FrancophonIA/ELRC3.0 huggingface dataset:
English: Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure.
Danish: Alkoholindtagelse sammen med Spedra kan give hurtig puls og sænke blodtrykket.
English: Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension (see section 4.5).
Danish: Alkoholindtagelse sammen med avanafil kan øge potentialet for symptomgivende hypotension (se pkt.
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.
Danish: I den generelle ED-population var den gennemsnitlige andel af forsøg, der endte med gennemført samleje, ca. 47 %, 58 % og 59 % for grupperne på henholdsvis 50 mg, 100 mg og 200 mg avanafil mod ca. 28 % for placebo.
English: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Danish: Prækliniske forsøg viste en yderligere dæmpende effekt på det systemiske blodtryk ved kombination af PDE5-hæmmere med riociguat.
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.
Danish: Beskrivelse af udvalgte bivirkninger, der er iagttaget med andre PDE5-hæmmere For andre PDE5-hæmmere er der indberettet et lille antal tilfælde af ikke-arteritisk anterior iskæmisk opticusneuropati (NAION) og pludseligt høretab i undersøgelser efter markedsføring og kliniske forsøg.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (forekommer hos indtil 1 ud af 10 behandlede):
English: A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Danish: Før farmakologisk behandling overvejes, bør der optages anamnese og foretages en objektiv undersøgelse til diagnosticering af erektil dysfunktion og udredning af mulige underliggende årsager.
English: Patients should be advised to stop taking PDE5 inhibitors, including avanafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing.
Danish: Patienterne skal have at vide, at de ved pludseligt opstået høretab skal holde op med at tage PDE5hæmmere, herunder avanafil, og straks søge lægehjælp.
English: No cases were reported during clinical trials of avanafil.
Danish: For avanafil blev der ikke indberettet sådanne tilfælde under de kliniske forsøg.
English: Use in patients using other medicinal products
Danish: Anvendelse sammen med anden medicin
English: Avanafil is a substrate of and predominantly metabolised by CYP3A4.
Danish: Avanafil er et substrat for CYP3A4 og metaboliseres fortrinsvis af dette.
English: In a rat pre- and post-natal development study, pups exhibited persistent decreases in body weight at 300 mg/kg/day and higher (approximately 15 times the MRHD on a mg/m basis) and delayed sexual development at 600 mg/kg/day (approximately 29 times the MRHD on a mg/m basis).
Danish: I et præ- og postnatal udviklingsstudie af rotter udviste ungerne persisterende nedsat kropsvægt ved 300 mg/kg/dag og derover (ca. 15 gange MRHD i mg/m2) og forsinket kønsmodning ved 600
English: Other moderate CYP3A4 inhibitors (e.g. amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil) would be expected to have similar effects.
Danish: Andre moderate CYP3A4-hæmmere (f.eks. amprenavir, aprepitant, diltiazem, fluconazol, fosamprenavir og verapamil) må forventes at have tilsvarende virkninger.
English: Dizziness Somnolence Sinus headache
Danish: Svimmelhed Somnolens Sinushovedpine
English: If any of the above apply to you talk to your doctor or pharmacist before taking Spedra.
Danish: Hvis noget af ovenstående gælder for dig, skal du straks fortælle det til lægen eller på apoteket, før du tager Spedra.
English: No cases were reported during clinical trials of avanafil (see section 4.4).
Danish: For avanafil blev der ikke indberettet sådanne tilfælde under de kliniske forsøg (se pkt.
English: The safety and efficacy of combinations of avanafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied (see section 4.4).
Danish: Der er ikke foretaget undersøgelser af sikkerheden og virkningen af kombinationer af avanafil med andre PDE5-hæmmere eller med andre midler mod erektil dysfunktion (se pkt.
English: Spedra works by helping the blood vessels in your penis to relax.
Danish: Spedras virkning består i, at det virker afslappende på blodkarrene i penis.
English: Amlodipine (5 mg daily) increased avanafil 200 mg single-dose Cmax and AUC by approximately 28% and 60%, respectively.
Danish: Amlodipin (5 mg dagligt) øgede Cmax og AUC for avanafil med henholdsvis ca. 28 % og 60 % efter en enkelt dosis af avanafil på 200 mg.
English: In clinical studies, riociguat has shown to augment the hypotensive effects of PDE5 inhibitors.
Danish: Kliniske forsøg har vist, at riociguat kan øge den hypotensive virkning af PDE5-hæmmere.
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.
Danish: I et klinisk studie omfattende raske frivillige og voksne mænd med svag erektil dysfunktion blev der over en periode på 26 uger med daglig administration af 100 mg avanafil i orale doser ikke fundet nogen forbindelse med uheldig indvirkning på sædkoncentrationen, -tallet, -motiliteten ellermorfologien.
English: Patients with left ventricular outflow obstruction (e.g. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure can be particularly sensitive to the actions of vasodilators including avanafil (see section 4.4).
Danish: Patienter med venstre ventrikel udløbsobstruktion (aortastenose og idiopatisk hypertrofisk subaortisk stenose) og patienter med svære forstyrrelser i den autonome kontrol af blodtrykket kan være særligt følsomme for virkningen af vasodilatorer, herunder avanafil (se pkt.
English: - Patients who have suffered from a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; - Patients with resting hypotension (blood pressure < 90/50 mmHg) or hypertension (blood pressure > 170/100 mmHg); - Patients with unstable angina, angina with sexual intercourse, or congestive heart failure categorised as New York Heart Association Class 2 or greater.
Danish: - tidligere myokardieinfarkt, apopleksi eller livstruende arytmi inden for de seneste seks måneder - hypotension i hvile (blodtryk < 90/50 mmHg) eller hypertension (blodtryk > 170/100 mmHg)
English: Breast-feeding There are no data on the use of avanafil during breast-feeding.
Danish: Amning Der foreligger ingen data om anvendelse af avanafil under amning.
English: If you are not sure, talk to your doctor or pharmacist before taking Spedra.
Danish: Hvis du er i tvivl, skal du tale med lægen eller apotekspersonalet, inden du tager Spedra.
English: Patients with severe renal impairment (creatinine clearance < 30 mL/min).
Danish: - svært nedsat nyrefunktion (kreatininclearance < 30 ml/min.)
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.
Danish: Hos mænd med enten type 1- eller type 2-diabetes mellitus var den gennemsnitlige andel af forsøg, der endte med gennemført samleje, ca. 34 % og 40 % for grupperne på henholdsvis 100 mg og 200 mg avanafil mod ca. 21 % for placebo.
English: The concomitant use of alpha-blockers and avanafil may lead to symptomatic hypotension in some patients due to additive vasodilatory effects (see section 4.5).
Danish: Samtidig administration af alfablokkere og avanafil kan hos visse patienter medføre symptomgivende hypotension på grund af additiv vasodilaterende virkning (se pkt.
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.
Danish: Hos personer med let nedsat leverfunktion (Child-Pugh A) medførte en enkelt dosis af avanafil på 200 mg samme eksponering som hos personer med normal leverfunktion.
English: • muscle aches or pains
Danish: • muskelømhed eller -smerter
English: • feeling sleepy or very tired
Danish: • søvnighed eller stærk træthed
English: • abnormal extra sound from the heart
Danish: • mislyd fra hjertet
English: • serious chest pain
Danish: • alvorlige brystsmerter
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.
Danish: Hos mænd med ED efter bilateralt nervebevarende radikal prostatektomi var den gennemsnitlige andel af forsøg, der endte med gennemført samleje, ca. 23 % og 26 % for grupperne på henholdsvis 100 mg og 200 mg avanafil, sammenlignet med ca. 9 % for placebo.
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
Danish: EU/1/13/841/008 4 tabletter EU/1/13/841/009 8 tabletter EU/1/13/841/010 12 tabletter EU/1/13/841/011 2 tabletter
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
Danish: EU/1/13/841/004 2tabletter EU/1/13/841/005 4 tabletter EU/1/13/841/006 8 tabletter EU/1/13/841/007 12 tabletter
English: • If you have a physical condition that affects the shape of your penis (such as angulation,
Danish: • hvis du har en fysisk lidelse, der ændrer formen på din penis, såsom vinkeldannelse, Peyronies sygdom eller fibrose (forhærdning) af svulmelegemet
English: In pregnant rabbits, no teratogenicity, embryotoxicity or fetotoxicity was observed at doses up to 240 mg/kg/day (approximately 23 times the MRHD on a mg/m basis.
Danish: Hos drægtige kaniner iagttoges ingen tegn på teratogenicitet, embryotoksicitet eller føtotoksicitet ved doser op til 240 mg/kg/dag (ca. 23 gange MRHD i mg/m2).
English: Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence).
Danish: Spedra er bestemt til behandling af voksne mænd, der lider af rejsningsproblemer (også kaldet impotens), dvs. manglende evne til at få eller opretholde tilstrækkelig rejsning til seksuel aktivitet.
English: One episode of “syncope” was observed in placebo and one episode on 100 mg of avanafil in phase III clinical trials.
Danish: I fase III-forsøg var der ét tilfælde af synkope med placebo og ét med 100 mg avanafil.
English: • feeling weak or tired all the time
Danish: • vedvarende svaghed eller træthed
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.
Danish: Hos patienter i stabil behandling med doxazosin var det placebokorrigerede gennemsnitlige fald i stående og liggende systolisk blodtryk efter administration af avanafil henholdsvis 2,5 og 6,0 mmHg.
English: In patients receiving concomitant treatment with moderate CYP3A4 inhibitors (including erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil), the maximum recommended dose of avanafil should not exceed 100 mg, with an interval of at least 48 hours between doses (see section 4.5).
Danish: Ved administration sammen med moderate CYP3A4-hæmmere (herunder erythromycin, amprenavir, aprepitant, diltiazem, fluconazol, fosamprenavir og verapamil) bør den maksimale anbefalede dosis af avanafil ikke overstige 100 mg med et interval på mindst 48 timers mellem doserne (se pkt.
English: A total of 1774 patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (four studies), respectively.
Danish: patienter avanafil efter behov i doser på henholdsvis 50 mg (et studie), 100 mg og 200 mg (fire studier).
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).
Danish: Der fandtes ingen virkning på parametre vedrørende fertilitet eller sæd ved doser op til 300 mg/kg/dag (baseret på AUC af ubundet stof svarer dette hos hanrotter til ni gange den humane eksponering ved en dosis på 200 mg).
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).
Danish: Hos drægtige rotter iagttoges ingen tegn på teratogenicitet, embryotoksicitet eller føtotoksicitet ved doser op til 300 mg/kg/dag (ca. 15 gange MRHD i mg/m hos en person på 60 kg).
English: inhibitors') including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.
Danish: hæmmere), herunder amprenavir, aprepitant, diltiazem, fluconazol, fosamprenavir og verapamil)
English: • swelling in the feet or ankles
Danish: • hævede fødder eller ankler
English: In a single-dose three-way crossover design study evaluating healthy subjects, the mean maximum reduction in diastolic blood pressure was significantly greater following avanafil administered in combination with alcohol than following avanafil alone (3.2 mmHg) or alcohol alone (5.0 mmHg) (see section 4.4).
Danish: I et trevejs enkeltdosis-overkrydsstudie af raske forsøgspersoner var det gennemsnitlige maksimale diastoliske blodtryksfald ved administration af avanafil sammen med alkohol signifikant større end med avanafil alene (3,2 mmHg) eller med alkohol alene (5,0 mmHg) (se pkt.
English: In total, 7/24 subjects experienced values or decreases from baseline that were of potential clinical significance following avanafil dosing (see section 4.4).
Danish: Efter dosering med avanafil fik i alt 7/24 personer værdier eller fald i forhold til baseline af potentiel klinisk betydning (se pkt.
English: Avanafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Danish: Avanafil udskilles overvejende ved metabolisering af hepatiske mikrosomale isoenzymer, hovedsagelig CYP3A4 og i mindre grad CYP2C9.
English: Dyspepsia Nausea
Danish: Dyspepsi Kvalme
English: A clinical study was conducted to assess the effect of avanafil on the potentiation of the blood pressure-lowering effects of selected antihypertensive medicinal products (amlodipine and enalapril).
Danish: Avanafils potenserende effekt på den blodtrykssænkende virkning af udvalgte antihypertensiva (amlodipin og enalapril) blev vurderet i et klinisk studie.
English: 4x1 tablets 8x1 tablets 12x1 tablets 2x1 tablets
Danish: 4x1 tabletter 8x1 tabletter 12x1 tabletter 2x1 tabletter
English: 2x1 tablets 4x1 tablets 8x1 tablets 12x1 tablets
Danish: 2x1 tabletter 4x1 tabletter 8x1 tabletter 12x1 tabletter
English: • medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,
Danish: • lægemidler mod uregelmæssig hjerterytme (arytmi) såsom kinidin, prokainamid, amiodaron og sotalol
English: Concomitant use of alpha-blockers
Danish: Samtidig brug af alfablokkere
English: • congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
Danish: • tilstoppet næse og tilstoppede bihuler eller øvre luftveje
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).
Danish: Disse forskelle blev opretholdt ved langvarig behandling (ifølge studier af patienter med erektil dysfunktion, af diabetikere med erektil dysfunktion og af mænd med erektil dysfunktion efter bilateral nervebevarende radikal prostatektomi og i en åben forlængelsesforsøg).
English: Patients who experience erections lasting 4 hours or more (priapism) should be instructed to seek immediate medical assistance.
Danish: Patienterne skal informeres om straks at søge lægehjælp, hvis de får erektion med en varighed af 4 timer eller derover (priapisme).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/004-007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/841/004-007
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.
Danish: Fire timer efter en enkelt dosis af avanafil på 200 mg var eksponeringen lavere hos personer med moderat nedsat leverfunktion (Child-Pugh B) end hos personer med normal leverfunktion.
English: Single dose of up to 800 mg of avanafil have been given to healthy subjects and multiple daily doses up to 300 mg have been given to patients.
Danish: Til raske forsøgspersoner er givet enkeltdoser af avanafil på op til 800 mg, og til patienter er givet gentagne daglige doser op til 300 mg. Bivirkningerne var de samme som ved lavere doser, men med øget hyppighed og sværhed.
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.
Danish: Ketoconazol (400 mg dagligt), der er en selektiv og højpotent hæmmer af CYP3A4, øgede Cmax og eksponering (AUC) for avanafil med henholdsvis en faktor 3 og faktor 14 efter en enkelt dosis af avanafil på 50 mg og forlængede halveringstiden af avanafil til ca. 9 timer.
English: • heartbeat changes seen on a heart tracing (ECG)
Danish: • forandringer på elektrokardiogrammet (EKG)
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).
Danish: Med andre PDE5-hæmmere er efter markedsføring beskrevet hypotension, og i de kliniske forsøg med avanafil er beskrevet svimmelhed, et symptom, der ofte forårsages af nedsat blodtryk (se pkt.
English: INFORMATION IN BRAILLE Spedra 100 mg
Danish: Spedra 100 mg
English: Hydroxypropylcellulose, low substituted
Danish: Hydroxypropylcellulose Hydroxypropylcellulose, lavsubstitueret Calciumcarbonat
English: Spedra is contraindicated in patients with severe hepatic impairment (Child Pugh class C) (see sections 4.3 and 5.2).
Danish: Spedra er kontraindiceret ved svært nedsat leverfunktion (Child-Pugh C) (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/841/008-011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/841/008-011
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.
Danish: Andre potente CYP3A4hæmmere (f.eks. itraconazol, voriconazol, clarithromycin, nefazodon, saquinavir, nelfinavir, indinavir, atazanavir og telithromycin) må forventes at have tilsvarende virkninger.
English: Spedra is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) (see sections 4.3 and 5.2).
Danish: Spedra er kontraindiceret ved svært nedsat nyrefunktion (kreatininclearance < 30 ml/min.)
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.
Danish: Ritonavir (600 mg to gange dagligt), der er en højpotent hæmmer af CYP3A4 og desuden hæmmer CYP2C9, øgede Cmax og eksponering (AUC) for avanafil med henholdsvis en faktor 2 og faktor 13 efter en enkelt dosis af avanafil på 50 mg, og forlængede halveringstiden af avanafil til ca. 9 timer.
English: INFORMATION IN BRAILLE Spedra 200 mg
Danish: Spedra 200 mg
English: In patients receiving stable tamsulosin treatment, the placebo-subtracted mean maximum decreases in standing and supine systolic blood pressure following avanafil dosing were 3.6 mmHg and 3.1 mmHg,
Danish: Hos patienter i stabil behandling med tamsulosin var det placebokorrigerede gennemsnitlige maksimale fald i stående og liggende systolisk blodtryk efter dosering med avanafil henholdsvis 3,6
English: INFORMATION IN BRAILLE Spedra 50 mg
Danish: Spedra 50 mg
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.
Danish: Erythromycin (500 mg to gange dagligt), der er en moderat hæmmer af CYP3A4, øgede Cmax og AUC med henholdsvis en faktor 2 og en faktor 3 efter en enkelt dosis på 200 mg af avanafil, og forlængede halveringstiden af avanafil til ca. 8 timer.
English: As dizziness and altered vision were reported in clinical trials with avanafil, patients should be aware of how they react to Spedra before driving or using machines.
Danish: Patienterne skal derfor være opmærksomme på, hvordan de reagerer på avanafil, før de fører motorkøretøj eller betjener maskiner.
English: Each tablet contains 200 mg of avanafil.
Danish: Hver tablet indeholder 200 mg avanafil.
English: Each tablet contains 50 mg of avanafil.
Danish: Hver tablet indeholder 50 mg avanafil.
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).
Danish: Samtidig administration af avanafil og potente CYP3A4-hæmmere såsom ketoconazol og ritonavir er kontraindiceret (se pkt.
English: Sinus congestion Dyspnoea exertional
Danish: Anstrengelsesdyspnø Øvre luftvejskongestion Epistakse
English: PHARMACEUTICAL FORM Tablet.
Danish: Receptpligtigt lægemiddel.
English: Concomitant use of CYP3A4 inhibitors
Danish: Samtidig anvendelse af CYP3A4-hæmmere
English: • increased heart beat
Danish: • øget hjerterytme
English: Each tablet contains 100 mg of avanafil.
Danish: Hver tablet indeholder 100 mg avanafil.
English: There was no effect on sperm motility or morphology after single 200 mg oral doses of avanafil in healthy volunteers.
Danish: En enkelt oral dosis på 200 mg avanafil havde ingen virkning på sædmotilitet eller -morfologi hos raske forsøgspersoner.
English: In subjects with mild (creatinine clearance ≥ 50 - < 80 mL/min) and moderate (creatinine clearance ≥ 30 - < 50 mL/min) renal impairment, the pharmacokinetics of a single 200 mg dose of avanafil were not altered.
Danish: Der var ikke afvigende farmakokinetik hos personer med let nedsat nyrefunktion (kreatininclearance  50 - < 80 ml/min) eller moderat nedsat nyrefunktion (kreatininclearance  30 - < 50 ml/min) efter en enkeltdosis af avanafil på 200 mg. Der findes ikke data for patienter med svært nedsat nyrefunktion eller dialysepatienter med nyresygdom i terminalstadiet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of avanafil.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 50 mg avanafil.
English: The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology.
Danish: Ved gentagen indtagelse af 100 mg avanafil over en periode på 26 uger blev der ikke fundet nogen forbindelse med uheldig indvirkning på sædkoncentrationen, -tallet, -bevægeligheden eller -udseendet, hos raske frivillige og voksne mænd med svag erektil dysfunktion.