FrancophonIA/ELRC3.0 huggingface dataset:
English: Some medicines may increase the effects of Trimbow and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Maltese: Xi mediċini jistgħu jżidu l-effetti ta' Trimbow, u t-tabib tiegħek għandu mnejn ikun irid jimmonitorjak b'attenzjoni jekk tkun qed tieħu dawn il-mediċini (inklużi xi mediċini għall-HIV: ritonavir, cobicistat).
English: This study also investigated the potential pharmacokinetic interaction between the active components of Trimbow by comparing the pharmacokinetic data obtained after a single dose of the extemporary combination or after a single dose of the single components beclometasone dipropionate/formoterol or glycopyrronium.
Maltese: Dan l-istudju investiga wkoll il-potenzjal ta' interazzjoni farmakokinetika bejn il-komponenti attivi ta' Trimbow billi tqabblet id-data farmakokinetika miksuba wara doża waħda tal-kombinazzjoni estemporanja jew wara doża waħda tal-komponenti waħedhom beclometasone dipropionate/formoterol jew glycopyrronium.
English: Compared with tiotropium, Trimbow improved pre-dose FEV1 by 51 mL after 26 weeks of treatment and by 61 mL after 52 weeks of treatment.
Maltese: Meta mqabbel ma' tiotropium, Trimbow tejjeb FEV1 qabel id-doża b'51 mL wara 26 ġimgħa ta' trattament u b'61 mL wara 52 ġimgħa ta' trattament.
English: No differences were observed when comparing Trimbow and the extemporary triple combination made of fluticasone and vilanterol fixed combination plus tiotropium.
Maltese: Ma ġew osservati l-ebda differenzi meta Trimbow kien imqabbel mal-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' fluticasone u vilanterol flimkien ma'
English: How to store Trimbow
Maltese: Jekk diġà qed tuża Trimbow
English: Glycopyrronium is a high-affinity, long-acting muscarinic receptor antagonist (anticholinergic) used for inhalation as bronchodilator treatment of COPD.
Maltese: M'hemm l-ebda użu rilevanti ta' Trimbow fil-popolazzjoni pedjatrika (ta' età inqas minn 18-il sena) għall-indikazzjoni ta' marda kronika ostruttiva tal-pulmun (COPD - chronic obstructive pulmonary disease).
English: Trimbow should be administered with caution in patients with active or quiescent pulmonary tuberculosis, fungal and viral infections in the airways.
Maltese: Trimbow għandu jingħata b'kawtela f'pazjenti b'tuberkulożi pulmonari attiva jew inattiva, u infezzjonijiet fungali u virali tal-passaġġi tan-nifs.
English: There are no relevant clinical data on the use of Trimbow during breast-feeding in humans.
Maltese: M'hemmx data klinika rilevanti dwar l-użu ta' Trimbow waqt it-treddigħ fil-bnedmin.
English: In an inhalation study in telemetered dogs, the cardiovascular system was a major target system for acute effects of Trimbow (increase in heart rate, decrease in blood pressure, ECG changes at higher doses), effects probably mainly related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium.
Maltese: Fi studju dwar it-teħid man-nifs fi klieb telemetered, is-sistema kardjovaskulari kienet is-sistema ewlenija fil-mira għal effetti akuti ta' Trimbow (żieda fir-rata tal-qalb, tnaqqis fil-pressjoni, bidliet fl-ECG b'dożi ogħla), effetti li probabbilment fil-biċċa l-kbira kienu relatati mal-attività beta2adrenerġika ta' formoterol u l-attività anti-muskarinika ta' glycopyrronium.
English: • medicines for treating - abnormal heart rhythms (quinidine, disopyramide, procainamide), - allergic reactions (antihistamines), - symptoms of depression or mental disorders such as monoamine oxidase inhibitors (for example phenelzine and isocarboxazid), tricyclic antidepressants (for example amitriptyline and imipramine), phenothiazines can cause some changes in the electrocardiogram (ECG, heart trace).
Maltese: • Disulfiram, mediċina li tintuża fit-trattament ta' persuni bl-alkoħoliżmu (problemi tax-xorb) jew metronidazole, antibijotiku għat-trattament ta' infezzjoni fil-ġisem tiegħek jistgħu jikkawżaw effetti sekondarji (eż. tħossok imdardar, tirremetti, uġigħ fl-istonku) minħabba l-ammont żgħir ta' alkoħol fi Trimbow.
English: However, available safety data from longterm clinical studies have not raised any significant safety concerns (see section 5.1).
Maltese: Madankollu, id-data tas-sigurtà disponibbli minn studji kliniċi fit-tul ma qajmitx tħassib sinifikanti dwar is-sigurtà (ara sezzjoni 5.1).
English: Oral drops,
Maltese: Qtar orali,
English: JANSSEN-CILAG A/S Bregnerødvej 133 3460 Birkerød Denmark
Maltese: JANSSEN-CILAG A/S Bregnerødvej 133 3460
English: United Kingdom Janssen-Cilag Limited 50-100 Holmers Farm
Maltese: Janssen-Cilag Limited 50-100
English: 56 Eirinis Ave, Pefki Athens GR-151 21 Greece
Maltese: Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki Athens GR-151 21 Greece
English: 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece
Maltese: Janssen-Cilag Pharmaceutical S.A.C.I. 56 Eirinis Ave, Pefki, Athens GR-151 21 Greece
English: F-92787 Issy Les Moulineaux, Cedex 9 France
Maltese: Janssen-Cilag 1, rue Camille Desmoulins, TSA 91003 F-92787 Issy Les Moulineaux, Cedex 9 France
English: Oral Drops, Solution Oral use
Maltese: Qtar orali, soluzzjoni Użu orali
English: HP12 4EG
Maltese: High Wycombe Buckinghamshire HP12 4EG
English: Buckinghamshire
Maltese: Il-Belġju
English: Oral drops, solution Oral use
Maltese: Qtar orali, Soluzzjoni
English: Wait 30 minutes.
Maltese: Stenna 30 minuta.
English: • made of a heavy-duty plastic;
Maltese: • magħmul minn plastik heavy-duty;
English: Ankylosing spondylitis 76 275
Maltese: Spondilite Ankylosing 76 275
English: City North Business Campus Stamullen, Co. Meath K32 YD60 Ireland
Maltese: City North Business Campus Stamullen, Co. Meath K32 YD60
English: 23, Academy-ro, Yeonsu-gu, Incheon, 22014 Republic of Korea
Maltese: 23, Academy-ro, Yeonsu-gu, Incheon, 22014
English: Units 2100, 2110, 2010, 2120, 2130 and 2500 Phase 18, Central Park
Maltese: Units 2100, 2110, 2010, 2120, 2130 and 2500
English: Crohn's disease2
Maltese: Crohn 2
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
English: CELLTRION, Inc. (Plant II, CLT2) 20, Academy-ro 51 beon-gil, Yeonsu-gu, Incheon, 22014
Maltese: (Plant II, CLT2) 20, Academy-ro 51 beon-gil, Yeonsu-gu, Incheon, 22014
English: ACR 20 response*
Maltese: ACR 20 rispons*
English: N/A 4.4% N/A 1.5%
Maltese: N/A 53.0 N/A 4.4% N/A 1.5%
English: Sustained Steroid-Free Remissionb a Reduction in CDAI ≥25% and ≥70 points.
Maltese: Tnaqqis Mingħajr Sterojdib a Tnaqqis fis-CDAI ≥ 25% u ≥ 70 punt.
English: ACCENT II (Week-14 responders)
Maltese: ACCENT II (Persuni li rrispondew sa ġimgħa 14)
English: The bioavailability of infliximab subcutaneous, estimated in a population PK model, is 58% (95% CI:
Maltese: Il-bijodisponibilità ta' infliximab subkutanju, stmata f'mudell PK tal-popolazzjoni, hija 58% (95% CI:
English: Tachycardia, palpitation
Maltese: Takikardija, palpitazzjoni.
English: 1 vial 2 vials 3 vials 4 vials 5 vials
Maltese: 1 kunjett 2 kunjetti 3 kunjetti 4 kunjetti 5 kunjetti
English: Patients with ACR20 response/Patients evaluated (%)
Maltese: Pazjenti b'reazzjoni ACR20 / Pazjenti evalwati (%)ċ
English: ACR 50 response*
Maltese: ACR 50 rispons*
English: Remsima is a biosimilar medicinal product.
Maltese: Remsima hu prodott mediċinali bijoloġiku simili.
English: Placebo → Infliximab
Maltese: Plaċebo → Infliximab
English: ATC code: L04AB02
Maltese: L04AB02.
English: Excipients: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate.
Maltese: Eċċipjenti: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate.
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: Remsima 120 mg injection infliximab
Maltese: Remsima 120 mg injezzjoni infliximab
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: il-figuri kienu 55.8% (29/52) u 23.5% (12/51) fil-gruppi ta' manteniment tal-ġimgħat q8 u q12, rispettivament (p < 0.001).
English: Week 6 103 (59.2%) 107 (64.8%) 45 (25.9%) 47 (28.5%) 18 (10.3%) 19 (11.5%)
Maltese: Ġimgħa 6 103 (59.2%) 107 (64.8%) 45 (25.9%) 47 (28.5%) 18 (10.
English: Pack sizes of 1, 2, 3, 4, 5 vials.
Maltese: Remsima jiġi f'pakketti ta'1, 2, 3, 4 jew 5 kunjetti.
English: Give the injection 8.
Maltese: Agħti l-injezzjoni 8.
English: Viral infection (e.g. influenza, herpes virus infection).
Maltese: Infezzjoni virali (eż. influwenza, infezzjonijiet bil-virus tal erpes).
English: Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), lichenoid reactions, acute generalised exanthematous pustulosis (AGEP).
Maltese: Nekroliżi tossika tal-epidermide, sindrome ta' Stevens-Johnson, erythema multiforme, furunkulosi, dermatosi bullarja lineari IgA (LABD - linear IgA bullous dermatosis), reazzjonijiet likenojdi,
English: Gastrointestinal haemorrhage, diarrhoea, dyspepsia, gastroesophageal reflux, constipation
Maltese: Emorraġija gastrointestinali, dijarea, dispepsja, rifluss gastroesofagali, stitikezza.
English: Table 5 Mean (SD) Actual Values of DAS28 (CRP and ESR)
Maltese: Valuri Medji (SD) Attwali ta' DAS28 (CRP u ESR)
English: Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections.
Maltese: Infezzjoni fil parti ta' fuq tal-apparat respiratorju (7/60 [12%]) u farinġite (5/60 [8%]) kienu l-aktar infezzjonijiet fis-sistema respiratorja rrappurtati b'mod frekwenti.
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)
English: ≥90% improvement
Maltese: Titjib ta' ≥ 90%
English: After the injection 12.
Maltese: Wara l-injezzjoni 12.
English: Remsima contains sodium
Maltese: Remsima fih sodium
English: Placebo (Week 16)
Maltese: Plaċebo (ġimgħa 16
English: ≥90% improvement ≥75% improvement ≥50% improvement
Maltese: Titjib ta' ≥ 90% Titjib ta' ≥ 75% Titjib ta' ≥ 50%
English: Infliximab Placebo 5 mg/kg 10 mg/kg Combined
Maltese: Infliximab Plaċebo 5 mg/kg 10 mg/kg Flimkien
English: Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT
Maltese: Effetti fuq ACR20, Ħsara Strutturali fil-Ġogi u Funzjoni Fiżika fil-ġimgħa 54, ATTRACT
English: Systemic injection reaction/ localised injection site reaction/ hypersensitivity
Maltese: Reazzjoni għal injezzjoni sistemika/ reazzjoni f'sit ta' injezzjoni lokalizzata/ sensittività eċċessiva
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%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Maltese: 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%),
English: Dispose of the pen (see Figure J).
Maltese: Armi l- pinna (ara l-Figura J).
English: • Pen
Maltese: • Pinna
English: START was a randomised, multicentre, double-blind, 3-arm, parallel-group safety study.
Maltese: multiċentriku, double-blind, bi 3 partijiet tal-istudji, ta' grupp parallel.
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 (inċidenza5.7% [95% CI 2.65%-10.6%].
English: There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]).
Maltese: Kien hemm każ wieħed ta' tumur malinn fost is-77 pazjent tal-kontroll (follow-up medjan ta' 0.8 snin; inċidenza 1.3% [95% CI 0.03%-7.0%]).
English: In Part 2 of this study, among 357 patients who were enrolled to receive 2 doses of Remsima 3 mg/kg intravenously at Weeks 0 and 2, 167 patients were randomised to receive Remsima 120 mg subcutaneously at Week 6 and every 2 weeks up to Week 54, while 176 patients were randomised to receive Remsima 3 mg/kg intravenously at Weeks 6, 14 and 22 and then switched to Remsima 120 mg subcutaneous at Week 30 once-every 2 weeks up to Week 54.
Maltese: F'Parti 2 ta' dan l-istudju, fost 357 pazjent li kienu rreġistrati biex jirċievu 2 dożi ta' Remsima 3 mg/kg ġol-vini fil-Ġimgħat 0 u 2, 167 pazjent ġew randomizzati biex jirċievu Remsima 120 mg taħt il-ġilda fil-Ġimgħa 6 u kull ġimagħtejn sa Ġimgħa 54, filwaqt li 176 pazjent ġew randomizzati biex jirċievu Remsima 3 mg/kg ġol-vina fil-Ġimgħat 6, 14 u 22 u mbagħad maqlubin għal Remsima 120 mg taħt il-ġilda fil-Ġimgħa 30 darba kull ġimagħtejn sal-Ġimgħa 54.
English: Excipients: acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80, water for injections
Maltese: Eċċipjenti: acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80, ilma għall-injezzjonijiet
English: Immunogenicity Antibodies to infliximab were detected in 4 (7.7%) patients through week 54.
Maltese: Antikorpi għal infliximab kienu osservati f'4 (7.7%) pazjenti sa ġimgħa 54.
English: • Alcohol swab
Maltese: • Swab tal-alkoħol
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: persuni li rrispondew għal ASAS 20 kienu 15/78 (19%) fil-grupp tal-plaċebo, u 123/201 (61) fil-grupp fuq 5 mg/kg infliximab (p < 0.001).
English: After the injection 13.
Maltese: Wara l-injezzjoni 13.
English: Remsima contains the active substance infliximab.
Maltese: Remsima fih is-sustanza attiva infliximab.
English: Pharmacotherapeutic group: immunosuppressants, tumour necrosis factor alpha (TNFα) inhibitors,
Maltese: Immunosoppressanti, inibituri tal-fattur tan-necrożi alfa (TNFα),
English: Mean ± SDa
Maltese: Marda ta'
English: Significant improvements from baseline were demonstrated in DLQI (p<0.001) and the physical and mental component scores of the SF 36 (p<0.001 for each component comparison).
Maltese: Titjib sinifikanti mil-linja bażi ġew osservati fil-DLQI (p < 0.001) u l-punteġġi fiżiċi u mentali tal komponenti tal-SF 36 (p < 0.001 għall-paragun ta' kull komponent).
English: The safety population consisted of 168 patients in the Remsima subcutaneous group and 175 patients in the Remsima intravenous group.
Maltese: Il-popolazzjoni tas-sigurtà kienet tikkonsisti minn 168 pazjent fil-grupp ta' Remsima subkutanju u 175 pazjent fil grupp ta' Remsima intravenuż.
English: Date of first authorisation: 10 September 2013 Date of latest renewal: 21 June 2018
Maltese: Data tal-aħħar tiġdid: 21 Ġunju 2018
English: Remsima 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 cyclosporine, methotrexate or psoralen ultra-violet A (PUVA) (see section 5.1).
Maltese: Psorjasi Remsima huwa 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 cyclosporine, methotrexate jew psoralen ultra-violet A (PUVA) (ara sezzjoni 5.1).
English: Celltrion Healthcare Hungary Kft. Τηλ: + 36 1 224 0900 agnes.tompa@noerr.com
Maltese: Τηλ: + 36 1 224 0900 agnes.tompa@noerr.com
English: Tel.: + 48 22 417 9200 recepcja@egis.pl
Maltese: EGIS Polska Dystrybucja Sp. z o.o. Tel.: + 48 22 417 9200 recepcja@egis.pl
English: Remsima contains sorbitol
Maltese: Remsima fih sorbitol
English: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion
Maltese: Edema fil-pulmun, bronkospażmu, plewriżi, effużjoni mill plewra.
English: ≥75% improvement
Maltese: Titjib ta' ≥ 75%
English: Endophthalmitis
Maltese: Endoftalmite.
English: Remsima is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Madankollu, Remsima jiġi ddilwit f'soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%).
English: Peripheral ischaemia, thrombophlebitis, haematoma
Maltese: Iskemija periferali, tromboflebite, ematoma.
English: Dispose of the syringe (see Figure H).
Maltese: Armi s-siringa (ara l-Figura H).
English: At week 24, the placebo group crossed over to infliximab induction therapy (5 mg/kg) followed by infliximab maintenance therapy (5 mg/kg).
Maltese: F'ġimgħa 24, il-grupp fuq plaċebo nqaleb fuq it terapija ta' induzzjoni b'infliximab (5 mg/kg) segwit minn terapija ta' manteniment b'infliximab (5 mg/kg).
English: Change from baseline in total van der Heijde-modified Sharp scoreb Mean ± SDa
Maltese: Bidla mil-linja bażi fit-total tal-punteġġ van der Heijde modifikat Sharpb
English: In the RA patients, the mean (± standard deviation) clearance of Remsima 120 mg subcutaneously was 18.8 ± 8.3 mL/hr at steady state.
Maltese: Fil-pazjenti RA, l-eliminazzjoni medja (± devjazzjoni standard) ta' Remsima 120 mg taħt il-ġilda kienet 18.8 ± 8.3 mL/siegħa fi stat fiss.
English: In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥5 swollen joints and ≥5 tender joints).
Maltese: Fit-tieni studju kliniku (IMPACT 2), l-effikaċja u s-sigurtà ta' infliximab kienu studjati f'200 pazjent b'artrite psorjatika attiva (≥ 5 ġogi minfuħin u ≥ 5 ġogi teneri).
English: Psoriatic arthritis, ankylosing spondylitis (Bechterew's disease), psoriasis, ulcerative colitis and Crohn's disease
Maltese: Artrite bi psorjasi, ankylosing spondylitis (Marda ta' Bechterew), psorjasi, kolite ulċerattiva u l marda ta' Crohn
English: Myocardial ischaemia/myocardial infarction
Maltese: Iskemija mijokardijaka/infart mijokardijaku.
English: < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid data disponibbli).
English: EU/1/13/853/001 EU/1/13/853/002 EU/1/13/853/003 EU/1/13/853/004 EU/1/13/853/005
Maltese: EU/1/13/853/001 EU/1/13/853/002 EU/1/13/853/003 EU/1/13/853/004
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
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 tal plaċebo (36/244; 14.
English: Tel: + 421 2 3240 9422 info@egis.sk
Maltese: Egis Slovakia spol.s r.o. Tel: + 421 2 3240 9422 info@egis.sk
English: In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: "Infusion reactions and hypersensitivity").
Maltese: F'pazjenti psorijatiċi kkurati b'infliximab bħala kors ta' manteniment fl-assenza ta' immunomodulaturi li jingħataw fl-istess ħin, madwar 28% żviluppaw antikorpi għal infliximab (ara sezzjoni 4.4: “Reazzjonijiet tal-infużjoni u sensittività eċċessiva”).
English: Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Maltese: Madwar 93% tal pazjenti qabel kienu ngħataw antibijotiċi jew terapija immunosoppressiva.
English: PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2)
Maltese: PGA ta' pazjenti bid-dwiefer imfejqa (0) jew minimu PGA ta' pazjenti bid-dwiefer imfejqa (0), minimu (1),
English: Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30 and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Maltese: Minn 22 individwu li kellhom fistuli fil-linja bażi, 63.6% (14/22), 59.1% (13/22) u 68.2% (15/22) kellhom rispons sħiħ tal-fistula f'ġimgħa 10, 30 u 54,
English: Complete fistula response (%)b a A ≥50% reduction from baseline in the number of draining fistulas over a period of ≥4 weeks.
Maltese: Rispons Fistula (%) a Rispons fistula komplet (%) b a Tnaqqis ta' ≥ 50% mil-linja bażi fin-numru ta' fistuli li kienu qed inixxu fuq perjodu ta'
English: The estimate of treatment difference was 0.27 with corresponding lower limit of the two-sided 95% confidence interval [CI] of 0.02 (95% CI: 0.02, 0.52), which was greater than the pre-specified non-inferiority margin of -0.6 indicating non-inferiority of Remsima subcutaneous formulation to Remsima intravenous formulation.
Maltese: L-istima tad-differenza fil-kura kienet 0.27 b'limitu aktar baxx korrespondenti tal-intervall ta' fiduċja ta' 95% ta' żewġ naħat [CI] ta' 0.02 (95% CI: 0.02, 0.52), li kien ikbar millmarġini ta' non-inferjorità speċifikat minn qabel ta' -0.6 li jindika non-inferjorità ta' formulazzjoni taħt il-ġilda ta' Remsima għal formulazzjoni ġol-vina ta' Remsima.
English: Remove the cap (see Figure D).
Maltese: Neħħi l-kappa (ara l-Figura D).
English: ≥ 3 x ULN
Maltese: ≥ 3 darbiet ULN ≥ 5 darbiet ULN
English: Baseline Week 6
Maltese: Linja bażi Ġimgħa 6
English: Rheumatoid arthritis
Maltese: Artrite rewmatoika
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE
Maltese: Effetti fuq l-ACRn, Ħsara Strutturali fuq il-Ġogi u Funzjoni Fiżika f'ġimgħa 54, ASPIRE
English: In studies in healthy subjects, the mean (± standard deviation) apparent clearance of Remsima 120 mg administered subcutaneously was 19.3 ± 6.9 mL/hr.
Maltese: Fi studji f'individwi b'saħħithom, l-eliminazzjoni apparenti medja (± devjazzjoni standard) ta' Remsima 120 mg mogħtija taħt il-ġilda kienet 19.3 ± 6.9 mL/siegħa.
English: In the REACH study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Maltese: Infezzjonijiet Fl-istudju REACH, infezzjonijiet kienu rrappurtati f'56.3% tal-individwi li ntgħażlu b'mod każwali kkurati b'infliximab.
English: At baseline 27.4% of patients were receiving systemic corticosteroids, 14.2% of patients were receiving budesonide, and 54.3% of patients were receiving 5-ASA compounds.
Maltese: tal-pazjenti kienu qed jirċievu kortikosterojdi sistemiċi, 14.2% tal-pazjenti kienu qed jirċievu budesonide, u 54.3% tal-pazjenti kienu qed jirċievu komposti ta' 5-ASA.
English: placebo infliximab placebo infliximab placebo infliximab placebo infliximab
Maltese: Inflixima b plaċeb o inflixima b plaċeb o inflixima b plaċeb o inflixima b
English: The mean terminal half-life ranged from 11.3 days to 13.7 days for 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects.
Maltese: Il-half-life terminali medju varja minn 11.3 jiem sa 13.7 jiem għal 120, 180 u 240 mg ta'
English: • Abnormal values of a blood protein called ‘complement factor' which is part of the immune system
Maltese: • Valuri mhux normali ta' proteina tad-demm imsejħa ‘complement factor' li hija parti mis sistema immuni
English: The safety profile of Remsima subcutaneous formulation (evaluated in 168 and 175 patients for the subcutaneous infliximab group and the intravenous infliximab group, respectively) from active rheumatoid arthritis patients was overall similar to the safety profile of the intravenous formulation.
Maltese: Il-profil ta' sigurtà ta' Remsima formulazzjoni taħt il-ġilda (evalwat f'168 u f'175 pazjent għall-grupp ta' infliximab subkutanju u għall-grupp ta' infliximab ġol-vini, rispettivament) minn pazjenti b'artrite rewmatojde attiva kien ġeneralment simili għall-profil ta' sigurtà tal-formulazzjoni ġol-vina.