FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition to the co-primary endpoint measures, benefit was also assessed using time to opiate use for cancer pain, time to initiation of cytotoxic chemotherapy, time to deterioration in ECOG performance score by ≥ 1 point and time to PSA progression based on Prostate Cancer Working Group-2 (PCWG2) criteria.
Danish: Ud over de co-primære endepunkter blev behandlingens fordele også evalueret vha. tiden indtil brug af opiat mod cancersmerter, tiden indtil påbegyndelse af cytotoksisk kemoterapi, tiden indtil forværring af ECOG-performancescore med ≥ 1 point og tiden indtil PSA-progression baseret på Prostata Cancer Working Group-2 (PCWG2-) kriterier.
English: There have been rare post-marketing reports of acute liver failure and hepatitis fulminant, some with fatal outcome (see section 4.8).
Danish: Der har været rapporteret om sjældne tilfælde af akut leversvigt og fulminant hepatitis efter markedsføringen, hvoraf nogle havde dødelig udgang (se pkt.
English: Potential for other medicinal products to affect abiraterone exposures In a clinical pharmacokinetic interaction study of healthy subjects pretreated with a strong CYP3A4 inducer rifampicin, 600 mg daily for 6 days followed by a single dose of abiraterone acetate 1,000 mg, the mean plasma AUC∞ of abiraterone was decreased by 55%.
Danish: Potentialet for, at andre lægemidler påvirker abirateroneksponeringen I et klinisk farmakokinetisk interaktionsstudie med raske forsøgspersoner, der var blevet præmedicineret med en potent CYP3A4-induktor rifampicin, givet som 600 mg dagligt i 6 dage, efterfulgt af en enkelt dosis abirateronacetat på 1.000 mg, faldt abiraterons gennemsnitlige plasmaAUC∞ med 55 %.
English: Tell your doctor if you have been told you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions.
Danish: Fortæl det til lægen, hvis du har fået at vide, at du har sygdomme, der vedrører hjertet eller blodkarrene, herunder problemer med hjerterytmen (arytmi), eller hvis du får lægemidler for sådanne sygdomme.
English: If clinical symptoms or signs suggestive of hepatotoxicity develop, serum transaminases should be measured immediately.
Danish: I tilfælde af kliniske symptomer, der indikerer udvikling af hepatotoksicitet, skal der straks udføres kontrol af aminotransferaser.
English: Abiraterone acetate (ZYTIGA) is converted in vivo to abiraterone, an androgen biosynthesis inhibitor.
Danish: Abirateronacetat (ZYTIGA) konverteres in vivo til abirateron - en androgen biosyntese-hæmmer.
English: How to take ZYTIGA
Danish: Sådan skal du tage ZYTIGA
English: Vascular disorders very common: hypertension
Danish: Vaskulære sygdomme meget almindelige: hypertension
English: Patients in the control arm received ADT and placebos for both ZYTIGA and prednisone.
Danish: Patienter i kontrolarmen fik ADT og placebo for både ZYTIGA og prednison.
English: - Take ZYTIGA at least two hours after eating and do not eat anything for at least one hour after taking ZYTIGA (see section 2, “ZYTIGA with food”).
Danish: - Tag først ZYTIGA, når der er gået mindst 2 timer efter et måltid, og lad være med at spise i mindst 1 time efter, at du har taget ZYTIGA (se ”Brug af ZYTIGA sammen med mad” under punkt 2).
English: The major compounds present in faeces are unchanged abiraterone acetate and abiraterone (approximately 55% and 22% of the administered dose, respectively).
Danish: Uomdannet abirateronacetat og abirateron udgør de største forekomster i fæces (henholdsvis ca. 55 % og 22 % af den indgivne dosis).
English: Subgroup survival analyses showed a consistent survival benefit for treatment with ZYTIGA (see Figure 7).
Danish: Analyser af overlevelse i subgrupperne viste, at overlevelse konsekvent faldt ud til fordel for behandling med ZYTIGA (se figur 7).
English: Each carton contains one bottle.
Danish: Hver æske indeholder 1 beholder.
English: In another trial, the pharmacokinetics of abiraterone were examined in subjects with pre-existing severe (n = 8) hepatic impairment (Child-Pugh Class C) and in 8 healthy control subjects with normal hepatic function.
Danish: I et andet forsøg blev abiraterons farmakokinetik undersøgt hos forsøgspersoner med svært nedsat leverfunktion (n=8) (Child-Pugh-klasse C) og hos 8 raske kontrolforsøgspersoner med normal leverfunktion.
English: Time to degradation in the FACT-P (Total Score): Treatment with ZYTIGA decreased the risk of FACT-P (Total Score) degradation by 22% compared with placebo (p = 0.0028).
Danish: Tid til forringelse af FACT-P (samlet score): Behandling med ZYTIGA reducerede risikoen for forringelse af FACT-P (samlet score) med 22 % sammenlignet med placebo (p=0,0028).
English: Respiratory, thoracic and mediastinal disorders rare: allergic alveolitis
Danish: Luftveje, thorax og mediastinum sjælden: allergisk alveolitis
English: All patients enrolled (both active and placebo-treated patients) were concomitantly treated with androgen deprivation therapy, predominantly with the use of LHRH analogues, which has been associated with diabetes, myocardial infarction, cerebrovascular accident and sudden cardiac death.
Danish: Alle patienter, der indgik i studiet, uanset om de fik aktiv behandling eller placebo, blev samtidig behandlet med androgen deprivationsbehandling, hovedsageligt i form af LHRH-analog, som har en mulig påvirkning af diabetes, myokardieinfarkt, cerebrovaskulært attak og pludselig hjertedød.
English: Systemic exposure to abiraterone after a single oral 1,000 mg dose increased by approximately 11% and 260% in subjects with mild and moderate pre-existing hepatic impairment,
Danish: Systemisk eksponering for abirateron efter en enkelt oral dosis på 1.000 mg øgedes med ca. 11 % og 260 % hos forsøgspersoner med eksisterende henholdsvis let og moderat nedsat leverfunktion.
English: Cases of myopathy and rhabdomyolysis have been reported in patients treated with ZYTIGA.
Danish: Der er rapporteret tilfælde af myopati og rabdomyolyse hos patienter i behandling med ZYTIGA.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksicitet (se pkt.
English: PARTICULARS TO APPEAR ON BLISTERS or STRIPS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
English: p-value is derived from a log-rank test stratified by ECOG performance status score (0-1 vs. 2), pain score (absent vs. present), number of prior chemotherapy regimens (1 vs. 2), and type of disease progression (PSA only vs. radiographic).
Danish: p-værdien er beregnet vha. log-rank-test stratificeret ud fra ECOG-score for funktionsklasse (0-1 vs. 2), smerte-score (ja vs. nej), antal tidligere kemoterapiforløb (1 vs. 2) og type sygdomsprogression (kun PSA vs. radiografi).
English: CYP17 inhibition also results in increased mineralocorticoid production by the adrenals (see section 4.4).
Danish: CYP17-hæmning medfører også øget produktion af mineralokortikoid i binyrerne (se pkt.
English: Pain: Treatment with ZYTIGA significantly reduced the risk of average pain intensity progression by 18% compared with placebo (p = 0.0490).
Danish: Smerter: Behandling med ZYTIGA reducerede risikoen for gennemsnitlig smerteintensitetetsprogression med 18 % sammenlignet med placebo (p=0,0490).
English: There are no data on the clinical safety and efficacy of multiple doses of abiraterone acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C).
Danish: Der foreligger ingen data om klinisk sikkerhed og virkning af gentagne doser abirateronacetat efter administration hos patienter med moderat eller svært nedsat leverfunktion (Child-Pugh-klasse B eller C).
English: 56 film-coated tablets 60 film-coated tablets
Danish: 56 filmovertrukne tabletter 60 filmovertrukne tabletter
English: Each pack contains one bottle.
Danish: Hver pakning indeholder 1 beholder.
English: The proportion of patients with pain palliation was statistically significantly higher in the ZYTIGA group than in the placebo group (44% vs. 27%, p = 0.0002).
Danish: Andelen af patienter med smertelindring var statistisk signifikant højere i ZYTIGA-gruppen end i placebo-gruppen (44 % vs. 27 %, p=0,0002).
English: Sixty-five percent (354 of 546) of patients treated with ZYTIGA, compared with 71% (387 of 542) of patients treated with placebo, had died.
Danish: 65 % (354 af 546) af de patienter, der var blevet behandlet med ZYTIGA, sammenlignet med 71 % (387 af 542) af patienterne i placeboarmen, var døde.
English: - This medicinal product does not require any special storage conditions.
Danish: - Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: WALLET 500 mg (30 days)
Danish: ETUI 500 mg (30 dage)
English: Your doctor will tell you if you need to change the amount of prednisone or prednisolone you take.
Danish: Din læge vil give dig besked, hvis du skal ændre din dosis af prednison eller prednisolon.
English: The pharmacokinetics of abiraterone acetate was examined in subjects with pre-existing mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) and in healthy control subjects.
Danish: Abirateronacetats farmakokinetik blev undersøgt hos forsøgspersoner med eksisterende let eller moderat nedsat leverfunktion (henholdsvis Child-Pugh-klasse A og B) og hos raske kontrolpersoner.
English: Failure of the liver to function (also called acute liver failure).
Danish: Ophør af leverens funktion (også kaldet akut leversvigt).
English: Control patients received placebo and low dose prednisone or prednisolone 5 mg twice daily.
Danish: Kontrolpatienterne fik placebo og lavdosis prednison eller prednisolon 5 mg to gange dagligt.
English: If at any time the ALT or AST rises above 5 times the ULN, treatment should be interrupted immediately and liver function closely monitored.
Danish: Hvis ALAT eller ASAT på noget tidspunkt stiger til > 5 x ULN, skal behandlingen ZYTIGA straks seponeres, og leverfunktionen skal overvåges nøje.
English: Based on this observed trend, the product information (SmPC Section 4.4) should be updated to reflect that rhabdomyolysis/myopathy may occur between 1 to 6 months after initiation of therapy with AA.
Danish: 4.4 i produktresuméet) opdateres for at afspejle, at rabdomyolyse/myopati kan forekomme mellem 1 og 6 måneder efter indledning af behandling med AA.
English: Decreased bone density may occur in men with metastatic advanced prostate cancer.
Danish: Der kan forekomme nedsat knoglemineraltæthed hos mænd med metastaserende avanceret prostatacancer.
English: Infections and infestations very common: urinary tract infection common: sepsis
Danish: Infektioner og parasitære sygdomme meget almindelige: urinvejsinfektion almindelig: sepsis
English: ANNEX IV SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF BETINGELSERNE FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: In studies of patients with metastatic advanced prostate cancer who were using an LHRH analogue, or were previously treated with orchiectomy, ZYTIGA was administered at a dose of 1,000 mg daily in combination with low dose prednisone or prednisolone (either 5 or 10 mg daily depending on the indication).
Danish: I studier med patienter med metastaserende avanceret prostatacancer, som blev behandlet med en LHRH-analog, eller som tidligere havde fået foretaget orkiektomi, blev ZYTIGA administreret i en dosis på 1.000 mg dagligt i kombination med lavdosis prednison eller prednisolon (enten 5 eller 10 mg dagligt afhængigt af indikationen).
English: Potential to affect exposures to other medicinal products Abiraterone is an inhibitor of the hepatic drug-metabolising enzymes CYP2D6 and CYP2C8.
Danish: Potentialet for, at eksponeringen for andre lægemidler påvirkes Abirateron hæmmer enzymerne CYP2D6 og CYP2C8, der metaboliserer lægemidler i leveren.
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for abiraterone the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing abiraterone is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for abirateron er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder abirateron, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Tablet White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed with AA250 on one side.
Danish: Tablet Hvide til offwhite, ovale tabletter (15,9 mm lange x 9,5 mm brede), præget AA250 på den ene side.
English: These two patients with normal baseline hepatic function, experienced ALT or AST elevations 15 to 40 x ULN and bilirubin elevations 2 to 6 x ULN.
Danish: De to patienter med normal leverfunktion ved baseline fik forhøjet ALAT eller ASAT på 15-40 x ULN og forhøjet bilirubin på 2-6 x ULN.
English: In patients treated with abiraterone acetate, CTCAE (version 4.0) Grades 3 and 4 hypokalaemia were observed in 6% and 2% of patients, CTCAE (version 4.0) Grades 3 and 4 hypertension were observed in 8% and 5% of patients, and fluid retention (peripheral oedema) Grades 3 and 4 were observed in 1% and 1% of patients, respectively.
Danish: Hos patienter der fik abirateronacetat, observeredes hypokaliæmi af CTCAE (version 4.0) grad 3 og 4 hos 6 % og 2 % af patienterne, hypertension af CTCAE (version 4.0) grad 3 og 4 hos henholdsvis 8 % og 5 % af patienterne og væskeretention (perifert ødem) grad 3 og 4 observeredes hos henholdsvis 1 % og 1 % af patienterne.
English: In addition to the observed improvements in overall survival and rPFS, benefit was demonstrated for ZYTIGA vs. placebo treatment in all prospectively-defined secondary endpoint measures as follows:
Danish: Ud over de observerede forbedringer i samlet overlevelse og rPFS blev der påvist en fordel for ZYTIGA vs. placebo i alle prospektivt definerede sekundære endepunkter på følgende måde:
English: The incidence of cardiovascular adverse reactions in the Phase 3 studies in patients taking abiraterone acetate versus patients taking placebo were as follows: atrial fibrillation 2.6% vs. 2.0%, tachycardia 1.9% vs. 1.0%, angina pectoris 1.7% vs. 0.8%, cardiac failure 0.7% vs. 0.2%, and arrhythmia 0.7% vs. 0.5%.
Danish: Forekomsten af kardiovaskulære bivirkninger i fase 3-studierne med patienter, der fik abirateronacetat, versus patienter, der fik placebo, var følgende: atrieflimren 2,6 % vs. 2,0 %, takykardi 1,9 % vs. 1,0 %, angina pectoris 1,7 % vs. 0,8 %, hjerteinsufficiens 0,7 % vs. 0,2 % og arytmi 0,7 % vs. 0,5 %.
English: In the 3011 trial, patients with baseline ALT and AST > 2.5 X ULN, bilirubin > 1.5 X ULN or those with active or symptomatic viral hepatitis or chronic liver disease; ascites or bleeding disorders secondary to hepatic dysfunction were excluded.
Danish: Studie 3011 ekskluderede patienter med baseline-ALAT og -ASAT ≥ 2,5 x ULN, bilirubin ≥ 1,5 x ULN, eller med aktiv eller symptomatisk viral hepatitis eller kronisk leversygdom, ascites eller blødningssygdom sekundært til hepatisk dysfunktion.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: In addition to the co-primary endpoint measures, benefit was also assessed using time to skeletal-related event (SRE), time to subsequent therapy for prostate cancer, time to initiation of chemotherapy, time to pain progression, and time to PSA progression.
Danish: Ud over de co-primære endepunkter blev behandlingens fordele også evalueret vha. tid indtil knoglerelateret hændelse (SRE), tid indtil efterfølgende behandling af prostatacancer, tid indtil påbegyndelse af kemoterapi, tid indtil smerte progression og tid indtil PSA-progression.
English: In a developmental toxicity study in the rat, abiraterone acetate affected pregnancy including reduced foetal weight and survival.
Danish: I et studie af udviklingstoksicitet hos rotter påvirkede abirateronacetat drægtigheden, herunder fostervægt og overlevelse.
English: In the event of an overdose, administration should be withheld and general supportive measures undertaken, including monitoring for arrhythmias, hypokalaemia and for signs and symptoms of fluid retention.
Danish: I tilfælde af overdosering skal behandlingen afbrydes, og generel understøttende behandling institueres med overvågning af patienten for arytmi, hypokaliæmi samt symptomer på væskeretention.
English: In addition to the observed improvements in overall survival and rPFS, benefit was demonstrated for ZYTIGA vs. placebo treatment in all secondary endpoint measures as follows:
Danish: Ud over de observerede forbedringer i samlet overlevelse og rPFS blev der demonstreret gavn af ZYTIGA vs. placebo i alle sekundære endepunkter på følgende måde:
English: WALLET 500 mg (28 days)
Danish: ETUI 500 mg (28 dage)
English: Treatment with ZYTIGA decreases serum testosterone to undetectable levels (using commercial assays) when given with LHRH analogues (or orchiectomy).
Danish: Behandling med ZYTIGA nedsætter serum-testosteron til et ikke-påviseligt niveau (målt med kommercielle kvantitative bestemmelser), når det gives sammen med LHRH-analoger (eller orkiektomi).
English: Across Phase 3 clinical studies, hepatotoxicity grades 3 and 4 (e.g., ALT or AST increases of > 5 x ULN or bilirubin increases > 1.5 x ULN) were reported in approximately 6% of patients who received abiraterone acetate, typically during the first 3 months after starting treatment.
Danish: På tværs af de fase 3 kliniske studier blev der rapporteret hepatotoksicitet af grad 3 og 4 (f.eks. stigning i ALAT eller ASAT til > 5 x ULN eller stigning i bilirubin til > 1,5 x ULN) hos ca. 6 % af de patienter, som fik abirateronacetat, typisk i de første 3 måneder efter indledning af behandlingen.
English: The tablets should be swallowed whole with water (see section 4.2).
Danish: Tabletterne skal synkes hele med vand (se pkt.
English: Metabolism and nutrition disorders very common: hypokalaemia common: hypertriglyceridaemia
Danish: Metabolisme og ernæring meget almindelige: hypokaliæmi almindelige: hypertriglyceridæmi
English: The median time to progression was 26.7 months in the ZYTIGA group and 18.4 months in the placebo group.
Danish: Mediantiden til progression var 26,7 måneder i ZYTIGA-gruppen og 18,4 måneder i placebogruppen.
English: Adrenal gland problems (related to salt and water problems), abnormal heart rhythm (arrhythmia), muscle weakness and/or muscle pain.
Danish: Binyrebarksvigt (relateret til problemer med væske- og saltbalancen), unormal hjerterytme (arytmi), muskelsvaghed og/eller muskelsmerter.
English: Film-coated tablet
Danish: Filmovertrukken tablet
English: The median time to degradation in FACT-P (Total Score) was 12.7 months in the ZYTIGA group and 8.3 months in the placebo group.
Danish: Mediantiden til forringelse af FACT-P (samlet score) var 12,7 måneder i ZYTIGA-gruppen og 8,3 måneder i placebogruppen.
English: The number of patients treated with ZYTIGA by racial group was Caucasian 832 (69.4%), Asian 246 (20.5%), Black or African American 25 (2.1%), other 80 (6.7%), unknown/not reported 13 (1.1%), and American Indian or Alaska Native 3 (0.3%).
Danish: Efter race var antallet af patienter, der blev behandlet med ZYTIGA, 832 (69,4 %) kaukasiere, 246 (20,5 %) asiater, 25 (2,1 %) sorte eller afrikanske amerikanere, 80 (6,7 %) andre, 13 (1,1 %) ukendt/ikke oplyst og 3 (0,3 %) amerikanske indianere eller indfødte fra Alaska.
English: In an analysis of adverse reactions of composite Phase 3 studies with ZYTIGA, adverse reactions that were observed in ≥10% of patients were peripheral oedema, hypokalaemia, hypertension urinary tract infection, and alanine aminotransferase increased and/or aspartate aminotransferase increased.
Danish: I en analyse af bivirkninger i sammensatte fase 3-studier med ZYTIGA sås følgende bivirkninger hos ≥ 10 % af patienterne: perifert ødem, hypokaliæmi, hypertension, urinvejsinfektion, forhøjet alaninaminotransferase og/eller forhøjet aspartat-aminotransferase.
English: If you stop taking ZYTIGA Do not stop taking ZYTIGA or prednisone or prednisolone unless your doctor tells you to.
Danish: Hvis du holder op med at tage ZYTIGA Hold ikke op med at tage ZYTIGA, prednison eller prednisolon, medmindre lægen anbefaler det.
English: p-value* Hazard ratio** (95% CI)
Danish: p-værdi* Hazard ratio** (95 % KI)
English: In study 302, (n = 1,088) the median age of enrolled patients was 71 years for patients treated with ZYTIGA plus prednisone or prednisolone and 70 years for patients treated with placebo plus prednisone or prednisolone.
Danish: I studie 302 (n=1088) var medianalderen 71 år for patienter, der blev behandlet med ZYTIGA plus prednison eller prednisolon, og 70 år for patienter, der blev behandlet med placebo plus prednison eller prednisolon.
English: When elevations of either ALT or AST > 5 x ULN, or elevations in bilirubin > 3 x ULN were observed, abiraterone acetate was withheld or discontinued.
Danish: Ved observation af enten forhøjet ALAT eller ASAT > 5 x ULN eller forhøjet bilirubin > 3 x ULN blev abirateronacetat-behandlingen midlertidigt eller permanent afbrudt.
English: In the 302 trial, patients with liver metastases were not eligible and patients with baseline ALT and AST ≥ 2.5 x ULN were excluded.
Danish: Studie 302 inkluderede ikke patienter med levermetastaser, og patienter med baseline-ALAT og -ASAT ≥ 2,5x ULN blev ekskluderet.
English: CTCAE (version 4.0) Grade 4 urinary tract infection, alanine aminotransferase increased and/or aspartate aminotransferase increased, hypokalemia, cardiac failure, atrial fibrillation, and fractures occurred in < 1% of patients.
Danish: CTCAE (version 4.0) grad 4 urinvejsinfektion, forhøjet alanin-aminotransferase og/eller forhøjet aspartataminotransferase, hypokaliæmi, hjerteinsufficiens, atrieflimren og frakturer forekom hos < 1 % af patienterne.
English: What ZYTIGA looks like and contents of the pack - ZYTIGA tablets are white to off-white, oval shaped (15.9 mm long x 9.5 mm wide), with
Danish: Udseende og pakningsstørrelser - ZYTIGA tabletter er hvide til offwhite, ovale tabletter (15,9 mm lange x 9,5 mm brede) med
English: Moderate hepatic impairment (Child-Pugh Class B) has been shown to increase the systemic exposure to abiraterone by approximately four-fold following single oral doses of abiraterone acetate 1,000 mg (see section 5.2).
Danish: Moderat nedsat leverfunktion (Child-Pugh-klasse B) har vist sig at øge den systemiske eksponering for abirateron med ca. faktor 4 efter enkeltdoser abirateronacetat på 1.000 mg per os (se pkt.
English: Study 301 (patients who had received prior chemotherapy) Study 301 enrolled patients who had received prior docetaxel.
Danish: Studie 301 (patienter som tidligere var behandlet med kemoterapi) Studie 301 omfattede patienter, som tidligere havde fået docetaxel.
English: Endocrine disorders uncommon: adrenal insufficiency
Danish: Det endokrine system ikke almindelige: binyreinsufficiens
English: Radiographic Progression-free Survival (rPFS) Progression or death Median rPFS in months (95% CI)
Danish: Radiografisk progressionsfri overlevelse (rPFS) Progression eller død Median rPFS i måneder (95 % KI)
English: Treatments could also be discontinued at the time of confirmed radiographic progression at the discretion of the investigator.
Danish: Efter investigators valg kunne behandlingen også seponeres på tidspunktet for bekræftet radiografisk progression.
English: For mCRPC, ZYTIGA is used with 10 mg prednisone or prednisolone daily.
Danish: Til mCRPC bruges ZYTIGA sammen med 10 mg prednison eller prednisolon dagligt.
English: Do not stop taking prednisone or prednisolone unless your doctor tells you to.
Danish: Du må ikke holde op med at tage prednison eller prednisolon, med mindre lægen anbefaler det.