FrancophonIA/ELRC3.0 huggingface dataset:
English: aProportion of Patients with Measured GFR < 60 ml/min/1.73 m2 or with a Decrease in Measured GFR ≥ 10 ml/min/1.73 m2 from Month 3 to Month 12. b Measured GFR was assessed by iothalamate at Year 1 and 2 only c Calculated GFR was assessed by MDRD formula at Month 1, Years 1, 2, and 3
Maltese: aProporzjon ta' Pazjenti b'GFR Imkejjel < 60 ml/min/1.73 m2 jew bi Tnaqqis fil-GFR Imkejjel ≥ 10 ml/min/1.73 m2 minn Xahar 3 sa Xahar 12.
English: Practical details on the preparation of the solution for infusion After reconstitution, dilute the product to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution for injection.
Maltese: Dettalji prattiċi dwar il-preparazzjoni tas-soluzzjoni għall-infużjoni Wara r-rikostituzzjoni, iddilwi l-prodott għal 100 ml b'sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew b'injezzjoni ta' 5% soluzzjoni għall-injezzjoni ta' glukożju.
English: Using aseptic technique, make up each vial with 10.5 ml of one of the following solvents (sterile water for injections, sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution for injection), using the co-packed disposable syringe (necessary to avoid aggregate formation) and an 1821 gauge needle.
Maltese: Permezz ta' teknika asettika, imla l-kunjett b'10.5 ml ta' wieħed mis-solventi li ġejjin (ilma sterili għall-injezzjoni, sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew 5% soluzzjoni għal injezzjoni ta' glukożju, permezz tas-siringa li tintrema wara l-użu li tinsab fil-pakkett (meħtieġa biex tkun evitata formazzjoni ta' frak) u labra b'gauge ta' 18 21.
English: No mutagenicity or clastogenicity was observed with abatacept in a battery of in vitro studies.
Maltese: Ma ġiet osservata l-ebda mutaġeniċità jew klastoġeniċità b'abatacept f'sensiela ta' studji in vitro.
English: At the recommended dosing regimen of belatacept there were 404 EBV positive recipients and 4 cases of PTLD occurred (1.0%); 2 of these presented in the CNS.
Maltese: Bil-kors taddożaġġ irrakkomandat ta' belatacept, kien hemm 404 pazjenti li rċivew trapjant, li kienu pożittivi għal EBV u kien hemm 4 każijiet ta' PTLD (1.0%); 2 minn dawn kienu fis-CNS.
English: EBV associated lymphoproliferative disorder**,lung cancer, rectal cancer, breast cancer, sarcoma, kaposi's sarcoma, prostate cancer, cervix carcinoma, laryngeal cancer, lymphoma, multiple myeloma, transitional cell carcinoma
Maltese: Mhux Komuni disturb limfoproliferattiv assoċjat ma' virus ta' Epstein-Barr (EBV)**, kanċer tal-pulmun, kanċer rektali, kanċer tas-sider, sarkoma, sarkoma ta' Kaposi, kanċer tal-prostata, karċinoma tal-għonq tal-utru, kanċer larinġeali, limfoma, majeloma multipla, karċinoma taċ-ċellola transizzjonali
English: The other ingredients are sodium chloride, sodium dihydrogen phosphate monohydrate, sucrose, sodium hydroxide (for pH adjustment) and hydrochloric acid (for pH adjustment).
Maltese: Is-sustanzi l-oħra huma sodium chloride, sodium dihydrogen phosphate monohydrate, sucrose, sodium hydroxide (għal aġġustament tal-pH) u hydrochloric acid (għal aġġustament tal-pH).
English: In a Phase 3 study in recipients of extended criteria donor (ECD) kidneys (Study 2), graft thrombosis occurred more frequently in the belatacept groups (4.3% and 5.1% for the MI and LI regimens respectively), versus 2.2% for ciclosporin.
Maltese: Fi studju ta' Fażi 3 f'pazjenti li rċivew kliewi ta' donaturi bi kriterji estiżi (ECD) (Studju 2), trombożi fil-parti ttrapjantata seħħet b'mod aktar frekwenti fil-gruppi ta' belatacept (4.3 % u 5.1 % għallkorsijiet MI u LI rispettivament), meta mqabbla ma' 2.2 % għal ciclosporin.
English: Reversible pharmacological effects consisted of minimal decreases in serum IgG and minimal to severe lymphoid depletion of germinal centers in the spleen and/or lymph nodes.
Maltese: L-effetti farmakoloġiċi riversibbli kienu jikkonsistu fi tnaqqis minimu fl-IgG fis-serum u fil-limfojde tnaqqis minimu sa sever taċ-ċelluli ġerminali fil-milsa u/jew fl-għoqod limfatiċi.
English: In a prespecified pooled analysis of Studies 1 and 2 at Year 1, the incidence of new onset diabetes mellitus (NODM), defined as use of an antidiabetic agent for ≥ 30 days or ≥ 2 fasting plasma glucose values > 126 mg/dl (7.0 mmol/l) post-transplantation, was 5% with belatacept and 10% with ciclosporin.
Maltese: Sena 1, l-inċidenza ta' bidu ġdid ta' dijabete mellitus (NODM), definita bħala l-użu ta' sustanza kontra d-dijabete għal ≥ 30 ġurnata jew ≥ 2 valuri ta' glucose fil-plażma fl-istat sajjem ta' > 126 mg/dl (7.0 mmol/l) wara t-trapjant, kienet ta' 5% b'belatacept u ta' 10% b'ciclosporin.
English: Overall occurrences of polyoma virus infections and fungal infections were numerically lower in the belatacept LI group compared with the belatacept MI and ciclosporin groups.
Maltese: L-għadd ta' każi ta' infezzjonijiet bil-virus talpolijoma u infezzjonijiet fungali kienu inqas fil-grupp ta' belatacept LI meta mqabbel ma' gruppi ta' belatacept MI u ciclosporin.
English: Post-transplant lymphoproliferative disorder (PTLD) In the Phase 2 and 3 studies (3 studies), the incidence of PTLD was higher in belatacept-treated patients than in ciclosporin-treated patients (see section 4.8).
Maltese: Fl-istudji ta' Fażi 2 u 3 (3 studji), l-inċidenza ta' PTLD kienet ikbar f'pazjenti kkurati b'belatacept milli f'pazjenti kkurati b'ciclosporin (ara sezzjoni 4.8).
English: Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
Maltese: Pazjenti li jingħataw trapjant li huma seronegattivi għall-virus ta' Epstein-Barr (EBV) jew li sserostatus tagħhom mhuwiex magħruf.
English: Table 5 summarises results for belatacept LI compared with ciclosporin for the co-primary efficacy endpoints of death and graft loss, composite renal impairment, and acute rejection (defined as clinically suspected biopsy proven acute rejection).
Maltese: Tabella 5 tiġbor fil-qosor ir-riżultati għal belatacept LI meta mqabbel ma' ciclosporin għall-punti tattmiem koprimarji tal-effikaċja ta' mewt u telf tal-parti ttrapjantata, indeboliment kompost tal-kliewi, u rifjut akut (definit bħala suspett ta' rifjut akut ippruvat minn bijopsija).
English: Uncommon hypoacusis
Maltese: Mhux Komuni ipoakużi
English: Uncommon renal artery thrombosis*, nephritis, nephrosclerosis, renal tubular atrophy, cystitis haemorrhagic, kidney fibrosis Reproductive system and breast disorders Uncommon epididymitis, priapism, cervical dysplasia, breast mass, testicular pain, vulval ulceration, atrophic vulvovaginitis, infertility, scrotal oedema Congenital, familial and genetic disorders Common hydrocele
Maltese: Mhux Komuni trombożi tal-arterji tal-kliewi*, nefrite, nefrosklerożi, atrofija tubulari tal-kliewi, ċistite emorraġika, fibrożi tal-kliewi Disturbi fis-sistema riproduttiva u fis-sider Mhux Komuni epididimite, priapiżmu, displasja ċervikali, għoqda tas-sider, uġigħ testikulari, ulċerazzjoni vulvali, vulvovaġinite atrofika, infertilità, edema tal-iskrotu Disturbi konġenitali, familjali u ġenetiċi Komuni idroċele
English: Presented in Table 2, by system organ classification and frequency categories, is the list of adverse reactions with at least a suspected causal relationship, reported in clinical trials cumulatively up to Year 3 and pooled for both belatacept regimens (MI and LI).
Maltese: Ippreżentati f'Tabella 2, skont il-klassifika tas-sistema tal-organi u l-kategoriji ta' frekwenzi, wieħed isib lista ta' reazzjonijiet avversi b'għallinqas relazzjoni kawżali suspettata, irrapportata fi provi kliniċi kumulattivament sas-Sena 3 u miġbura għaż-żewġ korsijiet ta' belatacept (MI u LI).
English: The pharmacokinetics of belatacept was linear and the exposure to belatacept increased proportionally in healthy subjects after a single intravenous infusion dose of 1 to 20 mg/kg.
Maltese: Il-farmakokinetika ta' belatacept kienet lineari u l-espożizzjoni għal belatacept żdiedet b'mod proporzjonali f'persuni b'saħħithom wara doża waħda ta' infużjoni fil-vini ta' minn 1 sa 20 mg/kg.
English: How to use NULOJIX 4.
Maltese: Kif għandek tuża NULOJIX 4.
English: Uncommon venous thrombosis, arterial thrombosis, thrombophlebitis, arterial stenosis, intermittent claudication, flushing
Maltese: Mhux Komuni trombożi fil-vini, trombożi arterjali, tromboflebite, stenożi arterjali,
English: End of Week 8 and Week 12 after transplantation
Maltese: Fl-aħħar ta' Ġimgħa 8 u Ġimgħa 12 wara trapjant
English: In general, antibody titers were low, not usually persistent, and often became undetectable with continued treatment.
Maltese: B'mod ġenerali, il-livelli ta' antikorpi mkejla kienu baxxi, normalment mhux persistenti, u ta' spiss sparixxew bit-tkomplija talkura.
English: Belatacept administered to female rats daily during gestation and throughout the lactation period was associated with infections in a small percentage of dams at all doses (≥ 20 mg/kg, ≥ 3 times the MRHD exposure based on AUC), and produced no adverse effects in offspring at doses up to 200 mg/kg representing 19 times the MRHD exposure based on AUC.
Maltese: Belatacept mogħti kuljum lil firien nisa matul it-tqala u matul il-perijodu kollu tat-treddigħ kien assoċjat ma' infezzjonijiet f'persentaġġ żgħir ta' ommijiet bid-dożi kollha (≥ 20 mg/kg, ≥ 3 darbiet l-espożizzjoni ta' MRHD ibbażat fuq l-AUC), u ma ġab l-ebda effett ħażin fuq il-frieħ b'dożi sa 200 mg/kg li jiġu 19-il darba lespożizzjoni ta' MRHD ibbażat fuq l-AUC.
English: Nine of 14 cases of PTLD in belatacept-treated patients were located in the CNS; within the observation period, 8 of 14 cases were fatal (6 of the fatal cases involved the CNS).
Maltese: Disa' mill-14-il każ ta' PTLD f'pazjenti kkurati b'belatacept instabu fisCNS; matul il-perjodu ta' osservazzjoni, 8 minn 14-il każ kienu fatali (6 mill-każijiet fatali involvew is-CNS).
English: This medicinal product contains 0.65 mmol or 15 mg sodium per vial.
Maltese: Dan il-prodott mediċinali fih 0.65 mmol jew 15 mg sodju għal kull kunjett.
English: Hepatic impairment
Maltese: Proċess awtoimmuni
English: Very Common hypertension, hypotension Common shock, infarction, haematoma, lymphocele, angiopathy, arterial fibrosis
Maltese: Ħafna pressjoni għolja, pressjoni baxxa Komuni xokk, infart, ematoma, limfoċele, anġjopatija, fibrożi arterjali
English: Dates of NULOJIX Treatment:
Maltese: Dati tal-Kura ta' NULOJIX:
English: From a 100 ml infusion bag or bottle (typically, an infusion volume of 100 ml will be appropriate for most patients and doses, but total infusion volume ranging from 50 ml to 250 ml may be used), withdraw a volume of sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution for injection equal to the volume (ml equals total dose in mg divided by 25) of the reconstituted belatacept solution required to provide the dose and discard it.
Maltese: Minn borża jew flixkun għall-infużjoni ta' 100 ml (normalment, volum tal-infużjoni ta' 100 ml, ikun biżżejjed għallbiċċa l-kbira tal-pazjenti u dożi, iżda jista' jintuża l-volum totali tal-infużjoni li jvarja minn 50 ml sa 250 ml), iġbed volum ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew ta' 5% soluzzjoni għall-injezzjoni ta' glukożju ugwali għall-volum (ml huwa ugwali għad-doża totali f'mg diviża b'25) tas-soluzzjoni ta' belatacept irrikostitwita meħtieġ biex jipprovdi d-doża u armih.
English: Uncommon acute respiratory distress syndrome, pulmonary hypertension, pneumonitis, haemoptysis, bronchopneumopathy, painful respiration, pleural effusion, sleep apnoea syndrome, dysphonia, oropharyngeal blistering
Maltese: Mhux Komuni sindromu ta' diffikultà respiratorja akuta, pressjoni għolja pulmonari, pulmonite, emoptiżi, bronkopnewmopatija, respirazzjoni b'uġigħ, effużjoni plewrali, sindromu ta' apnea l-irqad, disfonja, selħiet orofarinġeali Disturbi gastro-intestinali Komuni Ħafna dijarea, stitikezza, dardir, rimettar, uġigħ addominali
English: PML is usually diagnosed by brain imaging, including magnetic resonance imaging (MRI) or computed tomography (CT) scan, and cerebrospinal fluid (CSF) testing for JC viral DNA by polymerase chain reaction (PCR).
Maltese: Normalment, PML tiġi ddijanjostikata b'immaġni tal-moħħ, inkluż immaġni tar-reżonanza manjetika (MRI) jew computed tomography (CT) scan, u ttestjar tal fluwidu ċerebrospinali (CSF) għal DNA virali JC permezz ta' reazzjoni katina tal-polymerase (PCR).Meta s-suspett kliniku għal PML ikun għoli, għandu jiġi kkunsidrat li ssir bijopsija tal-moħħ filpazjenti jekk id-dijanjosi ta' PML ma tkunx tista' tiġi stabbilita permezz ta' CSF PCR u newroimmaġni.
English: Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (IFTA) The prevalence of CAN/IFTA at Year 1 in Studies 1 and 2, was numerically lower with belatacept than ciclosporin (~ 9.4% and 5%, respectively).
Maltese: Sena 1 fl-Istudji 1 u 2, kienet numerikament iżjed baxxa b'belatacept milli b'ciclosporin (~ 9.4% u 5%, rispettivament).
English: *Median follow-up excluding PTLD for pooled studies is 1,092 days for each treatment group.
Maltese: *Espożizzjoni medjana għal studji miġbura hija ta' 1,092 jum għal kull grupp ta' kura.
English: NULOJIX should not be used with siliconised syringes in order to avoid aggregate formation (see section 6.6).
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u id-dilwizzjoni tal-prodott mediċinali qabel lamministrazzjoni, ara sezzjoni 6.6.
English: In the individual studies, the percentage of patients with antibodies ranged from 4.5% and 5.2% in the Phase 3 studies to 11.8% in the long-term extension of the Phase 2 study.
Maltese: Fl-istudji individwali, il-perċentwal ta' pazjenti b'antikorpi varja minn 4.5% u 5.2% fl-istudji ta' Fażi 3 għal 11.8% fl-estensjoni fit-tul tal-istudju ta' Fażi 2.
English: From a 100 ml infusion bag or bottle (typically, an infusion volume of 100 ml will be appropriate for most patients and doses, but total infusion volume ranging from 50 ml to 250 ml may be used), withdraw a volume of sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution for injection equal to the volume (ml equals total dose in mg divided by 25) of the reconstituted NULOJIX solution required to provide the dose and discard it.
Maltese: Minn borża jew flixkun għall-infużjoni ta' 100 ml (normalment, volum tal-infużjoni ta' 100 ml, ikun xieraq għallbiċċa l-kbira tal-pazjenti u dożi, iżda jista' jintuża l-volum totali tal-infużjoni li jvarja minn 50 ml sa 250 ml), iġbed volum ta' sodium chloride 9 mg/ml (0.9%) soluzzjoni għall-injezzjoni jew 5% soluzzjoni għall-injezzjoni ta' glukożju ugwali għall-volum (ml huwa ugwali għad-doża totali f'mg diviża b'25) tas-soluzzjoni ta' NULOJIX irrikostitwita meħtieġ biex jipprovdi d-doża u armih.
English: Belatacept is produced by recombinant DNA technology in a mammalian cell expression system.
Maltese: G1. Belatacept huwa prodott b'teknoloġija ta' DNA rikombinanti f'sistema ta' espressjoni taċ-ċelluli mammiferi.
English: Polyomavirus 4.8
Maltese: .8 Effetti mhux mixtieqa
English: Total dose of belatacept in mg equals the patient weight in kg times the belatacept dose in mg/kg (5 or 10 mg/kg, see section 3) Dose modification of NULOJIX is not recommended for a change in body weight of less than
Maltese: Id-doża totali ta' belatacept f'mg hija ugwali għall-piż tal-pazjent f'kg immultiplikat bid-doża ta' belatacept f'mg/kg (5 jew 10 mg/kg, ara sezzjoni 3) Mhix irrakkomandata modifika fid-doża ta' NULOJIX għal bidla fil-piż tal-ġisem ta' inqas minn
English: Uncommon infusion related reaction*, irritability, fibrosis, inflammation, disease recurrence, feeling hot, ulcer
Maltese: Mhux Komuni reazzjoni relatata mal-infużjoni*, irritabilità, fibrożi, infjammazzjoni, rikorrenza tal-marda, ħass ta' sħana, ulċera
English: The trough concentration of belatacept was consistently maintained up to 5 years post-transplant.
Maltese: L-inqas konċentrazzjoni ta' belatacept inżammet b'mod konsistenti sa 5 snin wara ttrapjant.
English: Uncommon monocytopenia, pure red cell aplasia, agranulocytosis, haemolysis, hypercoagulation Immune system disorders Common blood immunoglobulin G decreased, blood immunoglobulin M decreased,
Maltese: Mhux Komuni monoċitopenija, aplasja pura taċ-ċelloli ħomor, agranuloċitożi, emoliżi, iperkoagulazzjoni Disturbi fis-sistema immuni Komuni immunoglubulina G tad-demm imnaqqsa, immunoglubulina M tad-demm imnaqqsa
English: EBV seronegative patients receiving immunosuppressants are at a particularly increased risk for PTLD (see sections 4.3 and 4.4).
Maltese: Pazjenti seronegattivi tal-EBV li qed jirċievu immunosoppressivi jinsabu f'riskju partikolarment miżjud għal PTLD (ara sezzjonijiet 4.3 u 4.4).
English: Vaccinations
Maltese: Tuberkolożi
English: One patient on belatacept MI regimen developed Guillian-Barré syndrome which led to treatment discontinuation and subsequently resolved.
Maltese: Pazjent wieħed fuq kors ta' belatacept MI żviluppa s-sindromu ta' Guillian-Barré li wassal għal waqfien tal-kura u sussegwentement fieq.
English: Acute rejection (AR) occurred more frequently with belatacept versus ciclosporin in Study 1 and with similar frequency with belatacept versus ciclosporin in Study 2.
Maltese: Rifjut akut (AR) seħħ aktar ta' spiss b'belatacept meta mqabbel ma' ciclosporin fi Studju 1 u bi frekwenza simili b'belatacept meta mqabbel ma' ciclosporin fi Studju 2.
English: In another Phase 3 study in recipients of living donor and standard criteria deceased donor kidneys (Study 1), the incidence of graft thrombosis was 2.3% and 0.4% for the MI and LI regimens respectively, versus 1.8% for ciclosporin.
Maltese: Fi studju ieħor ta' Fażi 3 f'pazjenti li rċivew kliewi ta' donaturi ħajjin u kliewi ta' donaturi mejtin bi kriterji standard (Studju 1), l-inċidenza ta' trombożi fil-parti ttrapjantata kienet ta' 2.3 % u 0.4 % għall-korsijiet MI u LI rispettivament, meta mqabbla ma' 1.8 % għal ciclosporin.
English: In a Phase 2 study, there were 2 cases of graft thrombosis, 1 each in MI and LI (incidence of 1.4% for both) versus 0 in the ciclosporin group.
Maltese: Fi studju ta' Fażi 2, kien hemm 2 każijiet ta' trombożi tal-parti ttrapjantata, wieħed f'MI u wieħed f'LI (inċidenza ta' 1.4 % għat-tnejn) kontra 0 filgrupp ta' ciclosporin.
English: In addition to PTLD, patients receiving immunosuppressive regimens, including belatacept, are at increased risk of malignancies, including skin cancer (see section 4.8).
Maltese: Barra minn PTLD, pazjenti li jirċievu korsijiet immunosuppressivi, inkluż belatacept, jinsabu f'riskju miżjud ta' tumuri malinni, inkluż ta' kanċer tal-ġilda (ara sezzjoni 4.8).
English: Uncommon gastrointestinal disorder, pancreatitis, large intestinal ulcer, melaena, gastroduodenal ulcer, rectal haemorrhage, small intestinal obstruction, cheilitis, gingival hyperplasia, salivary gland pain, faeces discoloured Hepatobiliary disorders
Maltese: Mhux Komuni disturbi gastro-intestinali, pankreatite, ulċera fil-musrana l-kbira, melaena, ulċera gastroduwodenali, emorraġija rektali, ostruzzjoni fil-musrana ż-żgħira, ċejlite, iperplasija ġinġivali, uġigħ fil-glandola tal-bżieq, telf fil-kulur tal-ippurgar Disturbi fil-fwied u fil-marrara
English: In the renal transplant studies of belatacept, one case of PML was reported in a patient who received an IL-2 receptor antagonist, mycophenolate mofetil (MMF) and corticosteroids as concomitant treatment.
Maltese: Fl-istudji ta' belatacept fi trapjant tal-kliewi, ġie rrappurtat każ wieħed ta' PML f'pazjent li rċieva antagonist ta' riċettur IL-2, mycophenolate mofetil (MMF) u kortikosterojdi bħala kura fl-istess ħin.
English: Abatacept administered to female rats every three days during gestation and throughout the lactation period, produced no adverse effects in offspring at doses up to 45 mg/kg, representing 3 times the exposure associated with the MRHD of 10 mg/kg based on AUC.
Maltese: Abatacept mogħti lil firien nisa kull tlett ijiem matul it-tqala u matul il-perijodu kollu tattreddigħ ma pproduċa l-ebda effett negattiv fuq il-frieħ b'dożi sa 45 mg/kg, li jiġu 3 darbiet lespożizzjoni assoċjata mal-MRHD ta' 10 mg/kg ibbażat fuq l-AUC.
English: However, at 200 mg/kg, 11 times the MRHD exposure, alterations in immune function were observed consisting of a 9-fold increase in T-cell dependent antibody response in female pups and thyroid inflammation in one female pup.
Maltese: Madankollu, b'doża ta' 200 mg/kg, 11-il darba l-espożizzjoni ta' MRHD, kienu osservati bidliet fil-funzjoni immuni li kienu jikkonsistu minn żieda ta' disa' darbiet fir-rispons tal-antikorpi dipendenti fuq iċ-ċelluli T fil-frieħ nisa u infjammazzjoni tat-tirojde f'ferħa waħda mara.
English: It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this belatacept-based regimen.
Maltese: Huwa rrakkomandat li jiżdied interleukin (IL)2 receptor antagonist għal terapija ta' induzzjoni ma' dan il-kors ibbażat fuq belatacept.
English: This will avoid foam formation.
Maltese: ml ta' fluwidu ta' rikostituzzjoni fil-kunjett.
English: Teл.
Maltese: C.
English: In Study 1, one additional case of PTLD was reported in the ciclosporin group, in a patient who was EBV seropositive at the time of transplant.
Maltese: Fi Studju 1, każ wieħed addizzjonali ta' PTLD ġie rrappurtat fil-grupp ta' ciclosporin, f'pazjent li kien seropożittiv għall-EBV fil-ħin tat-trapjant.
English: Genital herpes
Maltese: Ħerpes
English: Information for medical and healthcare professionals on dose calculation, preparation and administration of NULOJIX is provided at the end of the leaflet.
Maltese: Informazzjoni għall-professjonisti mediċi u tal-kura tas-saħħa dwar il-kalkolazzjoni, il-preparazzjoni u l-għoti ta' NULOJIX hija mogħtija fl-aħħar tal-fuljett.
English: NULOJIX Patient Alert Card
Maltese: X'inhu NULOJIX u għalxiex jintuża
English: Malignancies excluding nonmelanoma skin cancer and PTLD
Maltese: Kwalunkwe neoplażma malinna
English: PTLD in belatacept-treated patients most often presented in the central nervous system (CNS).
Maltese: PTLD f'pazjenti kkurati b'belatacept feġġ spiss fis-sistema nervuża ċentrali (CNS).
English: The most commonly reported adverse reactions (≥ 20%) among patients treated with both belataceptbased regimens (MI and LI) up to Year 3 are diarrhoea, anaemia, urinary tract infection, peripheral oedema, constipation, hypertension, pyrexia, nausea, graft dysfunction, cough, vomiting, leukopenia, hypophosphataemia, and headache.
Maltese: L-aktar reazzjonijiet avversi serji li ġew irrappurtati b'mod l-aktar komuni (≥ 20%) fost pazjenti kkurati biż-żewġ korsijiet (MI u LI) ibbażati fuq belatacept sas-Sena 3 kienu dijarea, anemija, infezzjoni tal-passaġġ tal-awrina, edema periferali, stitikezza, pressjoni għolja, deni, dardir, disfunzjoni tal-parti ttrapjantata, sogħla, rimettar, lewkopenija, ipofosfatemija, u wġigħ ta' ras.
English: More patients discontinued in the ciclosporin group (34.5%) versus each belatacept group (28.8% and 25.7% for MI and LI groups, respectively) during the long-term extension period.
Maltese: Aktar pazjenti waqfu fil-grupp ta' ciclosporin (34.5 %) meta mqabbel ma' kull grupp ta' belatacept (2.8 % u 25.
English: The time to death, graft loss, or GFR <30 mL/min/1.73 m2 was analyzed over the 7-year period: in Study 1, approximately 60% reduction in the risk of death, graft loss, or GFR <30 mL/min/1.73 m2 was observed among patients in the belatacept groups as compared with those assigned to ciclosporin.
Maltese: Il-ħin għal mewt, telf tal-parti jew GFR <30 mL/min/1.73 m2 ġie analizzat matul il-perjodu ta' 7 snin: fi Studju 1, madwar 60 % tnaqqis fir-riskju ta' mewt, telf tal-parti, jew GFR <30 mL/min/1.73 m2 ġie osservat fost il-pazjenti fil-grupp ta' belatacept meta mqabbel ma' dawk assenjati għal ciclosporin.
English: Corticosteroid Taper: Corticosteroid tapering in patients taking belatacept should be implemented cautiously, particularly in patients at high immunologic risk, such as those with 4 to 6 human leukocyte antigen (HLA) mismatches.
Maltese: It-tnaqqis gradwali tal-kortikosterojdi f'pazjenti li jkunu qed jieħdu belatacept għandu jiġi implimentat b'attenzjoni, partikularment f'pazjenti f'riskju immunoloġiku għoli, bħal dawk b'4 sa 6 nuqqasijiet ta' qbil ta' antiġen tal-lewkoċiti umani (HLA).
English: trichorrhexis
Maltese: Treddigħ