FrancophonIA/ELRC3.0 huggingface dataset:
English: Yellow iron oxide (E172)
Danish: Jernoxid, gul (E172)
English: There was no effect of a single dose of avanafil on amlodipine plasma levels.
Danish: En enkelt dosis af avanafil havde ingen indvirkning på plasmakoncentrationen af amlodipin.
English: Further, the metabolites of avanafil (M4, M16 and M27), also demonstrated a minimal inhibition of CYPs 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4.
Danish: Desuden havde avanafils metabolitter (M4, M16 og M27) kun minimalt hæmmende virkning på CYP 1A1/2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4.
English: The most common adverse reactions reported in clinical studies were headache, flushing, nasal and sinus congestion and back pain.
Danish: De hyppigst indberettede bivirkninger i de kliniske studier var hovedpine, rødme, næse- og bihulekongestion samt rygsmerter.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
English: In vitro studies with human platelets indicate that PDE5 inhibitors do not have an effect on platelet aggregation on their own, but at supratherapeutic doses they potentiate the anti-aggregatory effect of the nitric oxide donor sodium nitroprusside.
Danish: In vitro-studier med humane trombocytter viser, at PDE5-hæmmere ikke i sig selv påvirker trombocytaggregationen, men at de ved superterapeutiske koncentrationer potenserer den antiaggregatoriske virkning af nitrogenoxiddonoren natriumnitroprussid.
English: Avanafil was not found to accumulate in plasma when dosed 200 mg twice daily over 7 days.
Danish: Der fandtes ingen akkumulering af avanafil i plasma ved dosering med 200 mg to gange dagligt i 7 dage.
English: Since the in vitro data identified potential avanafil interactions with CYPs 2C19, 2C8/9, 2D6 and 3A4, further clinical studies using omeprazole, rosiglitazone and desipramine did not reveal clinically relevant interactions with CYPs 2C19, 2C8/9 and 2D6.
Danish: Selvom in vitro-data viste potentielle interaktioner mellem avanafil og CYPs 2C19, 2C8/9, 2D6 og 3A4, viste yderligere kliniske studier med omeprazol, rosiglitazon og desipramin ingen klinisk relevante interaktioner med CYPs 2C19, 2C8/9 og 2D6.
English: In a rat fertility and early embryonic development trial, a decrease in fertility and sperm motility, altered estrous cycles, and an increased percentage of abnormal sperm occurred at 1000 mg/kg/day, a dose which also caused parental toxicity in the treated males and females.
Danish: I et forsøg med fertilitet og tidlig embryonal udvikling hos rotter sås nedsat fertilitet og sædmotilitet, ændret østruscyklus og øget procentdel abnorme spermier ved 1.000 mg/kg/dag, en dosis, der desuden var toksisk for de behandlede forældredyr af han- og hunkøn.
English: • an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function
Danish: • unormal blodprøve for kreatinin, et stof, der udskilles i urinen og er et mål for nyrefunktionen
English: In vitro results showed for avanafil a modest potential for acting as P-gp substrate and P-gp inhibitor with digoxin as a substrate at concentrations lower than the calculated intestinal concentration.
Danish: In vitro-undersøgelser viste, at avanafil har moderat potentiale for at fungere som substrat for P-gp og som hæmmer af P-gp med digoxin som substrat ved koncentrationer under den beregnede koncentration i tarmen.
English: This medicinal product does not require any special storage conditions.
Danish: Der er ingen særlige krav til opbevaringsforholdene for dette lægemiddel.
English: This medicine 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).
Danish: Dette lægemiddel anvendes til behandling af pulmonal arteriel hypertension (forhøjet blodtryk i lungerne) samt kronisk tromboembolisk pulmonal hypertension (kronisk forhøjet blodtryk i lungerne som følge af blodpropper).
English: • If you have a serious liver or kidney problem
Danish: • hvis du har et alvorligt problem med leveren eller nyrerne
English: Patients were initially assigned to avanafil 100 mg and at any point during the trial, they could request to have their dose of avanafil increased to 200 mg or decreased to 50 mg based on their individual response to treatment.
Danish: Patienterne fik initialt avanafil 100 mg og kunne på ethvert tidspunkt under forsøget anmode om at få deres dosis af avanafil sat op til 200 mg eller sat ned til 50 mg, afhængigt af deres individuelle respons på behandlingen.
English: The M4 metabolite shows a phosphodiesterase selectivity profile similar to that of avanafil and an in vitro inhibitory potency for PDE5 18% of that of avanafil.
Danish: M4metabolitten udviser en selektivitet for fosfodiesterase svarende til avanafils og en hæmmende virkning på PDE5 in vitro svarende til 18 % af avanafils.
English: Gastrointestinal disorders
Danish: Opkastning Gastrointestinalt ubehag
English: • Patients should be stable on alpha-blocker therapy prior to initiating Spedra.
Danish: • Patienterne skal være i stabil behandling med en alfablokker før påbegyndelse af behandling med Spedra.
English: There was a statistically significant difference in maximum decrease from baseline in supine diastolic blood pressure with enalapril and avanafil only, which returned to baseline 4 hours after the dose of avanafil.
Danish: Kun med enalapril og avanafil var der signifikant forskel i det maksimale fald fra baseline i det liggende diastolisk blodtryk, og værdien returnerede til baseline fire timer efter doseringen af avanafil.
English: The patient should be advised that in case of sudden visual effects, he should stop taking Spedra and consult a physician immediately (see section 4.3).
Danish: Patienterne skal informeres om, at de ved pludselig påvirkning af synet skal ophøre med at tage Spedra og straks søge læge (se pkt.
English: CYP3A4 substrate
Danish: CYP3A4-substrat
English: Effects of other substances on avanafil
Danish: Andre lægemidlers effekter på avanafil
English: • In those patients already taking an optimised dose of Spedra, alpha-blocker therapy should be initiated at the lowest dose.
Danish: • Hvis patienten i forvejen får en optimeret dosis af Spedra, bør initiering af alfablokkerbehandling ske med den laveste dosis.
English: Patients who are using any form of organic nitrate or nitric oxide donors (such as amyl nitrite) (see section 4.5).
Danish: Patienter, der får en hvilken som helst form for organiske nitrat- eller nitrogenoxiddonorer (såsom amylnitrit) (se pkt.
English: Patients who demonstrate haemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of avanafil.
Danish: Patienter, der udviser hæmodynamisk ustabilitet ved behandling med alfablokkere alene, har øget risiko for symptomgivende hypotension ved samtidig anvendelse af Spedra.
English: Results showed a mean maximum decrease in supine blood pressure of 2/3 mmHg compared to placebo with enalapril and 1/-1 mmHg with amlodipine when avanafil was co-administered.
Danish: Undersøgelsen viste et gennemsnitlig maksimalt fald i forhold til placebo af det liggende blodtryk på 2/3 mmHg med enalapril og 1/1 mmHg med amlodipin ved samtidig administration af avanafil.
English: Consumption of alcohol in combination with avanafil can increase the potential for symptomatic hypotension.
Danish: Alkoholindtagelse sammen med avanafil kan øge potentialet for symptomgivende hypotension.
English: When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis.
Danish: Ved seksuel stimulation udløses lokal frigivelse af nitrogenmonoxid, og den af avanafil bevirkede hæmning af PDE5 øger koncentrationen af cGMP i corpus cavernosum i penis.
English: In clinical trials, avanafil was assessed for its effect on the ability of men with erectile dysfunction (ED) to achieve and maintain an erection sufficient for satisfactory sexual activity.
Danish: I de kliniske forsøg registreredes avanafils virkning på evnen til at opnå og opretholde tilfredsstillende erektion til seksuel aktivitet hos mænd med erektil dysfunktion (ED).
English: In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate.
Danish: Især skal du sige det til lægen og ikke tage Spedra, hvis du får nitratlægemidler mod brystsmerter (angina) såsom amylnitrit eller glyceryltrinitrat.
English: • pain or discomfort in the lower abdomen
Danish: • smerter eller ubehag i den nederste del af maven
English: Avanafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Danish: Der bør udvises forsigtighed, når avanafil anvendes ved anatomisk penisdeformitet (såsom vinkeldannelse, corpus cavernosum-fibrose eller Peyronies sygdom) eller ved sygdomme, der disponerer for priapisme (såsom seglcelleanæmi, multipelt myelom og leukæmi).
English: Premature ejaculation Inappropriate affect
Danish: Søvnløshed Præmatur ejakulation Upassende affekt
English: PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine.
Danish: Det har vist sig, at PDE5-hæmmere kan øge den hypotensive virkning af lægemidlet.
English: What Spedra contains
Danish: Spedra indeholder:
English: • If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl trinitrate.
Danish: • hvis du tager nitratlægemidler mod brystsmerter (angina), såsom amylnitrit eller glyceryltrinitrat.
English: Other medicines and Spedra
Danish: Brug af anden medicin sammen med Spedra
English: The co-administration of type 5 phosphodiesterase (PDE5) inhibitors, including avanafil, with guanylate cyclase stimulators, such as riociguat is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Danish: Samtidig indgivelse af fosfodiesterase type 5 (PDE5)-hæmmere, herunder avanafil, med stimulatorer med guanylatcyclase, såsom riociguat, er kontraindikeret, da det vil kunne føre til tilfælde af symptomatisk hypotension (se pkt.
English: Across all of the pivotal trials of avanafil, the percentage of successful intercourse attempts was significantly higher for all doses of avanafil compared to placebo for attempts at all post-dosing time intervals examined.
Danish: I alle hovedforsøg med avanafil var der signifikant højere andel af gennemførte samlejeforsøg med alle doser af avanafil end med placebo ved alle de undersøgte tidsintervaller efter dosering.
English: The potential of avanafil to interfere with the transport of other medicinal products mediated by P-gp is not known.
Danish: For andre lægemidler er avanafils potentiale for at gribe ind i den P-gpmedierede transport ukendt.
English: Concomitant use of other treatments for erectile dysfunction The safety and efficacy of combinations of Spedra and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Danish: Samtidig anvendelse af andre midler mod erektil dysfunktion Der er ikke foretaget undersøgelser af sikkerheden og virkningen af kombinationer af Spedra med andre PDE5-hæmmere eller med andre midler mod erektil dysfunktion.
English: Patients should be advised that concurrent use of avanafil and alcohol may increase the likelihood of hypotension, dizziness, or syncope.
Danish: Patienten skal have at vide, at anvendelse af avanafil sammen med alkoholindtagelse kan øge sandsynligheden for hypotension, svimmelhed og synkope.
English: • The other ingredients are mannitol, fumaric acid, hydroxypropylcellulose, hydroxypropylcellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).
Danish: • De andre indholdsstoffer er mannitol, fumarsyre, hydroxypropylcellulose, hydroxypropylcellulose lavsubstitueret, calciumcarbonat, magnesiumstearat og gul jernoxid (E172).
English: A total of 1774patients received avanafil, which was taken as needed at doses of 50 mg (one study), 100 mg and 200 mg (four studies), respectively.
Danish: I alt fik 1.774 patienter avanafil efter behov i doser på henholdsvis 50 mg (et studie), 100 mg og 200 mg (fire studier).
English: • increased blood pressure
Danish: • blodtryksstigning
English: • influenza-like illness
Danish: • influenzalignende sygdom
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: • If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
Danish: • hvis du får lægemidler mod svampeinfektioner såsom ketoconazol, itraconazol eller voriconazol, eller visse antibiotika mod bakterielle infektioner såsom clarithromycin eller telithromycin
English: It is eliminated predominantly by hepatic metabolism (mainly CYP3A4).
Danish: Det udskilles overvejende ved metabolisering i leveren (hovedsagelig af CYP3A4).
English: You should take Spedra about 30 minutes before you have sexual intercourse.
Danish: Du bør tage Spedra ca. 30 minutter før samleje.
English: Therefore, administration of avanafil to patients who are using any form of organic nitrate or nitric oxide donor (such as amyl nitrite) is contraindicated.
Danish: Avanafil er derfor kontraindiceret hos patienter, der får nogen form for organiske nitrateller nitrogenoxiddonorer (såsom amylnitrit).
English: (including not being able to get erections).
Danish: manglende evne til at få rejsning)
English: Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking avanafil.
Danish: Trinvis stigning i alfablokkerdosis kan medføre yderligere blodtryksfald under behandling med avanafil.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Danish: Brug ikke Spedra efter den udløbsdato, der står på blisterpakningen og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjælden (forekommer hos indtil 1 ud af 1.000 behandlede):
English: Abdominal pain lower Diarrhoea
Danish: Mundtørhed Gastritis Smerter i nedre abdomen Diarré
English: Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra').
Danish: Du må heller ikke tage Spedra, hvis du får medicin mod hiv eller aids såsom ritonavir, indinavir, saquinavir, nelfinavir eller atazanavir, eller hvis du får medicin mod svampeinfektioner såsom ketoconazol, itraconazol eller voriconazol eller visse antibiotika mod bakterielle infektioner såsom clarithromycin eller telithromycin (se i begyndelsen af punkt 2 under “Tag ikke Spedra”).
English: The impact of avanafil on other transporters is unknown.
Danish: Avanafils virkning på andre transportproteiner kendes ikke.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (forekommer hos indtil 1 ud af 100 behandlede)
English: Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators, including PDE5 inhibitors.
Danish: Patienter med obstruktion af fraløbet fra venstre ventrikel, f.eks. aortastenose og idiopatisk hypertrofisk subaortisk stenose, kan være følsomme over for virkningen af vasodilatorer, herunder PDE5-hæmmere.
English: Blood urine present Cardiac murmur Prostate specific antigen increased Weight increased Blood bilirubin increased
Danish: Blodtryksforhøjelse Blod i urinen Hjertemislyd Prostataspecifikt antigen forhøjet Vægtforøgelse Blodbilirubin forhøjet Blodkreatinin forhøjet Forhøjet legemstemperatur
English: • feeling unable to keep still
Danish: • vanskelighed ved at holde sig i ro
English: There were no treatment-related testicular findings in mice or rats treated with doses up to 600 or 1000 mg/kg/day for 2 years, and no testicular findings in dogs treated with avanafil for 9 months at exposures 110 times human exposure at the Maximum Recommended Human Dose (MRHD).
Danish: Der var ingen behandlingsrelaterede testikulære fund hos mus eller rotter ved doser op til 600 eller 1.000 mg/kg dagligt i to år, og ingen testikulære fund hos hunde, der blev behandlet med avanafil i 9 måneder med en eksponering svarende til 110 gange den humane eksponering ved den anbefalede maksimale dosis til mennesker (MRHD).
English: At a maternally toxic dose of 1000 mg/kg/day (approximately 49 times the MRHD on a mg/m basis), decreased fetal body weight occurred with no signs of teratogenicity.
Danish: Ved en maternelt toksisk dosis på 1.000 mg/kg/dag (ca. 49 gange MRHD i mg/m2) sås nedsat fostervægt uden tegn på teratogenicitet.
English: Studies have shown that medicinal products that inhibit CYP3A4 can increase avanafil exposure (see section 4.2).
Danish: Studier har vist, at eksponeringen for avanafil kan øges af lægemidler, der hæmmer CYP3A4 (se pkt.
English: Avanafil has not been evaluated in patients with erectile dysfunction due to spinal cord injury or other neurological disorders and in subjects with severe renal or hepatic impairment.
Danish: Avanafil er ikke evalueret ved erektil dysfunktion efter rygmarvstraumer eller andre neurologiske lidelser eller ved svært nedsat nyre- eller leverfunktion.
English: • pain in the lower back or side of lower chest
Danish: • smerter i lænden eller nederst i flanken
English: • If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
Danish: • hvis du får lægemidler mod hiv eller aids såsom ritonavir, indinavir, saquinavir, nelfinavir eller atazanavir
English: Penis disorder Spontaneous penile erection
Danish: Penislidelser Spontan erektion Genital pruritus
English: The concomitant use of potent CYP3A4 inhibitors (e.g. ketoconazole and ritonavir) is associated with increased plasma exposure of avanafil (see section 4.5).
Danish: Samtidig anvendelse af potente CYP3A4-hæmmere (f.eks. ketoconazol og ritonavir) er forbundet med øget plasmaeksponering for avanafil (se pkt.
English: Concomitant use of riociguat with PDE5 inhibitors, including avanafil, is contraindicated (see section 4.3).
Danish: Samtidig brug af riociguat med PDE5-hæmmere, herunder avanafil, er kontraindikeret (se pkt.
English: If Spedra is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Danish: Hvis Spedra tages sammen med et måltid, kan virkningen være længere om at indtræde end i fastende tilstand (se pkt.
English: Also some other medicines can affect the way Spedra works.
Danish: Andre lægemidler kan desuden ændre virkningen af Spedra.
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.
Danish: Det fjerde studie undersøgte, hvornår virkningen af avanafil intrådte for to doser (100 og 200 mg) i forhold til, hvor stor en andel af den enkelte forsøgspersons seksuelle forsøg, der resulterede i vellykket samleje.
English: Spedra can be taken with or without food; if taken with food, it may take longer to work.
Danish: Du kan tage Spedra i forbindelse med et måltid, men i så fald kan det være længere om at virke.
English: You should take Spedra approximately 15 to 30 minutes before you have sexual intercourse.
Danish: Du bør tage Spedra ca. 15-30 minutter før samleje.
English: Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease before prescribing Spedra.
Danish: Ved præeksisterende kardiovaskulær sygdom skal den potentielle kardiale risiko ved seksuel aktivitet tages i betragtning, før Spedra udskrives.
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 .
Danish: I studiet af tidspunktet for virkningens indtræden viste avanafil statistisk signifikant forbedring i variablen for det primære mål (gennemsnit pr. forsøgsperson for vellykket reaktion i forhold til den tid, der er gået efter indtagelse, for Sexual Encounter Profile 3 - SEP3) sammenlignet med placebo, hvilket resulterede i vellykket samleje i 24,71 % af forsøgene ved 100 mg dosis og 28,18 % for 200 mg dosis ca. 15 minutter efter indtagelse sammenlignet med 13,78 % for placebo.
English: No special requirements.
Danish: Ingen særlige krav til opbevaringsforhold.
English: Dose adjustments are not required in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 mL/min).
Danish: Der kræves ikke dosisjustering ved let til moderat nedsat nyre- eller leverfunktion (kreatininclearance ≥ 30 ml/min).
English: • In those patients who are stable on alpha-blocker therapy, avanafil should be initiated at the lowest dose of 50 mg.
Danish: • Hvis patienten er stabil på alfablokkerbehandling, bør initiering af behandlingen med Spedra ske med den laveste dosis på 50 mg.
English: • an abnormal blood test result for a prostate test called ‘PSA'
Danish: • unormale værdier af prostataprøven ”PSA”
English: • weight gain
Danish: • vægtforøgelse
English: • itching in the genital area
Danish: • kløe omkring kønsdelene
English: Based on in vitro data, at clinically relevant concentrations avanafil could be an inhibitor of BCRP.
Danish: Ud fra in vitro-data vil Avanafil kunne virke hæmmende på BCRP ved klinisk relevante koncentrationer.
English: Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure.
Danish: Spedra forstærker virkningen af sådanne lægemidler og medfører svært blodtryksfald.
English: Spedra can increase the effects of these medicines and severely lower your blood pressure
Danish: Spedra kan forstærke virkningen af sådanne lægemidler og medføre stærkt blodtryksfald
English: In a penile plethysmography (RigiScan) study, avanafil 200 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 20 minutes after dosing and overall response of these subjects to avanafil was statistically significant, compared to placebo, in the 20-40 minute time interval.
Danish: I en pletysmografisk studie af penis (RigiScan) frembragte avanafil 200 mg hos nogle mænd så tidligt som 20 minutter efter dosering erektion, der blev anset for tilstrækkelig til penetration (60 % stivhed i henhold til RigiScan), og den samlede respons for avanafil hos disse personer var statistisk signifikant i forhold til placebo i tidsintervallet 20-40 minutter.
English: The potential effect of CYP inducers, especially inducers of CYP3A4 (e.g. bosentan, carbamazepine, efavirenz, phenobarbital and rifampicin) on the pharmacokinetics and efficacy of avanafil has not been evaluated.
Danish: Der er ikke foretaget undersøgelser af den potentielle effekt af CYP-induktorer, navnlig CYP3A4induktorer (f.eks. bosentan, carbamazepin, efavirenz, phenobarbital og rifampicin) på farmakokinetikken og virkningen af avanafil.