FrancophonIA/ELRC3.0 huggingface dataset:
English: The following should be included under cardiac disorders: “Very rare: cardiac valvulopathy (including regurgitation) and related disorders (pericarditis and pericardial effusion).”
Maltese: Li ġej għandu jkun inkluż taħt Disturbi fil-qalb: “Rari ħafna: valvulopatija tal-qalb (inkluż regurġitazzjoni) u disturbi relatati (perikardite u effużjoni perikardjali).”
English: 4.8 Undesirable effects: The following should be included under Cardiac disorders:
Maltese: .8 Effetti mhux mixtieqa:
English: “Very rare side effect (affecting less than one person in10.000): heart valve and related disorders e.g. inflammation (pericarditis) or leaking of fluid in the pericardium (pericardial effusion).
Maltese: 000): disturb tal-valv tal-qalb u disturbi relatati, e.ż. infjammazzjoni (perikardite) jew tnixxija ta' fluwidu fil-perikardju (effużjoni perikardjali).
English: He/she will also have an echocardiogram (an ultrasound test of the heart) taken before treatment is started.
Maltese: Huwa/hija ssirlu/ssirilha ekokardjogramma (test ultrasound tal-qalb) qabel it-trattament u f'intervalli regolari matul it-trattament.
English: To ensure recognition of retroperitoneal fibrosis at early reversible stage it is recommended that its manifestations (e.g. back pain, oedema of the lower limbs, impaired kidney function) should be watched in this category of patients.
Maltese: Biex naċċertaw għarfien ta` fibrożi retroperitonejali fi stadju kmieni u riversibbli huwa rikomandat li l-manifestazjonijiet (per eżempju ugieh fid-dar, edema fissaqajn, tnaqqis fil funzjoni tal-kliewi) għandom jiġu osservati f`din il-kategorija ta` pażjenti.
English: 4.2 Posology and method of administration The following should be reflected as appropriate: Restriction of maximum dose to 30 mg/day.
Maltese: Restrizzjoni tad-doża massima ghal 30mg kuljum
English: “Among patients on dihydroergocryptine, particularly on long-term and high-dose treatment, pleural and pericardial effusions, as well as pleural and pulmonary fibrosis and constrictive pericarditis have occasionally been reported.
Maltese: “Fost pazjenti fuq dihydroergocryptine, speċjalment b'kura fit-tul u b'doża għolja, kultant kienu irrapportati effużjonijiet plewrali u perikardjali, kif ukoll fibrożi plewrali u pulmonari u perikardite kostruttiva.
English: ANNEX III AMENDMENTS TO THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS
Maltese: GĦALL-PRODOTTI LI FIHOM LISURIDE
English: Dihydroergocryptine medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.”
Maltese: Medikazzjoni ta' dihydroergocryptine għandha titwaqqaf jekk ikunu ddijanjostikati jew suspettati bidliet fibrotiċi fir-retroperitonejum.
English: “In patients treated with ergot derivatives such as lisuride cases of pericarditis (inflammation of the outer lining of the heart) and pericardial effusion (accumulation of fluid between the outer lining of the heart and the heart itself) have been reported very rarely (affecting less than one person in
Maltese: “F'pazjenti kkurati b'derivattivi ta' l-ergot bħal lisuride, każijiet ta' perikardite (infjammazzjoni talkisja ta' barra tal-qalb) u ħruġ ta' likwidu mill-perikardju (akkumulazzjoni ta' fluwidu bejn il-kisja ta' barra tal-qalb u l-qalb innifisha) kienu rrappurtati b'mod rari ħafna (jaffettwaw inqas minn persuna waħda minn kull 10,000).
English: In a few patients on bromocriptine, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported.
Maltese: Jekk iseħħu reazzjonijiet fibrotiċi, it-trattament ikollu jitwaqqaf.
English: Patients with unexplained pleuropulmonary disorders should be examined thoroughly and discontinuation of dihydroergocryptine therapy should be contemplated.
Maltese: Pazjenti b'disturbi plewropulmonari mhux spjegati għandhom jiġu eżaminati bir-reqqa u għandu jiġi kkontemplat waqfien tat-terapija ta' dihydroergocryptine.
English: If necessary he/she will have an echocardiogram taken (an ultrasound test of your heart).
Maltese: Jekk meħtieġ hu/hija ser jieħu/tieħu ekokardjogramma (test ultrasoniku tal-qalb).
English: Section 2 “Before you take [product name]”:
Maltese: Oqgħod attent ħafna b'[isem tal-prodott]”:
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET FOR BROMOCRIPTINE CONTAINING MEDICINAL PRODUCTS
Maltese: GĦALL-PRODOTTI LI FIHOM BROMOCRIPTINE
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR DIHYDROERGOCRYPTINE CONTAINING MEDICINAL PRODUCTS
Maltese: TAL-PRODOTT GĦALL-PRODOTTI LI FIHOM DIHYDROERGOCRYPTINE
English: 7 October 2011
Maltese: 7 ta' Ottubru 2011
English: What is Norvasc?
Maltese: X'inhu Norvasc?
English: Amlodipine is a calcium channel blocker.
Maltese: Amlodipine huwa imblokkatur tal-kanali tal-kalċju.
English: Norvasc is medicine that contains the active substance amlodipine.
Maltese: Norvasc huwa mediċina li fiha s-sustanza attiva amlodipine.
English: Norvasc is also available in the EU under other trade names: Amlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina, and Norvasc.
Maltese: Norvasc huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħra: Amlodipine Pfizer, Amlodipino, Amlor, Istin, Monopina, u Norvasc.
English: The CHMP also harmonised other sections of the SmPC including sections 4.5 (interaction with other medicinal products and other forms of interaction) and 5.1 (pharmacodynamic properties)
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħra tal-SmPC inkluż sezzjonijiet 4.5 (interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni) u 5.1 (karatteristiċi farmakodinamiċi)
English: Norvasc is authorised in the EU via national procedures.
Maltese: Norvasc huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The CHMP has recommended that no dose adjustments for Norvasc are required when used together with the following antihypertensive medicines: thiazide, beta blockers, and angiotensin-converting enzyme (ACE) inhibitors.
Maltese: Is-CHMP irrakkomanda li ma huwa meħtieġ l-ebda aġġustament tad-doża għal Norvasc meta użat flimkien mal-mediċini antiipertensivi li ġejjin: thiazide, beta blockers, u inibituri tal-enzima li tikkonverti l-anġjotensina (ACE).
English: The CHMP harmonised the indications, recommending that Norvasc be used for: hypertension, chronic stable angina and vasospastic or Prinzmetal's angina.
Maltese: Is-CHMP armonizza l-indikazzjonijiet, u rrakkomanda li Norvasc jintuża għal: l-ipertensjoni, l-anġina kronika stabbli u l-anġina vasospastika jew ta' Prinzmetal.
English: The European Medicines Agency has completed a review of Norvasc.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Norvasc.
English: The CHMP harmonised the contraindication as follows: hypersensitivity (allergy) to dihydropyridine derivatives, amlodipine or to any of the excipients; severe hypotension (low blood pressure), shock (a steep fall in blood pressure), obstruction of the outflow tract of the left ventricle (a chamber in the heart) and patients with heart failure following a heart attack.
Maltese: Is-CHMP armonizza l-kontra-indikazzjonijiet kif ġej: ipersensittività (allerġija) għal derivati ta' dihydropyridine, amlodipine jew għal xi wieħed mis-sustanzi mhux attivi; ipotensjoni severa (pressjoni tad-demm baxxa), xokk (tnaqqis qawwi fil-pressjoni tad-demm), imblukkar tal-passaġġ ta' ħruġ talventrikolu tax-xellug (kompartiment tal-qalb) u f'pazjenti b'insuffiċjenza tal-qalb wara attakk tal-qalb.
English: Why was Norvasc reviewed?
Maltese: Għaliex ġie rivedut Norvasc?
English: It has been used to treat cardiovascular problems such as hypertension (high blood pressure) and angina (chest pain caused by problems with the blood flow to the heart).
Maltese: Intuża fil-kura ta' problemi kardjovaskulari bħall-ipertensjoni (pressjoni tad-demm għolja) u anġina (uġigħ fis-sider ikkawżat minn problemi filfluss tad-demm lejn il-qalb).
English: A type of angina called vasospastic or Prinzmetal's angina was approved in all EU countries except Denmark and Sweden, while coronary artery disease was approved in Latvia and Romania.
Maltese: Tip ta' anġina msejħa anġina vasospastika jew ta' Prinzmeta kienet approvata fil-pajjiżi kollha tal-UE ħlief fid-Danimarka u flIsvezja, filwaqt li l-mard tal-arterji kornarji kien approvat fil-Latvja u fir-Rumanija.
English: It blocks special channels on the surface of cells called calcium channels, through which calcium particles normally enter.
Maltese: Jimblokka kanali speċjali fuq wiċċ iċ-ċelloli msejħa kanali tal-kalċju, li minnhom jidħlu normalment il-partikoli tal-kalċju.
English: On 2 February 2011, Pfizer referred the matter to the CHMP in order to harmonise the SmPCs as well as to standardise the test used for examining the quality of Norvasc in the EU.
Maltese: Fit-2 ta' Frar 2011, Pfizer irrefera l-kwistjoni lis-CHMP sabiex jarmonizza l-SmPCs kif ukoll sabiex jistandardizza t-test użat għall-eżaminazzjoni tal-kwalità ta' Norvasc fl-EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Norvasc in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm il-ħtieġa li l-informazzjoni dwar ilpreskrizzjoni ta' Norvasc tiġi armonizzata fl-Unjoni Ewropea (UE).
English: Norvasc had been used to treat hypertension and angina in all EU countries.
Maltese: Norvasc intuża fil-kura tal-ipertensjoni u tal-anġina fil-pajjiżi kollha tal-UE.
English: Grade ≥ 3 n (%)
Maltese: Grad ≥ 3 n (%)
English: Vaginal moniliasis f, leukorrhea
Maltese: Monilasi vaġinali f, leukorrhea
English: ADR was not observed in FALCON.
Maltese: ADR ma ġietx osservata f'FALCON.
English: Elevated hepatic enzymes (ALT, AST, ALP)
Maltese: Enzimi epatiċi għoljin (ALT, AST, ALP)
English: Pharmacotherapeutic group: Endocrine therapy, Antiestrogens, ATC code: L02BA03
Maltese: Terapija endokrinali, Anti-estroġeni, Kodiċi ATC: L02BA03
English: Faslodex is indicated:
Maltese: Faslodex huwa indikat:
English: Date of first authorisation: 10 March 2004 Date of latest renewal: 10 March 2009
Maltese: Data tal-aħħar tiġdid: 10 ta' Marzu 2009
English: Fulvestrant is eliminated mainly in metabolised form.
Maltese: Fulvestrant jiġi eliminat l-iktar forma metabolizzat.
English: Median DoR (months) CBR
Maltese: DoR medjana (xhur) CBR
English: SE-151 85 Södertälje Sweden
Maltese: SE-151 85 Södertälje L-Iżvezja
English: The event was not observed in major clinical studies (CONFIRM, FINDER 1, FINDER 2, NEWEST).
Maltese: L-avveniment ma deherx fl-istudji kliniċi maġġuri (CONFIRM, FINDER 1, FINDER 2, NEWEST).
English: 1 pre-filled syringe (5 ml) 1 safety needle
Maltese: 1 Siringa diġa' mimlija (5ml) 1 safety needle
English: % of patients with CB; absolute difference in
Maltese: % ta' pazjenti b'CB; differenza assoluta f'%
English: TTR*, Median [months (range)]
Maltese: TTR*, Medjan [xhur (medda)]
English: 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.
Maltese: Ilmetaboliti identifikati (jinkludu metaboliti ta' 17-ketone, sulphone, 3-sulphate, 3 u 17glucuronide) huma jew inqas attivi jew juru attivitajiet simili għal fulvestrant f'mudelli ta' antiestroġenu.
English: Adult females (including Elderly)
Maltese: Nisa adulti (inkluż l-Anzjani)
English: Treatment --- Fulvestrant 500 mg (N=230) - - - - - - Anastrozole 1 mg (N=232)
Maltese: Kura --- Fulvestrant 500 mg (N=230) - - - - - - Anastrozole 1 mg (N=232)
English: OS is presented for the final survival analyses at 75% maturity.
Maltese: OS hija ppreżentata għall-analiżi tas-sopravivenza finali f'maturità ta' 75%.
English: Excipients with known effect (per 5 ml) Ethanol (96%, 500 mg) Benzyl alcohol (500 mg) Benzyl benzoate (750 mg)
Maltese: Ethanol (96%, 500 mg) Benzyl alcohol (500 mg) Benzyl benzoate (750 mg)
English: Combination therapy with palbociclib
Maltese: Terapija kombinata ma' palbociclib
English: System Organ Class Frequency Preferred Term
Maltese: Klassi tal-Organu tas-Sistema Frekwenza
English: In Table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the Faslodex 500 mg treatment group in pooled safety analyses of studies that compared Faslodex 500 mg with Faslodex 250 mg [CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006), and NEWEST (Study D6997C00003) studies], or from FALCON (Study D699BC00001) alone that compared Faslodex 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented.
Maltese: F'Tabella 1, il-frekwenzi li jmiss għall-kategoriji ta' reazzjonijiet avversi tal-mediċina ġew ikkalkolati fuq grupp ta' trattament ta' Faslodex 500 mg miġbura f'analiżi ta' sigurtà ta' studji li qabblu Faslodex 500 mg ma' Faslodex 250 mg [CONFIRM (Studju D6997C00002), FINDER 1 (Studju D6997C00004), FINDER 2 (Studju D6997C00006), u NEWEST (Studju D6997C00003) studji], jew minn FALCON (Studju D699BC00001) waħdu li qabbel Faslodex 500 mg ma' anastrozole 1 mg.
English: PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Antiestrogen.
Maltese: OR:Rispons oġettiv; CBR:Rata ta' benefiċċju kliniku; CB:Benefiċċju kliniku; OS:Soppravivenza totali; K-M:KaplanMeier; CI:Intervall ta' fiduċja;
English: Table 2 reports the adverse reactions from PALOMA3.
Maltese: Tabella 2 tirrapporta r-reazzjonijiet avversi minn PALOMA3.
English: A more mature update of efficacy data is reported in Table 5.
Maltese: Aġġornament aktar matur tad-dejta taleffikaċja huwa rrappurtat f'Tabella 5.
English: Store and transport in a refrigerator (2°C - 8°C).
Maltese: Aħżen u ġorr fi friġġ (2°C - 8°C).
English: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, SK10 2NA United Kingdom
Maltese: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, SK 10 2NA Ir-Renju Unit
English: Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint.
Maltese: L-end-points sekondarji inkludew OR, CBR, OS, is-sigurtà, u ż-żmien għaddeterjorazzjoni (TTD, time-to-deterioration) fl-end-point tal-uġigħ.
English: Women with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Maltese: Nisa b'indeboliment epatiku qawwi (ChildPugh klassi C) ma ġewx evalwati.
English: *(31% maturity)-not final OS analysis **for patients with measurable disease
Maltese: *(31 % maturità)-mhux analiżi finali ta' OS **għal pazjenti b'marda li tista' titkejjel
English: For detailed instructions for administration, see section 6.6.
Maltese: Għal struzzjonijiet dettaljati dwar kif għandu jingħata, ara sezzjoni 6.6.
English: Frequency category differs between pooled safety dataset and FALCON.
Maltese: Il-kategorija tal-frekwenza tvarja bejn sett ta' dejta ta' sigurtà miġbur u FALCON.
English: Table 2 Adverse reactions based on PALOMA3 Study (N=517)
Maltese: Tabella 2 Reazzjonijiet avversi abbażi tal-istudju PALOMA3 (N=517)
English: Median duration of exposure to fulvestrant was 11.2 months in the fulvestrant + palbociclib arm and 4.9 months in the fulvestrant + placebo arm.
Maltese: Id-durata medjana tal-esponiment għal fulvestrant kienet ta' 11.2 xhur fil-fergħa ta' fulvestrant + palbociclib u 4.9 xhur fil-fergħa ta' fulvestrant + placebo.
English: Ethanol (96 per cent) Benzyl alcohol Benzyl benzoate Castor oil refined
Maltese: Ethanol 96% Benzyl alcohol Benzyl benzoate Castor oil raffinat
English: 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.
Maltese: Fl-istudju FALCON, in-numru ta' pazjenti li rrappurtaw reazzjoni avversa ta' uġigħ fil-ġogi u muskolu-skeletriku kien ta' 65 (31.2 %) u 48 (24.1 %) għal fergħat ta' fulvestrant u anastrozole, rispettivament.
English: Comparison between groups (Faslodex 500 mg/Faslodex 250 mg) Absolute difference in %
Maltese: Tqabbil bejn gruppi (Faslodex 500 mg / Faslodex 250 mg) Differenza assoluta f'%
English: • Remove the cap (A) in a straight upward direction.
Maltese: • Neħħi t-tapp (A) f'direzzjoni dritta 'l fuq.
English: ALT=alanine aminotransferase; AST=aspartate aminotransferase; N/n=number of patients Preferred Terms (PTs) are listed according to MedDRA 17.1.
Maltese: ALT= alanina aminotransferażi; AST= aspartat aminotransferażi; N/n=numru ta' pazjenti; N/A=mhux applikabbli.
English: 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).
Maltese: Komuni ħafna (>1/10), Komuni (>1/100, <1/10), Mhux komuni (> 1/1000, < 1/100).
English: Fulvestrant blocks the trophic actions of estrogens without any partial agonist (estrogen-like) activity.
Maltese: Fulvestrant jimblokka l-azzjonijiet trofiċi tal-estrogeni mingħajr xi attività agonista (simili għal estroġenu) parzjali.
English: 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'.
Maltese: Dan huwa kkalkulat bħala 3/560 (fejn 560 huwa n-numru ta' pazjenti fl-istudji kliniċi maġġuri), li jinħadem għall-kategorija ta' frekwenza ‘mhux komuni'.
English: 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.
Maltese: AUCs kienet ta' 4.2 (0.9) ng/mL u 3680 (1020) ng*hr/ml, rispettivament.
English: Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Maltese: Ir-reazzjonijiet avversi elenkati huma klassifikati skont il-frekwenza u s-sistema tal-klassifika talorgani (SOC).
English: What Faslodex contains - The active substance is fulvestrant.
Maltese: Is-sustanza attiva hi fulvestrant.
English: Gastrointestinal disorders
Maltese: Distubi gastro-intestinali
English: Fifty-five percent (55.0%) of patients had visceral metastasis at baseline.
Maltese: Ħamsa u ħamsin filmija (55.0 %) tal-pazjenti kellhom metastażi vixxerali fil-linja bażi.
English: N=number of patients; CI=confidence interval; OR=objective response; CBR=clinical benefit response
Maltese: N=numru ta' pazjenti; CI=intervall ta' kunfidenza; OR=rispons oġġettiv; CBR=rispons ta' benefiċċju kliniku
English: Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Maltese: Stomatite tal-ħalq, Kejlite, Glossite, Glossodinja, Ulċerazzjoni filħalq, Infjamazzjoni mukuża, Uġigħ orali, Skumdità orofarinġeali, Uġigħ orofarinġeali, Stomatite.
English: c
Maltese: B.
English: 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]).
Maltese: Ġie osservat ukoll benefiċċju irrispettivament mil-linji ta' terapija minn qabel fl-ambjent metastatiku, sew jekk kien kinux 0 (HR ta' 0.59 [95% CI: 0.37, 0.93]), 1 (HR ta' 0.46 [95% CI: 0.32, 0.64]), 2 (HR ta' 0.48 [95% CI: 0.30, 0.76]), jew ≥3 linji (HR ta' 0.59 [95% CI: 0.28, 1.22]).
English: Benzyl alcohol Faslodex contains benzyl alcohol as an excipient which may cause allergic reactions.
Maltese: Benzyl alcohol Faslodex fih benzyl alcohol bħala eċċipjent li jista' jikkawża reazzjonijiet allerġiċi.
English: Faslodex is contraindicated in pregnancy (see section 4.3).
Maltese: Faslodex huwa kontra-indikat waqt it-tqala (ara sezzjoni 4.3).
English: A clinical interaction study with midazolam (substrate of CYP3A4) demonstrated that fulvestrant does not inhibit CYP3A4.
Maltese: Studju kliniku fuq l-interazzjoni ma' midazolam (substrat ta' CYP3A4) wera li fulvestrant ma jinibixxix is-CYP3A4.
English: 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).
Maltese: Studju ta' Fażi 2 open label investiga s-sigurtà, l-effikaċja u l-farmakokinetika ta' fulvestrant fi 30 tifla ta' età minn 1 sa 8 snin b'Pubertà Prekoċi Progressiva assoċjata mas-sindrome ta' McCune Albright (MAS).
English: Ethanol (96 per cent), benzyl alcohol, benzyl benzoate and castor oil refined.
Maltese: Ethanol (96%), benzyl alcohol, benzyl benzoate u castor oil raffinat.
English: A total of 462 patients were randomised 1:1 sequentially to receive either fulvestrant 500 mg or anastrozole 1 mg.
Maltese: Total ta' 462 pazjent ġew randomizzati 1:1 sekwenzjalment sabiex jirċievu jew fulvestrant 500 mg jew anastrozole 1 mg.
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 (t1/2) jiġi regolat skont ir-rata ta' assorbiment u ġiet stmata li hi ta' madwar 50 jum .
English: The hazard ratio of Faslodex 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Maltese: Ilproporzjon ta' periklu ta' Faslodex 250 mg għal anastrozole għaż-żmien sal-mewt kien ta' 1.01 (95% CI 0.86 sa 1.19).
English: Febrile neutropenia has been reported in 0.9% patients receiving fulvestrant in combination with palbociclib.
Maltese: Ġiet irrappurtata newtropenja biddeni f'0.9 % pazjenti li kienu qed jirċievu fulvestrant flimkien ma' palbociclib.
English: Faslodex contains 750 mg benzyl benzoate per injection, equivalent to 150 mg/ml.
Maltese: Faslodex fih 750 mg benzyl benzoate għal kull injezzjoni, ekwivalenti għal 150 mg/ml.
English: Mild to moderate impairment of renal function did not influence the pharmacokinetics of fulvestrant to any clinically relevant extent.
Maltese: Indeboliment renali ħafif sa moderat ma kellux influwenza klinikament relevanti fuq ilfarmakokinetika ta' fulvestrant.
English: Kaplan-Meier plot of progression-free survival (investigator assessment, intent-to-treat population) - PALOMA3 study
Maltese: Plott Kaplan-Meier ta' sopravivenza mingħajr progressjoni (valutazzjoni millinvestigatur, popolazzjoni bl-intenzjoni li tiġi kkurata) - studju PALOMA3
English: No data are available regarding endometrial morphology.
Maltese: M'hemmx dejta rigward ilmorfoloġija tal-endometriju.
English: The objective response rate for Faslodex 250 mg was 19.2% compared with 16.5% for anastrozole.
Maltese: Ir-rata ta' rispons oġġettiv għal Faslodex 250 mg kienet ta' 19.2% meta mqabbla ma' 16.5% għal anastrozole.
English: 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.
Maltese: Fil-fergħa ta' fulvestrant + plaċebo (n=172), ġiet irrappurtata newtropenja ta' kwalunkwe grad f'7 (4.1%) pazjenti, b'newtropenja ta' Grad 3 li ġiet irrappurtata f'pazjent 1 (0.6%).
English: AstraZeneca AB, o.z.
Maltese: Slovenská republika AstraZeneca AB, o.z.
English: Severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Indeboliment serju tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: All Patients -AE subgroup (n=296) -AI subgroup (n=205) CBR
Maltese: Il-pazjenti kollha -Sotto grupp ta' AE (n=296) -Sotto grupp ta' AI (n=205)
English: 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.
Maltese: F'pazjenti li kienu qed jirċievu fulvestrant flimkien ma' palbociclib fl-istudju PALOMA3, ġiet irrappurtata newtropenja ta' kwalunkwe grad f'287 (83.2%) pazjent, b'newtropenja ta' Grad 3 li ġiet irrappurtata f'191 (55.4%) pazjent, u b'newtropenja ta' Grad 4 li ġiet irrappurtata f'37 (10.
English: Other medicines and Faslodex
Maltese: Mediċini oħra u Faslodex