FrancophonIA/ELRC3.0 huggingface dataset:
English: • Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to an infusion bag/container containing 0.9% Sodium Chloride.
Maltese: • Iġbed l-ammont meħtieġ ta' soluzzjoni ta' DARZALEX u ddilwixxi għall-volum li suppost billi żżidu fil-borża/kontenitur tal-infużjoni li fih 0.9% Sodium Chloride.
English: In patients receiving DARZALEX combination therapy, Grade 3 or 4 infections were reported as follows:
Maltese: F'pazjenti li jkunu qed jirċievu terapija kombinata b'DARZALEX, infezzjonjiet ta' Grad 3 jew 4 ġew irrappurtati kif ġej:
English: • chest discomfort
Maltese: Disturbi vaskulari
English: Daratumumab induced apoptosis in vitro after Fc mediated cross-linking.
Maltese: Daratumumab induċa apotosi in vitro wara irbit flimkien ta' katini ta'proteini medjat minn Fc.
English: DRd=daratumumab-lenalidomide-dexamethasone; Rd=lenalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval
Maltese: MRD, minimal residual disease=mard residwu minimu; CI, confidence interval=intervall ta' kunfidenza Ibbażat fuq il-popolazzjoni bl-intenzjoni li tiġi ttrattata
English: Figure 4: Kaplan-Meier Curve of PFS in Study MMY3004
Maltese: Kaplan-Meier ta' PFS fl-Istudju MMY3004
English: • Since DARZALEX does not contain a preservative, diluted solutions should be administered within 15 hours (including infusion time) at room temperature (15°C-25°C) and in room light.
Maltese: • Minħabba li DARZALEX ma fihx preservattiv, is-soluzzjonijiet iddilwiti għandhom jingħataw fi żmien 15-il siegħa (li jinkludi l-ħin tal-infużjoni) f'temperatura (15°C-25°C) u dawl ambjentali.
English: At a survival update with a median duration of follow-up of 14.7 months, median Overall Survival (OS) was 17.5 months (95% CI:13.7, not estimable).
Maltese: F'aġġornament dwar is-sopravivenza b'tul ta' żmien medjan ta' 14.7 xhur ta' segwitu, il-medjan ta' Sopravivenza Totali (OS - overall survival) kien ta' 17.5 xhur (95% CI:13.7, ma setax jiġi stmat).
English: For information concerning medicinal products given in combination with DARZALEX, see corresponding Summary of Product Characteristics.
Maltese: Għal informazzjoni dwar prodotti mediċinali mogħtija flimkien ma' DARZALEX, ara s-Sommarju tal-Karatteristiċi tal-Prodott tagħhom.
English: o All patients should be typed and screened prior to start treatment with daratumumab; alternatively, phenotyping may also be considered; o Daratumumab-mediated positive indirect Coombs test (interfering with cross-matching of blood) may persist for up to 6 months after the last product's infusion, therefore, the HCP should advise the patient to carry the Patient Alert Card until 6 months after the treatment has ended; o Daratumumab bound to Red Blood Cells (RBCs) may mask the detection of antibodies to minor antigens in the patient's serum; o The determination of a patient's ABO and Rh blood type are not impacted; o The interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods.
Maltese: o Messaġġ ta' twissija għal Professjonisti tal-Kura tas-Saħħa li qed jittrattaw il-pazjent fi kwalunkwe ħin, li jinkludi l-kondizzjonijiet ta' emerġenza, li l-pazjent qed juża DARZALEX (daratumumab), u li dan it-trattament hu assoċjat ma' Riskju Importanti Identifikat ta' Interferenza għat-tip ta' demm (antiġen minuri) (Test Pożittiv Indirett ta' Coombs) li jista' jippersisti għal sa 6 xhur wara l-aħħar infużjoni tal-prodott, u referenza ċara li l-pazjent għandu jkompli jġorr miegħu din il-kard għal sa 6 xhur wara tmiem it-trattament;
English: Figure 3: Kaplan-Meier Curve of PFS in Study MMY3003
Maltese: Kaplan-Meier ta' PFS fl-iStudju MMY3003
English: p-value is from a likelihood-ratio chi-squared test.
Maltese: Il-valur p huwa minn proporzjon ta' probabbiltà ta' test Chi-Squared.
English: Relapsed/Refractory multiple myeloma
Maltese: Disturbi fil-metaboiżmu u nnutrizzjoni
English: There has been no experience of overdosage in clinical studies.
Maltese: Ma kien hemm l-ebda esperjenza ta' doża eċċessiva fi studji kliniċi.
English: DVd (n=240)
Maltese: (N=247)
English: Study MMY3003 demonstrated an improvement in PFS in the DRd arm as compared to the Rd arm; the median PFS had not been reached in the DRd arm and was 18.4 months in the Rd arm (HR=0.37; 95% CI: 0.27, 0.52; p<0.0001), representing 63% reduction in the risk of disease progression or death in patients treated with DRd (see Figure 3).
Maltese: L-istudju MMY3003 wera titjib fil-PFS fil-fergħa ta' DRd meta mqabbla mal-fergħa ta' Rd; il-medjan ta' PFS ma kienx intlaħaq fil-fergħa ta' DRd u kien 18.4 xhur fil-fergħa ta' Rd (proporzjon ta' periklu [HR, hazard ratio]=0.37; 95% CI: 0.27, 0.52; p<0.0001), li jirrappreżenta tnaqqis ta' 63% fir-riskju ta' progressjoni tal-marda jew mewt f'pazjenti ttrattati b'DRd (ara Figura 3).
English: 9/L, and platelets > 50 x 10 9/L without transfusion).
Maltese: 9/L, u plejtlets > 50 x 10
English: Doses up to 24 mg/kg have been administered intravenously in a clinical study.
Maltese: Fi studju kliniku ngħataw dożi sa 24 mg/kg fil-vini.
English: The incidence of infusion modifications due to reactions was 36%.
Maltese: L-inċidenza ta' modifikazzjonijiet tal-infużjoni minħabba reazzjonijiet kienet ta' 36%.
English: Unopened vials 24 months
Maltese: Kunjetti mhux miftuħa 24 xahar
English: Based on the four population PK analyses (Analyses 1-4) body weight was identified as a statistically significant covariate for daratumumab clearance.
Maltese: Abbażi tal-erba' analiżi PK ta' popolazzjoni (analiżi 1-4) il-piż tal-ġisem ġie identifikat bħala kovarjat sinifikanti b'mod statistiku għat-tneħħija ta' daratumumab.
English: The safety and efficacy of DARZALEX in children aged below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' DARZALEX fit-tfal b'età taħt it-18-il sena ma ġewx determinati.
English: Consider administering low-dose oral methylprednisolone (≤ 20 mg) or equivalent the day after the DARZALEX infusion.
Maltese: Ikkunsidra l-għoti ta' doża baxxa ta' methylprednisolone (≤20 mg) mill-ħalq jew l-ekwivalenti tiegħu fil-jum ta' wara l-infużjoni ta' DARZALEX.
English: Significant increases in CD4+ and CD8+ T cell absolute counts, and percentages of lymphocytes, were observed with daratumumab treatment in peripheral whole blood and bone marrow.
Maltese: Ġew osservati żidiet sinifikanti fl-għadd assolut taċ-ċelluli T CD4+ u CD8+, u fil-perċentwal ta' limfoċiti, fid-demm periferali sħiħ u fil-mudullun tal-għadam bi trattament b'daratumumab.
English: Weeks 1, 2, 4 and 5 for the first 6-week cycle (Cycle 1; 8 doses), followed by once weekly administrations at Weeks 1, 2, 4 and 5 for eight more 6-week cycles (Cycles 2-9; 4 doses per cycle).
Maltese: erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa fil-Ġimgħat 1, 2, 4 u 5 għall-ewwel ċiklu ta' 6 ġimgħat (Ċiklu 1; 8 dożi), segwit minn għoti darba fil-ġimgħa fil-Ġimgħat 1, 2, 4 u 5 għal tmien ċikli oħra ta' 6 ġimgħat (Ċikli 2-9; 4 dożi f'kull ċiklu).
English: Permanently discontinue DARZALEX upon the third occurrence of a Grade 3 or greater infusion reaction.
Maltese: Waqqaf b'mod permanenti DARZALEX meta sseħħ ittielet reazzjoni għall-infużjoni ta' Grad 3 jew aktar.
English: NK cells are known to express high levels of CD38 and are susceptible to daratumumab mediated cell lysis.
Maltese: Minħabba l-affinità kbira ma' epitope uniku fuq CD38, daratumumab mhuwiex mistenni li jibdel l-enzimi li jimmetabolizzaw il-mediċina.
English: Odds ratio with 95% CI
Maltese: Proporzjon ta' probabbiltà b'95% CI
English: The median duration of response had not been reached in the DRd group and was 34.7 months (95% CI: 30.8, not estimable) in the Rd group.
Maltese: Il-medjan tat-tul ta' żmien ta' rispons ma ntlaħaqx fil-grupp ta' DRd u kien 34.7 xhur (95% CI: 30.8, ma jistax jiġi stmat) fil-grupp ta' Rd.
English: On the days of DARZALEX infusion, the dexamethasone dose was administered intravenously as a pre-infusion medication.
Maltese: Fil-jiem tal-infużjoni ta' DARZALEX, id-doża ta' dexamethasone ngħatat bħala mediċina ta'qabel l-infużjoni.
English: • constipation
Maltese: • frixa infjammata
English: EXP
Maltese: DRd
English: When dexamethasone is the background-regimen specific corticosteroid, the dexamethasone treatment dose will instead serve as pre-medication on DARZALEX infusion days (see section 5.1).
Maltese: Madankollu, jekk fl-isfond jingħata kortikosterojd speċifiku għar-reġimen (eż. dexamethasone, prednisone) fil-jum ta' wara linfużjoni ta' DARZALEX, jistgħu ma jkunux meħtieġa mediċini addizzjonali wara l-infużjoni (ara sezzjoni 5.1).
English: Overall response rate 1 (ORR: sCR+CR+VGPR+PR) [n (%)]
Maltese: 1 (ORR - overall response rate: sCR+CR+VGPR+PR) [n (%)] 95% CI (%) Rispons sħiħ strett (sCR - stringent complete response)
English: Alternatively, genotyping may also be considered; o In case of urgent need for transfusion, non-cross matched ABO/RhD compatible RBC units can be administered as per local bank practices; o In the event of a planned transfusion, the HCPs should notify blood transfusion centres about the interference with indirect antiglobulin tests; o Reference to the need to consult the Summary of Product Characteristics (SmPC); o Reference to the need of giving the Patient Alert Card to the patients and to advise them to consult the Package Leaflet (PL).
Maltese: o F'każ ta' ħtieġa urġenti għal trasfużjoni, unitajiet ta' ċelloli ħomor tad-demm kompatibbli ma' ABO/RhD bi tqabbil mhux inkroċjat (non-cross matched ABO/RhD compatible RBC) jistgħu jingħataw, b'mod konformi mal-prassi lokali tal-bank tad-demm; o Fil-każ ta' trasfużjoni ppjanata, il-professjonista fil-qasam tal-kura tas-saħħa għandu javża ċ-ċentri dwar l-interferenza ma' testijiet ta' antiglobulin indiretti.
English: Bortezomib is given twice weekly at Weeks 1, 2, 4 and 5 for the first 6-week cycle, followed by once weekly at Weeks 1, 2, 4 and 5 for eight more 6-week cycles.
Maltese: Bortezomib jingħata darbtejn fil-ġimgħa fil-Ġimgħat 1, 2, 4 u 5 għall-ewwel ċiklu ta' 6 ġimgħat, segwit minn darba fil-ġimgħa fil-Ġimgħat 1, 2, 4 u 5 għal tmien ċikli oħra ta' 6 ġimgħat.
English: Upper respiratory tract infection
Maltese: Infezzjoni fl-apparat tal-awrina
English: Manufacturer Janssen Biologics B.V. Einsteinweg 101
Maltese: Il-Manifattur Janssen Biologics B.V.
English: Do not give DARZALEX to children or young people below 18 years of age.
Maltese: Tagħtix DARZALEX lil tfal jew persuni żgħażagħ taħt l-età ta' 18-il sena.
English: • as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
Maltese: • bħala monoterapija għat-trattament ta' pazjenti adulti b'majeloma multipla li rkadiet jew li ma weġbitx għat-trattament, li t-terapija tagħhom qabel kienet tinkludi inibitur ta' proteasome u sustanza immunomodulatorja u li wrew progressjoni tal-marda meta kienu fuq l-aħħar terapija tagħhom.
English: Week 1 Day 1 (16 mg/kg) 1,000 mL 50 mL/hour 50 mL/hour every hour
Maltese: 1,000 mL 50 mL/siegħa 50 mL/siegħa kull siegħa
English: Patients refractory to bortezomib were excluded from the study.
Maltese: Dan il-prodott mediċinali qiegħed biex jintuża darba biss.
English: One mL of concentrate contains 20 mg daratumumab.
Maltese: Millilitru wieħed ta' konċentrat fih 20 mg daratumumab.
English: Very good partial response (VGPR)
Maltese: Rispons parzjali tajjeb ħafna (VGPR, Very good partial response)
English: VGPR or better (sCR + CR + VGPR) p-value
Maltese: CR jew aħjar (sCR+CR) Rispons Parzjali Tajjeb jew aħjar (sCR+CR+VGPR)
English: In the active controlled studies, discontinuations from treatment due to infections (1-4%) and fatal infections were generally infrequent and balanced between the DARZALEX containing regimens and active control arms.
Maltese: Fl-istudji kkontrollati b'mod attiv, waqfien mit-trattament minħabba infezzjonijiet (1-4%) u infezzjonijiet fatali ġeneralment ma kinux frekwenti u kienu bbilanċjati bejn ir-reġimens li kien fihom DARZALEX u l-fergħat ta' kontroll attiv.
English: In the event of a planned transfusion blood transfusion centres should be notified of this interference with indirect antiglobulin tests (see section 4.5).
Maltese: F'każ ta' trasfużjoni ppjanata ċ-ċentri ta' trasfużjoni tad-demm għandhom jiġu avżati b'din linterferenza mat-testijiet indiretti ta' antiglobulina (ara sezzjoni 4.5).
English: As an IgG1қ monoclonal antibody, renal excretion and hepatic enzyme-mediated metabolism of intact daratumumab are unlikely to represent major elimination routes.
Maltese: IgG1қ, it-tneħħija mill-kliewi u metaboliżmu fil-fwied medjat millenzimi, ta' daratumumab mhux mibdul huma improbabbli li jirrappreżentaw rotot prinċipali ta' eliminazzjoni.
English: The majority of patients (86%) received a prior PI, 55% of patients had received a prior IMiD, including 18% of patients who had received prior lenalidomide; and 44% of patients had received both a prior PI and IMiD.
Maltese: Il-biċċa l-kbira tal-pazjenti (86%) rċivew PI qabel, 55% tal-pazjenti kienu rċivew ImiD qabel, inkluż 18% tal-pazjenti li kienu rċivew lenalidomide qabel; u 44% tal-pazjenti kienu rċivew kemm PI kif ukoll ImiD qabel.
English: It belongs to a group of medicines called “monoclonal antibodies”.
Maltese: Huwa jappartjeni għal grupp ta' mediċini li jissejħu “antikorpi monoklonali”.
English: Very common (may affect more than 1 in 10 people):
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100):
English: Week 2 (16 mg/kg)infusion
Maltese: Infużjoni ta' Ġimgħa 2 (16-il mg/kg)
English: Study MMY3008, an open-label, randomized, active-controlled Phase III study, compared treatment with DARZALEX 16 mg/kg in combination with lenalidomide and low-dose dexamethasone (DRd) to treatment with lenalidomide and low-dose dexamethasone (Rd) in patients with newly diagnosed multiple myeloma.
Maltese: III, qabbel it-trattament b'DARZALEX 16-il mg/kg flimkien ma' lenalidomide u doża baxxa ta' dexamethasone (DRd) ma' trattament b'lenalidomide u doża baxxa ta' dexamethasone (Rd) f'pazjenti b'majeloma multipla li tkun għadha kemm ġiet dijanjostikata.
English: At a survival update with a median duration of follow-up of 15.2 months, median OS was not reached (95% CI: 19.9 months, not estimable), with 74% of subjects still alive.
Maltese: F'aġġornament dwar sopravivenza b'tul ta' żmien medjan ta' 15.2 xhur ta' segwitu, il-medjan ta' OS ma ntlaħaqx (95% CI: 19.9 xhur, ma setax jiġi stmat), b'74% tal-individwi baqgħu ħajjin.
English: VIAL
Maltese: Skeda
English: Muscle spasms
Maltese: Uġigħ fid-dahar
English: Infusion rates
Maltese: Rati tal-infużjoni
English: p-value is from a likelihood-ratio Chi-Squared test.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: • wheezing.
Maltese: mingħajr trasfużjoni).
English: D-VTd=daratumumab-bortezomib-thalidomide-dexamethasone; VTd=bortezomib-thalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval Based on intent-to-treat population p-value from Cochran Mantel-Haenszel Chi-Squared test.
Maltese: MRD, minimal residual disease =mard residwu minimu; CI, confidence interval = intervall ta' kunfidenza Abbażi tal-popolazzjoni bl-intenzjoni li tiġi ttrattata
English: EMA/PRAC/595696/2018
Maltese: EMA/PRAC/621113/2018 Corr2
English: Ipilimumab - Cytomegalovirus gastrointestinal infection (EPITT no 19207)
Maltese: Ipilimumab - Infezzjoni gastrointestinali cytomegalovirus (EPITT nru 19207)
English: Dimethyl fumarate (Tecfidera) - Immune thrombocytopenic purpura and thrombocytopenia (EPITT no
Maltese: Dimethyl fumarate (Tecfidera) - Purpura tromboċitopenika immuni u tromboċitopenija (EPITT nru
English: Fluoroquinolones for systemic and inhaled use2 - Aortic aneurysm and dissection (EPITT no 18651)
Maltese: 4. Fluoroquinolones għal użu sistemiku u mit-teħid man-nifs3 - Anewriżma aortika u dissezzjoni (EPITT nru 18651)
English: One study included a population comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to 1,430,833 and 172,462 population controls, respectively.
Maltese: Studju wieħed kien jinkludi popolazzjoni li kienet tikkonsisti minn 71,533 każ ta' BCC u 8,629 każ ta' SCC imqabbla ma' 1,430,8334 u għal 172,462 kontroll tal-popolazzjoni rispettivament.
English: Alemtuzumab - Cytomegalovirus infection (EPITT no
Maltese: Alemtuzumab - Infezzjoni Cytomegalovirus (EPITT nru
English: Summary of Product Characteristics 4.8.
Maltese: Sommarju tal-Karatteristiċi tal-Prodott 4.8.
English: Hydrochlorothiazide - Skin cancer (EPITT no 19138)
Maltese: Hydrochlorothiazide - Kanċer tal-ġilda (EPITT nru 19138)
English: A cumulative doseresponse relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Maltese: Studju ieħor wera assoċjazzjoni possibbli bejn il-kanċer tax-xoffa (SCC) u lesponiment għal HCTZ: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll tal-popolazzjoni, blużu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat Intweriet relazzjoni għar-rispons tad-doża kumulattiva b'OR aġġustata ta' 2.1 (95 % CI: 1.7-2.6) li tiżdied għal OR 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR 7.7 (5.7-10.5) għall-ogħla doża kumulattiva (~100,000 mg) (ara wkoll issezzjoni 4.4).
English: YEstimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.
Maltese: YStima tal-frekwenza tar-reazzjonijiet avversi rappurtati mis-sorveljanza wara t-tqegħid fis-suq; mhux osservata fil-provi kliniċi kkontrollati bi plaċebo.
English: Adopted at the 3-6 September 2018 PRAC
Maltese: Adottata fil-PRAC ta' bejn il-3 u 6 ta' Settembru 2018
English: Cytomegalovirus (CMV) infections including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Maltese: Infezzjonijiet ta' Cytomegalovirus (CMV) inkluż każijiet ta' riattivazzjoni ta' CMV ġew irrappurtati f'pazjenti ttrattati b'LEMTRADA.
English: Undesirable effects Tabulated list of adverse reactions Blood and lymphatic system disorders Frequency ‘uncommon': Thrombocytopenia
Maltese: Disturbi tad-demm u tas-sistema limfatika Frekwenza “mhux komuni”: Tromboċitopenija
English: Post-marketing cases of cytomegalovirus (CMV) infection/reactivation have been reported in patients with corticosteroid-refractory immune-related colitis.
Maltese: Wara t-tqegħid fis-suq, ġew irrapportati każijiet ta' infezzjoni/riattivazzjoni ta' cytomegalovirus (CMV) f'pazjenti b'kolite relatata mal-immunità b'kortikosterojde refrattorja.
English: - if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Maltese: - jekk esperjenzajt episodju preċedenti ta' dissezzjoni aortika (tiċrita fil-ħajt tal-aorta).
English: Frequency ‘rare': Interstitial lung diseaseX
Maltese: Frekwenza “rari”:
English: It can be found here (in English only).
Maltese: Figure corrected on 22 November 2018 (in line with the English original text).
English: Frequency ‘rare': Eosinophilic pneumoniaY
Maltese: Pulmonite eosinofilikaY
English: Special warnings and precautions Immune-related gastrointestinal reactions:
Maltese: Twissijiet u prekawzjonijiet speċjali Reazzjonijiet gastrointestinali relatati mal-immunità:
English: Infections and infestations: cytomegalovirus infection - frequency uncommon
Maltese: Infezzjonijiet u infestazzjonijiet:infezzjoni cytomegalovirus - frekwenza mhux komuni
English: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry.
Maltese: Ġie osservat riskju akbar ta' kanċer tal-ġilda mhux melanoma (NMSC) [karċinoma ta' ċellola bażali (BCC) u karċinoma ta' ċellola skwamuża (SCC)] b'doża kumulattiva li tiżdied ta' esponiment għal hydrochlorothiazide (HCTZ) fiż-żewġ studji epidemjoloġiċi bbażati fuq ir-Reġistru Nazzjonali tal-Kanċer tad-Danimarka.
English: - if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular EhlersDanlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Maltese: - jekk għandek storja fil-familja ta' anewriżmu aortiku jew dissezzjoni aortika jew fatturi ta' riskju oħrajn jew kundizzjonijiet ta' predispożizzjoni (eż. disturbi tat-tessut konnettiv bħas-sindromu ta' Marfan, jew is-sindromu ta' Ehlers-Danlos vaskulari, jew disturbi vaskulari bħal arterite Takayasu, arterite b'ċellola ġganteska, il-marda ta' Behcet, pressjoni għolja, jew aterosklerożi magħrufa).
English: However, aAddition of an alternative immunosuppressive agent to the corticosteroid regimen may should be considered in corticosteroid-refractory immune-related colitis if other causes are excluded (including Cytomegalovirus (CMV) infection/reactivation evaluated with viral PCR on biopsy, and other viral, bacterial and parasitic etiology) be considered.
Maltese: Madankollu, Għandha tiġi kkunsidrata Iż-żieda ta' aġent immunosuppressiv alternattiv għar-reġim ta' kortikosterojde tista' għandha tiġi kkunsidrata f'kolite relatata mal-immunità refrattarja għal kortikosterojde jekk ikunu esklużi kawżi oħrajn (inkluż infezzjoni/riattivazzjoni b'Cytomegalovirus (CMV) evalwata b'PCR virali fuq bijopsija, u etjoloġija virali, batterika u parassitika oħra).
English: Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
Maltese: Għalhekk, fluoroquinolones għandhom jintużaw biss wara valutazzjoni bir-reqqa tal-benefiċċju-riskju u wara kunsiderazzjoni ta' opzjonijiet terapewtiċi oħrajn f'pazjenti bi storja pożittiva tal-familja ta' marda ta' anewriżmu, jew f'pazjenti dijanjostikati b'anewriżma aortika li kienet hemm qabel u/jew dissezzjoni aortika, jew fil-preżenza ta' fatturi ta' riskju oħrajn jew ta' kundizzjonijiet predisposti għal anewriżmu aortiku u dissezzjoni (eż. is-sindromu ta' Marfan, is-sindromu ta' Ehlers-Danlos vaskulari, arterite Takayasu, arterite b'ċellola ġganteska, il-marda ta' Behcet, pressjoni għolja, aterosklerożi magħrufa).
English: XEstimated frequency based on placebo-controlled clinical trials and
Maltese: XStima tal-frekwenza bbażata fuq provi kliniċi kkontrollati minn plaċebo u
English: Patients must be monitored for gastrointestinal signs and symptoms that may be indicative of immunerelated colitis or gastrointestinal perforation.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi gastrointestinali li jistgħu jkunu indikattivi ta' kolite relatata mal-immunità jew tiċrita gastrointestinali.
English: In clinical trials, immune-related colitis was associated with evidence of mucosal inflammation, with or without ulcerations, and lymphocytic and neutrophilic infiltration.
Maltese: Fi provi kliniċi, kolite relatata mal-immunità ġiet assoċjata ma' evidenza ta' infjammazzjoni mukożali, bi u mingħajr ulċerazzjonijiet, u b'infiltrazzjoni limfoċitika u newtrofilika.
English: In clinical trials, a single dose of infliximab 5 mg/kg was added unless contraindicated.
Maltese: Fil-provi kliniċi, żdiedet doża waħda ta' infliximab 5 mg/kg sakemm dan ma jkunx kontraindikat.
English: Undesirable effects Tabulated list of adverse reactions Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Rare side effects (may affect up to 1 in 1000 people)
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1000)