FrancophonIA/ELRC3.0 huggingface dataset:
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebocontrolled, dose-response study.
Maltese: Kura ta' induzzjoni fil-marda ta' Crohn attiva b'mod moderat sa qawwi L-effikaċja ta' kura b'doża waħda ta' infliximab kien evalwat f'108 pazjenti bil-marda ta'Crohn attiva (Indiċi ta' Attività tal-marda ta' Crohn (CDAI) ≥ 220 ≤ 400) fi studju li fih il-parteċipanti ntgħażlu b'mod każwali, double-blinded, ikkontrollat bi plaċebo u li juri rispons għad-doża.
English: For storage conditions up to 25°C before reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna f'temperatura sa 25°C wara r-rikostituzzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: How to store Flixabi
Maltese: X'fih Flixabi
English: Autoantibody positive.
Maltese: Awto-antikorpi pożittivi.
English: • Merkel cell carcinoma (a type of skin cancer)
Maltese: • Karċinoma taċ-ċellula ta' Merkel (tip ta' kanċer tal-ġilda).
English: Immune system disorders
Maltese: Disturb fis-sistema immuni
English: Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24 and 50.
Maltese: Tabella 10 Sommarju tar-rispons PASI, rispons PGA u perċentwali tal-pazjenti li fiequlhom difrejhom kollha f'ġimgħat 10, 24 u 50.
English: In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF
Maltese: F'ACT 1 u ACT 2, infliximab tejjeb il-kwalità tal-ħajja, u dan ġie kkonfermat b'titjib statistikament sinifikanti kemm f'kejl speċifiku għall-marda, IBDQ, kif ukoll f'titjib fi stħarriġ qasir ġeneriku SF-36 b'36 mistoqsija.
English: • It is very important that you tell your doctor if you have ever had tuberculosis (TB), or if you have been in close contact with someone who has had TB.
Maltese: • Huwa importanti ħafna li tgħid lit-tabib tiegħek jekk qattx kellek tuberkolożi (TB), jew jekk kellek kuntatt mill-qrib ma' xi ħadd li kellu t-TB.
English: Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses.
Maltese: Fattur alfa tan-necrożi tat-tumur (TNFα) jikkontrolla l-infjammazzjoni u jimmodula ir-rispons immuni taċ-ċelluli.
English: Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukaemia, melanoma, cervical cancer.
Maltese: Limfoma, limfoma mhux ta' Hodgkin, marda ta' Hodgkin, lewkimja, melanoma, kanċer tal-għonq tal-utru.
English: Efficacy and safety were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
Maltese: L-effikaċja u s-sigurtà kienu evalwati f'żewġ studji multiċentriċi, double-blind, ikkontrollati bi plaċebo f'pazjenti b'artrite psorijatika attiva.
English: For patients receiving corticosteroids at baseline, the proportion of patients in remission and not receiving corticosteroids at week 54 was 38.5% (5/13) for the q8 week and 0% (0/13) for the q12 week maintenance treatment group.
Maltese: Għall-pazjenti li kienu qed jirċievu kortikosterojdi fil-linja bażi, il-proporzjon ta' pazjenti fi tnaqqis u li ma kinux qed jirċievu kortikosterojdi f'ġimgħa 54 kien ta' 38.5% (5/13) fil-grupp ta' kura ta' manteniment ta' q8 ġimgħat u 0% (0/13) fil-grupp ta' kura ta' manteniment ta' q12-il ġimgħa.
English: The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Maltese: In-nuqqas relattiv ta' TNFα ikkawżat minn terapija kontra TNF jista' jirriżulta għall-bidu ta' proċess awtoimmuni.
English: Write the new expiry date on the carton including day/month/year.
Maltese: Ikteb id-data ta' skadenza ġdida fuq il-kartuna, u inkludi ljum/xahar/sena.
English: Hepatobiliary disorders Common:
Maltese: Disturbi vaskulari Komuni:
English: There were 95 subjects from group 2 who continued on 5 mg/kg every 6 weeks.
Maltese: Kien hemm 95 individwu minn grupp 2 li komplew fuq il5 mg/kg kull 6 ġimgħat.
English: Sixty eight percent (21/31) of infliximab-treated patients receiving a 5 mg/kg dose regimen achieved a clinical response vs. 26% (8/31) placebo-treated patients (p=0.002).
Maltese: Tmienja u sittin fil-mija (21/31) tal-pazjenti li ngħataw infliximab b'kors b'doża ta' 5 mg/kg kellhom reazzjoni klinika kontra 26% (8/31) tal-pazjenti li ngħataw plaċebo (p=0.002).
English: Table 1 Undesirable effects in clinical studies and from post-marketing experience Infections and infestations Very Common:
Maltese: Tabella 1 Effetti mhux mixtieqa fi studji kliniċi u mill-esperjenza ta' wara t-tqegħid fis-suq Infezzjonijiet u infestazzjonijiet Komuni ħafna:
English: In rheumatoid arthritis clinical studies, the incidence of serious infections was greater in infliximab plus methotrexate-treated patients 65 years and older (11.3%) than in those under 65 years of age (4.6%).
Maltese: Fi studji kliniċi dwar artrite rewmatojde, l-inċidenza ta' infezzjonijiet serji kienet akbar f'pazjenti ta' 65 sena u akbar ikkurati b'infliximab flimkien ma' methotrexate (11.3%) minn f'dawk taħt il-65 sena (4.6%).
English: In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
Maltese: F'individwi kkurati b'infliximab, risponsi sinifikanti PASI 50 kienu evidenti malewwel żjara (ġimgħa 2) u rispons PASI 75 mat-tieni żjara (ġimgħa 6).
English: Intravenous use <IV>
Maltese: Użu għal ġol-vini <IV>
English: Flixabi is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Maltese: Flixabi jintuża għal kura tal-marda ta' Crohn attiva, severa fi tfal u adoloxxenti ta' etajiet bejn 6 sa 17-il sena, li ma kellhomx rispons għat-terapija konvenzjonali inklużi kortikosterojd, immunomodulatur u terapija ta' nutrizzjoni primarja, jew li huma intolleranti jew għandhom kontra-indikazzjonijiet għal dawn it-tipi ta' terapiji.
English: At 38 weeks, 9 of 101 patients treated with infliximab (2 at 5 mg/kg and 7 at 10 mg/kg) died compared to one death among the 49 patients on placebo.
Maltese: Wara 38 ġimgħa, 9 minn 101 pazjent li ngħataw infliximab (2 b'5 mg/kg u 7 b'10 mg/kg) mietu meta mqabbel ma' mewt waħda fost id-49 pazjent fuq plaċebo.
English: • Infection due to a live vaccine because of a weakened immune system.
Maltese: • Infezzjoni minn -tilqima ħajja minħabba sistema immuni mdgħajfa.
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
Maltese: Fiż-żewġ studji, l-użu flistess ħin ta' dożi stabbli ta' folic acid, kortikosterojdi orali (≤ 10 mg/jum) u/jew mediċini antiinfjammatorji mhux sterojdi (NSAIDs) ġie permess.
English: Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Maltese: Mard tal-interstizju tal-pulmun (inkluż mard li javvanza malajr, fibrożi fil-pulmun u pnewmonite).
English: In psoriatic arthritis patients who received 5 mg/kg with and without methotrexate, antibodies occurred overall in 15% of patients (antibodies occurred in 4% of patients receiving methotrexate and in 26% of patients not receiving methotrexate at baseline).
Maltese: F'pazjenti b'artrite psorijatika li rċevew 5 mg/kg b'methotrexate jew mingħajru, fi 15% talpazjenti seħħew antikorpi (l-antikorpi seħħew iffurmaw f'4% tal-pazjenti li rċevew methotrexate u f'26% tal-pazjenti li ma kinux qed jirċievu methotrexate fil-linja bażi).
English: Conjunctivitis.
Maltese: rispettivament.
English: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adult males with Crohn's disease or ulcerative colitis), Merkel cell carcinoma.
Maltese: Limfoma fil-fwied u fil-marrara taċ-ċelluli T (l-aktar f'adolexxenti u rġiel adulti żgħażagħ bil-marda ta' Crohn jew kolite ulċerattiva), karċinoma taċ-ċellula ta' Merkel.
English: Therefore, the combination of Flixabi and anakinra is not recommended.
Maltese: Għalhekk, il-kombinazzjoni ta' Flixabi u anakinra mhijiex rakkomandata.
English: • Swollen lymph nodes
Maltese: • Għoqiedi tal-limfa minfuħin
English: Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fissezzjonijiet 4.8 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: In REACH, 17.5% of randomised patients experienced 1 or more infusion reactions.
Maltese: F'REACH, 17.5% tal-pazjenti li ntgħażlu b'mod każwali ħassew 1 jew aktar reazzjonijiet tal-infużjoni.
English: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Maltese: Infezzjoni tan-naħa ta' isfel tal-passaġġ respiratorju (eż. bronkite, pulmonite), qtugħ ta' nifs, epistassi.
English: Flixabi should be used with caution in patients with mild heart failure (NYHA class I/II).
Maltese: Flixabi għandu jintuża b'attenzjoni f'pazjenti b'insuffiċjenza ħafifa tal-qalb (NYHA klassi I/II).
English: • Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems
Maltese: • Sinjali ta' problema fis-sistema nervuża (inklużi problemi fl-għajnejn) bħal sinjali ta' puplesija (tnemnim jew dgħufija f'daqqa waħda fil-wiċċ, fi driegħ jew riġel, speċjalment fuq naħa waħda ta' ġismek; konfużjoni f'daqqa waħda, diffikultà biex titkellem jew tifhem; diffikultà biex tara minn għajn waħda jew miż-żewġ għajnejn, diffikultà biex timxi, sturdament, telf talbilanċ jew tal-koordinazzjoni jew uġigħ ta' ras qawwi), aċċessjonijiet, tingiż/tnemnim fi kwalunkwe parti ta' ġismek, jew dgħjufija fid-dirgħajn jew fir-riġlejn, tibdil fil-vista bħal meta tara doppju jew problemi oħra tal-għajnejn
English: Table 5 Effects on response and remission rate, data from ACCENT I (week-2 responders)
Maltese: Tabella 5 Effetti fuq ir-rispons u r-rata ta' tnaqqis, dejta minn ACCENT I (persuni li rrispondew sa ġimgħa 2) ACCENT I (persuni li rrispondew ta' ġimgħa 2) % ta' Pazjenti
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including infliximab in the post-marketing setting.
Maltese: Tumuri malinni, xi wħud fatali, kienu rrappurtati fost tfal, adolexxenti u adulti żgħażagħ (sa 22 sena) ikkurati b'sustanzi li jimblokkaw it-TNF (bidu tat-terapija ≤ 18-il sena), inkluż infliximab fi sfond ta' wara t-tqegħid fis-suq.
English: Flixabi will be stored by the health professionals at the hospital or clinic.
Maltese: Flixabi ser jinħażen minn professjonisti fil-qasam tal-kura tas-saħħa ġol-isptar jew ġo klinika.
English: Flixabi 100 mg powder for concentrate for solution for infusion infliximab
Maltese: Flixabi 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni infliximab
English: Mean ± SDd a p < 0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
Maltese: a p < 0.001, għal kull grupp ta' kura b'infliximab vs il-kontroll.
English: Flixabi is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Maltese: Flixabi hu indikat għall-kura ta' kolite ulċerattiva attiva ħafna fi tfal u adolexxenti li għandhom minn 6 sa 17-il sena, li kellhom rispons mhux adegwat għal terapija konvenzjonali inkluż kortikosterojdi u
English: Powder for concentrate for solution for infusion 1 vial
Maltese: Trab għal konċentrat għal soluzzjoni għall-infużjoni 1 kunjett
English: Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1).
Maltese: Infliximab intwera li jtejjeb il-funzjoni fiżika f'pazjenti b'artrite psorijatika, u li jnaqqas ir-rata li bih tavvanza l-ħsara periferali fil-ġogi hekk kif imkejla bl-X-ray f'pazjenti b'sottotipi poliartikulari simmetriċi tal-marda (ara sezzjoni 5.1).
English: Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Maltese: Reazzjoni anafilattika, sindrome bħal tal-lupus, marda tas-serum jew reazzjoni bħal marda tas-serum.
English: Hepatic function abnormal, transaminases increased.
Maltese: Funzjoni mhux normali tal-fwied, żieda fit-transaminases.
English: Fistulising Crohn's disease
Maltese: Marda ta' Crohn fistulanti
English: Starting at week 16, placebo patients were switched to infliximab and all patients subsequently received 5 mg/kg infliximab every 8 weeks up to week 46.
Maltese: F'ġimgħa 16, ilpazjenti fuq plaċebo nqalbu għal infliximab u minn hemm 'il quddiem ingħataw 5 mg/kg infliximab kull 8 ġimgħat sa ġimgħa 46.
English: 10 mg/kg q 8 wks
Maltese: 10 mg/k g q
English: p-value week 54
Maltese: Ir-riżultati tal-ġimgħa 54
English: c HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Maltese: HAQ =Kwestjonarju Dwar l-Evalwazzjoni tas-Saħħa; valuri ikbar jindikaw inqas diżabilità.
English: In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Maltese: F'wieħed mill-partijiet tal-istudji (grupp 2, n=329), pazjenti li ma kellhomx rispons adegwat kellhom id-dożi ttitrati b'inkrementi ta' 1.5 mg/kg minn 3 sa 9 mg/kg.
English: Infliximab + AZA Combination therapy
Maltese: Kura mħallta b'infliximab + AZA
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Maltese: • Xi pazjenti li kienu qed jirċievu infliximab żviluppaw sintomi ta' disturb fis-sistema immuni msejjaħ lupus.
English: Placebo
Maltese: • Puplesija
English: dry skin, fungal dermatitis, eczema, alopecia.
Maltese: Newtropenija, lewkopenija, anemija, limfadenopatija.
English: 2 Placebo patients in the 2 Phase III studies in Crohn's disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/kg infliximab at study start and were on placebo in the maintenance phase.
Maltese: III fil-marda ta' Crohn's, ACCENT I u ACCENT II, irċivew doża tal-bidu ta' 5 mg/kg infliximab fil-bidu tal-istudju u kienu fuq plaċebo fil-fażi ta' manteniment.
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients.
Maltese: Antikorpi antinukleari (ANA)/ antikorpi kontra double stranded DNA (dsDNA) Madwar nofs il-pazjenti li ngħataw infliximab fi studji kliniċi u li fil-bidu kienu negattivi għal ANA fillinja bażi żviluppaw ANA waqt l-istudju meta mqabbel ma' madwar wieħed minn kull ħames pazjenti li ġew ikkurati bi plaċebo.
English: Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Maltese: Każijiet ta' tumuri malinni, inkluż limfoma kienu wkoll irrappurtati fl-isfond ta' wara t-tqegħid fis-suq (ara sezzjoni 4.4).
English: Respiratory, thoracic and mediastinal disorders Very common:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Komuni ħafna:
English: Neutropenia, leucopenia, anaemia, lymphadenopathy.
Maltese: Epatite, ħsara epatoċellulari, koleċistite.
English: Nervous system disease
Maltese: Mard tas-sistema nervuża
English: Pregnancy and breast-feeding, and fertility
Maltese: Tqala u treddigħ u fertilità
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Flixabi cannot be excluded (see section 4.8).
Maltese: Riskju li tiżviluppa limfoma epatosplenika taċ-ċelluli T f'pazjenti kkurati b'Flixabi ma jistax jiġi eskluż (ara sezzjoni 4.8).
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Flixabi.
Maltese: Id-dilwizzjoni tista' ssir billi jinġibed volum tas-soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) mil-flixkun tal-ħġieġ jew borża tal-infużjoni ta' 250 ml li jkun daqs ilvolum ta' Flixabi rikostitwit.
English: In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Maltese: Fi Grupp 2, mis-36 ġimgħa, pazjenti li kellhom BASDAI ≥ 3 wara żewġ viżti konsekuttivi, irċevew 7.5 mg/kg infliximab kull 6 ġimgħat minn hemm 'il quddiem sa ġimgħa 96.
English: The combination of Flixabi with other biological therapeutics used to treat the same conditions as Flixabi, including anakinra and abatacept, is not recommended (see section 4.4).
Maltese: Il-kombinazzjoni ta' Flixabi ma' sustanzi bijoloġiċi terapewtiċi oħrajn li jintużaw biex jikkuraw l-istess kundizzjonijiet bħal Flixabi, inkluż anakinra u abatacept, mhix irrakkomandata (ara sezzjoni 4.4).
English: Uncommon: may affect up to1 in 100 people
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna 1 minn kull 100
English: Instructions for use and handling - storage conditions Store at 2°C - 8°C.
Maltese: Qabel ir-rikostituzzjoni: 4 snin f'temperatura ta' 2°C - 8°C.
English: Patients with ACR20 response/ Patients evaluated (%) Total scored (van der Heijde-modified Sharp score) Change from baseline (Mean ± SD
Maltese: Pazjenti b'reazzjoni ACR 20 / Pazjenti evalwati (%)
English: Combined
Maltese: Konġuntivite
English: The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Maltese: Il-proporzjon ta' pazjenti b'infezzjonijiet f'C0168T72 kien simili għal dak fl-istudju dwar il-marda ta' Crohn fit-tfal (REACH) iżda ogħla millproporzjon fl-istudji dwar kolite bl-ulċeri fl-adulti (ACT 1 u ACT 2).
English: a p < 0.001, for each infliximab treatment group vs. control b n = 292 c Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Maltese: F'ġimgħa 102 kien hemm 80 individwu li kienu għadhom fuq il-kura b'infliximab u fost dawk, 71 (89%) irrispondew għal ASAS 20.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind studies: SPIRIT and EXPRESS.
Maltese: L-effikaċja ta' infliximab kienet evalwata f'żewġ studji multiċentriċi, li fihom il-parteċipanti ntgħażlu b'mod każwali, double-blind: SPIRIT u EXPRESS.
English: At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
Maltese: Flaħħar stima li saret, 57% tal-pazjenti li kienu ngħataw infliximab baqgħu pożittivi għal kontra dsDNA.
English: Adult Crohn's disease Flixabi is indicated for:  treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Maltese: • kura tal-marda ta' Crohn attiva b'mod moderat sa qawwi, f'pazjenti adulti li ma kellhomx rispons minkejja kors sħiħ u adegwat ta' terapija b'kortikosterojdi u/jew immunosoppressant; jew li ma jittollerawx jew ma jistgħux jingħataw dawn it-terapiji għal raġunijiet mediċi.
English: This includes multiple sclerosis, Guillain-Barre syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Maltese: Dan jinkludi sklerożi multipla, sindrome Guillain-Barre, jekk ituk aċċessjonijiet jew ġejt dijanjostikat li tbati b'nevrite ottika'.
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' infliximab fi tfal u adoloxxenti iżgħar minn 18-il sena għall-indikazzjoni talartrite idjopatka ġuvenili, artrite psorijatika u ankylosing spondylitis ma ġewx determinati s'issa.
English: • Flixabi will be given to you by your doctor or nurse.
Maltese: • Flixabi ser jiġi mogħti lilek mit-tabib tiegħek jew infermier.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Maltese: Użu ieħor ta' sustanzi terapewtiċi infettivi bħal batterji ħajjin attenwati (eż. l-instillazzjoni ta' BCG filbużżieqa tal-awrina għall-kura tal-kanċer) jista' jwassal għal infezzjonijiet kliniċi, inkluż infezzjonijiet mifruxa.
English: In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Maltese: Fi studju li dam 6 xhur dwar tossiċità b'dożi ripetuti li sar filġrieden, fejn intuża l-istess antikorp analogu kontra TNFα tal-ġrieden, depożiti kristallini kienu osservati fuq il-kapsula tal-lenti ta' wħud mil-ġrieden irġiel ikkurati.
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Flixabi treatment.
Maltese: • Jekk irċevejt Flixabi waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju akbar li tieħu infezzjoni.
English: The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n=45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy.
Maltese: It-tnaqqis fl-inċidenza tal-kolektomija kienet eżaminata wkoll fi studju ieħor li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind (C0168Y06) f'pazjenti fl-isptar (n=45) b'kolite ulċerattiva moderata sa severa li ma kellhomx rispons għal kortekosterojdi fil-vini u li għalhekk kellhom riskju akbar li jkollhom kolektomija.
English: • Infections of the vagina.
Maltese: • Infezzjonijiet tal-vaġina
English: Following administration of 5 mg/kg infliximab every 8 weeks, the predicted median steady-state infliximab exposure (area under concentration-time curve at steady state, AUCss) in paediatric patients aged 6 years to 17 years was approximately 20% lower than the predicted median steadystate drug exposure in adults.
Maltese: Wara għoti ta' 5 mg/kg ta' infliximab kull 8 ġimgħat, il-medjan imbassar tal-esponiment fi stat fiss ta' infliximab (żona taħt il-kurva konċentrazzjoni-ħin fi stat fiss, AUCss) f'pazjenti pedjatriċi li kellhom minn 6 snin sa 17-il sena kien madwar 20% iktar baxx mill-medjan imbassar tal-espożizzjoni tal-mediċina fi stat fiss f'persuni adulti.
English: • You may get infections more easily when you are being treated with Flixabi.
Maltese: • Għid lit-tabib tiegħek minnufih jekk tiżviluppa sintomi ta' lupus matul it-trattament b'Flixabi.