FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common serious adverse events that occurred with a frequency ≥ 1% in sildenafil patients (combined doses) were pneumonia (7.4%), cardiac failure, pulmonary hypertension (each 5.2%), upper respiratory tract infection (3.1%), right ventricular failure, gastroenteritis (each 2.6%), syncope, bronchitis, bronchopneumonia, pulmonary arterial hypertension (each 2.2%), chest pain, dental caries (each 1.7%), and cardiogenic shock, gastroenteritis viral, urinary tract infection (each 1.3%).
Slovenian: Najpogostejši resni neželeni učinki, ki so se pri bolnikih, ki so se zdravili s sildenafilom (vsi odmerki), pojavili s pogostnostjo ≥ 1%, so bili pljučnica (7,4%), srčno popuščanje, pljučna hipertenzija (oba 5,2%), okužba zgornjih dihal (3,1%), popuščanje desnega ventrikla, gastroenteritis (oba 2,6%), sinkopa, bronhitis, bronhopnevmonija, pljučna arterijska hipertenzija (vsi 2,2%), bolečina v prsnem košu, zobni karies (oba 1,7%), kardiogeni šok, virusni gastroenteritis in okužba sečil (vsi 1,3%).
English: Most patients were WHO Functional Class II (68/267, 26%) or III (175/267, 66%); fewer patients were Class I (3/267, 1%) or IV (16/267, 6%) at baseline; for a few patients (5/267, 2%), the WHO Functional Class was unknown.
Slovenian: Večina bolnikov je bila izhodiščno v funkcijskem razredu II (68/267, 26%) ali III (175/267, 66%) po razvrstitvi SZO; manj bolnikov je bilo v razredu I (3/267, 1%) ali IV (16/267, 6%); za nekaj bolnikov (5/267, 2%) funkcijski razred po SZO ni bil znan.
English: Sildenafil had no clinically significant impact on the plasma levels of oral contraceptives (ethinyloestradiol 30 µg and levonorgestrel 150 µg).
Slovenian: Sildenafil nima klinično pomembnega vpliva na koncentracijo peroralnih kontraceptivov (30 g etinilestradiola in 150 g levonorgestrela) v plazmi.
English: In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B) sildenafil clearance was reduced, resulting in increases in AUC (85%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
Slovenian: Pri prostovoljcih z blago do zmerno cirozo jeter (razred A in B po Child-Pughu) je bil očistek sildenafila manjši, zato je bila AUC za 85% večja, Cmax pa za 47% večja kot pri prostovoljcih primerljive starosti brez okvare jeter.
English: A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favour of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003).
Slovenian: Ugotovljeni povprečni za placebo korigirani učinek zdravljenja je bil -3,9 mm Hg v korist sildenafila (95% IZ: -5,7, -2,1) (p = 0,00003).
English: - The other ingredients are: Tablet core: microcrystalline cellulose (PH 102), calcium hydrogen phosphate anhydrous, croscarmellose sodium and magnesium stearate.
Slovenian: Jedro tablete: mikrokristalna celuloza (PH 102), brezvodni kalcijev hidrogenfosfat, premreženi natrijev karmelozat in magnezijev stearat.
English: What Mysildecard looks like and contents of the pack
Slovenian: Izgled zdravila Mysildecard in vsebina pakiranja
English: Among these 37 deaths, the number (%) of deaths was 5/55 (9.1%), 10/74 (13.5%), and 22/100 (22%) in the sildenafil low, medium, and high dose groups, respectively.
Slovenian: Med temi 37 primeri smrti je bilo število smrti (%) v skupini z majhnim odmerkom sildenafila 5/55 (9,1%), v skupini s srednjim odmerkom 10/74 (13,5%) in v skupini z velikim odmerkom 22/100 (22%).
English: Odds ratios for the sildenafil low, medium and high dose groups compared to placebo were 0.6 (95% CI: 0.18, 2.01), 2.25 (95% CI: 0.75, 6.69) and 4.52 (95% CI: 1.56, 13.10), respectively.
Slovenian: Razmerja obetov za skupine z majhnim, srednjim in velikim odmerkom v primerjavi s placebom so znašala 0,6 (95% IZ: 0,18, 2,01), 2,25 (95% IZ: 0,75, 6,69) oziroma 4,52 (95% IZ: 1,56, 13,10).
English: Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active Treatment Group Treatment group
Slovenian: Preglednica 2: S placebom korigiran % spremembe glede na izhodiščno vrednost pri največji vrednosti VO2 v skupini, ki je prejemala aktivno zdravilo
English: The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including the combined use of sildenafil for erectile dysfunction has not been studied in PAH patients and such concomitant use is not recommended (see section 4.5).
Slovenian: Varnosti in učinkovitosti sildenafila, uporabljenega hkrati z drugimi zaviralci PDE5, vključno s sočasno uporabo sildenafila za erektilno disfunkcijo, pri bolnikih s PAH niso raziskali, zato sočasna uporaba ni priporočljiva (glejte poglavje 4.5).
English: The most common adverse reactions that occurred (with a frequency ≥ 1%) in sildenafil patients (combined doses) and with a frequency > 1% over placebo patients were pyrexia, upper respiratory tract infection (each 11.5%), vomiting (10.9%), erection increased (including spontaneous penile erections in male subjects) (9.0%), nausea, bronchitis (each 4.6%), pharyngitis (4.0%), rhinorrhoea (3.4%), and pneumonia, rhinitis (each 2.9%).
Slovenian: Najpogostejši neželeni učinki, ki so se pojavljali (s pogostnostjo  1%) pri bolnikih, zdravljenih s sildenafilom (vsi odmerki), in pri katerih je bila pogostnost pojavljanja > 1% večja kot pri placebu, so bili pireksija, okužba zgornjega dela dihal (oba 11,5%), bruhanje (10,9%), močnejša erekcija (vključno s spontanimi erekcijami penisa pri bolnikih) (9,0%), navzea, bronhitis (oba 4,6%), faringitis (4,0%), rinoreja (3,4%) in pljučnica ter rinitis (oba
English: In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 92%, 81% and 74%, respectively.
Slovenian: Pri tej populaciji je 1-, 2- in 3-letno preživetje, ocenjeno po metodi Kaplan-Meier, znašalo 92%, 81% in 74%.
English: • have low blood pressure at rest.
Slovenian: - imate znižan krvni tlak v mirovanju.
English: After chronic dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic and diastolic blood pressure was a decrease of 9.4 mmHg and 9.1 mm Hg respectively.
Slovenian: Po kroničnem odmerjanju 80 mg trikrat na dan pri bolnikih s sistemsko hipertenzijo je bila povprečna sprememba sistoličnega krvnega tlaka v primerjavi z izhodiščem znižanje za 9,4 mm Hg, diastoličnega pa znižanje za 9,1 mm Hg.
English: Most subjects were WHO Functional Class I (75/234, 32%) or II (120/234, 51%) at baseline; fewer patients were Class III (35/234, 15%) or IV (1/234, 0.4%); for a few patients (3/234, 1.3%), the WHO Functional Class was unknown.
Slovenian: Večina preiskovancev se je na začetku uvrščala v funkcijski razred I po razvrstitvi SZO (75/234, 32%) ali razred II (120/234, 51%); manj bolnikov se je uvrščalo v razred III (35/234, 15%) ali IV (1/234, 0,4%); pri nekaj bolnikih (3/234, 1,3%) funkcijski razred po SZO ni bil znan.
English: Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125 mg twice daily with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease of sildenafil AUC.
Slovenian: Sočasna uporaba bosentana (zmeren induktor CYP3A4, CYP2C9 in morda CYP2C19) v odmerku 125 mg dvakrat na dan in sildenafila v odmerku 80 mg trikrat na dan (v stanju dinamičnega ravnovesja), 6 dni pri zdravih prostovoljcih je povzročila 63% zmanjšanje AUC sildenafila.
English: In this population, Kaplan-Meier estimates of 1, 2 and 3 year survival were 96%, 91% and 82%, respectively.
Slovenian: Pri tej populaciji je 1-, 2- in 3-letno preživetje, ocenjeno po metodi Kaplan-Meier, znašalo 96%, 91% oz. 82%.
English: Children Mysildecard should not be given to children below 1 year of age.
Slovenian: Otroci Otroci, mlajši od 1 leta, ne smejo jemati zdravila Mysildecard.
English: If you forget to take Mysildecard
Slovenian: Če ste pozabili vzeti zdravilo Mysildecard
English: Improvements were observed with cardiac index with all three sildenafil groups over placebo, 10%, 4% and 15% for the low, medium and high dose groups respectively.
Slovenian: Izboljšanja so opažali pri srčnem indeksu pri vseh treh skupinah, ki so prejemale sildenafil v primerjavi s placebom, in sicer za 10% pri skupini, ki je prejemala majhen odmerek, za 4% pri skupini, ki je prejemala srednji odmerek, oziroma za 15% pri skupini, ki je prejemala velik odmerek.
English: Survival in patients of WHO functional class II at baseline at 1, 2 and 3 years was 99%, 91%, and 84% respectively, and for patients of WHO functional class III at baseline was 94%, 90%, and 81%, respectively.
Slovenian: razreda po razvrstitvi SZO je 1-, 2- in 3-letno preživetje v osnovi znašalo 99%, 91% oz. 84%, pri bolnikih iz III. razreda po razvrstitvi SZO pa 94%, 90% oz. 81%.
English: Mysildecard 20 mg film-coated tablets sildenafil
Slovenian: Mysildecard 20 mg filmsko obložene tablete sildenafil
English: Subjects were allocated to one of three sildenafil treatment groups, low (10 mg), medium (10-40 mg) or high dose (20-80 mg) regimens of sildenafil given three times a day, or placebo.
Slovenian: Preiskovanci, zdravljeni s sildenafilom, so bili razporejeni v eno izmed treh skupin, režim zdravljenja z majhnimi odmerki (10 mg), srednjimi (10 - 40 mg) ali velikimi odmerki (20 - 80 mg) sildenafila, ki so ga prejemali trikrat na dan, ali s placebom.
English: The tablets are provided in blisters in packs containing 90, 300 and (90 x 1) tablets.
Slovenian: Tablete so na voljo v pretisnih omotih v pakiranjih po 90, 300 filmsko obloženih tablet in (90 x 1) filmsko obložena tableta.
English: At 3 years 68% of the patients were receiving a dose of 80 mg TID.
Slovenian: Po 3 letih je 68% bolnikov prejemalo zdravilo v odmerku 80 mg trikrat na dan.
English: Due to lack of data, Mysildecard should not be used in pregnant women unless strictly necessary.
Slovenian: Zaradi pomanjkanja podatkov zdravila Mysildecard pri nosečnicah ne smete uporabljati, če to ni nujno potrebno.
English: INFORMATION IN BRAILLE Mysildecard 20 mg tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Mysildecard 20 mg tablete
English: A mean placebo corrected increase in walk distance of 26 metres was observed in favour of sildenafil (95% CI: 10.8, 41.2) (p = 0.0009).
Slovenian: Povprečno za placebo korigirano podaljšanje prehojene razdalje je bilo s sildenafilom 26 metrov (95% IZ: 10,8, 41,2) (p = 0,0009).
English: In the pivotal placebo-controlled study of sildenafil in pulmonary arterial hypertension, a total of 207 patients were randomised to and treated with 20 mg, 40 mg, or 80 mg TID doses of sildenafil and 70 patients were randomised to placebo.
Slovenian: V ključni, s placebom nadzorovani študiji sildenafila za zdravljenje pljučne arterijske hipertenzije, je bilo skupno 207 bolnikov randomiziranih in zdravljenih s sildenafilom v odmerkih 20 mg, 40 mg ali 80 mg trikrat na dan, 70 bolnikov pa je bilo randomiziranih na placebo.
English: If you stop taking Mysildecard
Slovenian: Če ste prenehali jemati zdravilo Mysildecard
English: At 3 years 87% of the patients were receiving a dose of 80 mg TID.
Slovenian: Po 3 letih je 87% bolnikov prejemalo zdravilo v odmerku 80 mg trikrat na dan.
English: The overall frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was 2.9%, 3.0% and 8.5% respectively, compared to 2.9% with placebo.
Slovenian: Skupna pogostnost prekinitev je bila pri bolnikih, ki so prejemali sildenafil v odmerku 20 mg trikrat na dan 2,9%, 40 mg trikrat na dan 3,0% in 80 mg trikrat na dan 8,5%, v primerjavi s placebom, kjer je znašala 2,9%.
English: Musculoskeletal and connective tissue disorders Very common pain in extremity
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti bolečine v okončinah pogosti mialgija, bolečine v hrbtu
English: Mysildecard is used to treat adults and children and adolescents from 1 to 17 years old with high blood pressure in the blood vessels in the lungs (pulmonary arterial hypertension).
Slovenian: Zdravilo Mysildecard uporabljamo za zdravljenje visokega krvnega tlaka v pljučnih žilah (pljučne arterijske hipertenzije) pri odraslih ter pri otrocih in mladostnikih, starih med 1 in 17 let.
English: The sildenafil medium and high dose groups both showed PVRI reductions compared to placebo, of 18% (95% CI: 2% to 32%) and 27% (95% CI: 14% to 39%), respectively; whilst the low dose group showed no significant difference from placebo (difference of 2%).
Slovenian: Tako v skupini, ki je prejemala srednji odmerek, kot tudi v skupini, ki je prejemala velik odmerek sildenafila, so ugotovili zmanjšanje žilnega upora v pljučih v primerjavi s placebom, in sicer za 18% (95% IZ: 2% do 32%) oziroma 27% (95% IZ: 14% do 39%); medtem ko v skupini, ki je prejemala majhen odmerek, niso opazili nobene pomembne razlike v primerjavi s placebom (razlika v obsegu 2%).
English: The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43% and 66% higher, respectively, compared to patients not receiving these classes of medicines.
Slovenian: V primerjavi z bolniki, ki niso dobivali substratov CYP3A4 oz. substratov CYP3A4 in antagonistov beta, je bila izpostavljenost sildenafilu pri prejemnikih substratov CYP3A4 večja za 43%, pri prejemnikih substratov CYP3A4 in antagonistov beta pa za 66%.
English: Most patients were WHO Functional Class II (107/277, 39%) or III (160/277, 58%) with a mean baseline 6-minute walking distance of 378 meters and 326 meters respectively; fewer patients were Class I (1/277, 0.4%) or IV (9/277, 3%) at baseline.
Slovenian: Večina bolnikov je bila izhodiščno v funkcijskem razredu II (107/277, 39%) ali III (160/277, 58%) po razvrstitvi SZO, s povprečno doseženo razdaljo 378 metrov oz. 326 metrov na 6-minutnem testu hoje ob začetku študije; manj bolnikov je bilo ob začetku študije v razredu I (1/277, 0,4%) ali IV (9/277, 3%).
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. In patients with pulmonary arterial hypertension, plasma concentrations of N-desmethyl metabolite are approximately 72% those of sildenafil after 20 mg three times a day dosing (translating into a 36% contribution to sildenafil's pharmacological effects).
Slovenian: Pri bolnikih s pljučno arterijsko hipertenzijo je koncentracija N-dezmetilnega presnovka v plazmi približno 72% koncentracije sildenafila po uporabi 20 mg trikrat na dan (kar pomeni 36% prispevek k farmakološkim učinkom sildenafila).
English: Each tablet contains 20 mg of sildenafil (as the citrate).
Slovenian: Ena tableta vsebuje 20 mg sildenafila v obliki sildenafilijevega citrata.
English: How to take Mysildecard
Slovenian: Kako jemati zdravilo Mysildecard
English: When a single 100 mg dose of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
Slovenian: Ob uporabi posamičnega 100 mg odmerka sildenafila hkrati z eritromicinom, zmernim zaviralcem CYP3A4, je v stanju dinamičnega ravnovesja (500 mg dvakrat na dan 5 dni) prišlo do 182% povečanja sistemske izpostavljenosti (AUC) sildenafilu.
English: The percent reduction at 12 weeks for sildenafil 20 mg, 40 mg and 80 mg TID in PVR (11.2%, 12.9%, 23.3%) was proportionally greater than the reduction in systemic vascular resistance (SVR) (7.2%, 5.9%, 14.4%).
Slovenian: Odstotek znižanja pljučne žilne upornosti (11,2% za 20 mg trikrat na dan, 12,9% za 40 mg trikrat na dan in 23,3% za 80 mg trikrat na dan) je bil po 12 tednih proporcionalno večji kot znižanje sistemske žilne upornosti (7,2% za 20 mg trikrat na dan, 5,9% za 40 mg trikrat na dan in 14,4% za 80 mg trikrat na dan).
English: NAME OF THE MEDICINAL PRODUCT Mysildecard 20 mg film-coated tablets
Slovenian: IME ZDRAVILA Mysildecard 20 mg filmsko obložene tablete
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Mylan S.A.S
English: For subjects with primary PAH (67 subjects), mean changes from baseline were 26.39 m (95% CI: 10.70 to 42.08) and 11.84 m (95% CI: -8.83 to 32.52) for the sildenafil and placebo groups, respectively.
Slovenian: Pri preiskovancih s primarno PAH (67 preiskovancev) je bila povprečna sprememba od izhodišča 26,39 m (95% IZ: 10,70 do 42,08) v skupini s sildenafilom in 11,84 m (95% IZ: -8,83 do 32,52) v skupini s placebom.
English: 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.
Slovenian: Sočasna uporaba zaviralca proteaze HIV ritonavirja (zelo močan zaviralec P450) v stanju dinamičnega ravnovesja (500 mg dvakrat na dan) in sildenafila (posamičen odmerek 100 mg) je povzročila 300%, tj. 4-kratno, povečanje Cmax sildenafila in 1.000%, tj. 11-kratno, povečanje AUC sildenafila v plazmi.
English: A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy (62.5 mg - 125 mg twice a day) indicated an increase (20% (95% CI: 9.8 - 30.8)) of bosentan AUC with co-administration of steadystate sildenafil (20 mg three times a day) of a smaller magnitude than seen in healthy volunteers when co-administered with 80 mg sildenafil three times a day (see sections 4.4 and 5.1).
Slovenian: Populacijska farmakokinetična analiza podatkov iz študije pri odraslih bolnikih s PAH na osnovnem zdravljenju z bosentanom (62,5 - 125 mg dvakrat na dan) je pokazala povečanje (20%; 95% IZ: 9,8-30,8) AUC bosentana ob sočasni uporabi s sildenafilom v stanju dinamičnega ravnovesja (20 mg trikrat na dan).
English: 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) stabilised on doxazosin therapy.
Slovenian: V treh specifičnih študijah interakcij med zdravili so bolnikom z benigno hiperplazijo prostate (BPH), stabiliziranim na zdravljenju z doksazosinom, dali antagonist receptorjev alfa doksazosin (4 mg ali 8 mg) sočasno s sildenafilom (25 mg, 50 mg oz. 100 mg).
English: However, for subjects with PAH associated with connective tissue disease (36 subjects) mean changes from baseline were -18.32 m (95% CI: -65.66 to 29.02) and 17.50 m (95% CI: -9.41 to 44.41) for the sildenafil and placebo groups, respectively.
Slovenian: Pri preiskovancih z boleznimi vezivnega tkiva povezano PAH (36 preiskovancev) pa je bila povprečna sprememba od izhodišča -18,32 m (95% IZ: -65,66 do 29,02) v skupini s sildenafilom in 17,50 m (95% IZ: -9,41 do 44,41) v skupini s placebom.
English: • if you are taking medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
Slovenian: - če jemljete zdravila, ki vsebujejo nitrate, ali dajalce dušikovega oksida, kakršen je amilnitrat.
English: The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of -3.5 mmHg (95% CI: -8.9, 1.9) and -7.3 mmHg (95% CI: -12.4, -2.1), respectively; whilst the low dose group showed little difference from placebo (difference of 1.6 mmHg).
Slovenian: V skupinah, ki sta prejemali sildenafil v srednjem in velikem odmerku, so ugotovili spremembe pri povprečnem arterijskem tlaku v pljučih glede na izhodiščno vrednost v primerjavi s placebom, in sicer v obsegu -3,5 mm Hg (95% IZ: -8,9, 1,9) oziroma -7,3 mm Hg (95% IZ: -12,4, -2,1); medtem ko so pri skupini, ki je prejemala majhen odmerek, ugotovili le majhno spremembo v primerjavi s placebom (razlika v obsegu 1,6 mm Hg).
English: Do not stop taking Mysildecard unless your doctor tells you to.
Slovenian: Zdravila ne nehajte jemati, če vam tega ne naroči zdravnik.
English: 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.
Slovenian: Sočasna uporaba zaviralca proteaze HIV sakvinavirja, ki zavira CYP3A4, v stanju dinamičnega ravnovesja (1.200 mg trikrat na dan) in sildenafila (posamičen odmerek 100 mg) je povzročila 140% povečanje Cmax sildenafila in 210% povečanje AUC sildenafila.
English: Placebo corrected increases in 6MWD were 45 metres (p < 0.0001), 46 metres (p < 0.0001) and 50 metres (p < 0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Slovenian: Za placebo korigirano povečanje 6MWD je bilo za 20 mg sildenafila trikrat na dan 45 metrov (p < 0,0001), za 40 mg trikrat na dan 46 metrov (p < 0,0001) in za 80 mg trikrat na dan 50 metrov (p < 0,0001).
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 154% and 87%, respectively in cirrhotic subjects compared to subjects with normal hepatic function.
Slovenian: Poleg tega so pri preiskovancih s cirozo ugotovili pomembno večji AUC (za 154%) in Cmax (za 87%) N-dezmetilnega presnovka kot pri preiskovancih z normalnim delovanjem jeter.
English: The total body clearance of sildenafil is 41 l/h with a resultant terminal phase half-life of 3-5 h. 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).
Slovenian: Sildenafil se po peroralni in intravenski uporabi izloči v obliki presnovkov, pretežno v blatu (približno 80% peroralnega odmerka) in v manjši meri v urinu (približno 13% peroralnega odmerka).
English: Placebo-corrected treatment effects with PVR were -178 dyne.sec/cm5 (p=0.0051), -195 dyne.sec/cm5 (p=0.0017) and -320 dyne.sec/cm5 (p<0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID, respectively.
Slovenian: Za placebo korigiran učinek zdravljenja na pljučno žilno upornost je bil za 20 mg sildenafila trikrat na dan -178 din.s/cm5 (p = 0,0051), za 40 mg trikrat na dan -195 din.s/cm5 (p = 0,0017) in za 80 mg trikrat na dan -320 din.s/cm5 (p < 0,0001).
English: Titanium dioxide (E171)
Slovenian: Filmska obloga: hipromeloza 6 mPas titanov dioksid (E171) triacetin
English: 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).
Slovenian: S tem se sklada ugotovitev, da sildenafil okrepi hipotenzivno delovanje nitratov, zato je njegova sočasna uporaba z donorji dušikovega oksida ali nitrati v kakršni koli obliki kontraindicirana (glejte poglavje 4.3).
English: These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Slovenian: Ta zdravila se pogosto uporabljajo za olajšanje pri angini pektoris ali bolečini v prsnem košu (glejte poglavje 2, Kaj morate vedeti, preden boste vzeli zdravilo Mysildecard).
English: The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil (20 mg three times a day) and placebo (13.62 m (95% CI: -3.89 to 31.12) and 14.08 m (95% CI: -1.78 to 29.95), respectively).
Slovenian: Rezultati kažejo, da pri sildenafilu (20 mg trikrat na dan) (13,62 m; 95% IZ: -3,89 do 31,12) in placebu (14,08 m; 95% IZ: -1,78 do 29,95) ni pomembne razlike v povprečni spremembi od izhodišča pri 6MWD.
English: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section
Slovenian: Sočasna uporaba sildenafila pri bolnikih, ki dobivajo zdravljenje z antagonisti alfa, lahko pri občutljivih posameznikih povzroči simptomatsko hipotenzijo (glejte poglavje 4.4).
English: Respiratory, thoracic and mediastinal disorders Common epistaxis, cough, nasal congestion
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti epistaksa, kašelj, zamašenost nosu