FrancophonIA/ELRC3.0 huggingface dataset:
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 fulvestrant 500 mg group and 261 patients in the fulvestrant 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 fulvestrant 500 mg gruppen og 261 patienter i fulvestrant 250 mg gruppen).
English: Combined analysis of both studies showed that 83% of patients who received fulvestrant progressed, compared with 85% of patients who received anastrozole.
Danish: Kombineret analyse af begge studier viste, at 83% af patienterne, som fik fulvestrant, progredierede i forhold til 85% af patienterne, der fik anastrozol.
English: After administration of fulvestrant long-acting intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (Cmax) are reached after about 5 days.
Danish: Efter administration af fulvestrant langtidsvirkende intramuskulær injektion absorberes fulvestrant langsomt, og maksimale plasmakoncentrationer (Cmax) opnås efter cirka 5 dage.
English: The mechanism of action is associated with down-regulation of estrogen receptor protein levels.
Danish: Virkningsmekanismen hænger sammen med nedregulering af niveauet af østrogen receptor-protein.
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 fostervariationer hos kaniner (forskydning bagud af bækkenringen og 27. præ-sakrale hvirvel).
English: Fertility The effects of fulvestrant on fertility in humans has not been studied.
Danish: Fertilitet Fulvestrants virkning på fertiliteten hos mennesker er ikke blevet undersøgt.
English: Your doctor or nurse will give you Fulvestrant Mylan as a slow intramuscular injection, one into each of your buttocks.
Danish: Din læge eller sygeplejerske vil give dig Fulvestrant Mylan som en langsom intramuskulær injektion, én i hver balle.
English: Vomiting, diarrhoea
Danish: Opkastning, diarré
English: Efficacy results for the CONFIRM study are summarized in Table 3.
Danish: Effektresultater for CONFIRM-studiet er opsummeret i tabel 3.
English: In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).
Danish: Det er særligt vigtigt, at du fortæller din læge, hvis du tager blodfortyndende medicin (medicin, der forebygger blodpropper).
English: ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Danish: ALAT=alanin aminotransferase; ASAT=aspartat aminotransferase; N/n=antal patienter a Foretrukne Termer (PTs) er anført i henhold til MedDRA 17.1. b Infektioner inkluderer alle PTs, som er inkluderet i systemorganklassen Infektioner og parasitære sygdomme.
English: Manufacturer MYLAN TEORANTA Inverin
Danish: Fremstiller MYLAN TEORANTA Inverin
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 fordelingen fortrinsvis sker ekstravaskulært.
English: This should be taken into consideration when prescribing fulvestrant to patients at risk.
Danish: Dette bør tages i betragtning, når fulvestrant ordineres til risikopatienter.
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: For full instructions on the administration of Fulvestrant Mylan and the use of the safety needle see enclosed, Instructions for administration.
Danish: For fuldstændig instruktion vedrørende administration af Fulvestrant Mylan og brugen af den beskyttede kanyle, se vedlagte instruktioner vedrørende administration.
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: Due to the intramuscular route of administration, fulvestrant 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 fulvestrant anvendes med forsigtighed ved behandling af patienter med blødningsdiatese, thrombocytopeni eller patienter i antikoagulationsbehandling.
English: Fulvestrant Mylan contains 10% w/v ethanol (alcohol)
Danish: Fulvestrant Mylan indeholder 10 w/v % ethanol (alkohol)
English: Fulvestrant Mylan is not expected to affect your ability to drive or use machines.
Danish: Fulvestrant Mylan forventes ikke at påvirke din evne til at køre bil eller betjene maskiner.
English: treatment comparison
Danish: Behandlingssammenligning
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:Anti-estrogen.
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: Fulvestrant is contraindicated in pregnancy (see section 4.3).
Danish: Fulvestrant er kontraindiceret under graviditet (se pkt.
English: Animal studies suggest that no effects other than those related directly or indirectly to anti-estrogenic 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: However, as fulvestrant exposure may be increased, fulvestrant should be used with caution in these patients.
Danish: Da eksponeringen af fulvestrant kan være øget, skal man anvende fulvestrant med forsigtighed hos disse patienter.
English: Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations in gonadotropin levels caused by anti-estrogens 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: Fulvestrant Mylan contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Danish: Fulvestrant Mylan indeholder det aktive stof fulvestrant, som tilhører gruppen kaldet østrogenblokkere.
English: The efficacy and safety of fulvestrant (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
Danish: Sikkerheden og virkningen af fulvestrant (enten som monoterapi eller i kombination med palbociclib) er ikke klarlagt hos patienter med kritisk visceral sygdom.
English: A reduction in the risk of disease progression or death in the fulvestrant 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 fulvestrant plus palbociclib-armen i alle individuelle undergrupper af patienter defineret efter stratificeringsfaktorer og baselinekarakteristika.
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 effektendepunkter (PFS) og vigtige sekundære effektendepunkter i CONFIRM-studiet
English: Absolute difference in
Danish: Absolut forskel i %
English: Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its anti-estrogenic 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: If pregnancy occurs while taking fulvestrant, the patient must be informed of the potential hazard to the foetus and potential risk for loss of pregnancy.
Danish: Hvis graviditet indtræder under fulvestrant-behandlingen, skal patienten informeres om de mulige skadevirkninger på fostret og den potentielle risiko for spontan abort.
English: • Thromboembolism (increased risk of blood clots)*
Danish: • Tromboemboli (øget risiko for blodpropper)*
English: To maintain sterility do not touch the syringe tip (B) (see Figure 2).
Danish: For at bevare steriliteten må kanylens spids (B) ikke berøres (se figur 2).
English: Fulvestrant solution for injection and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
Danish: Fulvestrant injektionsvæske, opløsning og andre formuleringer af fulvestrant var veltolererede hos de involverede dyrearter i flerdosis studier.
English: NOTE: Activate away from self and others.
Danish: BEMÆRK: Den må ikke aktiveres i nærheden af brugeren eller andre personer.
English: Temperature excursions outside 2°C - 8°C should be limited and not exceeding a 28 day period where the average storage temperature for the product is below 25°C (but above 2°C - 8°C).
Danish: Temperaturudsving uden for 2°C - 8°C skal begrænses og bør ikke overskride en periode på 28 dage med gennemsnitlig opbevaringstemperatur for produktet på under 25°C (men over 2°C - 8°C).
English: Of the 65 patients in the fulvestrant 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 fulvestrant-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: 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: Overall, fulvestrant 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 fulvestrant, 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: 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: Table 2 Adverse reactions based on PALOMA3 Study (N=517)
Danish: Tabel 2 Bivirkninger baseret på PALOMA3-studiet (N=517)
English: Very common Elevated hepatic enzymes (ALT, AST, ALP) a
Danish: Meget almindelig Forhøjede leverenzymer (ALAT, ASAT, ALP)a
English: There is no evidence of adverse endometrial effects in the breast cancer patients studied.
Danish: Der var ingen tegn på utilsigtede virkninger i endometriet hos brystkræftpatienterne i studiet.
English: Two syringes must be administered to receive the 500 mg recommended monthly dose.
Danish: Der skal administreres to injektionssprøjter for at give den anbefalede 500 mg månedlige dosis.
English: In table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the fulvestrant 500 mg treatment group in pooled safety analyses of studies that compared fulvestrant 500 mg with fulvestrant 250 mg [CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006), and NEWEST (Study D6997C00003) studies], or from FALCON (Study D699BC00001) alone that compared fulvestrant 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented.
Danish: I nedenstående tabel 1 er frekvenskategorier for bivirkninger baseret på en fulvestrant 500 mg behandlingsgruppe i kombinerede sikkerhedsanalyser af studier, hvor fulvestrant 500 mg blev sammenlignet med fulvestrant 250 mg [CONFIRM (studie D6997C00002), FINDER 1 (studie D6997C00004), FINDER 2 (studie D6997C00006) og NEWEST (studie D6997C00003)], eller fra FALCON (Studie D699BC00001) alene, hvor fulvestrant 500 mg blev sammenlignet med anastrozol 1 mg. Hvor frekvenserne adskiller sig mellem de kombinerede sikkerhedsanalyser og FALCON, er den højeste frekvens præsenteret.
English: Anorexiaa
Danish: Anoreksia
English: The safety and efficacy of fulvestrant in children from birth to 18 years of age have not been established.
Danish: Fulvestrants sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
English: * Includes side effects for which the exact role of Fulvestrant Mylan cannot be assessed due to the underlying disease.
Danish: * Omfatter bivirkninger, hvor det nøjagtige omfang af Fulvestrant Mylans bidrag ikke kan bedømmes på grund af den tilgrundliggende sygdom.
English: Patients were well matched for baseline demographics and prognostic characteristics between the fulvestrant plus palbociclib arm and the fulvestrant plus placebo arm.
Danish: Patienterne var godt matchede udfra baselinedemografi og prognostiske karakteristika mellem fulvestrant plus palbociclib-armen og fulvestrant plus placebo-armen.
English: This medicinal product contains ethanol (alcohol), i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml of wine per dose.
Danish: Dette lægemiddel indeholder ethanol (alkohol), dvs. op til 1.000 mg pr. dosis svarende til 20 ml øl, eller 8 ml vin pr. dosis.
English: Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Danish: papulært udslæt, dermatitis, acneiform dermatitis, toksisk hududslæt.
English: The objective response rate for Fulvestrant 250 mg was 19.2% compared with 16.5% for anastrozole.
Danish: Den objektive responsrate for fulvestrant 250 mg var 19,2% i forhold til 16,5% for anastrozol.
English: The majority of patients (87.0%) had metastatic disease at baseline.
Danish: Størstedelen af patienterne (87,0%) havde metastatisk sygdom ved studiets udgangspunkt.
English: Due to the structural similarity of fulvestrant and estradiol, fulvestrant may interfere with antibody based-estradiol assays and may result in falsely increased levels of estradiol.
Danish: På grund af strukturligheden mellem fulvestrant og estradiol kan fulvestrant interferere med antistofbaserede estradiolanalyser og udvise falsk forhøjede estradiolniveauer.
English: If you can become pregnant, you should use effective contraception while being treated with Fulvestrant Mylan.
Danish: Hvis du kan blive gravid, skal du bruge sikker prævention, mens du er i behandling med Fulvestrant Mylan.
English: -AE subgroup (n=296) -AI subgroup (n=205)a CBRe
Danish: -AE-undergruppe (n=296) -AI-undergruppe (n=205)a CBRe
English: Fulvestrant has no or negligible influence on the ability to drive or use machines.
Danish: Fulvestrant påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Do not use this medicine after the expiry date which is stated on the carton or syringe labels after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen eller injektionssprøjtens etiket efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In two short-term studies (1 and 12 weeks) in premenopausal patients with benign gynaecologic disease, no significant differences in endometrial thickness were observed by ultrasound measurement between fulvestrant and placebo groups.
Danish: I to korttidsstudier (1 og 12 uger) med præmenopausale patienter med godartet gynækologisk sygdom, blev der ved ultralydsmålingerne ikke observeret nogen signifikante forskelle i endometriets tykkelse mellem fulvestrant- og placebogrupperne.
English: This medicinal product contains 500 mg benzyl alcohol in each 5 ml.
Danish: Dette lægemiddel indeholder 500 mg benzylalkohol pr. 5 ml.
English: Warnings and precautions Talk to your doctor or pharmacist or nurse before using Fulvestrant Mylan if any of these apply to you: - kidney or liver problems - low numbers of platelets (which help blood clotting) or bleeding disorders - previous problems with blood clots
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Fulvestrant Mylan, hvis nogen af følgende punkter gælder for dig: - nyre- eller leverproblemer - lavt antal blodplader (hjælper med at få blodet til at størkne) eller blødningsforstyrrelse
English: Clinical studies in postmenopausal women with primary breast cancer have shown that fulvestrant significantly down-regulates ER protein in ER positive tumours compared with placebo.
Danish: Kliniske studier hos postmenopausale kvinder med primær brystkræft har vist, at fulvestrant nedregulerer ER-protein signifikant i ER positive tumorer i forhold til placebo.
English: Prior to the start of treatment with the combination of fulvestrant plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.
Danish: Inden påbegyndelse af behandling med en kombination af fulvestrant og palbociclib, samt under hele behandlingens varighed, skal præ- og perimenopausale kvinder behandles med LHRH-agonister ifølge lokal klinisk praksis.
English: 117 Allée des Parcs 69800 Saint-Priest FRANCE
Danish: 117 Allée des Parcs 69800 Saint-Priest FRANKRIG
English: g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration,
Danish: g Stomatitis inkluderer de følgende PTs: aftøs stomatitis, cheilitis, glossitis, glossodyni, mundsår,
English: Updated Analysis (23 October 2015 cut-off) Fulvestrant plus palbociclib (N=347)
Danish: Opdateret analyse (skæringsdato 23. oktober 2015) Fulvestrant plus palbociclib (N=347)
English: • Increase of gamma-GT, a liver enzyme seen in a blood test
Danish: • Forhøjet gamma-GT (et leverenzym, der kan påvises ved en blodprøve)
English: Administration of fulvestrant 500 mg regimen achieves exposure levels at, or close to, steady state within the first month of dosing (mean [CV]: AUC 475 [33.4%] ng.days/ml, Cmax 25.1 [35.3%] ng/ml, Cmin 16.3 [25.9%] ng/ml, respectively).
Danish: Administration af fulvestrant 500 mg regime medfører eksponeringsniveauer ved, eller tæt ved, steady-state inden for den første måned (gennemsnitlig [variationskoefficient]: AUC 475 [33,4%] ng. dage/ml, Cmax 25,1 [35,3%] ng/ml, Cmin 16,3 [25,9%] ng/ml henholdsvis).
English: c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
Danish: c Neutropeni inkluderer de følgende PTs: neutropeni, nedsat neutrofiltal.
English: These studies compared the safety and efficacy of monthly administration of fulvestrant 250 mg versus the daily administration of 1 mg anastrozole (aromatase inhibitor).
Danish: Disse studier sammenlignede sikkerhed og virkning ved administration af fulvestrant 250 mg månedligt versus daglig administration af 1 mg anastrozol (aromatasehæmmer).
English: Includes adverse drug reactions for which the exact contribution of fulvestrant cannot be assessed due to the underlying disease.
Danish: Omfatter bivirkninger, hvor det nøjagtige omfang af fulvestrants bidrag ikke kan bedømmes på grund af den tilgrundliggende sygdom.
English: Fulvestrant Mylan should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).
Danish: Fulvestrant Mylan skal indgives som to på hinanden følgende 5 ml injektioner ved langsom intramuskulær injektion (1-2 minutter/injektion), én i hver balde (glutealområdet).
English: Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with fulvestrant (see section 4.8).
Danish: Thromboemboliske tilfælde ses ofte hos kvinder med fremskreden brystkræft og er observeret i kliniske studier med fulvestrant (se pkt.
English: Addition of palbociclib to fulvestrant resulted in a symptom benefit by significantly delaying Time-to-Deterioration in pain symptom compared with fulvestrant plus placebo (median 8.0 months versus 2.8 months; HR of 0.64 [95% CI: 0.49, 0.85]; p<0.001).
Danish: Tillæg af palbociclib til fulvestrant gav en symptomfordel ved i betydelig grad at forsinke tiden indtil forværring i smertesymptomer sammenlignet med fulvestrant plus placebo (median 8,0 måneder versus 2,8 måneder; HR på 0,64 [95 % CI: 0,49; 0,85]; p<0,001).
English: • Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
Danish: • Fastgør den beskyttede kanyle til sprøjtens LuerLocksystem og drej indtil den er tilstrækkelig fastgjort (se figur 3).
English: Temperature excursions have a cumulative effect on the product quality and the 28 day time period must not be exceeded over the duration of the shelf life of Fulvestrant Mylan.
Danish: Temperaturudsving har en kumulativ virkning på produktkvaliteten, og perioden på 28 dage må ikke overskrides i løbet af opbevaringstiden for Fulvestrant Mylan.
English: Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Danish: Kliniske interaktionsstudier med rifampicin (en CYP3A4 inducer) og ketoconazol (CYP3A4 hæmmer) viste ingen klinisk relevant ændring i fulvestrant-clearance.
English: In a two-year mouse oncogenicity study (daily oral administration) there was an increased incidence of ovarian sex cord stromal tumours (both benign and malignant) at doses of 150 and 500 mg/kg/day.
Danish: I et toårigt onkogenicitetsstudie hos mus (med daglig oral administration) sås en øget forekomst af sexcordstromale tumorer (både benigne og maligne) i ovarierne ved doser på 150 og 500 mg/kg/dag.
English: In dog studies following oral and intravenous administration, effects on the cardiovascular system (slight elevations of the S-T segment of the ECG [oral], and sinus arrest in one dog [intravenous]) were seen.
Danish: I forsøg med hunde efter oral og intravenøs administration sås påvirkninger af det kardiovaskulære system (svage stigninger af S-T segmentet i EKG [ved oral indgift], og hjertestop hos en hund [ved intravenøs indgift].
English: N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; DOR=duration of response
Danish: N=antal patienter; CI=konfidensinterval; NE=kan ikke estimeres; OR=objektivt respons; CBR=klinisk gevinstrate; DOR=responsvarighed
English: The European Medicines Agency has waived the obligation to submit the results of studies with fulvestrant in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med fulvestrant i alle undergrupper af den pædiatriske population med brystkræft (se pkt.
English: A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4.
Danish: Et klinisk interaktionsstudie med midazolam (substrat af CYP3A4) viste, at fulvestrant ikke hæmmer CYP3A4.