FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose is usually 12 mg once a day (3 capsules of 4 mg) if you weigh 60 kg or more and 8 mg once a day (2 capsules of 4 mg) if you weigh less than 60kg.
Maltese: u 8 mg darba kuljum (2 kapsuli ta' 4 mg) jekk tiżen inqas minn 60 kg.
English: • you are breast-feeding (see the section below on Contraception, pregnancy and breast-feeding).
Maltese: • qed tredda' (ara s-sezzjoni hawn taħt fuq Kontraċezzjoni, tqala u treddigħ).
English: Reactions of Grade 3 or higher (including 1 reaction of Grade 4) occurred in 44.4% of lenvatinib-treated patients compared with 3.8% of placebo-treated patients.
Maltese: Reazzjonijiet ta' Grad 3 jew ogħla (li jinkludu 1 reazzjoni ta' Grad 4) seħħew f'44.4% tal-pazjenti ttratti b'lenvatinib meta mqabbla ma' 3.8% tal-pazjenti ttratti bi plaċebo.
English: Females had a higher incidence of hypertension (including Grade 3 or 4 hypertension), proteinuria, and PPE, while males had a higher incidence of decreased ejection fraction and gastrointestinal perforation and fistula formation.
Maltese: In-nisa kellhom inċidenza ogħla ta' pressjoni għolja (li tinkludi pressjoni għolja ta' Grad 3 jew 4), proteinurija, u PPE, filwaqt li l-irġiel kellhom inċidenza ogħla ta' porzjon ta' tfigħ 'il barra mnaqqas u perforazzjoni gastrointestinali u l-formazzjoni ta' fistula.
English: The median OS had not been reached for either the lenvatinib group or the placebo crossover group.
Maltese: Naqqas id-doża u kompli lenvatinib insuffiċjenza talkliewi linja bażi.
English: Electrolyte disturbances such as hypokalaemia, hypocalcaemia, or hypomagnesaemia increase the risk of QT prolongation; therefore, electrolyte abnormalities should be monitored and corrected in all patients before starting treatment.
Maltese: Disturbi fl-elettroliti bħal ipokalemija, ipokalċemija, jew ipomanjesemija, iżidu r-riskju ta' titwil talQT; għalhekk, anormalitajiet fl-elettroliti għandhom jiġu mmonitorjati u kkoreġuti fil-pazjenti kollha qabel tinbeda l-kura.
English: Alternatively, the lenvatinib capsules may be added without breaking or crushing them to a tablespoon of water or apple juice in a small glass to produce a suspension.
Maltese: Alternattivament, il-kapsuli ta' lenvatinib jistgħu jiżdiedu mingħajr ma jitkissru jew jitgħaffġu ma' mgħarfa ilma jew meraq tat-tuffieħ f'tazza żgħira biex jipproduċu suspensjoni.
English: Elderly
Maltese: Avversa
English: Hazard ratio is for lenvatinib vs. sorafenib, based on a Cox model including treatment group as a factor.
Maltese: Lenvatinib jista' jaffettwa b'mod avvers il-proċess tal-fejqan tal-feriti, bħal f'sustanzi oħrajn tal-istess klassi.
English: PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances.
Maltese: PRES hu disturb newroloġiku li jista' jidher bħala wġigħ ta' ras, aċċessjoni, letarġija, konfużjoni, funzjoni mentali mibdula, għama, u disturbi oħrajn fil-vista jew disturbi newroloġiċi.
English: Cases of fistula formation or enlargement that involve areas of the body other than stomach or intestines were observed in clinical trials and in post-marketing experience (e.g. tracheal, tracheo-oesophageal, oesophageal, cutaneous, female genital tract fistulae).
Maltese: Każijiet ta' formazzjoni jew tkabbir ta' fistula li jinvolvu żoni tal-ġisem oħrajn ħlief l-istonku jew l-imsaren, ġew osservati fil-provi kliniċi u fl-esperjenza ta' wara t-tqegħid fis-suq (eż. fistula trakeali, fistula trakeoesofagali, fistula esofagali, fistula tal-passaġġ ġenitali tal-mara, u fistula tal-ġilda).
English: Patients were excluded who had prior systemic anticancer therapy for advanced/unresectable HCC or any prior anti-VEGF therapy.
Maltese: Pazjenti li kellhom terapija sistemika preċedenti għal HCC avvanzata jew li ma tistax titneħħa, jew kwalunkwe terapija preċedenti kontra VEGF, ġew esklużi.
English: The median time to objective responsive was 2.0 (95% CI: 1.9, 3.5) months; however, of the patients who experienced a complete or partial response to lenvatinib, 70.4% were observed to develop the response on or within 30 days of being on the 24-mg dose.
Maltese: Iż-żmien medjan għal rispons oġġettiv kien ta' 2.0 (95% CI: 1.9, 3.5) xhur; madankollu, mill-pazjenti li kellhom rispons komplet jew parzjali għal lenvatinib, 70.4% ġew osservati li żviluppaw ir-rispons nhar jew fi żmien 30 jum minn meta bdew jieħdu d-doża ta' 24 mg.
English: e.
Maltese: A.
English: Vomiting Nausea Oral inflammationg Oral painh
Maltese: Studji dwar it-tossiċità f'annimali ġuvenili
English: The toxicity of lenvatinib was more prominent in younger rats (dosing initiated on PND7) compared with those with dosing initiated on PND21 and mortality and some toxicities were observed earlier in the juvenile rats at 10 mg/kg compared with adult rats administered the same dose level.
Maltese: It-tossiċità ta' lenvatinib kienet aktar prominenti f'firien iżgħar (dożaġġ mibdi f'PND7) meta mqabbla ma' dawk bid-dożaġġ mibdi f'PND21 u l-mortalità u xi tossiċitajiet ġew osservati aktar kmieni filfirien ġuvenili f'doża ta' 10 mg/kg meta mqabbla ma' firien adulti li ngħataw l-istess livell ta' doża.
English: These cases were associated with adverse reactions consistent with the known safety profile of lenvatinib (i.e., renal and cardiac failure), or were without adverse reactions.
Maltese: Dawn il-każijiet ġew assoċjati ma' reazzjonijiet avversi konsistenti mal-profil tas-sigurtà magħruf ta' lenvatinib (i.e. insuffiċjenza tal-kliewi u kardijaka), jew kienu mingħajr reazzjonijiet avversi.
English: Renal failure cases includes: acute prerenal failure, renal failure, renal failure acute, acute kidney injury and renal tubular necrosis.
Maltese: Każijiet ta' insuffiċjenza tal-kliewi jinkludu: insuffiċjenza prerenali akuta, insuffiċjenza talkliewi, insuffiċjenza akuta tal-kliewi, ħsara akuta tal-kliewi u nekrożi tubulari tal-kliewi.
English: Lenvatinib exhibited good oral bioavailability in dogs (70.4%) and monkeys (78.4%).
Maltese: 4%) u fix-xadini (78.4%).
English: In the pivotal Phase 3 SELECT trial (see section 5.1), 88% of all patients had a baseline TSH level less than or equal to 0.5 mU/L.
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT (ara sezzjoni 5.1), 88% tal-pazjenti kollha kellhom livell ta' TSH fil-linja bażi li kien inqas minn jew ugwali għal 0.5 mU/L.
English: Following independent review confirmation of disease progression, 109 (83.2%) patients randomised to placebo had crossed over to open-label lenvatinib at the time of the primary efficacy analysis.
Maltese: Wara l-konferma indipendenti tal-evalwazzjoni tal-progressjoni tal-marda, 109 (83.2%) tal-pazjenti li ntgħażlu b'mod każwali għal plaċebo, qalbu għal open-label lenvatinib fil-ħin tal-analiżi tal-effikaċja primarja.
English: Females had a higher incidence of hypertension, fatigue, ECG QT prolongation and alopecia.
Maltese: In-nisa kellhom inċidenza ogħla ta' pressjoni għolja, għeja, titwil tal-QT tal-ECG u alopeċja.
English: Similarly, although not studied directly, the MOA for proteinuria is postulated to be mediated by downregulation of VEGFR1 and VEGFR2 in the podocytes of the glomerulus.
Maltese: Bl-istess mod, għalkemm ma ġiex studjat direttament, l-MOA għal proteinurija hu postulat li jiġi medjat minn regolazzjoni 'l isfel ta' VEGFR1 u VEGFR2 fil-podoċiti talglomerulus.
English: • severe pain in your belly (abdomen) - this may be due to a hole in the wall of your gut or a fistula (a hole in your gut which links through a tube-like passage to another part of your body or skin).
Maltese: • uġigħ qawwi f'żaqqek (addome) - dan jista' jkun minħabba toqba fil-ħajt tal-imsaren tiegħek jew fistula (toqba fl-imsaren tiegħek li tinfed għal parti oħra tal-ġisem jew tal-ġilda minn ġo passaġġ qisu tubu).
English: Patients with body weight <60 kg
Maltese: Pazjenti b'piż tal-ġisem ta' <60 kg
English: Diarrhoea has been reported frequently in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Maltese: Id-dijarea ġiet irrappurtata b'mod frekwenti f'pazjenti ttratti b'lenvatinib, u normalment seħħet kmieni fil-kors tal-kura (ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: • feeling unwell
Maltese: • insuffiċjenza tal-fwied
English: It is available as pink, round tablets (75 mg).
Maltese: Huwa disponibbli bħala pilloli tondi roża (75 mg).
English: Clopidogrel Mylan clopidogrel EPAR summary for the public
Maltese: Clopidogrel Mylan clopidogrel Sommarju tal-EPAR għall-pubbliku
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Mylan to Mylan S.A.S on 21 September 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Clopidogrel Mylan lil Milan S.A.S fil 21 ta' Settembru 2009.
English: Other information about Clopidogrel Mylan:
Maltese: Informazzjoni oħra dwar Clopidogrel Mylan:
English: What are the benefit and risk of Clopidogrel Mylan?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Clopidogrel Mylan?
English: The active substance in Clopidogrel Mylan, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva ta' Clopidogrel Mylan, clopidogrel, hu inibitur tal-aggregazzjoni tal-pjastrini.
English: Clopidogrel Mylan is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel Mylan jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: Clopidogrel Mylan is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Mylan huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: Clopidogrel Mylan can be given to the following groups of patients:
Maltese: Clopidogrel Mylan jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: Because Clopidogrel Mylan is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel Mylan huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: Clopidogrel Mylan is a ‘generic medicine'.
Maltese: Clopidogrel Mylan jista'
English: This means that Clopidogrel Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Clopidogrel Mylan huwa ‘mediċina ġenerika' Dan ifisser li Clopidogrel Mylan huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: What is Clopidogrel Mylan?
Maltese: X'inhu Clopidogrel Mylan?
English: Why has Clopidogrel Mylan been approved?
Maltese: Għaliex ġie approvat Clopidogrel Mylan?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Mylan has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel Mylan wera li għandu kwalità komparabbli ma' u huwa bijoekwivalenti għal Plavix.
English: Because Clopidogrel Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Maltese: Minħabba li Clopidogrel Mylan huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Therefore, the CHMP's view was that, as for Plavix, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Plavix, ilbenefiċċji huma akbar mir-riskji identifikati.
English: The standard dose of Clopidogrel Mylan is one 75 mg tablet once a day, taken with or without food.
Maltese: Id-doża standard ta' Clopidogrel Mylan hija ta' pillola waħda ta' 75 mg darba kuljum, mal-ikel jew fuq stonku vojt.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Maltese: Dan iwaqqaf il-platelets milli jibdew ‘iweħħlu', fejn b'hekk jitnaqqas ir-riskju li jiffurmaw l-għaqid tad-demm u jgħin fil-prevenzjoni ta' attakk tal-qalb ieħor jew ta' puplesija.
English: How is Clopidogrel Mylan used?
Maltese: Kif taħdem Clopidogrel Mylan?
English: How has Clopidogrel Mylan been studied?
Maltese: Kif ġie studjat Clopidogrel Mylan?
English: p-value versus adalimumab
Maltese: valur p versus adalimumab
English: Simvastatin is a CYP3A4 and OATP1B1 substrate.
Maltese: Simvastatin huwa sustrat ta' CYP3A4 u OATP1B1.
English: Component (range)
Maltese: Komponent (firxa)
English: DAS28-ESR (primary endpoint)
Maltese: DAS28-ESR (skop finali primarju)
English: • The injection can take up to 15 seconds.
Maltese: • L-injezzjoni tista' tieħu sa 15-il sekonda.
English: • The active substance is sarilumab.
Maltese: • Is-sustanza attiva hi sarilumab.
English: Interactions with CYP450 substrates
Maltese: Interazzjonijiet ma' sustrati ta' CYP450
English: 81 Columbia Turnpike
Maltese: Inc. 81 Columbia Turnpike Rensselaer
English: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait, France
Maltese: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait, Franza
English: Viral reactivation has been reported with immunosuppressive biologic therapies.
Maltese: Ġiet irrappurtata riattivazzjoni virali b'terapiji bijoloġiċi immunosoppressivi.
English: Industriepark Hochst 65926 Frankfurt am Main Germany
Maltese: Industriepark Hochst 65926 Frankfurt am Main
English: Table 3: Clinical Response at Weeks 12, 24, and 52 in Placebo-Controlled Studies, MOBILITY and TARGET
Maltese: Tabella 3: Rispons kliniku fil-Ġimgħat 12, 24, u 52 fl-iStudji Kkontrollati bi Plaċebo, MOBILITY u TARGET
English: Excipients: histidine, arginine, polysorbate 20, sucrose, water for injections.
Maltese: Eċċipjenti: histidine, arginine, polysorbate 20, sucrose, ilma għall-injezzjonijiet.
English: ALT > 1 to 3 x Upper Limit of Normal (ULN)
Maltese: ALT > 1 sa 3 x Il-Limitu ta' Fuq tan-Normal (ULN, Upper Limit of Normal)
English: ANC less than 0.5
Maltese: ANC inqas minn 0.5
English: Boulevard Industriel, Zone Industrielle, Le Trait, 76580,
Maltese: Sanofi Winthrop Industrie Boulevard Industriel, Zone Industrielle, Le Trait, 76580,
English: Table 6: Efficacy results for MONARCH
Maltese: Tabella 6: Riżultati ta' effikaċja għal MONARCH
English: • HIV infection;
Maltese: • infezzjoni bl-HIV;
English: • been exposed to tuberculosis; or
Maltese: • ġew esposti għat-tuberkulożi; jew
English: Dose modification:
Maltese: Modifikazzjoni fid-doża:
English: Cases of opportunistic infection have been reported (see section 4.4).
Maltese: Ġew irrappurtati każijiet ta' infezzjoni opportunistika (ara sezzjoni 4.4).
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: Il-frekwenza tar-reazzjonijiet avversi elenkati taħt hija ddefinita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari
English: Liver enzyme abnormalities are summarised in Table 2.
Maltese: Anormalitajiet fl-enzimi tal-fwied huma mqassra f'Tabella 2.
English: Placebo cDMARDs (N = 181)
Maltese: Plaċebo cDMARDs (N = 181)
English: EU/1/17/1196/005 EU/1/17/1196/006 EU/1/17/1196/007 EU/1/17/1196/008 EU/1/17/1196/009 EU/1/17/1196/010 EU/1/17/1196/011 EU/1/17/1196/012
Maltese: EU/1/17/1196/006 EU/1/17/1196/007 EU/1/17/1196/008 EU/1/17/1196/009 EU/1/17/1196/010
English: Placebo + DMARD N = 661
Maltese: Plaċebo + DMARD N = 661
English: It is a type of protein called a monoclonal antibody.
Maltese: Huwa tip ta' proteina msejħa antikorp monoklonali.
English: Age, gender, ethnicity and body weight
Maltese: Età, sess tal-persuna, etniċità u piż tal-ġisem
English: It is a type of protein - called a “monoclonal antibody”.
Maltese: Huwa tip ta' proteina msejħa “antikorp monoklonali”.
English: Table 1: ADRs in controlled clinical studies
Maltese: Tabella 1: ADRs fi studji kliniċi kkontrollati
English: Kevzara has not been investigated in combination with Janus kinase (JAK) inhibitors or biological DMARDs such as Tumor Necrosis Factor (TNF) antagonists.
Maltese: Kevzara ma ġiex investigat flimkien ma' inibituri ta' Janus kinase (JAK) jew DMARDs bijoloġiċi bħal antagonisti tal-Fattur ta' Nekrożi tat-Tumur (TNF, Tumor Necrosis Factor).
English: Table 2: Incidence of liver enzyme abnormalities in controlled clinical studies
Maltese: Tabella 2: L-inċidenza ta' anormalitajiet fl-enzimi tal-fwied fi studji kliniċi kkontrollati
English: Pack sizes:
Maltese: Pakkett multiplu:
English: Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of Transcription-3 (STAT-3).
Maltese: Sarilumab huwa antikorp monoklonali uman (sottotip IgG1) li jintrabat b'mod speċifku kemm ma' riċetturi ta' IL-6 (IL-6Rα) solubbli kif ukoll dawk marbuta mal-membrana, u jinibixxi l-għoti ta' sinjali medjati minn IL-6 li jinvolvi l-glikoproteina 130 (gp130) li titrasduċi s-sinjali u tinstab kullimkien u t-Trasduttur tas-Sinjali u Attivatur ta' Traskrizzjoni 3 (STAT-3 - Signal Transducer and Activator of Transcription-3).
English: • a history of serious or opportunistic infections;
Maltese: • storja ta' infezzjonijiet serji jew opportunistiċi;
English: • That Kevzara treatment may increase the risks of serious infections, neutropenia and intestinal perforation.
Maltese: • Li t-trattament b'Kevzara jista' jżid ir-riskji ta' infezzjonijiet serji, newtropenija u perforazzjoni intestinali.
English: • a group of medicines called “Janus kinase (JAK) inhibitors” (used for disease like rheumatoid arthritis and cancer)
Maltese: • grupp ta' mediċini msejħa “inibituri ta' Janus kinase (JAK)” (użati għal mard bħal artrite rewmatojd u kanċer)
English: Missed dose
Maltese: Kwalunkwe Doża
English: Major clinical response¶
Maltese: Rispons kliniku maġġuri¶
English: Treatment with Kevzara was associated with increases in lipid parameters such as LDL cholesterol, HDL cholesterol, and/or triglycerides (see section 4.8).
Maltese: It-trattament b'Kevzara kien assoċjat ma' żidiet fil-parametri tal-lipidi bħal kolesterol LDL, kolesterol HDL, u/jew trigliċeridi (ara sezzjoni 4.8).
English: Treatment with Kevzara should be withheld until >1 x 109/L.
Maltese: It-trattament b'Kevzara għandu jitwaqqaf sakemm >1 x 109/L.
English: • lived in or travelled to areas of endemic tuberculosis or endemic mycoses.
Maltese: • għexu f'postijiet jew żaru postijiet fejn hemm tuberkulożi endemika jew mikożi endemika.
English: Table 4: Mean reductions from baseline to Week 24 in components of ACR score
Maltese: Tabella 4: Medja ta' tnaqqis mil-linja bażi sa Ġimgħa 24 fil-komponenti tal-punteġġ ACR
English: How to store Kevzara 6.
Maltese: Kif taħżen Kevzara 6.
English: Population pharmacokinetic analyses in adult patients with RA (ranging in age from18 to 88 years with 14% over 65 years) showed that age, gender and race did not meaningfully influence the pharmacokinetics of sarilumab.
Maltese: Analiżi farmakokinetika ta' popolazzjoni f'pazjenti adulti b'RA (li varjaw fl-età minn 18 sa 88 sena b'14% li kellhom aktar minn 65 sena) uriet li l-età, is-sess tal-persuna u r-razza ma influwenzawx b'mod ta' sinifikat il-farmakokinetika ta' sarilumab.
English: Placebo + cDMA RDs* N = 181
Maltese: + cDMA RDs* N = 181
English: There are limited data available on overdose with Kevzara.
Maltese: Hemm disponibbli dejta limitata dwar doża eċċessiva b'Kevzara.
English: For the 200 mg every two weeks dose regimen, the estimated mean (± SD) steady-state AUC, Cmin and Cmax of sarilumab were 396 ± 194 mg.day/L, 16.7 ± 13.5 mg/L, and 35.4 ± 13.9 mg/L, respectively.
Maltese: Għall-iskeda ta' doża ta' 200 mg kull ġimagħtejn, l-istima tal-medja (± SD) tal-AUC, s-Cmin, u s-Cmax ta' sarilumab fl-istat fiss kienu 396 ± 194 mg.kuljum/L, 16.7 ± 13.5 mg/L, u 35.4 ± 13.9 mg/L, rispettivament.
English: When clinically indicated, consider other liver function tests such as bilirubin.
Maltese: Meta jkun indikat b'mod kliniku, qis testijiet oħra tal-funzjoni tal-fwied bħal bilirubin.
English: Date of first authorisation: 23 June 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Ġunju, 2017
English: Store in a refrigerator (2ºC - 8ºC).
Maltese: Aħżen fil-friġġ (2ºC - 8ºC).
English: (see section 5.2).Interaction of sarilumab with substrates of other CYPs (CYP2C9, CYP 2C19, CYP2D6) has not been studied.
Maltese: L-interazzjoni ta' sarilumab ma' sustrati ta' CYPs oħra (CYP2C9, CYP 2C19, CYP2D6) ma ġietx studjata.
English: sanofi-aventis groupe: 54, rue la Boétie 75008 Paris France
Maltese: sanofi-aventis groupe: 54, rue la Boétie 75008 Paris Franza
English: Body weight influenced the pharmacokinetics of sarilumab.
Maltese: Il-piż tal-ġisem influwenza l-farmakokinetika ta' sarilumab.
English: Levels were reduced to normal as early as 4 days after treatment initiation.
Maltese: Il-livelli naqsu għan-normal anke fi żmien 4 ijiem wara li beda t-trattament.
English: Physician global VAS‡ (0-100 mm) Patient global VAS‡ (0-100 mm) HAQ-DI
Maltese: VAS‡ totali tat-Tabib (0-100 mm) VAS‡ totali tal-Pazjent (0-100 mm) HAQ-DI CRP
English: Lipid parameters (LDL, HDL, and triglycerides) were first assessed at 4 weeks following initiation of Kevzara+ DMARDs in the placebo-controlled population.
Maltese: Il-parametri tal-lipidi (LDL, HDL, u t-trigliċeridi) ġew stmati l-ewwel 4 ġimgħat wara li nbeda Kevzara+ DMARDs fil-popolazzjoni kkontrollata bil-plaċebo.
English: KEVZARA 150 mg injection sarilumab
Maltese: KEVZARA 150 mg injezzjoni sarilumab
English: ACR50 response, n (%)
Maltese: Rispons ACR50, n (%)
English: Among opportunistic infections, tuberculosis, candidiasis, and pneumocystis were reported with Kevzara.
Maltese: Fost l-infezzjonijiet opportunistiċi, ġew irrappurtati tuberkulożi, kandidjażi, u pnewmosistis b'Kevzara.
English: ACR70 response, n (%)
Maltese: Rispons ACR70, n (%)
English: ANC greater than 1
Maltese: ANC akbar minn 1
English: For the 150 mg every two weeks dose regimen, the estimated mean (± standard deviation, SD) steadystate area under curve (AUC), Cmin, and Cmax of sarilumab were 210 ± 115 mg.day/L, 6.95 ± 7.60 mg/L, and 20.4 ± 8.27 mg/L, respectively.
Maltese: Għall-iskeda ta' doża ta' 150 mg kull ġimagħtejn, l-istima tal-medja (± devjazzjoni standard, SD standard deviation) tal-erja taħt il-kurva (AUC), s-Cmin, u s-Cmax ta' sarilumab fl-istat fiss kienu 210 ± 115 mg.kuljum/L, 6.95 ± 7.60 mg/L, u 20.4 ± 8.27 mg/L, rispettivament.
English: ACR20 response, n (%)
Maltese: Rispons ACR20, n (%)
English: Look at the label.
Maltese: Se jkun hemm it-tieni klikk.
English: The safety and efficacy of Kevzara have not been studied in patients with hepatic impairment, including patients with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) serology (see section 4.4).
Maltese: Is-sigurtà u l-effikaċja ta' Kevzara ma ġewx studjati f'pazjenti b'indeboliment tal-fwied, inkluż f'pazjenti b'seroloġija pożittivia għall-virus tal-epatite B (HBV, hepatitis B virus) jew tal-epatite C (HCV, hepatitis C virus) (ara sezzjoni 4.4).
English: Figure 1: Percent of ACR20 Response by Visit for MOBILITY
Maltese: Figura 1: Perċentwal ta' Rispons ACR20 skont il-Vista f'MOBILITY
English: • The other ingredients are arginine, histidine, polysorbate 20, sucrose, and water for injections.
Maltese: • Is-sustanzi l-oħra huma arginine, histidine, polysorbate 20, sucrose, u ilma għall-injezzjonijiet.
English: Figure 2: Percent of ACR20 Response by Visit for TARGET
Maltese: Figura 2: Perċentwal ta' Rispons ACR20 skont il-Vista għal TARGET
English: kevzara 200 mg pen
Maltese: kevzara 200 mg pinna