FrancophonIA/ELRC3.0 huggingface dataset:
English: Female volunteers receiving repeated doses directly to the cervix and vagina of up to five times the recommended dose for the male partner, had maximum plasma levels of lidocaine which were less than 8% of toxic levels, and prilocaine which were less than 1% of toxic levels.
Croatian: Žene koje su se javile dobrovoljno i primale više uzastopnih doza izravno na cerviks i vaginu u količini koja je odgovarala do peterostrukoj preporučenoj dozi za muškog partnera imale su najveće zabilježene razine lidokaina u plazmi manje od 8 % toksične razine,
English: There are no or limited amount of data from the use of lidocaine and prilocaine in pregnant women.
Croatian: Nema podataka ili su raspoložive ograničene količine podataka o primjeni lidokaina i prilokaina u trudnica.
English: • Abnormal taste
Croatian: • poremećen osjet okusa
English: Each dose consists of a total of 22.5 mg lidocaine and 7.5 mg prilocaine per application (1 dose is equal to 3 actuations).
Croatian: Svaka doza sadržava ukupno 22,5 mg lidokaina i 7,5 mg prilokaina po jednom nanošenju (1 doza jednaka je 3 potiska).
English: The efficacy of Fortacin was demonstrated in two multi-centre, multinational, randomised, double-blind, placebo controlled studies, both followed by an open-label phase.
Croatian: dvostruko slijepe, placebom kontrolirane studije, obje naknadno praćene otvorenom fazom.
English: Fortacin provides topical anaesthesia to the glans penis.
Croatian: Fortacin pruža topikalnu anesteziju glavića penisa.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING SPRAY CONTAINER LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU NALJEPNICA NA SPREMNIKU SPREJA
English: The clinical relevance of tumour findings in relation to short-term/intermittent use of lidocaine in humans is unknown.
Croatian: Klinička relevantnost nalaza tumora u odnosu na kratkotrajnu/povremenu primjenu lidokaina u ljudi nije poznata.
English: Therefore, both partners may feel slight numbness for a short while and should take care not to injure themselves, particularly during sexual activity.
Croatian: Posljedica toga je da bi oba partnera mogla osjetiti kratkotrajno blago utrnuće i trebaju paziti da se ne bi ozlijedili,
English: Talk to your doctor or pharmacist before using Fortacin - if you, or your sexual partner, have been diagnosed with a genetic disease or other condition affecting your red blood cells (glucose-6-phosphate deficiency, anaemia or methaemoglobinaemia); - if you have a history of medicine sensitivities, especially if you are not certain which medicine causes sensitivity; - if you suffer from severe liver problems.
Croatian: - ako vi ili vaša seksualna partnerica imate dijagnozu genetske bolesti ili drugog stanja koje ima utjecaja na crvene krvne stanice (nedostatak glukoza-6-fosfata, anemija ili methemoglobinemija), - ako ste nekada imali osjetljivosti na lijekove, posebno ako niste sigurni koji lijek je uzrok preosjetljivosti, - patite li od teških problema s jetrom.
English: • Metoclopramide - used to treat feelings of sickness (nausea) and vomiting, including in patients with migraine
Croatian: • Metoklopramid - koristi se za liječenje mučnine i povraćanja, uključujući i u bolesnika s migrenom
English: Prilocaine crosses the blood-brain barrier and also crosses the placenta.
Croatian: Prilokain prolazi krvno-moždanu i placentarnu barijeru.
English: After 5 minutes any excess spray should be wiped off prior to intercourse.
Croatian: 5 minuta ako postoji višak spreja treba ga obrisati prije snošaja.
English: Lidocaine
Croatian: Lidokain
English: As Fortacin is applied topically to the glans penis the risk of overdose is low.
Croatian: Budući da se Fortacin primjenjuje topikalno na glavić penisa, rizik od predoziranja je malen.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Fortacin Lijek čuvajte izvan pogleda i dohvata djece.
English: • abnormal orgasm
Croatian: • poremećaj orgazma
English: Contact your doctor or pharmacist if you experience any of these.
Croatian: Obratite se svojem liječniku ili ljekarniku javi li se bilo koji.
English: Deterioriation was observed when Fortacin was used with polyurethane-based female and male condoms (see section 4.4).
Croatian: Kad se Fortacin koristio s muškim i ženskim kondomima izrađenim od poliuretana primijećeno je da dolazi do njihova oštećenja (vidjeti dio 4.4).
English: Hypoaesthesia of male genital, erectile dysfunction, genital burning sensation
Croatian: Hipoestezija muških genitalija, erektilna disfunkcija, osjet pečenja u genitalijama
English: Prilocaine is excreted in the urine mainly as its metabolites, with only a small proportion excreted unchanged.
Croatian: Prilokain se izlučuje uglavnom putem urina u obliku metabolita, dok se jedan mali dio izlučuje nepromijenjen.
English: Patients hoping to achieve conception should either avoid using Fortacin, or, if it is essential to achieve penetration, should wash the glans penis as thoroughly as possible prior to intercourse.
Croatian: Pacijenti koji nastoje postići oplodnju bi trebali izbjegavati Fortacin, ili, ako je on nužan za postizanje penetracije, trebaju oprati glavić penisa što je temeljitije moguće prije snošaja.
English: One third of the glans penis should be covered with each actuation.
Croatian: Sa svakim potiskom potrebno je prekriti po jednu trećinu glavića penisa.
English: • discomfort or itching in the vulva and vagina
Croatian: • bol u vagini • nelagoda ili svrbež u vulvi i vagini
English: The clinical relevance of tumour findings in respect of short-term/intermittent use of prilocaine in humans is unknown.
Croatian: Klinička relevantnost nalaza tumora u odnosu na kratkotrajnu/povremenu primjenu prilokaina u ljudi nije poznata.
English: Holding the can upright (valve up), apply 1 dose (3 sprays) of Fortacin to the entire head of the penis, by covering one third with each spray.
Croatian: Držite spremnik uspravno (potisnik s gornje strane), a zatim nanesite 1 dozu (3 potiska spreja) Fortacin na cijelu površinu glavića penisa, pokrivajući svakim potiskom po jednu trećinu površine.
English: Any foreskin should be retracted from the glans penis.
Croatian: Kožica bi trebala biti potpuno povučena s glavića penisa.
English: In vitro interaction studies with topical antifungal (clotrimazole, econazole, imidazole, nystatin, miconazole, ketoconazole), antibacterial (clindamycin, metronidazole) and antiviral medicinal products (acyclovir), showed no effect on antimicrobial activity.
Croatian: In vitro studije interakcija s topikalnim antimikoticima (klotrimazol, ekonazol, imidazol, nistatin, mikonazol, ketokonazol), antibakterijskim (klindamicin, metronidazol) i antivirusnim lijekovima
English: Fortacin is not indicated for use by women.
Croatian: Fortacin nije indiciran za primjenu u žena.
English: Medicinal products subject to medical prescription.
Croatian: Lijek se izdaje na recept.
English: Cutaneous spray, solution 6.5 ml
Croatian: Sprej za kožu, otopina 6,5 ml
English: Fortacin sprayed onto a damaged tympanic membrane may cause ototoxicity of the middle ear.
Croatian: Kad se Fortacin rasprši po oštećenom bubnjiću, može doći do ototoksičnosti srednjeg uha.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing incidence.
Croatian: Nuspojave su unutar svake od skupina učestalosti navedene redom prema nižoj incidenciji.
English: Tel.: + 48 22 206 84 50
Croatian: RECORDATI POLSKA sp. z o.o. Tel.: + 48 22 206 84 50
English: Vulvovaginal burning sensation, hypoaesthesia Uncommon Vulvovaginal discomfort, vaginal pain, vulvovaginal pruritus
Croatian: Manje često Vulvovaginalna nelagoda, vaginalna bol, vulvovaginalni pruritis
English: Fortacin is indicated for the treatment of primary premature ejaculation in adult men.
Croatian: Fortacin indiciran je za liječenje primarne preuranjene ejakulacije u odraslih muškaraca.
English: The recommended dose is 3 actuations applied to cover the glans penis.
Croatian: Preporučena doza je 3 potiska nanesena na glavić penisa.
English: Absorption of Fortacin in conjunctival tissues has not been determined.
Croatian: Nije utvrđeno koliko se Fortacin apsorbira u tkivu konjunktive.
English: Name and address of the manufacturers responsible for batch release
Croatian: Nazivi i adresae proizvođača odgovornogih za puštanje serije lijeka u promet
English: If some medicine accidentally gets into your eyes or your partner's eyes, rinse them immediately with cold water or saline solution and cover them gently until any effects, such as numbness, wear off. Be aware that normal protective mechanisms, such as blinking, or sensation of a foreign body in the eye, may not occur until the numbness has worn off.
Croatian: Dospije li slučajno nešto lijeka u vaše oči ili oči vaše partnerice, odmah ih isperite hladnom vodom ili fiziološkom otopinom i pokrijte ih nježno dok učinci lijeka, kao što je utrnuće, ne prođu.
English: The risk of additional systemic toxicity should be considered when large doses of Fortacin are applied to patients already using other local anaesthetics or structurally related medicinal products, e.g. class I anti-arrhythmics such as mexiletine.
Croatian: Fortacin koriste u pacijenata koji već koriste druge lokalne anestetike ili strukturalno srodne lijekove npr. antiaritmike skupine
English: • Sulphonamides (also called sulpha medicines) e.g. sulfamethoxazole - an antibiotic used to treat urinary infections, and sulfasalazine - used to treat Crohn's disease, ulcerative colitis and rheumatoid arthritis
Croatian: • Nitrofurantoin - antibiotik koji se koristi za liječenje infekcije mokraćnog sustava i bubrežne infekcije • Sulfonamidi (koji se nazivaju sulfa lijekovi) npr. sulfametoksazol - antibiotik koji se koristi za liječenje infekcije mokraćnog sustava i sulfasalazin - koristi se za liječenje Crohnove bolesti,
English: Fortacin is indicated for the treatment of lifelong premature ejaculation in adult men.
Croatian: Fortacin je indiciran za liječenje stalne preuranjene ejakulacije u odraslih muškaraca.
English: Uncommon Genital erythema, ejaculation failure, paraesthesia of male genital, penile pain, penis disorder, pruritus genital
Croatian: Manje često Genitalni eritem, neuspješna ejakulacija, parestezija muških genitalija, bol penisa,
English: Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine.
Croatian: Jedan ml otopine sadržava 150 mg lidokaina i 50 mg prilokaina.
English: Package leaflet: Information for the user Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Croatian: Uputa o lijeku: Informacije za korisnika Fortacin 150 mg/ml + 50 mg/ml sprej za kožu, otopina lidokain/prilokain
English: For all of the three monthly assessments completed by the subjects, there was a significant difference between Fortacin and placebo (p < 0.0001).
Croatian: Statistički značajna razlika između skupina liječenih lijekom Fortacin i placebom javila se kod sve tri mjesečne ocjene (p < 0,0001).
English: • pain or discomfort in and around the penis
Croatian: • bol ili nelagoda u i oko penisa
English: Uncommon Vaginal candidiasis
Croatian: Manje često Vaginalna kandidijaza
English: At each of the three monthly assessments all subjects completed a Premature Ejaculation Profile (PEP) questionnaire relating to perceived control over ejaculation, personal distress related to ejaculation, satisfaction with sexual intercourse, and interpersonal difficulty relating to ejaculation.
Croatian: Premature Ejaculation Profil, PEP) koji se odnosio na percipiranu kontrolu nad ejakulacijom, osobnu tjeskobu povezanu s ejakulacijom, zadovoljstvo spolnim odnosom i interpersonalne teškoće povezane s ejakulacijom.
English: Recordati Pharmaceuticals Ltd. Tel: + 44 (0) 1491 576 336
Croatian: Tel: + 44 (0) 1491 576 336
English: They are very unlikely to happen if it is used as instructed:
Croatian: Vrlo je mala vjerojatnost da će se pojaviti postupite li prema uputama: • osjećaj ošamućenosti ili omaglice
English: Symptoms of using too much Fortacin are listed below.
Croatian: U nastavku su popisani simptomi predoziranja Fortacin lijekom.
English: A residual volume of fluid that is not usable will remain in the container after all doses have been administered.
Croatian: Nakon što su primijenjene sve doze, u spremniku će ostati određena rezidualna količina tekućine koja se ne može iskoristiti.
English: Common (may affect up to 1 in 10 people)
Croatian: Česte (mogu se javiti u do 1 na 10 osoba):
English: Each pack contains 1 spray container with 6.5 ml or 5 ml of solution.
Croatian: Svako pakiranje sadržava 1 spremnik spreja sa 6,5 ml ili 5 ml otopine.
English: Contents of the pack and other information
Croatian: Kako čuvati Fortacin Sadržaj pakiranja i druge informacije
English: Uncommon Pyrexia
Croatian: Manje često Pireksija
English: Uncommon (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba):
English: Uncommon Dysuria
Croatian: Manje često Dizurija
English: The clinically significant increases in IELT were paralleled by significant differences in the IPE scores (p <0.0001).
Croatian: Klinički značajno povećanje IELT bilo je usporedno sa značajnim razlikama u IPE rezultatima
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORANNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution
Croatian: Fortacin 150 mg/ml + 50 mg/ml sprej za kožu, otopina
English: Uncommon Throat irritation
Croatian: Manje često Iritacija grla
English: Each pack contains one spray container with 6.5 ml or 5 ml solution.
Croatian: Svako pakiranje sadržava jedan spremnik spreja koji sadržava 6,5 ml ili 5 ml otopine.
English: Fortacin 150 mg/ml + 50 mg/ml cutaneous spray, solution lidocaine/prilocaine
Croatian: Fortacin 150 mg/ml + 50 mg/ml sprej za kožu, otopina lidokain/prilokain
English: Retract any foreskin from the head of the penis.
Croatian: Povucite kožicu tako da oslobodite glavić penisa.
English: • reduced feeling in and around the penis
Croatian: • smanjen osjet u i oko penisa
English: Hypersensitivities
Croatian: Preosjetljivosti
English: The terminal elimination half-life of lidocaine from the plasma following intravenous administration is approximately 65 - 150 minutes and the systemic clearance is 10 - 20 mL/min/kg.
Croatian: 65 - 150 minuta, a sistemski klirens je 10 - 20 mL/min/kg.
English: Before initial use, briefly shake the spray container and then prime the pump mechanism by spraying the valve three times into the air.
Croatian: Upute za uporabu Prije prve uporabe spremnik spreja je potrebno nakratko protresti i pripremiti mehanizam spreja za rad tako što ćete tri puta istisnuti po jedan potisak u zrak.
English: Ask your pharmacist if you are unsure.
Croatian: Ako niste sigurni, upitajte svog ljekarnika.
English: Each container of 5 ml delivers a minimum of 12 doses.
Croatian: Jedan spremnik od 5 ml sadržava najmanje 12 doza.
English: Tel: + 34 91 659 15 50
Croatian: Casen Recordati, S.L. Tel: + 34 91 659 15 50
English: Recordati Ireland Ltd. Raheens East Ringaskiddy Co. Cork Ireland
Croatian: Raheens East Ringaskiddy Co.
English: Uncommon Skin irritation
Croatian: Manje često Iritacija kože
English: Adverse drug reactions in male glans-penis-treated subjects System Organ Class
Croatian: Nuspojave u muškaraca liječenih primjenom na glavić penisa
English: Before initial use, the spray container should be briefly shaken and then primed by spraying it into the air three times.
Croatian: Kako bi ga se pripremilo za prvo korištenje, spremnik spreja je potrebno nakratko protresti i istisnuti tri potiska u zrak.
English: Renal and urinary disorders
Croatian: ulceroznog kolitisa i reumatoidnog artritisa
English: A higher rate of erectile dysfunction and male genital hypoaesthesia may be experienced when using Fortacin with male condoms.
Croatian: Kad se Fortacin koristi s muškim kondomima, moguća je veća stopa erektilne disfunkcije i muške genitalne hipoestezije.
English: Each actuation delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine.
Croatian: Jedan potisak oslobađa 50 mikrolitara koji sadržavaju 7,5 mg lidokaina i 2,5 mg prilokaina.
English: Patients allergic to paraaminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine and/or prilocaine; however, Fortacin should be used with caution in patients with a history (or partner with a history) of sensitivities to medicinal products, especially if the aetiologic medicinal product is uncertain.
Croatian: Bolesnici koji su alergični na derivate paraaminobenzoatne kiseline (prokain, tetrakain, benzokain itd.) nisu pokazali ukriženu osjetljivost na lidokain i/ili prilokain.
English: Each container of 6.5 ml delivers a minimum of 20 doses.
Croatian: Jedan spremnik od 6,5 ml sadržava najmanje 20 doza.
English: - Each spray container of 5 ml delivers a minimum of 12 doses.
Croatian: - Jedan spremnik od 5 ml sadržava najmanje 12 doza.
English: Deterioriation was observed when Fortacin was used with polyurethane-based female and male condoms.
Croatian: Kad se Fortacin koristio s muškim i ženskim kondomima izrađenim od poliuretana primijećeno je da dolazi do njihovog oštećenja.
English: Before each subsequent dose, briefly shake the spray container and then re-prime the pump by spraying 1 time into the air.
Croatian: Prije svake sljedeće uporabe spremnik spreja potrebno je ponovno pripremiti kratkim protresanjem i jednim potiskom u zrak.
English: Prilocaine
Croatian: Prilokain
English: - Each spray container of 6.5 ml delivers a minimum of 20 doses.
Croatian: - Jedan spremnik od 6,5 ml sadržava najmanje 20 doza.
English: • redness on and around the penis
Croatian: • trnci u i oko penisa
English: Once the can is held upright (valve up), 1 dose of Fortacin should be applied to the entire glans penis, by actuating the valve 3 times.
Croatian: Fortacin se primjenjuje tako da se spremnik drži uspravno, a zatim se 1 doza nanese na cijelu površinu glavića penisa s pomoću 3 potiska na potisnik raspršivača.
English: • feeling of burning in and around the vagina • reduced feeling in and around the vagina
Croatian: • osjećaj pečenja u i oko vagine
English: Before each subsequent use, it should be briefly shaken and then the spray container should be re-primed by spraying it once.
Croatian: Prije svake sljedeće uporabe potrebno ga je ponovno pripremiti kratkim protresanjem i jednim potiskom u zrak.
English: Tel: + 420 466 741 915
Croatian: Herbacos Recordati s.r.o. Tel: + 420 466 741 915
English: 6.3 Shelf life
Croatian: 6.1 Popis pomoćnih tvari norfluran
English: Recordati Ireland Ltd. Puh/Tel: + 353 21 4379400
Croatian: Puh/Tel: + 353 21 4379400
English: Uncommon Anorectal discomfort, oral parasthesia
Croatian: Poremećaji probavnog sustava Manje često Anorektalna nelagoda, oralna parestezija Poremećaji bubrega i mokraćnog sustava
English: Recordati Ireland Ltd. Tlf: + 353 21 4379400
Croatian: Tlf: + 353 21 4379400
English: Norflurane
Croatian: Nuspojave
English: • discomfort in the anus and rectum
Croatian: • nelagoda u anusu i rektumu • gubitak osjeta u ustima
English: - If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Recordati Ireland Ltd. Tél/Tel: + 353 21 4379400
Croatian: Tél/Tel: + 353 21 4379400
English: No 2,6-xylidine or o-toluidine was detectable at any time-point in vaginal fluids following local application of the medicinal product in female volunteers.
Croatian: U ženskih dobrovoljnih ispitanica nije utvrđena prisutnost u vaginalnim tekućinama niti 2,6-ksilidina, kao ni o-toluidina niti u jednom trenutku nakon primjene.
English: Patients or their partner with a known history of sensitivity to local anaesthetics of the amide type.
Croatian: Poznata anamneza preosjetljivosti na lokalne anestetike amidnog tipa, bilo pacijenta, bilo njegove partnerice.
English: - Each ml of solution contains 150 mg lidocaine and 50 mg prilocaine - Each spray delivers 50 microlitres which contains 7.5 mg lidocaine and 2.5 mg prilocaine.
Croatian: - Jedan potisak oslobađa 50 mikrolitara koji sadržavaju 7,5 mg lidokaina i 2,5 mg prilokaina.
English: Recordati Ireland Ltd. Τηλ: + 353 21 4379400
Croatian: Τηλ: + 353 21 4379400
English: The lidocaine metabolite 2,6-xylidine has genotoxic potential in vitro.
Croatian: Metabolit lidokaina 2,6
English: 3 inhalers (3 x 60 doses)
Croatian: 3 inhalatora (3 x 60 doza)
English: 1 inhaler (60 doses)
Croatian: 1 inhalator (60 doza)
English: MA (EU) number Invented name Strength Pharmaceutical
Croatian: Broj (EU) odobrenja
English: Route of Administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje
English: The full EPAR for Revatio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Revatio nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 10-2016.
Croatian: Sažetak je posljednji put ažuriran: 10.2016.
English: Other information about Revatio
Croatian: Ostale informacije o lijeku Revatio
English: What is Revatio and what is it used for?
Croatian: Što je Revatio i za što se koristi?
English: The company that markets Revatio will agree with each European Union Member State on how the solution for injection will be distributed.
Croatian: Tvrtka koja stavlja na tržište lijek Revatio dogovorit će se sa svakom državom članicom Europske unije o načinu distribucije otopine za injekciju.
English: Why is Revatio approved?
Croatian: Zašto je lijek Revatio odobren?
English: This is a summary of the European public assessment report (EPAR) for Revatio.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Revatio.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revatio on 28 October 2005.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Revatio vrijedi na prostoru Europske unije od 28. listopada 2005.
English: The main study in children involved 235 children aged 1 to 17 years with PAH.
Croatian: Glavno ispitivanje u djece obuhvaćalo je 235 djece s PAH-om u dobi od 1 do 17 godina.
English: This leads to high blood pressure in the vessels taking blood from the heart to the lungs and reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Croatian: To dovodi do visokog krvnog tlaka u žilama koje krv odvode iz srca u pluća i smanjuje količinu kisika koji može doprijeti u krv u plućima, što otežava fizičku aktivnost.
English: It will also ensure that doctors and pharmacists who will prescribe or dispense the solution for injection in each Member State receive information about how it should be used and how to report side effects such as low blood pressure.
Croatian: Također će osigurati da liječnici i ljekarnici u svakoj državi članici koji će propisivati i dozirati otopinu za injekciju dobiju informacije o pravilnom načinu primjene i načinu prijave nuspojava kao što je nizak krvni tlak.
English: The active substance in Revatio, sildenafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Croatian: Djelatna tvar lijeka Revatio, sildenafil, ubraja se u skupinu lijekova naziva „inhibitori fosfodiesteraze tipa 5 (PDE5)”, što znači da blokira enzim PDE5.
English: The main study in adults involved 277 patients with PAH, most of whom had class II or class III disease.
Croatian: Glavno ispitivanje u odraslih osoba obuhvatilo je 277 bolesnika s PAH-om, od kojih je većina imala bolest funkcionalnog stupnja II ili III.
English: It is not intended to provide practical advice on how to use Revatio.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Revatio.