FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance (6MWD).
Danish: Det primære endepunkt var ændring i 6 minutters gangdistancen (6MWD) fra baseline ved uge 16.
English: If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Danish: Hvis der ordineres tadalafil, bør der foretages en omhyggelig benefit/risk vurdering af den ordinerende læge.
English: - sudden loss of vision (rarely reported).
Danish: - Pludseligt opstået synstab (hyppighed: Sjælden).
English: - are allergic to tadalafil or any of the other ingredients (see section 6).
Danish: - Hvis du er allergisk overfor tadalafil eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Syncope, Migraine5
Danish: Synkope Migræne5
English: There are limited data from the use of tadalafil in pregnant women.
Danish: Data for anvendelse af tadalafil til gravide er begrænsede.
English: Not known1
Danish: Ikke kendt1
English: What you need to know before you take ADCIRCA
Danish: Det skal du vide, før du begynder at tage ADCIRCA
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid ADCIRCA nøjagtigt efter lægens anvisning.
English: In patients with pulmonary hypertension not receiving concomitant bosentan, the average tadalafil exposure at steady-state following 40 mg was 26 % higher when compared to those of healthy volunteers.
Danish: Hos patienter med PAH, der ikke samtidig fik bosentan, var den gennemsnitlige tadalafileksponering ved steady-state efter indtagelse af 40 mg 26 % højere sammenlignet med raske frivillige.
English: Oral contraceptive pill
Danish: Oral kontraception
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ADCIRCA in one or more subsets of the paediatric population in the treatment of pulmonary arterial hypertension (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med ADCIRCA i en eller flere undergrupper af den pædiatriske population ved behandling af pulmonal arteriel hypertension (PAH) (se pkt.
English: Although other risk factors were present in some cases (such as age, diabetes, hypertension, previous hearing loss history and associated connective tissue diseases) patients should be advised to 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, høretab i anamnesen og tilhørende bindevævssygdomme) skal patienten, i tilfælde af pludseligt opstået høretab, informeres om straks at søge lægehjælp.
English: In the pivotal placebo-controlled study of ADCIRCA for the treatment of PAH, a total of 323 patients were treated with ADCIRCA at doses ranging from 2.5 mg to 40 mg once daily and 82 patients were treated with placebo.
Danish: I det pivotale placebo-kontrollerede studie med ADCIRCA til behandling af PAH blev i alt 323 patienter behandlet med ADCIRCA i daglige doser fra 2,5 mg til 40 mg, og 82 patienter blev behandlet med placebo.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddelA findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: ADCIRCA is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).
Danish: ADCIRCA er indiceret til behandling af voksne med pulmonal arteriel hypertension (PAH) klassificeret som WHO's funktionsklasse II og III, til forbedring af det fysiske funktionsniveau (se pkt.
English: Physicians should carefully consider whether their patients with certain underlying conditions, such as severe left ventricular outflow obstruction, fluid depletion, autonomic hypotension or patients with resting hypotension, could be adversely affected by such vasodilatory effects.
Danish: Lægerne bør nøje overveje, om de af deres patienter, der lider af visse underliggende sygdomme, såsom svær obstruktion i udløbet fra venstre ventrikel, væskemangel, hypotension, herunder autonom hypotension, kan påvirkes ugunstigt af en sådan vasodilatatorisk effekt.
English: Tadalafil 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: Tadalafil bør anvendes med forsigtighed hos patienter med anatomisk deformation af penis (såsom vinkling, kavernøs fibrose eller Peyronies sygdom) og hos patienter, som kan være disponerede for priapisme (såsom patienter med seglcelleanæmi, myelomatose eller leukæmi).
English: The efficacy and safety of tadalafil co-administered with prostacyclin or its analogues has not been studied in controlled clinical studies.
Danish: Virkning og sikkerhed af tadalafil givet sammen med prostacyclin eller dets analoger er ikke undersøgt i kontrollerede kliniske studier.
English: Drinking alcohol may temporarily lower your blood pressure.
Danish: Dit blodtryk kan sænkes midlertidigt, hvis du drikker alkohol.
English: Improvements compared to placebo were observed with tadalafil 40 mg in the EuroQol (EQ-5D) US and UK index scores comprising mobility, self-care, usual activities, pain/discomfort, anxiety/depression components, and in the visual analogue scale (VAS).
Danish: Forbedringer i forhold til placebo blev set med tadalafil 40 mg i EuroQol (EQ-5D) US og UK indeks score omfattende mobilitet, self-care, almindelige aktiviteter, smerte/ubehag, angst/depressionstegn og på den visuelle analogskala (VAS).
English: - rifampicin (to treat bacterial infections) - ketoconazole tablets (to treat fungal infections) - ritonavir (for HIV treatment) - tablets for erectile dysfunction (PDE5 inhibitors).
Danish: - rifampicin (til behandling af bakterieinfektioner) - ketoconazol-tabletter (til behandling af svampeinfektioner) - ritonavir (HIV-behandling) - tabletter for problemer med potensen (PDE5-hæmmere).
English: Currently available data are described in section 5.1.
Danish: De foreliggende data er beskrevet i pkt.
English: Tadalafil did not affect the exposure (AUC and Cmax) of bosentan or its metabolites.
Danish: Tadalafil påvirker ikke bosentans eller dets metabolitters eksponering (AUC og Cmax).
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 tilgængelige data for indtagelse af doser højere end 10 mg tadalafil hos patienter med nedsat leverfunktion.
English: Patients were at least 12 years of age and had a diagnosis of PAH that was idiopathic, related to collagen disease, related to anorexigen use, related to human immunodeficiency virus (HIV) infection, associated with an atrial-septal defect, or associated with surgical repair of at least 1 year in duration of a congenital systemic-to-pulmonary shunt (for example, ventricular septal defect, patent ductus arteriosus).
Danish: Patienterne, der indgik, var mindst 12 år og havde en PAH-diagnose, som var enten idiopatisk, relateret til kollagensygdom, relateret til brug af anoreksika, relateret til human immundefekt virus (HIV) infektion, associeret med atrieseptumdefekt eller associeret med kirurgisk behandling af medfødt systemisk til pulmonal shunt af mindst et års varighed (for eksempel ventrikulær septumdefekt, ductus arteriosus persistens).
English: Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Danish: Indehaver af markedsføringstilladelse: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.
English: There was no statistically significant effect of tadalafil on levonorgestrel which suggests the effect of ethinylestradiol is due to inhibition of gut sulphation by tadalafil.
Danish: Der sås ingen statistisk signifikant virkning af tadalafil på levonorgestrel, hvilket antyder, at virkningen af ethinylestradiol skyldes hæmning af sulfoneringen af tadalafil i tarmen.
English: - have ever had loss of vision - a condition described as “stroke of the eye” (non-arteritic anterior ischemic optic neuropathy - NAION).
Danish: - Hvis du på noget tidspunkt tidligere har haft synstab - en tilstand beskrevet som en ”blodprop i øjet” (non-arteritis anterior iskæmisk opticusneuropati - NAION).
English: CYP2C9 substrates (e.g.R-warfarin)
Danish: CYP2C9- substancer (f.eks.R-warfarin)
English: Tell your doctor or pharmacist if you are already taking: - bosentan (another treatment for pulmonary aterial hypertension) - nitrates (for chest pain) - alpha blockers used to treat high blood pressure or prostate problems.
Danish: Tal med lægen eller apotekspersonalet, hvis du allerede tager: - bosentan (en anden behandling for pulmonal arteriel hypertension) - nitrater (for brystsmerter) - alfa-blokkere til behandling af for højt blodtryk eller prostataproblemer - riociguat.
English: A similar increase in AUC and Cmax seen with ethinylestradiol may be expected with oral administration of terbutaline, probably due to inhibition of gut sulphation by tadalafil.
Danish: En tilsvarende øgning af AUC og Cmax, som sås med ethinylestradiol, må forventes ved oral behandling med terbutalin, sandsynligvis på grund af hæmning af tarmsulfoneringen af tadalafil.
English: In patients taking multiple antihypertensive medicinal products whose hypertension was not well controlled, greater reductions in blood pressure were observed compared to patients whose blood pressure was well controlled, where the reduction was minimal and similar to that in healthy subjects.
Danish: Der sås et større blodtryksfald hos patienter, som tog flere antihypertensiva, uden at hypertensionen var velkontrolleret, sammenlignet med personer, hvis blodtryk var velkontrolleret, hvor blodtryksfaldet var minimalt og svarende til det, der sås hos raske personer.
English: P-glycoprotein substrates (e.g. digoxin) Tadalafil (40 mg once per day) had no clinically significant effect on the pharmacokinetics of digoxin.
Danish: P-glykoprotein substancer (f.eks. digoxin) Tadalafil (40 mg en gang daglig) havde ingen klinisk signifikat virkning på digoxins farmakokinetik.
English: ADCIRCA contains the active substance tadalafil.
Danish: ADCIRCA indeholder det aktive stof tadalafil.
English: The table below lists the adverse reactions reported during the placebo-controlled clinical study in patients with PAH treated with ADCIRCA.
Danish: I tabellen nedenfor er angivet de bivirkninger, der er rapporteret i det placebo-kontrollerede kliniske studie med PAH-patienter, der blev behandlet med ADCIRCA.
English: Avda de la Industria 30 28108 Alcobendas (Madrid) Spain
Danish: de la Industria 30 28108 Alcobendas, Madrid Spanien.
English: - Patients with clinically significant aortic and mitral valve disease - Patients with pericardial constriction - Patients with restrictive or congestive cardiomyopathy - Patients with significant left ventricular dysfunction - Patients with life-threatening arrhythmias - Patients with symptomatic coronary artery disease - Patients with uncontrolled hypertension.
Danish: - Patienter med klinisk signifikant aorta- og mitralklapsygdom - Patienter med perikardial konstriktion - Patienter med restriktiv eller dilateret kardiomyopati - Patienter med betydelig venstre ventrikel dysfunktion - Patienter med livstruende arytmier - Patienter med symptomatisk koronararteriesygdom - Patienter med ukontrolleret hypertension
English: Haematuria Reproductive system and breast disorders Increased uterine bleeding4
Danish: Det reproduktive system og mammae Øget uterin blødning4
English: Unstable angina pectoris, Ventricular arrhythmia, Myocardial Infarction2
Danish: Ustabil angina pectoris, ventrikulær arytmi, myokardieinfarkt2
English: Terbutaline
Danish: Terbutalin
English: ADCIRCA should not be used during breast feeding.
Danish: ADCIRCA bør ikke anvendes under amning.
English: PDE5 is the predominant phosphodiesterase in the pulmonary vasculature.
Danish: PDE5 er den dominerende phosphodiesterase i pulmonale blodkar.
English: Posology The recommended dose is 40 mg (2 x 20 mg) taken once daily with or without food.
Danish: Dosering Den anbefalede dosis er 40 mg (2x20 mg) en gang daglig taget enten med eller uden mad.
English: Tadalafil 40 mg increased cardiac output (0.6 L/min) and reduced pulmonary artery pressures (-4.3 mmHg) and pulmonary vascular resistance (-209 dyn.s/cm5) compared to baseline (p<0.05).
Danish: Tadalafil 40 mg forøgede det kardielle output (0,6 l/min) og reducerede det pulmonale arterietryk (-4,3 mmHg) og den pulmonale vaskulære modstand (-209dyn.s/cm5) sammenlignet med baseline (p<0,05).
English: OTHER Mon, Tue, Wed, Thu, Fri, Sat, Sun.
Danish: ANDET Man., Tirs., Ons., Tors., Fre., Lør., Søn.
English: The incidence of clinical worsening by week 16 in patients treated with tadalafil 40 mg (5 %; 4 of 79 patients) was less than placebo (16 %; 13 of 82 patients).
Danish: Hyppigheden af klinisk forværring i uge 16 var lavere hos patienter, der blev behandlet med tadalafil 40 mg (5 %; 4 af 79 patienter), end for placebogruppen (16 %; 13 ud af 82 patienter).
English: - any heart problems other than your pulmonary hypertension - problems with your blood pressure - any hereditary eye disease - an abnormality of red blood cells (sickle cell anaemia) - cancer of the bone marrow (multiple myeloma) - cancer of the blood cells (leukaemia) - any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours - a serious liver problem - a serious kidney problem.
Danish: - andre hjerteproblemer end din pulmonale hypertension - problemer med dit blodtryk - en arvelig øjensygdom - unormale røde blodlegemer (seglcelleanæmi) - knoglemarvskræft (myelomatose) - blodkræft (leukæmi) - nogen form for deformitet af penis eller uønskede eller vedvarende erektioner, som varer i mere end 4 timer - alvorlige problemer med din lever - alvorlige problemer med dine nyrer
English: Chest pain2 (1) Events not reported in registration studies and cannot be estimated from the available data.
Danish: (1) Hændelser, der ikke blev rapporteret i de kliniske registreringsstudier, og som ikke kan estimeres ud fra forhåndenværende data.
English: Visual defects and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
Danish: Der er rapporteret synsdefekter og tilfælde af NAION i forbindelse med indtagelse af tadalafil og andre PDE5-hæmmere.
English: The safety and efficacy of combinations of tadalafil and other endothelin-1 receptor antagonists have not been studied.
Danish: Sikkerhed og virkning af kombination af tadalafil og andre endotelin 1receptorantagonister er ikke undersøgt.
English: Three hundred and fifty seven (357) patients who completed the pivotal study entered a long-term extension study.
Danish: 357 personer, som fuldførte det pivotale studie, indgik i et langtids-forlængelses-studie.
English: - are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.
Danish: - Hvis du tager nogen form for nitrater såsom amylnitrit, som bruges til behandling af brystsmerter (angina pectoris).
English: Alcohol concentrations were not affected by co-administration with tadalafil (10 mg or 20 mg).
Danish: Alkoholkoncentrationer blev ikke påvirket ved samtidig administration af tadalafil (10 mg eller 20 mg).
English: In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of doxazosin -see above) is, in general, minor and not likely to be clinically relevant.
Danish: adalafil 20 mg givet til patienter i samtidig behandling med antihypertensiva inducerer et blodtryksfald, der (med undtagelse af doxazosin, se ovenfor) generelt er lille og sandsynligvis ikke er klinisk relevant.
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: Due to limited clinical experience in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), following single doses of 10 mg, a starting dose of 20 mg once per day may be considered.
Danish: På grund af begrænset klinisk erfaring hos patienter med mild til moderat levercirrose (Child-Pugh klasse A og B) kan en startdosis på 20 mg en gang daglig overvejes efter enkelt-doser på 10 mg.
English: Additionally, improvements compared to placebo were observed with tadalafil 40 mg in the physical functioning, role-physical, bodily pain, general health, vitality and social functioning domains of the SF-36.
Danish: Ydermere blev der i forhold til placebo fundet forbedringer med tadalafil 40 mg i SF-36-domænerne vedrørende fysisk funktion, fysisk rolle, legemssmerter, generel sundhed, vitalitet og social funktion.
English: Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5.
Danish: In vitro undersøgelser har vist, at tadalafil er en selektiv hæmmer af PDE5.
English: The safety and efficacy of ADCIRCA in the paediatric population has not yet been established.
Danish: ADCIRCAs sikkerhed og virkning hos den pædiatriske population er endnu ikke klarlagt.
English: Cytochrome P450 Inducers
Danish: Cytochrom P450-induktorer
English: Only tadalafil 40 mg achieved the protocol defined level of significance with a placeboadjusted median increase in 6MWD of 26 metres (p=0.0004; 95 % CI: 9.5, 44.0; Pre-specified Hodges-Lehman method) (mean 33 metres, 95 % CI: 15.2, 50.3).
Danish: Kun tadalafil 40 mg opnåede det signifikansniveau, der var defineret i protokollen, med en placebokorrigeret gennemsnitlig stigning i 6MWD på 26 meter (p=0,0004; 95 % CI: 9,5-44,0; Præspecificeret Hodges-Lehman metode) (gennemsnit 33 meter, 95 % CI: 15,2-50,3).
English: Nervous system disorders Headache6
Danish: Nervesystemet Hovedpine6
English: The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Danish: Sikkerheden og virkningen af kombinationer af tadalafil og andre PDE5-hæmmere eller andre behandlinger for erektil dysfunktion er ikke undersøgt.
English: Doses studied were 20 mg and 40 mg once daily.
Danish: Doserne, der indgik, var mellem 20 mg og 40 mg en gang daglig.
English: If you take more ADCIRCA than you should If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you.
Danish: Hvis du eller andre har taget flere tabletter, end du eller de skulle, skal du kontakte din læge eller tage på skadestuen med det samme.
English: Vomiting, Gastroesophageal reflux
Danish: Opkastninger, gastro-øsofageal reflukssygdom
English: Papendorpseweg 83, 3528 BJ Utrecht The Netherlands
Danish: Papendorpseweg 83 3528 BJ Utrecht Holland.
English: (5) The adverse reactions have been included in the table as a result of postmarketing or clinical study data from the use of tadalafil in the treatment of erectile dysfunction; and in addition, the frequency estimates are based on only 1 or 2 patients experiencing the adverse reaction in the pivotal placebocontrolled study of ADCIRCA.
Danish: (5) Bivirkningerne i tabellen er data fra postmarketing eller kliniske studier, hvor tadalafil blev brugt til behandling af erektil dysfunktion, og i tillæg hertil er frekvensestimatet baseret på kun 1 eller 2 patienters oplevelse af disse bivirkninger i det pivotale placebo-kontrollerede studie med ADCIRCA.
English: (4) Clinical non-MedDRA term to include reports of abnormal/excessive menstrual bleeding conditions such as menorrhagia, metrorrhagia, menometrorrhagia, or vaginal hemorrhage.
Danish: (4) Kliniske ikke-MedDRA-termer inkluderer unormale/voldsomme tilstande relateret til menstruationsblødninger, såsom menoragi, metroragi, menometroragi eller vaginal hæmoragi.
English: Azole Antifungals (e.g. ketoconazole)
Danish: Azolantimykotika (f.eks. ketoconazol)
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 det gennemsnitlige blodtryksfald 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: Non-arteritic anterior ischemic optic neuropathy (NAION), Retinal vascular occlusion, Visual field defect
Danish: Non-arteritis anterior iskæmisk opticusneuropati (NAION), vaskulær okklusion i retina, synsfeltsdefekt
English: Over a dose range of 2.5 to 20 mg, tadalafil exposure (AUC) increases proportionally with dose in healthy subjects.
Danish: I dosisområdet 2,5-20 mg tadalafil øges eksponeringen (AUC) proportionalt med dosis hos raske forsøgspersoner.
English: Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical studies, and use in these patients is not recommended.
Danish: Anvendelse til patienter med kendte medfødte degenerative retinasygdomme, inklusive retinitis pigmentosa, anbefales ikke, da disse patienter ikke var inkluderet i de kliniske studier.
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 after a 10 mg dose.
Danish: Raske ældre forsøgspersoner (65 år eller derover) udviste en lavere clearance af tadalafil efter oral indgift af en dosis på 10 mg, hvilket resulterede i en 25 % højere eksponering (AUC) end hos raske forsøgspersoner mellem 19 og 45 år.
English: ADCIRCA is supplied as a 20 mg tablet.
Danish: ADCIRCA findes som en 20 mg tablet.
English: Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations within the pulmonary vascular smooth muscle.
Danish: Pulmonal arteriel hypertension er forbundet med nedsat frigørelse af nitrogenoxid fra det vaskulære endotel, og en deraf følgende reduktion af cGMP- koncentrationen i den glatte muskulatur i pulmonale blodkar.
English: Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
Danish: Eksponeringen for tadalafil (AUC) hos forsøgspersoner med mild og moderat leverfunktionsnedsættelse (Child-Pugh klasse A og B) er sammenlignelig med eksponeringen hos raske forsøgspersoner ved administration af en dosis på 10 mg.
English: The most commonly reported adverse reactions, occurring in ≥ 10 % of patients in the tadalafil 40 mg treatment arm, were headache, nausea, back pain, dyspepsia, flushing, myalgia, nasopharingitis and pain in extremity.
Danish: De hyppigst rapporterede bivirkninger, som blev set hos ≥ 10 % af patienterne i behandlingsarmen med 40 mg tadalafil, var hovedpine, kvalme, rygsmerter, dyspepsi, rødmen, myalgi, nasopharyngitis og smerter i ekstremiteterne.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret ADCIRCA til dig personligt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg tadalafil.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 20 mg tadalafil.