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, så som teofyllin eller dipyridamol.
English: Effects of other medicinal products on sildenafil
Danish: Virkninger af andre præparater på sildenafil
English: System Organ Class
Danish: Systemorgan-klasse Meget almindelig
English: Do not take Vizarsin with other medicines unless your doctor tells you that you can.
Danish: Tag ikke Vizarsin sammen med anden medicin, medmindre din læge har anbefalet det.
English: Vizarsin 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: Vizarsin er indiceret til voksne mænd med erektil dysfunktion, hvilket er manglende evne til at opnå eller vedligeholde en erektion af penis, som er tilstrækkelig til tilfredsstillende seksuel aktivitet.
English: Do not take Vizarsin orodispersible tablets with any other forms of Vizarsin.
Danish: Tag ikke Vizarsin smeltetabletter sammen med andre former af Vizarsin.
English: This is consistent with ritonavir's marked effects on a broad range of P450 substrates.
Danish: Dette er i overensstemmelse med ritonavirs udtalte virkning på et bredt udvalg af P450-substrater.
English: - Chest pains - this occurs uncommonly If this occurs during or after intercourse: - Get in a semi-sitting position and try to relax.
Danish: - Smerter i brystet - dette ses ikke almindeligt Hvis dette sker under eller efter samleje: - Sæt dig op i en tilbagelænet stilling og prøv at slappe af.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development.
Danish: De præ-kliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet og reproduktions- og udviklingstoksicitet.
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 vand-ladningsbesvær ved forstørret prostata, kan opleve svimmelhed eller uklarhed, som skyldes lavt blodtryk, når man hurtigt sætter sig ned eller rejser sig op.
English: - If you have certain rare inherited eye diseases (such as retinitis pigmentosa).
Danish: - hvis du har visse alvorlige arvelige øjensygdomme (som retinitis pigmentosa).
English: The major circulating metabolite results from N-demethylation of sildenafil.
Danish: Den væsentligste cirkulerende metabolit er resultatet af en Ndemethylering af sildenafil.
English: Vizarsin contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Vizarsin indeholder det aktive stof sildenafil, der tilhører en gruppe medicin, som kaldes fosfodiesterase type 5 (PDE5)-hæmmere.
English: Do not store above 30C.
Danish: Må ikke opbevares ved temperaturer over 30°C.
English: You should not use Vizarsin with any other oral or local treatments for erectile dysfunction.
Danish: Du bør ikke anvende Vizarsin sammen med andre orale eller lokale behandlinger for erektil dysfunktion.
English: Magnesium stearate (E572)
Danish: Magnesiumstearat (E572)
English: If Vizarsin is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Danish: Hvis Vizarsin indtages sammen med føde, kan virkningens indtræden forsinkes i forhold til indtagelse under fastende forhold (se pkt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Danish: 9 DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: - If you experience sudden decrease or loss of vision, stop taking Vizarsin and contact your doctor immediately.
Danish: - hvis du oplever pludselige nedsættelser af synet eller tab af synet, skal du stoppe med at tage Vizarsin og straks søge læge.
English: What you need to know before you take Vizarsin
Danish: Det skal du vide, før du begynder at tage Vizarsin
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 rinatovir, som begge er CYP3A4-substrater.
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: Paediatric population Vizarsin is not indicated for individuals below 18 years of age.
Danish: Pædiatrisk population Vizarsin er ikke beregnet til personer under 18 år.
English: It works by helping to relax the blood vessels in your penis, allowing blood to flow into your penis when you get sexually excited.
Danish: Det afslapper blodkarrene i penis og tillader blodet at strømme ind i penis ved seksuel stimulation.
English: How to take Vizarsin
Danish: Sådan skal du tage Vizarsin
English: Given sildenafil peak plasma concentrations of approximately 1 μM after recommended doses, it is unlikely that sildenafil will alter the clearance of substrates of these isoenzymes.
Danish: Med sildenafils maksimale plasmakoncentration på ca. 1 μM efter anbefalede doser, er det usandsynligt, at sildenafil vil ændre clearance af substrater af disse isoenzymer.
English: They should not be pushed through the foil in the blister pack as this will cause damage to the tablet.
Danish: De må ikke trykkes gennem blisterfolien, da dette vil ødelægge tabletten.
English: - If you currently have a stomach ulcer, or a bleeding problems (such as haemophilia).
Danish: - hvis du for tiden har mavesår eller blødningsforstyrrelser (som f.eks. hæmofili).
English: If you experience any of the following serious side effects stop taking Vizarsin and seek medical help immediately:
Danish: Hvis du oplever nogen af de følgende bivirkninger skal du stoppe med at tage Vizarsin og øjeblikkeligt søge læge:
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 studie data tyder på en reduktion af sildenafils clearance ved indgift sammen med CYP3A4-hæmmere (som f.eks. ketoconazol, erythromycin, cimetidin).
English: Pharmacotherapeutic group: Urologicals, drugs used in erectile dysfunction, ATC code: G04BE03.
Danish: Farmakoterapeutisk klassifikation: Urogenitalsystem og kønshormoner: Systemiske midler til erektil dysfunktion, ATC kode G04BE03.
English: Vizarsin contains sorbitol.
Danish: Vizarsin indeholder sorbitol.
English: You should not take Vizarsin if you do not have erectile dysfunction.
Danish: Du bør ikke tage Vizarsin, hvis du ikke har erektil dysfunktion.
English: - If you have a severe heart or liver problem.
Danish: - Hvis du har alvorlige hjerte-eller leverproblemer.
English: Effects of sildenafil on other medicinal products
Danish: Virkninger af sildenafil på andre præparater
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: No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
Danish: I reproduktionsstudier med rotter og kaniner sås ingen relevante ugunstige virkninger efter oral indgift af sildenafil.
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: You should be aware of how you react to Vizarsin before you drive or use machinery.
Danish: Vær opmærksom på, hvordan du reagerer på Vizarsin inden bilkørsel eller betjening af maskiner.
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: 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 sjældne syndrom multipel systematrofi, som manifesterer sig som alvorligt nedsat autonom kontrol af blodtrykket.
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: 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: If Vizarsin 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 Vizarsin ikke hjælper til at give erektion, eller hvis erektionen ikke varer længe nok til at gennemføre samleje, bør du sige det til lægen.
English: - Seizures or fits - this occurs rarely
Danish: - Kramper eller krampeanfald - dette ses sjældent
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 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: Do not take Vizarsin: - If you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section
Danish: Tag ikke Vizarsin: - hvis du er allergisk over for sildenafil eller et af de øvrige indholdsstoffer i denne medicin
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: Nitrogenoxyd aktiverer derefter enzymet guanylatcyklase, hvilket resulterer i øgede koncentrationer af cyklisk guanosinmonofosfat (cGMP), som fører til afslapning af den glatte muskulatur i corpus cavernosum og tillader blodet at strømme til.
English: In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.
Danish: I kontrollerede kliniske studier var antallet af patienter, som afbrød behandlingen lav og svarende til placebo.
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: Calcium silicate
Danish: Calciumsilicat
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: You may find that Vizarsin takes longer to work if you take it with a heavy meal.
Danish: Det kan vare længere inden Vizarsin virker, hvis det tages sammen med et tungt måltid.
English: - If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
Danish: - hvis du har en abnormitet af de røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi), knoglemarvskræft (multipelt myelom).
English: Elderly Dosage adjustments are not required in elderly patients (≥ 65 years old).
Danish: Ældre(≥65 år) Dosisjustering er ikke nødvendig hos ældre.
English: Always tell your doctor, pharmacist or nurse if you are taking any of these medicines that are often used for the relief of angina pectoris (or “chest pain”).
Danish: Fortæl altid lægen, på apoteket eller sundhedspersonalet, hvis du tager denne type medicin, der bruges til lindring af angina pectoris (smerter i brystet).
English: Use in adults:
Danish: Voksne:
English: for 1 tablet per blister:
Danish: for 1 tablet pr. blister:
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 afskalling og opsvumlen af huden, små vabler i munden samt omkring kønsorganerne og øjnene, feber.
English: Rare ( 1/10000 and
Danish: Sjælden ( 1/10.000 og <1/1.000)
English: In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased by 200 % and 79 % respectively.
Danish: Herudover er AUC og Cmax-værdierne for N-desmethylmetabolitten signifikant forhøjede, henholdsvis 200% og
English: PDE5 inhibitors, such as Vizarsin have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som Vizarsin, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: For 4 tablets per blister:
Danish: for 4 tabletter pr. blister:
English: Vizarsin is not indicated for use by women.
Danish: Vizarsin er ikke indiceret til anvendelse hos kvinder.
English: Since sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered.
Danish: Da sildenafil clearance er nedsat hos patienter med leverinsufficiens (f.eks. cirrhose) skal en 25 mg dosis overvejes.
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 givet alene til raske frivillige forsøgspersoner (se pkt.
English: If you are not certain, ask your doctor or pharmacist.
Danish: Er du usikker, så spørg lægen eller på apoteket.
English: Other medicines and Vizarsin
Danish: Brug af anden medicin sammen med Vizarsin
English: Tell your doctor if you are taking any of these medicines which are often given for relief of angina pectoris (or “chest pain”).
Danish: Fortæl det til lægen, hvis du tager denne type medicin, der bruges til at lindre angina pectoris (smerter i brystet).
English: However, you may find that Vizarsin takes longer to start working if you take it with a heavy meal.
Danish: Du kan måske opleve, at det kan tage lidt længere tid før Vizarsin virker, hvis du har spist et tungt måltid.
English: Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
Danish: Indeholder aspartam (E951) og pebermynteolie (sorbitol (E420)).
English: You should not use Vizarsin with treatments for pulmonary arterial hypertension (PAH) containing sildenafil or any other PDE5 inhibitors.
Danish: Du bør ikke tage Vizarsin, hvis du samtidig bliver behandlet for pulmonal arteriel hypertension (PAH) med et lægemiddel, der indeholder sildenafil, eller hvis du samtidig får en anden PDE5-hæmmere.
English: Pregnancy and breast-feeding Vizarsin is not indicated for use by women.
Danish: Graviditet og amning Vizarsin er ikke beregnet til at bruges af kvinder.
English: Vizarsin tablets may interfere with some medicines, especially those used to treat chest pain.
Danish: Vizarsin tabletter kan påvirke virkningen af anden medicin, især medicin til behandling af smerter i brystet.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Danish: Skønt der ikke er foretaget specifikke interaktionsundersøgelser for alle lægemidler, viste populationsfarmakokinetiske analyser, at sildenafils farmakokinetik ikke blev påvirket ved samtidig indgift med CYP2C9 hæmmere (som tolbutamid, warfarin, fenytoin), CYP2D6 hæmmere (som selektive serotonin re-uptake hæmmere, tricykliske antidepressiva), tiazider og beslægtede diuretika, loop- og kaliumbesparende diuretika, ACE-hæmmere, calciumblokkere, beta-adrenerge receptorantagonister eller stoffer, som inducerer CYP metabolisme (som rifampicin, barbiturater).
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: Uncommon ( 1/1000 and
Danish: Ikke almindelig ( 1/1.000 og
English: Talk to your doctor or pharmacist before taking Vizarsin: - If you have sickle cell anaemia (an abnormality of red blood cells), leukaemia (cancer of blood cells), multiple myeloma (cancer of bone marrow).
Danish: Kontakt lægen eller apotekspersonalet, før du tager Vizarsin: - hvis du har en abnormitet af de røde blodlegemer (seglcelleanæmi), blodkræft (leukæmi),
English: Blister (PVC-foil/Alu-foil): 1 film-coated tablet, in a carton.
Danish: Blisterpakning (PVC/alu-folie):1 filmovertrukket tablet i en æske.
English: Vizarsin contains sorbitol (E420).
Danish: Vizarsin indeholder sorbitol (E420).
English: - The other ingredients are hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951),
Danish: - Øvrige indholdsstoffer: hydroxypropylcellulose (E463), mannitol (E421), aspartam (E951),
English: Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrallyacting), 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: Peppermint oil (containing sorbitol (E420)) Crospovidone
Danish: Pebermynteolie (indeholder sorbitol (E420)) Crospovidon
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: The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred.
Danish: De hyppigst rapporterede bivirkninger i kliniske studier hos sildenafilbehandlede patienter var hovedpine, ansigtsrødme, dyspepsi, næsetilstopning, svimmelhed, kvalme, hedeture, synsforstyrrelser, cyanopsi (blåsyn) og sløret syn.
English: Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
Danish: Baseret på alle undersøgelser har følgende procentdele af patienterne rapporteret om forbedring efter behandling med sildenafil: Psykogen erektil dysfunktion (84%), blandet erektil dysfunktion (77%), organisk erektil dysfunktion (68%), ældre (67%), diabetes mellitus (59%), iskæmisk hjertesygdom (69%), hypertension (68%), TURP (61%), radikal prostatektomi (43%), rygmarvsskade (83%), depression (75%).
English: The mean AUC and Cmax of the N-desmethyl metabolite increased up to 126% and up to 73% respectively, compared to age-matched volunteers with no renal impairment.
Danish: Gennemsnitlig AUC og Cmax af N-desmethylmetabolitten øges med op til henholdsvis 126% og 73% sammenlignet med frivillige forsøgspersoner med samme alder uden nedsat nyrefunktion.
English: Neohesperidin-dihydrochalcone (E959) Spearmint oil
Danish: Neohesperidin-dihydrochalcon (E959) Mynteolie
English: Vizarsin with food, drink and alcohol
Danish: Brug af Vizarsin sammen med mad, drikke og alkohol Vizarsin kan tages sammen med mad eller uden mad.
English: There are no adequate and well-controlled studies in pregnant or breastfeeding women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af sildenafil til gravide eller ammende kvinder.