natgillin/translations-raw huggingface dataset:
Interim results showed an increased risk of mortality and serious adverse events in subjects receiving riociguat compared to those receiving
povečano tveganje za umrljivost in resne neželene učinke pri preiskovancih, ki so prejemali riociguat, v primerjavi s preiskovanci, ki so prejemali placebo.
A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early.
faze (RISE-IIP), ki je vrednotila učinkovitost in varnost riociguata pri bolnikih s simptomatsko pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP), je bila predčasno zaključena.
Section 4.3 - Contraindications - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) (see Section 5.1)
Poglavje 4.3 - Kontraindikacije - bolniki s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP) (glejte poglavje
Riociguat is therefore contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (see section 4.3).
Riociguat je zato pri bolnikih s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico, kontraindiciran (glejte poglavje 4.3).
Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
Bolniki s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP) Randomizirana, dvojno slepa, s placebom nadzorovana študija II.
When using the individual correction formulae, none of the values were out of the limit.
Ob uporabi korekcijske formule nobena od vrednosti ni bila zunaj meje.
Do not take Levitra more than once a day.
Ne vzemite zdravila Levitra več kot enkrat na dan.
(cannot be estimated from the available data)
Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
There may be physical or psychological causes, or a mixture of both.
Vzroki so lahko telesni ali duševni, ali kombinacija obeh.
Use in adult men
Uporaba pri odraslih moških
The mean absolute oral bioavailability is 15%.
Povprečna absolutna biološka uporabnost je 15-odstotna.
The combination should be avoided (see section 4.5).
Tej kombinaciji se je treba izogibati (glejte poglavje 4.5).
This was not associated with any muscle or neurological toxicity.
To pa ni bilo povezano z mišično ali nevrološko toksičnostjo.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Večina bolnikov, pri katerih so poročali o teh dogodkih, je imela že prisotne dejavnike tveganja za kardiovaskularne bolezni.
Of these, 900 patients have been treated for one year or longer.
Med njimi je 900 bolnikov prejemalo zdravilo eno leto ali dlje.
- Swallow one tablet with a glass of water.
- Tableto pogoltnite s kozarcem vode.
At least one in ten men has trouble getting or keeping an erection at some time.
Najmanj eden od desetih moških ima v določenem obdobju težave z doseganjem ali ohranjanjem erekcije.
The chance of having a side effect is described by the following categories:
Verjetnost, da se bo pri vas pojavil neželeni učinek, je opisana s sledečimi kategorijami:
This leaflet was last revised in {month YYYY}.
Navodilo je bilo nazadnje revidirano dne {mesec LLLL}
The actual clinical impact of these QT changes is unknown.
Dejanski klinični pomen QT sprememb ni znan.
- Alcoholic drink can make erection difficulties worse.
- Uživanje alkohola lahko težave z erekcijo še poslabša.
Effect on bleeding
Učinek na krvavitve
- The other ingredients of the tablets are:
- Druge sestavine zdravila so:
What Levitra is and what it is used for
Kaj je zdravilo Levitra in za kaj ga uporabljamo
Most of the men who experienced these side effects had heart problems before taking this medicine.
Večina moških, ki so imeli te neželene učinke, je imela težave s srcem že pred jemanjem tega zdravila.
Effect on QTc interval
Učinek na dobo QTc
Therefore the use of such combinations is not recommended.
Tovrstne kombinacije zato niso priporočljive.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake “EXP”.
Treatment of erectile dysfunction in adult men.
Zdravljenje erektilne disfunkcije pri odraslih moških.
Allergic reaction
- alergijske reakcije
The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is headache.
Neželeni učinek, o katerem so najpogosteje poročali in se je pojavil pri ≥ 10 % bolnikov je glavobol.
It is not possible to determine whether these events were directly related to vardenafil.
Ni mogoče ugotoviti ali so bili ti dogodki neposredno povezani z jemanjem vardenafila.
Penile erection is a haemodynamic process.
Erekcija penisa je hemodinamični proces.
In addition, in line with the product information of other PDE5s, a warning should also be included in section 4.4 to highlight these events, and reflect that it is not possible to definitively determine whether these events are related directly to any risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Dodatno je treba, v skladu z informacijami za druge PDE5, v poglavje 4.4 vključiti tudi opozorilo glede teh dogodkov in dejstvo, da ni mogoče ugotoviti, ali so ti dogodki neposredno povezani z dejavniki tveganja, z vardenafilom, s spolno aktivnostjo ali s kombinacijo teh ali drugih dejavnikov.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnih sprejetih posodobitvah RMP.
The clinical impact of these QT changes is unknown (see section 5.1).
Klinični pomen spremembe QT ni znan (glejte poglavje 5.1).
Dissolve in the mouth
Raztopite v ustih.
However, it is not possible to definitively determine whether these events are related directly to these risk factors, to vardenafil, to sexual activity, or to a combination of these or other factors.
Ni mogoče ugotoviti ali so ti dogodki, o katerih so poročali, neposredno povezani s temi dejavniki tveganja, z uporabo vardenafila, s spolno aktivostjo ali s kombinacijo teh ali drugih dejavnikov.
Effect on vision
Učinek na vid
Elderly (≥65 years old)
Starostniki (≥ 65 let)
Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Erektilna disfunkcija je nezmožnost doseganja ali ohranjanja erekcije penisa, ki omogoča zadovoljivo spolno aktivnost.
Store in the original package in order to protect from humidity and light.
Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago in svetlobo.
Effects on the QT interval were measured one hour post-dose (average tmax for vardenafil).
Učinke na dobo QT so merili eno uro po odmerku (povprečna vrednost tmax za vardenafil).
Due to the nitrate component it has the potential to have serious interaction with vardenafil.
Zaradi vsebnosti nitrata je možno resno medsebojno učinkovanje z vardenafilom.
There are no studies of vardenafil in pregnant women.
Ni študij o uporabi vardenafila pri nosečnicah.
He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.
Lahko vam bo predlagal zamenjavo z drugo obliko ali jakostjo zdravila Levitra, odvisno od tega kako zdravilo Levitra učinkuje pri vas.
An additional analysis, including data from clinical trials, post marketing experience and literature showed that some occurred with a close temporal association (the two first weeks) after the intake of vardenafil.
Dodatne analize, vključno s podatki iz kliničnih preskušanj, izkušenj iz obdobja trženja zdravila in literature so pokazale, da so se nekateri dogodki pojavili v tesni časovni povezanosti (v prvih dveh tednih) po zaužitju vardenafila.
The following adverse reactions have been reported:
Poročali so o naslednjih neželenih učinkih:
Over 2,500 patients have been treated with vardenafil for 6 months or longer.
Več kot 2.500 bolnikov je jemalo vardenafil šest mesecev ali dlje.
Use in patients using other medicinal products
Uporaba pri bolnikih, ki jemljejo druga zdravila
In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly higher in patients with a history of hypertension.
Incidenca neželenih učinkov (predvsem »omotica«) je nekoliko večja pri bolnikih s hipertenzijo v anamnezi.
The median time to reach Cmax varied between 45 to 90 minutes and was similar or slightly delayed (by 8 to 45 min) compared to the film-coated tablets.
Srednji čas do Cmax variira od 45 do 90 minut in je enak ali rahlo daljši (8 do 45 min) v primerjavi s filmsko obloženimi tabletami.
Most of the effects are mild or moderate.
Večina teh učinkov je zmernih do blagih.
The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets.
Tablete so na voljo v pretisnih omotih po 2, 4, 8, 12 ali 20 tablet.
In vitro studies have shown that vardenafil is more potent on PDE5 than on other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).
Študije in vitro so pokazale, da vardenafil močneje vpliva na PDE5 kot na druge znane fosfodiesteraze (> 15-krat v primerjavi s PDE6, > 130-krat v primerjavi s PDE1, > 300-krat v primerjavi s PDE11 in > 1.000-krat v primerjavi s PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 in PDE10).
Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum.
Vardenafil je močan in selektiven zaviralec cGMP specifičnih fosfodiesteraz tipa 5 (PDE5), ki so najpomembnejše PDE v človeškem kavernoznem tkivu.
Do not crush the tablet.
Ne zdrobite tablete.
Sudden decrease or loss of hearing has been reported.
Poročali so tudi o nenadnem poslabšanju ali izgubi sluha.
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
Vardenafil (10 mg) ni podaljšal časa krvavitve, ki jo je povzročila acetilsalicilna kislina (2 x 81 mg).
The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the tissues.
Povprečen porazdelitveni volumen stanja dinamičnega ravnovesja vardenafila je 208 l, kar kaže na porazdelitev v tkiva.
Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects.
Vardenafil povzroči blago in prehodno znižanje krvnega tlaka, ki v večini primerov nima kliničnih učinkov.
Partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes has been experienced by patients.
Obstajajo poročila o delnem, nenadnem, začasnem ali trajnem poslabšanju vida ali oslepitvi na eno ali obe očesi.
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITION OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
Date of first authorisation: 6 March 2003 Date of latest renewal: 6 March 2008
Datum zadnjega podaljšanja: 06.03.2008
Effects of other medicinal products on vardenafil
Učinki drugih zdravil na vardenafil
There are no fertility data available.
Podatki o vplivu vardenafila na plodnost niso na voljo.
Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC code: G04BE09.
Farmakoterapevtska skupina: zdravila za bolezni sečil, zdravila za zdravljenje erektilne disfunkcije, oznaka ATC: G04BE09
Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
Znaki alergijske reakcije so izpuščaji, srbečica, otekel obraz ali ustnice in kratka sapa.
Vardenafil AUC is not affected.
Vrednost AUC vardenafila se ne spremeni.
This in turn results in smooth muscle relaxation, allowing increased inflow of blood into the penis.
To povzroči sproščanje gladkih mišic, kar omogoči večji dotok krvi v penis.
Read the package leaflet for further information.
Preberite navodilo za uporabo glede dodatnih informacij.
On the basis of the scientific conclusions for vardenafil the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing vardenafil is unchanged subject to the proposed changes to the product information
Na podlagi znanstvenih zaključkov za vardenafil skupina CMDh meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) vardenafil nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at any time in any given patient.
Klinična pomembnost te ugotovitve ni znana in se je ne da posplošiti na vse bolnike v vseh okoliščinah.
At 24 hours, the plasma levels of vardenafil had fallen to approximately 4% of the maximum vardenafil plasma level (Cmax).
Po 24 urah se plazemska raven vardenafila zniža na približno 4 % največje plazemske vrednosti vardenafila (Cmax).
This drug is used to treat pulmonary arterial hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs secondary to blood clots).
To zdravilo se uporablja za zdravljenje pljučne arterijske hipertenzije (tj. visokega krvnega tlaka v pljučih) in kronične trombembolične pljučne hipertenzije (tj. visokega krvnega tlaka v pljučih, ki nastane zaradi krvnih strdkov).
Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins (approximately 95% for vardenafil or M1).
Vardenafil in njegovi glavni presnovek (M1) se obsežno vežeta na plazemske beljakovine (približno 95 % vardenafila ali M1).
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disintegrate, and then swallowed.
Orodisperzabilne tablete se dajo pod jezik, kjer se hitro razgradijo in nato pogoltnejo.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity (see section 4.3).
Pred začetkom kakršnega koli zdravljenja erektilne disfunkcije mora zdravnik upoštevati kardiovaskularno stanje bolnika, saj obstaja v povezavi s spolno aktivnostjo določena nevarnost poslabšanja srčnih bolezni (glejte poglavje 4.3).
Dose adjustments are not required in elderly patients.
Starejšim bolnikom odmerka ni treba prilagajati.
The recommended dose is 10 mg.
Priporočeni odmerek je 10 mg.
Vardenafil was not found to accumulate in the plasma in patients aged 45 years and below or 65 years or over following once-daily dosing of vardenafil 10 mg orodispersible tablets over ten days.
Vardenafil se ne kopiči v plazmi pri bolnikih starih 45 let in manj ali 65 let in več, če so deset dni enkrat na dan jemali orodisperzibilne tablete po 10 mg vardenafila.
Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction.
Vardenafil je peroralno zdravilo za izboljšanje erektilne funkcije pri moških z erektilno disfunkcijo.
The safety and efficacy of vardenafil was maintained in long-term studies.
V dolgoročnih študijah sta varnost in učinkovitost vardenafila ostali nespremenjeni.
Among subjects treated with terazosin, hypotension was observed more frequently when vardenafil and terazosin were given simultaneously than when the dosing was separated by a time interval of 6 hours.
Med preiskovanci, ki so dobivali terazosin, se je hipotenzija pojavila pogosteje, kadar so vardenafil in terazosin jemali sočasno, kot pa takrat, ko je od zaužitja odmerka enega in drugega zdravila minilo šest ur.
The maximum recommended dose is 20 mg.
Največji priporočeni odmerek je 20 mg.
Further information on clinical trials with vardenafil 10 mg orodispersible tablets Efficacy and safety of vardenafil 10 mg orodispersible tablets were separately demonstrated in a broad population in two studies including 701 randomized erectile dysfunction patients who were treated up to 12 weeks.
Dodatne informacije o kliničnih preskušanjih z orodisperzibilnimi tabletami po 10 mg vardenafila Učinkovitost in varnost orodisperzibilnih tablet po 10 mg vardenafila so ločeno dokazali v dveh kliničnih študijah na širši populaciji bolnikov, v kateri je bilo vključenih 701 randomiziranih bolnikov z erektilno disfunkcijo, ki so bili zdravljeni do 12 tednov.
There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Podatkov o medsebojnem učinkovanju vardenafila in nespecifičnih zaviralcev fosfodiesteraze, kot sta teofilin ali dipiridamol, ni.
If you feel dizzy, or if your vision is affected after taking Levitra don't drive or operate any tools or machines.
Če imate po zaužitju zdravila Levitra vrtoglavico ali se vam je vid poslabšal, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
Based on measurements of vardenafil in semen of healthy subjects 90 minutes after dosing, not more than 0.00012% of the administered dose may appear in the semen of patients.
Meritve vardenafila v semenu zdravih preiskovancev 90 minut po odmerjanju kažejo, da se v semenu bolnikov ne more pojaviti več kot 0,00012 % zaužitega odmerka.
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
Čeprav specifične študije medsebojnega delovanja niso bile opravljene za vsa zdravila, je analiza farmakokinetike v populaciji pokazala, da na vardenafilovo farmakokinetiko ni vplivala sočasna uporaba acetilsalicilne kisline, zaviralcev angiotenzinske konvertaze, zaviralcev receptorjev beta, šibkih zaviralcev CYP3A4, diuretikov in zdravil za zdravljenje sladkorne bolezni (sulfonilsečnine in metformin).
Penile haemorrhage, haematospermia and haematuria have been reported in clinical trials and spontaneous post-marketing data with the use of all PDE5 inhibitors, including vardenafil.
O penilni hemoragiji, hematospermiji in hematuriji so poročali v kliničnih preskušanjih in spontanih poročilih iz obdobja trženja pri uporabi vseh zaviralcev PDE5, tudi vardenafila.
In volunteers with severe renal impairment (creatinine clearance <30 ml/min) the mean AUC was increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal impairment.
Pri prostovoljcih s hudo ledvično okvaro (kreatininski očistek < 30 ml/min) se je povprečna vrednost AUC zvečala za 21 %, povprečna Cmax pa zmanjšala za 23 % v primerjavi s prostovoljci brez motenj delovanja ledvic.
(≥1/10,000 to
(≥1/10.000 do
There was no evidence of favourable clinical effect of the combination in the population studied.
V proučevani populaciji niso dokazali, da bi imela kombinacija zdravil ugoden klinični učinek.
may affect less than 1 in 10,000 users or frequency cannot be estimated from the available data - Blood in the urine (Haematuria) - Penile bleeding (Penile Haemorrhage) - Presence of blood in the semen (Haematospermia) - Sudden death - Bleeding in the brain
Zelo redki ali neznana pogostnost lahko se pojavijo pri manj kot 1 od 10.000 uporabnikov ali pa pogostnosti ni mogoče oceniti iz razpoložljivih podatkov - kri v urinu (hematurija) - krvavitev iz penisa (penilna hemoragija) - kri v izlivu (hematospermija) - nenadna smrt - krvavitev v možganih
The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections 4.5 and 5.1).
Sočasno jemanje vardenafila in nitratov ali donorjev dušikovega oksida (npr. amil nitrita) v kateri koli obliki je kontraindicirano (glejte poglavji 4.5 in 5.1).
Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as compared to healthy younger volunteers (18 - 45 years).
Pri zdravih starejših prostovoljcih (starih 65 let in več) se je izločanje vardenafila skozi jetra v primerjavi z zdravimi mlajšimi prostovoljci (18 do 45 let) zmanjšalo.
Vardenafil is rapidly absorbed after administration of Levitra 10 mg orodispersible tablets without water.
Vardenafil se hitro absorbira po zaužitju zdravila Levitra 10 mg orodisperzibilne tablete brez vode.
Parts of M1 are in the form of the glucuronide in systemic circulation.
Del M1 je v sistemskem obtoku v obliki glukuronida.
In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
V kliničnih študijah se je pokazalo, da riociguat povečuje hipotenzivne učinke zaviralcev PDE5.
Therefore, inhibitors of these isoenzymes may reduce vardenafil clearance.
Zaviralci teh izoencimov lahko zato zmanjšajo očistek vardenafila.
There is no relevant indication for use of Levitra orodispersible tablets in children and adolescents.
Ustreznih indikacij za uporabo zdravila Levitra orodisperzibilne tablete pri otrocih in mladostnikih ni.
In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged 18 - 89 years, many of whom had multiple co-morbid conditions.
V kliničnih preskušanjih je prejemalo vardenafil več kot 17.000 moških z erektilno disfunkcijo (ED), starih 18 do 89 let.
These effects are consistent with the vasodilatory effects of PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells.
Ti učinki so skladni z vazodilatacijskimi učinki zaviralcev PDE5 in so verjetno posledica višjih ravni cGMP v gladkomišičnih celicah žil.
Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Predklinične študije so pokazale aditiven učinek na znižanje sistemskega krvnega tlaka pri kombiniranju zaviralcev PDE5 z riociguatom.
The primary objective of this study was to rule out a greater than 10 msec effect (i.e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point.
Glavni namen te študije je bil izključiti več kot 10 msec dolg učinek (to je, pokazati, da ni učinka) enkratnega 80-miligramskega peroralnega odmerka vardenafila na dobo QTc v primerjavi s placebom, ki so ga merili s spremembo Fridericiasove korekcijske formule (QTcF=QT/RR1/3) glede na osnovno vrednost 1 uro po odmerku.
When vardenafil was administered in higher doses and more frequently than the recommended dose regimen (40 mg film-coated tablets twice daily) cases of severe back pain have been reported.
Pri preiskovancih, ki so jemali večje odmerke vardenafila in pogosteje od priporočenega režima odmerjanja (40 mg filmsko obložene tablete dvakrat na dan), so se pojavile hude bolečine v hrbtu.
Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to PDE5 inhibitors such as vardenafil, tadalafil and sildenafil (see section 4.8).
Analize podatkov iz spremljanj kažejo na povečano tveganje za akutno NAION pri moških z erektilno disfunkcijo, ki so jemali zaviralce PDE5 kot so vardenafil, tadalafil in sildelafil (glejte poglavje 4.8).