FrancophonIA/ELRC3.0 huggingface dataset:
English: This refers to two indications (treatment of locally advanced prostatic carcinoma without metastases, for which surgical castration or other type of medical intervention is not indicated or unacceptable; and as monotherapy in early treatment or as an adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostatic carcinoma (T3-T4, any Stage N, M0) and this was considered to be of serious public health concern.
Danish: Det drejer sig om to indikationer (behandling af lokalt fremskreden prostatakarcinom uden metastaser, hvor kirurgisk kastration eller anden form for medicinsk indgreb ikke er indiceret eller ikke kan anbefales, og monoterapi i initialbehandlingen eller som supplement til strålebehandling eller radikal prostatektomi hos patienter med prostatakarcinom (T3-T4, på ethvert stadium N, M0), hvilket blev anset for at udgøre et alvorligt problem for folkesundheden.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Bicaluplex and associated names International Non-Proprietary Name (INN): bicalutamide
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER (CHMP) UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 41, OM Bicaluplex og tilknyttede navne Internationalt fællesnavn (INN): bicalutamid
English: Ingers Industrials Solutions s.r.o submitted applications for mutual recognition of Bicaluplex and associated names, 150 mg, film-coated tablet on the basis of the marketing authorisation granted by Czech Republic on 30 November 2005.
Danish: Ingers Industrials Solutions s.r.o indgav ansøgninger om gensidig anerkendelse af Bicaluplex og tilknyttede navne, 150 mg, filmovertrukket tablet, på grundlag af den markedsføringstilladelse, som Den Tjekkiske Republik udstedte den 30. november 2005.
English: During their September 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Bicaluplex and associated names, that the objections raised by Germany should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Danish: På baggrund af alle de forelagte oplysninger og den faglige drøftelse i udvalget var CHMP på sit møde i september 2007 af den opfattelse, at benefit/risk-forholdet er gunstigt for Bicaluplex og tilknyttede navne, at de indsigelser, der er rejst af Tyskland, ikke bør forhindre udstedelse af en markedsføringstilladelse, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel bør ændres.
English: Bicaluplex and associated names, 150 mg, film-coated tablet, is an oral anti-androgen used in the management of prostate cancer.
Danish: Bicaluplex og tilknyttede navne, 150 mg, filmovertrukket tablet, er et oralt antiandrogen til behandling af prostatacancer.
English: Pack size bottle (HDPE) 30 tablets bottle (HDPE) 90 (3 x 30) tablets
Danish: Flaske (HDPE) 90 (3 x 30) tabletter
English: Route of Administration
Danish: Lægemiddelform Administrationsvej Emballage Pakningsstørrelse
English: This may lead to increased procedural complications during the operation.
Danish: Dette kan føre til flere procedurerelaterede komplikationer under operationen.
English: 20148 Milan
Danish: 20148 Milano
English: The absolute bioavailability is approximately 32%.
Danish: Den absolutte biotilgængelighed er ca. 32 %.
English: • a more frequent need to pass water, even at night.
Danish: • et hyppigere behov for at lade vandet, selv om natten.
English: The observed effect was reversible.
Danish: Den observerede virkning var reversibel.
English: 03410 Saint Victor France
Danish: 03410 Saint Victor Frankrig
English: Do not give this medicine to children and adolescents below 18 years since there is no relevant indication for this age group.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år, da der ikke er nogen relevant indikation for denne aldersgruppe.
English: It does not distribute into blood cells.
Danish: Det fordeles ikke i blodlegemerne.
English: You may take your capsule later the same day if you have forgotten to take it earlier.
Danish: De kan tage Deres kapsel senere samme dag, hvis De har glemt at tage den tidligere på dagen.
English: Baseline value (± SD)
Danish: Baseline værdi (± SD)
English: Tell your doctor in particular, if you take:
Danish: Fortæl det især til Deres læge, hvis De tager:
English: If you stop treatment, your symptoms may re-appear.
Danish: Hvis De holder op med behandlingen, kan Deres symptomer komme igen.
English: Data observed in the Intent-to-treat populations of each study are shown below:
Danish: Data observeret i Intent-to-treat-populationerne i hvert studie er vist nedenfor:
English: • a feeling of not completely emptying the bladder,
Danish: • en følelse af at blæren ikke tømmes fuldstændigt,
English: This makes it easier for you to pass water and relieves your symptoms.
Danish: Dette gør det lettere for Dem at lade vandet, og det lindrer Deres symptomer.
English: Do not take a double dose to make up for a forgotten capsule.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte kapsel.
English: The possible side effects are listed below:
Danish: Mulige bivirkninger er anført nedenfor:
English: Please inform your doctor if you are planning to have children.
Danish: Fortæl det til Deres læge, hvis De planlægger at få børn.
English: Study Treatment arm
Danish: Studie Behandlings arm
English: This change is clinically not relevant and no dose adjustment is required.
Danish: Denne ændring er ikke af klinisk relevans, og der kræves ingen dosisjustering.
English: * p < 0.001 vs Placebo; ° p = 0.002 vs Placebo
Danish: * p < 0,001 versus placebo; ° p = 0,002 versus placebo
English: It has been demonstrated in vitro that the α1A:α1B binding ratio of silodosin (162:1) is extremely high.
Danish: Det er blevet vist in vitro, at α1A:α1B bindingsforholdet af silodosin (162:1) er ekstremt højt.
English: The specialist can take appropriate precautions with respect to medicine and surgical techniques to be used.
Danish: Specialisten kan tage de nødvendige forholdsregler angående medicin og den kirurgiske teknik, der anvendes.
English: This may temporarily affect male fertility.
Danish: Dette kan midlertidigt påvirke den mandlige fertilitet.
English: If it is almost time for the next dose, skip the dose you missed.
Danish: Hvis det næsten er tidspunktet for den næste dosis, skal De springe den glemte dosis over.
English: 10 hard capsules 20 hard capsules 30 hard capsules 50 hard capsules 90 hard capsules 100 hard capsules
Danish: 10 hårde kapsler 20 hårde kapsler 30 hårde kapsler 50 hårde kapsler 90 hårde kapsler 100 hårde kapsler
English: However, a reduction in blood pressure can occur in individual patients, leading in rare cases to syncope.
Danish: Et blodtryksfald kan dog forekomme hos enkelte patienter, hvilket i sjældne tilfælde fører til synkope.
English: • Fainting/ Loss of consciousness
Danish: • Besvimelse/bevidstløshed
English: Pharmacotherapeutic group: Urologicals, alpha-adrenoreceptor antagonists, ATC code: G04CA04.
Danish: Farmakoterapeutisk klassifikation: urologica, alfa-adrenoreceptor-antagonister, ATC-kode: G04CA04.
English: If you have moderate kidney problems, your doctor may prescribe a different dose.
Danish: Hvis De har moderate nyreproblemer, kan Deres læge ordinere en anden dosis.
English: Contact your doctor immediately if you notice any of the following allergic reactions: swelling of the face or throat, difficulty in breathing, feeling faint, itchy skin or hives since the consequences could become serious.
Danish: Kontakt straks Deres læge, hvis De bemærker nogle af de følgende allergiske reaktioner: hævelse af ansigt eller hals, vejrtrækningsbesvær, følelse af at skulle besvime, hudkløe eller nældefeber, da konsekvenserne heraf kan blive alvorlige.
English: It is reversible within a few days upon discontinuation of treatment (see section 4.4).
Danish: Det er reversibelt i løbet af få dage efter afbrydelse af behandlingen (se pkt.
English: Very rare side effects (may affect up to 1 in 10,000 people) • Other allergic reactions with swelling of the face or throat
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer) • Andre allergiske reaktioner med hævelse af ansigt eller hals
English: The dose-limiting adverse reaction was postural hypotension.
Danish: Den dosisbegrænsende bivirkning var postural hypotension.
English: Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.
Danish: Der bør udføres digital rektalundersøgelse og, når det er nødvendigt, bestemmelse af prostataspecifikt antigen (PSA) før behandlingens begyndelse og med regelmæssige mellemrum derefter.
English: Positive orthostatic tests were only slightly more common during co-administration; however, no symptomatic orthostasis or dizziness occurred.
Danish: Et positivt udfald af de ortostatiske undersøgelser var kun en smule mere almindeligt under samtidig administration; dog forekom der ikke symptomatisk ortostase eller svimmelhed.
English: Dizziness, including dizziness when standing up, and occasionally fainting, may occur.
Danish: Svimmelhed, herunder svimmelhed når De rejser Dem op, og besvimelse ind imellem kan forekomme.
English: Before starting treatment, the patient should be informed that this effect may occur, temporarily affecting male fertility.
Danish: Før behandlingsstart skal patienten oplyses om, at denne virkning kan forekomme, hvilket midlertidigt påvirker den mandlige fertilitet.
English: This is because some patients treated with this kind of medicine experienced a loss of muscle tone in the iris (the coloured circular part of the eye) during such a surgery.
Danish: Dette skyldes, at nogle patienter, som blev behandlet med denne form for medicin, har været udsat for, at muskelspændingen i iris (den farvede cirkulære del af øjet) blev nedsat under sådan en operation.
English: Minimal pharmacodynamic interactions have been observed between silodosin and maximum doses of sildenafil or tadalafil.
Danish: Minimale farmakodynamiske interaktioner er blevet observeret mellem silodosin og maksimale doser af sildenafil eller tadalafil.
English: In vitro data indicate that silodosin does not have the potential to inhibit or induce cytochrome P450 enzyme systems.
Danish: In vitro-data tyder på, at silodosin ikke har potentiale til at hæmme eller inducere cytokrom P450-enzymsystemer.
English: By blocking these receptors, it causes smooth muscle in these tissues to relax.
Danish: Ved at blokere disse receptorer, får det den glatte muskulatur i disse væv til at slappe af.
English: Dialysis is unlikely to be of significant benefit since silodosin is highly (96.6%) protein bound.
Danish: Det er ikke sandsynligt, at dialyse har en signifikant fordel, da silodosin i høj grad (96,6 %) er proteinbundet.
English: Not known (frequency cannot be estimated from the available data) • Floppy pupil during cataract surgery (see also above, in this section)
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data) • Slap pupil under operation for grå stær (se også ovenfor i dette punkt)
English: • Abnormal results of liver function tests
Danish: • Unormale resultater fra leverfunktionsprøver
English: At the first signs of orthostatic hypotension (such as postural dizziness), the patient should sit or lie down until the symptoms have disappeared.
Danish: Ved de første tegn på ortostatisk hypotension (såsom postural svimmelhed), bør patienten sidde eller ligge ned, indtil symptomerne går væk.
English: Difference (95% CI) vs placebo
Danish: Forskel (95 % KI) versus placebo
English: Exposure to silodosin and its main metabolites does not change significantly with age, even in subjects of age over 75 years.
Danish: Eksponering over for silodosin og de primære metabolitter ændrer sig ikke signifikant med alderen, selv hos patienter over 75 år.
English: Irritative symptoms
Danish: Irritative symptomer
English: Results from this study should be interpreted with caution, since enrolled patients had normal biochemistry values, indicating normal metabolic function, and they were classified as having moderate liver impairment based on ascites and hepatic encephalopathy.
Danish: Resultater fra dette studie bør fortolkes med forsigtighed, da de inkluderede patienter havde normale biokemiske værdier, hvilket indikerer normal metabolisk funktion, og de blev klassificeret som havende moderat nedsat leverfunktion, baseret på ascites og hepatisk encefalopati.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, carcinogenic, mutagenic and teratogenic potential.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, karcinogenicitet, mutagent og teratogent potentiale.
English: If this occurs, make sure you sit or lie down straight away until the symptoms have disappeared and inform your doctor as soon as possible (see also section “Driving and using machines”).
Danish: Hvis dette forekommer, skal De straks sætte eller lægge Dem ned, indtil symptomerne er forsvundet, og informere Deres læge snarest muligt (se også punktet “Trafik- og arbejdssikkerhed”).
English: In all studies, patients who did not respond to placebo during a 4-week placebo run-in phase were randomised to receive the study treatment.
Danish: I alle studier blev de patienter, der ikke responderede på placebo i løbet af en 4-ugers indkøringsfase med placebo, randomiseret til at få studiebehandlingen.
English: • Dizziness, including dizziness when standing up (see also above, in this section)
Danish: • Svimmelhed, herunder svimmelhed når De rejser Dem op (se også ovenfor i dette punkt)
English: • difficulty in starting to pass water,
Danish: • besvær med at påbegynde vandladning,
English: Packs of 10, 20, 30, 50, 90, 100 capsules.
Danish: Pakninger på 10, 20, 30, 50, 90 og 100 kapsler.
English: The capsule should be taken with food, preferably at the same time every day.
Danish: Kapslen bør tages sammen med mad, helst på samme tid hver dag.
English: If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De planlægger at blive far til et barn, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.
English: The terminal half-life of parent drug and its glucuronide is approximately 11 hours and 18 hours, respectively.
Danish: Den terminale halveringstid af det oprindelige lægemiddel og dets glukuronid er hhv. ca. 11 timer og 18 timer.
English: • Fast or irregular heart beats (called palpitations)
Danish: • Følelse af hurtige eller uregelmæssige hjerteslag (hjertebanken eller palpitationer)
English: Do not drive or operate machines if you feel faint, dizzy, drowsy or have blurred vision.
Danish: Kør ikke bil og betjen ikke maskiner, hvis De føler dem svag, svimmel, døsig eller har sløret syn.
English: If you have moderate kidney problems, your doctor will start Silodosin Recordati with caution and possibly with a lower dose (see section 3 “Dose”).
Danish: Hvis de har moderate nyreproblemer, vil Deres læge begynde behandlingen med Silodosin Recordati med forsigtighed og muligvis med en lavere dosis (se punkt 3 “Dosis”).
English: Discontinuing treatment with an α1-blocker 1-2 weeks prior to cataract surgery has been recommended, but the benefit and duration of stopping the therapy prior to cataract surgery has not yet been established.
Danish: Det har været anbefalet at afbryde behandling med en α1-blokker 1-2 uger før en operation for grå stær, men fordelen ved at stoppe behandlingen og varigheden af behandlingsstoppet før operationen for grå stær er endnu ikke blevet fastlagt.
English: Take the capsule always with food, preferably at the same time every day.
Danish: Kapslen bør altid tages sammen med mad, helst på samme tid hver dag.
English: Total score
Danish: Total scoring
English: In total, 1,581 patients have received silodosin at a dose of 8 mg once daily, including 961 patients exposed for at least 6 months and 384 patients exposed for 1 year.
Danish: I alt 1.581 patienter har fået silodosin i en dosis på 8 mg én gang dagligt, herunder 961 patienter, der blev behandlet i mindst 6 måneder, og 384 patienter, der blev behandlet i 1 år.
English: Silodosin and its glucuronide reach steady-state after 3 days and 5 days of treatment, respectively.
Danish: Silodosin og den tilhørende glukuronid når til steady-state efter henholdsvis 3 dages og 5 dages behandling.
English: Food decreases Cmax by approximately 30%, increases tmax by approximately 1 hour and has little effect on AUC.
Danish: Føde reducerer Cmax med ca. 30 %, forlænger tmax med ca. 1 time og har kun en lille virkning på AUC.
English: Silodosin administered orally is well absorbed and absorption is dose proportional.
Danish: Oral administration af silodosin absorberes godt, og absorptionen er proportional med dosen.
English: Should overdose of silodosin lead to hypotension, cardiovascular support has to be provided.
Danish: Hvis en overdosis af silodosin fører til hypotension, skal der ydes kardiovaskulær støtte.
English: The incidence of orthostatic hypotension in placebo-controlled clinical studies was 1.2% with silodosin and 1.0% with placebo.
Danish: Forekomsten af ortostatisk hypotension i placebo-kontrollerede kliniske studier var 1,2 % ved behandling med silodosin og 1,0 % med placebo.
English: IFIS (a variant of small pupil syndrome) has been observed during cataract surgery in some patients on α1-blockers or previously treated with α1-blockers.
Danish: Der er blevet observeret IFIS (en variant af lille pupil-syndrom) under operation for grå stær hos nogle patienter i behandling med α1-blokkere eller tidligere behandling med α1-blokkere.
English: Injury, poisoning and procedural complication
Danish: Traumer, forgiftninger og behandlingskomplikationer
English: Silodosin has not been evaluated in patients less than 18 years of age.
Danish: Pædiatrisk population Silodosin er ikke blevet evalueret hos patienter under 18 år.
English: 1 - adverse reactions from spontaneous reporting in the worldwide post-marketing experience (frequencies calculated from events reported in Phase I-IV clinical trials and non-interventional studies).
Danish: 1 - bivirkninger fra spontan rapportering efter markedsføring globalt (hyppigheder beregnet fra bivirkninger rapporteret i kliniske Fase I-IV-studier og fra studier uden intervention).
English: The incidence of orthostatic effects with silodosin is very low.
Danish: Forekomsten af ortostatiske virkninger i forbindelse med silodosin er meget lille.
English: Pregnancy and breast-feeding Not applicable as silodosin is intended for male patients only.
Danish: Graviditet og amning Ikke relevant, da silodosin kun er beregnet til mandlige patienter.
English: If you do feel weak or dizzy, make sure you sit or lie down straight away until the symptoms have disappeared.
Danish: Hvis De føler Dem svag eller svimmel, skal De sørge for at sætte Dem eller lægge Dem ned med det samme, indtil symptomerne forsvinder.
English: Obstructive symptoms
Danish: Obstruktive symptomer
English: • Difficulties in getting or keeping an erection
Danish: • Problemer med at få eller vedligeholde rejsning af penis
English: Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects.
Danish: Silodosin blev evalueret ved doser på op til 48 mg/dag hos raske mandlige forsøgspersoner.
English: Patients taking PDE-5 inhibitors concomitantly with silodosin should be monitored for possible adverse reactions.
Danish: Patienter, der tager PDE-5-hæmmere samtidigt med silodosin, bør overvåges for mulige bivirkninger.
English: Silodosin is also a substrate for P-glycoprotein.
Danish: Silodosin er også et substrat for P-glykoprotein.
English: Orthostatic hypotension may occasionally lead to syncope (see section 4.4).
Danish: Ortostatisk hypotension kan fra tid til anden føre til synkope (se pkt.
English: No significant reduction in supine blood pressure was observed in all clinical studies conducted with silodosin.
Danish: Der blev ikke observeret nogen signifikant reduktion i blodtrykket målt på patienten i liggende stilling i nogen af de kliniske studier udført med silodosin.
English: Starch, pregelatinised (maize) Mannitol (E421)
Danish: Stivelse, pregelatineret (majs) Mannitol (E421)
English: Silodosin 8 mg and 24 mg daily had no statistically significant effect on ECG intervals or cardiac repolarisation relative to placebo.
Danish: Silodosin 8 mg og 24 mg dagligt havde ingen statistisk signifikant virkning på EKG-intervaller eller hjertets repolarisering i forhold til placebo.
English: The responder rate (i.e. improvement in the IPSS total score by at least 25%) was significantly higher in the silodosin (68%) and tamsulosin group (65%), as compared to placebo (53%).
Danish: Hyppigheden af respons (dvs. forbedring i IPSS total-scoring med mindst 25 %) var signifikant højere i gruppen med silodosin (68 %) og tamsulosin (65 %), sammenlignet med placebo (53 %).
English: The pharmacokinetics of silodosin and its main metabolites have been evaluated in adult male subjects with and without BPH after single and multiple administrations with doses ranging from 0.1 mg to 48 mg per day.
Danish: Silodosins farmakokinetik og primære metabolitter er blevet evalueret hos voksne mandlige patienter med og uden BPH efter en enkelt og flere administrationer med doser fra 0,1 mg til 48 mg pr. dag.
English: Patients should be informed about the possible occurrence of symptoms related to postural hypotension (such as dizziness) and should be cautioned about driving or operating machines until they know how silodosin will affect them.
Danish: Patienterne bør dog informeres om den mulige forekomst af symptomer med relation til postural hypotension (såsom svimmelhed) og bør rådes til at udvise forsigtighed, når de fører motorkøretøjer eller betjener maskiner, indtil de ved, hvordan silodosin påvirker dem.
English: Dizziness when standing up and occasionally fainting may occur when taking Silodosin Recordati, particularly when starting treatment or if you are taking other medicines that lower blood pressure.
Danish: Hvis De oplever svimmelhed, når De rejser Dem op, og hvis De besvimer ind imellem, når De tager Silodosin Recordati, specielt når De begynder med behandlingen, eller hvis De tager andre lægemidler, der sænker blodtrykket.
English: The capsule should not be broken or chewed but swallowed whole, preferably with a glass of water.
Danish: Kapslen bør ikke deles eller tygges, men synkes hel, helst med et glas vand.
English: Nevertheless, caution should be exercised when starting concomitant use with antihypertensives and patients should be monitored for possible adverse reactions.
Danish: Ikke desto mindre skal der udvises forsigtighed, når samtidig brug af antihypertensiva påbegyndes, og patienterne bør monitoreres for mulige bivirkninger.
English: In the subjects over 65 years, the mean decreases at the various time points were between 5 and 15 mmHg (systolic) and 0 and 10 mmHg (diastolic).
Danish: Hos patienter over 65 år var de gennemsnitlige blodtryksfald ved de forskellige tidspunkter mellem 5 og 15 mmHg (systolisk) og 0 og 10 mmHg (diastolisk).
English: Exposure to the main metabolites, silodosin glucuronide and KMD3293, was also increased.
Danish: Eksponeringen over for de primære metabolitter, silodosinglukuronid og KMD-3293 var også forhøjet.
English: Silodosin Recordati belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Danish: Silodosin Recordati tilhører en gruppe af lægemidler, der kaldes alfa1A-adrenoreceptorblokkere.
English: The capsules are provided in PVC/PVDC/aluminium foil blisters, packed in cartons.
Danish: Kapslerne leveres i blisters af PVC/PVDC/aluminiumfolie, pakket i kartoner.