FrancophonIA/ELRC3.0 huggingface dataset:
English: Similarly, patients treated with Gazyvaro and chlorambucil lived significantly longer on average without their disease getting worse than patients treated with rituximab and chlorambucil (26.7 months versus 15.2 months).
Danish: Tilsvarende sås, at patienter, der blev behandlet med Gazyvaro og chlorambucil, gennemsnitligt levede væsentligt længere uden forværring af sygdommen end de, der blev behandlet med rituximab og chlorambucil (26,7 måneder mod 15,2 måneder).
English: Gazyvaro is used together with chlorambucil (another cancer medicine) in patients for whom the cancer medicine fludarabine is not recommended;
Danish: Gazyvaro anvendes i kombination med chlorambucil (et andet lægemiddel mod kræft) til patienter, som det ikke anbefales at behandle med fludarabin
English: It is also used with the medicine bendamustine in patients whose disease has not responded to treatment involving the medicine rituximab or whose cancer has progressed during or up to 6 months after such treatment.
Danish: Gazyvaro anvendes sammen med bendamustin til patienter, som ikke har responderet på behandling med lægemidlet rituximab, eller hvis kræft har udviklet sig i løbet af de første 6 måneder efter behandling.
English: How is Gazyvaro used?
Danish: Hvordan anvendes Gazyvaro?
English: Gazyvaro is used together with chemotherapy (other cancer medicines) in patients who have not had previous treatment for advanced FL.
Danish: Gazyvaro anvendes i kombination med kemoterapi (et andet lægemiddel mod kræft) til patienter, som ikke tidligere er behandlet for fremskredent follikulært lymfom.
English: How does Gazyvaro work?
Danish: Hvordan virker Gazyvaro?
English: CLL is a cancer of B-lymphocytes, a type of white blood cell.
Danish: Kronisk lymfatisk leukæmi er blodkræft udgående fra en type hvide blodlegemer, der kaldes B-lymfocytter.
English: The active substance in Gazyvaro, obinutuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein CD20, which is found on the surface of Blymphocytes.
Danish: Det aktive stof i Gazyvaro, obinutuzumab, er et monoklonalt antistof (et særligt protein).
English: January 2020
Danish: Januar 2020
English: UGT1A1 may have been induced as well.
Danish: UGT1A1 kan også være blevet induceret.
English: See results below (Table 2).
Danish: Se resultater nedenfor (tabel 2).
English: 2333 BE Leiden The Netherlands
Danish: 2333 BE Leiden Holland
English: (See also section 4 ‘Possible side effects').
Danish: (Se også punkt 4 ”Bivirkninger”).
English: An updated survival analysis was conducted when 784 deaths were observed.
Danish: Der blev udført en opdateret analyse af overlevelse, da 784 dødsfald var observeret.
English: Groups of medicinal products that can be affected include, but are not limited to:
Danish: De grupper af lægemidler, der kan være påvirket, omfatter, men er ikke begrænset til:
English: The clinical relevance of this observation remains unknown.
Danish: Den kliniske relevans af denne observation er ukendt.
English: Theoretically, induction of these transporters is also possible, and the net effect is presently unknown.
Danish: Teoretisk er induktion af disse transportører også mulig, og nettovirkningen er endnu ikke kendt.
English: NR = Not reached.
Danish: NR = Ikke nået.
English: Other possible side effects include:
Danish: Andre mulige bivirkninger omfatter:
English: This includes rare cases of seizure with complications leading to death.
Danish: Dette inkluderer sjældne tilfælde af anfald med komplikationer som fører til død.
English: The median duration of treatment was 9.3 months.
Danish: Median behandlingstid var 9,3 måneder.
English: At the time of the primary analysis there were 1,633 patients randomised.
Danish: På tidspunktet for den primære analyse var der 1.633 randomiserede patienter.
English: You need to know the names of the medicines you take.
Danish: Du skal kende navnene på den medicin, du tager.
English: Date of first authorisation: 21 June 2013
Danish: Dato for første markedsføringstilladelse: 21. juni 2013
English: Date of latest renewal: 8 February 2018
Danish: Dato for seneste fornyelse: 8. februar 2018
English: No overall differences in safety or effectiveness were observed between these elderly patients and younger patients.
Danish: Der observeredes ingen forskelle i sikkerhed eller effekt mellem ældre og yngre patienter.
English: - Xtandi can be taken with or without food.
Danish: Xtandi kan tages med eller uden mad.
English: Based on Kaplan-Meier estimates.
Danish: Baseret på Kaplan-Meier-estimater.
English: Medicinal products which prolong the QT interval
Danish: Lægemidler, som forlænger QT-intervallet
English: Therefore, in the three studies it was recommended that patients be maintained on their study treatments until discontinuation criteria were met as specified below for each study.
Danish: Det blev derfor i de tre studier anbefalet, at patienterne fortsatte med deres studiebehandling, indtil ophørskriterierne var opfyldt som specificeret nedenfor for hvert enkelt studie.
English: There is also a risk of increased formation of active metabolites.
Danish: Der er også risiko for øget dannelse af aktive metabolitter.
English: In addition to the co-primary efficacy endpoints, statistically significant improvements were also demonstrated in the following prospectively defined endpoints.
Danish: Foruden de co-primære effektendepunkter blev der endvidere påvist statistisk signifikante forbedringer i følgende prospektivt definerede endepunkter:
English: Results from this analysis were consistent with those from the interim analysis (Table 3, Figure 4).
Danish: Resultaterne fra denne analyse var i overensstemmelse med resultaterne fra interimanalysen (tabel 3, figur 4).
English: ‡ Includes all preferred terms with the word ‘fracture' in bones.
Danish: ‡ Omfatter alle foretrukne termer med ordet ”fraktur” i skelettet.
English: The reduction in plasma concentrations can be substantial, and lead to lost or reduced clinical effect.
Danish: Reduktionen i plasmakoncentrationer kan være væsentlig og medføre tabt eller nedsat klinisk effekt.
English: The median was not reached in either treatment group and neither analysis showed a statistically significant difference between treatment arms.
Danish: Medianen blev ikke nået i begge behandlingsgrupper og ingen analyse viste en statistisk signifikant forskel mellem behandlingsarme.
English: In the event of an overdose, treatment with enzalutamide should be stopped and general supportive measures initiated taking into consideration the half-life of 5.8 days.
Danish: I tilfælde af overdosering bør behandling med enzalutamid afbrydes og generelle understøttende foranstaltninger initieres under hensyntagen til halveringstiden på 5,8 dage.
English: This should be taken into account if Xtandi is prescribed in these patients.
Danish: Dette skal tages i betragtning, hvis Xtandi ordineres til disse patienter.
English: Based on a mass balance study in humans, oral absorption of enzalutamide is estimated to be at least 84.2%.
Danish: Baseret på et massebalancestudie hos mennesker vurderes den orale absorption af enzalutamid at være mindst 84,2 %.
English: Maximum plasma concentrations (Cmax) of enzalutamide in patients are observed 1 to 2 hours after administration.
Danish: De maksimale plasmakoncentrationer (Cmax) af enzalutamid hos patienter observeres 1 til 2 timer efter administration.
English: Most patients in the controlled clinical trials (> 74%) were Caucasian.
Danish: De fleste patienter i de kontrollerede kliniske studier (>74 %) var kaukasiere.
English: These medicines may influence the effect of Xtandi, or Xtandi may influence the effect of these medicines.
Danish: Disse former for medicin kan påvirke virkningen af Xtandi, eller Xtandi kan påvirke virkningen af disse former for medicin.
English: Interactions with certain medicinal products that are eliminated through metabolism or active transport are expected.
Danish: Der forventes interaktioner med visse lægemidler, der elimineres ved metabolisering eller ved aktiv transport.
English: Co-administration with warfarin and coumarin-like anticoagulants should be avoided.
Danish: Samtidig administration af warfarin og coumarinlignende antikoagulantia bør undgås.
English: Although there was a limited response in some patients from treatment with enzalutamide after abiraterone, the reason for this finding is currently unknown.
Danish: Selv om der hos nogle patienter var et begrænset respons fra behandling med enzalutamid efter abirateron, er årsagen til dette fund på nuværende tidspunkt ukendt.
English: P-gp substrates
Danish: P-gp-substrater
English: The active metabolite is 95% bound to plasma proteins.
Danish: Den aktive metabolit bindes 95 % til plasmaproteiner.
English: Xtandi is a medicine that works by blocking the activity of hormones called androgens (such as testosterone).
Danish: Xtandi er et lægemiddel, som virker ved at blokere aktiviteten af de hormoner, som kaldes androgener (såsom testosteron).
English: Patients with serum creatinine > 177 μmol/L (2 mg/dL) were excluded from clinical trials.
Danish: Patienter med serumkreatinin >177 μmol/l (2 mg/dl) blev udelukket fra kliniske studier.
English: Xtandi is indicated for:
Danish: Xtandi er indiceret til:
English: The radioactivity in the fetus decreased to 0.08 times the maximum concentration at 72 hours after administration.
Danish: Radioaktiviteten i fosteret faldt til 0,08 gange maksimumkoncentrationen 72 timer efter administration.
English: * Spontaneous reports from post-marketing experience
Danish: * Spontane indberetninger efter markedsføring
English: There were no other important changes in clinical pathology or histopathology in any other organ system, including the liver, in either species.
Danish: Der var ingen andre væsentlige ændringer i den kliniske patologi eller histopatologi for noget andet organsystem, herunder leveren, hos nogen af arterne.
English: The volume of distribution of enzalutamide is greater than the volume of total body water, indicative of extensive extravascular distribution.
Danish: Distributionsvolumenet for enzalutamid er større end kroppens totale vandvolumen, hvilket indikerer omfattende ekstravaskulær distribution.
English: Changes in the reproductive organs in both species were consistent with the pharmacological activity of enzalutamide and reversed or partially resolved after an 8-week recovery period.
Danish: Ændringer i de reproduktive organer hos begge arter var i overensstemmelse med den farmakologiske aktivitet af enzalutamid og var reverseret eller delvist forsvundet efter en 8-ugers restitutionsperiode.
English: Patients should be advised of the potential risk of experiencing a psychiatric or neurological event while driving or operating machines.
Danish: Patienter bør advares om den potentielle risiko for at opleve en psykiatrisk eller neurologisk hændelse når de fører motorkøretøj eller betjener maskiner.
English: - If you are pregnant or may become pregnant (see ‘Pregnancy, breast-feeding and fertility')
Danish: hvis du er gravid eller i den fødedygtige alder (se "Graviditet, amning og frugtbarhed")
English: The study design could neither identify the patients who are likely to benefit, nor the order in which enzalutamide and abiraterone should be optimally sequenced.
Danish: Studiedesignet kunne hverken identificere hvilke patienter, behandlingen sandsynligvis vil gavne, eller den rækkefølge, hvori enzalutamid og abirateron optimalt bør administreres.
English: At study entry, 41% of randomised patients had PSA progression only, whereas 59% of patients had radiographic progression.
Danish: Ved indtrædelse i studiet havde 41 % af de randomiserede patienter kun PSA-progression, mens 59 % af patienterne havde radiografisk progression.
English: Enzalutamide is 97% to 98% bound to plasma proteins, primarily albumin.
Danish: Enzalutamid bindes 97 % til 98 % til plasmaproteiner, primært albumin.
English: Xtandi is for oral use.
Danish: Xtandi er til oral anvendelse.
English: The final clinical study report should be submitted by.
Danish: Den finale kliniske studierapport skal indsendes:
English: - Do not take a double dose to make up for the dose you forgot.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Analysis of rPFS utilised centrally-reviewed radiographic assessment of progression.
Danish: Analysen af rPFS benyttede centralt bedømte radiografiske vurderinger af progression.
English: When taken at the same time as Xtandi, these medicines may increase the risk of a seizure:
Danish: Når de samtidig tages med Xtandi, kan disse former for medicin øge risikoen for et krampeanfald:
English: ECOG: Eastern Cooperative Oncology Group; BPI-SF: Brief Pain Inventory-Short Form; PSA: Prostate Specific Antigen
Danish: ECOG: Eastern Cooperative Oncology Group, BPI-SF: Brief Pain Inventory-Short Form, PSA: Prostataspecifikt antigen
English: - Swallow the tablets whole with water.
Danish: Synk tabletterne hele med vand.
English: Common: anxiety Uncommon: visual hallucination
Danish: Almindelig: Angst Ikke almindelig: Visuelle hallucinationer
English: Benign Leydig cell tumours are expected based on the pharmacological properties of this antiandrogen drug and not considered relevant to humans.
Danish: Benigne Leydigs celle-tumorer er forventet baseret på de farmakologiske egenskaber af dette antiandrogene lægemiddel, og anses ikke som relevant for mennesker.
English: Seizures are more likely if you take more than the recommended dose of this medicine, if you take certain other medicines, or if you are at higher than usual risk of seizure.
Danish: Sandsynligheden for krampeanfald øges, hvis du tager mere end den anbefalede dosis af dette lægemiddel, hvis du tager visse andre lægemidler, eller hvis din risiko for krampeanfald er større end den sædvanlige risiko.
English: There is no antidote for enzalutamide.
Danish: Der findes ingen antidot til enzalutamid.
English: Your doctor may decide that you should stop taking Xtandi.
Danish: Lægen kan beslutte, at du skal stoppe med at tage Xtandi.
English: If you have a seizure, worsening headache, confusion, blindness or other vision problems, please contact your doctor as soon as possible.
Danish: Hvis du får krampeanfald, hovedpine, der bliver værre, forvirring, blindhed eller andre synsproblemer, skal du hurtigst muligt kontakte din læge.
English: Fifty-one percent (51%) of patients were on bisphosphonates at baseline.
Danish: 51 % af patienterne var på bisphosphonater ved baseline.
English: This medicine contains 57.8 mg sorbitol (a type of sugar) per soft capsule.
Danish: Dette lægemiddel indeholder 57,8 mg sorbitol (en form for sukker) pr. bløde kapsel.
English: - This medicine could possibly have an effect on male fertility.
Danish: Dette lægemiddel kan muligvis påvirke mænds frugtbarhed.
English: - Swallow the soft capsules whole with water.
Danish: Synk de bløde kapsler hele med vand.
English: Your doctor may also prescribe other medicines while you are taking Xtandi.
Danish: Din læge kan også ordinere anden medicin samtidig med, at du tager Xtandi.
English: All patients continued on a LHRH analogue or had prior bilateral orchiectomy.
Danish: Alle patienter fortsatte med en LHRH-analog eller havde tidligere fået foretaget bilateral orkiektomi.
English: If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose.
Danish: Hvis en patient glemmer en dosis en hel dag, skal behandlingen genoptages den følgende dag med den sædvanlige daglige dosis.
English: There are insufficient data to evaluate potential differences in the pharmacokinetics of enzalutamide in other races.
Danish: Der var utilstrækkelige data til at evaluere potentielle forskelle i enzalutamids farmakokinetik hos andre racer.
English: Additional secondary endpoints included time to first use of cytotoxic chemotherapy and chemotherapy-free survival.
Danish: Yderligere sekundære endepunkter inkluderede tid til første brug af cytotoksisk kemoterapi og kemoterapifri overlevelse.
English: Leydig cell hypertrophy and/or hyperplasia were observed in mice (4 weeks) and dogs (39 weeks).
Danish: Leydigcellehypertrofi og/eller -hyperplasi blev observeret hos mus (4 uger) og hunde (39 uger).
English: Despite low or even undetectable levels of serum androgen, androgen receptor signalling continues to promote disease progression.
Danish: På trods af lave eller endda upåviselige niveauer af serumandrogen fremmer androgenreceptorsignalering fortsat sygdomsprogression.
English: P-value is derived from an unstratified log-rank test.
Danish: P-værdien er afledt fra en ikke-stratificeret log-rank-test
English: 112 soft capsules
Danish: 112 bløde kapsler
English: A condom is required during and for 3 months after treatment with enzalutamide if the patient is engaged in sexual activity with a pregnant woman.
Danish: Der skal anvendes kondom under og i 3 måneder efter behandling med enzalutamid, hvis patienten er seksuelt aktiv med en gravid kvinde.
English: There was no protein binding displacement between enzalutamide and other highly bound medicinal products (warfarin, ibuprofen and salicylic acid) in vitro.
Danish: Der var ingen proteinbindingsfortrængning mellem enzalutamid og andre stærkt bundne lægemidler (warfarin, ibuprofen og salicylsyre) in vitro.
English: EU/1/13/846/002 (film-coated tablet 40 mg) EU/1/13/846/003 (film-coated tablet 80 mg)
Danish: EU/1/13/846/002 (filmovertrukken tablet 40 mg) EU/1/13/846/003 (filmovertrukken tablet 80 mg)
English: The HR is relative to placebo with < 1 favouring enzalutamide.
Danish: HR står i forhold til placebo med < 1 favoriserende enzalutamid.
English: Based on pharmacokinetic data from studies in Japanese and Chinese patients with prostate cancer, there were no clinically relevant differences in exposure among the populations.
Danish: Farmakokinetiske data fra studier med japanske og kinesiske patienter med prostatacancer viste ingen klinisk relevante forskelle i eksponering mellem populationerne.
English: You should not start or stop taking any medicine before you talk with the doctor that prescribed Xtandi.
Danish: Du bør ikke begynde på eller holde op med at tage anden medicin, før du har talt med lægen, der udskrev Xtandi til dig.
English: The other ingredients of the film-coated tablets are:
Danish: Øvrige indholdsstoffer i de filmovertrukne tabletterer:
English: The AUC and Cmax of caffeine decreased by 11% and 4% respectively.
Danish: AUC og Cmax for koffein blev reduceret med henholdsvis 11 % og 4 %.
English: Recent cardiovascular disease
Danish: Nylig kardiovaskulær sygdom
English: Most patients (approximately 71%) in the study were Caucasian; 16% were Asian and 2% were Black.
Danish: De fleste patienter (ca. 71 %) i studiet var kaukasiere; 16 % var asiatiske og 2 % var sorte.
English: Do not take any soft capsule that is leaking, damaged, or shows signs of tampering.
Danish: Tag ikke eventuelt bløde kapsler, som er utætte, beskadigede eller viser tegn på manipulation.
English: With daily oral administration, enzalutamide accumulates approximately 8.3-fold relative to a single dose.
Danish: Ved daglig oral administration akkumuleres enzalutamid med en faktor ca. 8,3 i forhold til en enkeltdosis.
English: This medicine contains less than 1 mmol sodium (less than 23 mg) per film-coated tablet, that is to say essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (mindre end 23 mg) pr. filmovertrukne tablet, dvs. den er i det væsentlige natriumfri.
English: The soft capsules should not be dissolved or opened.
Danish: De bløde kapsler bør ikke opløses eller åbnes.
English: If you are allergic to enzalutamide, this may result in a rash or swelling of the face, tongue, lip or throat.
Danish: Hvis du er allergisk over for enzalutamid, kan det medføre udslæt eller hævelse af ansigtet, tungen, læberne eller svælget.
English: Changes in PSA serum concentration independently do not always predict clinical benefit.
Danish: Ændring i PSA-serumkoncentrationen alene er ikke altid en indikator for en klinisk gavnlig effekt.
English: If their therapeutic effect is of large importance to the patient, and dose adjustments are not easily performed based on monitoring of efficacy or plasma concentrations, these medicinal products are to be avoided or used with caution.
Danish: Hvis den terapeutiske virkning har stor betydning for patienten og der ikke nemt kan foretages dosisjusteringer på baggrund af monitorering af effekt eller plasmakoncentrationer, skal den type lægemidler undgås eller anvendes med forsigtighed.
English: • the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Danish: • behandling af voksne mænd med metastatisk CRPC, hvis sygdom er progredieret under eller efter docetaxelbehandling.
English: Other important adverse reactions include fall, cognitive disorder, and neutropenia.
Danish: Andre vigtige bivirkninger inkluderer fald, kognitiv forstyrrelse og neutropeni.
English: Posterior reversible encephalopathy syndrome
Danish: Posteriort reversibelt encefalopati-syndrom
English: In clinical trials, Xtandi was administered without regard to food.
Danish: I kliniske studier blev Xtandi administreret uden hensyntagen til mad.
English: The decision to continue treatment in patients who develop seizure should be taken case by case.
Danish: Beslutningen om at fortsætte behandlingen af patienter, der udvikler krampeanfald, skal tages fra sag til sag.
English: No studies to evaluate the effects of enzalutamide on the ability to drive and use machines have been conducted.
Danish: Der er ikke udført studier til vurdering af virkningerne af enzalutamid på evnen til at føre motorkøretøj og betjene maskiner.
English: The safety and efficacy of concomitant use of Xtandi with cytotoxic chemotherapy has not been established.
Danish: Sikkerheden og effekten af samtidig anvendelse af Xtandi og cytotoksisk kemoterapi er ikke fastslået.
English: P-value1
Danish: P-værdi1
English: The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers.
Danish: Der er mistanke om, at risikoen for leverskader efter administration af paracetamol er højere hos patienter, der samtidig behandles med enzyminduktorer.
English: In preclinical studies, the absorption of enzalutamide was increased when dissolved in caprylocaproyl macrogolglycerides.
Danish: I prækliniske studier blev absorptionen af enzalutamid øget, når det blev opløst i caprylcaproylmacrogolglycerider.
English: The AUC of pioglitazone increased by 20% while Cmax decreased by 18%.
Danish: AUC for pioglitazon blev forøget med 20 %, mens Cmax faldt med 18 %.
English: PRES is a rare, reversible, neurological disorder which can present with rapidly evolving symptoms including seizure, headache, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension.
Danish: PRES er en sjælden, reversibel, neurologisk lidelse, der kan vise sig med symptomer, der udvikler sig hurtigt, herunder krampeanfald, hovedpine, forvirring, blindhed og andre visuelle og neurologiske forstyrrelser, med eller uden ledsagende hypertension.
English: A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Danish: En diagnose med PRES kræver bekræftelse ved scanning af hjernen, fortrinsvis magnetisk resonans (MR)-scanning.
English: It is not known if enzalutamide is present in human milk.
Danish: Det vides ikke, om enzalutamid udskilles i human mælk.
English: Caution is required in patients with severe renal impairment as enzalutamide has not been studied in this patient population.
Danish: Forsigtighed er påkrævet hos patienter med svært nedsat nyrefunktion, da enzalutamid ikke er undersøgt i denne patientpopulation.
English: Xtandi contains sorbitol
Danish: Xtandi indeholder sorbitol
English: There are no human data on the use of Xtandi in pregnancy and this medicinal product is not for use in women of childbearing potential.
Danish: Der er ingen humane data fra anvendelse af Xtandi under graviditet, og dette lægemiddel er ikke beregnet til kvinder i den fertile alder.