FrancophonIA/ELRC3.0 huggingface dataset:
English: Contact with natural rubber latex may cause severe allergic reactions in individuals sensitive to latex.
Maltese: Kuntatt ma' latex ta' gomma naturali jista' jikkawża reazzjonijiet allerġiċi severi f'individwi sensittivi għal-latex.
English: Evaluation for treatment of signs and symptoms and inhibition of structural damage.
Maltese: Evalwazzjoni tat-trattament tas-sinjali u sintomi u l-inibizzjoni ta' ħsara strutturali.
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (≥ 1/10,000 sa < 1/1000);
English: • immune disorders such as sarcoidosis (rash, joint pain, fever), serum sickness, inflammation of the fat tissue, angioneurotic oedema (swelling of the lips, face, throat)
Maltese: • mard immuni bħal sarkojdożi (raxx, uġigħ fil-ġogi, deni), mard tas-serum, infjammazzjoni tat tessut tax-xaħam, edima angjonewrotika (nefħa fix-xofftejn, wiċċ, gerżuma)
English: Patients were evaluated in a double-blind placebo-controlled manner through Week 48.
Maltese: Il-pazjenti kienu evalwati b'mod doubleblind ikkontrollat bil-plaċebo matul Ġimgħa 48.
English: Sustained remission* (DAS28(ESR) <2.6 at both Week 40 and Week 52) Sustained low disease activity (DAS28(ESR) ≤3.2 at both Week 40 and Week 52) *Primary endpoint of C-EARLY trial (to Week 52) Full analysis set, non-responder imputation for missing values.
Maltese: Rimissjoni sostenuta* (DAS28(ESR) <2.6 kemm f'Ġimgħa 40 u Ġimgħa 52) Attivita`baxxa tal-marda sostenuta (DAS28(ESR) ≤3.2 kemm f'Ġimgħa 40 u Ġimgħa 52) *Il-punt tal-aħħar tal-prova C-EARLY (għal Ġimgħa 52) Set ta' analiżi sħiħ, imputazzjoni għall-valuri nieqsa ta' min ma rrispondiex. **Cimzia+MTX vs placebo+MTX: p<0.001 p value kien stmat minn mudell ta; rigressjoni loġistiku b'fatturi għal trattament, reġjun, u ħin minn dijanjożi ta' RA mill-Linja Bażi (≤4 xhur vs >4 xhur)
English: Ankylosing spondylitis Non-radiographic axial spondyloarthritits
Maltese: Spondilite ankilosing Spondiloartrite axjali mhux radjografika
English: Non-radiographic axial spondyloarthritis (nr-axSpA) The efficacy and safety of Cimzia were assessed in a 52 weeks multicenter, randomized, double-blind, placebo-controlled study (AS0006) in 317 patients ≥18 years of age with adult-onset axial spondyloarthritis and back pain for at least 12 months.
Maltese: L-effikaċja u s-sigurta`ta' Cimzia kienu mkejla fi studju ta' 52 ġimgħa, multi-ċentrali, randomizzat, double-blind, ikkontrollat mill-plaċebo (AS0006) fi 317-il pazjent ≥18 -il sena bi spondiloartrite axjali li bdiet meta kienu adulti u uġigħ fid-dahar għal mill-inqas 12-il xahar.
English: Cimzia-treated patients reported significant improvements in health-related quality of life as measured by the psoriatic arthritis QoL (PsAQoL) and the SF-36 Physical and Mental Components and in psoriatic arthritis-related productivity at work and within household, as reported by the Work Productivity Survey compared to placebo.
Maltese: Il-pazjenti ttrattati b'Cimzia irrapurtaw emeljorament sinifikanti filkwalita` tal-ħajja relatata mas-saħħa kif mkejjla mill-artrite psorijatika QoL (PsAQoL) u lSF-36 Komponenti Fiżiċi u Mentali u fil-produttivita` fix-xogħol u fid-dar relatata mal-artrite psorijatika, kif irrappurtati fis-Survey tal-Produttivita` fix-Xogħol meta mqabbla mal- plaċebo.
English: At Week 4 and Week 8, all infant concentrations were BLQ.
Maltese: F'Ġimgħa 4 u Ġimgħa 8, il-konċentrazzjonijiet kollha fit-trabi kienu BLQ.
English: Table 5 Changes over 12 months in RA-I Placebo + MTX N=199 Mean (SD)
Maltese: Tibdil matul 12-il xahar f' RAI Plaċebo + MTX N=199 Medja (SD)
English: The pharmacokinetics of the PEG fraction of certolizumab pegol are expected to be dependent on renal function but have not been assessed in patients with renal impairment.
Maltese: Huwa mistenni li l-farmakokinetika tal-frazzjoni PEG (polyethylene glycol) ta' certolizumab pegol tiddependi mill-funzjoni renali, iżda ma ġietx eżaminata f'pazjenti b'indeboliment renali.
English: Immunogenicity
Maltese: Immunoġeniċita`
English: • lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
Maltese: • reazzjonijiet likenojdi (raxx tal-ġilda ħamrani fil-vjola bil-ħakk u/jew ħjut bojod fil-griż fuq il membrani mukużi)
English: • improve your physical function and performance of daily tasks.
Maltese: • ikun hemm titjib tal-funzjoni fiżika u t-twettieq ta' attivitajjiet ta' kuljum.
English: The overall percentage of patients with antibodies to Cimzia detectable on at least 1 occasion was 9.6% in RA placebo-controlled trials.
Maltese: Il-persentaġġ fuq kollox tal-pazjenti b'antikorpi għal Cimzia li nstagħbu f'mill-inqas okkażjoni 1 kien ta' 9.6% fil-provi RA ikkontrollati mill-plaċebo.
English: Table11: Clinical response in studies CIMPASI-1 and CIMPASI-2 at Week 16 and Week 48 Week 16
Maltese: Tabella 11: Rispons kliniku fl-istudji CIMPASI-1 u CIMPASI-2 f'Ġimgħa 16 u Ġimgħa 48 Ġimgħa 16
English: The efficacy and safety of Cimzia were evaluated versus etanercept in the CIMPACT study.
Maltese: L-effikaċja u s-sigurtà ta' Cimzia kienu evalwati kontra etanercept fl-istudju CIMPACT.
English: PASI 75 PASI 90 a) Cimzia 200 mg administered every 2 weeks preceded by a loading dose of 400 mg at Week 0, 2, 4. b) PGA 5 category scale.
Maltese: PASI 90 a) Cimzia 200 mg mogħti kull ġimagħtejn wara doża inizjali qawwija ta' 400 mg f'Ġimgħa 0, 2, 4.
English: 879 400 mg (0,2,4 weeks) with MTX 200 mg every 2 weeks with MTX
Maltese: 879 400 mg (0,2,4 ġimgħat) b' MTX 200 mg kull ġimagħtejn b' MTX
English: The Fab' fragment comprises protein compounds and is expected to be degraded to peptides and amino acids by proteolysis.
Maltese: Il-framment Fab` jikkonsisti minn proteini u hu mistenni li jitkisser f'peptidi u amino aċidi bilproteoliżi.
English: Clinical response at Week 16 and 48 The key results of CIMPASI-1 and CIMPASI-2 studies are presented in Table 11.
Maltese: Rispons kliniku f'Ġimgħa 16 u 48 Ir-riżultati prinċipali tal-istudji CIMPASI-1 u CIMPASI-2 huma ppreżentati f'Tabella 11.
English: At week 12, significant inhibition of inflammatory signs in both sacroiliac joints and the spine was observed in the Cimzia-treated patients (all dose group), in the overall axial spondyloarthritis population as well as in the sub-populations of ankylosing spondylitis and non-radiographic axial spondyloarthritis.
Maltese: F' Ġimgħa 12, inhibizzjoni sinifikanti ta' sinjali infjammatorji kemm fil-ġogi sakroiljaċi u s-sinsla kienu osservati f'pazjenti trattati b'Cimzia (grupp ta' kull doża), fil-popolazzjoni totali ta' spondiloartrite axjali kif ukoll fis-sub-popolazzjoni ta' spondilite ankilosing u spondiloartite axjali mhux radjografika.
English: ACR70 Week 12 Week 24
Maltese: ACR70 Ġimgħa 12 Ġimgħa 24
English: These 3 groups were well balanced with regards to clinical response following the active run-in period (ACR 20: 83-84% at week 18).
Maltese: Dawn it-tlett gruppi kienu bbilanċjati fir-rigward tra-rispons kliniku segwit minn perjodu run-in (ACR 20; 83-84% f'ġimgħa 18).
English: Nervous system disorders
Maltese: Disturb fis-sistema endokrinarja
English: • the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.
Maltese: • għat-trattament ta'RA progressiva, severa u attiva f'adulti li ma kienux ittrattati qabel b'MTX jew DMARDs oħra.
English: Treatment regimen week 0 to 16 Cimzia 400 mg + MTX at week 0, 2 and 4, followed by
Maltese: Cimzia 400 mg + MTX f'ġimgħa 0, 2 u 4, segwit minn Cimzia 200 mg + MTX kull ġimagħtejn
English: • nausea
Maltese: • uġigħ
English: Cimzia, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
Maltese: Cimzia, flimkien ma' MTX, huwa indikat għat-trattament ta' artrite psorijatika fl' adulti meta r-rispons għal terapija DMARD li ngħatat qablel kienet inadekwata.
English: The percentage of the maternal certolizumab pegol dose reaching an infant during a 24 hour period was estimated to 0.04% to 0.30 %.
Maltese: Il-perċentwal tad-doża ta' certolizumab pegol fl-omm li jilħaq tarbija f'perjodu tipiku ta' 24 siegħa, ġie stmat għal 0.04 % sa 0.30 %.
English: 982 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
Maltese: 982 400 mg (0,2,4 ġimgħa) b' MTX 200 mg jew 400 mg kull ġimagħtejn b'MTX
English: Medication information chip 5.
Maltese: Ċippa ta' informazzjoni tal-medikazzjoni 5. tapp tal-labra
English: The axial spondyloarthritis overall population included subpopulations with and without (non-radiographic axial spondyloarthritis [nraxSpA]) radiographic evidence for ankylosing spondylitis (AS) (also known as radiographic axial spondyloarthritis).
Maltese: Il-popolazzjoni b'kollox ta' spondiloartrite axjali inkludiet sub-popolazzjonijiet kemm bi u kif ukoll mingħajr (spondiloartrite axjali mhux radjografika [nr-axSpA]) evidenza radjografika għal spondilite ankilosing (AS) (magħrufa wkoll bħala spondiloartrite axjali radjografika).
English: Multipack containing 6 (3 packs of 2) pre-filled syringes and 6 (3 packs of 2) alcohol wipes.
Maltese: Pakkett multiplu ta' 6 (3 pakketti ta' 2) siringi mimlija għal-lest u 6 (3 pakketti ta' 2) biċċiet blalkoħol.
English: • Guillain Barré syndrome*
Maltese: • is-sindromu ta' Guillain-Barré
English: • blood and lymphatic system cancers like lymphoma and leukaemia
Maltese: • kanċers fid-demm u s-sistema limfatika bħal limfoma u lukemja
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines usually methotrexate.
Maltese: Jekk għandek artrite rewmatika attiva moderata għal severa, jista' jkun li l-ewwel jingħatalek mediċini oħra normalment methotrexate.
English: The proportion of patients who discontinued treatment due to adverse events during the controlled trials was 4.4% for patients treated with Cimzia and 2.7% for patients treated with placebo.
Maltese: Il-proporzjon tal-pazjenti li waqqfu t-trattament minħabba effetti mhux mixtieqa waqt studji kkontrollati kien ta' 4.4% għal pazjenti trattati b'Cimzia u 2.7% għal pazjenti trattati bil-plaċebo.
English: Not known Merkel cell carcinoma* Common eosinophilic disorders, leukopaenia (including neutropaenia, lymphopaenia)
Maltese: Disturbi ejosinofiliċi, lewkopenja (inkluż newtropenja, limfopenja)
English: The key results of the CIMPACT trial are presented in Table 12.
Maltese: Ir-riżultati prinċipali tal-prova CIMPACT huma ppreżentati f'Tabella 12.
English: Spinal mobility was assessed in the double-blind, placebo-controlled period by using BASMI at several time points including Baseline, Week 12 and Week 24.
Maltese: BASMI f'diversi punti inkluż fil-Punt ta' bażi, Ġimgħa 12 u Ġimgħa 24.
English: (with bluebox)
Maltese: (inkluż xokk anafilattiku)
English: Of the 138 patients randomised to Cimzia 200 mg every 2 weeks, 92, 68 and 48 had an ACR 20/50/70 response, at Week 48, respectively.
Maltese: Mill138 pazjent randomizzat fuq Cimzia 200 mg kull ġimagħtejn, 92, 68 u 48 kellhom rispons ACR 20/50/70, f' Ġimgħa 48, rispettivament.
English: In clinical trials with Cimzia and other TNF-antagonists, more cases of lymphoma and other malignancies have been reported among patients receiving TNF-antagonists than in control patients receiving placebo (see section 4.8).
Maltese: F'studji kliniċi b' Cimzia u mediċini ta' kontra TNF, kienu rrapportati iżjed każijiet ta' limfoma u tumuri malinni oħrajn f' pazjenti li jieħdu l-mediċina ta' kontra TNF milli f'pażjenti ta' kontroll li kienu fuq il-plaċebo (ara sezzjoni 4.8).
English: Rare cholelithiasis Common rash Uncommo alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis) and related conditions, dermatitis and eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discolouration, dry skin, nail and nail bed disorders
Maltese: Mhux komuni alopaċja, bidu ta' psorajiżi jew żieda filkundizzjoni (inkluż psorajiżi palmoplantar pustular) u kondizzjonijiet relatati, dermatite u ekżema, mard tal-glandoli tal-għaraq, ulċeri talġilda, fotosensittivita`, akne, diskolorazzjoni talġilda, ġilda xotta u mard tas-dwiefer u s-sodda taddwiefer
English: Multiple doses of up to 800 mg subcutaneously and 20 mg/kg intravenously have been administered.
Maltese: Dożi multipli ta' mhux iżjed minn 800 mg li ngħataw taħt il-ġilda u ta' 20mg/kg li ngħataw ġol-vina.
English: Among PASI75 responders at Week 16 who received Cimzia 200 mg every 2 weeks and were re-randomized to either Cimzia 400 mg every 4 weeks, Cimzia 200 mg every 2 weeks, or placebo, there was also a higher percentage of PASI 75 responders at Week 48 in the Cimzia groups as compared to placebo (88.6%, 79.5%, and 45.5%, respectively).
Maltese: Fost dawk li wrew rispons għal PASI75 f'Ġimgħa 16 li rċevew Cimzia 200 mg kull ġimagħtejn u li ġew magħżula mill-ġdid b'mod każwali, jew għal Cimzia 400 mg kull 4 ġimgħat, għal Cimzia 200 mg kull ġimagħtejn, jew għal plaċebo, kien hemm ukoll perċentwali ogħla ta' dawk li wrew rispons għal PASI 75 f'Ġimgħa 48 meta mqabbel malplaċebo (88.6%, 79.5%, u 45.5%, rispettivament).
English: The pH of the solution is approximately 4.7.
Maltese: Il-pH tas-soluzzjoni hija madwar 4.7.
English: Multipack containing 10 (5 packs of 2) pre-filled syringes and 10 (5 packs of 2) alcohol wipes.
Maltese: Pakkett multiplu ta' 10 (5 pakketti ta' 2) siringi mimlija għal-lest u 10 (5 pakketti ta' 2) biċċiet blalkoħol.
English: *p<0.01, Cimzia vs placebo **p<0.001, Cimzia vs placebo ***p<0.001(nominal), Cimzia vs placebo
Maltese: BSA fil-Linja Bażi * p<0.01, Cimzia vs plaċebo ** p<0.001, Cimzia vs plaċebo *** p<0.
English: See also section 6.4 for shelf-life related to storage at room temperature up to a maximum of 25°C.
Maltese: Ara wkoll sezzjoni 6.4 għal informazzjoni dwar kemm idum tajjeb il-prodott f'temperatura tal-kamra sa massimu ta' 25°C.
English: • lung inflammation (interstitial lung disease, pneumonitis)
Maltese: • infjammazzjoni fil-pulmun (mard tal-pulmun interstitali, pnewmonite)
English: Use of TNF-antagonists has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease, including multiple sclerosis.
Maltese: L-użu ta' mediċini kontra TNF kien assoċjat ma każi rari ta' sintomi kliniċi ġodda jew li jaggravaw u/jew evidenza radjografika ta' mard fejn jittnaqqas il-majelin, inkluż sklerożi multipla.
English: dizziness, tremor
Maltese: Tqala u Treddigħ
English: For both the Cimzia and placebo arms, MTX was initiated as of Week 0 (10 mg/week), titrated up to maximum tolerated dose by Week 8 (min 15 mg/week, max 25 mg/week allowed), and maintained throughout the study (average dose of MTX after Week 8 for placebo and Cimzia was 22.3 mg/week and 21.1 mg/week respectively).
Maltese: Għal kemm il-fergħa Cimzia kif ukoll dik tal-plaċebo, MTX iinbeda f'Ġimgħa 0 (10 mg/ġimgħa), ittitrat sad-doża massima ttollerata sa Ġimgħa 8 (minimu 15 mg/ġimgħa, massimu 25 mg/ġimgħ), u mantenut tul listudju kollu (doża medja ta' MTX wara Ġimgħa 8 għal plaċebo u Cimzia kienu 22.3 mg/ġimgħa u 21.1 mg/ġimgħa rispettivament).
English: Active tuberculosis or other severe infections such as sepsis or opportunistic infections (see section 4.4).
Maltese: Tuberkulożi attiva jew infezzjonijiet serji oħra bħal sepsis u infezzjonijiet opportunistiċi (ara sezzjoni 4.4).
English: Of these, 427 completed 2 years of open-label follow-up and thus had a total exposure to Cimzia of 148 weeks overall.
Maltese: Minn dawn, 427 minnhom temmew sentejn ta' follow-up open label u għalhekk kellhom esponiment totali għal Cimzia ta'148 ġimgħa b'kollox.
English: In addition, at Week 16, Cimzia treatment was associated with a greater proportion of patients achieving a DLQI score of 0 or 1 (Cimzia 400 mg every 2 weeks, 45.5% and 50.6% respectively; Cimzia 200 mg every 2 weeks, 47.4% and 46.2% respectively, versus placebo, 5.9% and 8.2% respectively).
Maltese: Barra minn hekk, f'Ġimgħa 16, it-trattament b'Cimzia kien assoċjat ma' proporzjon akbar ta' pazjenti li laħqu punteġġ ta' 0 jew 1 tad-DLQI (Cimzia 400 mg kull ġimagħtejn, 45.5% u 50.6% rispettivament; Cimzia 200 mg kull ġimagħtejn, 47.
English: In the pivotal studies, for subjects who were ANA negative at baseline, 16.7% of those treated with Cimzia developed positive ANA titers, compared with 12.0% of subjects in the placebo group.
Maltese: F'studji ta' importanza, għal pazjenti li kienu negattiv għal ANA fil-linja bażi, 16.7% ta' dawk trattati b'Cimzia żvilluppaw titers għal ANA pożittivi, meta mqabbla ma' 12.0% tal-pazjenti fil-grupp talplaċebo.
English: In the placebo-controlled clinical trials, there were more new cases of serious infection in the Cimzia treatment groups (0.07 per patient-year; all doses), compared with placebo (0.02 per patient-year).
Maltese: F'provi kliniċi kontrollati bil-plaċebo, kien hemm iżjed każijiet ġodda ta' effetti mhux mixtieqa ta' infezzjonijiet serji fil-gruppi trattati b'Cimzia (0.07 kull sena ta' pazjent; id-dożi kollha), meta mqabbel mal-plaċebo (0.02 kull sena ta' pazjent).
English: ACR 20 Week 24 Week 52
Maltese: ACR 20 Ġimgħa 24
English: Uncommo anxiety and mood disorders (including associated symptoms)
Maltese: Mhux komuni anzjeta` u disturbi fil-burdati (inklużi sintomi assoċjati)
English: Similarly, on the basis of Phase III clinical trial data in patients with psoriasis, a population exposure-response relationship was established between plasma concentration of certolizumab pegol and PASI with an EC90 of 11.1 µg/ml.
Maltese: III f'pazjenti bi psorjasi, kienet stabbilita relazzjoni ta' esponiment-rispons filpopolazzjoni bejn il-konċentrazzjoni medja fil-plażma ta' certolizumab pegol u PASI b'EC90 ta' 11.1 µg/ml.
English: Cimzia will be given to you by your doctor or nurse, in hospital or clinic.
Maltese: Cimzia ser jingħata lilek minn tabib jew infermier tiegħek, fl-isptar jew klinika.
English: (a) Cimzia all dosing regimen = data from Cimzia 200 mg administered every 2 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 plus Cimzia 400 mg administered every 4 weeks preceded by a loading dose of 400 mg at Weeks 0, 2 and 4 (b) Results are from the randomized set (c) Wald p-values are quoted for the comparison of treatments using logistic regression with factors for treatment and region.
Maltese: Cimzia dożi kollha = dejta minn Cimzia 200 mg li ngħatat kull ġimagħtejn wara doża kbira talbidu ta' 400 mg f' Ġimgħa 0, 2 u 4 flimkien ma' Cimzia 400 mg li ngħata kull 4 ġimgħat wara doża kbira tal-bidu ta' 400 mg f' Ġimgħa 0, 2 u 4
English: Cimzia patients demonstrated significantly less radiographic progression than patients receiving placebo at Week 24 and Week 52 (see Table 5).
Maltese: Pazjenti fuq Cimzia wrew inqas progressjoni radjografika minn pazjenti fuq plaċebo f' Ġimgħa 24 u Ġimgħa 52 (ara Tabella 5).
English: • thyroid disorders (goitre, tiredness, weight loss)
Maltese: • mard tat-tirojde (gotta, għejja, nuqqas fil-piż)
English: Inhibition of radiographic progression was maintained with Cimzia treatment up to Week 48 in the subset of patients at higher risk of radiographic progression (patients with a Baseline mTSS score of > 6).
Maltese: Fis-sub-sett tal-pazjenti b'riskju ogħla ta' progressjoni radjografika (pazjenti mil-punti mTSS fil-Linja Bażi ta' > 6) kellhom inibizzjoni tal-progressjoni radjografika mantenuta bit-trattament b'Cimzia sa Ġimgħa 48.
English: Axial spondyloarthritis
Maltese: Reazzjonijiet ematoloġiċi
English: 619 400 mg (0,2,4 weeks) with MTX 200 mg or 400 mg every 2 weeks with MTX
Maltese: 619 400mg (0,2,4 ġimgħa) b' MTX 200 mg jew 400 mg kull ġimagħtejn b' MTX
English: Multipack containing 10 (5 packs of 2) dose-dispenser cartridge and 10 (5 packs of 2) alcohol wipes.
Maltese: Pakkett multiplu ta' 10 (5 pakketti ta' 2) skartoċċ li jagħti d-doża u 10 (5 pakketti ta' 2) biċċiet blalkoħol.
English: Treatment with Cimzia may result in the formation of antinuclear antibodies (ANA) and, uncommonly, in the development of a lupus-like syndrome (see section 4.8).
Maltese: Trattament b'Cimzia twassal għall-formazzjoni ta' antikorpi anti-nuklejari (ANA) u, rarament, f'żvillup ta' sindromu li jixbaħ lil lupus (ara sezzjoni 4.8).
English: ACR 70 Week 24 Week 52
Maltese: ACR 70 Ġimgħa 24 Ġimgħa 52
English: Both doses of Cimzia demonstrated efficacy compared to placebo regardless of age, gender, body weight, BMI, psoriasis disease duration, previous treatment with systemic therapies and previous treatment with biologics.
Maltese: Iż-żewġ dożi ta' Cimzia wrew effikaċja meta mqabbla mal-plaċebo irrispettivament mill-età, sess talpersuna, piż tal-ġisem, BMI, it-tul tal-marda tal-psorjasi, trattament preċedenti b'terapiji sistemiċi u trattament preċedenti b'mediċini bijoloġiċi.
English: Rare blood uric acid increased
Maltese: Rari żieda fil-uric acid fid-demm
English: - Press the
Maltese: Skrijn ta' informazzjoni
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati flRMP maqbul ippreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Multipack containing 6 (3 packs of 2) dose-dispenser cartridge and 6 (3 packs of 2) alcohol wipes.
Maltese: Pakkett multiplu ta' 6 (3 pakketti ta' 2) skartoċċ li jagħti d-doża u 6 (3 pakketti ta' 2) biċċiet blalkoħol.
English: Cimzia was also studied in 317 patients with nonradiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006).
Maltese: Cimzia ġie studjat ukoll fi 317-il pazjent bi spondiartrite axjali mhux radjografika fi studju kkontrollat bi plaċebo għal 52 ġimgħa (AS0006).
English: In 2 long-term (up to 5 years of exposure) open-label studies, the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 13% (8.4% of the overall patients had transient formation of antibodies and an additional 4.7% had persistent formation of antibodies to Cimzia).
Maltese: F'żewġt studji fit-tul (sa mhux iżjed minn 5 snin ta' esponiment), il-persentaġġ totali ta' pazjenti b'antikorpi għal Cimzia li kienu nstagħbu f' mill-inqas okkażżjoni waħda kien ta' 13% (8.4% talpazjenti kellhom formazzjoni ta' antikorpi ghal ftit żmien u 4.7% kellhom formazzjoni persistenti ta' antikorpi għal Cimzia).
English: In rats and monkeys, at doses higher than those given to humans, histopathology revealed cellular vacuolation, present mainly in macrophages, in a number of organs (lymph nodes, injection sites, spleen, adrenal, uterine, cervix, choroid plexus of the brain, and in the epithelial cells of the choroid plexus).
Maltese: Fil-firien u x-xadini, f'dożi akbar minn dawk li jingħataw lil bniedem, il-ħistopatoloġija wriet vakwolazzjoni ċellulari, li jinstab prinċiparjament fil-makrofagi, f'numru ta' organi (glandoli limfatiċi, postijiet ta' l-injezzjoni, milsa, glandola adrenali, utru, għonq ta' l-utru, choroid plexus tal-moħħ, u fiċ-ċelloli epitelju tal-choroid plexus).
English: • sensory abnormalities such as numbness, tingling, burning sensation
Maltese: • abnormalitajjiet fis-sensi bħal tnemnim, textix, sensazzjoni ta' ħruq
English: Psoriatic arthritis
Maltese: Artrite Psorijatika
English: One case of lymphoma was also observed in the Phase III psoriatic arthritis clinical trial.
Maltese: Każ wieħed ta' limfoma kien osservat wkoll f'Fażi III tal-prova klinika ta' artrite psorijatika.
English: Patients had a mean time since diagnosis at baseline of 2.9 months and were DMARD naïve (including MTX).
Maltese: Il-pazjenti kellhom ħin medju mid-dijanjożi fil-linja bażi ta' 2.9 xhur u kienu DMARD naïve (inkluż MTX).
English: Patients received loading doses of Cimzia 400 mg at weeks 0, 2, and 4 followed by Cimzia 200 mg every 2 weeks during the initial open label period.
Maltese: Pazjenti rċievew dożi tal-bidu ta' Cimzia 400 mg f'ġimgħa 0, 2, u 4 segwiti b' Cimzia 200 mg kull ġimgħatejn waqt il-perjodu open-label tal-bidu.
English: • plaque psoriasis
Maltese: • psorjasi tal-plakka