FrancophonIA/ELRC3.0 huggingface dataset:
English: A placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with a thiazolidinedione (TZD) in patients with inadequate glycaemic control (HbA1c 7-10.5%) on TZD alone.
Maltese: Studju kontrollat bil-plaċebo ta' 24-ġimgħa sar sabiex jiġu evalwati l-effikaċja u s-sigurtà ta' saxagliptin mħallat ma' thiazolidinedione (TZD) f'pazjenti li ma kellhomx kontroll xieraq taz-zokkor fid-demm (HbA1c 7-10.
English: Uncommon Uncommon Uncommon Uncommon
Maltese: Komuni ħafna
English: Hepatic impairment
Maltese: Disfunzjoni talerezzjoni
English: An add-on to metformin placebo-controlled study of 24-week duration was conducted to evaluate the efficacy and safety of saxagliptin in combination with metformin in patients with inadequate glycaemic control (HbA1c 7-10%) on metformin alone.
Maltese: Studju kontrollat bi plaċebo, miżjud ma metformin li dam 24 ġimgħa sar sabiex jiġu evalwati leffikaċja u s-sigurtà ta' saxagliptin mogħti ma' metformin f'pazjenti li m'għandhomx kontroll xieraq (HbA1c 7.-10%) b'metformin waħdu.
English: • Common: infection of the upper chest or lungs, infection of the urinary tract, inflamed stomach or gut usually caused by an infection (gastroenteritis), infection of the sinuses with a feeling of pain and fullness behind your cheeks and eyes (sinusitis), headache, stomach ache and vomiting.
Maltese: • Komuni: infezzjoni tal-parti ta' fuq tas-sider jew tal-pulmun, infezzjoni ta' mnejn tgħaddi lawrina, infjammazzjoni fl-istonku jew musrana, normalment ikkawżata minn infezzjoni (gastroenterite), infezzjoni tas-sinużite, b'sensazzjoni ta' uġigħ u ebusija wara ħaddejk u għajnejk (sinużite), uġigħ ta' ras, uġigħ fl-istonku u tirremetti.
English: The saxagliptin and dapagliflozin group achieved significantly greater reductions in HbA1c versus either the saxagliptin group or dapagliflozin group at 24 weeks (see Table 3).
Maltese: Il-grupp ta' saxagliptin u dapagliflozin kiseb tnaqqis ferm akbar f'HbA1c meta mqabbel mal-grupp ta' saxagliptin jew il-grupp ta' dapagliflozin f'24 ġimgħa (ara Tabella 3).
English: Table 3 HbA1c at Week 24 in active-controlled study comparing the combination of saxagliptin and dapagliflozin added concurrently to metformin with either saxagliptin or dapagliflozin added to metformin
Maltese: Tabella 3 HbA1c f'Ġimgħa 24 fi studju kkontrollat b'mod attiv li jqabbel it-taħlita ta' saxagliptin u dapagliflozin miżjuda fl-istess ħin ma' metformin b'jew saxagliptin jew dapagliflozin miżjud ma' metformin
English: In rabbits, the effects of saxagliptin were limited to minor skeletal variations observed only at maternally toxic doses (NOEL 158 and 224 times the human exposure for saxagliptin and the major metabolite, respectively at RHD).
Maltese: Fil-fniek, l-effetti ta' saxagliptin kienu limitati għal bidliet żgħar fl-għadam li dehru biss b'dożi li kienu tossiċi għall-omm (NOEL 158 u 224 darba l-esponiment fil-bniedem għal saxagliptin u l-metabolu ewlieni rispettivament bl-RHD).
English: OUTER CARTON Onglyza 5 mg film-coated tablets
Maltese: KARTUNA TA' BARRA Onglyza 5 mg pilloli miksija b' rita
English: Event rate per 100 patient-yrs
Maltese: Rata ta' avveniment għal kull 100 pazjent-sena
English: No dose- and time-dependence was observed in the clearance of saxagliptin and its major metabolite over 14 days of once-daily dosing with saxagliptin at doses ranging from 2.5 mg to 400 mg.
Maltese: L-ebda dipendenza ta' doża jew ħin ma kienet osservata fittneħħija ta' saxagliptin u l-metabolu ewlieni tiegħu fuq perjodu ta' 14 il-ġurnata b'dożaġġ ta' darba kuljum ta' saxagliptin b'dożi minn 2.5 mg sa 400 mg.
English: OUTER CARTON Onglyza 2.5 mg film-coated tablets
Maltese: KARTUNA TA' BARRA Onglyza 2.5 mg pilloli miksija b' rita
English: Invented name
Maltese: Numru ta' l-UE Isem inventat
English: l t o r
Maltese: Mnejn jingħata Il-pakkett
English: 1/1 M
Maltese: Daqs tal-pakkett t x
English: (furunculosis)
Maltese: (ċellulite)
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Sinjali jinkludu qtugħ ta' nifs jew nefħa f'saqajk.
English: Depression, insomnia.
Maltese: Depressjoni, insomnja.
English: Control a
Maltese: Kontroll a
English: EU/1/16/1106/001 EU/1/16/1106/002 EU/1/16/1106/003 EU/1/16/1106/004 EU/1/16/1106/005
Maltese: EU/1/16/1106/001 EU/1/16/1106/002 EU/1/16/1106/003 EU/1/16/1106/004
English: Endophthalmitis.
Maltese: Endoftalmite.
English: a Reduction in CDAI ≥ 25% and ≥ 70 points.
Maltese: Tnaqqis fis-CDAI ≥ 25% u ≥ 70 punt.
English: Tachycardia, palpitation.
Maltese: Takikardija, palpitazzjoni.
English: Icepharma hf.
Maltese: Ísland Icepharma hf.
English: Clinical Response a
Maltese: Rispons Kliniku a
English: Allergic respiratory symptom.
Maltese: Sintomu respiratorju allerġiku.
English: including bovine tuberculosis (disseminated BCG infection), see section 4.4
Maltese: * inkluż tuberkulosi bovina (infezzjoni mifruxa ta' BCG), ara sezzjoni 4.4
English: Table 9 Effects on ACR and PASI in IMPACT and IMPACT 2
Maltese: Tabella 9 Effetti fuq l-ACR u PASI f'IMPACT u IMPACT 2 IMPACT
English: Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups.
Maltese: Proporzjonijiet globali ta' avvenimenti avversi u reazzjonijiet għallinfużjoni kienu simili bejn il-gruppi ta' età ta' 6 sa 11 u 12 sa 17-il sena.
English: Complete fistula response (%)
Maltese: Rispons fistula komplet (%)
English: Apathy.
Maltese: Apatija.
English: ACR 20 response* ACR 50 response* ACR 70 response* PASI response (% of patients)b
Maltese: ACR 20 rispons* ACR 50 rispons* ACR 70 rispons* Rispons PASI (% ta' pazjenti)b
English: ≥ 5 x ULN placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Maltese: ≥ 3 darbiet ULN ≥ 5 darbiet ULN plaċebo infliximab plaċebo infliximab plaċebo infliximab plaċebo infliximab
English: Elevations of ALT ≥ 5 x Upper Limit of Normal (ULN) have been observed (see Table 2).
Maltese: Żidiet tal-ALT ≥ 5 darbiet il-Limitu ta' Fuq tan-Normal (ULN) ġew osservati (ara Tabella 2).
English: d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Maltese: d p = 0.030 u < 0.001 għall-gruppi ta' kura b'3 mg/kg u 6 mg/kg rispettivament vs. plaċebo + MTX.
English: EU/1/16/1106/001 1 vial EU/1/16/1106/002 2 vials EU/1/16/1106/003 3 vials EU/1/16/1106/004 4 vials EU/1/16/1106/005 5 vials
Maltese: EU/1/16/1106/001 1 kunjett EU/1/16/1106/002 2 kunjetti EU/1/16/1106/003 3 kunjetti EU/1/16/1106/004 4 kunjetti EU/1/16/1106/005 5 kunjetti
English: Ankylosing spondylitis Psoriatic arthritis Plaque psoriasis
Maltese: Spondilite Ankylosing Artrite psorijatika Plakka psorijatika
English: Fistula Response (%)
Maltese: Rispons Fistula (%)
English: Flixabi contains the active substance infliximab.
Maltese: Flixabi fih is-sustanza attiva infliximab.
English: • Melanoma (a type of skin cancer).
Maltese: • Melanoma (tip ta' kanċer tal-ġilda).
English: The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%].
Maltese: Il-follow-up dam medjan ta' 0.8 snin (inċidenza 5.7% [95% CI 2.65%-10.6%].
English: Pyelonephritis.
Maltese: Pajilonefrite.
English: Flixabi is a biosimilar medicinal product.
Maltese: Flixabi hu prodott mediċinali bijoloġiku simili.
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT
Maltese: Tabella 3 Effetti fuq ACR 20, Ħsara Strutturali fil-Ġogi u Funzjoni Fiżika fl-ġimgħa 54, ATTRACT
English: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Maltese: Nekroliżi tossika tal-epidermide, Sindrome ta' Stevens-Johnson, erythema multiforme, furunkulosi, dermatosi bullarja lineari IgA (LABD - linear IgA bullous dermatosis), pustullożi ekżantematuża mifruxa akuta (AGEP - acute generalised exanthematous pustulosis), reazzjonijiet likenojdi.
English: Placebo Maintenance (n=99)
Maltese: Manteniment bi Plaċebo (n = 99)
English: Granulomatous lesion.
Maltese: Leżjoni granulomatoża.
English: Flixabi is produced in packs of 1, 2, 3, 4, or 5 vial(s).
Maltese: Flixabi jiġi f'pakketti jinkludu 1, 2, 3, 4 u 5 kunjetti.
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leucopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Maltese: Ir-reazzjonijiet avversi- li ġejjin kienu rrappurtati b'mod aktar komuni f'pazjenti tfal bil-marda ta' Crohn fl-istudju REACH (ara sezzjoni 5.1) milli f'pazjenti adulti bil-marda ta' Crohn: anemija (10.7%), demm fl-ippurgar (9.7%), lewkopenja (8.7%), fwawar (8.7%), infezzjonijiet virali (7.8%), newtropenija (6.8%), infezzjoni kkawżata minn batterja (5.8%), u reazzjoni allerġika fil-passaġġ respiratorju (5.8%).
English: Myocardial ischaemia/myocardial infarction.
Maltese: Iskemija mijokardijaka/infart mijokardijaku.
English: Excipients: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate.
Maltese: Eċċipjenti: sucrose, polysorbate 80, monobasic sodium phosphate monohydrate u dibasic sodium phosphate heptahydrate
English: Placebo Maintenance (n=110)
Maltese: Manteniment bi Plaċebo (n = 110)
English: ACR response (% of patients) N
Maltese: ACR rispons (% ta' pazjenti) N
English: At week 54, the figures were 55.8% (29/52) and 23.5% (12/51) in the q8 weeks and q12 weeks maintenance groups, respectively (p < 0.001).
Maltese: F'ġimgħa 54, ilfiguri kienu 55.8% (29/52) u 23.5% (12/51) fil-gruppi ta' manteniment tal-ġimgħat q8 u q12, rispettivament (p < 0.001).
English: Viral infection (e.g. influenza, herpes virus infection).
Maltese: Infezzjoni virali (eż. influwenza, infezzjonijiet bil-virus tal-erpes)
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for Csection (1.50, 1.14-1.96; p=0.0032), preterm birth (1.48, 1.05-2.09; p=0.024), small for gestational age (2.79, 1.54-5.04; p=0.0007), and low birth weight (2.03, 1.41-2.94; p=0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Maltese: Abbażi ta' studju ta' osservazzjoni mill-Ewropa tat-Tramuntana, ġew osservati żieda fir-riskju (OR, CI ta' 95%; valur p) ta' ċesarja (1.50, 1.14-1.96; p = 0.0032), twelid qabel iż-żmien (1.48, 1.05-2.09; p = 0.024), tarbija żgħira għall-età tat-tqala (2.79, 1.54-5.04; p = 0.0007), u piż tat-twelid baxx (2.03, 1.41-2.94; p = 0.0002) f'nisa esposti għal infliximab matul it-tqala (flimkien ma' immunomodulaturi/kortikosterojdi jew mingħajrhom, 270 tqala) meta mqabbla ma' nisa esposti għal immunomodulaturi u/jew kortikosterojdi biss (6,460 tqala).
English: ≥ 50% improvement PGA of cleared (0) or minimal (1)
Maltese: Titjib ta' ≥ 50% PGA ta' pazjenti bid-dwiefer imfejqa (0) jew minimu (1)
English: Agranulocytosis (including infants exposed in utero to infliximab), thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
Maltese: Agranuloċitożi (inkluż trabi esposti in utero għal infliximab), purpura trombotika tromboċitopenika, panċitopenija, anemija emolitika, purpura tromboċitopenika idjopatika.
English: N ≥ 90% improvement
Maltese: Titjib ta' ≥ 90%
English: Autoimmune hepatitis, jaundice.
Maltese: Epatite awtoimmuni, suffejra.
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation.
Maltese: Emorraġija gastrointestinali, dijarea, dispepsja, rifluss gastroesofagali, stitikezza.
English: Infliximab Maintenance (5 mg/kg) (n=96)
Maltese: Manteniment b'Infliximab (5 mg/kg) (n = 96)
English: 275 (94.2%)ab
Maltese: 44.4% (75/169) (p
English: Flixabi contains sodium
Maltese: Flixabi fih sodium
English: Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Maltese: Punteġġi medji fil-linja bażi kienu 4.6 u 4.3 fil-grupp fuq infliximab u fuq il-plaċebo.
English: Marketing Authorisation Holder Samsung Bioepis NL B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Samsung Bioepis NL B.V.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Fil-klassijiet tassistema tal-organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli tal-frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Peripheral ischaemia, thrombophlebitis, haematoma.
Maltese: Iskemija periferali, tromboflebite, ematoma.
English: In this trial, sixty six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less.
Maltese: F'din il-prova, sitta u sittin fil-mija tal-pazjenti (686 minn 1,040) irċevew mill-anqas infużjoni waħda mqassra ta' 90 minuta jew anqas u 44% tal-pazjenti (454 minn 1,040) irċevew mill-anqas infużjoni waħda imqassra ta' 60 minuta jew anqas.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118 and 277 micrograms/mL, respectively.
Maltese: F'dożi waħidhom ta' 3, 5, jew 10 mg/kg, il-valuri Cmax medjani kienu 77, 118 u 277 mikrogrammi/mL
English: Flixabi is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Maltese: Flixabi hu indikat għall-kura għal psorjasi tal-plakka minn moderata sa severa f'pazjenti adulti li ma jkunux urew rispons għal, jew li huma kontra-indikati għal, jew li huma intolleranti għal terapija sistemika oħra li tinkludi ciclosporin, methotrexate jew psoralen ultra-violet A (PUVA) (ara sezzjoni 5.1).
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group (36/244; 14.8%).
Maltese: jew 11.6% [N.S.]) u l-grupp ta' 10 mg/kg infliximab (18/242 jew 7.4% [p=0.011]) milli fil-grupp talplaċebo (36/244; 14.
English: Change from baseline in total van der Heijde-modified Sharp score b
Maltese: Bidla mil-linja bażi fit-total tal-punteġġ van der Heijde modifikat Sharp b
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab (see section 4.8).
Maltese: Melanoma u karċinoma taċ-ċellula ta' Merkel kienu rrappurtati f'pazjenti kkurati b'terapija li timblokka TNF, inkluż infliximab (ara sezzjoni 4.8).
English: Clinical remission at week 8 was 33.3% (17/51) as measured by the Paediatric Ulcerative Colitis Activity Index (PUCAI) score.
Maltese: Tnaqqis kliniku f'ġimgħa 8 kienet ta' 33.3% (17/51) kif imkejjel bil-punteġġ tal-Indiċi tal-Attività ta' Kolite ulerattiva fit-Tfal (PUCAI).
English: Liver failure.
Maltese: Fejqan indebolit.
English: • Store in a refrigerator (2°C - 8°C).
Maltese: • Aħżen fi-friġġ (2 °C - 8 °C).
English: Infliximab Maintenance 5 mg/kg (n=113) (p value)
Maltese: Manteniment b'Infliximab 5 mg/kg (n = 113) (Valur p)
English: Combined data from ACT 1 & 2
Maltese: Dejta kollettiva minn ACT 1 u 2 Plaċebo
English: Amnesia, agitation, confusion, somnolence, nervousness.
Maltese: Amneżija, aġitazzjoni, konfużjoni, ħedla tan-ngħas, nervożiżmu.
English: START was a randomised, multicentre, double-blind, 3-arm, parallel-group safety study.
Maltese: START kien studju li fih il-parteċipanti ntgħażlu b'mod każwali, multiċentriku, double-blind, bi 3 partijiet tal-istudji, ta' grupp parallel.
English: The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
Maltese: L-aktar ADRs serji assoċjati ma' użu ta' imblokkaturi ta' TNF li kienu rrappurtati għal infliximab jinkludu attivazzjoni mill-ġdid ta' HBV, CHF (congestive heart failure, insuffiċjenza konġestiva tal-qalb), infezzjonijiet serji (li jinkludu sepsis, infezzjonijiet opportunistiċi u TB), mard tas-serum (reazzjonijiet ta' sensittività eċċessiva li jdumu biex iseħħu), reazzjonijiet ematoloġiċi, lupus erythematosus sistemiku/sindrome jixbah il-lupus, disturbi ta' demijelinazzjoni, avvenimenti tal-fwied u tal-marrara, limfoma, HSTCL, lewkimja, karċinoma taċċellula ta' Merkel, melanoma, tumuri malinni fit-tfal, sarkojdosi/ reazzjoni li tixbah lil sarkojdosi, axxess fl-imsaren jew perianali
English: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Maltese: Meninġite, infezzjonijiet opportunistiċi (bħal infezzjonijiet invażivi fungali [pnewmoċistożi, istoplasmożi, asperġillożi, kokkidijoidomikożi, kriptokokkożi, blastomikożi], infezzjonijiet batterjali [b'mikobatterji mhux tipiċi, listerijożi, salmonellożi] u infezzjonijiet virali [ċitomegalovirus]), infezzjonijiet parassitiċi, attivazzjoni mill-ġdid tal-epatite B.
English: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Maltese: Edema fil-pulmun, bronkospażmu, plewriżi, effużjoni mill-plewra
English: Flixabi 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: Flixabi jista' jinħażen f'temperaturi sa massimu ta' 25°C għal perjodu wieħed ta' sa 6 xhur, iżda li ma jaqbiżx id-data ta' skadenza oriġinali.
English: Infliximab Maintenance 10 mg/kg (n=112) (p value)
Maltese: Manteniment b'Infliximab 10 mg/kg (n = 112) (Valur p)
English: Infliximab was studied in a clinical study in 120 patients (age range: 4-17 years old) with active juvenile rheumatoid arthritis despite methotrexate.
Maltese: Infliximab kien studjat fi studju kliniku b'120 pazjent (medda ta' etajiet: 4-17-il sena) b'artrite rewmatojde ġuvenili attiva minkejja methotrexate.
English: Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Maltese: Infliximab ġie studjat biss f'kombinazzjoni ma' terapija konvenzjonali immunosoppressiva.
English: Flixabi belongs to a group of medicines called ‘TNF blockers'.
Maltese: Flixabi jagħmel parti minn grupp ta' mediċini magħrufa bħala ‘imblokkaturi TNF'.
English: Table 7 Effects on response rate, data from ACCENT II (week-14 responders)
Maltese: Tabella 7 Effetti fuq ir-rata ta' rispons, dejta minn ACCENT II (persuni li rrispondew sa ġimgħa 14) ACCENT II (Persuni li rrispondew sa ġimgħa 14)
English: Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
Maltese: Infużjonijiet ġol-vina ta' darba ta' 1, 3, 5, 10 jew 20 mg/kg ta' infliximab irriżultaw f'żidiet proporzjonali għad-dożi tal-konċentrazzjoni massima fis-serum (Cmax) u fl-erja taħt il-kurva tal konċentrazzjoni mal-ħin (AUC).
English: Flixabi 100 mg powder for concentrate infliximab
Maltese: Flixabi 100 mg trab għal konċentrat infliximab
English: The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Maltese: Is-sigurtà u l-effikaċja ta' infliximab kienu evalwati f'żewġ studji kliniċi (ACT 1 u ACT 2) li fihom ilparteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollati bi plaċebo f'pazjenti adulti b'kolite ulċerattiva attiva b'mod moderat sa sever (Punteġġ Mayo 6 sa 12; Sottopunteġġ tal-endoskopija ≥ 2) b'rispons inadegwat għat-terapiji konvenzjonali [kortikosterojdi orali, aminosalicylates u/jew immunomodulaturi (6-MP, AZA)].
English: * Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Maltese: IgG1 kimeriku tal-bniedem-ġrieden magħmul f'ċelluli talOvarji tal-Ħamster Ċiniż (Chinese Hamster Ovary (CHO)) b'teknoloġija ta' DNA rikombinata.
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Maltese: Proporzjon akbar ta' pazjenti fil-grupp ta' kura b'infliximab kombinat setgħu jwaqqfu l-kortikosterojdi fil-waqt li baqgħu bi tnaqqis kliniku meta mqabbla ma' grupp ta' kura bi plaċebo kemm f'ġimgħa 30 (22.3% vs 7.2%, p < 0.001, dejta ACT 1 u ACT 2 mgħaqqdin flimkien) u ġimgħa 54 (21.0% vs. 8.9%, p=0.022, dejta ACT 1).
English: • Treat active Crohn's disease,
Maltese: • Tikkura marda ta' Crohn attiva,
English: Placebo → Infliximab 5 mg/kg (at week 24)
Maltese: Plaċebo → Infliximab 5 mg/kg (f'ġimgħa 24)
English: Decreases in parameters of peripheral activity characteristic of psoriatic arthritis (such as number of swollen joints, number of painful/tender joints, dactylitis and presence of enthesopathy) were seen in the infliximab-treated patients.
Maltese: Tnaqqis fil-parametri ta' attività periferali karatteristika ta' artrite psorijatika ( bħan-numru ta' ġogi minfuħin, numru ta' ġogi bl-uġigħ/teneri, daktilite u preżenza ta' entesopatija) ġew osservati f'pazjenti kkurati b'infliximab.
English: At week 24, the number of ASAS 20 responders was 15/78 (19%) in the placebo group, and 123/201 (61%) in the 5 mg/kg infliximab group (p < 0.001).
Maltese: Mal-24 ġimgħa, in-numru ta' persuni li rrispondew għal ASAS 20 kienu 15/78 (19%) fil-grupp tal-plaċebo, u 123/201 (61) filgrupp fuq 5 mg/kg infliximab (p < 0.001).
English: There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Maltese: Hemm esperjenza limitata dwar is-sigurtà tal-kura b'infliximab f'pazjenti li kellhom proċeduri kirurġiċi, inkluż arthroplasty infliximab.
English: Efficacy and safety of infliximab were assessed in two multicentre, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
Maltese: L-effikaja u s-sigurtà ta' infliximab kienu evalwati f'żewġ studji multiċentriċi, double-blind, ikkontrollati bi plaċebo f'pazjenti b'ankylosing spondylitis attiva (Indiċi tal-Marda Ankylosing Spondylitis ta' Bath [BASDAI] punteġġ ≥ 4 u wġigħ fis-sinsla ≥ 4 fuq skala minn 1-10).
English: Date of first authorisation: 26/05/2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26/05/2016