FrancophonIA/ELRC3.0 huggingface dataset:
English: Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Norwegian Bokmål: Mard interstizjali talpulmun (li jinkludi pnewmonite u fibrożi pulmonari)*
English: Respiratory, thoracic, and mediastinal disorders
Norwegian Bokmål: Disturbi respiratorji, toraċiċi u medjastinali
English: 8 pre-filled syringes of 1 ml solvent 8 stainless steel injection needles 8 vial adaptors
Norwegian Bokmål: 8 siringi mimlija għal-lest b'1 ml ta' solvent 8 labar ta' l-istainless steel għall-injezzjoni 8 adapters tal-kunjetti
English: Adult patients with ankylosing spondylitis
Norwegian Bokmål: Pazjenti adulti li għandhom ankylosing spondylitis
English: The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.
Norwegian Bokmål: It-tnaqqis tal-ħsara periferali tal-ġogi kien osservat f'pazjenti b'involviment simmetriku poliartikulari tal-ġogi.
English: Dosing for adult patients (aged 18 years or over)
Norwegian Bokmål: Doża għal pazjenti adulti (ta' 18-il sena jew aktar)
English: Expiry date
Norwegian Bokmål: DATA META JISKADI
English: LIFMIOR showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
Norwegian Bokmål: LIFMIOR wera titjib akbar li kien statistikament sinifikanti mil-linja bażi sal-ġimgħa 12 meta mqabbel ma' plaċebo f'ħafna mill-valutazzjonijiet tal-kwalità tal-ħajja relatata mas-saħħa u f'valutazzjonijiet tal-funzjoni fiżika, inklużi BASFI (Indiċi Funzjonali Spondilite Ankilosing ta' Bath), il-Punteġġ Globali tal-Istat tas-Saħħa EuroQol 5D u l-Punteġġ tal-Komponent Fiżiku SF-36.
English: Paediatric plaque psoriasis
Norwegian Bokmål: Psorjasi pedjatrika tal-plakka
English: Inject the solution after it has reached room temperature (15 to 30 minutes after taking the product from the refrigerator).
Norwegian Bokmål: Injetta s-soluzzjoni meta tkun laħqet it-temperatura ambjentali tal-kamra (15 sa 30 minuta wara li tkun ħriġt il-prodott minn ġol-friġġ).
English: The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l.
Norwegian Bokmål: Ilvolum ċentrali tad-distribuzzjoni ta' etanercept hu ta' 7.6 l, waqt li l-volum tad-distribuzzjoni fl-istat fiss hu ta' 10.4 l.
English: Inject slowly, at an angle of 45° to 90° to the skin.
Norwegian Bokmål: Injetta bil-mod, f'angolu ta' 45° sa 90° minn mal-ġilda.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Norwegian Bokmål: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of LIFMIOR (n=57) or placebo (n=55) twice a week for 24 weeks.
Norwegian Bokmål: Mija u tnax-il pazjent (112) intgħażlu b'mod każwali biex jingħataw doża ta' 25 mg ta' LIFMIOR (n=57) jew plaċebo (n=55) darbtejn fil-ġimgħa għal 24 ġimgħa.
English: Diagram 6
Norwegian Bokmål: Dijagramma 6
English: 28b a: p <0.001, LIFMIOR vs. placebo b: p = 0.002, LIFMIOR vs. placebo
Norwegian Bokmål: ASAS 70 Ġimagħtejn 3 xhur 6 xhur a: p<0.001, LIFMIOR vs. plaċebo b: p = 0.002, LIFMIOR vs. plaċebo
English: A placebo-controlled trial, in which 89 adult patients were treated with LIFMIOR in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown LIFMIOR to be an effective treatment for Wegener's granulomatosis.
Norwegian Bokmål: Prova kkontrollata bil-plaċebo, fejn 89 pazjent adult kienu kkurati b'LIFMIOR ukoll flimkien matterapija standard (inklużi cyclophosphamide u/jew methotrexate, u glukokortikojdi) fuq żmien medjan ta' 25 xahar, ma wrietx li LIFMIOR hu kura effettiva għal granulomatożi ta' Wegener.
English: • The risk of Congestive Heart Failure (CHF).
Norwegian Bokmål: • Ir-riskju ta' Kollass Konġestiv tal-Qalb (CHF).
English: In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Norwegian Bokmål: Fil-provi double-blind u open-label fuq pazjenti b'artrite psorjatika, pazjent wieħed irrapporta infezzjoni serja (pnewmonja).
English: Diagram 14
Norwegian Bokmål: Dijagramma 14
English: LIFMIOR in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Norwegian Bokmål: LIFMIOR f'taħlita ma' methotrexate hu indikat għall-kura ta' artrite rewmatojde attiva minn moderata sa severa fl-adulti meta r-rispons għall-mediċini antirewmatiċi li jimmodifikaw il-marda, inkluż methotrexate (kemm-il darba mhux kontraindikat), kienet inadegwata.
English: Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
Norwegian Bokmål: Infezzjoni (inkluż infezzjoni fl-apparat respiratorju ta' fuq, bronkite, ċistite, infezzjoni tal-ġilda)*
English: Diagram 11
Norwegian Bokmål: Dijagramma 11
English: Diagram 13
Norwegian Bokmål: Dijagramma 13
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Norwegian Bokmål: Sensittività eċċessiva għas-sustanzi attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1).
Norwegian Bokmål: Terapija kontinwa ta' aktar minn 24 ġimgħa tista' tkun adattata għal xi pazjenti adulti (ara sezzjoni 5.1).
English: Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including LIFMIOR, has been reported.
Norwegian Bokmål: Kienet irrappurtata l-attivazzjoni mill-ġdid tal-epatite B f'pazjenti li qabel kienu infettati bil-virus talepatite B (HBV) u li rċivew antagonisti ta' TNF, li jinkludu LIFMIOR.
English: Diagram 4
Norwegian Bokmål: Dijagramma 4
English: New onset cardiac failure congestive (see section 4.4)
Norwegian Bokmål: Bidu mill-ġdid ta' insuffiċjenza kardijaka konġestiva (ara sezzjoni 4.4)
English: In study 4, the LIFMIOR-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p<0.0001).
Norwegian Bokmål: Fi studju 4, il-grupp ikkurat b'LIFMIOR kellu proporzjon ogħla ta' pazjenti b'PASI 75 f'ġimgħa 12 (38%) meta mqabbel mal-grupp ikkurat bil-plaċebo (2%) (p<0.0001).
English: Reporting of suspected adverse reactions
Norwegian Bokmål: Rappurtar ta' reazzjonijiet avversi suspettati
English: The primary measure of efficacy (ASAS 20) was a ≥20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Norwegian Bokmål: Il-kejl ewlieni ta' l-effikaċja (ASAS 20) kienet titjib ta' ≥ 20% f'mill-inqas 3 mill-4 dominji ta' lEvalwazzjoni f'Ankylosing Spondylitis (ASAS) (evalwazzjonijiet globali tal-pazjent, uġigħ fid-dahar, BASFI, u infjammazzjoni) u n-nuqqas ta' deterjorament fid-dominju li jkun fadal.
English: Radiographic Progression: Comparison of LIFMIOR vs. Methotrexate vs. LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration (12 Month Results)
Norwegian Bokmål: Progressjoni Radjografika: Paragun ta' LIFMIOR vs. Methotrexate vs. LIFMIOR Flimkien ma' Methotrexate f'Pazjenti b'RA ta' bejn 6 Xhur u 20 Sena (Riżultati Wara 12-il Xahar)
English: In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received LIFMIOR were observed compared with younger patients.
Norwegian Bokmål: Fi studji ta' Fażi 3 dwar artrite rewmatojde, artrite psorjatika, u ankylosing spondylitis, ma kienu osservati l-ebda differenzi globali f'avvenimenti avversi, avvenimenti avversi serji, u infezzjonijiet serji f'pazjenti li kellhom 65 sena jew aktar, li rċivew LIFMIOR, meta mqabbel ma pazjenti iżgħar.
English: In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in LIFMIOR-treated patients.
Norwegian Bokmål: Fi studji kliniċi magħmula għal aktar minn sentejn bi 351 pazjent b'ankylosing spondylitis, 6 tumuri malinni kienu rrappurtati f'pazjenti kkurati b'LIFMIOR.
English: Various malignancies have also been reported with use of LIFMIOR, including cancers of the breast, lung, skin and lymph glands (lymphoma).
Norwegian Bokmål: Diversi tumuri malinni kienu wkoll irrappurtati bl-użu ta' LIFMIOR, inkluż kanċer tas-sider, talpulmun, tal-ġilda u glandoli limfatiċi (limfoma).
English: Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Norwegian Bokmål: Fost ilpazjenti li temmew l-24 xahar kollha ta' terapija fl-istudju, ir-rati fejn ma sar l-ebda progress kienu ta' 78%, 70%, u 61%, rispettivament.
English: 8 pre-filled syringes 8 alcohol swabs
Norwegian Bokmål: 8 siringi mimlija għal-lest 8 swabs ta' l-alkoħol
English: Infections and infestations
Norwegian Bokmål: Infezzjonijiet u infestazzjonijiet
English: Serious infections experienced by LIFMIOR-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Norwegian Bokmål: Infezzjonijiet serji li seħħew f'pazjenti kkurati b'LIFMIOR, kienu jinkludu ċellulite, gastroenterite, pnewmonja, koleċistite, osteomajelite, gastrite, appendiċite, faxxite Streptokokkali, mijosite, xokk settiku, divertikulite u axxess.
English: Mean (SE) Annualized Change from Baseline in Total Sharp Score Placebo
Norwegian Bokmål: Il-Medja (SE) tal-Bidla Annwalizzata mil-Linja Bażi b'Punteġġ Totali Sharp Plaċebo
English: LIFMIOR was considered to be non-genotoxic from a battery of in vitro and in vivo studies.
Norwegian Bokmål: LIFMIOR kien ikkunsidrat li mhuwiex ġenotossiku minn serje ta' studji in vitro u in vivo.
English: n = 166 wk 12
Norwegian Bokmål: n = 162 ġimgħ a 24
English: 8 alcohol swabs
Norwegian Bokmål: 8 swabs ta' l-alkoħol
English: Alcoholic hepatitis
Norwegian Bokmål: Epatite alkoħolika
English: Diagram 12
Norwegian Bokmål: Dijagramma 12
English: No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.
Norwegian Bokmål: Ma kienu osservati l-ebda interazzjonijiet farmakokinetiċi sinifikanti bejn mediċina u oħra fi studji b'methotrexate, digoxin jew warfarin.
English: Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Norwegian Bokmål: Kura ta' adulti bi psorjasi tal-plakka minn moderata sa severa li ma rreaġixxewx għal, jew li għandhom kontraindikazzjoni għal, jew li ma jittollerawx terapija sistemika oħra inkluż ciclosporin, methotrexate jew psoralen u dawl ultravjola A (PUVA) (ara sezzjoni 5.1).
English: • Inflammatory bowel disease (IBD): There have been cases of IBD in patients with juvenile idiopathic arthritis (JIA) treated with LIFMIOR.
Norwegian Bokmål: • Mard infjammatorju tal-imsaren (IBD): Kien hemm każijiet ta' IBD f'pazjenti b'artrite idjopatika taż-żgħażagħ (JIA) ikkurati b'LIFMIOR.
English: The efficacy of LIFMIOR versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing LIFMIOR with other systemic therapies.
Norwegian Bokmål: L-effikaċja ta' LIFMIOR meta mqabbla ma' terapiji sistemiċi oħra f'pazjenti bi psorjasi minn moderata sa severa (li rrispondiet għal terapiji sistemiċi oħra) ma ġietx evalwata fi studji li qabblu LIFMIOR direttament ma' terapiji sistemiċi oħrajn.
English: A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 LIFMIOR-treated psoriatic arthritis patients.
Norwegian Bokmål: Total ta' 2 tumuri malinni kienu rrappurtati fi studji kliniċi li damu bejn wieħed u ieħor sentejn li involvew 240 pazjenti b'artrite psorjatika kkurati b'LIFMIOR.
English: Pairwise comparison p-values: * = p < 0.05 for comparisons of LIFMIOR vs. methotrexate, † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. LIFMIOR.
Norwegian Bokmål: Paragun f'pari tal-valuri p: * = p < 0.05 għall-paragun ta' LIFMIOR vs. methotrexate, † = p < 0.05 għall-paraguni ta' LIFMIOR + methotrexate vs. methotrexate u  = p < 0.05 għall-paraguni ta' LIFMIOR + methotrexate vs. LIFMIOR.
English: Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
Norwegian Bokmål: B'mod alternattiv, intwera li 50 mg ta' LIFMIOR mogħtija darba fil-ġimgħa huma siguri u effettivi (ara sezzjoni 5.1).
English: In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 μg•hr/ml and 474 μg•hr/ml for 50 mg LIFMIOR once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Norwegian Bokmål: F'analiżi farmakokinetika tal-popolazzjoni f'pazjenti b'ankylosing spondylitis, l-AUCs fl-istat fiss ta' etanercept kienu ta' 466 μg*h/ml u 474 μg*h/ml għal 50 mg LIFMIOR darba fil-ġimgħa (N = 154) u 25 mg darbtejn fil-ġimgħa (N = 148), rispettivament.
English: Each pack contains 4 vials, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Norwegian Bokmål: Kull pakkett fih 4 kunjetti, 4 siringi mimlija għal-lest bl-ilma għall-injezzjonijiet, 4 labar, 4 adapters tal-kunjetti u 8 swabs bl-alkoħol.
English: In a double blind, placebo controlled, randomised clinical study in adult patients with psoriatic arthritis 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
Norwegian Bokmål: Fi studju kliniku randomised, double blind, ikkontrollat bil-plaċebo f'pazjenti adulti b'artrite psorjatika, 184 pazjent ingħataw ukoll multivalent pneumococcal polysaccharide vaccine fir-4 ġimgħa.
English: Each vial contains 10 mg of etanercept.
Norwegian Bokmål: Kull kunjett fih 10 mg ta' etanercept.
English: At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Norwegian Bokmål: Fil-linja bażi, il-pazjenti kellhom diżabilità moderata, b'punteġġi medji ta' HAQ ta' 1.4 sa 1.5.
English: Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis.
Norwegian Bokmål: Il-fattur nekrotiku tat-tumur (TNF) hu cytokine dominanti fil-proċess infjammatorju ta' l-artrite rewmatojde.
English: 50 mg QW
Norwegian Bokmål: 50 mg/1 ml
English: Adult patients with psoriatic arthritis
Norwegian Bokmål: Pazjenti adulti b'artrite psorjatika
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Norwegian Bokmål: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Norwegian Bokmål: L-impatt ta' l-età avvanzata kien studjat f'analiżi farmakokinetika ta' konċentrazzjonijiet ta' etanercept fis-serum f'populazzjoni ta' età avvanzata.
English: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with LIFMIOR for up to 48 months.
Norwegian Bokmål: Infezzjonijiet serji seħħew f'6.3% tal-pazjenti b'artrite rewmatojde kkurati b'LIFMIOR sa 48 xahar.
English: Plaque psoriasis
Norwegian Bokmål: Psorjasi tal-plakka
English: Serious and fatal infections have been reported during use of LIFMIOR; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Norwegian Bokmål: Infezzjonijiet serji u fatali kienu rrappurtati wara li LIFMIOR beda jintuża; patoġeni rrappurtati jinkludu batterji, mikobatterji (inkuż it-tuberkolosi), viruses u fungi.
English: The efficacy of LIFMIOR in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice-weekly administration of 25 mg LIFMIOR with placebo.
Norwegian Bokmål: L-effikaċja ta' LIFMIOR f'ankylosing spondylitis kienet evalwata fi 3 studji randomised, double-blind li qabblu l-għoti ta' 25 mg LIFMIOR darbtejn fil-ġimgħa mal-plaċebo.
English: Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including LIFMIOR.
Norwegian Bokmål: Kanċer tal-ġilda melanoma u mhux melanoma (NMSC) kienu rrappurtati f'pazjenti kkurati b'antagonisti ta' TNF, li jinkludu LIFMIOR.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Norwegian Bokmål: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal web Ewropew tal-mediċini.
English: The efficacy of LIFMIOR was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (<3 years duration) who had never received treatment with methotrexate.
Norwegian Bokmål: L-effikaċja ta' LIFMIOR tqabblet ma' methotrexate fi studju randomised, ikkontrollat attivament b'evalwazzjonijiet radjografiċi blinded bħala endpoint primarju fi 632 pazjent adult bl-artrite rewmatojde attiva (għal < 3 snin) u li qatt ma kienu ħadu kura b'methotrexate.
English: Do NOT push down the adaptor at an angle (see Diagram 4).
Norwegian Bokmål: TIMBUTTAX l-adapter 'l isfel b'mod angolat (ara Dijagramma 4).
English: Diagram 3.
Norwegian Bokmål: Dijagramma 3
English: One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with LIFMIOR for up to approximately 6 years, including 231 patients treated with LIFMIOR in combination with methotrexate in the 2-year active-controlled study.
Norwegian Bokmål: Mija u disgħa u għoxrin (129) tumuri malinni ġodda ta' diversi tipi kienu osservati f'4,114-il pazjent b'artrite rewmatojde kkurati b'LIFMIOR fi provi kliniċi għal madwar bejn wieħed u ieħor 6 snin, li kienu jinkludu 231 pazjent ikkurati b'LIFMIOR flimkien ma' methotrexate fl-istudju b'kontroll attiv li dam sentejn.
English: See section 4.4 for vaccination advice.
Norwegian Bokmål: Ara sezzjoni 4.4 dwar pariri fuq it-tilqim.
English: There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Norwegian Bokmål: Kien hemm 4 rapporti tas-sindrome ta' l-attivazzjoni tal-makrofagu fi provi kliniċi dwar l-artrite idjopatika taż-żgħażagħ.
English: You should allow 15 to 30 minutes for the LIFMIOR solution in the syringe to reach room temperature.
Norwegian Bokmål: Għandek tħalli 15 sa 30 minuta għas-soluzzjoni ta' LIFMIOR biex tilħaq it-temperatura tal-kamra.
English: A higher rate of major birth defects was observed in one observational study comparing pregnancies exposed to etanercept (n=370) during the first trimester with pregnancies not exposed to etanercept or other TNF-antagonists (n=164) (adjusted odds ratio 2.4, 95% CI: 1.0-5.5).
Norwegian Bokmål: Rata ogħla ta' difetti kbar mattwelid kienet osservata fi studju ta' osservazzjoni wieħed li jqabbel it-tqaliet esposti għal etanercept matul l-ewwel trimestru, ma' tqaliet mhux esposti għal etanercept (n=370) jew antagonisti oħrajn ta' TNF (n=164) (proporzjon ta' probabbiltà aġġustat 2.4, 95% CI: 1.0-5.5).
English: Autoantibody formation Treatment with LIFMIOR may result in the formation of autoimmune antibodies (see section 4.8).
Norwegian Bokmål: Formazzjoni tal-awtoantikorpi Il-kura b'LIFMIOR tista' tirriżulta fil-formazzjoni ta' antikorpi awtoimmunitarji (ara sezzjoni 4.8).
English: (Note: After you have completed these steps, a small amount of liquid may remain in the vial.
Norwegian Bokmål: (Nota: Wara li tkun lestejt dawn il-passi, jista' jibqa' ammont żgħir ta' likwidu fil-kunjett.
English: Diagram 3 White needle cap
Norwegian Bokmål: Djiagramma 2 Dijagramma 3 Dijagramma 4
English: The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis (see section 4.4).
Norwegian Bokmål: Il-maġġoranza tar-rapporti b'riżultat fatali kienu f'pazjenti bi pnewmonja Pneumocystis, infezzjonijiet fungali sistemiċi mhux speċifiċi, u aspergillosi (ara sezzjoni 4.4).
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. LIFMIOR.
Norwegian Bokmål: Paragun f'pari tal-valuri p: † = p < 0.05 għal LIFMIOR + methotrexate vs. methotrexate u  = p < 0.05 għall-paraguni ta' LIFMIOR + methotrexate vs. LIFMIOR.
English: 4 pre-filled syringes of 1 ml solvent 4 stainless steel injection needles 4 vial adaptors
Norwegian Bokmål: 4 siringi mimlija għal-lest b'1 ml ta' solvent 4 labar ta' l-istainless steel għall-injezzjoni 4 adapters tal-kunjetti
English: Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Norwegian Bokmål: Kienu studjati pazjenti ta' bejn 4 u 17-il sena b'artrite idjopatika taż-żgħażagħ b'kors poliartikulari bejn moderata u severa li ma fiqitx b'methotrexate jew li kienet intolleranti għal methotrexate; il-pazjenti baqgħu fuq doża waħda stabbli ta' mediċina kontra l-infjammazzjoni li mhix sterojdi u/jew fuq prednisone (< 0.2 mg/kg/kuljum jew massimu ta' 10 mg).
English: A 25 mg strength of LIFMIOR is available for doses of 25 mg.
Norwegian Bokmål: Qawwa ta' 25 mg hija disponibbli għal dożi ta' 25 mg.
English: Renal and hepatic impairment
Norwegian Bokmål: Indeboliment renali u epatiku
English: INFORMATION IN BRAILLE LIFMIOR 50 mg
Norwegian Bokmål: LIFMIOR 50 mg
English: These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Norwegian Bokmål: Dawn jinkludu wġigħ ta' ras (19% tal-pazjenti, 1.7 avvenimenti kull pazjent kull sena), dardir (9%, 1.0 avveniment kull pazjent kull sena), uġigħ addominali (19%, 0.74 ta' avveniment kull pazjent kull sena), u rimettar (13%, 0.74 ta' avveniment kull pazjent kull sena).
English: c.
Norwegian Bokmål: b.
English: Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age.
Norwegian Bokmål: L-istimi u l-volum tat-tneħħija f'pazjenti ta' bejn 65 u 87 sena kienu simili f'pazjenti li kellhom inqas minn 65 sena.
English: At week 104, the mean change from baseline in the SPARCC score measured on MRI for all LIFMIOR-treated subjects was 4.64 for the SIJ (n=153) and 1.40 the spine (n=154).
Norwegian Bokmål: Fil-ġimgħa 104, it-tibdil medju mil-linja bażi fil-punteġġ SPARCC imkejjel fuq MRI għall-individwi kollha kkurati b'LIFMIOR kien 4.64 għall-SIJ (n=153) u 1.40 issinsla (n=154).