FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200% and 79% respectively.
Danish: Herudover er AUC og Cmaxværdierne for N-desmethylmetabolitten signifikant forhøjede, henholdsvis 200% og 79%.
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) påvirker ikke steady state farmakokinetikken af HIV-proteasehæmmerne saquinavir og ritonavir, som begge er CYP3A4-substrater.
English: If you experience sudden decrease or loss of vision, stop taking Sildenafil ratiopharm and contact your doctor IMMEDIATELY.
Danish: Hvis du oplever pludselig nedsættelse eller tab af synet, skal du STRAKS stoppe med at tage Sildenafil ratiopharm og kontakte lægen.
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 CYP-isoformer 1A2, 2C9, 2C19, 2D6, 2E1 og 3A4 (IC50 >150 μM).
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 vasodilatatoriske virkning, sandsynligvis som følge af øgede cGMP-niveauer i den glatte muskulatur i karrene.
English: This medicine 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 (højt blodtryk i lungerne) og kronisk tromboembolisk pulmonal hypertension (højt blodtryk i lungerne som følge af blodpropper).
English: At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7,
Danish: Ved den maksimale anbefalede dosis er der en over 80-gange større selektivitet over for PDE1 og mere end 700-gange over for PDE2, 3, 4, 7, 8, 9, 10 og 11.
English: Hypoaesthesia oral
Danish: Oral hypæstesi
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%), rygmarvsskade (0,6%), depression (5,2%), transuretral resektion af prostata (TURP) (3,7%), radikal prostatektomi (3,3%).
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 plasmakoncentration af fri sildenafil ca. 40%.
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: Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction
Danish: Samtidig brug af andre PDE5-hæmmere eller andre behandlinger af erektil dysfunktion
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 ses gennemsnitlig ekstra reduktioner i det systoliske og diastoliske blodtryk 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: NAME OF THE MARKETING AUTHORISATION HOLDER ratiopharm
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN ratiopharm
English: Sildenafil had no effect on ritonavir pharmacokinetics.
Danish: Sildenafil har ingen virkning på ritonavirs farmakokinetik.
English: (≥ 1/1,000 and
Danish: (≥ 1/1.000 og
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) er 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: Sildenafil has a peripheral site of action on erections.
Danish: Sildenafil har en perifer virkningsmekanisme på erektioner.
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: Skønt der ikke ses en øget incidens af bivirkninger hos disse patienter, når sildenafil gives sammen med CYP3A4-hæmmere, bør en startdosis på 25 mg overvejes.
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 penispletysmografiundersøgelse (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 (fra 12-37 minutter), når de fik sildenafil.
English: Tachycardia, Palpitations
Danish: Takykardi, palpitationer
English: - The other ingredients are: microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate, calcium hydrogen phosphate anhydrous, talc, macrogol 6000, titanium dioxide, iron oxide red.
Danish: - Øvrige indholdsstoffer: Cellulose, mikrokrystallinsk, hypromellose, croscarmellosenatrium, magnesiumstearat, calciumhydrogenfosfat (vandfrit), talkum, macrogol 6000, titandioxid, rød jernoxid
English: Effects of sildenafil on other medicinal products In vitro studies
Danish: Virkninger af sildenafil på andre præparater In vitro studier
English: In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.
Danish: I en anden RigiScan-undersøgelse var sildenafil stadig i stand til at give erektion efter seksuel stimulation 4-5 timer efter dosisindtagelsen.
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 CYP3A4-hæmmere (som f.eks. ketoconazol, erythromycin, cimetidin).
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Sildenafil ratiopharm i alle undergrupper af den pædiatriske population for behandling af erektil dysfunktion (se pkt.
English: Tell your doctor if you are taking any of these medicines.
Danish: Fortæl det til lægen, hvis du tager denne type medicin.
English: Sildenafil ratiopharm is not indicated for use by women.
Danish: Sildenafil ratiopharm er ikke indiceret til anvendelse hos kvinder.
English: Effects of other medicinal products on sildenafil In vitro studies
Danish: Virkninger af andre præparater på sildenafil In vitro studier
English: Since sildenafil (and its major circulating N-desmethyl metabolite) is 96% bound to plasma proteins, this results in the mean maximum free plasma concentration for sildenafil of 18 ng/mL (38 nM).
Danish: Da 96% af sildenafil (og dets væsentligste cirkulerende N-desmethylmetabolit) er bundet til plasmaproteiner, resulterer dette i den gennemsnitlige frie plasmakoncentration af sildenafil på ca. 18 ng/ml (38 nM).
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 gives samtidigt til patienter, der er stabiliseret på doxazosinbehandling, ses af og til rapporter, hvor patienter oplever symptomatisk postural hypotension.
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 hjerteinfarkt og kendte arvelige degenerative sygdomme i retina som retinitis pigmentosa (et mindretal af disse patienter har arvelige sygdomme i nethindens fosfodiesteraser).
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.
English: Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects.
Danish: Sildenafil giver let og forbigående fald i blodtrykket, som i størstedelen af tilfældene ikke kan opfattes som klinisk relevant.
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 er sildenafils plasmaniveauer stadig ca. 200 ng/ml sammenlignet med ca. 5 ng/ml, når sildenafil bliver givet alene.
English: Taking Sildenafil ratiopharm together with some medicines may lead to problems.
Danish: Hvis Sildenafil ratiopharm tages sammen med visse medicintyper kan de give problemer.
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 postulerede mekanisme bag denne forandring i farveskelnen skyldes en hæmning af PDE6, som er involveret i lysoverførelsen i retina.
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 givet sammen med amlodipin til hypertensive patienter, sås en ekstra reduktion i systolisk blodtryk i liggende stilling på 8 mmHg.
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) anvendt samtidigt hos patienter med benign prostatahyperplasi (BPH) stabiliseret på doxazosinbehandling.
English: In a study of the haemodynamic 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 en 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: 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 vasodilatatorer omfatter patienter med obstruktion af venstresidig ventrikulær udløb (f.eks. aorta stenose, hypertrofisk obstruktiv kardiomyopati) eller patienter med det sjældne syndrom multipel systematrofi, som manifesterer sig som alvorligt nedsat autonom kontrol af blodtrykket.
English: There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration.
Danish: Der findes ingen oplysninger om sikkerhed ved indgift af sildenafil hos patienter med blødningsforstyrrelser eller aktivt peptisk mavesår.
English: This is when a man cannot get or keep a hard, erect penis suitable for sexual activity.
Danish: Dette kendetegnes ved manglende evne til at opnå eller opretholde rejsning af penis, som gør den egnet til seksuel aktivitet.
English: In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.
Danish: I kontrollerede kliniske undersøgelser var antallet af patienter, som afbrød behandlingen lav og svarende til placebo.
English: Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to 100 mg as necessary.
Danish: Vurderet ud fra effekt og tolerance kan dosis øges trinvis til 50 mg og op til 100 mg efter behov.
English: Adverse reactions from post-marketing surveillance has been gathered covering an estimated period > 10 years.
Danish: I bivirkningsovervågningen efter markedsføringen er der indsamlet bivirkninger i en periode på mere end 10 år.
English: In a medical emergency, you must tell anyone treating you that you have taken Sildenafil ratiopharm.
Danish: I tilfælde af akut sygdom eller tilskadekomst, skal du fortælle det sundhedspersonale, som behandler dig, at du har taget Sildenafil ratiopharm.
English: If you take more Sildenafil ratiopharm than you should Men who take too much Sildenafil ratiopharm may experience more side effects or may get severe muscle pain.
Danish: Hvis du har taget for mange Sildenafil ratiopharm tabletter Mænd, som tager for mange Sildenafil ratiopharm-tabletter, kan få flere bivirkninger og alvorlige muskelsmerter.
English: Taking these medicines with Sildenafil ratiopharm could seriously affect your blood pressure.
Danish: Hvis denne medicintype tages sammen med Sildenafil ratiopharm, kan det have en stærk indvirkning på dit blodtryk.
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 moderat nedsat nyrefunktion (kreatininclearance = 30-80 ml/min) ændres farmakokinetikken ikke efter en enkelt oral dosis på 50 mg.
English: If you experience any of the following serious side effects stop taking Sildenafil ratiopharm and seek medical help immediately:
Danish: Hvis du oplever nogen af de følgende bivirkninger skal du stoppe med at tage Sildenafil ratiopharm og øjeblikkeligt søge læge:
English: When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP.
Danish: Når NO/cGMPvejen er aktiveret, som det sker ved seksuel stimulation, fører sildenafils hæmning af PDE5 til øgede cGMP-niveauer i corpus cavernosum.
English: The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg.
Danish: Det gennemsnitlige maksimale fald i systolisk blodtryk i liggende stilling efter 100 mg sildenafil oralt var 8,4 mmHg.
English: In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
Danish: Hos normale raske mandlige frivillige forsøgspersoner var der for azithromycin (500 mg dagligt i 3 dage) ingen tegn på ændringer af AUC, Cmax, tmax, eliminationshastighedskonstanten eller efterfølgende halveringstid for sildenafil eller dets væsentligste cirkulerende metabolit.
English: Do not use this medicine after the expiry date which is stated on the outer carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In healthy volunteers receiving sildenafil (100 mg single dose), less than 0.0002% (average 188 ng) of the administered dose was present in ejaculate 90 minutes after dosing.
Danish: Hos raske forsøgspersoner, som fik sildenafil (100 mg som enkeltdosis), fandtes mindre end 0,0002% (gennemsnitlig 188 ng) af indgivet dosis i ejakulatet 90 minutter efter indgift.
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, placebo-kontrolleret 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, farvesskelnen ved simuleret trafiklys, Humphrey perimeter og fotostress).
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, inklusive 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: Concomitant use with ritonavir
Danish: Samtidig brug af ritonavir
English: Symptoms may include severe peeling and swelling of the skin, blistering of the mouth, genitals and around the eyes, fever.
Danish: Symptomerne kan omfatte kraftig afskalling og opsvumlen af huden, små vabler i munden samt omkring kønsorganerne og øjnene, feber.
English: A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Sygdomshistorie bør gennemgås, og en objektiv undersøgelse foretages for at stille diagnosen erektil dysfunktion og mulige underliggende årsager skal fastslås, før farmakologisk behandling overvejes.
English: Pooling of the following classes of antihypertensive medication, diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment.
Danish: Pooling af følgende klasser af antihypertensiva: Diuretika, beta-blokkere, ACE-hæmmere, angiotensin II antagonister, antihypertensiva (vasodilatatorer og centralt virkende), adrenerge neuroblokkere, calciumblokkere og alfa-adrenerge receptorblokkere viste ingen forskel i bivirkningsprofil hos patienter, som tog sildenafil sammenlignet med placebobehandling.
English: - if you have a severe liver problem.
Danish: - hvis du har alvorlige leverproblemer.
English: Agents for the treatment of erectile dysfunction, including sildenafil, should 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).
Danish: Stoffer til behandling af erektil dysfunktion, inklusive sildenafil, bør ikke anvendes af mænd, som frarådes seksuel aktivitet (f.eks. patienter med alvorlige kardiovaskulære lidelser som ustabil angina pectoris eller alvorligt hjertesvigt).
English: The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
Danish: Følgende grupper var ikke tilstrækkeligt repræsenteret eller var ekskluderet fra kliniske studier: Patienter med bækkenindgreb, patienter i behandling med radioterapi, patienter med alvorlig nyre- eller leverinsufficiens og patienter med visse hjerte-karsygdomme (se pkt.
English: Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Danish: Sildenafil har vasodilatatoriske egenskaber, som resulterer i lette og forbigående fald i blodtrykket (se pkt.
English: Do NOT take Sildenafil ratiopharm if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called “poppers”).
Danish: Tag IKKE Sildenafil ratiopharm, hvis du tager medicin, som indeholder nitrater (f.eks. glyceryltrinitrat) eller nitrogenoxiddonorer (f.eks. amylnitrit, også kaldet “poppers”).
English: The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied.
Danish: Farmakokinetikken af sildenafil er ikke undersøgt hos patienter med alvorlig leverinsufficiens.
English: Other medicines and Sildenafil ratiopharm Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Sildenafil ratiopharm Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Sildenafil ratiopharm indeholder det aktive stof sildenafil, der tilhører en gruppe medicin, som kaldes fosfodiesterase type 5 (PDE5)-hæmmere.
English: In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Danish: For at reducere muligheden for udvikling af postural hypotension bør patienter være hæmodynamisk stabile på alfa-blokker-behandling, før sildenafil-behandling initieres.
English: Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
Danish: Enkelte orale doser af sildenafil på op til 100 mg bevirkede ingen klinisk relevant virkning på EKG hos raske frivillige forsøgspersoner.
English: Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
Danish: Doser på 200 mg giver ikke øget effekt, men incidensen af bivirkninger (hovedpine, flushing, svimmelhed, dyspepsi, tilstopning af næsen, synsforstyrrelser) øges.