FrancophonIA/ELRC3.0 huggingface dataset:
English: In male rats, decreased fertility was observed from exposures which were approximately twice the exposure at the maximum recommended human dose.
Danish: Hos hanrotter blev en nedsat fertilitet set ved eksponeringer, som var ca. dobbelt så høje som eksponeringen ved den maksimalt anbefalede humane dosis.
English: An in vitro study with Caco-2 cells showed that silodosin is a substrate for P-glycoprotein.
Danish: Et in vitro-studie med Caco-2-celler viste, at silodosin er et substrat for P-glykoprotein.
English: • Abnormal ejaculation (less or no noticeable semen is released during sex, see section “Warnings and precautions”)
Danish: • Unormal ejakulation (mindre eller ikke registrerbar mængde sæd frigøres under samleje, se punktet “Advarsler og forsigtighedsregler”)
English: • If you have problems with your kidneys, please ask your doctor for advice.
Danish: • Hvis De har problemer med Deres nyrer, skal De rådføre Dem med Deres læge.
English: The most common side effect is a decrease in the amount of semen released during sex.
Danish: Den hyppigste bivirkning er en reduktion i mængden af sæd, som frigøres under samleje.
English: Silodosin has a substantially lower affinity for the α1B-adrenoreceptors that are primarily located in the cardiovascular system.
Danish: Silodosin har en betydeligt lavere affinitet over for de α1B-adrenoreceptorer, der primært findes i det kardiovaskulære system.
English: Silodosin has a volume of distribution of 0.81 L/kg and is 96.6% bound to plasma proteins.
Danish: Silodosin har et fordelingsvolumen på 0,81 l/kg og en plasmaproteinbinding på 96,6 %.
English: Blockade of these α1A-adrenoreceptors causes smooth muscle in these tissues to relax, thus decreasing bladder outlet resistance, without affecting detrusor smooth muscle contractility.
Danish: Hvis disse α1A-adrenoreceptorer blokeres, fører det til en afslapning af den glatte muskulatur i disse væv, hvilket reducerer blærens resistens mod afløb, uden at påvirke kontraktiliteten af den glatte detrusormuskulatur.
English: Approximately half of the patients reported an improvement in the most bothersome symptoms complained at baseline by the patients (i.e. nocturia, frequency, decreased stream, urgency, terminal dribbling and incomplete emptying), as assessed by the ICS-male questionnaire.
Danish: Ca. halvdelen af patienterne rapporterede en forbedring af de mest generende symptomer, som patienterne klagede over ved baseline (dvs. nykturi, hyppighed, tyndere stråle, trang, efterdryp og ufuldstændig tømning), vurderet på basis af ICS-spørgeskemaet for mænd (International Continence Society).
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing silodosin in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet, som indeholder silodosin, i alle undergrupper af den pædiatriske population med BPH (se pkt.
English: Consequently, the concomitant use of other α-adrenoreceptor antagonists is not recommended.
Danish: Derfor bør andre α-adrenoreceptorantagonister ikke anvendes samtidig.
English: Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Danish: Efter oral administration af 14C-mærket silodosin blev ca. 33,5 % og 54,9 % af radioaktiviteten genfundet i henholdsvis urin og afføring efter 7 dage.
English: Intraoperative Floppy Iris Syndrome (IFIS)
Danish: Intraoperativt Floppy-iris-syndrom (IFIS)
English: Substances that inhibit (such as ketoconazole, itraconazole, ritonavir or cyclosporine) or induce (such as rifampicin, barbiturates, carbamazepine, phenytoin) these enzymes and transporters may affect the plasma concentrations of silodosin and its active metabolite.
Danish: Stoffer, der hæmmer (såsom ketoconazol, itraconazol, ritonavir eller ciclosporin) eller inducerer (såsom rifampicin, barbiturater, carbamazepin, phenytoin) disse enzymer og transportører, kan påvirke plasmakoncentrationerne af silodosin og dets aktive metabolit.
English: Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Danish: Behandling af tegn og symptomer på godartet prostatahyperplasi (benign prostatic hyperplasia, BPH) hos voksne mænd.
English: Titanium dioxide (E171) Yellow iron oxide (E172) (4 mg capsules only)
Danish: Titandioxid (E171) Gul jernoxid (E172) (kun 4mg kapsel)
English: • If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Silodosin Recordati.
Danish: • Hvis De på noget tidspunkt er besvimet eller har følt Dem svimmel, når De pludseligt rejser Dem op, skal De informere lægen, før De tager Silodosin Recordati.
English: Ejaculatory disorders, including retrograde ejaculation, anejaculation
Danish: Ejakulationsforstyrrelser, herunder retrograd ejakulation Anejakulation
English: Steady state levels of digoxin, a substrate of P-glycoprotein, were not significantly affected by co-administration with silodosin 8 mg once daily.
Danish: Steady-state-niveauer af digoxin, et substrat for P-glykoprotein, var ikke signifikant påvirket af samtidig administration med silodosin 8 mg én gang dagligt.
English: Silodosin Recordati is available in packs containing 10, 20, 30, 50, 90, 100 capsules.
Danish: Silodosin Recordati findes i pakningsstørrelser med 10, 20, 30, 50, 90 og 100 kapsler.
English: • Symptoms of allergic reaction affecting the skin like rash, itching, hives and rash caused by a medicine
Danish: • Symptomer på allergisk reaktion, der påvirker huden, som udslæt, kløe, nældefeber og lægemiddelfremkaldt udslæt
English: Do not use this medicine if you notice that is damaged or shows signs of tampering.
Danish: Brug ikke lægemidlet, hvis det er beskadiget, eller pakningen viser tegn på, at den har været åbnet.
English: Silodosin Recordati may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Danish: Silodosin Recordati kan forårsage komplikationer under en operation for grå stær (øjenoperation på grund af en uklar linse, se punktet “Advarsler og forsigtighedsregler”).
English: In the clinical study program, many patients were on concomitant antihypertensive therapy (mostly agents acting on the renin-angiotensin system, beta-blockers, calcium antagonists and diuretics) without experiencing an increase in the incidence of orthostatic hypotension.
Danish: I det kliniske studieprogram var mange patienter i samtidig antihypertensiv behandling (hovedsageligt med lægemidler med indvirkning på renin-angiotensin-systemet, beta-blokkere, calciumantagonister og diuretika), uden at forekomsten af ortostatisk hypotension blev forøget.
English: During pre-operative assessment, eye surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with silodosin, in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
Danish: Under den præoperative vurdering skal øjenkirurgen og de oftalmologiske medarbejdere være opmærksomme på, om patienter, der skal opereres for grå stær, får eller har fået behandling med silodosin, for at sørge for at de relevante forholdsregler er på plads til at håndtere IFIS under operationen.
English: Since BPH and prostate carcinoma may present the same symptoms and can co-exist, patients thought to have BPH should be examined prior to starting therapy with silodosin, to rule out the presence of carcinoma of the prostate.
Danish: Da BPH og prostatakarcinom kan optræde med de samme symptomer og kan sameksistere, bør patienter, der menes at have BPH, undersøges, før behandlingen med silodosin påbegyndes for at udelukke tilstedeværelsen af prostatakarcinom.
English: Silodosin Recordati has minor or moderate influence on the ability to drive and use machines.
Danish: Silodosin Recordati påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Europe
Danish: Europa
English: Alpha-blockers There is inadequate information about the safe use of silodosin in association with other α-adrenoreceptor antagonists.
Danish: Der er utilstrækkelig information om sikker anvendelse af silodosin i forbindelse med andre α-adrenoreceptorantagonister.
English: The pharmacokinetics of silodosin is linear throughout this dose range.
Danish: Silodosins farmakokinetik er lineær over hele dette dosisinterval.
English: When silodosin was co-administered with a CYP3A4 inhibitor of moderate potency such as diltiazem, an increase in silodosin AUC of approximately 30% was observed, but Cmax and half-life were not affected.
Danish: Når silodosin blev administreret samtidigt med en moderat potent CYP3A4-hæmmer såsom diltiazem, blev en forhøjelse af silodosins AUC på ca. 30 % observeret, men Cmax og halveringstiden var ikke påvirket.
English: Body clearance of silodosin was approximately 0.28 L/h/kg.
Danish: Kroppens udskillelse af silodosin var ca. 0,28 l/h/kg.
English: In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1%were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Danish: I et klinisk Fase IV-studie, der blev udført i Europa, med en gennemsnitlig IPSS total-score ved baseline på 18,9 points, havde 77,1 % respons på silodosin (vurderet ved en ændring i IPSS total-score fra baseline på mindst 25 %).
English: • Since a benign enlargement of the prostate and prostate cancer may present the same symptoms, your doctor will check you for prostate cancer before starting treatment with Silodosin Recordati.
Danish: • Da en godartet forstørrelse af blærehalskirtlen og prostatakræft kan have de samme symptomer, vil Deres læge undersøge Dem for prostatakræft, før De begynder behandlingen med Silodosin Recordati.
English: It is important that you immediately inform your eye specialist if you are using or have previously used Silodosin Recordati.
Danish: Det er vigtigt, at De straks informerer Deres øjenspecialist, hvis De tager eller tidligere har taget Silodosin Recordati.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og blisteren efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies.
Danish: Silodosins sikkerhed er blevet evalueret i fire Fase II-III dobbelt-blindede, kontrollerede kliniske studier (med 931 patienter, der fik silodosin 8 mg én gang dagligt og 733 patienter, der fik placebo) og i to udvidede, åbne langtidsstudier.
English: Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥ 13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Danish: Over 800 patienter med moderate til svære symptomer på BPH (International Prostate Symptom Score, IPSS, baseline-værdi ≥ 13) fik silodosin 8 mg én gang dagligt i to placebo-kontrollerede kliniske Fase III-studier udført i USA, og i et placebo-kontrolleret og aktivt kontrolleret klinisk studie udført i Europa.
English: In all studies, patients treated with silodosin had a greater decrease in both storage (irritative) and voiding (obstructive) symptoms of BPH as compared to placebo as assessed after 12 weeks of treatment.
Danish: I alle studierne havde de patienter, der blev behandlet med silodosin, en større reduktion i BPH-symptomer både med hensyn til irritative og obstruktive symptomer, sammenlignet med placebo, ved vurdering efter 12 ugers behandling.
English: The main metabolite in plasma, the glucuronide conjugate of silodosin (KMD-3213G), that has been shown to be active in vitro, has an extended half-life (approximately 24 hours) and reaches plasma concentrations approximately four times higher than those of silodosin.
Danish: Den primære metabolit i plasma, silodosins glukuronidkonjugat (KMD-3213G), som har vist sig at være aktiv in vitro, har en forlænget halveringstid (ca. 24 timer) og når op på plasmakoncentrationer ca. fire gange højere end silodosins.
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodosin Recordati may be reduced.
Danish: • medicin mod epilepsi eller rifampicin (medicin til behandling af tuberkulose), da virkningen af Silodosin Recordati kan være nedsat.
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Silodosin Recordati.
Danish: • medicin, der sænker blodtrykket (især medicin kaldet alfa1-blokkere, såsom prazosin eller doxazosin), da der kan være en risiko for, at virkningen af sådanne former for medicin forstærkes, mens De tager Silodosin Recordati.
English: Silodosin is metabolised extensively, mainly via CYP3A4, alcohol dehydrogenase and UGT2B7.
Danish: Silodosin undergår omfattende metabolisering, primært via CYP3A4, alkoholdehydrogenase og UGT2B7.
English: Ask your doctor whether or not you should postpone or temporarily stop taking Silodosin Recordati when undergoing cataract surgery.
Danish: Spørg Deres læge, om De bør udskyde eller midlertidigt stoppe med at tage Silodosin Recordati, hvis De skal gennemgå en operation for grå stær.
English: If you become dizzy or feel weak, tell your doctor straight away.
Danish: Hvis De bliver svimmel eller føler Dem svag, skal De straks fortælle det til Deres læge.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. kapsel, dvs. det er i det væsentlige natriumfrit.
English: For special patient populations, one capsule of Silodosin Recordati 4 mg daily is recommended (see below).
Danish: Til specielle patientpopulationer anbefales en kapsel Silodosin Recordati 4 mg dagligt (se nedenfor).
English: The most frequent adverse reactions reported with silodosin in placebo controlled clinical studies and during long-term use were ejaculatory disorders such as retrograde ejaculation and anejaculation (ejaculatory volume reduced or absent), with a frequency of 23%.
Danish: De bivirkninger, som oftest blev indberettet med silodosin i placebo-kontrollerede, kliniske studier og under langtidsanvendelse, var ejakulationsforstyrrelser, såsom retrograd ejakulation og anejakulation (reduceret eller fraværende ejakulationsvolumen), med en frekvens på 23 %.
English: No. of patients
Danish: Antal patienter
English: In subjects with severe renal impairment (n = 5) increase of exposure was 2.2-fold for Cmax and 3.7-fold for AUC.
Danish: Hos patienter med svært nedsat nyrefunktion (n = 5) var eksponeringen forhøjet med 2,2 gange for Cmax og med 3,7 gange for AUC.
English: Treatment with silodosin leads to a decrease in the amount of semen released during orgasm that may temporarily affect male fertility.
Danish: Behandling med silodosin fører til en reduktion i mængden af sæd, der frigives under orgasme, hvilket midlertidigt kan påvirke den mandlige fertilitet.
English: In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference (95% CI) in the IPSS Total Score between treatments in the per-protocol population was 0.4 (-0.4 to 1.1).
Danish: I det aktivt kontrollerede, kliniske studie udført i Europa blev det vist, at silodosin 8 mg én gang dagligt var non-inferior sammenlignet med tamsulosin 0,4 mg én gang dagligt: Den justerede gennemsnitlige forskel (95 % KI) i IPSS total-score mellem behandlinger i pr. protokol-populationen var 0,4 (-0,4 til 1,1).
English: This medicine contains less than 1 mmoL sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. kapsel, dvs. den er i det væsentlige natriumfri.
English: If dizziness when standing up or fainting occurs, please inform your doctor as soon as possible.
Danish: Hvis der forekommer svimmelhed, når De rejser Dem op, eller besvimelse, skal De informere Deres læge så snart som muligt.
English: Silodosin Recordati is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Danish: Silodosin Recordati anvendes hos voksne mænd for at behandle urinsvejssymptomer forbundet med en godartet forstørrelse af blærehalskirtlen (prostatahyperplasi), såsom:
English: • If you have severe liver problems, you should not take Silodosin Recordati, as it was not tested in this condition.
Danish: • Hvis De har alvorlige leverproblemer, bør De ikke tage Silodosin Recordati, da det ikke er undersøgt i forbindelse med alvorlig leversygdom.
English: In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Danish: I et dobbelt-blindet, placebo-kontrolleret klinisk dose-finding, Fase II-studie med silodosin 4 eller 8 mg én gang dagligt, blev der observeret en større forbedring i index score af symptomer i henhold til American Urologic Association (AUA) med silodosin 8 mg (-6,8 ± 5,8; n = 90; p = 0,0018) og silodosin 4 mg (-5,7 ± 5,5; n = 88; p = 0,0355) sammenlignet med placebo (-4,0 ± 5,5; n = 83).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/ALUMINIUM FOIL BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTERS AF PVC/PVDC/ALUMINIUMFOLIE
English: Do not break or chew the capsule, but swallow it whole, preferably with a glass of water.
Danish: Kapslen må ikke deles eller tygges, men skal synkes hel, helst med et glas vand.
English: There is no relevant use of Silodosin Recordati in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Danish: Det er ikke relevant at anvende Silodosin Recordati hos den pædiatriske population til indikationen godartet prostatahyperplasi (BPH).
English: If you have severe kidney problems, you should not take Silodosin Recordati.
Danish: Hvis De har alvorlige nyreproblemer, bør De ikke tage Silodosin Recordati.
English: A review of safety data of patients enrolled in all clinical studies does not indicate that mild renal impairment (n = 487) poses an additional safety risk during silodosin therapy (such as an increase in dizziness or orthostatic hypotension) as compared to patients with normal renal function (n = 955).
Danish: En gennemgang af sikkerhedsdata for patienter inkluderet i alle kliniske studier tyder ikke på, at let nedsat nyrefunktion (n = 487) udgør en yderligere sikkerhedsrisiko under behandling med silodosin (såsom en forøgelse i svimmelhed eller ortostatisk hypotension), sammenlignet med patienter med normal nyrefunktion (n = 955).
English: • If you are undergoing eye surgery because of cloudiness of the lens (cataract surgery), it is important that you immediately inform your eye specialist that you are using or have previously used Silodosin Recordati.
Danish: • Hvis De skal gennemgå en øjenoperation på grund af uklarhed af linsen (operation for grå stær), er det vigtigt, at De straks informerer Deres øjenspecialist om, at De tager eller tidligere har taget Silodosin Recordati.
English: Drug eruption1
Danish: Medikamentel eruption1
English: In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).
Danish: < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Silodosin undergoes extensive metabolism through glucuronidation (UGT2B7), alcohol and aldehyde dehydrogenase and oxidative pathways, mainly CYP3A4.
Danish: Silodosin gennemgår omfattende metabolisme via glukuronidation (UGT2B7), alkohol- og aldehyddehydrogenase og via oxidative metaboliseringsveje, primært CYP3A4.
English: Intraoperative Floppy Iris Syndrome
Danish: Intraoperativt Floppy-irissyndrom
English: The pharmacokinetics of silodosin in patients with severe hepatic impairment has not been studied.
Danish: Silodosins farmakokinetik hos patienter med svært nedsat leverfunktion er ikke blevet undersøgt.
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Silodosin Recordati.
Danish: • medicin mod svampeinfektion (såsom ketoconazol eller itraconazol), medicin der anvendes mod hiv-infektion/AIDS (såsom ritonavir) eller medicin der anvendes efter transplantationer for at forhindre organafstødning (såsom ciclosporin), da disse former for medicin kan forhøje koncentrationen af Silodosin Recordati i blodet.
English: Common Uncommon Rare
Danish: Almindelig Ikke almindelig
English: In healthy male subjects of the target age range (n = 16, mean age 55 ± 8 years) after once-a-day oral administration of 8 mg immediately after breakfast for 7 days, the following pharmacokinetic parameters were obtained: Cmax 87 ± 51 ng/mL (sd), tmax 2.5 hours (range 1.0-3.0), AUC 433 ± 286 ng • h/mL.
Danish: Hos raske mandlige frivillige blev de følgende farmakokinetiske parametre opnået inden for målintervallet for alder (n = 16, gennemsnitlig alder 55 ± 8 år) efter oral administration én gang dagligt på 8 mg straks efter morgenmaden i 7 dage: Cmax 87 ± 51 ng/ml (SD), tmax 2,5 timer (interval 1,0-3,0), AUC 433 ± 286 ng • h/ml.
English: • medicines used for treating problems in getting or keeping an erection (such as sildenafil or tadalafil), since the concomitant use with Silodosin Recordati might lead to a slight decrease in blood pressure.
Danish: • medicin til behandling af problemer med at få og opretholde en erektion (såsom sildenafil eller tadalafil), da samtidig anvendelse med Silodosin Recordati kan føre til et let blodtryksfald.
English: In patients with orthostatic hypotension, treatment with silodosin is not recommended.
Danish: Patienter med ortostatisk hypotension bør ikke behandles med silodosin.
English: In a single-dose study, the pharmacokinetics of silodosin was not altered in nine patients with moderate hepatic impairment (Child-Pugh scores 7 to 9), compared to nine healthy subjects.
Danish: I et enkeltdosisstudie var silodosins farmakokinetik uændret hos ni patienter med moderat nedsat leverfunktion (Child-Pugh-scoringer fra 7 til 9), sammenlignet med ni raske frivillige.
English: Silodosin is highly selective for α1A-adrenoreceptors that are primarily located in the human prostate, bladder base, bladder neck, prostatic capsule and prostatic urethra.
Danish: Silodosin er i høj grad selektiv over for α1A-adrenoreceptorer, som hos mennesker primært befinder sig i blærehalskirtlen, den nederste del af blæren, blærehalsen, prostatakapslen og pars prostatica urethrae.