FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 International Units simoctocog alfa (200 IU/ml after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 500 internationale enheder simoctocog alfa (200 IE/ml efter rekonstitution).
English: Vihuma 1000 IU contains approximately 400 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Danish: Vihuma 1000 IE indeholder ca. 400 IE/ml human koagulationsfaktor VIII (rDNA), simoctocog alfa efter rekonstitution.
English: Vihuma 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Danish: Vihuma 3000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 3000 IE human koagulationsfaktor VIII (rDNA), simoctocog alfa.
English: NAME OF THE MEDICINAL PRODUCT Vihuma 2500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Vihuma 2500 internationale enheder pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 2500 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vihuma 2500 internationale enheder pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 250 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Vihuma 250 internationale enheder pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: Vihuma 1000 IU powder and solvent for solution for injection.
Danish: Vihuma 1000 IE pulver og solvens til injektionsvæske, opløsning.
English: NAME OF THE MEDICINAL PRODUCT Vihuma 500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Vihuma 500 internationale enheder pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: IVR (%/IU/kg) 2.5 (1.7 - 3.2)
Danish: (78,2 IE/kg vs. 41,7 IE/kg).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 250 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vihuma 250 internationale enheder pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 2000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Vihuma 2000 internationale enheder pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 2000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vihuma 2000 internationale enheder pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1168/007
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 1000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vihuma 1000 internationale enheder pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII).
English: Chromogenic assay
Danish: Mave-tarm-kanalen
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 3000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vihuma 3000 internationale enheder pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 1000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Vihuma 1000 internationale enheder pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT Vihuma 3000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Vihuma 3000 internationale enheder pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT Vihuma 4000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Danish: Vihuma 4000 internationale enheder pulver og solvens til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 500 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vihuma 500 internationale enheder pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1168/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1168/002
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 International Units simoctocog alfa (400 IU/ml after reconstitution).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hætteglas med pulver indeholder 1000 internationale enheder/hætteglas simoctocog alfa (400 IE/ml efter rekonstitution).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 4000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Vihuma 4000 internationale enheder pulver til injektionsvæske, opløsning simoctocog alfa (rekombinant human koagulationsfaktor VIII).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/006
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1168/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1168/003
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1168/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1168/001
English: The estimated difference is 42 days while the mean survival time is 2 years.
Danish: Den estimerede forskel er 42 dage, mens den gennemsnitlige overlevelsestid er 2 år.
English: The applicant has applied for a Marketing Authorisation in several member states through the Mutual Recognition Procedure with Czech Republic as reference member state (RMS).
Danish: Ansøgeren har søgt markedsføringstilladelse i flere medlemsstater gennem den gensidige anerkendelsesprocedure med Tjekkiet som referencemedlemsstat (RMS).
English: The bioequivalence between the reference and test products was sufficiently proven and was not questioned in this referral.
Danish: Bioækvivalensen mellem reference- og testprodukter er tilstrækkeligt dokumenteret og blev ikke draget i tvivl ved henvisningen.
English: Viale G. Richard 7, 20143 Milano Italy
Danish: Viale G. Richard 7, 20143 Milano Italien
English: The Article 29 referral procedure was initiated due to concerns raised by Germany on the potential serious risk to public health regarding the benefit/risk ratio of this product.
Danish: En artikel 29indbringelseprocedure blev indledt som følge af betænkeligheder rejst af Tyskland vedrørende den potentielle alvorlige sundhedsrisiko, der er forbundet med produktets benefit/risk forhold.
English: Watchful waiting
Danish: Observation (watchful waiting)
English: A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression.
Danish: Der blev observeret en reduktion i risikoen for objektiv sygdomsprogression hos de fleste patientgrupper, men den var tydeligst hos de grupper med størst risiko for sygdomsprogression.
English: Therefore, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products and to grant Marketing Authorisations for all applications referred to in Annex I of the Opinion in accordance with the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflet, set out in Annex III of the Opinion.
Danish: CHMP anbefalede derfor opretholdelse af markedsføringstilladelserne for alle de lægemidler og udstedelse af markedsføringstilladelse for alle de ansøgninger, der er omhandlet i bilag I til udtalelsen i overensstemmelse med ændringerne af de pågældende afsnit i produktresuméet og indlægssedlen, således som disse fremgår af bilag III til udtalelsen.
English: In view of this, the benefit-risk profile for the use of bicalutamide is not considered favourable in this group of patients.
Danish: Dette betyder, at risiko-fordele-profilen for brug af bicalutamid, ikke anses for at være fordelagtig for denne gruppe patienter.
English: Bicalutamide Teva 150 mg Εpικaλυµµέν a µe λeptό υµένιο dιsκίa
Danish: Bicalutamide Teva 150 mg Εpικaλυµµένa µe λeptό υµένιο dιsκίa
English: National Competent Authorities, coordinated by the Reference Member State (RMS), shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN De nationale kompetente myndigheder sikrer med referencemedlemsstaten (RMS) som koordinerende instans, at indehaverne af markedsføringstilladelserne opfylder følgende betingelser:
English: are generic preparations containing bicalutamide as the active substance.
Danish: er generiske præparater med bicalutamid som aktivt indholdsstof.
English: It binds to androgen receptors without activating gene expression and thus inhibits androgen stimulation.
Danish: Det binder til en androgenreceptor uden at aktivere genekspression, hvorved det hæmmer den androgene stimulation.
English: Jeneweinova 51a, 617 00 Brno, Czech Republic
Danish: Jeneweinova 51a, 617 00 Brno
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Anti-androgens act against the effects of androgens (male sex hormones).
Danish: Antiandrogener modvirker indvirkningen af androgener (mandlige kønshormoner).
English: Radical prostatectomy 179/870 (20.6)
Danish: Radikal prostatektomi 179/870 (20,6)
English: Hazard ratio (95% CI)
Danish: Relativ risiko (95 % KI)
English: Progression-free survival and overall survival data for patients with locally advanced disease are summarised in the following tables:
Danish: Progressionsfri overlevelse og total overlevelse for patienter med lokalt avanceret sygdom er vist i de følgende tabeller:
English: For patients with localised disease, receiving bicalutamide alone, there was no significant difference in progression free survival.
Danish: For patienter med lokaliseret sygdom, som fik bicalutamid som monoterapi, blev der ikke observeret signifikant forskel i progressionsfri overlevelse.
English: Radical prostatectomy 137/870 (15.7)
Danish: Radikal prostatektomi 137/870 (15,7)
English: Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
Danish: Derfor kan behandlende læger beslutte, at den optimale medicinske behandling, for en patient med lav risiko for sygdomsprogression særlig ved indsættelse af adjuvant behandling efter radikal prostatektomi, kan være at udsætte hormonal behandling, indtil der opstår tegn på sygdomsprogression.
English: TEVA Classics S.A. 1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
Danish: 1, cours du Triangle, Immeuble Palatin 1 92936 Paris La Défense cedex 12, Frankrig
English: Bicalutamide is a non-steroidal anti-androgen without any other endocrine activity.
Danish: Bicalutamid er et nonsteroidt antiandrogen uden anden endokrin aktivitet.
English: WHAT BICALUTAMIDE IS AND WHAT IT IS USED FOR Bicalutamide belongs to the group of anti-androgens.
Danish: BICALUTAMIDS VIRKNING OG HVAD DU SKAL BRUGE DET TIL Bicalutamid tilhører gruppen af antiandrogener.
English: TEVA Sweden AB PO Box 1070, SE - 25110
Danish: TEVA Sweden AB PO Box 1070
English: At 7.4 years median follow-up, 27.4 % of all bicalutamide-treated patients and 30.7 % of all placebo-treated patients had experienced objective disease progression.
Danish: Ved opfølgning efter i median 7,4 år, blev der observeret objektiv sygdomsprogression hos hhv. 27,4 % af alle patienter, som blev behandlet med bicalutamid og hos 30,7 % af alle patienter, som blev behandlet med placebo.
English: Pharmacotherapeutic group: anti-androgens, ATC code: L02BB03
Danish: Farmakoterapeutisk klassifikation: Antiandrogener, ATC-kode: L02 BB 03
English: The CHMP also concluded that a potential association between the use of bicalutamide 150 mg and heart failure could not be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
Danish: CHMP konkluderede desuden, at det ikke kan udelukkes, at der er sammenhæng mellem brugen af bicalutamid, 150 mg, og hjerteinsufficiens, og fandt det derfor fortsat nødvendigt med yderligere undersøgelser af den kardiovaskulære morbiditet og mortalitet.
English: A general trend with respect to quality of life in favour of bicalutamide 150 mg in comparison with castration was observed; the subgroups that provided these data showed significantly higher sexual appetence (p=0.029) and fitness (p=0.046).
Danish: Der blev observeret en generel tendens til forbedret livskvalitet ved behandling med bicalutamid 150 mg i forhold til kastration; undergrupperne som frembragte disse data, viste signifikant større sexlyst (p=0,029) og udholdenhed (p=0,046).
English: In these patients there was also a trend toward decreased survival compared with placebo patients (HR=1.16, 95% CI 0.99 to 1.37).
Danish: Hos disse patienter sås også en tendens til mindsket overlevelse sammenlignet med placebopatienter (RR=1,16, 95 % KI 0,99 til 1,37).
English: There was no significant difference in survival (HR=1.05 (CI=0.81-1.36), p=0.669) or in the interval until progression (HR=1.20 (CI 0.96-1.51), p=0.107) between the group treated with bicalutamide 150 mg and the group treated with castration.
Danish: Der var ingen signifikant forskel i overlevelse (RR=1,05 (KI=0,81-1,36), p=0,669) eller i intervallet indtil progression (RR=1,20 (KI 0,96-1,51), p=0,107) mellem gruppen, som blev behandlet med bicalutamid 150 mg og gruppen, som blev behandlet med kastration.
English: - In addition to routine pharmacovigilance activities, identified and potential risks highlighted for increased monitoring and follow-up should include heart failure, hepatic failure, interstitial lung disease, breast cancer, and reports concerning pregnancy in partners of patients taking bicalutamide.
Danish: - Ud over den rutinemæssige lægemiddelovervågning foretages forstærket overvågning og opfølgning af konstaterede og potentielle risici vedrørende hjerteinsufficiens, leversvigt, interstitiel lungesygdom og brystcancer samt af indberettede graviditeter hos partnere til patienter, der er i behandling med bicalutamid.
English: No overall survival difference was seen at 7.4 years median follow-up with 22.9% mortality (HR = 0.99; 95% confidence interval 0.91 to 1.09).
Danish: Der sås ingen generel forskel i overlevelse ved opfølgning efter i median 7,4 år med 22,9 % mortalitet (RR=0,99; 95 % KI 0,91 til 1,09).
English: Bicalutamide is used in adult men for the treatment of prostate cancer without metastases, when castration or other types of treatment are not indicated or unacceptable.
Danish: Bicalutamid anvendes til behandling af prostatacancer (kræft i blærehalskirtlen) uden metastaser hos voksne mænd, når kastration eller andre former for behandling ikke er tilrådelige eller er uacceptabele.
English: The CHMP concluded that the benefit/risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
Danish: CHMP konkluderede, at benefit/risk-forholdet for lægemidler indeholdende bicalutamid, 150 mg, til den godkendte indskrænkede indikation er gunstigt.
English: Combined analysis of 2 clinical studies comprising 805 patients with metastatic prostatic carcinoma, who had not been treated before with expected mortality 43%, showed that the treatment with bicalutamide 150 mg is less effective than castration as for the survival time (HR = 1.30 [confidence interval 1.04 - 1.65]).
Danish: Kombinerede analyser af 2 kliniske studier, der omfattede 805 patienter med metastatisk prostatakarcinom, som ikke var blevet behandlet før og med en forventet mortalitet på 43 %, viste at behandlingen med bicalutamid 150 mg er mindre effektiv end kastration i forhold til overlevelsestiden (RR=1,30[konfidensinterval 1,04 - 1,65]).
English: Treatment discontinuation may result in antiandrogen withdrawal syndrome in some patients.
Danish: Seponering af behandlingen med bicalutamid kan resultere i et ”antiandrogent abstinenssymdrom” hos nogle patienter.
English: acceptable for registration based on a positive benefit/risk ratio of bicalutamide 150mg containing products as recently assessed in the Casodex Article 31 Referral.
Danish: kan godkendes til registrering på grundlag af det positive benefit/risk forhold for lægemidler indeholdende bicalutamid, 150 mg, der for nylig blev vurderet ved artikel 31-indbringelsen for Casodex.
English: CONDITIONS OF THE MARKETING AUTHORISATION
Danish: Indehaver af markedsføringstilladelse
English: It may be used in combination with radiotherapy or prostate surgery in early treatment programmes.
Danish: Bicalutamid kan anvendes i kombination med strålebehandling eller ved operation af prostata (blærehalskirtlen) i tidlige behandlingsprogrammer.
English: The valid labelling text is the final version achieved during the Coordination group procedure.
Danish: Den gældende tekst til etikettering er den endelige version der er fastlagt ved behandling i koordinationsgruppen.
English: Inhibition results in the regression of prostatic tumours.
Danish: Denne hæmning fører til regression af prostatatumorer.
English: Events (%) in placebo patients
Danish: Tilfælde (%) hos placebopatienter
English: The Committee, considering the Casodex Referral (bicalutamide 150 mg) made under article 31 of Directive 2001/83/EC for medicinal products containing bicalutamide, reached the conclusion that bicalutamide 150mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to: “Bicalutamide 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression”.
Danish: Idet udvalget tog den indbringelse for Casodex (bicalutamid 150 mg) i betragtning, der i overensstemmelse med artikel 31 i direktiv 2001/83/EF havde fundet sted for lægemidler indeholdende bicalutamid, konkluderede udvalget, at bicalutamid, 150 mg, er effektivt til behandling af lokal avanceret prostatacancer, men at den terapeutiske indikation bør indskrænkes til følgende: "Bicalutamid, 150 mg, er indiceret til patienter med lokal avanceret prostatacancer med høj risiko for progression af sygdommen, enten som eneste behandling eller som adjuverende behandling til radikal prostatektomi eller strålebehandling".
English: Deaths (%) in placebo patients
Danish: Dødsfald (%) hos placebopatienter
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BICALUTAMIDE 150 mg CONTAINING MEDICINAL PRODUCTS
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE BICALUTAMID 150 mg
English: Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3,
Danish: TEVA Pharma - Produtos Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3, 2740-264 Porto Salvo, Portugal
English: Based on these conclusions, the CHMP considered generic Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s.r.o.)
Danish: På baggrund af disse konklusioner fandt CHMP, at generiske filmovertrukne tabletter indeholdende bicalutamid, 150 mg, (Ingers Industrial Solutions s.r.o.)
English: Magyarország Rt Rákóczi út 70-72, Budapest, H-1074, Hungary
Danish: TEVA Magyarország Rt Rákóczi út 70-72
English: 0.81 (0.66 to 1.01)
Danish: 0,81 (0,66 til 1,01)
English: The United Kingdom
Danish: Storbritannien
English: 1.09 (0.85 to 1.39)
Danish: 1,09 (0,85 til 1,39)
English: 3640 AE Mijdrecht The Netherlands
Danish: Industrieweg 23, P.O. Box 217 3640 AE Mijdrecht Nederlandene
English: The scope of Bicaluplex Article 29 Referral concerns the benefit/risk ration of both indications: treatment of locally advanced prostatic cancer and monotherapy in early treatment or as adjunct to treatment with radiotherapy or radical prostatectomy in patients with prostate cancer.
Danish: Artikel 29-henvisningen for Bicaluplex vedrører benefit/risk forholdet for begge indikationer: behandling af lokal avanceret prostatacancer og tidlig behandling som monoterapi, og adjuverende behandling til strålebehandling eller radikal prostatektomi ved prostatacancer.
English: Bicalutamide 150 mg was studied as a treatment for patients with localized (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer, in a combined analysis of 3 placebo-controlled double-blind studies in 8,113 patients, where the product was given as immediate hormone therapy or as adjuvant to radical prostatectomy or radiotherapy (primarily external beam radiation).
Danish: Bicalutamid 150 mg blev undersøgt til behandling af patienter med lokaliseret (T1-T2, N0 eller NX, M0) eller lokalt avanceret (T3-T4, alle N, M0; T1-T2, N+, M0) ikke-metastaserende prostatacancer i en kombineret analyse af 3 placebokontrollerede dobbeltblinde studier, der omfattede 8113 patienter.
English: Bicalutamide is an oral-androgen used in the management of locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Danish: Bicalutamid er et oralt antiandrogen, der anvendes til umiddelbar behandling af lokal avanceret prostatacancer, enten anvendt alene eller som adjuverende behandling til radikal prostatektomi eller strålebehandling.
English: Helsingborg Sweden
Danish: SE - 25110 Helsingborg Sverige
English: However some trends were apparent for patients in exploratory subgroup analyses.
Danish: Ved analyse af patienter i behandlingsundergrupperne var visse overlevelsestendenser dog tydelige.
English: 0.65 (0.44 to 0.95)
Danish: 0,65 (0,44 til 0,95)
English: 0.60 (0.49 to 0.73)
Danish: 0,60 (0,49 til 0,73)