FrancophonIA/ELRC3.0 huggingface dataset:
English: Results from a human mass-balance study and in vitro experiments mentioned above indicated that the CYP enzymes are unlikely to be involved in the metabolism of decitabine.
Maltese: Riżultati minn studju tal-bilanċ tal-massa fil-bnedmin u esperimenti in vitro msemmijin hawn fuq indikaw li lenzimi CYP x'aktarx li mhumiex involuti fil-metaboliżmu ta' decitabine.
English: The most common adverse drug reactions (≥ 35%) reported are pyrexia, anaemia and thrombocytopaenia.
Maltese: L-aktar reazzjonijiet avversi komuni għall-mediċina (≥ 35%) rrappurtati huma deni, anemija u tromboċitopenija.
English: The use of Dacogen as initial therapy was also evaluated in an open-label, single-arm, Phase II study (DACO-017) in 55 subjects > 60 years with AML according to the WHO classification.
Maltese: L-użu ta' Dacogen bħala terapija tal-bidu ġie ukoll stmat fi studju tal-Fażi 2, open-label, b'fergħa waħda (DACO-017) f'55 individwu ta' > 60 sena b'AML skont il-klassifikazzjoni tal-WHO.
English: Standard procedures for dealing with cytotoxic medicinal products should be adopted.
Maltese: Għandhom jiġu adottati l-proċeduri standard ta' kif wieħed jitratta prodotti mediċinali ċitotossiċi.
English: Worst National Cancer Institute Common Terminology Criteria for Adverse Events Grade.
Maltese: Kriterji għat-Terminoloġiji Komuni għall-Agħar Gradi ta' Każijiet Avversi tal-Istitut Nazzjonali tal-Kanċer.
English: The population PK analysis on the limited decitabine data indicated no significant PK parameter dependencies on normalized creatinine clearance, an indicator of renal function.
Maltese: L-analiżi tal-PK tal-popolazzjoni ta' dejta limitata dwar decitabine ma indikat l-ebda dipendenzi sinifikanti ta' parametri PK fuq it-tneħħija normalizzata tal-krejatinina, li hija indikazzjoni tal-funzjoni tal-kliewi.
English: • This medicine contains 0.5 mmol potassium in each vial.
Maltese: • Din il-mediċina fiha 0.5 mmol ta' potassium f'kull kunjett.
English: In clinical studies, the majority of patients had baseline Grade 3/4 myelosuppression.
Maltese: Fi studji kliniċi, il-maġġoranza tal-pazjenti kellhom majelosoppressjoni ta' grad 3/4 fil-linja bażi.
English: Children and adolescents Dacogen is not for use in children or adolescents under the age of 18.
Maltese: Tfal u adolexxenti Dacogen mhux qiegħed biex jntuża fi tfal u adoloxxenti taħt l-età ta' 18-il sena.
English: Very common headache
Maltese: Komuni stomatite
English: It is supplied in a 20 ml glass vial containing 50 mg decitabine.
Maltese: Huwa jiġi fornut f'kunjett tal-ħġieġ ta' 20 ml li fih 50 mg ta' decitabine.
English: After reconstitution and dilution of the solution for intravenous infusion, this medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium- free'.
Maltese: Wara r-rikostituzzjoni u d-dilwizzjoni tas-soluzzjoni għall-infużjoni ġol-vina, din il-mediċina jkun fiha inqas minn 1 mmol (39 mg) ta' potassium f'kull doża, i.e. hija essenzjalment ‘ħielsa mill-potassium'.
English: The need for dose adjustment in patients with renal impairment has not been evaluated (see section 4.4 and 5.2).
Maltese: Il-bżonn ta' aġġustament fid-doża ta' pazjenti b'indeboliment tal-kliewi ma ġiex stmat (ara sezzjoni 4.4 u 5.2).
English: B. PACKAGE LEAFLET
Maltese: Komuni ħafna epistassi
English: • Chest pain or shortness of breath (with or without fever or cough): these may be signs of an infection of the lung called “pneumonia” (very common) or inflamed lungs (interstitial lung disease [frequency not known]) or cardiomyopathy (heart muscle disease [uncommon]) which can be accompanied with swelling of ankles, hands, legs and feet.
Maltese: • Uġigħ fis-sider jew qtugħ ta' nifs (bid-deni jew mingħajru jew bis-sogħla) - dawn jistgħu jkunu sinjali ta' infezzjoni fil-pulmun msejħa “pnewmonja” (komuni ħafna) jew pulmuni infjammati (mard tal-interstizju tal-pulmun [frekwenza mhux magħrufa]) jew kardjomijopatija (marda talmuskolu tal-qalb [mhux komuni] li tista' tkun akkumpanjata minn nefħa fl-għekiesi, fl-idejn u fis-saqajn.
English: Impact of decitabine on co-administered medicinal products Given its low in vitro plasma protein binding ( 1%), decitabine is unlikely to displace co-administered medicinal products from their plasma protein binding.
Maltese: Impatt ta' decitabine fuq prodotti mediċinali mogħtija flimkien miegħu Meta wieħed iqis il-livell baxx tal-irbit tiegħu mal-proteini tal-plażma in vitro (< 1%), decitabine x'aktarx li ma jihux post prodotti mediċinali mogħtija flimkien miegħu mill-irbit tagħhom mal-proteini tal-plażma.
English: Myelosuppression caused by Dacogen is reversible.
Maltese: Majelosoppressjoni kkawżata b'Dacogen hija riversibbli.
English: Renal function tests should be performed prior to initiation of therapy and prior to each treatment cycle, and as clinically indicated (see section 4.2).
Maltese: Għandhom isiru testijiet tal-funzjoni tal-kliewi qabel tinbeda t-terapija u qabel kull ċiklu ta' trattament, u skont kif ikun indikat b'mod kliniku (ara sezzjoni 4.2).
English: Hypersensitivity to decitabine or to any of the excipients, listed in section 6.1.
Maltese: Sensittività eċċessiva għal decitabine jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Progression-free survival and Event-free survival were tertiary endpoints.
Maltese: Fertilità fl-irġiel u fin-nisa u kontraċezzjoni
English: Eighty-one percent of subjects had significant comorbidities (e.g., infection, cardiac impairment, pulmonary impairment).
Maltese: Wieħed u tmenin filmija tal-individwi kellhom komorbiditajiet sinifikanti (eż. infezzjoni, indeboliment tal-qalb, indeboliment tal-pulmuni).
English: Frequency All Grades
Maltese: Frekwenza Il-Gradi Kollha
English: For situations where decitabine administration should be delayed, see section 4.2.
Maltese: Għal sitwazzjonijiet fejn l-għoti ta' decitabine għandu jiġi pospost, ara sezzjoni 4.2.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Maltese: Għal kundizzjonijiet tal-ħażna tal-prodott mediċinali rrikostitwit u ddilwit, ara sezzjoni 6.3.
English: Decitabine has been shown to be a weak inhibitor of P-gp mediated transport in vitro and is therefore, also not expected to affect P-gp mediated transport of co-administered medicinal products (see section 5.2).
Maltese: Decitabine ntwera li huwa impeditur dgħajjef tat-trasport medjat minn P-gp in vitro u għalhekk, mhuwiex mistenni li jaffettwa t-trasport medjat minn P-gp tal-prodotti mediċinali mogħtija flimkien miegħu (ara sezzjoni 5.2).
English: Gastrointestinal toxicity was also observed and in males, testicular atrophy which did not reverse over the scheduled recovery periods.
Maltese: Tossiċità gastrointestinali kienet osservata wkoll u fl-irġiel, atrofija tat-testikoli li fil-perijodi ta' rkupru skedati ma reġgħetx lura għal dak li kienet qabel.
English: VIAL LABEL
Maltese: Mard kardijaku
English: • The other ingredients are potassium dihydrogen phosphate (E340), sodium hydroxide(E524), and hydrochloric acid (for pH-adjustment).
Maltese: • Is-sustanzi l-oħra huma potassium dihydrogen phosphate (E340), sodium hydroxide (E524), u hydrochloric acid (għal aġġustament ta' pH).
English: Adverse drug reactions reported in 293 AML patients treated with Dacogen are summarised in Table 1.
Maltese: Lista ta' reazzjonijiet avversi għall-mediċina miġbura f'tabella Reazzjonijiet avversi għall-mediċina rrappurtati f'293 pazjent b'AML ikkurati b'Dacogen huma mniżżla fil-qosor f'Tabella 1.
English: The most commonly reported haematologic adverse drug reactions associated with Dacogen treatment included febrile neutropaenia, thrombocytopaenia, neutropaenia, anaemia and leukopaenia.
Maltese: L-aktar reazzjonijiet ematoloġiċi avversi għall-mediċina rrappurtati b'mod komuni assoċjati ma' kura b'Dacogen kienu jinkludu newtropenija bid-deni, tromboċitopenija, newtropenija, anemija u lewkopenija.
English: Occurrences of enterocolitis, including neutropaenic colitis, caecitis have been reported during treatment with decitabine.
Maltese: Każijiet ta' enterokolite, inkluż kolite newtropenika, ċekite kienu rrapurtati waqt kura b'decitabine.
English: Dacogen (n = 242) was compared to treatment choice (TC, n = 243) which consisted of patient's choice with physician's advice of either supportive care alone (n = 28, 11.5%) or 20 mg/m cytarabine subcutaneously once daily for 10 consecutive days repeated every 4 weeks (n = 215, 88.5%).
Maltese: L-użu ta' Dacogen ġie studjat fi studju tal-Fażi 3 open-label, każwali, b'ħafna ċentri (DACO-016) f'individwi li kienet għadhom kemm saritilhom id-dijanjosi ta' AML de novo jew sekondarja skont ilklassifikazzjoni tal-WHO. Dacogen (n = 242) tqabbel ma' kura magħżula (TC, n = 243) li kienet tikkonsisti f'kura li għażel il-pazjent bil-parir tat-tabib li jew kienet kura ta'sostenn waħedha (n = 28, 11.5%) jew inkella 20 mg/m2 ta' cytarabine taħt il-ġilda darba kuljum għal għaxart ijiem konsekuttivi rrepetut kull 4 ġimgħat (n = 215, 88.5%).
English: Dacogen 50 mg powder for concentrate for solution for infusion.
Maltese: Dacogen 50 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: 20 ml clear colourless Type I glass vial sealed with a butyl rubber stopper and an aluminium seal with plastic flip-off cap containing 50 mg decitabine.
Maltese: Il-preżenza ta' dawn il-metaboliti fl-awrina flimkien mat-tneħħija totali tal-biċċa l-kbira mill-ġisem u t-tneħħija żgħira mill-awrina ta' decitabine mhux mibdul fl-awrina (~4% tad-doża) tindika li decitabine jiġi mmetabolizzat b'mod konsiderevoli in vivo.
English: The use of decitabine with hormonal contraceptives has not been studied.
Maltese: L-użu ta' decitabine ma' kontraċettivi tal-ormoni ma ġiex studjat.
English: This prepared diluted solution for intravenous infusion can be stored at 2°C - 8°C for up to a maximum of 3 hours, followed by up to 1 hour at room temperature (20°C - 25°C) before administration.
Maltese: Din issoluzzjoni ddilwita li tiġi ppreparata għal infużjoni ġol-vina għandha tinħażen f'temperatura ta' 2°C - 8°C għal mhux aktar minn 3 sigħat, u tista' imbagħad tinħażen f'temperatura tal-kamra (20°C - 25°C) sa siegħa qabel ma tingħata.
English: Cardiac disease
Maltese: Esperjenza klinika
English: Posology In a treatment cycle, Dacogen is administered at a dose of 20 mg/m body surface area by intravenous infusion over 1 hour repeated daily for 5 consecutive days (i.e., a total of 5 doses per treatment cycle).
Maltese: Pożoloġija Fiċ-ċiklu ta' kura, Dacogen jingħata f'doża ta' 20 mg/m ta' erja tas-superfiċje tal-ġisem permezz ta' infużjoni fil-vini fuq perijodu ta' siegħa ripetuta kuljum għal ħamest ijiem konsekuttivi (jiġifieri, total ta' 5 dożi kull ċiklu ta' kura).
English: Each vial of powder for concentrate for solution for infusion contains 50 mg decitabine.
Maltese: Kull kunjett ta' trab għal konċentrat għal soluzzjoni għall-infużjoni fih 50 mg decitabine.
English: Tests or checks
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: The secondary endpoint was complete remission rate that was assessed by independent expert review.
Maltese: L-iskop finali sekondarju kien ir-rata ta' kontroll sħiħ tal-mard li kienet stmata permezz ta' analiżi mill-ġdid minn espert indipendenti.
English: Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, pyrimidine analogues; ATC Code: L01BC08
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Liver function tests should be performed prior to initiation of therapy and prior to each treatment cycle, and as clinically indicated (see sections 4.2 and 5.2).
Maltese: Għandhom isiru testijiet tal-funzjoni tal-fwied qabel tinbeda t-terapija u qabel kull ċiklu ta' trattament, u skont kif ikun indikat b'mod kliniku (ara sezzjonijiet 4.2 u 5.2).
English: Uncommon Cardiomyopathy
Maltese: IL-PRODOTT MEDIĊINALI
English: Population pharmacokinetic analysis of decitabine did not show any clinically relevant difference between men and women.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni ta' decitabine ma wrietx xi differenza klinikament relevanti bejn l-irġiel u n-nisa.
English: In vitro metabolism data and the human mass balance study results indicated that the cytochrome P450 system is not involved in the metabolism of decitabine.
Maltese: Dejta ta' metaboliżmu in vitro u r-riżultati tal-istudju tal-bilanċ tal-massa fil-bniedem indikaw li ssistema taċ-ċitokroma P450 mhijiex involuta fil-metaboliżmu ta' decitabine.
English: Frequency (all Grades) Adverse Drug Reaction
Maltese: Reazzjonijiet ematoloġiċi avversi għall-mediċina
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2)
English: In addition, in vitro data show that decitabine is a poor P-gp substrate.
Maltese: Għaldaqstant, esponiment għal decitabine x'aktarx li mhuwiex affettwat f'pazjenti b'funzjoni indebolita tal-kliewi.
English: Serious infection-related adverse drug reactions, with potentially fatal outcome, such as septic shock, sepsis, pneumonia, and other infections (viral, bacterial and fungal) were reported in patients receiving decitabine.
Maltese: Infezzjonijiet u infestazzjonijiet bħala reazzjonijiet avversi għall-mediċina Infezzjonijiet bħala reazzjonijiet avversi serji għall-mediċina jistgħu jwasslu għal konsegwenzi fatali, bħal xokk settiku, sepsis, pulmonite u infezzjonijiet oħra (virali, batteriċi u fungali) ġew irrappurtati f'pazjenti li kienu qed jieħdu decitabine.
English: The remainder of the subjects had intermediate-risk cytogenetics.
Maltese: Il-kumplament tal-individwi kellhom ċitoġenetika ta' riskju intermedju.
English: Dacogen was administered as a 1-hour intravenous infusion of 20 mg/m2 once daily for 5 consecutive days repeated every 4 weeks.
Maltese: Dacogen ingħata bħala infużjoni ta' 20 mg/m2 fuq perijodu ta' siegħa minn ġolvina darba kuljum għal ħamest ijiem konsekuttivi u ġie rrepetut kull 4 ġimgħat.
English: Because of the possibility of infertility as a consequence of Dacogen therapy, men should seek advice on conservation of sperm and female patients of childbearing potential should seek consultation regarding oocyte cryopreservation prior to initiation of treatment.
Maltese: Minħabba l-possibbiltà ta' infertilità bħala konsegwenza ta' terapija b'Dacogen, l-irġiel għandhom ifittxu parir dwar ilpreservazzjoni tal-isperma u pazjenti nisa f'età li jista' jkollhom it-tfal għandhom ifittxu konsultazzjoni dwar il-krijopreservazzjoni tal-ooċiti qabel il-bidu tal-kura.
English: Thus; CYP-mediated metabolic drug interactions are not anticipated, and decitabine is unlikely to interact with agents metabolized through these pathways.
Maltese: Għaldaqstant; mhumiex mistennija interazzjonijiet metaboliċi tal-mediċina medjati minn CYP, u decitabine mhuwiex mistenni li jkollu interazzjoni ma' sustanzi mmetabolizzati permezz ta' dawn ir-rotot.
English: Dacogen is used to treat a type of cancer called ‘acute myeloid leukaemia' or ‘AML'.
Maltese: Dacogen jintuża biex jikkura tip ta' kanċer msejjaħ ‘lewkimja majelojde akuta' jew ‘AML'.
English: Toxicity is likely to manifest as exacerbations of adverse drug reactions, primarily myelosuppression.
Maltese: It-tossiċità x'aktarx li tintwera bħala aggravar tarreazzjonijiet avversi għall-mediċina, l-aktar majelosoppressjoni.
English: • abnormal liver function
Maltese: • funzjoni mhux normali tal-fwied
English: The powder should be aseptically reconstituted with 10 ml of water for injections.
Maltese: It-trab għandu jiġi rrikostitwit b'mod asettiku b'10 ml ta' ilma għall-injezzjonijiet.
English: Dacogen has moderate influence on the ability to drive and use machines.
Maltese: Dacogen għandu influwenza moderata fuq il-ħila biex issuq u tħaddem magni.
English: How to store Dacogen
Maltese: X'fih Dacogen
English: • nausea
Maltese: • nawsja
English: The total dose per cycle was 100 mg/m
Maltese: Id-doża totali f'kull ċiklu kienet ta' 100 mg/m
English: After reconstitution with 10 ml of water for injections, each ml of concentrate contains 5 mg of decitabine.
Maltese: Wara rrikostituzzjoni b'10 ml ta' ilma għall-injezzjonijiet, kull ml tal-konċentrat ikun fih 5 mg ta' decitabine.
English: Very common hyperglycaemia
Maltese: Reazzjoni Avversa għallMediċina
English: Haematologic adverse drug reactions
Maltese: Aktar informazzjoni fuq popolazzjonijiet speċjali
English: • heart muscle disease
Maltese: • infezzjoni fl-awrina
English: • Do not use this medicine after the expiry date, which is stated on the carton and on the vial label after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u t-tikketta tal-flixkun wara
English: Talk to your doctor or nurse if you have any questions about how Dacogen works or why this medicine has been prescribed for you.
Maltese: Dacogen se jingħatalek minn tabib jew infermier li huwa mħarreġ fl-għoti ta' din it-tip ta' mediċina.
English: Xtandi (enzalutamide)
Maltese: Xtandi (enzalutamid)
English: Further information on Xtandi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Xtandi.
Maltese: Aktar informazzjoni dwar Xtandi tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/Xtandi.
English: The medicine contains the active substance enzalutamide.
Maltese: Il-mediċina fiha s-sustanza attiva enzalutamid.
English: Metastatic prostate cancer
Maltese: Kanċer tal-prostata metastatiku
English: Xtandi is available as capsules (40 mg) and tablets (40 and 80 mg) and can only be obtained with a prescription.
Maltese: Xtandi jiġi bħala kapsuli (40 mg) u bħala pilloli (40 u 80 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Other information about Xtandi
Maltese: Informazzjoni oħra dwar Xtandi
English: The active substance in Xtandi, enzalutamide, works by blocking the action of the male hormone testosterone and other male hormones known as androgens.
Maltese: Is-sustanza attiva fi Xtandi, l-enzalutamid taħdem billi timblokka l-azzjoni tal-ormon maskili testosteron u ormoni maskili oħra magħrufa bħala androġeni.
English: Xtandi received a marketing authorisation valid throughout the EU on 21 June 2013.
Maltese: Xtandi ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-21 ta' Ġunju 2013.
English: Xtandi has also been compared with placebo in a second main study involving 1,717 patients with metastatic, castration-resistant prostate cancer in whom hormone therapy had failed, but who had no symptoms or mild symptoms and had not previously been treated with chemotherapy.
Maltese: Xtandi tqabbel ukoll ma' plaċebo fit-tieni studju ewlieni li fih ħadu sehem 1,717-il pazjent b'kanċer talprostata metastatiku reżistenti għall-kastrazzjoni li fuqhom it-terapija ormonali ma kinitx ħadmet, iżda li ma kellhom ebda sintomu jew sintomi ħfief u li ma kinux ingħataw kura preċedenti b'kimoterapija.
English: Xtandi has been compared with placebo (a dummy treatment) in a main study involving 1,199 patients with metastatic, castration-resistant prostate cancer who were previously treated with docetaxel.
Maltese: Xtandi tqabbel ma' plaċebo (kura finta) fi studju ewlieni li involva 1,199 pazjent b'kanċer tal-prostata metastatiku reżistenti għall-kastrazzjoni li kienu rċevew kura preċedenti b'docetaxel.
English: Other important side effects include falls, cognitive disorder (problems with thinking, learning and memory), and neutropenia (low levels of neutrophils, a type of white blood cells).
Maltese: Effetti sekondarji importanti oħra jinkludu waqgħat, disturbi konjittivi (problemi bil-ħsieb, bit-tagħlim u bil-memorja), u newtropenja (livelli baxxi ta' newtrofili, tip ta' ċelloli tad-demm bojod ).
English: Xtandi has been compared with placebo in a study involving 1,401 patients with castration-resistant prostate cancer at high risk of becoming metastatic.
Maltese: Xtandi tqabbel ma' plaċebo fi studju li involva 1,401 pazjenti b'kanċer tal-prostata reżistenti għallkastrazzjoni b'riskju għoli li jsir metastatiku.
English: As for all medicines, data on the use of Xtandi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Xtandi hija ssorveljata kontinwament.
English: What are the risks associated with Xtandi?
Maltese: X'inhuma r-riskji assoċjati ma' Xtandi?
English: In addition, seizures (fits) can occur in around 4 patients in 1,000.
Maltese: Barra minn hekk, aċċessjonijiet (attakki) jistgħu jseħħu f'madwar 4 pazjenti minn kull 1,000.
English: The most common side effects with Xtandi (which may affect more than 1 in 10 people) are tiredness, fractures (broken bones), hot flushes and hypertension (high blood pressure).
Maltese: L-effetti sekondarji l-aktar komuni bi Xtandi (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 ) huma għeja, uġigħ ta' ras, fwawar u ipertensjoni (pressjoni tad-demm għolja).
English: How does Xtandi work?
Maltese: Kif jintuża Xtandi?
English: In addition, patients treated with Xtandi lived for longer without their disease showing signs of worsening in a radiographic scan: 20 months compared with 5 months for patients treated with placebo.
Maltese: Barra minn hekk il-pazjenti li ngħataw kura bi Xtandi għexu għal aktar żmien mingħajr ma l-marda tagħhom uriet sinjali ta' aggravar fuq skan radjografiku: 20 xahar imqabbla ma' 5 xhur għal pazjenti li ngħataw kura bi plaċebo.
English: The usual dose is 160 mg once a day, at about the same time each day.
Maltese: Iddoża normali hija ta' 160 mg darba kuljum, bejn wieħed u ieħor fl-istess ħin kuljum.
English: Xtandi is a cancer medicine used to treat men with prostate cancer.
Maltese: Xtandi huwa mediċina kontra l-kanċer li tintuża biex tikkura rġiel b'kanċer tal-prostata.
English: It is used when the cancer is metastatic (has spread to other parts of the body), castration resistant (worsens despite treatment to lower production of testosterone or after surgical removal of the testes) and when either:
Maltese: Jintuża meta l-kanċer ikun metastatiku (ikun infirex għal partijiet oħra tal-ġisem), reżistenti għallkastrazzjoni (jaggrava minkejja l-kura biex titnaqqas il-produzzjoni testosteron jew wara t-tneħħija kirurġika tat-testikoli) u meta jew:
English: Why is Xtandi authorised in the EU?
Maltese: Għaliex Xtandi huwa awtorizzat fl-UE?
English: • treatment with docetaxel (a cancer medicine) has not worked or no longer works; or
Maltese: • il-kura b'docetaxel (mediċina kontra l-kanċer) ma tkunx ħadmet jew ma tkunx għadha taħdem;
English: Xtandi has also been shown to delay the development of metastatic disease.
Maltese: Xtandi wera wkoll li dan idewwem l-iżvilupp tal-mard metastatiku.
English: • hormone therapy has not worked, and the patient has either no symptoms or mild symptoms and does not yet require chemotherapy (another type of cancer treatment).
Maltese: • meta t-terapija ormonali ma tkunx ħadmet, u l-pazjent jew ma jkollu ebda sintomu jew ikollu sintomi ħfief u jkun għadu ma jeħtieġx kimoterapija (tip ieħor ta' kura kontra l-kanċer).
English: For the full list of side effects with Xtandi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji bi Xtandi, ara l-fuljett ta' tagħrif.
English: Side effects reported with Xtandi are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Xtandi huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Because prostate cancer needs testosterone and other male hormones to survive and grow, by blocking the effects of these hormones, enzalutamide slows down the growth of the prostate cancer.
Maltese: Minħabba li l-kanċer tal-prostata jeħtieġ it testosteron u ormoni maskili oħra biex jgħix u jikber, billi timblokka l-effetti ta' dawn l-ormoni, lenzalutamid tnaqqas ir-ritmu li bih jikber il-kanċer tal-prostata.
English: Patients treated with Xtandi lived for an average of 37 months without their disease becoming metastatic compared with 15 months on placebo.
Maltese: Il-pazjeti kkurati bi Xtandi għexu medja ta' 37 xahar mingħajr ma l-marda saret metastatika meta mqabbla ma' 15-il xahar f'pazjenti li ħadu l-plaċebo.