FrancophonIA/ELRC3.0 huggingface dataset:
English: The amount of time VIAGRA takes to work varies from person to person, but it normally takes between half an hour and one hour.
Danish: Den tid, som det tager for VIAGRA at virke varierer fra person til person, men det tager normalt mellem ½ og 1 time.
English: If you are taking riociguat.
Danish: - Hvis du tager riociguat.
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: If you have recently had a stroke or a heart attack, or if you have low blood pressure.
Danish: - Hvis du for nyligt har haft slagtilfælde eller hjerteanfald, eller hvis du har lavt blodtryk.
English: It should be taken immediately upon removal from the blister.
Danish: Den skal tages straks efter, at den er taget ud af blisterpakningen.
English: Certain patients have experienced these symptoms when taking VIAGRA with alpha-blockers.
Danish: Visse patienter har oplevet disse symptomer, når de tager VIAGRA sammen med alfa-blokkere.
English: Orodispersible tablets can be taken with or without water.
Danish: Orodispergible tabletter kan tages med eller uden vand.
English: The safety profile of VIAGRA is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Danish: VIAGRAs sikkerhedsprofil er baseret på 9.570 patienter i 74 dobbeltblindede, placebo-kontrollerede kliniske studier.
English: You should not take VIAGRA more than once a day.
Danish: Du bør ikke tage VIAGRA mere end 1 gang dagligt.
English: • A sudden decrease or loss of vision - this occurs rarely
Danish: • Pludselig nedsættelse eller tab af synet - dette ses sjældent
English: If you feel that the effect of VIAGRA is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du mener, at virkningerne af VIAGRA er for kraftige eller for svage, bør du tale med lægen eller apoteket.
English: The side effects reported in association with the use of VIAGRA are usually mild to moderate and of a short duration.
Danish: De bivirkninger, der er rapporteret i forbindelse med brug af VIAGRA er normalt milde til moderate og af kort varighed.
English: If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Danish: - Hvis du har visse alvorlige arvelige øjensygdomme (som retinitis pigmentosa).
English: It is not possible to determine whether these events were directly related to VIAGRA.
Danish: Det er ikke muligt at bestemme, om disse bivirkninger er direkte relateret til VIAGRA.
English: SECONDARY HEAT SEALED CARD PACKAGING
Danish: SEKUNDÆR VARMEFORSEGLET KORTPAKNING
English: VIAGRA can cause dizziness and can affect vision.
Danish: VIAGRA kan forårsage svimmelhed og kan påvirke synet.
English: VIAGRA will only help you to get an erection if you are sexually stimulated.
Danish: VIAGRA vil kun hjælpe dig med at få en erektion, hvis du bliver seksuelt stimuleret.
English: VIAGRA can be taken with or without food.
Danish: VIAGRA kan tages sammen med mad eller uden mad.
English: Given sildenafil peak plasma concentrations of approximately 1 μM after recommended doses, it is unlikely that VIAGRA 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 VIAGRA vil ændre clearance af substrater af disse isoenzymer.
English: This is most likely to happen within 4 hours after taking VIAGRA.
Danish: Det er mest sandsynligt, at det vil indtræde inden for 4 timer efter, at du har indtaget VIAGRA.
English: VIAGRA may have a minor influence on the ability to drive and use machines.
Danish: VIAGRA kan i mindre grad påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to VIAGRA, 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 VIAGRA, inden de kører bil eller betjener maskiner.
English: To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking VIAGRA.
Danish: For at få den fulde virkning af din medicin, bør du ikke drikke alkohol i store mængder, før du tager VIAGRA.
English: Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately 40%.
Danish: Som følge af aldersforskelle i plasmaproteinbindingen er den tilsvarende stigning i plasmakoncentration af fri sildenafil ca. 40%.
English: If a dose of 25 mg is required, the use of the 25 mg film-coated tablets should be recommended.
Danish: Hvis en dosis på 25 mg er nødvendig, anbefales det at anvende 25 mg filmovertrukne tabletter.
English: Do not take VIAGRA
Danish: Tag ikke VIAGRA
English: Paediatric population VIAGRA is not indicated for individuals below 18 years of age.
Danish: Pædiatrisk population VIAGRA er ikke beregnet til personer under 18 år.
English: In the same study, the AUC was unchanged but the mean Cmax was 14% lower when 50 mg orodispersible tablets were administered with water compared to 50 mg film-coated tablet.
Danish: I samme studie sås det, at AUC var uændret, men gennemsnitlig Cmax var 14% lavere, når 50 mg orodispergible tabletter blev taget med vand sammenlignet med 50 mg filmovertrukne tabletter.
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 post-marketing 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: If you have ever had loss of vision due to non-arteritic anterior ischaemic optic neuropathy (NAION).
Danish: - Hvis du på noget tidspunkt tidligere har haft tab af synet på grund af non-arteritis anterior iskæmisk opticusneuropati (NAION).
English: Recommend tablet be taken on an empty stomach.
Danish: Det anbefales, at tabletten tages på tom mave.
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 guanosinmonofosfat (cGMP), som fører til afslapning af den glatte muskulatur i corpus cavernosum og tillader blodet at strømme til.
English: • Chest pains - this occurs uncommonly If this occurs during or after intercourse - Get in a semi-sitting position and try to relax.
Danish: • Smerter i brystet - dette ses ikke almindeligt Hvis dette sker under eller efter samleje - Sæt dig op i en tilbagelænet stilling og prøv at slappe af.
English: The film coating of the tablet contains lactose.
Danish: Tablettens filmovertræk indeholder lactose.
English: Children and adolescents VIAGRA should not be given to individuals under the age of 18.
Danish: VIAGRA bør ikke gives til personer under 18 år.
English: The European Medicines Agency has waived the obligation to submit the results of studies with VIAGRA in all subsets of the paediatric population for the treatment of erectile dysfunction.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med VIAGRA i alle undergrupper af den pædiatriske population for behandling af erektil dysfunktion (se pkt.
English: If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
Danish: hvis du for tiden har mavesår eller blødningsforstyrrelser (som f.eks. hæmofili).
English: If VIAGRA 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 VIAGRA ikke hjælper til at give erektion, eller hvis erektionen ikke varer længe nok til at gennemføre samleje, bør du sige det til lægen.
English: You should not take VIAGRA if you do not have erectile dysfunction.
Danish: Du bør ikke tage VIAGRA, hvis du ikke har erektil dysfunktion.
English: VIAGRA contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: VIAGRA indeholder det aktive stof sildenafil, der tilhører en gruppe medicin, som kaldes fosfodiesterase type 5 (PDE5)-hæmmere.
English: Viagra should be taken as needed approximately one hour before sexual activity.
Danish: VIAGRA tages efter behov cirka 1 time før seksuel aktivitet.
English: It is recommended that orodispersible tablets be taken on an empty stomach.
Danish: Det anbefales, at orodispergible tabletter indtages på tom mave.
English: Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of VIAGRA without sexual activity.
Danish: Få hændelser er rapporteret som opstået kort tid efter brugen af VIAGRA uden seksuel aktivitet.
English: You should be aware of how you react to VIAGRA before you drive or use machinery.
Danish: Vær opmærksom på, hvordan du reagerer på VIAGRA inden bilkørsel eller betjening af maskiner.
English: The orodispersible tablets should be taken on an empty stomach as you may find that it takes longer to start working if you take it with a heavy meal.
Danish: Den orodispergible tablet bør tages på tom mave, da det vil vare længere tid, før der opnås virkning, hvis du tager den sammen med et måltid.
English: VIAGRA with food and drink and alcohol
Danish: Brug af VIAGRA sammen med mad, drikke og alkohol
English: • Seizures or fits - this occurs rarely
Danish: • Kramper eller krampeanfald - dette ses sjældent
English: You should not use VIAGRA with any other oral or local treatments for erectile dysfunction.
Danish: Du bør ikke anvende VIAGRA sammen med andre orale eller lokale behandlinger for erektil dysfunktion.
English: VIAGRA potentiates the hypotensive effect of nitrates (see section 4.3).
Danish: Viagra forstærker nitraters hypotensive effekt (se pkt.
English: The recommended dose is 50 mg taken on an empty stomach as concomitant intake with food delays absorption and delays the effect of the orodispersible tablet (see section 5.2).
Danish: Den anbefalede dosis er 50 mg, som tages på tom mave, da samtidig fødeindtagelse forsinker virkningen af den orodispergible tablet (se pkt.
English: In a clinical study in 36 healthy males 45 years or older, 50 mg orodispersible tablets administered without water were observed to be bioequivalent to the 50 mg film-coated tablets.
Danish: I et klinisk studie med 36 raske mænd i alderen 45 år eller derover fandt man, at 50 mg orodispergible tabletter taget uden vand var bioækvivalente med 50 mg filmovertrukne tabletter.
English: You should take VIAGRA about one hour before you plan to have sex.
Danish: VIAGRA bør tages ca. 1 time inden du planlægger seksuel aktivitet.
English: If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i VIAGRA (angivet i punkt 6).
English: The active substance is sildenafil.
Danish: - Aktivt stof: sildenafil.
English: VIAGRA tablets may interfere with some medicines, especially those used to treat chest pain.
Danish: VIAGRA tabletter kan påvirke virkningen af anden medicin, især medicin til behandling af smerter i brystet.
English: Orodispersible tablet.
Danish: Orodispergible tabletter.
English: If you experience any of the following serious side effects stop taking VIAGRA and seek medical help immediately:
Danish: Hvis du oplever nogen af de følgende bivirkninger skal du stoppe med at tage VIAGRA og øjeblikkeligt søge læge:
English: VIAGRA with alcohol
Danish: Brug af VIAGRA sammen med alkohol
English: VIAGRA should not be administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: VIAGRA bør derfor ikke anvendes til mænd med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: The manufacturer of VIAGRA is Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Danish: VIAGRA fremstilles af Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-surCisse, Frankrig.
English: If you experience sudden decrease or loss of vision, stop taking VIAGRA and contact your doctor immediately.
Danish: hvis du oplever pludselige nedsættelser af synet eller tab af synet, skal du stoppe med at tage VIAGRAog straks søge læge.
English: If you have a severe heart or liver problem.
Danish: Hvis du har alvorlige hjerte- eller leverproblemer.
English: What VIAGRA contains
Danish: VIAGRA indeholder
English: There is a significant delay in absorption when orodispersible tablets are taken with a high fat meal compared to the fasted state (see section 5.2).
Danish: Der er signifikant forsinkelse i absorptionen, når orodispergible tabletter tages sammen med et måltid med højt fedtindhold sammenlignet med fastende indtagelse (se pkt.
English: If VIAGRA is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Danish: Hvis VIAGRA indtages sammen med føde, kan virkningens indtræden forsinkes i forhold til indtagelse under fastende forhold (se pkt.
English: VIAGRA 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: VIAGRA 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: 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 (1/1000 til <1/100), sjælden (1/10.000 til <1/1000).
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200% and 79% respectively.
Danish: Herudover er AUC og Cmax- værdierne for N-desmethylmetabolitten signifikant forhøjede, henholdsvis 200% og
English: Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment.
Danish: Pooling af følgende klasser af antihypertensiva: Diuretika, beta-blokkere, ACE-hæmmere, angiotensin II antagonister, antihypertensiva (vasodilatatorer og centralt virkende), adrenerge neuroblokkere, calciumblokkere og alfa-adrenerge receptorblokkere viste ingen forskel i bivirkningsprofil hos patienter, som tog sildenafil sammenlignet med placebobehandling.
English: What you need to know before you take VIAGRA
Danish: Det skal du vide, før du begynder at tage VIAGRA
English: Do not take VIAGRA orodispersible tablets in combination with film-coated tablets containing sildenafil including VIAGRA film-coated tablets.
Danish: Tag ikke VIAGRA orodispergible tabletter sammen med filmovertrukne tabletter, der indeholder sildenafil herunder VIAGRA filmovertrukne tabletter.
English: • Serious skin reactions - this occurs rarely Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.
Danish: • Alvorlige hudreaktioner - dette ses sjældent Symptomerne kan omfatte kraftig afskalling og opsvumlen af huden, små vabler i munden samt omkring kønsorganerne og øjnene, feber.
English: Do not take VIAGRA film-coated tablets in combination with VIAGRA orodispersible tablets.
Danish: Tag ikke VIAGRA filmovertrukne tabletter sammen med VIAGRA orodispergible tabletter.
English: VIAGRA contains lactose
Danish: VIAGRA indeholder lactose
English: For patients requiring a second 50 mg orodispersible tablet to make a 100 mg dose, the second tablet should be taken upon full disintegration of the first tablet.
Danish: Patienter, der skal tage en ekstra 50 mg orodispergibel tablet for at få en 100 mg dosis, skal tage den anden tablet efter, at den første er fuldstændigt opløst.
English: Polyvinyl acetate
Danish: Polyvinylacetat Povidon
English: In volunteers with mild to moderate renal impairment (creatinine clearance = 30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Danish: Hos frivillige forsøgspersoner med let til moderat nedsat nyrefunktion (kreatininclearance = 3080 ml/min) ændres farmakokinetikken ikke efter en enkelt oral dosis på 50 mg.
English: PDE5 inhibitors, such as Viagra have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som VIAGRA, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: The other ingredients are: microcrystalline cellulose, silica hydrophobic colloidal, croscarmellose sodium, magnesium stearate, indigo carmine aluminium lake (E132), sucralose, mannitol, crospovidone, polyvinyl acetate, povidone, flavouring containing: maltodextrin and dextrin, natural flavouring containing: maltodextrin, glycerol (E422) and propylene glycol (E1520), lemon flavouring containing: maltodextrin and alpha-tocopherol (E307)).
Danish: - Øvrige indholdsstoffer: - Mikrokrystallinsk cellulose, hydrofob kolloid silica, croscarmellosenatrium, magnesiumstearat, indigotin I(E132), sukralose, mannitol, crospovidon, polyvinylacetat, povidon, - smag indeholder: maltodextrin og dextrin, - naturlig smag indeholder: maltodextrin, glycerol (E422) og propylenglycol (E1520), - citronsmag indeholder: maltodextrin og alfa-tokoferol (E307).
English: Epidermal Necrolysis (TEN)*
Danish: Stevens-Johnsons syndrom (SJS)*,toksisk epidermal nekrolyse (TEN)*
English: If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg) of VIAGRA.
Danish: Hvis du tager medicin, som kaldes proteasehæmmere, for eksempel til behandling af hiv, kan din læge starte behandlingen på den laveste dosis VIAGRA (25 mg).
English: If you require a second 50 mg orodispersible tablet to make a 100 mg dose, you should wait until the first one has completely disintegrated and you have swallowed it before taking the second orodispersible tablet.
Danish: Hvis du skal bruge yderligere en 50 mg orodispergibel tablet for at få en dosis på 100 mg, skal du venter med at tage den, indtil den tablet første er fuldstændig opløst og du har slugt den.
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μM).
Danish: Sildenafil er en svag hæmmer af CYP-isoformer 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50 >150 µM).
English: Place the orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva or water.
Danish: Læg den orodispergible tablet i munden oven på tungen, hvor den vil opløses i løbet af få sekunder.
English: Other medicines and VIAGRA
Danish: Brug af anden medicin sammen med VIAGRA
English: Your doctor may start you on a lower dose (25 mg) of VIAGRA.
Danish: Lægen kan give dig en lavere begyndelsesdosis (25 mg) af VIAGRA.
English: Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered.
Danish: Da sildenafil-clearance er nedsat hos patienter med leverinsufficiens (f.eks. cirrhose) skal en 25 mg dosis overvejes.
English: You may find that VIAGRA takes longer to work if you take it with a heavy meal.
Danish: Det kan vare længere inden VIAGRA virker, hvis det tages sammen med et tungt måltid.
English: In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.
Danish: I en anden RigiScan-undersøgelse var sildenafil stadig i stand til at give erektion efter seksuel stimulation 4-5 timer efter dosisindtagelse.
English: The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
Danish: Følgende grupper var ikke tilstrækkeligt repræsenteret eller var ekskluderet fra kliniske studier: Patienter med bækkenindgreb, patienter i behandling med radioterapi, patienter med alvorlig nyreeller leverinsufficiens og patienter med visse hjerte-karsygdomme (se pkt.
English: Your doctor may start you on a lower dose (25 mg film-coated tablets) of VIAGRA.
Danish: Lægen kan give dig en lavere begyndelsesdosis (25 mg filmovertrukne tabletter) af VIAGRA.
English: Patients should be advised that in the event of any sudden visual defect, they should stop taking VIAGRA and consult a physician immediately (see section 4.3).
Danish: Patienten skal informeres om at stoppe med at tage VIAGRA og omgående konsultere en læge, hvis der pludseligt opstår synsdefekt (se pkt.
English: When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP.
Danish: Når NO/cGMP-vejen er aktiveret, som det sker ved seksuel stimulation, fører sildenafils hæmning af PDE5 til øgede cGMP-niveauer i corpus cavernosum.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Danish: Skønt der ikke er foretaget specifikke interaktionsundersøgelser for alle lægemidler, viste populationsfarmakokinetiske analyser, at sildenafils farmakokinetik ikke blev påvirket ved samtidig indgift med CYP2C9-hæmmere (som tolbutamid, warfarin, fenytoin), CYP2D6-hæmmere (som selektive serotonin re-uptake-hæmmere, tricykliske antidepressiva), tiazider og beslægtede diuretika, loop- og kaliumbesparende diuretika, ACE-hæmmere, calciumblokkere, beta-adrenerge receptorantagonister eller stoffer, som inducerer CYP-metabolisme (som rifampicin, barbiturater).
English: Flavouring contains: Maltodextrin Dextrin
Danish: Smag indeholder: Maltodextrin Dextrin
English: VIAGRA is not indicated for use by women.
Danish: VIAGRA er ikke indiceret til anvendelse hos kvinder.
English: If you are taking medicines known as protease inhibitors, such as for the treatment of HIV, your doctor may start you on the lowest dose (25 mg film-coated tablets) of VIAGRA.
Danish: Hvis du tager medicin, som kaldes proteasehæmmere, for eksempel til behandling af hiv, kan din læge starte behandlingen på den laveste dosis VIAGRA (25 mg filmovertrukne tabletter).
English: The orodispersible tablet should be placed in the mouth, on the tongue, and allowed to disintegrate before swallowing with or without water.
Danish: Den orodispergible tablet skal placeres i munden oven på tungen, og skal opløses helt inden den synkes.