natgillin/translations-raw huggingface dataset:
It is available as blue, diamond- shaped tablets (25, 50 or 100 mg).
Na voljo je v modrih tabletah v obliki romba (25, 50 ali 100 mg).
Viagra is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Zdravilo Viagra se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, kadar ne zmorejo doseči ali ohraniti takšne erekcije penisa, ki bi zadoščala za zadovoljivo spolno aktivnost.
For Viagra to be effective, sexual stimulation is required.
Da bi bilo zdravilo Viagra je učinkovito, je potrebna spolna stimulacija.
The recommended dose of Viagra is 50 mg taken as needed about one hour before sexual activity.
Priporočeni odmerek zdravila Viagra je 50 mg, ki se vzame, ko je potreben, približno eno uro pred spolno aktivnostjo.
If Viagra is taken with food, the onset of activity may be delayed compared with taking Viagra without food.
Če se zdravilo Viagra zaužije s hrano, lahko začne delovati pozneje, kot če se zaužije brez nje.
The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Odmerek zdravila se lahko glede na učinkovitost in stranske učinke poveča na največ 100 mg ali zmanjša na 25 mg.
Patients with liver problems or severe kidney problems should start treatment with the 25-mg dose.
Bolniki z jetrnimi obolenji ali resnimi motnjami v delovanju ledvic naj začnejo zdravljenje s 25- miligramskim odmerkom.
The active ingredient in Viagra, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Zdravilna učinkovina v zdravilu Viagra, sildenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP).
Deluje tako, da zavira encim fosfodiesterazo, ki običajno razgrajuje snov, znano kot ciklični gvanozinmonofosfat (cGMP).
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.
Med normalno spolno stimulacijo se cGMP proizvaja v penisu, kjer povzroča, da se mišica v gobastem tkivu penisa (corpora cavernosa) sprosti, kar omogoči dotok krvi v predel corpora, posledica česar je erekcija.
By blocking the breakdown of cGMP, Viagra restores erectile function.
Z zaviranjem razgradnje cGMP zdravilo Viagra ponovno vzpostavi erektilno funkcijo.
Sexual stimulation is still needed to produce an erection.
Da se to zgodi, pa je še vedno potrebna spolna stimulacija.
Viagra has been studied in four main studies including 1,690 men aged 19 to 87 years, where it was compared with placebo (a dummy treatment) for between 12 and 26 weeks.
Zdravilo Viagra so preučevali v štirih glavnih študijah, v katerih je sodelovalo 1690 moških, starih od 19 do 87 let, in v katerih so zdravilo primerjali s placebom (zdravilom brez zdravilne učinkovine) v trajanju od 12 do 26 tednov.
Two of these studies used fixed doses (patients allocated to 25, 50 or 100 mg) and two studies were flexible (patients started on 25 mg and could be moved to 50 or 100 mg depending on their response).
V dveh študijah so bili uporabljeni nespremenljivi odmerki (bolniki so dobivali 25, 50 ali 100 mg), v dveh pa so odmerke prilagajali (bolniki so začeli s 25- miligramskim odmerkom, nato pa so lahko prejeli 50 - ali 100- miligramski odmerek, odvisno od njihovega odziva).
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. eu. int
Reproduction is authorised provided the source is acknowledged. studies in patients with spinal cord injury and with diabetes.
Poleg tega so bile izvedene tudi študije pri bolnikih s poškodbami hrbtenjače in pri bolnikih s sladkorno boleznijo.
The main measure of effectiveness was based on the ability of the men to get and maintain an erection.
Glavno merilo učinkovitosti je temeljilo na tem, ali so moški sposobni doseči in ohraniti erekcijo.
This was recorded in a special questionnaire completed at home using a scoring system on a five-point scale, where a score of 5 represents the best result.
Beleženje tega je potekalo doma s posebnim vprašalnikom, v katerem je uporabljen sistem 5- točkovne lestvice, pri čemer 5 točk predstavlja najboljši rezultat.
In the questionnaire, scores for the question on how often the patient was able to achieve intercourse went from about 2 without treatment to 3 or 4 with Viagra 50 mg.
Rezultat na vprašanje v vprašalniku, kako pogosto je bolnik sposoben imeti spolne odnose, je bil brez zdravljenja 2 točki in po jemanju zdravila Viagra 50 mg 3 ali 4 točke.
In the 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 with 25% on placebo.
V študiji z nespremenljivimi odmerki je bil delež bolnikov, ki so poročali o izboljšanju erekcije, 62% (25 mg), 74% (50 mg) in 82% (100 mg) v primerjavi s 25% bolnikov, ki so jemali placebo.
The most common side effect with Viagra (seen in more than 1 patient in 10) is headache.
Najpogostejši neželeni učinek zdravila Viagra (opažen pri več kot 1 bolniku od 10) je glavobol.
For the full list of all side effects reported with Viagra, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Viagra, glejte navodilo za uporabo.
Viagra should not be used in people who may be hypersensitive (allergic) to sildenafil or any of the other ingredients, or where sexual activity is inadvisable (e. g. men with severe heart disease such as unstable angina or severe heart failure).
Zdravila Viagra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične) na sildenafil ali katero koli drugo sestavino, ali osebe, katerim je spolna aktivnost odsvetovana (npr. moški s hudimi boleznimi srca, kot je nestabilna angina pektoris, ali hudim srčnim popuščanjem).
It should also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Prav tako ga ne smejo uporabljati osebe, ki so kdaj koli izgubile vid zaradi dotoka krvi v očesni živec (nearteritična ishemična optična nevropatija ali NAION).
Viagra should not be taken with nitrates (medicines used to treat angina).
Zdravilo Viagra se ne sme jemati skupaj z nitrati (zdravili za zdravljenje angine pektoris).
Because Viagra has not been studied in patients with severe liver disease, hypotension (low blood pressure), recent stroke or myocardial infarction (heart attack), or a hereditary eye disease, such as retinitis pigmentosa, these patients should not use it.
Ker zdravila Viagra niso preučevali pri bolnikih s hudimi jetrnimi boleznimi, hipotenzijo (nizkimi krvnim tlakom), nedavno možgansko kapjo ali miokardnim infarktom (srčni napad) ali dedno očesno boleznijo, kot je na primer retinitis pigmentosa, ga ti bolniki ne smejo jemati.
The Committee for Medicinal Products for Human Use (CHMP) decided that Viagra’ s benefits are greater than its risks for the treatment of men with erectile dysfunction.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Viagra pri zdravljenju moških z erektilno disfunkcijo večje od z njim povezanih tveganj.
The Committee recommended that Viagra be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Viagra odobri dovoljenje za promet z zdravilom.
Other information about Viagra:
Druge informacije o zdravilu Viagra:
The European Commission granted a marketing authorisation valid throughout the European Union for Viagra to Pfizer Limited on 14 September 1998.
Evropska komisija je dovoljenje za promet z zdravilom Viagra, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 14. septembra 1998.
The marketing authorisation was renewed on 14 September 2003 and on 14 September 2008.
Dovoljenje za promet z zdravilom je bilo obnovljeno dne 14. septembra 2003 in 14. septembra 2008.
The full EPAR for Viagra is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Viagra je na voljo tukaj.
Number
Številka EU
EU/ 1/ 98/ 077/ 002 EU/ 1/ 98/ 077/ 003 EU/ 1/ 98/ 077/ 004 EU/ 1/ 98/ 077/ 006 EU/ 1/ 98/ 077/ 007 EU/ 1/ 98/ 077/ 008 EU/ 1/ 98/ 077/ 010 EU/ 1/ 98/ 077/ 011 EU/ 1/ 98/ 077/ 012 EU/ 1/ 98/ 077/ 013 EU/ 1/ 98/ 077/ 014 EU/ 1/ 98/ 077/ 015 EU/ 1/ 98/ 077/ 016 EU/ 1/ 98/ 077/ 017 EU/ 1/ 98/ 077/ 018 EU/ 1/ 98/ 077/ 019
EU/ 1/ 98/ 077/ 002 EU/ 1/ 98/ 077/ 003 EU/ 1/ 98/ 077/ 004 EU/ 1/ 98/ 077/ 006 EU/ 1/ 98/ 077/ 007 EU/ 1/ 98/ 077/ 008 EU/ 1/ 98/ 077/ 010 EU/ 1/ 98/ 077/ 011 EU/ 1/ 98/ 077/ 012 EU/ 1/ 98/ 077/ 013 EU/ 1/ 98/ 077/ 014 EU/ 1/ 98/ 077/ 015 EU/ 1/ 98/ 077/ 016
VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA
VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA VIAGRA
25 mg 25 mg 25 mg 50 mg 50 mg 50 mg 100 mg 100 mg 100 mg 25 mg 50 mg 100 mg 50 mg 50 mg 50 mg 50 mg
25 mg 25 mg 25 mg 50 mg 50 mg 50 mg 100 mg 100 mg 100 mg 25 mg 50 mg 100 mg 50 mg
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta filmsko obložena tableta
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba Peroralna uporaba
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Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v škatlici Pretisni omot (PVC / alu) v zavarjenem kartonskem pakiranju
4 8 12 4 8 12 4 8 12 2 2 2 2 4 8 12
12
Each tablet contains 25 mg of sildenafil(as citrate)
Ena tableta vsebuje 25 mg sildenafila v obliki sildenafilijevega citrata.
Lactose
Pomožna snov: laktoza.
Blue rounded diamond-shaped tablets, marked “ PFIZER ” on one side and “ VGR 25 ” on the other.
Tablete so modre barve, imajo obliko romba z zaobljenimi robovi ter oznako "PFIZER" na eni in "VGR 25" na drugi strani.
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Zdravljenje moških z erektilno disfunkcijo, tj. nezmožnostjo doseči ali ohraniti erekcijo penisa, ki bi zadoščala za zadovoljivo spolno aktivnost.
Based on efficacy and toleration, the dose may be increased to 100 mg or decreased to 25 mg.
Glede na učinkovitost in prenašanje je odmerek mogoče zvečati na 100 mg ali zmanjšati na 25 mg.
If VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Če se zdravilo VIAGRA zaužije s hrano, lahko začne delovati pozneje, kot če je zaužito na prazen želodec (glejte poglavje 5. 2).
Dosage adjustments are not required in elderly patients.
Pri starejših bolnikih odmerka ni potrebno prilagajati.
The dosing recommendations described in ‘ Use in adults ’ apply to patients with mild to moderate renal impairment (creatinine clearance = 30 - 80 ml/ min).
Priporočila za odmerjanje, opisana pri "Uporaba pri odraslih", veljajo tudi za bolnike z blago do zmerno okvaro ledvic (očistek kreatinina = 30 do 80 ml/ min).
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 ml/ min) a 25 mg dose should be considered.
Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/ min) je očistek sildenafila zmanjšan, zato je priporočljivi začetni odmerek 25 mg.
Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg.
Glede na učinkovitost in prenašanje se odmerek lahko zveča na 50 mg ali 100 mg.
2 Use in patients with impaired hepatic function:
2 Uporaba pri bolnikih z okvarjenim delovanjem jeter:
Since sildenafil clearance is reduced in patients with hepatic impairment (e. g. cirrhosis) a 25 mg dose should be considered.
Pri bolnikih z okvaro jeter (npr. ciroza) je očistek sildenafila zmanjšan, zato je priporočljivi začetni odmerek 25 mg.
Use in patients using other:
Uporaba pri bolnikih, ki uporabljajo druga zdravila:
With the exception of ritonavir for which co-administration with sildenafil is not advised (see section 4.4) a starting dose of 25 mg should be considered in patients receiving concomitant treatment with CYP3A4 inhibitors (see section 4.5).
Pri bolnikih, ki sočasno dobivajo zaviralce CYP3A4, je priporočljivi začetni odmerek 25 mg (glejte poglavje 4. 5) razen pri ritonavirju, katerega sočasna uporaba s sildenafilom ni priporočljiva (glejte poglavje 4. 4).
In order to minimise the potential for developing postural hypotension, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Da bo možnost za pojav posturalne hipotenzije čim manjša, morajo biti bolniki pred začetkom zdravljenja s sildenafilom stabilni na terapiji z zaviralci adrenergičnih receptorjev alfa.
In addition, initiation of sildenafil at a dose of 25 mg should be considered (see sections 4.4 and 4.5).
Poleg tega je treba razmisliti o uvedbi sildenafila v odmerku 25 mg (glejte poglavji 4. 4 in 4. 5).
Consistent with its known effects on the nitric oxide/ cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Znano je, da sildenafil učinkuje na pot dušikov oksid/ ciklični gvanozinmonofosfat (cGMP) (glejte poglavje 5. 1), in tako okrepi hipotenzivno delovanje nitratov, zato je njegova sočasna uporaba z donorji dušikovega oksida (npr. amilnitritom) ali nitrati v kakršnikoli obliki kontraindicirana.
Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (e. g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).
Zdravil za zdravljenje erektilne disfunkcije, vključno s sildenafilom, ne smejo uporabljati moški, za katere spolna dejavnost ni priporočljiva (npr. bolniki s hudimi kardiovaskularnimi motnjami, kot sta nestabilna angina pektoris ali hudo srčno popuščanje).
VIAGRA is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Zdravilo VIAGRA je kontraindicirano pri bolnikih, ki so izgubili vid na enem očesu zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), tudi če ta dogodek ni bil povezan s predhodnim jemanjem zaviralcev PDE5 (glejte poglavje 4. 4).
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure < 90/ 50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Varnost sildenafila ni raziskana pri naslednjih podskupinah bolnikov, pri katerih je njegova uporaba zato kontraindicirana: huda okvara jeter, hipotenzija (krvni tlak < 90/ 50 mmHg), nedavna možganska kap ali miokardni infarkt in znane dedne degenerativne bolezni mrežnice, npr. retinitis pigmentosa (manjši del teh bolnikov ima genetske motnje mrežničnih fosfodiesteraz).
Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Sildenafil ima vazodilatacijske lastnosti, ki povzročijo blago in prehodno znižanje krvnega tlaka (glejte poglavje 5. 1).
Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e. g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
Med bolnike z zvečano občutljivostjo za vazodilatatorje spadajo bolniki z obstrukcijo iztoka iz levega prekata (npr. z aortno stenozo, hipertrofično obstruktivno kardiomiopatijo) ali z redkim sindromom multiple sistemske atrofije, ki se kaže kot huda okvara avtonomnega uravnavanja krvnega tlaka.
VIAGRA potentiates the hypotensive effect of nitrates (see section 4.3).
Zdravilo VIAGRA okrepi hipotenzivni učinek nitratov (glejte poglavje 4. 3).
3 Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of VIAGRA.
3 V obdobju trženja so bili v časovni povezanosti z uporabo zdravila VIAGRA opisani resni kardiovaskularni dogodki, med drugim miokardni infarkt, nestabilna angina pektoris, nenadna srčna smrt, ventrikularna aritmija, cerebrovaskularna krvavitev, tranzitorna ishemična ataka, hipertenzija in hipotenzija.
Agents for the treatment of erectile dysfunction, including sildenafil, 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).
Zdravila za zdravljenje erektilne disfunkcije, vključno s sildenafilom, je treba previdno uporabljati pri bolnikih z anatomskimi deformacijami penisa (npr. z angulacijo, kavernozno fibrozo ali Peyroniejevo boleznijo) in bolnikih z določenimi boleznimi, ki povzročajo nagnjenost k priapizmu (npr. s srpastocelično anemijo, multiplim mielomom ali levkemijo).
Therefore the use of such combinations is not recommended.
Varnost in učinkovitost kombinacije sildenafila z drugimi zdravili za zdravljenje erektilne disfunkcije nista raziskani, zato uporaba takih kombinacij ni priporočljiva.
Visual defects and cases of non-arteritic anterior ischaemic optic neuropathy have been reported in connection with the intake of sildenafil and other PDE5 inhibitors.
V povezavi z jemanjem sildenafila in drugih zaviralcev PDE5 so poročali o okvarah vida in primerih nearteritične anteriorne ishemične optične nevropatije.
The patient should be advised that in case of sudden visual defect, he should stop taking VIAGRA and consult a physician immediately (see section 4.3).
Bolnika je treba opozoriti, da naj v primeru nenadne izgube vida preneha jemati zdravilo VIAGRA in o tem nemudoma obvesti svojega zdravnika (glejte poglavje 4. 3).
Co-administration of sildenafil with ritonavir is not advised (see section 4.5).
Sočasna uporaba sildenafila z ritonavirjem ni priporočljiva (glejte poglavje 4. 5).
Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals (see section 4.5).
Previdnost je potrebna med uporabo sildenafila pri bolnikih, ki jemljejo zaviralce adrenergičnih receptrojev alfa, ker sočasna uporaba pri maloštevilnih občutljivih posameznikih lahko povzroči simptomatsko hipotenzijo (glejte poglavje 4. 5).
In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha- blocker therapy prior to initiating sildenafil treatment.
Da bo možnost za pojav posturalne hipotenzije čim manjša, morajo biti bolniki, pred začetkom zdravljenja s sildenafilom, hemodinamsko stabilni na terapiji z zaviralci adrenergičnih receptorjev alfa.
Initiation of sildenafil at a dose of 25 mg should be considered (see section 4.2).
Razmisliti je treba o uvedbi sildenafila v odmerku 25 mg (glejte poglavje 4. 2).
The film coating of the VIAGRA tablet contains lactose.
Filmska obloga tablet zdravila VIAGRA vsebuje laktozo.
VIAGRA should not be administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Zdravilo VIAGRA ne smemo uporabiti pri bolnikih z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze.
In vitro studies:
Študije in vitro:
Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance.
Zaviralci teh izoencimov zato lahko zmanjšajo očistek sildenafila.
4 Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
4 Sočasna uporaba zaviralca proteaz HIV ritonavirja, ki je zelo močan zaviralec P450, je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan) in sildenafila (enkratni odmerek 100 mg) povzročila 300- odstotno (4- kratno) zvečanje Cmax sildenafila in 1, 000- odstotno (11- kratno) zvečanje AUC sildenafila v plazmi.
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ ml, compared to approximately 5 ng/ ml when sildenafil was administered alone.
Po 24 urah je bila koncentracija sildenafila v plazmi še vedno približno 200 ng/ ml v primerjavi s približno 5 ng/ ml v primeru, ko je bil sildenafil apliciran sam.
Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised (see section 4.4) and in any event the maximum dose of sildenafil should under no circumstances exceed 25 mg within 48 hours.
Glede na te farmakokinetične ugotovitve sildenafila ni priporočljivo uporabljati z ritonavirjem (glejte poglavje 4. 4), največji odmerek sildenafila pa nikakor ne sme preseči 25 mg v 48 urah.
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Sočasna uporaba zaviralca proteaz HIV sakvinavirja, ki zavira CYP3A4, je v stanju dinamičnega ravnovesja (1. 200 mg trikrat na dan) in sildenafila (enkratni odmerek 100 mg) povzročila 140 - odstotno zvečanje Cmax sildenafila in 210- odstotno zvečanje AUC sildenafila.
Sildenafil had no effect on saquinavir pharmacokinetics (see section 4.2).
Sildenafil ni vplival na farmakokinetiko sakvinavirja (glejte poglavje 4. 2).