FrancophonIA/ELRC3.0 huggingface dataset:
English: Febrile neutropenia has been reported in 0.9% patients receiving fulvestrant in combination with palbociclib.
Danish: Febril neutropeni blev rapporteret hos 0,9 % af patienterne, der fik fulvestrant i kombination med palbociclib.
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Danish: 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: There are isolated reports of overdose with Faslodex in humans.
Danish: Der findes enkeltstående rapporter om overdosering med Faslodex hos mennesker.
English: Administer the injection according to the local guidelines for performing large volume intramuscular injections.
Danish: Injektionen skal administreres ifølge lokale retningslinjer for intramuskulær injektion af stort volumen.
English: ORR was assessed in patients who were evaluable for response at baseline (i.e. those with measurable disease at baseline: 240 patients in the Faslodex 500 mg group and 261 patients in the Faslodex 250 mg group).
Danish: ORR blev vurderet hos patienter, som kunne evalueres for respons ved baseline (dvs. dem med sygdom, som kunne måles ved baseline: 240 patienter i Faslodex 500 mg gruppen og 261 patienter i Faslodex 250 mg gruppen).
English: Women with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Danish: Kvinder med svært nedsat leverfunktion, (Child-Pugh klasse C), blev ikke undersøgt.
English: Arteritis involving a range of different tissues was seen in some dogs after chronic (12 months) dosing.
Danish: Arteritis i forskellige væv blev observeret hos nogle hunde efter kronisk dosering (12 måneder).
English: Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Danish: Infektioner inkluderer alle PTs, som er inkluderet i systemorganklassen Infektioner og parasitære sygdomme.
English: Fertility The effects of Faslodex on fertility in humans has not been studied.
Danish: Fertilitet Faslodex' virkning på fertiliteten hos mennesker er ikke blevet undersøgt.
English: Combined analysis of both studies showed that 83% of patients who received Faslodex progressed, compared with 85% of patients who received anastrozole.
Danish: Kombineret analyse af begge studier viste, at 83% af patienterne, som fik Faslodex, progredierede i forhold til 85% af patienterne, der fik anastrozol.
English: Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint.
Danish: De sekundære endepunkter omfattede OR, CBR, OS, sikkerhed og tid indtil forværring (TTD) af smerter.
English: Seventy seven percent (77%) of the study population had estrogen receptor positive breast cancer.
Danish: 77 % af studiepopulationen havde østrogen receptor positiv brystkræft.
English: There was an increased incidence of foetal variations in rabbits (backwards displacement of the pelvic girdle and 27 pre-sacral vertebrae).
Danish: Der var en øget forekomst af foster variationer hos kaniner (forskydning bagud af bækkenringen og 27. præ-sakrale hvirvel).
English: Grade ≥ 3 n (%)
Danish: Grad ≥ 3 n (%)
English: For full instructions on the administration of Faslodex and the use of the safety needle see enclosed, Instructions for administration.
Danish: For fuldstændig instruktion vedrørende administration af Faslodex og brugen af den beskyttede kanyle, se vedlagte instruktioner vedrørende administration.
English: Table 2 reports the adverse reactions from PALOMA3.
Danish: Tabel 2 viser bivirkningerne fra PALOMA3.
English: • Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
Danish: • Parenterale væsker skal inspiceres visuelt for partikler og misfarvning forud for administration.
English: Combination therapy with palbociclib
Danish: Kombinationsbehandling med palbociclib
English: PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Antiestrogen.
Danish: PFS: Progressionsfri overlevelse; ORR: objektiv respons rate; OR: objektiv respons; CBR: klinisk gevinstrate; CB: klinisk gevinst; OS: overordnet overlevelse; K-M: Kaplan-Meier; CI: konfidensinterval; AI: Aromatasehæmmer; AE: Anti-østrogen.
English: There were no reports of Grade 4 neutropenia in the fulvestrant + placebo arm.
Danish: Der var ingen rapporteringer om grad 4 neutropeni i fulvestrant + placebo-armen.
English: The large apparent volume of distribution at steady state (Vdss) of approximately 3 to 5 l/kg suggests that distribution is largely extravascular.
Danish: Det store tilsyneladende distributionsvolumen ved steady state (Vdss) på ca. 3-5 l/kg, tyder på, at distributionen fortrinsvis sker ekstravasculært.
English: Pre/perimenopausal women received the LHRH agonist goserelin.
Danish: Præ-/perimenopausale kvinder modtog LHRH-agonisten goserelin.
English: A total of 17.1% of patients received a prior chemotherapy regimen for advanced disease; 84.2% of patients had measurable disease.
Danish: I alt 17,1 % af patienterne havde tidligere modtaget kemoterapi imod fremskreden sygdom; 84,2 % af patienterne havde målbar sygdom.
English: Time-to-Deterioration was pre-specified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores.
Danish: Tid indtil forværring blev præspecificeret som tiden mellem baseline og første forekomst af ≥10 points stigning fra baseline i score for smertesymptomer.
English: In toxicity studies with multiple intramuscular doses of fulvestrant in rats and dogs, the antiestrogenic activity of fulvestrant was responsible for most of the effects seen, particularly in the female reproductive system, but also in other organs sensitive to hormones in both sexes.
Danish: I intramuskulære flerdosis toksicitetsstudier med rotter og hunde var den antiøstrogene aktivitet af fulvestrant årsag til de fleste observerede virkninger, specielt i hunkønnenes reproduktionssystem, men også i andre organer, som hos begge køn er følsomme overfor hormoner.
English: This 12-month study investigated a range of MAS endpoints and showed a reduction in the frequency of vaginal bleeding and a reduction in the rate of bone age advancement.
Danish: Denne undersøgelse, der forløb over 12 måneder og undersøgte en række MASendepunkter, viste en reduktion i hyppigheden af vaginalblødning samt en reduktion af knoglealderens fremadskriden.
English: In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).
Danish: Det er specielt vigtigt, at du fortæller din læge, hvis du tager blodfortyndende medicin (medicin der forebygger blodpropper).
English: Listen for click and visually confirm needle tip is fully covered.
Danish: Lyt efter klik og bekræft visuelt, at kanylespidsen er helt dækket.
English: In a population pharmacokinetic analysis of data from Phase 3 studies, no difference in fulvestrant's pharmacokinetic profile was detected with regard to age (range 33 to 89 years), weight (40-127 kg) or race.
Danish: I en farmakokinetisk populationsanalyse af data fra fase 3-studier, var der ingen forskel i den farmakokinetiske profil for fulvestrant hvad angår alder (interval 33 til 89 år), vægt (40-127 kg) eller race.
English: Local reactions, including myositis and granulomata at the injection site were attributed to the vehicle but the severity of myositis in rabbits increased with fulvestrant, compared to the saline control.
Danish: Lokale reaktioner inklusive myositis og granulomata ved injektionsstedet blev tilskrevet vehiklet, men sværhedsgraden af myositis hos kaniner steg i takt med fulvestrant i forhold til saltkontrollen.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl
English: Faslodex is not recommended for use in children and adolescents as safety and efficacy have not been established in this group of patients (see section 5.1).
Danish: Faslodex anbefales ikke til børn og unge, da sikkerheden og virkningen ikke er klarlagt hos denne patientgruppe (se pkt.
English: A total of 462 patients were randomised 1:1 sequentially to receive either fulvestrant 500 mg or anastrozole 1 mg.
Danish: I alt 462 patienter blev randomiseret 1:1 sekventielt til at modtage enten fulvestrant 500 mg eller anastrozol 1 mg.
English: Includes: arthralgia, and less frequently musculoskeletal pain, myalgia and pain in extremity.
Danish: Inkluderer: artralgi og mindre hyppigt smerter i muskler og knogler, myalgi og smerter i ekstremiteterne.
English: • After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
Danish: • Efter injektion skub omgående med en enkelt finger på den assisterede vippearm for at aktivere beskyttelsesmekanismen (se figur 5).
English: If pregnancy occurs while taking Faslodex, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Danish: Hvis graviditet indtræder under Faslodexbehandlingen, skal patienten informeres om de mulige skadevirkninger på fostret og den potentielle risiko for spontan abort.
English: Animal studies suggest that no effects other than those related directly or indirectly to antiestrogenic activity were evident with higher doses of fulvestrant (see section 5.3).
Danish: Dyreforsøg tyder på, at ingen påvirkninger, udover de direkte eller indirekte relaterede til antiøstrogen aktivitet, var evidente ved højere doser af fulvestrant (se pkt.
English: Pre-filled syringes are for single use only.
Danish: Fyldte sprøjter er kun til engangsbrug.
English: In each treatment arm the majority of patients were White, had documented sensitivity to prior hormonal therapy, and were postmenopausal.
Danish: I begge behandlingsarme var størstedelen af patienterne hvide, havde dokumenteret følsomhed over for tidligere hormonbehandling og var postmenopausale.
English: Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Danish: Faslodex indeholder det aktive stof fulvestrant, som tilhører gruppen kaldet østrogen-blokkere.
English: However, as fulvestrant exposure may be increased, Faslodex should be used with caution in these patients.
Danish: Da eksponeringen af fulvestrant kan være øget, skal man anvende Faslodex med forsigtighed hos disse patienter.
English: Due to the intramuscular route of administration, Faslodex should be used with caution if treating patients with bleeding diatheses, thrombocytopenia or those taking anticoagulant treatment.
Danish: På grund af den intramuskulære administrationsvej skal Faslodex anvendes med forsigtighed ved behandling af patienter med blødningsdiatese, thrombocytopeni eller patienter i antikoagulationsbehandling.
English: Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations in gonadotropin levels caused by antiestrogens in cycling animals.
Danish: Udvikling af sådanne tumorer er i overensstemmelse med de farmakologiske endokrine feedback-ændringer i gonadotropinniveauer, forårsaget af antiøstrogener hos dyr med cyklus.
English: • Vomiting, diarrhoea, or loss of appetite*
Danish: • Opkastning, diarré eller appetitløshed*
English: This may be harmful for those suffering from alcoholism and should be taken into account in high risk groups such as patients with liver disease and epilepsy.
Danish: Skadelig for alkoholikere og bør tages i betragtning i højrisikogrupper såsom patienter med leversygdomme og epilepsi.
English: Faslodex is contraindicated in pregnancy (see section 4.3).
Danish: Faslodex er kontraindiceret under graviditet (se pkt.
English: The efficacy and safety of Faslodex (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
Danish: Sikkerheden og virkningen af Faslodex (enten som monoterapi eller i kombination med palbociclib) er ikke klarlagt hos patienter med kritisk visceral sygdom.
English: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, SK10 2NA United Kingdom
Danish: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, SK10 2NA Storbritannien
English: Environmental risk assessment studies have shown that fulvestrant may have potential to cause adverse effects to the aquatic environment (see section 6.6).
Danish: Miljørisikovurderingsstudier har vist, at fulvestrant potentielt kan medføre skadelige virkninger for vandmiljøet (se pkt.
English: Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its antiestrogenic activity, at doses similar to the clinical dose.
Danish: Fulvestrant påvirkede reproduktionen og embryo/fosterudvikling i overensstemmelse med dets antiøstrogene aktivitet, ved doser svarende til den kliniske dosis.
English: Fulvestrant has a high clearance, 11±1.7 ml/min/kg, suggesting a high hepatic extraction ratio.
Danish: Fulvestrant har en høj clearance, 11+/- 1,7 ml/min/kg, som tyder på en høj udskillelsesratio via leveren.
English: A reduction in the risk of disease progression or death in the Faslodex plus palbociclib arm was observed in all individual patient subgroups defined by stratification factors and baseline characteristics.
Danish: Der blev observeret en reduktion i risikoen for sygdomsprogression eller dødsfald i Faslodex plus palbociclib-armen i alle individuelle undergrupper af patienter defineret efter stratificeringsfaktorer og baselinekarakteristika.
English: Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis du bemærker en af følgende bivirkninger:
English: A more mature update of efficacy data is reported in Table 5.
Danish: En opdatering af effektdata er angivet i tabel 5.
English: Patients enrolled in this study had a median age of 63 years (range 36-90).
Danish: Patienterne, der deltog i dette studie, havde en medianalder på 63 år (interval 36-90).
English: Mechanism of action and pharmacodynamic effects Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.
Danish: Virkningsmekanisme og farmakodynamisk virkning Fulvestrant er en kompetitiv østrogen receptor (ER)-antagonist med en affinitet sammenlignelig med østradiol.
English: Efficacy results for the CONFIRM study are summarized in Table 3.
Danish: Effektresultater for CONFIRM-forsøget er opsummeret i tabel 3.
English: After intramuscular administration, the exposure is approximately dose-proportional in the dose range 50 to 500 mg.
Danish: Efter intramuskulær administration er eksponeringen omtrentlig dosis-proportional i dosisintervallet 50-500 mg.
English: Clear, colourless to yellow, viscous solution.
Danish: Klar, farveløs til gul, viskøs opløsning.
English: The frequencies in Table 1 were based on all reported adverse drug reactions, regardless of the investigator assessment of causality.
Danish: Frekvenserne i tabel 1 er baseret på alle indberettede bivirkninger, uden hensyn til om investigatoren mente, at der var en årsagssammenhæng.
English: The primary efficacy endpoint of the study was investigator assessed progression-free survival (PFS) evaluated according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumours).
Danish: Det primære effektmål af studiet var investigatorvurderet, progressionsfri overlevelse (PFS) evalueret ifølge RECIST 1.1 (Response Evaluation Criteria in Solid Tumours).
English: • Bruising and bleeding at the site of injection
Danish: • Blå mærker og blødning ved injektionsstedet
English: See package leaflet for information on temperature excursions.
Danish: Se indlægssedlen for information om temperaturudsving.
English: Women who have not reached menopause will also be treated with a medicine called a luteinizing hormone releasing hormone (LHRH) agonist.
Danish: Kvinder, der ikke har nået overgangsalderen, vil også blive behandlet med et lægemiddel kaldet en luteiniserende hormonfrigivende hormon (LHRH)-agonist.
English: • Hold the syringe upright on the ribbed part (C).
Danish: • Hold sprøjten lodret og hold på den riflede del (C).
English: Warning - Do not autoclave safety needle (BD SafetyGlide Shielding Hypodermic Needle) before use.
Danish: Advarsel - Den beskyttede kanyle (BD SafetyGlide Shielding Hypodermic Needle) må ikke autoklaveres forud for anvendelse.
English: Asthenia a, injection site reactions
Danish: Meget almindelig Asteni a, reaktioner ved injektionsstedet
English: Patients were well matched for baseline demographics and prognostic characteristics between the Faslodex plus palbociclib arm and the Faslodex plus placebo arm.
Danish: Patienterne var godt matchede udfra baselinedemografi og prognostiske karakteristika mellem Faslodex plus palbociclib-armen og Faslodex plus placebo-armen.
English: However, if you feel tired after treatment do not drive or use machines.
Danish: Hvis du føler dig træt efter behandling med Faslodex, bør du ikke køre bil eller betjene maskiner.
English: The median age of patients enrolled in this study was 57 years (range 29, 88).
Danish: Medianalderen for de patienter, der deltog i dette studie, var 57 år (interval 29-88).
English: A high dose of a shorter duration intramuscular injection formulation was used.
Danish: En høj dosis i en formulering med en kortere virkningstid til intramuskulær injektion blev anvendt.
English: Overall, Faslodex at the 250 mg monthly dose was at least as effective as anastrozole in terms of progression-free survival, objective response, and time to death.
Danish: Overordnet var Faslodex, med en dosis på 250 mg månedligt, mindst lige så effektiv som anastrozol, når man så på progressionsfri overlevelse, objektivt respons og tid indtil død.
English: There are no long-term data on the effect of fulvestrant on bone.
Danish: Der er ingen langtidsdata vedrørende effekten af fulvestrant på knogler.
English: ADR was not observed in FALCON.
Danish: Der blev ikke observeret bivirkninger i FALCON.
English: Of the 65 patients in the Faslodex arm, 40% (26/65) of patients reported joint and musculoskeletal pain within the first month of treatment, and 66.2% (43/65) of patients within the first 3 months of treatment.
Danish: Ud af de 65 patienter i Faslodex-armen rapporterede 40 % (26/65) af patienterne om smerter i led, muskler og knogler inden for den første måneds behandling, og 66,2 % (43/65) af patienterne inden for de første 3 måneders behandling.
English: Median duration of exposure to palbociclib in the fulvestrant + palbociclib arm was 10.8 months.
Danish: Medianvarigheden af eksponering for palbociclib i fulvestrant + palbociclib-armen var 10,8 måneder.
English: If you can become pregnant, you should use effective contraception while you are being treated with Faslodex and for 2 years after your last dose.
Danish: Hvis du kan blive gravid, skal du bruge sikker prævention, mens du er i behandling med Faslodex og i 2 år efter din sidste dosis.
English: Studies in animals have shown reproductive toxicity including an increased incidence of foetal abnormalities and deaths (see section 5.3).
Danish: Dyreforsøg har vist reproduktionstoksicitet, Inklusive en øget forekomst af føtale abnormiteter og dødsfald (se pkt.
English: Faslodex is not expected to affect your ability to drive or use machines.
Danish: Faslodex forventes ikke at påvirke din evne til at køre bil eller betjene maskiner.
English: Table 3 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints in the CONFIRM study
Danish: Tabel 3 Resumé af resultater for det primære effektendepunkt (PFS) og vigtige sekundære effektendepunkter i CONFIRM forsøget
English: It is not known whether fulvestrant is excreted in human milk.
Danish: Det er ukendt, om fulvestrant udskilles i human brystmælk.
English: NOTE: Activate away from self and others.
Danish: BEMÆRK: Den må ikke aktiveres i nærheden af brugeren og andre personer.
English: * Includes side effects for which the exact role of Faslodex cannot be assessed due to the underlying disease.
Danish: * Omfatter bivirkninger, hvor det nøjagtige omfang af Faslodex bidrag ikke kan bedømmes på grund af den tilgrundliggende sygdom.
English: Mild to moderate impairment of renal function did not influence the pharmacokinetics of fulvestrant to any clinically relevant extent.
Danish: Let til moderat nedsat nyrefunktion påvirkede ikke farmakokinetikken for fulvestrant i klinisk relevant omfang.
English: The descriptions included below are based on the safety analysis set of 228 patients who received at least one (1) dose of fulvestrant and 232 patients who received at least one (1) dose of anastrozole, respectively in the Phase 3 FALCON study.
Danish: De nedenstående beskrivelser er baseret på sikkerhedsanalysesættet med henholdsvis 228 patienter, som fik mindst én (1) dosis fulvestrant og 232 patienter, som fik mindst én (1) dosis anastrozol i fase 3 FALCON-studiet.
English: Adverse reactions by system organ class and frequency Infections and infestations
Danish: Bivirkninger efter systemorganklasse og hyppighed Infektioner og parasitære sygdomme
English: Dose adjustment is therefore not necessary in patients who are receiving fulvestrant and CYP3A4 inhibitors or inducers concomitantly.
Danish: Dosisjustering er derfor ikke nødvendig hos patienter, som får fulvestrant og CYP3A4 hæmmere eller inducere samtidig.
English: In vitro data suggest that fulvestrant does not inhibit CYP450 isoenzymes.
Danish: In vitro-data indikerer at fulvestrant ikke hæmmer CYP450 isoenzymer.
English: Increases in placental weight and post-implantation loss of foetuses were seen.
Danish: Der blev observeret stigninger i placentavægt og foster post-implantationstab.
English: All Grades n (%)
Danish: Enhver grad n (%)
English: The pre-filled syringe presentation consists of:
Danish: Den fyldte injektionssprøjte består af:
English: The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the pre-specified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Danish: Studiet opfyldte det primære endepunkt med forlængelse af investigatorvurderet PFS i interimanalysen, som blev udført på 82 % af de planlagte PFS-hændelser; resultaterne overskred den præspecificerede Haybittle-Peto-effektgrænse (α=0,00135), hvilket viste en statistisk signifikant forlængelse af PFS og en klinisk betydende behandlingseffekt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: No patients reported events that were CTCAE Grade ≥3 or that required a dose reduction, dose interruption, or discontinued treatment due to these adverse reactions.
Danish: Der var ingen patienter, som rapporterede om bivirkninger, der var af CTCAE grad ≥3, eller som krævede dosisreduktion, dosisafbrydelse eller seponering af behandlingen som følge af disse bivirkninger.
English: Store and transport in a refrigerator.
Danish: Opbevares i køleskab og transporteres nedkølet.
English: N=number of patients; CI=confidence interval; OR= objective response; TTR=time to first tumour response.
Danish: N=antal patienter; CI=konfidensinterval; OR= objektivt respons; TTR=tid til første tumorrespons.
English: Non-visceral Disease
Danish: Ikke-visceral sygdom
English: Neuropathy peripheral e, sciatica
Danish: Perifer neuropati e, iskias