FrancophonIA/ELRC3.0 huggingface dataset:
English: Comparison between groups (Fulvestrant 500 mg/Fulvestrant 250 mg)
Maltese: Tqabbil bejn gruppi (Fulvestrant 500 mg/Fulvestrant 250 mg) Differenza assoluta f'%
English: - osteoporosis (loss of bone density) - alcoholism
Maltese: - osteoporożi (telf fid-densità tal-għadam) - alkoħoliżmu
English: Neuropathy peripherale, sciaticae
Maltese: Newropatija periferalie, xjatikae
English: • Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area).
Maltese: • Agħti bil-mod fil-muskolu tal-warrani (12 minuti/injezzjoni)(iż-żona gluteali).
English: Fulvestrant plus palbociclib (N=141)
Maltese: Fulvestrant u palbociclib (N=141)
English: Vaginal moniliasis f, leukorrhea f
Maltese: Monilasi vaġinalif, leukorrheaf
English: Vaginal haemorrhagee
Maltese: Emorraġija vaġinalie
English: Venous thromboembolisma
Maltese: Tromboemboliżmu fil-vinia
English: 2 pre-filled syringes (5 ml each) 2 safety needles
Maltese: 2 siringi mimlija għal-lest (5 mL kull waħda) 2 labar tas-sigurtà
English: Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat 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: Mylan EPD d.o.o.
Maltese: Mylan Hrvatska d.o.o.
English: A total of 335 patients in the fulvestrant plus palbociclib arm and 166 patients in the fulvestrant plus placebo arm completed the questionnaire at baseline and at least 1 post-baseline visit.
Maltese: Total ta' 335 pazjenta fil-fergħa ta' fulvestrant u palbociclib u 166 pazjenta fil-fergħa ta' fulvestrant u l-plaċebo mlew il-kwestjonarju fil-linja bażi u tal-inqas żjara 1 wara l-linja bażi.
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' CYP3A4) u ma ketoconazole (inibitur potenti ta' CYP3A4), ma wrew l-ebda evidenza ta' tibdil klinikament relevanti fit-tneħħija ta' fulvestrant.
English: Supportive PFS analyses were based on an Independent Central Radiology Review.
Maltese: Analiżijiet ta' PFS ta' sostenn kienu bbażati fuq Reviżjoni tar-Radjoloġija Ċentrali Indipendenti.
English: A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of fulvestrant 500 mg plus palbociclib 125 mg versus fulvestrant 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' fulvestrant 500 mg flimkien ma' palbociclib 125 mg kontra fulvestrant 500 mg flimkien mal-plaċebo 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: Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its anti-estrogenic activity, at doses similar to the clinical dose.
Maltese: Fulvestrant wera effetti fuq is-sistema riproduttiva u l-iżvilupp tal-embriju/fetu konsistenti mal-azzjoni antiestroġenika tiegħu b'dożi simili għal dik klinika.
English: This study compared the efficacy and safety of fulvestrant 500 mg (n=362) with fulvestrant 250 mg (n=374).
Maltese: Din il-prova qabblet l-effikaċja u s-sigurta ta' fulvestrant 500 mg (n=362) ma' fulvestrant 250 mg (n=374).
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.
Maltese: Dan il-prodott mediċinali fih l-ethanol (alkoħol), i.e. sa 1000 mg f'kull doża, ekwivalenti għal 20 mL birra jew 8 mL inbid f'kull doża.
English: Fulvestrant Mylan 500 mg (2 x 250 mg/5 ml solution for injection) should be administered using two pre-filled syringes, see section 3.
Maltese: Fulvestrant Mylan 500 mg (2 × 250 mg/5 mL soluzzjoni għall-injezzjoni) għandu jingħata billi tuża żewġ siringi mimlija għal-lest, ara sezzjoni 3.
English: Fulvestrant has a high clearance, 11±1.7 ml/min/kg, suggesting a high hepatic extraction ratio.
Maltese: Fulvestrant għandu eliminazzjoni qawwija, 11±1.7 mL/min/kg li tissuġġerixxi proporzjon għoli ta' estrazzjoni epatika.
English: • Abnormal levels of liver enzymes (in blood tests)*
Maltese: • Livelli anormali tal-enzimi tal-fwied (fit-testijiet tad-demm)*
English: palbociclib+fulvestrant placebo+fulvestrant
Maltese: Kif jidher Fulvestrant
English: Interference with estradiol antibody assays
Maltese: Interferenza ma' assaġġi ta' antikorpi ta' estradiol
English: Fulvestrant Mylan is used either:
Maltese: Fulvestrant Mylan jintuża jew:
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 fil-bniedem (HER2, human epidermal growth factor receptor 2), lokalment avvanzat jew metastatiku fin-nisa li rċivew terapija endokrinali minn qabel (ara sezzjoni 5.1).
English: Caution should be taken while administering fulvestrant at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and 4.8).
Maltese: Għandha tingħata kawtela waqt li fulvestrant jingħata fis-sit tal-injezzjoni dorsogluteali minħabba l-prossimità tan-nerv xjatiku sottostanti (ara s-sezzjonijiet 4.2 u 4.8).
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.
Maltese: ALT= alanina aminotransferażi; AST= aspartat aminotransferażi; N/n=numru ta' pazjenti; N/A=mhux applikabbli.
English: Other medicines and Fulvestrant Mylan
Maltese: Mediċini oħra u Fulvestrant
English: Induction of such tumours is consistent with pharmacology-related endocrine feedback alterations in gonadotropin levels caused by anti-estrogens in cycling animals.
Maltese: L-induzzjoni ta' dawn it-tumuri hija konsistenti ma' tibdil endokrinali relatat mal-farmakoloġija fil-livelli ta' gonadotrophin ikkawżati mill-antiestroġeni fl-annimali fiċ-ċiklu.
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 3 u f'Figura 1.
English: Fulvestrant plus placebo (N=174)
Maltese: Fulvestrant u l-plaċebo (N=174)
English: Table 1 Adverse Drug Reactions reported in patients treated with fulvestrant monotherapy
Maltese: Tabella 1 Reazzjonijiet Avversi tal-Mediċina rrappurtati f'pazjenti kkurati b'monoterapija b'fulvestrant
English: Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Maltese: Fulvestrant Mylan 250 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest fulvestrant
English: Warning - Do not autoclave safety needle (BD SafetyGlide Shielding Hypodermic Needle) before use.
Maltese: Twissija - Tisterilizzax il-labra tas-sigurtà (BD SafetyGlide Shielding Hypodermic Needle) qabel l-użu.
English: Fulvestrant Mylan contains the active substance fulvestrant, which belongs to the group of estrogen blockers.
Maltese: Fulvestrant Mylan fih is-sustanza attiva fulvestrant li tagħmel parti mill-grupp li jimblokka l-estroġenu.
English: There are no data in patients with severe hepatic impairment (see sections 4.3, 4.4 and 5.2).
Maltese: M'hemm l-ebda dejta fuq pazjenti b'indeboliment serju tal-fwied (ara s-sezzjonijiet 4.3, 4.4 u 5.2).
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 il-menopawża (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: 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 filfrekwenza ta' tumuri stromali tal-korda sesswali tal-ovarji (kemm bennini kif ukoll malinni) f'dożi ta' 150 u 500 mg/kg/jum.
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).
Maltese: Dawn l-istudji qabblu s-sigurtà u leffikaċja talamministrazzjoni ta' 250 mg fulvestrant kull xahar ma' anastrozole, (inibittur ta' aromatase) b'doża ta' 1 mg kuljum.
English: OR [% (95% CI)] TTR*, Median [months (range)]
Maltese: OR [% (CI ta' TTR*, Medjan [xhur (medda)]
English: Figure 2
Maltese: Figura 2.
English: The terminal half-life (t1/2) after intramuscular administration is governed by the absorption rate and was estimated to be 50 days.
Maltese: Il-half-life terminali (t½) jiġi regolat skont ir-rata ta' assorbiment u ġiet stmata li hi ta' madwar 50 jum.
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).
Maltese: Fulvestrant Mylan għandu jingħata bħala żewġ injezzjonijiet ta' 5 mL konsekuttivi, bil-mod, filmuskolu tal-warrani (1 - 2 minuti kull injezzjoni), waħda fuq kull naħa tal-warrani (żona gluteali).
English: DOR (measurable disease) [months (95% CI)]
Maltese: DOR (marda li titkejjel) [xhur (CI ta' 95%)]
English: When fulvestrant is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Maltese: Meta fulvestrant jingħata flimkien ma' palbociclib, huwa importanti li inti taqra wkoll il-fuljett ta' tagħrif għal palbociclib.
English: Fulvestrant plus placebo (N=69)
Maltese: Fulvestrant u lplaċebo (N=69)
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).
Maltese: dożaġġ (medja [CV]: AUC 475 [33.4%] ng.jiem, Cmax 25.
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 prova klinika b'doża waħda li sar fuq nisa b'indeboliment epatiku ħafif sa moderat (Child-Pugh klassi A u B).
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).
Maltese: Id-drabi li l-prodott ma jinżammx f'temperatura ta' 2°C - 8°C għandhom ikunu limitati, u l-ħżin għal perjodu ta' aktar minn 28 jum fejn it-temperatura medja tal-ħżin għall-prodott tkun inqas minn 25°C (iżda aktar minn 2°C - 8°C).
English: h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular,
Maltese: Raxx, Raxx makulo-papulari, Raxx pruritku, Raxx eritematiku, Raxx papulari,
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 fulvestrant 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 fulvestrant 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' fulvestrant meta mqabbel mal-fergħa ta' anastrozole.
English: There was an increased incidence of foetal variations in rabbits (backwards displacement of the pelvic girdle and 27 pre-sacral vertebrae).
Maltese: Kien hemm żieda fl-inċidenza ta' varjazzjonijiet fetali fil-fniek (iċ-ċintura pelvika u s-27 vertebra pre-sakrali resqu lura).
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 tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Fulvestrant plus placebo (N=105)
Maltese: Fulvestrant u lplaċebo (N=105)
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa mimlija għal-lest u li fiha 250 mg fulvestrant f'soluzzjoni ta' 5 mL.
English: The paediatric patients were aged 1 to 8 years and received 4 mg/kg monthly intramuscular dose of fulvestrant.
Maltese: Il-pazjenti pedjatriċi kellhom bejn 1 sa 8 snin u rċivew doża ta' 4 mg/kg fil-muskolu fix-xahar ta' fulvestrant.
English: Fertility The effects of fulvestrant on fertility in humans has not been studied.
Maltese: Fertilità L-effetti ta' fulvestrant fuq il-fertilità fin-nies ma ġewx studjati.
English: A total of 17.1% of patients received a prior chemotherapy regimen for advanced disease; 84.2% of patients had measurable disease.
Maltese: Total ta' 17.1% tal-pazjenti rċivew reġimen ta' kimoterapija preċedenti għal marda avvanzata; 84.2 % kellhom marda li tista' titkejjel.
English: The results in the AI subgroup are inconclusive.
Maltese: Ir-riżultati fis-sotto grupp AI mhumiex konklussivi.
English: In the pooled dataset of fulvestrant monotherapy, the most frequently reported adverse reactions were injection site reactions, asthenia, nausea, and increased hepatic enzymes (ALT, AST, ALP).
Maltese: Fis-sett tad-dejta miġbur ta' monoterapija ta' fulvestrant, ir-reazzjonijiet avversi rrapportati l-aktar frekwenti kienu reazzjonijiet fis-sit tal-injezzjoni, astenja, dardir u żieda fl-enżimi epatiċi (ALT, AST, ALP).
English: The large apparent volume of distribution at steady state (Vdss) of approximately 3 to 5 l/kg suggests that distribution is largely extravascular.
Maltese: Il-volum kbir apparenti ta' distribuzzjoni fi stat fiss (Vdss) huwa bejn wieħed u ieħor minn 3 sa 5 l/kg, li jissuġġerixxi li d-distribuzzjoni komposta tas-sustanza hija fil-parti l-kbira tagħha ekstra-vaskulari.
English: Approximately 20% of patients were pre/perimenopausal.
Maltese: Madwar 20% tal-pazjenti kienu fi żmien ta' qabel/waqt il-menopawża.
English: Elevated bilirubina
Maltese: GĦAMLA KWALITTATIVA
English: Progression-Free Survival Median [months (95% CI)] Hazard ratio (95% CI) and p-value
Maltese: Sopravivenza Mingħajr Progressjoni Medjana [xhur (CI ta' 95%)] Proporzjon ta' riskju (CI ta' 95%) u valur-p
English: Ethanol, anhydrous
Maltese: • Reazzjonijiet anafilattiċi
English: Each pre-filled syringe (5 ml) contains 250 mg fulvestrant.
Maltese: Kull siringa mimlija għal-lest (5 mL) fiha 250 mg fulvestrant.
English: The steady-state trough concentrations of fulvestrant in children in this study were consistent with that in adults (see section 5.2).
Maltese: Il-konċentrazzjonijiet minimi ta' stat fiss ta' fulvestrant fit-tfal f'dan l-istudju kienu konsistenti ma dawk fl-adulti (ara sezzjoni 5.2).
English: Figure 2 Kaplan-Meier plot of progression-free survival (investigator assessment, intentto-treat population) - PALOMA3 study
Maltese: Plott Kaplan-Meier ta' sopravivenza mingħajr progressjoni (valutazzjoni millinvestigatur, popolazzjoni bl-intenzjoni li tiġi kkurata) - studju PALOMA3 palbociclib + fulvestrant ---- plaċebo + fulvestrant
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 tal-effikaċja addizzjonali (OR u TTR) ivvalutat fis-sottogruppi tal-pazjenti bi jew mingħajr mard vixxerali qed jidher f'Tabella 6.
English: Very common Hypersensitivity reactionse Uncommon
Maltese: Reazzjonijiet ta' sensittività eċċessivae
English: 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.
Maltese: F'pazjenti li kienu qed jiriċevu fulvestrant flimkien ma' palbociclib, iż-żmien medjan għall-ewwel episodju ta' newtropenja ta' kwalunkwe grad kien ta' 15-il jum (medda: 13-317) u d-durata medjana ta' newtropenja ta' Grad ≥3 kienet ta' 7 ijiem.
English: - The other ingredients (excipients) are benzyl benzoate, benzyl alcohol, ethanol, anhydrous, castor oil, refined.
Maltese: - Is-sustanzi mhux attivi l-oħra (eċċipjenti) huma benzyl benzoate, benzyl alcohol, ethanol,
English: Mechanism of action and pharmacodynamic effects Fulvestrant is a competitive estrogen receptor (ER) antagonist with an affinity comparable to estradiol.
Maltese: Fulvestrant huwa antagonista kompetittiv tar-riċettur tal-estroġenu u jeħel mar-riċetturi tal-estroġenu b'affinità li komparabbli ma' dik ta' estradiol.
English: f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Maltese: f It-tromboċitopenia tinkludi l-PTs li ġejjin:
English: IM use
Maltese: UŻU
English: This medicine contains 500 mg benzyl alcohol in each 5 ml.
Maltese: Din il-mediċina fiha 500 mg benzyl alcohol f'kull 5 ml. Benzyl alcohol jista 'jikkawża reazzjonijiet allerġiċi.
English: The term injection site reactions does not include the terms injection site haemorrhage, injection site haematoma, sciatica, neuralgia and neuropathy peripheral.
Maltese: Bl-injezzjoni ta' fulvestrant ġew irrappurtati episodji relatati mas-sit tal-injezzjoni inklużi xjatika, newralġija, uġigħ newropatiku, u newropatija periferali.
English: Renal impairment
Maltese: Reazzjonijiet anafilattiċi
English: The primary endpoint of the study was investigator-assessed PFS evaluated according to RECIST 1.1.
Maltese: L-end-point primarju tal-istudju kien il-PFS ivvalutata mill-investigatur evalwata skont RECIST1.1.
English: CARTON
Maltese: Mylan
English: Joint and musculoskeletal pain
Maltese: Uġigħ fil-ġogi u fil-muskoluskeletriċid
English: NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Fulvestrant Mylan at the dorsogluteal injection site (see section 4.4).
Maltese: Mylan jingħata fit-sit tal-injezzjoni dorsoglutejali (ara s-sezzjoni 4.4).
English: There is no evidence of adverse endometrial effects in the breast cancer patients studied.
Maltese: Ma hemm l-ebda evidenza tal-effetti endometrijali avversi filpazjenti b'kanċer tas-sider li ġew studjati.
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.
Maltese: Ġie osservat tnaqqis fir-riskju tal-progressjoni tal-marda jew mewt fil-fergħa ta' fulvestrant u palbociclib fis-sottogruppi tal-pazjenti individwali kollha definit permezz ta' fatturi ta' stratifikazzjoni u karatteristiċi tal-linja bażi.
English: • Peel open the safety needle (SafetyGlide) outer packaging.
Maltese: • Qaxxar u iftaħ il-pakkett ta' barra tal-labra tas-sigurtà (SafetyGlide).
English: When fulvestrant is combined with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Maltese: Meta fulvestrant ħa jiġi kkombinat ma' palbociclib, jekk jogħġbok irreferi wkoll għas-Sommarju talKaratteristiċi tal-Prodott ta' palbociclib.
English: 4.4 Special warnings and precautions for use Fulvestrant should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Maltese: Fulvestrant għandu jintuża b'kawtela f'pazjenti b'indeboliment tal-fwied minn ħafif għal moderat (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Type of estimate; treatment comparison
Maltese: Tip ta' stima; tqabbil tal-kura
English: A two-year oncogenicity study in rats (intramuscular administration of fulvestrant) 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.
Maltese: Studju tal-onkoġeniċità ta' sentejn fil-firien, (fulvestrant mogħti ġol-muskolu) wera żieda fl-inċidenza ta' tumuri beninni taċ-ċelluli granulożi tal-ovarji fil-firien nisa bid-doża l-għolja, 10 mg/far/15-il ġurnata u żdiedet ukoll l-inċidenza ta' tumuri testikulari taċ-ċelluli Leydig fil-firien irġiel.
English: The study met its primary endpoint of prolonging investigator-assessed PFS at the interim analysis conducted on 82% of the planned PFS events; the results crossed the pre-specified Haybittle-Peto efficacy boundary (α=0.00135), demonstrating a statistically significant prolongation in PFS and a clinically meaningful treatment effect.
Maltese: L-istudju ssodisfa l-end-point primarju tiegħu li jtawwal il-PFS ivvalutata mill-investigatur fl-analiżi interim li saret fuq 82% tal-avvenimenti ppjanati ta' PFS; ir-riżultati għaddew il-konfini tal-effikaċja ta' Haybittle-Peto speċifikat minn qabel (α=0.00135), li wrew titwil statistikament sinifikanti fil-PFS u effett ta' kura klinikament sinifikanti.
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.
Maltese: Mill-65 pazjent fil-fergħa ta' fulvestrant, 40% (26/65) tal-pazjenti rrappurtaw uġigħ fil-ġogi u uġigħ muskolu-skeletriku fl-ewwel xahar tal-kura, u 66.2% (43/65) tal-pazjenti flewwel 3 xhur tal-kura.
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 Fig. 3).
English: Time (Month)
Maltese: NUMRU(I)
English: Updated Analysis (23 October 2015 cut-off) Fulvestrant plus palbociclib (N=347)
Maltese: Analiżi Aġġornata (cut-off tat-23 ta' Ottubru 2015)
English: • Vaginal bleeding
Maltese: • Insuffiċjenza tal-fwied
English: Stomatitisg Diarrhoea Vomiting Skin and subcutaneous tissue disorders Very common Alopecia Rashh Common Dry skin General disorders and administration site conditions Very common Fatigue Pyrexia Common Asthenia Investigations Common AST increased ALT increased
Maltese: • Dgħufija f'daqqa, tnemnim, tingiż, jew telf fil-moviment f'sieqek, b'mod speċjali fuq naħa waħda biss ta' ġismek, problemi għall-għarrieda fil-mixi jew fil-bilanċ (newropatija periferali)
English: • Thromboembolism (increased risk of blood clots)*
Maltese: • Tromboemboliżmu (riskju akbar li jiffurmaw emboli tad-demm)*
English: e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Maltese: a It-Termini Ppreferuti (PTs, Preferred Terms) huma mniżżla skont MedDRA 17.1.
English: Marketing Authorisation Holder MYLAN S.A.S.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq MYLAN S.A.S.