
zelo pogosto pogosto občasno redko ni znano Očesne bolezni
Headache Dizziness Somnolence, Hypoaesthesia Cerebrovascular accident, Syncope Transient ischaemic attack, Seizure, Seizure recurrence
glavobol omotica zaspanost, hipestezija cerebrovaskularna poškodba, sinkopa tranzitorni ishemični napad, konvulzije, ponavljajoče konvulzije
Common Uncommon
pogosto občasno
Visual disorders, Visual colour distortion Conjunctival disorders, Eye Disorders, Lacrimation Disorders, Other Eye Disorders
motnje vida, motnje zaznavanja barv motnje konjunktive, motnje oči, motnje solzenja, druge motnje oči
Not known Ear and labyrinth disorders
ni znano
Non-arteritic anterior ischaemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
nearteritična anteriorna ishemična optična nevropatija (NAION), zapora mrežnične vene in izpad vidnega polja.
Uncommon Rare Vascular disorders
Ušesne bolezni, vključno z motnjami labirinta občasno redko Žilne bolezni
Vertigo, Tinnitus Deafness*
vrtoglavica, tinitus oglušelost *
Common Rare Cardiac disorders
pogosto redko Srčne bolezni
Flushing Hypertension, Hypotension
zardevanje hipertenzija, hipotenzija
Uncommon Rare Not known
občasno redko ni znano
Palpitations, Tachycardia Myocardial infarction, Atrial fibrillation Ventricular arrhythmia, Unstable angina, Sudden cardiac death
palpitacije, tahikardija miokardni infarkt, atrialna fibrilacija ventrikularna aritmija, nestabilna angina pektoris, nenadna srčna smrt
Respiratory, thoracic and mediastinal disorders Common Rare Gastrointestinal disorders
Bolezni dihal, prsnega koša, in mediastinalnega prostora pogosto redko Bolezni prebavil
Nasal congestion Epistaxis
zamašenost nosu epistaksa
7
7 pogosto občasno Bolezni kože in podkožja
System Organ Class
dispepsija bruhanje, slabost, suha usta
Adverse Reactions
kožni izpuščaj tkiva mialgija
General disorders and administration site conditions Uncommon Investigations
neznano Splošne težave in spremembe na mestu aplikacije
Chest pain, Fatigue
priapizem, dolgotrajna erekcija
Uncommon
občasno Preiskave
Heart rate increased
bolečine v prsih, utrujenost
* Ear disorders:
občasno
decrease or loss of hearing has been reported in a small
zvišan srčni utrip
number of post-marketing and clinical trials cases with the use of all PDE5 inhibitors, including sildenafil.
Med uporabo zaviralcev PDE5, vključno s sildenafilom, so v obdobju trženja in v kliničnih preskušanjih zabeležili majhno število primerov nenadnega poslabšanja sluha ali izgube sluha.
Drugs used in erectile dysfunction.
Farmakoterapevtska skupina: zdravila za zdravljenje erektilne disfunkcije.
G04B E03.
G04BE03.
In the natural setting, i. e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.
V naravnih okoliščinah, tj. ob spolni stimulaciji, z zvečanjem dotoka krvi v penis obnovi okvarjeno erektilno funkcijo.
When the NO/ cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP.
Ko je aktivirana pot NO/ cGMP, kot se to zgodi pri spolni stimulaciji, zavrtje PDE5 s sildenafilom zviša raven cGMP v corpusu cavernosumu.
At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
8 PDE2, 3, 4, 7, 8, 9, 10 in 11.
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Še posebno pa je selektivnost sildenafila več kot 4. 000- krat večja za PDE5 kakor za PDE3 – za cAMP specifično izoobliko fosfodiesteraze, ki sodeluje pri nadzoru krčljivosti srca.
In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60%
12 do 37 minut).
The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg.
Srednje največje znižanje sistoličnega krvnega tlaka leže je bilo po 100- mg peroralnem odmerku sildenafila 8, 4 mmHg.
The corresponding change in supine diastolic blood pressure was 5.5 mmHg.
Ustrezna sprememba diastoličnega krvnega tlaka leže je bila 5, 5 mmHg.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
V študiji hemodinamičnih učinkov enkratnega peroralnega 100- mg odmerka sildenafila pri 14 bolnikih s hudo boleznijo koronarnih arterij (> 70 -% stenoza vsaj ene koronarne arterije) se je srednji sistolični tlak v mirovanju v primerjavi z izhodiščem znižal za 7%, povprečni diastolični tlak v mirovanju pa za 6%.
Mean pulmonary systolic blood pressure decreased by 9%.
Srednji pljučni sistolični krvni tlak se je zmanjšal za 9%.
No clinical relevant differences were demonstrated in time to limiting angina for sildenafil when compared with placebo in a double blind, placebo controlled exercise stress trial in 144 patients with erectile dysfunction and chronic stable angina, who were taking on a regular basis anti-anginal medications (except nitrates).
V dvojno slepi, s placebom kontrolirani študiji z obremenitvenim testiranjem pri 144 bolnikih z erektilno disfunkcijo in kronično stabilno angino pektoris, ki so redno jemali zdravila za zdravljenje angine pektoris (razen nitratov), pri sildenafilu v primerjavi s placebom ni bilo klinično pomembnih razlik v času do pojava omejujoče angine pektoris.
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
V majhni s placebom kontrolirani študiji pri bolnikih s potrjeno zgodnjo starostno degeneracijo makule (n = 9) sildenafil v enkratnem 100- mg odmerku ni imel pomembnega vpliva na preiskave vida (ostrina vida, Amslerjeva mrežica, ločevanje barv na simuliranem semaforju, Humphreyev perimeter in fotostres).
There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers.
Sildenafil po enem samem 100- mg peroralnem odmerku ni vplival na gibljivost ali morfologijo semenčic zdravih prostovoljcev.
Further information on clinical trials In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Dodatne informacije o kliničnih študijah V kliničnih študijah je sildenafil dobivalo več kot 8000 bolnikov, starih od 19 do 87 let.
The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
Zastopane so bile naslednje skupine bolnikov: starostniki (19, 9%), bolniki z zvišanim krvnim tlakom (30, 9%), sladkorno boleznijo (20, 3%), ishemično boleznijo srca in drugimi kardiovaskularnimi boleznimi (5, 8%), hiperlipidemijo (19, 8%), poškodbo hrbtenjače (0, 6%), depresijo (5, 2%), transuretralno resekcijo prostate (3, 7%) in po radikalni prostatektomiji (3, 3%).
The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
Naslednje skupine niso bile zadovoljivo zastopane ali so bile izključene iz kliničnih študij: bolniki po operacijah na medenici, po radioterapiji, s hudo ledvično ali jetrno okvaro in bolniki z nekaterimi kardiovaskularnimi motnjami (glejte poglavje 4. 3).
In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo.
82% (100 mg) v primerjavi s 25% pri bolnikih s placebom.
Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
9 V vseh študijah skupaj so bili deleži bolnikov, ki so s sildenafilom navajali izboljšanje, naslednji: psihogena erektilna disfunkcija (84%), mešana erektilna disfunkcija (77%), organska erektilna disfunkcija (68%), starostniki (67%), sladkorna bolezen (59%), ishemična bolezen srca (69%), zvišan krvni tlak (68%), transuretralna resekcija prostate (61%), radikalna prostatektomija (43%), poškodba hrbtenjače (83%), depresija (75%).
The mean absolute oral bioavailability is 41% (range 25-63%).
Srednja absolutna peroralna biološka uporabnost je 41% (razpon: od 25 do 63%).
When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in tmax of 60 minutes and a mean reduction in Cmax of 29%.
Če je sildenafil uporabljen s hrano, se stopnja absorpcije zmanjša s srednjo zakasnitvijo tmax 60 minut in srednjim zmanjšanjem Cmax za 29%.
After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/ ml (CV 40%).
Po enkratnem 100- mg peroralnem odmerku je srednja največja celotna koncentracija sildenafila v plazmi približno 440 ng/ ml (CV 40%).
Since sildenafil (and its major circulating N- desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/ ml (38 nM).
Ker je sildenafil (in njegov glavni krožeči N - desmetilni presnovek) 96- odstotno vezan na beljakovine v plazmi, je srednja največja koncentracija prostega sildenafila v plazmi 18 ng/ ml (38 nM).
In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Pri zdravih prostovoljcih, ki so dobili sildenafil (en 100- mg odmerek), je bilo v ejakulatu 90 minut po uporabi manj kot 0, 0002% (povprečno 188 ng) uporabljenega odmerka.
The major circulating metabolite results from N-demethylation of sildenafil.
Glavni presnovek v obtoku je posledica N- demetilacije sildenafila.
This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Selektivnost tega presnovka za fosfodiesteraze je podobna sildenafilovi, njegov vpliv na PDE5 pa je in vitro približno 50% vpliva prvotnega zdravila.
The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
N- desmetilni presnovek se presnovi naprej; končni razpolovni čas je približno 4 ure.
After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the faeces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Sildenafil se po peroralni in intravenski uporabi izloča v obliki presnovkov, pretežno z blatom (približno 80% peroralnega odmerka) in v manjši meri z urinom (približno 13% peroralnega odmerka).
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90% higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years).
Zdravi starejši prostovoljci (stari 65 let ali več) so imeli manjši očistek sildenafila, zato so imeli koncentracijo sildenafila in aktivnega N- desmetilnega presnovka v plazmi približno 90% večjo kot mlajši zdravi prostovoljci (18 do 45 let).
Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%.
Zaradi starostno pogojenih razlik v vezavi na beljakovine v plazmi so se plazemske koncentracije prostega sildenafila ustrezno zvečale za približno 40%.
In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 ml/ min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Pri prostovoljcih z blago do zmerno okvaro ledvic (očistek kreatinina = 30 do 80 ml/ min) farmakokinetika sildenafila po enkratnem 50- mg peroralnem odmerku ni bila spremenjena.
The mean AUC and Cmax of the N-desmethyl metabolite increased 126% and 73% respectively, compared to age-matched volunteers with no renal impairment.
Srednja AUC N- desmetilnega presnovka se je zvečala za 126%, srednji Cmax pa za 73% v primerjavi s prostovoljci primerljive starosti brez okvare ledvic.
However, due to high inter-subject variability, these differences were not statistically significant.
Vendar te razlike zaradi velike variabilnosti med
In volunteers with severe renal impairment (creatinine clearance < 30 ml/ min), sildenafil clearance was reduced, resulting in mean increases in AUC and Cmax of 100% and 88% respectively compared to age-matched volunteers with no renal impairment.
Pri prostovoljcih s hudo okvaro ledvic (očistek kreatinina < 30 ml/ min) se je očistek sildenafila zmanjšal, to pa je povzročilo povprečno zvečanje AUC za 100% in Cmax za 88% v primerjavi s prostovoljci primerljive starosti brez okvare ledvic.
In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 79% and 200% respectively.
Poleg tega sta se pomembno zvečali tudi AUC (za 79%) in Cmax (za 200%) N- desmetilnega presnovka.
10 Hepatic insufficiency:
Jetrna insuficienca:
In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh A and B) sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
Pri prostovoljcih z blago do zmerno cirozo jeter (Child- Pugh A in B) je bil očistek sildenafila zmanjšan, kar je povzročilo zvečanje AUC (84%) in Cmax (47%) v primerjavi s prostovoljci primerljive starosti brez okvare jeter.