FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of sildenafil has not been studied in patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) and therefore its use is not recommended.
Croatian: Sigurnost sildenafila nije ispitivana u bolesnika s poznatim nasljednim degenerativnim poremećajima mrežnice, kakav je retinitis pigmentosa (manji dio tih bolesnika ima genetske poremećaje mrežničnih fosfodiesteraza), te se stoga njegova primjena ne preporučuje.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja lijeka nakon rekonstitucije lijeka vidjeti u dijelu 6.3.
English: Subjects (38 % male and 62 % female) had a body weight  8 kg, and had primary pulmonary hypertension (PPH) [33 %], or PAH secondary to congenital heart disease [systemic-to-pulmonary shunt 37 %, surgical repair 30 %].
Croatian: Ispitanici (38% muškog i 62% ženskog spola) su imali tjelesnu težinu  8 kg, a imali su primarnu plućnu hipertenziju (PPH) [33%] ili PAH kao posljedicu prirođene bolesti srca [sistemsko-plućni spoj u 37%, a kirurški zahvat u 30% slučajeva].
English: The powder contains sorbitol.
Croatian: Prašak sadrži sorbitol.
English: Your pharmacist should advise you how to measure the medicine using the oral dosing syringe provided in the pack.
Croatian: Ljekarnik Vam treba objasniti kako ćete odmjeriti dozu lijeka pomoću dozirne štrcaljke za usta priložene u pakiranju.
English: Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated (see sections 4.8 and 5.1).
Croatian: Procijenjeno je istodobno liječenje peroralnim sildenafilom i intravenski primijenjenim epoprostenolom (vidjeti dijelove 4.8 i 5.1).
English: The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all healthcare professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided with the following:
Croatian: Nositelj odobrenja će s nadležnim tijelima u državama članicama dogovoriti pojedinosti o sustavu kontrolirane distribucije bočice od 20 ml lijeka Revatio 0,8 mg/ml otopina za injekciju te u svakoj zemlji mora ustanoviti takav program koji će osigurati da prije propisivanja lijeka svi zdravstveni radnici koji namjeravaju propisivati i/ili izdavati Revatio 0,8 mg/ml otopina za injekciju dobiju sljedeće:
English: • Blood thinning medicines (for example warfarin) although these did not result in any side effects.
Croatian: lijekove za razrjeđivanje krvi (primjerice varfarin), iako oni nisu izazivali nuspojave.
English: Remove the cap.
Croatian: Skinite zatvarač.
English: These medicines are often given for relief of chest pain (or “angina pectoris”).
Croatian: Ti se lijekovi često daju za ublažavanje boli u prsnom košu ("angine pektoris").
English: Revatio with food and drink You should not drink grapefruit juice while you are being treated with Revatio.
Croatian: Ne smijete piti sok od grejpa dok se liječite lijekom Revatio.
English: In this trial, 63 of 234 (27 %) patients were < 7 years old (sildenafil low dose = 2; medium dose = 17; high dose = 28; placebo = 16) and 171 of 234 (73 %) patients were 7 years or older (sildenafil low dose = 40; medium dose = 38; and high dose = 49; placebo = 44).
Croatian: U tom ispitivanju, 63 od 234 (27%) bolesnika bila su mlađa od 7 godina (niska doza sildenafila = 2; srednja doza = 17; visoka doza = 28; placebo = 16), dok je 171 od 234 (73%) bolesnika imao 7 ili više godina (niska doza sildenafila = 40; srednja doza = 38, visoka doza = 49; placebo = 44).
English: In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered (see section 4.3).
Croatian: U slučaju iznenadnog poremećaja vida liječenje lijekom Revatio je potrebno odmah prekinuti i razmotriti zamjensko liječenje (vidjeti dio 4.3).
English: The consequences of the subsequent lower exposure to the active Ndesmethyl metabolite observed after repeated IV administration of Revatio have not been documented.
Croatian: Posljedice kasnije manje izloženosti aktivnom N-dezmetil metabolitu, opažene nakon višekratne intravenske primjene lijeka Revatio, nisu dokumentirane.
English: What Revatio is and what it is used for What you need to know before you take Revatio How to take Revatio
Croatian: Što je Revatio i za što se koristi Što morate znati prije nego počnete uzimati Revatio Kako uzimati Revatio
English: Oral suspension Store below 30°C or in refrigerator (2°C to 8°C).
Croatian: Oralna suspenzija Čuvati na temperaturi ispod 30°C ili u hladnjaku (2°C - 8°C).
English: Slowly pull back the plunger of the oral dosing syringe to the graduation mark that marks the dose for you (withdrawing 1 ml provides a 10 mg dose, withdrawing 2 ml provides a 20 mg dose).
Croatian: Polako izvlačite klip štrcaljke za usta do oznake koja označava Vašu dozu (izvlačenje 1 ml daje dozu od 10 mg, a izvlačenje 2 ml daju dozu od 20 mg).
English: Measure 30 ml of water by filling the measuring cup (included in the carton) to the marked line then pour the water into the bottle.
Croatian: Odmjerite 30 ml vode tako da odmjernu čašicu (priloženu u kutiji lijeka) napunite do oznake, a zatim ulijete vodu u bocu.
English: Revatio powder for oral suspension is for oral use only.
Croatian: Revatio prašak za oralnu suspenziju namijenjen je samo za peroralnu primjenu.
English: The estimated difference between the medium sildenafil dose and placebo was 11.33 % (95 % CI: 1.72 to 20.94) (see Table 2).
Croatian: Procijenjena razlika između srednje doze sildenafila i placeba iznosila je 11,33% (95% CI: 1,72 do 20,94) (vidjeti Tablicu 2).
English: Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Croatian: Ograničeni podaci upućuju na to da nagli prekid primjene lijeka Revatio nije povezan s povratnim pogoršanjem plućne arterijske hipertenzije.
English: For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4.3.
Croatian: Za informacije o primjeni sildenafila s najjačim inhibitorima CYP3A4, vidjeti dio 4.3.
English: Of the 94 subjects reporting a serious adverse event, 14/55 (25.5%) subjects were in the low dose group, 35/74 (47.3%) in the medium dose group, and 45/100 (45%) in the high dose group.
Croatian: Od 94 ispitanika koji su prijavili ozbiljnu nuspojavu, 14/55 (25,5%) ispitanika bili su u skupini s niskom dozom, 35/74 (47,3%) u skupini sa srednjom dozom, i 45/100 (45%) u skupini s visokom dozom.
English: These medicines are often given for relief of angina pectoris or “chest pain” (see section 2.
Croatian: Ti se lijekovi često daju za ublažavanje angine pektoris, odnosno "boli u prsnom košu" (vidjeti dio 2.
English: Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease (see section 5.1).
Croatian: Djelotvornost u smislu poboljšanja tjelesne sposobnosti ili plućne hemodinamike dokazana je u primarnoj plućnoj hipertenziji i plućnoj hipertenziji povezanoj s prirođenom srčanom bolešću (vidjeti dio 5.1).
English: The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/267, 79 %) and PAH associated with connective tissue disease (55/267, 21 %).
Croatian: Obuhvaćeni su bili bolesnici s primarnom plućnom arterijskom hipertenzijom (212/267, 79%) i PAH-om povezanim s bolešću vezivnog tkiva (55/267, 21%).
English: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
Croatian: U kliničkim ispitivanjima, riociguat je pokazao da pojačava hipotenzivni učinak PDE5 inhibitora.
English: Tap the bottle to release the powder.
Croatian: Lupkajte po boci da rastresete prašak.
English: At 3 years 87 % of the patients were receiving a dose of 80 mg TID.
Croatian: Nakon 3 godine je 87% bolesnika primalo dozu od 80 mg TID.
English: In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively were observed.
Croatian: U populacijama bolesnika u ta tri ispitivanja zabilježena je srednja vrijednost dodatnog sniženja sistoličkog i dijastoličkog krvnog tlaka u ležećem položaju od 7/7 mmHg, 9/5 mmHg, odnosno 8/4 mmHg te srednja vrijednost dodatnog sniženja krvnog tlaka u stojećem položaju od 6/6 mmHg, 11/4 mmHg, odnosno 4/5 mmHg.
English: Since there are limited data for intravenous Revatio use and since pharmacokinetic models predict that 20 mg oral and 10 mg intravenous formulations will yield similar plasma exposures, the safety information for intravenous Revatio is supported by that of oral Revatio.
Croatian: Budući da su podaci o intravenskoj primjeni lijeka Revatio ograničeni, a farmakokinetički modeli predviđaju da će peroralna doza od 20 mg i intravenska doza od 10 mg dovesti do podjednake izloženosti lijeka u plazmi, podaci o sigurnosti primjene peroralnog oblika lijeka Revatio podupiru i njegovu intravensku primjenu.
English: 175 patients (63 %) included were diagnosed with primary pulmonary hypertension, 84 (30 %) were diagnosed with PAH associated with connective tissue disease and 18 (7 %) of the patients were diagnosed with PAH following surgical repair of congenital heart lesions.
Croatian: 175 uključenih bolesnika (63%) imalo je dijagnozu primarne plućne hipertenzije, 84 (30%) dijagnozu PAH-a povezanog s bolešću vezivnog tkiva, a 18 (7%) dijagnozu PAH-a nastalog nakon kirurškog popravka prirođenih srčanih lezija.
English: A downward dose adjustment to 10 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Croatian: Snižavanje doze na 10 mg dva puta na dan treba razmotriti nakon pažljive procjene koristi i rizika samo ako bolesnik dobro ne podnosi lijek.
English: A total of 134 patients were treated with Revatio in the initial study, and their long term survival status was assessed for a minimum of 3 years.
Croatian: U inicijalnom su ispitivanju lijekom Revatio liječena ukupno 134 bolesnika te je praćeno njihovo dugoročno preživljenje tijekom najmanje 3 godine.
English: At 3 years 68 % of the patients were receiving a dose of 80 mg TID.
Croatian: Nakon 3 godine je 68% bolesnika primalo dozu od 80 mg TID.
English: How to take Revatio
Croatian: Kako uzimati Revatio
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.
Croatian: Snižavanje doze na 20 mg dva puta na dan treba razmotriti nakon pažljive procjene koristi i rizika samo ako bolesnik dobro ne podnosi lijek.
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.
Croatian: Drugi farmaceutski oblici mogu biti primjereniji za primjenu u bolesnika koji imaju 20kg ili manje i udrugih mlađih bolesnika koji ne mogu progutati tablete.
English: The proportion of subjects receiving supportive medicinal products at baseline (anticoagulants, digoxin, calcium channel blockers, diuretics and/or oxygen) was similar in the combined sildenafil treatment group (47.7 %) and the placebo treatment group (41.7 %).
Croatian: Udio ispitanika koji su na početku liječenja primali potpornu terapiju (antikoagulanse, digoksin, blokatore kalcijevih kanala, diuretike i/ili kisik) bio je podjednak u kombiniranoj skupini liječenoj sildenafilom (47,7%) i skupini koja je primala placebo (41,7%).
English: Combination with the most potent of the CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) (see section 4.5).
Croatian: Kombinacija s najjačim inhibitorima CYP3A4 (npr. ketokonazolom, itrakonazolom, ritonavirom) (vidjeti dio 4.5).
English: Patients were naïve for specific PAH therapy and the use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted in the study, and neither was arginine supplementation, nitrates, alpha-blockers and potent CYP450 3A4 inhibitors.
Croatian: Bolesnici prethodno nisu primali terapiju specifičnu za PAH, a u ispitivanju nije bila dopuštena primjena prostaciklina, analoga prostaciklina i antagonista endotelinskih receptora kao ni uzimanje nadomjestaka arginina, nitrata, alfa-blokatora i jakih inhibitora izoenzima CYP3A4 citokroma P450.
English: Subjects who had been in the placebo group in the shortterm study were randomly reassigned to sildenafil treatment; subjects weighing ≤ 20 kg entered the medium or high dose groups (1:1), while subjects weighing > 20 kg entered the low, medium or high dose groups (1:1:1).
Croatian: Ispitanici koji su bili u skupini koja je primala placebo u kratkotrajnom ispitivanju, bili su ponovno randomizirani za liječenje sildenafilom; ispitanici tjelesne težine ≤ 20 kg uključeni su u skupine sa srednjom ili visokom dozom (1:1), a ispitanici tjelesne težine > 20 kg uključeni su u skupine s niskom, srednjom ili visokom dozom (1:1:1).
English: When used to treat male erectile dysfunction (ED), the following visual side effects have been reported with PDE5 inhibitors, including sildenafil at an unknown frequency; partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.
Croatian: Kod primjene inhibitora PDE5, uključujući sildenafil, u liječenju muške erekcijske disfunkcije prijavljene su sljedeće očne nuspojave: djelomično, iznenadno, privremeno ili trajno smanjenje ili gubitak vida na jednom ili oba oka.
English: If you forget to take Revatio
Croatian: Ako ste zaboravili uzeti Revatio
English: There was no evidence of favourable clinical effect of the combination in the population studied.
Croatian: U ispitivanoj skupini nije dokazan povoljan klinički učinak kombinirane terapije.
English: What Revatio looks like and contents of the pack Revatio film-coated tablets are white and round in shape.
Croatian: Revatio filmom obložene tablete su bijele i okrugle.
English: If you receive more Revatio than you should If you are concerned that you may have been given too much Revatio, tell your doctor or nurse immediately.
Croatian: Ako se brinete da ste možda primili previše lijeka Revatio, odmah o tome obavijestite svog liječnika ili medicinsku sestru.
English: For patients with primary PAH, the treatment effect was 31.1 metres compared to 7.7 metres for patients with PAH associated with connective tissue disease.
Croatian: U bolesnika s primarnim PAH-om je učinak liječenja bio 31,1 metar, u usporedbi sa 7,7 metara u bolesnika s PAH-om povezanim s bolešću vezivnog tkiva.
English: 1 press-in bottle adapter, 1 measuring cup and 1 oral dosing syringe
Croatian: 1 nastavak za bocu, 1 odmjerna čašica i 1 dozirna štrcaljka za usta
English: Revatio 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).
Croatian: Revatio se koristi za liječenje odraslih bolesnika te djece i adolescenata u dobi od 1 do 17 godina koji imaju visok krvni tlak u krvnim žilama u plućima (plućnu arterijsku hipertenziju).
English: Doses up to 80 mg TID were administered and after 3 years 68 % of 133 patients on study treatment were receiving Revatio 80 mg TID.
Croatian: Primjenjivale su se doze do 80 mg tri puta na dan te je nakon 3 godine 68% od 133 bolesnika liječenih ispitivanim lijekom primalo Revatio u dozi od 80 mg TID.
English: If you stop taking Revatio
Croatian: Ako prestanete uzimati Revatio
English: Manufacturer: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Croatian: Proizvođač: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Francuska.
English: What Revatio looks like and contents of the pack Revatio is supplied as a white to off-white powder for oral suspension providing a white, grape flavoured oral suspension when constituted with water.
Croatian: Revatio se isporučuje u obliku bijelog do bjelkastog praška za oralnu suspenziju, od kojeg nakon pripreme s vodom nastaje bijela oralna suspenzija s okusom grožđa.
English: Women of childbearing potential and contraception in males and females Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Croatian: Zbog nedostatka podataka o učincima lijeka Revatio u trudnica ne preporučuje se primjena lijeka Revatio u žena reproduktivne dobi, osim ako istodobno ne primjenjuju odgovarajuće mjere kontracepcije.
English: The most potent of the CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects similar to ritonavir (see section 4.3).
Croatian: Za očekivati je da će najjači inhibitori CYP3A4, poput ketokonazola i itrakonazola, imati slične učinke kao ritonavir (vidjeti dio 4.3).
English: The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients.
Croatian: Tableta od 20 mg se ne bi trebala koristiti u slučajevima kada treba primijeniti
English: Tap the bottle to release the powder and remove the cap.
Croatian: Lupkajte po boci da rastresete prašak i skinite zatvarač.
English: Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11 %), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Croatian: Sildenafil nije imao značajan učinak na izloženost atorvastatinu (AUC povećan za 11%), što upućuje na to da sildenafil nema klinički značajan učinak na CYP3A4.
English: Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Croatian: Riociguat: Neklinička ispitivanja su pokazala dodatan učinak na sniženje sistemskog krvnog tlaka kada se PDE5 inhibitori koriste u kombinaciji sa riociguatom.
English: If you miss a dose of Revatio
Croatian: Ako ste propustili dozu lijeka Revatio
English: No clinical data is available for sildenafil IV administration in patients who are clinically or haemodynamically unstable.
Croatian: Nema kliničkih podataka o intravenskoj primjeni sildenafila u bolesnika koji su klinički ili hemodinamički nestabilni.
English: If you have an erection, which lasts continuously for more than 4 hours, stop taking Revatio and contact your doctor immediately (see also section 4).
Croatian: Ako imate erekciju, koja neprekidno traje dulje od 4 sata, prestanite uzimati Revatio i odmah se javite liječniku (pogledajte i dio 4).
English: Any remaining oral suspension should be discarded 30 days after constitution.
Croatian: Preostalu oralnu suspenziju treba baciti 30 dana nakon pripreme.
English: If reconstituted, the oral suspension is in a liquid form.
Croatian: Ako je pripremljena, oralna suspenzija je tekućina.
English: Revatio 20 mg tablets Sildenafil
Croatian: Revatio 20 mg tablete sildenafil
English: The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
Croatian: Nije utvrđena djelotvornost lijeka Revatio u bolesnika s teškom plućnom arterijskom hipertenzijom (funkcionalni stupanj IV).
English: *These adverse events/reactions have been reported in patients taking sildenafil for the treatment of male erectile dysfunction (MED).
Croatian: *Ove nuspojave koje su prijavljene u bolesnika koji su uzimali sildenafil za liječenje muške erekcijske disfunkcije.
English: The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as addon therapy, and neither was arginine supplementation.
Croatian: Nije bila dopuštena primjena prostaciklina, analoga prostaciklina ni antagonista endotelinskih receptora kao dodatne terapije, kao ni nadomještanje arginina.
English: Store below 30°C or in refrigerator at 2ºC to 8°C.
Croatian: Čuvati na temperaturi ispod 30°C ili u hladnjaku na temperaturi od 2°C do 8°C.
English: An additional 5 deaths were reported subsequently.The causes of deaths were related to PAH.
Croatian: Naknadno je prijavljeno još 5 smrtnih slučajeva.
English: Effects of other medicinal products on intravenous sildenafil Predictions based on a pharmacokinetic model suggest that drug-drug interactions with CYP3A4 inhibitors should be less than observed after oral sildenafil administration.
Croatian: Učinci drugih lijekova na sildenafil primijenjen intravenski Predviđanja na temelju farmakokinetičkog modela upućuju na to da bi interakcije s inhibitorima CYP3A4 trebale biti manje od onih zabilježenih nakon peroralne primjene sildenafila.
English: 5 % glucose solution sodium chloride 9 mg/ml (0.9 %) solution Lactated Ringer's solution 5 % glucose/0.45 % sodium chloride solution 5 % glucose/lactated Ringer's solution 5 % glucose/20 mEq potassium chloride solution
Croatian: 5 %-tnom otopinom glukoze/ 0,45 %-tnom otopinom natrijevog klorida 5 %-tnom otopinom glukoze/ otopinom Ringerovog laktata 5 %-tnom otopinom glukoze/ otopinom kalijevog klorida od 20 mEq
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.
Croatian: Izloženost sildenafilu u bolesnika koji su uzimali supstrate CYP3A4 bila je 43% veća, a u onih koji su uzimali supstrate CYP3A4 s beta-blokatorima 66% veća u usporedbi s bolesnicima koji nisu uzimali lijekove iz navedenih skupina.
English: • 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).
Croatian: lijekove koji sadrže gospinu travu (biljni lijek), rifampicin (koristi se za liječenje bakterijskih infekcija), karbamazepin, fenitoin i fenobarbital (koriste se, između ostalog, za liječenje epilepsije).
English: Using the cup measure another 30 ml of water and add this to the bottle.
Croatian: Pomoću odmjerne čašice odmjerite novih 30 ml vode i dodajte je u bocu.
English: In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (> 70 % stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7 % and 6 % respectively compared to baseline.
Croatian: U ispitivanju hemodinamičkih učinaka jedne peroralne doze od 100 mg sildenafila u 14 bolesnika s teškom bolešću koronarnih arterija (stenoza > 70% u barem jednoj koronarnoj arteriji), srednja vrijednost sistoličkog krvnog tlaka u mirovanju snižena je za 7%, a dijastoličkog za 6% u odnosu na početne vrijednosti.
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.
Croatian: Ukupna učestalost prekida liječenja u bolesnika liječenih sildenafilom u dozama od 20 mg, 40 mg i 80 mg TID iznosila je 2,9%, 3,0% odnosno 8,5%, u odnosu na 2,9% kod primjene placeba.
English: Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John's wort and rifampicine.
Croatian: Mora se pomno nadzirati djelotvornost sildenafila u bolesnika koji istodobno uzimaju jake induktore CYP3A4, poput karbamazepina, fenitoina, fenobarbitala, gospine trave i rifampicina.
English: 23 subjects experienced clinical worsening events in the placebo group (17.6 %) compared with 8 subjects in the sildenafil group (6.0 %).
Croatian: U skupini koja je primala placebo, epizode kliničkog pogoršanja doživjela su 23 ispitanika (17,6%) u usporedbi s 8 ispitanika u skupini liječenoj sildenafilom (6,0%).