natgillin/translations-raw huggingface dataset:
Forekomsten og sværhedsgraden af bivirkningerne var højere i subgrupperne af patienter med ECOG2 i performancestatusgrad ved baseline såvel som hos ældre patienter (≥ 75 år).
The incidence and severity of adverse events was higher in the subgroup of patients with baseline ECOG2 performance status grade and also in elderly patients (≥75 years).
I ingen af de tre studier var anvendelse af spironolacton tilladt, eftersom spironolacton binder til androgenreceptoren og kan øge PSA-koncentrationen.
In all studies spironolactone use was not allowed as spironolactone binds to the androgen receptor and may increase PSA levels.
Spironolacton binder til androgenreceptoren og kan øge koncentrationen af prostataspecifikt antigen (PSA).
Spironolactone binds to the androgen receptor and may increase prostate specific antigen (PSA) levels.
Hvis en daglig dosis af enten ZYTIGA, prednison eller prednisolon springes over, skal behandlingen fortsætte næste dag med den sædvanlige daglige dosis.
In the event of a missed daily dose of either ZYTIGA, prednisone or prednisolone, treatment should be resumed the following day with the usual daily dose.
I studie 3011 sås hepatotoksicitet af grad 3 eller 4 hos 8,4 % af de patienter, der blev behandlet med ZYTIGA.
In Study 3011, grade 3 or 4 hepatotoxicity was observed in 8.4% of patients treated with ZYTIGA.
Blandt forsøgspersoner med registrerbar bløddelssygdom blev der set signifikant flere tilfælde af fuldstændigt eller delvist tumorrespons med ZYTIGA-behandling.
In subjects with measurable soft tissue disease, significantly increased numbers of complete and partial tumor responses were seen with ZYTIGA treatment.
ZYTIGA hindrer kroppen i at fremstille testosteron og kan derved nedsætte væksten af prostatacancer.
ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer.
I et 24måneders karcinogenicitetsstudie hos rotter øgede abirateronacetat incidensen af interstitialcelletumorer i testiklerne.
In a 24-month carcinogenicity study in the rat, abiraterone acetate increased the incidence of interstitial cell neoplasms in the testes.
Studie 3011 (patienter med nydiagnosticeret mHSPC med høj risiko) I studie 3011 (n=1199) var medianalderen for de deltagende patienter 67 år.
Study 3011 (patients with newly diagnosed high risk mHSPC) In Study 3011, (n=1199) the median age of enrolled patients was 67 years.
Andre vigtige bivirkninger omfatter hjertelidelser, levertoksicitet, frakturer og allergisk alveolitis.
Other important adverse reactions include, cardiac disorders, hepatotoxicity, fractures, and allergic alveolitis.
Baseret på en kumulativ gennemgang af data i forbindelse med latenstiden for tilfældene af rabdomyolyse/myopati forekom næsten halvdelen af disse tilfælde mellem 1 og 6 måneder efter indledning af behandling med abirateronacetat (AA).
Based on a cumulative review of the data in relation to latency of rhabdomyolysis/myopathy cases, almost half of these cases occurred between 1 to 6 months after initiation of therapy with abiraterone acetate (AA).
Hos patienter, som får levertoksicitet under behandlingen (alanin-aminotransferase [ALAT] eller aspartat-aminotransferase [ASAT] stiger til > 5 x øvre normalgrænse [ULN]), bør behandlingen omgående indstilles (se pkt.
For patients who develop hepatotoxicity during treatment (alanine aminotransferase [ALT] increases or aspartate aminotransferase [AST] increases above 5 times the upper limit of normal [ULN]), treatment should be withheld immediately (see section 4.4).
I kliniske studier begrænsedes risikoen for hepatotoksicitet ved at udelukke patienter med baseline hepatitis eller signifikante unormale leverfunktionstest.
In clinical trials, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline hepatitis or significant abnormalities of liver function tests.
Hjælpestoffer, som behandleren skal være opmærksom på: Hver tablet indeholder 189 mg lactose og 6,8 mg natrium.
Excipients with known effect Each tablet contains 189 mg of lactose and 6.8 mg of sodium.
AA-P=forsøgspersoner, der fik abirateronacetat og prednison.
AA-P= subjects who received abiraterone acetate and prednisone.
C-mærket abirateronacetat som kapsler hydrolyseres abirateronacetat til abirateron, som dernæst gennemgår metabolisme inklusiv omdannelse til sulfat, hydroxylering og oxidation primært i leveren.
C-abiraterone acetate as capsules, abiraterone acetate is hydrolysed to abiraterone, which then undergoes metabolism including sulphation, hydroxylation and oxidation primarily in the liver.
CYP17 katalyserer konverteringen af henholdsvis pregnenolon og progesteron til testosteron-forstadierne DHEA og androstenedion ved hjælp af 17α-hydroxylering og spaltning af C17,20-bindingen.
CYP17 catalyses the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively, by 17α-hydroxylation and cleavage of the C17,20 bond.
Administration sammen med føde medfører en signifikant øget absorption af abirateronacetat.
Administration with food significantly increases the absorption of abiraterone acetate.
• behandling af (mCRPC) hos voksne mænd med progression af sygdommen under eller efter kemoterapi baseret på docetaxel.
• the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
ZYTIGA er udelukkende beregnet til brug hos mandlige patienter.
ZYTIGA is for use in male patients only.
- ZYTIGA må ikke tages sammen med mad.
- Do not take ZYTIGA with food.
Under behandlingen bør blodtryk, serumkalium, væskeretention (vægtstigning, perifere ødemer) og andre symptomer på kongestiv hjerteinsufficiens kontrolleres hver anden uge i tre måneder og derefter månedligt, og uregelmæssigheder skal korrigeres.
During treatment, blood pressure, serum potassium, fluid retention (weight gain, peripheral oedema), and other signs and symptoms of congestive heart failure should be monitored every 2 weeks for 3 months, then monthly thereafter and abnormalities corrected.
Patienter, der var blevet behandlet med tidligere farmakoterapi, stråleterapi eller operation af metastaserende prostatacancer blev ekskluderet med undtagelse af ADT i op til 3 måneder eller 1 forløb med palliativ stråling eller kirurgisk behandling af symptomer som følge af metastaserende sygdom.
Patients that were treated with prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer were excluded with the exception of up to 3 months of ADT or 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease.
Efter administration af abirateronacetat blev farmakokinetikken af abirateron og abirateronacetat undersøgt hos raske forsøgspersoner, patienter med metastaserende avanceret prostatacancer og forsøgspersoner uden cancer med nedsat lever- eller nyrefunktion.
Following administration of abiraterone acetate, the pharmacokinetics of abiraterone and abiraterone acetate have been studied in healthy subjects, patients with metastatic advanced prostate cancer and subjects without cancer with hepatic or renal impairment.
Administration til patienter med nedsat nyrefunktion inklusiv alvorligt nedsat nyrefunktion kræver ikke dosisreduktion (se pkt.
Administration in patients with renal impairment, including severe renal impairment, does not require dose reduction (see section 4.2).
I et separat klinisk farmakokinetisk interaktionsstudie med raske forsøgspersoner havde samtidig administration af ketoconazol, en potent CYP3A4-hæmmer, ingen klinisk relevant indvirkning på abiraterons farmakokinetik.
In a separate clinical pharmacokinetic interaction study of healthy subjects, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.
CTCAE (version 4.0) grad 3-hypertriglyceridæmi og angina pectoris forekom hos < 1 % af patienterne.
CTCAE (version 4.0) Grade 3 hypertriglyceridaemia and angina pectoris occurred in < 1% of patients.
Der blev observeret en signifikant forskel i rPFS mellem de 2 behandlingsgrupper (se tabel 2 og figur 1).
A significant difference in rPFS between treatment groups was observed (see Table 2 and Figure 1).
Der kan opstå anæmi og seksuel dysfunktion hos mænd med metastaserende prostatacancer - også hos mænd i behandling med ZYTIGA.
Anaemia and sexual dysfunction may occur in men with metastatic prostate cancer including those undergoing treatment with ZYTIGA.
Seponering af kortikosteroider og håndtering af stressende situationer Forsigtighed tilrådes, og patienterne bør overvåges for adrenokortikal insufficiens, hvis de får stoppet behandling med prednison eller prednisolon.
Corticosteroid withdrawal and coverage of stress situations Caution is advised and monitoring for adrenocortical insufficiency should occur if patients are withdrawn from prednisone or prednisolone.
- Brug ikke lægemidlet efter den udløbsdato, der står på æsken, papetuiet og blisterpakningen.
- Do not use this medicine after the expiry date which is stated on the carton, cardboard wallet, and the blister.
Tiden til første knoglerelaterede hændelse ved 25. percentilen i ZYTIGA-gruppen var dobbelt så lang som i kontrolgruppen efter 9,9 måneder versus 4,9 måneder.
th percentile in the ZYTIGA group was twice that of the control group at 9.9 months versus 4.9 months.
Samtidig anvendelse af et kortikosteroid reducerer incidensen og sværhedsgraden af disse bivirkninger (se pkt.
Concomitant use of a corticosteroid reduces the incidence and severity of these adverse reactions (see section 4.4).
Radiografisk progression omfattede progression ved knoglescanning (i henhold til modificeret PCWG2) eller progression af bløddelslæsioner ved CT- eller MRI-scanning (i henhold til RECIST 1.1).
Radiographic progression included progression by bone scan (according to modified PCWG2) or progression of soft tissue lesions by CT or MRI (according to RECIST 1.1).
Hvis patienten dyrker sex med en fertil kvinde, bør parret anvende kondom sammen med en anden metode til sikker kontraception.
If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method.
Helt specifikt er abirateron en selektiv hæmmer af enzymet 17α-hydroxylase/C17,20-lyase (CYP17).
Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17).
Tag ikke ZYTIGA: - hvis du er allergisk over for abirateronacetat eller et af de øvrige indholdsstoffer i ZYTIGA
Do not take ZYTIGA - if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
Mediantiden til SRE er ikke opnået i ZYTIGA- eller placeboarmen i studiet.
The median time to SRE has not been reached for the ZYTIGA or placebo study arm.
Nedsat antal røde blodlegemer, nedsat sexlyst (libido) samt muskelsvaghed og/eller muskelsmerter kan forekomme.
Decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.
ZYTIGA i kombination med prednison eller prednisolon kan øge knogletabet.
ZYTIGA in combination with prednisone or prednisolone may increase bone loss.
Filmovertræk Sort jernoxid (E172) Rød jernoxid (E172) Macrogol 3350
Iron oxide black (E172) Iron oxide red (E172) Macrogol 3350
4.3 og 4.4 i produktresuméet ændres for at afspejle kontraindikationen for brug af Xofigo (Radium-223) i kombination med abirateronacetat og prednison/prednisolon og den øgede risiko for frakturer og dødelighed hos patienter behandlet med Radium-223 i kombination med abirateron.
Moreover, sections 4.3 and 4.4 of the SmPC should be amended to reflect the contraindication of the use of Xofigo (Radium-223) in combination with abiraterone acetate and prednisone/prednisolone and the increased risk for fractures and mortality in patients treated with Radium-223 in combination with abiraterone.
Der savnes dog klinisk erfaring hos patienter med prostatacancer og svært nedsat nyrefunktion.
However, there is no clinical experience in patients with prostate cancer and severe renal impairment.
Hypertension blev rapporteret hos 36,7 % af patienterne i den hormonfølsomme population (studie 3011) sammenlignet med henholdsvis 11,8 % og 20,2 % i studierne 301 og 302.
Hypertension was reported in 36.7% of patients in the hormone sensitive population (study 3011) compared to 11.8% and 20.2% in studies 301 and 302, respectively.
Potente CYP3A4-induktorer (f.eks. phenytoin, carbamazepin, rifampicin, rifabutin, rifapentin, phenobarbital, perikon [Hypericum perforatum]) skal undgås under behandlingen, medmindre der ikke er andre behandlingsmuligheder.
Strong inducers of CYP3A4 (e.g., phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarbital, St John's wort [Hypericum perforatum]) during treatment are to be avoided, unless there is no therapeutic alternative.
Eksempler på lægemidler, der metaboliseres af CYP2D6, omfatter metoprolol, propranolol, desipramin, venlafaxin, haloperidol, risperidon, propafenon, flecainid, codein, oxycodon og tramadol (de sidste tre lægemidler kræver CYP2D6 ved omdannelse til de aktive analgetiske metabolitter).
Examples of medicinal products metabolised by CYP2D6 include metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone and tramadol (the latter three medicinal products requiring CYP2D6 to form their active analgesic metabolites).
Blodtryk, serumkalium og væskeretention bør kontrolleres hver måned.
Blood pressure, serum potassium and fluid retention should be monitored monthly.
Fremstiller Janssen-Cilag SpA Via C. Janssen Borgo San Michele I-04100 Latina, Italien
Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele I-04100 Latina, Italy
Forsigtighed tilrådes hos disse patienter (se pkt.
Caution is advised in these patients (see section 4.4).
Patienterne var i behandling med en LHRH-analog eller var tidligere orkiektomerede.
Patients were using an LHRH analogue or were previously treated with orchiectomy.
Tabletterne bør tages mindst to timer efter et måltid, og føde må ikke indtages i mindst en time efter indtagelse af tabletterne.
The tablets should be taken at least two hours after eating and no food should be eaten for at least one hour after taking the tablets.
Der blev observeret en signifikant forskel i rPFS mellem de 2 behandlingsgrupper (se tabel 4 og figur 3).
A significant difference in rPFS between treatment groups was observed (see Table 4 and Figure 3).
Hvis du har glemt at tage ZYTIGA - Hvis du glemmer at tage ZYTIGA, prednison eller prednisolon, skal du tage den sædvanlige dosis næste dag.
If you forget to take ZYTIGA - If you forget to take ZYTIGA or prednisone or prednisolone, take your usual dose the following day.
Forsigtighed tilrådes hos patienter i samtidig behandling med lægemidler, der er sat i forbindelse med myopati/rabdomyolyse.
Caution is recommended in patients concomitantly treated with medicinal products known to be associated with myopathy/rhabdomyolysis.
Brug af anden medicin sammen med ZYTIGA Spørg din læge eller apoteket til råds, inden du tager nogen form for medicin.
Other medicines and ZYTIGA Ask your doctor or pharmacist for advice before taking any medicine.
QT-forlængelse er blevet observeret hos patienter, der udvikler hypokaliæmi i forbindelse med ZYTIGA-behandling.
QT prolongation has been observed in patients experiencing hypokalaemia in association with ZYTIGA treatment.
- Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
Ask your pharmacist how to throw away medicines you no longer use.
EU/1/11/714/002 (56 filmovertrukne tabletter) EU/1/11/714/003 (60 filmovertrukne tabletter)
EU/1/11/714/002 (56 film-coated tablets) EU/1/11/714/003 (60 film-coated tablets)
Patienter med kendt hjernemetastase, ukontrolleret hypertension, signifikant hjertesygdom eller NYHA-klasse II-IV hjerteinsufficiens blev ekskluderet.
Patients with known brain metastasis, uncontrolled hypertension, significant heart disease, or NYHA Class IIIV heart failure were excluded.
Væske i ben eller fødder, lavt indhold af kalium i blodet, forhøjede leverfunktionsprøver, højt blodtryk, urinvejsinfektion, diaré.
Fluid in your legs or feet, low blood potassium, liver function test increases, high blood pressure, urinary tract infection, diarrhoea.
I disse studier af fertilitet og udviklingstoksicitet hos rotter blev alle virkninger relateret til abiraterons farmakologiske virkning.
In these fertility and developmental toxicity studies performed in the rat, all effects were related to the pharmacological activity of abiraterone.
Studie 3011 omfattede patienter, der var nydiagnosticerede (inden for 3 måneder før randomiseringen) med mHSPC, hvor højrisikofaktorer indgik i patienternes prognose.
Study 3011 enrolled patients who were newly diagnosed (within 3 months of randomization) mHSPC who had high-risk prognostic factors.
Hepatotoksicitet med forhøjet ALAT, ASAT og total bilirubin er forekommet hos patienter i behandling med abirateronacetat.
Hepatotoxicity with elevated ALT, AST and total bilirubin has been reported in patients treated with abiraterone acetate.
PVdC/PE/PVC/aluminium-blister med 14 tabletter i papetui.
PVdC/PE/PVC/aluminum blister of 14 film-coated tablets in a cardboard wallet.
Derved nedsættes risikoen for, at du får højt blodtryk, for meget væske i kroppen (væskeretention) eller nedsat indhold af mineralet kalium i blodet.
This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a chemical known as potassium in your blood.
PVdC/PE/PVC/aluminium-blister med 12 tabletter i papetui.
PVdC/PE/PVC/aluminum blister of 12 film-coated tablets in a cardboard wallet.
C-mærket abirateronacetat blev ca. 88 % af den radioaktive dosis genfundet i fæces og ca. 5 % i urinen.
C-abiraterone acetate 1,000 mg, approximately 88% of the radioactive dose is recovered in faeces and approximately 5% in urine.
I to tilfælde sås markante stigninger i leverfunktionsprøver (se pkt.
In two instances marked increases in liver function tests occurred (see section 4.4).
Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
I en planlagt analyse udført efter observation af 552 dødsfald var 42 % (333 ud af 797) af de patienter, der fik ZYTIGA, sammenlignet med 55 % (219 ud af 398) af de patienter, der fik placebo, afgået ved døden.
In a planned analysis conducted after 552 deaths were observed, 42% (333 of 797) of patients treated with ZYTIGA compared with 55% (219 of 398) of patients treated with placebo, had died.
ZYTIGA er indiceret til brug sammen med prednison eller prednisolon til:
ZYTIGA is indicated with prednisone or prednisolone for:
Før behandling af patienter med betydelig risiko for kongestiv hjerteinsufficiens (f.eks. anamnese med hjerteinsufficiens, ukontrolleret hypertension eller hjertetilfælde såsom iskæmisk hjertesygdom) bør det overvejes at evaluere hjertefunktionen (f.eks. med ekkokardiogram).
Before treating patients with a significant risk for congestive heart failure (e.g.a history of cardiac failure, uncontrolled hypertension, or cardiac events such as ischaemic heart disease), consider obtaining an assessment of cardiac function (e.g. echocardiogram).
Andelen af forsøgspersoner med registrerbar sygdom ved baseline, som havde et objektivt respons, var 36 % i ZYTIGA-gruppen og 16 % i placebogruppen (p < 0,0001).
The proportion of subjects with measurable disease at baseline who had an objective response was 36% in the ZYTIGA group and 16% in the placebo group (p < 0.0001).
Patienter, der fik ZYTIGA, opnåede en signifikant højere total PSA-responsrate (defineret som reduktion fra baseline ≥ 50 %), sammenlignet med patienter, der fik placebo, 38 % vs. 10 %, p < 0,0001.
Patients receiving ZYTIGA demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 38% vs. 10%, p < 0.0001.
Abirateronacetat var ikke karcinogent hos hunrotter.
Abiraterone acetate was not carcinogenic in female rats.
Bivirkninger observeret i kliniske studier og efter markedsføring med ZYTIGA er anført nedenfor inddelt efter hyppighed.
Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency category.
Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 253,2 mg lactose og 13,5 mg natrium.
Excipients with known effect Each film-coated tablet contains 253.2 mg of lactose and 13.5 mg of sodium.
Co-primære effektendepunkter var samlet overlevelse (OS) og radiografisk progressionsfri overlevelse (rPFS).
Co-primary efficacy endpoints were overall survival (OS) and radiographic progression-free survival (rPFS).
Anormale leverfunktionsprøver, der udvikledes hos patienter, der deltog i kliniske studier, blev håndteret konsekvent, ved at kræve seponering af behandlingen, og udelukkende tillade genoptagelse af behandlingen, hvis leverfunktionsprøverne faldt til patientens baselineværdier (se pkt.
Abnormal liver function tests developing in patients participating in clinical trials were vigorously managed by requiring treatment interruption and permitting re-treatment only after return of liver function tests to the patient's baseline (see section 4.2).
ZYTIGAs sikkerhed og virkning ved anvendelse sammen med cytotoksisk kemoterapi er ikke klarlagt (se pkt.
The safety and efficacy of concomitant use of ZYTIGA with cytotoxic chemotherapy has not been established (see section 5.1).
Medmindre der ikke findes andre behandlingsmuligheder, bør stærke CYP3A4-induktorer undgås under behandlingen på grund af risiko for nedsat eksponering for abirateron (se pkt.
Strong inducers of CYP3A4 during treatment are to be avoided unless there is no therapeutic alternative, due to risk of decreased exposure to abiraterone (see section 4.5).
Hvor meget Den anbefalede dosis er 1.000 mg (fire tabletter) en gang dagligt.
How much to take The recommended dose is 1,000 mg (four tablets) once a day.
I studie 302 blev der observeret grad 3 eller 4 ALAT- eller ASAT-forhøjelser hos 35 (6,5 %) af de patienter, der blev behandlet med abirateronacetat.
In study 302, Grade 3 or 4 ALT or AST elevations were observed in 35 (6.5%) patients treated with abiraterone acetate.
En responder i forhold til smertelindring defineredes som en patient, som opnåede mindst 30 % reduktion fra baseline i BPI-SF-score for værste smerteintensitet i løbet af de seneste 24 timer uden samtidig øgning i scoren for analgetikaforbrug observeret ved to konsekutive evalueringer med fire ugers mellemrum.
A responder for pain palliation was defined as a patient who experienced at least a 30% reduction from baseline in the BPI-SF worst pain intensity score over the last 24 hours without any increase in analgesic usage score observed at two consecutive evaluations four weeks apart.
Dette studie omfattede patienter, som ikke tidligere havde fået kemoterapi, og som var asymptomatiske eller havde lettere symptomer, og som endnu ikke havde et klinisk behov for kemoterapi.
This study enrolled chemotherapy naïve patients who were asymptomatic or mildly symptomatic and for whom chemotherapy was not yet clinically indicated.
Co-primære effektendepunkter var samlet overlevelse og radiografisk progressionsfri overlevelse (rPFS).
Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS).
Hypokaliæmi sås hos 20,4 % af patienterne i den hormonfølsomme population (studie 3011) sammenlignet med henholdsvis 19,2 % og 14,9 % i studierne 301 og 302).
Hypokalemia was observed in 20.4% of patients in the hormone sensitive population (study 3011) compared to 19.2% and 14.9% in 301 and 302, respectively).
AUC for abirateron øgedes med ca. 600 %, og fraktionen af frit lægemiddel øgedes med 80 % hos forsøgspersoner med svært nedsat leverfunktion sammenlignet med forsøgspersoner med normal leverfunktion.
The AUC to abiraterone increased by approximately 600% and the fraction of free drug increased by 80% in subjects with severe hepatic impairment compared to subjects with normal hepatic function.