natgillin/translations-raw huggingface dataset:
Det virker ved at blokere fosfodiesteraseenzymet, som normalt nedbryder et stof, der kaldes cyklisk GMP (cGMP).
It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic GMP (cGMP).
Dette fører til en afslapning af musklerne i svulmelegemet (corpora cavernosa), hvorved blodstrømningen til corpora øges, hvilket medfører erektion.
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the inflow of blood in the corpora that produces the erection.
Ved at blokere nedbrydningen af cGMP genopretter Levitra den erektile funktion.
By blocking the break down of cGMP, Levitra restores erectile function.
Hvordan blev Levitra undersøgt?
How has Levitra been studied?
Levitra blev undersøgt i fire hovedundersøgelser af 2 431 patienter i alderen 20 til 83 år og sammenlignet med placebo (en uvirksom behandling).
Levitra has been studied in four main studies including 2,431 patients aged 20 to 83 years, where it was compared with placebo (a dummy treatment).
I undersøgelserne indgik mænd med sukkersyge og post prostatektomerede patienter (mænd, som har fået deres prostatakirtel fjernet).
One study was carried out in diabetic men and another in post-prostatectomy patients (men who have had their prostate gland removed).
Den
This was recorded in two questionnaires completed at home.
Reproduction is authorised provided the source is acknowledged. vigtigste målestok for virkningen var evnen til at få og opretholde erektion.
Reproduction is authorised provided the source is acknowledged.
Levitra var betydelig mere virkningsfuld end placebo i alle målinger i samtlige undersøgelser.
Levitra was significantly more effective than placebo for all measures in all studies.
De hyppigste bivirkninger (som ses hos flere end 1 ud af 10 patienter) er hovedpine og rødmen.
The most common side effects (seen in more than 1 patient in 10) are headache and flushing.
Den fuldstændige liste over de indberettede bivirkninger ved Levitra fremgår af indlægssedlen.
For the full list of all side effects reported with Levitra, see the Package Leaflet.
Levitra må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for vardenafil eller over for nogen af indholdsstofferne, og som frarådes seksuel aktivitet (for eksempel mænd med alvorlige hjertesygdomme såsom ustabile hjertekramper eller alvorlig hjerteinsufficiens).
Levitra should not be used in people who may be hypersensitive (allergic) to vardenafil or any of the other ingredients, and where sexual activity is inadvisable (e. g. men with severe heart disease such as unstable angina or severe heart failure).
Det må heller ikke indtages af patienter, som på noget tidspunkt har haft synstab forårsaget af et problem med blodtilførslen til nerven i øjet (NAION eller non- arteritis anterior iskæmisk opticusneuropati, ” blodprop i øjet ”).
It should also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Levitra må ikke indtages sammen med nitrater (lægemidler, der anvendes til behandling af hjertekrampe (angina)).
Levitra should not be taken with nitrates (medicines used to treat angina).
Levitra må ikke anvendes til patienter med alvorlige lever - og nyresygdomme og patienter, som har problemer med blodtrykket, eller som har haft et hjerte - eller et slagtilfælde inden for de seneste seks måneder, da Levitra ikke er blevet undersøgt hos disse patienter.
Because Levitra has not been studied in patients with severe liver or kidney disease, patients who have problems with their blood pressure, or who have had a stroke or a heart attack within the last six months, they should not use it.
Levitra må ikke gives sammen med visse lægemidler, såsom ketoconazol og itraconazol (til behandling af svampeinfektioner), til mænd over 75 år, eller sammen med ritonavir og indinavir (til behandling af hiv- infektion).
Levitra should not be taken with some medicines, such as ketoconazole and itraconazole (to treat fungal infections) in men over 75 years, or ritonavir or indinavir (to treat HIV infection).
Hvorfor blev Levitra godkendt?
Why has Levitra been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) besluttede, at fordelene ved Levitra er større end risiciene ved behandling af erektil dysfunktion hos mænd.
The Committee for Medicinal Products for Human Use (CHMP) decided that Levitra’ s benefits are greater than its risks for the treatment of men with erectile dysfunction.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Levitra.
The Committee recommended that Levitra be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levitra til Bayer AG den 6. marts 2003.
The European Commission granted a marketing authorisation valid throughout the European Union for Levitra to Bayer AG on 6 March 2003.
Den fuldstændige EPAR om Levitra findes her.
The full EPAR for Levitra is available here.
Blister (PP/ Alu)
Blister (PP/ Alu)
Levitra 5 mg filmovertrukne tabletter.
Levitra 5 mg film-coated tablets
Hver tablet indeholder 5 mg vardenafil (som hydrochloridtrihydrat).
Each tablet contains 5 mg of vardenafil (as hydrochloride trihydrate).
Orange, runde tabletter, mærket med BAYER- kors på den ene side og ” 5 ” på den anden side.
Orange round tablets marked with the BAYER-cross on one side and “ 5 ” on the other side.
Levitra er ikke indiceret til brug hos kvinder.
Levitra is not indicated for use by women.
Indsætning af effekt kan forsinkes hvis tabletterne tages sammen med et fedtrigt måltid (se pkt. 5. 2).
The onset of activity may be delayed if taken with a high fat meal (see section 5.2).
Anvendelse hos ældre mænd
Use in elderly men
Det er ikke nødvendigt at justere dosis hos ældre mænd.
Dosage adjustments are not required in elderly patients.
4. 4 og 4. 8).
However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8).
Levitra er ikke beregnet til personer under 18 år.
Levitra is not indicated for individuals below 18 years of age.
Der er ingen relevant indikation for brug af Levitra til børn.
There is no relevant indication for use of Levitra in children.
En startdosis på 5 mg bør overvejes hos patienter med let og moderat nedsat leverfunktion (Child - Pugh A- B).
A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B).
4. 3 og 5. 2).
The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg (see sections 4.3 and 5.2).
2 Anvendelse hos patienter med nedsat nyrefunktion
2 Use in patients with renal impairment
Hos patienter med stærk nedsat nyrefunktion (kreatinin clearance < 30 ml/ min) bør en startdosis på 5 mg overvejes.
In patients with severe renal impairment (creatinine clearance < 30 ml/ min), a starting dose of 5 mg should be considered.
4. 5).
When used in combination with the CYP 3A4 inhibitors such as erythromycin or clarithromycin, the dose of vardenafil should not exceed 5 mg (see section 4.5).
4. 5 og 5. 1).
The coadministration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections 4.5 and 5.1).
4. 4).
Levitra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Generelt bør stoffer til behandling af erektil dysfunktion ikke anvendes af mænd som frarådes seksuel aktivitet (f. eks. patienter med alvorlige cardiovaskulære lidelser som ustabil angina pectoris eller alvorligt hjertesvigt [New York Heart Association III eller IV]).
Agents for the treatment of erectile dysfunction should generally not be used in men for whom sexual activity is inadvisable (e. g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]).
Sikkerheden af vardenafil er ikke undersøgt i følgende patientundergrupper og dets anvendelse er derfor kontraindiceret indtil yderligere information er tilgængelig:
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available:
Alvorlig leverinsufficiens (Child - Pugh C), terminal nyresygdom med behov for dialyse, hypotension (blodtryk < 90/ 50 mmHg), nyligt overstået stroke eller hjerteinfarkt (indenfor de sidste seks måneder), ustabil angina pectoris og kendte arvelige degenerative sygdomme i retina som retinitis pigmentosa.
- hypotension (blood pressure < 90/ 50 mmHg),
Samtidig administration af vardenafil og de potente CYP3A4- inhibitorer ketoconazol og itraconazol (oral formulering) er kontraindiceret hos mænd over 75 år.
Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years.
4. 5).
Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are very potent inhibitors of CYP3A4 (see section 4.5).
4. 3).
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).
5. 1).
Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Patienter med obstruktion af venstresidig ventrikulær udløb, f. eks. aorta stenose og idiopatisk hypertrofisk subaorta stenose, kan være følsomme over for virkningen af vasodilatorer inklusiv phosphodiesterase type 5 inhibitorer.
Patients with left ventricular outflow obstruction, e. g., aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Præparater til behandling af erektil dysfunktion bør anvendes med forsigtighed hos patienter med anatomisk deformitet af penis (som f. eks. vinkling, kavernøs fibrose eller Peyronie’ s sygdom), eller hos patienter med lidelser, som kan prædisponere til priapisme (som f. eks. seglcellanæmi, multipelt myelom eller leukæmi).
Agents for the treatment of erectile dysfunction 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
3 Sikkerhed og effektivitet af kombinationer af vardenafil og andre behandlinger for erektil dysfunktion er ikke undersøgt.
The safety and efficacy of combinations of vardenafil with other treatments for erectile dysfunction have not been studied.
Samtidig anvendelse af alfa- blokkere og vardenafil kan hos nogle patienter føre til symptomatisk hypotension, da de begge er vasodilatorer.
The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators.
Behandling samtidigt med vardenafil bør kun initieres såfremt patienten er i stabil alfa- blokker- behandling.
Concomitant treatment with vardenafil should only be initiated if the patient has been stabilised on his alpha-blocker therapy.
Hos de patienter, der er i stabil alfa- blokker - behandling, bør vardenafil initieres med den laveste anbefalede startdosis på 5 mg.
In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg.
Vardenafil kan administreres på et hvilket som helst tidspunkt med tamsulosin.
Vardenafil may be administered at any time with tamsulosin.
4. 5).
With other alpha blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.5).
Hos de patienter, der allerede får en optimeret dosis af vardenafil, bør behandling med alfa - blokker initieres med den laveste dosis.
In those patients already taking an optimized dose of vardenafil, alpha-blocker therapy should be initiated at the lowest dose.
4. 5 og 4. 3).
Concomitant use of vardenafil with potent CYP 3A4 inhibitors such as itraconazole and ketoconazole (oral form) should be avoided as very high plasma concentrations of vardenafil are reached if the medicinal products are combined (see sections 4.5 and 4.3).
4. 5 og 4. 2).
Vardenafil dose adjustment might be necessary if moderate CYP 3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see sections 4.5 and 4.2).
Samtidigt indtag af grapefrugt juice forventes at øge plasmakoncentrationen af vardenafil.
Concomitant intake of grapefruit juice is expected to increase the plasma concentrations of vardenafil.
4. 5).
The combination should be avoided (see section 4.5).
Enkeltdoser på 10 mg og 80 mg vardenafil har vist sig at kunne forlænge QTc- intervallet med en middelværdi på henholdsvis 8 msek og 10 msek.
Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively.
Enkeltdoser på 10 mg vardenafil givet samtidig med 400 mg gatifloxacin, et lægemiddel med sammenlignelig QT- effekt, viste også en additiv QTc- effekt på 4 msek. i forhold til effekten ved hvert lægemiddel for sig.
And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either drug alone.
5. 1).
The clinical impact of these QT changes is unknown (see section 5.1).
Lægemidler som kan forlænge QTc- intervallet, inklusiv vardenafil, bør undgås hos patienter med relevante risikofaktorer, f. eks. hypokaliæmi; medfødt QT - forlængelse; samtidig administration af klasse 1a antiarytmika (f. eks. chinidin, prokainamid) eller klasse 3 (f. eks. amiodaron, sotalol).
Medicinal products that may prolong QTc interval, including vardenafil, are best avoided in patients with relevant risk factors, for example, hypokalaemia; congenital QT prolongation; concomitant administration of antiarrhythmic medicinal products in Class 1ª (e. g. quinidine, procainamide), or Class III (e. g. amiodarone, sotalol).
Der er rapporteret synsdefekter og tilfælde af non- arteritis anterior iskæmisk opticusneuropati (NAION) i forbindelse med indtagelse af Levitra og andre PDE5- hæmmere.
Visual defects and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in connection with the intake of Levitra and other PDE5 inhibitors.
4. 3).
The patient should be advised that in the case of sudden visual defect, he should stop taking Levitra and consult immediately a physician (see section 4.3).
4. 2 og 4. 8).
Tolerability of the maximum dose of 20 mg may be lower in elderly patients (≥ 65 years old) (see sections 4.2 and 4.8).
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.
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.
Derfor bør vardenafil kun gives til disse patienter efter omhyggeligt at have vurderet fordele overfor risici.
Therefore vardenafil should be administered to these patients only after careful benefit-risk assessment.
In vitro- undersøgelser:
In vitro studies:
Vardenafil metaboliseres overvejende af leverenzymer via cytokrom P450 (CYP) - isoformen 3A4 men også via CYP3A5 - og CYP2C- isoformer.
Vardenafil is metabolised predominantly by hepatic enzymes via cytochrome P450 (CYP) isoform 3A4, with some contribution from CYP3A5 and CYP2C isoforms.
In vivo- undersøgelser:
In vivo studies:
Samtidig indgift af HIV- proteasehæmmeren indinavir (800 mg 3 gange daglig), en potent CYP3A4 - inhibitor, og vardenafil (10 mg) medførte en 16 dobbelt stigning af vardenafil AUC og en 7 dobbelt øgning af vardenafil Cmax.
Co-administration of the HIV protease inhibitor indinavir (800 mg three times a day), a potent CYP3A4 inhibitor, with vardenafil (10 mg) resulted in a 16-fold increase in vardenafil AUC and a 7-fold increase in vardenafil Cmax.
Samtidig indgift af vardenafil og ritonavir (600 mg 2 gange dagligt) medførte en 13 dobbelt øgning af vardenafil Cmax og en 49 dobbelt stigning af vardenafil AUC0- 24 ved samtidig indgift af 5 mg vardenafil.
Co-administration of vardenafil with ritonavir (600 mg twice daily) resulted in a 13-fold increase in vardenafil Cmax and a 49-fold increase in vardenafil AUC0-24 when co-administered with vardenafil 5 mg.
Ritonavir er en meget potent CYP3A4- inhibitor som også hæmmer CYP2C9.
The interaction is a consequence of blocking hepatic metabolism of Levitra by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9.
4. 3).
Ritonavir significantly prolonged the half-life of Levitra to 25.7 hours (see section 4.3).
4. 4).
Co-administration of ketoconazole (200 mg), a potent CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 10-fold increase in vardenafil AUC and a 4-fold increase in vardenafil Cmax (see section 4.4).
Skønt der ikke er foretaget specifikke interaktionsundersøgelser, kan samtidig anvendelse af andre potente CYP3A4- inhibitorer (som itraconazol) forventes at medføre vardenafil plasmaniveauer sammenlignelige med dem frembragt af ketoconazol.
Although specific interaction studies have not been conducted, the concomitant use of other potent CYP3A4 inhibitors (such as itraconazole) can be expected to produce vardenafil plasma levels comparable to those produced by ketoconazole.
Samtidig indgift af vardenafil og potente CYP 3A4- inhibitorer som f. eks. itraconazol og ketoconazol (oral anvendelse) bør undgås (se pkt 4. 3 og 4. 4).
Concomitant use of vardenafil with potent CYP 3A4 inhibitors such as itraconazole and ketoconazole (oral use) should be avoided (see sections 4.3 and 4.4).
4. 3).
In men older than 75 years the concomitant use of vardenafil with itraconazole or ketoconazole is contraindicated (see section 4.3)
Samtidig indgift af erythromycin (500 mg 3 gange dagligt), en CYP3A4- inhibitor, og vardenafil (5 mg) medførte en 4 dobbelt øgning af vardenafil AUC og en 3 dobbelt øgning af Cmax.
Co-administration of erythromycin (500 mg three times a day), a CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax.
4. 2. og 4. 4).
When used in combination with a moderate CYP 3A4 inhibitor such as erythromycin or clarithromycin, vardenafil dose adjustment might be necessary (see sections 4.2 and 4.4).
Hos raske frivillige forsøgspersoner havde cimetidin (400 mg 2 gange dagligt), en non- specifik cytokrom P450- inhibitor, ingen effekt på vardenafil AUC og Cmax ved indgift sammen med vardenafil (20 mg).
Cimetidine (400 mg twice daily), a non-specific cytochrome P450 inhibitor, had no effect on vardenafil AUC and Cmax when co-administered with vardenafil (20 mg) to healthy volunteers.
4. 4).
Grapefruit juice being a weak inhibitor of CYP3A4 gut wall metabolism, may give rise to modest increases in plasma levels of vardenafil (see section 4.4).
Farmakokinetikken af vardenafil (20 mg) blev ikke påvirket af samtidig indgift af H2- antagonisten ranitidin (150 mg 2 gange dagligt), digoxin, warfarin, glibenclamid, alkohol (gennemsnitligt maksimalt niveau på 73 mg/ dl alkohol i blodet), eller enkeltdoser af antacida (magnesiumhydroxid/ aluminiumhydroxid).
The pharmacokinetics of vardenafil (20 mg) was not affected by co-administration with the H2-antagonist ranitidine (150 mg twice daily), digoxin, warfarin, glibenclamide, alcohol (mean maximum blood alcohol level of 73 mg/ dl) or single doses of antacid (magnesium hydroxide/ aluminium hydroxide).
Acetylsalicylsyre, ACE- hæmmere, beta- blokkere, svage CYP3A4 - inhibitorer, diuretika og lægemidler til behandling af diabetes (sulfonylurinstoffer og metformin).
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 CYP 3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
5 Virkninger af vardenafil på andre præparater
5 Effects of vardenafil on other medicinal products
Der findes ikke data for interaktion mellem vardenafil og non- specifikke phosphodiesterase inhibitorer som theofyllin eller dipyridamol.
There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Der blev ikke observeret en forstærket hypotensiv effekt af sublingual nitroglycerin (0, 4 mg), når vardenafil (10 mg) blev givet med varierende tidsintervaller (1 til 24 timer) forud for nitroglycerindosen i et studie med 18 raske mandlige forsøgspersoner.
No potentiation of the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) was observed when vardenafil (10 mg) was given at varying time intervals (1 h to 24 h) prior to the dose of nitroglycerin in a study in 18 healthy male subjects.
Vardenafil 20 mg forstærkede den hypotentive effekt af sublingual nitroglycerin (0, 4 mg) indtaget 1 og 4 timer efter vardenafil administration hos raske midaldrende forsøgspersoner.
Vardenafil 20 mg potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4mg) taken 1 and 4 hours after vardenafil administration to healthy middle aged subjects.
Der sås ingen effekt på blodtrykket når nitroglycerin blev indtaget 24 timer efter administration af en enkelt dosis vardenafil på 20 mg.
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg.
4. 3).
However, there is no information on the possible potentiation of the hypotensive effects of nitrates by vardenafil in patients, and concomitant use is therefore contraindicated (see section 4.3).
Eftersom alfa- blokker- monoterapi kan medføre markant blodtrykssænkning, især postural hypotension og synkope, blev der udført interaktionsstudier med vardenafil.
Since alpha-blocker monotherapy can cause marked lowering of blood pressure, especially postural hypotension and syncope, interaction studies were conducted with vardenafil.
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.
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.