FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal toxicity has been observed after administration of other subcutaneously and intravenously administered antisense oligonucleotides.
Slovenian: Po dajanju drugih subkutano ali intravensko apliciranih protismiselnih oligonukleotidov so opazili toksičnost za ledvice.
English: The analysis was conducted in the ITT population (Spinraza: n=84; sham-control: n=42), and post-baseline HFMSE data for patients without a Month 15 visit were imputed using the multiple imputation method.
Slovenian: placebo: n=42), poizhodiščne podatke HFMSE pa so bolnikom brez pregleda v 15. mesecu pripisali z metodo večkratne imputacije.
English: Mean change from baseline to month 15 in total RULM score2,3
Slovenian: Povprečna sprememba celotnega rezultata RULM od izhodišča do
English: WHO motor milestones
Slovenian: odzivnega z motoričnimi mejniki
English: Adverse reactions have been identified during post-approval use of Spinraza.
Slovenian: Med uporabo zdravila Spinraza po pridobitvi dovoljenja za promet so ugotovili neželene učinke.
English: MedDRA System Organ Class
Slovenian: Organski sistemi po MedDRA Priporočeni izraz po MedDRA
English: Package leaflet: Information for the user Spinraza 12 mg solution for injection nusinersen
Slovenian: Navodilo za uporabo Spinraza 12 mg raztopina za injiciranje nusinersen
English: Breast-feeding
Slovenian: Hidrocefalus
English: Study CS4 (CHERISH) was a Phase 3, randomised, double-blind, sham-procedure controlled study conducted in 126 symptomatic patients with later-onset SMA (symptom onset after 6 months of age).
Slovenian: Študija CS4 (CHERISH) je bila randomizirana, dvojno slepa, s placebom kontrolirana študija 3. faze,
English: Patients with Type III SMA demonstrated a mean improvement from baseline HFMSE score of 1.3 (SD 1.87, n=16) at Day 253 and 1.2 (SD 4.64, n=11) at Day 1050.
Slovenian: (SD 1,87, n=16) po 253 dneh in 1,2 (SD 4,64, n=11) po 1050 dneh zdravljenja.
English: The median age of onset of clinical signs and symptoms of SMA was 6.5 weeks and 8 weeks for Spinraza treated versus sham-control patients respectively, with 99% of patients having 2 copies of the SMN2 gene and therefore deemed most likely to develop Type I SMA.
Slovenian: Mediana starost ob začetku kliničnih znakov in simptomov SMA je bila pri bolnikih, zdravljenih z zdravilom Spinraza, 6,5 tedna, pri kontrolnih bolnikih na placebu pa 8 tednov.
English: If removed from the original carton, the total time out of refrigeration should not exceed 30 hours, at a temperature that does not exceed 25°C.
Slovenian: 30 ur pri temperaturi, ki ni višja od 25 °C.
English: 4.2(95% CI: 3.4, 5.0) p=0.00000016
Slovenian: 4,2 (95-% IZ: 3,4, 5,0)
English: OTHER
Slovenian: Od
English: The median age at first dose was 162 days.
Slovenian: Smatrali so, da je najbolj verjetno, da se bo pri bolnikih v tej študiji razvila SMA tipa I. Mediana starost pri prvem odmerku je bila 162 dni.
English: Interactions
Slovenian: Odmerjanje
English: Spinraza is given;
Slovenian: Spinraza.
English: out of 20 patients (55%) met the endpoint of an increase in total CHOP INTEND score of ≥4 points as of the last study visit.
Slovenian: doseglo končni opazovani dogodek zvečanja rezultata CHOP INTEND za ≥ 4 točke do zadnjega pregleda v študiji pred zaključkom zbiranja podatkov.
English: Further information on Gefitinib Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Gefitinib Mylan so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Gefitinib Mylan?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gefitinib Mylan?
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan.
Slovenian: Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Iressa, zato jih ni treba ponoviti za zdravilo Gefitinib Mylan.
English: EGFR is involved in the growth and spread of cancer cells.
Slovenian: EGFR je vpleten v rast in širjenje rakavih celic.
English: It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Slovenian: Uporablja se pri bolnikih, katerih rakave celice imajo mutacijo v genih, ki tvorijo beljakovino, imenovano receptor epidermalnega rastnega dejavnika (EGFR).
English: Because Gefitinib Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Gefitinib Mylan generično zdravilo in je bioekvivalentno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: An overview of Gefitinib Mylan and why it is authorised in the EU
Slovenian: Pregled zdravila Gefitinib Mylan in zakaj je odobreno v EU
English: This means that it blocks specific enzymes known as tyrosine kinases.
Slovenian: To pomeni, da zavira delovanje določenih encimov, imenovanih tirozin-kinaze.
English: As for every medicine, the company provided studies on the quality of Gefitinib Mylan.
Slovenian: Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Gefitinib Mylan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Gefitinib Mylan primerljivo raven kakovosti in je bioekvivalentno referenčnemu zdravilu Iressa.
English: Side effects reported with Gefitinib Mylan are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Gefitinib Mylan, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gefitinib Mylan have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Gefitinib Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What are the benefits and risks of Gefitinib Mylan?
Slovenian: Kakšne so koristi in tveganja zdravila Gefitinib Mylan?
English: These enzymes can be found on the surface of cancer cells, such as EGFR on the surface of non-small cell lung cancer cells.
Slovenian: Te encime je mogoče najti na površini rakavih celic, denimo EGFR na površini celic nedrobnoceličnega raka pljuč.
English: Gefitinib Mylan is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body).
Slovenian: Gefitinib Mylan je zdravilo proti raku, ki se uporablja za zdravljenje odraslih bolnikov z lokalno napredovalim ali metastatskim (kadar so se rakave celice s prvotnega mesta razsejale v druge dele telesa) nedrobnoceličnim rakom pljuč.
English: For more information about using Gefitinib Mylan, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Gefitinib Mylan glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Gefitinib Mylan can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience with anticancer treatments.
Slovenian: Predpisovanje in izdaja zdravila Gefitinib Mylan je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: As for all medicines, data on the use of Gefitinib Mylan are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Gefitinib Mylan stalno spremljajo.
English: Other information about Gefitinib Mylan
Slovenian: Druge informacije o zdravilu Gefitinib Mylan
English: Why is Gefitinib Mylan authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Gefitinib Mylan odobreno v EU?
English: This means that Gefitinib Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Iressa.
Slovenian: To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Iressa.
English: What is Gefitinib Mylan and what is it used for?
Slovenian: Kaj je zdravilo Gefitinib Mylan in za kaj se uporablja?
English: The active substance in Gefitinib Mylan, gefitinib, is a protein tyrosine kinase inhibitor.
Slovenian: Učinkovina v zdravilu Gefitinib Mylan, gefitinib, je „zaviralec protein-tirozin kinaze“.
English: The tablet can be dispersed in water for patients who have difficulty swallowing.
Slovenian: Pri bolnikih, ki težko požirajo, se tableta lahko raztopi v vodi.
English: Gefitinib Mylan contains the active substance gefitinib and is a ‘generic medicine'.
Slovenian: Zdravilo Gefitinib Mylan vsebuje učinkovino gefitinib in je „generično zdravilo“.
English: Gefitinib Mylan is available as 250 mg tablets to be taken by mouth.
Slovenian: Na voljo je v obliki 250-miligramskih tablet, ki se jemljejo peroralno.
English: By blocking EGFR, Gefitinib Mylan helps to slow down the growth and spread of the cancer.
Slovenian: Zdravilo Gefitinib Mylan z zaviranjem EGFR pripomore k manjši rasti in širjenju raka.
English: Gefitinib Mylan works only in non-small cell lung cancer cells that have a mutation in their EGFR.
Slovenian: Tako deluje samo v celicah nedrobnoceličnega raka pljuč, ki imajo mutacijo EGFR.
English: Therefore, the Agency's view was that, as for Iressa, the benefit of Gefitinib Mylan outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Zato je agencija menila, da koristi zdravila Gefitinib Mylan enako kot pri zdravilu Iressa odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: How is Gefitinib Mylan used?
Slovenian: Kako se zdravilo Gefitinib Mylan uporablja?
English: How has Gefitinib Mylan been studied?
Slovenian: Kako je bilo zdravilo Gefitinib Mylan raziskano?
English: How does Gefitinib Mylan work?
Slovenian: Kako zdravilo Gefitinib Mylan deluje?
English: * Equivalent to titre prior to inactivation (log10)
Slovenian: (*) Ekvivalent titru pred inaktivacijo (log 10)
English: Subcutaneous use Type I glass bottle with a chlorobutyl rubber stopper and aluminium cap
Slovenian: Govedo, ovce Subkutano Steklenička tipa I s klorobutilno gumijasto zaporko
English: EMEA Number Invented name
Slovenian: EU številka Izmišljeno ime
English: Withdrawal period
Slovenian: Suspenzija za injiciranje
English: Adopted at the 6-9 June 2016 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 6. in 9. junijem 2016
English: Page 2/2
Slovenian: Vmesni rezultati so pokazali stran 2/2
English: The available data do not indicate a clinically significant benefit from riociguat treatment in these patients.
Slovenian: Razpoložljivi podatki ne kažejo klinično pomembne koristi zdravljenja z riociguatom pri teh bolnikih.
English: Section 2 - What you need to know before you take Adempas Do NOT take Adempas: - If you have increased pressure in your pulmonary circulation associated with scarring of the lungs, of unknown cause (idiopathic pulmonary pneumonia).
Slovenian: Poglavje 2 - Kaj morate vedeti, preden boste vzeli zdravilo Adempas NE jemljite zdravila Adempas: - če imate zvišan tlak v pljučnem krvnem obtoku, povezan z brazgotinjenjem pljuč neznanega vzroka (idiopatsko pljučnico).
English: Riociguat - Increased mortality and serious adverse events (SAEs) in patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) in a single clinical trial (EPITT no 18681)
Slovenian: Riociguat - povečana umrljivost in pojavnost resnih neželenih učinkov pri bolnikih s pljučno hipertenzijo (PH), povezano z idiopatsko intersticijsko pljučnico (IIP), v kliničnem preskušanju (št. EPITT 18681)
English: Interim results showed an increased risk of mortality and serious adverse events in subjects receiving riociguat compared to those receiving
Slovenian: povečano tveganje za umrljivost in resne neželene učinke pri preiskovancih, ki so prejemali riociguat, v primerjavi s preiskovanci, ki so prejemali placebo.
English: 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.
Slovenian: 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.
English: Section 4.3 - Contraindications - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) (see Section 5.1)
Slovenian: Poglavje 4.3 - Kontraindikacije - bolniki s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP) (glejte poglavje
English: Riociguat is therefore contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (see section 4.3).
Slovenian: Riociguat je zato pri bolnikih s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico, kontraindiciran (glejte poglavje 4.3).
English: Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
Slovenian: Bolniki s pljučno hipertenzijo, povezano z idiopatsko intersticijsko pljučnico (PH-IIP) Randomizirana, dvojno slepa, s placebom nadzorovana študija II.
English: Macrogol 400
Slovenian: makrogol 400
English: When using the individual correction formulae, none of the values were out of the limit.
Slovenian: Ob uporabi korekcijske formule nobena od vrednosti ni bila zunaj meje.
English: Do not take Levitra more than once a day.
Slovenian: Ne vzemite zdravila Levitra več kot enkrat na dan.
English: (cannot be estimated from the available data)
Slovenian: Neznana (ni mogoče oceniti iz razpoložljivih podatkov)
English: There may be physical or psychological causes, or a mixture of both.
Slovenian: Vzroki so lahko telesni ali duševni, ali kombinacija obeh.
English: Use in adult men
Slovenian: Uporaba pri odraslih moških
English: The mean absolute oral bioavailability is 15%.
Slovenian: Povprečna absolutna biološka uporabnost je 15-odstotna.
English: The combination should be avoided (see section 4.5).
Slovenian: Tej kombinaciji se je treba izogibati (glejte poglavje 4.5).
English: This was not associated with any muscle or neurological toxicity.
Slovenian: To pa ni bilo povezano z mišično ali nevrološko toksičnostjo.
English: Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors.
Slovenian: Večina bolnikov, pri katerih so poročali o teh dogodkih, je imela že prisotne dejavnike tveganja za kardiovaskularne bolezni.
English: Of these, 900 patients have been treated for one year or longer.
Slovenian: Med njimi je 900 bolnikov prejemalo zdravilo eno leto ali dlje.
English: - Swallow one tablet with a glass of water.
Slovenian: - Tableto pogoltnite s kozarcem vode.
English: At least one in ten men has trouble getting or keeping an erection at some time.
Slovenian: Najmanj eden od desetih moških ima v določenem obdobju težave z doseganjem ali ohranjanjem erekcije.
English: The chance of having a side effect is described by the following categories:
Slovenian: Verjetnost, da se bo pri vas pojavil neželeni učinek, je opisana s sledečimi kategorijami:
English: This leaflet was last revised in {month YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne {mesec LLLL}
English: The actual clinical impact of these QT changes is unknown.
Slovenian: Dejanski klinični pomen QT sprememb ni znan.
English: - Alcoholic drink can make erection difficulties worse.
Slovenian: - Uživanje alkohola lahko težave z erekcijo še poslabša.
English: Effect on bleeding
Slovenian: Učinek na krvavitve
English: - The other ingredients of the tablets are:
Slovenian: - Druge sestavine zdravila so:
English: What Levitra is and what it is used for
Slovenian: Kaj je zdravilo Levitra in za kaj ga uporabljamo
English: Most of the men who experienced these side effects had heart problems before taking this medicine.
Slovenian: Večina moških, ki so imeli te neželene učinke, je imela težave s srcem že pred jemanjem tega zdravila.
English: Effect on QTc interval
Slovenian: Učinek na dobo QTc
English: Therefore the use of such combinations is not recommended.
Slovenian: Tovrstne kombinacije zato niso priporočljive.
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake “EXP”.
English: Treatment of erectile dysfunction in adult men.
Slovenian: Zdravljenje erektilne disfunkcije pri odraslih moških.
English: Allergic reaction
Slovenian: - alergijske reakcije
English: The most commonly reported adverse drug reaction occurring in ≥ 10% of patients is headache.
Slovenian: Neželeni učinek, o katerem so najpogosteje poročali in se je pojavil pri ≥ 10 % bolnikov je glavobol.
English: It is not possible to determine whether these events were directly related to vardenafil.
Slovenian: Ni mogoče ugotoviti ali so bili ti dogodki neposredno povezani z jemanjem vardenafila.
English: Penile erection is a haemodynamic process.
Slovenian: Erekcija penisa je hemodinamični proces.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The clinical impact of these QT changes is unknown (see section 5.1).
Slovenian: Klinični pomen spremembe QT ni znan (glejte poglavje 5.1).
English: Dissolve in the mouth
Slovenian: Raztopite v ustih.
English: 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.
Slovenian: 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.
English: Effect on vision
Slovenian: Učinek na vid
English: Elderly (≥65 years old)
Slovenian: Starostniki (≥ 65 let)
English: Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Slovenian: Erektilna disfunkcija je nezmožnost doseganja ali ohranjanja erekcije penisa, ki omogoča zadovoljivo spolno aktivnost.
English: Store in the original package in order to protect from humidity and light.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred vlago in svetlobo.
English: Effects on the QT interval were measured one hour post-dose (average tmax for vardenafil).
Slovenian: Učinke na dobo QT so merili eno uro po odmerku (povprečna vrednost tmax za vardenafil).
English: Due to the nitrate component it has the potential to have serious interaction with vardenafil.
Slovenian: Zaradi vsebnosti nitrata je možno resno medsebojno učinkovanje z vardenafilom.
English: There are no studies of vardenafil in pregnant women.
Slovenian: Ni študij o uporabi vardenafila pri nosečnicah.
English: He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.
Slovenian: Lahko vam bo predlagal zamenjavo z drugo obliko ali jakostjo zdravila Levitra, odvisno od tega kako zdravilo Levitra učinkuje pri vas.
English: 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.
Slovenian: 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.
English: The following adverse reactions have been reported:
Slovenian: Poročali so o naslednjih neželenih učinkih:
English: Over 2,500 patients have been treated with vardenafil for 6 months or longer.
Slovenian: Več kot 2.500 bolnikov je jemalo vardenafil šest mesecev ali dlje.
English: Use in patients using other medicinal products
Slovenian: Uporaba pri bolnikih, ki jemljejo druga zdravila
English: In general, the incidence of adverse reactions (especially “dizziness”) has been shown to be slightly higher in patients with a history of hypertension.
Slovenian: Incidenca neželenih učinkov (predvsem »omotica«) je nekoliko večja pri bolnikih s hipertenzijo v anamnezi.
English: 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.
Slovenian: 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.
English: Most of the effects are mild or moderate.
Slovenian: Večina teh učinkov je zmernih do blagih.
English: The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets.
Slovenian: Tablete so na voljo v pretisnih omotih po 2, 4, 8, 12 ali 20 tablet.
English: 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).
Slovenian: 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).
English: Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum.
Slovenian: Vardenafil je močan in selektiven zaviralec cGMP specifičnih fosfodiesteraz tipa 5 (PDE5), ki so najpomembnejše PDE v človeškem kavernoznem tkivu.
English: Do not crush the tablet.
Slovenian: Ne zdrobite tablete.
English: Sudden decrease or loss of hearing has been reported.
Slovenian: Poročali so tudi o nenadnem poslabšanju ali izgubi sluha.
English: 51368 Leverkusen Germany
Slovenian: 51368 Leverkusen
English: Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
Slovenian: Vardenafil (10 mg) ni podaljšal časa krvavitve, ki jo je povzročila acetilsalicilna kislina (2 x 81 mg).