FrancophonIA/ELRC3.0 huggingface dataset:
English: As this medecine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Maltese: Peress li din il-mediċina qed tingħata lilek mit-tabib jew l-infermier tiegħek, hija improbabli li inti ser tingħata iżjed milli suppost.
English: However, no effect of age was observed in a population pharmacokinetic analysis in patients with rheumatoid arthritis in which 78 subjects (13.2% of the population) were aged 65 or greater and the oldest subject was aged 83 years.
Maltese: Iżda l-età ma dehret li kella ebda effett ta' fuq lanaliżi fuq il-farmakokinetika fil-popolazzjoni totali tal-pazjenti b'artrite rewmatika fejn 78 pazjent (13.2% tal-popolazzjoni) li kienu t'età ta' 65 sena jew akbar u l-akbar pazjent kellu 83 sena.
English: Patients in the Cimzia+MTX group had a greater reduction from baseline in DAS 28 (ESR) compared with the placebo+MTX group observed as early as Week 2 and continued through Week 52 (p<0.001 at each visit).
Maltese: Pazjenti fil-ġrupp Cimzia+MTX kellhom tnaqqis akbar mill-linja bażi f' DAS 28 (ESR) meta mqabbel mal-grupp plaċebo+MTX osservat kmieni saħansitra minn Ġimgħa 2 u kompla sa Ġimgħa 52 (p<0.
English: • fungal infections (occur when the ability to fight off infection is lessened)
Maltese: • infezzjonijiet fungali (jiġru meta tonqos l-abbilta` li tiġġieled l-infezzjonijet)
English: Adverse reactions reactions based primarily on experience from the placebo-controlled clinical trials and postmarketing cases at least possibly related to Cimzia are listed in Table 1 below, according to frequency and system organ class.
Maltese: Reazzjonijiet avversi bbażati primarjament fuq l-esperjenza mill-provi kliniċi kkontrollati bil-plaċebo u każijiet ta' wara t-tqegħid fis-suq li huma mill-inqas possibbilment relatati ma' Cimzia huma elenkati f'Tabella 1 hawn taħt, skont il-frekwenza u s-sistema tal-klassifika tal-organi.
English: At Week 52, patients treated with Cimzia showed a clinical meaningful improvement in the MASES compared to placebo (LS mean change from baseline -2.4 ; -0.2 respectively).
Maltese: F'Ġimgħa 52, il-pazjenti kkurati b'Cimzia wrew titjib klinikament sinifikanti fil-MASES meta mqabbel ma' plaċebo (bidla medja LS mil-linja bażi -2.4; -0.2 rispettivament).
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta l-pjan ta' minimizzazzjoni tar-riskju jiġi modifikat speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil tal-benefiċċju/ riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Responders (achieved ACR 20) at week 16 were randomised at week 18 to Cimzia 200 mg every 2 weeks, Cimzia 400 mg every 4 weeks, or placebo in combination with MTX for an additional 16 weeks (total trial length: 34 weeks).
Maltese: Dawk li rrispondew (intlaħaq ACR 20) f' ġimgħa 16 kienu rrandomizzati f'ġimgħa 18 għal Cimzia 200 mg kull ġimgħatejn, Cimzia 400 mg, kull 4 ġimgħat, jew plaċebo flimkien ma' MTX għal 16-il ġimgħa oħra (tul totali talprova: 34 ġimgħa).
English: Incubation of monocytes with Cimzia resulted in a dose-dependent inhibition of lipopolysaccharide (LPS)-induced TNFα and IL1β production in human monocytes.
Maltese: L-inkubazzjoni ta' monoċiti b' Cimzia irriżulta f'inibazzjoni li tiddependi fuq id-doża ta' TNFα indutti b'lipopolysaccharide (LPS) u l-produzzjoni ta' IL1β f' monoċiti umani.
English: Patients with an inadequate response at Week 16 (PASI 50 non-responders) were eligible to receive Cimzia 400 mg every 2 weeks until Week 48 in an open label manner.
Maltese: Pazjenti b'rispons inadegwat f'Ġimgħa 16 (pazjenti li ma wrewx rispons PASI 50) kienu eliġibbli biex jirċievu Cimzia 400 mg kull ġimagħtejn sa Ġimgħa 48 b'mod open-label.
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 9.1%.
Maltese: Il-persentaġġ totali ta' pazjenti li kienu pożittivi għal antikorpi bit-tnaqqis persistenti tal-konċentrazzjonijiet tal-mediċina fil-plażma kienu stmati li kienu 9.1%.
English: In both placebo-controlled and open-label follow-up clinical trials for rheumatoid arthritis, cases of lupus-like syndrome were reported uncommonly.
Maltese: F'provi kliniċi follow up kontrollati mill-plaċebo u open label fuq lartrite rewmatika, kien hemm rapporti mhux komuni ta' każijiet ta' sindrome li jixbah lil lupus.
English: Lifepharma (Z.A.M.)
Maltese: Labra (ġot-tapp)
English: - Once the needle cap has been removed, you must give the injection within 5 minutes.
Maltese: - Meta jitneħħa t-tapp tal-labra, trid tinjetta fi żmien 5 minuti.
English: In a placebo-controlled clinical trial in patients with rheumatoid arthritis, similar antibody response between Cimzia and placebo treatment were observed when the pneumococcal polysaccharide vaccine and influenza vaccine were administered concurrently with Cimzia.
Maltese: F'prova klinika kkontrollata minn plaċebo ta' pazjenti b'artrite rewmatika, ma nstabx differenza firrispons ta' antikorpi bejn l-gruppi ta' trattament b'Cimzia u u dak tal-plaċebo meta ngħataw il-vaċċin tal-polysaccharide kontra l-pneumococcus u l-vaċċin kontra l-influwenza flimkien ma' Cimzia.
English: - Repeat the injection process starting at Step 2.
Maltese: - Irrepeti l-proċess tal-injezzjoni minn Pass 2.
English: • nerve disorders in the extremities including symptoms of numbness, tingling, burning sensation,
Maltese: • mard tan-nervituri fl-estremitajjiet inkluż sintomi ta' tnemnim, textix, sensazzjoni ta' ħruq,
English: Cimzia is used to treat severe active ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis (sometimes referred to as non-radiographic axial spondyloarthritis).
Maltese: Cimzia huwa wżat biex jittratta spondilite ankylosing u spondiloartrite axjali mingħajr evidenza radjografika ta' spondilite ankylosing (kultant irreferite bħala spondiloartrite axjali mhux radjografika).
English: Among 273 patients initially randomised to Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks, 237 (86.8%) were still on this treatment at Week 48.
Maltese: Fost il- 273 pazjent li kienu inizzjalment randomizzati fuq Cimzia 200 mg kull ġimagħtejn u Cimzia 400 mg kull 4 ġimgħat, 237 (86.8%) kienu għadhom fuq dan it-trattament f' Ġimgħa 48.
English: It is usually injected into the thigh or tummy.
Maltese: Normalment tiġi injettata fil-koxxa jew fiż-żaqq.
English: Rare interstitial lung disease, pneumonitis Common nausea Uncommo ascites, gastrointestinal ulceration and perforation, gastrointestinal tract inflammation (any site), stomatitis, dyspepsia, abdominal distension, oropharyngeal dryness
Maltese: Mhux komuni axxiti, ulċerazzjoni ġastro-intestinali u perforazzjoni, infjammazzjoni fl-apparat ġastrointestinali (kwalunqwe sit), stomatite, dispepsja, distenzzjoni abdominali, ħalq u farinġi xotti
English: On the basis of Phase II and Phase III clinical trial data in patients with rheumatoid arthritis, a population exposure-response relationship was established between average plasma concentration of certolizumab pegol during a dosing interval (Cavg) and efficacy (ACR 20 responder definition).
Maltese: III f'pazjenti b'artrite rewmatika, kienet stabbilita relazzjoni ta' esponiment-rispons fil-popolazzjoni bejn il-konċentrazzjoni medja fil-plażma ta' certolizumab pegol matul l-intervall bejn id-doża (Cavg) u l-effikaċja (ACR 20 definizzjoni ta' persuna li rrispondiet għat-trattament).
English: Over the course of the entire study (up to 4 years of exposure), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 17.3% (8.7% had transient formation and an additional 8.7% had persistent formation of antibodies to Cimzia).
Maltese: Fuq il-medda tal-istudju kollu (sa 4 snin ta' esponiment), il-perċentaġġ totali ta' pazjenti b'antikorpi għal Cimzia li inqabbdu f'mill-inqas waħda kien ta' 17.3% (8.7 % kellhom formazzjoni mhux permanenti u 8.7 % addizjonali kellhom formazzjoni persistenti ta' antikorpi għal Cimzia).
English: PGA clear or almost clear b) 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: PGA xejn jew kważi xejn b) a) Cimzia 200 mg mogħti kull ġimagħtejn wara doża inizjali qawwija ta' 400 mg f'Ġimgħa 0, 2, 4.
English: Solution for injection in a pre-filled pen (AutoClicks) 2 AutoClicks pre-filled pens 2 alcohol wipes
Maltese: 2 pinen mimlija għal-lest AutoClicks 2 biċċiet bl-alkoħol
English: • some blood parameters increased (blood alkaline phosphatase increased)
Maltese: • żieda f'xi parametri fid-demm (żieda fil phosphatase alkalin fid-demm)
English: Uncommo menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders
Maltese: Mhux komuni mard taċ-ċiklu menstrwali u fsad tal-utru (inkluż amenorreja), mard tas-sider
English: At Weeks 12 and 24, the percentage of subjects with an ASAS40 response was greater in the Cimzia-treated groups compared to placebo.
Maltese: F'Ġimgħa 12 u 24, il-perċentwali ta' pazjenti b'rispons ASAS40 kien ikbar mill-gruppi ttrattati b'Cimzia meta mqabbel mal-plaċebo.
English: Response rates and p-values for PASI and PGA were estimated based on a logistic regression model where missing data were imputed using multiple imputation based on the MCMC method.
Maltese: Rati ta' rispons u valuri p għal PASI u PGA kienu evalwati skont il-mudell ta' rigressjoni loġistika fejn id-dejta nieqsa kienet imputata bl-użu ta' imputazzjoni multipla bbażata fuq il-metodu MCMC.
English: Cimzia 200 mg + MTX every 2 weeks N=393
Maltese: Cimzia 200 mg + MTX kull ġimagħtejn N=393
English: Plaque psoriasis
Maltese: Artrite psorijatika
English: Cimzia 200 mg + MTX every 2 weeks N=70
Maltese: Cimzia 200 mg + MTX kull ġimgħatejn N=70
English: Cimzia 200 mg + MTX every 2 weeks N=246
Maltese: Cimzia 200 mg + MTX kull ġimagħtejn N=246
English: Cimzia-treated patients had a statistically significant higher ACR 20 response rate at Week 12 and Week 24 compared with placebo-treated patients (p<0.001).
Maltese: Pazjenti ttrattati b'Cimzia kellhom rispons ACR 20 sinifikament ogħla f'Ġimgħa 12 u Ġimgħa 24 meta mqabbla ma' pazjenti ttrattati bil-plaċebo (p<0.
English: • respiratory disorders and inflammation (including asthma, shortness of breath, cough, blocked sinuses, pleurisy, or difficulty breathing)
Maltese: • disturbi respiratorji u infjammazzjoni (inkluż ażżma, qtugħ ta' nifs, sogħla, sinus blokkat,
English: The needle shield inside the removable cap of the CIMZIA pre-filled syringe contains a derivative of natural rubber latex (see section 6.5).
Maltese: L-għatu tal-labra ġot-tapp li jitneħħa ta' Cimzia siringa mimlija għal-lest fiha derivattiv ta' latex ta' gomma naturali (ara sezzjoni 6.5).
English: The overall percentage of patients that were antibody positive with a persistent reduction of drug plasma concentration was estimated to be 11.5%.
Maltese: Ilperċentaġġ globali tal-pazjenti li kienu pożittivi għall-antikorpi b'reduzjoni persistenti għal konċentrazzjoni tal-mediċina fil-plażma kien stmat li hu ta' 11.5%.
English: Cimzia does not contain a fragment crystallisable (Fc) region, which is normally present in a complete antibody, and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro.
Maltese: Cimzia ma fiħx reġjun ta' framment kristillabli (Fc), li normalment ikun preżenti f'antikorp komplet, u għalhekk m'għandux effett in vitro fuq in-numru komplet jew jikkawża ċitotossiċita` li hija medjata miċ-ċelloli u dependenti fuq l-antikorpi.
English: Study AS0006, performed in subjects without radiographic signs of inflammation in the SI joints, confirmed the effect previously demonstrated in this subgroup in the AS001 study.
Maltese: Studju AS0006, li sar f'individwi mingħajr sinjali radjografiċi ta' infjammazzjoni fil-ġogi SI, ikkonferma l-effett li ntwera preċedentement f'dan is-sottogrupp fl-istudju AS001.
English: In a clinical trial to assess the effect of certolizumab pegol on semen quality parameters, 20 healthy male subjects were randomized to receive a single subcutaneous dose of 400 mg of certolizumab pegol or placebo.
Maltese: F'prova klinika biex jitkejjel l-effett ta' certolizumab pegol fuq il-parametri tal-kwalita` tassemen, 20 irġiel f'saħħithom kienu magħżulin bl'addoċċ biex jirċievu doża singola minn taħt il-ġilda ta' 400 mg ta' certolizumab pegol jew plaċebo.
English: - TUBERCULOSIS (TB) cases have been reported in patients treated with Cimzia, your doctor will check you for signs and symptoms of tuberculosis before starting Cimzia.
Maltese: - Każijiet ta' TUBERKULOŻI (TB) ġew rappurtati fil-pazjenti trattati b'Cimzia, it-tabib ser jiċċekkja għal sinjali u sintomi ta' tuberkulożi qabel ma' tibda tieħu Cimzia.
English: Needle cap
Maltese: Komuni dardir
English: In an integrated analysis of CIMPASI-1 and CIMPASI-2, among patients who were PASI 75 responders at Week 16 and received Cimzia 400 mg every 2 weeks or Cimzia 200 mg every other week, the maintenance response rates at Week 48 were 98.0% and 87.5%, respectively.
Maltese: F'analiżi integrata ta' CIMPASI-1 u CIMPASI-2, fost pazjenti li kienu wrew rispons għal PASI 75 f'Ġimgħa 16 u rċevew Cimzia 400 mg kull ġimagħtejn jew Cimzia 200 mg ġimgħa iva u ġimgħa le, ir-rati ta' rispons tal-manteniment f'Ġimgħa 48 kienu 98.% u 87.5%, rispettivament.
English: Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Cimzia (see section 4.8).
Maltese: Jista' jkun hemm sturdament (inkluż vertigo, disturbi fil-viżjoni u għejja), wara t-teħid ta' Cimzia (ara sezzjoni 4.8).
English: The 24-week double-blind placebo controlled treatment period of the study was followed by a 24-week dose-blind treatment period and an 168-week open-label treatment period.
Maltese: Il-perjodu tal-istudju ta' trattament double blind ikkontrollat minn plaċebo ta' 24-il ġimgħa kien segwit minn perjodu ta' trattament dose-blind u perjodu ta' trattament open-label ta' 168-il ġimgħa.
English: Patients on Cimzia 200 mg every 2 weeks were re-randomized to Cimzia 200 mg every 2 weeks, Cimzia 400 mg every 4 weeks or placebo.
Maltese: Pazjenti fuq Cimzia 200 mg kull ġimagħtejn intgħażlu mill-ġdid b'mod każwali għal Cimzia 200 mg kull ġimagħtejn, Cimzia 400 mg kull 4 ġimgħat jew plaċebo.
English: • rash or itching
Maltese: TWISSIJA/IET SPEĊJALI
English: The majority of reported TNF-antagonist cases occurred in adolescent and young adult males with Crohn's disease or ulcerative colitis.
Maltese: Il-maġġoranza tal-każijiet irrapportati b'antagonisti ta' TNF ġraw f'addoloxxenti u adulti maskili għadhom żgħar bil-marda ta' Crohn u kolite ulċerattiva.
English: In the overall population, the percentage of ASAS20 responders was clinically relevant and significantly higher for the Cimzia 200 mg every 2 weeks and Cimzia 400 mg every 4 weeks treatment groups compared to placebo group at every visit from Week 1 through Week 24 (p≤0.001 at each visit).
Maltese: Fil-popolazzjoni kollha, il-perċentwali ta' min irrisponda għal ASAS20 kien klinikament rilevanti u ogħla sinifikament għal gruppi ta' trattament Cimzia 200 mg kull ġimagħtejn u Cimzia 400 mg kull 4 ġimgħat meta mqabbla mal-grupp tal-plaċebo f'kull vista minn Ġimgħa 1 sa Ġimgħa 24 (p≤0.001 f'kull vista).
English: Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Maltese: L-analiżi tal- farmakokinetika fil-popolazzjoni, ma wera ebda effett ta' l-eta` (ara sezzjoni 5.2).
English: Solution for injection in dose-dispenser cartridge 2 single-use dose-dispenser cartridges 2 alcohol wipes
Maltese: 2 pinen mimlija għal-lest AutoClicks għal użu ta' darba 2 biċċiet bl-alkoħol
English: Paediatric malignancy
Maltese: Kanċer tal-ġilda
English: Rare haemosiderosis
Maltese: Rari cholelithiasis
English: The two primary endpoints were the percentage of patients achieving ACR 20 response at Week 12 and change from baseline in modified Total Sharp Score (mTSS) at Week 24.
Maltese: Iż-żewġt punti tal-aħħar primarji kienu il-perċentwali tal-pazjenti li kellhom rispons ACR 20 f'Ġimgħa 12 u l-bidla mill-punt ta' bażi fil-Total Sharp Score (mTSS) modifikat f' Ġimgħa 24.
English: • With the other hand, hold syringe at a 45-degree angle to skin.
Maltese: • Bl-id l-oħra, żomm is-siringa f-angolu ta' 45-il grad mal-ġilda.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One dose-dispenser cartridge contains 200 mg certolizumab pegol in one ml.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa mimlija għal-lest waħda fiha 200 mg ta' certolizumab pegol f'ml wieħed.
English: • This is followed by a maintenance dose of 200 mg every 2 weeks.
Maltese: • Din hija segwita minn doża ta' manteniment ta' 200 mg darba kull ġimgħatejn.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in dose-dispenser cartridge Multipack: 10 (5 x 2) single-use dose-dispenser cartridge and 10 (5 x 2) alcohol wipes
Maltese: Soluzzjoni għall-injezzjoni f' skartoċċ li jagħti d-doża Il-pakkett multiplu: 10 (5 x ta' 2) skartoċċ li jagħti d-doża għal użu ta' darba u 10 (5 x ta' 2) biċċiet blalkoħol)
English: One ml pre-filled pen (AutoClicks) containing a pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), containing 200 mg of certolizumab pegol.
Maltese: Pinna mimlija għal-lest waħda (AutoClicks) li fiha siringa mimlija għal-lest (ħġieġ tat-tip I) b'tapp planger (gomma tal-bromobutyl) li fiha 200 mg ta' certolizumab.
English: Cimzia has a high affinity for human TNFα and binds with a dissociation constant (KD) of 90 pM. TNFα is a key pro-inflammatory cytokine with a central role in inflammatory processes.
Maltese: Cimzia għandu affinita` kbira għal TNFα uman u jeħel b' dissociation constant (KD) ta' 90pM.
English: Patients originally randomized to placebo that achieved a PASI 50 response but not a PASI 75 response at Week 16 received Cimzia 200 mg every 2 weeks (with a loading dose of Cimzia 400 mg at Weeks 16, 18, and 20).
Maltese: Pazjenti oriġinarjament magħżula b'mod każwali għal plaċebo li kisbu rispons PASI 50 iżda mhux rispons PASI 75 f'ġimgħa 16 irċevew Cimzia 200 mg kull ġimagħtejn (b'doża inizjali qawwija ta' Cimzia 400 mg f'Ġimgħat 16, 18, u 20).
English: The dosedispenser cartridge is to be used with the electromechanical injection device ava.
Maltese: Liskartoċċ li jagħti d-doża għandu jintuża bil-makkinarju ta' injezzjoni elettromekkaniku ava.
English: Physical function response and health-related outcomes In PsA001 clinical trial, Cimzia-treated patients reported significant improvements in physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI), in pain as assessed by the PAAP and in tiredness (fatigue) as reported by the Fatigue Assessment Scale (FAS) as compared to placebo.
Maltese: Rispons tal-funzjoni fiżika u r-riżultati relatati mas-saħħa Fil-prova klinika PsA001, pazjenti ttrattati b' Cimzia irrappurtaw emeljorament sinifikanti fil-funzjoni fiżika kif mkejla fil-Qwestjonarju tal-Assessjar tas-Saħħa- Indiċi ta' Diżabbilita` (HAQ-DI), fl-uġigħ kif mkejjla mill-Assessjar tal- PAAP u mill-għajja kif irrappurtat fl-is-Skala tal-Assessjar tal-Għajja (FAS) kif mqabbla mal- plaċebo.
English: The overall percentage of patients with antibodies to Cimzia detectable on at least one occasion up to Week 24 was 11.7% in the Phase III placebo-controlled trial in patients with psoriatic arthritis.
Maltese: Il-perċentwali b'kollox ta' pazjenti b' antikorpi għal Cimzia li ġew misjuba f'mill-inqas okkażjoni waħda sa Ġimgħa 24 kien 11.7% f'prova kkontrollata minn plaċebo f'Fażi III f'pazjenti b'artrite psorijatika.
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Maltese: Artrite rewmatika hija marda infjammatorja talġogi.
English: Patients had active disease as defined by the BASDAI ≥4, and spinal pain ≥4 on a 0 to 10 NRS.
Maltese: Il-pazjenti kellhom marda attiva kif definit mill-BASDAI ≥4, u uġigħ fis-sinsla tad-dahar ≥4 fuq NRS ta' 0 sa 10.
English: Uncommo electrolyte imbalance, dyslipidaemia, appetite disorders, weight change
Maltese: Mhux komuni żbilanċ fl-elektroliti, dislipidemja, disturbi fl-aptit, tibdil fil-piż
English: respectively.
Maltese: INDIVIDWALI.
English: If you respond to the medicine, your doctor may prescribe an alternative maintenance dosing of 400 mg every 4 weeks.
Maltese: La darba r-rispons kliniku jkun ikkonfermat, jista' jkun ikkonfermat dosaġġ ta' manteniment alternattiv ta' 400 mg kull 4 ġimgħat.
English: In patients who develop HBV reactivation, Cimzia should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Maltese: F'pazjenti li jiżviluppaw irriattivazzjoni ta' l-HBV, Cimzia għandu jitwaqqaf u terapija effettiva anti-virali tinbeda flimkien ma' kura ta' support.
English: Cimzia 200 mg solution for injection in pre-filled syringe Pre-filled syringe with needle guard certolizumab pegol
Maltese: Cimzia 200 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest certolizumab pegol
English: Uncommo vasculitides, lupus erythematosus, drug hypersensitivity (including anaphylactic shock), allergic disorders, auto-antibody positive
Maltese: Mhux komuni vaskulitide, lupus erythematosus, sensittivita` eċċessiva għall-mediċina (inkluż xokk anafillatiku), mard allerġiku, test pożittiv għal awto-antikorpi
English: The other ingredients are: sodium acetate, sodium chloride and water for injection (see “Cimzia contains sodium acetate and sodium chloride” in section 2).
Maltese: (ara “Cimzia fih sodium acetate u sodium chloride” f'sezzjoni 2).
English: • after 16 weeks if you have plaque psoriasis.
Maltese: • wara 16-il ġimgħa jekk għandek psorjasi tal-plakka.
English: Cimziaa 200 mg every 2 weeks N= 159
Maltese: Cimziaa 200 mg kull ġimagħtejn N= 159
English: Over the course of the entire study (up to 192 weeks), the overall percentage of patients with antibodies to Cimzia detectable on at least one occasion was 9.6% (4.8% had transient formation and an additional 4.8% had persistent formation of antibodies to Cimzia).
Maltese: Fuq il-medda tal-istudju kollu (sa 192-il ġimgħa), il-perċentaġġ totali ta' pazjenti b'antikorpi għal Cimzia li inqabbdu f'mill-inqas waħda kien ta' 9.6% (4.8% kellhom formazzjoni mhux permanenti u 4.8% addizjonali kellhom formazzjoni persistenti ta' antikorpi għal Cimzia).
English: Previous treatment with one TNF-antagonist was allowed and 20% of patients had prior TNF-antagonist exposure.
Maltese: Trattament qabel b' antagonista ta' TNF wieħed kien aċċettat u 20% tal-pazjenti kellhom esponiment qabel għal antagonista tat-TNF.
English: Rare suicide attempt, delirium, mental impairment Common headaches (including migraine), sensory abnormalities Uncommo peripheral neuropathies, dizziness, tremor
Maltese: Disturbi fis-sistema nervuża Komuni uġigħ ta' ras (inkluż migranja), abnormalitajjiet sensorjali
English: Axial spondyloarthritis (non-radiographic axial spondyloarthritis and ankylosing spondylitis subpopulations)
Maltese: Spondiloartrite axjali (subpopolazzjonijiet ta' spondiloartrite axjali mhux radjograifka u spondilite ankilosing)
English: Figure 1 1: Needle cap 2: Plunger head
Maltese: 1: Tapp tal-labra 2: Tarf tal-planġer 3:
English: Pack size of 2 pre-filled pens and 2 alcohol wipes, a multipack containing 6 (3 packs of 2) pre-filled pens and 6 (3 packs of 2) alcohol wipes, a multipack of 10 (5 packs of 2) pre-filled pens and 10 (5 packs of 2) alcohol wipes
Maltese: Il-pakketti ta' daqs ta' 2 pinen mimlija għal-lest u żewġt biċċiet bl-alkoħol, pakkett multiplu ta' 6 (3 pakketti ta' 2) pinen mimlija għal-lest u 6 (3 pakketti ta' 2) biċċiet bl-alkoħol, pakkett multiplu ta' 10 (5 pakketti ta' 2) pinen mimlija għal-lest u 10 (5 pakketti ta' 2) biċċiet bl-alkoħol.