FrancophonIA/ELRC3.0 huggingface dataset:
English: Undesirable effects in paediatric patients with plaque psoriasis In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Norwegian Bokmål: Effetti mhux mixtieqa f'pazjenti pedjatriċi bi psorjasi tal-plakka Fi studju li dam 48 ġimgħa li sar fuq 211-il tifel u tifla ta' bejn l-4 u s-17-il sena li kellhom psorjasi pedjatrika tal-plakka, l-avvenimenti avversi rrappurtati kienu simili għal dawk li kienu osservati fi studji li saru fil-passat fuq adulti bi psorjasi tal-plakka.
English: • Periodic Safety Update Reports
Norwegian Bokmål: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: Clearance is approximately 0.066 l/hr in patients with rheumatoid arthritis, somewhat lower than the value of 0.11 l/hr observed in healthy volunteers.
Norwegian Bokmål: It-tneħħija hi ta' madwar 0.066 l/h f'pazjenti bl-artrite rewmatojde, xi ftit aktar baxxa minn dik ta' 0.11 l/h osservata f'voluntiera b'saħħithom.
English: Diagram 1 The MYCLIC pre-filled pen
Norwegian Bokmål: Pass 1: Kif tipprepara għall-injezzjoni
English: Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available.
Norwegian Bokmål: Dejta adegwata miġbura mill-kura ta' pazjenti infettati bl-HBV b'terapija antivirali flimkien ma' terapija b'antagonisti ta' TNF mhijiex disponibbli.
English: Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Norwegian Bokmål: Il-kura ta' psorjasi kronika severa tal-plakka fit-tfal u fl-adolexxenti mill-età ta' 6 snin, li huma kkontrollati b'mod inadegwat minn, jew li huma intolleranti għal, terapiji jew fototerapiji sistemiċi oħrajn.
English: Radiographic Progression: Comparison of LIFMIOR vs. Methotrexate in Patients with RA of <3 Years Duration
Norwegian Bokmål: Progressjoni Radjografika: Paragun ta' LIFMIOR vs. Methotrexate f'Pazjenti b'RA ta' < 3 Snin la id ja il-lin
English: The other ingredients in LIFMIOR are: Powder: Mannitol, sucrose and trometamol.
Norwegian Bokmål: Is-sustanzi l-oħra f'LIFMIOR huma: Trab: Mannitol, sucrose u trometamol Solvent: Ilma għall-injezzjonijiet.
English: The safety and efficacy of LIFMIOR were assessed in a two-part study in 69 children with polyarticular-course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Norwegian Bokmål: Is-sigurtà u l-effikaċja ta' LIFMIOR ġew evalwati fi studju maqsum f'żewġ partijiet fejn 69 tifel u tifla b'artrite idjopatika taż-żgħażagħ b'kors poliartikulari, li kellhom varjetà ta' tipi tal-bidu ta' artrite idjopatika taż-żgħażagħ (poliartrite, pawċiartrite, feġġa sistemika).
English: Read the package leaflet before use.
Norwegian Bokmål: Jista' jkun li mhux ilpakketti tad-daqsijiet kollha jkunu fis-suq.
English: 24a n = 193 wk 12
Norwegian Bokmål: Plaċebo n = 193 ġimgħa
English: EXP
Norwegian Bokmål: HAQ
English: The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Norwegian Bokmål: It-tipi ta' infezzjonijiet murija fi provi kliniċi f'pazjenti b'artrite idjopatika taż-żgħażagħ li għandhom bejn sentejn u 18-il sena kienu ġeneralment minn ħfief sa moderati u konsistenti ma' dawk li komunament jidhru fil-popolazzjonijiet pedjatriċi outpatient.
English: Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of LIFMIOR compared to the 349 adult rheumatoid arthritis patients.
Norwegian Bokmål: Diversi avvenimenti avversi kienu rrappurtati aktar ta' spiss fil-każ ta' 69 pazjent bl-artrite idjopatika taż-żgħażagħ li ħadu LIFMIOR għal 3 xhur, imqabbla mat-349 pazjent adult b'artrite rewmatojde.
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use is supplied as a white powder with solvent for solution for injection (powder for injection).
Norwegian Bokmål: LIFMIOR 10 mg u solvent għal soluzzjoni għall-injezzjonijiet għal użu pedjatriku jiġi bħala trab abjad u solvent għal soluzzjoni għall-injezzjoni (trab għall-injezzjoni).
English: LIFMIOR 25 mg solution for injection in pre-filled syringe etanercept
Norwegian Bokmål: LIFMIOR 25 mg injezzjoni etanercept
English: Step 1: Preparing for an LIFMIOR injection Step 2: Choosing an injection site Step 3: Injecting the LIFMIOR solution Step 4: Disposing of the used MYCLIC pen
Norwegian Bokmål: Pass 1: Kif tipprepara għall-injezzjoni Pass 2: Kif tagħżel is-sit ta' l-injezzjoni Pass 3: Kif tinjetta s-soluzzjoni ta' LIFMIOR Pass 4: Kif tarmi l-oġġetti użati għall-injezzjoni
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of interstitial lung disease was 0.47% (frequency uncommon).
Norwegian Bokmål: Fil-provi kliniċi kkontrollati li ppermettew kura konkomitanti b'etanercept u methotrexate, il-frekwenza (il-proporzjon ta' inċidenza) ta' mard interstizjali tal-pulmun kienet ta' 0.47 % (frekwenza mhux komuni).
English: You have been prescribed a 50 mg strength of LIFMIOR.
Norwegian Bokmål: Int ġejt preskritt qawwa ta' 50 mg ta' LIFMIOR.
English: Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes); inflammation of the liver caused by the body's own immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon).
Norwegian Bokmål: • Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1000): reazzjonijiet allerġiċi serji (li jinkludu nefħa lokalizzata qawwija tal-ġilda u tħarħir); limfoma (tip ta' kanċer tad-demm); lewkimja (kanċer li jaffettwa d-demm u l-mudullun); melanoma (tip ta' kanċer tal-ġilda); għadd baxx ta' plejtlits, taċ-ċelluli ħomor u taċ-ċelluli bojod; disturbi tassistema nervuża (b'debbulizza severa fil-muskoli u sinjali u sintomi simili għal dawk ta' sklerosi multipla jew infjammazzjoni tan-nervituri tal-għajnejn jew tal-korda spinali); tuberkolosi; bidu mill-ġdid ta' insuffiċjenza konġestiva tal-qalb, aċċessjonijiet, sindrome ta' lupus jew bħal ta' lupus (is-sintomi jistgħu jinkludu raxx persistenti, deni, uġigħ fil-ġogi u għeja); infjammazzjoni tal-fwied ikkawżata mis-sistema immunitarja stess tal-ġisem (epatite awtoimmunitarja; f'pazjenti li jkunu qed jirċievu wkoll kura b'methotrexate, il-frekwenza hi mhux komuni); raxx tal-ġilda li jista' jwassal għal infafet u tqaxxir sever tal-ġilda; reazzjonijiet liċenojdi (raxx tal-ġilda ħamrani fil-vjola bil-ħakk u/jew ħjut bojod fil-griż fuq il-membrani mukużi); disturb fis-sistema immuni li jista' jaffetwa l-pulmun, il-ġilda u l-glandoli limfatiċi żgħar (sarkojdożi); infjammazzjoni jew ċikatriċi tal-pulmun (f'pazjenti li jkunu qed jirċievu wkoll kura b'methotrexate, il-frekwenza tal-infjammazzjoni jew taċ-ċikatriċi tal-pulmun hi mhux komuni)..
English: Adult patients with plaque psoriasis
Norwegian Bokmål: Pazjenti adulti bi psorjasi tal-plakka
English: Paediatric plaque psoriasis (age 6 years and above) The recommended dose is 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks.
Norwegian Bokmål: Psorjasi pedjatrika tal-plakka (mill-età ta' 6 snin 'il fuq) Id-doża rakkomandata hi ta' 0.8 mg/kg (sa massimu ta' 50 mg kull doża) darba f'ġimgħa għal sa 24 ġimgħa.
English: Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with LIFMIOR use.
Norwegian Bokmål: Avvenimenti ta' mard li jneħħi l-majelin tas-sistema ċentrali u periferali ġew irrapurtati b'mod rari u rari ħafna, rispettivament, bl-użu ta' LIFMIOR.
English: LIFMIOR 50 mg solution for injection in pre-filled syringe etanercept
Norwegian Bokmål: LIFMIOR 50 mg injezzjoni etanercept
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare).
Norwegian Bokmål: Fi provi kliniċi kkontrollati ta' etanercept fl-indikazzjonijiet kollha, il-frekwenza (il-proporzjon ta' inċidenza) ta' mard interstizjali tal-pulmun f'pazjenti li kienu qed jirċievu etanercept mingħajr methotrexate konkomitanti kienet ta' 0.06 % (frekwenza rari).
English: This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative.
Norwegian Bokmål: Dan jinkludi rapporti ta' attivazzjoni mill-ġdid tal-epatite B f'pazjenti li kienu pożittivi għal anti-HBc iżda negattivi għal HBsAg.
English: The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with LIFMIOR, relative to placebo (p < 0.001).
Norwegian Bokmål: Il-punteġġ ta' l-indiċi tad-diżabilità kien b'mod sinifikanti aħjar f'kull punt ta' żmien f'pazjenti bl-artrite psorjatika kkurati b'LIFMIOR, meta mqabbel mal-plaċebo (p<0.001).
English: LIFMIOR did not elicit dose-limiting or target organ toxicity in cynomolgus monkeys following twice weekly subcutaneous administration for 4 or 26 consecutive weeks at a dose (15 mg/kg) that resulted in AUC-based serum drug concentrations that were over 27-fold higher than that obtained in humans at the recommended dose of 25 mg.
Norwegian Bokmål: LIFMIOR ma kkawżax tossiċità li tillimita d-doża jew tossiċità fl-organu fil-mira fixxadini tat-tip cynomolgus wara li ngħataw injezzjonijiet taħt il-ġilda darbtejn fil-ġimgħa għal 4 jew 26 ġimgħa konsekuttiva b'doża (15 mg/kg) li rriżultat f'konċentrazzjoni tal-mediċina fis-serum ibbażata fuq l-AUC li kienet aktar minn 27 darba iktar minn dak miksub fil-bniedem bid-doża rakkomandata ta' 25 mg.
English: In part 2, 6 of 25 (24%) patients remaining on LIFMIOR experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
Norwegian Bokmål: Fit-tieni parti, 6 minn 25 (24%) tal-pazjenti li baqgħu fuq LIFMIOR kellhom żieda qawwija fl-intensità tal-marda meta mqabbla ma' 20 minn 26 (77%) pazjent li rċivew il-plaċebo (p=0.007).
English: Each pack contains 4, 8 or 24 pre-filled syringes and 4, 8 or 24 alcohol swabs.
Norwegian Bokmål: Kull pakkett fih 4, 8 jew 24 siringi mimlija għal-lest u 4, 8 jew 24 swab bl-alkoħol.
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Norwegian Bokmål: Għal pazjenti li jkunu pożittivi għal infezzjoni tal-HBV, konsultazzjoni ma' tabib b'kompetenza filkura tal-epatite B hi rakkomandata.
English: LIFMIOR is recommended for use in patients as defined in section 4.1.
Norwegian Bokmål: LIFMIOR hu rakkomandat għall-użu f'pazjenti kif definit f'sezzjoni 4.1.
English: For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of LIFMIOR per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of LIFMIOR per kg bodyweight (up to a maximum of 50 mg) given once weekly.
Norwegian Bokmål: Għal poliartrite jew għal oligoartrite estiża f'pazjenti minn età ta' sentejn, jew artrite relatata ma' entesite jew artrite psorjatika f'pazjenti minn età ta' 12-il sena, id-doża li ssoltu tingħata hija 0.4 mg ta' LIFMIOR għal kull kg ta' piż tal-ġisem (sa massimu ta' 25 mg), mogħtija darbtejn fil-ġimgħa, jew 0.8 mg ta' LIFMIOR għal kull kg piż tal-ġisem (sa massimu ta' 50 mg) mogħtija darba fil-ġimgħa.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory
Norwegian Bokmål: Kienu rrappurtati diversi avvenimenti avversi inklużi l-ġidri r-riħ b'sinjali u sintomi ta' meninġite asettika li kienu mfejqa mingħajr sintomi wara l-marda (ara wkoll sezzjoni 4.4.
English: Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis, depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.
Norwegian Bokmål: ), appendiċite, gastroenterite, dipressjoni/disturb tal-personalità, ulċera fil-ġilda, esofaġite/gastrite, xokk settiku minn streptokokku tat-tip A, dijabete mellitus ta' tip I, u infezzjoni fit-tessut l-artab u fil-ferita wara l-operazzjoni.
English: Responses of Patients with Psoriatic Arthritis in a Placebo-Controlled Trial Percent of Patients Placebo
Norwegian Bokmål: Risponsi ta' Pazjenti b'Artrite Psorjatika fi Prova Kkontrollata bil-Plaċebo
English: • The needle has been placed in a plastic container to keep it sterile.
Norwegian Bokmål: Il-labra tqiegħdet f'kontenitur tal-plastik biex tinżamm sterilizzata.
English: The possibility exists for TNF-antagonists, including LIFMIOR, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Norwegian Bokmål: Teżisti l-possibbiltà għal antagonisti ta' TNF, inkluż LIFMIOR, li jaffettwaw id-difiża tal-bniedem kontra infjammazzjonijiet u tumuri malinni, peress li t-TNF jimmedja l-infjammazzjoni u jimmodula rispons immunitarju taċ-ċelluli.
English: Pyrexia
Norwegian Bokmål: Siringa
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including LIFMIOR, in the postmarketing setting.
Norwegian Bokmål: Tumuri malinni, xi wħud minnhom fatali, kienu rrappurtati fost tfal, adolexxenti u żgħażagħ adulti (li kellhom sa 22 sena) ikkurati b'antagonisti ta' TNF (il-bidu tat-terapija sar f'età ta' ≤ 18-il sena), li jinkludu LIFMIOR fl-isfond ta' wara t-tqegħid fis-suq.
English: BATCH NUMBER
Norwegian Bokmål: NUMRU TAL-LOTT
English: The safety and efficacy profiles of the 50 mg once-weekly and 25 mg twice-weekly regimens were similar.
Norwegian Bokmål: Il-profili tas-sigurta u l-effikaċja tal-korsijiet ta' 50 mg darba fil-ġimgħa jew ta' 25 mg darbtejn fil-ġimgħa kienu simili.
English: In clinical studies, concurrent administration of abatacept and LIFMIOR resulted in increased incidences of serious adverse events.
Norwegian Bokmål: Fi studji kliniċi, l-għoti ta' abatacept u LIFMIOR fl-istess ħin irriżulta f'żieda ta' inċidenzi ta' avvenimenti avversi serji.
English: See section 5 for instructions on how to store LIFMIOR.
Norwegian Bokmål: Jekk jogħġbok ara sezzjoni 5 għal istruzzjonijiet dwar kif taħżen LIFMIOR.
English: The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Norwegian Bokmål: L-aktar avvenimenti avversi rrapurtati b'mod komuni huma reazzjonijiet fis-sit fejn tingħata linjezzjoni (bħal uġigħ, nefħa, ħakk, ħmura u ħruġ ta' demm minn parti li kienet mtaqqba), infezzjonijiet (bħal infezzjonijiet fis-sistema respiratorja ta' fuq, bronkite, infezzjonijiet fil-bużżieqa ta' l-awrina ċistite, infezzjonijiet tal-ġilda), reazzjonijiet allerġiċi, formazzjoni ta' awtoantikorpi, ħakk, u deni.
English: CARTON TEXT - (50 mg Pre-filled Syringe) - EU/1/16/1165/008-010
Norwegian Bokmål: KITBA FUQ IT-TIKKETTA TAS-SIRINGA - EU/1/16/1165/002-004
English: LIFMIOR was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
Norwegian Bokmål: LIFMIOR kien b'mod sinifikanti aħjar mill-plaċebo meta tkejlet l-attività tal-marda (p < 0.001), u r-risponsi kienu simili bi jew mingħajr it-terapija fl-istess ħin b'methotrexate.
English: Patients treated with LIFMIOR should be given the Patient Alert Card.
Norwegian Bokmål: Pazjenti kkurati b'LIFMIOR għandhom jingħataw Patient Alert Card.
English: Disposing of supplies a. Introduction
Norwegian Bokmål: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA
English: The efficacy of LIFMIOR in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study.
Norwegian Bokmål: Pazjenti adulti bi spondiloartrite assjali mhux radjografika L-effikaċja ta' LIFMIOR f'pazjenti bi spondiloartrite assjali mhux radjografika (nr-AxSpa) ġiet evalwata fi studju każwali, double-blind u kkontrollat bil-plaċebo ta' 12-il ġimgħa.
English: In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the LIFMIOR group compared with the placebo group (73% vs. 47%, respectively, p ≤ 0.001).
Norwegian Bokmål: F'analiżi li fiha l-pazjenti kollha li ħarġu mill-istudju għal xi raġuni kienu kkunsidrati li kellhom progress, il-perċentwali ta' pazjenti mingħajr progressjoni (bidla fit-TSS ta' ≤ 0.5) wara 12-il xahar kien ogħla fil-grupp ta' LIFMIOR meta mqabbel mal-grupp talplaċebo (73% vs. 47%, rispettivament, p ≤ 0.001).
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of autoimmune hepatitis was 0.24% (frequency uncommon).
Norwegian Bokmål: Fil-provi kliniċi kkontrollati li ppermettew kura konkomitanti b'etanercept u methotrexate, il-frekwenza (il-proporzjon ta' inċidenza) ta' epatite awtoimmunitarja kienet ta' 0.24 % (frekwenza mhux komuni).
English: Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash
Norwegian Bokmål: Prurite, raxx Anġjoedema, psorjasi (li tinkludi bidu mill-ġdid jew aggravament ta' psorjasi, u psorjasi bil-ponot, primarjament filkeffa tal-id u filqiegħ tas-saqajn), urtikarja, raxx psorjasiformi
English: OTHER
Norwegian Bokmål: JIS
English: LIFMIOR 25 mg powder and solvent for solution for injection etanercept
Norwegian Bokmål: LIFMIOR 25 mg trab u solvent għal soluzzjoni għall-injezzjoni Etanercept
English: LIFMIOR 25 mg powder and solvent for solution for injection Etanercept
Norwegian Bokmål: LIFMIOR 25 mg trab u solvent għal soluzzjoni għall-injezzjoni etanercept
English: ACR 50 Month 3
Norwegian Bokmål: ASAS 50 Ġimagħtejn 3 xhur 6 xhur
English: Cartons contain 4 vials of LIFMIOR, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Norwegian Bokmål: Il-kaxxi tal-kartun fihom 4 kunjetti ta' LIFMIOR b'4 siringi mimlija għal-lest bl-ilma għallinjezzjonijiet, 4 labar, 4 adapters tal-kunjetti u 8 swabs bl-alkoħol.
English: Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate.
Norwegian Bokmål: Il-kura ta' artrite psorjatika attiva u progressiva f'adulti meta r-rispons ma kienx adegwat meta ngħataw terapija b'mediċini anti-rewmatiċi li jimmodifikaw il-marda.
English: Elderly
Norwegian Bokmål: Treddigħ
English: Hepatic impairment
Norwegian Bokmål: Indeboliment epatiku
English: This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy.
Norwegian Bokmål: Din l-evalwazzjoni għandha tinkludi storja medika dettaljata bi storja medika personali ta' tuberkulosi jew kuntatt possibbli fil-passat mat-tuberkulosi, u terapija immunosoppressiva fil-passat u/jew fil-preżent.
English: • Vaccinations: If possible, children should be up to date with all vaccinations before using LIFMIOR.
Norwegian Bokmål: • Tilqim: Jekk ikun possibbli, it-tfal għandhom ikunu ngħataw it-tilqim kollu qabel ma jużaw LIFMIOR.
English: In this study, 53 patients received placebo, 214 patients received 50 mg LIFMIOR once weekly and 153 patients received 25 mg LIFMIOR twice weekly.
Norwegian Bokmål: F'dan l-istudju, 53 pazjent ingħataw il-plaċebo, 214-il pazjent ingħataw 50 mg ta' LIFMIOR darba fil-ġimgħa u 153 pazjent ingħataw 25 mg LIFMIOR darbtejn fil-ġimgħa.
English: Study 2
Norwegian Bokmål: ANNESS II
English: The primary measure of efficacy (ASAS 40) was a 40% improvement in at least three of the four ASAS domains and absence of deterioration in the remaining domain.
Norwegian Bokmål: Il-miżura ewlenija tal-effikaċja (ASAS 40) kienet titjib ta' 40% f'mill-inqas tlieta mill-erba' oqsma ASAS u nuqqas ta' deterjorament fil-qasam li fadal.
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of autoimmune hepatitis in patients receiving etanercept without concomitant methotrexate was 0.02% (frequency rare).
Norwegian Bokmål: Fi provi kliniċi kkontrollati ta' etanercept fl-indikazzjonijiet kollha, il-frekwenza (il-proporzjon ta' inċidenza) ta' epatite awtoimmunitarja f'pazjenti li kienu qed jirċievu etanercept mingħajr methotrexate konkomitanti kienet ta' 0.02 % (frekwenza rari).
English: 2 pre-filled syringes2 alcohol swabs
Norwegian Bokmål: 2 siringi mimlija għal-lest 2 swabs ta' l-alkoħol
English: (It may be helpful to keep notes on the location of the previous injections.)
Norwegian Bokmål: (Jista' jkun utli jekk iżżomm nota tal-postijiet fejn ikunu ngħataw l-injezzjonijiet ta' qabel.)
English: • Remove the needle cover by firmly pulling it straight off the syringe taking care not to touch the needle or allow the needle to touch any surfaces (see Diagram 15).
Norwegian Bokmål: • jekk it-tifel/tifla li qed tieħu ħsieb ikun/tkun allerġiku/ka għal etanercept jew sustanzi oħra ta' LIFMIOR (elenkati fis-sezzjoni 6).
English: The clinical impact of this is unknown, however, infants may be at increased risk of infection.
Norwegian Bokmål: Jekk irċevejt LIFMIOR waqt it-tqala, it-tarbija tiegħek jista' jkollha riskju ogħla li tieħu infezzjoni.
English: ACR 20 Month 3
Norwegian Bokmål: ASAS 20 Ġimagħtejn 3 xhur 6 xhur
English: These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal).
Norwegian Bokmål: Dawn huma effetti rari jew mhux komuni, imma huma kundizzjonijiet serji (fejn xi wħud jistgħu rarement ikunu fatali).
English: Merkel cell carcinoma (see section 4.4)
Norwegian Bokmål: Karċinoma taċċelluli Merkel (ara sezzjoni
English: Psoriatic Arthritis Response n = 104
Norwegian Bokmål: % ta' Pazjenti Plaċebo n = 104