FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding safety, the data from study TEC062 showed no differences between Teicoplanin Hospira and Targocid, however, the premature termination of the study does not allow solid conclusions to be drawn, although there were no suggestions of any differential safety profile between the two products.
Maltese: Rigward is-sigurtà, id-dejta mill-istudju TEC062 ma wriet l-ebda differenza bejn Teicoplanin Hospira u Targocid, madankollu, it-tmiem prematur tal-istudju ma jippermettix li wieħed jasal għal xi konklużjonijiet solidi, għalkemm ma kienx hemm suġġerimenti ta' xi profil ta' sigurtà differenti bejn iż-żewġ prodotti.
English: The Applicant undertook an extensive testing program to characterise the activity of Teicoplanin Hospira versus Targocid against a series of clinically relevant species and demonstrated essential similarity between Teicoplanin Hospira and Targocid for all individual strains and species.
Maltese: L-Applikant wettaq programm ta' ttestjar estensiv sabiex jikkaratterizza l-attività ta' Teicoplanin Hospira mqabbel ma' Targocid kontra sensiela ta' speċi klinikament rilevanti u wera xebħ essenzjali bejn
English: Question 1 - The differences in composition between the two products and the resulting differences between the AUC values do not clearly demonstrate that Teicoplanin Hospira and the reference product Targocid are essentially similar.
Maltese: Mistoqsija 1 - Id-differenzi fil-kompożizzjoni bejn iż-żewġ prodotti u d-differenzi li jirriżultaw bejn il-valuri AUC ma jurux b'mod ċar li Teicoplanin Hospira u l-prodott ta' referenza Targocid huma essenzjalment simili.
English: The Applicant claimed essential similarity to the innovator product Targocid, despite acknowledging differences in the profile of glycopeptides.
Maltese: L-Applikant afferma li hemm xebħ essenzjali mal-prodott innovatur Targocid, minkejja li rrikonoxxa xi differenzi fil-profil tal-glikopeptidi.
English: Therefore, PK/PD relationships for antimicrobials are based on free drug.
Maltese: Għaldaqstant, ir-relazzjonijiet bejn il-PK u l-PD għallantimikrobjali huma bbażati fuq mediċina libera.
English: Teicoplanin 400 mg Powder and Solvent for Solution for Injection or Infusion
Maltese: Teicoplanina Hospira 400 mg Pó e solvente para solução injectável ou solução para perfusão
English: The CHMP noted the Applicant data and agreed that free drug is more important for biological activity and is thus the better parameter to demonstrate “pharmacodynamic”-equivalence.
Maltese: Is-CHMP nnota d-dejta tal-Applikant u qabel li mediċina libera hija aktar importanti għal attività bijoloġika u hija għalhekk l-aħjar parametru biex turi lekwivalenza “farmakodinamika”.
English: Question 4 - The Applicant states that in clinical practice, the dose of teicoplanin is adjusted to the clinical course and the trough serum concentrations especially in severe infections.
Maltese: Mistoqsija 4 - L-Applikant jiddikjara li fil-prattika klinika, id-doża ta' teicoplanin tiġi aġġustata skont il-kors kliniku u l-konċentrazzjonijiet minimi fis-serum b'mod speċjali fl-infezzjonijiet severi.
English: The Applicant discussed the variation in subcomponent levels and stated that bioequivalence or essential similarity for Teicoplanin is best assessed by comparing the sum of free AUC/MIC for the subcomponents.
Maltese: L-Applikant iddiskuta l-varjazzjoni fil-livelli tas-subkomponenti u ddikjara li lbijoekwivalenza jew xebħ essenzjali għal Teicoplanin huwa evalwat bl-aħjar mod billi jitqabbel it-total ta' AUC/MIC liberi għas-subkomponenti.
English: The Applicant did not further discuss the outcomes of the partially completed bioequivalence studies evaluating AUC and Cmax, as the CHMP considered that due to the nature of this drug, the whole drug (total) AUC is not appropriate to demonstrate bioequivalence.
Maltese: L-Applikant ma kompliex jiddiskuti l-eżiti tal-istudji ta' bijoekwivalenza parzjalment kompluti li jevalwaw l-AUC u s-Cmax, minħabba li s-CHMP kkunsidra li minħabba n-natura ta' din il-mediċina, l-AUC sħiħa (totali) tal-mediċina mhijiex adattata biex turi l-bijoekwivalenza.
English: The Applicant therefore conducted a series of preclinical studies and reviewed the published literature on the biological activity of the individual subcomponents of teicoplanin.
Maltese: Għalhekk, l-Applikant wettaq sensiela ta' studji prekliniċi u rreveda l-litteratura ppubblikata dwar l-attività bijoloġika tas-subkomponenti individwali ta' teicoplanin.
English: The Applicant acknowledged that AUC 0-tlast and AUC 0-inf were below the accepted range, indicating that the two preparations were not PK equivalent for total drug exposure.
Maltese: L-Applikant irrikonoxxa li AUC 0-tlast u AUC 0-inf kienu iktar baxxi mill-firxa aċċettata, u dan jindika li żżewġ preparazzjonijiet ma kellhomx ekwivalenza PK għall-espożizzjoni totali tal-mediċina.
English: The CHMP considers that with respect to pharmacodynamics, the study demonstrated that serum bactericidal activity was similar for both the Teicoplanin Hospira and Targocid and that the free drug proportion for each sub-component was similar for the two products.
Maltese: Is-CHMP jikkunsidra li rigward il-farmakodinamika, l-istudju wera li l-attività batteriċida fis-serum kienet simili kemm għal Teicoplanin Hospira kif ukoll għal Targocid u li l-proporzjon ta' mediċina libera għal kull subkomponent kien simili għaż-żewġ prodotti.
English: The CHMP accepted the Applicant response, as the provided guidance documents supporting teicoplanin monitoring were considered relevant.
Maltese: Is-CHMP aċċetta t-tweġiba tal-Applikant, minħabba li d-dokumenti ta' gwida li jappoġġjaw il-monitoraġġ ta' teicoplanin pprovduti tqiesu rilevanti.
English: The Applicant also discussed the data from the neutropenic mouse thigh infection study, arguing that the results clearly show that Teicoplanin Hospira and Targocid were equally effective in reducing bacterial count, confirming that the differences in relative composition of individual components do not affect the biological activity of the product.
Maltese: L-Applikant iddiskuta wkoll id-dejta mill-istudju ta' infezzjoni fil-koxxa ta' ġurdien newtropeniku, u argumenta li r-riżultati juru biċ-ċar li Teicoplanin Hospira u Targocid kienu effettivi indaqs fit-tnaqqis tal-għadd batteriku, li jikkonferma li d-differenzi filkompożizzjoni relattiva tal-komponenti individwali ma jaffettwawx l-attività bijoloġika tal-prodott.
English: Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung
Maltese: Teicoplanin Hospira 400 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung
English: The CHMP noted that for Teicoplanin Hospira to be considered as a generic product, the difference in the amounts of glycopeptides subcomponents must be acceptable and that this difference must not lead to a difference in safety and/or efficacy.
Maltese: Is-CHMP nnota li biex Teicoplanin Hospira jitqies bħala prodott ġeneriku, id-differenza fl-ammonti ta' subkomponenti glikopeptidi għandha tkun aċċettabbli u li din id-differenza m'għandhiex twassal għal differenza fis-sigurtà u/jew fl-effikaċja.
English: The Applicant submitted a request for a re-examination of the CHMP opinion, responding to the grounds supporting the decision that Teicoplanin Hospira cannot be considered to be a generic of the innovator Targocid and addressed one by one the three grounds for refusal of the granting of the Marketing Authorisations.
Maltese: L-Applikant issottometta talba għal eżami mill-ġdid tal-opinjoni tas-CHMP, filwaqt li wieġeb għar-raġunijiet li jsostnu d-deċiżjoni li Teicoplanin Hospira ma jistax jitqies li huwa ġeneriku tal-innovatur Targocid u indirizza b'mod individwali t-tliet raġunijiet għar-rifjut tal-għoti tal-Awtorizzazzjonijiet għat-Tqegħid fisSuq.
English: The Applicant considers that the achieved product is in line with the published EDQM teicoplanin monograph, but stated that only the originator MAH was invited to comment on this monograph, and that comments submitted by Hospira were not accepted.
Maltese: L-Applikant ikkunsidra li l-prodott miksub huwa konformi mal-monografu ta' teicoplanin ippubblikat mill-EDQM, iżda ddikjara li l-MAH tal-oriġinatur biss kien mistieden jikkumenta dwar dan ilmonografu, u li l-kummenti sottomessi minn Hospira ma ġewx aċċettati.
English: The full EPAR for Protopic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Protopic is an ointment that contains the active substance tacrolimus (0.1% and 0.03%).
Maltese: Protopic huwa ingwent li fih is-sustanza attiva tacrolimus (0.1% u 0.03%).
English: The active substance in Protopic, tacrolimus, is an immunomodulator.
Maltese: Is-sustanza attiva fi Protopic, it-tacrolimus, hija immunomodulatur.
English: This is a summary of the European public assessment report (EPAR) for Protopic.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Protopic.
English: The use of Protopic in the treatment of flare-ups has been studied in six main studies involving 1,202 patients over the age of 16 years, and 1,535 aged from two to 16 years.
Maltese: L-użu ta' Protopic fit-trattament ta' żidiet f'daqqa ġie studjat f'sitt studji prinċipali li ħadu sehem fihom 1,202 pazjenti ta' 'l fuq minn 16-il sena, u 1,535 pazjent ta' bejn sentejn u 16-il sena.
English: Maintenance treatment with Protopic has been studied in two main studies involving 224 patients aged 16 years or over, and 250 aged from two to 15 years.
Maltese: Il-manteniment tat-trattament bi Protopic ġie studjat f'żewġ studji prinċipali li ħadu sehem fihom 224 pazjent ta' 16-il sena jew aktar, u 250 pazjent minn sentejn sa 15-il sena.
English: While Protopic 0.03% can be used in all patients over two years of age, Protopic 0.1% is only used in adults and adolescents over 16 years of age.
Maltese: Filwaqt li Protopic 0.03% jista' jintuża fil-pazjenti kollha li għandhom aktar minn sentejn, Protopic 0.1% jintuża biss f'adulti u f'adoloxxenti ta' 'l fuq minn 16-il sena.
English: What is the risk associated with Protopic?
Maltese: X'inhuma r-riskji assoċjati ma' Protopic?
English: In atopic dermatitis, an over-reaction of the skin's immune system causes skin inflammation (itchiness, redness and dryness).
Maltese: Fid-dermatite atopika, reazzjoni eċċessiva mis-sistema immunitarja tal-ġilda tikkawża infjammazzjoni tal-ġilda (ħakk, ħmura u ġilda niexfa).
English: Another study looked at the repeated use of Protopic for up to four years in about 800 patients.
Maltese: Studju ieħor stħarreġ l-użu ripetut ta' Protopic sa erba' snin f'madwar 800 pazjent.
English: The most common side effects with Protopic (seen in more than 1 patient in 10) are a burning sensation and itching at the application site.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Protopic (li dehru f'aktar minn pazjent 1 minn 10) huma sensazzjoni ta' ħruq u ħakk fis-sit tal-applikazzjoni.
English: What is Protopic?
Maltese: X'inhu Protopic?
English: All of the patients had atopic dermatitis that had responded to a maximum of six weeks of previous treatment with Protopic.
Maltese: Il-pazjenti kollha kellhom dermatite atopika li kienu rrispondew għal massimu ta' sitt ġimgħat ta' trattament preċedenti bi Protopic.
English: Protopic was compared either with placebo (a dummy treatment) or with hydrocortisone (a corticosteroid often used for eczema).
Maltese: Protopic tqabbel ma' plaċebo (trattament finta) jew mal-idrokortiżon (kortikosterojde li spiss tintuża għall-ekżema).
English: Why has Protopic been approved?
Maltese: Għaliex ġie approvat Protopic?
English: When used for flare-ups, Protopic can be used for short-term and intermittent long-term treatment, but it should not be used continuously on a long-term basis.
Maltese: Fl-istudju li kien itwal, Protopic intuża ripetutament mingħajr ma tilef xejn mill-effikaċja tiegħu.
English: Protopic is used to treat ‘flare-ups' (recurrence or worsening) of moderate to severe atopic dermatitis (eczema, an itchy red rash of the skin).
Maltese: It-tacrolimus ilha tintuża sa min-nofs id-disgħinijiet sabiex tgħin filprevenzjoni tar-rifjut f'pazjenti li jkunu rċivew trapjant (meta s-sistema immunitarja tattakka l-organu trapjantat).
English: Tacrolimus reduces the activity of the immune system, helping to relieve the skin inflammation and the itching.
Maltese: It-tacrolimus tnaqqas l-attività tas-sistema immunitarja, billi tgħin biex jittaffew l-infjammazzjoni tal-ġilda u l-ħakk.
English: In the treatment of flare-ups of atopic dermatitis, Protopic was more effective than hydrocortisone at producing improvements in symptoms, although it also produced more burning than hydrocortisone.
Maltese: Fit-trattament ta' żidiet f'daqqa tad-dermatite atopika, Protopic kien aktar effettiv mill-idrokortiżon fittitjib tas-sintomi, għalkemm ipproduċa wkoll aktar ħruq mill-irokortiżon.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Protopic on 28 February 2002.
Maltese: Il-Kummissjoni Ewropea tat l-awtorizzazzjoni għat-tqegħid fis-suq għal Protopic valida fl-Unjoni Ewropea kollha fit-28 ta' Frar 2002.
English: The CHMP decided that Protopic's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Protopic huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The studies compared twice-weekly Protopic with placebo, although both groups of patients could use Protopic whenever they had a flare-up of the disease.
Maltese: Kull parti affettwata għandha tiġi ttrattata darbtejn kuljum bi Protopic sakemm il-ġilda ssir ċara.
English: How has Protopic been studied?
Maltese: Kif ġie studjat Protopic?
English: How does Protopic work?
Maltese: Għal xiex jintuża Protopic?
English: Wait 15-30 minutes
Maltese: Stenna 15-30 minuta
English: ATC code: L04AB04
Maltese: Kodiċi ATC: L04AB04
English: NOTE:
Maltese: NOTA:
English: Dose + 0.1 ml
Maltese: Doża + 0.1 mL
English: ASDASc,d,e
Maltese: c,d,e
English: Ped ACR 30 response (n/N)
Maltese: Ped ACR 30 rispons (n/N)
English: • nervous system problems
Maltese: • problemi fis-sistema nervuża
English: • psoriasis,
Maltese: • psorijasi,
English: SPARCCh MRI Sacroiliac Jointsd,i
Maltese: SPARCCh MRI Ġogi Sacroiliac d,i
English: Standard dose
Maltese: Doża standard
English: Clinical response (CR-100)
Maltese: Rispons kliniku (CR-100)
English: Uncommon Rhabdomyolysis, systemic lupus erythematosus
Maltese: Rabdomijoliżi, lupus erythematosus sistemiku
English: Placebo/MTXAdalimumab/MTX (95% Confidence Interval b)
Maltese: Plaċebo/MTXAdalimumab /MTX (95 % Intervall ta' Konfidenza b)
English: Table 25 Maintenance regimen
Maltese: Tabella 25 Reġim ta' Manteniment
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen fi friġġ (2 °C - 8 °C).
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jistgħu jaffetwaw sa persuna waħda minn kull 1,000):
English: Week 52 Open-label
Maltese: 52 Ġimgħa Open-label
English: Table 19 Maintenance regimen
Maltese: Tabella 19 Reġim ta' Manteniment
English: Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Maltese: Ir-rispons kliniku (CR-100) kien mantenut f'102 u 233 pazjent , rispettivament.
English: Packs of:
Maltese: Pakketti ta':
English: ASDASc Inactive Disease
Maltese: ASDASc Marda Inattiva
English: 40 mg/0.8 ml
Maltese: INDIVIDWALI 40 mg/0.8 mL
English: 4) Dose Preparation
Maltese: 4) Preparazzjoni tad-Doża
English: Analysis Treatment
Maltese: Analiżi Trattament
English: Imraldi contains sodium and sorbitol
Maltese: Imraldi fih sodium u sorbitol
English: ASASa Partial Remission
Maltese: ASASa Remissjoni Parzjali
English: Placebo (treatment withdrawal) N = 73
Maltese: Plaċebo (trattament irtirat) N = 73
English: Very common Leukopenia (including neutropenia and agranulocytosis), anaemia
Maltese: Lewkopenja (li tinkludi newtropenja u agranulocytosis), anemija
English: HS Study II
Maltese: HS Studju II
English: Usually, Imraldi is used with methotrexate.
Maltese: Ġeneralment, Imraldi jintuża ma' methotrexate.
English: 2616LR Delft The Netherlands
Maltese: 2616LR Delft L-Olanda
English: EU/1/17/1216/001 1 pre-filled syringe EU/1/17/1216/002 2 pre-filled syringes EU/1/17/1216/003 4 pre-filled syringes EU/1/17/1216/004 6 pre-filled syringes
Maltese: EU/1/17/1216/001 1 siringa mimlija għal-lest EU/1/17/1216/002 2 siringi mimlijin għal-lest EU/1/17/1216/003 4 siringi mimlijin għal-lest EU/1/17/1216/004 6 siringi mimlijin għal-lest
English: Hidradenitis Suppurativa Clinical Response (HiSCR)a
Maltese: Hidradenitis Suppurativa Rispons Kliniku (HiSCR)
English: EU/1/17/1216/005 1 pre-filled pen EU/1/17/1216/006 2 pre-filled pens EU/1/17/1216/007 4 pre-filled pens EU/1/17/1216/008 6 pre-filled pens
Maltese: EU/1/17/1216/005 1 pinna mimlija għal-lest EU/1/17/1216/006 2 pinen mimlija għal-lest EU/1/17/1216/007 4 pinen mimlija għal-lest EU/1/17/1216/008 6 pinen mimlija għal-lest
English: Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
Maltese: studju HS-II (PIONEER II) evalwa 326 pazjenti b'żewġ perjodi ta' trattament.
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18 % vs. 9 % respectively, p=0.031) and study UC-II (17 % vs. 9 % respectively, p=0.019).
Maltese: Pazjenti li ngħataw 160/80 mg adalimumab kellhom titjib kliniku f'perċentwali akbar li kienu statistikament sinjifikanti meta mqabbla ma plaċebo f'ġimgħa 8 fi studju UC-I (18 % vs. 9 % rispettivament, p = 0.031) u fi studju UC-II (17 % vs. 9 % rispettivament, p = 0.019).
English: • cancer, including cancer of the lymph system (lymphoma) and melanoma (a type of skin cancer);
Maltese: • kanċer, inkluż kanċer tas-sistema limfatika (limfoma) u melanoma (tip ta' kanċer tal-ġilda);
English: • hidradenitis suppurativa,
Maltese: • hidradenitis suppurtiva,
English: The proportions of subjects with PaedACR50/70/90 at week 12 and week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Maltese: Il-proporzjonijiet ta' pazjenti b' PedACR50/70/90 f'ġimgħa 12 u ġimgħa 24 kienu ta' 90.3 %/61.3 %/38.7 % u 83.3 %/73.3 %/36.
English: Syringe disposal
Maltese: Disfunzjoni erettili
English: Placebo/MTXa
Maltese: Plaċebo/ MTX
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Maltese: Figura 1: Sommarju tal-Kurvi Kaplan-Meier tal-Ħin tal-Flare fi Studju nr-axSpA II
English: - the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Maltese: - trattament ta' artrite rewmatika attiva u progressiva severa f'adulti li ma jkunux ingħataw trattament b'methotrexate qabel.
English: Uncommon Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Maltese: Limfoma**, neoplażmi fl-organi solidi (li jinkludu kanċer tas-sider, neoplażma fil-pulmun u neoplażma fit-tirojde), melanoma**
English: * p<0.05, ***p<0.001, adalimumab versus placebo a
Maltese: * p< 0.05, ***p< 0.001, adalimumab kontra plaċebo a
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
Maltese: Immunosuppressanti, Inibitturi ta' Tumur Nekrosi Fattur alfa (TNF-α).
English: Table 29 Time to Treatment Failure in Studies UV I and UV II
Maltese: Tabella 29 Żmien għall-Falliment tat-Trattament fi Studji UV I and UV II
English: Placebo N=398 n (%)
Maltese: Plaċebo N=398 n (%)
English: Table 19 Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Maltese: Tabella 19 Ps Studju IV Riżultati tal-Effikaċja f'Ġimgħat 16, 26 u 52
English: The active ingredient in Imraldi, adalimumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Imraldi, adalimumab, hija anti-korp monoklonali.
English: Table 16 Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Maltese: Tabella 16 Ps Studju IV Riżultati tal-Effikaċja f'16, 26 u 52 ġimgħa
English: Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Maltese: Tabella 18 Studju Ps II (CHAMPION)
English: Double-Blind Response at Week 12
Maltese: Rispons Double-Blind f'Ġimgħa 12
English: Imraldi is a biosimilar medicinal product.
Maltese: Imraldi huwa prodott mediċinali bijoloġiku simili.
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 4.4).
Maltese: Tuberkulosi attiva jew infezzjonijiet oħra severi bħal sepsis, u infezzjonijiet opportunistiċi (ara sezzjoni 4.4).
English: Adalimumab significantly decreased the risk of treatment failure by 75 % relative to placebo, as shown by the hazard ratio (HR = 0.25 [95 % CI: 0.12, 0.49]).
Maltese: Adalimumab naqqas b'mod sinifikanti r-riskju ta' falliment tat-trattament b'75% meta mqabbel mal-plaċebo, kif inhu muri mill-proporzjon ta' periklu (HR = 0.25 [95% CI: 0.12, 0.49]).
English: Uncommon Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Maltese: Anewriżma tal-aorta, sadd fl-arterji, tromboflebite
English: The corresponding proportions of patients with no radiographic progression were 31.3 %, 23.7 % and 36.7 % respectively.
Maltese: Il-proporzjonijiet li jikkorrispondu ta' pazjenti bl-ebda progressjoni radjografika kienu 31.3%, 23.7% u 36.7% rispettivament.
English: • hepatitis;
Maltese: • epatite;
English: Standard Dose 40/20 mg eow
Maltese: Doża Standard 40/20 mg eow
English: The adjusted OR (accounting for baseline differences) was 1.10 (95 % CI 0.45-2.73) with RA and CD combined.
Maltese: L-OR aġġustata (li tammonta għal differenzi fil-linja bażi) kienet 1.10 (95% CI 0.45-2.73) b'RA u CD ikkombinati.
English: Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Maltese: Pazjenti rċevew adalimumab 0.8 mg/kg eow (sa 40 mg), 0.4 mg/kg eow (sa 20 mg), jew methotrexate 0.1 - 0.4 mg/kg kull ġimgħa (sa 25 mg).
English: Study nr-axSpA I
Maltese: studju nr-axSpA I
English: P value*
Maltese: Valur P*
English: Total Sharp Score
Maltese: Punteġġ Totali Sharp c
English: The safety and efficacy of multiple doses of adalimumab were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Maltese: Is-sigurtà u l-effikaċja ta' dożi multipli ta' adalimumab ġew stimati f' pazjenti adulti b'kolite ulċerattiva moderata sa severa (Punteġġ Mayo 6 sa 12; Sottopunteġġ 2 sa 3 bl-endoskopija) fi studji ikkontrollati bi plaċebo, randomizzati u double-blind.
English: Table 28 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Maltese: Tabella 28 Rispons, Titjib kliniku u Fejqan tal-Mukoża fi Studju UC-II (Persentaġġ ta' pazjenti)
English: Excipients: Sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injections.
Maltese: Sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, u l-ilma għall-injezzjoni.