FrancophonIA/ELRC3.0 huggingface dataset:
English: You may experience any of the side effects described in section 4.
Danish: Det kan være, at du får nogle af de bivirkninger, som er nævnt i punkt 4.
English: It is not possible to determine whether these events were related directly to tadalafil.
Danish: Det er ikke muligt at afgøre, hvorvidt disse bivirkninger var direkte relateret til tadalafil.
English: de la Industria 30, 28108 Alcobendas, Madrid, Spain
Danish: de la Industria 30, 28108 Alcobendas, Madrid, Spanien.
English: The dose may be increased to 40 mg once per day, based on individual efficacy and tolerability.
Danish: Dosis kan øges med 40 mg en gang daglig, baseret på den individuelle effekt og tolerance.
English: Do NOT take a double dose to make up for the one that you have forgotten.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: The clinical relevance of this finding is uncertain.
Danish: Den kliniske relevans af denne observation er uvis.
English: The improvement in walk distance was apparent from 8 weeks of treatment.
Danish: Gangdistanceforbedringen var tydelig efter 8 ugers behandling.
English: Of these, 311 patients had been treated with tadalafil for at least 6 months and 293 for 1 year (median exposure 365 days; range 2 days to 415 days).
Danish: Af disse havde 311 patienter været behandlet med tadalafil i mindst 6 måneder og 293 i et år (gennemsnitlig behandlingstid 365 dage; interval 2 dage til 415 dage).
English: Therefore, the combination of tadalafil and doxazosin is not recommended.
Danish: Kombinationen af tadalafil og doxazosin tilrådes derfor ikke.
English: Prolonged erections
Danish: Forlænget erektion
English: Therefore, this combination is not recommended (see section 4.4).
Danish: Denne kombination kan derfor ikke anbefales (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/476/005-006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/476/005-006
English: This interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Danish: Denne interaktion varer i mere end 24 timer og kan ikke spores 48 timer efter den sidste tadalafildosis.
English: Acetylsalicylic acid
Danish: Acetylsalicylsyre
English: Between 20 mg to 40 mg, a less than proportional increase in exposure is observed.
Danish: Mellem 20 mg og 40 mg sås en mindre end proportional stigning i eksponeringen.
English: The rate and extent of absorption of tadalafil are not influenced by food, thus ADCIRCA may be taken with or without food.
Danish: Hverken hastigheden eller omfanget af absorptionen af tadalafil påvirkes af fødeindtagelse, så ADCIRCA kan tages med eller uden mad.
English: Cardiopulmonary hemodynamics was performed in 93 patients.
Danish: Kardiopulmonal hæmodynamik blev udført hos 93 patienter.
English: In addition, no changes in tadalafil concentrations were seen after co-administration with alcohol.
Danish: Ydermere blev der ikke set ændringer i tadalafilkoncentrationen efter administration sammen med alkohol.
English: Frequency estimate: 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 the available data).
Danish: Hyppighedsestimat: 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) og Ikke kendt
English: Treatments for erectile dysfunction
Danish: Behandling for erektil dysfuntion
English: Stevens-Johnson Syndrome, Exfoliative dermatitis
Danish: Stevens-Johnsons syndrom, eksfoliativ dermatitis
English: Warnings and precautions Talk to your doctor before taking ADCIRCA.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager ADCIRCA.
English: Significant improvement (p<0.01) in the 6MWD was demonstrated at week 12 when the patients were asked to delay taking study medicinal product in order to reflect trough active substance concentration.
Danish: Der sås signifikant bedring (p<0,01) i 6MWD i 12. uge hvor patienterne blev bedt om at udsætte indtagelsen af studiemedicinen for at afspejle det aktive indholdsstofs dalkoncentration (trough koncentration).
English: More than half (53.3 %) of the patients in the study were receiving concomitant bosentan therapy.
Danish: I studiet fik mere end halvdelen (53,3 %) af patienterne samtidig bosentanbehandling.
English: There were no clinically relevant differences in Cmax compared to healthy volunteers.
Danish: Der var ingen klinisk signifikant forskel på Cmax sammenlignet med raske frivillige.
English: Changes in the Borg dyspnoea score were small and non-significant with both placebo and tadalafil 40 mg.
Danish: Ændringer i Borg dyspnø-score var lille og ikkesignifikant for både placebo og tadalafil 40 mg.
English: The majority of patients had a World Health Organization (WHO) Functional Class III (65.2 %) or II (32.1 %).
Danish: De fleste af patienterne var klassificeret til World Health Organization (WHO) funktionsklasse III (65,2 %) eller II (32,1 %).
English: They are in the shape of almonds and have "4467" marked on one side.
Danish: De har form som mandler og er mærket ”4467” på den ene side.
English: Some side effects have been rarely reported: - Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious allergic reaction which causes swelling of the face or throat.
Danish: Visse bivirkninger er indberettet sjældent: - Delvis, midlertidig eller permanent nedsættelse eller tab af synet på det ene eller begge øjne og alvorlig allergisk reaktion, som medfører hævelse i ansigtet eller svælget.
English: Results were generally consistent in subgroups according to age, gender, PAH aetiology and baseline WHO functional class and 6MWD.
Danish: Resultaterne var generelt ens i subgrupper efter alder, køn, PAH- ætiologi og baseline WHO funktionsklasse og 6MWD.
English: Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breastfeeding.
Danish: Spørg din læge eller apotekspersonalet til råds, før du tager nogen form for medicin, mens du er gravid eller ammer.
English: Aluminium/PVC/PE/PCTFE blisters in cartons of 28 and 56 film-coated tablets.
Danish: Aluminium/PVC/PE/PCTFE blisterkort i pakninger á 28 og 56 filmovertrukne tabletter.
English: The time of dosing (morning versus evening after a single 10 mg administration) had no clinically relevant effects on the rate and extent of absorption.
Danish: Doseringstidspunktet (morgen versus aften efter administration af en enkelt dosis på 10 mg) havde ingen klinisk relevante indvirkninger på hastigheden eller omfanget af absorptionen.
English: Major classes of antihypertensive medicinal products were studied either as monotherapy or as part of combination therapy.
Danish: De vigtigste typer antihypertensiva blev undersøgt enten som monoterapi eller som del af kombinationsterapi.
English: INFORMATION IN BRAILLE ADCIRCA 20 mg
Danish: INFORMATION I BRAILLESKRIFT ADCIRCA 20 mg
English: ADCIRCA with alcohol
Danish: Brug af ADCIRCA sammen alkohol
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: The following groups of patients with cardiovascular disease were not included in PAH clinical studies:
Danish: Kardiovaskulær Følgende patientgrupper med hjerte-karsygdomme blev ikke inkluderet i PAH kliniske studier:
English: The mean age of all patients was 54 years (range 14 to 90 years) with the majority of patients being Caucasian (80.5 %) and female (78.3 %).
Danish: Gennemsnitsalderen af alle patienterne var 54 år (interval 14 til 90 år) og hovedparten var af kaukasisk oprindelse (80,5 %) og kvinder (78,3 %).
English: The overall frequency of discontinuation due to adverse events was low (ADCIRCA 11 %, placebo 16 %).
Danish: Den samlede hyppighed for ophør med behandling på grund af bivirkninger var lav (ADCIRCA 11 %, placebo 16 %).
English: Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil.
Danish: De fleste, men ikke alle, af de mænd, som fik høj puls, uregelmæssig hjerteslag, hjerteanfald, slagtilfælde og pludselig hjertedød havde eksisterende hjerteproblemer, før de tog tadalafil.
English: Dizziness has been reported.
Danish: Svimmelhed er rapporteret.
English: ADCIRCA is a treatment for pulmonary arterial hypertension in adults.
Danish: ADCIRCA er til behandling af pulmonal arteriel hypertension hos voksne.
English: Additionally, 6 minute walk distance and WHO functional class status appeared to be stable in those treated with tadalafil for 1 year.
Danish: Desuden syntes 6 minutter gangdistancen og WHO funktionsklassen at være stabil hos de patienter, der blev behandlet med tadalafil i et år.
English: As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking ADCIRCA and consult a physician immediately (see section 4.3).
Danish: Da dette kan være relevant for alle patienter som anvender tadalafil, skal patienten informeres om, at han skal stoppe med at tage ADCIRCA og omgående skal konsultere en læge, hvis der pludseligt opstår en synsdefekt (se pkt 4.3).
English: Palpitations2, 5
Danish: Palpitationer2,5
English: A risk to the breastfed child cannot be excluded.
Danish: Det kan ikke udelukkes, at der kan være en risiko for det ammede barn.
English: The mean volume of distribution is approximately 77 l at steady state, indicating that tadalafil is distributed into tissues.
Danish: Det gennemsnitlige fordelingsvolumen er ca. 77 l ved steady state, hvilket indikerer, at tadalafil fordeles i vævet.
English: ADCIRCA contains lactose If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: ADCIRCA indeholder lactose Hvis du ved, at du ikke tåler visse sukkerarter, skal du kontakte lægen, før du tager denne medicin.
English: No improvements were observed in the role emotional and mental health domains of the SF36.
Danish: Der blev ikke set forbedringer i SF-36-domænerne emotionel rolle og mental velbefindende.
English: These effects are normally mild to moderate in nature.
Danish: Bivirkningerne er som regel lette til moderate.
English: Three studies were conducted in men to assess the potential effect on spermatogenesis of tadalafil 10 mg (one 6-month study) and 20 mg (one 6-month and one 9-month study) administered daily.
Danish: Der er blevet udført tre studier hos mænd for at vurdere den mulige effekt på spermatogenesen af tadalafil 10 mg (ét 6 måneders studie) og 20 mg (ét 6 måneders og ét 9 måneders studie), daglig administration.
English: If you stop taking ADCIRCA Do not stop taking your tablets, unless advised otherwise by your doctor.
Danish: Hvis du holder op med at tage ADCIRCA Du må ikke holde op med at tage medicinen, medmindre din læge har rådet dig til det.
English: Tadalafil is excreted predominantly as inactive metabolites, mainly in the faeces (approximately 61 % of the dose) and to a lesser extent in the urine (approximately 36 % of the dose).
Danish: Tadalafil udskilles overvejende som inaktive metabolitter, for størsteparten i fæces (ca. 61 % af dosis) og i mindre grad i urinen (ca. 36 % af dosis).
English: Check carefully how you react to the medicines before driving or using any machinery.
Danish: Vær opmærksom på hvordan du reagerer på medicinen, før du begynder at køre bil eller betjene maskiner.
English: Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical studies was similar, patients should be aware of how they react to ADCIRCA, before driving or operating machinery.
Danish: Selvom hyppigheden af rapporter omhandlende svimmelhed var ens i placebo- og tadalafilarmene i de kliniske studier, bør patienterne være opmærksomme på, hvordan de reagerer på ADCIRCA, før de fører bil eller betjener maskiner.
English: As a precautionary measure, it is preferable to avoid the use of tadalafil during pregnancy.
Danish: Som en sikkerhedsforanstaltning bør brug af tadalafil under graviditet undgås.
English: (3) Actual MedDRA terms included are abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and stomach discomfort.
Danish: (3) Aktuelle MedDRA-termer inkluderer abdominalt ubehag, abdominale smerter, nedre abdominale smerter, øvre abdominale smerter og maveubehag.
English: (6) Headache was the most commonly reported adverse reaction.
Danish: (6) Hovedpine var den mest almindelige rapporterede bivirkning.
English: Patients were randomised to one of five treatment groups (tadalafil 2.5 mg, 10 mg, 20 mg, 40 mg, or placebo).
Danish: Patienterne blev randomiseret til en af fem behandlingsgrupper (tadalafil 2,5 mg, 10 mg, 20 mg, 40 mg eller placebo).
English: ADCIRCA has negligible influence on the ability to drive or use machines.
Danish: ADCIRCA påvirker kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyreforsøg indikerer ikke direkte eller indirekte skadelige virkninger på drægtighed, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Orange and almond shaped film-coated tablets, marked "4467" on one side.
Danish: Orange og mandelformede filmovertrukne tabletter, mærket ”4467” på den ene side.
English: Pharmacotherapeutic group: Urologicals, drugs used in erectile dysfunction, ATC code: G04BE08.
Danish: Farmakoterapeutisk klassifikation: Urologika, lægemidler anvendt ved erektil dysfunktion, ATC-kode: G04BE08.
English: Method of administration ADCIRCA is for oral use.
Danish: Administration ADCIRCA er til oral brug.
English: Do not breastfeed while taking these tablets as it is not known if the medicine passes into human breast milk.
Danish: Du må ikke amme, mens du tager disse tabletter, fordi det er uvist, om medicinen udskilles i mælken hos mennesker.
English: Pharmacokinetic studies have included subjects and patients from different ethnic groups, and no differences in the typical exposure to tadalafil have been identified.
Danish: Pharmakokinetiske studier har inkluderet personer og patienter fra forskellige etniske grupper, og der er ikke set nogen forskel i den typiske tadalafil-eksponering.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk.
Danish: Tilgængelige farmakodynamiske/toksikologiske data hos dyr har vist, at tadalafil udskilles i mælk.
English: If you experience any of the following side effects stop using the medicine and seek medical help immediately: - allergic reactions including skin rashes (frequency common).
Danish: Hvis du får nogen af disse bivirkninger, skal du stoppe med at tage dette lægemiddel og straks søge læge: - Allergiske reaktioner herunder hududslæt (hyppighed: almindelig).
English: These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is unknown: - swelling of the eyelids, eye pain, red eyes, heart attack and stroke.
Danish: Disse bivirkninger er ikke set i kliniske studier for pulmonal arteriel hypertension, og hyppigheden er derfor ikke kendt: - hævelse af øjenlåg, øjensmerter, røde øjne, hjertetilfælde og slagtilfælde.
English: In the pregnant rat the AUC for calculated free active substance at this dose was approximately 18 times the human AUC at a 20 mg dose.
Danish: Hos den drægtige rotte var AUC for beregnet frit aktivt stof ved denne dosis ca. 18 gange større end den humane AUC ved en 20 mg dosis.
English: If you experience sudden decrease or loss of vision, contact your doctor immediately.
Danish: Hvis du oplever en pludselig nedsættelse af synet eller tab af synet, skal du straks kontakte din læge.
English: Sudden cardiac death2, 5, Tachycardia2, 5
Danish: Pludselig hjertedød2,5, takykardi2,5
English: Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 4 hours after dosing.
Danish: Tadalafil absorberes hurtigt efter oral administration, og den gennemsnitlige maksimale plasmakoncentration (Cmax) opnås efter en median tid på 4 timer efter administration.
English: For those patients for which there are data, the survival rate at 1 year is 96.4 %.
Danish: Overlevelsesraten efter 1 år var 96,4 % for de patienter, der var data for.
English: The mean baseline 6-minute-walk-distance (6MWD) was 343.6 meters.
Danish: Den gennemsnitlige 6 minutters gangdistance (6MWD) var ved baseline 343,6 meter.
English: The results suggest a lower clearance of tadalafil in patients with pulmonary hypertension compared to healthy volunteers.
Danish: Resultaterne indikerer en lavere tadalafilclearance hos patienter med pulmonal hypertension sammenlignet med raske frivillige.
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) there was no pharmacokinetic interaction.
Danish: Når taladafil 10 mg blev administreret med theophyllin (en non-selektiv phosphodiesterasehæmmer), var der ingen farmakokinetisk interaktion.
English: Sudden decrease or loss of hearing has also been reported.
Danish: Pludselig hørenedsættelse eller høretab er også indberettet.
English: Urticaria5, Hyperhydrosis (sweating)5
Danish: Urticaria5, hyperhidrose (svedsekretion)5
English: Tadalafil has systemic vasodilatory properties that may result in transient decreases in blood pressure.
Danish: Tadalafil har systemiske vasodilatatoriske egenskaber, der kan resultere i forbigående blodtryksfald.
English: The mean oral clearance for tadalafil is 3.4 l/h at steady state and the mean terminal half-life is 16 hours in healthy subjects.
Danish: Den gennemsnitlige clearance for tadalafil efter oral indgift er 3,4 l/time ved steady state, og den gennemsnitlige terminale halveringstid er 16 timer hos raske forsøgspersoner.
English: Priapism has been reported in men treated with PDE5 inhibitors.
Danish: Priapisme er rapporteret hos mænd, der blev behandlet med PDE5-hæmmere.
English: 357 patients from the placebo-controlled study entered a long-term extension study.
Danish: 357 personer fra det placebokontrollerede studie indgik i et langtids-forlængelsesstudie.
English: However, post hoc analyses demonstrated that changes from baseline in cardiopulmonary hemodynamic parameters for the tadalafil 40 mg treatment group were not significantly different compared to placebo.
Danish: Derimod viste post hoc analyser, at ændringerne fra baseline for de kardiopulmonale hæmodynamiske parametre for 40 mg tadalafil behandlingsgruppen ikke var signifikant forskellig sammenlignet med placebogruppen.
English: Efficacy in patients with pulmonary arterial hypertension (PAH) A randomised, double-blind, placebo-controlled study was conducted in 405 patients with pulmonary arterial hypertension.
Danish: Virkning hos patienter med pulmonal arteriel hypertension (PAH) Et randomiseret dobbeltblindt placebokontrolleret studie blev udført på 405 patienter med pulmonal arteriel hypertension.
English: If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.
Danish: Hvis du har let eller moderat nedsat lever- eller nyrefunktion, kan din læge råde dig til kun at tage 1 tablet på 20 mg om dagen.
English: Eli Lilly Holdings Limited pārstāvniecība Latvijā
Danish: Latvija Eli Lilly Holdings Limited pārstāvniecība Latvijā
English: ADCIRCA 20 mg is available in blister packs containing 28 or 56 tablets.
Danish: ADCIRCA 20 mg fås i blisterpakninger med 28 eller 56 tabletter.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i punkt 6.1.
English: Due to increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis, tadalafil is not recommended in patients with severe renal impairment.
Danish: På grund af en øget tadalafileksponering (AUC), begrænset klinisk erfaring og manglende mulighed for at påvirke clearance ved dialyse anbefales tadalafil ikke til patienter med svært nedsat nyrefunktion.
English: If you have taken or are planning to take ADCIRCA, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.
Danish: Hvis du har taget eller har planer om at tage ADCIRCA, skal du undgå overdreven alkoholindtagelse (over 5 genstande alkohol).
English: During tadalafil 20 mg and 40 mg once daily dosing, steady-state plasma concentrations are attained within 5 days, and exposure is approximately 1.5 fold of that after a single dose.
Danish: Ved indtagelse af tadalafil 20 mg og 40 mg en gang daglig opnås steady-state plasmakoncentration i løbet af 5 dage, og eksponeringen er ca. 1,5 gange så stor som efter en enkelt dosis.
English: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).
Danish: Pulmonære vasodilatatorer kan forværre den kardiovaskulære status signifikant hos patienter med pulmonal veneokklusiv sygdom (PVOD).
English: Pulmonary arterial hypertension (PAH) etiologies were predominantly idiopathic PAH (61.0 %) and related to collagen vascular disease (23.5 %).
Danish: Ætiologien af pulmonal arteriel hypertension var overvejende idiopatisk PAH (61,0 %) og relateret til vaskulær bindevævssygdom (23,5 %).
English: In haemodialysis patients, Cmax was 41 % higher than that observed in healthy subjects.
Danish: Hos hæmodialysepatienter var Cmax 41 % højere end hos raske forsøgspersoner.
English: These events have either been assigned a frequency of “Not known,” as the frequency in PAH patients cannot be estimated from the available data or assigned a frequency based on the clinical study data from the pivotal placebo-controlled study of ADCIRCA.
Danish: Disse bivirkninger er enten angivet med frekvensen ”ikke kendt”, da frekvensen hos PAH-patienter ikke kan estimeres ud fra de forhåndenværende data, eller angivet med en frekvens baseret på data fra det pivotale kliniske placebo-kontrollerede studie med ADCIRCA.
English: Across all clinical studies, reports of changes in colour vision were rare (< 0.1 %).
Danish: Rapporter vedrørende ændringer i farvesynet var sjældne (< 0,1 %) på tværs af alle studier.
English: Allowed background therapy included bosentan (stable maintenance dose up to 125 mg twice daily) and chronic anticoagulation, digoxin, diuretics and oxygen.
Danish: Tilladt tillægsbehandling inkluderede bosentan (stabil vedligeholdelsesdosis på op til 125 mg to gange daglig) og kontinuerlig antikoagulansbehandling, digoxin, diuretika og oxygen.
English: Single doses of up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients with erectile dysfunction.
Danish: Enkeltdoser på op til 500 mg er givet til raske forsøgspersoner, og flere daglige doser af op til 100 mg er givet til patienter med erektil dysfunktion.
English: Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Danish: Virkningen er set ved idiopatisk PAH (IPAH) og ved PAH i forbindelse med vaskulær bindevævssygdom.
English: Tadalafil is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP).
Danish: Tadalafil er en potent og selektiv hæmmer af phosphodiesterase type 5 (PDE5), som er det enzym, der er ansvarlig for nedbrydningen af cyklisk guanosinmonophosphat (cGMP).
English: - priapism, a prolonged and possibly painful erection after taking ADCIRCA (frequency uncommon).
Danish: - Priapisme, en forlænget og muligvis smertefuld rejsning efter indtagelse af ADCIRCA