FrancophonIA/ELRC3.0 huggingface dataset:
English: To assess for the presence of neutralising antibodies, samples from 29 patients with confirmed binding activity to the modified cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) region of the molecule were assessed by an in vitro assay; 8 (27.6%) patients were shown to possess neutralising antibodies.
Maltese: Biex tiġi evalwata l-preżenza ta' antikorpi newtralizzanti, ġew evalwati kampjuni minn 29 pazjent b'attività ta' twaħħil ikkonfermata tal-molekula għar-reġjun ta' cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) modifikat b'assaġġ in vitro; 8 (27.6%) pazjenti ntwerew li kellhom antikorpi newtralizzanti.
English: A total of 250 subjects were randomised to 1 of 5 treatment groups (3 belatacept and 2 tacrolimus groups).
Maltese: B'kollox ħadu sehem 250 individwu b'mod każwali għal 1 minn 5 gruppi ta' kura (3 gruppi għal belatacept u 2 gruppi għal tacrolimus).
English: NULOJIX contains the active substance belatacept which belongs to a group of medicines called immunosuppressants.
Maltese: NULOJIX fih is-sustanza attiva belatacept li tagħmel parti minn grupp ta' mediċini msejħa immunosuppressanti.
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 4.2).
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 4.2).
English: Uncommon progressive multifocal leukoencephalopathy*, cerebral fungal infection, cytomegalovirus (CMV) colitis, polyomavirus-associated nephropathy, genital herpes, staphylococcal infection, endocarditis, tuberculosis*, bronchiectasis, osteomyelitis, strongyloidiasis, blastocystis infection, giardiasis, lymphangitis Neoplasms, benign, malignant and unspecified (incl cysts and polyps)* Common squamous cell carcinoma of skin, basal cell carcinoma, skin papilloma
Maltese: Mhux Komuni lewkoenċefalopatija multifokali progressiva*, infezzjoni fungali ċerebrali, kolite tas-cytomegalovirus (CMV), nefropatija assoċjata ma' polijomavirus, herpes ġenitali, infezzjoni stafilokokkali, endokardite, tuberkolożi*, bronkiektassi, osteomijelite, strongyloidiasis, blastoċistite, giardiasis, limfanġite
English: Common sepsis, pneumonia, influenza, gastroenteritis, herpes zoster, sinusitis, herpes simplex, oral candidiasis, pyelonephritis, onychomycosis, BK virus infection, respiratory tract infection, candidiasis, rhinitis, cellulitis, wound infection, localised infection, herpes virus infection, fungal infection, fungal skin infection
Maltese: Komuni sepsis, pulmonite, influwenza, gastroenterite, herpes żoster, sinusite, herpes simplex, kandidijażi orali, pijelonefrite, onikomikożi, infezzjoni bil-virus BK, infezzjoni tal-passaġġ respiratorju, kandidijażi, rinite, ċellulite, infezzjoni talferita, infezzjoni lokalizzata, infezzjoni bil-virus tal-herpes, infezzjoni fungali, infezzjoni fungali tal-ġilda
English: In a pre- and postnatal development study in rats, limited changes in immune function were observed at 19-fold a human 10 mg/kg dose based on AUC (see section 5.3).
Maltese: Fi studju dwar l-iżvilupp ta' qabel u wara t-twelid fil-firien, ġie osservat tibdil limitat fil-funzjoni immuni ta' 19-il darba tad-doża umana ta' 10 mg/kg ibbażat fuq l-AUC (ara sezzjoni 5.3).
English: The safety and efficacy of belatacept in children and adolescents 0 to 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' belatacept fit-tfal u adoloxxenti minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: Common tremor, paraesthesia, cerebrovascular accident, dizziness, syncope, lethargy, neuropathy peripheral
Maltese: Komuni rogħda, paraestesija, aċċident ċerebrovaskulari, sturdament, sinkope, letarġija, newropatija periferali
English: Belatacept was not teratogenic when administered to pregnant rats and rabbits at doses up to 200 mg/kg and 100 mg/kg daily, respectively, representing approximately 16 and 19 times the exposure associated with the maximum recommended human dose (MRHD) of 10 mg/kg based on AUC.
Maltese: Belatacept ma kienx teratoġeniku meta ngħata lil firien u fniek tqal f'dożi sa 200 mg/kg u 100 mg/kg kuljum, rispettivament, li jiġu madwar 16 u 19-il darba l-espożizzjoni assoċjata mad-doża massima rrakkomandata fi-bniedem (MRHD) ta' 10 mg/kg ibbażata fuq l-AUC.
English: Start (Day of Transplant):_______________ Most recent: _________________________ Next treatment date:____________________ Patient's Name:_______________________ Doctor's Name:_______________________ Doctor's Phone:_______________________ If NULOJIX is stopped, keep this card with you for an additional 3 months.
Maltese: Isem tat-Tabib:________________________ Numru tat-Telefon tat-Tabib:_____________ Jekk NULOJIX jitwaqqaf, żomm din il-kard miegħek għal 3 xhur addizzjonali.
English: An excess in mortality and graft loss was observed in the belatatacept LI + MMF group and an excess in mortality was observed in the belatacept MI + MMF group.
Maltese: Kienet osservat żieda fil-mortalità u t-telf tal-parti trapjantata fil-grupp li ngħata belatacept LI + MMF u kif ukoll fil-mortalità fil-grupp li ngħata belatacept MI + MMF.
English: NULOJIX, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant (see section 5.1 for data on renal function).
Maltese: NULOJIX, flimkien mal-kortikosterojdi u ma' aċidu majkofenoliku (MPA, mycophenolic acid), huwa indikat għall-profilassi ta' rifjut tal-parti ttrapjantata f'adulti li jkunu qed jirċievu trapjant tal-kliewi (ara sezzjoni 5.1 għal dejta dwar il-funzjoni tal-kliewi).
English: In Study 2, mean calculated GFR at 7 years was 57.6, 59.1 and 44.6 mL/min/1.73 m2, in the same groups, respectively.
Maltese: Fi Studju 2, il-GFR medja kkalkulata wara 7 snin kienet ta' 57.6, 59.1 u 44.6 mL/min/1.73 m2, fl-istess gruppi, rispettivament.
English: Malignancies and post-transplant lymphoproliferative disease Year 1 and 3 frequencies of malignancies are shown in Table 3, except for cases of PTLD which are presented at 1 year and > 3 years (median days of follow-up were 1,199 days for belatacept MI, 1,206 days for belatacept LI, and 1,139 days for ciclosporin).
Maltese: Tumuri malinni u mard limfoproliferattiv wara t-trapjant Il-frekwenzi ta' malinni ta' Sena 1 u 3 huma murija f'Tabella 3, għajr għal każijiet ta' PTLD li huma ppreżentati f'sena 1 u > 3 snin (jiem medjana ta' follow-up kienu 1,199 jum għal belatacept MI, 1,206 jum għal belatacept LI, u 1,139 jum għal ciclosporin).
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate belatacept
Maltese: NULOJIX 250 mg trab għal konċentrat belatacept
English: In clinical studies, belatacept-treated transplant recipients with EBV seronegative status were at an increased risk for PTLD compared with those who were EBV positive (7.7%; 7/91 versus 0.7%; 6/810, respectively).
Maltese: Fi studji kliniċi, pazjenti li rċivew trapjant ikkurati b'belatacept bi stat seronegattiv tal-EBV kienu f'riskju miżjud għal PTLD meta mqabbla ma' dawk li kienu pożittivi għall-EBV (7.7%; 7/91 meta mqabbel ma' 0.7%; 6/810, rispettivament).
English: The median corticosteroid doses administered with the belatacept recommended regimen up to months 1, 3, and 6 were 21 mg, 13 mg and 10 mg, respectively.
Maltese: Il-medjan tad-dożi tal-kortikosterojdi mogħtija mal-kors irrakkomandat ta' belatacept sa xhur 1, 3, u 6 kien ta' 21 mg, 13 mg u 10 mg, rispettivament.
English: When belatacept was compared to placebo infusions, there were no differences in event rates (placebo infusions were administered at Weeks 6 and 10 of the belatacept LI regimen to blind the MI and LI regimens).
Maltese: Meta belatacept tqabbel ma' infużjonijiet tal-plaċebo, ma kienx hemm differenzi fir-rati tal-avvenimenti (infużjonijiet ta' plaċebo ngħataw f'Ġimgħat 6 u 10 tal-kors ta' belatacept LI sabiex jaħbu (blind) lkorsijiet MI u LI).
English: Long-term extension in Study 1 and Study 2
Maltese: Estensjoni fit-tul fi Studju 1 u Studju 2
English: In the 3 studies (one Phase 2 and two Phase 3 studies, Study 1 and Study 2), the cumulative frequency of PTLD was higher in belatacept treated patients at the recommended dosing regimen (LI) (1.3%; 6/472) than in the ciclosporin group (0.6%; 3/476), and was highest in the belatacept MI group (1.7%; 8/477).
Maltese: Fit-3 studji (studju wieħed ta' Fażi 2 u żewġ studji ta' Fażi 3, Studju 1 u Studju 2), il-frekwenza kumulattiva ta' PTLD kienet ogħla f'pazjenti kkurati b'belatacept bil-kors tad-dożaġġ irrakkomandat (LI) (1.3%; 6/472) milli fil-grupp ta' ciclosporin (0.6%; 3/476), u kienet l-ogħla fil-grupp MI ta' belatacept (1.7%; 8/477).
English: No clinically relevant effects of age, gender, race, renal function (calculated GFR), diabetes, or concomitant dialysis on clearance of belatacept was identified.
Maltese: Ma kinux identifikati effetti klinikament rilevanti ta' l-età, is-sess tal-persuna, ir-razza, il-funzjoni tal-kliewi (GFR ikkalkulata), iddijabete, jew id-dijalisi fl-istess fuq it-tneħħija ta' belatacept.
English: The median corticosteroid doses administered with the belatacept recommended regimen up to months 1, 3, and 6 were 20 mg, 12 mg and 10 mg, respectively.
Maltese: Il-medjan tad-dożi tal-kortikosterojdi mogħtija mal-kors irrakkomandat ta' belatacept sa xhur 1, 3, u 6 kien ta' 20 mg, 12 mg u 10 mg, rispettivament.
English: Tuberculosis was more frequently observed in patients receiving belatacept than ciclosporin in clinical studies (see section 4.8).
Maltese: It-tuberkolożi ġiet osservata b'mod aktar frekwenti f'pazjenti li kienu qegħdin jirċievu belatacept aktar milli ciclosporin fi studji kliniċi (ara sezzjoni 4.8).
English: Common cushingoid
Maltese: Disturbi fis-sistema endokrinarja Komuni cushingoid
English: Uncommon adrenal insufficiency Metabolism and nutrition disorders Very Common hypophosphataemia, hypokalaemia, dyslipidaemia, hyperkalaemia, hyperglycaemia, hypocalcaemia
Maltese: Mhux Komuni insuffiċjenza adrenali Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni Ħafna ipofosfatemija, ipokalamija, dislipidemija, iperkalemija, ipregliċemija, ipokalkemija
English: During the long-term extension period, serious infections occurred in 30.3% and 23.5% of patients in the belatacept MI and LI groups, respectively, and in 27.2% of patients in the ciclosporin group in Study 1; and in 35.6% and 38.1% of patients in the belatacept MI and LI groups, respectively, and in 37.9% of patients in the ciclosporin group in Study 2.
Maltese: Matul il-perjodu ta' estensjoni fit-tul, seħħew infezzjonijiet serji f'30.3 % u 23.5 % tal-pazjenti filgruppi ta' belatacept MI u LI, rispettivament, u f'27.2 % tal-pazjenti fil-grupp ta' ciclosporin fi Studju 1; u f'35.6 % u 38.1 % tal-pazjenti fil-gruppi ta' belatacept MI u LI, rispettivament, u f'37.9 % tal-pazjenti fil-grupp ta' ciclosporin fi Studju 2.
English: Belatacept is therefore not expected to affect cytochrome P450 enzymes via effects on cytokines.
Maltese: Għaldaqstant, Belatacept mhuwiex mistenni li jaffettwa l-enzimi ta' ċitokrom P450 permezz ta' effetti fuq cytokines.
English: This medicine contains 0.65 mmol (or 15 mg) sodium per vial which corresponds to 1.95 mmol (or 45 mg) sodium per maximum dose of three vials.
Maltese: Din il-mediċina fiha 0.65 mmol (jew 15 mg) sodium kull kunjett li tikkorrespondi għal 1.95 mmol (jew 45 mg) sodju għal kull doża massima ta' tliet kunjetti.
English: Injury, poisoning and procedural complications Very Common graft dysfunction Common chronic allograft nephropathy (CAN), incisional hernia
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Komuni Ħafna disfunzjoni tal-parti ttrapjantata Komuni nefropatija kronika tal-allograft (CAN), ftuq inċiżjonali
English: Study 2: Recipients of Extended Criteria Donor Kidneys Extended criteria donors were defined as deceased donors with at least one of the following: (1) donor age ≥ 60 years; (2) donor age ≥ 50 years and other donor comorbidities (≥ 2 of the following: stroke, hypertension, serum creatinine > 1.5 mg/dl); (3) donation after cardiac death or (4) anticipated cold ischemia time of ≥ 24 hours.
Maltese: (1) età tad-donatur ta' ≥ 60 sena; (2) età ta' tad-donatur ≥ 50 sena u komorbożitajiet oħrajn tad-donatur (≥ 2 minn dawn li ġejjin: puplesija, pressjoni għolja, krejatinina fis-serum > 1.5 mg/dl); (3) donazzjoni wara l-mewt tal-qalb jew (4) ħin antiċipat ta' iskemija kiesħa ta' ≥ 24 siegħa.
English: In Study 1, mean calculated GFR at 7 years was 74.0, 77.9 and 50.7 mL/min/1.73 m2 in the belatacept MI, belatacept LI and ciclosporin groups, respectively.
Maltese: Fi Studju 1, il-GFR medja kkalkulata wara 7 snin kienet ta' 74.0, 77.9 u 50.7 mL/min/1.73 m2 fil-gruppi ta' belatacept MI, belatacept LI u ciclosporin, rispettivament.
English: EBV is the virus that causes glandular fever.
Maltese: EBV huwa l-virus li jikkawża d-deni talglandoli.
English: In addition to EBV seronegative status, other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell-depleting therapy, which was more commonly used to treat acute rejection in belatacept-treated patients in Phase 3 clinical studies (see section 5.1).
Maltese: Barra minn stat seronegattiv ta' EBV, fatturi oħrajn magħrufin ta' riskju għal PTLD jinkludu infezzjoni b'cytomegalovirus (CMV) u kura ta' tkissir taċ-ċelluli-T, li ntużat b'mod aktar komuni biex tikkura rifjut akut f'pazjenti kkurati b'belatacept fi studji kliniċi ta' Fażi 3 (ara sezzjoni 5.1).
English: Belatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA technology.
Maltese: Belatacept huwa proteina ta' fużjoni prodotta miċ-ċelluli tal-ovarji tal-ħamster Ċiniż b'teknoloġija ta' DNA rikombinanti.
English: During the long-term extension period, autoimmune events occurred in 2.6% and 3.0% of patients in the belatacept MI and LI groups, respectively, and in 3.7% of patients in the ciclosporin group in Study 1; and in 5.8% and 3.5% of patients in the belatacept MI and LI groups, respectively, and in 0% of patients in ciclosporin group in Study 2.
Maltese: Matul il-perjodu ta' estensjoni fit-tul, avvenimenti awtoimmuni seħħew f'2.6 % u 3.0 % tal-pazjenti fil-gruppi ta' belatacept MI u LI, rispettivament, u f'3.7 % tal-pazjenti fil-grupp ta' ciclosporin fi Studju 1; u f'5.8 % u 3.5 % tal-pazjenti fil-gruppi ta' belatacept MI u LI, rispettivament, u f'0 % talpazjenti fil-grupp ta' ciclosporin fi Studju 2.
English: During the first month post-transplantation, 85% saturation of CD86 was maintained.
Maltese: Matul l-ewwel xahar ta' wara t-trapjant, inżammet 85% saturazzjoni ta' CD86.
English: Fungal infections Tuberculosis
Maltese: Infezzjonijiet fungali
English: Malignancies
Maltese: Polijomavirus
English: Other medicines and NULOJIX
Maltese: Mediċini oħra u NULOJIX
English: A total of 217 belatacept (MI: 104 and LI: 113) and 87 ciclosporin patients completed 3 years of treatment in Study 2 and entered the 4-year long-term open label extension period (up to 7 years in total).
Maltese: Total ta' 217-il pazjent fuq belatacept (MI: 104 u LI: 113) u 87 pazjent fuq ciclosporin temmew 3 snin ta' kura fi Studju 2 u daħlu fil-perjodu ta' estensjoni bit-tikketta mikxufa ta' 4 snin (massimu ta' 7 snin b'kollox).
English: Use with other immunosuppressive medicines
Maltese: Użu ma' mediċini immunosoppressivi oħra
English: For patients who may be switched from belatacept to another immunosuppressant, physicians should be aware of the 8-10 day half-life of belatacept to avoid potential under- or over-immunosuppression following discontinuation of belatacept.
Maltese: Għal pazjenti li tista' tinbidlilhom il-mediċina minn belatacept għal immunosuppressant ieħor, it-tobba għandhom ikunu konxji tal-half-life ta' 8-10 ijiem ta' belatacept biex jevitaw immunosuppressjoni nieqsa jew eċċessiva potenzjali wara li jitwaqqaf belatacept.
English: Adverse reactions resulting in interruption or discontinuation of belatacept in ≥ 1% of patients up to Year 3 were renal vein thrombosis and CMV infection.
Maltese: Reazzjonijiet avversi li jirriżultaw f'interruzzjoni jew waqfien ta' belatacept f'≥ 1% tal-pazjenti sasSena 3 kienu trombożi u infezzjoni bis-CMV.
English: The concentration of belatacept in the infusion should be between 2 mg and 10 mg belatacept per ml solution.
Maltese: Il-konċentrazzjoni ta' belatacept flinfużjoni għandha tkun bejn 2 mg u 10 mg ta' belatacept għal kull ml ta' soluzzjoni.
English: The diluted solution must be administered as an intravenous infusion at a relatively constant rate over 30 minutes.
Maltese: Is-soluzzjoni dilwita għandha tingħata bħala infużjoni ġol-vini b'rata relattivament kostanti fuq 30 minuta.
English: Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development at doses up to 16-fold and 19-fold a human 10 mg/kg dose based on AUC.
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti dwar l-iżvilupp embrijoniku/fetali f'dożi sa mhux aktar minn 16-il darba u 19-il darba tad-doża fil-bniedem ta' 10 mg/kg ibbażat fuq l-AUC.
English: Uncommon diabetic ketoacidosis, diabetic foot, alkalosis, decreased appetite, vitamin D
Maltese: Mhux Komuni ketoaċidożi dijabetika, sieq dijabetika, alkalożi, tnaqqis fl-aptit, nuqqas ta' Vitamina D
English: Progression of Chronic Kidney Disease (CKD) Staging In Study 1 by Year 3, mean calculated GFR was 21 ml/min/1.73 m2 higher with belatacept, and 10% and 20% of patients reached CKD stage 4/5 (GFR < 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
Maltese: Fi Studju 1 sa Sena 3, il-GFR medja kkalkulata kienet ta' 21 ml/min/1.73 m2 ogħla b'belatacept, u 10% u 20% tal-pazjenti laħqu CKD stadju 4/5 (GFR < 30 ml/min/1.73 m2) b'belatacept kontra ciclosporin, rispettivament.
English: The most common serious adverse reactions (≥ 2%) reported with belatacept in both regimens (more intensive [MI] and less intensive [LI]) cumulative up to Year 3 were urinary tract infection, CMV infection, pyrexia, increased blood creatinine, pyelonephritis, diarrhoea, gastroenteritis, graft dysfunction, leukopenia, pneumonia, basal cell carcinoma, anaemia, dehydration.
Maltese: L-aktar reazzjonijiet avversi serji komuni (≥ 2%) rrappurtati b'belatacept fiż-żewġ korsijiet (aktar intensiv [MI] u inqas intensiv [LI]) kumulattivi sas-Sena 3 kienu infezzjoni tal-passaġġ tal-awrina, infezzjoni bis-CMV, deni, żieda fil-krejatinina fid-demm, pijelonefrite, dijarea, gastroenterite, disfunzjoni tal-parti ttrapjantata, lewkopenija, pnewmonja, karċinoma fiċ-ċelluli bażali, anemija, deidratazzjoni.
English: Blood and lymphatic system disorders Very Common anaemia, leukopenia Common thrombocytopenia, neutropenia, leukocytosis, polycythaemia, lymphopenia
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni Ħafna anemija, lewkopenija Komuni tromboċitopenija, newtropenija, lewkoċitożi, poliċitemija, limfopenija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/694/001
English: Elderly patients No dose adjustment is required (see sections 5.1 and 5.2).
Maltese: Pazjenti anzjani Mhu meħtieġ l-ebda aġġustament fid-doża (ara sezzjonijiet 5.1 u 5.2).
English: For Studies 1 and 2 at Years 1 and 3, belatacept was associated with 6 to 9 mmHg lower mean systolic blood pressure, approximately 2 to 4 mmHg lower mean diastolic blood pressure, and less use of antihypertensive medicinal products than ciclosporin.
Maltese: Fl-Istudji 1 u 2 f'Sena 1 u 3, belatacept kien assoċjat ma' 6 sa 9 mmHg pressjoni sistolika medja taddemm aktar baxxa, madwar 2 sa 4 mmHg pressjoni dijastolika medja tad-demm aktar baxxa, u inqas użu ta' prodotti mediċinali kontra l-pressjoni għolja meta mqabbel ma' ciclosporin.
English: Patient and graft survival were similar between belatacept and ciclosporin.
Maltese: Is-sopravivenza tal-pazjenti u tal-partijiet ittrapjantati kienu simili bejn belatacept u ciclosporin.
English: During the long-term extension period, malignancies (including PTLD) were reported in 10.3%, 8.4%, and 14.7% of patients in the belatacept MI, belatacept LI, and ciclosporin groups, respectively, in Study 1; and in 19.2%, 13.3% and 16.1% of patients in the belatacept MI, belatacept LI, and ciclosporin groups, respectively, in Study 2.
Maltese: Matul il-perjodu ta' estensjoni fit-tul, ġew irrappurtati malinni (inkluż PTLD) f'10.3%, 8.4%, u 14.7% tal-pazjenti fil-gruppi ta' belatacept MI, belatacept LI, u ciclosporin, rispettivament, fi Studju 1; u f'19.
English: The most common CNS infection was cryptococcal meningitis.
Maltese: L-iktar infezzjoni ta' CNS komuni kienet il-meninġite kriptokokkali.
English: Do not use NULOJIX
Maltese: Tużax NULOJIX
English: There is a theoretical concern that treatment with belatacept might increase the risk of autoimmune processes (see section 4.8).
Maltese: Hemm tħassib teoretiku li kura b'belatacept tista' żżid ir-riskju ta' proċessi awtoimmuni (ara sezzjoni 4.8).
English: Year 1a P-value AR (%) Year 1 (%) [95% CI] Year 3 (%) [95% CI] Mean Measured
Maltese: Sena 1a Valur P AR (%) Sena 1 (%) [95% CI] Sena 3 (%) [95% CI] GFR Imkejla Medjana b ml/min/1.73 m2 Sena 1 Sena 2
English: In Study 2 by Year 3, mean calculated GFR was 11 ml/min/1.73 m2 higher with belatacept, and 27% and 44% of patients reached CKD stage 4/5 (GFR < 30 ml/min/1.73 m2) with belatacept versus ciclosporin, respectively.
Maltese: m2 ogħla b'belatacept, u 27% u 44% tal-pazjenti laħqu CKD stadju 4/5 (GFR < 30 ml/min/1.73 m2) b'belatacept kontra ciclosporin, rispettivament.
English: This corresponds to 1.95 mmol (or 45 mg) sodium per maximum dose of 3 vials.
Maltese: Dan jikkorrispondi għal 1.95 mmol (jew 45 mg) sodju għal kull doża massima ta' 3 kunjetti.
English: These Grade III rejections occurred in patients with 4 to 6 HLA mismatches (see sections 4.2 and 5.1).
Maltese: Dawn ir-rifjuti ta' Grad III seħħew f'pazjenti b'4 sa 6 nuqqasijiet ta' qbil ta' HLA (ara sezzjonijiet 4.2 u 5.1).
English: Low platelet counts in your blood, too many white blood cells, too many red blood cells Changes in blood levels of carbon dioxide, fluid retention, low protein in the blood Abnormal liver function tests, blood parathyroid hormone increased Increased protein (c-reactive protein) in blood indicating inflammation A decrease of antibodies (proteins that fight infection) in your blood
Maltese: Bidla fil-livelli ta' dijossidu tal-karbonju fid-demm, żamma ta' fluwidu, proteina baxxa fid-demm Testijiet anormali tal-funzjoni tal-fwied, żieda tal-ormon paratirojde fid-demm Żieda fil-proteini (proteina ċ-reattiva) fid-demm li tindika infjammazzjoni Tnaqqis ta' antikorpi (proteini li jiġġieldu infezzjoni) fid-demm tiegħek
English: Study 1: Recipients of Living Donor and Standard Criteria Deceased Donor Kidneys Standard criteria donor organs were defined as organs from a living donor, or a deceased donor with anticipated cold ischemia time of < 24 hours and not meeting the definition of extended criteria donor organs.
Maltese: L-organi ta' donaturi skont kriterji standard kienu definiti bħala organi minn donatur ħaj, jew donatur mejjet b'ħin antiċipat ta' iskemija bil-kesħa ta' < 24 siegħa u li ma jissodisfax id-definizzjoni ta' organi minn donaturi skont il-kriterji estiżi.
English: The median age was 45 years; 58% of donor organs were from living patients; 3% were re-transplanted; 69% of the study population was male; 61% of patients were white, 8% were black/African-American, 31% were categorised as of other races; 16% had PRA  10%; and 41% had 4 to 6 HLA mismatches.
Maltese: L-età medjana kienet 45 sena; 58% tal-organi tad-donaturi kienu minn pazjenti ħajjin; 3% ġew trapjantati mill-ġdid; 69% talpopolazzjoni tal-istudju kienu rġiel; 61% tal-pazjenti kienu bojod, 8% kienu suwed/Afrikani
English: Based on population pharmacokinetic analysis of 944 renal transplant patients up to 1 year posttransplant, the pharmacokinetics of belatacept were similar at different time periods post-transplant.
Maltese: Fuq il-bażi tal-analiżi farmakokinetika tal-popolazzjoni ta' 944 pazjent li għamlu trapjant tal-kliewi sa sena wara t-trapjant, il-farmakokinetiċi ta' belatacept kienet simili f'perijodi taż-żmien differenti wara t-trapjant.