natgillin/translations-raw huggingface dataset:
Lever og galdeveje meget almindelige: forhøjet ALAT og/eller forhøjet ASAT sjælden: fulminant hepatitis, akut leversvigt
Hepatobiliary disorders very common: alanine aminotransferase increased and/or aspartate aminotransferase increased rare: hepatitis fulminant, acute hepatic failure
ZYTIGA indeholder lægemidlet abirateronacetat.
ZYTIGA contains a medicine called abiraterone acetate.
Efter at patientens leverfunktionsprøver er faldet til baselineniveauet, kan behandlingen genoptages med en reduceret dosis på 500 mg (en tablet) en gang dagligt.
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.
Interim overlevelsesanalyse Dødsfald (%) Median overlevelse (i måneder) (95 % KI)
Interim survival analysis Deaths (%) Median survival (months) (95% CI)
ZYTIGA 500 mg filmovertrukne tabletter
ZYTIGA 500 mg film-coated tablets
Fødevarers virkning på abirateronacetat
Effect of food on abiraterone acetate
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.
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.
Hver æske indeholder (60 filmovertrukne tabletter) 5 etuier.
Each carton contains (60 film-coated tablets) 5 wallets.
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 %.
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%.
- Dette lægemiddel indeholder også ca. 27 mg natrium i den daglige dosis på fire tabletter.
- This medicine also contains approximately 27 mg of sodium in a four tablet daily dose.
Anvendelse af abirateronacetat hos patienter med moderat nedsat leverfunktion bør vurderes nøje, og fordelen skal klart overstige risikoen hos disse patienter (se pkt.
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).
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 %.
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%.
Graaf Engelbertlaan 75 NL-4837 DS BREDA Tel: +31 76 711 1111
Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
Graaf Engelbertlaan 75 NL-4837 DS Breda Tel: +31 76 711 1111
Janssen-Cilag B.V. Graaf Engelbertlaan 75 NL-4837 DS BREDA Tel: +31 76 711 1111
Ved samtidig fødeindtagelse øges den systemiske eksponering for abirateron (se pkt.
Taking the tablets with food increases systemic exposure to abiraterone (see sections 4.5 and 5.2).
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.
Take ZYTIGA at least two hours after eating and do not eat anything for at least one hour after taking ZYTIGA.
Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
- Do not throw away any medicines via wastewater or household waste.
Hos patienter med forhøjet ALAT eller ASAT > 20 x ULN blev behandlingen ikke genoptaget.
AST > 20 x ULN were not re-treated.
Figur 2: Kaplan-Meier-afbildning af samlet overlevelse; intent-to-treat-population (studie PCR3011)
Figure 2: Kaplan-Meier Plot of Overall Survival; Intent-to-treat Population (Study PCR3011)
Figur 1: Kaplan-Meier-afbildning af radiografisk progressionsfri overlevelse; intent-to-treatpopulation (studie PCR3011)
Figure 1: Kaplan-Meier Plot of Radiographic Progression-free Survival; Intent-to-treat Population (Study PCR3011)
Dag
Day
- Dette lægemiddel indeholder også ca. 27 mg natrium i den daglige dosis på to tabletter.
- This medicine also contains approximately 27 mg of sodium in a two tablet daily dose.
- vides at øge risikoen for problemer med hjerterytmen [f.eks. methadon (som anvendes til smertelindring samt i forbindelse med afvænning ved stofmisbrug), moxifloxacin (et antibiotikum), antipsykotika (som anvendes til alvorlige psykiske lidelser)].
Tell your doctor if you are receiving medicine - used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol); - known to increase the risk of heart rhythm problems [e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics (used for serious mental illnesses)].
Mave-tarm-kanalen meget almindelige: diaré almindelige: dyspepsi
Gastrointestinal disorders very common: diarrhoea common: dyspepsia
ECOG=Eastern Cooperative Oncology Groupfunktionsscore.
= confidence interval; ECOG = Eastern Cooperative Oncology Group performance score; HR = hazard ratio; NE = not evaluable
Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp lactase deficiency) eller glucose/galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
I de fase 3 kliniske studier blev seponering på grund af ALAT- og ASATstigning eller unormal leverfunktion rapporteret hos 1,1 % af de patienter, der fik abirateronacetat, og hos 0,6 % af de patienter, der fik placebo.
In Phase 3 clinical studies, treatment discontinuations due to ALT and AST increases or abnormal hepatic function were reported in 1.1% of patients treated with abiraterone acetate and 0.6% of patients treated with placebo; no deaths were reported due to hepatotoxicity events.
Der observeredes en statistisk signifikant forbedring i OS til fordel for AA-P plus ADT med en 38 % reduktion i risiko for død sammenlignet med placebo plus ADT (HR=0,621; 95 % KI: 0,509: 0,756; p < 0,0001), hvilket er på den anden side af den på forhånd specificerede stopgrænse for OS på 0,010 ved interimanalyse 1 (se tabel 3 og figur 2).
A statistically significant improvement in OS in favor of AA-P plus ADT was observed with a 38% reduction in the risk of death compared to Placebo plus ADT (HR=0.621; 95% CI: 0.509, 0.756; p<0.0001), crossing the pre-specified boundary for OS at Interim Analysis 1 of 0.010 (see Table 3 and Figure 2).
Anvendelse sammen med ZYTIGA frarådes (se pkt.
Use with ZYTIGA is not recommended (see section 5.1).
Samlet overlevelse (måneder) Median (95 % KI)
Overall Survival (months) Median (95% CI)
Smerter
Pain
Amning ZYTIGA er ikke beregnet til kvinder.
Breast-feeding ZYTIGA is not for use in women.
Mikrokrystallinsk cellulose (silicificeret) Croscarmellosenatrium Hypromellose 2910 (15 mPa.S) Lactosemonohydrat
Microcrystalline cellulose (silicified) Croscarmellose sodium Hypromellose 2910 (15 mPa.S) Lactose monohydrate Magnesium stearate Colloidal anhydrous silica Sodium laurilsulfate
Abiraterons metabolitter tegner sig for hovedparten af radioaktiviteten i blodet (ca. 92 %).
The majority of circulating radioactivity (approximately 92%) is found in the form of metabolites of abiraterone.
Tiden indtil forringelse af ECOG-performancescore med ≥ 1 point: Mediantiden indtil forringelse af ECOG-performancescore med ≥ 1 point var 12,3 måneder for patienter, der fik ZYTIGA, og 10,9 måneder for patienter, der fik placebo (HR=0,821); 95 % KI: [0,714; 0,943], p=0,0053).
Time to deterioration in ECOG performance score by ≥ 1 point: The median time to deterioration in ECOG performance score by ≥ 1 point was 12.3 months for patients receiving ZYTIGA and 10.9 months for patients receiving placebo (HR = 0.821; 95% CI: [0.714; 0.943], p = 0.0053).
I kontrollerede kliniske studier sås markante stigninger i leverenzymer, hvilket førte til seponering af behandlingen eller dosismodifikation (se pkt.
Marked increases in liver enzymes leading to treatment discontinuation or dose modification occurred in controlled clinical studies (see section 4.8).
Tabel 2: Radiografisk progressionsfri overlevelse - stratificeret analyse; intent-to-treatpopulation (studie PCR3011)
Radiographic Progression-Free Survival - Stratified Analysis; Intent-to-treat Population (Study PCR3011)
Median radiografisk progressionsfri overlevelse var 5,6 måneder for patienter, der blev behandlet med ZYTIGA, og 3,6 måneder for patienter, der fik placebo (HR=0,673; 95 % KI: [0,585; 0,776]; p < 0,0001).
The median radiographic progression-free survival was 5.6 months for patients treated with ZYTIGA and 3.6 months for patients who received placebo (HR = 0.673; 95% CI: [0.585; 0.776], p < 0.0001).
BEHOLDERENS ETIKET 250 mg
BOTTLE LABEL 250 mg
Tid til PSA-progression baseret på PCWG2-kriterier: Mediantiden til PSA-progression var 33,2 måneder for patienter, der fik ZYTIGA, og 7,4 måneder for patienter, der fik placebo (HR = 0,299; 95 % KI: [0,255, 0,352], p < 0,0001).
Time to PSA progression based on PCWG2 criteria: The median time to PSA progression was 33.2 months for patients receiving ZYTIGA and 7.4 months for patients receiving placebo (HR = 0.299; 95% CI: [0.255, 0.352], p <0.0001).
KARTON 500 mg
CARTON 500 mg
Patienter på natrium- eller saltfattig diæt skal tage hensyn hertil.
To be taken into consideration by patients on a controlled sodium diet.
Patienter med atrieflimren eller anden hjertearytmi, der kræver medicinsk behandling, blev ekskluderet fra studie 3011 og 302.
In studies 3011 and 302, patients with atrial fibrillation, or other cardiac arrhythmia requiring medical therapy were excluded.
Det er ikke nødvendigt at justere dosis hos patienter med nedsat nyrefunktion (se pkt.
No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Tiden indtil anvendelse af opiat mod cancersmerter: Mediantiden indtil brug af opiat mod prostatacancersmerter på tidspunktet for den endelige analyse var 33,4 måneder for patienter, der fik ZYTIGA, og 23,4 måneder for patienter, der fik placebo (HR =0,721; 95 % KI [0,614; 0,846], p < 0,0001).
Time to opiate use for cancer pain: The median time to opiate use for prostate cancer pain at the time of final analysis was 33.4 months for patients receiving ZYTIGA and was 23.4 months for patients receiving placebo (HR = 0.721; 95% CI: [0.614; 0.846], p < 0.0001).
- Brug kondom for at beskytte fostret, hvis du har sex med en gravid kvinde.
- If you are having sex with a pregnant woman, use a condom to protect the unborn child.
• Behandling af nydiagnosticeret, metastaserende hormonfølsom prostatacancer (mHSPC) med høj risiko hos voksne mænd i kombination med androgen deprivationsbehandling (ADT) (se pkt.
(mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section
Knogler, led, muskler og bindevæv ikke almindelige: myopati, rabdomyolyse
Musculoskeletal and connective tissue disorders uncommon: myopathy, rhabdomyolysis
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose (silicificeret), croscarmellosenatrium, hypromellose 2910 (15 mPa.S), lactosemonohydrat, magnesiumstearat, kolloid vandfri silica, natriumlaurilsulfat; (se ”ZYTIGA indeholder lactose og natrium” under punkt 2).
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone (K29/K32), colloidal anhydrous silica, and sodium laurilsulfate (see section 2, “ZYTIGA contains lactose and sodium”).
Tid til efterfølgende behandling: På tidspunktet for interimanalysen var mediantiden til efterfølgende behandling ikke nået hos patienter, der fik ZYTIGA, og den var 21,6 måneder for patienter, der fik placebo (HR = 0,415; 95 % KI: [0,346, 0,497], p < 0,0001).
Time to subsequent therapy: The median time to subsequent therapy at the time of interim analysis was not reached for patients receiving ZYTIGA and was 21.6 months for patients receiving placebo (HR = 0.415; 95% CI: [0.346, 0.497], p <0.0001).
I den aktive arm blev ZYTIGA administreret i en dosis på 1000 mg dagligt i kombination med lavdosis prednison 5 mg en gang dagligt udover ADT (LHRH-agonist eller orkiektomi), som var standardbehandlingen.
In the active arm, ZYTIGA was administered at a dose of 1000 mg daily in combination with low dose prednisone 5 mg once daily in addition to ADT
70 % havde radiografisk dokumenteret sygdomsprogression med eller uden PSA-progression.
Eleven percent of patients enrolled had an ECOG performance score of 2; 70% had radiographic evidence of disease progression with or without PSA progression; 70% had received one prior cytotoxic chemotherapy and 30% received two.
* p-værdi er beregnet fra en log-rank test stratificeret ved baseline-ECOG-score (0 eller 1) ** Hazard ratio < 1 indikere en fordel for ZYTIGA
* p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1) ** Hazard ratio < 1 favours ZYTIGA
Tid til smerteprogression: Mediantiden til smerteprogression blev ikke nået for patienter, der fik ZYTIGA, og var 16,6 måneder for patienter, der fik placebo (HR = 0,695; 95 % KI: [0,583, 0,829], p < 0,0001).
Time to pain progression: The median time to pain progression was not reached for patients receiving ZYTIGA and was 16.6 months for patients receiving placebo (HR = 0.695; 95% CI: [0.583, 0.829], p <0.0001).
Median tid til PSA-progression var 10,2 måneder for patienter, der blev behandlet med ZYTIGA, og 6,6 måneder for patienter, der fik placebo (HR=0,580; 95 % KI: [0,462; 0,728]; p < 0,0001).
The median time to PSA progression was 10.2 months for patients treated with ZYTIGA and 6.6 months for patients treated with placebo (HR = 0.580; 95% CI: [0.462; 0.728], p < 0.0001).
Almindelige (kan berøre op til 1 ud af 10 behandlede):
Common (may affect up to 1 in 10 people):
Tid til påbegyndelse af kemoterapi: Mediantiden til påbegyndelse af kemoterapi blev ikke nået for patienter, der fik ZYTIGA, og var 38,9 måneder for patienter, der fik placebo (HR = 0,443; 95 % KI: [0,349, 0,561], p < 0,0001).
Time to initiation of chemotherapy: The median time to initiation of chemotherapy was not reached for patients receiving ZYTIGA and was 38.9 months for patients receiving placebo (HR = 0.443; 95% CI: [0.349, 0.561], p < 0.0001).
Tid til PSA-progression baseret på PCWG-kriterier: Mediantiden til PSA-progression var 11,1 måneder for patienter, der fik ZYTIGA, og 5,6 måneder for patienter, der fik placebo (HR=0,488; 95 % KI: [0,420; 0,568], p < 0,0001).
Time to PSA progression based on PCWG2 criteria: The median time to PSA progression was 11.1 months for patients receiving ZYTIGA and 5.6 months for patients receiving placebo (HR = 0.488; 95% CI: [0.420; 0.568], p < 0.0001).
Tiden indtil påbegyndelse af cytotoksisk kemoterapi: Mediantiden indtil påbegyndelse af cytotoksisk kemoterapi var 25,2 måneder for patienter, der fik ZYTIGA, og 16,8 måneder for patienter, der fik placebo (HR=0,580; 95 % KI: [0,487; 0,69], p < 0,0001).
Time to initiation of cytotoxic chemotherapy: The median time to initiation of cytotoxic chemotherapy was 25.2 months for patients receiving ZYTIGA and 16.8 months for patients receiving placebo (HR = 0.580; 95% CI: [0.487; 0.691], p < 0.0001).
NE= Ikke estimeret * p-værdi er beregnet fra en log-rank test stratificeret ved baseline-ECOG-score (0 eller 1) ** Hazard ratio < 1 indikere en fordel for ZYTIGA
NE = Not estimated * p-value is derived from a log-rank test stratified by baseline ECOG score (0 or 1) ** Hazard ratio < 1 favours ZYTIGA
- Svært nedsat leverfunktion [Child--Pugh-klasse C (se pkt.
- Severe hepatic impairment [Child-Pugh Class C (see sections 4.2, 4.4 and 5.2)].
Abirateronacetat bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
abiraterone acetate should not be used in patients with severe hepatic impairment (see sections 4.2, 4.3 and 4.4).
Det skal du vide, før du begynder at tage ZYTIGA Sådan skal du tage ZYTIGA Bivirkninger
What ZYTIGA is and what it is used for What you need to know before you take ZYTIGA How to take ZYTIGA
Ikke almindelige (kan berøre op til 1 ud af 100 patienter):
Uncommon (may affect up to 1 in 100 people):
Tabel 3: Samlet overlevelse, stratificeret analyse; intent-to-treat-population (studie PCR3011)
Overall Survival, Stratified Analysis; Intent-to-treat Population (Study PCR3011) AA-P
Knoglerelaterede hændelser
Skeletal-related events
Tabel 4: Studie 302: Radiografisk progressionsfri overlevelse hos patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi ZYTIGA (N=546)
Table 4: Study 302: Radiographic progression-free survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy ZYTIGA (N = 546)
Hver tablet indeholder 250 mg abirateronacetat.
Each tablet contains 250 mg of abiraterone acetate.
Note: += Censureret observation, NE= ikke evaluerbar.
b 0.466 (0.394, 0.550) Note: += censored observation, NE=not estimable.
I fertilitetsstudier med både han- og hunrotter reducerede abirateronacetat fertiliteten.
In fertility studies in both male and female rats, abiraterone acetate reduced fertility, which was completely reversible in 4 to 16 weeks after abiraterone acetate was stopped.
Tabletterne skal sluges hele med vand.
Swallow the tablets whole with water.
ZYTIGA bør ikke anvendes til patienter med svært nedsat leverfunktion (se pkt.
ZYTIGA should not be used in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Hver filmovertrukken tablet indeholder 500 mg abirateronacetat.
Each film-coated tablet contains 500 mg of abiraterone acetate.
Figur 4: Kaplan Meier-kurver af radiografiske progressionsfri overlevelse hos patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi (ved den anden interimanalyse af OS-investigators vurdering)
Figure 4: Kaplan Meier curves of radiographic progression-free survival in patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy (At second interim analysis of OS-Investigator Review)
Figur 5: Kaplan Meier overlevelseskurver for patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi, endelig analyse
Figure 5: Kaplan Meier survival curves of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy, final analysis
Tabel 5: Studie 302: Radiografisk progressionsfri overlevelse hos patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi (ved den anden interimanalyse af OSinvestigators vurdering)
Table 5: Study 302: Radiographic progression-free survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy (At second interim analysis of OS-Investigator Review)
p-værdi* Hazard ratio** (95 % KI) Endelig overlevelsesanalyse Dødsfald (%) Median samlet overlevelse (i måneder) (95 % KI) p-værdi* Hazard ratio** (95 % KI)
Final survival analysis Deaths Median overall survival in months (95% CI) p-value* Hazard ratio** (95% CI)
Figur 3: Kaplan Meier kurver af radiografisk progressionsfri overlevelse hos patienter, der er behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analoger eller tidligere orkiektomi
Figure 3: Kaplan Meier curves of radiographic progression-free survival in patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
Tabel 7: Samlet overlevelse hos patienter i behandling med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog- eller tidligere orkiektomi
Table 7: Overall survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
Tabel 6: Studie 302: Samlet overlevelse hos patienter behandlet med enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi.
Table 6: Study 302: Overall survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
- Kontakt straks lægen, hvis du har glemt at tage ZYTIGA, prednison eller prednisolon i mere end en dag.
- If you forget to take ZYTIGA or prednisone or prednisolone for more than one day, talk to your doctor without delay.
ZYTIGA må derfor ikke indtages i forbindelse med et måltid, men indtages mindst to timer efter fødeindtagelse, og føde må ikke indtages i mindst én time efter indtagelse af ZYTIGA.
It should be taken at least two hours after eating and no food should be eaten for at least one hour after taking ZYTIGA.
En filmovertrukken tablet indeholder 500 mg abirateronacetat.
Each film-coated tablet contains 500 mg abiraterone acetate.
Tiden til smerteprogression ved den 25. percentil var 7,4 måneder i ZYTIGA-gruppen versus 4,7 måneder i placebo-gruppen.
versus 4.7 months in the placebo group.
- Opbevar lægemidlet utilgængeligt for børn.
- Keep this medicine out of the sight and reach of children.
Figur 6: Kaplan Meier-overlevelseskurver for patienter, der fik enten ZYTIGA eller placebo i kombination med prednison eller prednisolon plus LHRH-analog eller tidligere orkiektomi
Figure 6: Kaplan Meier survival curves of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy
Nyrer og urinveje almindelige: hæmaturi
Renal and urinary disorders common: haematuria
Magnesiumstearat
Tablet core
HR=hazard ratio; NE=ikke evaluerbar.
Range p value Hazard ratio (95% CI) Note:+= censored observation, NE = not estimable.
Gravide kvinder eller kvinder, som kan være gravide, bør ikke håndtere det uden at anvende sikkerhedsudstyr, f.eks. handsker.
Based on its mechanism of action, this medicinal product may harm a developing foetus; therefore, women who are pregnant or may be pregnant should not handle it without protection, e.g., gloves.
Efter oral administration af 1.000 mg
Following oral administration of
Forsøgspersoner med risiko
Patients with elevations of ALT or
I tilfælde af et klinisk signifikant fald i hjertefunktionen bør det overvejes at seponere ZYTIGA (se pkt.
Assess cardiac function as clinically indicated, institute appropriate management and consider discontinuation of this treatment if there is a clinically significant decrease in cardiac function (see section 4.2).
4.8) som følge af de forhøjede mineralokortikoidniveauer forårsaget af CYP17-hæmning (se pkt.
Hypertension, hypokalaemia, fluid retention and cardiac failure due to mineralocorticoid excess ZYTIGA may cause hypertension, hypokalaemia and fluid retention (see section 4.8) as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition (see section 5.1).