FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical efficacy and the clinical relevance of Selincro were analysed in patients with a high or very high DRL at screening and randomisation.
Maltese: L-effikaċja klinika u r-relevanza klinika ta' Selincro kienu analizzati f'pazjenti b'DRL għoli jew għoli ħafna waqt l-ewwel eżaminazzjoni u waqt l-għażla b'mod arbitrarju.
English: For HDDs there were 19 days/month at baseline in the Selincro-group (n=141) and19 days/month at baseline in the placebo group (n=42).
Maltese: Għall-HDDs kien hemm 19-il ġurnata/xahar bħala linja bażi filgrupp ta' Selincro (n=141) u 19-il ġurnata/xahar bħala linja bażi fil-grupp tal-plaċebo (n=42).
English: For HDDs there were 23 days/month at baseline in the Selincro group (n=171) and 23 days/month at baseline in the placebo group (n=167).
Maltese: Għall-HDDs kien hemm 23 ġurnata/xahar bħala linja bażi fil-grupp ta' Selincro (n=171) u 23 ġurnata/xahar bħala linja bażi fil-grupp tal-plaċebo (n=167).
English: This is unlikely to present a problem with occasional use, but if long-term concurrent treatment with a potent UGT2B7 inhibitor is initiated, a potential for an increase in nalmefene exposure cannot be excluded (see section 4.4).
Maltese: Wisq probabbli, din ma tkunx problema jekk l-użu ma jkunx frekwenti, iżda jekk tinbeda kura fl-istess ħin fit-tul b'inibitur qawwi ta' UGT2B7, mhux eskluż li jkun hemm il-possibbiltà ta' żieda fl-espożizzjoni ta' nalmefene (ara sezzjoni 4.4).
English: Alcohol dependence occurs when a person has a physical or psychological dependence on the consumption of alcohol.
Maltese: Id-dipendenza fuq l-alkoħol isseħħ meta persuna għandha dipendenza fiżika jew psikoloġika għallkonsum tal-alkoħol.
English: If you continue treatment with Selincro, or start again after a break in treatment, you will probably not have side effects.
Maltese: Jekk tkompli l-kura b'Selincro jew terġa' tibda wara li tkun waqaft għal perijodu qasir, wisq probabbli mhux se jkollok effetti sekondarji.
English: If you require emergency medical attention, tell your doctor that you are taking Selincro.
Maltese: Jekk ikollok bżonn attenzjoni medika ta' emerġenza, għid lit-tabib tiegħek li qed/a tieħu Selincro.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of nalmefene/metabolites in milk (see section 5.3).
Maltese: Dejta disponibbli farmakodinamika/tossikoloġika fl-annimali uriet li nalmefene/metaboliti jiġu eliminati fil-ħalib (ara sezzjoni 5.3).Mhuwiex magħruf jekk nalmefene jiġix eliminat fil-ħalib uman.
English: Caution is advised if Selincro is co-administered with a potent UGT2B7 inhibitor (see section 4.5).
Maltese: Hija rrakkomandata l-kawtela jekk Selincro jingħata flimkien ma' inibituri qawwijin ta' UGT2B7 (ara sezzjoni 4.5).
English: For the patients who continued in the study and provided efficacy data at Month 6, the TAC was 44 g/day in the Selincro group (n=103) and 52 g/day in the placebo group (n=111).
Maltese: Għall-pazjenti li baqgħu fl-istudju u pprovdew tagħrif dwar l-effikaċja fis-6 Xahar, it-TAC kien ta' 44 g/ġurnata fil-grupp ta' Selincro (n=103) u ta' 52 g/ġurnata fil-grupp tal-plaċebo (n=111).
English: Side effects such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur when beginning Selincro treatment.
Maltese: Effetti sekondarji bħal disturbi fl-attenzjoni, ma tħossokx normali, dardir, sturdament, ngħas, insomnja u uġigħ ta' ras jistgħu jseħħu meta tibda l-kura b'Selincro.
English: For the patients who continued in the study and provided efficacy data at Month 6, the TAC was 40 g/day in the Selincro-group (n=85) and 57 g/day in the placebo group (n=114).
Maltese: Għall-pazjenti li baqgħu fl-istudju u pprovdew tagħrif dwar l-effikaċja fis-6 Xahar, it-TAC kien ta' 40 g/ġurnata fil-grupp ta' Selincro (n=85) u ta' 57 g/ġurnata fil-grupp tal-plaċebo (n=114).
English: 52% of these patients had a high or very high DRL at baseline; of these, 52% (representing 27% of the total population) continued to have a high or very high DRL at randomisation.
Maltese: Dan l-istudju kien fih total ta' 665 pazjent, 52% ta' dawn il-pazjenti kellhom DRL għoli jew għoli ħafna fil-linja bażi: minn dawn 52% (li jirrappreżentaw 27% tal-popolazzjoni totali) baqgħu b'DRL għoli jew għoli ħafna meta ġew għall-għażla b'mod arbitrarju.
English: For the patients who continued in the study and provided efficacy data at 1 year, the number of HDDs was 5 days/month in the Selincro group (n=78) and 10 days/month in the placebo group (n= 29).
Maltese: Għallpazjenti li baqgħu fl-istudju u pprovdew tagħrif dwar l-effikaċja wara sena, in-numru ta' HDDs kien ta' 5 ġranet/xahar fil-grupp ta' Selincro (n=73) u ta' 10 ġranet/xahar fil-grupp tal-plaċebo (n=29).
English: The efficacy of Selincro was measured using two co-primary endpoints: the change from baseline to Month 6 in the monthly number of heavy drinking days (HDDs) and the change from baseline to Month 6 in the daily total alcohol consumption (TAC).
Maltese: L-effikaċja ta' Selincro ġiet imkejla bl-użu ta' żewġ endpoints primarji: il-bidla mil-linja bażi għas6 Xahar fin-numru ta' ġranet ta xorb eċċessiv ta' kull xahar (HDDs) u l-bidla mil-linja bażi għas6 Xahar fil-konsum ta' alkoħol totali ta' kuljum (TAC).
English: Administration of a single oral dose of nalmefene 18.06 mg to patients with mild, moderate or severe renal impairment, classified using the estimated glomerular filtration rate, resulted in an increased exposure to nalmefene relative to that in healthy subjects.
Maltese: L-għoti ta' doża orali waħda ta' nalmefene 18.06 mg lil pazjenti b'indeboliment renali ħafif, moderat jew sever, ikklassifikat permezz ta' rata ta' filtrazzjoni glomerulari stmata, irriżulta f'espożizzjoni miżjuda għal nalmefene meta mqabbel ma' dik f'individwi b'saħħithom.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA(ĊI) ATTIVA(I)
English: Very Common Nausea Common
Maltese: Komuni ħafna
English: While these events were generally shortlasting, they could represent alcoholic psychosis, alcohol withdrawal syndrome, or comorbid psychiatric disease.
Maltese: Wara li jingħata nalmefene, jidher li hemm indeboliment żgħir fl-imġiba konoxxittiva u psikometrika.
English: Further, the Cmax and elimination half-life for nalmefene was up to 1.6 times higher in patients with severe renal impairment.
Maltese: Barra minn hekk, is- Cmax u l-half-life ta' eliminazzjoni għal nalmefene kienu sa 1.6 drabi ogħla f'pazjenti b'indeboliment renali sever.
English: You may experience acute opioid withdrawal symptoms (such as feeling sick, vomiting, shakiness, sweating and anxiety) - if you experience, or suspect you are experiencing opioid withdrawal symptoms - if your liver or kidney function is poor - if you are experiencing or have recently experienced several alcohol withdrawal symptoms
Maltese: Jista' jkollok sintomi akuti ta' rtirar mill-opjojdi (bħal tħossok ma tiflaħx, tirremetti, titriegħed,, tibda tegħreq u tħossok ansjuż/a) - jekk ikollok jew taħseb li qed ikollok sintomi ta' rtirar mill-opjojdi - jekk il-livell tal-funzjoni tal-fwied jew tal-kliewi huwa baxx - jekk qed/a tgħaddi jew għaddejt dan l-aħħar minn ħafna sintomi minħabba nuqqas ta' alkoħol (bħal li tara, tisma' jew tħoss xi affarijiet li mhumiex hemm, aċċessjonijiet jew tregħid)
English: A high level of alcohol consumption is defined as drinking more than 60 g of pure alcohol per day for men and more than 40 g of pure alcohol per day for women.
Maltese: Livell għoli ta' konsum tal-alkoħol huwa definit bħala xorb ta' aktar minn 60 g ta' alkoħol pur kuljum għall-irġiel u aktar minn 40 g ta' alkoħol pur kuljum għan-nisa.
English: Pregnancy
Maltese: Astinja
English: How to store Selincro
Maltese: X'fih Selincro
English: Other side effects (cannot be estimated from the available data) - seeing, hearing or sensing things that are not there - feeling detached from oneself - swelling of face, lips, tongue or throat - hives - itching - rash - redness of skin - muscle pain - prolonged erection (priapism)
Maltese: Effetti sekondarji oħra (ma tistax tittieħed stima mid-data disponibbli). - tisma', tara jew tħoss affarijiet li mhumiex hemm - tħossok maqtugħ minnek innifsek. - nefħa fil-wiċċ, ix-xufftejn, l-ilsien jew il-griżmejn
English: Muscle spasms
Maltese: TWISSIJA(IET) SPEĊJALI
English: There is limited experience in patients with a history of seizure disorders, including alcohol withdrawal seizures.
Maltese: Hemm esperjenza limitata f'pazjenti b'passat mediku ta' aċċessjonijiet, inkluż aċessjonijiet minħabba l-irtirar mill-alkoħol.
English: The efficacy of Selincro in reducing alcohol consumption in patients with alcohol dependence (DSMIV) was evaluated in two efficacy studies.
Maltese: L-effikaċja ta' Selincro fuq it-tnaqqis tal-konsum tal-alkoħol f'pazjenti b'dipendenza fuq l-alkoħol (DSM-IV) ġiet evalwata f'żewġ studji dwar l-effikaċja.
English: Data from the nonclinical studies, the clinical studies, and the literature do not suggest any form of dependence or abuse potential with Selincro.
Maltese: Tagħrif mill-istudji mhux kliniċi, mill-istudji kliniċi, u mill-letteratura ma jissuġġerixi ebda tip ta' dipendenza jew potenzjal ta' abbuż minn Selincro.
English: - Selincro is for oral use.
Maltese: - Selincro hu għal użu orali.
English: In patients with moderate hepatic impairment, exposure increased 2.9 times for AUC and 1.7 times for Cmax, while oral clearance decreased by approximately 60%.
Maltese: F'pazjenti b'indeboliment tal-fwied moderat, l-espożizzjoni żdiedet b'2.9 darba aktar għal AUC u 1.7 darbiet għal Cmax, filwaqt li tneħħija orali naqset b'madwar 60%.
English: For the patients who continued in the study and provided efficacy data at Month 6, the number of HDDs was 9 days/month in the Selincro group (n=85) and 14 days/month in the placebo group (n=114).
Maltese: Għall-pazjenti li baqgħu fl-istudju u pprovdew tagħrif dwar l-effikaċja fis-6 Xahar, in-numru ta' HDDs kien ta' 9 ġranet/xahar fil-grupp ta' Selincro (n=85) u ta' 14-il ġurnata/xahar fil-grupp talplaċebo (n=114).
English: Metabolism by glucuronide conjugation is the primary mechanism of clearance for nalmefene, with renal excretion being the main route of elimination of nalmefene and its metabolites.
Maltese: Selincro huwa metabolizzat b'mod estensiv mill-fwied u eliminat fil-biċċa l-kbira fl-awrina.
English: Caution should be exercised when prescribing Selincro to patients ≥65 years of age (see sections 4.2 and 5.2).
Maltese: Mhu rrakkomandat ebda aġġustament fid-doża għal din il-popolazzjoni ta' pazjenti (ara sezzjonijiet 4.4 u 5.2).
English: Selincro should be temporarily discontinued for 1 week prior to the anticipated use of opioids, for example, if opioid analgesics might be used during elective surgery.
Maltese: Selincro għandu jitwaqqaf temporanjament għal ġimgħa qabel l-użu antiċipat tal-opjojdi, per eżempju, jekk opjojdi b'effett analġeżiku jkunu x'aktarx se jintużaw waqt kirurġija elettiva.
English: Patients with acute symptoms of opioid withdrawal.
Maltese: Pazjenti b'sintomi akuti ta' rtirar mill-opjojdi.
English: In a study in patients diagnosed with pathological gambling, doses of nalmefene up to 90 mg/day for 16 weeks were investigated.
Maltese: Fi studju f'pazjenti li kellhom dijanjosi patoloġika għal-logħob, ġew studjati dożi ta' nalmefene sa 90 mg/jum għal 16-il ġimgħa.
English: Selincro can help you reduce the amount of alcohol you drink, and keep the reduced level of alcohol consumption.
Maltese: Selincro jista' jgħinek biex tnaqqas l-ammont ta' alkoħol li tixrob u żżomm dan illivell imnaqqas ta' konsum tal-alkoħol.
English: The full EPAR for Topotecan Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Topotecan Hospira jista' jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom kkontrollati qabel it-trattament biex ikun aċċertat li jkunu ogħla mil-livelli minimi stabbiliti.
English: It contains the active substance topotecan.
Maltese: Fih issustanza attiva topotecan.
English: The active substance in Topotecan Hospira, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Maltese: Is-sustanza attiva ta' Topotecan Hospira, topotecan, hija mediċina kontra l-kanċer li tappartjeni għallgrupp tal-‘inibituri tat-topojsomerażi' (topoisomerase).
English: When used with cisplatin in cervical cancer, Topotecan Hospira is given on days 1, 2 and 3 (with cisplatin given on day 1).
Maltese: Meta użat ma' cisplatin f'kanċer ċervikali, Topotecan Hospira jingħata bħala infużjoni fil-jiem numru 1, 2 u 3 (b'cisplatin mogħti f'jum 1).
English: This document is a summary of the European Public Assessment Report (EPAR) for Topotecan Hospira.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Topotecan Hospira.
English: The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Hospira on 10 June 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Topotecan Hospira fl-10 ta' Ġunju 2010.
English: What are the benefit and risk of Topotecan Hospira?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Topotecan Hospira?
English: It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Maltese: Timblokka enzima li tissejjaħ topojsomerażi I li hija involuta fid-duplikazzjoni tad-DNA.
English: The reference medicine Hycamtin is available as a powder to be made up into a solution for infusion and not as a concentrate.
Maltese: Il-mediċina ta' referenza Hycamtin hija disponibbli bħala trab biex isir soluzzjoni għall-infużjoin u mhux bħala konċentrat.
English: No additional studies were needed as Topotecan Hospira is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Maltese: Ma kien jinħtieġ l-ebda studju addizzjonali fil-pazjenti peress li Topotecan Hospira jingħata permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Hycamtin.
English: Therefore, the CHMP's view was that, as for Hycamtin, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Hycamtin, ilbenefiċċji huma akbar mir-riskji identifikati.
English: This is repeated every 21 days for six courses or until the disease gets worse.
Maltese: Dan jiġi rripetut kull 21 jum għal sitt ċikli jew sa ma taggrava lmarda.
English: Because Topotecan Hospira produces the same levels of the active substance in the body as the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Maltese: Minħabba li Topotecan Hospira jipproduċi l-istess livelli tas-sustanza attiva fil-ġisem bħall-mediċina ta' referenza, il-benefiċċju u r-riskju huma meħuda bħala li huma l-istess bħall-mediċina ta' referenza.
English: Why has Topotecan Hospira been approved?
Maltese: Għaliex ġie approvat Topotecan Hospira?
English: What is Topotecan Hospira?
Maltese: X'inhu Topotecan Hospira?
English: The CHMP concluded that, in accordance with EU requirements, Topotecan Hospira has been shown to be comparable to Hycamtin.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-Unjoni Ewropea, Topotecan Hospira wera ruħu paragunabbli ma' Hycamtin.
English: The company has provided data from the published literature on topotecan.
Maltese: Il-kumpanija pprovdiet tagħrif mil-letteratura ppubblikata dwar topotecan.
English: Topotecan Hospira is a concentrate that is made up into a solution for infusion (drip into a vein).
Maltese: Topotecan Hospira huwa konċentrat li jitħallat biex isir soluzzjoni għall-infużjoni (dripp fil-vina).
English: Topotecan Hospira is a ‘hybrid medicine'.
Maltese: Topotecan Hospira huwa ‘mediċina ibrida' Dan ifisser li Topotecan Hospira huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE).
English: It is also used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Maltese: Jintuża wkoll flimkien maċ-ċisplatinu (cisplatin - mediċina oħra kontra l-kanċer) fit-trattament ta' nisa bil-kanċer tal-għonq tal-utru (ċerviċi), f'każ ta' kanċer reċidiv wara r-radjoterapija jew fil-każ meta lmarda tkun fi stadju avvanzat (stadju IVB: il-kanċer ikun infirex lil hinn miċ-ċerviċi).
English: Further information on Kanjinti can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: After treatment of up to a year, 48% of those given Kanjinti (172 of 358) and 41% of those given the reference medicine Herceptin (137 of 338) had no invasive cancer cells in the breasts or surrounding lymph nodes.
Maltese: Wara kura sa sena, 48 % ta' dawk li ngħataw Kanjiti (172 minn 358) u 41 % ta' dawk li ngħataw il-mediċina ta' referenza Herceptin (137 minn 338) ma kellhom l-ebda ċellola ta' kanċer invażiv fis-sider jew fil-limfonodi talmadwar.
English: Kanjinti contains the active substance trastuzumab.
Maltese: Kanjinti fih is-sustanza attiva trastuzumab.
English: Kanjinti is a ‘biosimilar medicine'.
Maltese: Kanjinti hija ‘mediċina bijosimili'.
English: The active substance in Kanjinti, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Maltese: Is-sustanza attiva f'Kanjinti, it-trastuzumab, hija antikorp monoklonali (tip ta' proteina) imfassla biex tagħraf u teħel mal-proteina HER2.
English: Other information about Kanjinti
Maltese: Informazzjoni oħra dwar Kanjinti
English: Laboratory studies comparing Kanjinti with Herceptin have shown that the active substance in Kanjinti is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Kanjinti ma' Herceptin urew li s-sustanza attiva f'Kanjinti hija simili ħafna għal dik f'Herceptin f'termini ta' struttura, purità u attività bijoloġika.
English: Patients who do not have significant reactions to the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Maltese: Il-pazjenti li ma jkollhomx reazzjonijiet sinifikanti għall-ewwel infużjoni ta' 90-minuta jistgħu jirċievu infużjonijiet sussegwenti għal 30 minuta.
English: The reference medicine for Kanjinti is Herceptin.
Maltese: Il-mediċina ta' referenza għal Kanjinti hija Herceptin.
English: What are the risks associated with Kanjinti?
Maltese: X'inhuma r-riskji assoċjati ma' Kanjinti?
English: As for all medicines, data on the use of Kanjinti are continuously monitored.
Maltese: Bħal fil-mediċini kollha, id-data dwar l-użu ta' Kanjinti hija ssorveljata kontinwament.
English: This means that Kanjinti is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Kanjinti huwa simili ħafna għal mediċina bijoloġika oħra (il-‘mediċina ta' referenza') li diġà hija awtorizzata fl-UE.
English: For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Kanjinti is used before surgery in combination with chemotherapy and then again after surgery on its own;
Maltese: Għal kanċers li huma lokalment avvanzati (inkluż dawk li huma infjammatorji) jew usa' aktar minn 2 cm, Kanjinti jintuża qabel il-kirurġija flimkien malkimoterapija mbagħad għal darb'oħra wara l-kirurġija waħdu;
English: In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Kanjinti would behave in the same way as Herceptin in its approved indications.
Maltese: Fid-dawl tad-data kollha pprovduta, id-differenza ma ġietx ivvalutata bħala rilevanti u ġie konkluż li Kanjiti jġib ruħu bl-istess mod ta' Herceptin fl-indikazzjonijiet approvati tiegħu.
English: The most common or serious side effects with Kanjinti are heart problems, reactions related to the Kanjinti infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Maltese: L-effetti sekondarji l-aktar komuni jew serji b'Kanjinti huma problemi fil-qalb, reazzjonijiet relatati malinfużjoni ta' Kanjinti, livelli mnaqqsa ta' ċelloli tad-demm (speċjalment taċ-ċelloli bojod tad-demm), infezzjonijiet u problemi fil-pulmun.
English: In addition, one study involving 696 patients with early breast cancer that overexpressed HER2 showed that Kanjinti was effective in treating the condition.
Maltese: Barra minn hekk, studju wieħed li involva 696 pazjent b'kanċer tas-sider li jkun għadu fil-bidu li esprima żżejjed minn HER2 wera li Kanjiti kien effettiv biex jikkura l-kondizzjoni.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Kanjinti has been shown overall to have a comparable quality, safety and effectiveness to Herceptin.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Kanjinti wera li għandu kwalità, sigurtà u effikaċja komparabbli għal Herceptin.
English: What measures are being taken to ensure the safe and effective use of Kanjinti?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Kanjinti?
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Maltese: • kanċer tas-sider li jkun għadu fil-bidu (meta l-kanċer ikun infirex fis-sider jew fil-glandoli taħt iddriegħ iżda mhux f'partijiet oħra tal-ġisem) wara kirurġija, kimoterapija (mediċini biex jikkuraw ilkanċer), u radjoterapija (kura bir-radjazzjoni) jekk applikabbli.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Maltese: Billi jeħel ma' HER2, it-trastuzumab tattiva ċ-ċelloli tas-sistema immuni, li mbagħad joqtlu liċ-ċelloli tat-tumur.
English: Studies have also shown that giving Kanjinti produces similar levels of the active substance in the body to giving Herceptin.
Maltese: L-istudji wrew ukoll li l-għoti ta' Kanjinti jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Herceptin.
English: How does Kanjinti work?
Maltese: Kif jintuża Kanjinti?
English: For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.
Maltese: Għaldaqstant, il-fehma tal-Aġenzija kienet li, bħal fil-każ ta' Herceptin, il-benefiċċju ta' Kanjinti huwa akbar mir-riskju identifikat u li jista' jiġi awtorizzat.
English: Kanjinti can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Maltese: Kanjinti jista' jikkawża kardjotossiċità (ħsara lill-qalb), inkluż insuffiċjenza kardijaka (meta l-qalb ma taħdimx tajjeb kemm suppost).
English: Kanjinti can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Maltese: Kanjinti jista' jintuża biss meta l-kanċer “jesprimi żżejjed minn HER2”: dan ifisser li l-kanċer jipproduċi proteina li tissejjaħ HER2 fi kwantitajiet kbar fuq iċ-ċelloli tal-kanċer.
English: Total parenteral nutrition:
Maltese: Nutrizzjoni parenterali totali:
English: Osmolality: 500± 50 mOsm/kg
Maltese: Osmolalità: 500 ± 50 mOsm/kg
English: Oral Contraceptives*
Maltese: Kontraċettivi orali*
English: System Organ Class
Maltese: Sistema talklassifika talorgani
English: • Serious dermatological adverse reactions (including SCC)
Maltese: • Reazzjonijiet avversi dermatoloġiċi serji (inkluż SCC)
English: Rare ≥ 1/10,000 to <
Maltese: Rari ≥ 1/10,000 sa <