FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported uncommonly (may affect 1 in 100 people) included: reduced sharpness of vision, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and breast enlargement in men.
Slovenian: Občasno opisani neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) so zmanjšana ostrina vida, dvojni vid, nenormalni občutki v očesu, krvavitev iz penisa, prisotnost krvi v spermi in/ali urinu ter povečanje prsi pri moških.
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: Film coat: hypromellose (15cp) (E464), titanium dioxide (E171), lactose monohydrate, triacetin.
Slovenian: Filmska obloga: hipromeloza (15 cp) (E464), titanov dioksid (E171), laktoza monohidrat, triacetin.
English: Long-term Survival Data in the background epoprostenol study Patients enrolled into the epoprostenol add-on therapy study were eligible to enter a long term open label extension study.
Slovenian: Podatki o dolgoročnem preživetju za študijo, v kateri so bolniki prejemali še epoprostenol Bolniki, vključeni v študijo, v kateri so kot dodatno zdravljenje prejemali še epoprostenol, so bili primerni za dolgoročno odprto podaljšano študijo.
English: High dose (n=27)
Slovenian: Velik odmerek (n = 27)
English: Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers (see section 4.5).
Slovenian: Morebiti bo potrebna prilagoditev odmerka sildenafila med sočasno uporabo z induktorji CYP3A4 (glejte poglavje 4.5).
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 μg etinilestradiola in 150 μg 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: PVC/Alu blisters of 300 tablets.
Slovenian: Pretisni omoti iz PVC/Alu s 300 tabletami.
English: Hypromellose (15 cp) (E464) Titanium dioxide (E171) Lactose monohydrate Triacetin
Slovenian: Filmska obloga: hipromeloza (15 cp) (E464) titanov dioksid (E171) laktoza monohidrat triacetin
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: 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: Table 2: Placebo Corrected % Change from Baseline in Peak VO2 by Active 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 population pharmacokinetic analysis in pulmonary arterial hypertension patients suggested that co-administration of beta-blockers in combination with CYP3A4 substrates might result in an additional increase in sildenafil exposure compared with administration of CYP3A4 substrates alone.
Slovenian: Populacijska farmakokinetična analiza pri bolnikih s pljučno arterijsko hipertenzijo je pokazala, da lahko sočasna uporaba antagonistov beta in substratov CYP3A4 v primerjavi z uporabo substratov CYP3A4 samih, dodatno poveča izpostavljenosti sildenafilu.
English: There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina.
Slovenian: Za PDE5 je 10-krat bolj selektiven kot za PDE6, ki je vključena v fototransdukcijsko pot v mrežnici.
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 mmHg, diastoličnega pa znižanje za 9,1 mmHg.
English: In post-marketing experience with sildenafil for male erectile dysfunction, serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association with the use of sildenafil.
Slovenian: V obdobju trženja so v časovni povezanosti s sildenafilom, uporabljenim za erektilno disfunkcijo pri moških, poročali o resnih kardiovaskularnih dogodkih, vključno z miokardnim infarktom, nestabilno angino pektoris, nenadno srčno smrtjo, ventrikularno aritmijo, cerebrovaskularno krvavitvijo, tranzitorno ishemično atako, hipertenzijo in hipotenzijo.
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 major circulating metabolite results from N-demethylation of sildenafil.
Slovenian: Glavni presnovek v obtoku nastane z N-demetilacijo sildenafila.
English: The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section
Slovenian: Sočasno dajanje zaviralcev PDE5, vključno s sildenafilom, skupaj s stimulatorji gvanilat-ciklaze, kot je riociguat, je kontraindicirano, saj lahko privede do simptomatske hipotenzije (glejte poglavje 4.5).
English: Mean baseline peak volume of oxygen consumed (VO2) values were comparable across the sildenafil treatment groups (17.37 to 18.03 ml/kg/min), and slightly higher for the placebo treatment group (20.02 ml/kg/min).
Slovenian: Povprečne izhodiščne vrednosti največjega volumna porabljenega kisika (VO2) so bile primerljive v vseh skupinah, v katerih so preiskovanci prejemali sildenafil (17,37 do 18,03 ml/kg/min), v skupini, ki je prejemala placebo, pa so bile malo večje (20,02 ml/kg/min).
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: 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: 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: 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: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy and embryonal/foetal development.
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost in razvoj zarodka/plodu, pokazale pa so toksične učinke na postnatalni razvoj (glejte poglavje 5.3).
English: For class II and class III, placebo corrected increases of 49 metres (p = 0.0007) and 45 metres (p = 0.0031) were observed respectively.
Slovenian: in III. razredu so ugotovili placebo korigirani povečanji 49 metrov (p = 0,0007) oz. 45 metrov (p = 0,0031).
English: In the pivotal placebo-controlled study of sildenafil in pulmonary arterial hypertension, a total of 207 patients were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of sildenafil and 70 patients were randomized to placebo.
Slovenian: V ključni, s placebom nadzorovani študiji sildenafila za zdravljenje pljučne arterijske hipertenzije, je skupno 207 bolnikov bilo 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: The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not been studied in pulmonary arterial hypertension patients (see section 4.4).
Slovenian: Varnost in učinkovitost sildenafila, uporabljenega hkrati z drugimi zaviralci PDE5, pri bolnikih s pljučno arterijsko hipertenzijo nista raziskani (glejte poglavje 4.4).
English: Therefore, doses higher than the recommended doses should not be used in paediatric patients with PAH (see also sections 4.2 and 5.1).
Slovenian: Zato se odmerkov, večjih od priporočenih, pri pediatričnih bolnikih s PAH ne sme uporabljati (glejte tudi poglavji 4.2 in 5.1).
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
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: - Therapies for pulmonary hypertension (e.g. bosentan, iloprost) - Medicines containing St. John's Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy) - Blood thinning medicines (for example warfarin) although these did not result in any side effect.
Slovenian: - zdravila, ki vsebujejo šentjanževko (zeliščno zdravilo), rifampicin (uporablja se za zdravljenje bakterijskih okužb), karbamazepin, fenitoin ali fenobarbital (med drugim se uporabljata za zdravljenje epilepsije).
English: Marketing Authorisation Holder Accord Healthcare S.L.U.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Accord Healthcare S.L.U.
English: For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg three times a day for children and adolescents ≤20 kg or 20 mg three times a day for children and adolescents >20 kg, taken with or without food.
Slovenian: Pri otrocih in mladostnikih, starih od 1 leta do 17 let, priporočeni odmerek pri bolnikih s telesno maso ≤ 20 kg znaša 10 mg trikrat na dan, pri bolnikih s telesno maso > 20 kg pa 20 mg trikrat na dan, s hrano ali brez nje.
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: 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: 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: Ne uporabljajte zdravila Granpidam).
English: What Granpidam looks like and contents of the pack White to off white, round shaped, approximately 6.6 mm in diameter, biconvex, film-coated tablets, debossed with ‘20' on one side and plain on other side.
Slovenian: bele do sivkasto bele, okrogle, s premerom približno 6,6 mm, bikonveksne, filmsko obložene tablete, z vtisnjenim znakom »20« na eni strani in brez znakov na drugi strani.
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: In a placebo-controlled study of sildenafil as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with sildenafil (in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day, as tolerated) and epoprostenol, and 131 patients were treated with placebo and epoprostenol.
Slovenian: V študiji, nadzorovani s placebom, v kateri so preučevali sildenafil kot dodatek intravenskemu epoprostenolu pri pljučni arterijski hipertenziji, je skupno 134 bolnikov dobivalo sildenafil (v fiksni titraciji najprej 20 mg, nato 40 mg in 80 mg trikrat na dan, kot so ga prenašali) in epoprostenol, 131 bolnikov pa placebo in epoprostenol.
English: Granpidam contains lactose
Slovenian: Zdravilo Granpidam vsebuje laktozo
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: Cmax after a single 20 mg sildenafil dose administered PO was estimated at 49, 104 and 165 ng/ml for 70, 20 and 10 kg patients, respectively.
Slovenian: Cmax po enkratnem peroralno uporabljenem 20 mg odmerku sildenafila je bila ocenjena na 49, 104 oziroma 165 ng/ml za 70, 20 oziroma 10 kg bolnike.
English: For patients with a baseline 6MWD <325 m improved efficacy was observed with higher doses (placebo-corrected improvements of 58 metres, 65 metres and 87 metres for 20 mg, 40 mg and 80 mg doses TID, respectively).
Slovenian: Pri bolnikih z izhodiščnim 6MWD < 325 m je bila pri večjih odmerkih opažena povečana učinkovitost (za placebo korigirano izboljšanje je bilo za 20 mg sildenafila trikrat na dan 58 metrov, za 40 mg trikrat na dan 65 metrov in za 80 mg trikrat na dan 87 metrov).
English: Warnings and precautions Talk to your doctor before taking Granpidam if you:
Slovenian: Pred začetkom jemanja zdravila Granpidam se posvetujte z zdravnikom, če:
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: Cmax after a single 10 mg sildenafil dose administered PO was estimated at 24, 53 and 85 ng/ml for 70, 20 and 10 kg patients, respectively.
Slovenian: Cmax po enkratnem peroralno uporabljenem 10 mg odmerku sildenafila je bila ocenjena na 24, 53 oziroma 85 ng/ml za 70, 20 oziroma 10 kg bolnike.
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: Other pharmaceutical forms may be more appropriate for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets.
Slovenian: To zdravilo se lahko uporablja samo za odmerjanje 20 mg trikrat na dan. Za uporabo pri bolnikih s telesno maso ≤ 20 kg in pri drugih mlajših bolnikih, ki ne morejo pogoltniti tablet, so lahko primernejše druge farmacevtske oblike.
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: PVC/Alu blisters of 90 tablets.
Slovenian: Pretisni omoti iz PVC/Alu z 90 tabletami.
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: Metabolism and nutrition disorders Common fluid retention
Slovenian: Presnovne in prehranske motnje pogosti zastajanje tekočine
English: Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose (5cp) (E464), magnesium stearate
Slovenian: Jedro tablete: mikrokristalna celuloza, brezvodni kalcijev hidrogenfosfat, premreženi natrijev karmelozat, hipromeloza (5 cp) (E464), magnezijev stearat.
English: For paediatric patients aged 1 year to 17 years old, the recommended dose in patients ≤20 kg is 10 mg three times a day and for patients >20 kg is 20 mg three times a day.
Slovenian: Priporočeni odmerek za pediatrične bolnike med 1. in 17. letom starosti in telesno maso ≤ 20 kg je 10 mg trikrat na dan, za bolnike s telesno maso > 20 kg pa 20 mg trikrat na dan.
English: Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route).
Slovenian: Sildenafil v glavnem odstranjujeta jetrna mikrosomska izoencima CYP3A4 (glavna pot) in CYP2C9 (v manjši meri).
English: The PAH patients included those with primary PAH, and PAH associated with connective tissue disease.
Slovenian: Med bolniki s PAH so bili takšni s primarno PAH in z boleznimi vezivnega tkiva povezano PAH.
English: The following serious adverse events were considered to be treatment related and were reported uncommonly (may affect up to 1 in 100 people), allergic reaction (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsion, irregular heart-beat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to disrupted airflow.
Slovenian: O naslednjih resnih neželenih učinkih, za katere menijo, da so povezani z zdravljenjem, so poročali občasno (pojavijo se lahko pri največ 1 od 100 bolnikov): alergijska reakcija (npr. kožni izpuščaj, otekanje obraza, ustnic in jezika, piskajoče dihanje, težave z dihanjem in požiranjem), epileptični krči, neredno bitje srca, okvara sluha, kratka sapa, vnetje prebavnega trakta, piskajoče dihanje zaradi motenega pretoka zraka.
English: Microcrystalline cellulose Anhydrous calcium hydrogen phosphate Croscarmellose sodium Hypromellose (5 cp) (E464) Magnesium stearate
Slovenian: Jedro tablete: mikrokristalna celuloza bezvodni kalcijev hidrogenfosfat premreženi natrijev karmelozat hipromeloza (5 cp) (E464) magnezijev stearat
English: The following serious adverse events have been reported commonly (may affect up to 1 in 10 people); pneumonia, heart failure, right heart failure, heart related shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral infection in the stomach and intestines, urinary tract infections and tooth cavities.
Slovenian: O naslednjih resnih neželenih učinkih so poročali pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov): pljučnica, srčno popuščanje, popuščanje desne strani srca, z okvaro srca povezan šok, visok krvni tlak v pljučih, bolečina v prsnem košu, omedlevica, okužba dihal, bronhitis, virusna okužba v želodcu in prebavilih, okužba sečil in zobna gniloba.
English: Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients (see section 4.3).
Slovenian: Glede na te farmakokinetične podatke je sočasna uporaba sildenafila z ritonavirjem pri bolnikih s pljučno arterijsko hipertenzijo kontraindicirana (glejte poglavje 4.3).
English: 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: 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).