FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended dose is 1,000 mg (four 250 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below).
Danish: Den anbefalede dosis ZYTIGA er 1.000 mg (fire tabletter a 250 mg) dagligt som en enkelt dosis, der ikke må indtages sammen med føde (se ”Administration” nedenfor).
English: Discard unused contents appropriately in accordance with local requirements.
Danish: Ikke anvendt indhold skal bortskaffes i henhold til lokale retningslinjer.
English: Cardiac disorders common: cardiac failure*, angina pectoris, atrial fibrillation, tachycardia uncommon: other arrhythmias not known: myocardial infarction, QT prolongation (see sections 4.4 and 4.5)
Danish: Hjerte almindelige: hjerteinsufficiens*, angina pectoris, atrieflimren, takykardi ikke almindelige: anden arytmi ikke kendt: myokardieinfarkt, QT-forlængelse (se pkt.
English: Bone loss may occur in men treated for prostate cancer.
Danish: Knogletab kan forekomme hos mænd, der behandles for prostatacancer.
English: For patients who develop hepatotoxicity during treatment, suspension of treatment and dose adjustment may be required (see sections 4.2 and 4.4).
Danish: Hos patienter, som får hepatotoksicitet under behandlingen, kan der opstå behov for at indstille behandlingen og justere dosis (se pkt.
English: In a Phase 3 clinical study of patients who failed prior chemotherapy with taxanes, 38% of patients treated with abiraterone acetate, versus 10% of patients treated with placebo, had at least a 50% decline from baseline in PSA levels.
Danish: I et klinisk fase 3-studie med patienter, som oplevede behandlingssvigt af tidligere kemoterapi med taxaner, blev der set et fald på mindst 50 % fra PSA-værdier ved baseline hos 38 % af de patienter, der fik abirateronacetat, versus 10 % af de patienter der fik placebo.
English: Dosage of prednisone or prednisolone For mHSPC, ZYTIGA is used with 5 mg prednisone or prednisolone daily.
Danish: Dosis af prednison eller prednisolon Til mHSPC bruges ZYTIGA sammen med 5 mg prednison eller prednisolon dagligt.
English: Each 30 day carton contains 60 film-coated tablets in 5 cardboard wallets of 12 film-coated tablets each.
Danish: Hver æske til 30 dage indeholder 60 filmovertrukne tabletter i 5 papetuier med 12 filmovertrukne tabletter i hver.
English: Hazard ratio < 1 favours ZYTIGA
Danish: En hazard ratio  1 indikerer en fordel for ZYTIGA
English: Take the prednisone or prednisolone exactly as your doctor has told you.
Danish: Tag prednison eller prednisolon nøjagtigt efter lægens anvisning.
English: The recommended dose is 1,000 mg (two 500 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below).
Danish: Den anbefalede dosis ZYTIGA er 1.000 mg (to tabletter a 500 mg) dagligt som en enkelt dosis, der ikke må indtages sammen med føde (se ”Administration” nedenfor).
English: Treatment with abiraterone acetate decreased the risk of radiographic progression or death by 47% compared with placebo (HR = 0.530; 95% CI: [0.451; 0.623], p < 0.0001).
Danish: Behandling med abirateronacetat reducerede risikoen for radiografisk progression eller død med 47 % sammenlignet med placebo (HR=0,530; 95 % KI: [0,451; 0,623]; p < 0,0001).
English: This medicinal product also contains more than 1.18 mmol (or 27 mg) sodium per dose of two tablets.
Danish: Lægemidlet indeholder også over 1,18 mmol (eller 27 mg) natrium pr. dosis på 2 tabletter.
English: Each 28 day carton contains 56 film-coated tablets in 4 cardboard wallets of 14 film-coated tablets each.
Danish: Hver æske til 28 dage indeholder 56 filmovertrukne tabletter i 4 papetuier med 14 filmovertrukne tabletter i hver.
English: What ZYTIGA looks like and contents of the pack - ZYTIGA tablets are purple, oval-shaped, film-coated (20 mm long by 10 mm wide) with “AA” written on one side and “500” on the other side.
Danish: Udseende og pakningsstørrelser - ZYTIGA tabletter er lilla, ovale, filmovertrukne tabletter (20 mm lange og 10 mm brede) med “AA” skrevet på den ene side og “500” skrevet på den anden side.
English: The proportion of subjects with a confirmed PSA response was greater in the ZYTIGA group than in the placebo group (62% vs. 24%; p < 0.0001).
Danish: Andelen af forsøgspersoner med bekræftet PSA-respons var højere i ZYTIGA-gruppen end i placebogruppen (62 % vs. 24 %); p < 0,0001).
English: The pharmacokinetics of abiraterone acetate was compared in patients with end-stage renal disease on a stable haemodialysis schedule versus matched control subjects with normal renal function.
Danish: Abirateronacetats farmakokinetik hos patienter med nyresygdom i terminalstadiet, som var i stabil hæmodialysebehandling, blev sammenlignet med matchende kontrolpersoner med normal nyrefunktion.
English: ZYTIGA is not for use in women.
Danish: ZYTIGA er ikke beregnet til kvinder.
English: In Phase 3 studies, anticipated mineralocorticoid adverse reactions were seen more commonly in patients treated with abiraterone acetate than in patients treated with placebo: hypokalaemia 18% vs.8%, hypertension 22% vs. 16% and fluid retention (peripheral oedema) 23% vs. 17%, respectively.
Danish: I fase 3-studier sås de forventede mineralokortikoide bivirkninger hyppigere hos patienter, der fik abirateronacetat, end hos patienter, der fik placebo: henholdsvis hypokaliæmi 18 % vs. 8 %, hypertension 22 % vs. 16 % og væskeretention (perifert ødem) 23 % vs. 17 %.
English: Systemic exposure to abiraterone after a single oral 1,000 mg dose did not increase in subjects with end-stage renal disease on dialysis.
Danish: Systemisk eksponering for abirateron øgedes ikke efter en enkelt oral dosis på 1.000 mg hos forsøgspersoner med nyresygdom i terminalstadiet, som var i dialyse.
English: Purple, oval-shaped, film-coated tablets (20 mm long by 10 mm wide), debossed with “AA” on one side and “500” on the other side.
Danish: Lilla, ovale, filmovertrukne tabletter (20 mm lange x 10 mm brede) præget ”AA” på den ene side og ”500” på den anden side.
English: Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30
Danish: Indehaver af markedsføringstilladelsen Janssen-Cilag International NV Turnhoutseweg 30
English: Subgroup analyses consistently favor treatment with ZYTIGA.
Danish: Analyser af subgrupperne gav en konsistent indikation af en fordel ved behandling med ZYTIGA.
English: What ZYTIGA contains - The active substance is abiraterone acetate.
Danish: ZYTIGA indeholder: - Aktivt stof: abirateronacetat.
English: Skin and subcutaneous tissue disorders common: rash
Danish: Hud og subkutane væv almindelige: udslæt
English: Subjects randomised Event
Danish: Randomiserede forsøgspersoner Hændelse
English: A lower proportion of patients in the ZYTIGA group had skeletal-related events compared with the placebo group at 6 months (18% vs. 28%), 12 months (30% vs. 40%), and 18 months (35% vs. 40%).
Danish: En mindre andel af patienter i ZYTIGA-gruppen havde knoglerelaterede hændelser sammenlignet med placebo-gruppen efter 6 måneder (18 % vs. 28 %), 12 måneder (30 % vs. 40 %), og 18 måneder (35 % vs. 40 %).
English: p value is from a log-rank test stratified by ECOG PS score (0/1 or 2) and visceral lesion (absent or present).
Danish: p-værdien er fra en log-rank-test stratificeret ud fra ECOG PS-score (0/1 eller 2) og visceral læsion (ja eller nej).
English: - Swallow the tablets whole with water.
Danish: - Synk tabletterne hele med vand.
English: In the 301 trial, patients with baseline ALT and AST ≥ 2.5 x ULN in the absence of liver metastases and > 5 x ULN in the presence of liver metastases were excluded.
Danish: 301-studiet ekskluderede patienter med baseline-ALAT og -ASAT ≥ 2,5 x ULN, hvis der ikke forekom levermetastaser, og > 5 x ULN ved forekomst af levermetastaser.
English: Your doctor may also prescribe other medicines while you are taking ZYTIGA and prednisone or prednisolone.
Danish: Lægen kan også foreskrive anden medicin under din behandling med ZYTIGA og prednison eller prednisolon.
English: 14 film-coated tablets
Danish: 14 filmovertrukne tabletter
English: BATCH NUMBER
Danish: FREMSTILLERENS BATCHNUMMER
English: Overall survival was longer for ZYTIGA than placebo with a 25% reduction in risk of death (HR = 0.752; 95% CI: [0.606; 0.934], p = 0.0097), but OS was not mature and interim results did not meet the pre-specified stopping boundary for statistical significance (see Table 4).
Danish: Samlet overlevelse var længere med ZYTIGA end med placebo med en 25 % reduktion af dødsrisiko (HR = 0,752; 95 % KI: [0,606; 0,934]; p=0,0097), men data for OS var ikke modne, og interimresultaterne opfyldte ikke den på forhånd specificerede stopgrænse for statistisk signifikans (se tabel 6).
English: A lower proportion of patients treated with ZYTIGA had pain progression compared to patients taking placebo at 6 (22% vs. 28%), 12 (30% vs. 38%) and 18 months (35% vs. 46%).
Danish: En lavere andel af patienter behandlet med ZYTIGA fik smerteprogression sammenlignet med patienter, der fik placebo, efter henholdsvis 6 (22 % vs. 28 %), 12 (30 % vs. 38 %) og 18 måneder (35 % vs. 46 %).
English: Skeletal muscle effects
Danish: Påvirkning af skeletmuskulatur
English: For patients being re-treated, serum transaminases should be monitored at a minimum of every two weeks for three months and monthly thereafter.
Danish: Patienter, der starter på behandlingen igen, skal have kontrolleret aminotransferaser mindst hver anden uge i tre måneder og en gang om måneden derefter.
English: A statistically significant OS benefit in favour of the ZYTIGA-treated group was demonstrated with a 19.4% reduction in risk of death (HR = 0.806; 95% CI: [0.697; 0.931], p = 0.0033) and an improvement in median OS of 4.4 months (ZYTIGA 34.7 months, placebo 30.3 months) (see Table 6 and Figure 5).
Danish: Der påvistes en statistisk signifikant OS-fordel i den ZYTIGA-behandlede gruppe med en 19,4 % reduktion i risiko for død (HR=0,806; 95 % KI: [0,697; 0,931]; p=0,0033) og en forbedring af median OS på 4,4 måneder (ZYTIGA 34,7 måneder, placebo 30,3 måneder) (se tabel 6 og figur 5).
English: ZYTIGA 250 mg tablets abiraterone acetate
Danish: ZYTIGA 250 mg tabletter abirateronacetat
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE
English: See leaflet for further information.
Danish: Se yderligere oplysninger i indlægssedlen.
English: This medicinal product also contains more than 1 mmol (or 27.2 mg) sodium per dose of four tablets.
Danish: Lægemidlet indeholder også over 1 mmol (eller 27,2 mg) natrium pr. dosis på 4 tabletter.
English: Safety in patients with left ventricular ejection fraction (LVEF) < 50% or NYHA Class III or IV heart failure (in study 301) or NYHA Class II to IV heart failure (in studies 3011 and 302) was not established (see sections 4.8 and 5.1).
Danish: ZYTIGAs sikkerhed hos patienter med venstre ventrikels uddrivningsfraktion (LVEF) < 50 % eller hjerteinsufficiens af NYHA-klasse III eller IV hjerteinsufficiens (i studie 301) eller NYHA-klasse II til IV hjerteinsufficiens (i studie 3011 og 302) er ikke klarlagt (se pkt.
English: Time to Event (months) Median (95% CI)
Danish: Tid til hændelse (måneder) Median (95 % KI)
English: - if you have an irregular or rapid heart rate - if you have shortness of breath - if you have gained weight rapidly - if you have swelling in the feet, ankles, or legs - if you have taken a medicine known as ketoconazole in the past for prostate cancer - about the need to take this medicine with prednisone or prednisolone - about possible effects on your bones - if you have high blood sugar.
Danish: - hvis du har fået at vide, at du har højt blodtryk eller hjertesvigt eller lavt indhold af kalium i blodet (lavt indhold af kalium i blodet kan øge risikoen for problemer med hjerterytmen) - hvis du har haft andre problemer med hjerte eller blodkar - hvis du har en uregelmæssig eller hurtig puls - hvis du er kortåndet - hvis du har taget hurtigt på i vægt - hvis du har hævede fødder, ankler eller ben - hvis du tidligere har taget ketoconazol mod prostatacancer - om nødvendigheden af at tage dette lægemiddel sammen med prednison eller prednisolon - om hvordan lægemidlet kan påvirke knoglerne - hvis du har højt blodsukker.
English: Alanine aminotransferase increased and/or aspartate aminotransferase increased includes ALT increased, AST increased, and hepatic function abnormal.
Danish: Forhøjet ALAT og/eller forhøjet ASAT omfatter forhøjet alanin-aminotransferase, forhøjet aspartat-aminotransferase og unormal leverfunktion.
English: Range p value Hazard ratio (95% CI)
Danish: Interval p-værdi Hazard ratio (95 % KI)
English: ZYTIGA 250 mg tablets
Danish: ZYTIGA 250 mg tabletter
English: Round white HDPE bottles fitted with a polypropylene child-resistant closure containing 120 tablets.
Danish: Runde, hvide beholdere af HDPE med børnesikret polyprolylenlukke.
English: 12 film-coated tablets
Danish: 12 filmovertrukne tabletter
English: Re-treatment may take place only after return of liver function tests to the patient's baseline and at a reduced dose level (see section 4.2).
Danish: Behandlingen må først genoptages, når leverfunktionsprøverne er vendt tilbage til patientens baselineværdier, og kun med et reduceret dosisniveau (se pkt.
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Povidone (K29/K32) Colloidal anhydrous silica Sodium laurilsulfate
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat Povidon (K29/K32) Kolloid, vandfri silica Natriumlaurilsulfat
English: Each carton contains (56 film-coated tablets) 4 wallets.
Danish: Hver æske indeholder (56 filmovertrukne tabletter) 4 etuier.
English: Intolerance to excipients
Danish: Intolerans over for hjælpestoffer
English: Time to skeletal-related event (SRE): There was a 30% reduction in the risk of skeletal-related events (HR = 0.703; 95% CI: [0.539, 0.916], p = 0.0086).
Danish: Tid til knoglerelateret hændelse (SRE): Risikoen for knoglerelaterede hændelser blev reduceret med 30 % (HR = 0,703; 95 % KI: [0,539, 0,916], p = 0,0086).
English: If patients develop severe hepatotoxicity (ALT or AST 20 times the ULN) anytime while on therapy, treatment should be discontinued and patients should not be re-treated.
Danish: Hvis patienten på noget tidspunkt under behandlingen udvikler alvorlig hepatotoksicitet (ALAT eller ASAT 20 x ULN), bør behandlingen seponeres og ikke genoptages senere.
English: - Do not break the tablets.
Danish: - Tabletterne må ikke deles.
English: Serum transaminases should be measured prior to starting treatment, every two weeks for the first three months of treatment and monthly thereafter.
Danish: Aminotransferaser bør måles før indledning af behandlingen, hver anden uge i de første tre måneders behandling og hver måned derefter.
English: The number of patients treated with ZYTIGA by racial group was Caucasian 520 (95.4%), Black 15 (2.8%), Asian 4 (0.7%) and other 6 (1.1%).
Danish: Efter race var antallet af patienter, der blev behandlet med ZYTIGA, 520 (95,4 %) kaukasiere, 15 (2,8 %) sorte, 4 (0,7 %) asiatere og andre 6 (1,1 %).
English: At the planned rPFS analysis there were 401 events, 150 (28%) of patients treated with ZYTIGA and 251 (46%) of patients treated with placebo had radiographic evidence of progression or had died.
Danish: 150 (28 %) patienter behandlet med ZYTIGA og 251 (46 %) patienter behandlet med placebo havde radiografisk tegn på progression eller var døde.
English: Rare (may affect up to 1 in 1,000 people):
Danish: Sjældne (kan berøre op til 1 ud af 1.000 patienter):
English: The use of ZYTIGA should be cautiously assessed in patients with moderate hepatic impairment, in whom the benefit clearly should outweigh the possible risk (see sections 4.2 and 5.2).
Danish: Behandling med ZYTIGA bør overvejes nøje hos patienter med moderat nedsat leverfunktion, og fordelene bør klart overstige risikoen hos disse patienter (se pkt.
English: - ZYTIGA is taken with a medicine called prednisone or prednisolone.
Danish: - ZYTIGA skal tages sammen med lægemidlet prednison eller prednisolon.
English: Abiraterone acetate is rapidly converted in vivo to abiraterone, an androgen biosynthesis inhibitor (see section 5.1).
Danish: Abirateronacetat konverteres hurtigt in vivo til abirateron, der hæmmer biosyntesen af androgener (se pkt.
English: Very common (may affect more than 1 in 10 people):
Danish: Meget almindelige (kan berøre flere end 1 ud af 10 behandlede):
English: When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone.
Danish: Mens du er i behandling med dette lægemiddel, vil din læge også ordinere enten prednison eller prednisolon til dig.
English: Re-treatment following return of liver function tests to the patient's baseline may be given at a reduced dose of 500 mg (two tablets) once daily.
Danish: Efter at patientens leverfunktionsprøver er faldet til baselineniveauet, kan behandlingen genoptages med en reduceret dosis på 500 mg (to tabletter) en gang dagligt.
English: The number of patients treated with ZYTIGA by racial group was Caucasian 737 (93.2%), Black 28 (3.5%), Asian 11 (1.4%) and other 14 (1.8%).
Danish: Opstillet efter race fordelte patienterne, som fik ZYTIGA, sig med 737 (93,2 %) kaukasiere, 28 (3,5 %) sorte, 11 (1,4 %) asiater og 14 (1,8 %) andre racer.
English: Radiographic Progression-free Survival (rPFS) Progression or death Median rPFS in months (95% CI) p-value* Hazard ratio** (95% CI)
Danish: Radiografisk progressionsfri overlevelse (rPFS) Progression eller død Median-rPFS i måneder (95 % KI) p-værdi* Hazard ratio** (95 % KI)
English: Driving and using machines This medicine is not likely to affect your being able to drive and use any tools or machines.
Danish: Trafik- og arbejdssikkerhed Dette lægemiddel påvirker sandsynligvis ikke arbejdssikkerheden eller evnen til at færdes i trafikken.
English: Hazard ratio (95% CI) Updated Survival Analysis Deaths (%) Median survival (months) (95% CI) Hazard ratio (95% CI)
Danish: p-værdi Hazard ratio (95 % KI) Opdateret analyse af overlevelse Død (%) Median overlevelse (måneder) (95 % KI) Hazard ratio (95 % KI)
English: CARTON 250 mg
Danish: KARTON 250 mg
English: General disorders and administration site conditions very common: oedema peripheral
Danish: Almene symptomer og reaktioner på administrationsstedet meget almindelige: perifert ødem
English: The following CTCAE (version 4.0) Grade 3 adverse reactions occurred in patients treated with abiraterone acetate: hypokalaemia 5%; urinary tract infection 2%; alanine aminotransferase increased and/or aspartate aminotransferase increased 4%; hypertension 6%; fractures 2%; peripheral oedema, cardiac failure, and atrial fibrillation 1% each.
Danish: Følgende CTCAE (version 4.0) grad 3-bivirkninger opstod hos patienter, der fik abirateronacetat: hypokaliæmi 5 %; urinvejsinfektion 2 %; forhøjet ALAT og/eller forhøjet ASAT 4 %; hypertension 6 %, frakturer 2 %, perifert ødem, hjerteinsufficiens og atrieflimren alle 1 %.
English: Hepatobiliary disorders very common: alanine aminotransferase increased and/or aspartate aminotransferase increased rare: hepatitis fulminant, acute hepatic failure
Danish: Lever og galdeveje meget almindelige: forhøjet ALAT og/eller forhøjet ASAT sjælden: fulminant hepatitis, akut leversvigt
English: ZYTIGA contains a medicine called abiraterone acetate.
Danish: ZYTIGA indeholder lægemidlet abirateronacetat.
English: Re-treatment following return of liver function tests to the patient's baseline may be given at a reduced dose of 500 mg (one tablet) once daily.
Danish: Efter at patientens leverfunktionsprøver er faldet til baselineniveauet, kan behandlingen genoptages med en reduceret dosis på 500 mg (en tablet) en gang dagligt.
English: Interim survival analysis Deaths (%) Median survival (months) (95% CI)
Danish: Interim overlevelsesanalyse Dødsfald (%) Median overlevelse (i måneder) (95 % KI)
English: ZYTIGA 500 mg film-coated tablets
Danish: ZYTIGA 500 mg filmovertrukne tabletter
English: Effect of food on abiraterone acetate
Danish: Fødevarers virkning på abirateronacetat
English: In the active treatment arm, ZYTIGA was administered at a dose of 1,000 mg daily in combination with low dose prednisone or prednisolone 5 mg twice daily.
Danish: I den aktive behandlingsarm blev ZYTIGA administreret i en dosis på 1000 mg dagligt i kombination med lavdosis prednison eller prednisolon 5 mg to gange dagligt.
English: Each carton contains (60 film-coated tablets) 5 wallets.
Danish: Hver æske indeholder (60 filmovertrukne tabletter) 5 etuier.
English: The three Phase 3 studies excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or NYHA Class III or IV heart failure (study 301) or Class II to IV heart failure (studies 3011 and 302) or cardiac ejection fraction measurement of < 50%.
Danish: De 3 fase 3-studier ekskluderede patienter med ukontrolleret hypertension, klinisk signifikant hjertesygdom udtrykt som myokardieinfarkt, arterielle trombotiske hændelser i de seneste 6 måneder, svær eller ustabil angina pectoris, NYHA-klasse III eller IV hjerteinsufficiens (studie 301) eller klasse II til IV hjerteinsufficiens (studie 3011 og 302) eller uddrivningsfraktion < 50 %.
English: - This medicine also contains approximately 27 mg of sodium in a four tablet daily dose.
Danish: - Dette lægemiddel indeholder også ca. 27 mg natrium i den daglige dosis på fire tabletter.
English: The use of abiraterone acetate should be cautiously assessed in patients with moderate hepatic impairment in whom the benefit clearly should outweigh the possible risk (see sections 4.2 and 4.4).
Danish: Anvendelse af abirateronacetat hos patienter med moderat nedsat leverfunktion bør vurderes nøje, og fordelen skal klart overstige risikoen hos disse patienter (se pkt.
English: The Phase 3 studies conducted with ZYTIGA excluded patients with uncontrolled hypertension, clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association Class (NYHA) III or IV heart failure (study 301) or Class II to IV heart failure (studies 3011 and 302) or cardiac ejection fraction measurement of < 50%.
Danish: Fase 3-studier udført med ZYTIGA udelukkede patienter med ukontrolleret hypertension, klinisk signifikant hjertesygdom udtrykt som myokardieinfarkt, arterielle trombotiske hændelser i de seneste 6 måneder, svær eller ustabil angina pectoris, hjerteinsufficiens af New York Heart Association (NYHA-) klasse III eller IV (studie 301) eller klasse II til IV hjerteinsufficiens (studie 3011 og 302) eller uddrivningsfraktion < 50 %.
English: Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
Danish: Graaf Engelbertlaan 75 NL-4837 DS BREDA Tel: +31 76 711 1111
English: Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS BREDA Tel: +31 76 711 1111
Danish: Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
English: Taking the tablets with food increases systemic exposure to abiraterone (see sections 4.5 and 5.2).
Danish: Ved samtidig fødeindtagelse øges den systemiske eksponering for abirateron (se pkt.
English: Take ZYTIGA at least two hours after eating and do not eat anything for at least one hour after taking ZYTIGA.
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.
English: - Do not throw away any medicines via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: AST > 20 x ULN were not re-treated.
Danish: Hos patienter med forhøjet ALAT eller ASAT > 20 x ULN blev behandlingen ikke genoptaget.
English: Figure 2: Kaplan-Meier Plot of Overall Survival; Intent-to-treat Population (Study PCR3011)
Danish: Figur 2: Kaplan-Meier-afbildning af samlet overlevelse; intent-to-treat-population (studie PCR3011)