natgillin/translations-raw huggingface dataset:
Farmakokinetikken for fulvestrant er blevet undersøgt i et klinisk enkeltdosis-studie, der blev gennemført hos kvinder som havde let til moderat nedsat leverfunktion, (Child-Pugh klasse A og B).
The pharmacokinetics of fulvestrant has been evaluated in a single-dose clinical study conducted in women with mild to moderate hepatic impairment (Child-Pugh class A and B).
Når Faslodex gives i kombination med palbociclib er det vigtigt, at du også læser indlægssedlen for palbociclib.
When Faslodex is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Faslodex i alle undergrupper af den pædiatriske population med brystkræft (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Faslodex in all subsets of the paediatric population in breast cancer (see section 4.2 for information on paediatric use).
• Smerter i lænden, der stråler ned i det ene ben (iskias)
• Lower back pain irradiating to leg on one side (sciatica)
Thrombocytopeni inkluderer de følgende PTs: thrombocytopeni, nedsat trombocyttal.
Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Det er vist, at fulvestrant passerer placenta hos rotter og kaniner efter en enkelt intramuskulær dosis.
Fulvestrant has been shown to cross the placenta after single intramuscular doses in rat and rabbit.
Hos patienter, der fik fulvestrant i kombination med palbociclib, var mediantid til første tilfælde af enhver grad af neutropeni 15 dage (interval: 13-317), og medianvarigheden af grad ≥3-neutropeni var 7 dage.
In patients receiving fulvestrant in combination with palbociclib, the median time to first episode of any grade neutropenia was 15 days (range: 13-317) and the median duration of Grade ≥3 neutropenia was 7 days.
Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer (se pkt.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements (see section 5.3).
Amning skal ophøre under behandling med Faslodex.
Breast-feeding must be discontinued during treatment with Faslodex.
I et toårigt onkogenicitetsstudie hos mus (med daglig oral administration) sås en øget forekomst af sex cordstromale tumorer (både benigne og maligne) i ovarierne ved doser på 150 og 500 mg/kg/dag.
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.
• Nedsat antal blodplader (trombocytopeni)
• Decreased levels of platelets (thrombocytopenia)
I FALCON-studiet var antallet af patienter, som rapporterede en bivirkning i form af smerter i led, muskler og knogler, henholdsvis 65 (31,2 %) og 48 (24,1 %) for fulvestrant-armen og anastrozol-armen.
In the FALCON study, the number of patients who reported an adverse reaction of joint and musculoskeletal pain was 65 (31.2%) and 48 (24.1%) for fulvestrant and anastrozole arms, respectively.
Hos kvinder med nedsat leverfunktion sås en stigning i AUC på op til 2,5 gange sammenlignet med raske forsøgspersoner.
There was up to about 2.5-fold increase in AUC in women with hepatic impairment compared to healthy subjects.
Omfatter bivirkninger, hvor det nøjagtige omfang af Faslodexs bidrag ikke kan bedømmes på grund af den tilgrundliggende sygdom.
Includes adverse drug reactions for which the exact contribution of Faslodex cannot be assessed due to the underlying disease.
Faslodex indeholder: - Aktivt stof: fulvestrant.
What Faslodex contains - The active substance is fulvestrant.
Du må ikke amme, mens du behandles med Faslodex.
You must not breast-feed while on treatment with Faslodex.
Der skal administreres to injektionssprøjter for at give den anbefalede 500 mg månedlig dosis.
Two syringes must be administered to receive the 500 mg recommended monthly dose.
Hos patienter, der fik fulvestrant i kombination med palbociclib i PALOMA3-studiet, blev der rapporteret neutropeni af enhver grad hos 287 patienter (83,2 %), hvor der blev rapporteret grad 3neutropeni hos 191 patienter (55,4 %), og neutropeni i grad 4 blev rapporteret hos 37 patienter (10,7 %).
In patients receiving fulvestrant in combination with palbociclib in the PALOMA3 study, neutropenia of any grade was reported in 287 (83.2%) patients, with Grade 3 neutropenia being reported in 191 (55.4%) patients, and Grade 4 neutropenia being reported in 37 (10.7%) patients.
Opdateret analyse (skæringsdato 23. oktober 2015) Faslodex plus palbociclib (N=347)
Updated Analysis (23 October 2015 cut-off) Faslodex plus palbociclib (N=347)
Den anbefalede dosis er 500 mg fulvestrant (to 250 mg/5 ml-injektioner), der gives en gang om måneden, samt en ekstra 500 mg dosis givet 2 uger efter den første dosis.
The recommended dose is 500 mg fulvestrant (two 250 mg/5 ml injections) given once a month, with an additional 500 mg dose given 2 weeks after the initial dose.
Efter temperaturudsving skal produktet straks igen opbevares ved de anbefalede opbevaringsforhold (opbevares i køleskab og transporteres nedkølet ved 2 °C - 8 °C).
After temperature excursions, the product should be returned immediately to the recommended storage conditions (store and transport in a refrigerator 2°C - 8°C).
Effektresultater i visceral og ikke-visceral sygdom fra PALOMA-3-studiet (intent-to-treat-population)
Table 6 Efficacy results in visceral and non-visceral disease from PALOMA3 study (intentto-treat population)
For brugervenlighed vendes kanylens skråspids opad mod vippearmen (se figur 4).
For user convenience, the needle bevel-up position is oriented to the lever arm (see Figure 4).
• Flyt den fyldte injektionssprøjte til administrationsstedet.
• Transport filled syringe to point of administration.
166 patienter i Faslodex plus placebo-armen udfyldte spørgeskemaet ved baseline og ved mindst et besøg efterfølgende.
A total of 335 patients in the Faslodex plus palbociclib arm and 166 patients in the Faslodex plus placebo arm completed the questionnaire at baseline and at least 1 post-baseline visit.
-AE-undergruppe (n=423)
-AE subgroup (n=423)
Faslodex leveres i 2 forskellige pakninger, enten en pakning indeholdende 1 fyldt glasinjektionssprøjte eller en pakning med 2 fyldte glas-injektionssprøjter.
Faslodex has 2 pack presentations, either a pack containing 1 glass pre-filled syringe or a pack containing 2 glass pre-filled syringes.
• Svaghedsfølelse, træthed*
• Weakness, tiredness*
Den geometriske, gennemsnitlige steady-state-(ss)dalkoncentration af fulvestrant (Cmin,ss) og AUCss var henholdsvis 4,2 (0,9) ng/ml og 3.680 (1.020) ng t/ml (standardafvigelse).
The geometric mean (standard deviation) steady state trough concentration (Cmin,ss) and AUCss was 4.2 (0.9) ng/mL and 3680 (1020) ng*hr/mL, respectively.
I fulvestrant + placebo-armen (n = 172) blev neutropeni af enhver grad rapporteret hos 7 patienter (4,1 %), og grad 3-neutropeni blev rapporteret hos 1 patient (0,6 %).
In the fulvestrant + placebo arm (n=172), neutropenia of any grade was reported in 7 (4.1%) patients, with Grade 3 neutropenia reported in 1 (0.6%) patient.
Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige, de er.
Within each frequency grouping adverse reactions are reported in order of decreasing seriousness.
Med henblik på muligheden for potentielt alvorlige bivirkninger hos ammede børn på grund af fulvestrant, er anvendelse under amning kontraindiceret (se pkt.
Considering the potential for serious adverse reactions due to fulvestrant in breast-fed infants, use during lactation is contraindicated (see section 4.3).
Hos rotter sås en reversibel nedsat kvindelig fertilitet og embryo-overlevelse, dyctocia samt en øget forekomst af fosterabnormaliteter inkl.
In rats, a reversible reduction in female fertility and embryonic survival, dystocia and an increased incidence of foetal abnormalities including tarsal flexure were observed.
Leukopeni inkluderer de følgende PTs: leukopeni, nedsat antal hvide blodlegemer.
Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
Sammenligning mellem grupper (Faslodex 500 mg/Faslodex 250 mg) Absolut forskel i %
Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Absolute difference in %
livstruende komplikationer på kort sigt (herunder patienter med massivt ukontrolleret ekssudat [pleural, perikardiel, peritoneal], pulmonal lymfangitis samt mere end 50 % leverpåvirkning), var ikke egnede til deltagelse i studiet.
massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement), were not eligible for enrolment into the study.
Tabel 5 Effektresultater - PALOMA-3-studiet (investigatorvurdering, intent-to-treat-population)
Table 5 Efficacy results - PALOMA3 study (Investigator assessment, intent-to-treat population)
Kombineret analyse for begge studier viste, at hazard ratio for Faslodex 250 mg i forhold til anastrozol, med henblik på progressionsfri overlevelse var 0,95 (95% konfidensinterval 0,82-1,10).
Combined analysis of both studies showed the hazard ratio of Faslodex 250 mg to anastrozole for progression-free survival was 0.95 (95% CI 0.82 to 1.10).
• Forhøjet bilirubin (galdefarvestof, der dannes i leveren)
• Increase of bilirubin (bile pigment produced by the liver)
Et forsøg på 2 uger med raske postmenopausale frivillige forsøgspersoner, behandlet med 20 μg ethinylestradiol dagligt, viste, at præmedicinering med Faslodex 250 mg resulterede i en signifikant reduceret stimulation af det postmenopausale endometrium, sammenlignet med placebo, vurderet via ultralydsmålinger af endometriets tykkelse.
A 2-week study in healthy postmenopausal volunteers treated with 20 μg per day ethinylestradiol showed that pretreatment with Faslodex 250 mg resulted in significantly reduced stimulation of the postmenopausal endometrium, compared to pre-treatment with placebo, as judged by ultrasound measurement of endometrium thickness.
• Åbn den ydre pakning af den beskyttede kanyle (SafetyGlide).
• Peel open the safety needle (SafetyGlide) outer packaging.
Steady state-dalkoncentrationen af fulvestrant hos børnene i denne undersøgelse svarede til den, som blev observeret hos voksne (se pkt.
The steady-state trough concentrations of fulvestrant in children in this study were consistent with that in adults (see section 5.2).
De pædiatriske patienter var i alderen 1 til 8 år og fiken intramuskulær dosis på 4 mg fulvestrant/kg hver måned.
The paediatric patients were aged 1 to 8 years and received 4 mg/kg monthly intramuscular dose of fulvestrant.
Dosisjustering anbefales ikke til patienter med let til moderat nedsat leverfunktion.
No dose adjustments are recommended for patients with mild to moderate hepatic impairment.
• Allergiske reaktioner (overfølsomhed), der kan omfatte hævelser i ansigt, læber, tunge og/eller svælg, som kan være tegn på anafylaktisk reaktion/shock.
• Allergic (hypersensitivity) reactions, including swelling of the face, lips, tongue and/or throat that may be signs of anaphylactic reactions
Visceral sygdom
Visceral Disease
Dosisjustering anbefales ikke til patienter med let til moderat nedsat nyrefunktion (kreatinin clearance ≥ 30 ml/min).
No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance 30 ml/min).
Et åben-label fase-2-forsøg undersøgte sikkerhed og virkning samt farmakokinetiske egenskaber ved fulvestrant hos 30 piger i alderen 1 til 8 år med progressiv pubertas præcox i forbindelse med McCune Albright-syndrom (MAS).
An open-label Phase 2 study investigated the safety, efficacy and pharmacokinetics of fulvestrant in 30 girls aged 1 to 8 years with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).
Alle patienter -AE-undergruppe (n=296) -AI-undergruppe (n=205) CBR
All Patients -AE subgroup (n=296) -AI subgroup (n=205) CBR
Faslodex' sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke klarlagt.
The safety and efficacy of Faslodex in children from birth to 18 years of age have not been established.
Systemorganklasse Hyppighed
System Organ Class Frequency Preferred Term
Brug af anden medicin sammen med Faslodex
Other medicines and Faslodex
• Fastgør den beskyttede kanyle til sprøjtens LuerLock system og drej indtil den er tilstrækkelig fastgjort (se figur 3).
• Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
Bivirkninger rapporteret hos patienter behandlet med Faslodex monoterapi
Table 1 Adverse Drug Reactions reported in patients treated with Faslodex monotherapy
Temperaturudsving har en kumulativ virkning på produktkvaliteten, og perioden på 28 dage må ikke overskrides i løbet af Faslodex opbevaringstiden på 4 år for Faslodex.
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 4-year shelf life of Faslodex.
Interferens med estradiol antistofanalyser
Interference with estradiol antibody assays
Faslodex er indiceret til patienter med recidiverende eller progredierende sygdom under antiøstrogen-behandling.
Faslodex is indicated in patients whose disease had recurred or progressed on an antiestrogen therapy.
Anastrozol 1 mg (N=232)
Anastrozole 1 mg (N=232)
Fulvestrants farmakokinetiske egenskaber er blevet evalueret i et klinisk studie med 30 piger med progressiv pubertas præcox i forbindelse med McCune Albright Syndrom (se pkt.
The pharmacokinetics of fulvestrant has been evaluated in a clinical study conducted in 30 girls with Progressive Precocious Puberty associated with McCune Albright Syndrome (see section 5.1).
Udsættelse for temperaturer under 2 °C vil ikke beskadige produktet, forudsat at det ikke opbevares ved temperaturer under -20 °C.
Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Tabel 4 Sammenfatning af resultater af de primære effektmål (PFS) og vigtige sekundære effektmål (investigatorvurdering, intent-to-treat-population) ─ FALCON-studiet
Table 4 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints (Investigator Assessment, Intent-To-Treat Population) ─ FALCON study
I alt 521 præ-/peri- og postmenopausale kvinder, som havde progredieret under eller inden for 12 måneder efter fuldførelse af adjuverende endokrin behandling, under eller inden for 1 måned efter tidligere endokrin behandling mod fremskreden sygdom, blev randomiseret 2:1 til Faslodex plus palbociclib eller Faslodex plus placebo og stratificeret efter dokumenteret følsomhed over for tidligere hormonbehandling, menopausalstatus ved studiets start (præ-/peri- versus postmenopausal) og forekomst af viscerale metastaser.
A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to Faslodex plus palbociclib or Faslodex plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Spørg lægen, hvis du har spørgsmål om palbociclib.
If you have any questions about palbociclib, please ask your doctor.
Stomatitis inkluderer de følgende PTs: aftøs stomatitis, cheilitis, glossitis, glossodyni, mundsår, slimhindeinflammation, mundsmerter, orofaryngealt ubehag, orofaryngeale smerter, stomatitis.
Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Faslodex 500 mg (2 x 250 mg/5 ml injektionsvæske, opløsning) skal administreres med 2 fyldte injektionssprøjter, se pkt.
Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Til intramuskulær injektion.
Solution for injection.
Dette var tydeligt for præ-/perimenopausale kvinder (HR på 0,46 [95 % CI: 0,28; 0,75]) og postmenopausale kvinder (HR på 0,52 [95 % CI: 0,40; 0,66]) samt patienter med visceral metastatisk sygdom (HR på 0,50 [95 % CI: 0,38; 0,65]) og ikke-visceral metastatisk sygdom (HR på 0,48 [95 % CI: 0,33; 0,71]).
This was evident for pre/perimenopausal women (HR of 0.46 [95% CI: 0.28, 0.75]) and postmenopausal women (HR of 0.52 [95% CI: 0.40, 0.66]) and patients with visceral site of metastatic disease (HR of 0.50 [95% CI: 0.38, 0.65]) and non-visceral site of metastatic disease (HR of 0.48 [95% CI: 0.33, 0.71]).
Et to-årigt onkogenicitetsstudie med rotter (intramuskulær administration af Faslodex) viste øget forekomst af godartede ovarietumorer i granulosa-celler hos hunrotter ved den høje dosis på 10 mg/rotte/15 dage og en øget forekomst af Leydigs tumorer i testiklerne hos hanrotter.
A two-year oncogenicity study in rats (intramuscular administration of Faslodex) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/rat/15 days and an increased incidence of testicular Leydig cell tumours in males.
De mest almindelige (≥2 %) grad ≥3-bivirkninger var neutropeni, leukopeni, anæmi, infektioner, øget ASAT, trombocytopeni og træthed.
The most common (≥2%) Grade ≥3 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.
Dette indbefatter at undgå opbevaring ved temperaturer, der overstiger 30 °C, samt at undgå at overskride en periode på 28 dage med gennemsnitlig opbevaringstemperatur for produktet på under 25 °C (men over 2 °C - 8 °C ).
This includes avoiding storage at temperatures exceeding 30°C, 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).
• som monoterapi til behandling af østrogen-receptor-positiv, lokal fremskreden eller metastatisk brystkræft hos postmenopausale kvinder: - der ikke tidligere har modtaget endokrin behandling, eller - med sygdomstilbagefald under eller efter adjuverende behandling med antiøstrogen, eller sygdomsprogression under antiøstrogenbehandling.
• as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: - not previously treated with endocrine therapy, or - with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
Hver fyldt injektionssprøjte (5 ml) indeholder 250 mg fulvestrant.
Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Hazard ratio for Faslodex 250 mg i forhold til anastrozol for tid til død, var 1,01 (95% konfidensinterval, 0,86 til 1,19).
The hazard ratio of Faslodex 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
FYLDT SPRØJTE ETIKET
PRE-FILLED SYRINGE LABEL
Forsøget omfattede 423 patienter med recidiverende eller progredierende sygdom under antiøstrogen-behandlingen (AE-undergruppe), og 313 patienter med recidiverende eller progredierende sygdom under aromatasehæmmer-behandlingen (AI-undergruppe).
The study included 423 patients whose disease had recurred or progressed during antiestrogen therapy (AE subgroup) and 313 patients whose disease had recurred or progressed during aromatase inhibitor therapy (AI subgroup).
Hold fast i låget (A) med den anden hånd og vip forsigtigt frem og tilbage, indtil låget brækkes af og kan trækkes af, drej ikke låget.
With the other hand, take hold of the cap (A) and carefully tilt back and forth until the cap disconnects and can be pulled off, do not twist (see Figure 1).
Der blev også observeret fordele uanset tidligere behandlingslinjer i metastatisk regi, uden hensyntagen til om det var 0 (HR på 0,59 [95 % CI: 0,37; 0,93]), 1 (HR på 0,46 [95 % CI: 0,32; 0,64]), 2 (HR på 0,48 [95 % CI: 0,30; 0,76]) eller ≥3 linjer (HR på 0,59 [95 % CI: 0,28; 1,22]).
Benefit was also observed regardless of lines of prior therapy in the metastatic setting, whether 0 (HR of 0.59 [95% CI: 0.37, 0.93]), 1 (HR of 0.46 [95% CI: 0.32, 0.64]), 2 (HR of 0.48 [95% CI: 0.30, 0.76]), or ≥3 lines (HR of 0.59 [95% CI: 0.28, 1.22]).
Faslodex indeholder 750 mg benzylbenzoat per injektion, hvilket svarer til 150 mg/ml.
Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.
55 % af patienterne havde viscerale metastaser ved studiets udgangspunkt.
Fifty-five percent (55.0%) of patients had visceral metastasis at baseline.
• alene, til behandling af postmenopausale kvinder med en type brystkræft kaldet østrogenreceptor-positiv brystkræft, der er lokalt fremskreden eller har spredt sig til andre dele af kroppen (metastatisk), eller
• alone, to treat postmenopausal women with a type of breast cancer called estrogen receptor positive breast cancer that is locally advanced or has spread to other parts of the body (metastatic), or
De mest almindelige bivirkninger (≥20 %) af enhver grad rapporteret hos patienter, der fik fulvestrant i kombination med palbociclib, var neutropeni, leukopeni, infektioner, træthed, kvalme, anæmi, stomatitis, diarré og trombocytopeni.
The most common (≥20%) adverse reactions of any grade reported in patients receiving fulvestrant in combination with palbociclib were neutropenia, leukopenia, infections, fatigue, nausea, anaemia, stomatitis, diarrhoea, and thrombocytopenia.
Patienter med fremskreden/metastatisk, symptomatisk, visceral spredning, som havde risiko for
Patients with advanced/metastatic, symptomatic, visceral spread, that were at risk of life-threatening complications in the short term (including patients with
Behold den fyldte injektionssprøjte i den originale pakning, for at beskytte den mod lys.
Keep the pre-filled syringe in the original package, in order to protect from light.
Blandt de vigtigste sekundære effektendepunkter var objektiv responsrate (ORR), klinisk gevinstrate (CBR) og total overlevelse (OS).
was the primary endpoint; key secondary efficacy endpoints included objective response rate (ORR), clinical benefit rate (CBR) and overall survival (OS).
Ved niveauet ”ingen effekt” for disse fund var den systemiske eksponering (AUC) cirka 1,5 gange niveauet af den forventede humane eksponeringer hos hunrotter og 0,8 gange hos hanrotter.
At the no-effect level for these findings, systemic exposure levels (AUC) were, in rats, approximately 1.5-fold the expected human exposure levels in females and 0.8-fold in males, and in mice, approximately 0.8-fold the expected human exposure levels in both males and females.
Figur 1 Kaplan-Meier-diagram over progressionsfri overlevelse (investigatorvurdering, intent-to-treat-population) ─ FALCON-studiet
Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-ToTreat Population) ─ FALCON Study
En opdateret RMP skal fremsendes
An updated RMP should be submitted • At the request of the European Medicines Agency;
Der bør udvises forsigtighed, hvis Faslodex injiceres i det dorsogluteale område på grund af den nært underliggende iskiasnerve.
Caution should be taken if injecting Faslodex at the dorsogluteal site due to the proximity of the underlying sciatic nerve.
Kaplan-Meier-diagram over progressionsfri overlevelse (investigatorvurdering, intent-to-treat-population) - PALOMA-3-studiet
Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA3 study
Der blev udført et randomiseret, dobbeltblindet, dobbelt-dummy, fase 3-multicenterstudie med Faslodex 500 mg versus anastrozol 1 mg med postmenopausale kvinder med ER-positiv og/eller PgR-positiv lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere havde fået hormonbehandling.
A Phase 3, randomised, double-blind, double-dummy, multicentre study of Faslodex 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Der vedlægges også beskyttede kanyler (BD SafetyGlide) til montering på hver sprøjte.
Safety needles (BD SafetyGlide) for connection to each barrel are also provided.