FrancophonIA/ELRC3.0 huggingface dataset:
English: After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/3TC/ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26 % of subjects on the ZDV/3TC/ABC arm, 16 % on the ZDV/3TC/EFV arm and 13 % on the 4 drug arm categorised as having virological failure (HIV RNA >200 copies/ml).
Danish: Ved en middelvurdering efter 32 uger blev 3-stofskombinationen af de tre nucleosider ZDV/3TC/ABC påvist at være virologisk inferiør til de to andre behandlingsregimer uanset baseline for den virale påvirkning (< eller > 100.000 kopier/ml).
English: No Trizivir dosage adjustment necessary, unless patient has
Danish: Dosisjustering ikke nødvendig for Trizivir, medmindre patienten har nedsat nyrefunktion (se pkt.
English: : + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
Danish: ViiV Healthcare SAS Tél: + 33 (0)1 39 17 6969 Infomed@viivhealthcare.com
English: They are blue/green and capsuleshaped and are provided in blister packs containing 60 tablets or bottles containing 60 tablets with child-resistant tops.
Danish: De findes i blisterpakninger med 60 tabletter og beholdere med børnesikret låg med 60 tabletter.
English: Phenytoin/Zidovudine
Danish: Phenytoin / zidovudin
English: Other medicines and Trizivir
Danish: Brug af anden medicin sammen med Trizivir
English: Probenecid/Zidovudine (500 mg four times daily/2mg/kg thrice daily)
Danish: Probenecid / zidovudin (500 mg 4 gange daglig / 2 mg/kg 3 gange daglig)
English: Other symptoms include:
Danish: Andre symptomer:
English: Retinoid compounds (e.g. isotretinoin)/Zidovudine
Danish: Retinoid-forbindelser (f.eks. isotretinoin) / zidovudin
English: Probenecid/Lamivudine
Danish: Probenecid / lamivudin
English: Abacavir, lamivudine and zidovudine are all NRTIs, and are potent selective inhibitors of HIV-1 and HIV-2.All three medicinal products are metabolised sequentially by intracellular kinases to the respective 5′-triphosphate (TP).
Danish: Abacavir, lamivudin og zidovudin er alle NRTI'er og er potente selektive hæmmere af hiv-1 og hiv-2.
English: Haematological parameters should therefore be carefully monitored (see section 4.3) in patients receiving Trizivir.
Danish: Hæmatologiske parametre bør derfor monitoreres omhyggeligt (se pkt.
English: • loss of appetite, weight loss
Danish: • appetitløshed, vægttab
English: If the doctor thinks they may have been related, you will be told never again to take Trizivir, or any other medicine containing abacavir (Kivexa,Triumeq or Ziagen).
Danish: Hvis lægen mener, at du har en overfølsomhedsreaktion, vil du få besked på aldrig mere at tage Trizivir eller ethvert andet lægemiddel med abacavir (Kivexa, Triumeq eller Ziagen).
English: Transmission
Danish: Overførsel/transmission
English: • numbness
Danish: • kløe
English: Common side effects that may show up in blood tests are:
Danish: Almindelige bivirkninger, som kan ses i blodprøver:
English: Didanosine/Zidovudine
Danish: Didanosin / zidovudin
English: Fluconazole/Lamivudine
Danish: Fluconazol / lamivudin
English: Trizivir 300 mg/150 mg/300 mg film-coated tablets abacavir/lamivudine/zidovudine
Danish: Trizivir 300 mg / 150 mg / 300 mg filmovertrukne tabletter abacavir / lamivudin / zidovudin
English: Ethanol/Zidovudine
Danish: Ethanol / zidovudin
English: Rifampicin/Zidovudine (600mg once daily/200 mg thrice daily)
Danish: Rifampicin / zidovudin (600 mg én gang daglig / 200 mg 3 gange daglig)
English: Very common: headache Common: dizziness Rare: insomnia, paraesthesia, somnolence, loss of mental acuity, convulsions
Danish: Sjælden: Søvnløshed, paræstesi, somnolens, mental sløring, kramper.
English: NAME OF THE MEDICINAL PRODUCT Trizivir 300 mg/150 mg/300 mg tablets abacavir/lamivudine/zidovudine
Danish: LÆGEMIDLETS NAVN Trizivir 300 mg/150 mg/300 mg abacavir/lamivudin/zidovudin
English: Pharmacokinetic data has been obtained for abacavir, lamivudine and zidovudine separately.
Danish: Nedsat leverfunktion: Der foreligger farmakokinetiskedata separat for abacavir, lamivudin og zidovudin.
English: An uncommon side effect that may show up in blood tests is:
Danish: En ikke almindelig bivirkning, som kan ses i blodprøver:
English: Common side effects These may affect up to 1 in 10 people:
Danish: Almindelige bivirkninger Kan forekomme hos op til 1 ud af 10 personer:
English: Lactic acidosis is a rare but serious side effect Some people taking Trizivir develop a condition called lactic acidosis, together with an enlarged liver.
Danish: Nogle personer, der får Trizivir, kan udvikle en tilstand, der kaldes laktacidose, og samtidig en forstørret lever.
English: Uncommon: thrombocytopenia and pancytopenia with marrow hypoplasia
Danish: Thrombocytopeni og pancytopeni med knoglemarvshypoplasi.
English: Atovaquone/Lamivudine
Danish: Atovaquon / lamivudin
English: URICOSURIC Probenecid/Abacavir
Danish: URIKOSURISKE LÆGEMIDLER Probenecid / abacavir
English: Immune system disorders Common: hypersensitivity Metabolism and nutrition disorders Common: anorexia Very Rare : lactic acidosis
Danish: Metabolisme og ernæring Almindelig: Appetitmangel.
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
Danish: Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunsuppression, højere Body Mass Index (BMI)).
English: The malformative risk is unlikely in humans based on the mentioned moderate amount of data.
Danish: Ud fra den begrænsede datamængde forventes ingen malformativ risiko i mennesker.
English: A moderate amount of data on pregnant women taking the individual actives abacavir, lamivudine and zidovudine in combination indicates no malformative toxicity (more than 300 outcomes from first trimester exposures).
Danish: Moderate datamængder (mere end 600 graviditeter, hvor der er forekommet eksponering i første trimester) indikerede ingen tegn på malformationer over for abacavir.
English: The clinical relevance of this finding has not been determined.
Danish: Den kliniske relevans er endnu ikke fastlagt.
English: Trizivir should not be administered to patients with end-stage renal disease (see sections 4.3 and 5.2).
Danish: Trizivir bør ikke gives til patienter med nyresvigt (se pkt.
English: Clarithromycin/Zidovudine (500 mg twice daily/100 mg every 4 hours)
Danish: Clarithromycin / zidovudin (500 mg 2 gange daglig /
English: Treatment related findings were limited to lateoccurring vaginal epithelial tumours, which were seen with a similar incidence and time of onset as in the standard oral carcinogenicity study.
Danish: Såvel incidensen som tidspunktet for fremkomsten svarede til fundene i det orale standard karcinogenicitetsstudie.
English: Musculoskeletal and connective tissue disorders Common: arthralgia, muscle disorders
Danish: Knogler, led, muskler og bindevæv Almindelig: Ledsmerter og muskellidelser.
English: Valproic acid/Abacavir
Danish: Valproinsyre / abacavir
English: Rare: pure red cell aplasia Very rare: aplastic anaemia
Danish: Meget sjælden: Ren erytrocyt aplasi.
English: • high doses of co-trimoxazole, an antibiotic
Danish: • høje doser af sulfamethoxazol/trimethoprim, til behandling af bakterieinfektioner
English: Rare: gynaecomastia
Danish: Sjælden: Rabdomyolyse.
English: Trimethoprim: AUC ↔ Sulfamethoxazole: AUC ↔
Danish: Lamivudin: AUC  40 % Trimethoprim: AUC  Sulfamethoxazol: AUC  (Hæmning af organisk kation transportører)
English: Zidovudine AUC ↓48% (UGT induction)
Danish: Zidovudin: AUC  48 % (UGT-induktion)
English: Zidovudine AUC ↑43% Methadone AUC ↔
Danish: Zidovudin: AUC  43 % Methadon: AUC 
English: Anyone taking Trizivir could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Trizivir.
Danish: Alle, som tager Trizivir, kan udvikle en overfølsomhedsreaktion over for abacavir.
English: In oral carcinogenicity studies with zidovudine in mice and rats, late appearing vaginal epithelial tumours were observed.
Danish: Der blev observeret sent forekommende tumorer i vaginalt epitel hos mus og rotter i orale karcinogenicitetsstudier med zidovudin.
English: Where discontinuation of therapy with one of the active substances of Trizivir is indicated, or where dose reduction is necessary separate preparations of abacavir, lamivudine and zidovudine are available.
Danish: Der findes særskilte præparater med abacavir, lamivudin og zidovudin, hvis seponering af et af de aktive indholdsstoffer i Trizivir eller dosisreduktion er påkrævet.
English: - nausea or vomiting or diarrhoea or abdominal pain
Danish: Almindelig: Kvalme, opkast, abdominalsmerter og diarré.
English: Some medicines interact with Trizivir These include:
Danish: Tag ikke disse lægemidler sammen med Trizivir:
English: Uncommon: rash and pruritus Rare: nail and skin pigmentation, urticaria and sweating
Danish: Sjælden: Pigmentering af negle og hud, nældefeber og øget svedtendens.
English: In case of any symptoms suggesting hypersensitivity reactions, contact your doctor IMMEDIATELY.
Danish: Kontakt STRAKS din læge i tilfælde af symptomer, der tyder på overfølsomhedsreaktioner.
English: Uncommon: transient rises in liver enzymes (AST, ALT) Rare: hepatitis
Danish: Ikke almindelig: Forbigående stigninger i leverenzymer (ASAT og ALAT).
English: Cimetidine/Zidovudine
Danish: Cimetidin / zidovudin
English: indicates no malformative toxicity for abacavir.
Danish: Cmin kunne ikke fastlægges for abacavir.
English: Respiratory tract
Danish: • åndenød
English: • feeling sick (nausea), being sick (vomiting)
Danish: • symptomer fra næsen (irritation, løbenæse)
English: Common: malaise Uncommon: fever, generalised pain and asthenia Rare: chills, chest pain, and influenza-like syndrome
Danish: Ikke almindelig: Feber, generaliserede smerter og asteni.
English: The concomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.5).
Danish: På grund af øget risiko for anæmi bør ribavirin og zidovudin ikke anvendes samtidig (se pkt.
English: Gastrointestinal disorders Common: nausea, vomiting, diarrhoea
Danish: Almindelig: Kvalme, opkast og diarré.
English: • Clinical description of abacavir HSR
Danish: • Klinisk beskrivelse af overfølsomhedsreaktion over for abacavir
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL x 60 FILM-COATED TABLETS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ETIKET TIL BEHOLDER 60 FILMOVERTRUKNE TABLETTER
English: Do not stop taking Trizivir unless your doctor advises you to do so.
Danish: Du må kun stoppe med at tage Trizivir efter aftale med lægen.
English: Valproic acid/Lamivudine
Danish: Valproinsyre / lamivudin
English: Very common: Nausea Common: vomiting, abdominal pain, and diarrhoea Uncommon: flatulence Rare: oral mucosa pigmentation, taste disturbance dyspepsia, pancreatitis
Danish: Sjælden: Pigmentering af mundslimhinden, smagsforstyrrelser, dyspepsi, pancreatitis.
English: • sensation of weakness in the limbs
Danish: • prikkende fornemmelse i huden
English: Common: nausea, vomiting, abdominal pain, diarrhoea Rare: rises in serum amylase, pancreatitis
Danish: Sjælden: Stigninger i serumamylase, pancreatitis.
English: • stiffness in the joints
Danish: • betændelse i bugspytkirtlen
English: These may affect up to 1 in 100 people:
Danish: Ikke almindelige bivirkninger Kan forekomme hos op til 1 ud af 100 personer:
English: Moderate amount of data (more than 600 outcomes from first trimester)
Danish: Disse data indikerer ingen tegn på malformationer (baseret på mere end 300 graviditeter, hvor der er forekommet eksponering i første trimester).
English: Zidovudine
Danish: Laktacidose
English: ANTIFUNGALS Fluconazole/Abacavir
Danish: LÆGEMIDLER MOD SVAMPEINFEKTIONER Fluconazol / abacavir
English: These medicines should not be used with Trizivir: • stavudine or emtricitabine, to treat HIV infection
Danish: • stavudin eller emtricitabin, til behandling af hiv-infektion
English: Zidovudine is primarily metabolised by UGT enzymes; co-administration of inducers or inhibitors of UGT enzymes could alter zidovudine exposure.
Danish: Samtidig administration af UGT-enzym-induktorer ellerhæmmere kan ændre eksponeringen over for zidovudin.
English: Mitochondrial dysfunction following exposure in utero
Danish: Hæmatologiske bivirkninger ved zidovudin
English: • an increase in the level of liver enzymes
Danish: • forhøjet leverenzymtal
English: Immediate Packaging Pack size
Danish: Lægemiddelform Administration Emballage Pakningsstørrelse
English: Ελλάδα ΒΙΑΝΕΞ Α.Ε.
Danish: ΒΙΑΝΕΞ Α.Ε.
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: Date of first authorisation: 29/01/2010 Date of latest renewal: 18/09/2014
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 29/01/2010 Dato for seneste fornyelse: 18/09/2014
English: * p < 0.001 vs Placebo;°p = 0.002 vs Placebo
Danish: * p < 0,001 versus placebo; ° p = 0,002 versus placebo
English: IPSS Irritative symptoms
Danish: IPSS Irritative symptomer
English: IPSS Total score
Danish: IPSS Total scoring
English: Paediatric population 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: If you have moderate kidney problems, your doctor will start Silodyx with caution and possibly with a lower dose (see section 3 “Dose”).
Danish: Hvis de har moderate nyreproblemer, vil Deres læge begynde behandlingen med Silodyx med forsigtighed og muligvis med en lavere dosis (se punkt 3 “Dosis”).
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: I den nedenstående tabel er de bivirkninger, som er indberettet fra alle kliniske studier og fra erfaring efter markedsføring globalt, og for hvilke der findes et rimeligt kausalt forhold, opstillet i henhold til MedDRA-systemorganklasse og hyppighed: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 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: 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 punkt “Trafik- og arbejdssikkerhed”).
English: The requirements for submission of marketing authorisation holder shall submit periodic safety update reports for this medicinal product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: 5 hard capsules 10 hard capsules 20 hard capsules 30 hard capsules 50 hard capsules 90 hard capsules 100 hard capsules
Danish: 5 hårde kapsler 10 hårde kapsler 20 hårde kapsler 30 hårde kapsler 50 hårde kapsler 90 hårde kapsler 100 hårde kapsler
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements..
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
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: Packs of 5, 10, 20, 30, 50, 90, 100 capsules.
Danish: Pakninger på 5, 10, 20, 30, 50, 90 og 100 kapsler.
English: Silodyx has minor or moderate influence on the ability to drive and use machines.
Danish: Silodyx påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
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: 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: It is important that you immediately inform your eye specialist if you are using or have previously used Silodyx.
Danish: Det er vigtigt, at De straks informerer Deres øjenspecialist, hvis De tager eller tidligere har taget Silodyx.
English: What you need to know before you take Silodyx Do not take Silodyx if you are allergic to silodosin or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal De vide, før De begynder at tage Silodyx Tag ikke Silodyx hvis De er allergisk over for silodosin eller et af de øvrige indholdsstoffer i Silodyx (angivet i punkt 6).
English: Dizziness when standing up and occasionally fainting may occur when taking Silodyx, 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 Silodyx, specielt når De begynder med behandlingen, eller hvis De tager andre lægemidler, der sænker blodtrykket.
English: Silodyx belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Danish: Silodyx tilhører en gruppe af lægemidler, der kaldes alfa1A-adrenoreceptorblokkere.
English: If you have severe kidney problems, you should not take Silodyx.
Danish: Hvis De har alvorlige nyreproblemer, bør De ikke tage Silodyx.
English: Exposure to the main metabolites, silodosin glucuronide and KMD3293, was also increased.
Danish: Eksponeringen over for de primære metabolitter, silodosinglukoronid og KMD-3293 var også forhøjet.
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: Talk to your doctor or pharmacist before taking Silodyx
Danish: Kontakt lægen eller apotekspersonalet, før De tager Silodyx.
English: Ask your doctor whether or not you should postpone or temporarily stop taking Silodyx when undergoing cataract surgery.
Danish: Spørg Deres læge om De bør udskyde eller midlertidigt stoppe med at tage Silodyx, hvis De skal gennemgå en operation for grå stær.
English: • If you have ever fainted or felt dizzy when suddenly standing up, please inform your doctor before taking Silodyx.
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 Silodyx.
English: Silodyx may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Danish: Silodyx kan forårsage komplikationer under en operation for grå stær (øjenoperation på grund af en uklar linse, se punktet “Advarsler og forsigtighedsregler”).
English: For special patient populations, one capsule of Silodyx 4 mg daily is recommended (see below).
Danish: Til specielle patientpopulationer anbefales en kapsel Silodyx 4 mg dagligt (se nedenfor).
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 Silodyx.
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 Silodyx.
English: • If you have severe liver problems, you should not take Silodyx, as it was not tested in this condition.
Danish: • Hvis De har alvorlige leverproblemer, bør De ikke tage Silodyx, da det ikke er undersøgt i forbindelse med alvorlig leversygdom.
English: Teл.
Danish: Тел.
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: Elimination 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: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodyx may be reduced.
Danish: • medicin mod epilepsi eller rifampicin (medicin til behandling af tuberkulose), da virkningen af Silodyx kan være nedsat.
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 Silodyx.
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 Silodyx.
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: The active substance is silodosin.
Danish: Aktivt stof: silodosin.
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 Silodyx.
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 Silodyx.
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.