FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients with pulmonary arterial hypertension, the average steady state concentrations were 20-50 % higher over the investigated oral dose range of 20-80 mg three times a day compared to healthy volunteers.
Croatian: U bolesnika s plućnom arterijskom hipertenzijom, prosječne koncentracije u stanju dinamičke ravnoteže su u ispitivanom rasponu peroralnih doza od 20 do 80 mg tri puta na dan bile 20-50% više nego u zdravih dobrovoljaca.
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 %).
Croatian: Poboljšanje za najmanje jedan SZO funkcionalni stupanj pokazao je u 12. tjednu veći postotak bolesnika na svakoj dozi sildenafila (tj. u 28% ispitanika koji su primali dozu od 20 mg, u 36% ispitanika koji su primali dozu od 40 mg i u 42% ispitanika koji su primali dozu od 80 mg TID), u usporedbi s bolesnicima koji su primali placebo (7%).
English: figure 7
Croatian: slika 7
English: Each pack contains one 20 ml clear, type I glass vial with a chlorobutyl rubber stopper and an aluminium overseal.
Croatian: Jedno pakiranje sadrži jednu prozirnu staklenu bočicu od 20 ml (staklo tipa I), s klorobutilnim gumenim čepom i aluminijskim zaštitnim zatvaračem.
English: For patients with a low baseline 6 MWD < 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).
Croatian: U bolesnika čiji je početni 6MWD bio < 325 metara opažena je poboljšana djelotvornost kod primjene viših doza (poboljšanje korigirano za placebo za 58 metara pri dozi od 20 mg TID, za 65 metara pri dozi od 40 mg TID te za 87 metara pri dozi od 80 mg TID).
English: figure 6
Croatian: slika 6
English: In clinical trials the side effects reported commonly (may affect up to 1 in 10 people) were facial flushing, headache, low blood pressure and nausea.
Croatian: Nuspojave koje su u kliničkim ispitivanjima prijavljene često (mogu se javiti u do 1 na 10 osoba) bile su: navale crvenila, glavobolja, nizak krvni tlak i mučnina.
English: A downward dose adjustment to 10 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir.
Croatian: Mora se razmotriti snižavanje doze na 10 mg dva puta na dan kada se sildenafil primjenjuje u bolesnika koji već primaju inhibitore CYP3A4 poput eritromicina ili sakvinavira.
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.
Croatian: Osim toga, vrijednosti AUC i Cmax N-dezmetil metabolita bile su značajno povećane (154% odnosno 87%) u ispitanika s cirozom u odnosu na ispitanike s normalnom funkcijom jetre.
English: - The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.
Croatian: Jezgra tablete: mikrokristalična celuloza, kalcijev hidrogenfosfat (bezvodni), umrežena karmelozanatrij, magnezijev stearat.
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.
Croatian: Međutim, za ispitanike s PAH-om povezanim s bolešću vezivnog tkiva (36 ispitanika), srednje vrijednosti promjena u odnosu na početne vrijednosti bile su -18,32 m (95% CI:65,66 do 29,02) za skupinu koja je primala sildenafil odnosno 17,50 m (95% CI: -9,41 do 44,41), za skupinu koja je primala placebo.
English: Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Croatian: Jedna filmom obložena tableta sadrži 20 mg sildenafila (u obliku sildenafilcitrata).
English: A downward dose adjustment to 10 mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone.
Croatian: Preporučuje se snižavanje doze na 10 mg jedanput na dan u slučaju istodobne primjene s jakim inhibitorima CYP3A4 poput klaritromicina, telitromicina i nefazodona.
English: For children and adolescents aged 1 year to 17 years old, the recommended dose is either 10 mg (1 ml of oral suspension) three times a day for children and adolescents weighing 20 kg or under, or 20 mg (2 ml of oral suspension) three times a day for children and adolescents weighing over 20 kg, taken with or without food.
Croatian: Za djecu i adolescente u dobi od 1 do 17 godina preporučena doza je ili 10 mg (1 ml oralne suspenzije) tri puta na dan ako im je tjelesna težina 20 kg ili manja, ili 20 mg (2 ml oralne suspenzije) tri puta na dan ako im je tjelesna težinaveća od20kg.
English: In the two-placebo controlled oral Revatio studies adverse events were generally mild to moderate in severity.
Croatian: U ta dva placebom kontrolirana ispitivanja peroralne primjene lijeka Revatio štetni događaji su općenito bili blagi do umjereni u težini.
English: Turn the bottle upside down while holding the oral dosing syringe in place.
Croatian: Držeći štrcaljku za usta na mjestu, preokrenite bocu u uspravan položaj.
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.
Croatian: Podaci o dugoročnom preživljenju u populaciji prethodno neliječenih bolesnika Bolesnici uključeni u pivotalno ispitivanje s peroralnom primjenom lijeka bili su pogodni za ulazak u dugotrajan produžetak otvorenog ispitivanja.
English: When prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by sildenafil's mild to moderate vasodilatory effects, for example patients with hypotension, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction (see section 4.4)
Croatian: Kad propisuju sildenafil, liječnici moraju pažljivo razmotriti hoće li blagi do umjereni vazodilatacijski učinci sildenafila štetno utjecati na bolesnike s određenim podležećim stanjima, kao što su hipotenzija, gubitak tekućine, teška opstrukcija istisnog dijela lijeve klijetke ili autonomna disfunkcija (vidjeti dio
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 %).
Croatian: U skupini koja je primala srednju dozu sildenafila uočeno je smanjenje indeksa plućnog krvožilnog otpora u odnosu na placebo za 18% (95% CI: 2% do 32%), a u skupini koja je primala visoku dozu smanjenje za 27% (95% CI: 14% do 39%), dok u skupini koja je primala nisku dozu sildenafila nije zabilježena značajna razlika u odnosu na placebo (razlika od 2%).
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.
Croatian: Većina bolesnika imala je bolest funkcionalnog stupnja II (68/267, 26%) ili III (175/267, 66%) prema SZO klasifikaciji.
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.
Croatian: Osim toga, vrijednosti AUC i Cmax N-dezmetil metabolita bile su značajno povećane (200% odnosno 79%) u ispitanika s teškim oštećenjem bubrega u odnosu na ispitanike s normalnom funkcijom bubrega.
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the oral bioavailability of sildenafil.
Croatian: Pojedinačne doze antacida (magnezijev hidroksid/aluminijev hidroksid) nisu utjecale na bioraspoloživost sildenafila nakon peroralne primjene.
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 %).
Croatian: Postotno smanjenje plućnog krvožilnog otpora nakon 12 tjedana primjene sildenafila u dozama od 20 mg, 40 mg odnosno 80 mg TID (11,2%, 12,9% odnosno 23,3%) bilo je razmjerno veće od smanjenja sustavnog krvožilnog otpora (7,2%, 5,9%, odnosno 14,4%).
English: Wash the oral dosing syringe as instructed below.
Croatian: Operite štrcaljku za usta prema uputama u nastavku.
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.
Croatian: Većina ispitanika imala je bolest funkcionalnog stupnja I (75/234, 32%) ili II (120/234, 51%) prema SZO klasifikaciji.
English: Each ml of solution contains 0.8 mg of sildenafil (as citrate).
Croatian: Jedan ml otopine sadrži 0,8 mg sildenafila (u obliku sildenafilcitrata).
English: When constituted the powder provides a white grape flavoured oral suspension.
Croatian: Nakon pripreme, iz praška nastaje bijela oralna suspenzija s okusom grožđa.
English: Sildenafil exposure was 5-fold higher at an oral dose of 80 mg three times a day compared to the exposure at an oral dose of 20 mg three times a day.
Croatian: Izloženost sildenafilu pri peroralnoj dozi od 80 mg tri puta na dan bila je peterostruko veća u odnosu na izloženost pri peroralnoj dozi od 20 mg tri puta na dan.
English: Effects of other medicinal products on oral sildenafil
Croatian: Učinci drugih lijekova na sildenafil primijenjen peroralno
English: Placebo-corrected treatment effects with mPAP were -2.7 mm Hg (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.
Croatian: Učinci liječenja na srednju vrijednost plućnog arterijskog tlaka, korigirani za placebo, bili su -2,7 mmHg (p = 0,04) kod primjene sildenafila u dozi od 20 mg TID, -3,0 mmHg (p = 0,01) kod primjene sildenafila u dozi od 40 mg TID te -5,1 mmHg (p < 0,0001) kod primjene sildenafila u dozi od 80 mg TID.
English: A downward dose adjustment to 20 mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors clarithromycin, telithromycin and nefazodone.
Croatian: Preporučuje se snižavanje doze na 20 mg jedanput na dan u slučaju istodobne primjene s jakim inhibitorima CYP3A4: klaritromicinom, telitromicinom i nefazodonom.
English: In the pivotal placebo-controlled study of Revatio 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 oral Revatio and 70 patients were randomized to placebo.
Croatian: U pivotalnom placebom kontroliranom ispitivanju lijeka Revatio u liječenju plućne arterijske hipertenzije ukupno je 207 bolesnika randomizirano na liječenje lijekom Revatio u peroralnoj dozi od 20 mg, 40 mg ili 80 mg TID, dok je 70 bolesnika randomizirano na placebo.
English: In clinical trials with Revatio tablets 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.
Croatian: U kliničkim ispitivanjima Revatio tableta nuspojave koje su prijavljene vrlo često (mogu se javiti u više od 1 na 10 osoba) bile su: glavobolja, navale crvenila lica, probavne smetnje, proljev i bol u rukama ili nogama.
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.
Croatian: CPET test se mogao provesti u ukupno 106 od 234 ispitanika (45%), koji su obuhvaćali djecu u dobi od ≥ 7 godina i razvojno sposobnu za izvođenje testa.
English: Microcrystalline cellulose Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete: celuloza, mikrokristalična kalcijev hidrogenfosfat (bezvodni) karmelozanatrij, umrežena magnezijev stearat
English: At steady state plasma concentrations of N-desmethyl metabolite are approximately 16 % versus 61 % those of sildenafil after IV and oral dosing, respectively.
Croatian: N-dezmetil metabolita nakon intravenske primjene iznose približno 16% koncentracije sildenafila, dok nakon peroralne primjene one iznose 61% koncentracije sildenafila.
English: Note: A total volume of 90 ml (3 x 30 ml) of water irrespective of the dose to be taken should be used to reconstitute the contents of the bottle
Croatian: Napomena: Za rekonstituciju sadržaja boce mora se uzeti ukupan volumen od 90 ml (3 x 30 ml) vode, bez obzira na to koju će dozu bolesnik uzimati.
English: While the bottle is upright, on a flat surface, insert the tip of the oral dosing syringe into the adaptor (figure 7).
Croatian: Postavite bocu uspravno na ravnu površinu i gurnite vrh štrcaljke za usta u nastavak za bocu (slika 7).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP
English: Kaplan-Meier estimates of survival at 3 years in patients > 20 kg in weight at baseline were 94 %, 93 % and 85 % in the low, medium and high dose groups, respectively; for patients ≤ 20 kg in weight at baseline, the survival estimates were 94 % and 93 % for subjects in the medium and high dose groups respectively (see sections 4.4 and 4.8).
Croatian: Kaplan-Meierove procjene trogodišnjeg preživljenja u bolesnika tjelesne težine > 20 kg na početku ispitivanja bile su: 94% za skupinu koja je primala nisku dozu, 93% za skupinu koja je primala srednju dozu i 85% za skupinu koja je primala visoku dozu sildenafila.
English: Efficacy in adult patients with pulmonary arterial hypertension (PAH) 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.
Croatian: Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje provedeno je u 278 bolesnika s primarnom plućnom hipertenzijom, PAH-om povezanim s bolešću vezivnog tkiva i PAH-om koji je nastao nakon kirurškog popravka prirođenih srčanih lezija.
English: At the recommended oral dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen.
Croatian: Pri preporučenoj peroralnoj dozi od 20 mg tri puta na dan nije zabilježeno sniženje sistoličkog ni dijastoličkog tlaka.
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).
Croatian: N-dezmetil metabolita iznose približno 72% koncentracije sildenafila nakon primjene peroralne doze od 20 mg tri puta na dan (što čini doprinos od 36% farmakološkim učincima sildenafila).
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.
Croatian: Za ispitanike s primarnim PAH-om (67 ispitanika), srednje vrijednosti promjena u odnosu na početne vrijednosti bile su 26,39 m (95% CI: 10,70 do 42,08) i 11,84 m (95% CI: -8,83 do 32,52) za skupinu koja je primala placebo.
English: How to store Revatio
Croatian: Kako primjenjivati Revatio
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici bočice i na kutiji iza "Rok valjanosti".
English: This medicine should be used only in case of administration of 20 mg three times a day.
Croatian: U djece se ne smiju primjenjivati veće doze.Ovaj lijek treba uzimati samo kada se radi o primjeni 20mg tri puta na dan.
English: Note: A total volume of 90 ml (3 x 30 ml) of water irrespective of the dose you are taking should be used to reconstitute the contents of the bottle.
Croatian: Napomena: Za pripremu sadržaja boce mora se uzeti ukupan volumen od 90 ml (3 x 30 ml) vode, bez obzira na to koju dozu ćete uzimati.
English: Each 20 ml vial contains 12.5 ml (10 mg sildenafil, as citrate).
Croatian: Jedna bočica od 20 ml sadrži 12,5 ml (10 mg sildenafila u obliku sildenafilcitrata).
English: A 10 mg dose of Revatio solution for injection is predicted to provide total exposure of free sildenafil and its N-desmethyl metabolite and their combined pharmacological effects comparable to those of a 20 mg oral dose.
Croatian: Revatio otopine za injekciju od 10 mg postići ukupna izloženost slobodnom sildenafilu i njegovu N-dezmetil metabolitu te da su njihovi objedinjeni farmakološki učinci usporedivi s onima kod primjene peroralne doze od 20 mg.
English: After reconstitution, each ml of the oral suspension contains 10 mg of sildenafil (as citrate) One bottle of reconstituted oral suspension (112 ml) contains 1.12 g of sildenafil (as citrate)
Croatian: Jedna boca pripremljene oralne suspenzije (112 ml) sadrži 1,12 g sildenafila (u obliku sildenafilcitrata).
English: In the pivotal placebo-controlled study of Revatio 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 Revatio and 70 patients were randomized to placebo.
Croatian: U pivotalnom placebom kontroliranom ispitivanju lijeka Revatio u liječenju plućne arterijske hipertenzije ukupno je 207 bolesnika randomizirano na liječenje lijekom Revatio u dozi od 20 mg, 40 mg ili 80 mg tri puta na dan (TID), dok je 70 bolesnika randomizirano na placebo.
English: After chronic oral dosing of 80 mg three times a day to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed (a reduction in both systolic and diastolic pressure of 2 mmHg).
Croatian: Nakon kronične primjene peroralne doze od 80 mg tri puta na dan u bolesnika s plućnom arterijskom hipertenzijom opaženi su slabiji učinci na sniženje krvnog tlaka (sniženje i sistoličkog i dijastoličkog tlaka za 2 mmHg).
English: A 10 mg dose of Revatio solution for injection is predicted to provide exposure of sildenafil and its N-desmethyl metabolite and pharmacological effects comparable to those of a 20 mg oral dose.
Croatian: Revatio otopine za injekciju od 10 mg postići izloženost sildenafilu i njegovu N-dezmetil metabolitu te farmakološki učinci usporedivi s onima kod primjene peroralne doze od 20 mg.
English: Glucose Water for injections
Croatian: 6.1 Popis pomoćnih tvari glukoza voda za injekcije
English: Each ml of reconstituted suspension contains 10 mg of sildenafil (as citrate).
Croatian: Jedan ml pripremljene suspenzije sadrži 10 mg sildenafila (u obliku sildenafilcitrata).
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).
Croatian: Nakon peroralne ili intravenske primjene sildenafil se izlučuje u obliku metabolita pretežito fecesom (oko 80% primijenjene peroralne doze) te u manjoj mjeri mokraćom (oko 13% primijenjene peroralne doze).
English: In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with Revatio (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.
Croatian: U placebom kontroliranom ispitivanju lijeka Revatio kao dodatka intravenskoj terapiji epoprostenolom u liječenju plućne arterijske hipertenzije, ukupno su 134 bolesnika liječena lijekom Revatio (u fiksnoj titraciji, počevši od 20 mg, zatim 40 mg te na kraju 80 mg tri puta na dan, ovisno o podnošljivosti) i epoprostenolom, dok je 131 bolesnik primao placebo i epoprostenol.
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.
Croatian: Omjer izgleda u odnosu na placebo iznosio je 0,6 (95% CI: 0,18; 2,01) za skupinu koja je primala nisku dozu sildenafila, 2,25 (95% CI: 0,75; 6,69) za skupinu koja je primala srednju dozu sildenafila, odnosno 4,52 (95% CI: 1,56, 13,10) za skupinu koja je primala visoku dozu sildenafila.
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.
Croatian: Za djecu i adolescente u dobi od 1 do 17 godina preporučena doza je ili 10 mg tri puta na dan ako im je tjelesna težina≤20kg, ili 20mg tri puta na dan ako im je tjelesna težina >20kg.
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).
Croatian: Kada je jedna doza od 100 mg sildenafila primijenjena s umjerenim inhibitorom CYP3A4, eritromicinom, u stanju dinamičke ravnoteže (500 mg dva puta na dan tijekom 5 dana), sustavna izloženost sildenafilu (AUC) povećala se za 182%.
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.
Croatian: Većina je bolesnika imala bolest funkcionalnog stupnja II (107/277, 39%) ili III (160/277, 58%) prema klasifikaciji SZO.
English: When a single 100 mg dose of oral 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).
Croatian: Kada je jedna peroralna doza od 100 mg sildenafila primijenjena sa umjerenim inhibitorom CYP3A4 eritromicinom u stanju dinamičke ravnoteže (500 mg dva puta na dan tijekom 5 dana), sustavna izloženost sildenafilu (AUC) povećala se za 182%.
English: If you are taking riociguat or are unsure tell your doctor.
Croatian: Provjerite s liječnikom ako uzimate riociguat ili ako niste sigurni.
English: (p<0.0001) for sildenafil 20 mg, 40 mg and
Croatian: 5 (p=0,0017) kod primjene sildenafila u dozi od 40 mg TID te -320 dyn.s/cm
English: The Marketing Authorisation Holder shall agree the Information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.
Croatian: Nositelj odobrenja će prije stavljanja u promet lijeka Revatio 0,8 mg/ml otopina za injekciju u bočici od 20 ml u svakoj državi članici s nadležnim tijelom pojedine države članice dogovoriti Informacije za zdravstvene radnike kao i ciljnu skupinu zdravstvenih radnika.