FrancophonIA/ELRC3.0 huggingface dataset:
English: Distribution The plasma protein binding of
Danish: Fordeling Plasmaproteinbindingen af
English: Interactions with other medicinal products
Danish: Interaktion med andre lægemidler
English: This medicine is not for use in children and adolescents.
Danish: Dette lægemiddel er ikke beregnet til børn og unge.
English: It is used to treat prostate cancer in adult men that has spread to other parts of the body.
Danish: Det anvendes til at behandle voksne mænd med prostatacancer, som har spredt sig til andre dele af kroppen.
English: The active substance, abiraterone, shows an environmental risk for the aquatic environment, especially to fish.
Danish: Det aktive stof, abirateron, udgør en miljørisiko for vandmiljøet, især for fisk.
English: The planned final analysis for OS was conducted after 741 deaths were observed (median follow up of 49 months).
Danish: Den planlagte endelige analyse af OS blev gennemført, efter at der var observeret 741 dødsfald (median opfølgningstid var 49 måneder).
English: These may be signs that the level of potassium in your blood is low.
Danish: Dette kan være tegn på, at blodets indhold af kalium er lavt.
English: Study treatments were discontinued at the time of unequivocal clinical progression.
Danish: Studiebehandlingen blev seponeret på det tidspunkt, hvor der var utvetydig klinisk progression.
English: - in combination with Ra-223 (which is used to treat prostate cancer).
Danish: - i kombination med Ra-223 (som anvendes til behandling af prostatacancer).
English: Patients were not required to show disease progression on docetaxel, as toxicity from this chemotherapy may have led to discontinuation.
Danish: Det blev ikke krævet, at patienter skulle vise sygdomsprogression på docetaxel, da toksicitet fra denne kemoterapi kan have ført til seponering.
English: ZYTIGA must not be given in combination with Ra-223 due to a possible increase in the risk of bone fracture or death.
Danish: ZYTIGA må ikke gives i kombination med Ra-223 på grund af en mulig forøgelse af risikoen for knoglebrud eller dødsfald.
English: Lung irritation (also called allergic alveolitis).
Danish: Lungeirritation (også kaldet allergisk alveolitis).
English: - The amount of prednisone or prednisolone you take may need to change if you have a medical emergency.
Danish: - Den mængde prednison eller prednisolon, som du får, skal måske ændres hvis der opstår en akut medicinsk tilstand.
English: This may lead to side effects or to ZYTIGA not working as well as it should.
Danish: Det kan medføre bivirkninger eller resultere i, at ZYTIGA ikke virker så godt, som det skal.
English: The median age of enrolled patients was 69 years (range 39-95).
Danish: Median alder for de deltagende patienter var 69 år (interval 39-95).
English: Therefore, in all studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Danish: Derfor anbefaledes det i alle studier, at patienterne fortsatte med deres studiebehandling, indtil ophørskriteriet var opfyldt som angivet herunder for hvert studie.
English: Date of latest renewal: 26 May 2016
Danish: Dato for første markedsføringstilladelse: 05. september 2011 Dato for seneste fornyelse: 26. maj 2016
English: A planned interim analysis (IA) for OS was conducted after 333 deaths were observed.
Danish: Der blev udført en planlagt interimanalyse af OS, efter at der var observeret 333 dødsfald.
English: A higher incidence of hypertension and hypokalemia was observed in the hormone sensitive population (study 3011).
Danish: Der sås en højere forekomst af hypertension og hypokaliæmi hos den hormonfølsomme population (studie 3011).
English: The safety of re-treatment in such patients is unknown.
Danish: Sikkerheden ved at genoptage behandlingen hos disse patienter er ikke klarlagt.
English: Given the normal variation in the content and composition of meals, taking ZYTIGA with meals has the potential to result in highly variable exposures.
Danish: I betragtning af den normale variation i måltiders indhold og sammensætning kan indtagelse af ZYTIGA i forbindelse med et måltid potentielt resultere i stærkt variabel eksponering.
English: Androgen deprivation treatment may increase the risk of heart rhythm problems.
Danish: Androgen deprivationsbehandling kan øge risikoen for problemer med hjerterytmen.
English: Other side effects include:
Danish: Andre bivirkninger:
English: Adverse reaction and frequency
Danish: Bivirkning og hyppighed
English: The ECOG performance status was 0 or 1 for 97% of patients.
Danish: ECOG-performancestatus var 0 eller 1 for 97 % af patienterne.
English: Titanium dioxide
Danish: Titandioxid
English: Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (frequency cannot be estimated from the available data).
Danish: Hyppigheden klassificeres som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: - Women who are pregnant or who may be pregnant should wear gloves if they need to touch or handle ZYTIGA.
Danish: - Kvinder, som er gravide, eller kvinder, som måske kan være gravide, skal anvende handsker, hvis det er nødvendigt, at de rører ved eller håndterer ZYTIGA.
English: In all animal toxicity studies, circulating testosterone levels were significantly reduced.
Danish: I alle toksicitetsstudier hos dyr var koncentrationen af cirkulerende testosteron signifikant reduceret.
English: Analysis of rPFS utilised centrally-reviewed radiographic assessment of progression.
Danish: Analyser af rPFS benyttede centralt opgjort radiografisk evaluering af progression.
English: ZYTIGA is for oral use.
Danish: ZYTIGA er til oral anvendelse.
English: Do not take this medicine if any of the above apply to you.
Danish: Tag ikke dette lægemiddel, hvis noget af dette gælder for dig.
English: Use with Spironolactone
Danish: Anvendelse sammen med spironolacton
English: Patients with active or symptomatic viral hepatitis were excluded from clinical trials; thus, there are no data to support the use of ZYTIGA in this population.
Danish: Patienter med aktiv eller symptomatisk viral hepatitis var ekskluderet fra kliniske studier, og der foreligger således ingen data, der understøtter brug af ZYTIGA hos denne population.
English: The mechanism for hepatotoxicity is not understood.
Danish: Mekanismen bag hepatotoksicitet er ikke klarlagt.
English: Contraception in males and females
Danish: Kontraception hos mænd og kvinder
English: The apparent volume of distribution is approximately 5,630 l, suggesting that abiraterone extensively distributes to peripheral tissues.
Danish: Fordelingsvolumen er ca. 5.630 l, hvilket tyder på, at abirateron fordeles i udstrakt grad til de perifere væv.
English: Table 1: Adverse reactions identified in clinical studies and post-marketing System Organ Class
Danish: Tabel 1: Bivirkninger påvist i kliniske studier og efter markedsføring Systemorganklasse
English: Before treatment with ZYTIGA, cardiac failure should be treated and cardiac function optimised.
Danish: Før behandling med ZYTIGA bør hjerteinsufficiens behandles og hjertefunktionen optimeres.
English: Treatment with ZYTIGA should not be reinitiated until symptoms of the toxicity have resolved to Grade 1 or baseline.
Danish: Behandling med ZYTIGA bør ikke genoptages, før toksicitetssymptomerne er faldet til grad 1 eller baseline-niveau.
English: The investigator radiographic review of rPFS performed as a follow up sensitivity analysis is presented in Table 5 and Figure 4.
Danish: Investigators radiografiske evaluering af rPFS udført som en opfølgende sensibilitetsanalyse ses i tabel 5 og figur 4.
English: The use of ZYTIGA in combination with a glucocorticoid could increase this effect.
Danish: Anvendelse af ZYTIGA i kombination med et glukokortikoid kan muligvis øge denne virkning.
English: The European Medicines Agency has waived the obligation to submit the results of studies with ZYTIGA in all subsets of the paediatric population in advanced prostate cancer.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med ZYTIGA i alle undergrupper af den pædiatriske population med avanceret prostatacancer.
English: The Eastern Cooperative Oncology Group (ECOG) performance status was 0 for 76% of patients, and 1 for 24% of patients in both arms.
Danish: Eastern Cooperative Oncology Group- (ECOG-) performance status var 0 for 76 % patienter og 1 for 24 % patienter i begge arme.
English: Following oral administration of abiraterone acetate in the fasting state, the time to reach maximum plasma abiraterone concentration is approximately 2 hours.
Danish: Efter oral administration af abirateronacetat i fastende tilstand er tiden til maksimal plasmakoncentration ca. 2 timer.
English: ZYTIGA has no or negligible influence on the ability to drive and use machines.
Danish: ZYTIGA påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: This medicinal product should be prescribed by an appropriate healthcare professional.
Danish: Dette lægemiddel skal ordineres af en passende kvalificeret læge.
English: All treatment-related hormonal changes reversed or were shown to be resolving after a 4-week recovery period.
Danish: Alle behandlingsrelaterede hormonelle forandringer var reverseret eller i færd med at forsvinde efter en 4ugers periode uden behandling.
English: The AUC24 for dextrorphan, the active metabolite of dextromethorphan, increased approximately 33%.
Danish: AUC24 for dextrorphan, dextromethorphans aktive metabolit, steg med ca. 33 %.
English: The primary efficacy endpoint was overall survival.
Danish: Det primære effektendepunkt var total overlevelse.
English: - The tablets are provided in a plastic bottle with a child-resistant closure.
Danish: - Tabletterne udleveres i en plastbeholder med børnesikret lukke.
English: Injury, poisoning and procedural complications common: fractures**
Danish: Traumer, forgiftninger og behandlingskomplikationer almindelige: frakturer**
English: Women who are or may be pregnant should not handle ZYTIGA without gloves.
Danish: Kvinder, som er eller kan være gravide, bør ikke håndtere ZYTIGA uden handsker.
English: Radiographic progression-free survival was defined as the time from randomization to the occurrence of radiographic progression or death from any cause.
Danish: Radiografisk progressionsfri overlevelse blev defineret som tiden fra randomisering til forekomst af radiografisk progression eller død uanset årsag.
English: The use of glucocorticoids could increase hyperglycaemia, therefore blood sugar should be measured frequently in patients with diabetes.
Danish: Anvendelse af glukokortikoider kan forårsage hyperglykæmi, og blodglucose bør måles hyppigt hos patienter med diabetes.
English: Taking this medicine - Take this medicine by mouth.
Danish: Sådan skal du tage medicinen - Dette lægemiddel skal indtages gennem munden.
English: Patients with visceral metastases were excluded.
Danish: Patienter med viscerale metastaser blev ekskluderet.
English: Effects on the external genitalia were observed though abiraterone acetate was not teratogenic.
Danish: Der blev observeret virkninger på de ydre genitalier, selv om abirateronacetat ikke var teratogent.
English: Study 302 (chemotherapy naïve patients)
Danish: Studie 302 (kemoterapinaive patienter)
English: Hypertension, hypokalaemia and fluid retention should be corrected and controlled.
Danish: Hypertension, hypokaliæmi og væskeretention bør korrigeres og kontrolleres.
English: This medicinal product may pose a risk to the aquatic environment (see section 5.3).
Danish: Dette lægemiddel kan udgøre en risiko for vandmiljøet (se pkt.
English: ZYTIGA should be used with caution in patients with a history of cardiovascular disease.
Danish: ZYTIGA bør anvendes med forsigtighed til patienter med en anamnese med kardiovaskulær sygdom.
English: Paediatric population There is no relevant use of ZYTIGA in the paediatric population.
Danish: Pædiatrisk population Der er ingen relevante indikationer for ZYTIGA i den pædiatriske population.
English: Aside from reproductive organ changes seen in all animal toxicology studies, non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Danish: Bortset fra forandringerne i kønsorganer, der opstod i alle toksikologistudier hos dyr, viser de prækliniske data ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet og carcinogent potentiale.
English: Abiraterone acetate was not carcinogenic in a 6-month study in the transgenic (Tg.rasH2) mouse.
Danish: Abirateronacetat var ikke karcinogent i et 6-måneders studie i transgene (Tg.rasH2) mus.
English: The radiographic progression and death are considered in defining the rPFS event.
Danish: Der er taget højde for den radiografiske progression og dødsfald i definitionen af rPFS-hændelsen.
English: - This medicine may cause harm to the unborn child if it is taken by women who are pregnant.
Danish: - Dette lægemiddel kan skade fostret, hvis det tages af kvinder, som er gravide.
English: Stop taking ZYTIGA and see a doctor immediately if you notice any of the following: - Muscle weakness, muscle twitches or a pounding heart beat (palpitations).
Danish: Hold op med at tage ZYTIGA, og kontakt straks en læge, hvis du bemærker følgende: - Muskelsvaghed, muskeltrækninger eller hjertebanken (palpitationer).
English: - Do not use this medicine after the expiry date which is stated on the carton and the bottle label.
Danish: - Brug ikke lægemidlet efter den udløbsdato, der står på æsken og på etiketten på beholderen.
English: 120 tablets.
Danish: 120 tabletter.
English: - You need to take prednisone or prednisolone every day while you are taking ZYTIGA.
Danish: - Du skal tage prednison eller prednisolon dagligt, mens du tager ZYTIGA.
English: This improvement was demonstrated even though 44% of patients in the placebo arm received ZYTIGA as subsequent therapy.
Danish: Denne forbedring påvistes, selv om 44 % af patienterne i placeboarmen efterfølgende fik ZYTIGA.
English: Blood monitoring
Danish: Blodprøvekontrol
English: Only patients with a baseline pain score of ≥ 4 and at least one post-baseline pain score were analysed (N = 512) for pain palliation.
Danish: Kun patienter med smertescore ved baseline ≥ 4 og mindst én smertescore efter baseline blev analyseret (N=512) for smertelindring.
English: PSA serves as a biomarker in patients with prostate cancer.
Danish: PSA fungerer som biomarkør hos patienter med prostatacancer.
English: Mineralocorticoid reactions generally were able to be successfully managed medically.
Danish: Bivirkningerne af mineralokortikoider kunne generelt behandles medicinsk.
English: There are no human data on the use of ZYTIGA in pregnancy and this medicinal product is not for use in women of childbearing potential.
Danish: Der foreligger ingen humane data om anvendelse af ZYTIGA under graviditet, og dette lægemiddel er ikke beregnet til fertile kvinder.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for abiraterone, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for abirateron er CHMP nået frem til følgende videnskabelige konklusioner:
English: Most cases developed within the first 6 months of treatment and recovered after ZYTIGA withdrawal.
Danish: De fleste tilfælde indtraf inden for de første 6 behandlingsmåneder og normaliseredes efter seponering af ZYTIGA.
English: Contains lactose and sodium.
Danish: Indeholder lactose og natrium.
English: - Taking ZYTIGA with food may cause side effects.
Danish: - Indtagelse af ZYTIGA sammen med mad kan give bivirkninger.
English: Prior use of ketoconazole
Danish: Tidligere anvendelse af ketoconazol
English: Patients were maintained on study treatments until there was PSA progression (confirmed 25% increase over the patient's baseline/nadir) together with protocol-defined radiographic progression and symptomatic or clinical progression.
Danish: Patienter blev fastholdt på studiemedicin, indtil der var PSA-progression (bekræftet 25 % stigning over patientens baseline/nadir) sammen med protokoldefineret radiografisk progression og symptomatisk eller klinisk progression.
English: ZYTIGA contains lactose and sodium - ZYTIGA contains lactose (a type of sugar).
Danish: ZYTIGA indeholder lactose og natrium - ZYTIGA indeholder lactose (sukkerart).
English: It is recommended that subsequent treatment with Ra-223 is not initiated for at least 5 days after the last administration of ZYTIGA in combination with prednisone/prednisolone.
Danish: Efterfølgende behandling med Ra-223 må ikke påbegyndes før mindst 5 dage efter den sidste administration af ZYTIGA i kombination med prednison/prednisolon.
English: ZYTIGA with food - This medicine must not be taken with food (see section 3, “Taking this medicine”).
Danish: Brug af ZYTIGA sammen med mad - Dette lægemiddel må ikke tages sammen med mad (se "Sådan skal du tage medicinen" under punkt 3).
English: Survival continued to be followed after this IA.
Danish: Overlevelse blev fortsat fulgt efter denne interimanalyse.
English: Heart attack, changes in ECG - electrocardiogram (QT prolongation).
Danish: Hjerteanfald, ændringer i elektrokardiogram (QT-forlængelse i EKG).
English: AA = ZYTIGA; BPI = Brief Pain Inventory; C.I.
Danish: BPI=Brief Pain Inventory.
English: ZYTIGA may affect your liver, and you may not have any symptoms.
Danish: ZYTIGA kan påvirke leveren, uden at du får symptomer.
English: In vitro, the major metabolites abiraterone sulphate and N-oxide abiraterone sulphate were shown to inhibit the hepatic uptake transporter OATP1B1 and as a consequence it may increase the concentrations of medicinal products eliminated by OATP1B1.
Danish: Det blev påvist in vitro, at hovedmetabolitterne abirateronsulfat og N-oxidabirateronsulfat hæmmer den hepatiske optagelsestransportør OATP1B1, og som følge heraf kan øge koncentrationen af lægemidler, som elimineres af OATP1B1.
English: Fifty percent of patients had only bone metastases, an additional 31% of patients had bone and soft tissue or lymph node metastases and 19% of patients had only soft tissue or lymph node metastases.
Danish: 50 % af patienterne havde kun knoglemetastaser, yderligere 31 % patienter havde knogle- og bløddelseller lymfekirtelmetastaser, og 19 % af patienterne havde kun bløddels- eller lymfekirtelmetastaser.
English: Although these results indicate that no clinically meaningful increases in exposure are expected when ZYTIGA is combined with medicinal products that are predominantly eliminated by CYP2C8, patients should be monitored for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly.
Danish: Skønt disse resultater peger på, at der ikke kan forventes klinisk relevante stigninger i eksponeringen, når ZYTIGA kombineres med lægemidler, som overvejende elimineres af CYP2C8, skal patienterne overvåges for tegn på toksicitet, hvis et CYP2C8-substrat med et smalt terapeutisk indeks anvendes samtidigt med ZYTIGA.
English: Androgen-sensitive prostatic carcinoma responds to treatment that decreases androgen levels.
Danish: Androgen-følsomme prostatakarcinomer responderer på behandling, der nedsætter androgenniveauet.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighed er bivirkningerne opstillet med faldende sværhedsgrad.
English: The changes in the reproductive organs and androgen-sensitive organs are consistent with the pharmacology of abiraterone.
Danish: Forandringerne i forplantningsorganer og androgen-følsomme organer er overensstemmende med abiraterons farmakologiske virkninger.
English: When you are taking this medicine, your doctor will check your blood periodically to look for any effects on your liver.
Danish: Når du tager dette lægemiddel, skal du have taget jævnlige blodprøver hos lægen for at få kontrolleret, om medicinen påvirker din lever.
English: The time to PSA progression was approximately doubled with ZYTIGA treatment (HR = 0.488).
Danish: Tiden til PSA-progression var omtrent fordoblet med ZYTIGAbehandling (HR=0,488).
English: Pharmacotherapeutic group: endocrine therapy, other hormone antagonists and related agents, ATC code: L02BX03
Danish: Farmakoterapeutisk klassifikation: Endokrin terapi, andre hormonantagonister og lignende stoffer, ATC-kode: L02BX03
English: This results from the selective inhibition of the CYP17 enzyme required for androgen biosynthesis.
Danish: Det skyldes den selektive hæmning af CYP17-enzymet, som er nødvendig for androgen-biosyntesen.
English: Upon discontinuation of treatment, both patients had normalisation of their liver function tests and one patient was re-treated without recurrence of the elevations.
Danish: Efter seponering af behandlingen normaliseredes leverfunktionsprøverne hos begge patienter, og den ene patient genoptog behandlingen, uden at forhøjelserne indtraf igen.
English: Tell your doctor if you are taking any of the medicines listed above.
Danish: Fortæl det til din læge, hvis du tager nogen af de ovenstående lægemidler.
English: High-risk prognosis was defined as having at least 2 of the following 3 risk factors: (1) Gleason score of ≥8; (2) presence of 3 or more lesions on bone scan; (3) presence of measurable visceral (excluding lymph node disease) metastasis.
Danish: En højrisikoprognose var defineret som en prognose med mindst 2 af følgende 3 risikofaktorer: (1) Gleason-score på ≥ 8; (2) tilstedeværelse af 3 eller flere læsioner på knoglescanning; (3) tilstedeværelse af målbar visceral (lymfeknudesygdom var ekskluderet) metastase.
English: * Cardiac failure also includes congestive heart failure, left ventricular dysfunction and ejection fraction decreased ** Fractures includes osteoporosis and all fractures with the exception of pathological fractures Spontaneous reports from post-marketing experience
Danish: * Hjerteinsufficiens omfatter også kongestiv hjerteinsufficiens, nedsat funktion af venstre ventrikel og nedsat uddrivningsfraktion ** Frakturer omfatter osteoporose og alle former for fraktur med undtagelse af patologiske frakturer Spontane indberetninger efter markedsføring
English: Hyperglycaemia
Danish: Hyperglykæmi
English: In patients on prednisone or prednisolone who are subjected to unusual stress, an increased dose of corticosteroids may be indicated before, during and after the stressful situation.
Danish: Hos patienter, der får prednison eller prednisolon, og som er udsat for usædvanligt stress, kan der opstå behov for en øget dosis kortikosteroider før, under og efter den stressende situation.
English: The median baseline pain score, as measured by the Brief Pain Inventory Short Form (BPI-SF) was 2.0 in both the treatment and Placebo groups.
Danish: Medianen for smertescore ved baseline i Brief Pain Inventory Short Form (BPI-SF) var 2,0 i både behandlings- og placebogruppen.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendte lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: As a result, reduction in organ weights and morphological and/or histopathological changes in the reproductive organs, and the adrenal, pituitary and mammary glands were observed.
Danish: Som et resultat heraf blev der observeret reduktion af organvægt og morfologiske og/eller histopatologiske forandringer i forplantningsorganerne samt binyrer, hypofyse og brystkirtler.