natgillin/translations-raw huggingface dataset:
Increase in liver enzymes, dizziness, sleeplessness, confusion, feeling breathless, vomiting (with or without blood), constipation, blood in your urine, difficulty in urinating, rash, itching (urticaria), low levels of potassium in the blood, burning feeling when passing urine with also an increased frequency of urination, slow healing of wounds, nose bleeds, high blood pressure, pain (including pain in legs, stomach and/ or chest).
Zvišanje jetrnih encimov, omotica, nespečnost, zmedenost, občutek težke sape, bruhanje (krvavo ali brez krvi), zaprtje, kri v urinu, oteženo uriniranje, izpuščaj, srbenje (koprivnica), nizka koncentracija kalija v krvi, občutek pečenja pri odvajanju vode skupaj z večjo pogostnostjo uriniranja, upočasnjeno celjenje ran, krvavitev iz nosu, zvišan krvni tlak, bolečine (tudi v spodnjih udih, želodcu in/ ali prsih).
Rare side effects (likely to affect between 1 in 1,000 and 1 in 10,000 patients):
Redki neželeni učinki (verjetno se bodo pojavljali pri 1 od 1. 000 do 1 od 10. 000 bolnikov):
Anti-hirudin antibodies have been detected upon re-exposure
Po ponovni izpostavitvi so odkrili antihirudinska protitelesa.
What Revasc contains
Kaj vsebuje zdravilo Revasc
The active substance is desirudin (15mg/ 0.5ml powder).
Zdravilna učinkovina je desirudin (15 mg/ 0, 5 ml).
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i. e. essentially ‘ sodium- free’.
To zdravilo vsebuje manj od 1 mmola (23 mg) natrija na 0, 5 ml, kar pomeni, da praktično ‘ ne vsebuje natrija ’.
1 vial and 1 ampoule in one package 2 vials and 2 ampoules in one package 10 vials and 10 ampoules in one package
1 viala in 1 ampula v enem zavitku 2 viali in 2 ampuli v enem zavitku 10 vial in 10 ampul v enem zavitku
Not all pack sizes may be marketed.
Na trgu ni vseh navedenih
The marketing authorisation holder is:
Imetnik dovoljenja za promet z zdravilom je:
Canyon Pharmaceuticals Limited 20-22 Bedford Row London WC1R 4JS United Kingdom.
Canyon Pharmaceuticals Limited 20- 22 Bedford Row London WC1R 4JS Velika Britanija.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Če potrebujete več informacij o vaši bolezni ali zdravljenju, preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
What is Revatio?
Kaj je zdravilo Revatio?
Revatio is a medicine that contains the active substance sildenafil.
Revatio je zdravilo, ki vsebuje zdravilno učinkovino sildenafil.
It is available as round, white tablets (20 mg).
Na voljo je v obliki okroglih, belih tablet (20 mg).
What is Revatio used for?
Za kaj se zdravilo Revatio uporablja?
Revatio is used to treat adults with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Revatio se uporablja za zdravljenje odraslih s pljučno arterijsko hipertenzijo (PAH) III. funkcijskega razreda za izboljšanje sposobnosti za telesno obremenitev.
PAH is abnormally high blood pressure in the arteries of the lungs.
Bolezen PAH pomeni neobičajno visok krvni tlak v pljučnih arterijah.
The ‘ class ’ reflects the seriousness of the disease: ‘ class III ’ involves marked limitation of physical activity.
„ funkcijski razred III “ vključuje izrazite omejitve fizične aktivnosti.
Revatio has been shown to be effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Zdravilo Revatio se je izkazalo učinkovito pri bolezni PAH, ki se pojavi iz neznanih vzrokov, in pri bolezni PAH, ki jo povzroča bolezen vezivnega tkiva.
Because the number of patients with PAH is low, the disease is considered ‘ rare’, and Revatio was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 12 December 2003.
Ker je število bolnikov z boleznijo PAH majhno, velja ta bolezen za „ redko “, zato je bilo zdravilo Revatio dne 12. decembra 2003 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Revatio treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Zdravljenje z zdravilom Revatio sme uvesti in nadzorovati le zdravnik, ki ima izkušnje z zdravljenjem bolezni PAH.
The recommended dose is 20 mg three times a day.
Priporočeni odmerek je 20 mg trikrat na dan.
The tablets should be taken about six to eight hours apart, with or without food.
Tablete je treba vzeti v presledku približno šest do osem ur, s hrano ali brez nje.
The same dose is used in patients with kidney or liver problems, and should only be lowered if the patient does not tolerate the normal dose.
Isti odmerek naj jemljejo bolniki, ki imajo težave z ledvicami ali jetri, odmerek pa naj se zmanjša le, kadar bolnik ne prenaša običajnega odmerka.
Revatio can be used with epoprostenol (another medicine used in PAH).
Zdravilo Revatio se lahko uporablja z epoprostenolom (drugim zdravilom za bolezen PAH).
It causes high blood pressure in the pulmonary artery (the vessel taking blood from the heart to the lungs).
To povzroča zelo visok krvni tlak v pljučni arteriji (žili, po kateri se pretaka kri iz srca v pljuča).
This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Zaradi visokega tlaka se zmanjša količina kisika v krvi v pljučih, zaradi česar je fizična aktivnost otežena.
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.
Zdravilna učinkovina v zdravilu Revatio, sildenafil, spada v skupino zdravil imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5), kar pomeni da blokira encim PDE5.
This enzyme is found in the blood vessels of the lungs.
Ta encim se nahaja v krvnih žilah v pljučih.
When it is blocked, a substance called ‘ cyclic guanine monophosphate’ (cGMP) cannot be broken down, so that it remains in the vessels where it causes the relaxation and widening of the blood vessels (‘ vasodilation’).
Če je encim PDE5 blokiran, se snov, imenovana ciklični gvanozinmonofosfat (cGMP), ne more razgraditi, tako da ostane v žilah, kjer povzroči sprostitev in vazodilacijo (razširitev žil).
In patients with PAH, sildenafil widens the pulmonary artery and other blood vessels in the lungs, which lowers the blood pressure in the pulmonary artery.
Pri bolnikih z boleznijo PAH sildenafil razširja pljučno arterijo in druge krvne žile v pljučih, s čimer znižuje tlak v pljučni arteriji.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided that the source is acknowledged.
How has Revatio been studied?
Kako je bilo zdravilo Revatio raziskano?
Three doses of Revatio (20, 40 and 80 mg) have been compared with placebo (a dummy treatment) in 277 patients.
Tri odmerke zdravila Revatio (20, 40 in 80 mg) so primerjali s placebom (zdravilom brez zdravilne učinkovine) pri 277 bolnikih.
One study also compared the effects of adding Revatio or placebo to epoprostenol in 267 patients.
V eni od študij so epoprostenolu dodajali zdravilo Revatio ali placebo in primerjali učinke pri 267 bolnikih.
In this study, the dose of Revatio started at 20 mg three times a day, and was increased to 40 mg and then to 80 mg at weeks 4 and 8.
V tej študiji je bil začetni odmerek zdravila Revatio 20 mg trikrat na dan in so ga v 4 tednu povečali na 40 mg, v 8 tednu pa na 80 mg.
In all studies, the main measure of effectiveness was the distance patients could walk in six minutes.
V vseh študijah je bilo glavno merilo učinkovitosti razdalja, ki so jo bolniki lahko prehodili v šestih minutah.
This measures the patients’ exercise capacity.
To je način merjenja sposobnosti za telesno obremenitev.
What benefit has Revatio shown during the studies?
Kakšne koristi je zdravilo Revatio izkazalo med študijami?
Patients could walk significantly further after treatment with Revatio.
Bolniki so lahko prehodili bistveno večjo razdaljo po zdravljenju z zdravilom Revatio.
Before treatment, the average walking distance was 345 metres, which increased by 45 to 50 metres after 12 weeks of treatment.
Pred zdravljenjem je bila povprečna prehojena razdalja 345 metrov, po 12 tednih zdravljenja pa se je povečala za 45 do 50 metrov.
This is not a large increase but it is a significant improvement.
Povečanje ni veliko, vendar pomeni znatno izboljšanje.
As the three doses of Revatio had similar effects, the lowest dose (20 mg) was chosen for use in patients.
Učinki vseh treh odmerkov zdravila Revatio so bili enaki, zato je bil za uporabo pri bolnikih izbran najnižji (20 - miligramski) odmerek.
Revatio was more effective than placebo when it was added to epoprostenol, with walking distances increasing by 30.1 and 4.1 metres, respectively, after 16 weeks of treatment.
Zdravilo Revatio, dodano epoprostenolu, je bilo učinkovitejše od placeba, saj se je prehojena razdalja po 16 tednih zdravljenja povečala za 30, 1 metra v primerjavi s 4, 1 metra, doseženih s placebom.
What is the risk associated with Revatio?
Kakšna tveganja so povezana z zdravilom Revatio?
The most common side effects with Revatio (seen in more than 1 patient in 10) are headache, flushing, dyspepsia (indigestion), diarrhoea and limb pain.
Najpogostejši stranski učinki, povezani z zdravilom Revatio (opaženi pri več kot 1 bolniku od 10), so glavobol, zardevanje, dispepsija (prebavne težave), driska in bolečine v okončinah.
For the full list of all side effects reported with Revatio, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Revatio, glejte navodilo za uporabo.
Revatio should not be used in people who may be hypersensitive (allergic) to sildenafil or any of the other ingredients.
Zdravila Revatio ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za sidenafil (alergične nanj) ali katerokoli drugo sestavino.
It should also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischemic optic neuropathy (NAION).
Zdravilo se odsvetuje tudi bolnikom, ki so izgubili vid zaradi dotoka krvi v očesni živec (nearteritična anteriorna ishemična optična nevropatija).
Revatio should not be taken with nitrates (a group of medicines used to treat angina), with ketoconazole or itraconazole (anti-fungal medicines), or with ritonavir (used to treat HIV infection).
Zdravilo Revatio se ne sme jemati skupaj z nitrati (skupina zdravil za zdravljenje angine), ketokonazolom ali itrakonazolom (zdravili proti glivicam) ali ritonavirjem (ki se uporablja za zdravljenje okužbe HIV).
Because Revatio has not been studied in patients with severe liver disease or severe hypotension (very low blood pressure), or who have recently had a stroke or myocardial infarction (heart attack), these patients should not take it.
Zdravila Revatio niso proučevali pri bolnikih z resnimi jetrnimi obolenji, hudo hipotenzijo (zelo nizek krvni tlak) ali pri bolnikih, ki so nedavno doživeli možgansko kap ali miokardni infarkt (srčni napad), zato ti bolniki zdravila ne smejo jemati.
Why has Revatio been approved?
Zakaj je bilo zdravilo Revatio odobreno?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Revatio provides an alternative treatment option for PAH.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da zdravilo Revatio predstavlja alternativno možnost za zdravljenje bolezni PAH.
The Committee decided that Revatio’ s benefits are greater than its risks for the treatment of PAH classified as WHO functional class III, to improve exercise capacity.
Odbor je odločil, da so za zdravljenje bolezni PAH III. funkcijskega razreda za izboljšanje sposobnosti za telesno obremenitev po razvrstitvi Svetovne zdravstvene organizacije (SZO) koristni učinki zdravila Revatio večji od z njim povezanih tveganj.
The Committee recommended that Revatio be given marketing authorisation.
Odbor je priporočil, da se za Revatio odobri dovoljenje za promet z zdravilom.
Revatio was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, limited information was available at the time of approval.
Zdravilo Revatio je bilo prvotno odobreno v „ izjemnih okoliščinah “, gre namreč za redko bolezen, zato so bile ob odobritvi na voljo le omejene informacije.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 25 August 2008.
Ker je družba posredovala zahtevane dodatne informacije, je odobritev „ v izjemnih okoliščinah “ prenehala veljati dne 25. avgusta 2008.
Which measures are being taken to ensure the safe use of Revatio?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila?
Before Revatio is launched in each Member State, the company that makes the medicine will send a letter to healthcare workers explaining that it must not be taken with nitrates.
Pred začetkom trženja zdravila v vseh državah članicah bo družba, ki proizvaja zdravilo, zdravstvenim delavcem poslala dopis s pojasnilom, da se zdravila ne sme jemati z nitrati.
Other information about Revatio:
Druge informacije o zdravilu Revatio:
The European Commission granted a marketing authorisation valid throughout the European Union for Revatio to Pfizer Limited on 28 October 2005.
Evropska komisija je dovoljenje za promet z zdravilom Revatio, veljavno po vsej Evropski uniji, odobrila družbi Pfizer Limited dne 28. oktobra 2005.
The summary of opinion of the Committee for Orphan Medicinal Products for Revatio is available here.
Povzetek mnenja Odbora za zdravila sirote o zdravilu Revatio je na voljo tukaj.
The full EPAR for Revatio can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Revatio je na voljo tukaj.
EU/ 1/ 05/ 318/ 001
Številka EU EU/ 1/ 05/ 318/ 001
Revatio
Zaščiteno ime Revatio
20 mg
Jakost 20 mg
Film-coated tablet
Farmacevtska oblika Filmsko obložena tableta
Blister (PVC/ Alu)
Ovojnina Pretisni omot (PVC/ Alu)
90 Tablets
Velikost pakiranja 90 tablet
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Ena filmsko obložena tableta vsebuje 20 mg sildenafila (v obliki citrata).
Revatio tablets also contain lactose.
Tablete Revatio vsebujejo tudi laktozo.
White, round, biconvex film-coated tablets marked “ PFIZER” on one side and “ RVT 20” on the other.
Bele, okrogle, na obeh straneh izbočene filmsko obložene tablete z oznako "PFIZER" na eni in "RVT 20" na drugi strani.
Treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity.
Zdravljenje bolnikov s pljučno arterijsko hipertenzijo v III. funkcijskem razredu po razvrstitvi Svetovne zdravstvene organizacije (SZO) za izboljšanje sposobnosti za telesno obremenitev.
Revatio is intended for oral use.
Revatio je namenjen za peroralno uporabo.
In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered.
Če se klinično stanje kljub zdravljenju z Revatiom poslabša, je treba pretehtati druge terapevtske možnosti.
Use in adults (≥ 18 years):
Uporaba pri odraslih (≥ 18 let):
Tablets should be taken approximately 6 to 8 hours apart with or without food.
Tablete je treba vzeti v presledku približno 6 do 8 ur, s hrano ali brez nje.
Use in the elderly (≥ 65 years):
Uporaba pri starejših (≥ 65 let):
Dosage adjustments are not required in elderly patients.
Pri starejših bolnikih odmerka ni treba prilagajati.
Use in patients with impaired renal function:
Uporaba pri bolnikih z okvarjenim delovanjem ledvic:
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/ min).
Pri bolnikih z okvaro ledvic – tudi pri tistih s hudo okvaro (očistek kreatinina < 30 ml/ min) – na začetku terapije odmerka ni treba prilagoditi.
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.
Le če bolnik terapije ne prenaša dobro, je treba po natančni oceni koristi in tveganj razmisliti o zmanjšanju odmerka na 20 mg dvakrat na dan.
Use in patients with impaired hepatic function:
Uporaba pri bolnikih z okvarjenim delovanjem jeter:
Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B).
Pri bolnikih z okvaro jeter (razred A in B po Child- Pughu) na začetku terapije odmerka ni treba prilagoditi.
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.
Le če bolnik terapije ne prenaša dobro, je treba po natančni oceni koristi in tveganj razmisliti o zmanjšanju odmerka na 20 mg dvakrat na dan.
Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C), (see section 4.3).
Revatio je kontraindiciran pri bolnikih s hudo okvaro jeter (razred C po Child- Pughu); glejte poglavje 4. 3.
2 Use in children and adolescents (< 18 years):
2 Uporaba pri otrocih in mladostnikih (< 18 let):
Therefore, the use of sildenafil is not recommended in these patients.
Varnost in učinkovitost pri otrocih in mladostnikih nista bili raziskani v velikih, kontroliranih kliničnih preskušanjih, zato sildenafila pri teh bolnikih ni priporočljivo uporabljati.
Discontinuation of treatment:
Prekinitev zdravljenja:
Use in patients using other medicines:
Uporaba pri bolnikih, ki uporabljajo druga zdravila:
Co-administration of sildenafil and intravenous epoprostenol has been evaluated (see section 4.8 and 5.1).
Raziskana je bila sočasna uporaba sildenafila in intravenskega epoprostenola (glejte poglavji 4. 8 in 5. 1).
The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (eg. bosentan, iloprost) has not been studied in controlled clinical trials.
Učinkovitost in varnost sočasne uporabe sildenafila in drugih zdravil za pljučno arterijsko hipertenzijo (npr. bosentana, iloprosta) nista bili raziskani v kontroliranih kliničnih preskušanjih.
Therefore, caution is recommended in case of co-administration.
V primeru sočasne uporabe je torej potrebna previdnost.
The safety and efficacy of Revatio when co-administered with other PDE5 inhibitors has not been studied in pulmonary arterial hypertension patients.
Varnost in učinkovitost zdravila Revatio, uporabljenega hkrati z drugimi zaviralci PDE5, pri bolnikih s pljučno arterijsko hipertenzijo ni raziskana.
Consistent with its known effects on the nitric oxide/ cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Zato je kontraindicirana njegova sočasna uporaba z donorji dušikovega oksida (npr. amilnitritom) ali nitrati v kakršnikoli obliki.
Combination with potent CYP3A4 inhibitors (eg. ketoconazole, itraconazole, ritonavir) (see section 4.5).
Kombinacija z močnimi zaviralci CYP3A4 (npr. ketokonazolom, itrakonazolom, ritonavirjem) (glejte poglavje 4. 5).
Revatio is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Revatio je kontraindiciran pri bolnikih, ki so izgubili vid na enem očesu zaradi nearteriitične anteriorne ishemične optične nevropatije (NAION), tudi če ta dogodek ni bil povezan s predhodnim jemanjem zaviralcev PDE5 (glejte poglavje 4. 4).
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, recent history of stroke or myocardial infarction, severe hypotension (blood pressure < 90/ 50 mmHg) at initiation.
Uporaba sildenafila pri takšnih bolnikih je zato kontraindicirana.
If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (e. g. epoprostenol) should be considered (see section 4.2).
Če se klinično stanje poslabša, je treba razmisliti o uporabi zdravil, ki pridejo v poštev v hudi fazi bolezni (npr. epoprostenol) (glejte poglavje 4. 2).
The benefit-risk balance of sildenafil has not been established in patients with class I functional classification of pulmonary arterial hypertension.
Razmerje med koristjo in tveganjem sildenafila ni bilo preverjeno pri bolnikih s pljučno arterijsko hipertenzijo v funkcijskem razredu I.
No studies have been performed in related forms of pulmonary arterial hypertension other than related to connective tissue disease and surgical repair.
Razen pri pljučni arterijski hipertenziji ob boleznih vezivnega tkiva in po kirurški popravi pri sorodnih oblikah pljučne arterijske hipertenzije ni bilo izvedenih študij.
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.
Varnost sildenafila ni raziskana pri bolnikih z znanimi dednimi degenerativnimi boleznimi mrežnice, npr. pri retinitis pigmentosa (manjši del teh bolnikov ima genetsko motnjo mrežničnih fosfodiesteraz), zato uporaba sildenafila pri njih ni priporočljiva.
3 In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
3 Na splošno je treba vsako prilagoditev odmerka izvesti šele po natančni oceni koristi in tveganja.
A downward dose adjustment to 20 mg twice daily should be considered when sildenafil is co- administered to patients already receiving medium potency CYP3A4 inhibitors like erythromycin or saquinavir.
O zmanjšanju odmerka na 20 mg dvakrat na dan je treba razmisliti pri bolnikih, ki dobijo sildenafil in že prejemajo srednje močne zaviralce CYP3A4, npr. eritromicin ali sakvinavir.
A downward dose adjustment to 20 mg once daily is recommended in case of co- administration with CYP3A4 inhibitors of intermediate potency like clarithromycin, telithromycin and nefazodone.
Zmanjšanje odmerka na 20 mg enkrat na dan je priporočljivo v primeru sočasne uporabe z izrazitejšimi zaviralci CYP3A4, npr. s klaritromicinom, telitromicinom in nefazodonom.
Co-administration of potent CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir) with sildenafil for pulmonary arterial hypertension is contraindicated (see section 4.3).
Sočasna uporaba sildenafila in močnih zaviralcev CYP3A4 (npr. ketokonazola, itrakonazola, ritonavirja) je pri pljučni arterijski hipertenziji kontraindicirana (glejte poglavje 4. 3).
Dose adjustments of sildenafil may be required when co-administered with CYP3A4 inducers (see section 4.5).
Prilagoditve odmerka sildenafila utegnejo biti potrebne med sočasno uporabo z induktorji CYP3A4 (glejte poglavje 4. 5).
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).
Preden zdravnik predpiše sildenafil, mora natančno razmisliti, ali bi blagi do zmerni vazodilatacijski učinki sildenafila lahko imeli neželene posledice za bolnike z določenimi že obstoječimi boleznimi, npr. hipotenzijo, pomanjkanjem tekočine, hudo obstrukcijo iztočnega dela levega prekata ali motnjami avtonomnega uravnavanja krvnega tlaka (glejte poglavje 4. 4).
Sildenafil potentiates the hypotensive effect of nitrates therefore concomitant use of Revatio with nitrates is contraindicated (see section 4.3).
Sildenafil stopnjuje hipotenzivni učinek nitratov, zato je sočasna uporaba zdravila Revatio in nitratov kontraindicirana (glejte poglavje 4. 3).