FrancophonIA/ELRC3.0 huggingface dataset:
English: • You may see an air bubble, this is normal.
Maltese: • Jista' jkun li tara bużżieqa tal-arja, dan huwa normali.
English: Decreases in neutrophil counts below 1 x 109/L occurred in 6.4% and 3.6% of patients in the 200 mg and 150 mg Kevzara + DMARDs group, respectively, compared to no patients in the placebo + DMARDs group.
Maltese: Tnaqqis fl-għadd tan-newtrofili inqas minn 1 x 109/L seħħ f'6.4% u 3.6% tal-pazjenti fil-grupp ta' 200 mg u 150 mg Kevzara + DMARDs, rispettivament, meta mqabbel mal-ebda pazjent fil-grupp ta' plaċebo + DMARDs.
English: Pre-filled syringe 150 mg:
Maltese: Pinna mimlija għal-lest 150 mg:
English: GENERAL CLASSIFICATION FOR SUPPLY 15.
Maltese: Sa 15-il sek it-tieni klikk!
English: ≥0.3 units) at Week 52 compared to 26.1% in the placebo + MTX treatment group.
Maltese: 1% fil-grupp ta' trattament bil-plaċebo + MTX.
English: Various in vitro and limited in vivo human studies have shown that cytokines and cytokine modulators can influence the expression and activity of specific cytochrome P450 (CYP) enzymes (CYP1A2, CYP2C9, CYP2C19, and CYP3A4) and therefore have the potential to alter the pharmacokinetics of concomitantly administered medicinal products that are substrates of these enzymes.
Maltese: Diversi studji in vitro u studji limitati in vivo fil-bnedmin urew li ċ-ċitokini u l-modulaturi taċ-ċitokini jistgħu jinfluwenzaw l-espressjoni u l-attività ta' enzimi speċifiċi taċ-ċitokrom P450 (CYP) (CYP1A2,
English: Kevzara is not recommended in children and adolescents under 18 years of age.
Maltese: Kevzara mhuwiex irrakkomandat fi tfal u adolexxenti li għandhom taħt it-18-il sena.
English: The most frequently observed serious infections with Kevzara included pneumonia and cellulitis (see section 4.8).
Maltese: L-aktar infezzjonijiet serji osservati b'mod frekwenti b'Kevzara kienu jinkludu pulmonite u ċellulite (ara sezzjoni 4.8).
English: Hypercholesterolemia Hypertriglyceridemia
Maltese: Iperkolesterolimja
English: In vitro and in vivo studies with sarilumab using human tumour cell lines showed inhibition of STAT-3 activation and inhibition of tumour growth in human tumour xenograft animal models.
Maltese: Studji in vitro u in vivo b'sarilumab bl-użu ta' linji ta' ċelluli umani ta' tumuri urew inibizzjoni ta' attivazzjoni ta'
English: Clinically appropriate dose modification of concomitant DMARDs should be considered.
Maltese: Għandha titqies modifikazzjoni xierqa b'mod kliniku fid-doża ta' DMARDs konkomitanti.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Rappurtar ta' reazzjonijiet avversi ssuspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: In MOBILITY, structural joint damage was assessed radiographically and expressed as change in van der Heijde-modified Total Sharp Score (mTSS) and its components, the erosion score, and joint space narrowing score at Week 52.
Maltese: F'MOBILITY, il-ħsara strutturali tal-ġog ġiet stmata b'mod radjugrafiku u ġiet espressa bħala bidla fil-Punteġġ Totali ta' Sharp modifikat minn van der Heijde (mTSS) u l-komponenti tiegħu, il-punteġġ tat-tgħawwir tal-għadam, u l-punteġġ ta' djuq tal-ispazju tal-ġog f'Ġimgħa 52.
English: Do
Maltese: L
English: MONARCH was a 24 -week randomised double-blind, double-dummy study that compared Kevzara 200 mg monotherapy with adalimumab 40 mg monotherapy administered subcutaneously every two weeks in 369 patients with moderately to severely active RA who were inappropriate for treatment with MTX including those who were intolerant of or inadequate responders to MTX.
Maltese: MONARCH kien studju ta' 24 ġimgħa, fejn il-pazjenti ntagħżlu b'mod arbitrarju biex jew jirċievu ssustanza tal-istudju u plaċebo jew il-kumparatur attiv u plaċebo u fejn la l-investigaturi u lanqas il pazjenti ma kienu jafu liema sustanzi qed jintużaw, li qabbel monoterapija b'Kevzara 200 mg ma' monoterapija b'adalimumab 40 mg mogħtija taħt il-ġilda kull ġimagħtejn fi 369 pazjent b'RA attiva b'mod moderat jew sever li ma kinux xierqa għat-trattament b'MTX inkluż dawk li ma kinux tolleranti għal jew ma rrispondewx b'mod xieraq għal MTX.
English: The impact of treatment with Kevzara on the development of malignancies is not known but malignancies were reported in clinical studies (see section 4.8).
Maltese: L-impatt tat trattament b'Kevzara fuq l-iżvilupp ta' tumuri malinni mhuwiex magħruf iżda kienu rrappurtati tumuri malinni fi studji kliniċi (ara sezzjoni 4.8).
English: Treatment with immunosuppressants may result in an increased risk of malignancies.
Maltese: It-trattament b'immunosoppressanti jista' jwassal għal żieda fir-riskju ta' tumuri malinni.
English: It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled syringes (3 packs of 2).
Maltese: Hija disponibbli f'daqs ta' pakkett1 ta' 1 jew 2 jew pakkett b'ħafna ta' 6 siringi mimlija għal-lest (3 pakketti ta' 2).
English: Kevzara in combination with methotrexate (MTX) is indicated for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs).
Maltese: Kevzara flimkien ma' methotrexate (MTX) huwa indikat għat-trattament ta' artrite rewmatojd (RA, rheumatoid arthritis) attiva b'mod minn moderat sa sever f'pazjenti adulti li ma rrispondewx b'mod adegwat għal, jew li ma ttollerawx mediċina jew mediċini antirewmatiċi li jimmodifikaw il-marda
English: Pharmacotherapeutic group: Immunosupressants, Interleukin inhibitors, ATC code: L04AC14
Maltese: It-trattament b'Kevzara ġie assoċjat ma' inċidenza akbar ta' żidiet fit-transaminase.
English: Decreases in platelet counts below 100 x 103/µL occurred in 1.2% and 0.6% of patients on 200 mg and 150 mg Kevzara + DMARDs, respectively, compared to no patients on placebo + DMARDs.
Maltese: Tnaqqis fl-għadd tal-plejtlets inqas minn 100 x 103/µL seħħ f'1.2% u 0.6% tal-pazjenti fuq 200 mg u 150 mg Kevzara + DMARDs, rispettivament, meta mqabbel mal-ebda pazjent fuq plaċebo + DMARDs.
English: • cold sores (“oral herpes”)
Maltese: • ponta mal-ħalq (“erpete fil-ħalq”)
English: Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant conventional DMARDs (cDMARDs).
Maltese: terapija ta' pazjent, fil-gruppi ta' 200 mg, 150 mg Kevzara + DMARDs, u plaċebo + DMARDs, rispettivament.
English: In patients who develop an ANC less than 0.5 x 109/L, treatment with Kevzara should be discontinued.
Maltese: F'pazjenti li jiżviluppaw ANC inqas minn 0.5 x 109/L, it trattament b'Kevzara għandu jitwaqqaf.
English: No formal study of the effect of hepatic impairment on the pharmacokinetics of sarilumab was conducted (see section 4.2).
Maltese: Ma sar l-ebda studju formali dwar l-effett ta' indeboliment tal-fwied fuq il-farmakokinetika ta' sarilumab (ara sezzjoni 4.2).
English: Each pre-filled pen contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 150 mg sarilumab f'1.14 ml ta' soluzzjoni (131.6 mg/ml).
English: Kevzara is available as 150 mg or 200 mg pre-filled syringes.
Maltese: Kevzara huwa disponibbli bħala siringi mimlijin għal-lest ta' 150 mg jew 200 mg.
English: Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with Kevzara.
Maltese: Kif jiġri bil-proteini terapewtiċi l-oħra kollha, hemm il-possibiltà ta' immunoġeniċità b'Kevzara.
English: For recommended dose modifications based on ANC results see section 4.2.
Maltese: Għall-modifikazzjonijiet fid-doża rrakkomandati abbażi tar-riżultati tal-ANC ara sezzjoni 4.2.
English: Biotransformation
Maltese: Nutrizzjoni
English: The safety of Kevzara in combination with DMARDs was evaluated based on data from seven clinical studies, of which two were placebo-controlled, consisting of 2887 patients (long- term safety population).
Maltese: Is-sigurtà ta' Kevzara flimkien ma' DMARDs ġiet ivvalutata abbażi ta' dejta minn seba' studji kliniċi, li tnejn minnhom kienu kkontrollati bi plaċebo, li kienu jikkonsistu f'2,887 pazjent (popolazzjoni ta' sigurtà fit-tul).
English: After the last steady state dose of 150 mg and 200 mg sarilumab, the median times to non-detectable concentration are 30 and 49 days, respectively.
Maltese: Wara l-aħħar doża fl-istat fiss ta' 150 mg u 200 mg sarilumab, iż-żminijiet medjani għal konċentrazzjoni li ma tistax titkejjel huma 30 u 49 jum, rispettivament.
English: Each single-dose pre-filled syringe contains 150 mg sarilumab in 1.14 ml solution (131.6 mg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 150 mg sarilumab f'1.14 ml ta' soluzzjoni (131.6 mg/ml).
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the rates of malignancies were consistent with the rate observed in the placebo-controlled population (see section 4.4).
Maltese: Fil-popolazzjoni ta' sigurta fit-tul b'Kevzara + DMARDs u l-popolazzjoni ta' monoterapija b'Kevzara, ir-rati ta' tumuri malinni kienu konsistenti mar-rata osservata fil-popolazzjoni kkontrollata bi plaċebo (ara sezzjoni 4.4).
English: Lay the pen on a flat surface and allow it to warm up to room temperature (<25°C) for at least 60 minutes.
Maltese: Poġġi l-pinna fuq superfiċje ċatt u ħalliha tilħaq it-temperatura tal-kamra (<25°C) għal mill inqas 60 minuta.
English: No dose adjustment is required in patients with mild to moderate renal impairment.
Maltese: Indeboliment minn ħafif sa moderat tal-kliewi m'affettwax il-farmakokinetika ta'
English: IL-6 is involved in diverse physiological processes such as migration and activation of T-cells, B-cells, monocytes, and osteoclasts leading to systemic inflammation, synovial inflammation, and bone erosion in patients with RA.
Maltese: IL-6 huwa involut fi proċessi fiżjoloġiċi li jvarjaw ħafna bħal migrazzjoni u attivazzjoni taċ-ċelluli T, ċelluli B, monoċiti, u osteoklasts li jwasslu għal infjammazzjoni sistemika, infjammazzjoni sinovjali, u ttgħawwir tal-għadam f'pazjenti b'RA.
English: The metabolic pathway of sarilumab has not been characterised.
Maltese: Is-sensiela ta' reazzjonijiet metaboliċi ta' sarilumab ma ġietx deskritta.
English: In patients who develop a platelet count less than 50 x 103/ µL, treatment with Kevzara should be discontinued.
Maltese: F'pazjenti li jiżviluppaw għadd tal-plejtlits anqas minn 50 x 103/µL, it-trattament b'Kevzara għandu jitwaqqaf.
English: Pre-filled syringe 200 mg:
Maltese: Siringa mimlija għal-lest 200 mg:
English: Following single-dose sarilumab administration, in patients with RA, ANC decreased to the nadir between 3 to 4 days and thereafter recovered towards baseline (see section 4.4).
Maltese: Wara l-għoti ta' doża waħda ta' sarilumab, f'pazjenti b'RA, l-ANC naqas għall-inqas livell tiegħu fi 3 sa 4 ijiem u mbagħad irkupra sal-linja bażi (ara sezzjoni 4.4).
English: In a usability study sarilumab exposure after 200 mg Q2W was slightly higher (Cmax + 24-34%, AUC(0-2w) +7-21%) after use of a pre-filled pen compared to the pre-filled syringe.
Maltese: 24-34%, AUC(0-2w) +7-21%) wara l-użu ta' pinna mimlija għal-lest meta mqabbla ma' siringa mimlija għal-lest.
English: The most frequent adverse reactions observed with Kevzara in clinical studies were neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.
Maltese: L-aktar reazzjonijiet avversi frekwenti osservati b'Kevzara fl-istudji kliniċi kienu newtropenija, żieda fl-ALT, eritema fil-post tal-injezzjoni, infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju, u infezzjonijiet fl-apparat tal-awrina.
English: EU/1/17/1196/004 6 pre-filled syringes (3 packs of 2)
Maltese: EU/1/17/1196/004 6 siringi mimlija għal-lest (3 pakketti ta' 2)
English: Other medicines and Kevzara
Maltese: Monoterapija b'Kevzara
English: Liver enzymes
Maltese: Postijiet tal-injezzjoni
English: The total content (1.14 ml) of the pre-filled syringe/pre-filled pen should be administered as a subcutaneous injection.
Maltese: Il-kontenut totali (1.14 ml) tas-siringa/tal-pinna mimlija għal-lest għandu jingħata bħala injezzjoni taħt il-ġilda.
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on neutrophil counts were consistent with those seen in the placebo-controlled population (see section 4.4).
Maltese: Fil-popolazzjoni ta' sigurtà fit-tul b'Kevzara + DMARDs u fil-popolazzjoni ta' monoterapija b'Kevzara, l-osservazzjonijiet fuq l-għadd tan-newtrofili kienu konsistenti ma' dawk li dehru filpopolazzjoni kkontrollata bil-plaċebo (ara sezzjoni 4.4).
English: Each single-dose pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 200 mg sarilumab f'1.14 ml ta' soluzzjoni (175 mg/ml).
English: Patients received Kevzara 200 mg, Kevzara 150 mg, or placebo every 2 weeks with concomitant MTX.
Maltese: 30 għal Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, u plaċebo + MTX, kull ġimagħtejn, rispettivament).
English: Lay the syringe on a flat surface and allow it to warm up to room temperature (<25°C) for at least 30 minutes.
Maltese: Poġġi s-siringa fuq superfiċje ċatt u ħalliha tilħaq it-temperatura tal-kamra (<25°C) għal mill-inqas 30 minuta.
English: Liver Enzyme Abnormalities Lab Value
Maltese: Anormalitajiet fl-Enzimi tal-Fwied Valur tal-Laboratorju Rakkomadazzjoni
English: After multiple dosing of 150 to 200 mg every two weeks, steady state was reached in 12 to 16 weeks with a 2- to 3-fold accumulation compared to single dose exposure.
Maltese: Wara dożaġġ multiplu ta' 150 sa 200 mg kull ġimagħtejn, l-istat fiss intlaħaq f'minn 12 sa 16-il ġimgħa b'akkumulazzjoni ta' darbtejn sa 3 darbiet aktar meta mqabbla ma'
English: EU/1/17/1196/008 6 pre-filled pens (3 packs of 2)
Maltese: EU/1/17/1196/008 6 pinen mimlija għal-lest (3 pakketti ta' 2)
English: In patients who develop elevated ALT greater than 5 x ULN, treatment with Kevzara should be discontinued (see section 4.2).
Maltese: F'pazjenti li jiżviluppaw żieda fl-ALT aktar minn 5 x ULN, it trattament b'Kevzara għandu jitwaqqaf (ara sezzjoni 4.2).
English: Sarilumab had no effect on maintenance of pregnancy or on the neonates evaluated up to 1 month after birth in body weight measurements, in parameters of functional or morphological development including skeletal evaluations, in immunophenotyping of peripheral blood lymphocytes, and in microscopic evaluations.
Maltese: Sarilumab ma kellu l-ebda effett fuq iż-żamma tat-tqala jew fuq il-frieħ wara ttwelid ivvalutati sa xahar wara t-twelid fil-kejl tal-piż tal-ġisem, fil-parametri tal-iżvilupp funzjonali jew morfoloġiku inkluż evalwazzjonijiet skeletriċi, fil-fenotipikar immuni ta' limfoċiti periferali tad demm u fl-evalwazzjonijiet mikroskopiċi.
English: TARGET TNF Inhibitor Inadequate Responders
Maltese: TARGET Ma Rrispondewx b'Mod Xieraq b'Inibitur ta' TNF
English: • Check the expiry date (EXP).
Maltese: • Iċċekkja d-data ta' meta jiskadi (JIS).
English: In MOBILITY, a greater proportion of patients treated with Kevzara 200 mg or 150 mg every two weeks plus MTX achieved remission, defined as Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) < 2.6 compared with placebo + MTX at Week 52.
Maltese: F'MOBILITY, proporzjon akbar ta' pazjenti ttrattati b'Kevzara 200 mg jew150 mg kull ġimagħtejn flimkien ma' MTX kisbu remissjoni, iddefinita bħala Punteġġ tal-Attività tal-Marda 28 bi Proteina C
English: Traceability of Kevzara
Maltese: Tużax Kevzara:
English: Reports of gastrointestinal perforation were primarily reported as complications of diverticulitis including lower GI perforation and abscess.
Maltese: Rapporti ta' perforazzjoni gastrointestinali kienu rrappurtati l-aktar bħala komplikazzjonijiet ta'
English: It is available in pack sizes of 1 or 2 or a multipack of 6 pre-filled pens (3 packs of 2).
Maltese: Hija disponibbli f'daqs ta' pakketti ta' 1 jew 2 jew pakkett b'ħafna ta' 6 pinen mimlija għal-lest (3 pakketti ta' 2).
English: Prior to launch of Kevzara in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of patient alert card, including communication media, distribution modalities, and any other aspects, with the National Competent Authority.
Maltese: Tqegħid fis-Suq (MAH - Marketing Authorisation Holder) għandu jaqbel dwar il-kontenut u l-format tal-biljett ta' twissija għall-pazjent, inkluż il-mezzi ta' komunikazzjoni, il-mod ta' kif se ssir id distribuzzjoni, u kwalunkwe aspett ieħor, mal-Awtorità Kompetenti Nazzjonali.
English: The efficacy of sarilumab with concomitant DMARDs on inhibition of radiographic progression that was assessed as part of the primary endpoints at Week 52 in MOBILITY was sustained up to three years from the start of treatment.
Maltese: L-effikaċja ta' sarilumab fimkien ma' DMARDs fuq l-inibizzjoni ta' progressjoni radjografika li ġiet stmata bħala parti mill-iskopijiet finali primarji f'Ġimgħa 52 f'MOBILITY inżammet sa tliet snin mill bidu tat-trattament.
English: Kevzara can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see section 5.1).
Maltese: Kevzara jista' jingħata bħala monoterapija f'każ ta' intolleranza għal MTX jew meta t-trattament b'MTX ma jkunx xieraq (ara sezzjoni 5.1).
English: The single-use pre-filled syringe has a styrene-butadiene elastomer needle cap and is equipped with a white polystyrene plunger rod and a light-orange polypropylene finger flange.
Maltese: Is-siringa mimlija għal-lest li tintuża darba biss għandha tapp tal-labra tal-elastomer styrene-butadiene u hija mgħammra b'lasta tal-planġer bajda tal-polystyrene u flanġ oranġjo ċar tal-polypropylene għas swaba.
English: Patients receiving Kevzara 200 mg or 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline in physical function compared to placebo at Week 16 and Week 12 in MOBILITY and TARGET, respectively.
Maltese: 200 mg jew 150 mg + DMARDs kull ġimagħtejn urew titjib akbar mil-linja bażi fil-funzjoni fiżika meta mqabbla ma' plaċebo f'Ġimgħa 16 u Ġimgħa 12 f'MOBILITY u TARGET, rispettivament.
English: Low Platelet Count Lab Value (cells x 103/µL)
Maltese: (ċelluli x 103/µL)
English: Tender Joints Swollen Joints Pain VAS†
Maltese: Jekk tuża Kevzara aktar milli suppost
English: EU/1/17/1196/002 6 pre-filled syringes (3 packs of 2)
Maltese: EU/1/17/1196/002 6 siringi mimlija għal-lest (3 pakketti ta' 2)
English: In MOBILITY and TARGET, patients receiving Kevzara 200 mg + DMARDs every two weeks or Kevzara 150 mg + DMARDs every two weeks demonstrated greater improvement from baseline compared to placebo + DMARDs in physical component summary (PCS) and no worsening on the mental component summary (MCS) at Week 24.
Maltese: F'MOBILITY u TARGET, il-pazjenti li kienu qed jirċievu Kevzara 200 mg + DMARDs kull ġimagħtejn jew Kevzara 150 mg + DMARDs kull ġimagħtejn urew titjib akbar mil-linja bażi meta mqabbla ma' plaċebo + DMARDs fis-sommarju tal-komponent fiżiku (PCS, physical component summary) u ma marrux għall-agħar fuq is-sommarju tal-komponent mentali (MCS, mental component summary) f'Ġimgħa 24.
English: Following single-dose subcutaneous (SC) administration of sarilumab 200 mg and 150 mg in patients with RA rapid reduction of CRP levels was observed.
Maltese: Wara l-għoti ta' doża waħda taħt il-ġilda (SC, subcutaneous) ta' sarilumab 200 mg u 150 mg f'pazjenti b'RA ġie osservat tnaqqis malajr tal-livelli tas-CRP.
English: The excretion of sarilumab in milk has not been studied in animals (see section 5.3).
Maltese: L-eliminazzjoni ta' sarilumab fil-ħalib ma ġietx studjata fl-annimali (ara sezzjoni 5.3).
English: Each pre-filled syringe contains 200 mg sarilumab in 1.14 ml solution (175 mg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 200 mg sarilumab f'1.14 ml ta' soluzzjoni (175 mg/ml).
English: EU/1/17/1196/006 6 pre-filled pens (3 packs of 2)
Maltese: EU/1/17/1196/006 6 pinen mimlija għal-lest (3 pakketti ta' 2)
English: solution for injection Multipack: 6 (3 packs of 2) pre-filled pens.
Maltese: KARTUNA TA' BARRA bil-Kaxxa l-Blu - PAKKETT MULTIPLU TA' 6 (3 PAKKETTI TA' 2) PINEN MIMLIJA GĦAL-LEST
English: Fertility studies conducted in male and female mice using a murine surrogate antibody against mouse IL-6Rα showed no impairment of fertility.
Maltese: Studji flannimali ma wrew l-ebda indeboliment fil-fertilità tal-irġiel jew tan-nisa (ara sezzjoni 5.3).
English: In the Kevzara + DMARDs long-term safety population and the Kevzara monotherapy population, the observations on platelet counts were consistent with those seen in the placebo-controlled population.
Maltese: Fil-popolazzjoni ta' sigurta fit-tul b'Kevzara + DMARDs u l-popolazzjoni ta' monoterapija b'Kevzara, l-osservazzjonijiet fil-parametri tal-lipidi kienu konsistenti ma' dawk li dehru fil popolazzjoni kkontrollata bi plaċebo.
English: Treatment with Kevzara is not recommended in patients with active hepatic disease or hepatic impairment (see sections 4.2 and 4.8).
Maltese: It-trattament b'Kevzara mhuwiex irrakkomandat f'pazjenti b'mard attiv tal-fwied jew indeboliment tal-fwied (ara sezzjonijiet 4.2 u 4.8).
English: Increased frequency and magnitude of these elevations were observed when potentially hepatotoxic medicinal products (e.g., MTX) were used in combination with Kevzara.
Maltese: Żieda fil-frekwenza u l-kobor ta' dawn iż-żidiet kienet osseervata meta prodotti mediċinali possibilment tossiċi għall-fwied (eż., MTX) intużaw flimkien ma' Kevzara.
English: • Based on the pharmacodynamics of the changes in ANC, use results obtained at the end of the dosing interval when considering dose modification (see section 5.1).
Maltese: • Abbażi tal-farmakodinamika tal-bidliet fl-ANC, uża r-riżultati miksuba fi tmiem l-intervall tal għoti tad-doża meta tqis modifikazzjoni fid-doża (ara sezzjoni 5.1).
English: Renal impairment:
Maltese: Indeboliment tal-kliewi:
English: To allow for a direct comparison of frequency of laboratory abnormalities between placebo and active treatment, data from weeks 0-12 were used as this was prior to patients being permitted to switch from placebo to Kevzara.
Maltese: Anormalitajiet tal-laboratorju Biex tippermetti tqabbil dirett tal-frekwenza ta' anormailtajiet tal-laboratorju bejn il-plaċebo u t trattament attiv, intużat dejta mill-ġimgħat 0-12 minħabba li dan kien qabel iż-żmien li l-pazjenti tħallew jaqilbu minn plaċebo għal Kevzara.
English: Renal impairment
Maltese: Erpete orali
English: • statins, used to reduce cholesterol level
Maltese: • statins, jintużaw biex inaqqsu l-livell tal-kolesterol
English: Mean change at Week 24 Modified Total Sharp Score (mTSS) Erosion score (0-280) Joint space narrowing score Mean change at Week 52 Modified Total Sharp Score (mTSS) ‡ Erosion score (0-280) Joint space narrowing score
Maltese: Modifikazzjonjiet fid-doża rrakkomandati f'każ ta' newtropenija, tromboċitopenija jew żidiet fl enzimi tal-fwied (ara sezzjonijiet 4.4 u 4.8): Għadd Assolut Baxx tan-Newtrofili (ara sezzjoni 5.1)
English: • Carefully follow the “Instructions for Use” provided in the carton.
Maltese: • Segwi b'attenzjoni l-“Istruzzjonijiet dwar l-Użu” pprovduti fil-kartuna.
English: Laboratory abnormalities
Maltese: Anormalitajiet tal-lipidi
English: In the placebo-controlled population, injection site reactions were reported in 9.5%, 8%, and 1.4% of patients receiving Kevzara 200 mg, 150 mg, and placebo respectively.
Maltese: 8%, u 1.4% tal-pazjenti li kienu qed jirċievu Kevzara 200 mg, 150 mg, u plaċebo rispettivament.
English: MOBILITY demonstrated significant improvement in physical function, as measured by the HAQ-DI at Week 16 compared to placebo (-0.58, -0.54, and -0.30 for Kevzara 200 mg + MTX, Kevzara 150 mg + MTX, and placebo + MTX, every two weeks, respectively).
Maltese: MOBILITY wera titjib sinifikanti fil-funzjoni fiżika, kif imkejjel b'HAQ-DI f'Ġimgħa 16 meta mqabbel mal-plaċebo (-0.58, -0.54, u -0.
English: Lipid parameters should be assessed approximately 4 to 8 weeks following initiation of treatment with Kevzara, then at approximately 6 month intervals.
Maltese: Parametri tal-lipidi għandhom jiġu evalwati minn madwar 4 sa 8 ġimgħat wara l-bidu tat-trattament b'Kevzara, imbagħad f'intervalli ta' madwar 6 xhur.