FrancophonIA/ELRC3.0 huggingface dataset:
English: In the Time to onset study, avanafil demonstrated statistically significant improvement in the primary efficacy variable (average per subject proportion of successful responses by time after dose administration, to the Sexual Encounter Profile 3 - SEP3) as compared with placebo, resulting in successful intercourse in 24.71% of the attempts for the 100 mg dose and 28.18% for the 200 mg dose at approximately 15 minutes after dosing compared to 13.78% for placebo .
Slovenian: V študiji “In the Time to onset” je avanafil izkazal statistično pomembno izboljšanje primarne spremenljivke za učinkovitost (povprečno število poskusov uspešnih spolnih odnosov (Sexual Encounter Profile 3 - SEP3) v času po odmerjanju) v primerjavi s placebom, kjer je bilo 24,71% uspešnih spolnih odnosov z odmerkom 100 mg in 28,18% z odmerkom 200 mg po pri približno 15 minutah po odmerku, medtem ko je s placebom izboljšanje 13,8%.
English: Spedra can make you feel dizzy or affect your vision.
Slovenian: Zdravilo Spedra lahko povzroči omotičnost ali težave z vidom.
English: No cases were reported during clinical trials of avanafil.
Slovenian: Med kliničnimi študijami uporabe avanafila o tovrstnih primerih niso poročali.
English: Premature ejaculation Inappropriate affect
Slovenian: Psihiatrične motnje nespečnost prezgodnja ejakulacija neprimerni afekt
English: These differences were maintained with long term treatment (as per studies in the general ED population, in diabetics with EDand in men with ED following bilateral nerve-sparing radical prostatectomy and in the open-label extension trial).
Slovenian: Razlike so ostale enake tudi med dolgoročnim zdravljenjem (kot v študijah splošne populacije moških z ED, bolnikov s sladkorno boleznijo z ED, bolnikov z ED, ki je bila posledica radikalne prostatektomije z ohranjanjem živcev in v poskusno odprtem podaljšanem preskušanju).
English: Avanafil is a substrate of and predominantly metabolised by CYP3A4.
Slovenian: Avanafil je substrat CYP3A4, ki se s CYP3A4 tudi pretežno presnavlja.
English: The exposure 4 hours post-dose was lower in subjects with moderate hepatic impairment (Child-Pugh B) compared to subject with normal hepatic function after 200 mg of avanafil.
Slovenian: Izpostavljenost 4 ure po uporabi enkratnega odmerka 200 mg avanafila je bila manjša pri bolnikih z zmerno okvaro jeter (Child-Pugh B) kot pri osebah z normalnim delovanjem jeter.
English: Heart rate increased
Slovenian: • povečano bitje srca
English: • itching in the genital area
Slovenian: • srbečica v genitalnem predelu
English: In a clinical trial performed in healthy volunteers and adult males with mild erectile dysfunction, the daily administration of avanafil 100 mg oral doses over a period of 26 weeks was not associated with any untoward effects on sperm concentration, count, motility, or morphology.
Slovenian: V klinični študiji na zdravih prostovoljcih in odraslih moških z blago erektilno disfunkcijo dnevna uporaba avanafila 100 mg peroralno v obdobju 26 tednov ni bila povezana z neugodnimi učinki na koncentracijo in število spermijev, njihovo gibljivost ali morfologijo.
English: EU/1/13/841/008 4 tablets EU/1/13/841/009 8 tablets EU/1/13/841/010 12 tablets EU/1/13/841/011 2 tablets
Slovenian: EU/1/13/841/008 4 tablete EU/1/13/841/009 8 tablet EU/1/13/841/010 12 tablet EU/1/13/841/011 2 tableti
English: EU/1/13/841/004 2 tablets EU/1/13/841/005 4 tablets EU/1/13/841/006 8 tablets EU/1/13/841/007 12 tablets
Slovenian: EU/1/13/841/004 2 tableti EU/1/13/841/005 4 tablete EU/1/13/841/006 8 tablet EU/1/13/841/007 12 tablet
English: CYP3A4 substrate
Slovenian: Substrat CYP3A4
English: In patients receiving stable doxazosin treatment, the placebo-subtracted mean maximum decreases in standing and supine systolic blood pressure following avanafil dosing were 2.5 mmHg and 6.0 mmHg, respectively.
Slovenian: Pri bolnikih, ki so prejemali stalne odmerke doksazosina, je bilo po uporabi avanafila povprečno največje znižanje stoje oziroma leže izmerjenega sistoličnega krvnega tlaka z odšteto spremembo pri placebu 2,5 mmHg oziroma 6,0 mmHg.
English: INFORMATION IN BRAILLE Spedra 200 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Spedra 200 mg
English: Other moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil) would be expected to have similar effects.
Slovenian: Pri drugih srednje močnih zaviralcih CYP3A4 (npr. amprenavirju, aprepitantu, diltiazemu, flukonazolu, fosamprenavirju in verapamilu) je mogoče pričakovati podoben učinek.
English: INFORMATION IN BRAILLE Spedra 50 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Spedra 50 mg
English: What Spedra contains
Slovenian: Kaj vsebuje zdravilo Spedra
English: Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking avanafil.
Slovenian: Postopno povečanje odmerka zaviralcev receptorjev alfa lahko ob sočasnem jemanju avanafila vpliva na nadaljnje znižanje krvnega tlaka;
English: • swelling in the feet or ankles
Slovenian: • otekanje stopal ali gležnjev
English: In pregnant rats, no evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed at doses up to 300 mg/kg/day (approximately 15 times the MRHD on a mg/m basis in a 60 kg subject).
Slovenian: Pri brejih podganah niso opazili nobenih znakov teratogenosti, embriotoksičnosti ali fetotoksičnosti pri odmerkih do 300 mg/kg/dan (približno 15-krat večjem odmerku od MRHD na podlagi mg/m2 pri osebi z maso 60 kg).
English: INFORMATION IN BRAILLE Spedra 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Spedra 100 mg
English: Hypotension has been reported post marketing with other PDE5 inhibitors, and dizziness, a symptom commonly caused by lowered blood pressure, has been reported in clinical trials with avanafil (see section 4.5).
Slovenian: V obdobju trženju zdravila so pri uporabi skupaj z drugimi zaviralci PDE5 poročali o hipotenziji, med kliničnimi študijami z avanafilom pa so poročali o omotici, tj. simptomu, ki ga pogosto povzroča nizek krvni tlak (glejte poglavje 4.5).
English: Ketoconazole (400 mg daily), a selective and highly potent inhibitor of CYP3A4, increased avanafil 50 mg single-dose Cmax and exposure (AUC) equal to 3-fold and 14-fold respectively and prolonged the half-life of avanafil to approximately 9 hours.
Slovenian: Ketokonazol (400 mg na dan), selektivni in zelo močan zaviralec CYP3A4, je povečal Cmax in izpostavljenost (AUC) po enkratnem odmerku 50 mg avanafila za 3-krat oziroma 14-krat ter podaljšal razpolovni čas avanafila na približno 9 ur.
English: Ritonavir (600 mg twice daily), a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9, increased avanafil 50 mg single-dose Cmax and AUC equal to approximately 2-fold and 13-fold, and prolonged the half-life of avanafil to approximately 9 hours.
Slovenian: Ritonavir (600 mg dvakrat na dan), zelo močan zaviralec CYP3A4, ki zavira tudi CYP2C9, je povečal Cmax in AUC po enkratnem odmerku 50 mg avanafila za približno 2-krat oziroma 13-krat ter podaljšal razpolovni čas avanafila na približno 9 ur.
English: In the general population with ED, the mean percentage of attempts resulting in successful intercourse was approximately 47%, 58%, and 59% for the 50 mg, 100 mg, and 200 mg avanafil groups, respectively, as compared with approximately 28% for placebo.
Slovenian: Pri splošni populaciji moških z ED je bila povprečna stopnja poskusov, ki so se končali z uspešnim spolnim odnosom, približno 47 %, 58 % oziroma 59 % v skupinah, ki so prejemale 50 mg, 100 mg oziroma 200 mg avanafila, pri placebu pa je bila stopnja približno 28 %.
English: You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you.
Slovenian: Če je učinek odmerka 100 mg tablete prešibak, lahko zdravnik odmerek poveča na eno 200 mg tableto, če pa je učinek 100 mg tablete premočan, lahko odmerek zmanjša na eno 50 mg tableto.
English: Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra.
Slovenian: Preden zdravniki predpišejo zdravilo Spedra, naj preučijo morebitno srčno-žilno tveganje pri spolni aktivnosti pri bolnikih s kardiovaskularnimi boleznimi.
English: Consequently, the maximum recommended dose of avanafil is 100 mg, not to exceed once every 48 hours for patients taking concomitant moderate CYP3A4 inhibitors (see section 4.2).
Slovenian: Zato se pri bolnikih, ki sočasno jemljejo srednje močne zaviralce CYP3A4, ne sme preseči največjega priporočenega odmerka avanafila 100 mg enkrat na 48 ur (glejte poglavje 4.2).
English: Other strong inhibitors of CYP3A4 (e.g. itraconazole, voriconazole, clarithromycin, nefazodone, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin) would be expected to have similar effects.
Slovenian: Pri drugih močnih zaviralcih CYP3A4 (npr. itrakonazolu, vorikonazolu, klaritromicinu, nefazodonu, sakvinavirju, nelfinavirju, indinavirju, atazanavirju in telitromicinu) je mogoče pričakovati podoben učinek.
English: • medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,
Slovenian: • zdravila za nepravilen srčni utrip („aritmijo“), na primer kinidin, prokainamid, amiodaron ali sotalol;
English: Co-administration of avanafil with potent inhibitors of CYP3A4, such as ketoconazole or ritonavir is contraindicated (see sections 4.2, 4.3 and 4.5).
Slovenian: Sočasna uporaba avanafila z močnimi zaviralci CYP3A4, kot sta ketokonazol ali ritonavir, je kontraindicirana (glejte poglavja 4.2, 4.3 in 4.5).
English: • serious chest pain
Slovenian: • resne težave v prsih
English: In men with ED following bilateral nerve-sparing radical prostatectomy, the mean percentage of attempts resulting in successful intercourse was approximately 23% and 26% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 9% for placebo.
Slovenian: Pri moških z ED, ki je bila posledica radikalne prostatektomije z ohranjanjem živcev, je bila povprečna stopnja poskusov, ki so se končali z uspešnim spolnim odnosom, približno 23% oziroma 26% v skupinah, ki sta prejemali 100 mg oziroma 200 mg avanafila, pri placebu pa je bila stopnja približno 9%.
English: Subjects with mild hepatic impairment (Child-Pugh A) had comparable exposure to subjects with normal hepatic function when a single dose of 200 mg avanafil was administered.
Slovenian: Pri bolnikih z blago okvaro jeter (Child-Pugh A) so po uporabi enkratnega odmerka 200 mg avanafila zabeležili podobno izpostavljenost kot pri osebah z normalnim delovanjem jeter.
English: Patients who are using potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (see sections 4.2, 4.4 and 4.5).
Slovenian: Bolniki, ki uporabljajo močne zaviralce CYP3A4 (vključno s ketokonazolom, ritonavirjem, atazanavirjem, klaritromicinom, indinavirjem, itrakonazolom, nefazodonom, nelfinavirjem, sakvinavirjem in telitromicinom) (glejte poglavja 4.2, 4.4 in 4.5).
English: Maximum observed plasma concentrations are reached within 0.5 to 0.75 hours of oral dosing in the fasted state.
Slovenian: Najvišje koncentracije v plazmi doseže 30 do 45 minut po peroralni uporabi na tešče.
English: Blood urine present Cardiac murmur Prostate specific antigen increased Weight increased Blood bilirubin increased
Slovenian: Preiskave povišane vrednosti jetrnih encimov nenormalen elektrokardiogram povišan srčni utrip povišan krvni tlak prisotnost krvi v urinu šum na srcu zvišanje za prostato specifičnega antigena povišana telesna masa povišane ravni bilirubina v krvi povišane ravni kreatinina v krvi povišana telesna temperatura
English: Medicinal products reducing systemic blood pressure As a vasodilator, avanafil may reduce systemic blood pressure.
Slovenian: Ker avanafil deluje kot vazodilatator, lahko zniža sistemski krvni tlak.
English: You should take Spedra approximately 15 to 30 minutes before you have sexual intercourse.
Slovenian: Zdravilo Spedra vzemite približno 15 do 30 minut pred načrtovanim spolnim odnosom.
English: • heartbeat changes seen on a heart tracing (ECG)
Slovenian: • spremembe srčnega utripa na elektrokardiogramu (EKG-ju)
English: Erythromycin (500 mg twice daily), a moderate CYP3A4 inhibitor, increased avanafil 200 mg singledose Cmax and AUC equal to approximately 2-fold and 3-fold, respectively, and prolonged the half-life of avanafil to approximately 8 hours.
Slovenian: Eritromicin (500 mg dvakrat na dan), srednje močan zaviralec CYP3A4, je povečal Cmax in AUC po enkratnem odmerku 200 mg avanafila za približno 2-krat oziroma 3-krat ter podaljšal razpolovni čas avanafila na približno 8 ur.
English: In men with either Type 1 or Type 2 diabetes mellitus, the mean percentage of attempts resulting in successful intercourse was approximately 34% and 40% for the 100 mg and 200 mg avanafil groups, respectively, compared to approximately 21% for the placebo group.
Slovenian: Pri moških bodisi s sladkorno boleznijo tipa 1 ali 2 je bila povprečna stopnja poskusov, ki so se končali z uspešnim spolnim odnosom, približno 34 oziroma 40% v skupinah, ki sta prejemali 100 mg oziroma 200 mg avanafila, pri placebu pa je bila stopnja približno 21%.
English: Description of selected adverse reactions observed with other PDE5 inhibitors Non-arteritic anterior ischaemic optic neuropathy (NAION) and sudden loss of hearing have been reported in a small number of postmarketing and clinical trial cases with other PDE5 inhibitors.
Slovenian: Opis nekaterih neželenih učinkov, o katerih so poročali pri uporabi drugih zaviralcev PDE5 V obdobju po trženju zdravila in med kliničnimi študijami uporabe drugih zaviralcev PDE5 so poročali o majhnem številu primerov nearteritične anteriorne ishemične optične nevropatije (NAION) in nenadne izgube sluha.
English: Each tablet contains 50 mg of avanafil.
Slovenian: Ena tableta vsebuje 50 mg avanafila.
English: • indigestion, feeling or being sick to your stomach
Slovenian: • prebavne motnje, slabost v želodcu ali bruhanje
English: Influenza Nasopharyngitis
Slovenian: Infekcijske in parazitske bolezni gripa nazofaringitis
English: Each tablet contains 200 mg of avanafil.
Slovenian: Ena tableta vsebuje 200 mg avanafila.
English: There was no effect on sperm motility or morphology after single 200 mg oral doses of avanafil in healthy volunteers.
Slovenian: Enkratni peroralni odmerki 200 mg avanafila niso vplivali na gibljivost ali morfologijo semenčic zdravih prostovoljcev.
English: CYP3A4 Inhibitors
Slovenian: Zaviralci CYP3A4
English: Each tablet contains 100 mg of avanafil.
Slovenian: Ena tableta vsebuje 100 mg avanafila.
English: Co-administration of avanafil with potent CYP3A4 inhibitors (including ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) is contraindicated (see sections 4.3, 4.4 and 4.5).
Slovenian: Sočasna uporaba avanafila z močnimi zaviralci CYP3A4 (vključno s ketokonazolom, ritonavirjem, atazanavirjem, klaritromicinom, indinavirjem, itrakonazolom, nefazodonom, nelfinavirjem, sakvinavirjem in telitromicinom) je kontraindicirana (glejte poglavja 4.3, 4.4 in 4.5).
English: Dose adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min).
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina ≥ 30 ml/min) odmerka ni treba prilagajati.
English: Chest pain Influenza like illness Oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost astenija bolečine v prsih gripi podobna bolezen periferni edem
English: If you are not sure, talk to your doctor or pharmacist before taking Spedra.
Slovenian: Če ste negotovi, se pred uporabo zdravila Spedra posvetujte z zdravnikom ali farmacevtom.
English: • If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
Slovenian: • če jemljete zdravila za zdravljenje okužbe s virusom HIV ali aidsa, kot so ritonavir, indinavir,
English: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Slovenian: Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611Luxembourg Luksemburg
English: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Slovenian: Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611Luxembourg, Luksemburg
English: If any of the above apply to you talk to your doctor or pharmacist before taking Spedra.
Slovenian: Če karkoli od naštetega velja za vas, se pred uporabo zdravila Spedra posvetujte s svojim zdravnikom ali farmacevtom.
English: 4 hours, this must be treated as soon as possible or lasting damage can happen to your penis
Slovenian: Če se pojavi erekcija, ki traja več kot 4 ure, je treba čim prej poiskati zdravniško pomoč, sicer lahko pride do trajnih okvar penisa (vključno z nezmožnostjo doseganja erekcij);
English: • Patients should be stable on alpha-blocker therapy prior to initiating Spedra.
Slovenian: • pred začetkom uporabe zdravila Spedra mora biti zdravstveno stanje bolnikov, ki jemljejo zaviralce receptorjev alfa, stabilno.
English: Talk to your doctor or pharmacist before taking Spedra:
Slovenian: Pred začetkom jemanja zdravila Spedra se posvetujte z zdravnikom ali farmacevtom:
English: • feeling dizzy
Slovenian: • občutki nemira
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of avanafil.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 50 mg avanafila.
English: • stuffy or runny nose
Slovenian: • zamašen nos ali izcedek iz nosu
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of avanafil.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 200 mg avanafila.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of avanafil.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 100 mg avanafila.
English: You should take Spedra about 30 minutes before you have sexual intercourse.
Slovenian: Zdravilo Spedra vzemite približno 30 minut pred načrtovanim spolnim odnosom.
English: NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets
Slovenian: IME ZDRAVILA Spedra 50 mg tablete
English: Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje protin
English: inhibitors') including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.
Slovenian: CYP3A4“), vključno z amprenavirjem, aprepitantom, diltiazemom, flukonazolom,
English: NAME OF THE MEDICINAL PRODUCT Spedra 100 mg tablets
Slovenian: IME ZDRAVILA Spedra 100 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Spedra 200 mg tablets
Slovenian: IME ZDRAVILA Spedra 200 mg tablete
English: No effects on fertility or sperm parameters were noted at doses up to 300 mg/kg/day (in male rats 9 times human exposure based on unbound AUC at a dose of 200 mg).
Slovenian: Pri odmerkih do 300 mg/kg/dan (pri podganjih samcih to pomeni izpostavljenost, ki je 9-krat večja od izpostavljenosti pri človeku glede na nevezano AUC pri odmerku 200 mg) niso opazili učinkov na plodnost ali parametre semenčic.
English: Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg.
Slovenian: Glede na učinkovitost in prenašanje zdravila pri posamezniku se lahko odmerek poveča na največ 200 mg ali zmanjša na 50 mg. Največja priporočena pogostnost odmerjanja je enkrat na dan. Za odziv na zdravljenje je potrebno spolno vzburjenje.
English: • dry mouth
Slovenian: • zamašen nos
English: Cytochrome P450 Induction
Slovenian: Indukcija citokroma P450
English: Spedra is a pale yellow oval tablet, marked “50”on one side.
Slovenian: Zdravilo Spedra je bledo rumena ovalna tableta z vtisnjeno oznako „50“ na eni strani.
English: Pale yellow oval tablets, debossed with “50” on one side.
Slovenian: Bledo rumene ovalne tablete z vtisnjeno oznako “50” na eni strani.
English: • hot flush
Slovenian: • vročinski oblivi
English: NAME OF THE MEDICINAL PRODUCT Spedra 50 mg tablets avanafil
Slovenian: IME ZDRAVILA Spedra 50 mg tablete avanafil
English: NAME OF THE MEDICINAL PRODUCT Spedra 200 mg tablets avanafil
Slovenian: IME ZDRAVILA Spedra 200 mg tablete avanafil
English: Spedra is a pale yellow oval tablet, marked “200” on one side.
Slovenian: Zdravilo Spedra je bledo rumena ovalna tableta z vtisnjeno oznako „200“ na eni strani.
English: Pale yellow oval tablets, debossed with “100” on one side.
Slovenian: Bledo rumene ovalne tablete z vtisnjeno oznako “100” na eni strani.
English: Spedra is a pale yellow oval tablet, marked “100” on one side.
Slovenian: Zdravilo Spedra je bledo rumena ovalna tableta z vtisnjeno oznako „100“ na eni strani.
English: Pale yellow oval tablets, debossed with “200” on one side.
Slovenian: Bledo rumene ovalne tablete z vtisnjeno oznako “200” na eni strani.
English: amiodarone or sotalol
Slovenian: sakvinavir, nelfinavir ali atazanavir;
English: NAME OF THE MEDICINAL PRODUCT Spedra 100 mg tablets avanafil
Slovenian: IME ZDRAVILA Spedra 100 mg tablete avanafil
English: Psychomotor hyperactivity
Slovenian: Bolezni živčevja glavobol omotica somnolenca sinusni glavobol psihomotorna hiperaktivnost
English: • blurred vision.
Slovenian: • zamegljen vid;
English: PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 2x1, 4x1, 8x1 and 12x1 tablets.
Slovenian: Perforiran pretisni omot za enkratni odmerek iz PVC/PCTFE/aluminija v škatlah s po 2x1, 4x1, 8x1 in 12x1 tabletami.
English: EU/1/13/841/002 8 tablets
Slovenian: EU/1/13/841/008-011
English: Dizziness Somnolence Sinus headache
Slovenian: Očesne bolezni zamegljen vid
English: PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets.
Slovenian: Perforiran pretisni omot za enkratni odmerek iz PVC/PCTFE/aluminija v škatlah s po 4x1, 8x1 in 12x1 tabletami.
English: The fourth study investigated the onset of action of avanafil at two doses (100 and 200 mg) in terms of per-subject proportion of sexual attempts resulting in satisfactory completion of sexual intercourse.
Slovenian: V četrti študiji so preučevali nastop delovanja avanafila v odmerkih 100 in 200 mg.
English: Priapism has been reported in a small number of post-marketing and clinical trial cases with other PDE5 inhibitors.
Slovenian: V obdobju po trženju zdravila in med kliničnimi študijami uporabe drugih zaviralcev PDE5 so poročali o majhnem številu primerov priapizma.
English: The tablets are provided in perforated unit dose blister packs containing 2x1, 4x1, 8x1, or 12x1 tablets.
Slovenian: Tablete so na voljo v perforiranem pretisnem omotuv za enkratni odmerek, ki vsebujejo 2x1, 4x1, 8x1 ali 12x1 tablet.
English: The tablets are provided in perforated unit dose blister packs containing 4x1, 8x1, or 12x1 tablets.
Slovenian: Tablete so na voljo v perforiranem pretisnem omotu za enkratni odmerek, ki vsebujejo 4x1, 8x1 ali 12x1 tablet.
English: The tablets are provided in perforated unit dose blister packs containing 2x1, 4x1, 8, or 12x1 tablets.
Slovenian: Tablete so na voljo v perforiranem pretisnem omotu za enkratni odmerek, ki vsebujejo 2x1, 4x1, 8x1 ali 12x1 tablet.
English: • nasal congestion
Slovenian: • seneni nahod
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/004-007
Slovenian: EU/1/13/841/004-007
English: EU/1/13/841/003 12 tablets
Slovenian: EU/1/13/841/001-003
English: Fumaric acid
Slovenian: • mišični krči
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg avanafil.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 100 mg avanafila.
English: Nervous system disorders
Slovenian: Zaviralci receptorjev alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 200 mg avanafil.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 200 mg avanafila.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg avanafil.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 50 mg avanafila.
English: • gout
Slovenian: • protin
English: • weight gain
Slovenian: • zasoplost ob naporu