natgillin/translations-raw huggingface dataset:
Venøs thromboembolisme
Venous thromboembolism
OS vises for de endelige overlevelsesanalyser ved 75 % modenhed.
OS is presented for the final survival analyses at 75% maturity.
Sandsynlighed for progressionsfri overlevelse (%)
Progression-Free Survival Probability (%)
Virkning på postmenopausal endometrium
Effects on the postmenopausal endometrium
Dette estimat beregnes som 3/560 (hvor 560 er antallet af patienter i de vigtigste kliniske studier), hvilket svarer til hyppighedskategorien ‘ikke almindelig'.
This is calculated as 3/560 (where 560 is the number of patients in the major clinical studies), which equates to a frequency category of ‘uncommon'.
Dette afsnit giver information baseret på alle bivirkninger fra kliniske studier, post-marketing-studier eller rapporterede spontane bivirkninger.
This section provides information based on all adverse reactions from clinical studies, post-marketing studies or spontaneous reports.
Very low density lipoprotein (VLDL), low density lipoprotein (LDL) og high density lipoprotein (HDL) fraktioner er de primære bindende bestanddele.
Very low density lipoprotein (VLDL), low density lipoprotein (LDL), and high density lipoprotein (HDL) fractions are the major binding components.
, hepatitis f, forhøjet gamma-GT
, hepatitis f, elevated gamma-GT
På grund af fulvestrants virkningsmekanisme, er der en potentiel risiko for osteoporose.
Due to the mechanism of action of fulvestrant, there is a potential risk of osteoporosis.
ALAT=alanin aminotransferase; ASAT=aspartat aminotransferase; N/n=antal patienter Foretrukne Termer (PTs) er anført i henhold til MedDRA 17.1.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients Preferred Terms (PTs) are listed according to MedDRA 17.1.
Frekvenskategorien er ikke den samme i de kombinerede sikkerhedsdatasæt og i FALCON.
Frequency category differs between pooled safety dataset and FALCON.
Personalet har ansvar for den korrekte opbevaring, brug og destruktion af Faslodex.
Your healthcare professional will be responsible for the correct storage, use and disposal of Faslodex.
Faslodex er ikke indiceret til brug hos børn.
Faslodex is not indicated for use in children.
Frekvensopdelingen er defineret i henhold til følgende: Meget almindelig (≥1/10), Almindelig (≥1/100 til <1/10), Ikke almindelig (≥1/1.000 til <1/100).
Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100).
• Pludselig svaghed, følelsesløshed, snurren eller manglende bevægelse i benet, især kun i den ene side af kroppen, pludselige problemer med at gå eller med balancen (perifer neuropati)
• Sudden weakness, numbness, tingling, or loss of movement in your leg, especially on only one side of your body, sudden problems with walking or balance (peripheral neuropathy)
Virkningen af det kønshormonbindende globulin (SHBG) er ikke fastlagt.
The role of sex hormone-binding globulin (SHBG) has not been determined.
Hænderne skal til enhver tid holdes bag ved kanylen under anvendelse og ved destruktion.
Hands must remain behind the needle at all times during use and disposal.
Mere end halvdelen (62 %) havde en ECOG PS på 0, 60 % havde viscerale metastaser, og 60 % havde modtaget mere end 1 tidligere hormonbehandlingsforløb for den primære diagnose.
More than half (62%) had an ECOG PS of 0, 60% had visceral metastases, and 60% had received more than 1 prior hormonal regimen for their primary diagnosis.
Effekt på knogle
Effects on bone
Akut toksicitet for fulvestrant er lav.
The acute toxicity of fulvestrant is low.
Den terminale halveringstid (t1/2) efter intramuskulær administration er bestemt af absorbtionshastigheden og blev estimeret til at være 50 dage.
The terminal half-life (t1/2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
K-M median i måneder; hazard ratio
K-M median in months; hazard ratio
Patienterne fortsatte med at få den tildelte behandling, indtil objektiv sygdomsprogression, symptomatisk forværring, uacceptabel toksicitet, dødsfald eller tilbagetrækning af informeret samtykke indtraf, hvad der end opstod først.
Patients continued to receive assigned treatment until objective disease progression, symptomatic deterioration, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
Disse betragtninger anses derfor ikke for relevante for brugen af fulvestrant til postmenopausale kvinder med fremskreden brystkræft.
Therefore these findings are not considered to be relevant to the use of fulvestrant in postmenopausal women with advanced breast cancer.
Det primære endepunkt for studiet var investigatorvurderet PFS evalueret ifølge RECIST 1.1.
The primary endpoint of the study was investigator-assessed PFS evaluated according to RECIST 1.1.
Børn og unge Faslodex er ikke beregnet til børn og teenagere under 18 år.
Children and adolescents Faslodex is not indicated in children and adolescents under 18 years.
Dette bør tages i betragtning, når Faslodex ordineres til risikopatienter.
This should be taken into consideration when prescribing Faslodex to patients at risk.
Medianvarigheden af behandling med fulvestrant 500 mg på tværs af det poolede datasæt (inklusive ovennævnte studier plus FALCON) var 6,5 måneder.
The median duration of fulvestrant 500 mg treatment across the pooled dataset (including the studies mentioned above plus FALCON) was 6.5 months.
Hos patienter der får Faslodex forventes en stigning i eksponering af denne størrelse at være veltolereret.
In patients administered Faslodex, an increase in exposure of this magnitude is expected to be well tolerated.
Metabolismen af fulvestrant er ikke fuldstændig undersøgt men involverer kombinationer af en række mulige biotransformationsveje, analog til endogene steroider.
The metabolism of fulvestrant has not been fully evaluated, but involves combinations of a number of possible biotransformation pathways analogous to those of endogenous steroids.
Udskillelsesvejen er primært via fæces, med mindre end 1% udskilt i urinen.
The major route of excretion is via the faeces, with less than 1% being excreted in the urine.
Din læge eller sygeplejerske vil give dig Faslodex som en langsom intramuskulær injektion, én i hver balle.
Your doctor or nurse will give you Faslodex as a slow intramuscular injection, one into each of your buttocks.
Yderligere effektmål (OR og TTR) vurderet i undergrupperne med patienter med eller uden visceral sygdom er angivet i tabel 6.
Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 6.
% patienter med CB; absolut forskel i%
% of patients with CB; absolute difference in
Farmakoterapeutisk klassifikation: Endokrin behandling, antiøstrogener, ATC-kode: L02BA03
Pharmacotherapeutic group: Endocrine therapy, Antiestrogens, ATC code: L02BA03
Faslodex og andre formuleringer af fulvestrant var veltolererede hos de involverede dyrearter i flerdosis studier.
Faslodex and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
Den gennemsnitlige tid til død var 27,4 måneder for patienter i behandling med Faslodex og 27,6 måneder for patienter i behandling med anastrozol.
The median time to death was 27.4 months for patients treated with Faslodex and 27.6 months for patients treated with anastrozole.
% patienter med OR; absolut forskel i%
% of patients with OR; absolute difference in
Temperaturudsving uden for 2 °C - 8 °C skal begrænses.
Temperature excursions outside 2°C - 8°C should be limited.
Se indlægssedlen for mere information.
See the package leaflet for further information.
Nominel p-værdi uden foretagne justeringer for multiplicitet mellem de indledende samlede overlevelsesanalyser ved 50 % modenhed og de opdaterede overlevelsesanalyser ved 75 % modenhed.
Nominal p-value with no adjustments made for multiplicity between the initial overall survival analyses at 50% maturity and the updated survival analyses at 75% maturity.
Faslodex er indiceret:
Faslodex is indicated:
• Unormale niveauer af leverenzymer (i blodprøver)*
• Abnormal levels of liver enzymes (in blood tests)*
Identificerede metabolitter (inkluderer 17-keton, sulfon, 3 sulfat 3- og 17-glucoronid metabolitter) er enten mindre aktive eller viser tilsvarende aktivitet som fulvestrant i antiøstrogene modeller.
Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in antiestrogen models.
Der er ingen tilgængelige data vedrørende endometrisk morfologi.
No data are available regarding endometrial morphology.
Virkningsmekanismen hænger sammen med nedregulering af niveauet af østrogen receptor-protein.
The mechanism of action is associated with downregulation of estrogen receptor protein levels.
Ved steady state er fulvestrant plasmakoncentrationer bibeholdt indenfor et relativt smalt koncentrationsområde med op til cirka 3 foldig difference mellem maksimale og trough koncentrationer.
At steady state, fulvestrant plasma concentrations are maintained within a relatively narrow range with up to an approximately 3-fold difference between maximum and trough concentrations.
Opkastning, diarré.
Vomiting, diarrhoea
Efter administration af Faslodex langtidsvirkende intramuskulær injektion, absorberes fulvestrant langsomt, og maksimale plasmakoncentrationer (Cmax) opnås efter cirka 5 dage.
After administration of Faslodex long-acting intramuscular injection, fulvestrant is slowly absorbed and maximum plasma concentrations (Cmax) are reached after about 5 days.
Der sås også en signifikant nedsat progesteron receptor-ekspression i overensstemmelse med en manglende intrinsic østrogen agonist effekt.
There was also a significant decrease in progesterone receptor expression consistent with a lack of intrinsic estrogen agonist effects.
TTR*, median [måneder (interval)]
TTR*, Median [months (range)]
De patientrapporterede symptomer blev vurderet under anvendelse af EORTC (European Organization for Research and Treatment of Cancer)-spørgeskema om livskvalitet (QLQ)-C30 og brystkræftmodulet (EORTC QLQ-BR23).
Patient-reported symptoms were assessed using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 and its Breast Cancer Module (EORTC QLQ-BR23).
Febril neutropeni blev rapporteret hos 0,9 % af patienterne, der fik fulvestrant i kombination med palbociclib.
Febrile neutropenia has been reported in 0.9% patients receiving fulvestrant in combination with palbociclib.
5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Der findes enkeltstående rapporter om overdosering med Faslodex hos mennesker.
There are isolated reports of overdose with Faslodex in humans.
Injektionen skal administreres ifølge lokale retningslinjer for intramuskulær injektion af stort volumen.
Administer the injection according to the local guidelines for performing large volume intramuscular injections.
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).
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).
Kvinder med svært nedsat leverfunktion, (Child-Pugh klasse C), blev ikke undersøgt.
Women with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Arteritis i forskellige væv blev observeret hos nogle hunde efter kronisk dosering (12 måneder).
Arteritis involving a range of different tissues was seen in some dogs after chronic (12 months) dosing.
Infektioner inkluderer alle PTs, som er inkluderet i systemorganklassen Infektioner og parasitære sygdomme.
Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Fertilitet Faslodex' virkning på fertiliteten hos mennesker er ikke blevet undersøgt.
Fertility The effects of Faslodex on fertility in humans has not been studied.
Kombineret analyse af begge studier viste, at 83% af patienterne, som fik Faslodex, progredierede i forhold til 85% af patienterne, der fik anastrozol.
Combined analysis of both studies showed that 83% of patients who received Faslodex progressed, compared with 85% of patients who received anastrozole.
De sekundære endepunkter omfattede OR, CBR, OS, sikkerhed og tid indtil forværring (TTD) af smerter.
Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint.
77 % af studiepopulationen havde østrogen receptor positiv brystkræft.
Seventy seven percent (77%) of the study population had estrogen receptor positive breast cancer.
Der var en øget forekomst af foster variationer hos kaniner (forskydning bagud af bækkenringen og 27. præ-sakrale hvirvel).
There was an increased incidence of foetal variations in rabbits (backwards displacement of the pelvic girdle and 27 pre-sacral vertebrae).
Grad ≥ 3 n (%)
Grade ≥ 3 n (%)
For fuldstændig instruktion vedrørende administration af Faslodex og brugen af den beskyttede kanyle, se vedlagte instruktioner vedrørende administration.
For full instructions on the administration of Faslodex and the use of the safety needle see enclosed, Instructions for administration.
Tabel 2 viser bivirkningerne fra PALOMA3.
Table 2 reports the adverse reactions from PALOMA3.
• Parenterale væsker skal inspiceres visuelt for partikler og misfarvning forud for administration.
• Parenteral solutions must be inspected visually for particulate matter and discolouration prior to administration.
Kombinationsbehandling med palbociclib
Combination therapy with palbociclib
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.
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.
Der var ingen rapporteringer om grad 4 neutropeni i fulvestrant + placebo-armen.
There were no reports of Grade 4 neutropenia in the fulvestrant + placebo arm.
Det store tilsyneladende distributionsvolumen ved steady state (Vdss) på ca. 3-5 l/kg, tyder på, at distributionen fortrinsvis sker ekstravasculært.
The large apparent volume of distribution at steady state (Vdss) of approximately 3 to 5 l/kg suggests that distribution is largely extravascular.
Præ-/perimenopausale kvinder modtog LHRH-agonisten goserelin.
Pre/perimenopausal women received the LHRH agonist goserelin.
I alt 17,1 % af patienterne havde tidligere modtaget kemoterapi imod fremskreden sygdom; 84,2 % af patienterne havde målbar sygdom.
A total of 17.1% of patients received a prior chemotherapy regimen for advanced disease; 84.2% of patients had measurable disease.
Tid indtil forværring blev præspecificeret som tiden mellem baseline og første forekomst af ≥10 points stigning fra baseline i score for smertesymptomer.
Time-to-Deterioration was pre-specified as time between baseline and first occurrence of ≥10 points increase from baseline in pain symptom scores.
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.
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.
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.
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.
Det er specielt vigtigt, at du fortæller din læge, hvis du tager blodfortyndende medicin (medicin der forebygger blodpropper).
In particular, you should tell your doctor if you are using anticoagulants (medicines to prevent blood clots).
Lyt efter klik og bekræft visuelt, at kanylespidsen er helt dækket.
Listen for click and visually confirm needle tip is fully covered.
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.
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.
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.
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.
• 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
• 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.
Faslodex anbefales ikke til børn og unge, da sikkerheden og virkningen ikke er klarlagt hos denne patientgruppe (se pkt.
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).
I alt 462 patienter blev randomiseret 1:1 sekventielt til at modtage enten fulvestrant 500 mg eller anastrozol 1 mg.
A total of 462 patients were randomised 1:1 sequentially to receive either fulvestrant 500 mg or anastrozole 1 mg.
Inkluderer: artralgi og mindre hyppigt smerter i muskler og knogler, myalgi og smerter i ekstremiteterne.
Includes: arthralgia, and less frequently musculoskeletal pain, myalgia and pain in extremity.
• Efter injektion skub omgående med en enkelt finger på den assisterede vippearm for at aktivere beskyttelsesmekanismen (se figur 5).
• After injection, immediately apply a single-finger stroke to the activation assisted lever arm to activate the shielding mechanism (see Figure 5).
Hvis graviditet indtræder under Faslodexbehandlingen, skal patienten informeres om de mulige skadevirkninger på fostret og den potentielle risiko for spontan abort.
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.
Dyreforsøg tyder på, at ingen påvirkninger, udover de direkte eller indirekte relaterede til antiøstrogen aktivitet, var evidente ved højere doser af fulvestrant (se pkt.
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).
Fyldte sprøjter er kun til engangsbrug.
Pre-filled syringes are for single use only.
I begge behandlingsarme var størstedelen af patienterne hvide, havde dokumenteret følsomhed over for tidligere hormonbehandling og var postmenopausale.
In each treatment arm the majority of patients were White, had documented sensitivity to prior hormonal therapy, and were postmenopausal.
Faslodex indeholder det aktive stof fulvestrant, som tilhører gruppen kaldet østrogen-blokkere.
Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Da eksponeringen af fulvestrant kan være øget, skal man anvende Faslodex med forsigtighed hos disse patienter.
However, as fulvestrant exposure may be increased, Faslodex should be used with caution in these patients.
På grund af den intramuskulære administrationsvej skal Faslodex anvendes med forsigtighed ved behandling af patienter med blødningsdiatese, thrombocytopeni eller patienter i antikoagulationsbehandling.
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.
Udvikling af sådanne tumorer er i overensstemmelse med de farmakologiske endokrine feedback-ændringer i gonadotropinniveauer, forårsaget af antiøstrogener hos dyr med cyklus.
Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations in gonadotropin levels caused by antiestrogens in cycling animals.
• Opkastning, diarré eller appetitløshed*
• Vomiting, diarrhoea, or loss of appetite*
Skadelig for alkoholikere og bør tages i betragtning i højrisikogrupper såsom patienter med leversygdomme og epilepsi.
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.
Faslodex er kontraindiceret under graviditet (se pkt.
Faslodex is contraindicated in pregnancy (see section 4.3).
Sikkerheden og virkningen af Faslodex (enten som monoterapi eller i kombination med palbociclib) er ikke klarlagt hos patienter med kritisk visceral sygdom.
The efficacy and safety of Faslodex (either as monotherapy or in combination with palbociclib) have not been studied in patients with critical visceral disease.
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Miljørisikovurderingsstudier har vist, at fulvestrant potentielt kan medføre skadelige virkninger for vandmiljøet (se pkt.
Environmental risk assessment studies have shown that fulvestrant may have potential to cause adverse effects to the aquatic environment (see section 6.6).
Fulvestrant påvirkede reproduktionen og embryo/fosterudvikling i overensstemmelse med dets antiøstrogene aktivitet, ved doser svarende til den kliniske dosis.
Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its antiestrogenic activity, at doses similar to the clinical dose.
Fulvestrant har en høj clearance, 11+/- 1,7 ml/min/kg, som tyder på en høj udskillelsesratio via leveren.
Fulvestrant has a high clearance, 11±1.7 ml/min/kg, suggesting a high hepatic extraction ratio.
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.
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.
Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis du bemærker en af følgende bivirkninger:
Tell your doctor, pharmacist, or nurse if you notice any of the following side effects:
En opdatering af effektdata er angivet i tabel 5.
A more mature update of efficacy data is reported in Table 5.
Patienterne, der deltog i dette studie, havde en medianalder på 63 år (interval 36-90).
Patients enrolled in this study had a median age of 63 years (range 36-90).
Virkningsmekanisme og farmakodynamisk virkning Fulvestrant er en kompetitiv østrogen receptor (ER)-antagonist med en affinitet sammenlignelig med østradiol.
Mechanism of action and pharmacodynamic effects Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.