FrancophonIA/ELRC3.0 huggingface dataset:
English: Ethinylestradiol and terbutaline
Danish: Ethinylestradiol og terbutalin
English: However, caution should be exercised when using tadalafil in patients treated with any alpha-blockers, and notably in the elderly.
Danish: Der bør dog udvises forsigtighed, når tadalafil anvendes til patienter i behandling med alfa-blokkere og særligt hos ældre.
English: You may experience side effects described in section 4.
Danish: Du kan muligvis få bivirkninger, som beskrevet i punkt 4.
English: Before treatment with CIALIS
Danish: Før behandling med CIALIS
English: CIALIS has been shown to improve these urinary symptoms as early as 1-2 weeks after starting treatment.
Danish: Det er vist, at CIALIS forbedrer disse urinvejssymptomer allerede 1-2 uger efter behandlingens start.
English: A. MANUFACTUR ER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: CIALIS tablets are for oral use in men only.
Danish: CIALIS-tabletterne er til oral brug og kun til mænd.
English: The time of dosing (morning versus evening) had no clinically relevant effects on the rate and extent of absorption.
Danish: Doseringstidspunktet (morgen versus aften) havde ingen klinisk relevante indvirkninger på hastigheden eller omfanget af absorptionen.
English: The improvements in total international prostate symptom score occurred as early as 1 week.
Danish: Forbedringen i den totale international prostate symptom score er set så tidligt som efter 1 uge.
English: However, you have been given the dose of one 20mg tablet as your doctor has decided that the recommended dose of 10mg is too weak.
Danish: Du har fået dog fået en dosis på én 20 mg tablet, fordi din læge har vurderet, at den anbefalede dosis på 10 mg er for svag.
English: The major circulating metabolite is the methylcatechol glucuronide.
Danish: Den væsentligste cirkulerende metabolit er methylcatecholglucoronid.
English: If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Danish: Hvis priapisme ikke behandles straks, kan det resultere i skader på det penile væv samt permanent impotens.
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: • Always take CIALIS exactly as your doctor has told you.
Danish: • Tag altid CIALIS nøjagtigt efter lægens anvisning.
English: Treatments should be initiated at minimal dosage and progressively adjusted.
Danish: Behandling bør initieres med minimal dosering og gradvist justeres.
English: The effect of alcohol on cognitive function was not augmented by tadalafil (10 mg).
Danish: Effekten af alkohol på den kognitive funktion blev ikke forstærket af tadalafil (10 mg).
English: - are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite.
Danish: - Tager nogen form for organisk nitrat eller nitrogenoxid-donorer såsom amylnitrit.
English: When dogs were treated there was reduced sperm development in the testes.
Danish: Når hunde blev behandlet, så man en nedsat udvikling af sædceller i testiklerne.
English: When the submission of a PSUR and the update of a RMP coincide, they should be submitted at the same time.
Danish: Når tidsfristen for fremsendelse af en PSUR er sammenfaldende med tidsfristen for opdatering af en RMP, kan de fremsendes samtidig.
English: This effect of age is not clinically significant and does not warrant a dose adjustment.
Danish: Denne alderseffekt er ikke klinisk signifikant og berettiger ikke en justering af dosis.
English: Therefore there is the potential of drug interactions mediated by inhibition of transporters.
Danish: Der er derfor mulighed for lægemiddelinteraktioner medieret ved inhibition af transportproteiner.
English: In addition, there was no evidence of efficacy from any of the secondary analyses performed in this study.
Danish: Ydermere blev der ikke påvist nogen effekt for de sekundære endepunkter i dette studie.
English: - any deformation of your penis.
Danish: - En hvilken som helst form for misdannelse af penis.
English: In the pregnant rat the AUC for calculated free drug 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 lægemiddel ved denne dosis ca. 18 gange større end den humane AUC ved en 20 mg dosis.
English: Most of these ECG abnormalities were not associated with adverse reactions.
Danish: De fleste af disse abnorme ekg'er var ikke associeret med bivirkninger.
English: OTHER MON, TUE, WED, THU, FRI, SAT, SUN
Danish: ANDET MAN, TIR, ONS, TOR, FRE, LØR, SØN
English: The only pharmacodynamic effect was a small (3.5 bpm) increase in heart rate.
Danish: Den eneste farmakodynamiske effekt var en lille stigning (3,5 slag pr. minut) i hjertefrekvensen.
English: Absolute bioavailability of tadalafil following oral dosing has not been determined.
Danish: Den absolutte biotilgængelighed af tadalafil efter oral administration er ikke bestemt.
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 hverken direkte eller indirekte skadelige virkninger hvad angår graviditet, embryo/føtal udvikling, fødsel eller postnatal udvikling (se pkt.
English: This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway.
Danish: Dette menes at være et resultat af den kombinerede effekt af nitrater og tadalafil på nitrogenoxid/cGMP-syntesevejen.
English: This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity.
Danish: Dette er, når en mand ikke kan få eller bevare en hård, rejst penis, som er egnet til seksuel aktivitet.
English: A reduction in sperm was seen in some men.
Danish: Der er også set nedsættelse i antallet af sædceller hos nogle mænd.
English: In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin.
Danish: I interaktionsstudier udført med et begrænset antal raske forsøgspersoner blev denne virkning ikke set med alfuzosin eller tamsulosin.
English: - leukaemia (cancer of the blood cells).
Danish: - Leukæmi (blodkræft).
English: Three studies were conducted in men to assess the potential effect on spermatogenesis of CIALIS 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 CIALIS 10 mg (ét 6 måneders studie) og 20 mg (ét 6 måneders og ét 9 måneders studie), daglig administration.
English: Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart.
Danish: Vær opmærksom på at seksuel aktivitet indebærer en mulig risiko for patienter med hjertesygdom, fordi aktiviteten giver ekstra anstrengelse til hjertet.
English: There was no evidence of teratogenicity, embryotoxicity or foetotoxicity in rats or mice that received up to 1000 mg/kg/day tadalafil.
Danish: Der var ingen tegn på teratogenicitet, embryotoksicitet eller føtotoksicitet hos rotter eller mus, der fik op til 1000 mg tadalafil/kg/dag.
English: Tell your doctor or pharmacist if you are already taking:
Danish: Fortæl lægen eller apotekspersonalet hvis du allerede tager:
English: The rate and extent of absorption of tadalafil are not influenced by food, thus CIALIS may be taken with or without food.
Danish: Hverken hastigheden eller omfanget af absorptionen af tadalafil påvirkes af fødeindtagelse, så CIALIS kan tages med eller uden mad.
English: Warnings and precautions Talk to your doctor before taking CIALIS.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager CIALIS.
English: In cases of overdose, standard supportive measures should be adopted as required.
Danish: I tilfælde af overdosering iværksættes normal støttende behandling efter behov.
English: - rifampicin, erythromycin , clarithromycin or itraconazole.
Danish: - Rifampicin, erythromycin, clarithromycin og itraconazol.
English: The recommended starting dose is one 10 mg tablet before sexual activity.
Danish: Den anbefalede startdosis er én 10 mg tablet før seksuel aktivitet.
English: Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance.
Danish: Patienter, som oplever erektioner, der varer i 4 timer eller mere, bør opfordres til at søge læge straks.
English: Once a day dosing of CIALIS may be useful to men who anticipate having sexual activity two or more times per week.
Danish: Dosering af CIALIS én gang daglig kan være velegnet til mænd, der forventer at have seksuel aktivitet to eller flere gange om ugen.
English: Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration (Cmax) is achieved at a median time of 2 hours after dosing.
Danish: Tadalafil absorberes hurtigt efter oral administration, og den gennemsnitlige maksimale plasmakoncentration (Cmax) opnås efter en median tid på 2 timer efter administration.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk.
Danish: Forhåndenværende farmakodynamiske/toksikologiske data fra dyr har vist udskillelse af tadalafil i mælk.
English: Your doctor may adjust the dose to 2.5 mg based on your response to CIALIS.
Danish: Din læge kan justere dosis til 2,5 mg, så den passer til din reaktion på CIALIS.
English: If you forget to take CIALIS
Danish: Hvis du har glemt at tage CIALIS
English: If you take more than you should, tell your doctor.
Danish: Hvis du tager mere, end du skal, så kontakt din læge.
English: If you have a heart problem you should tell your doctor.
Danish: Hvis du har problemer med hjertet, bør du tale med din læge.
English: Steady-state plasma concentrations are attained within 5 days of once-daily dosing.
Danish: Steady-state plasmakoncentrationer opnås indenfor 5 dage med dosering en gang dagligt.
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 10 film-coated tablets 12 film-coated tablets
Danish: 2 filmovertrukne tabletter 4 filmovertrukne tabletter 8 filmovertrukne tabletter 10 filmovertrukne tabletter 12 filmovertrukne tabletter
English: Manufacturer: Lilly S.A., Avda.
Danish: Fremstiller: Lilly S.A., Avda.
English: The maximum dose frequency is once per day.
Danish: Den maksimale doseringshyppighed er en gang daglig.
English: CIALIS has been shown to increase the effects of these medicines.
Danish: CIALIS har vist sig at øge virkningen af disse typer medicin.
English: In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried.
Danish: Hos de patienter, hvor tadalafil 10 mg ikke giver tilstrækkelig effekt, kan 20 mg forsøges.
English: Consequently, it is not expected to be clinically active at observed metabolite concentrations.
Danish: På den baggrund anses den ikke for at være klinisk aktiv ved de observerede metabolitkoncentrationer.
English: The appropriateness of continued use of the daily regimen should be reassessed periodically.
Danish: Valget af vedvarende daglig behandling bør evalueres med jævne mellemrum.
English: Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).
Danish: To efterfølgende kliniske studier tyder på, at denne virkning ikke er sandsynlig hos mennesker, selvom en nedsat koncentration af spermatocytter blev set hos nogle mænd (se pkt.
English: These effects are normally mild to moderate in nature.
Danish: Disse bivirkninger er som regel lette til moderate.
English: This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac contractility.
Danish: Denne selektivitet for PDE5 i forhold til PDE3 er vigtig, fordi PDE3 er et enzym, der er involveret i hjertets kontraktivitet.
English: Adult men
Danish: Voksne mænd
English: However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicinal products.
Danish: Hensigtsmæssig klinisk rådgivning bør imidlertid gives til patienter omkring et muligt blodtryksfald, hvis de behandles med antihypertensiv medicin.
English: In another clinical pharmacology study tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives.
Danish: I et andet klinisk farmakologisk studie blev tadalafil (20 mg) undersøgt i kombination med op til 4 klasser af antihypertensiva.
English: Following sexual stimulation CIALIS works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis.
Danish: Ved seksuel stimulation virker CIALIS ved at hjælpe blodkarrene i penis til at slappe af, så blodet kan strømme ind i penis.
English: - priapism, a prolonged and possibly painful erection after taking CIALIS (frequency rare).
Danish: - Priapisme, en forlænget og muligvis smertefuld rejsning efter indtagelse af CIALIS (hyppighed:
English: This is when the prostate gland gets bigger with age.
Danish: Dette er, når blærehalskirtlen bliver større med alderen.
English: The mean oral clearance for tadalafil is 2.5 l/h and the mean half-life is 17.5 hours in healthy subjects.
Danish: Den gennemsnitlige clearance for tadalafil efter oral indgift er 2,5 l/time, og den gennemsnitlige halveringstid er 17,5 timer hos raske forsøgspersoner.
English: Tadalafil exposure (AUC) in patients with diabetes was approximately 19 % lower than the AUC value for healthy subjects.
Danish: Eksponeringen for tadalafil (AUC) hos patienter med diabetes var ca. 19% lavere end AUC hos raske forsøgspersoner.
English: - sudden loss of vision (frequency rare).
Danish: - Pludseligt opstået synstab (hyppighed: Sjælden).
English: You may take a CIALIS tablet at least 30 minutes before sexual activity.
Danish: Tag CIALIS-tabletten mindst 30 minutter før seksuel aktivitet.
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.
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.
English: In patients who anticipate a frequent use of CIALIS (i.e., at least twice weekly) a once daily regimen with the lowest doses of CIALIS might be considered suitable, based on patient choice and the physician's judgement.
Danish: Hos patienter, som forventer et hyppigt brug af CIALIS (mindst 2 gange ugentligt), kan en én gang dagligt dosering med de laveste CIALIS-doser anses for at være hensigtsmæssig, baseret på patientens valg og lægens vurdering.
English: In a study to assess the effects of tadalafil on vision, no impairment of colour discrimination (blue/green) was detected using the Farnsworth-Munsell 100-hue test.
Danish: I en undersøgelse med henblik på at vurdere tadalafils virkning på synet, blev der ikke fundet nogen forringelse af evnen til at skelne farver (blå/grøn) ved brug af Farnsworth-Munsell 100-nuancer testen.
English: CIALIS, must not be used in men with cardiac disease for whom sexual activity is inadvisable.
Danish: CIALIS må ikke anvendes hos mænd med hjertesygdom, for hvem seksuel aktivitet ikke kan tilrådes.
English: Decreased or sudden hearing loss has been noted in some patients taking tadalafil.
Danish: Nedsat hørelse eller pludseligt høretab er observeret hos nogle patienter der har taget tadalafil.
English: Studies have confirmed that tadalafil does not inhibit or induce CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.
Danish: Undersøgelser har bekræftet, at tadalafil ikke inhiberer eller inducerer CYP450-isoformerne CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 og CYP2C19.
English: Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Danish: Tadalafil er en selektiv, reversibel inhibitor af cyklisk guanosinmonophosphat (cGMP)-specifik phosphodiesterase type 5 (PDE5).
English: This difference in exposure does not warrant a dose adjustment.
Danish: Denne forskel berettiger ikke en justering af dosis.
English: With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out.
Danish: For de interaktionsundersøgelser, hvor kun 10 mg tadalafil blev anvendt, kan klinisk relevante interaktioner ved højere doser ikke udelukkes.
English: In a rat prenatal and postnatal development study, the no observed effect dose was 30 mg/kg/day.
Danish: I et prænatalt og postnatalt udviklingsforsøg hos rotter var den dosis, hvor der ikke sås effekt, 30 mg/kg/dag.
English: Effects were seen in dogs that might indicate impairment of fertility.
Danish: Hos hunde er der set virkninger, som kan tyde på nedsat fertilitet.
English: Over a dose range of 2.5 to 20 mg, exposure (AUC) increases proportionally with dose.
Danish: I dosisområdet 2,5 - 20 mg øges eksponeringen (AUC) proportionalt med dosis.
English: One of these studies assessed improvements in erectile dysfunction and signs and symptoms of benign prostatic hyperplasia in patients with both conditions.
Danish: Et af studierne vurderede forbedringerne af erektil dysfunktion og af tegn og symptomer på benign prostatahyperplasi hos patienter med begge tilstande.
English: (1) Most of the patients had pre-existing cardiovascular risk factors (see section 4.4).
Danish: (1) De fleste af patienterne havde eksisterende kardiovaskulære risikofaktorer (se pkt.
English: You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Danish: Du og din partner må indlede et forspil, ligesom du ville gøre, hvis du ikke tog medicin for erektil dysfunktion.
English: Analysis of phase 3 clinical trial data showed no difference in adverse events in patients taking tadalafil with or without antihypertensive medicinal products.
Danish: En analyse af data fra kliniske fase 3 studier viste ingen forskel på bivirkningerne hos patienter, som fik tadalafil med eller uden antihypertensiv medicin.
English: Grapefruit juice may affect how well CIALIS will work and should be taken with caution.
Danish: Grapefrugtjuice kan påvirke virkningen af CIALIS og bør indtages med forsigtighed.
English: Tachycardia, Palpitations
Danish: Takykardi, Palpitationer
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: CIALIS 5 mg is used to treat adult men with: - erectile dysfunction.
Danish: CIALIS 5 mg bruges til at behandle voksne mænd for: - Erektil dysfunktion.
English: Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of CIALIS is not recommended in patients with severe renal impairment.
Danish: På grund af forhøjet tadalafil eksponering (AUC), begrænset klinisk erfaring og manglende mulighed for at påvirke clearance via dialyse, anbefales én gang dagligt dosering af CIALIS ikke til patienter med svær nyreinsufficiens.
English: The effect of tadalafil is more potent on PDE5 than on other phosphodiesterases.
Danish: Tadalafils effekt er mere potent på PDE5 end på andre phosphodiesteraser.
English: CIALIS will not help you if you do not have erectile dysfunction.
Danish: CIALIS hjælper ikke, hvis du ikke har erektil dysfunktion.
English: Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
Danish: Før iværksættelse af en hvilken som helst behandling af erektil dysfunktion bør lægen overveje den kardiovaskulære status for patienten, da der er en vis risiko for hjerteproblemer forbundet med seksuel aktivitet.
English: When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum.
Danish: Når seksuel stimulation medfører lokal frigivelse af nitrogenoxid, giver tadalafils hæmning af PDE5 øgede mængder af cGMP i corpus cavernosum.
English: If you experience any of the following side effects stop using the medicine and seek medical help immediately: - allergic reactions including rashes (frequency uncommon).
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: Ikke almindelig).
English: CIALIS has negligible influence on the ability to drive or use machines.
Danish: CIALIS påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: It is not known if CIALIS is effective in patients who have undergone pelvic surgery or radical non-nervesparing prostatectomy.
Danish: Det vides ikke, hvorvidt CIALIS er effektiv hos patienter, som har gennemgået kirurgi i bækkenet eller radikal ikke-nervebevarende prostatektomi.
English: The majority of headaches reported with CIALIS once-aday dosing are experienced within the first 10 to 30 days of starting treatment.
Danish: Størsteparten af de tilfælde af hovedpine, som blev indberettet for CIALIS én gang daglig-doseringen, opstod indenfor de første 10 til 30 dage efter behandlingsstart.
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: Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose.
Danish: Tadalafils farmakokinetik hos raske forsøgspersoner er lineær med hensyn til tid og dosis.
English: When tadalafil was administered with lower doses of alcohol (0.6 g/kg), hypotension was not observed and dizziness occurred with similar frequency to alcohol alone.
Danish: Når tadalafil blev administreret sammen med lavere doser alkohol (0,6 g/kg) blev hypotension ikke observeret og svimmelhed forekom med tilsvarende frekvens som ved alkohol alene.
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 inhibitor af PDE5.
English: Tadalafil is principally metabolised by CYP3A4.
Danish: Tadalafil bliver primært metaboliseret af CYP3A4.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagen dosering, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Other inducers of CYP3A4 such as phenobarbital, phenytoin and carbamazepine, may also decrease plasma concentrations of tadalafil.
Danish: Andre CYP3A4-inducere, såsom phenobarbital, phenytoin og carbamazepin, kan også nedsætte plasmakoncentrationen af tadalafil.
English: CIALIS contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors.
Danish: CIALIS indeholder det aktive stof tadalafil, som tilhører en gruppe af lægemidler kaldet phosphodiesterase type 5-hæmmere.
English: Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below.
Danish: Interaktionsundersøgelserne blev, som beskrevet nedenfor, udført med 10 mg og/eller 20 mg tadalafil.
English: Do not take CIALIS if you are already taking nitrates.
Danish: Tag ikke CIALIS hvis du også bruger nitrater.