natgillin/translations-raw huggingface dataset:
I klinisk praksis sker dette kun i tilfælde af, at det ikke er muligt at anvende en
In clinical practice these cases are usually restricted to cases when a combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae is not possible or in cases of therapeutic failure with a different therapy.
6 kombination med et godkendt stof, der er aktivt imod fluoroquinolon- resistent N. gonorrhoeae, eller i tilfælde af anden fejlslagen behandling.
6 The CHMP considered that due to the emergence of fluoroquinolone-resistant N. gonorrhoeae strains moxifloxacin should not be used in empirical monotherapy of mild to moderate PID, unless a resistance against moxifloxacin can be ruled out.
CHMP var af den opfattelse, at moxifloxacin på grund af fremkomsten af fluoroquinolon- resistente N. gonorrhoeae- stammer ikke bør anvendes i empirisk monoterapi i forbindelse med let til moderat PID, medmindre moxifloxacin- resistens kan udelukkes.
In clinical practice, this would mean that moxifloxacin should be used in combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae (e. g. a cephalosporin) for empirical treatment of PID unless moxifloxacin- resistant N. gonorrhoeae can be excluded.
7 Overordnet var CHMP enig i, at der foreligger et positivt benefit/ risk- forhold for moxifloxacin til indikationen for PID over en periode på 14 dage.
Overall, the CHMP agreed that the benefit/ risk balance of moxifloxacin in the PID indication over 14 days is positive.
8 BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ OG INDLÆGSSEDDEL
7 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET
12, i Kommissionens
- The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC)
1084/ 2003, for Avalox og tilknyttede navne (se bilag I).
No 1084/ 2003, for Avalox and associated names (See Annex 1).
- Udvalget var af den opfattelse, at der eksisterer fyldestgørende data for virkningen af Avalox i
- The Committee considered that robust data is available showing the efficacy of Avalox in the
benefit/ risk- forholdet var positivt for Avalox og tilknyttede navne i forbindelse med "Behandlingen af let til moderat PID (pelvic inflammatory disease), dvs. infektioner i de øvre genitaler, herunder salpingitis og endometritis", dog med de anførte restriktioner i forbindelse med empirisk monoterapi.
Risk balance for Avalox and associated names in the “ The treatment of mild to moderate pelvic inflammatory disease (PID), i. e. infections of upper genital tract, including salpingitis and endometritis” with the restrictions concerning empirical monotherapy was favourable;
- CHMP anbefalede derfor, at der for Avalox og tilknyttede navne (se bilag I) foretages ændring af
Characteristics sections 4.1, 4.2, 4.3, 4.4, 5.1 and 5.2 and Package Leaflet relevant sections as set out in Annex III for Avalox and associated names (see Annex I).
9 BILAG III
9 SUMMARY OF PRODUCT CHARACTERISTICS
10 PRODUKTRESUME
10 4.
I kliniske studier har man undersøgt behandling med [Lægemidlets navn] 400 mg filmovertrukne tabletter i op til 14 dage.
11 [Invented name] 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
12 4. 3 Kontraindikationer
4.3 Contraindications
- [Lægemidlets navn] 400 mg filmovertrukne tabletter bør ikke anvendes til patienter med
- For patients with complicated pelvic inflammatory disease (e. g. associated with a tubo-ovarian
kompliceret bækkenbetændelse (f. eks. forbundet med abscess i æggestokkene eller bækkenet), hvor intravenøs behandling skønnes nødvendig.
or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with [Invented name] 400 mg film-coated tablets is not recommended.
I sådanne
- Pelvic inflammatory disease may be caused by fluoroquinolone resistant Neisseria
14 Effekt på tarmfloraen hos mennesker Følgende forandringer blev observeret i tarmfloraen hos frivillige forsøgspersoner efter oral administration af moxifloxacin:
Effect on the intestinal flora in humans The following changes in the intestinal flora were seen in volunteers following oral administration of moxifloxacin:
Clinical and Laboratory Standards Institute™ (CLSI) MIC - og disk- diffusions brydningspunkt for Staphylococcus spp. og følsomme organismer (M100- S17, 2007) og MIC brydningspunkt for anaerobe (M11- A7, 2007):
14 Clinical and Laboratory Standards Institute™ (CLSI) MIC and disc diffusion breakpoints for Staphylococcus spp. and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007):
15 Forekomsten af resistens kan variere geografisk og over tid for udvalgte arter, og lokal information om resistensudviklingen er ønskelig, specielt ved behandling af alvorlige infektioner.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections.
Intermedius) * Streptococcus pneumoniae * Streptococcus pyogenes * (Gruppe A) Aerobe gramnegative mikroorganismer Haemophilus influenzae * Haemophilus parainfluenzae * Klebsiella pneumoniae * # Moraxella (Branhamella) catarrhalis * Anaerobe mikroorganismer Fusobacterium spp.
15 Commonly susceptible species Aerobic Gram-positive micro-organisms Gardnerella vaginalis Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B) Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae* Streptococcus pyogenes* (Group A) Aerobic Gram-negative micro-organisms Haemophilus influenzae* Haemophilus parainfluenzae* Klebsiella pneumoniae*# Moraxella (Branhamella) catarrhalis* Anaerobic micro-organisms Fusobacterium spp.
16 Farmakokinetikken er linær i intervallet 50– 800 mg givet som enkelt dosis og op til 600 mg ved en daglig dosering i 10 dage.
Pharmacokinetics are linear in the range of 50 - 800 mg single dose and up to 600 mg once daily dosing over 10 days.
Moxifloxacin distribueres hurtigt til det ekstravaskulære rum; Efter en dosis på 400 mg blev et AUC på 35 mg h/ l observeret.
16 Distribution Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m·gh/ l is observed.
17 Der blev observeret højere plasmakoncentrationer i raske forsøgspersoner med lav kropsvægt (eksempelvis kvinder) og i ældre forsøgspersoner.
Higher plasma concentrations are observed in healthy volunteers with low body weight (such as women) and in elderly volunteers.
I takt med at nyrefunktionens clearance nedsættes, øges koncentrationen af M2- metabolitten (glucuronid) med op til en faktor 2, 5 (ved kreatin clearance på < 30 ml/ min/ 1, 73 m2).
17 concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/ min/ 1.73 m2).
18 INDLÆGSSEDDEL
18 PACKAGE LEAFLET
2:
[Invented name] tablets are not sufficient for sole therapy of this kind of infections and therefore another antibiotic in addition to [Invented name] tablets should be prescribed by your doctor for the treatment of infections of the female upper genital tract (see section 2.
Det skal De vide, før De begynder at tage [Lægemidlets navn] …. Vær ekstra forsigtig …. Før De tager [Lægemidlets navn] 400 mg filmovertrukne tabletter).
Before you take [Invented name] …, Take special care …, Before taking [Invented name] 400 mg film-coated tablets).
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE [LÆGEMIDLETS NAVN]
BEFORE YOU TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS
behandling af mild til moderat betændelse i den øvre del af underlivet.
If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
Hvis Deres symptomer ikke bedres efter tre dages behandling, skal De kontakte Deres læge.
When taking [Invented name] 400 mg film-coated tablets
- Samtidig indtagelse af oralt medicinsk kul (indtaget via munden) og [Lægemidlets navn] -
- If you are currently taking oral anti-coagulants (e. g. warfarin), it may be necessary for your
tabletter nedsætter virkningen af [Lægemidlets navn].
doctor to monitor your blood clotting times.
Det anbefales derfor, at denne medicin ikke anvendes samtidigt.
Taking [Invented name] 400 mg film-coated tablets with food and drink The effect of [Invented name] is not influenced by food including dairy products.
- Hvis De for tiden indtager orale antikoagulantia (indtaget via munden) (f. eks. warfarin), kan det
Pregnancy and breast-feeding Do not take [Invented name] if you are pregnant or breast-feeding.
være nødvendigt, at lægen følger blodets størkningsevne.
Ask your doctor or pharmacist for advice before taking any medicine.
Graviditet og amning Spørg Deres læge eller apotek til råds, før De tager nogen form for medicin.
Driving and using machines [Invented name] may make you feel dizzy or light-headed.
Tag ikke [Lægemidlets navn], hvis De er gravid eller ammer.
If you are affected in this way do not drive or operate machinery.
Hvis De bliver påvirket på denne måde, må De ikke køre bil eller betjene maskiner.
Important information about some of the ingredients of [Invented name] 400 mg film-coated tablets [Invented name] tablets contain lactose.
22 Hvis det er muligt, skal De tage de resterende tabletter, pakningen og denne indlægsseddel med til lægen eller apoteket for at vise, hvad De har indtaget.
22 If you take more than the prescribed one tablet a day, seek medical advice immediately and, if possible, take any remaining tablets, the packaging or this leaflet with you to show the doctor or pharmacist what you have taken.
London, den 14. august 2008 EMEA/ CHMP/ 524248/ 2008
London, 14 August 2008 EMEA/ CHMP/ 524251/ 2008
Avelox og tilknyttede navne
Avelox and associated names
LISTE OVER NAVNE, LÆGEMIDDELFORMER OG STYRKER, ADMINISTRATIONVEJ, OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE OCH NORGE OG ISLAND
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
1 Medlems - land
1 Member State
Indehaver af markedføringstilladelsen
Marketing autorisation Holder
Sœrnavn
Invented Name
Lœgemiddel- form
Pharmaceutical form
6 - 10 1160 Wien, Østrig
6 - 10 1160 Wien, Austria
Filmovertrukne tabletter
film-coated tablets
Bayer Hellas AG 18- 20 Sorou Str 15125 Amaroussion Athens, Grækenland
Bayer Hellas AG 18-20 Sorou Str 15125 Amaroussion Athens, Greece
2 Medlems - land
2 Germany
KG Otto – Schott – Str.
KG Otto - Schott - Str.
15 D- 07745 Jena Tyskland
15 D-07745 Jena Germany
Aida
aida
Bayer Hellas AG 18- 20 Sorou Str 15125 Amaroussion Athens Grækenland
Bayer Hellas AG 18-20 Sorou Str 15125 Amaroussion Athens Greece
The Atrium, Blackthorn Road Dublin 18 Irland
The Atrium, Blackthorn Road Dublin 18 Ireland
Energieweg 1 3641 RT Mijdrecht Nederlandene
Energieweg 1 3641 RT Mijdrecht The Netherlands
Baix Llobregat, 3- 5 08970 Sant Joan Despí, Barcelona Spanien
Baix Llobregat, 3-5 08970 Sant Joan Despí, Barcelona Spain
Sverige
4 Sweden
FAGLIGE KONKLUSIONER FAGLIGE KONKLUSIONER
6 SCIENTIFIC CONCLUSIONS
Belanette- blisteren er limet i en pakning, som efterfølgende foldes, så den får form som et omslag.
The Belanette blister is glued in a carton which is subsequently folded to a wallet configuration.
7 BILAG III
7 ANNEX III
PRODUKTRESUMÉ, MÆRKNING OCH INDLÆGSSEDDEL
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
8 Det gældende produktresumé, den gældende etikettering og indlægsseddel er endelige versioner, der er fremkommet under Koordinationsgruppens procedure.
8 The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
London, den 17. juni 2008 EMEA/ 340377/ 2008
London, 17 June 2008 EMEA/ CHMP/ 332403/ 2008
111, OM Belanette og tilknyttede navne (se bilag I)
OPINION FOLLOWING AN ARTICLE 5(11)1 REFERRAL FOR Belanette and associated names (see Annex I)
Belanette og tilknyttede navne er et kombineret oralt antikonceptionsmiddel, som indeholder 0, 02 mg ethinylestradiol og 3 mg drospirenon.
Belanette and associated names, is a combined oral contraceptive containing 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
1084/ 2003 indgivet ansøgning om ændring under proceduren for gensidig anerkendelse af markedsføringstilladelserne for lægemidlet.
The MAH submitted variation application subject to the Mutual Recognition Procedure to the Marketing Authorisations of the medicinal product in the framework of Article 5 of Commission Regulation (EC) No 1084/ 2003.
På baggrund af alle de fremlagte oplysninger og den faglige drøftelse i udvalget var CHMP på sit møde i december 2007 af den opfattelse, at benefit/ risk- forholdet er gunstigt for Belanette og tilknyttede navne, at de indsigelser, der er rejst af Ungarn, ikke bør forhindre godkendelse af den ændring, hvorom der er indgivet ansøgning, og at referencemedlemsstatens produktresumé, etikettering og indlægsseddel skulle udgøre den endelige udgave, som var opnået under koordineringsgruppens procedure.
During their December 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 Yasminelle and associated names, that the objections raised by Hungary should not prevent the approval of the variation applied for and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be the final versions achieved during the Coordination group procedure.
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa- Kommissionen den 17 juni 2008.
The final opinion was converted into a Decision by the European Commission on 17 June 2008.
1084/ 2003 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
1 Article 5(11) of Commission Regulation (EC) No 1084/ 2003 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM( ER), STYRKE( R), INDGIVELSESVEJ( E), ANSØGER( E), INDEHAVER( E) AF MARKEDSFØRINGSTILLADELSE( R) I MEDLEMSSTATERNE Medlemsstat
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Indehaver af markedsføringstilladelse
(Invented)
Navn
Route of
Styrke
State
Lægemiddelform Indgivelsesvej
Authorisation Holder
Østrig
form
Box 217 3640 AE Mijdrecht Nederlandene
Box 217 3640 AE Mijdrecht The Netherlands
Filmovertrukket Oral anvendelse tablet
Film-coated tablet
Jeneweinova 51a, 617 00 Brno Tjekkiske republik
Jeneweinova 51a, 617 00 Brno, Czech Republic
Bicamid- GRY 150 mg Filmtabletten
Bicamid- GRY 150 mg Filmtabletten
TEVA Sweden AB PO Box 1070 SE - 25110 Helsingborg Sverige
TEVA Sweden AB PO Box 1070, SE - 25110 Helsingborg Sweden
Estland
Oral use
Teva Pharma B. V.
Estonia
Frankrig
2 Greece
Bicalutamide Teva 150 mg,
Bicalutamide Teva 150 mg Ε pικ aλυ µµέν a µe λ eptό υ µένιο dι sκί a
Filmovertrukket Oral anvendelse
Film-coated tablet
tablet
Oral use
Box 217 3640 AE Mijdrecht Nederlandene
1, cours du Triangle, Immeuble Palatin 1, 92936 Paris La Défense cedex 12 France
TEVA Magyarország Rt Rákóczi út 70- 72 Budapest, H- 1074, Ungarn
TEVA Magyarország Rt Rákóczi út 70-72, Budapest, H-1074, Hungary
Richard 7, 20143 Milano Italien
Richard 7, 20143 Milano Italy
Styrke
Latvia
Litauen
Oral use
Teva Pharma B. V.
Lithuania
Nederlandene
3 The Netherlands
Swensweg 5, Postbus 552 2003 RN Haarlem Nederlandene
Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
Bicalutamid TEVA 150 mg 150 mg tabletter, filmdrasjerte
Bicalutamid TEVA 150 mg tabletter, filmdrasjerte
Bicalutamide Ingers 150 mg 150 mg tabletki powlekane
Bicalutamide Ingers 150 mg tabletki powlekane
TEVA Pharma - Produtos Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3, 2740- 264 Porto Salvo, Portugal
TEVA Pharma - Produtos Farmacêuticos Lda Lagoas Park, Edifício 1, Piso 3, 2740-264 Porto Salvo, Portugal
Bicalutamida Teva 150 mg
150 mg
Bicalutamid- Teva 150 mg 150 mg
Bicalutamid- Teva 150 mg
Slovenien
4 Slovenia
Bikalutamid TEVA 150 mg 150 mg filmsko obložene tablete
Bikalutamid TEVA 150 mg filmsko oblož ene tablete
Jeneweinova 51a, 617 00 Brno Tjekkiske republik
Ingers Industrial Solutions s. r. o., Jeneweinova 51 a 617 00 Brno, Tjeckien
Bicalutamide 150 mg Film - 150 mg coated Tablets
Bicalutamide 150 mg Film- coated Tablets
5 FAGLIGE KONKLUSIONER
5 ANNEX II
Bicalutamid, filmovertrukne tabletter, 150 mg (Ingers Industrial Solutions s. r. o.) er generiske præparater med bicalutamid som aktivt indholdsstof.
Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s. r. o.) are generic preparations containing bicalutamide as the active substance.
En artikel 29 - indbringelseprocedure blev indledt som følge af betænkeligheder rejst af Tyskland vedrørende den potentielle alvorlige sundhedsrisiko, der er forbundet med produktets benefit/ risk forhold.
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.
Bioækvivalensen mellem reference - og testprodukter er tilstrækkeligt dokumenteret og blev ikke draget i tvivl ved henvisningen.
The bioequivalence between the reference and test products was sufficiently proven and was not questioned in this referral.
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.
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.
"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".
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”.
CHMP konkluderede, at benefit/ risk- forholdet for lægemidler indeholdende bicalutamid, 150 mg, til den godkendte indskrænkede indikation er gunstigt.
The CHMP concluded that the benefit/ risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
På baggrund af disse konklusioner fandt CHMP, at generiske filmovertrukne tabletter indeholdende bicalutamid, 150 mg, (Ingers Industrial Solutions s. r. o.) 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.
Based on these conclusions, the CHMP considered generic Bicalutamide 150mg film-coated tablets (Ingers Industrial Solutions s. r. o.) acceptable for registration based on a positive benefit/ risk ratio of bicalutamide 150mg containing products as recently assessed in the Casodex Article 31 Referral.
7 PRODUKTRESUME,
7 ANNEX III
ETIKETTERING OG INDLÆGSSEDDEL
SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
8 PRODUKTRESUME
8 SUMMARY OF PRODUCT CHARACTERISTICS
9 Den gældende tekst til produktresumé er den endelige version der er fastlagt ved behandling i koordinationsgruppen med følgende ændringer.
9 The valid summary of product characteristics is the final version achieved during the Coordination group procedure with the following amendments:
Bicaluplex 150 mg tabletter er indiceret til behandling af lokalt avanceret prostatacancer med høj risiko for sygdomsprogression, enten som behandling alene eller som adjuvant behandling ved radikal prostatektomi eller ved strålebehandling (se afsnit 5. 1).
Bicaluplex 150 mg tablets are indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
Antiandrogener, ATC- kode:
Pharmacotherapeutic group: anti-androgens, ATC code:
L02 BB 03 Bicalutamid er et nonsteroidt antiandrogen uden anden endokrin aktivitet.
L02BB03 Bicalutamide is a non-steroidal anti-androgen without any other endocrine activity.
Seponering af behandlingen med bicalutamid kan resultere i et ” antiandrogent abstinenssymdrom ” hos nogle patienter.
Treatment discontinuation may result in anti- androgen withdrawal syndrome in some patients.
Den antiandrogene effekt skyldes næsten udelukkende (R) - enantiomeren.
Bicalutamide is a racemate, the (R)-enantiomer of which has most of the anti-androgen activity.
Bicaluplex blev givet enten som umiddelbar hormonbehandling eller som adjuvant behandling til radikal prostatektomi eller strålebehandling (primært ekstern stråling).
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).
27, 4% af alle patienter, som blev behandlet med bicalutamid og hos 30, 7% af alle patienter, som blev behandlet med placebo.
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.
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).
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).
Tabel 1 Progressionsfri overlevelse ved lokalt avanceret sygdom pr. behandlingsundergruppe
Table 1 Progression-free survival in locally advanced disease by therapy sub-group
Analysepopulation Observation
Analysis population
Tilfælde (%) hos bicalutamidpatienter
Events (%) in Bicalutamide patients
Relativ risiko (95% KI)
Hazard ratio (95% CI)
(watchful waiting) Strålebehandling Radikal prostatektomi
Watchful waiting Radiotherapy Radical prostatectomy
0, 60 (0, 49 til 0, 73) 0, 56 (0, 40 til 0, 78) 0, 75 (0, 61 til 0, 91)
0.60 (0.49 to 0.73) 0.56 (0.40 to 0.78) 0.75 (0.61 to 0.91)
10 Tabel 2 Total overlevelse ved lokalt avanceret sygdom pr. behandlingsundergruppe
10 Table 2 Overall survival in locally advanced disease by therapy sub-group
Dødsfald (%) hos bicalutamidpatienter
Deaths (%) in Deaths (%) in Bicalutamide patients placebo patients
0, 81 (0, 66 til 1, 01) 0, 65 (0, 44 til 0, 95) 1, 09 (0, 85 til 1, 39)
0.81 (0.66 to 1.01) 0.65 (0.44 to 0.95) 1.09 (0.85 to 1.39)
Hos disse patienter sås også en tendens til mindsket overlevelse sammenlignet med placebopatienter (RR=1, 16, 95% KI 0, 99 til 1, 37).
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).
Dette betyder, at risiko- fordele- profilen for brug af bicalutamid, ikke anses for at være fordelagtig for denne gruppe patienter.
In view of this, the benefit-risk profile for the use of bicalutamide is not considered favourable in this group of patients.