FrancophonIA/ELRC3.0 huggingface dataset:
English: What CIALIS contains - The active substance is tadalafil.
Danish: CIALIS indeholder: - Aktivt stof: Tadalafil.
English: Benign prostatic hyperplasia
Danish: Benign prostatahyperplasi
English: The improvement in the total international prostate symptom score with CIALIS 5mg in the four studies were -4.8, -5.6, -6.1 and -6.3 compared to -2.2,3.6, -3.8 and -4.2 with placebo.
Danish: Forbedringen i den totale international prostate symptom score med CIALIS 5 mg i de fire studier var -4,8, -5,6, -6,1 og -6,3 sammenlignet med -2,2, -3,6, -3,8 og -4,2 for placebo.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONVEJ (E)
English: For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day.
Danish: For voksne mænd i behandling for både benign prostatahyperplasi og erektil dysfunktion er den anbefalede dosis også 5 mg, som skal tages på omtrent samme tidspunkt hver dag.
English: Men with diabetes Dose adjustments are not required in diabetic patients.
Danish: Mænd med diabetes Det er ikke nødvendigt at justere dosis hos patienter med diabetes.
English: These vascular effects may be complemented by inhibition of bladder afferent nerve activity and smooth muscle relaxation of the prostate and bladder.
Danish: De vaskulære virkninger suppleres muligvis af hæmning af aktiviteten af blærens afferente nerver og afslapning af den glatte muskulatur i prostata og blære.
English: Pharmacotherapeutic group: Urologicals, Drugs used in erectile dysfunction, ATC Code: G04BE08.
Danish: Lægemidler anvendt ved erektil dysfunktion, ATCkode: G04BE08.
English: Cytochrome P450 metabolised medicinal products Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of medicinal products metabolised by CYP450 isoforms.
Danish: Tadalafil forventes ikke at medføre en klinisk signifikant inhibition eller induktion af clearance for lægemidler, som metaboliseres via CYP450-isoformer.
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE1, PDE2, and PDE4, enzymes which are found in the heart, brain, blood vessels, liver, and other organs.
Danish: Tadalafil er > 10.000 gange mere potent overfor PDE5 end for PDE1, PDE2 og PDE4, som er enzymer, der findes i hjerte, hjerne, blodårer, lever og andre organer.
English: If the effect of this dose is too weak your doctor may increase the dose to 20 mg. CIALIS tablets are for oral use.
Danish: Hvis effekten af denne dosis er for svag, kan din læge øge dosis til 20 mg.
English: In clinical trials with tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age.
Danish: I kliniske studier med tadalafil taget efter behov for behandling af erektil dysfuktion blev diarré hyppigere indberettet for patienter over 65 år.
English: Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials.
Danish: Alvorlige kardiovaskulære hændelser, inklusiv myokardieinfarkt, pludselig hjertedød, ustabil angina pectoris, ventrikulær arytmi, apopleksi, forbigående iskæmiske anfald, brystsmerter, hjertebanken og takykardi er rapporteret efter markedsføringen og/eller i kliniske studier.
English: A CYP3A4 inducer, rifampicin, reduced tadalafil AUC by 88 %, relative to the AUC values for tadalafil alone (10 mg).
Danish: Rifampicin, der inducerer CYP3A4 metabolisme, reducerede tadalafil AUC med 88% i forhold til AUC-værdierne for tadalafil alene (10 mg).
English: Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4).
Danish: Selvom specifikke interaktioner ikke er undersøgt, bør samtidig administration af andre proteasehæmmere, såsom saquinavir, og andre CYP3A4-inhibitorer, såsom erythromycin, clarithromycin, itraconazol og grapefrugt juice foretages med forsigtighed, da de forventes at øge plasmakoncentrationen af tadalafil (se pkt.
English: A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo.
Danish: Der er rapporteret en lidt højere hyppighed af abnormt ekg, primært sinus bradykardi, hos patienter behandlet med tadalafil en gang dagligt end hos patienter behandlet med placebo.
English: <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) and not known (cannot be estimated from the available data).
Danish: Hyppighedskonvention: 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 (kan ikke estimeres ud fra forhåndenværende data).
English: If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
Danish: Hvis du får sådan en rejsning, som vedvarer i mere end 4 timer, skal du straks søge lægehjælp.
English: The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).
Danish: Samtidig administration af PDE5-hæmmere, inklusive tadalafil, med guanylatcyklase-stimulatorer, som f.eks. riociguat, er kontraindikeret, da det kan føre til symptomatisk hypotension (se pkt.
English: Tadalafil demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients' ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing.
Danish: Tadalafil udviste en statistisk signifikant forbedring i forhold til placebo af den erektile funktion og af evnen til at gennemføre et samleje i op til 36 timer efter doseringen, såvel som af patienternes evne til at opnå og opretholde erektioner til gennemførelse af samleje så tidligt som 16 minutter efter dosering.
English: Caution should be exercised when prescribing CIALIS to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).
Danish: Der bør udvises forsigtighed ved ordination af CIALIS til patienter, som er i behandling med potente CYP3A4 inhibitorer (ritonavir, saquinavir, ketoconazol, itraconazol og erythromycin), idet øget tadalafil eksponering (AUC) er blevet observeret, hvis lægemidlerne kombineres (se pkt.
English: A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy (DMD) in which no evidence of efficacy was seen.
Danish: I et studie med tadalafil udført hos børn med Duchennes muskeldystrofi (DMD) blev der ikke påvist nogen effekt.
English: Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers).
Danish: Væsentlige klasser af antihypertensiva blev undersøgt, heriblandt calciumantagonister (amlodipin), angiotensinkonverterende enzym (ACE) hæmmere (enalapril), betablokkere (metoprolol), thiazid diuretika (bendrofluazid) og angiotensin II blokkere (forskellige typer og doser, alene eller i kombination med thiazider, calciumantagonister, betablokkere og/eller alfablokkere).
English: What you need to know before you take CIALIS
Danish: Det skal du vide, før du begynder at tage CIALIS
English: Prolonged erections Priapism, Penile haemorrhage,
Danish: Forlænget erektion Priapisme, Blødning fra penis,
English: Pharmacokinetics determined with a population approach in patients with erectile dysfunction are similar to pharmacokinetics in subjects without erectile dysfunction.
Danish: Farmakokinetikken bestemt med hensyn til populationer hos patienter med erektil dysfunktion er den samme som farmakokinetikken hos raske forsøgspersoner.
English: In clinical trials with tadalafil 5mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.
Danish: I kliniske studier med tadalafil 5 mg taget en gang dagligt for behandling af benign prostatahyperplasi blev svimmelhed og diarré hyppigere indberettet for patienter over 75 år.
English: Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (mean maximal decrease of 1.6/0.8 mm Hg, respectively), in standing systolic and diastolic blood pressure (mean maximal decrease of 0.2/4.6 mm Hg, respectively), and no significant change in heart rate.
Danish: Administreret til raske forsøgspersoner, viste tadalafil ingen signifikant forskel i forhold til placebo på det liggende systoliske og diastoliske blodtryk (gennemsnitligt maksimalt fald på henholdsvis 1,6 og 0,8 mm Hg), på det stående systoliske og diastoliske blodtryk (gennemsnitligt maksimalt fald på henholdsvis 0,2 og 4,6 mm Hg) og ingen signifikant ændring i hjertefrekvens.
English: Sudden hearing loss
Danish: Pludseligt høretab
English: The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with CIALIS 5 mg compared to 1.8 and -3.8 with placebo, respectively.
Danish: Forbedringerne i scoren for erektil funktion i international index of erectile function og den totale international prostate symptom score i dette studie var henholdsvis 6,5 og -6,1 med CIALIS 5 mg sammenlignet med henholdsvis 1,8 og -3,8 for placebo.
English: Dose adjustments are not required in elderly patients.
Danish: Det er ikke nødvendigt at justere dosis hos ældre patienter.
English: Ritonavir, a protease inhibitor (200 mg twice daily), which is an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax.
Danish: Ritonavir, en proteasehæmmer (200 mg 2 gange dagligt), som er en inhibitor af CYP3A4, CYP2C9, CYP2C19 og CYP2D6, øgede tadalafil (20 mg dosis) eksponeringen (AUC) 2 gange uden nogen ændring i Cmax.
English: CIALIS 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Danish: CIALIS 10 mg og 20 mg er beregnet til brug før forventet seksuel aktivitet og anbefales ikke til vedvarende daglig brug.
English: METHOD AND ROUTE(S) OF ADMINISTRATION How to take CIALIS once-a-day
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONVEJ(E) Vejledning i brug af CIALIS én gang dagligt
English: Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.
Danish: Behandling af tegn og symptomer på benign prostatahyperplasi (BPH) hos voksne mænd.
English: PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum.
Danish: PDE5 er et enzym, som findes i den glatte muskulatur i corpus cavernosum, i vaskulær og visceral glat muskulatur, skeletmuskulatur, blodplader, nyrer, lunger samt cerebellum.
English: Therefore, administration of CIALIS to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Danish: Derfor er administration af CIALIS kontraindiceret til patienter, som bruger enhver form for organisk nitrat (se pkt.
English: Facial oedema2, Sudden cardiac death1, 2
Danish: Ansigtsødem2, Pludselig hjertedød1,2
English: Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.
Danish: Tadalafil metaboliseres overvejende af cytokrom P450 (CYP) 3A4 isoformen.
English: In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects.
Danish: Hos forsøgspersoner i denne sammenhæng, som var velbehandlede med blodtrykskontrollerende lægemidler, var reduktionen af blodtrykket minimal og sammenlignelig med det fundne hos raske forsøgspersoner.
English: Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure.
Danish: Hvis du drikker alkohol, kan det påvirke din evne til at få en erektion, og dit blodtryk kan sænkes midlertidigt.
English: Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors.
Danish: Data fra observationsstudier tyder på en øget risiko for akut NAION hos mænd med erektil dysfunktion, som følge af episodisk brug af tadalafil og PDE5-hæmmere.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Less than 0.0005 % of the administered dose appeared in the semen of healthy subjects.
Danish: Hos raske forsøgspersoner genfandtes mindre end 0,0005% af den administrerede dosis i sperma.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Danish: Brug ikke dette lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: See leaflet for further information.
Danish: Se indlægssedlen for nærmere information.
English: In a clinical trial that compared tadalafil 5 mg coadministered with finasteride 5 mg to placebo plus finasteride 5 mg in the relief of BPH symptoms, no new adverse reactions were identified.
Danish: I et klinisk studie, der sammenlignede tadalafil 5 mg administreret samtidig med finasterid 5 mg versus placebo plus finasterid 5 mg til lindring af symptomer på benign prostatahyperplasi (BPH), blev der ikke identificeret nye bivirkninger.
English: The dose may be decreased to 2.5 mg once a day based on individual tolerability.
Danish: Baseret på individuel tolerance kan dosis muligvis sænkes til 2,5 mg én gang dagligt.
English: In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.
Danish: To af disse tre studier viste et fald i spermatocyttal og spermatocytkoncentration, der var relateret til tadalafil behandling.
English: Nederland Eli Lilly Nederland B.V.
Danish: Eli Lilly Nederland B.V.
English: Once-a-day administration either for the treatment of erectile dysfunction or benign prostatic hyperplasia has not been evaluated in patients with hepatic insufficiency.
Danish: En gang daglig administration til behandling af enten erektil dysfunktion eller benign prostatahyperplasi er ikke blevet evalueret hos patienter med leverinsufficiens.
English: The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: - patients with myocardial infarction within the last 90 days, - patients with unstable angina or angina occurring during sexual intercourse, - patients with New York Heart Association Class 2 or greater heart failure in the last 6 months, - patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension, - patients with a stroke within the last 6 months.
Danish: Følgende grupper af patienter med hjerte-/karsygdomme blev ikke inkluderet i de kliniske studier og brugen af tadalafil er derfor kontraindiceret: - Patienter med myokardieinfarkt indenfor de seneste 90 dage - Patienter med ustabil angina, eller angina forekommende under samleje - Patienter med hjerteinsufficiens, New York Heart Association klasse 2 eller højere, indenfor de seneste 6 måneder - Patienter med ukontrollerede arytmier, hypotension (< 90/50 mm Hg) eller ukontrolleret hypertension - Patienter med en apopleksi inden for de seneste 6 måneder
English: PDE5 inhibitors, such as CIALIS, have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som CIALIS, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: The result of this is improved erectile function.
Danish: Resultatet af dette er en forbedret rejsning.
English: CYP1A2 substrates (e.g. theophylline)
Danish: CYP1A2-substrater (f.eks. theophyllin)
English: Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).
Danish: Samtidig brug af riociguat med PDE5-hæmmere, inklusive tadalafil, er kontraindikeret (se pkt.
English: In a subsequent study, 217 patients who were treatment-naïve to PDE5 inhibitors were randomized to CIALIS 5 mg once a day vs. placebo.
Danish: I et efterfølgende studie blev 217 patienter, som var behandlingsnaive med hensyn til PDE5-inhibitorer, randomiseret til Cialis 5 mg en gang dagligt versus placebo.
English: The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with CIALIS 5mg.
Danish: Dette viste, at den forbedring i den totale international prostate symptom score, som blev set ved 12 uger, blev opretholdt i op til 1 år yderligere ved behandling med CIALIS 5mg.
English: The most commonly reported adverse reactions in patients taking CIALIS for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of CIALIS.
Danish: De hyppigst rapporterede bivirkninger hos patienter, som tog CIALIS til behandling af erektil dysfunktion eller benign prostatahyperplasi, var hovedpine, dyspepsi, rygsmerter og myalgi, hvor hyppigheden steg ved øget dosis af CIALIS.
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction.
Danish: Når taladafil 10 mg blev administreret med theophyllin (en non-selektiv phosphodiesterase inhibitor) i en klinisk farmakologisk undersøgelse var der ingen farmakokinetisk interaktion.
English: In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
Danish: I kliniske studier har riociguat vist sig at forstærke den hypotensive virkning af PDE5-hæmmere.
English: In clinical pharmacology studies using single-dose tadalafil (5 to 20 mg), tadalafil exposure (AUC) approximately doubled in subjects with mild (creatinine clearance 51 to 80 ml/min) or moderate (creatinine clearance 31 to 50 ml/min) renal impairment and in subjects with end-stage renal disease on dialysis.
Danish: I kliniske farmakologisk-undersøgelser med enkelt-indgift af tadalafil (5til 20 mg) var eksponeringen for tadalafil (AUC) ca. fordoblet hos forsøgspersoner med mild (kreatinin-clearance 51 til 80 ml/min) eller moderat (kreatinin-clearance 31 til 50 ml/min) nyrefunktionsnedsættelse samt hos dialysepatienter med nyresvigt i slutstadie.
English: Urticaria, StevensJohnson syndrome2, Exfoliative dermatitis2, Hyperhydrosis (sweating)
Danish: Urticaria, StevensJohnsons syndrom2, Eksfoliativ dermatitis2, Hyperhidrose
English: It is important to note that CIALIS does not work if there is no sexual stimulation.
Danish: Det er vigtigt at huske, at CIALIS kun virker ved seksuel stimulation.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplsyninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: If you are taking any form of nitrate or are unsure tell your doctor.
Danish: Fortæl lægen, hvis du tager nogen form for nitrat, eller hvis du er i tvivl.
English: Myocardial infarction, Unstable angina pectoris2, Ventricular arrhythmia2
Danish: Myokardieinfarkt, Ustabil angina pectoris2, Ventrikulær arytmi2
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22 %.
Danish: Ketoconazol (400 mg dagligt) øgede tadalafil (20 mg dosis) eksponeringen (AUC) 4 gange og Cmax med 22%.
English: Anti-hypertensives (including calcium channel blockers) The co-administration of doxazosin (4 and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg as a single dose) increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.
Danish: Samtidig indgift af doxazosin (4 og 8 mg dagligt) og tadalafil (5 mg daglig dosis og 20 mg som en enkeltdosis) øger signifikant den blodtrykssænkende virkning af denne alfa-blokker.
English: Most patients in these three studies were responders to previous on-demand treatment with PDE5 inhibitors.
Danish: De fleste patienter i disse tre studier havde effekt af tidligere p.n.-behandling med PDE5-inhibitorer.
English: There was no impairment of fertility in male and female rats.
Danish: Der sås ingen forringelse af fertiliteten hos han- og hunrotter.
English: CIALIS is not intended for use by women.
Danish: CIALIS er ikke beregnet til kvinder.
English: Tablet core: lactose monohydrate, croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Danish: Tabletkerne: lactosemonohydrat, croscarmellosenatrium, hydroxypropylcellulose, mikrokrystallinsk cellulose, natriumlaurilsulfat, magnesiumstearat.
English: There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (ChildPugh Class C).
Danish: Der er begrænsede kliniske data vedrørende sikkerheden af CIALIS hos patienter med svær leverinsufficiens (Child-Pugh klasse C).
English: The table below lists the adverse reactions observed from spontaneous reporting and in placebocontrolled clinical trials (comprising a total of 8022 patients on CIALIS and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.
Danish: Nedenstående tabel angiver observerede bivirkninger fra spontane indberetninger samt fra placebokontrollerede kliniske studier (omfattende i alt 8.022 patienter på Cialis og 4.422 patienter på placebo) ved behandling af erektil dysfunktion (dosering ved behov eller én gang daglig) og benign prostatahyperplasi (dosering én gang daglig).
English: A medical history and physical examination should be undertaken to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying causes, before pharmacological treatment is considered.
Danish: En anamnese bør optages og en fysisk undersøgelse bør foretages for at diagnosticere erektil dysfunktion eller benign prostatahyperplasi og bestemme potentielle tilgrundliggende årsager, før farmakologisk behandling overvejes.
English: Other medicines and CIALIS Tell your doctor if you are taking, have recently taken or might take any other medicines
Danish: Brug af anden medicin sammen med CIALIS Fortæl det til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Transporters
Danish: Transportproteiner
English: Tadalafil is > 10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.
Danish: Tadalafil er > 10.000 gange mere potent overfor PDE5 end for PDE3, som er et enzym, der findes i hjerte og blodkar.