FrancophonIA/ELRC3.0 huggingface dataset:
English: CIALIS was studied in 4 clinical studies of 12 weeks duration enrolling over 1500 patients with signs and symptoms of benign prostatic hyperplasia.
Danish: CIALIS blev undersøgt i 4 kliniske studier, som varede i 12 uger og inkluderede over 1.500 patienter med tegn og symptomer på benign prostatahyperplasi.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Lilly S.A., Avda.
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Lilly S.A., Avda.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIPS BLISTER
English: Some men taking CIALIS in clinical studies have reported dizziness.
Danish: Nogle mænd, der fik CIALIS i kliniske studier, rapporterede om svimmelhed.
English: This finding is consistent with the low affinity of tadalafil for PDE6 compared to PDE5.
Danish: Dette resultat er i overensstemmelse med tadalafils lave affinitet for PDE6 sammenlignet med PDE5.
English: The randomised, double-blind, placebo-controlled, parallel, 3-arm study of tadalafil was conducted in 331 boys aged 7-14 years with DMD receiving concurrent corticosteroid therapy.
Danish: Det randomiserede, dobbeltblinde, placebokontrollerede studie med 3 parallelle arme blev gennemført hos 331 drenge med DMD i alderen 7-14 år, som samtidig fik kortikosteroid.
English: Blurred vision, Sensations described as eye pain
Danish: Sløret syn Fornemmelse beskrevet som øjensmerte
English: In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha blockers -see above-) is, in general, minor and not likely to be clinically relevant.
Danish: Hos patienter, som får samtidig antihypertensiv medicin, kan tadalafil 20 mg inducere blodtryksfald, som (med undtagelse af alfa-blokkere -se ovenfor-) sædvanligvis er af mindre størrelsesorden og sandsynligvis ikke er klinisk relevant.
English: Healthy elderly subjects (65 years or over), had a lower oral clearance of tadalafil, resulting in 25 % higher exposure (AUC) relative to healthy subjects aged 19 to 45 years.
Danish: Raske ældre forsøgspersoner (65 år eller derover) udviste en lavere clearance af tadalafil efter oral indgift, hvilket resulterede i en 25% højere eksponering (AUC) end hos raske forsøgspersoner mellem 19 og 45 år.
English: This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection.
Danish: Dette medfører afslapning af den glatte muskulatur og tilstrømning af blod til de penile væv, hvorved erektionen fremkommer.
English: CIALIS, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Danish: CIALIS bør anvendes med forsigtighed hos patienter med anatomisk deformation af penis (såsom vinkling, kavernøs fibrose eller Peyronies sygdom) eller hos patienter, som på grund af deres tilstand kan være disponerede for priapisme (såsom seglcelleanæmi, myelomatose eller leukæmi).
English: (2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.
Danish: (2) Bivirkninger rapporteret efter markedsføring, ikke set i placebo-kontrollerede kliniske studier.
English: CIALIS and other treatments for erectile dysfunction The safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Danish: CIALIS og andre behandlinger for erektil dysfunktion Sikkerheden og virkningen af kombinationer af CIALIS og andre PDE5-hæmmere eller andre behandlinger for erektil dysfunktion er ikke undersøgt.
English: Tadalafil (10 mg except for studies with angiotensin II receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes.
Danish: Tadalafil (10 mg, undtagen i undersøgelser med angiotensin II blokkere og amlodipin, hvor en 20 mg dosis blev anvendt) havde ingen klinisk signifikant interaktion med nogle af disse klasser.
English: CIALIS contains lactose.
Danish: CIALIS indeholder lactose.
English: Cases of sudden hearing loss have been reported after the use of tadalafil.
Danish: Der er rapporteret tilfælde af pludseligt høretab efter brug af tadalafil.
English: In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7 - 18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.
Danish: Hos hunde, som fik tadalafil dagligt i 6 til 12 måneder i doser på 25 mg/kg/dag (hvilket resulterer i en mindst 3 gange større eksponering (fra 3,7 til 18,6) end den, som ses hos mennesker ved en enkelt dosis på 20 mg) og højere, sås regression af det seminiferøse tubulære epithel, som medførte nedsat spermatogenese hos nogle hunde.
English: Heart attack and stroke have also been reported rarely in men taking CIALIS.
Danish: Hjertetilfælde og slagtilfælde er også set sjældent hos mænd, som tager CIALIS.
English: - medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
Danish: - Medicin, som f.eks. ketoconazoltabletter (til behandling af svampeinfektioner) og protease hæmmere til behandling af aids eller hiv-infektion.
English: - other medicines to treat high blood pressure.
Danish: - Anden medicin mod for højt blodtryk.
English: Effects of tadalafil on other medicinal products
Danish: Tadalafils virkning på andre lægemidler
English: The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med CIALIS i alle undergrupper af den pædiatriske population med erektil dysfunktion (se pkt.
English: Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.
Danish: Selvom andre risikofaktorer i nogle tilfælde er tilstede (såsom alder, diabetes, hypertension og høretab i anamnesen) skal patienten, i tilfælde af pludseligt opstået høretab, informeres om at stoppe med at tage tadalafil og straks søge lægehjælp.
English: Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
Danish: Prækliniske studier viste en additiv systemisk blodtrykssænkende virkning, når PDE5-hæmmere blev kombineret med riociguat.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Læs indlægssedlen før brug.
English: If you experience sudden decrease or loss of vision, stop taking CIALIS and contact your doctor immediately.
Danish: Hvis du oplever en pludselig nedsættelse af synet eller tab af synet, skal du stoppe med at tage CIALIS og straks kontakte din læge.
English: The overall safety results from this study were generally consistent with the known safety profile of tadalafil and with adverse events (AEs) expected in a paediatric DMD population receiving corticosteroids.
Danish: De samlede resultater vedrørende sikkerhed var generelt i overenstemmelse med den kendte sikkerhedsprofil for tadalafil og med bivirkninger, som kan forventes i en pædiatrisk DMD-population, som får kortikosteroider.
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 CIALIS 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 CIALIS og omgående konsultere en læge, hvis der pludseligt opstår synsdefekt (se pkt.
English: BATCH NUMBER Lot.
Danish: FREMSTILLERENS BATCHNUMMER Lot.
English: Alcohol concentrations (mean maximum blood concentration 0.08 %) were not affected by coadministration with tadalafil (10 mg or 20 mg).
Danish: Alkoholkoncentrationer (gennemsnitlige maksimum koncentration i blodet 0,08%) blev ikke påvirket ved samtidig administration af tadalafil (10 mg eller 20 mg).
English: Elderly men
Danish: Ældre mænd
English: Protein binding is not affected by impaired renal function.
Danish: Proteinbindingen påvirkes ikke ved nedsat nyrefunktion.
English: There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.
Danish: Der er ingen data om administration af doser højere end 10 mg tadalafil hos patienter med nedsat leverfunktion.
English: Also, patients with erectile dysfunction in all severity categories reported improved erections whilst taking CIALIS (86 %, 83 %, and 72 % for mild, moderate, and severe, respectively, as compared to 45 %, 42 %, and 19 % with placebo).
Danish: Desuden rapporterede patienter med erektil dysfunktion i alle sværhedsgrader forbedrede erektioner, når de tog CIALIS (86%, 83% og 72% for henholdsvis mild, moderat og svær i forhold til 45%, 42% og 19% for placebo).
English: This will be given as a 2.5mg tablet.
Danish: Denne vil blive givet som én 2,5 mg tablet.
English: Visual defects and cases of NAION have been reported in connection with the intake of CIALIS and other PDE5 inhibitors.
Danish: Der er rapporteret synsdefekter og tilfælde af NAION i forbindelse med indtagelse af CIALIS og andre PDE5-hæmmere.
English: Dose adjustments are not required in patients with mild to moderate renal impairment.
Danish: Dosisjustering er ikke påkrævet for patienter med let til moderat nedsat nyrefunktion.
English: Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose.
Danish: Baseret på resultater fra et klinisk studie, hvor 150 forsøgspersoner daglig modtog 20 mg tadalafil i 7 dage og 0,4 mg nitroglycerin sublingualt på forskellige tidspunkter, varede denne interaktion mere end 24 timer og var ikke længere målbar, når der var gået 48 timer efter sidste tadalafil dosis.
English: Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Danish: Papendorpseweg 83 3528 BJ Utrecht Holland
English: Nitrates
Danish: Nitrater
English: Drinking alcohol may affect your ability to get an erection.
Danish: Hvis du drikker alkohol, kan det påvirke din evne til at få en erektion.
English: The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment.
Danish: Evaluering af erektil dysfunktion bør inkludere en bestemmelse af potentielle tilgrundliggende årsager og en identifikation af den relevante behandling på baggrund af en relevant medicinsk vurdering.
English: In study subjects whose blood pressure was not controlled, the reduction was greater although this reduction was not associated with hypotensive symptoms in the majority of subjects.
Danish: Hos forsøgspersoner, som ikke fik blodtrykskontrollerende lægemidler, var reduktionen af blodtrykket større, dog var reduktionen ikke forbundet med hypotensive symptomer hos størstedelen af forsøgspersonerne.
English: Abdominal pain, Vomiting, Nausea, Gastro-oesophageal reflux
Danish: Abdominal-smerter, Opkastning, Kvalme, Gastro-øsofageal reflukssygdom
English: CIALIS is not indicated for use by women.
Danish: CIALIS er ikke indiceret til anvendelse hos kvinder.
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: CIALIS is a treatment for adult men with erectile dysfunction.
Danish: CIALIS er en behandling til voksne mænd med erektil dysfunktion.
English: Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Danish: Tadalafil er også > 10.000 gange mere potent overfor PDE5 end for PDE7-PDE10.
English: This metabolite is at least 13,000-fold less potent than tadalafil for PDE5.
Danish: Denne metabolit er mindst 13.000 gange mindre potent overfor PDE5 end tadalafil.
English: This drug is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots).
Danish: Dette lægemiddel bruges til at behandle pulmonal arteriel hypertension (højt blodtryk i lungerne) og kronisk tromboembolisk pulmonal hypertension (højt blodtryk i lungerne som følge af blodpropper).
English: Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited.
Danish: Data for patienter over 65 år, som har fået tadalafil i kliniske studier enten for behandling af erektil dysfunktion eller benign prostatahyperplasi, er begrænsede.
English: In clinical studies, tadalafil (5, 10 and 20 mg) was shown to augment the hypotensive effects of nitrates.
Danish: Det er i kliniske studier vist, at tadalafil (5, 10 og 20 mg) forstærker den hypotensive effekt af nitrater.
English: CYP2C9 substrates (e.g. R-warfarin)
Danish: CYP2C9-substrater (f.eks. R-warfarin)
English: It may be taken at least 30 minutes prior to sexual activity.
Danish: Tabletten tages mindst 30 minutter før seksuel aktivitet.
English: The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is also observed in the smooth muscle of the prostate, the bladder and their vascular supply.
Danish: Effekten af PDE5-hæmning på cGMP-koncentrationen i corpus cavernosum er også observeret i den glatte muskulatur i prostata, blære og de tilførende kar.
English: In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood-pressure control.
Danish: Hos forsøgspersoner i behandling med flere antihypertensiva viste ændringerne i det ambulatoriske blodtryk sig at relatere sig til graden af blodtrykskontrol.
English: The resulting vascular relaxation increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia are reduced.
Danish: Den resulterende vaskulære afslapning øger blodgennemstrømningen, og det kan være denne mekanisme, som medfører reducerede symptomer ved benign prostatahyperplasi.
English: Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to CIALIS, before driving or using machines.
Danish: Selvom hyppigheden af rapporter omhandlende svimmelhed var ens i placebo- og tadalafil-armene i de kliniske studier, bør patienterne være opmærksomme på, hvordan de reagerer på CIALIS, før de fører bil eller betjener maskiner.
English: Tadalafil (10 mg and 20 mg) had no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin (CYP2C9 substrate), nor did tadalafil affect changes in prothrombin time induced by warfarin.
Danish: Tadalafil (10 mg og 20 mg) havde ingen klinisk signifikant effekt på eksponeringen (AUC) for Swarfarin eller R-warfarin (CYP2C9 substrat), og tadalafil påvirkede heller ikke ændringer i protrombintiden induceret af warfarin.
English: Tadalafil (10 mg and 20 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid.
Danish: Tadalafil (10 mg og 20 mg) forstærkede ikke forlængelsen af blødningstiden, forårsaget af acetylsalicylsyre.
English: In patients who are taking alpha1 blockers, concomitant administration of CIALIS may lead to symptomatic hypotension in some patients (see section 4.5).
Danish: Hos patienter, som er i behandling med alfa1-blokkere, kan samtidig indgift af CIALIS give anledning til symptomatisk hypotension hos visse patienter (se pkt.
English: What you need to know before you take CIALIS Do not take CIALIS if you: - are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage CIALIS Tag ikke CIALIS, hvis du: - Er allergisk overfor tadalafil eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: - are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
Danish: - Er allergisk overfor tadalafil eller et af de øvrige indholdsstoffer i dette lægemiddel(angivet i punkt 6).
English: Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.
Danish: Lægen bør overveje den potentielle risiko for hjerteproblemer som følge af seksuel aktivitet hos patienter med eksisterende hjerte-/karsygdom.
English: Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance (6MWD) endpoint: least squares (LS) mean change in 6MWD at 48 weeks was -51.0 meters (m) in the placebo group, compared with -64.7 m in the tadalafil 0.3 mg/kg group (p = 0.307) and -59.1 m in the tadalafil 0.6 mg/kg group (p = 0.538).
Danish: Tadalafil viste ingen effekt på at forsinke nedgangen i mobilitet, målt ved 6 minutters gangtest (6MWD), som var det primære endepunkt: Den gennemsnitlige ændring i 6MWD efter 48 uger, bestemt ved mindste kvadraters metode (LS), var 51,0 meter i placebogruppen, sammenlignet med 64,7 meter i tadalafilgruppen med 0,3 mg/kg (p = 0,307) og 59,1 meter i tadalafilgruppen med 0,6 mg/kg (p = 0,538).
English: Tadalafil has no effect in the absence of sexual stimulation.
Danish: Tadalafil har ingen effekt uden seksuel stimulation.
English: In one of the studies, which also included tamsulosin 0.4 mg as an active comparator, the improvement in total international prostate symptom score with CIALIS 5mg, tamsulosin and placebo were -6.3, -5.7 and -4.2 respectively.
Danish: I et af studierne, som også omfattede tamsulosin 0,4 mg som aktiv komparator, var forbedringen i den totale international prostate symptom score med CIALIS 5 mg, tamsulosin og placebo henholdsvis -6,3, -5,7 og -4,2.
English: Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain.
Danish: En lignende øgning kan forventes ved oral administration af terbutalin, selvom den kliniske konsekvens heraf er usikker.
English: The study included a 48-week double-blind period where patients were randomised to tadalafil 0.3 mg/kg, tadalafil 0.6 mg/kg, or placebo daily.
Danish: Studiet havde en 48-ugers dobbeltblind periode, hvor patienterne blev randomiseret til at få en daglig dosis tadalafil på 0,3 mg/kg eller 0,6 mg/kg eller placebo.
English: In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure decrease.
Danish: Hos patienter, der er i samtidig behandling med antihypertensiva, kan tadalafil fremme et fald i blodtrykket.
English: Additionally, tadalafil is approximately 700-fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction.
Danish: Tadalafil er tilmed ca. 700 gange mere potent overfor PDE5 end for PDE6, som er et enzym, der findes i retina, og som er ansvarlig for fototransduktionen.
English: Tadalafil (20 mg) did not augment the mean blood pressure decrease produced by alcohol (0.7 g/kg or approximately 180 ml of 40 % alcohol [vodka] in an 80-kg male) but in some subjects, postural dizziness and orthostatic hypotension were observed.
Danish: Tadalafil (20 mg) forstærkede ikke den gennemsnitlige blodtrykssænkning forårsaget af alkohol (0,7 g/kg eller ca. 180 ml 40% alkohol [vodka] til en mand på 80 kg), men hos nogle forsøgspersoner blev der observeret ortostatisk svimmelhed og ortostatisk hypotension.
English: Since benign prostatic hyperplasia and prostate cancer may have the same symptoms, your doctor will check you for prostate cancer before starting treatment with CIALIS for benign prostatic hyperplasia.
Danish: Da godartet forstørrelse af blærehalskirtlen og kræft i blærehalskirtlen (prostatakræft) kan have de samme symptomer, vil din læge undersøge dig for kræft i blærehalskirtlen, før du begynder behandlingen med CIALIS for godartet forstørrelse af blærehalskirtlen.
English: Haemodialysis contributes negligibly to tadalafil elimination.
Danish: Hæmodialyse bidrager ubetydeligt til elimination af tadalafil.
English: • Drinking alcohol may affect your ability to get an erection so avoid excessive drinking with CIALIS.
Danish: • Indtagelse af alkohol kan påvirke din evne til at få erektion, så undgå overdrevent alkoholindtag, når du tager CIALIS.
English: - phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
Danish: - Phenobarbital, phenytoin og carpamazepin (mod krampeanfald).
English: Before taking the tablets, tell your doctor if you have: - sickle cell anaemia (an abnormality of red blood cells).
Danish: Inden du begynder at tage tabletterne, skal du tale med din læge, hvis du har: - Seglcelleanæmi (abnorme røde blodceller).
English: The recommended dose is 5 mg, taken at approximately the same time every day with or without food.
Danish: Den anbefalede dosis er 5 mg, som skal tages på omtrent samme tidspunkt hver dag med eller uden mad.
English: Patients who are unable to tolerate tadalafil 5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil 2.5mg for the treatment of benign prostatic hyperplasia has not been demonstrated.
Danish: For de patienter, som ikke tolererer tadalafil 5 mg for behandling af benign prostatahyperplasi, skal anden behandling overvejes, da virkningen af tadalafil 2,5 mg til behandling af benign prostatahyperplasi ikke er vist.
English: LIST OF EXCIPIENTS lactose
Danish: LISTE OVER HJÆLPESTOFFER lactose
English: In the primary efficacy studies of general populations, 81 % of patients reported that CIALIS improved their erections as compared to 35 % with placebo.
Danish: I de primære undersøgelser af effekt hos den generelle population rapporterede 81% af patienterne, at CIALIS forbedrede deres erektion, i forhold til 35% for placebo.
English: Erectile dysfunction in adult men
Danish: Erektil dysfunktion hos voksne mænd
English: Use with CYP3A4 inhibitors
Danish: Samtidig brug af CYP3A4-inhibitorer
English: Prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions (see section 4.3).
Danish: Før behandling af benign prostatahyperplasi med tadalafil påbegyndes, skal patienten undersøges for at udelukke tilstedeværelse af prostatakarcinom og grundigt vurderes for kardiovaskulære tilstande (se pkt.
English: Effects of other substances on tadalafil
Danish: Andre lægemidlers virkning på tadalafil
English: - removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non nerve-sparing prostatectomy).
Danish: - Har fået fjernet hele eller dele af blærehalskirtlen, og nerverne til blærehalskirtlen derved er blevet skåret over (radikal ikke-nervebevarende prostatektomi).
English: Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
Danish: Tadalafil 10 og 20 mg er tiltænkt brug før forventet seksuel aktivitet og anbefales ikke til vedvarende daglig brug.