natgillin/translations-raw huggingface dataset:
The primary objective of the study was to assess the efficacy of 16 weeks of chronic treatment with oral sildenafil in paediatric subjects to improve exercise capacity as measured by the Cardiopulmonary Exercise Test (CPET) in subjects who were developmentally able to perform the test, n = 115). 
Primarni cilj ispitivanja bio je procijeniti djelotvornost 16-tjednog kroničnog peroralnog liječenja sildenafilom u pedijatrijskih ispitanika na poboljšanje tjelesne sposobnosti, mjereno testom srčanoplućnog opterećenja (CPET test) u ispitanika koji su s obzirom na stupanj razvoja bili sposobni izvesti taj test (n = 115).
Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse France 
Fareva Amboise Zone Industrielle 29 route des Industries 37530 Pocé-sur-Cisse Francuska
The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (eg, ambrisentan, iloprost) has not been studied in controlled clinical trials. 
Djelotvornost i sigurnost sildenafila primijenjenog istodobno s drugim lijekovima za plućnu arterijsku hipertenziju (npr. ambrisentan, iloprost) nije ispitana u kontroliranim kliničkim ispitivanjima.
In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n = 9), sildenafil (single dose, 100 mg) demonstrated no significant changes in visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress). 
U malom, placebom kontroliranom ispitivanju u bolesnika s dokumentiranom, ranom, dobno uvjetovanom degeneracijom makule (n = 9), sildenafil (jedna doza od 100 mg) nije pokazao značajne promjene u provedenim testovima vida (oštrina vida, Amslerova mreža, razlikovanje boja simulacijom semafora, Humphreyev perimetar i fotostres test).
Blood and lymphatic system disorders Common anaemia 
Poremećaji krvi i limfnog sustava često anemija
Other pharmaceutical forms are available for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets. 
Drugi farmaceutski oblici su dostupni za primjenu u bolesnika tjelesne težine ≤ 20 kg i drugih mlađih bolesnika koji ne mogu progutati tablete.
Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets. 
Revatio otopina za injekciju predstavlja zamjenski oblik lijeka Revatio za bolesnike koji privremeno ne mogu uzimati Revatio tablete.
Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 90 % higher plasma concentrations of sildenafil and the active N-desmethyl metabolite compared to those seen in healthy younger volunteers (18-45 years). 
Zdravi stariji dobrovoljci (65 ili više godina) su imali smanjen klirens sildenafila, što je rezultiralo približno 90% višim plazmatskim koncentracijama sildenafila i aktivnog N-dezmetil metabolita u odnosu na one u zdravih mlađih dobrovoljaca (18-45 godina).
Revatio solution for injection is for intravenous use as a bolus injection. 
Revatio otopina za injekciju namijenjena je samo za intravensku primjenu u obliku bolusne injekcije.
Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. 
Sildenafil, stoga, povećava koncentracije cGMP-a u glatkim mišićnim stanicama krvnih žila u plućima, što dovodi do njihova opuštanja.
In study A1481262 Cmax, CL and AUC (0-8) of 248 ng/ml, 30.3 l/h and 330 ng h/ml, were observed respectively. 
U ispitivanju A1481262 zabilježeni su Cmax od 248 ng/ml, klirens od 30,3 l/h i AUC(0-8) od 330 ng.h/ml.
You should always add a total of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking (figure 3). 
Uvijek morate dodati ukupno 90 ml (3 x 30 ml) vode bez obzira na dozu koju uzimate. (slika 3)
Reconstituted oral suspension 
Pripremljena oralna suspenzija
The magnitude of the interaction is expected to be reduced for intravenous sildenafil, as interactions for oral sildenafil are due, at least in part, to effects on oral first pass metabolism. 
Očekuje se da će kod intravenske primjene sildenafila opseg interakcija biti manji jer su interakcije kod peroralne primjene barem djelomično posljedica učinaka metabolizma prvog prolaza kroz jetru.
• Medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), as your dose may need to be adjusted. 
lijekove koji sadrže eritromicin, klaritromicin, telitromicin (to su antibiotici koji se koriste za liječenje nekih bakterijskih infekcija), sakvinavir (za liječenje HIV infekcije) ili nefazodon (za liječenje depresije), jer će možda trebati prilagoditi dozu.
The recommended dose is 10 mg (corresponding to 12.5 ml) three times a day administered as an intravenous bolus injection (see section 6.6). 
Preporučena doza je 10 mg (što odgovara 12,5 ml) tri puta na dan, a primjenjuje se u obliku intravenske bolusne injekcije (vidjeti dio 6.6).
PVC/Aluminium blisters of 90 tablets. 
PVC/aluminij blisteri sa 90 tableta.
Add a total of 90 ml of water (3 x 30 ml) strictly following the package leaflet, ensuring the bottle is shaken vigorously after adding 60 ml and the remaining 30 ml. 
Dodajte ukupno 90 ml vode (3 x 30 ml) pažljivo slijedeći uputu o lijeku te snažno protresite nakon što ste dodali 60 ml i preostalih 30 ml.
Any unused oral suspension should be discarded or returned to your pharmacist after this date. 
Nakon tog datuma neupotrijebljenu oralnu suspenziju treba baciti ili vratiti ljekarniku.
Infections and infestations Common cellulitis,influenza, bronchitis, sinusitis, rhinitis, gastroenteritis 
Infekcije i infestacije često celulitis, gripa, bronhitis, sinusitis, rinitis, gastroenteritis
Reconstitution instructions: 
Upute za pripremu:
Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were administered and after 3 years 87 % of 183 patients on study treatment were receiving Revatio 80 mg TID. 
Primjenjivale su se doze do 80 mg tri puta na dan (4 puta više od preporučene doze od 20 mg tri puta na dan), a nakon 3 godine je 87% od 183 bolesnika liječenih ispitivanim lijekom primalo Revatio u dozi od 80 mg TID.
Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets. 
Nuspojave koje su prijavljene u kliničkim ispitivanjima u kojima se Revatio primjenjivao intravenski bile su slične onima prijavljenima u kliničkim ispitivanjima Revatio tableta.
There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study. 
Zabilježena je jedna ozbiljna nuspojava u ispitanika s teškom ishemijskom kardiomiopatijom, u kojeg je 6 dana nakon ispitivanja došlo do ventrikularne fibrilacije te je nastupila smrt.
90 x 1 tablets in PVC/Aluminium perforated unit dose blisters. 
90x1 tableta u PVC/aluminij perforiranim blisterima s jediničnim dozama.
• Therapies for pulmonary hypertension (e.g. bosentan, iloprost). 
lijekove za liječenje plućne hipertenzije (npr. bosentan, iloprost).
Once reconstituted one bottle contains 1.12 g of sildenafil (as citrate) with a final volume of 112 ml. 
Nakon pripreme, jedna boca sadrži 1,12 g sildenafila (u obliku sildenafilcitrata) u konačnom volumenu od 112 ml.
Powder: Do not store above 30°C. 
Prašak: Ne čuvati na temperaturi iznad 30°C.
Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary. 
Zbog nedostatnih podataka Revatio se ne smije primjenjivati u trudnica, osim ako to nije izričito potrebno.
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. 
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.
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
Uvjete čuvanja lijeka nakon rekonstitucije lijeka vidjeti u dijelu 6.3.
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 %]. 
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].
The powder contains sorbitol. 
Prašak sadrži sorbitol.
Your pharmacist should advise you how to measure the medicine using the oral dosing syringe provided in the pack. 
Ljekarnik Vam treba objasniti kako ćete odmjeriti dozu lijeka pomoću dozirne štrcaljke za usta priložene u pakiranju.
Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated (see sections 4.8 and 5.1). 
Procijenjeno je istodobno liječenje peroralnim sildenafilom i intravenski primijenjenim epoprostenolom (vidjeti dijelove 4.8 i 5.1).
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: 
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:
• Blood thinning medicines (for example warfarin) although these did not result in any side effects. 
lijekove za razrjeđivanje krvi (primjerice varfarin), iako oni nisu izazivali nuspojave.
Remove the cap. 
Skinite zatvarač.
These medicines are often given for relief of chest pain (or “angina pectoris”). 
Ti se lijekovi često daju za ublažavanje boli u prsnom košu ("angine pektoris").
Revatio with food and drink You should not drink grapefruit juice while you are being treated with Revatio. 
Ne smijete piti sok od grejpa dok se liječite lijekom Revatio.
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). 
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).
In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered (see section 4.3). 
U slučaju iznenadnog poremećaja vida liječenje lijekom Revatio je potrebno odmah prekinuti i razmotriti zamjensko liječenje (vidjeti dio 4.3).
The consequences of the subsequent lower exposure to the active Ndesmethyl metabolite observed after repeated IV administration of Revatio have not been documented. 
Posljedice kasnije manje izloženosti aktivnom N-dezmetil metabolitu, opažene nakon višekratne intravenske primjene lijeka Revatio, nisu dokumentirane.
What Revatio is and what it is used for What you need to know before you take Revatio How to take Revatio 
Što je Revatio i za što se koristi Što morate znati prije nego počnete uzimati Revatio Kako uzimati Revatio
Oral suspension Store below 30°C or in refrigerator (2°C to 8°C). 
Oralna suspenzija Čuvati na temperaturi ispod 30°C ili u hladnjaku (2°C - 8°C).
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). 
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).
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. 
Odmjerite 30 ml vode tako da odmjernu čašicu (priloženu u kutiji lijeka) napunite do oznake, a zatim ulijete vodu u bocu.
Revatio powder for oral suspension is for oral use only. 
Revatio prašak za oralnu suspenziju namijenjen je samo za peroralnu primjenu.
The estimated difference between the medium sildenafil dose and placebo was 11.33 % (95 % CI: 1.72 to 20.94) (see Table 2). 
Procijenjena razlika između srednje doze sildenafila i placeba iznosila je 11,33% (95% CI: 1,72 do 20,94) (vidjeti Tablicu 2).
Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension. 
Ograničeni podaci upućuju na to da nagli prekid primjene lijeka Revatio nije povezan s povratnim pogoršanjem plućne arterijske hipertenzije.
For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4.3. 
Za informacije o primjeni sildenafila s najjačim inhibitorima CYP3A4, vidjeti dio 4.3.
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. 
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.
These medicines are often given for relief of angina pectoris or “chest pain” (see section 2. 
Ti se lijekovi često daju za ublažavanje angine pektoris, odnosno "boli u prsnom košu" (vidjeti dio 2.
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). 
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).
The PAH patients included those with Primary Pulmonary Arterial Hypertension (212/267, 79 %) and PAH associated with connective tissue disease (55/267, 21 %). 
Obuhvaćeni su bili bolesnici s primarnom plućnom arterijskom hipertenzijom (212/267, 79%) i PAH-om povezanim s bolešću vezivnog tkiva (55/267, 21%).
In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. 
U kliničkim ispitivanjima, riociguat je pokazao da pojačava hipotenzivni učinak PDE5 inhibitora.
Tap the bottle to release the powder. 
Lupkajte po boci da rastresete prašak.
At 3 years 87 % of the patients were receiving a dose of 80 mg TID. 
Nakon 3 godine je 87% bolesnika primalo dozu od 80 mg TID.
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. 
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.
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. 
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.
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. 
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.
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. 
Snižavanje doze na 10 mg dva puta na dan treba razmotriti nakon pažljive procjene koristi i rizika samo ako bolesnik dobro ne podnosi lijek.
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. 
U inicijalnom su ispitivanju lijekom Revatio liječena ukupno 134 bolesnika te je praćeno njihovo dugoročno preživljenje tijekom najmanje 3 godine.
At 3 years 68 % of the patients were receiving a dose of 80 mg TID. 
Nakon 3 godine je 68% bolesnika primalo dozu od 80 mg TID.
How to take Revatio 
Kako uzimati Revatio
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. 
Snižavanje doze na 20 mg dva puta na dan treba razmotriti nakon pažljive procjene koristi i rizika samo ako bolesnik dobro ne podnosi lijek.
Other pharmaceutical forms may be more appropriate for administration to patients ≤ 20 kg and other younger patients who are not able to swallow tablets. 
Drugi farmaceutski oblici mogu biti primjereniji za primjenu u bolesnika koji imaju 20kg ili manje i udrugih mlađih bolesnika koji ne mogu progutati tablete.
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 %). 
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%).
Combination with the most potent of the CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir) (see section 4.5). 
Kombinacija s najjačim inhibitorima CYP3A4 (npr. ketokonazolom, itrakonazolom, ritonavirom) (vidjeti dio 4.5).
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. 
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.
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). 
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).
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. 
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.
If you forget to take Revatio 
Ako ste zaboravili uzeti Revatio
There was no evidence of favourable clinical effect of the combination in the population studied. 
U ispitivanoj skupini nije dokazan povoljan klinički učinak kombinirane terapije.
What Revatio looks like and contents of the pack Revatio film-coated tablets are white and round in shape. 
Revatio filmom obložene tablete su bijele i okrugle.
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. 
Ako se brinete da ste možda primili previše lijeka Revatio, odmah o tome obavijestite svog liječnika ili medicinsku sestru.
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. 
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.
1 press-in bottle adapter, 1 measuring cup and 1 oral dosing syringe 
1 nastavak za bocu, 1 odmjerna čašica i 1 dozirna štrcaljka za usta
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). 
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).
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. 
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.
If you stop taking Revatio 
Ako prestanete uzimati Revatio
Manufacturer: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France. 
Proizvođač: Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Francuska.
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. 
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.
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. 
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.
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). 
Za očekivati je da će najjači inhibitori CYP3A4, poput ketokonazola i itrakonazola, imati slične učinke kao ritonavir (vidjeti dio 4.3).
The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients. 
Tableta od 20 mg se ne bi trebala koristiti u slučajevima kada treba primijeniti