FrancophonIA/ELRC3.0 huggingface dataset:
English: Upper respiratory tract infection was the most common adverse drug reaction (ADR) reported in clinical trials with infliximab, occurring in 25.3% of infliximab-treated patients compared with 16.5% of control patients.
Maltese: Infezzjoni fin-naħa ta' fuq tal-apparat tan-nifs kienet l-aktar reazzjoni avversa komuni għall-mediċina (ADR) rrappurtata fi provi kliniċi b'infliximab, li seħħet f'25.3% ta' pazjenti kkurati b'infliximab meta mqabbla ma' 16.5% ta' pazjenti fil-grupp tal-kontroll.
English: In addition:
Maltese: Nota:
English: Some of these infections have been fatal; the most frequently reported opportunistic infections with a mortality rate of >5% include pneumocystosis, candidiasis, listeriosis and aspergillosis.
Maltese: Uħud minn dawn l-infezzjonijiet kienu fatali; l-infezzjonijiet opportunistiċi li kienu rrappurtati l-aktar frekwenti b'rata ta' mortalità > 5% jinkludu pnewmoċistożi, kandidijasi, listerjożi u asperġillożi.
English: Remsima 120 mg solution for injection in pre-filled syringe Each 1 mL single dose pre-filled syringe contains 120 mg of infliximab*.
Maltese: Remsima 120 mg soluzzjoni għal injezzjoni ġo siringa mimlija għal-lest Kull 1 mL siringa mimlija għal-lest ta' doża waħda fiha 120 mg ta' infliximab*.
English: Remsima IV 3 mg/kga (N=174)
Maltese: Remsima IV 3 mg/kga
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'
English: 10 mg/kg q 8 wks
Maltese: 10 mg/kg q 8 ġimg ħat
English: Insert the syringe into the injection site (see Figure E).
Maltese: Daħħal is-siringa fis-sit tal-injezzjoni (ara l-Figura E).
English: Tel: +386 1 519 29 22 info@oktal-pharma.si
Maltese: OKTAL PHARMA d.o.o. Tel: +386 1 519 29 22 info@oktal-pharma.si
English: Inspect the medicine (see Figure B).
Maltese: 3. Spezzjona l-mediċina (ara l-Figura B).
English: Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI <150) and clinical response over time.
Maltese: Il-punti aħħarin sekondarji kienu jinkludu l-proporzjon ta' pazjenti b'fejqan kliniku fir-4 ġimgħa (CDAI < 150) u rispons kliniku maż-żmien.
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% tal-pazjenti seħħew antikorpi (l-antikorpi seħħew f'4% tal-pazjenti li rċevew methotrexate u f'26% talpazjenti li ma kinux qed jirċievu methotrexate fil-linja bażi).
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils (furunculosis)
Maltese: • Problemi oħra fil-ġilda bħal eritema multiforme, infafet u ġilda titqaxxar, jew imsiemer (furunkulożi)
English: After administration of infliximab 120 mg subcutaneously every 2 weeks (from Week 6 after 2 doses of intravenous infliximab at Weeks 0 and 2) to patients with active rheumatoid arthritis who were concomitantly treated with MTX, the median (CV%) Ctrough level at Week 22 was 12.8 µg/mL
Maltese: Wara għoti ta' infliximab 120 mg taħt il-ġilda kull ġimagħtejn (minn Ġimgħa 6 wara 2 dożi ta' infliximab ġol-vina f'Ġimgħat 0 u 2) lil pazjenti b'artrite rewmatodje attiva li ġew ikkurati b'mod konkomitanti b'MTX, il-livell medjan (CV%) Cminimu fil-Ġimgħa 22 kien 12.8 µg/mL (80.
English: EU/1/13/853/006 1 pre-filled syringe EU/1/13/853/009 1 pre-filled syringe with automatic needle guard EU/1/13/853/007 2 pre-filled syringes EU/1/13/853/010 2 pre-filled syringes with automatic needle guard EU/1/13/853/008 4 pre-filled syringes EU/1/13/853/011 4 pre-filled syringes with automatic needle guard
Maltese: EU/1/13/853/006 1 siringa mimlija għal-lest EU/1/13/853/009 1 siringa mimlija għal-lest bi lqugħ awtomatiku għal-labra EU/1/13/853/007 2 siringi mimlijin għal-lest EU/1/13/853/010 2 siringi mimlijin għal-lest bi lqugħ awtomatiku għal-labra EU/1/13/853/008 4 siringi mimlijin għal-lest EU/1/13/853/011 4 siringi mimlijin għal-lest bi lqugħ awtomatiku għal-labra
English: • Cotton ball or gauze*
Maltese: • Faxxa li teħel*
English: The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function.
Maltese: College of Rheumatology (ACR20 għal ATTRACT, landmark ACR-N għal ASPIRE), il-prevenzjoni ta' ħsara strutturali fil-ġogi, u t-titjib fil-funzjoni fiżika.
English: Patients did not receive any concomitant immunosuppressant therapy.
Maltese: likwidu u terapija immunosoppressiva).
English: • Remsima will be given to you by your doctor or nurse.
Maltese: • Remsima ser jiġi mogħti lilek mit-tabib tiegħek jew infermier.
English: Remsima 120 mg solution for injection in pre-filled pen Each 1 mL single dose pre-filled pen contains 120 mg of infliximab*.
Maltese: Remsima 120 mg soluzzjoni għal injezzjoni f'pinna mimlija għal-lest Kull 1 mL pinna mimlija għal-lest ta' doża waħda fiha 120 mg ta' infliximab*.
English: ‘Re-administration' below and section 4.4).
Maltese: Prodott, sezzjoni 4.2).
English: • Syringe
Maltese: • Siringa
English: • That treatment with Remsima may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP
Maltese: • Li t-trattament b'Remsima jista' jżid ir-riskji ta' infezzjonijiet serji/sepsi, infezzjonijiet opprotunistiċi, tuberkulożi, riattivazzjoni tal-epatite B, u ifiġġ BCG fi trabi b'esponiment għal infliximab in utero, u meta għandek tfittex għajnuna mingħand HCP • Id-dettalji biex tikkuntattja lill-persuna li ordnat il-mediċina
English: At week 16, 47 placebo patients with <10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
Maltese: F'ġimgħa 16, 47 pazjent fuq plaċebo b'< 10% titjib mil-linja bażi kemm fl-għadd ta' dawk b'ġogi minfuħin kif ukoll b'dawk teneri inqalbu għall-induzzjoni fuq infliximab (early escape).
English: Each Remsima vial contains 100 mg infliximab.
Maltese: Kull kunjett fih 100 mg ta' infliximab.
English: About the Remsima syringe Parts of the syringe (see Figure A):
Maltese: Dwar ir-Remsima siringa Partijiet tas-siringa (ara l-Figura A):
English: • Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
Maltese: • Xi pazjenti li kienu qed jirċievu Remsima żviluppaw sintomi ta' disturb fis-sistema immuni msejjaħ lupus.
English: Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Remsima in the infusion bag only.
Maltese: Ħażna għal aktar minn 24 siegħa f'temperatura ta' 2 °C - 8 °C tapplika biss għal Remsima ippreparat fil borża tal-infużjoni.
English: The recommended dose for Remsima subcutaneous formulation is 120 mg once every 2 weeks.
Maltese: Id-doża rakkomandata għal Remsima formulazzjoni subkutaneja hija 120 mg darba kull ġimagħtejn.
English: Remsima may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date.
Maltese: Remsima jista' jinħażen f'temperaturi sa massimu ta' 25°C għal perjodu wieħed sa 6 xhur, iżda li ma jaqbiżx id-data ta' skadenza oriġinali.
English: Clinical remission at Week 8a Clinical remission at Week 30a Sustained remission(in remission at both Week 8 and Week 30)a
Maltese: Rispons sostnut (rispons kliniku f'ġimgħa 8 kif ukoll f'ġimgħa 30)a
English: Signs of a local injection site reaction can include redness, pain, itching, swelling, hardness, bleeding, bruising, cold sensation, irritation, tingling sensation, ulcer, hives, rash and scab on the skin of the injection site.
Maltese: Sinjali ta' reazzjoni lokali fis-sit tal-injezzjoni jistgħu jinkludu ħmura, uġigħ, ħakk, nefħa, ebusija, fsada, tbenġil, sensazzjoni ta' kesħa, irritazzjoni, sensazzjoni ta' tagħrix, ulċera, ħorriqija, raxx u qoxra xotta fuq il-ġilda tas-sit tal-injezzjoni.
English: In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus <1% (1/222) on maintenance therapy.
Maltese: Fil-parti tal-istudju dwar dawk li ngħataw kura mill-ġdid, 4% (8/219) tal-pazjenti kellhom reazzjoni serja għall-infużjoni kontra < 1% (1/222) ta' dawk fuq terapija ta' manteniment.
English: In clinical studies using single and multiple infliximab doses ranging from 1 to 20 mg/kg, antibodies to infliximab were detected in 14% of patients with any immunosuppressant therapy, and in 24% of patients without immunosuppressant therapy.
Maltese: instabu antikorpi għal infliximab f'14% tal-pazjenti fuq xi terapija immunosoppressiva, u f'24% tal pazjenti mingħajr terapija immunosoppressiva.
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 fis sezzjonijiet 4.8 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
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 Remsima.
Maltese: Id-dilwizzjoni tista' ssir billi jinġibed volum tas-soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/mL (0.9%) mill-flixkun tal-ħġieġ jew borża tal-infużjoni ta' 250 mL li jkun daqs il-volum ta' Remsima rikostitwit.
English: Eighty nine percent (50/56) of patients who lost clinical response on infliximab 5 mg/kg maintenance therapy after week 14 responded to treatment with infliximab 10 mg/kg.
Maltese: Disgħa u tmenin fil-mija (50/56) tal-pazjenti li tilfu r-rispons kliniku fuq infliximab 5 mg/kg bħala terapija ta' manteniment wara ġimgħa 14 kellhom rispons għal kura b'infliximab 10 mg/kg.
English: Egis Slovakia spol.s r.o.
Maltese: GĦALL-ĦRUĠ TAL-LOTT
English: The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p=0.019 and p=0.007, respectively).
Maltese: In-numru ta' dawk li kellhom imorru l-isptar minħabba kolite ulċerattiva kien aktar baxx b'mod sinifikanti fil gruppi ta' kura b'5 u 10 mg/kg infliximab milli fil-grupp tal-plaċebo (il-medja tan-numru ta' dawk li marru l-isptar għal kull 100 sena ta' individwu: 21 u 19 kontra 40 fil-grupp tal-plaċebo; p=0.019 u p=0.007, rispettivament).
English: The efficacy of infliximab intravenous formulation was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Maltese: L-effikaċja ta' infliximab kienet evalwata f'żewġ studji importanti ħafna multiċentriċi, li fihom ilparteċipanti ntgħażlu b'mod każwali, double-blind: ATTRACT u ASPIRE.
English: Remsima 100 mg powder for concentrate for solution for infusion infliximab
Maltese: Remsima 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni infliximab
English: Mucosal healing at Week 8a
Maltese: Rispons kliniku f'ġimgħa 30a
English: In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 vs.15/60).
Maltese: sa 11-il sena (45/60 vs. 15/60).
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors, ATC code: L04AB02
Maltese: It-tarbija tiegħek m'għandhiex tirċievi ‘tilqim ħaj', bħal BCG (użat biex jipprevjeni t-tuberkulosi)
English: • Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remsima treatment.
Maltese: • Jekk irċevejt Remsima waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju akbar li tieħu infezzjoni.
English: 5 years at 2°C - 8°C.
Maltese: Qabel ir-rikostituzzjoni 5 snin f'temperatura ta' 2°C - 8°C.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji bil-prodott mediċinali ta' referenza li jkun fih infliximab f'kull sett tal-popolazzjoni pedjatrika fl artrite rewmatojde, artrite idjopatika taż-żgħar, artrite psorjatika, ankylosing spondylitis, psorjasi u lmarda ta' Crohn (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: 3 mg/kg q 8 wks
Maltese: Kontrolla 3 mg/kg q 8 ġimg ħat
English: Remsima 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: Remsima huwa 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 6-MP jew AZA, jew li huma intolleranti għal jew għandhom kontra-indikazzjonijiet mediċi għal terapiji bħal dawn.
English: Package leaflet: Information for the user Remsima 100 mg powder for concentrate for solution for infusion infliximab
Maltese: Informazzjoni għall-utent Remsima 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni infliximab
English: Sorbitol 45 mg per 1 mL
Maltese: Eċċipjent(i) b'effett magħruf Sorbitol 45 mg għal kull 1 mL
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 kien eżaminat ukoll 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: The incidence of localised injection site reactions (e.g. injection site erythema, pain, pruritus and swelling) was 17.6 per 100 patient-years in the Remsima subcutaneous group (from Week 6) and 21.4 per 100 patient-years in those who switched to Remsima subcutaneous administration (from Week 30).
Maltese: L-inċidenza ta' reazzjonijiet lokalizzati għas-sit tal-injezzjoni (eż. eritema fis-sit tal-injezzjoni, uġigħ, ħakk u nefħa) kienet 17.6 għal kull 100 sena ta' pazjent fil-grupp ta' Remsima subkutanju (minn Ġimgħa 6) u 21.4 għal kull 100 sena ta' pazjent f'dawk li qelbu għal Remsima għoti subkutanju (minn Ġimgħa 30).
English: Solution for injection 1 pre-filled pen with 2 alcohol pads 2 pre-filled pens with 2 alcohol pads 4 pre-filled pens with 4 alcohol pads
Maltese: Kull pakkett fih 1 siringa mimlija għal-lest b'2 pads tal-alkoħol, 2 siringi mimlijin għal-lest b'2 pads tal-alkoħol jew 4 siringi mimlijin għal-lest b'4 pads tal-alkoħol.
English: • Hepatitis B infection when you have had hepatitis B in the past
Maltese: • Sinjali ta' problemi tal-fwied (inkluża infezzjoni tal-epatite B meta tkun qabditek epatite B
English: EU/1/13/853/001 1 vial EU/1/13/853/002 2 vials EU/1/13/853/003 3 vials EU/1/13/853/004 4 vials EU/1/13/853/005 5 vials
Maltese: EU/1/13/853/001 1 kunjett EU/1/13/853/002 2 kunjetti EU/1/13/853/003 3 kunjetti EU/1/13/853/004 4 kunjetti EU/1/13/853/005 5 kunjetti
English: Tel: +34 93 700 25 25
Maltese: KERN PHARMA, S.L. Tel: +34 93 700 25 25
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: EXP, if not refrigerated ___________________
Maltese: JIS, jekk mhux fil-friġġ ___________________
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji bil-prodott mediċinali ta' referenza li jkun fih infliximab f'kull sett tal-popolazzjoni pedjatrika fl artrite rewmatojde, artrite idjopatika taż-żgħar, artrite psorjatika, ankylosing spondylitis u psorjasi (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • 4 prefilled syringes (1 mL sterile solution) with 4 alcohol pads.
Maltese: • 4 siringi mimlijin għal-lest (1 mL soluzzjoni sterili) b'4 pads tal-alkoħol.
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, placebo-controlled, dose-response study.
Maltese: L-effikaċja ta' kura b'doża waħda ta' infliximab kienet evalwata 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: MTX.
Maltese: Treddigħ
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: 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: 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 steady-state medicinal product 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- prodott mediċinali fi stat fiss f'persuni adulti.
English: 1 hour.
Maltese: 1 klikk
English: Remove the syringe from the injection site (see Figure G).
Maltese: Neħħi s-siringa mis-sit tal-injezzjoni (ara l-Figura G).
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-36.
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
English: Total scored (van der Heijde-modified Sharp score) Change from baseline (Mean ± SDc)
Maltese: Punteġġ totalid (punteġġ van der Heijde Sharp) Bdil mil-linja bażi (Medja ±
English: 3.4 (1.3)b a Two-sided 95% CI for difference in the mean change from baseline for DAS28 (CRP) at Week 22 was well above the pre-defined non-inferiority margin of -0.6 b Remsima IV was switched to Remsima SC at Week 30
Maltese: B'mod globali, 8 (13.3%) mis-60 pazjent ikkurati kellhom esperjenza ta' reazzjoni għall-infużjoni waħda jew aktar, b'4 minn 22 (18.2%) fil-grupp ta' kura ta' manteniment ta' q8 ġimgħat u 3 minn 23
English: • 1 prefilled syringe (1 mL sterile solution) with 2 alcohol pads.
Maltese: • 1 siringa mimlija għal-lest (1 mL soluzzjoni sterili) b'2 pads tal-alkoħol.
English: • Sharps disposal container* *Items not included in the carton.
Maltese: • Reċipjent għar-rimi ta' affarijiet jaqtgħu* *Oġġetti mhux inklużi fil-kartuna.
English: Write the new expiry date on the carton including day/month/year.
Maltese: Ikteb id-data l-ġdida ta' skadenza fuq il kartuna inkluż jum/xahar/sena.
English: • 2 prefilled syringes (1 mL sterile solution) with 2 alcohol pads.
Maltese: • 2 siringi mimlijin għal-lest (1 mL soluzzjoni sterili) b'2 pads tal-alkoħol.
English: Remsima and Kineret should not be used together.
Maltese: Il-kombinazzjoni ta' infliximab ma' abatacept mhux rakkomandata.
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥220 ≤450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Maltese: Infliximab b'AZA jew mingħajru kien evalwat fi studju komparatur b'mod attiv, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind (SONIC) ta' 508 pazjenti adulti b'marda ta' Crohn minn moderata sa severa (CDAI ≥ 220 ≤ 450) li qatt ma kienu ħadu sustanzi bijoloġiċi u immunosoppressanti u li kellhom il-marda għal tul ta' żmien medjan ta' 2.3 snin.
English: EU/1/13/853/012 1 pre-filled pen EU/1/13/853/013 2 pre-filled pens EU/1/13/853/014 4 pre-filled pens
Maltese: EU/1/13/853/012 1 pinna mimlija għal-lest EU/1/13/853/013 2 pinen mimlijin għal-lest EU/1/13/853/014 4 pinen mimlijin għal-lest
English: In rheumatoid arthritis patients, there are indications that concomitant use of methotrexate and other immunomodulators reduces the formation of antibodies against infliximab and increases the plasma concentrations of infliximab.
Maltese: F'pazjenti b'sintomi ta' artrite rewmatojde, hemm indikazzjonijiet li meta jingħataw methotrexate u immunomodulaturi oħra fl-istess ħin, dan inaqqas il-formazzjoni ta' antikorpi kontra infliximab u jżid il-konċentrazzjonijiet ta' infliximab fil-plażma.
English: Date of first authorisation: DD month YYYY
Maltese: Formulazzjoni taħt il-ġilda
English: Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
Maltese: Ħsara strutturali fil-ġogi (tmermir u tidjiq fl-ispazju tal-ġogi) kemm fl-idejn kif ukoll fis saqajn tkejlet permezz tal-bidla mil-linja bażi fil-punteġġ totali ta' modifikat ta' van der Heijde Sharp (0-440).
English: One serious infusion reaction (<1%) occurred in a patient on infliximab monotherapy.
Maltese: Seħħet reazzjoni għall-infużjoni waħda ta' grad serju (< 1%) f'pazjent li kien fuq terapija b'infliximab waħdu.
English: • 4 prefilled pens (1 mL sterile solution) with 4 alcohol pads.
Maltese: • 4 pinen mimlijin għal-lest (1 mL soluzzjoni sterili) b'4 pads tal-alkoħol.