FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
Danish: Der er ingen data vedrørende interaktion af sildenafil og ikke specifikke fosfodiesterasehæmmere, som teofyllin eller dipyridamol.
English: After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range (25-100 mg).
Danish: Efter oral indgift af sildenafil øges AUC og Cmax proportionalt med dosis over det anbefalede dosisområde (25-100 mg).
English: Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity.
Danish: Før ordination af sildenafil bør lægen omhyggeligt overveje, om patienter med visse underliggende tilstande vil kunne blive påvirket på en uønsket måde af den vasodilatoriske effekt, specielt i forbindelse med seksuel aktivitet.
English: You should not take Sildenafil Actavis if you are a woman.
Danish: Du bør ikke tage Sildenafil Actavis, hvis du er kvinde.
English: Pregnancy, breast-feeding and fertility Sildenafil Actavis is not indicated for use by women.
Danish: Graviditet, amning og frugtbarhed Sildenafil Actavis er ikke beregnet til at bruges af kvinder.
English: In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on placebo.
Danish: I fastdosisundersøgelser var den del af patienterne, som rapporterede, at behandlingen forbedrede deres erektioner 62% (25 mg), 74% (50 mg) og 82% (100 mg) sammenlignet med 25% på placebo.
English: Lactose monohydrate Microcrystalline cellulose Povidone K29-32
Danish: Lactosemonohydrate Mikrokrystallinsk cellulose Povidon K29-32
English: When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension.
Danish: Når sildenafil og doxazosin blev administreret samtidigt til patienter, der var stabiliseret på doxazosinbehandling, sås af og til rapporter om patienter, som oplevede symptomatisk postural hypotension.
English: Sildenafil Actavis is not indicated for use by women.
Danish: Sildenafil Actavis er ikke indiceret til anvendelse hos kvinder.
English: Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Danish: Nitrogenoxid aktiverer derefter enzymet guanylatcyklase, hvilket resulterer i øgede koncentrationer af cyklisk guanosimonofosfat (cGMP), som fører til afslapning af den glatte muskulatur i corpus cavernosum og tillader blodet at strømme til.
English: Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation.
Danish: To kliniske studier var specielt udarbejdet med henblik på at bestemme den tidsramme efter indtagelse, indenfor hvilken sildenafil kunne producere en erektion efter seksuel stimulation.
English: The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.
Danish: Den fysiologiske mekanisme bag erektion af penis omfatter frigivelse af nitrogenoxid (NO) i copus cavernosum under seksuel stimulation.
English: Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly.
Danish: Nogle patienter, som er i behandling med en alfa-blokker til behandling af højt blodtryk eller vandladningsbesvær ved forstørret prostata, kan opleve svimmelhed eller uklarhed, som skyldes lavt blodtryk, når man hurtigt sætter sig ned eller rejser sig op.
English: Titanium dioxide (E171) Macrogol 6000
Danish: Hypromellose Titandioxid (E171) Magrogol 6000
English: These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
Danish: Disse yderligere blodtryksreduktioner var af samme størrelsesorden, som når sildenafil blev administreret alene til raske frivillige forsøgspersoner (se pkt.
English: In these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed.
Danish: Hos disse studiepopulationer blev der observeret gennemsnitlig ekstra reduktioner i blodtrykket i liggende stilling på henholdsvis 7/7 mmHg, 9/5 mmHg og 8/4 mmHg, og gennemsnitlig ekstra reduktioner i blodtryk i stående stilling på henholdsvis 6/6 mmHg, 11/4 mmHg og 4/5 mmHg.
English: Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.
Danish: Undersøgelse med humane blodplader indikerer, at sildenafil forstærker den antiaggregatoriske effekt af natriumnitroprussid in vitro.
English: At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was administered alone.
Danish: Efter 24 timer var sildenafils plasmaniveauer stadig ca. 200 ng/ml sammenlignet med ca. 5 ng/ml, når sildenafil blev administreret alene.
English: As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil Actavis, before driving or operating machinery.
Danish: Da der er rapporteret svimmelhed og ændret syn i kliniske studier med sildenafil, bør patienter være opmærksomme på, hvordan de reagerer på Sildenafil Actavis, inden de kører bil eller betjener maskiner.
English: The dosing recommendations described in ‘Use in adults' apply to patients with mild to moderate renal impairment (creatinine clearance=30-80 mL/min).
Danish: Dosisanbefalingerne under ”anvendelse hos voksne” gælder for patienter med let til moderat nedsat nyrefunktion (kreatininclearance = 30-80 ml/min).
English: Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP.
Danish: Sildenafil er en potent og selektiv hæmmer af cGMP-specifik fosfodiesterase type 5 (PDE5) i corpus cavernosum, hvor PDE5 er ansvarlig for nedbrydning af cGMP.
English: From post-marketing experience cases of unstable angina (a heart condition) and sudden death have been reported rarely.
Danish: Efter markedsføring er der rapporteret om sjældne tilfælde af en hjertelidelse, kaldet ustabil angina, og pludselig død.
English: Sildenafil Actavis can cause dizziness and can affect vision.
Danish: Sildenafil Actavis kan forårsage svimmelhed og kan påvirke synet.
English: Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
Danish: Sildenafil (100 mg) påvirkede ikke steady state farmakokinetikken af HIV-proteasehæmmerne, saquinavir og rinatovir, som begge er CYP3A4-substrater.
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50>150 µM).
Danish: Sildenafil er en svag hæmmer af cytokrom P450-isoformer 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50>150 µM).
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 79% and 200% respectively.
Danish: Herudover er AUC og Cmax vædierne for N-desmethylmetabolitten signifikat forhøjede, henholdsvis 79% og 200%.
English: Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg.
Danish: På basis af effekt og tolerabilitet kan dosis øges til 100 mg eller sænkes til 25 mg.
English: Due to age-differences in plasma protein binding, the corresponding increase in free sildenafil plasma concentration was approximately
Danish: Som følge af aldersforskelle i plasmaproteinbindingen er den tilsvarende stigning i plasmakoncentartionen af fri sildenafil ca. 40%.
English: Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with no effects evident after 2 hours post-dose.
Danish: Lette og forbigående forskelle i evnen til at skelne farver (blå/grøn) blev set hos nogle individer ved hjælp af Farnsworth-Munsell 100 nuance test 1 time efter en dosis på 100 mg dog uden synlig effekt 2 timer efter indtagelse.
English: To get the maximum benefit from your medicine, you are advised not to drink excessive amounts of alcohol before taking Sildenafil Actavis.
Danish: For at få den fulde virkning af din medicin, bør du ikke drikke alkohol i meget store mængder, før du tager Sildenafil Actavis.
English: No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Danish: Der sås ingen signifikante interaktioner ved indgift af sildenafil (50 mg) sammen med tolbutamid (250 mg) eller warfarin (40 mg), som begge metaboliseres af CYP2C9.
English: Your doctor may start you on a lower dose (25 mg) of Sildenafil Actavis.
Danish: Lægen kan give dig en lavere begyndelsesdosis (25 mg) af Sildenafil Actavis.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: Sildenafil Actavis contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Sildenafil Actavis indeholder det aktive stof sildenafil, der tilhører en gruppe medicin, som kaldes fosfodiesterase type 5 (PDE5)-hæmmere.
English: Sildenafil had no effect on ritonavir pharmacokinetics.
Danish: Sildenafil har ingen effekt på ritonavirs farmakokinetik.
English: These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle.
Danish: Disse blodtryksfald svarer til sildenafils vasadilatoriske effekt, sandsynligvis som følge af øgede cGMP-niveauer i den vaskulære glatte muskulatur.
English: Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.
Danish: Defor er seksuel stimulation nødvendig for sildenafils tilsigtede fordelagte farmakologiske effekt.
English: The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
Danish: Følgende patientgrupper var repræsenteret: Ældre(19,9%), patienter med hypertension (30,9%), diabetes mellitus (20,3%), iskæmisk hjertesygdom (5,8%), hyperlipidæmi (19,8%), rygmarvskade (0,6%), depression (5,2%), transuretal resektion af prostata (TURP) (3,7%), radikal prostatektomi (3,3%).
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Danish: Denne metabolit har en fosfodiesterase selektivitetsprofil svarende til sildenafil og in vitro styrke over for PDE5 på ca 50% af moderstoffet.
English: In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil.
Danish: I en penis-pletysmonografiundersøgelse (RigiScan) hos fastende patienter var den gennemsnitlige tid til indsættende effekt for dem, som fik erektioner med 60% stivhed (nok til gennemførelse af samleje) 25 minutter (intervallet 12-37 minutter), når de fik sildenafil.
English: Sildenafil Actavis is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Danish: Sildenafil Actavis er indiceret til voksne mænd med erektil dysfunktion, hvilket er manglende evne til at opnå eller vedligeholde en erektion af penis, som er tilstrækkelig tilfredsstillende til seksuel aktivitet.
English: Table 1: Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance
Danish: Tabel 1: Medicinsk vigtige bivirkninger, som er rappoteret i kontrollerede kliniske studier med en hyppighed større end placebo samt medicinsk vigtige bivirkninger rappoteret gennem overvågning efter markedsføring.
English: Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered.
Danish: Selvom der ikke ses en øget incidens af bivirkninger hos disse patienter, når sildenafil administreres sammen med CYP3A4-hæmmere, bør en startdosis på 25 mg overvejes.
English: Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine).
Danish: Populationsfarmakokinetiske analyser af kliniske studiedata tyder på en reduktion af sildenafils clearance ved indgift sammen med CYPP3A4-hæmmere (som f.eks. ketoconazol, erythromycin, cimetidin).
English: Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of sildenafil without sexual activity.
Danish: Få hændelser er rappoteret som opstået kort tid efter brugen af sildenafil uden seksuel aktivitet.
English: Sildenafil Actavis tablets may interfere with some medicines, especially those used to treat chest pain.
Danish: Sildenafil Actavis tabletter kan påvirke virkningen af anden medicin, især medicin til behandling af brystsmerter.
English: This is most likely to happen within 4 hours after taking Sildenafil Actavis.
Danish: Dette vil for det meste ske inden for 4 timer efter, at du har taget Sildenafil Actavis.
English: The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction and known hereditary degenerative retinal disorders such as retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
Danish: Sikkerheden af sildenafil er ikke undersøgt i følgende patientundergrupper, og dets anvendelse er derfor kontraindiceret: Alvorlig leverinsufficiens, hypotension (blodtryk under 90/50 mmHg), nyligt overstået stroke eller hjerteinfakt og kendte arvelige degenerative sygdommer i retina som retinitis pigmentose (et mindretal af disse patienter har arvelige sygdomme i nethindens fosfodiesteraser).
English: In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Danish: I 3 specifikke lægemiddellægemiddel interaktionsundersøgelser blev alfa-blokkeren doxazosin (4 mg og 8 mg) og sildenafil (25 mg, 50 mg eller 100 mg) administreret samtidig hos patienter med benign prostatahyperplasi (BPH) stabiliseret på dosazosinbehandling.
English: Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
Danish: Patienter med øget følsomhed over for vasodilatorer, omfatter patienter med obstruktion af venstresidig ventrikulær udløb (f.eks. aorta stenose, hypertrofisk obstruktiv kardiomyopati) eller patienter med det sjælne syndrom multipel systematrofi, som manifesterer sig som alvorligt nedsat autonom kontrol af blodtrykket.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: DATO FOR ÆNDRING AF TEKSTEN <Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.>
English: The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina.
Danish: Den postulerende mekanisme bag denne forandring i farveskelen skyldes en hæmning af PDE6, som er involveret i lysoverførelsen i retina.
English: You should be aware of how you react to Sildenafil Actavis before you drive or use machinery.
Danish: Vær opmærksom på, hvordan du reagere på Sildenafil Actavis inden bilkørsel eller betjening af maskiner.
English: Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years.
Danish: I bivirkningsovervågningen efter markedsføring er der indsamlet bivirkninger i en periode på mere end 10 år.
English: - Serious skin reactions - this occurs rarely Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.
Danish: - Alvorlige hudreaktioner - dette ses sjældent Symptomerne kan omfatte kraftig afskalning og hævelse af huden, små vabler i munden samt omkring kønsorganerne og øjnene, feber.
English: Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors (see section 4.8).
Danish: Tilfælde af non-arteritis anterior iskæmisk opticus-neuropati, der er en sjælden tilstand, er både rapporteret spontant og i et observationsstudie i forbindelse med indtagelse af sildenafil og andre PDE5-hæmmere (se pkt.
English: In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Danish: I et klinisk studie af de hæmodynamiske virkninger efter én enkelt oral dosis på 100 mg sildenafil hos 14 patienter med alvorlig koronararteriesygdom (CAD) (>70% stenoser i mindst 1 koronararterie) faldt det gennemsnitlige hvilende systoliske og diastoliske blodtryk med henholdsvis 7% og 6% sammenlignet med baseline.
English: If Sildenafil Actavis does not help you to get an erection, or if your erection does not last long enough for you to complete sexual intercourse you should tell your doctor.
Danish: Hvis Sildenafil Actavis ikke hjælper til at give erektion, eller hvis erektionen ikke varer længe nok til at gennemføre samleje, bør lægen informeres.
English: You should not take Sildenafil Actavis if you do not have erectile dysfunction.
Danish: Du bør ikke tage Sildenafil Actavis, hvis du ikke har erektil dysfunktion.
English: In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress).
Danish: I en mindre, placebokontrolleret undersøgelse hos patienter med dokumenteret tidlig aldersrelateret makuløs degenerering (n=9) viste sildenafil (100 mg enkeltdosis) ingen signifikante ændringer i de udførte visuelle test (visuel skarphed, Amsler-kort, farveskelen ved simuleret trafiklys, Humphrey perimeter og fotostress).
English: Sildenafil Actavis contains lactose
Danish: Sildenafil Actavis indeholder lactose
English: Do not take Sildenafil Actavis with other medicines unless your doctor tells you that you can.
Danish: Tag ikke Sildenafil Actavis sammen med anden medicin, uden din læge har anbefalet det.
English: croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide (E171),
Danish: croscarmellosenatrium, magnesiumstearat, hypromellose, titandioxid (E171), magrogol 6000,
English: In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Danish: I en særlig interaktionsundersøgelse, hvor sildenafil (100 mg) blev administreret sammen med amlodipin til hypertensive patienter, sås en ektra reduktion i systolisk blodtryk i liggende stilling på 8 mmHg.
English: In volunteers with mild to moderate renal impairment (creatinine clearance=30-80 mL/min), the pharmacokinetics of sildenafil were not altered after receiving a 50 mg single oral dose.
Danish: Hos frivillige forsøgspersoner med let til modrat nedsat nyrefunktion (kreatininclearance = 30-80 ml/min) ændres farmakokinetikken ikke efter én enkelt oral dosis på 50 mg.
English: The mean AUC and Cmax of the N-desmethyl metabolite increased 126% and 73% respectively, compared to age-matched volunteers with no renal impairment.
Danish: Gennemsnitlig AUC og Cmax af N-desmethylmetabolitten øges med henholdsvis 126% og 73% sammenlignet med frivillige forsøgspersoner med samme alder uden nedsat nyrefunktion.
English: Stevens-Johnson Syndrome (SJS),*
Danish: Stevens-Johnsons syndrom (SJS)*, toksisk epidermal nekrolyse (TEN)*
English: Sildenafil Actavis should not be administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Danish: Sildenafil Actavis bør derfor ikke anvendes til mænd med arvelig galactoseintolerans, en særlig form for hereditær lactasemangel, Lapp Lactase deficiency eller glucose/galactosemalabsorption.
English: If you get any side effects, talk to you doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.
Danish: Grapefrugtjuice er en svag CYP3A4-hæmmer af tarmvæggens metabolisme og kan give en mindre stigning i plasmakoncentrationen af sildenafil.
English: Agents for the treatment of erectile dysfunction, including sildenafil, 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: Præparater til behandling af erektil dysfunktion, herunder sildenafil, bør anvendes med forsigtighed hos patienter med anatomisk deformitet af penis (som f.eks. vinkling, kavernøs fibrose eller Peyronies sygdom), eller hos patienter med lidelser, som kan prædisponere til priapisme (som f.eks. seglcelleanæmi, multipelt myelom eller leukæmi).
English: You should not use Sildenafil Actavis with any other oral or local treatments for erectile dysfunction.
Danish: Du bør ikke anvende Sildenafil Actavis sammen med andre orale eller lokale behandlinger for erektildysfunktion.
English: Sildenafil Actavis potentiates the hypotensive effect of nitrates (see section 4.3).
Danish: Sildenafil Actavis forstærker nitraters hypotensive effekt (se pkt.