FrancophonIA/ELRC3.0 huggingface dataset:
English: The median age of patients enrolled in this study was 57 years (range 29, 88).
Maltese: L-età medjana tal-pazjenti li rreġistraw fl-istudju kienet ta' 57 sena (medda 29, 88).
English: % of patients with OR; absolute difference in
Maltese: % ta' pazjenti b' OR; differenza assoluta f'%
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjonijiet 5.1 u 5.2, imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: This study compared the efficacy and safety of Faslodex 500 mg (n=362) with Faslodex 250 mg (n=374).
Maltese: Dan l-istudju qabbel l-effikaċja u ssigurta ta' Faslodex 500 mg (n=362) ma' Faslodex 250 mg (n=374).
English: Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with Faslodex (see section 4.8).
Maltese: Avvenimenti tromboemboliċi huma osservati ta' spiss f'nisa b'kanċer tas-sider avvanzat u ġew osservati fi studji kliniċi b'Faslodex (ara sezzjoni 4.8).
English: The most common (≥2%) Grade ≥3 adverse reactions were neutropenia, leukopenia, anaemia, infections, AST increased, thrombocytopenia, and fatigue.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (≥2%) ta' Grad ≥3 kienu newtropenja, lewkopenja, anemija, infezzjonijiet, żieda fl-AST, tromboċitopenia u għeja.
English: 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).
Maltese: Il-farmakokinetiċi ta' fulvestrant ġew evalwati fi studju kliniku mwettaq fuq 30 tifla b'Pubertà Prekoċi Progressiva assoċċjata mas-Sindromu ta' McCune Albright (ara sezzjoni 5.1).
English: The acute toxicity of fulvestrant is low.
Maltese: It-tossiċità akuta ta' fulvestrant hija baxxa.
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.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji ta' Fażi 3, ma rriżultat ebda differenza fil-profil farmakokinetiku ta' fulvestrant fir-rigward tal-età (fil-medda ta' bejn 33 sa 89 sena), tal-piż (40-127kg) jew tar-razza.
English: Hepatic failure c, f
Maltese: Insuffiċjenza epatika ċ, f
English: The efficacy results of the FALCON study are presented in Table 4 and Figure 1.
Maltese: Irriżultati tal-effikaċja tal-istudju FALCON huma ppreżentati f'Tabella 4 u f'Figura 1.
English: Faslodex contains 500 mg benzyl alcohol per injection, equivalent to 100 mg/ml.
Maltese: Faslodex fih 500 mg benzyl alcohol għal kull injezzjoni, ekwivalenti għal 100 mg/ml.
English: Children and adolescents Faslodex is not indicated in children and adolescents under 18 years.
Maltese: Tfal u adolexxenti Faslodex mhux indikat għal tfal u adolexxenti ta' taħt it-18-il sena.
English: Pre/perimenopausal women received the LHRH agonist goserelin.
Maltese: In-nisa ta' qabel/waqt il-menopawża rċivew l-agonista ta' LHRH goserelin.
English: AstraZeneca A.E. Τηλ: + 30 210 6871500
Maltese: Τηλ: + 30 210 6871500
English: Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Maltese: Raxx, Raxx makulo-papulari, Raxx pruritku, Raxx eritematiku, Raxx papulari, Dermatite, Dermatite akneiforma, Eruzzjoni tossika tal-ġilda.
English: • Increase of bilirubin (bile pigment produced by the liver)
Maltese: • Żieda fil-bilirubin, (pigment biljari magħmul mill-fwied)
English: Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its antiestrogenic activity, at doses similar to the clinical dose.
Maltese: Fulvestrant wera effetti fuq is-sistema riproduttiva u l-iżvilupp tal-embriju/fetu konsistenti malazzjoni antiestroġenika tiegħu b'dożi simili għal dik klinika.
English: Faslodex + placebo (N=172)
Maltese: Faslodex + plaċebo (N=172)
English: The frequency has been calculated using the upper limit of the 95% confidence interval for the point estimate.
Maltese: Il-frekwenza ġiet ikkalkulata permezz tal-limitu ta' fuq tal-intervall ta' fiduċja ta' 95% għall-estimi tal-punt.
English: Uncommon Febrile neutropenia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Common Dysgeusia Eye disorders Common Lacrimation increased Vision blurred Dry eye Respiratory, thoracic and mediastinal disorders Common Epistaxis Gastrointestinal disorders Very common Nausea Stomatitis Diarrhoea Vomiting Skin and subcutaneous tissue disorders Very common Alopecia Rash Common Dry skin General disorders and administration site conditions Very common Fatigue Pyrexia Common Asthenia Investigations Common AST increased ALT increased
Maltese: Komuni ħafna Newtropenja Lewkopenja Anemija Tromboċitopenia Mhux komuni Newtropenja bid-deni Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna Nuqqas ta' aptit Disturbi fis-sistema nervuża Komuni Diżgewżja Disturbi fl-għajnejn Komuni Żieda fil-lakrimazzjoni Vista mċajpra Għajn xotta Disturbi respiratorji, toraċiċi u medjastinali Komuni Epistassi Disturbi gastro-intestinali
English: Clinical interaction studies with rifampicin (inducer of CYP3A4) and ketoconazole (inhibitor of CYP3A4) showed no clinically relevant change in fulvestrant clearance.
Maltese: Riżultati li ħarġu minn studji kliniċi, fuq l-interazzjoni ma' rifampiċin (iżid l-attività ta' CYP 3A4) u ma ketoconazole (inibitur potenti ta' CYP 3A4), ma wrew l-ebda evidenza ta' tibdil klinikament relevanti fit-tneħħija ta' fulvestrant.
English: Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-ToTreat Population) ─ FALCON Study
Maltese: Figura 1 Plott Kaplan-Meier ta' Sopravivenza Mingħajr il-Marda (Valuazzjoni talInvestigatur, Intenzjoni li Jikkura l-Popolazzjoni ─ l-istudju FALCON
English: Faslodex 250 mg solution for injection fulvestrant
Maltese: Faslodex 250 mg soluzzjoni għall-injezzjoni fulvestrant
English: 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.
Maltese: Total ta' 335 pazjenta fil-fergħa ta' Faslodex u palbociclib u 166 pazjenta fil-fergħa ta' Faslodex u l-plaċebo mlew il-kwestjonarju fil-linja bażi u tal-inqas żjara 1 wara l-linja bażi.
English: Fulvestrant has a high clearance, 11±1.7 ml/min/kg, suggesting a high hepatic extraction ratio.
Maltese: Fulvestrant għandu eliminazzjoni qawwija, 11±1.7ml/min/kg li tissuġġerixxi proporzjon għoli ta' estrazzjoni epatika.
English: Warning - Do not autoclave safety needle (BD SafetyGlide Shielding Hypodermic Needle) before use.
Maltese: Tisterilizzax il-labra tas-sigurtà (BD SafetyGlide Shielding Hypodermic Needle) qabel l-użu.
English: Faslodex plus palbociclib (N=206)
Maltese: Faslodex u palbociclib (N=206)
English: Faslodex plus palbociclib (N=141)
Maltese: Faslodex u palbociclib (N=141)
English: • in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy (see section 5.1).
Maltese: • flimkien ma' palbociclib għall-kura ta' kanċer tas-sider pożittiv għar-riċettur tal-ormon (HR, hormone receptor), negattiv għar-riċettur 2 tal-fattur tat-tkabbir epidermali filbniedem (HER2, human epidermal growth factor receptor 2), lokalment avvanzat jew metastatiku fin-nisa li rċivew terapija endokrinali minn qabel (ara sezzjoni 5.1).
English: • Thick, whitish vaginal discharge and candidiasis (infection)
Maltese: • Tisfija magħquda u bajdanija mill-vaġina u kandidjażi (infezzjoni)
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).
Maltese: Il-punt tat-tmien tal-effikaċja primarju tal-istudju kien is-sopravivenza mingħajr il-marda (PFS) ivvalutata mil-investigatur evalwata skont RECIST 1:1 (Kriterji ta' Evalwazzjoni tar-Reazzjoni f'Tumuri Solidi).
English: Administration of Faslodex 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).
Maltese: Meta jingħata Faslodex 500 mg, jintlaħqu livelli ta' esponiment daqs jew viċin ta' stat fiss mal-ewwel xahar ta' dożaġġ (medja [CV]; AUC 475 [33.4%] ng.ġranet/ml, Cmax 25.
English: 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).
Maltese: Is-sintomi rrappurtati mill-pazjenti ġew ivvalutati bl-użu tal-kwestjonarju dwar il-kwalità tal-ħajja (QLQ, quality of life questionnaire)-C30 tal-Organizzazzjoni Ewropea għar-Riċerka u l-Kura talKanċer (EORTC, European Organization for Research and Treatment of Cancer) u l-Modulu talKanċer tas-Sider tagħha (EORTC QLQ-BR23).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/
English: 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.
Maltese: Il-metaboliżmu ta' fulvestrant ma ġiex evalwat kompletament, iżda jinvolvi kombinazzjonijiet ta' mogħdijiet ta' bijotransformazzjoni possibbli analogi għal dawk tal-isterojdi endoġini.
English: Faslodex 250 mg solution for injection.
Maltese: Faslodex 250 mg soluzzjoni għall-injezzjoni.
English: 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.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni (≥20%) ta' kwalunkwe grad irrappurtati f'pazjenti li kienu qed jirċievu fulvestrant flimkien ma' palbociclib kienu newtropenja, lewkopenja, infezzjonijiet, għeja, dardir, anemija, stomatite, dijarea u tromboċitopenia.
English: All Patients -AE subgroup (n=423) -AI subgroup (n=313)
Maltese: -Sotto grupp ta' AE (n=423) -Sotto grupp ta' AI (n=313)
English: - previous problems with blood clots - osteoporosis (loss of bone density) - alcoholism
Maltese: - osteoporożi (telf fid-densità tal-għadam) - alkoħoliżmu
English: How to use Faslodex
Maltese: X'fih Faslodex
English: Table 5 Efficacy results - PALOMA3 study (Investigator assessment, intent-to-treat population)
Maltese: Riżultati tal-effikaċja - studju PALOMA3 (Valutazzjoni mill-investigatur, popolazzjoni bl-intenzjoni li tiġi kkurata)
English: 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.
Maltese: Aktar minn nofs (62%) kellhom ECOG PS ta' 0, 60% kellhom metastażi vixxerali, u 60% kienu rċivew aktar minn reġimen ormonali 1 minn qabel għad-dijanjożi primarja tagħhom.
English: • Peel open the safety needle (SafetyGlide) outer packaging.
Maltese: • Qaxxar u iftaħ il-pakkett ta' barra tal labra tas-sigurtà (SafetyGlide).
English: Environmental risk assessment studies have shown that fulvestrant may have potential to cause adverse effects to the aquatic environment (see section 6.6).
Maltese: Studji dwar l-istima tar-riskju ambjentali wrew li fulvestrant jista' jkollu potenzjal li jikkawża effetti avversi għall-ambjent akwatiku (ara sezzjoni 6.6).
English: • Numbness, tingling and pain
Maltese: • Tnemnim, tingiż u uġigħ
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi wieħed mill-eċċipjenti elenkati f'sezzjoni 6.1.
English: A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of Faslodex 500 mg plus palbociclib 125 mg versus Faslodex 500 mg plus placebo was conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo) adjuvant or metastatic setting.
Maltese: Sar studju ta' Fażi 3, internazzjonali, randomizzat, double-blind, ta' grupp parallel, multiċentriku ta' Faslodex 500 mg flimkien ma' palbociclib 125 mg kontra Faslodex 500 mg flimkien malplaċebo f'nisa b'kanċer tas-sider pożittiv għall-HR, negattiv għall-HER, lokalment avvanzat mhux amenabbli għal resezzjoni jew terapija b'radjazzjoni b'intenzjoni li tikkura jew b'kanċer tas-sider metastatiku, irrispettivament mill-istatus tal-menopawża tagħhom, li l-marda tagħhom avvanzat wara terapija endokrinali fl-ambjent (neo) aġġuvanti jew metastatiku.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Preclinical data do not suggest a stimulatory effect of fulvestrant on the postmenopausal endometrium (see section 5.3).
Maltese: Dejta preklinika ma tindikax effett stimulanti ta' fulvestrant fuq l-endometriju fi żmien ta' wara lmenopawża (ara sezzjoni 5
English: Table 3 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints in the CONFIRM study
Maltese: Tabella 3 Sommarju tar-riżultati tal-punt tat-tmiem primarju tal-effikaċja (PFS) u punti ta' tmiem sekondarji importanti dwar l-effikaċja fl-istudju CONFIRM
English: Faslodex plus placebo (N=69)
Maltese: Faslodex u plaċebo (N=69)
English: Faslodex contains 10% w/v ethanol (alcohol) as an excipient, i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Maltese: Falsodex fih 10% w/v etanol (alkoħol) bħala eċċipjent, jiġifieri sa 500 mg għal kull injezzjoni, ekwivalenti għal 10 ml birra jew 4 ml inbid.
English: Faslodex plus placebo (N=105)
Maltese: Faslodex u plaċebo (N=105)
English: AstraZeneca A/S Tlf: +45 43 66 64 62
Maltese: Tlf: +45 43 66 64 62
English: In vitro data suggest that fulvestrant does not inhibit CYP450 isoenzymes.
Maltese: Dejta in vitro tissuġġerixxi li fulvestrant ma jimpedixxix l-isoenżimi CYP450.
English: Adverse reactions by system organ class and frequency Infections and infestations
Maltese: Reazzjonijiet avversi skont il-klassi tal-organu tas-sistema Infezzjonijiet u infestazzjonijiet
English: CBR Odds Ratio (95% CI) and p-value
Maltese: Proporzjon ta' Probabilità CBR (95 % CI) u valur-p
English: Faslodex and other formulations of fulvestrant were well tolerated in animal species used in multiple dose studies.
Maltese: Faslodex u formulazzjonijiet oħra ta' fulvestrant ġew ittollerati tajjeb fi speċi tal-annimali użati fi studji b'dożi multipli.
English: This medicine may pose a risk to the aquatic environment.
Maltese: Din il-mediċina tista' toħloq riskju għall-ambjent akwatiku.
English: The paediatric patients received 4 mg/kg monthly intramuscular dose of fulvestrant.
Maltese: Il-pazjenti pedjatriċi rċivew doża ta' 4 mg/kg fulvestrant fil-muskolu fix-xahar.
English: Table 1 Adverse Drug Reactions reported in patients treated with Faslodex monotherapy
Maltese: Tabella1 Reazzjonijiet Avversi tal-Mediċina rrappurtati f'pazjenti kkurati b'monoterapija b'Faslodex
English: 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]).
Maltese: Dan kien evidenti fin-nisa ta' qabel/waqt ilmenopawża (HR ta' 0.46 [95% CI: 0.28, 0.75]) u fin-nisa li għaddew mill-menopawża (HR ta' 0.52 [95% CI: 0.40, 0.66]) u f'pazjenti b'sit vixxerali ta' marda metastatika (HR ta' 0.50
English: Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 6.
Maltese: Il-kejl taleffikaċja addizzjonali (OR u TTR) ivvalutat fis-sottogruppi tal-pazjenti bi jew mingħajr mard vixxerali qed jidher f'Tabella 6.
English: Temperature excursions outside 2°C - 8°C should be limited.
Maltese: Id-drabi li l-prodott ma jinżammx f'temperatura ta' bejn 2°C u 8°C għandhom ikunu limitati.
English: Approximately 20% of patients were pre/perimenopausal.
Maltese: Madwar 20 % tal-pazjenti kienu fi żmien ta' qabel/waqt ilmenopawża.
English: Table 4 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints (Investigator Assessment, Intent-To-Treat Population) ─ FALCON study
Maltese: Tabella 4 Sommarju tar-riżultati tal-punt tat-tmiem primarju tal-effikaċja u punti ta' tmiem sekondarji importanti dwar l-effikaċja fl-istudju (Valutazzjoni tal-Investigatur, Intenzjoni li Jikkura l-Popolazzjoni) ─ l-istudju FALCON
English: One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Maltese: Siringa diġa` mimlija u li fiha 250mg fulvestrant f'soluzzjoni ta' 5ml.
English: K-M median in months; hazard ratio
Maltese: K-M medjan f'xuhur; proporzjon ta' periklu
English: Faslodex contains 10% w/v ethanol (alcohol), i.e. up to 500 mg per injection, equivalent to 10 ml beer or 4 ml wine.
Maltese: Faslodex fih 10% w/v ethanol (alkoħol), jiġifieri sa 500 mg kull injezzjoni, ekwivalenti għal 10 ml birra jew 4 ml inbid f'kull doża.
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.
Maltese: Fi studju tal-onkoġeniċità ta' sentejn fil-ġrieden (amministrazzjoni mill-ħalq kuljum) kien hemm żieda fil-frekwenza ta' tumuri stromali tal-korda sesswali tal-ovarji (kemm bennini kif ukoll malinni) f'dożi ta' 150 u 500 mg/kg/jum.
English: Faslodex contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Maltese: Faslodex fih is-sustanza attiva fulvestrant li tagħmel parti mill-grupp li jimblokka l-estroġenu.
English: There was also a significant decrease in progesterone receptor expression consistent with a lack of intrinsic estrogen agonist effects.
Maltese: Kien hemm ukoll nuqqas sinifikanti f'espressjonijiet tar-riċettur ta' progesterone konsistenti ma' nuqqas ta' effetti agonistiċi intrinsiċi estroġenali.
English: Median duration of exposure to palbociclib in the fulvestrant + palbociclib arm was 10.8 months.
Maltese: Id-durata medjana tal-esponiment għal palbociclib fil-fergħa ta' fulvestrant + palbociclib kienet 10.
English: The major route of excretion is via the faeces, with less than 1% being excreted in the urine.
Maltese: Il-mod prinċipali ta' eliminazzjoni huwa permezz tal-ippurgar u inqas minn 1% jiġi eliminat fl-awrina.
English: The majority of patients (87.0%) had metastatic disease at baseline.
Maltese: Ilmaġġoranza tal-pazjenti (87.0 %) kellhom marda metastatika fil-linja bażi.
English: 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).
Maltese: Il-farmakokinteka ta' fulvestrant ġiet evalwata fi studju kliniku b'doża waħda li sar fuq nisa b'indeboliment epatiku ħafif sa moderat (Child-Pugh klassi A u B).
English: For the subgroup of patients with disease limited to non-visceral metastasis (n=208), the HR was 0.592 (95% CI: 0.419, 0.837) for the Faslodex arm compared to the anastrozole arm. For the subgroup of patients with visceral metastasis (n=254), the HR was 0.993 (95% CI: 0.740, 1.331) for the Faslodex arm compared to the anastrozole arm.
Maltese: Għas-sottogrupp ta' pazjenti b'metastażi vixxerali (n=254), l-HR kien ta' 0.993 (95 % CI: 0.740, 1.331) għall-fergħa ta' Faslodex meta mqabbel mal-fergħa ta' anastrozole.
English: Very low density lipoprotein (VLDL), low density lipoprotein (LDL), and high density lipoprotein (HDL) fractions are the major binding components.
Maltese: Fulvestrant jeħel ħafna (99%) mal-proteini tal-plasma. Lipoproteini ta' densità żgħira ħafna (VLDL), lipoproteini ta' densità żgħira (LDL) u lipoproteini ta' densità għolja (HDL) huma l-komponenti li l-aktar li jeħlu.
English: ORR Odds Ratio (95% CI) and p-value
Maltese: Proporzjon ta' Probabilità ORR (95 % CI) u valur-p
English: Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Hazard ratio 95% CI p-value
Maltese: Tqabbil bejn gruppi (Faslodex 500 mg/Faslodex 250 mg) Proporzjon ta' periklu
English: Neutropenia
Maltese: Infezzjonijiet
English: When Faslodex is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Maltese: Meta Faslodex jingħata flimkien ma' palbociclib, huwa importanti li inti taqra wkoll il-fuljett ta' tagħrif għal palbociclib.
English: Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Maltese: Kull siringa mimlija għal-lest (5 ml) fiha 250 mg fulvestrant.
English: Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations in gonadotropin levels caused by antiestrogens in cycling animals.
Maltese: L-induzzjoni ta' dawn it-tumuri hija konsistenti ma' tibdil endokrinali relatat malfarmakoloġija fil-livelli ta' gonadotrophin ikkawżati mill-antiestroġeni fl-annimali fiċ-ċiklu.
English: Faslodex 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Maltese: Faslodex 500 mg (2 x 250 mg/5ml soluzzjoni għall-injezzjoni) għandu jingħata billi tuża żewġ. siringi mimlijin għal-lest, ara sezzjoni 3.
English: 2 pre-filled syringes (5 ml each) 2 safety needles
Maltese: 2 Siringi diġa' mimlija (5 ml kull waħda)
English: • Attach the safety needle to the Luer-Lok and twist until firmly seated (see Figure 3).
Maltese: • Qabbad il-labra tas-sigurtà mal-Luer Lok u dawwar sakemm tkun tpoġġiet sew (ara Figura. 3).
English: Faslodex plus placebo (N=174)
Maltese: Faslodex u l-plaċebo (N=174)
English: Faslodex should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Maltese: Faslodex għandu jintuża b'kawtela f'pazjenti b'indeboliment tal-fwied minn ħafif għal moderat (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Faslodex should be administered as two consecutive 5 ml injections by slow intramuscular injection (1-2 minutes/injection), one in each buttock (gluteal area).
Maltese: Faslodex għandu jingħata bħala żewġ injezzjonijiet ta' 5 ml konsekuttivi, bil-mod, fil-muskolu tal-warrani (1-2 minuti kull injezzjoni), waħda fuq kull naħa tal-warrani (żona gluteali).
English: Vomiting, diarrhoea
Maltese: Rimettar u dijarea
English: • Expel excess gas from the syringe.
Maltese: • Neħħi l-arja żejda mis-siringa.
English: 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).
Maltese: Dan jinkludi l-evitar tal-ħżin f'temperatura ta' aktar minn 30°C, u l-ħżin għal perjodu ta' aktar minn 28 jum fejn it-temperatura medja tal-ħżin għall-prodott tkun hija inqas minn 25°C (iżda aktar minn 2°C - 8°C).
English: ANAS1 232
Maltese: ANNESS II
English: Type of estimate; treatment comparison
Maltese: Tip ta' stima; tqabbil talkura