FrancophonIA/ELRC3.0 huggingface dataset:
English: - Do not use this medicine after the expiry date which is stated on the carton, cardboard wallet, and the blister.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på æsken, papetuiet og blisterpakningen.
English: th percentile in the ZYTIGA group was twice that of the control group at 9.9 months versus 4.9 months.
Danish: 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.
English: Concomitant use of a corticosteroid reduces the incidence and severity of these adverse reactions (see section 4.4).
Danish: Samtidig anvendelse af et kortikosteroid reducerer incidensen og sværhedsgraden af disse bivirkninger (se pkt.
English: 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).
Danish: 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).
English: If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method.
Danish: Hvis patienten dyrker sex med en fertil kvinde, bør parret anvende kondom sammen med en anden metode til sikker kontraception.
English: Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17).
Danish: Helt specifikt er abirateron en selektiv hæmmer af enzymet 17α-hydroxylase/C17,20-lyase (CYP17).
English: Do not take ZYTIGA - if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke ZYTIGA: - hvis du er allergisk over for abirateronacetat eller et af de øvrige indholdsstoffer i ZYTIGA
English: The median time to SRE has not been reached for the ZYTIGA or placebo study arm.
Danish: Mediantiden til SRE er ikke opnået i ZYTIGA- eller placeboarmen i studiet.
English: Decrease in red blood cells, reduced sex drive (libido), muscle weakness and/or muscle pain may occur.
Danish: Nedsat antal røde blodlegemer, nedsat sexlyst (libido) samt muskelsvaghed og/eller muskelsmerter kan forekomme.
English: ZYTIGA in combination with prednisone or prednisolone may increase bone loss.
Danish: ZYTIGA i kombination med prednison eller prednisolon kan øge knogletabet.
English: Iron oxide black (E172) Iron oxide red (E172) Macrogol 3350
Danish: Filmovertræk Sort jernoxid (E172) Rød jernoxid (E172) Macrogol 3350
English: 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.
Danish: 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.
English: However, there is no clinical experience in patients with prostate cancer and severe renal impairment.
Danish: Der savnes dog klinisk erfaring hos patienter med prostatacancer og svært nedsat nyrefunktion.
English: 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.
Danish: 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.
English: 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.
Danish: Potente CYP3A4-induktorer (f.eks. phenytoin, carbamazepin, rifampicin, rifabutin, rifapentin, phenobarbital, perikon [Hypericum perforatum]) skal undgås under behandlingen, medmindre der ikke er andre behandlingsmuligheder.
English: 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).
Danish: 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).
English: Blood pressure, serum potassium and fluid retention should be monitored monthly.
Danish: Blodtryk, serumkalium og væskeretention bør kontrolleres hver måned.
English: Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele I-04100 Latina, Italy
Danish: Fremstiller Janssen-Cilag SpA Via C. Janssen Borgo San Michele I-04100 Latina, Italien
English: Caution is advised in these patients (see section 4.4).
Danish: Forsigtighed tilrådes hos disse patienter (se pkt.
English: Patients were using an LHRH analogue or were previously treated with orchiectomy.
Danish: Patienterne var i behandling med en LHRH-analog eller var tidligere orkiektomerede.
English: 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.
Danish: Tabletterne bør tages mindst to timer efter et måltid, og føde må ikke indtages i mindst en time efter indtagelse af tabletterne.
English: A significant difference in rPFS between treatment groups was observed (see Table 4 and Figure 3).
Danish: Der blev observeret en signifikant forskel i rPFS mellem de 2 behandlingsgrupper (se tabel 4 og figur 3).
English: If you forget to take ZYTIGA - If you forget to take ZYTIGA or prednisone or prednisolone, take your usual dose the following day.
Danish: Hvis du har glemt at tage ZYTIGA - Hvis du glemmer at tage ZYTIGA, prednison eller prednisolon, skal du tage den sædvanlige dosis næste dag.
English: Caution is recommended in patients concomitantly treated with medicinal products known to be associated with myopathy/rhabdomyolysis.
Danish: Forsigtighed tilrådes hos patienter i samtidig behandling med lægemidler, der er sat i forbindelse med myopati/rabdomyolyse.
English: Other medicines and ZYTIGA Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Brug af anden medicin sammen med ZYTIGA Spørg din læge eller apoteket til råds, inden du tager nogen form for medicin.
English: QT prolongation has been observed in patients experiencing hypokalaemia in association with ZYTIGA treatment.
Danish: QT-forlængelse er blevet observeret hos patienter, der udvikler hypokaliæmi i forbindelse med ZYTIGA-behandling.
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: - Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: EU/1/11/714/002 (56 film-coated tablets) EU/1/11/714/003 (60 film-coated tablets)
Danish: EU/1/11/714/002 (56 filmovertrukne tabletter) EU/1/11/714/003 (60 filmovertrukne tabletter)
English: Patients with known brain metastasis, uncontrolled hypertension, significant heart disease, or NYHA Class IIIV heart failure were excluded.
Danish: Patienter med kendt hjernemetastase, ukontrolleret hypertension, signifikant hjertesygdom eller NYHA-klasse II-IV hjerteinsufficiens blev ekskluderet.
English: Fluid in your legs or feet, low blood potassium, liver function test increases, high blood pressure, urinary tract infection, diarrhoea.
Danish: Væske i ben eller fødder, lavt indhold af kalium i blodet, forhøjede leverfunktionsprøver, højt blodtryk, urinvejsinfektion, diaré.
English: In these fertility and developmental toxicity studies performed in the rat, all effects were related to the pharmacological activity of abiraterone.
Danish: I disse studier af fertilitet og udviklingstoksicitet hos rotter blev alle virkninger relateret til abiraterons farmakologiske virkning.
English: Study 3011 enrolled patients who were newly diagnosed (within 3 months of randomization) mHSPC who had high-risk prognostic factors.
Danish: Studie 3011 omfattede patienter, der var nydiagnosticerede (inden for 3 måneder før randomiseringen) med mHSPC, hvor højrisikofaktorer indgik i patienternes prognose.
English: Hepatotoxicity with elevated ALT, AST and total bilirubin has been reported in patients treated with abiraterone acetate.
Danish: Hepatotoksicitet med forhøjet ALAT, ASAT og total bilirubin er forekommet hos patienter i behandling med abirateronacetat.
English: PVdC/PE/PVC/aluminum blister of 14 film-coated tablets in a cardboard wallet.
Danish: PVdC/PE/PVC/aluminium-blister med 14 tabletter i papetui.
English: 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.
Danish: Derved nedsættes risikoen for, at du får højt blodtryk, for meget væske i kroppen (væskeretention) eller nedsat indhold af mineralet kalium i blodet.
English: PVdC/PE/PVC/aluminum blister of 12 film-coated tablets in a cardboard wallet.
Danish: PVdC/PE/PVC/aluminium-blister med 12 tabletter i papetui.
English: C-abiraterone acetate 1,000 mg, approximately 88% of the radioactive dose is recovered in faeces and approximately 5% in urine.
Danish: C-mærket abirateronacetat blev ca. 88 % af den radioaktive dosis genfundet i fæces og ca. 5 % i urinen.
English: In two instances marked increases in liver function tests occurred (see section 4.4).
Danish: I to tilfælde sås markante stigninger i leverfunktionsprøver (se pkt.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: 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.
Danish: 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.
English: ZYTIGA is indicated with prednisone or prednisolone for:
Danish: ZYTIGA er indiceret til brug sammen med prednison eller prednisolon til:
English: 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).
Danish: 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).
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Abiraterone acetate was not carcinogenic in female rats.
Danish: Abirateronacetat var ikke karcinogent hos hunrotter.
English: Adverse reactions observed during clinical studies and post-marketing experience are listed below by frequency category.
Danish: Bivirkninger observeret i kliniske studier og efter markedsføring med ZYTIGA er anført nedenfor inddelt efter hyppighed.
English: Excipients with known effect Each film-coated tablet contains 253.2 mg of lactose and 13.5 mg of sodium.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 253,2 mg lactose og 13,5 mg natrium.
English: Co-primary efficacy endpoints were overall survival (OS) and radiographic progression-free survival (rPFS).
Danish: Co-primære effektendepunkter var samlet overlevelse (OS) og radiografisk progressionsfri overlevelse (rPFS).
English: 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).
Danish: 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.
English: The safety and efficacy of concomitant use of ZYTIGA with cytotoxic chemotherapy has not been established (see section 5.1).
Danish: ZYTIGAs sikkerhed og virkning ved anvendelse sammen med cytotoksisk kemoterapi er ikke klarlagt (se pkt.
English: 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).
Danish: Medmindre der ikke findes andre behandlingsmuligheder, bør stærke CYP3A4-induktorer undgås under behandlingen på grund af risiko for nedsat eksponering for abirateron (se pkt.
English: How much to take The recommended dose is 1,000 mg (four tablets) once a day.
Danish: Hvor meget Den anbefalede dosis er 1.000 mg (fire tabletter) en gang dagligt.
English: In study 302, Grade 3 or 4 ALT or AST elevations were observed in 35 (6.5%) patients treated with abiraterone acetate.
Danish: 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.
English: 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.
Danish: 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.
English: This study enrolled chemotherapy naïve patients who were asymptomatic or mildly symptomatic and for whom chemotherapy was not yet clinically indicated.
Danish: 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.
English: Co-primary efficacy endpoints were overall survival and radiographic progression-free survival (rPFS).
Danish: Co-primære effektendepunkter var samlet overlevelse og radiografisk progressionsfri overlevelse (rPFS).
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: The median rPFS was 16.5 months in the abiraterone acetate group and 8.3 months in the placebo group.
Danish: Median-rPFS var 16,5 måneder i abirateronacetat-gruppen og 8,3 måneder i placebogruppen.
English: Study 302 enrolled docetaxel naïve patients; whereas, study 301 enrolled patients who had received prior docetaxel.
Danish: Studie 302 omfattede docetaxel-naive patienter, mens studie 301 omfattede patienter, der tidligere havde fået docetaxel.
English: In the Phase 3 clinical studies, patients whose baseline ALT or AST were elevated were more likely to experience liver function test elevations than those beginning with normal values.
Danish: I de fase 3 kliniske studier var de patienter, som havde forhøjet ALAT eller ASAT ved baseline, mere tilbøjelige til at få forhøjede leverfunktionsprøver end dem, som havde normale værdier ved start.
English: When ZYTIGA is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy ).
Danish: Når ZYTIGA anvendes i sygdommens tidlige fase, hvor den stadig reagerer på hormonbehandling, anvendes det sammen med en behandling, der nedsætter dannelsen af testosteron (androgen deprivationsbehandling).
English: A skeletal-related event was defined as a pathological fracture, spinal cord compression, palliative radiation to bone, or surgery to bone.
Danish: En knoglerelateret hændelse defineredes som en patologisk fraktur, krompression af rygsøjlen, palliativ strålebehandling af knogler eller knoglekirurgi.
English: No dose adjustment is necessary for patients with pre-existing mild hepatic impairment, Child-Pugh Class A.
Danish: Det er ikke nødvendigt at justere dosis hos patienter med eksisterende let nedsat leverfunktion, Child-Pugh-klasse A.
English: However, patients with a significant risk for congestive heart failure should be monitored every 2 weeks for the first three months of treatment and monthly thereafter (see section 4.4).
Danish: Patienter med en væsentlig risiko for at få kongestiv hjerteinsufficiens bør dog kontrolleres hver anden uge i de første tre måneder af behandlingen og derefter hver måned (se pkt.
English: Use with chemotherapy
Danish: Anvendelse sammen med kemoterapi
English: • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)
Danish: • behandling af metastatisk kastrationsresistent prostatacancer (mCRPC) hos voksne mænd, som er asymptomatiske eller har lette symptomer efter mislykket androgen deprivationsbehandling, og hvor kemoterapi endnu ikke er klinisk indiceret (se pkt.
English: How much to take The recommended dose is 1,000 mg (two tablets) once a day.
Danish: Hvor meget Den anbefalede dosis er 1.000 mg (to tabletter) en gang dagligt.
English: Pain progression was defined as an increase from baseline of ≥ 30% in the BPI-SF worst pain intensity score over the previous 24 hours without a decrease in analgesic usage score observed at two consecutive visits, or an increase of ≥ 30% in analgesic usage score observed at two consecutive visits.
Danish: Smerteprogression defineredes som en stigning fra baseline på ≥ 30 % i BPI-SF-score for værste smerteintensitet i løbet af de forudgående 24 timer, uden at der blev observeret et fald i brug af analgetika ved to konsekutive besøg, eller en stigning på ≥ 30% i brug af analgetika observeret ved to konsekutive besøg.
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Danish: Hvis du er i tvivl, så spørg din læge eller apotekspersonalet, inden du tager dette lægemiddel.
English: Use with products known to prolong QT interval Since androgen deprivation treatment may prolong the QT interval, caution is advised when administering ZYTIGA with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc.
Danish: Anvendelse sammen med lægemidler, der vides at forlænge QT-intervallet Da androgen deprivationsbehandling kan forlænge QT-intervallet, skal der udvises forsigtighed ved administration af ZYTIGA sammen med lægemidler, der vides at forlænge QT-intervallet, eller lægemidler, der kan inducere torsades de pointes såsom klasse IA-antiarytmika (f.eks. kinidin, disopyramid) eller klasse III-antiarytmika (f.eks. amiodaron, sotalol, dofetilid, ibutilid), methadon, moxifloxacin, antipsykotika osv.
English: In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone was increased by 46% and the AUCs for M-III and M-IV, the active metabolites of pioglitazone, each decreased by 10% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate.
Danish: I et lægemiddelinteraktionsforsøg med CYP2C8, som blev foretaget med raske forsøgspersoner, blev AUC for pioglitazon øget med 46 %, og AUC'er for M-III og M-IV, pioglitazons aktive metabolitter, blev begge formindsket med 10 %, når pioglitazon blev givet sammen med en enkelt dosis på 1.000 mg abirateronacetat.
English: If hepatotoxicity recurs at the reduced dose of 500 mg daily, treatment should be discontinued.
Danish: Hvis der atter opstår levertoksicitet med den reducerede dosis på 500 mg dagligt, bør behandlingen seponeres.
English: Liver metastasis was present in 11% of patients treated with ZYTIGA.
Danish: Levermetastaser forekom hos 11 % af de patienter, der fik ZYTIGA.
English: The mean half-life of abiraterone is prolonged to approximately 18 hours in subjects with mild hepatic impairment and to approximately 19 hours in subjects with moderate hepatic impairment.
Danish: Abiraterons gennemsnitlige halveringstid forlænges til ca. 18 timer hos forsøgspersoner med let nedsat leverfunktion og til ca. 19 timer hos forsøgspersoner med moderat nedsat leverfunktion.
English: ZYTIGA decreases serum testosterone and other androgens to levels lower than those achieved by the use of LHRH analogues alone or by orchiectomy.
Danish: ZYTIGA nedsætter serum-testosteron og andre androgener til lavere koncentrationer, end der opnås ved hjælp af LHRH-analoger alene eller med orkiektomi.
English: This finding is considered related to the pharmacological action of abiraterone and rat specific.
Danish: Dette fund anses for at være relateret til abiraterons farmakologiske virkning og specifikt for rotter.
English: Caution is required in treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalaemia (e.g., those on cardiac glycosides), or fluid retention (e.g., those with heart failure, severe or unstable angina pectoris, recent myocardial infarction or ventricular arrhythmia and those with severe renal impairment).
Danish: Der skal udvises forsigtighed ved behandling af patienter, hvis tilgrundliggende medicinske tilstande kan kompromitteres af blodtryksstigning, hypokaliæmi (f.eks. patienter, der får hjerteglykosider) eller væskeretention (f.eks. patienter med hjerteinsufficiens samt hos patienter med svær eller ustabil angina pectoris, nylig hjerteinfarkt eller ventrikulær arytmi eller med svært nedsat nyrefunktion).
English: High fat levels in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, rapid heart rate, severe infections called sepsis, bone fractures, indigestion, blood in urine, rash.
Danish: Højt indhold af fedt i blodet, smerter i brystet, uregelmæssig puls (atrieflimren), hjertesvigt, hurtig puls, alvorlige infektioner, som kaldes blodforgiftning (sepsis), knoglebrud, mavebesvær, blod i urinen, udslæt.