FrancophonIA/ELRC3.0 huggingface dataset:
English: Romiplostim should not be used in patients with moderate to severe hepatic impairment unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Maltese: Romiplostim m'għandux jintuża f'pazjenti b'indeboliment moderat sa sever tal-fwied sakemm il-benefiċċju mistenni ma jkunx ogħla mir-riskju identifikat ta' trombożi fil-vini portali.
English: Background rates of reticulin in the bone marrow in ITP patients and the observed incidence and potential mechanism of action of reticulin deposition in response to romiplostim.
Maltese: Rati eżistenti ta' reticulin fil-mudullun tal-għadam f'pazjenti b'ITP u l-inċidenza osservata u l-mekkaniżmu potenzjali ta' azzjoni ta' depożizzjoni ta' reticulin bħala rispons għal romiplostim.
English: • The documents will discuss the following identified and potential risks: The incidence in clinical trials and likelihood of reoccurrence of thrombocytopenia after cessation of treatment.
Maltese: • Id-dokumenti se jiddiskutu ir-riskji identifikati u potenzjali li ġejjin:
English: • Obligations of the health care professional in relation to the prescribing of romiplostim and the need to provide comprehensive advice on risk-benefit to patients.
Maltese: • Obligazzjonijiet tal-professjonist fil-qasam tas-saħħa rigward il-preskrizzjoni ta' romiplostim u l-ħtieġa li jiġu pprovduti pariri komprensivi lill-pazjenti dwar ir-riskji u l-benefiċċji.
English: Advice on management of patients upon cessation of romiplostim.
Maltese: Parir dwar l-immaniġġjar ta' pazjenti wara li jitwaqqaf romiplostim.
English: Advice to follow dose adjustment guidelines to avoid platelet counts above the normal range.
Maltese: Parir biex jiġu segwiti l-linji gwida dwar l-aġġustament fid-doża biex ikun evitat għadd ta' plejtlits 'l fuq mill-firxa normali.
English: Warning that, whilst no data exists, an outcome of reticulin deposition in response to romiplostim may be bone marrow fibrosis.
Maltese: Twissija li, waqt li m'hemm l-ebda data disponibbli, depożizzjoni ta' reticulin bħala rispons għal romiplostim tista' twassal għal fibrosi tal-mudullun tal-għadam.
English: The incidence of neutralising antibodies to romiplostim in clinical trials.
Maltese: L-inċidenza ta' antikorpi newtralizzanti għal romiplostim fil-provi kliniċi. Limplikazzjonijiet jekk antikorpi newtralizzanti għal romiplostim jirreaġixxu ma' trombopoetin endoġenu (TPO).
English: SIA Ingen Pharma Cefuroxime Ingen Pharma
Maltese: Cefuroxime Ingen Pharma
English: Cefuroxime 250 mg Tablet
Maltese: Cefuroxime 250 mg Pillola
English: Slovak Republic Krka d.d., Novo mesto
Maltese: Ir-Repubblika Ċeka
English: Cefuroxima KRKA 250 mg comprimidos recubiertos con película
Maltese: KRKA 250 mg comprimidos recubiertos con película
English: Cefuroxima KRKA 500 mg comprimidos recubiertos con película
Maltese: KRKA 500 mg comprimidos recubiertos con película
English: Ricefan 250 mg Cefuroxime 250 mg Film-coated tablet
Maltese: Ricefan 250 mg Cefuroxime 250 mg Pillola miksija b'rita
English: Annex IA: Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established
Maltese: Prodotti mediċinali rrakkomandati għall-applikazzjonijiet għall-awtorizzazzjoni għaż-żamma u għat-tqegħid fis-suq li għalihom ġiet stabbilita l-bijoekwivalenza fir-rigward tal-prodott mediċinali ta' referenza tal-UE
English: 14 October 2016 EMA/659373/2016 EMEA/H/C/004306
Maltese: 14 ta' Ottubru 2016 EMA/659373/2016 EMEA/H/C/004306
English: Pemetrexed (as ditromethamine) Hospira was expected to be used to treat two types of lung cancer: malignant pleural mesothelioma (a cancer of the lining of the lungs usually caused by exposure to asbestos) and advanced non-small-cell lung cancer of the kind known as ‘non-squamous'.
Maltese: Pemetrexed (bħala ditromethamine) Hospira kien mistenni li jintuża għall-kura ta' żewġ tipi ta' kanċer tal-pulmun: mesoteljoma plewrali malinna (kanċer tar-rita tal-pulmun ġeneralment ikkawżat minħabba esponiment għall-asbestos) u kanċer tal-pulmun avvanzat taċ-ċelloli mhux żgħar tat-tip magħruf bħala ‘mhux skwamuż'.
English: On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer.
Maltese: Fit-22 ta' Settembru 2016, Hospira UK Limited għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Pemetrexed (bħala ditromethamine) Hospira, għall-kura ta' mesoteljoma plewrali malinna u tal-kanċer tal-pulmun ta' ċelloli mhux żgħar.
English: Pemetrexed (as ditromethamine) Hospira is a cancer medicine that contains the active substance pemetrexed.
Maltese: Pemetrexed (bħala ditromethamine) Hospira huwa mediċina tal-kanċer li fiha s-sustanza attiva pemetrexed.
English: What is Pemetrexed (as ditromethamine) Hospira?
Maltese: Kif jaħdem Pemetrexed (bħala ditromethamine) Hospira?
English: Pemetrexed (as ditromethamine) Hospira was developed as a ‘generic medicine'.
Maltese: Pemetrexed (bħala ditromethamine) Hospira ġie żviluppat bħala ‘mediċina ġenerika'.
English: The active substance in both medicines, pemetrexed, is changed in the body into an active form that blocks enzymes needed to make genetic material (DNA and RNA).
Maltese: Fiż-żewġ mediċini, is-sustanza attiva, pemetrexed, tinbidel fil-ġisem f'forma attiva li timblokka l-enzimi meħtieġa biex isir il-materjal ġenetiku (DNA u RNA).
English: Pemetrexed (as ditromethamine) Hospira is expected to work in the same way as the reference medicine, Alimta.
Maltese: Pemetrexed (bħala ditromethamine) Hospira huwa mistenni li jaħdem bl-istess mod bħall-mediċina ta' referenza, Alimta.
English: The CHMP thought that the company could have addressed these questions and was of the provisional opinion that Pemetrexed (as ditromethamine) Hospira could have been approved for the treatment of malignant pleural mesothelioma and nonsmall-cell lung cancer.
Maltese: Is-CHMP kien tal-opinjoni li l-kumpanija setgħet tindirizza dawn il-mistoqsijiet u kien tal-opinjoni provviżorja li Pemetrexed (bħala ditromethamine) Hospira seta' jiġi approvat għall-kura ta' mesoteljoma plewrali malinna u tal-kanċer tal-pulmun taċċelloli mhux żgħar.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this product.
Maltese: X'inhuma l-konsegwenzi ta' dan l-irtirar għall-pazjenti fi provi kliniċi <jew fi programmi ta' użu b'kompassjoni?
English: Further information on Enurev Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Enurev Breezhaler tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Enurev Breezhaler (glycopyrronium bromide) EMA/326865/2018
Maltese: Enurev Breezhaler (bromur tal-glikopirronju) EMA/326865/2018
English: Enurev Breezhaler (glycopyrronium bromide)
Maltese: Enurev Breezhaler (bromur tal-glikopirronju)
English: Other information about Enurev Breezhaler
Maltese: Informazzjoni oħra dwar Enurev Breezhaler
English: The most common side effects with Enurev Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Maltese: L-effetti sekondarji l-aktar komuni b'Enurev Breezhaler (li dehru f'aktar minn pazjent 1 minn kull 100) huma ħalq xott, nasofarinġite (infjammazzjoni tal-imnieħer u l-gerżuma), insomnja (diffikultà fl-irqad), uġigħ fil-muskoli u fl-għadam u gastroenterite (diarrea u remetter).
English: The active substance in Enurev Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Maltese: Is-sustanza attiva f'Enurev Breezhaler, il-bromur tal-glikopirronju, hija antagonista tar-riċettur muskariniku.
English: Enurev Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Maltese: Enurev Breezhaler instab li hu iktar effettiv mill-plaċebo (kura finta) fit-taffija tas-sintomi tas-COPD f'żewġ studji li involvew total ta' 1,888 pazjent b'COPD.
English: Enurev Breezhaler contains the active substance glycopyrronium bromide.
Maltese: Enurev Breezhaler fih is-sustanza attiva bromur tal-glikopirronju.
English: After 12 weeks of treatment, Enurev Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Maltese: Wara 12-il ġimgħa ta' kura, Enurev Breezhaler żied il-FEV1 b'97 ml iktar mill-plaċebo fl-ewwel studju, u b'iktar minn 108 ml fit-tieni studju.
English: As for all medicines, data on the use of Enurev Breezhaler are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Enurev Breezhaler hija ssorveljata kontinwament.
English: In addition, there were no major safety concerns with Enurev Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Maltese: Barra minn hekk, ma kien hemm ebda tħassib maġġuri dwar is-sigurtà b'Enurev Breezhaler, b'effetti sekondarji li huma simili għal mediċini antagonisti tar-riċettur muskariniku.
English: Enurev Breezhaler capsules, which contain a powder for inhalation, are only used with the Enurev Breezhaler inhaler and must not be swallowed.
Maltese: Il-kapsuli ta' Enurev Breezhaler, li fihom trab għall-inalazzjoni, jintużaw biss mal-inalatur ta' Enurev Breezhaler u ma jistgħux jinbelgħu.
English: How does Enurev Breezhaler work?
Maltese: Kif jintuża Enurev Breezhaler?
English: How is Enurev Breezhaler used?
Maltese: Kif jaħdem Enurev Breezhaler?
English: What are the risks associated with Enurev Breezhaler?
Maltese: X'inhuma r-riskji assoċjati ma' Enurev Breezhaler?
English: the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Maltese: it-titjib fil-volumi espiratorji furzati tal-pazjenti (FEV1, il-volum massimu ta' arja li persuna tista' toħroġ f'sekonda).
English: For the full list of side effects and restrictions with Enurev Breezhaler, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Enurev Breezhaler, ara l-fuljett ta' tagħrif.
English: Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways.
Maltese: Ir-riċetturi muskariniċi jikkontrollaw il-kontrazzjoni tal-muskoli u meta lbromur tal-glikopirronju jkun inalat, dan jirrilassa l-muskoli tal-passaġġi tal-arja.
English: Enurev Breezhaler received a marketing authorisation valid throughout the EU on 28 September 2012.
Maltese: Enurev Breezhaler irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-28 ta' Settembru
English: Side effects reported with Enurev Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Enurev Breezhaler huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Cartridge (glass) 3 ml (3.5 mg/ml) 1 cartridge
Maltese: Daqs talpakkett skartoċċ 1
English: Film-coated tablet Oral use
Maltese: Il-pakkett li jmiss mal-prodott
English: 5mg
Maltese: Mnejn għandu jingħata
English: It may harm them,
Maltese: Tumuri fit-tfal
English: • spontaneous abortion.
Maltese: • abort spontaneju
English: • multiple sclerosis*
Maltese: • Sklerożi multipla*
English: (Stevens-Johnson syndrome)
Maltese: (Is-sindromu Stevens-Johnson).
English: CH-1630 Bulle Switzerland
Maltese: CH-1630 Bulle Żvizzera
English: • antibody directed against normal tissue
Maltese: • antikorp kontra tessut normali
English: Start/Pause button
Maltese: Buttuna Start/Pause
English: Uncommo tinnitus, vertigo
Maltese: Mhux komuni tinnitus, vertigo
English: Date of latest renewal: 16 May 2014
Maltese: Data ta' l-aħħar tiġdid: 16 Mejju 2014
English: Micro-USB Port
Maltese: Dħul Micro-USB
English: • azoospermia (lack of sperm production).
Maltese: • azoospermia (nuqqas ta' produzzjoni ta' sperma)
English: PASI 75 PASI 90 CIMPASI-2
Maltese: PASI 90 CIMPASI-2
English: Allée de la Recherche 60 1070 Brussels Belgium
Maltese: Allée de la Recherche 60 1070 Brussel Il-Belġju
English: Rare odynophagia, hypermotility
Maltese: Rari odinofaġia, ipermotilita`
English: Chronic obstructive pulmonary disease (COPD)
Maltese: Mard pulmonary ostruttiv kroniku (COPD)
English: This will take from 30 to 45 minutes.
Maltese: Din tieħu 30 sa 45 minuta.
English: Frequency Adverse reactions
Maltese: Frekwenza Reazzjonijiet Avversi
English: Creatine phosphokinase elevations
Maltese: Elevazzjonijiet ta' creatinine phosphokinase
English: • Merkel cell carcinoma (a type of skin cancer)*
Maltese: • Merkel cell carcinoma (tip ta' kanċer tal-ġilda)*
English: Rare pericarditis, atrioventricular block
Maltese: Rari perikardite, blokk atrijoventrikolari
English: On/Off Button
Maltese: Buttuna On/Off
English: The active substance is certolizumab pegol.
Maltese: - Is-sustanza attiva hi certolizumab pegol.
English: ASAS 40 was a secondary endpoint.
Maltese: ASAS 40 kien punt aħħari sekondarju.
English: • Press the (Start/Pause button).
Maltese: • Agħfas (buttuna Start/Pause).
English: Patients receiving concomitant NSAIDs and conventional DMARDs were 72.6% and 70.2% respectively.
Maltese: Il-pazjenti li ħadu f'istess ħin NSAIDs u DMARDs konvenzjonali kienu 72.6% u 70.2% rispettivament.
English: • gastrointestinal cancer, melanoma
Maltese: • kanċer gastrointestinali, melanoma,
English: Table 2 Clinical trial description Study number
Maltese: Tabella 2 Deskrizzjoni tal-prova klinika Numru tal
English: CIMPASI-1 and CIMPASI-2 evaluated 234 patients and 227 patients respectively.
Maltese: CIMPASI-1 u CIMPASI-2 evalwaw 234 pazjent u 227 pazjent rispettivament.
English: Figure 2.
Maltese: Figura 3
English: Manufacturer UCB Pharma S.A. Chemin du Foriest B-1420 Braine l'Alleud Belgium
Maltese: Manifattur UCB Pharma S.A. Chemin du Foriest B-1420 Braine l'Alleud Belġju
English: Rare cerebrovascular accident, arteriosclerosis, Raynaud's phenomenon, livedo reticularis, telangiectasia
Maltese: Rari aċċident cerebrovaskulari, arterosklerożi, fenomenu ta' Raynaud, livedo reticularis, telangiectasia
English: Injection device: ava
Maltese: Makkinarju ta' injezzjoni: ava
English: • tuberculosis infection
Maltese: • tuberkulożi
English: 1: Orange band 2: Viewing window 3: Black handle 4: Clear cap
Maltese: 1: Linja oranġjo band 2: Tieqa mnejn tara 3: Manku iswed 4: Tapp trasparenti
English: C-EARLY (to 52 wee ks)
Maltese: C-EARLY (sa 52 ġimgħa t)
English: INFORMATION IN BRAILLE Cimzia 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Cimzia 200 mg
English: Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for:
Maltese: Artrite Rewmatika CIMZIA flimkien ma' methotrexate (MTX) huwa indikat:
English: B-1070 Bruxelles Belgium
Maltese: B-1070 Brussel Il-Belġju
English: Hepatitis B virus (HBV) reactivation
Maltese: Ir-Ri-attivazzjoni tal-virus Epatite B (HBV)
English: • increased gastrointestinal motility
Maltese: • żieda fil-motilita`gastrointestinali
English: This will take 30 minutes.
Maltese: Din tieħu 30 minuta.
English: • vertigo (dizziness)
Maltese: • vertigo (sturdament)
English: • Turn on ava:
Maltese: • Ixegħel ava:
English: • fistula (tract from one organ to another) (any site)
Maltese: • fistula (tratt bejn organu u ieħor) (kwalunque sit)
English: Not known multiple sclerosis*, Guillain-Barré syndrome*
Maltese: Mhux magħruf sklerożi multipla*, sindromu Guillain-Barré*
English: Table 3 ACR response in clinical trials RA-I and RA-II Study RA-I Methotrexate combination (24 and 52 weeks)
Maltese: Tabella 3 Rispons ACR f' provi kliniċi RA-I u RA-II Studju RAI Kombinat ma' Methotrexate (24 u 52 ġimgħat)
English: Placebo + MTX
Maltese: Plaċebo + MTX
English: • solid organ cancers
Maltese: • kanċers solidi tal-organi
English: Moderate to severe heart failure (NYHA classes III/IV) (see section 4.4).
Maltese: Insuffiċjenza tal-qalb moderata u severa (klassijiet NYHA III/IV) (ara sezzjoni 4.4).
English: • muscle problems including increased muscle enzymes
Maltese: • problem fil-muskoli, inkluż żieda fl-enżimi tal-muskoli
English: • suicide attempt, mental impairment, delirium
Maltese: • attentat ta' suwiċidju, indeboliment mentali, delirju,
English: PlaceboN= 158
Maltese: PlaċeboN= 158
English: This effect has been observed with the PTT-Lupus Anticoagulant (LA) test and Standard Target Activated Partial Thromboplastin time (STA-PTT) Automate tests from Diagnostica Stago, and the HemosIL APTT-SP liquid and HemosIL lyophilised silica tests from Instrumentation Laboratories.
Maltese: Dan l-effett kien osservat bit -test PTT-Lupus Anticoagulant (LA) u bis-Standard Target Activated Partial Thromboplastin time (STA-PTT) Testijiet awtomati minn Diagnostica Stago, u bit-testijiet HemosIL likwidu APTT-SP u l-HemosIL silica lajofilizzat minn Instrumentation Laboratories.
English: Week 12 Week 24 ASAS 5/6(c,d)
Maltese: ASAS 5/6(c,d)
English: Cimzia selectively neutralises TNFα (IC90 of 4 ng/ml for inhibition of human TNFα in the in vitro L929 murine fibrosarcoma cytotoxicity assay) but does not neutralise lymphotoxin α (TNFβ).
Maltese: Cimzia jinnewtralizza selettivament TNFα (IC90 ta' 4 ng/ml għal-inibizzjoni ta' TNFα uman fl- analiżi taċċitotossiċita` ta' in vitro L929 murine fibrosarcoma) imma ma jinnewtralizzax il-limfotoxin α (TNF).
English: RA-I (52 weeks)
Maltese: RA-I (52 ġimgħa)
English: Clinical
Maltese: KLINIKU
English: The baseline PGA score ranged from moderate (70%) to severe (30%).
Maltese: Il-punteġġ PGA tal-linja bażi kien ivarja minn moderat (70%) sa sever (30%).
English: Rare angioneurotic oedema, sarcoidosis, serum sickness, panniculitis (including erythema nodosum), worsening of symptoms of dermatomyositis**
Maltese: Rari edima angjonewrotika, sarkojdożi, mard tas-serum, pannikulite (inkluż eritema nodosum), aggravar tas-sintomi ta'dermatomijosite**
English: Missing data were imputed using multiple imputation based on the MCMC method.
Maltese: Id-dejta nieqsa kienet imputata bl-użu ta' imputazzjoni multipla bbażata fuq il-metodu MCMC.
English: PASI75 and PGA at Week 16 were key secondary endpoints.
Maltese: PASI75 u PGA f'Ġimgħa 16 kienu punti aħħarin sekondarji importanti.
English: The typical Cavg that produces half the maximum probability of ACR 20 response (EC50) was 17 µg/ml (95% CI: 10-23 µg/ml).
Maltese: Il-medda ta' konċentrazzjoni tipika tal-plażma waqt interval tad-doża (Cavg) li jipproduci nofs il-probabilita` massima ta' rispons ACR 20 (EC50) kien ta' 17µg/ml (95% CI: 10-23µg/ml).
English: • stomach problems including abdominal fluid collection, ulcers (including oral ulcers),
Maltese: • problem fl-istonku inkluż (ġemgħa ta' fluwidu abdominali, ulċeri (inkluż ulċeri orali),
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 October 2009
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data ta' l-ewwel awtorizazzjoni: 01 Ottobru 2009
English: Interference with thrombin time (TT) and prothrombin time (PT) assays have not been observed.
Maltese: Ma kienitx osservata interferenza bl- analiżi thrombin time(TT) u prothrombin time(PTT).
English: RA-II (24 weeks)
Maltese: RA-II (24 ġimgħa)
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Maltese: Neoplażmi beninni, malinni u dawk mhux specifikati (including ċesti and polipi)
English: A total of 199 subjects (61.2% of randomized subjects) completed the study through Week 204.
Maltese: Total ta' 199 pazjent (61.2% tal-pazjenti randomizzati) spiċċaw l-istudju sa Ġimgħa 204.
English: ASAS 40 Week 12
Maltese: ASAS 40 Ġimgħa 12
English: The CIMPACT study evaluated 559 patients.
Maltese: L-istudju CIMPACT evalwa 559 pazjent.
English: * Cimzia vs placebo: p< 0.0001.
Maltese: * Cimzia vs plaċebo: p < 0.0001.
English: The apparent volume of distribution (V/F) was estimated at 8.01 l in a population pharmacokinetic analysis of patients with rheumatoid arthritis and at 4.71 l in a population pharmacokinetic analysis of patients with plaque psoriasis.
Maltese: Il-volum li jidher ta' distribuzzjoni (V/F) kien smat bħala 8.01 l f'analiżi tal-farmakokinetika filpopolazzjoni ta' pazjenti b'artrite rewmatika u ta' 4.71 l f'analiżi farmakokinetika tal-popolazzjoni ta' pazjenti bi psorjasi tal-plakka.
English: PASI 75 (c) Week 12 Week 24 Week 48
Maltese: PASI 75 (c) Ġimgħa 12 Ġimgħa 24
English: Cimzia vs. placebo: *p≤0.01, ** p<0.001
Maltese: Cimzia vs. plaċebo: *p≤0.01, ** p<0.001
English: Compared with a 70 kg person, clearance is 29% lower and 38% higher, respectively, in individual RA patients weighing 40 kg and 120 kg.
Maltese: Meta mqabbel ma' persuna li tiżen 70kg, it-tneħħija hija 29% inqas minn u 38% ogħla, rispettivament, f' pazjenti individwali RA li jiżnu 40kg u 120kg.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA(I) BIJOLOĠIKA ATTIVA U MANIFATTUR
English: Rare fistula (any site)
Maltese: Rari fistula (f' kwalunque sit)
English: 87.7% of patients received concomitant NSAIDs.
Maltese: 87.7% tal-pazjenti rċievew NSAIDs fl-istess ħin.
English: Responsea.
Maltese: Risponse
English: Patients had a Psoriasis Area and Severity Index (PASI) score ≥ 12, body surface area (BSA) involvement of ≥ 10%, Physician Global Assessment (PGA) of ≥ 3, and were candidates for systemic therapy and/or phototherapy and/or chemophototherapy.
Maltese: Il-pazjenti kellhom punteġġ tal-Indiċi taż-Żona ta' Psorjasi u Severità (PASI, Psoriasis Area and Severity Index) ta' ≥ 12, involviment tal-erja tas-superfiċje tal-ġisem (BSA, body surface area) ta' ≥ 10%, Stima Ġenerali tatTabib (PGA, Physician Global Assessment) ta' ≥ 3, u kienu kandidati għat-terapija sistemika u/jew fototerapija u/jew kimofototerapija.
English: Placebo N=136
Maltese: Plaċebo N=136
English: For the full list of excipients, see section 6.1.
Maltese: Għall- lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Cimzia 200 mg + MTXPlacebo +MTX Difference*
Maltese: Cimzia 200 mg + MTXPlaċebo +MTX Differenza*
English: Latex-sensitivity
Maltese: Sensittività eċċessiva
English: This can take up to 15 seconds.
Maltese: Din tieħu sa 15-il sekonda.
English: Placebo N=86
Maltese: Plaċebo N=86
English: A total of 264 subjects (64.5%) completed the study through Week 216.
Maltese: Total ta' 264 pazjenti (64.5%) lestew l-istudju sa Ġimgħa 216.
English: Responses were maintained through Weeks 52 (RA-I) and 24 (RA-II).
Maltese: Ir-rispons kienu mantenuti matul Ġimgħat 52 (RA-I) u 24 (RA-II).
English: Not known (frequency cannot be estimated from the available data):
Maltese: Mhux magħruf (il-frekwenza ma ġietx smata mid-dejta disponibbli):
English: PASI 90 at Week 16 was a key secondary endpoint in all 3 studies.
Maltese: PASI 90 f'Ġimgħa 16 kien punt aħħari sekondarju importanti fit-3 studji kollha.
English: Table 6 Radiographic change at Week 52 in trial C-EARLY Placebo +MTX N= 163 Mean (SD)
Maltese: Tabella 6 Tibdil radjografiku f' Ġimgħa 52 f' prova C-EARLY Plaċebo +MTX N= 163 Medja (SD)
English: No dose recommendations can be made (see section 5.2).
Maltese: Ma jistgħux isiru rikommandazzjonijiet ta' dożaġġ (ara sezzjoni 5.2).
English: Rare skin exfoliation and desquamation, bullous conditions, hair texture disorder, Stevens-Johnson syndrome**, erythema multiforme**, lichenoid reactions
Maltese: Rari esfoljazzjoni u deskwemazzjoni tal-ġilda, kondizzjonijiet bullożi, disturbi fil-konsistenza taxxagħar, sindromu ta' Stevens-Johnson**, eritema multiforme**, reazzjonijiet likenojdi
English: The value of these data to the evaluation of human risk may be limited.
Maltese: Il-valur ta' dan id-dejta għal levalwazzjoni tar-riskju uman jista' jkun limitat.