FrancophonIA/ELRC3.0 huggingface dataset:
English: • Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
Maltese: • Kanċer tas-sider avvanzat wara rikaduta jew progressjoni tal-marda, f'nisa fi stat endokrinali kkaġunat b'mod naturali jew artifiċjali, li diġà ngħataw trattament permezz ta' antioestroġeni.
English: In a similar study involving subjects with varying degrees of hepatic function, the mean AUC values of the volunteers with moderate hepatic impairment (Child-Pugh B) was 37% higher than in normal subjects, but still within the range seen in subjects without impaired function.
Maltese: Fi studju simili li jinvolvi suġġetti b'livelli varji tal-funzjoni tal-fwied, il-medja tal-valuri AUC talvoluntiera b'indeboliment tal-fwied moderat (Child-Pugh B) kienet 37% aktar minn dik tas-suġġetti normali, imma xorta kienet skont il-medda li dehret fost suġġetti li ma kellhomx funzjoni dgħajfa.
English: The benefit in favour of letrozole was observed regardless of nodal status.
Maltese: Il-benefiċċju favur letrozole kien osservat minkejja l-istat nodali.
English: Anaphylactic reaction Metabolism and nutrition disorders Very common:
Maltese: Reazzjoni anafilattika Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna:
English: Some adverse reactions have been reported with notably different frequencies in the adjuvant treatment setting.
Maltese: Uħud mir-reazzjonijiet avversi kienu rrappurtati bi frekwenzi mill-aktar differenti f'sitwazzjoni ta' trattament adjuvanti.
English: Weight loss 1 Adverse drug reactions reported only in the metastatic setting
Maltese: Telf ta' piż 1 Reazzjonijiet avversi mill-mediċina rrappurtati biss fis-sitwazzjoni metastatika
English: Metabolic clearance to a pharmacologically inactive carbinol metabolite is the major elimination pathway of letrozole (CLm = 2.1 l/h) but is relatively slow when compared to hepatic blood flow (about 90 l/h).
Maltese: Il-mogħdija ewlenija tal-eliminazzjoni ta' letrozole (CLm = 2.1 l/h) hi t-tneħħija metabolika talmetabolit carbinol inattiv farmakolġikament għalkemm issir relattivament bil-mod meta mqabbel malinfluss tad-demm epatiku (madwar 90 l/h).
English: No changes were noted in plasma concentrations of androgens (androstenedione and testosterone) among healthy postmenopausal women after 0.1 mg, 0.5 mg, and 2.5 mg single doses of letrozole or in plasma concentrations of androstenedione among postmenopausal patients treated with daily doses of 0.1 mg to 5 mg, indicating that the blockade of oestrogen biosynthesis does not lead to accumulation of androgenic precursors.
Maltese: Ma kienx hemm tidbiliet fil-konċentrazzjonijiet tal-plażma ta' androġeni (androstenedione u testosterone) fost nista b'saħħithom li qabżu l-menopawża wara li ngħataw dożi waħdanija ta' 0.1 mg, 0.5 mg u 2.5 mg letrozole jew fil-konċentrazzjonijiet tal-plażma ta' androstenedione fost pazjenti li qabżu l-menopawża ttrattati b'dożi singoli kuljum ta' bejn 0.1 mg u 5 mg, li jindika li l-imblukkar talbijosintesi tal-oestroġenu ma jwassalx biex jinġemgħu l-prekursuri androġeniċi.
English: It is a hormonal (or “endocrine”) breast cancer treatment.
Maltese: Hu trattament ormonali (jew “endokrinali”) tal-kanċer tas-sider.
English: Formation of minor unidentified metabolites and direct renal and faecal excretion play only a minor role in the overall elimination of letrozole.
Maltese: Il-formazzjoni ta' metaboliti minuri mhux identifikati u l-eskrezzjoni diretta mill-kliewi u mal-ippurgar għandhom sehem żgħir fl-eliminazzjoni globali ta' letrozole.
English: In postmenopausal women, oestrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens - primarily androstenedione and testosterone - to oestrone and oestradiol.
Maltese: F'nisa li qabżu l-menopawża, l-oestroġeni jiġu primarjament mill-azzjoni tal-enzima tal-aromatasi, li tbiddel l-androġeni adrenalali - primarjament landrostenedione u t-testosterone - f'oestrone u oestradiol.
English: One controlled double-blind trial was conducted comparing {Invented Name} (letrozole) 2.5 mg to tamoxifen 20 mg as first-line therapy in postmenopausal women with advanced breast cancer.
Maltese: Saret prova waħda kkontrollata double-blind li qablet 2.5 mg {Isem (Ivvintat)} (letrozole) ma' 20 mg tamoxifen bħala l-ewwel terapija ppreferuta ma' nisa b'kanċer tas-sider avvanzat wara l-menopawża.
English: {Invented Name} treatment in the first-line therapy of advanced breast cancer resulted in a median overall survival of 34 months compared with 30 months for tamoxifen (logrank test P=0.53, not significant).
Maltese: It-trattament b'{Isem (Ivvintat)} bħala t-tieni terapija ppreferuta f'każ ta' kanċer avvanzat tas-sider wassal għal sopravivenza globali medja ta' 34 xahar imqabbel mat-30 xahar għal tamoxifen (test talpożizzjoni tal-logaritimi P=0.53, mhux sinjifikanti).
English: Letrozole is a non-steroidal aromatase inhibitor.
Maltese: Letrozole hu inibitur tal-aromatasi mhux sterojdjali.
English: Letrozole was embryotoxic and foetotoxic in pregnant rats and rabbits following oral administration at clinically relevant doses.
Maltese: Letrozole kien tossiku għall-embrijun u għall-fetu f'firien u fniek tqal mogħtija oralment dożi relevanti klinikament.
English: Based on clinical assessment there were 55% objective responses in the {Invented Name} arm versus 36% for the tamoxifen arm (P<0.001).
Maltese: Skont evalwazzjoni klinika kien hemm 55% ta' rispons objettiv fil-grupp mogħti {Isem (Ivvintat)} kontra 36% fil-grupp mogħti tamoxifen (P<0.
English: The Sequential Treatments Analysis (STA) addresses the second primary question of BIG 1-98, namely whether sequencing of tamoxifen and letrozole would be superior to monotherapy.
Maltese: L-Analiżi tat-Trattamenti Sekwenzjali (STA) tindirizza t-tieni mistoqsija primarja ta' BIG 1-98, primarjament jekk l-għoti sekwenzjali ta' tamoxifen u letrozole ikunx superjuri għall-monoterapija.
English: A double blind trial (P024) was conducted in 337 postmenopausal breast cancer patients randomly allocated either {Invented Name} 2.5 mg for 4 months or tamoxifen for 4 months.
Maltese: Trattament neoadjuvanti Prova double blind (P024) saret fost 337 pazjent b'kanċer tas-sider li qabżu l-menopawża mogħtija b'mod randomizzat jew 2.5 mg {Isem (Ivvintat)} għal 4 xhur jew tamoxifen għal 4 xhur.
English: {Invented Name} is contraindicated during pregnancy (see sections 4.3 and 5.3).
Maltese: {Isem (Ivvintat)} m'għandux jingħata waqt it-tqala (ara sezzjonijiet 4.3 u 5.3).
English: Table 6 Sequential treatments analysis of disease-free survival with letrozole as initial endocrine agent (STA switch population)
Maltese: Tabella 6 Analiżi tat-trattamenti sekwenzjali tas-sopravivenza mingħajr mard b'letrozole bħala aġent endokriniku inizjali (il-popolazzjoni li qalbet waqt STA)
English: There were no significant differences in DFS, OS, SDFS, or DDFS from switch with respect to monotherapy (Table 6).
Maltese: Ma kienx hemm differenzi kbar fid-DFS, OS, SDFS, jew DDFS wara li saret il-qalba vis-à-vis lmonoterapija (Tabella 6).
English: In a multicentre, double-blind, randomised, placebo-controlled study (MA-17), over 5,100 postmenopausal women with receptor-positive or unknown primary breast cancer who had completed adjuvant treatment with tamoxifen (4.5 to 6 years) were randomised to either {Invented Name} or placebo for 5 years.
Maltese: Fi studju multiċentriku, double-blind, randomizzat ikkontrollat bi plaċebo (MA-17), aktar minn 5,100 mara li qabżu l-menopawża b'riċettur pożittiv jew b'kanċer primarju tas-sider mhux magħruf li kienu ħadu t-trattament adjuvanti b'tamoxifen (bejn 4.5 u 6 snin) kienu randomizzati biex jew jieħdu {Isem (Ivvintat)} jew il-plaċebo għal 5 snin.
English: Cardiac adverse reactions
Maltese: Reazzjonijiet avversi kardijaċi
English: Plasma protein binding of letrozole is approximately 60%, mainly to albumin (55%).
Maltese: It-twaħħil tal-proteina tal-plażma ta' letrozole hu ta' madwar 60%, l-aktar mal-albumina (55%).
English: Tamoxifen, other anti-oestrogens or oestrogen-containing therapies may diminish the pharmacological action of letrozole.
Maltese: Tamoxifen, antioestroġeni oħrajn jew oestroġeni li jinkludu terapiji jistgħu jnaqqsu l-azzjoni farmakoloġika ta' letrozole.
English: Time to progression was significantly longer for letrozole irrespective of dominant site of disease.
Maltese: Iż-żmien ta' progressjoni kien ħafna itwal għal letrozole irrispettivament mis-sit dominanti tal-marda.
English: Vaginal bleeding
Maltese: Fsada vaġinali
English: A total of 262 patients were assigned either letrozole for 5 years or tamoxifen for 2 years followed by letrozole for 3 years.
Maltese: Total ta' 262 pazjent ingħataw letrozole għal 5 snin jew tamoxifen għal sentejn u wara letrozole għal 3 snin.
English: Plasma levels of LH and FSH are not affected by letrozole in patients, nor is thyroid function as evaluated by TSH, T4, and T3 uptake test.
Maltese: Il-livelli tal-plażma għal LH u FSH mhumiex affettwati b'letrozole fil-pazjenti, u lanqas mhi l-funzjoni tat-tirojde kif evalwat fit-test li kellu jittieħed ta' TSH, T4, u T3.
English: Age had no effect on the pharmacokinetics of letrozole.
Maltese: L-età ma kellha l-ebda effett fuq il-farmakokinetiċi ta' letrozole.
English: During the 4-month pre-operative treatment period, 12% of patients treated with {Invented Name} and 17% of patients treated with tamoxifen had disease progression on clinical assessment.
Maltese: Matul il-perjodu ta' trattament ta' qabel l-operazzjoni li dam 4 xhur, 12% tal-pazjenti ttrattati b'{Isem (Ivvintat)} u 17% tal-pazjenti ttrattati b'tamoxifen kellhom progressjoni tal-marda skont evalwazzjoni klinika.
English: The 5-year DFS rates were 84% for {Invented Name} and 81.4% for tamoxifen.
Maltese: Ir-rati tad-DFS għal 5 snin kienu ta' 84% għal {Isem (Ivvintat)} u 81.
English: Systemic exposure to metabolites is therefore low.
Maltese: L-espożizzjoni sistemika għall-metaboliti hi għaldaqstant baxxa.
English: Annex III
Maltese: Tabella 5
English: In patients with severe hepatic impairment (Child-Pugh C), systemic exposure and terminal half-life were approximately doubled compared to healthy volunteers.
Maltese: F'pazjenti li għandhom indeboliment tal-fwied gravi (Child-Pugh C), l-espożizzjoni sistemika u l-halflife terminali kważi rduppjaw meta mqabblin ma' dawk ta' voluntiera b'saħħithom.
English: In postmenopausal patients with advanced breast cancer, daily doses of 0.1 mg to 5 mg suppressed plasma concentration of oestradiol, oestrone, and oestrone sulphate by 75-95% from baseline in all patients treated.
Maltese: F'pazjenti b'kanċer tas-sider avvanzat li qabżu l-menopawża, id-doża ta' kuljum ta' bejn 0.1 mg u 5 mg rażżnet il-konċentrazzjoni tal-plażma ta' oestradiol, oestrone, u s-sulfat tal-oestrone b'75-95% mil-linja bażi fil-pazjenti kollha ttrattati.
English: 3 Observations in the tamoxifen arm censored at the date of selectively switching to letrozole
Maltese: 3 Osservazzjonijiet fil-grupp mogħti tamoxifen fid-data li fiha għaddew b'mod selettiv għal letrozole
English: labelled letrozole to healthy postmenopausal volunteers, 88.2 ± 7.6% of the radioactivity was recovered in urine and 3.8 ± 0.9% in faeces.
Maltese: Fi żmien ġimagħtejn wara li ngħataw 2.5 mg14 letrozole tikketta-C lil voluntiera b'saħħithom wara l-menopawża, 88.2 ± 7.6% tar-radjuattività kienet irkuprata fl-awrina u 3.8 ± 0.9% l-ippurgar.
English: Second-line treatment
Maltese: IL-PRODOTT MEDIĊINALI
English: In a variety of preclinical safety studies conducted in standard animal species, there was no evidence of systemic or target organ toxicity.
Maltese: F'firxa ta' studji prekliniċi dwar is-sigurtà fi speċi standard tal-annimali, ma kienx hemm evidenza ta' tossiċità sistemika jew tossiċità tal-organi milquta.
English: Tumour pain1 Blood and the lymphatic system disorders Uncommon:
Maltese: Lewkopenija Disturbi fis-sistema immuni Mhux magħruf:
English: At baseline all patients had tumours stage T2-T4c, N0-2, M0, ER and/or PgR positive and none of the patients would have qualified for breast-conserving surgery.
Maltese: Fil-linja bażi l-pazjenti kollha kellhom tumuri fi stadju T2-T4c, N0-2, M0, ER u/jew PgR pożittiv u ħadd millpazjenti ma kien jikkwalifika għal operazzjoni li ssalva s-sider.
English: Median total cholesterol levels in the tamoxifen arm were decreased by 16% after 6 months compared to baseline and this decrease was maintained at subsequent visits up to 24 months.
Maltese: Il-livelli medji tal-kolesterol sħiħ fil-grupp mogħti tamoxifen tnaqqsu b'16% wara 6 xhur imqabbla mal-linja bażi u dan it-tnaqqis inżamm waqt il-viżti ta' kontroll ta' wara sa 24 xahar.
English: In the second study, the response rate was not significantly different between letrozole 2.5 mg and aminoglutethimide (P=0.06).
Maltese: Fit-tieni studju, ir-rata ta' rispons ma kenitx differenti b'mod qawwi bejn 2.5 mg letrozole u aminoglutethimide (P=0.06).
English: Protocol definition of disease-free survival events: loco-regional recurrence, distant metastasis or contralateral breast cancer.
Maltese: Id-definizjoni tal-protokoll tal-episodji ta' sopravivenza mingħajr mard: rikorrenza lokoreġjonali, metastasi distanti jew kanċer tas-sider kontralaterali.
English: What {Invented Name} contains
Maltese: Numru ta' ta' kunfidenza)
English: After administration of 2.5 mg 14C-labelled letrozole, approximately 82% of the radioactivity in plasma was unchanged compound.
Maltese: Wara l-għoti ta' 2.5 mg4 letrozole tikketta-C, madwar 82% tar-radjuattività fil-plażma kienet komponent mhux mibdul.
English: First-line treatment
Maltese: L-ewwel trattament ippreferut
English: You should only take this medicine under strict medical supervision.
Maltese: Viżti ta' kontroll matul it-trattament b'{Isem (Ivvintat)} Għandek tieħu din il-mediċina biss taħt superviżjoni medika stretta.
English: The concentration of letrozole in erythrocytes is about 80% of that in plasma.
Maltese: Ilkonċentrazzjoni ta' letrozole fl-eritroċiti hi ta' madwar 80% tiegħu fil-plażma.
English: Dryness of mucous membranes
Maltese: Lista ttabulata tal-effetti mhux mixtieqa
English: Caution is therefore indicated when giving letrozole contomitantly with medicinal products whose elimination is mainly dependent on these isoenzymes and whose therapeutic index is narrow (e.g. phenytoin, clopidrogel).
Maltese: Wieħed għalhekk għandu joqgħod attent meta jagħti letrozole flimkien ma' prodotti mediċinali li l-eliminazzjoni tagħhom tiddependi primarjament fuq dawn liżoenzimi u li l-indiċi terapewtiku tagħhom hu dejjaq (eż. phenytoin, clopidrogel).
English: Hazard Ratio1 (95% CI)
Maltese: Rata ta' Periklu1 95% CI
English: The effect of potent CYP450 inhibitors is unknown.
Maltese: L-effett tal-inibituri qawwija ta'CYP450 mhuwiex magħruf.
English: Two well-controlled clinical trials were conducted comparing two letrozole doses (0.5 mg and 2.5 mg) to megestrol acetate and to aminoglutethimide, respectively, in postmenopausal women with advanced breast cancer previously treated with anti-oestrogens.
Maltese: Saru żewġ provi kliniċi kkontrollati sew li qabblu żewġ dożi ta' letrozole (0.5 mg u 2.5 mg) ma' megestrol acetate u aminoglutethimide, rispettivament, f'nisa li qabżu l-menopawża b'kanċer avvanzat tas-sider li qabel ingħataw trattament b'antioestroġeni.
English: Nausea, dyspepsia1, constipation, abdominal pain, diarrhoea, vomiting
Maltese: Dardir, dispepsja1, xedda, uġigħ fl-addome, dijarrea, rimettar
English: Table 5 Monotherapy Arms Analysis: Disease-free and overall survival at a median follow-up of 73 months (ITT population)
Maltese: Is-sopravivenza mingħajr mard u globali b'medja ta' viżti ta' kontroll ta' 73 xahar (il-popolazzjoni ITT)
English: • Neo-adjuvant treatment of postmenopausal women with hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Maltese: • Trattament adjuvanti ġdid ta' nisa wara l-menopawża b'kanċer tas-sider bikri HER-2, birriċettur tal-ormon pożittiv fejn il-kimoterapija mhijiex adattata u mhix indikata operazzjoni immedjata.
English: Plasma concentrations at steady state are approximately 7 times higher than concentrations measured after a single dose of 2.5 mg, while they are 1.5 to 2 times higher than the steady-state values predicted from the concentrations measured after a single dose, indicating a slight non-linearity in the pharmacokinetics of letrozole upon daily administration of 2.5 mg.
Maltese: Il-konċentrazzjonijiet talplażma fi stat stabbli huma madwar 7 darbiet ogħla mill-konċentrazzjonijiet imkejla wara l-għoti ta' dożi singoli ta' 2.5 mg, filwaqt li huma bejn 1.5 drabi u darbtejn ogħla mill-valuri fl-istat stabbli mbassra mill-konċentrazzjonijiet imkejla wara l-għoti ta' doża singola, li jindika nuqqas żgħir ta' linearità fil-farmakokinetiċi ta' letrozole meta jingħataw 2.5 mg kuljum.
English: What {Invented Name} is and how it works {Invented Name} contains an active substance called letrozole.
Maltese: X'inhu {Isem (Ivvintat)} u kif jaħdem {Isem (Ivvintat)} fih sustanza attiva msejħa letrozole.
English: Table 4 Primary Core Analysis: Disease-free and overall survival,at a median follow-up of 26 months and at median follow-up of 60 months (ITT population)
Maltese: Is-sopravivenza mingħajr mard u globali, b'medja ta' viżti ta' kontroll ta' 26 xahar u ammont medju ta' viżti ta' kontroll ta' 60 xahar (ilpopolazzjoni tal-ITT)
English: Co-administration of {Invented Name} with tamoxifen, other anti-oestrogens or oestrogen-containing therapies should be avoided as these substances may diminish the pharmacological action of letrozole (see section 4.5).
Maltese: Twissijiet oħrajn Għandu jkun evitat l-għoti flimkien ta' {Isem (Ivvintat)} ma' tamoxifen, antioestroġeni oħrajn jew oestroġeni li fihom it-terapija minħabba li dawn is-sustanzi jistgħu jnaqqsu l-azzjoni farmakoloġika ta' letrozole (ara sezzjoni 4.5).
English: Dry skin
Maltese: Żieda fil-piż
English: This leaflet was last revised in {MM/YYYY}.
Maltese: Episodji ta' sopravivenza ħielsa mill
English: Increased hepatic enzymes
Maltese: Terapija endokrinika.
English: In the letrozole arm, total cholesterol levels were relatively stable over time, giving a statistically significant difference in favor of tamoxifen at each time point.
Maltese: Fil-grupp mogħti letrozole, il-livelli totali tal-kolesterol kienu relattivament stabbli mal-medda taż-żmien, li wassal għal differenza qawwija statistikament favur tamoxifen f'kull perjodu ta' żmien.
English: {Invented Name} monotherapy
Maltese: Analżi tal-Gruppi ta' Monoterapija:
English: • Extended adjuvant treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
Maltese: • Trattament adjuvanti estiż ta' nisa wara l-menopawża b'kanċer tas-sider bikri bir-riċettur talormon pożittiv li diġà ngħataw terapija adjuvanti standard b'tamoxifen għal 5 snin.
English: Disease-free survival (primary) - events (protocol definition2)
Maltese: Episodji (primarji) ta' sopravivenza ħielsa mill-mard(definizzjoni talprotokoll2) Sopravivenza (sekondarja) globali
English: In the MA-17 lipid substudy there were no significant differences between letrozole and placebo in total cholesterol or in any lipid fraction.
Maltese: Waqt is-sottostudju tal-lipidi MA-17 ma kienx hemm differenzi qawwija bejn letrozole u plaċebo flammont sħiħ tal-kolesterol jew f'xi frazzjoni ta' kwalunkwe lipidi.
English: When the study was unblinded in 2003, 1551 patients in the randomised placebo arm (60% of those eligible to switch, i.e. who were disease-free) switched to letrozole at a median 31 months after randomisation.
Maltese: HR = Il-proporzjon ta' periklu; CI = L-intervall ta' kunfidenza Meta l-istudju kien unblinded fl-2003, 1551 pazjent fil-grupp mogħti l-plaċebo b'mod randomizzat (60% ta' dawk eliġibbli biex jaqilbu, jiġifieri dawk li ma kellhomx mard) qalbu għal letrozole madwar 31 xahar wara r-randomizzazzjoni.
English: Dry mouth, stomatitis1 Hepatobiliary disorders Uncommon:
Maltese: Uġigħ mit-tumur1 Disturbi tad-demm u tas-sistema limfatika
English: Bone fracture
Maltese: Artralġja
English: Fever
Maltese: Fwawar
English: These side effects may affect between 1 to 10 in every 100 patients.
Maltese: Dawn l-effetti sekondarji jistgħu jaffettwaw aktar minn 10 pazjenti f'kull 100.
English: Skin rash
Maltese: TAGĦRIF
English: The recommended dose of {Invented Name} is 2.5 mg once daily.
Maltese: Id-doża rrakkomandata ta' {Isem (Ivvintat)} hi 2.5 mg darba kuljum.
English: Reporting period includes treatment period plus 30 days after stopping treatment.
Maltese: Il-perjodi ta' rappurtar jinkludu lperjodu ta' trattament flimkien ma' 30 jum wara li jitwaqqaf it-trattament.
English: Note: Median duration of treatment 60 months.
Maltese: It-trattament idum bejn wieħed u ieħor 60 xahar.
English: Median time to progression was 12.1 months for {Invented Name} and 6.4 months for tamoxifen in patients with soft tissue disease only and median 8.3 months for {Invented Name} and 4.6 months for tamoxifen in patients with visceral metastases.
Maltese: Iż-żmien medju talprogressjoni kien ta' 12.1 xhur għal {Isem (Ivvintat)} u ta' 6.4 xhur għal tamoxifen fil-pazjenti biss morda b'tessuti rotob u l-medja kienet ta' 8.3 xhur għal {Isem (Ivvintat)} u ta' 4.6 xhur għal tamoxifen f'pazjenti b'metastasi vixxerali.
English: In the adjuvant setting a sequential treatment schedule (letrozole 2 years followed by tamoxifen 3 years) could also be considered (see sections 4.4 and 5.1).
Maltese: F'sitwazzjoni adjuvanti wieħed jista' jikkunsidra wkoll skema ta' trattament sekwenzjali (letrozole għal sentejn segwit b'tamoxifen għal 3 snin) (ara sezzjonijiet 4.4 u 5.1).
English: No patient with a normal BMD at baseline became osteoporotic during 2 years of treatment and only 1 patient with osteopenia at baseline (T score of -1.9) developed osteoporosis during the treatment period (assessment by central review).
Maltese: L-ebda pazjent b'BMD normali fil-linja bażi ma spiċċa osteoprotiku matul is-sentejn ta' trattament u pazjent wieħed biss b'osteopenija fil-linja bażi (skor T -1.9) żviluppa osteoporożi matul il-perjodu ta' trattament (evalwazzjoni magħmula waqt il-konsulta ċentrali).
English: Pharmacotherapeutic group: Endocrine therapy.
Maltese: Żieda fl-enzima tal-fwied
English: Increased urinary frequency Reproductive system and breast disorders Common:
Maltese: Żieda fil-frekwenza tal-awrina Disturbi fis-sistema riproduttiva u fis-sider Komuni:
English: Adult and elderly patients
Maltese: Pożoloġija Pazjenti adulti u anzjani
English: Malaise (generally feeling unwell)
Maltese: disturb fil-ġilda).
English: Insufficient data are available in cases of renal insufficiency with creatinine clearance lower than 10 ml/min (see sections 4.4 and 5.2).
Maltese: M'hemmx biżżejjed informazzjoni dwar każijiet ta' indeboliment tal-kliewi meta t-tneħħija tal-kreatinina hi anqas minn 10 ml/min (ara sezzjonijiet 4.4 u
English: Thus, {Invented Name} should be administered with caution to patients with severe hepatic impairment and after consideration of the risk/benefit in the individual patient.
Maltese: Għalhekk, {Isem (Ivvintat)} għandu jingħata b'kawtela lil pazjenti b'indeboliment tal-fwied gravi u wara li jitqiesu r-riskju u lbenefiċċju għall-pazjent individwali.
English: Leukopenia
Maltese: Varjabbli
English: There were no significant differences in DFS, OS, SDFS or DDFS in any of the STA from randomisation pairwise comparisons (Table 7).
Maltese: Ma kienx hemm differenzi kbar fid-DFS, OS, SDFS, jew DDFS fi kwalunkwe STA wara li sar tqabbil randomizzat bejn il-pari (Tabella 7).
English: Arthritis Renal and urinary disorders Uncommon:
Maltese: Artrite Disturbi fil-kliewi u fis-sistema urinarja Mhux komuni:
English: No dosage adjustment of {Invented Name} is required for patients with renal insufficiency with creatinine clearance ≥10 ml/min.
Maltese: Mhux meħtieġ aġġustament tad-doża b'{Isem (Ivvintat)} għal pazjenti b'indeboliment tal-kliewi bittneħħija tal-kreatinina ta' ≥10 ml/min.
English: • Premenopausal endocrine status
Maltese: • Stat endokrinali qabel il-menopawża