FrancophonIA/ELRC3.0 huggingface dataset:
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: Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia
Slovenian: Očesne bolezni pogosti mrežnična krvavitev, okvara vida, zamegljen vid, fotofobija, kromatopsija, cianopsija, draženje oči, očesna hiperemija občasni neznana
English: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals (see section 4.4).
Slovenian: Sočasna uporaba sildenafila pri bolnikih, ki dobivajo zdravljenje z antagonisti alfa, lahko pri občutljivih posameznikih povzroči simptomatsko hipotenzijo (glejte poglavje 4.4).
English: Manufacturer
Slovenian: Izdelovalec:
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: Granpidam 20 mg film-coated tablets sildenafil
Slovenian: Granpidam 20 mg filmsko obložene tablete sildenafil
English: Children Granpidam should not be given to children below 1 year of age.
Slovenian: Otroci, mlajši od 1 leta, ne smejo jemati zdravila Granpidam.
English: Common gastritis, gastrooesophageal reflux disease, haemorrhoids, abdominal distension, dry mouth
Slovenian: Bolezni prebavil zelo pogosti diareja, dispepsija pogosti gastritis, gastroezofagealna refluksna bolezen, hemoroidi, napenjanje v trebuhu, suha usta
English: Patients on sildenafil achieved a statistically significant reduction in mean Pulmonary Arterial Pressure (mPAP) compared to those on placebo.
Slovenian: Bolnikom, ki so dobivali sildenafil, se je povprečni pljučni arterijski tlak statistično pomembno znižal v primerjavi z bolniki, ki so dobivali placebo.
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,
English: The study population consisted of 68 (25%) men and 209 (75%) women with a mean age of 49 years (range: 18-81 years) and baseline 6-minute walk test distance between 100 and 450 metres inclusive (mean: 344 metres).
Slovenian: Povprečna starost je bila 49 let (razpon: od 18 do 81 let), dosežena razdalja na 6-minutnem testu hoje ob začetku študije pa od 100 do vključno 450 metrov (povprečje: 344 metrov).
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 steady-state 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: - Medicines containing nitrates, or nitric oxide donors such as amyl nitrate (“poppers”).
Slovenian: - zdravila, ki vsebujejo nitrite, ali dajalce dušikovega oksida, kot je amilnitrat.
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: Combined dose groups (n=77)
Slovenian: Vsi odmerki (n = 77)
English: The respective odds ratios were 2.92 (p=0.0087), 4.32 (p=0.0004) and 5.75 (p<0.0001).
Slovenian: Razmerja obetov so bila za 20 mg trikrat na dan 2,92 (p = 0,0087), za 40 mg trikrat na dan 4,32 (p = 0,0004) in za 80 mg trikrat na dan 5,75 (p < 0,0001).
English: Common migraine, tremor, paraesthesia, burning sensation, hypoaesthesia
Slovenian: Bolezni živčevja zelo pogosti glavobol pogosti migrena, tremor, parestezija, pekoč občutek, hipestezija
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: Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature.
Slovenian: PDE5 je encim, odgovoren za razgradnjo cGMP; prisoten je v kavernoznem korpusu penisa, poleg tega pa tudi v pljučnem ožilju.
English: Each tablet contains 20 mg of sildenafil (as citrate).
Slovenian: Ena tableta vsebuje 20 mg sildenafila v obliki sildenafilijevega citrata.
English: Granpidam 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 Granpidam 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: Of the total 229 subjects who received sildenafil, there were 55, 74, and 100 subjects in the low, medium and high dose groups, respectively.
Slovenian: Od skupno 229 preiskovancev, ki so prejemali sildenafil, je bilo v skupini z majhnim odmerkom 55 preiskovancev, v skupini s srednjim odmerkom 74 preiskovancev, v skupini z velikim odmerkom pa 100 preiskovancev.
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: Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with pulmonary arterial hypertension compared to healthy volunteers.
Slovenian: da je pri bolnikih s pljučno arterijsko hipertenzijo očistek sildenafila manjši in/ali njegova peroralna biološka uporabnost večja kot pri zdravih prostovoljcih.
English: - have a problem with the pumping chambers of your heart - have high blood pressure in the blood vessels in the lungs.
Slovenian: - imate zvišan krvni tlak v krvnih žilah v pljučih.
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: Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance <30 ml/min).
Slovenian: Pri bolnikih z okvaro ledvic - tudi pri tistih s hudo okvaro (očistek kreatinina < 30 ml/min) - na začetku zdravljenja odmerka ni treba prilagoditi.
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: Side effects reported commonly (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia and runny nose.
Slovenian: Pogosto opisani neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) so občutek siljenja na bruhanje, povečane erekcije, pljučnica in izcedek iz nosu.
English: Dose related improvements were observed with pulmonary vascular resistance index (PVRI) and mean pulmonary arterial pressure (mPAP).
Slovenian: Pri indeksu žilnega upora v pljučih (PVRI - pulmonary vascular resistance index) in pri povprečnem arterijskem tlaku v pljučih (mPAP - mean pulmonary arterial pressure) so opažali z odmerkom povezana izboljšanja.
English: Prolonged erections and priapism have been reported with sildenafil in post-marketing experience.
Slovenian: V obdobju trženja so pri sildenafilu poročali o podaljšanih erekcijah in priapizmu.
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: A randomised, double-blind, placebo-controlled study was conducted in 278 patients with primary pulmonary hypertension, PAH associated with connective tissue disease, and PAH following surgical repair of congenital heart lesions.
Slovenian: Pri 278 bolnikih s primarno pljučno arterijsko hipertenzijo (PAH), PAH povezano z boleznimi vezivnega tkiva in PAH po kirurški popravi prirojenih srčnih hib so izvedli randomizirano, dvojno slepo, s placebom nadzorovano študijo.
English: Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Slovenian: Pri nekaterih preiskovancih so s Farnsworth-Munsellovim testom s 100 barvnimi odtenki 1 uro po 100 mg odmerku ugotovili blage in prehodne spremembe razločevanja barv (modra/zelena); 2 uri po odmerku ta učinek ni bil več opazen.
English: Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co-administration may lead to symptomatic hypotension in susceptible individuals (see section 4.5).
Slovenian: Sildenafil je treba previdno uporabljati pri bolnikih, ki jemljejo antagonist receptorjev alfa, kajti takšna sočasna uporaba lahko pri občutljivih posameznikih povzroči simptomatsko hipotenzijo (glejte poglavje 4.5).
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: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
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: Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Granpidam Vsebina pakiranja in dodatne informacije
English: Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B).
Slovenian: Pri bolnikih z okvaro jeter (razred A in B po Child-Pughu) na začetku zdravljenja odmerka ni treba prilagoditi.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Accord
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI PRETISNEM TRAKU
English: CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in vivo interaction study with CYP3A4 inducer bosentan.
Slovenian: Kaže, da induktorji CYP3A4 pri bolnikih s pljučno arterijsko hipertenzijo močno vplivajo na farmakokinetiko sildenafila.
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 kakršnikoli obliki kontraindicirana (glejte poglavje
English: How to store Granpidam
Slovenian: Shranjevanje zdravila Granpidam
English: Side effects reported very commonly (may affect more than 1 in 10 people) were headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.
Slovenian: Zelo pogosto opisani neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) so glavobol, zardevanje obraza, prebavne motnje, driska in bolečine v rokah ali nogah.
English: The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD.
Slovenian: Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje pri 6MWD od izhodišča do 12. tedna.
English: What Granpidam contains - The active substance is sildenafil.
Slovenian: Vsebina pakiranja in dodatne informacije informacije Kaj vsebuje zdravilo Granpidam - Zdravilna učinkovina je sildenafil.
English: Higher than recommended doses should not be used in paediatric patients with PAH (see sections 4.2 and 4.4).
Slovenian: Pri pediatričnih bolnikih s PAH se ne sme uporabljati odmerkov, večjih od priporočenih (glejte poglavji 4.2 in 4.4).
English: Lactose monohydrate is present in the tablet film coat.
Slovenian: Filmska obloga tablete vsebuje laktozo monohidrat.
English: The benefit-risk balance of sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension.
Slovenian: Razmerje med koristjo in tveganjem sildenafila ni bilo preverjeno pri bolnikih s pljučno arterijsko hipertenzijo v funkcijskem razredu I po SZO.
English: Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR) compared to those on placebo.
Slovenian: Bolnikom na vseh treh odmerkih sildenafila sta se povprečni pljučni arterijski tlak in sprememba pljučne žilne upornosti statistično pomembno znižali v primerjavi z bolniki, ki so dobivali placebo.
English: Results were generally consistent in subgroups according to aetiology (primary and connective tissue disease-associated PAH), WHO functional class, gender, race, location, mean PAP and PVRI.
Slovenian: Rezultati so bili po podskupinah praviloma skladni glede na etiologijo (primarna PAH in PAH,
English: A total of 106 out of 234 (45%) subjects were evaluable for CPET, which comprised those children ≥7 years old and developmentally able to perform the test. Children <7 years (sildenafil combined dose = 47; placebo = 16) were evaluable only for the secondary endpoints.
Slovenian: CPET je bilo mogoče ovrednotiti pri skupno 106 izmed 234 (45 %) preiskovancev, v tem številu pa so bili zajeti otroci, stari ≥7 let, ki so bili glede na stopnjo razvoja sposobni opraviti preskus.
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function.
Slovenian: Poleg tega sta se pri preiskovancih s hudo okvaro ledvic v primerjavi s preiskovanci z normalnim delovanjem ledvic pomembno povečali AUC (za 200 %) in Cmax (za 79 %) N
English: Placebo-corrected treatment effects with mPAP were -2.7 mmHg (p = 0.04), -3.0 mm Hg (p = 0.01) and -5.1 mm Hg (p <0.0001) for sildenafil 20 mg, 40 mg and 80 mg TID respectively.
Slovenian: Za placebo korigiran učinek zdravljenja na povprečni pljučni arterijski tlak je bil za 20 mg sildenafila trikrat na dan -2,7 mmHg (p = 0,04), za 40 mg trikrat na dan -3,0 mmHg (p = 0,01) in za 80 mg trikrat na dan -5,1 mmHg (p < 0,0001).
English: Prolonged and sometimes painful erections have been reported in men after taking sildenafil.
Slovenian: Pri moških so po jemanju sildenafila poročali o podaljšanih erekcijah, ki so bile včasih boleče.
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) stabilized 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
English: In pups of rats which were pre- and postnatally treated with 60 mg/kg sildenafil, a decreased litter size, a lower pup weight on day 1 and a decreased 4-day survival were seen at exposures which were approximately fifty times the expected human exposure at 20 mg three times a day.
Slovenian: Pri izpostavljenosti, ki je približno petdesetkrat presegala pričakovano izpostavljenost ob odmerku 20 mg trikrat na dan pri človeku, so pri mladičih podgan, tretiranih pred skotitvijo in po njej s 60 mg sildenafila/kg, ugotovili zmanjšanje velikosti legla, manjšo telesno maso mladičev 1. dan in manjše 4-dnevno preživetje.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Slovenian: Ena filmsko obložena tableta vsebuje 20 mg sildenafila v obliki sildenafilijevega citrata.
English: You should not take more medicine than your doctor tells you to.
Slovenian: Če ste vzeli večji odmerek zdravila Granpidam, kot bi smeli Ne vzemite več zdravila, kot vam je naročil zdravnik.
English: A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Slovenian: Le če bolnik zdravljenja ne prenaša dobro, je treba po natančni oceni koristi in tveganj razmisliti o zmanjšanju odmerka na 20 mg dvakrat na dan.
English: You should be aware of how you react to the medicine before you drive or use machines.
Slovenian: Zdravilo Granpidam lahko povzroči omotico in vpliva na vid. Preden vozite ali upravljate s stroji, morate vedeti, kako se odzivate na to zdravilo.
English: After oral three times a day dosing of sildenafil, AUC and Cmax increase in proportion with dose over the dose range of 20-40 mg. After oral doses of 80 mg three times a day a more than dose proportional increase in sildenafil plasma levels has been observed.
Slovenian: Po peroralni uporabi sildenafila trikrat na dan se AUC in Cmax v priporočenem razponu odmerkov (od 20 do 40 mg) večata sorazmerno z odmerkom.
English: The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance.
Slovenian: Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje, prehojene med 6-minutnim testom hoje, od izhodišča do 16. tedna.
English: The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance (6MWD).
Slovenian: Glavni opazovani dogodek učinkovitosti je bila sprememba razdalje, prehojene med 6-minutnim testom hoje (6MWD - 6 minute walk distance), od začetka študije do 12. tedna.
English: - if you experience sudden decrease or loss of vision (frequency not known) - if you have an erection, which lasts continuously for more than 4 hours.
Slovenian: - če imate erekcijo, ki neprekinjeno traja več kot 4 ure.
English: NAME OF THE MEDICINAL PRODUCT Granpidam 20 mg tablets sildenafil
Slovenian: Granpidam 20 mg tablete sildenafil
English: NAME OF THE MEDICINAL PRODUCT Granpidam 20 mg film-coated tablets
Slovenian: Granpidam 20 mg filmsko obložene tablete
English: A greater percentage of patients on each of the sildenafil doses (i.e. 28%, 36% and 42% of subjects who received sildenafil 20 mg, 40 mg and 80 mg TID doses, respectively) showed an improvement by at least one WHO functional class at week 12 compared to placebo (7%).
Slovenian: Po 12 tednih je v primerjavi s placebom (7 %) v vseh skupinah s sildenafilom večji odstotek bolnikov kazal izboljšanje vsaj enega funkcijskega razreda po SZO (28 % za bolnike, ki so prejemali 20 mg trikrat na dan; 36 % za bolnike, ki so prejemali 40 mg trikrat na dan in 42 % za bolnike, ki so prejemali 80 mg trikrat na dan).
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,
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
English: Non-arteritic anterior ischaemic optic neuropathy (NAION)*, Retinal vascular occlusion*, Visual field defect*
Slovenian: Žilne bolezni zmanjšanje ostrine vida, diplopija, nenormalni občutki v očesu nearteritična anteriorna ishemična optična nevropatija (NAION)*, zapora mrežnične vene*, izpad vidnega polja*
English: If you experience any of the following side effects you should stop taking Granpidam and contact a doctor immediately (see also section 2):
Slovenian: Če se vam pojavi kateri od naslednjih neželenih učinkov, nemudoma prenehajte z jemanjem zdravila Granpidam in obvestite zdravnika (glejte tudi poglavje 2): - če doživite nenadno poslabšanje ali izgubo vida (pogostnost ni znana).