FrancophonIA/ELRC3.0 huggingface dataset:
English: Protein binding is independent of total drug concentrations.
Danish: Proteinbindingen er uafhængig af de totale stofkoncentrationer.
English: 036 80 Martin Slovak Republic
Danish: 036 80 Martin Slovakiet
English: You should not take more film-coated tablets than your doctor tells you to.
Danish: Du bør ikke tage flere filmovertrukne tabletter, end din læge har anvist.
English: Elderly Dosage adjustments are not required in elderly patients (≥ 65 years old).
Danish: Ældre Dosisjustering er ikke nødvendig hos ældre (≥65 år).
English: Because not all adverse reactions are reported to the Marketing Authorisation Holder and included in the safety database, the frequencies of these reactions cannot be reliably determined.
Danish: Da det ikke er alle bivirkninger, der er rapporteret til indehaveren af markedsføringstilladelsen, og derfor ikke indgår i sikkerhedsdatabasen, kan frekvensen af disse bivirkninger ikke bestemmes pålideligt.
English: Pharmacokinetics in special patient groups Elderly
Danish: Farmakokinetik hos særlige patientgrupper Ældre
English: The amount of time Sildenafil ratiopharm takes to work varies from person to person, but it normally takes between half an hour and one hour.
Danish: Den tid, det tager for Sildenafil ratiopharm at virke varierer fra person til person, men det tager normalt mellem en halv og en hel time.
English: - if you have recently had a stroke or a heart attack.
Danish: - hvis du for nyligt har haft slagtilfælde eller hjerteanfald.
English: The safety and efficacy of sildenafil was maintained in long-term studies.
Danish: Sikkerhed og effekt af sildenafil fastholdes i langtidsundersøgelser.
English: PVdC/PVC/Aluminium blisters.
Danish: PVdC/PVC/Aluminium blisterpakninger.
English: In order to get the maximum benefit from your medicine, it is recommended that you avoid alcohol before intake of this medicine.
Danish: For at få den fulde virkning af din medicin, anbefales det, at du undgår alkohol, før du tager dette lægemiddel.
English: You should not take Sildenafil ratiopharm more than once a day.
Danish: Du bør ikke tage Sildenafil ratiopharm mere end én gang dagligt.
English: Very common (may affect more than 1 in 10 people): headache.
Danish: Meget almindelig (kan ses hos mere end 1 ud af 10 personer): hovedpine.
English: Stevens-Johnson Syndrome (SJS)*, Toxic Epidermal Necrolysis (TEN)*
Danish: Stevens-Johnsons syndrom (SJS)*, toksisk epidermal nekrolyse (TEN)*
English: It is not possible to determine whether these events were directly related to Sildenafil ratiopharm.
Danish: Det er ikke muligt at afgøre, om disse hændelser var direkte forbundet med indtagelse af Sildenafil ratiopharm.
English: The maximum recommended dosing frequency is once per day.
Danish: Den anbefalede maksimale dosisfrekvens er 1 gang i døgnet.
English: - if you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Danish: - hvis du har visse sjældne arvelige øjensygdomme (f.eks. retinitis pigmentosa).
English: Date of latest renewal: 9 September 2014.
Danish: Dato for første markedsføringstilladelse: 23. december 2009 Dato for seneste fornyelse: 9. september 2014
English: These reports included dizziness and light-headedness, but not syncope.
Danish: Disse rapporter omfatter svimmelhed og uklarhed, men ikke synkope.
English: Swallow the film-coated tablet whole with a glass of water.
Danish: Synk den filmovertrukne tablet hel med et glas vand.
English: The recommended dose is 50 mg taken as needed approximately one hour before sexual activity.
Danish: Den anbefalede dosis er 50 mg, som tages efter behov cirka 1 time før seksuel aktivitet.
English: Due to the nitrate component it has the potential to result in a serious interaction with sildenafil.
Danish: På grund af nitratkomponenten har det potentiale for en alvorlig interaktion med sildenafil.
English: Of note, most, but not all, of the men who experienced these side effects had heart problems before taking this medicine.
Danish: Det bør tages i betragtning, at de fleste, men ikke alle, af de mænd, som fik disse bivirkninger, havde allerede hjerteproblemer, inden de tog medicinen.
English: In clinical trials sildenafil was administered to more than 8,000 patients aged 19-87.
Danish: I kliniske studier blev sildenafil givet til mere end 8.000 patienter mellem 19 og 87 år.
English: The safety profile of sildenafil is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Danish: Sildenafils sikkerhedsprofil er baseret på 9.570 patienter i 74 dobbeltblindede, placebo-kontrollerede kliniske studier.
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af indflydelsen på evnen til at føre bil og betjene maskiner.
English: Your doctor should in that case carefully check whether your heart can take the additional strain of having sex.
Danish: Din læge skal omhyggeligt undersøge, om dit hjerte kan tåle den ekstra anstrengelse, det er at have sex.
English: If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
Danish: Hvis priapisme ikke behandles med det samme, kan det resultere i beskadigelse af penisvæv og permanent impotens.
English: Effects on vision
Danish: Virkninger på synet
English: - Prolonged and sometimes painful erections - this occurs rarely (may affect up to 1 in 1,000 people).
Danish: Vedvarende og nogle gange smertefulde erektioner - dette ses sjældent (kan ses hos op til 1 ud af 1.000 personer).
English: You may find that this medicine takes longer to work if you take it with a heavy meal.
Danish: Det kan vare længere inden dette lægemiddel virker, hvis det tages sammen med et tungt måltid.
English: You should NOT take this medicine - if you are already undergoing other treatments for erectile dysfunction.
Danish: Du bør IKKE tage dette lægemiddel - hvis du allerede er i behandling for erektil dysfunktion.
English: - if you do not have erectile dysfunction.
Danish: - hvis du ikke har erektil dysfunktion.
English: It reduces the action of the natural chemical in your body, which makes erections go away.
Danish: Det nedsætter virkningen af det naturlige stof i kroppen, som får erektionen til at forsvinde.
English: In this case, he/she may decide to give you a lower dose.
Danish: Din læge vil muligvis give dig en lavere dosis.
English: Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
Danish: Renal dialyse forventes ikke at øge clearance, da sildenafil er meget bundet til plasmaproteiner og ikke udskilles i urinen.
English: Paediatric population Sildenafil ratiopharm is not indicated for individuals below 18 years of age.
Danish: Pædiatrisk population Sildenafil ratiopharm er ikke indiceret til personer under 18 år.
English: The side effects reported in association with the use of sildenafil are usually mild to moderate and of a short duration.
Danish: De bivirkninger, der er rapporteret i forbindelse med brug af sildenafil er normalt milde til moderate og af kort varighed.
English: Further information on clinical trials
Danish: Yderligere oplysninger om kliniske studier
English: This medicine allows an erection to last long enough for you to satisfactorily complete sexual activity.
Danish: Dette lægemiddel bevirker, at en erektion varer længe nok til, at du kan fuldføre seksuel aktivitet på tilfredsstillende vis.
English: - A sudden decrease or loss of vision - this occurs rarely.
Danish: Pludselig nedsættelse eller tab af synet - dette ses sjældent.
English: In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms.
Danish: Derudover bør lægen informere patienten om, hvad der skal gøres i tilfælde af, at posturale hypotensive symptomer opstår.
English: This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
Danish: Dette er i overensstemmelse med ritonavirs udtalte virkning på et bredt udvalg af P450- substrater.
English: Talk to your doctor or pharmacist before taking Sildenafil ratiopharm - if you have problems with your heart.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Sildenafil ratiopharm - hvis du har problemer med hjertet.
English: Effect on bleeding
Danish: Virkninger på blødning
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Danish: Maksimale plasmakoncentrationer nås inden for 30-120 minutter (gennemsnitlig 60 minutter) efter oral indgift i fastende tilstand.
English: Most, but not all, of these patients had pre-existing cardiovascular risk factors.
Danish: Hovedparten af disse patienter havde allerede eksisterende kardiovaskulære risikofaktorer.
English: Sildenafil ratiopharm will only work when you are sexually stimulated.
Danish: Sildenafil ratiopharm fungerer kun, når du stimuleres seksuelt.
English: Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.
Danish: Derfor bør sildenafil kun gives til disse patienter efter omhyggeligt at have opvejet fordele mod risici.
English: Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue.
Danish: Sildenafil har ingen direkte afslappende effekt på isoleret human corpus cavernosum, men øger kraftigt den afslappende effekt af NO på dette væv.
English: Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.
Danish: Stærkere CYP3A4-hæmmere, som ketokonazol og itraconazol, forventes at have større effekt.
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
Danish: N-desmethylmetabolitten metaboliseres yderligere med en halveringstid på ca. 4 timer.
English: These symptoms usually occur within 4 hours of taking Sildenafil ratiopharm.
Danish: Disse symptomer opstår sædvanligvis inden for 4 timer efter, at du har taget Sildenafil ratiopharm.
English: Single doses of antacid (magnesium hydroxide/aluminium hydroxide) did not affect the bioavailability of sildenafil.
Danish: Enkeltdoser af antacida (magnesiumhydroxid/aluminiumhydroxid) påvirkede ikke biotilgængeligheden af sildenafil.
English: Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Danish: In vitro-studier har vist, at sildenafil er selektiv for PDE5, som er involveret i erektionsprocessen.
English: These medicines are often used to relieve the symptoms of chest pain (angina pectoris).
Danish: Disse typer medicin bruges ofte til at lindre symptomerne ved brystsmerter (angina pectoris).
English: Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.
Danish: Derfor kan hæmmere af disse isoenzymer nedsætte sildenafil-clearance, og induktorer af disse isoenzymer kan øge sildenafil-clearance.
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.
Danish: Inden påbegyndelse af nogen form for behandling af erektil dysfunktion bør lægen undersøge patientens kardiovaskulære tilstand, fordi der er en vis kardial risiko forbundet med seksuel aktivitet.
English: The mean steady state volume of distribution (Vd) for sildenafil is 105 l, indicating distribution into the tissues.
Danish: Det gennemsnitlige steady state fordelingsvolumen (Vd) for sildenafil er 105 l, hvilket tyder på fordeling i vævet.
English: Given sildenafil peak plasma concentrations of approximately 1 µM after recommended doses, it is unlikely that sildenafil will alter the clearance of substrates of these isoenzymes.
Danish: Med sildenafils maksimale plasmakoncentration på ca. 1 μM efter anbefalede doser, er det usandsynligt, at sildenafil vil ændre clearance af substrater af disse isoenzymer.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to sildenafil, before driving or operating machinery.
Danish: Da der er rapporteret svimmelhed og ændret syn i kliniske studier med sildenafil, bør patienter være opmærksomme på, hvordan de reagerer på sildenafil, inden de kører bil eller betjener maskiner.
English: These are symptoms of a fall in blood pressure upon rising quickly from sitting or lying (postural hypotension).
Danish: Det er symptomer på et fald i blodtrykket, som opstår, når man hurtigt rejser sig op fra siddende eller liggende position (postural hypotension).
English: Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg.
Danish: På basis af effekt og tolerance kan dosis øges til 100 mg eller sænkes til 25 mg.
English: - An allergic reaction - this occurs uncommonly (may affect up to 1 in 100 people).
Danish: En allergisk reaktion - dette ses ikke almindeligt (kan ses hos op til 1 ud af 100 personer).
English: - if you have a severe heart problem.
Danish: - hvis du har alvorlige hjerteproblemer.
English: In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency [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)].
Danish: I tabellen nedenfor er alle medicinsk vigtige bivirkninger, som er opstået i kliniske studier med en hyppighed større end placebo, anført efter organklasse og frekvens [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).
English: There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Danish: Der er ingen data vedrørende interaktion af sildenafil og ikke specifikke fosfodiesterasehæmmere, så som theophyllin eller dipyridamol.
English: Microcrystalline cellulose Hypromellose
Danish: Mikrokrystallinsk cellulose, Hypromellose
English: - alpha blockers (group of medicines for the treatment of high blood pressure or an enlarged prostate [benign prostatic hyperplasia]).
Danish: alfablokkere (en gruppe medicin til behandling af højt blodtryk eller forstørret prostata [godartet prostatahyperplasi]).
English: Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity.
Danish: Før ordination af sildenafil bør lægen omhyggeligt overveje, om patienter med visse underliggende tilstande vil kunne blive påvirket på uønsket måde af den vasodilatoriske virkning, specielt i forbindelse med seksuel aktivitet.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
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: After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil is approximately 440 ng/mL (CV 40%).
Danish: Efter en enkelt oral dosis på 100 mg er den gennemsnitlige maksimale totale plasmakoncentration af sildenafil ca. 440 ng/ml (CV 40%).
English: If you have an erection, which lasts for more than 4 hours, you should contact a doctor immediately.
Danish: Hvis du får erektion, som varer længere end 4 timer, bør du straks kontakte lægen.
English: In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
Danish: Hvis det forekommer, at en erektion varer længere end 4 timer, skal patienten straks søge læge.
English: This medicine will only help you to get an erection if you are sexually stimulated.
Danish: Dette lægemiddel hjælper dig kun med at få rejsning, hvis du stimuleres seksuelt.
English: In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.
Danish: I enkeltdosisundersøgelser med frivillige forsøgspersoner med doser op til 800 mg er bivirkningerne de samme, som ses efter lavere doser, men incidensrater og sværhedsgrader er forhøjede.
English: When sildenafil is taken with food, the rate of absorption is reduced with a mean delay in tmax of 60 minutes and a mean reduction in Cmax of 29%.
Danish: Ved indgift af sildenafil sammen med føde reduceres absorptionshastigheden med en gennemsnitlig forsinkelse i tmax på 60 minutter og en gennemsnitlig sænkning af Cmax på 29%.
English: If you are taking ritonavir, you may not exceed a maximum dose of 25 mg sildenafil within a period of 48 hours.
Danish: Hvis du tager ritonavir, må du ikke tage mere end den maksimale dosis på 25 mg sildenafil inden for en periode på 48 timer.
English: Sildenafil ratiopharm is a treatment for adult men with erectile dysfunction, sometimes known as impotence.
Danish: Sildenafil ratiopharm er en behandling til voksne mænd med erektil dysfunktion, også kendt som impotens.
English: Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Danish: Nitrogenoxid aktiverer derefter enzymet guanylatcyklase, hvilket resulterer i øgede koncentrationer af cyklisk guanosinmonophosphat (cGMP), som fører til afslapning af den glatte muskulatur i corpus cavernosum og tillader blodet at strømme til.
English: Sildenafil ratiopharm with food, drink and alcohol When this medicine is taken with food, it may take a little longer for Sildenafil ratiopharm to work.
Danish: Brug af Sildenafil ratiopharm sammen med mad og alkohol Når dette lægemiddel tages sammen med mad, kan det tage lidt længere tid, før Sildenafil ratiopharm virker.
English: The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.
Danish: Den fysiologiske mekanisme bag erektion af penis omfatter frigivelse af nitrogenoxid (NO) i corpus cavernosum under seksuel stimulation.
English: These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
Danish: Disse yderligere blodtryksreduktioner var af samme størrelsesorden, som når sildenafil blev givet alene til raske frivillige forsøgspersoner (se pkt.5.1).
English: Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Danish: Riociguat: Prækliniske studier viste en additiv systemisk blodtrykssænkende virkning, når PDE5hæmmere blev kombineret med riociguat.
English: Table 1: Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through postmarketing surveillance
Danish: Tabel 1: Medicinsk vigtige bivirkninger, som er rapporteret i kontrollerede kliniske studier med en hyppighed større end placebo samt medicinsk vigtige bivirkninger rapporteret gennem overvågning efter markedsføring.
English: Sildenafil ratiopharm is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Danish: Sildenafil er indiceret til voksne mænd med erektil dysfunktion, hvilket er manglende evne til at opnå eller vedligeholde en erektion af penis, som er tilstrækkelig til tilfredsstillende seksuel aktivitet.
English: After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range (25-100 mg).
Danish: Oral indgift af sildenafil øger AUC og Cmax proportionalt med dosis over det anbefalede dosisområde (25-100 mg).
English: Plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil.
Danish: Plasmakoncentrationerne af denne metabolit er ca. 40% af sildenafils.
English: Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation.
Danish: 2 kliniske studier var specielt udarbejdet med henblik på at bestemme den tidsramme efter indtagelse, indenfor hvilken sildenafil kunne producere en erektion efter seksuel stimulation.
English: If this medicine does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse, you should tell your doctor.
Danish: Hvis dette lægemiddel ikke hjælper dig med at få erektion, eller hvis din erektion ikke varer længe nok til at gennemføre samleje, bør lægen informeres.
English: In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo.
Danish: I fastdosisstudier var den del af patienterne, som rapporterede, at behandlingen forbedrede deres erektioner 62% (25 mg), 74% (50 mg) og 82% (100 mg) sammenlignet med 25% på placebo.
English: Sildenafil has no effect on visual acuity or contrast sensitivity.
Danish: Sildenafil har ingen effekt på skarpsyn eller kontrastfølsomhed.
English: Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP.
Danish: Sildenafil er en potent og selektiv hæmmer af cGMP-specifik fosfodiesterase type 5 (PDE5) i corpus cavernosum, hvor PDE5 er ansvarlig for nedbrydningen af cGMP.
English: Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.
Danish: Derfor er seksuel stimulation nødvendig for sildenafils tilsigtede fordelagtige farmakologiske effekt.
English: Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.
Danish: Undersøgelser med humane blodplader indikerer, at sildenafil forstærker den antiaggregatoriske effekt af natriumnitroprussid in vitro.
English: Some patients taking alpha blockers may experience dizziness or light-headedness when getting up.
Danish: Nogle patienter, som tager alfablokkere, kan opleve svimmelhed eller uklarhed, når de rejser sig op.
English: Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil.
Danish: Det forventes derfor, at samtidig administration af potente CYP3A4-induktorer, som f.eks. rifampin, vil forårsage større reduktioner i sildenafils plasmakoncentration.
English: Nausea, Dyspepsia
Danish: Kvalme, dyspepsi
English: This medicine might make some people feel dizzy or affect their vision or hearing.
Danish: Dette lægemiddel kan hos nogle personer forårsage svimmelhed og påvirke synet.
English: Concomitant use with alpha-blockers
Danish: Samtidig brug af alfa-blokker
English: No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Danish: Der ses ingen signifikante interaktioner ved indgift af sildenafil (50 mg) sammen med tolbutamid (250 mg) eller warfarin (40 mg), som begge metaboliseres af CYP2C9.
English: Do NOT take Sildenafil ratiopharm: - if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Sildenafil ratiopharm - hvis du er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i Sildenafil ratiopharm (angivet i punkt 6).