FrancophonIA/ELRC3.0 huggingface dataset:
English: ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis (pJIA) in paediatric patients 6 years of age and older who have had an inadequate response to previous DMARD therapy.
Maltese: ORENCIA flimkien ma' methotrexate hu indikat għall-kura ta' artrite idjopatika ġovanili poliartikulari attiva (pJIA) minn moderata sa severa f'pazjenti pedjatriċi li għandhom 6 snin u aktar li kellhom rispons inadegwat għal terapija b'DMARD preċedenti.
English: ORENCIA 125 mg solution for injection in pre-filled syringe with needle guard Abatacept
Maltese: ORENCIA 125 mg soluzzjoni għall-injezzjoni ġo siringa mimlija għal-lest bil-protezzjoni għal-labra Abatacept
English: ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults and also polyarticular juvenile idiopathic arthritis in children 2 years of age and older.
Maltese: ORENCIA jintuża biex jikkura l-artrite rewmatojde u l-artrite psorjatika fl-adulti u wkoll artrite idjopatika ġovanili poliartikulari fit-tfal ta' età ta' sentejn u ikbar.
English: From a 100 mL infusion bag or bottle, withdraw a volume of 0.9% sodium chloride injection equal to the volume of the reconstituted ORENCIA vials.
Maltese: Minn borża għall-infużjoni jew flixkun, iġbed volum ta' 0.9% soluzzjoni ta' injezzjoni ta' sodium chloride ugwali għall-volum talkunjetti ta' ORENCIA rikostitwiti.
English: How to use ORENCIA 4.
Maltese: Kif għandek tuża ORENCIA 4.
English: Look at the liquid in the syringe (Figure 2).
Maltese: Ħares lejn il-likwidu fis-siringa (Figura 2).
English: Abatacept in pJIA patients has also been studied with the subcutaneous formulation in children and adolescents with moderate to severe active pJIA, ages 2 to 17 years with an inadequate response or intolerance to at least one DMARD, which may have included biologic agents.
Maltese: Abatacept f'pazjenti ta' pJIA ġie wkoll studjat mal-formulazzjoni taħt il-ġilda fi tfal u adolexxenti b'pJIA attiva moderata sa severa, etajiet sentejn sa 17-il sena b'rispons inadegwat jew intolleranza għal tal-inqas DMARD wieħed, li seta' inkluda aġenti bijoloġiċi.
English: In study PsA-II, 424 patients were randomised 1:1 to receive in a double-blind manner weekly doses of subcutaneous placebo or abatacept 125 mg without a loading dose for 24 weeks, followed by openlabel abatacept 125 mg subcutaneous weekly.
Maltese: Fi studju PsA-II, 424 pazjent ġew randomizzati 1:1 biex jirċievu b'mod double-blind dożi fil-ġimgħa ta' plaċebo taħt il-ġildajew abatacept 125 mg mingħajr doża għolja tal-bidu għal 24 ġimgħa, segwiti minn abatacept open-label 125 mg taħt il-ġilda fil-ġimgħa.
English: Recommended dose
Maltese: Proċessi awtoimmuni
English: The rate is consistent with previous experience, and there was no effect of immunogenicity on pharmacokinetics, safety, or efficacy.
Maltese: Ir-rata hija konsistenti malesperjenza ta' qabel, u ma kien hemm l-ebda effett ta' immunoġeniċità fuq il-farmakokinetika, issigurtà, jew l-effikaċja.
English: Inadequate response to TNF Inhibitor
Maltese: Reazzjonijiet għall-injezzjoni
English: EU/1/07/389/011 4 pre-filled pens
Maltese: EU/1/07/389/011 4 pinen mimlijin għal-lest
English: In a pre- and postnatal development study with abatacept in rats, no undesirable effects were observed in pups of dams given abatacept at doses up to 45 mg/kg, representing 3-fold a human 10 mg/kg exposure based on AUC.
Maltese: Fi studju dwar l-iżvilupp ta' qabel u wara t-twelid b'abatacept fil-firien, ma dehru l-ebda effetti mhux mixtieqa fi frieħ tal-firien nisa li ngħataw abatacept f'doża sa 45 mg/kg, li tirrappreżenta 3-darbiet l-espożizzjoni umana ta' 10 mg/kg ibbażata fuq AUC.
English: See Package Leaflet for additional disposal information.
Maltese: TUŻAHIEX jekk id-data ta' skadenza għaddiet.
English: In study PsA-II, the proportion of radiographic non-progressors (≤ 0 change from baseline) in total PsA-modified SHS on x-rays at Week 24 was greater with abatacept 125 mg subcutaneous (42.7%) than placebo (32.7%) (10.0 [1.0, 19.1] estimate of difference [95% CI]).
Maltese: Fi studju PsA-II, il-proporzjon ta' pazjenti li ma jipprogressawx radjografiċi (bidla ta' ≤ 0 mil-linja bażi) f'SHS totali modifikati mill-PsA fuq ir-raġġi X f'Ġimgħa 24 kien akbar b'abatacept 125 mg taħt il-ġilda (42.7%) milli bi plaċebo (32.7%) (10.0
English: In placebo-controlled clinical trials, in comparison with patients treated with TNFinhibitors and placebo, patients who received combination TNF-inhibitors with abatacept experienced an increase in overall infections and serious infections (see section 4.5).
Maltese: Fi provi kliniċi kkontrollati bi plaċebo, meta pazjenti ttrattati b'inibituri ta' TNF tqabblu mal-pazjenti li kienu qed jieħdu plaċebo, pazjenti li rċevew kombinazzjoni ta' inibituri ta' TNF ma' abatacept, esperjenzaw żieda fl-infezzjonijiet globali u f'infezzjonijiet serji (ara sezzjoni 4.5).
English: d Reduction in HAQ-DI of ≥ 0.3 units from baseline.
Maltese: Xi wħud minn dawn l-infezzjonijiet kienu fatali.
English: A randomised and double-blinded study evaluated abatacept SC in combination with methotrexate (abatacept + MTX), abatacept SC monotherapy, or methotrexate monotherapy (MTX group) in induction of remission following 12 months of treatment, and maintenance of drug-free remission after complete drug withdrawal in MTX-naive adult patients with highly active early rheumatoid arthritis with poor prognostic factors.
Maltese: Studju li fih il-parteċipanti ntgħażlu b'mod każwali u double-blinded evalwa abatacept SC f'kombinament ma' methotrexate (abatacept + MTX), monoterapija ta' abatacept SC, jew monoterapija ta' methotrexate (grupp MTX) fl-induzzjoni tar-remissjoni wara 12-il xahar ta' kura, u żżamma ta' remissjoni mingħajr mediċina wara rtirar sħiħ tal-mediċina f'pazjenti adulti li qatt ma ġew ikkurati b'MTX qabel, b'artrite rewmatojde attiva ħafna, bikrija b'fatturi ta' tbassir dgħajfin.
English: ORENCIA should not be used with biological medicines for rheumatoid arthritis, including TNFblockers like adalimumab, etanercept, and infliximab; there is not enough evidence to recommend its being given with anakinra and rituximab.
Maltese: Prodotti mediċinali li jaffettwaw is sistema immuni, inkluż abatacept, jistgħu jnaqqsu l-effikaċja ta' xi immunizzazzjonijiet (arasezzjonijiet 4.4 u 4.6).
English: - From a 100 mL infusion bag or bottle, withdraw a volume of sodium chloride 9 mg/mL (0.9%)
Maltese: - Minn borża għall-infużjoni jew flixkun ta' 100 mL, iġbed volum ta' 9 mg/mL (0.9%) ta' soluzzjoni għall-injezzjoni ta' sodium chloride ugwali għall-volum tal-kunjetti rikostitwiti.
English: Consistent with the intravenous data, population pharmacokinetic analyses for subcutaneous abatacept in RA patients revealed that there was a trend toward higher clearance of abatacept with increasing body weight.
Maltese: Analiżi farmakokinetika tal-popolazjoni żvelat li kien hemm tendenza lejn eliminazzjoni ogħla ta' abatacept ma' żieda fil-piż tal-ġisem.
English: Your weight
Maltese: Numru ta' pazjenti
English: Abatacept decreases antigen specific TNFα, interferon-γ, and interleukin-2 production by T lymphocytes.
Maltese: • Uri din il-kartuna lil kwalunkwe tabib involut fit-trattament tiegħek.
English: In the placebo-controlled clinical trials, abatacept treatment did not lead to increased autoantibody formation, such as antinuclear and anti-dsDNA antibodies, relative to placebo treatment (see sections 4.8 and 5.3).
Maltese: Fi provi kliniċi kkontrollati bi plaċebo, trattament b'abatacept ma wassalx għal żieda fil-formazzjoni ta' awtoantikorpi, bħal anitkorpi antinukleari u anti-dsDNA, meta mqabbel ma' trattament bi plaċebo (ara sezzjonijiet 4.8 u 5.3).
English: If you have active psoriatic arthritis you will first be given other medicines.
Maltese: Jekk għandek artrite psorjatika attiva, l-ewwel se tingħata mediċini oħrajn.
English: The GDH-PQQ based glucose monitoring systems may react with the maltose present in ORENCIA, resulting in falsely elevated blood glucose readings on the day of infusion.
Maltese: Is-sistemi ta' monitoraġġ tal-glucose ibbażata fuq GDH-PQQ tista' tirreaġġixxi malmaltose preżenti f'ORENCIA, bil-konsegwenza li tirriżulta f'qari falz ta' livell għoli ta' glucose fiddemm dak inhar ta' l-infużjoni.
English: ORENCIA should NOT be used with siliconised syringes (see section 6.6).
Maltese: ORENCIA ma GĦANDUX jintuża b'siringi bis-silikon (ara sezzjoni 6.6).
English: ORENCIA 125 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 125 mg of abatacept in one mL.
Maltese: ORENCIA 125 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Kull siringa mimlija għal-lest fiha 125 mg ta' abatacept f'1 mL.
English: Insert the needle with a quick motion into the pinched skin at a 45° angle (Figure 5).
Maltese: Daħħal il-labra b'moviment ħafif fil-ġilda magħfusa f'angolu ta' 45° (Figura 5).
English: The potential clinical relevance of neutralizing antibody formation is not known.
Maltese: Ir-rilevanza klinika potenzjali għal formazzjoni ta' antikorpi newtralizzanti mhijiex magħrufa.
English: During the cumulative study period when all subjects treated with abatacept in 7 SC studies were included the frequency of injection site reactions was 4.6% (116/2,538) with an incidence rate of 1.32 per 100 person-years.
Maltese: Matul il-perjodu kumulattiv tal-istudju meta ġew inklużi l-individwi kollha ttrattati b'abatacept f'7 studji fejn il-mediċina ngħatat taħt il-ġilda, il-frekwenza ta' reazzjonijiet fis-sit talinjezzjoni kienet ta' 4.6% (116/2,538) b'rata ta' inċidenza ta' 1.32 għal kull 100 sena ta' persuna.
English: Exploratory studies to assess the effect of abatacept on the antibody response to vaccination in healthy subjects as well as the antibody response to influenza and pneumococcal vaccines in rheumatoid arthritis patients suggested that abatacept may blunt the effectiveness of the immune response, but did not significantly inhibit the ability to develop a clinically significant or positive immune response.
Maltese: Studji esploratorji biex jevalwaw l-effett ta' abatacept fuq ir-rispons tal-antikorpi għat-tilqima f'persuni b'saħħithom kif ukoll ir-rispons tal-antikorpi għat-tilqima kontra l-influwenza u t-tilqim pnewmokokkali f'pazjenti b'artrite rewmatojde jissuġġerixxu li abatacept jista' jnaqqas l-effettività tar-rispons immuni, iżda ma jinibixxix b'mod sinifikanti l-ħila li persuna tiżviluppa rispons immuni klinikament sinifikanti jew pożittiv.
English: MRI Osteitis/Bone Oedema Score
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA GĦAS-SIRINGA
English: Patients in the sub-study (n=117) of the open-label extension of study SC-I received 125 mg of subcutaneous abatacept administered weekly via the pre-filled syringe for at least 4 months, and were then switched to receive 125 mg SC abatacept administered weekly via the pre-filled pen for 12 weeks.
Maltese: Il-pazjenti fis-sottostudju (n = 117) tal-estensjoni open-label tal-istudju SC-I rċivew 125 mg ta' abatacept mogħti taħt il-ġilda kull ġimgħa permezz tas-siringa mimlija għal-lest għal tal-anqas 4 xhur, imbagħad inqalbu biex jirċievu 125 mg abatacept SC mogħti kull ġimgħa permezz tal-pinna mimlija għal-lest għal 12-il ġimgħa.
English: Care of injection site:
Maltese: Kategorija farmakoterapewtika:
English: Packs of 4 pre-filled syringes with needle guard.
Maltese: Pakketti ta' 4 siringi mimlijn għal-lest bi protezzjoni għal-labra.
English: The proportion of patients who discontinued treatment due to ARs was 3.0% for abatacept-treated patients and 2.0% for placebo-treated patients.
Maltese: Il-proporzjon ta' pazjenti li ma komplewx it-trattament minħabba ARs kien ta' 3.0% għal pazjenti ttrattati b'abatacept u 2.0% għal dawk ittrattati bi plaċebo.
English: 1 mL Fill line
Maltese: 1 mL
English: ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate.
Maltese: ORENCIA jintuża biex jikkura artrite psorjatika waħdu jew f'kombinament ma' methotrexate.
English: The ACR 20 responses with abatacept 125 mg subcutaneous vs placebo in patients who did not use nonbiological DMARDs were 27.3% vs 12.1%, respectively, (15.15 [1.83, 28.47], estimate of difference [95% CI]), and in patients who had used non-biological DMARDs were 44.9% vs 26.9%, respectively, (18.00 [7.20, 28.81], estimate of difference [95% CI]).
Maltese: [1.83, 28.47], stima ta' differenza [95% CI]), u f'pazjenti li kienu użaw DMARDs mhux bijoloġiċi kienu ta' 44.9% vs 26.9%, rispettivament, (18.00 [7.20, 28.81], stima ta' differenza [95% CI]).
English: In study II, 43% of the patients who had not achieved an ACR 20 response at 6 months developed an ACR 20 response at 12 months.
Maltese: Fi studju II, 43% tal-pazjenti li ma laħqux risponsi ta' ACR 20 wara 6 xhur żviluppaw respons ta' ACR 20 fi tnax il-xahar.
English: The percent of abatacept-treated patients achieving ACR 20, 50, and 70 responses in study II (patients with inadequate response to methotrexate), study III (patients with inadequate response to TNFinhibitor), study VI (methotrexate-naive patients), and study SC-I (subcutaneous abatacept) are shown in Table 3.
Maltese: Il-perċentwali ta' pazjenti ttrattati b'abatacept li ġabu ACR ta' 20, 50 jew 70 rispons fi studju II (pazjenti b'rispons mhux adegwat għal methotrexate), fi studju III (pazjenti b'rispons mhux adegwat għal inibitur ta' TNF), fi studju VI (pazjenti li qatt ma ġew ikkurati b'methotrexate), u fi studju SC-I (abatacept taħt il-ġilda) jidhru f'Tabella 3.
English: Packs of 1, 3 or 4 pre-filled syringes with needle guard and multipack containing 12 pre-filled syringes with needle guard (3 packs of 4).
Maltese: Pakketti ta' 1, 3 jew 4 siringi mimlijin għal-lest bi protezzjoni għal-labra u pakkett multiplu li fih 12-il siringa mimlijin għal-lest bi protezzjoni għal-labra (3 pakketti ta' 4).
English: Dilution
Maltese: Manifattur
English: Gently clean injection site
Maltese: GĦAMLA KWALITATTIVA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR PACKS OF 1, 3 AND 4 PRE-FILLED SYRINGES WITH NEEDLE GUARD
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' BARRA GĦALL-PAKKETTI TA' 1, 3 U 4 SIRINGI MIMLIJIN GĦAL-LEST
English: Antibodies directed against the entire abatacept molecule or to the CTLA-4 portion of abatacept were assessed by ELISA assays in patients with pJIA following repeated treatment with intravenous ORENCIA.
Maltese: Huwa importanti li jiġu rrappurtati effetti sekondarji suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: In study VI, statistically significant improvement in the ACR 20 response in abatacept plus methotrexate-treated patients versus methotrexate plus placebo-treated patients was observed at 29 days, and was maintained through the duration of the study.
Maltese: Fi studju VI, ġie osservat titjib statistkament sinifikanti fir rispons ta' ACR 20 f'pazjenti li kienu qed jiġu kkurati b'abatacept flimkien ma' methotexate metamqabbel ma' methotrexate flimkien ma' plaċebo għal 29 jum, u dan baqa' jiġi sostnut matul il-perjodu tal-istudju.
English: Among the patients who entered the open-label 12 month period, 59% (125/213) of patients receiving continuous abatacept plus methotrexate treatment and 48% (92/192) of patients who initially received methotrexate and switched to combination with abatacept had no progression.
Maltese: Fost il-pazjenti li daħlu fil-perjodu open label għal 12-il xahar, 59% (125/213) tal-pazjenti li rċivew it-trattament ta' abatacept flimkien ma' methotrexate u 48% (92/192) tal-pazjenti li inizjalment irċivew methotrexate u wara qalbu għal kombinazzjoni ma' abatacept ma kellhomx progressjoni.
English: 50 mg 25 kg to less than 50kg 87.5mg 50 kg or more
Maltese: 25 kg sa anqas minn 50 kg
English: Needle Cover (ORANGE Cap)
Maltese: Għatu tal-Labra (Għatu ORANĠJO)
English: Study SC-II investigated the relative efficacy and safety of abatacept and adalimumab, both given subcutaneously without an intravenous loading dose and with background MTX, in patients with moderate to severely active RA and an inadequate response to previous MTX therapy.
Maltese: Studju SC-II investiga l-effikaċja u s-sigurtà relattiva ta' abatacept u adalimumab, it-tnejn mogħtija taħt il-ġilda mingħajr doża għolja tal-bidu ġolvina u b'MTX fl-isfond, f'pazjenti b'RA attiva minn moderata sa severa u b'rispons inadegwat għal terapija b'MTX fil-passat.
English: The percent of abatacept-treated patients achieving ACR 20, 50, and 70 responses in study II (patients with inadequate response to methotrexate), study III (patients with inadequate response to TNFinhibitor), study VI (methotrexate-naive patients), and study SC-I (subcutaneous abatacept) are shown in Table 2.
Maltese: Il-perċentwali ta' pazjenti ttrattati b'abatacept li ġabu ACR ta' 20, 50 jew 70 rispons fi studju II (pazjenti b'rispons mhux adegwat għal methotrexate), fi studju III (pazjenti b'rispons mhux adegwat għal inibitur ta' TNF), fi studju VI (pazjenti li qatt ma ġew ikkurati b'methotrexate), u fi studju SC-I (abatacept taħt il-ġilda) jidhru f'Tabella 2.
English: The side effects experienced in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those experienced in adults as described above, with the following differences:
Maltese: L-effetti sekondarji esperjenzati fi tfal u adoloxxenti b'artrite idjopatika ġuvenili poliartikulari huma simili għal dawk esperjenzati fl-adulti kif deskritt hawn fuq, bid-differenzi li ġejjin:
English: See Table 6 and Figure 1.
Maltese: Ara t-Tabella 6 u l-Figura 1.
English: Pneumonitis (ILD)
Maltese: Pulmonite (ILD)
English: Trastuzumab emtansine (N=740) All Grade % Grade 3 (%) Grade 4 (%)
Maltese: Trastuzumab emtansine (N=740) Il-Gradi kollha % Grad 3 (%) Grad 4 (%)
English: In vitro, DM1 was a substrate of P-glycoprotein (P-gp).
Maltese: In vitro, DM1 kien sottostrat ta' P-glycoprotein (P-gp).
English: DM1 did not inhibit major CYP450 enzymes in vitro.
Maltese: DM1 ma inibixxiex l-enzimi CYP450 maġġuri in vitro.
English: Grade 3-4
Maltese: Grad 3-4
English: Drug Induced Liver Injury (DILI)
Maltese: (DILI - Drug Induced Liver Injury)
English: Date of latest renewal: 17 September 2018
Maltese: Data tal-aħħar tiġdid: 17 ta' Settembru 2018
English: Key to abbreviations (Table6): HR: Hazard Ratio; CI: Confidence Intervals, 1.
Maltese: Tifsira tat-tqassir (Tabella 6): HR: Hazard Ratio (Proporzjon ta' Periklu); CI: Confidence Intervals (Intervalli ta' Kunfidenza),
English: Nodular Regenerative Hyperplasia (NRH)
Maltese: Nodular Regenerative Hyperplasia)
English: System Organ Class
Maltese: Klassi tas-sistemi u talorgani
English: ALT = alanine transaminase; AST = aspartate transaminase, CHF = congestive heart failure, LVEF = left ventricular ejection fraction, LVSD = left ventricular systolic dysfunction, TBILI = Total Bilirubin, ULN = upper limit of normal * Prior to starting trastuzumab emtansine treatment.
Maltese: AST = aspartate transaminase, CHF = congestive heart failure (insuffiċjenza konġestiva talqalb), LVEF = left ventricular ejection fraction (porzjon imbuttat 'il barra mill-ventrikolu tax-xellug), LVSD = left ventricular systolic dysfunction (disfunzjoni sistolika tal-ventrikolu tax-xellug), TBILI = Total Bilirubin (Bilirubin Totali), ULN = upper limit of normal (il-limitu ta' fuq tan-normal) * Qabel il-bidu tat-trattament bi trastuzumab emtansine.
English: 2,% [95% CI]
Maltese: 2,% [CI ta'
English: Musculoskeletal pain, Arthralgia, Myalgia
Maltese: Uġigħ muskoluskeletriku, Artralġja, Mijalġja
English: Treatment modification
Maltese: Modifikazzjoni fit-trattament
English: Thrombocytopenia, Anaemia
Maltese: Tromboċitopenija, Anemija
English: Trastuzumab Emtansine N = 743
Maltese: N = 743
English: Pulmonary toxicity
Maltese: Tossiċità Pulmonari
English: Increased Alanine Transaminase (ALT)
Maltese: Żieda fl-Alanine Transaminase (ALT)
English: Grade 4 (< 25,000/mm3)
Maltese: Grad 4 (< 25,000/mm
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC14
Maltese: Sustanzi antineoplastiċi, sustanzi antineoplastiċi oħra, antikorpi monoklonali, Kodiċi ATC: L01XC14
English: No significant difference was observed in the PK of trastuzumab emtansine among patients < 65 years (n = 577), patients between 65-75 years (n = 78) and patients > 75 years (n = 16).
Maltese: Ma kinitx osservata differenza sinifikanti fil-PK ta' trastuzumab emtansine fost pazjenti b'età ta' < 65 sena (n = 577), pazjenti b'età ta' 65-75 sena (n = 78) u pazjenti ta' > 75 sena (n = 16).
English: Increased Aspartate Transaminase (AST)
Maltese: Żieda fl-Aspartate Transaminase (AST)
English: The ORR was 32.7% (95% CI: 24.1, 42.1), n = 36 responders, by both IRC and investigator review.
Maltese: L-ORR kienet ta' 32.7% (CI ta' 95%: 24.1, 42.1), n = 36 li rrispondew, kemm skont analiżi ta' IRC kif ukoll skont analiżi ta' investigatur.
English: Discontinue trastuzumab emtansine
Maltese: Trastuzumab Emtansine
English: Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The data are from an open-label study and no firm conclusions can be drawn.
Maltese: Id-data hija minn studju open-label u ma jistgħux jittieħdu konklużjonijiet definiti.
English: Impairment of fertility and teratogenicity
Maltese: Indeboliment tal-fertilità u teratoġeniċità
English: · Additional risk minimisation measures
Maltese: ● Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: In patients with MBC, the overall incidence of peripheral neuropathy was 29.0% and 8.6% for Grade ≥ 2.
Maltese: F'pazjenti b'MBC, l-inċidenza globali ta' newropatija periferali kienet ta' 29.0% u 8.6% għal Grad ≥ 2.
English: · Heart problems can occur.
Maltese: ● Problemi ta' fsada:
English: Kadcyla delayed patient-reported time to symptom progression for 7.1 months compared with 4.6 months for the control arm (Hazard Ratio 0.796 (0.667, 0.951); p-value 0.0121).
Maltese: Kadcyla ittardja iż-żmien meta l-pazjenti rrappurtaw progressjoni tas-sintomi għal 7.1 xhur meta mqabbel ma' 4.6 xhur għall-grupp tal-kontroll (Proporzjon ta' Periklu 0.796 (0.667, 0.951); valur p 0.0121).
English: Results from in vitro cytotoxicity assays show that DM1 is 20-200 times more potent than taxanes and vinca alkaloids.
Maltese: Riżultati minn testijiet ċitotossiċi in vitro juru li DM1 huwa 20-200 darba aktar potenti minn taxanes u vinca alkaloids.
English: · you are receiving treatment with blood thinning medicines (e.g. warfarin, heparin).
Maltese: • qed tirċievi trattament b'mediċini li jraqqu d-demm (eż. warfarin, heparin).
English: · you have already received the medicine trastuzumab and a medicine known as a taxane.
Maltese: • inti tkun diġà rċevejt il-mediċina trastuzumab u mediċina magħrufa bħala taxane.
English: The objective response rate (ORR) was 58.0% with trastuzumab plus docetaxel and 64.2% with trastuzumab emtansine.
Maltese: Ir-rata ta' rispons oġġettiv (ORR - objective response rate) kienet ta' 58.0% b'trastuzumab flimkien ma' docetaxel u 64.2% b'trastuzumab emtansine.
English: Pharmacokinetics of trastuzumab emtansine in patients with mild (creatinine clearance CLcr 60 to 89 mL/min, n = 254) or moderate (CLcr 30 to 59 mL/min, n = 53) renal impairment were similar to those in patients with normal renal function (CLcr ³ 90 mL/min, n = 361).
Maltese: Il-farmakokinetika ta' trastuzumab emtansine f'pazjenti b'indeboliment renali ħafif (tneħħija tal-kreatinina CLcr 60 sa 89 mL/min, n = 254) jew moderat (CLcr 30 sa 59 mL/min, n = 53) kienet simili għal dik f'pazjenti b'funzjoni renali normali (CLcr ≥ 90 mL/min, n = 361).
English: A clinically meaningful and statistically significant improvement in IDFS was observed in patients who received trastuzumab emtansine compared with trastuzumab (HR = 0.50, 95% CI [0.39, 0.64], p <0.0001.
Maltese: Ġie osservat titjib klinikament u statistikament sinifikanti fl-IDFS f'pazjenti li rċevew trastuzumab emtansine meta mqabbel ma' trastuzumab (HR = 0.50, CI ta' 95% [0.39, 0.64], p < 0.0001).