FrancophonIA/ELRC3.0 huggingface dataset:
English: In the small number of patients who attempted intercourse up to four to five hours after dosing the success rate for penetration and maintenance of erection was consistently greater than placebo.
Danish: Hos det begrænsede antal patienter, som forsøgte samleje op til fire til fem timer efter indtagelse af dosis var succesraten for penetration og vedligeholdelse af erektion konsistent større end for placebo.
English: Central nervous system haemorrhages and cerebrovascular accidents (CVA) have been monitored in the last PSURs.
Danish: Blødninger i centralnervesystemet og cerebrovaskulære hændelser (CVA) har være monitoreret i de seneste PSUR'er.
English: Ritonavir significantly prolonged the half-life of vardenafil to 25.7 hours (see section 4.3).
Danish: Ritonavir forlængede signifikant halveringstiden af vardenafil til 25,7 timer (se pkt.
English: Vardenafil may be administered at any time with tamsulosin or with alfuzosin.
Danish: Vardenafil kan administreres på et hvilket som helst tidspunkt sammen med tamsulosin eller med alfuzosin.
English: Allergic oedema and angioedema
Danish: Allergisk ødem og angioødem
English: The following adverse reactions have been reported:
Danish: Følgende bivirkninger er rapporteret:
English: The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators.
Danish: Samtidig anvendelse af alfa-blokkere og vardenafil kan hos nogle patienter føre til symptomatisk hypotension, da de begge er vasodilatorer.
English: In vardenafil film-coated tablets, vardenafil is rapidly absorbed with maximum observed plasma concentrations reached in some men as early as 15 minutes after oral administration.
Danish: Efter indgift af vardenafil filmovertrukne tabletter absorberes vardenafil hurtigt med maksimal observeret plasmakoncentration opnået hos nogle mænd så tidligt som 15 minutter efter oral administration.
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 (dvs. højt blodtryk i lungerne) og kronisk tromboembolisk pulmonal hypertension (dvs. højt blodtryk i lungerne som følge af blodpropper).
English: Taking these medicines with Levitra could seriously affect your blood pressure.
Danish: Indtagelse af denne medicin sammen med Levitra kan have en alvorlig påvirkning på Deres blodtryk.
English: Concomitant use of alpha-blockers
Danish: Samtidig anvendelse af alfa-blokkere
English: Dose adjustments are not required in elderly patients.
Danish: Dosisjustering er ikke nødvendigt hos ældre patienter.
English: Based on measurements of vardenafil in semen of healthy subjects 90 minutes after dosing, not more than 0.00012% of the administered dose may appear in the semen of patients.
Danish: Baseret på målinger af vardenafil i sæd fra raske forsøgspersoner 90 minutter efter indgift, forekommer der ikke mere end 0,00012% af indgivet dosis i patienters sæd.
English: Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic hyperplasia (BPH) on stable tamsulosin, terazosin or alfuzosin therapy:
Danish: Baseret på resultater af interaktionsstudierne med vardenafil hos patienter med benign prostatahyperplasi (BPH) i stabil behandling med tamsulosin, terazosin eller alfuzosin:
English: Metabolite M1 shows a phosphodiesterase selectivity profile similar to vardenafil and an in vitro potency for phosphodiesterase type 5 of approximately 28% compared to vardenafil, resulting in an efficacy contribution of about 7%.
Danish: Metabolitten M1 udviser en phosphodiesterase selektivitetsprofil svarende til vardenafil og en in vitro-styrke over for phosphodiesterase type 5 på ca. 28% sammenlignet med vardenafil, resulterende i et effektbidrag på ca. 7%.
English: There is no relevant indication for use of Levitra in children.
Danish: Der er ingen relevante indikationer for brug af Levitra til børn.
English: Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum.
Danish: Vardenafil er en potent og selektiv hæmmer af cGMP-specifik phosphodiesterase type 5 (PDE5), den mest markante PDE i human corpus cavernosum.
English: In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the nitric oxide donor sodium nitroprusside.
Danish: In vitro-undersøgelser med humane blodplader indikerer at vardenafil ikke har antiaggregatorisk effekt i sig selv men ved høje (over-terapeutiske) koncentrationer forstærker vardenafil den antiaggregatoriske effekt af nitrogenoxiddonoren natriumnitroprussid.
English: This includes conditions called angulation, Peyronie's disease and cavernosal fibrosis.
Danish: Dette omfatter tilstande kaldet krummerik, Peyronies plaque og cavernosa fibrose.
English: It can interfere with the usual effect of the medicine.
Danish: Det kan påvirke effekten af medicinen.
English: Effects of other medicinal products on vardenafil
Danish: Virkninger af andre præparater på vardenafil
English: Since alpha-blocker monotherapy can cause marked lowering of blood pressure, especially postural hypotension and syncope, interaction studies were conducted with vardenafil.
Danish: Eftersom alfa-blokker-monoterapi kan medføre markant blodtrykssænkning, især postural hypotension og synkope, blev der udført interaktionsstudier med vardenafil.
English: In clinical trials vardenafil was administered to over 17,000 men with erectile dysfunction (ED) aged 18 - 89 years, many of whom had multiple co-morbid conditions.
Danish: I kliniske studier blev vardenafil givet til mere end 17.000 mænd med erektil dysfunktion (ED) i alderen 18-89 år, hvoraf mange havde flere samtidige sygdomstilstande.
English: Hypotension was not observed when vardenafil 5 mg and terazosin administration was separated by 6 hours.
Danish: Hypotension blev ikke observeret, når administrationen af 5 mg vardenafil og terazosin blev separeret med 6 timer.
English: In vitro studies
Danish: In vitro-undersøgelser
English: In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is subject to further metabolism with a plasma elimination half-life of approximately 4 hours.
Danish: Hos mennesker er den væsentligste cirkulerende metabolit (M1) et resultat af en deethylering af vardenafil og er underlagt yderligere metabolisme med en plasma eliminationshalveringstid på ca. fire timer.
English: Talk to your doctor or pharmacist before taking Levitra.
Danish: Kontakt lægen eller apotekspersonalet, før De tager Levitra.
English: If you have an illness that can cause erections which won't go away (priapism).
Danish: Hvis De har en sygdom der kan medføre erektioner, som ikke forsvinder (priapisme).
English: Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard.
Danish: Uanset årsagen er effekten den samme: Muskel- og blodkarsændringer gør, at der ikke er tilstrækkeligt blod i penis til at opnå og bevare stivhed.
English: Levitra 10 mg orodispersible tablets are round and white.
Danish: Levitra 10 mg smeltetabletter er runde og hvide.
English: Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
Danish: Enkeltdoser og flere orale doser af vardenafil på op til 40 mg bevirkede ingen klinisk relevante EKG-ændringer for normale mandlige frivillige forsøgspersoner.
English: A percentage of 71% of all sexual attempts reported in the clinical trials had successful penetration compared to 44% of all attempts in the placebo group.
Danish: 71% af de seksuelle forsøg, der blev gjort i de kliniske studier, resulterede i succesfuld penetration sammenlignet med 44% af forsøgene i placebogruppen.
English: Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
Danish: Tegn på en allergisk reaktion omfatter hududslæt, kløe, opsvulmet ansigt, opsvulmede læber og åndenød.
English: - Erythromycin or clarithromycin, macrolide antibiotics.
Danish: - Erythromycin eller clarithromycin, antibiotika.
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 (see section 4.3).
Danish: Inden påbegyndelse af nogen som helst form for behandling af erektil dysfunktion bør lægen undersøge patientens kardiovaskulære tilstand, da der er en vis kardiel risiko forbundet med seksuel aktivitet (se pkt.
English: Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction.
Danish: Vardenafil er en oral behandling til forbedring af erektil funktion hos mænd med erektil dysfunktion.
English: The total body clearance of vardenafil is 56 l/h with a resultant terminal half-life of approximately 4-5 hours.
Danish: Vardenafils totale kropsclearance er 56 l/t med en resulterende terminal halveringstid på 4-5 timer.
English: If you feel dizzy, or if your vision is affected after taking Levitra don't drive or operate any tools or machines.
Danish: Hvis De føler Dem svimmel eller Deres syn er påvirket efter at have taget Levitra, bør De ikke køre bil eller betjene maskiner.
English: Sexual stimulation is therefore required for vardenafil to produce its beneficial therapeutic effects.
Danish: Derfor er seksuel stimulation nødvendig for vardenafils positive terapeutiske effekt.
English: Some medicines may cause problems, especially these: - Nitrates, medicines for angina, or nitric oxide donors, such as amyl nitrite.
Danish: Visse typer medicin kan give problemer, især disse: - Nitrater, medicin for angina, eller nitrogen-oxid-donorer, som amylnitrit.
English: The median time to reach Cmax varied between 45 to 90 minutes and was similar or slightly delayed (by 8 to 45 min) compared to the film-coated tablets.
Danish: Mediantiden til Cmax varierede fra 45 til 90 min. og var lig med eller lettere forsinket (med 8-45 min.) sammenlignet med filmovertrukne tabletter.
English: The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disintegrate, and then swallowed.
Danish: Smeltetabletten skal placeres på tungen, hvor den hurtigt bliver opløst, og derefter sluges.
English: - If you have an illness that can cause erections which won't go away (priapism).
Danish: - Hvis De har en sygdom der kan medføre erektioner, som ikke forsvinder (priapisme).
English: Effect on bleeding
Danish: Virkning på blødning
English: These include sickle cell disease, multiple myeloma and leukaemia.
Danish: Disse omfatter seglcelleanæmi, multibel myeloma og leukæmi.
English: Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects.
Danish: Vardenafil forårsager let og forbigående blodtryksfald, der i de fleste tilfælde ikke kommer til udtryk som klinisk virkning.
English: The maximum recommended dose is 20 mg.
Danish: Den anbefalede maksimale dosis er 20 mg.
English: These effects are consistent with the vasodilatory effects of PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells.
Danish: Denne effekt er i overensstemmelse med den vasodilatoriske effekt af PDE-inhibitorer og skyldes formentlig øgede cGMP-niveauer i vasculære glatte muskelceller.
English: Although a specific interaction study has not been conducted, the co-administration of clarithromycin can be expected to result in similar effects on vardenafil AUC and Cmax.
Danish: Selv om der ikke er udført et specifikt interaktionsstudie, kan samtidig indgift af clarithromycin forventes at medføre lignende indvirkninger på vardenafil AUC og Cmax.
English: In two interaction studies with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin to high doses, hypotension (in some cases symptomatic) was reported in a significant number of subjects after co-administration of vardenafil.
Danish: I to interaktionsstudier med raske normotensive frivillige efter forceret titrering til høje doser af alfa-blokkerne tamsulosin eller terazosin blev hypotension (i nogle tilfælde symptomatisk) rapporteret i et signifikant antal af personer efter samtidig administration af vardenafil.
English: He or she may suggest a switch to an alternative Levitra formulation with a different dose, depending on how well it works for you.
Danish: Lægen kan da foreslå, at De skifter til en anden formulering af Levitra med en anden dosis, afhængigt af hvordan virkningen er på Dem.
English: Therefore, inhibitors of these isoenzymes may reduce vardenafil clearance.
Danish: Derfor kan hæmmere af disse isoenzymer reducere vardenafil clearance.
English: What you need to know before you take Levitra Do not take Levitra
Danish: Det skal De vide, før De begynder at tage Levitra Tag ikke Levitra
English: Levitra is not indicated for use by women.
Danish: Levitra er ikke indiceret til anvendelse hos kvinder.
English: The recommended dose is 10 mg.
Danish: Den anbefalede dosis er 10 mg.
English: Myocardial infarction Ventricular tachy-arrhythmias Angina pectoris
Danish: Myokardieinfarkt Ventrikulære takyarytmier Angina pectoris
English: Further information on clinical trials with vardenafil 10 mg orodispersible tablets Efficacy and safety of vardenafil 10 mg orodispersible tablets were separately demonstrated in a broad population in two studies including 701 randomized erectile dysfunction patients who were treated up to 12 weeks.
Danish: Yderligere information om kliniske studier med vardenafil 10 mg smeltetabletter Virkning og sikkerhed for vardenafil 10 mg smeltetabletter blev vist separat i to studier omfattende en bredt sammensat population, herunder 701 randomiserede patienter med erektil dysfunktion, som blev behandlet i op til 12 uger.
English: Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
Danish: Vardenafil (10 mg) forstærkede ikke den af acetylsalicylsyre (81 mg x 2) forlængede blødningstid.
English: Levitra might make some people feel dizzy or affect their vision.
Danish: Levitra kan medføre svimmelhed eller synspåvirkning hos nogle.
English: Levitra will only work when you are sexually stimulated.
Danish: Levitra fungerer kun i forbindelse med seksuel stimulation.
English: If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis De er allergisk over for vardenafil eller et af de øvrige indholdsstoffer i Levitra (angivet i punkt 6).
English: Preclinical studies showed 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: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
Danish: Selvom der ikke er foretaget specifikke interaktionsundersøgelser for alle lægemidler, viste populationsfarmakokinetiske analyser, at vardenafils farmakokinetik ikke blev påvirket ved samtidig indgift af følgende stoffer: Acetylsalicylsyre, ACE-hæmmere, beta-blokkere, svage CYP3A4inhibitorer, diuretika og lægemidler til behandling af diabetes (sulfonylurinstoffer og metformin).
English: - If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
Danish: - Hvis De på noget tidspunkt tidligere har haft tab af synet på grund af beskadigelse af synsnerven i forbindelse med utilstrækkelige forsyning af blod til synsnerven, også kendt som non-arteritis anterior iskæmisk opticusneuropati (NAION).
English: The mean terminal half-life of vardenafil in patients receiving Levitra 10 mg orodispersible tablets ranged between 4 - 6 hours.
Danish: Den gennemsnitlige terminale halveringstid for vardenafil hos patienter, der fik Levitra 10 mg smeltetabletter, var mellem 4-6 timer.
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 20 film-coated tablets
Danish: 2 filmovertrukne tabletter 4 filmovertrukne tabletter 8 filmovertrukne tabletter 12 filmovertrukne tabletter 20 filmovertrukne tabletter
English: Cases of sudden death, fast or altered heart beat, heart attack, chest pain, and trouble in cerebral circulation (including temporarily decreased blood flow to parts of the brain and bleeding in the brain) have been reported in men taking vardenafil.
Danish: Tilfælde af pludselig død, hurtig eller ændret hjerteslag, hjerteanfald, brystsmerter og problemer i cerebral cirkulation (inklusive midlertidigt nedsat blodforsyning til dele af hjernen og blødning i hjernen), har været rapporteret hos mænd, der tager vardenafil.
English: The maximum dose for Levitra orodispersible tablet is 10 mg/day.
Danish: Den maksimale dosis af Levitra smeltetablet er 10 mg/dag.
English: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (can not be estimated from available data).
Danish: (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til
English: After a meal containing 30% fat, the rate and extent of absorption of vardenafil (tmax, Cmax and AUC) are unchanged compared to administration under fasting conditions.
Danish: Efter et måltid indeholdende 30% fedt er hastigheden og graden af absorptionen af vardenafil (Tmax, Cmax og AUC) uændret sammenlignet med indgift i fastende tilstand.
English: After oral administration, vardenafil is excreted as metabolites predominantly in the faeces (approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately 2-6% of the administered dose).
Danish: Efter oral indgift udskilles vardenafil som metabolitter hovedsageligt i faeces (ca. 91-95% af indgiven dosis) og i mindre grad i urinen (ca. 2-6% af indgiven dosis).
English: If vardenafil 10 mg orodispersible tablets are taken with water, the AUC is reduced by 29%, Cmax remains unchanged and median tmax is shortened by 60 minutes compared to intake without water.
Danish: Hvis vardenafil 10 mg smeltetabletter tages med vand, reduceres AUC med 29%, Cmax forbliver uændret, og den mediane tmax bliver nedsat med 60 min. sammenlignet med indgift uden vand.
English: The adverse reactions reported with Levitra film-coated tablets or 10 mg orodispersible tablets in clinical trials were generally transient and mild to moderate in nature.
Danish: De bivirkninger, der blev indberettet med Levitra filmovertrukne tabletter eller 10 mg smeltetabletter i kliniske studier, var generelt forbigående og lette til moderate.
English: The overall response of these subjects to vardenafil became statistically significant, compared to placebo, 25 minutes after dosing.
Danish: Disse forsøgspersoners samlede respons på vardenafil var statistisk signifikant 25 minutter efter indtagelse, sammenlignet med placebo.
English: Concomitant use of CYP3A4 inhibitors
Danish: Samtidig anvendelse af CYP3A4-inhibitorer
English: Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors.
Danish: Levitra indeholder vardenafil og tilhører en gruppe lægemidler, der kaldes fosfodiesterase type 5hæmmere.
English: Across the pivotal trials, treatment with vardenafil (film-coated tablets) resulted in an improvement of erectile function compared to placebo.
Danish: I de pivotale studier resulterede behandling med vardenafil (filmovertrukne tabletter) i en forbedring af erektil funktion sammenlignet med placebo.
English: • When vardenafil 5 mg (film-coated tablets) was given simultaneously with terazosin 5 or 10 mg, one of 21 patients experienced symptomatic postural hypotension.
Danish: • Når 5 mg vardenafil (filmovertrukne tabletter) blev givet samtidig med 5 eller 10 mg terazosin, oplevede én ud af 21 patienter symptomatisk postural hypotension.
English: The primary objective of this study was to rule out a greater than 10 msec effect (i.e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/RR1/3) from baseline at the 1 hour post-dose time point.
Danish: Det primære formål med dette studie var at udelukke en effekt større end 10 msek (dvs. påvise manglende effekt) på QTcintervallet med en enkelt oral dosis på 80 mg vardenafil sammenlignet med placebo, målt som ændringen i Fridericia's korrektionsformel (QTcF=QT/RR1/3) en time efter dosering, sammenlignet med udgangsværdien.
English: Contains aspartame (E951) and sorbitol (E420).
Danish: Indeholder aspartam (E951) og sorbitol (E420).
English: Palpitation Tachycardia
Danish: Palpitationer Takykardi
English: Vardenafil AUC and Cmax in elderly patients (65 years or over) taking vardenafil orodispersible tablets were increased by 31 to 39% and 16 to 21%, respectively, in comparison to patients aged 45 years and below.
Danish: Vardenafils AUC og Cmax hos ældre patienter (65 år eller derover), der tager vardenafil smeltetabletter, steg med henholdsvis 31-39% og 16-21% sammenlignet med patienter på 45 år og derunder.
English: may affect more than 1 in 10 users - Headache
Danish: forekommer hos flere end 1 ud af 10 behandlede - Hovedpine
English: Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Danish: Vardenafil har vasodilaterende egenskaber resulterende i mild og forbigående sænkning af blodtrykket (se pkt.
English: No statistically significant correlation was observed between creatinine clearance and vardenafil exposure (AUC and Cmax) (see section 4.2).
Danish: Ingen statistisk signifikant korrelation observeredes mellem kreatininclearance og eksponering for vardenafil (AUC og Cmax).
English: Contents of the pack and other information What Levitra contains
Danish: Pakningsstørrelser og yderligere oplysninger Levitra indeholder:
English: About 63% of all reported sexual attempts with vardenafil 10 mg orodispersible tablets were successful in terms of erection maintenance compared to about 26% of all placebo-controlled sexual attempts.
Danish: Omkring 63% af alle registrerede seksuelle forsøg med vardenafil 10 mg smeltetabletter var succesfulde med hensyn til vedligeholdelse af erektion sammenlignet med omkring 26% af alle seksuelle forsøg i placebo-gruppen.
English: There was no consistent difference in mean Cmax between orodispersible tablets and film-coated tablets.
Danish: Gennemgående var der ingen forskel i middel-Cmax mellem smertetabletter og filmovertrukne tabletter.
English: There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Danish: Der findes ikke data for interaktion mellem vardenafil og non-specifikke phosphodiesterase inhibitorer som theofyllin eller dipyridamol.
English: The level of cGMP is regulated by the rate of synthesis via guanylate cyclase and by the rate of degradation via cGMP hydrolysing phosphodiesterases (PDEs).
Danish: Niveauet af cGMP reguleres af syntesehastigheden via guanulatcyklase og af nedbrydningshastigheden via cGMP hydrolyserende phosphodiesteraser (PDE'er).