FrancophonIA/ELRC3.0 huggingface dataset:
English: Consult your doctor WHILE using Effentora if:
Maltese: Ikkonsulta lit-tabib tiegħek WAQT li tkun qed tuża Effentora jekk:
English: Muscle twitching Muscular weakness
Maltese: Kontrazzjonijiet tal-muskoli
English: Effentora should be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet which usually takes approximately 14-25 minutes.
Maltese: Effentora għandu jitpoġġa u jinżamm fil-kavità tal-ħalq għall-perjodu suffiċjenti biex issir id disintegrazzjoni tal-pillola li s-soltu tieħu madwar 14-25 minuta.
English: Patients receiving Effentora concomitantly with moderate or strong CYP3A4 inhibitors should be carefully monitored for an extended period of time.
Maltese: Pazjenti li qed jirċeivu Effentora flimkien ma' inibituri moderati jew qawwija ta' CYP3A4 għandhom jiġu sorveljati b'attenzjoni għal perjodu mtawwal ta' żmien.
English: Concentrate and solvent for solution for infusion
Maltese: Konċentrat għal soluzzjoni għallinfużjoni
English: London, 24 May 2007 Doc.
Maltese: Londra, l-24 ta' Mejju 2007 Ref. tad-Dok.
English: Ref. EMEA/195786/2007
Maltese: EMEA/253865/2007
English: International non-proprietary name (INN): hyaluronidase (ovine)
Maltese: Mhux Patentat (INN): hyaluronidase (ovine)
English: What is Vitragan?
Maltese: X'inhu Vitragan?
English: Vitragan is a powder containing the active substance hyaluronidase (ovine).
Maltese: Vitragan hu trab bis-sustanza attiva hyaluronidase (ovine).
English: How far into the evaluation was the application when it was withdrawn?
Maltese: Sa fejn kienet waslet l-evalwazzjoni ta' l-applikazzjoni meta din ġiet irtirata?
English: The active substance in Vitragan, hyaluronidase (ovine), is an enzyme extracted from sheep.
Maltese: Is-sustanza attiva f'Vitragan, hyaluronidase (ovine), hu enzim estratt min-nagħaġ.
English: On 25 April 2007, ISTA Pharma Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vitragan, for the treatment of vitreous haemorrhage.
Maltese: Fil-25 ta' April 2007, ISTA Pharma Limited uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Vitragan, għat-trattament ta' emorraġiji vitrużi.
English: Vitragan was expected to be used to treat vitreous haemorrhage (bleeding into the vitreous humour, the jelly-like fluid in the central chamber of the eye) in adults.
Maltese: Vitragan kellu jintuża fit-trattament ta' emorraġiji vitrużi (fil-fluwidu vitruż, il-fluwidu li jixbah iljelly fil-kompartament ċentrali tal-għajn) fl-adulti.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Skond analiżi taddokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-120 jum, u jibgħathom lillkumpanija.
English: The company also presented the results of two main studies involving 1,306 patients with vitreous haemorrhage, where the effects of a single injection of Vitragan were compared with those of placebo (a dummy treatment).
Maltese: Il-kumpanija ppreżentat ukoll ir-riżultati ta' żewġ studji li fihom ħadu sehem 1,306 pazjenti b'emorraġija vitruża, fejn l-effetti ta' injezzjoni waħda ta' Vitragan tqabblu ma' dawk ta' plaċebo (trattament finta).
English: The effects of Vitragan were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Vitragan għall-ewwel ġew ittestjati f'mudelli esperimentali qabel ma ġew studjati filbnedmin.
English: It is expected to work by breaking down a molecule in the vitreous humour called hyaluronic acid.
Maltese: Mistenni jaħdem billi jkisser molekolu fil-fluwidu vitruż magħruf bħala hyaluronic acid.
English: What was Vitragan expected to be used for?
Maltese: Kif hu mistenni li jaħdem Vitragan?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vitragan could not have been approved for the treatment of vitreous haemorrhage.
Maltese: Skond l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li Vitragan ma setax jiġi approvat għattrattament ta' l-emorraġija vitruża.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: Ladarba l-kumpanija tkun tat it-tweġibiet għall-mistoqsijiet, is-CHMP janalizzahom u jista', qabel ma jagħti opinjoni, jistaqsi xi mistoqsijiet oħra fil-180 jum.
English: This was expected to allow phagocytes (specialised ‘scavenger' cells of the immune system) to clear away any blood clots from the vitreous humour.
Maltese: Dan kien mistenni jippermetti lill-fagoċiti (ċelloli speċjalizzati tassistema immunitajra) jneħħu kull traċċi ta' demm magħqud mill-fluwidu vitruż.
English: MA (EU) number (Invented) name Strength Pharmaceutical
Maltese: Il-pakkett li jmiss malprodott
English: The active substance is belatacept.
Maltese: Is-sustanza attiva hi belatacept.
English: Up to Year 3*,**
Maltese: Sa Sena 3*,**
English: (see section 4.8).
Maltese: (ara sezzjoni 4.8).
English: Dublin 15 - Ireland
Maltese: Dublin 15 - L-Irlanda
English: Day 5, Day 14 and Day 28
Maltese: Jum 5, Jum 14 u Jum 28
English: Contrada Fontana del Ceraso 03012 Anagni (FR) - Italy
Maltese: Contrada Fontana del Ceraso 03012 Anagni (FR) - L-Italja
English: Contrada Fontana del Ceraso I-03012 Anagni-Frosinone Italy
Maltese: Contrada Fontana del Ceraso I-03012 Anagni-Frosinone L-Italja
English: 2 vials 2 syringes
Maltese: 2 kunjetti 2 siringi
English: Up to Year 3*
Maltese: Sa Sena 3*
English: Two amino acid substitutions (L104 to E; A29 to Y) were made in the ligand binding region of CTLA-4.
Maltese: Saru żewġ sostituzzjonijiet tal-amino acid (L104 għal E; A29 għal Y) fil-ligand binding region ta' CTLA-4.
English: 1 vial 1 syringe
Maltese: 1 kunjett 1 siringa
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 June 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Ġunju, 2011
English: Belatacept has not been studied in patients with PRA > 30% (see section 4.2).
Maltese: Belatacept ma ġiex studjat f'pazjenti bi PRA > 30% (ara sezzjoni 4.2).
English: Tel: +385 1 2078 508
Maltese: s r.o. Tel: +385 1 2078 508
English: The frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100).
Maltese: Il-kategoriji tal-frekwenza huma ddefiniti kif ġej: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100).
English: Study 2: extended criteria donors
Maltese: Studju 2: donaturi skont kriterji estiżi
English: Belatacept is a fusion protein that is not expected to be metabolised by the cytochrome P450 enzymes (CYPs) and UDP-glucuronosyltransferases (UGTs).
Maltese: Belatacept huwa proteina ta' fużjoni li mhijiex mistennija li tiġi mmetabolizzata bl-enzimi ta' ċitokrom P450 (CYPs) u UDP-glucuronosyltransferases (UGTs).
English: NULOJIX is supplied in a 20 ml vial (Type I flint glass) with a stopper (20 mm grey butyl rubber) and flip off seal (aluminum).
Maltese: NULOJIX jiġi f'kunjett ta' 20 ml (ħġieġ flint ta' Tip I) b'għatu (20 mm tal-lastiku butyl griż) u b'siġill flip off (aluminju).
English: Of the 6 PTLD cases in the LI regimen, 3 involved the CNS and were fatal.
Maltese: Mis-6 każijiet ta' PTLD fil-kors LI, 3 involvew is-CNS u kienu fatali.
English: Patient and Graft Survival (%) Year 1 [95% CI]
Maltese: Sopravivenza tal-Pazjent u talParti Ttrapjantata (%) Sena 1 [95% CI]
English: Up to Year 1
Maltese: Sa Sena 1
English: PML is a rare, often rapidly progressive and fatal, opportunistic infection of the CNS that is caused by the John Cunningham (JC) virus.
Maltese: PML hija infezzjoni opportunistika rari tas-CNS, li spiss tiżviluppa malajr u tkun fatali, li hija kkawżata mill-virus John Cunningham (JC).
English: Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - U.S.A.
Maltese: Thompson Road, East Syracuse New York 13057 - L-Istati Uniti tal-Amerika
English: A total of 45 of 847 patients (5.3%) developed antibodies during treatment with belatacept.
Maltese: Total ta' 45 minn 847 pazjent (5.3%) żviluppaw antikorpi matul il-kura b'belatacept.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1 (ara sezzjoni 4.4).
English: Single doses up to 20 mg/kg have been administered without apparent toxic effect.
Maltese: Ingħataw dożi singoli sa 20 mg/kg bla ebda effett tossiku apparenti.
English: At Month 1, 4, and 6 post-transplant, the mean (range) trough concentrations of belatacept were 22.7 (11.1-45.2), 7.6 (2.1-18.0), and 4.0 (1.5-6.6) μg/ml, respectively.
Maltese: Fix-Xahar 1, 4 u 6 wara t-trapjant, l-inqas konċentrazzjonijiet medji (medda) ta' belatacept kienu ta' 22.7 (11.1-45.2), 7.6 (2.1-18.0), u 4.0 (1.5-6.6) μg/ml, rispettivament.
English: For a list of symptoms please see section 4, “Possible side effects”.
Maltese: Għal lista ta' sintomi, jekk jogħġbok ara sezzjoni 4, “Effetti sekondarji li jista' jkollu”.
English: Belatacept has less activity in rodents than abatacept, a fusion protein that differs from belatacept by two amino acids in the CD80/86 binding domains.
Maltese: Belatacept għandu inqas attività f'annimali gerriema minn abatacept, proteina ta' fużjoni li tvarja minn belatacept b'żewġ amino acids fil-binding domains CD80/86.
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, sodium chloride, and for pH adjustment sodium hydroxide and hydrochloric acid.
Maltese: Eċċipjenti: sucrose, sodium dihydrogen phosphate monohydrate, sodium chloride, u għallaġġustament tal-pH sodium hydroxide u hydrochloric acid.
English: In both studies, in patients with AR by Year 2, donor-specific antibodies, one of the criteria for diagnosis of antibody-mediated rejection, were present in 6% (2/32, Study 2)-8% (3/39, Study 1) and 20% (4/20, Study 1)-26% (7/27, Study 2) in the belatacept and ciclosporin groups by year 3, respectively.
Maltese: Fiż-żewġ studji, fil-pazjenti b'AR sa Sena 2, antikorpi speċifiċi għad-donatur, li huwa wieħed mill-kriterji għad-dijanjosi ta' rifjut medjat mill-antikorpi, kienu preżenti f'6% (2/32, Studju 2), 8% (3/39, Studju 1) u 20% (4/20, Studju 1), 26% (7/27, Studju 2) fil-gruppi li ħadu belatacept u ciclosporin sas-sena 3, rispettivament.
English: Belatacept binds to CD80 and CD86 on antigen presenting cells.
Maltese: Belatacept jeħel ma' CD80 u CD86 fuq ċelluli li jippreżentaw antiġens.
English: Belatacept has not been studied in patients with Panel Reactive Antibody (PRA) > 30% (who often require increased immunosuppression).
Maltese: Belatacept ma ġiex studjat f'pazjenti b'Panel Reactive Antibody (PRA) > 30% (li spiss jeħtieġu wkoll immunosuppressjoni).
English: (See section 2)
Maltese: (Ara sezzjoni 2).
English: Common cytolytic hepatitis, liver function test abnormal
Maltese: Komuni epatite ċitolitika, test tal-funzjoni tal-fwied abnormali
English: At Year 3, the incidence of NODM was 8% with belatacept and 10% with ciclosporin.
Maltese: F'Sena 3, l-inċidenza ta' NODM kienet ta' 8% b'belatacept u ta' 10% b'ciclosporin.
English: The median age was 58 years; 67% of the study population was male; 75% of patients were white, 13% were black/African-American, 12% were categorised as of other races; 3% had PRA  10%; and 53% had 4 to 6 HLA mismatches.
Maltese: L-età medjana kienet 58 sena; 67% tal-popolazzjoni tal-istudju kienu rġiel; 75% tal-pazjenti kienu bojod, 13% kienu suwed/AfrikaniAmerikani, 12% kienu kkaratterizzati bħala ta' razez oħrajn; 3% kellhom PRA  10%; u 53% kellhom 4 sa 6 nuqqas ta' taqbil ta' HLA.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001-002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/694/001-002
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA28.
Maltese: Immunosuppressanti, immunosuppressanti selettivi, Kodiċi ATC:
English: Belatacept, a selective costimulation blocker, is a soluble fusion protein consisting of a modified extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) fused to a portion (hinge-CH2-CH3 domains) of the Fc domain of a human immunoglobulin G1 antibody.
Maltese: Belatacept, imblokkatur selettiv ta' kostimulazzjoni, huwa proteina ta' fużjoni li tinħall li tikkonsisti minn parti extraċellulari modifikat tal-antiġen ċitotossiku uman assoċjat mal-limfoċit-T (CTLA-4) imwaħħal ma' porzjon (hinge-CH2-CH3 domains) tad-domain Fc ta' antikorp uman talimmunoglobulina
English: Infections and infestations Serious infections Viral infections
Maltese: Infezzjonijiet u infestazzjonijiet Infezzjonijiet serji Infezzjonijiet virali
English: As compared to ciclosporin and assessed by the hazard ratio (HR) estimates (for death or graft loss) from an ad hoc Cox regression analysis, overall patient and graft survival was higher for belatacepttreated patients in Study 1, HR 0.588 (95% CI: 0.356-0.972) for the MI group and HR 0.585 (95% CI: 0.356-0.961) for the LI group, and comparable across treatment groups in Study 2, HR 0.932 (95% CI: 0.635-1.367) for the MI group and HR 0.944 (95% CI: 0.644-1.383) for the LI group.
Maltese: Meta mqabbla ma' ciclosporin u vvalutata bl-estimi tal-proporzjon tal-periklu (HR, hazard ratio) (għal mewt jew telf ta' graft) minn analiżi tar-rigressjoni Cox ad hoc, is-sopravivenza totali tal-pazjent u talgraft kienet ogħla għal pazjenti kkurati b'belatacept fi Studju 1, HR 0.588 (95% CI: 0.356-0.972) għall-grupp MI u HR 0.585 (95% CI: 0.356-0.961) għall-grupp LI u komparabbli tul il-gruppi ta' kura fi Studju 2, HR 0.932 (95% CI: 0.
English: The higher proportion of deaths in the LI group in Study 2 was mainly due to neoplasms (MI: 3.8%, LI: 7.1%, ciclosporin: 2.3%).
Maltese: Il-proporzjon ogħla ta' mwiet fil-grupp LI fi Studju 2 kien prinċipalment dovut għal neoplasmi (MI: 3.8%, LI: 7.1%, ciclosporin:
English: It is important that you read the entire PL for more information.
Maltese: Huwa importanti li taqra l-PL kollu għal aktar informazzjoni.
English: Mean Calculated GFRc ml/min/1.73 m2 Month 1 Year 1 Year 2 Year 3
Maltese: GFR Ikkalkulata Medjac ml/min/1.73 m2 Xahar 1 Sena 1 Sena 2 Sena 3
English: Date of latest renewal: 18 February 2016
Maltese: Data tal-aħħar tiġdid: 18 ta' Frar 2016
English: Nulojix is normally given with steroids.
Maltese: Nulojix normalment jingħata ma' sterojdi.
English: In this study, 666 patients were enrolled, randomised, and transplanted; 219 to belatacept MI, 226 to belatacept LI, and 221 to ciclosporin.
Maltese: F'dan l-istudju li fih il-pazjenti ntgħażlu b'mod każwali, ġew irreġistrati u ttrapjantati 666 pazjent; 219 għal belatacept MI, 226 għal belatacept LI, u 221 għal ciclosporin.
English: Each vial contains 250 mg belatacept.
Maltese: Kull kunjett fih 250 mg ta' belatacept.
English: Pack sizes: 1 vial and 1 syringe or 2 vials and 2 syringes.
Maltese: Daqsijiet tal-pakkett: 1 kunjett u 1 siringa jew 2 kunjetti u 2 siringi.
English: It is used with other immunosuppressive medicines, including mycophenolic acid and corticosteroids.
Maltese: Jintuża flimkien ma' mediċini immunosuppressivi oħrajn, fosthom mycophenolic acid u kortikosterojdi.
English: Year 3 [95% CI] Death (%) Year 1 Year 3 Graft Loss (%) Year 1 Year 3 % of Patients meeting Composite renal impairment endpoint at
Maltese: Sena 3 [95% CI] Mewt (%) Sena 1 Sena 3 Telf tal-Parti Ttrapjantata (%) Sena 1 Sena 3 % ta' Pazjenti li jissodisfaw ilPunt tat-tmiem tal-indeboliment kompost tal-kliewi wara
English: Abnormal collection of fluid
Maltese: Ġbir anormali ta' fluwidu
English: In this study, 543 patients were enrolled, randomised, and transplanted; 184 to belatacept MI, 175 to belatacept LI, and 184 to ciclosporin.
Maltese: F'dan l-istudju li fih il-pazjenti ntgħażlu b'mod każwali, ġew irreġistrati u ttrapjantati 543 pazjent; 184 għal belatacept MI, 175 għal belatacept LI, u 184 għal ciclosporin.
English: By Year 3 recurrent AR was similar across groups (< 3%) and subclinical AR identified on the 1 year protocol biopsy was 5% in both groups.
Maltese: Sa Sena 3, l-AR rikorrenti kien simili bejn il-gruppi (< 3%) u l-AR subkliniku identifikat fil-bijopsija tal-protokoll ta' sena kien 5% fiż-żewġ gruppi.
English: Uncommon hypophosphatasia
Maltese: Mhux Komuni ipofosfatasja
English: Most events were not serious, were mild to moderate in intensity, and did not recur.
Maltese: Ħafna mill-avvenimenti ma kinux serji, iżda kienu ta' intensità moderata u ma reġgħux seħħew.
English: In 153 patients assessed for antibodies at least 56 days (approximately 7 half-lives) after discontinuation of belatacept, an additional 10 (6.5%) developed antibodies.
Maltese: F'153 pazjent evalwati għall-antikorpi, mill-inqas 56 jum (madwar 7 half-lives) wara ttwaqqif ta' belatacept, 10 addizzjonali (6.5%) żviluppaw antikorpi.
English: In Study 1, in the MI, LI, and ciclosporin groups, respectively, death occurred in 7.8%, 7.5%, and 11.3% of patients, and graft loss occurred in 4.6%, 4.9%, and 7.7% of patients.
Maltese: MI, LI, u ciclosporin, rispettivament, il-mewt seħħet f'7.8 %, 7.5 %, u 11.3 % tal-pazjenti, u t-telf tal-parti seħħet f'4.6 %, 4.9 %, u 7.7 % tal-pazjenti.
English: There was one case of PML reported (Study 1) in the ciclosporin group at 82 months post-transplant (more than 56 days after discontinuing therapy).
Maltese: Kien hemm każ wieħed ta' PML irrappurtat (Studju 1) fil-grupp ta' ciclosporin wara 82 xahar wara t-trapjant (aktar minn 56 jum wara t-twaqqif tat-terapija).
English: The overall proportion of patients with death or graft loss was comparable across treatment groups (29.3%, 30.9%, and 28.3% for MI, LI and ciclosporin, respectively) in Study 2.
Maltese: Il-popolazzjoni globali ta' pazjenti b'mewt jew telf tal-parti kienet komparabbli fost il-gruppi ta' kura (29.3 %, 30.9 %, u 28.3 % għal MI, LI u ciclosporin, rispettivament) fi Studju 2.
English: Corticosteroid tapering in patients taking belatacept should be implemented cautiously, particularly in patients with 4 to 6 human leukocyte antigen (HLA) mismatches (see sections 4.4 and 5.1)
Maltese: It-tnaqqis gradwali tal-kortikosterojdi f'pazjenti li jkunu qed jieħdu belatacept għandu jiġi implimentat b'attenzjoni, partikularment f'pazjenti b'4 sa 6 nuqqasijiet ta' qbil ta' antiġen tallewkoċiti umani (HLA - human leukocyte antigen) (ara sezzjonijiet 4.4 u 5.1).
English: Within the belatacept clinical program, there were 2 patients diagnosed with PML.
Maltese: Fi ħdan il-programm kliniku ta' belatacept, kien hemm 2 pazjenti ddijanjostikati b'PML.
English: The occurrence of autoimmune events across the core clinical studies was infrequent, occurring at rates of 1.7%, 1.7%, and 1.9% by Year 3 for the MI, LI, and ciclosporin groups respectively.
Maltese: L-okkorrenza ta' avveniment ta' awtoimmunità tul l-istudji kliniċi ewlenin ma kinitx frekwenti; din seħħet b'rati ta' 1.7%, 1.7%, u 1.9% sa Sena 3 għall-MI, LI, u gruppi ta' ciclosporin rispettivament.
English: In Study 2, in the MI, LI, and ciclosporin groups, respectively, death occurred in 20.1%, 21.1%, and 15.8% of patients, and graft loss occurred in 11.4%, 13.1%, and 15.8% of patients.
Maltese: MI, LI, u ciclosporin, rispettivament, il-mewt seħħet f'20.1 %, 21.1 %, u 15.8 % tal-pazjenti, u t-telf tal-parti seħħet f'11.4 %, 13.1 %, u 15.
English: The mean (range) pharmacokinetic parameters of belatacept after multiple intravenous infusions at doses of 5 and 10 mg/kg in renal transplant subjects were: terminal half-life, 8.2 (3.1-11.9) and 9.8 (6.1-15.1) days, respectively; systemic clearance 0.51 (0.33-0.75) and 0.49 (0.23-0.70) ml/h/kg, respectively; and distribution volume at steady state, 0.12 (0.09-0.17) and 0.11 (0.067-0.17) l/kg, respectively.
Maltese: Il-parametri farmakokinetiċi medji (medda) ta' belatacept wara diversi infużjonijiet fil-vini b'dożi ta' 5 u 10 mg/kg f'individwi li għamlu trapjant tal-kliewi kienu: half-life terminali, 8.2 (3.1-11.9) u 9.8 (6.1-15.1) jiem, rispettivament; tneħħija sistemika 0.51 (0.33-0.75) u 0.
English: Belatacept, a modified form of CTLA4-Ig, binds CD80 and CD86 more avidly than the parent CTLA4-Ig molecule from which it is derived.
Maltese: Belatacept, li huwa forma modifikata ta' CTLA4-Ig, iwaħħal CD80 u CD86 aktar malajr millmolekula CTLA4-Ig prinċipali li minnha huwa derivat.
English: How to store NULOJIX 6.
Maltese: Kif taħżen NULOJIX 6.
English: Table 2: Adverse reactions in clinical trials Infections and infestations Very Common urinary tract infection, upper respiratory infection, cytomegalovirus infection*, bronchitis
Maltese: Tabella 2: Reazzjonijiet avversi fi provi kliniċi Infezzjonijiet u infestazzjonijiet Komuni Ħafna infezzjoni fil-passaġġ tal-awrina, infezzjoni fil-parti ta' fuq tal-apparat respiratorju, infezzjoni b'cytomegalovirus*, bronkite
English: Cardiac disorders Common tachycardia, bradycardia, atrial fibrillation, cardiac failure, angina pectoris, left ventricular hypertrophy
Maltese: Disturbi fil-qalb Komuni takikardija, bradikardija, fibrillazzjoni atrijali, indeboliment kardijaku, anġina pektoris, ipertrofija ventrikulari tax-xellug
English: Infections involving the CNS were more frequent in the belatacept MI group (8 cases, including the PML case discussed above; 1.7%) than the belatacept LI (2 cases, 0.4%) and ciclosporin (one case; 0.2%) groups.
Maltese: Infezzjonijiet li jinvolvu s-CNS kienu aktar frekwenti fil-grupp ta' belatacept MI (8 każijiet, inkluż ilkaż ta' PML diskuss hawn fuq; 1.7%) minn fil-gruppi ta' belatacept LI (2 każijiet, 0.4%) u l-grupp ta' ciclosporin (każ wieħed; 0.2%).
English: Uncommon acute coronary syndrome, atrioventricular block second degree, aortic valve disease, arrhythmia supraventricular
Maltese: Mhux Komuni sindromu koronarju akut, imblokk atrijoventrikulari tat-tieni grad, mard tal-valv tal-aorta, arritmija supraventrikulari
English: Use of immunosuppressants, including belatacept, can increase susceptibility to infection, including fatal infections, opportunistic infections, tuberculosis, and herpes (see progressive multifocal leukoencephalopathy (PML) warning below and also section 4.8).
Maltese: L-użu ta' immunosuppressanti, inkluż belatacept, jista' jżid is-suxxettibbiltà għal infezzjoni, inklużi infezzjonijiet fatali, infezzjonijiet opportunistiċi, tuberkulożi u herpes (ara t-twissija dwar lewkoenċefalopatija multifokali progressiva (PML) hawn taħt u ara wkoll sezzjoni 4.8).
English: Efficacy was similar between MI and LI while the overall safety profile was better for the LI.
Maltese: L-effikaċja kienet simili bejn MI u LI filwaqt li l-profil ġenerali tas-sigurtà kien aħjar għal LI.
English: All patients received basiliximab, MMF, and corticosteroids.
Maltese: Il-pazjenti kollha rċivew basiliximab, MMF, u kortikosterojdi.
English: Inflammation of the stomach and intestines, usually caused by a virus Upset stomach
Maltese: Infjammazzjoni tal-istonku u tal-intestini, normalment ikkawżata minn virus Stonku mqalleb
English: A total of 321 belatacept (MI: 155 and LI: 166) and 136 ciclosporin patients completed 3 years of treatment in Study 1 and entered the 4-year long-term open label extension period (up to 7 years in total).
Maltese: Total ta' 321 pazjent fuq belatacept (MI: 155 u LI: 166) u 136 pazjent fuq ciclosporin temmew 3 snin ta' kura fi Studju 1 u daħlu fil-perjodu ta' estensjoni bit-tikketta mikxufa ta' 4 snin (massimu ta' 7 snin b'kollox).
English: Make up each vial with 10.5 ml reconstitution solution.
Maltese: Ħallat kull kunjett b'10.5 ml ta' soluzzjoni għar-rikostituzzjoni.
English: Unopened vials 3 years
Maltese: Kunjetti mhux miftuħin 3 snin
English: End of Week 8 and Week 12 after transplantation Maintenance Phase
Maltese: Tmiem ta' Ġimgħa 8 u Ġimgħa 12 wara trapjant Fażi ta' Manteniment
English: PTLD
Maltese: Tilqim