FrancophonIA/ELRC3.0 huggingface dataset:
English: The table below lists the adverse reactions observed in placebo-controlled clinical trials according to the MedDRA frequency convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).
Danish: Nedenstående tabel angiver de observerede bivirkninger i de placebokontrollerede kliniske forsøg, inddelt efter hyppighed i henhold til MedDRA: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke beregnes af foreliggende data).
English: Based on these data avanafil is not anticipated to have a significant effect on other medicinal products metabolised by these enzymes.
Danish: Avanafil forventes derfor ikke at have nævneværdig effekt på andre lægemidler, der metaboliseres af disse enzymer.
English: Antihypertensives other than alpha-blockers
Danish: Antihypertensiva bortset fra alfablokkere
English: These exposure changes are not considered clinically significant.
Danish: Denne virkning på eksponeringen anses ikke for klinisk betydningsfuld.
English: It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.
Danish: Det vides ikke, om problemerne hænger direkte sammen med Spedra, med eventuelle andre sygdomme eller med en kombination af flere faktorer.
English: • other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4
Danish: • andre lægemidler, der kan mindske nedbrydningen af Spedra i kroppen (moderate CYP3A4
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTER ELLER BLISTERSTRIPS
English: It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors.
Danish: Det har ikke kunnet fastslås, om sådanne hændelser har direkte sammenhæng med anvendelse af PDE5-hæmmere eller med andre faktorer.
English: Its effect is more potent on PDE5 than on other known phosphodiesterases (> 100-fold for PDE6; > 1,000-fold for PDE4, PDE8 and PDE10; > 5,000-fold for PDE2 and PDE7; > 10,000-fold for PDE1, PDE3, PDE9, and PDE11).
Danish: Det har mere potent virkning på PDE5 end på andre kendte fosfodiesteraser (> 100 gange mere end på PDE6, > 1.000 gange mere end på PDE4, PDE8 og PDE10, > 5.000 gange PDE2 og PDE7, > 10.000 gange mere end på PDE1, PDE3, PDE9 og PDE11).
English: In cases of overdose, standard supportive measures should be adopted as required.
Danish: Overdosering behandles med sædvanlig støttende behandling efter behov.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner bedes indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Effects of avanafil on other medicinal products
Danish: Virkningen af avanafil på andre lægemidler
English: • If you have chest pain (angina) or you get chest pain during sexual intercourse
Danish: • hvis du har brystsmerter (angina), eller hvis du får brystsmerter under samleje
English: • sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).
Danish: • pludseligt større eller mindre høretab (undertiden med svimmelhed eller ringen for ørerne).
English: This can happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.
Danish: Dette kan ske for mænd med sygdomme som seglcellesygdom, multipelt myelom eller leukæmi.
English: Patients with known hereditary degenerative retinal disorders.
Danish: - kendt hereditær degenerativ retinal sygdom.
English: Renal dialysis is not expected to accelerate clearance as avanafil is highly bound to plasma proteins and it is not eliminated in the urine.
Danish: Dialyse forventes ikke at fremskynde clearance af avanafil, som har høj binding til plasmaproteiner og ikke udskilles i urinen.
English: In such circumstances, nitrates should still only be administered under close medical supervision with appropriate haemodynamic monitoring (see section 4.3).
Danish: Under sådanne omstændigheder bør nitrater kun administreres under tæt lægeligt opsyn og fornøden hæmodynamisk overvågning (se pkt.
English: Influenza Nasopharyngitis
Danish: Influenza Nasofaryngitis
English: Overall adverse events and adverse reactions for avanafil-treated subjects were more frequent in subjects with a Body Mass Index (BMI) <25 (normal BMI subjects).
Danish: Overordnet var uønskede hændelser og bivirkninger ved behandling med avanafil hyppigere ved legemsmasseindeks (BMI) <25 (normalt BMI).
English: Spedra can make you feel dizzy or affect your vision.
Danish: Spedra kan gøre dig svimmel eller give synsforstyrrelser.
English: Avanafil is extensively metabolised in humans.
Danish: Avanafil metaboliseres vidtgående hos mennesker.
English: Maximum observed plasma concentrations are reached within 0.5 to 0.75 hours of oral dosing in the fasted state.
Danish: Den maksimale plasmakoncentration nås 0,5-0,75 timer efter fastende oral indgift.
English: Use in adult men
Danish: Voksne mænd
English: Avanafil had no effect on the pharmacokinetics of amlodipine, but amlodipine increased the maximum and total exposure of avanafil by 28% and 60%, respectively (see section 4.4).
Danish: Avanafil havde ingen indvirkning på farmakokinetikken af amlodipin, men amlodipin øgede den maksimale og totale eksponering for avanafil med henholdsvis 28 % og 60 % (se pkt.
English: In order for Spedra to be effective, sexual stimulation is required.
Danish: For at Spedra skal virke effektivt, kræves seksuel stimulation.
English: Based upon measurements of avanafil in semen of healthy volunteers 45-90 minutes after dosing, less than 0.0002% of the administered dose may appear in the semen of patients.
Danish: På grundlag af målinger af avanafil i sæd hos raske forsøgspersoner 45-90 minutter efter dosering forventes mindre end 0,0002 % af den administrerede dosis at genfindes i sæden hos patienterne.
English: In both cohorts, one subject experienced a decrease in blood pressure without symptoms of hypotension, which resolved within 1 hour of onset.
Danish: I begge kohorter fik én person blodtryksfald uden symptomer på hypotension, og dette svandt inden for 1 time efter sin indtræden.
English: Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Hold op med at bruge Spedra, og fortæl det straks til lægen, hvis du får en eller flere af følgende alvorlige bivirkninger - du kan have behov for øjeblikkelig lægehjælp:
English: • so called “alpha-blockers” - for prostate problems or for lowering your high blood pressure
Danish: • såkaldte ”alfablokkere”- anvendes mod prostataproblemer eller til at sænke for højt blodtryk
English: There is no safety information on the administration of avanafil to patients with bleeding disorders or active peptic ulceration.
Danish: Der er ingen sikkerhedsoplysninger om administration af avanafil til patienter med blødningsforstyrrelser eller aktivt ulcus pepticum.
English: Pregnancy Spedra is not indicated for use in women.
Danish: Graviditet Spedra er ikke bestemt til anvendelse hos kvinder.
English: In addition, a subset of patients was enrolled into an open-label extension trial with 493 patients receiving avanafil for at least 6 months and 153 patients for at least 12 months.
Danish: Derudover indgik en undergruppe på 493 patienter i en åben forlængelsesforsøg, hvor de fik avanafil i mindst seks måneder, og 153 patienter, der fik avanafil i mindst 12 måneder.
English: You should not take Spedra more than once a day.
Danish: Tag ikke mere end én tablet om dagen.
English: This is because Spedra can affect the way some other medicines work.
Danish: Grunden er, at Spedra kan ændre virkningen af visse andre lægemidler.
English: Based on individual efficacy and tolerability, the dose may be increased to a maximum dose of 200 mg or decreased to 50 mg.
Danish: Afhængigt af virkningen og tolerabiliteten hos den enkelte patient kan dosis øges til den maksimale dosis på 200 mg eller mindskes til 50 mg.
English: Patients with mild to moderate hepatic impairment (Child-Pugh class A or B) should initiate treatment with the minimum efficacious dose and adjust posology based on tolerance.
Danish: Patienter med let til moderat nedsat leverfunktion (Child-Pugh A eller B) bør begynde med den mindste effektive dosis og justere denne afhængigt af tolerancen.
English: Studies in vitro have shown that avanafil is highly selective for PDE5.
Danish: In vitro-studier har vist, at avanafil er højselektivt for PDE5.
English: Avanafil was evaluated in 4 randomized, double-blind, placebo-controlled, parallel group trials of up to 3 months in duration in the general population with ED, in patients with Type 1 or Type 2 diabetes and ED, and in patients with ED following bilateral nerve-sparing radical prostatectomy.
Danish: Avanafil blev vurderet i 4 randomiserede, dobbeltblindede, placebokontrollerede parallelgruppeforsøg af indtil 3 måneders varighed hos den generelle ED-population, hos patienter med type 1- eller type 2-diabetes og hos patienter med ED efter bilateralt nervebevarende radikal prostatektomi.
English: 4 hours, this must be treated as soon as possible or lasting damage can happen to your penis
Danish: timer, skal den behandles snarest muligt, ellers kan din penis blive varigt beskadiget (med bl.a.
English: This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection.
Danish: Dette medfører afslapning af glatmuskulaturen og blodtilløb til penisvævet og dermed erektion.
English: What you need to know before you take Spedra
Danish: Det skal du vide, før du begynder at tage Spedra
English: Use in men with diabetes Dose adjustments are not required in diabetic patients.
Danish: Mænd med diabetes Der kræves ikke dosisjustering ved diabetes.
English: Drinking alcohol may also decrease your ability to get an erection.
Danish: Alkoholindtagelse kan desuden nedsætte din evne til at få rejsning.
English: In the rabbit study, maternal toxicity was observed at 240 mg/kg/day.
Danish: I kaninstudiet iagttoges maternel toksicitet ved 240 mg/kg/dag.
English: The plasma concentrations of the major circulating metabolites, M4 and M16, are approximately 23% and 29% that of the parent compound, respectively.
Danish: Plasmakoncentrationerne af de vigtigste metabolitter i kredsløbet, M4 og M16, er henholdsvis ca. 23 % og 29 % af moderstoffets.
English: Pharmacotherapeutic group: Urologicals: Drugs used in erectile dysfunction.
Danish: Farmakoterapeutisk klassifikation: Urologika: Lægemidler anvendt ved erektil dysfunktion.
English: • If certain serious eye problems run in your family (such as retinitis pigmentosa).
Danish: • hvis der er visse alvorlige øjenproblemer i familien såsom nethindebetændelse med pigmentaflejring (retinitis pigmentosa)
English: There are no data from the use of avanafil in pregnant women.
Danish: Der foreligger ingen data om anvendelse af avanafil hos gravide kvinder.
English: The approximately 20,000-fold selectivity for PDE5 versus PDE3, and enzyme found in heart and blood vessels, is important because PDE3 is involved in control of cardiac contractility.
Danish: Den ca. 20.000 gange større selektivitet for PDE5 end for PDE3, et enzym, der findes i hjerte og blodkar, er vigtig, da PDE3 medvirker ved reguleringen af hjertets kontraktilitet.
English: • The safety of combined use of avanafil and alpha-blockers may be affected by other variables, including intravascular volume depletion and other anti-hypertensive medicinal products.
Danish: • Sikkerheden ved samtidig administration af avanafil og alfablokkere kan påvirkes af andre variabler, herunder intravaskulær volumendepletion og behandling med andre antihypertensiva.
English: Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5.
Danish: Avanafil er en højpotent selektiv, reversibel hæmmer af cyklisk guanosinmonofosfat- (cGMP-) specifik fosfodiesterase type 5.
English: In humans, PDE5 inhibitors do not appear to affect bleeding time alone or in combination with acetylsalicylic acid.
Danish: Hos mennesker synes PDE5hæmmere ikke at påvirke blødningstiden, hvad enten de anvendes alene eller i kombination med acetylsalicylsyre.
English: At clinically relevant concentrations avanafil is not an inhibitor of OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 and BSEP.
Danish: Ved klinisk relevante koncentrationer virker Avanafil ikke hæmmende på OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3 og BSEP.
English: • If you have a serious cardiac problem
Danish: • hvis du har et alvorligt hjerteproblem
English: The potential induction of CYP1A2, CYP2B6 and CYP3A4 by avanafil evaluated in primary human hepatocytes in vitro did not reveal any potential interaction at clinically relevant concentrations.
Danish: Avanafils potentielle induktion af CYP1A2, CYP2B6 og CYP3A4, vurderet i primære humane hepatocytter in vitro, viste ingen potentiel interaktion ved klinisk relevante koncentrationer.
English: Concomitant use of alcohol
Danish: Samtidig alkoholindtagelse
English: In the long term clinical study, the percentage of patients who experienced adverse reactions decreased with increasing length of exposure.
Danish: I det langvarige kliniske studie aftog den procentdel af patienterne, der fik bivirkninger, med eksponeringens varighed.
English: Although specific interactions of avanafil with rivaroxaban and apixaban (both CYP3A4 substrates) have not been studied, an interaction is not expected.
Danish: Selvom der ikke er udført særlige undersøgelser af interaktionen mellem rivaroxaban og apixaban (som begge er CYP3A4-substrater), forventes der ingen interaktion.
English: Patients with severe hepatic impairment (Child-Pugh C).
Danish: - svært nedsat leverfunktion (Child-Pugh C).
English: The recommended dose is a 100 mg tablet, as needed.
Danish: Den sædvanlige dosis er én 100 mg tablet efter behov.
English: Its pharmacokinetics are dose-proportional over the recommended dose range.
Danish: Dets farmakokinetik er lineær i det anbefalede dosisområde.
English: Limited data are available in elder patients aged 70 years or above.
Danish: Der foreligger kun begrænsede data for patienter over 70 år.
English: In phase III clinical trials no events of “hypotension” but occasional episodes of “dizziness” were observed (see section 4.8).
Danish: I fase III-kliniske forsøg var der ikke hændelser med “hypotension”, men lejlighedsvise episoder med “svimmelhed” (se pkt.
English: Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.
Danish: Brug ikke Spedra sammen med anden medicin mod rejsningsproblemer såsom sildenafil, tadalafil eller vardenafil.
English: The recommended dose is 100 mg taken as needed approximately 15 to 30 minutes before sexual activity (see section 5.1).
Danish: Den anbefalede dosis er 100 mg, der tages efter behov ca. 15-30 minutter før seksuel aktivitet (se pkt.
English: • If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic ischemic optic neuropathy [NAION])
Danish: • hvis du nogensinde har haft synsnedsættelse på det ene øje på grund af manglende blodtilførsel til øjet (ikke-arteritisk iskæmisk opticusneuropati (NAION))
English: If you get an erection that lasts more than
Danish: Hvis du får en rejsning, der varer længere end 4
English: Avanafil is > 100-fold more potent for PDE5 than PDE6, which is found in the retina and is responsible for phototransduction.
Danish: Avanafils virkning er > 100 gange mere potent på PDE5 end på PDE6, som medvirker ved fototransduktionen i retina.
English: Paediatric population There is no relevant use of Spedra in the paediatric population in the indication of erectile dysfunction.
Danish: Der er ingen relevant anvendelse af Spedra hos den pædiatriske population til indikationen erektil dysfunktion.
English: Spedra will not help you if you do not have erectile dysfunction.
Danish: Spedra vil ikke hjælpe dig, hvis du ikke har rejsningsproblemer.
English: Therefore, avanafil should be administered to such patients only after careful benefit-risk assessment.
Danish: Hos sådanne patienter bør avanafil derfor kun anvendes efter foregående nøje vurdering af benefit/risk-forholdet.
English: Talk to your doctor or pharmacist before taking Spedra:
Danish: Kontakt lægen eller apotekspersonalet, før du tager Spedra:
English: • If you have any bleeding disorder or active peptic ulceration.
Danish: • hvis du har en blødningsforstyrrelse eller aktivt mavesår.
English: Avanafil was shown to augment the hypotensive effects of nitrates compared to placebo in healthy subjects.
Danish: Avanafil øgede den hypotensive virkning af nitrater i forhold til placebo hos raske forsøgspersoner.
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.
Danish: Din læge kan have ordineret dig en dosis på en 200 mg tablet, hvis vedkommende har vurderet, at en dosis på 100 mg ville være for lidt for dig, eller en dosis på en 50 mg tablet, hvis vedkommende har vurderet, at en dosis på 100 mg ville være for meget for dig.
English: • an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of red blood cells
Danish: • unormalt indhold i blodet af bilirubin, et stof, der dannes ved nedbrydning af de røde blodlegemer
English: The European Medicines Agency has waived the obligation to submit the results of studies with Spedra in all subsets of the paediatric population in erectile dysfunction (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Spedra i alle undergrupper af den pædiatriske population ved erektil dysfunktion (se pkt.
English: Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects above.
Danish: Hold op med at bruge Spedra, og fortæl det straks til lægen, hvis du får en eller flere af ovenstående alvorlige bivirkninger.
English: Patients with mild or moderate renal impairment (creatinine clearance ≥30 mL/min but <80 mL/min) who were enrolled in phase 3 studies showed decreased efficacy compared to those with normal renal function.
Danish: Hos patienter med let eller moderat nedsat nyrefunktion (kreatininclearance ≥30 ml/min, men <80 ml/min), som deltog i fase 3-studier, var virkningen nedsat i forhold til virkningen hos patienter med normal nyrefunktion.
English: Physicians should also advise patients on what to do in the event of postural hypotensive symptoms.
Danish: Lægen bør desuden fortælle patienten, hvad han skal gøre ved tegn på ortostatisk hypotension.
English: When avanafil is taken with a high fat meal, the rate of absorption is reduced with a mean delay in Tmax of 1.25 hours and a mean reduction in Cmax of 39% (200 mg).
Danish: Når avanafil indtages sammen med et måltid med højt fedtindhold, nedsættes absorptionen med en gennemsnitlig forsinkelse af Tmax på 1,25 timer og en gennemsnitlig reduktion i Cmax på 39 % (200 mg).
English: It is important to note that Spedra only works if you are sexually stimulated.
Danish: Det er vigtigt at være klar over, at Spedra kun virker, når man bliver stimuleret seksuelt.
English: Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients since there is a degree of cardiac risk associated with sexual activity (see section 4.3).
Danish: Før påbegyndelse af enhver behandling for erektil dysfunktion bør patientens kardiovaskulære status gennemgås, da seksuel aktivitet er forbundet med en vis kardial risiko (se pkt.
English: The maximum concentration and exposure was similar to that observed after subjects with normal hepatic function received an efficacious avanafil 100 mg dose.
Danish: Maksimalkoncentrationen og eksponeringen var den samme som hos personer med normal leverfunktion, der fik en effektiv dosis avanafil på 100 mg.
English: Other treatments for erectile dysfunction
Danish: Andre midler mod erektil dysfunktion
English: If Spedra is used in combination with another medicinal product which reduces systemic blood pressure, the additive effects may result in symptomatic hypotension (e.g. dizziness, light-headedness, syncope or near-syncope).
Danish: Ved anvendelse af Spedra sammen med andre lægemidler, der nedsætter det systemiske blodtryk, kan de additive virkninger medføre symptomgivende hypotension(f.eks. svimmelhed, synkope eller synkopelignende anfald).
English: You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations).
Danish: Dette kan gøre dig svimmel (især når du står op) og give hovedpine eller hjertebanken.
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.
Danish: Indehaveren af markedsføringstilladelsen udfører de lægemiddelovervågningsaktiviteter og -tiltag, der er fastsat i den vedtagne risikostyringsplan, som fremgår af modul 1.8.2 af markedsføringstilladelsen samt alle efterfølgende vedtagne ajourføringer af risikostyringsplanen.
English: Haemodynamic interactions with doxazosin and tamsulosin were studied in healthy subjects in a twoperiod crossover-design trial.
Danish: Den hæmodynamiske interaktion med doxazosin og tamsulosin blev undersøgt i en to-perioders overkrydsningsforsøg hos raske forsøgspersoner.
English: The concomitant use of avanafil and a CYP inducer is not recommended as it may decrease the efficacy of avanafil.
Danish: Anvendelse en CYP-induktor sammen med avanafil frarådes, da det kan forringe virkningen af avanafil.
English: In the fourth study patients were encouraged to attempt sexual intercourse approximately 15 minutes post-dosing, to assess the onset of the erectogenic effect of avanafil, taken on an as needed basis, at 100 and 200 mg dose.
Danish: I det fjerde studie blev forsøgspersonerne opfordret til at forsøge samleje ca. 15 minutter efter indtagelse af dosis for at vurdere, hvornår den erektogene virkning af avanafil indtrådte ved indtagelse efter behov i doser på 100 og 200 mg.
English: In all trials, statistically significant improvement in all primary efficacy measures were observed for all three doses of avanafil compared to placebo.
Danish: Samtlige forsøg viste statistisk signifikant bedring i alle de primære mål for virkning ved alle tre doser af avanafil i forhold til placebo.
English: It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Det et er lægemiddel af gruppen fosfodiesterase type 5hæmmere (PDE5-hæmmere).
English: In in vitro studies in human liver microsomes, avanafil showed a negligible potential for drug-drug interactions with CYP1A1/2, 2A6, 2B6 and 2E1.
Danish: I in vitro-studier med humane levermikrosomer viste avanafil ikke nævneværdigt potentiale for lægemiddelinteraktion gennem CYP1A1/2, 2A6, 2B6 eller 2E1.
English: How to take Spedra
Danish: Sådan skal du tage Spedra
English: If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Danish: Manglende øjeblikkelig behandling af priapisme medfører risiko for beskadigelse af penis og varigt nedsat potens.