FrancophonIA/ELRC3.0 huggingface dataset:
English: No no-effect levels were established for anastrozole in the toxicity studies, but those effects that were observed at the low doses (1 mg/kg/day) and mid doses (dog 3 mg/kg/day; rat 5 mg/kg/day) were related to either the pharmacological or enzyme inducing properties of anastrozole and were unaccompanied by significant toxic or degenerative changes.
Maltese: Ma ġewx stabbiliti livelli fejn ma jkunx hemm effett għal anastrozole fl-istudji dwar tossiċità, iżda dawk l-effetti li deheru b'dożi baxxi (1 mg/kg/jum) u dożi tan-nofs (kelb 3 mg/kg/jum; far 5 mg/kg/jum) kienu relatati mal-karatteristiċi farmakoloġiċi jew li jinduċu l-enzimi ta' anastrozole u ma kienux akkumpanjati b'bidliet tossiċi jew deġenerattivi sinifikanti.
English: The apparent clearance (CL/F) of anastrozole, following oral administration, was approximately 30% lower in volunteers with stable hepatic cirrhosis than in matched controls (Study 1033IL/0014).
Maltese: It- tneħħija apparenti (CL/F) ta' anastrozole, wara li jingħata mill-ħalq, kien bejn wieħed u ieħor 30% anqas f' voluntiera b' ċirrożi epatika stabbli milli fil-kontrolli mqabbla (Studju 1033IL/0014).
English: Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Maltese: Ir-reazzjonijiet avversi elenkati hawn taħt huma klassifikati skont il-Klassi tas-Sistema tl-Organu (SOC).
English: • Inflammation of the liver (hepatitis).
Maltese: • Infjammazzjoni tal-fwied (epatite)
English: Fracture rates of 22 per 1,000 patient-years and 15 per 1,000 patient-years were observed for the Arimidex and tamoxifen groups, respectively, after a median follow-up of 68 months.
Maltese: Rati tal-fratturi ta' 22 għal kull 1,000 sena-pazjent u 15 għal kull 1,000 sena-pazjent deheru għal gruppi fuq Arimidex u tamoxifen, rispettivament, wara medja ta' follow-up ta' 68 xahar.
English: A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11 to 16 years inclusive) with GHD treated for 12 to 36 months with Arimidex 1 mg/day or placebo in combination with growth hormone.
Maltese: Statura qasira minħabba Nuqqas ta' Ormon ta' Tkabbir Studju randomised, double blind, multi ċentriku evalwa 52 tifel fil-pubertà (bejn 11 u 16-il sena inklużi) b'GHD ikkurati għal 12 sa 36 xahar b'Arimidex 1mg/jum jew plaċebo flimkien ma' ormon tat-tkabbir.
English: Tell your doctor or pharmacist if you are taking the following: - A medicine known as an ‘LHRH analogue'.
Maltese: - Mediċina magħrufa bħala “analogu ta' LHRH”.
English: Study 1033IL/0027 showed that Arimidex and tamoxifen had similar objective tumour response rates and time to tumour progression.
Maltese: Studju 1033IL/0027 wera li Arimidex u tamoxifen kellhom rati ta' rispons oġġettiv għat-tumur u żmien biex javvanza t-tumur simili.
English: Reproductive toxicology
Maltese: Tossiċità fuq is-sistema riproduttiva
English: First-line therapy in postmenopausal women with advanced breast cancer Two double-blind, controlled clinical studies of similar design (Study 1033IL/0030 and Study 1033IL/0027) were conducted to assess the efficacy of Arimidex compared with tamoxifen as first-line therapy for hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer in postmenopausal women.
Maltese: L-ewwel Terapija f'Nisa wara l-Menopawża b'Kanċer tas-Sider Avvanzat Żewġ studji kliniċi double-blind, kontrollati mfassla b'mod simili (Studju 1033IL/0030 u Studju 1033IL/0027) saru sabiex tiġi stmata l-effikaċja ta' Arimidex imqabbla ma' tamoxifen bħala l-ewwel terapija għal kanċer lokalment avvanzat jew metastatiku f'nisa wara l-menopawża li jkunu pożittivi għar-riċettur tal-ormon jew mhux magħruf ir-riċettur tal-ormon.
English: Rare side effects (affect 1 to 10 people in 10,000)
Maltese: Effetti sekondarji rari (jeffettwaw 1 sa 10 min-nies f'10,000)
English: No significant difference in the number of patients who had a 50% or greater reduction in total breast volume after 6 months of treatment was observed between the Arimidex 1 mg treated group and the placebo group.
Maltese: Ma dehrietx differenza sinifikanti fin-numru ta' pazjenti li kellhom tnaqqis ta' 50% jew aktar fil-volum totali tas-sider wara 6 xhur ta' kura bejn il-grupp ikkurat b'1 mg Arimidex u l-grupp bil-plaċebo.
English: A decrease in 50% or more of total breast volume was seen in 56% (20/36) of the boys after 6 months.
Maltese: Nuqqas ta' 50% jew aktar fil-volum totali tas-sider intwera f' 56% (20/36) tassubien wara sitt xhur.
English: There were no clinically significant interactions with bisphosphonates (see section 5.1).
Maltese: Ma kienx hemm interazzjonijiet klinikament sinifikanti ma' bisfosfonejts (ara sezzjoni 5.1).
English: 0.73 to 0.94
Maltese: 0.73 sa' 0.94
English: Each film-coated tablet contains 1 mg of anastrozole.
Maltese: Kull pillola miksija b' rita fiha 1 mg anastrozole.
English: Clinical studies with antipyrine and warfarin showed that anastrozole at a 1 mg dose did not significantly inhibit the metabolism of antipyrine and R- and S-warfarin indicating the co-administration of Arimidex with other medicinal products is unlikely to result in clinically significant medicinal product interactions mediated by CYP enzymes.
Maltese: Studji kliniċi b' antipyrine u warfarina wrew li anastrozole b' doża ta' 1 mg ma inibixxix sinifikament l-metaboliżmu ta' antipyrine u warfarina R- u S- li jindika li meta Arimidex jingħata flimkien ma prodotti mediċinali oħra ma għandux jirriżulta f' interazzjonijiet klinikament sinifikanti ta' prodotti mediċinali medjati b' enżimi CYP.
English: • Skin rash.
Maltese: • Raxx tal-ġilda.
English: Dialysis may be helpful because Arimidex is not highly protein bound.
Maltese: Arimidex ma jintrabatx ħafna mal-proteina.
English: There is limited clinical experience of accidental overdose.
Maltese: Hemm esperjenza klinika limitata dwar doża eċċessiva aċċidentali.
English: Arimidex does not possess any progestogenic, androgenic, or estrogenic activity.
Maltese: Arimidex m'għandu l-ebda attività proġestoġenika, androġenika, jew estroġenika.
English: A total of 764 patients were randomised to receive either a single daily dose of 1 mg or 10 mg of Arimidex or megestrol acetate 40 mg four times a day.
Maltese: Totali ta' 764 pazjenta kienu mgħażulin għall-għarrieda biex jirċievu doża waħda kuljum ta' 1 mg jew 10 mg ta' Arimidex jew megestrol acetate 40 mg erba' darbiet kuljum.
English: In animal studies, anastrozole demonstrated low acute toxicity.
Maltese: Fi studji fuq annimali, anastrozole wera tossiċità akuta baxxa.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction for the indicated population.
Maltese: Informazzjoni mhux klinika, magħmula fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer, effett tossiku fuq is-sistema riproduttiva, ma turi l-ebda periklu speċjali għall-bnedmin.
English: An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2 to 9 years) with familial male-limited precocious puberty, also known as testotoxicosis, treated with combination of Arimidex and bicalutamide.
Maltese: Studju multiċentriku, mhux kumparattiv, open-label evalwa 14-il pazjent maskili (etajiet bejn 2 u 9 snin) b'pubertà prekoċi limitata għall-membri maskili tal-familja, magħrufa wkoll bħala testotossikożi, ikkurata b'taħlita ta' Arimidex u bicalutamide.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 1 mg anastrozole.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija b' rita fiha 1 mg anastrozole
English: The secondary objectives were to evaluate the proportion of patients with reductions from baseline in the calculated volume of gynaecomastia of both breasts combined of at least 50% between day 1 and after 6 months of study treatment, and patient tolerability and safety.
Maltese: L-għanijiet sekondarji kienu biex jevalwaw il-proporzjon ta' pazjenti bi tnaqqis mill-linja bażi fil-volum kalkulat ta' gajnekomastja tażżewġ isdra kombinati ta' mill-anqas 50% bejn jum 1 u wara 6 xhur mill-kura studjata, u tollerabilità u sigurtà tal-pazjent.
English: General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
Maltese: Kura ġenerali ta' support, inkluż monitoraġġ frekwenti għal sinjali vitali u osservazzjoni bir-reqqa tal-pazjent, hija indikata.
English: • Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand).
Maltese: • Sindrome “Karpal tunnil” (tingiż, uġigħ, ksieħ, dgħjufija f'xi partijiet ta' jdejk).
English: • Skin rash caused by hypersensitivity (this can be from allergic or anaphylactoid reaction).
Maltese: • Raxx fil-ġilda kkawżata minn sensitivita' eċċessiva (din tista' tkun minn reazzjoni allerġika jew reazzjoni anafilattika).
English: Trial 0006 was a randomised, double-blind, multi-centre study of 82 pubertal boys (aged 11-18 years inclusive) with gynaecomastia of greater than 12 months duration treated with Arimidex 1 mg/day or placebo daily for up to 6 months.
Maltese: Prova 0006 kienet studju multi-ċentriku, double blind, randomised ta' 82 tifel waqt il-pubertà (etajiet 11-18-il sena inklużi) b'gajnekomastja ta' aktar minn 12-il xahar ikkurata b'Arimidex 1 mg/jum jew plaċebo kuljum sa' 6 xhur.
English: Osteoporosis
Maltese: FARMAĊEWTIKU
English: A two-year mouse oncogenicity study resulted in the induction of benign ovarian tumours and a disturbance in the incidence of lymphoreticular neoplasms (fewer histiocytic sarcomas in females and more deaths as a result of lymphomas).
Maltese: Studju fuq l-effett kanċeroġenu fil-ġurdien li dam sentejn wassal biex joħorġu tumuri beninji tal-ovarji u disturb fil-frekwenza ta' nejoplażmi limforetikulari (anqas sarkomi ħistjoċitiċi fil-ġrieden ta' sess femminili u aktar imwiet minħabba limfomi).
English: Trial 0001 was an open-label, multiple-dose pharmacokinetic study of Arimidex 1 mg/day in 36 pubertal boys with gynaecomastia of less than 12 months duration.
Maltese: Prova 0001 kien studju farmakokinetiku b'ħafna dożi, open label ta' Arimidex 1 mg/jum f'36 tifel filpubertà b'gajnekomastja li kienet ilha anqas minn 12-il xahar.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas ta' lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Arimidex in one or several subsets of the paediatric population in short stature due to growth hormone deficiency (GHD), testotoxicosis, gynaecomastia, and McCune-Albright syndrome (see section 4.2).
Maltese: L-Aġenzija Ewropeja Dwar il-Mediċini neħħiet l-obbligu li jiġu sottomessi dawn ir-riżultati b'Arimidex f'sottogrupp wieħed jew aktar ta' popolazzjoni pedjatrika ta' statura qasira minħabba nuqqas tal-ormon ta' tkabbir (GHD), testotossikożi, gajnekomastja, u sindrome McCune-Albright (ara sezzjoni 4.2).
English: Two further similar trials (GABG/ARNO 95 and ITA), in one of which patients had received surgery and chemotherapy, as well as a combined analysis of ABCSG 8 and GABG/ARNO 95, supported these results.
Maltese: Żewġ provi ulterjuri (GABG/ARNO 95 u ITA), li f'wieħed minnhom il-pazjenti kienu ġew operati u ingħataw kemoterapija, kif ukoll l-analiżi kombinata ta' ABCSG 8 u GABG/ARNO 95, kienu konsistenti ma' dawn ir-riżultati.
English: Arimidex has not been investigated in breast cancer patients with severe renal impairment.
Maltese: Arimidex ma ġiex investigat f' pazjenti b' kanċer tas-sider li għandhom indeboliment renaliqawwi.
English: Approximately 90 to 95% of plasma anastrozole steady-state concentrations are attained after 7 daily doses, and accumulation is 3- to 4-fold.
Maltese: Madwar 90 sa 95% tal-konċentrazzjonijiet ta' anastrozole fil-plażma fi stat fiss jinkisbu wara 7 dożi meħudin darba kuljum, u l-akkumukazzjoni hija ta'3- sa 4- darbiet aktar.
English: Daily doses of Arimidex up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard adrenocorticotrophic hormone (ACTH) challenge testing.
Maltese: Dożi ta' Arimidex sa' 10 mg kuljum m'għandhom l-ebda effett fuq is-sekrezzjoni ta' kortisol jew aldosterown, imkejjla qabel u wara eżami ta' sfida bl-ormon adrenokortikotrofiku (ACTH) standard.
English: Arimidex has not been investigated in breast cancer patients with moderate or severe hepatic impairment.
Maltese: Arimidex ma ġiex investigat f' pazjenti b' kanċer tas-sider li għandhom indeboliment epatiku moderat jew qawwi.
English: Gynaecomastia studies
Maltese: Popolazzjonijiet speċjali
English: See leaflet for further information.
Maltese: L-effett ta' inibitturi qawwija CYP mhux magħruf.
English: • Feeling sleepy.
Maltese: • Nixfa fil-vaġina.
English: A review of the clinical trial safety database did not reveal evidence of clinically significant interaction in patients treated with Arimidex who also received other commonly prescribed medicinal products.
Maltese: Reviżjoni tad-dejtabejż tas-sigurtà waqt provi kliniċi ma weriex evidenza ta' interazzjoni klinikament sinifikanti f'pazjenti li ngħataw Arimidex u li rċievew ukoll prodotti mediċinali oħra li jingħataw ta' spiss bir-riċetta.
English: Myocardial ischaemia
Maltese: Wedel Il- Ġermanja
English: In acute toxicity studies in rodents, the median lethal dose of anastrozole was greater than 100 mg/kg/day by the oral route and greater than 50 mg/kg/day by the intraperitoneal route.
Maltese: Fi studji fuq tossiċità akuta fuq gerriema, il medja tad-doża letali ta' anastrozole kienet akbar minn 100 mg/kg/jum mogħtija mill-ħalq u aktar minn 50 mg/kg/jum mogħtija fil-peritonew.
English: Oral administration of anastrozole to pregnant rats and rabbits caused no teratogenic effects at doses up to 1.0 and 0.2 mg/kg/day respectively.
Maltese: L-għotja mill-ħalq ta' anastrozole lill-firien u fniek waqt it-tqala ma kkawżat l-ebda effett teratoġeniku b'dożi sa' 1.0 u 0.2 mg/kg/jum rispettivament.
English: The reduction was transient as all mating and fertility parameters were similar to control group values following a 9 week treatment-free recovery period.
Maltese: It-tnaqqis kien temporanju hekk kif il-parametri kollha ta' tgħammir kienu simili għall-grupp ta' kontroll wara perijodu mingħajr il-kura ta' 9 ġimgħat.
English: As Arimidex lowers circulating estrogen levels it may cause a reduction in bone mineral density with a possible consequent increased risk of fracture (see section 4.8).
Maltese: Peress li Arimidex ibaxxi l-livelli tal-estroġeni li jiċċirkolaw hu jista' jikkawża tnaqqis fid-densità minerali tal-għadam bil-possibiltà ta' riskju akbar ta' frattura (ara sezzjoni 4.8).
English: Co-administration of tamoxifen or estrogen-containing therapies with Arimidex should be avoided as this may diminish its pharmacological action (see section 4.5 and 5.1).
Maltese: It- teħid ta' tamoxifen u kuri li fihom l-estroġeni flimkien ma Arimidex għandu jiġi evitat għax dan jista' jnaqqas l-azzjoni farmakoloġika tiegħu (ara sezzjoni 4.5 u 5.1).
English: Pharmacotherapeutic group: Enzyme inhibitors, ATC code: L02B G03
Maltese: Fi studji fuq l-annimali effetti avversi intwerew biss b' dożi għoljin.
English: In a large phase III study conducted in 9,366 postmenopausal women with operable breast cancer treated for 5 years (see below), Arimidex was shown to be statistically superior to tamoxifen in disease-free survival.
Maltese: III li sar fuq 9,366 mara wara l-menopawża b'kanċer tas-sider li kien operabbli u ikkurat għal 5 snin (ara hawn taħt), Arimidex wera li kien statistikament superjuri għal tamoxifen fissopravivenza mingħajr il-marda.
English: In the phase III/IV study (Study of Anastrozole with the Bisphosphonate Risedronate [SABRE]), 234 postmenopausal women with hormone receptor-positive early breast cancer scheduled for treatment with Arimidex 1 mg/day were stratified to low, moderate and high risk groups according to their existing risk of fragility fracture.
Maltese: III/IV (Studju ta' Anastrozole ma' Bisphosphonate Residronate [SABRE]), 234 mara wara l-menopawża b'kanċer bikri pożittiv għar-riċettur tal-ormon skedati għal kura b'Arimidex 1 mg/jum kienu imqassma fi gruppi ta' riskju baxx, moderat u għoli skont ir-riskju attwali tagħhom ta' riskju ta' fraġilità għal frattura.
English: The table below presents the frequency of pre-specified adverse events in the ATAC study after a median follow-up of 68 months, irrespective of causality, reported in patients receiving trial therapy and up to 14 days after cessation of trial therapy.
Maltese: It-tabella ta' hawn taħt tippreżenta il-frekwenza ta' każijiet avversi speċifikati minn qabel fl-istudju ATAC wara medja ta' follow up ta' 68 xahar, irrispettivament jekk kienx ikkawżat minnu, li kienu irrappurtati f'pazjenti li ħadu t-terapija tal-prova u sa' 14-il jum wara li twaqqfet it-terapija tal-prova.
English: The metabolites are excreted primarily via the urine.
Maltese: Il-metaboli jiġu eskretati l-aktar permezz tal-awrina.
English: In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
Maltese: Fil-prova klinika pivitali, l-effikaċja ma ntwerietx u s-sigurtà ma ġietx stabbilita (ara sezzjoni 5.1).
English: Arimidex contains a substance called anastrozole.
Maltese: X'fih Arimidex - Is-sustanza attiva hi anastrozole.
English: Any venous thromboembolic event Deep venous thromboembolic events including PE (pulmonary embolism)
Maltese: Kwalunkwe każ trombo-emboliku fil-vini Każijiet tromboemboliċi fil-vini fondi inkluż PE (emboliżmu fil-pulmun) Każijiet iskemiċi ċerebrovaskolari Kanċer fl-endometriju
English: Disease-free survivala Hazard ratio 2-sided 95% CI
Maltese: Żmien biex tirkadi kwalunkwe marda Proporzjon ta' periklu 95% CI b'2 lati
English: NAME OF THE MEDICINAL PRODUCT Arimidex and associated names (see Annex I) 1 mg film-coated tablets [See Annex I - To be completed nationally] anastrozole
Maltese: Arimidex u ismijiet assoċjati (Ara Anness I) 1 mg pilloli miksija b' rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] anastrozole
English: Hypercholesterolaemia Very common Headache
Maltese: Iperkolesterolemija Komuni ħafna Uġigħ ta' ras
English: Joint pain/stiffness
Maltese: Uġigħ fil-ġogi/ebusija
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali wrew tossiċità fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Table 3 ATAC endpoint summary: 5-year treatment completion analysis Efficacy endpoints
Maltese: Analiżi wara 5-snin ta' kura li ntemmet Fini tal-effikaċja
English: Effect on bone mineral density
Maltese: GĦAMLA KWALITATTIVA
English: The following table presents adverse reactions from clinical trials, post-marketing studies or spontaneous reports.
Maltese: It-tabella li ġejja turi r-reazzjonijiet avversi minn provi kliniċi, studji ta' wara tqegħid fis-suq jew rapporti spontanji.
English: • Hot flushes.
Maltese: • Fwawar.
English: In boys with pubertal gynaecomastia (10-17 years), anastrozole was rapidly absorbed, was widely distributed, and was eliminated slowly with a half-life of approximately 2 days.
Maltese: F'subien b'gajnekomastja fil-pubertà (10-17-il sena), anastrozole kien assorbit malajr, infirex b'mod estensiv, u kien eliminat bil-mod b'half-life ta' madwar jumejn.
English: A greater magnitude of benefit was observed for disease free survival in favour of Arimidex versus tamoxifen for the prospectively defined hormone receptor-positive population.
Maltese: Benefiċċju akbar deher għas-sopravivenza mingħajr il-marda favur Arimidex kontra tamoxifen għall-popolazzjoni pożittiva għar-riċettur tal-ormon definit b'mod prospettiv.
English: Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4).
Maltese: Għandha titieħed kawtela f' pazjenti b' indeboliment epatiku moderat jew qawwi (ara sezzjoni 4.4).
English: Trigger finger
Maltese: Fratturi tas-sinsla
English: Take special care with Arimidex
Maltese: Oqgħod attent ħafna b'Arimidex
English: Excipients
Maltese: Ġenerali
English: Bone mineral density (BMD)
Maltese: Effett fuq id-densità minerali tal-għadam
English: Arimidex and associated names (see Annex I) 1 mg film-coated tablets
Maltese: Arimidex u ismijiet assoċjati (Ara Anness I) 1 mg pilloli miksijin b'rita
English: In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks.
Maltese: Fi studju fuq fertilità firien tas-sess maskili żgħar ingħataw doża mill-ħalq ta' 50 jew 400 mg/l anastrozole permezz tal-ilma tax-xorb għal 10 ġimgħat.
English: Do not use Arimidex after the expiry date which is stated on the carton and <container> [To be completed nationally].
Maltese: Tużax Arimidex wara d-data ta' skadenza li tidher fuq il-kartuna u l-kontenitur.
English: In addition, a decrease in BMD which was not statistically significant was seen in the low risk group treated with Arimidex 1 mg/day alone.
Maltese: Minbarra hekk, tnaqqis fil-BMD li ma kienx statistikament sinifikanti deher fil-grupp ta' riskju baxx ikkurat b'Arimidex 1 mg/jum waħdu.
English: In postmenopausal women, estradiol is produced primarily from the conversion of androstenedione to estrone through the aromatase enzyme complex in peripheral tissues.
Maltese: F'nisa wara lmenopawża, estradajol jiġi magħmul l-aktar mill-konverżjoni ta' androstenedione f'estrown permezz ta' kumpless ta' enzima aromatase f'tessuti periferali.
English: This is known as ‘angioedema'.
Maltese: Din hi magħrufa bħala ‘anġjoedima'
English: 2-sided 95% CI
Maltese: Proporzjon ta' periklu 95% CI b'2 lati
English: Time to any recurrence Hazard ratio 2-sided 95% CI
Maltese: Żmien biex tirkadi fit-tul Proporzjon ta' periklu 95% CI b'2 lati
English: In this leaflet:
Maltese: Sewqan u tħaddim ta' magni:
English: Arimidex is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Maltese: Arimidex mhux irrakkomandat għall-użu fit-tfal u adolexxenti peress li m'hemmx biżżejjed informazzjoni dwar is-sigurtà u l-effikaċja (ara sezzjoni 4.4 u 5.1).
English: The recommended dose of Arimidex for adults including the elderly is one 1 mg tablet once a day.
Maltese: Id-doża rakkomandata ta' Arimidex għall-adulti inklużi l-anzjani hija ta' pillola waħda ta' 1 mg darba kuljum.
English: Only 14 subjects on Arimidex completed 36 months.
Maltese: 14 individwu biss fuq Arimidex temmew is-36 xahar.
English: Vaginal bleeding
Maltese: Tnixxija mill-vaġina
English: Clinical trials have been conducted with various dosages of Arimidex, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were well tolerated.
Maltese: Provi kliniċi saru b'diversi dożaġġi ta' Arimidex, sa' 60 mg mogħtija f'doża waħda lill-voluntiera rġiel b'saħħithom u sa' 10 mg kuljum mogħtija lill-nisa wara lmenopawża b'kanċer avvanzat tas-sider; dawn id-dożaġġi kienu tollerati sew.
English: Second-line therapy in postmenopausal women with advanced breast cancer Arimidex was studied in two controlled clinical trials (Study 0004 and Study 0005) in postmenopausal women with advanced breast cancer who had disease progression following tamoxifen therapy for either advanced or early breast cancer.
Maltese: Terapija tat-Tieni Għażla f'Nisa wara l-Menopawża b'Kanċer tas-Sider Avvanzat Arimidex kien studjat f'żewġ provi kliniċi ikkontrollati (Studju 0004 u Studju 0005) f'nisa wara lmenopawża b'kanċer avvanzat tas-sider li kellhom avvanz tal-marda wara terapija b'tamoxifen għal kanċer tas-sider avvanzat jew fil-bidu.