FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients not given concomitant methotrexate, the incidence was 16/185 (8.6%), compared to 1/19 (5.3%) when adalimumab was used as add-on to methotrexate.
Slovenian: Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 16/185 (8,6 %), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 1/19
English: If you forget to give your child a Humira injection, you should inject the Humira dose as soon as you remember.
Slovenian: Če pozabite dati vašemu otroku injekcijo zdravila Humira, mu morate odmerek zdravila Humira injicirati takoj, ko se spomnite.
English: • Do not attempt to inject your child until you are sure that you understand how to prepare and give the injection.
Slovenian: • Ne poskušajte vašemu otroku zdravila injicirati, dokler popolnoma ne obvladate priprave in dajanja injekcije.
English: Do not try to touch the needle housed in the barrel.
Slovenian: Ne poskušajte se dotakniti igle, ki je v brizgi.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
Slovenian: • sindrom Stevens-Johnson (zgodnji znaki vključujejo slabo počutje, povišano telesno temperaturo, glavobol in izpuščaj)
English: • In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding.
Slovenian: • Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki pomagajo pri premagovanju okužbe ali ustavitvi krvavitve.
English: Humira can slow down the damage to the joints caused by the disease and can help them move more freely.
Slovenian: Zdravilo Humira lahko upočasni napredovanje prizadetosti sklepov, ki jo povzroča bolezen, in jim lahko pomaga, da se bolj prosto gibljejo.
English: One 0.8 ml vial contains 40 mg adalimumab.
Slovenian: Ena 0,8 ml viala vsebuje 40 mg adalimumaba.
English: • moderate to severe Crohn's disease in adults and
Slovenian: • zmerne do hude Crohnove bolezni pri odraslih in
English: Erythema multiforme Stevens-Johnson syndrome angioedema cutaneous vasculitis lichenoid skin reaction
Slovenian: brazgotinjenje redki multiformni eritem1), sindrom Stevens-Johnson1), angioedem1), kožni vaskulitis1) lihenoidna kožna reakcija1)
English: Table 20: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Slovenian: Preglednica 20: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
English: Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Slovenian: Ankilozirajoči spondilitis (AS) Zdravilo Humira je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (<1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Slovenian: V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 19,7, izhodiščna PGA pa je segala od "blage" (< 1 %), "zmerne" (48 %) in
English: Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly.
Slovenian: Z drugo roko stisnite kožo na mestu injiciranja, tako da se površina dvigne, in jo držite čvrsto.
English: The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Slovenian: Priporočeni odmerek zdravila Humira pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
English: By Week 68, patients receiving continuous Humira treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Slovenian: Rezultati do 68. tedna so pokazali statistično značilno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so neprekinjeno prejemali zdravilo Humira v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
English: • vasculitis (inflammation of blood vessels)
Slovenian: • vaskulitis (vnetje krvnih žil)
English: The safety and efficacy of Humira was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Slovenian: Varnost in učinkovitost zdravila Humira so ocenili v dveh študijah (pJIA I in II) pri otrocih z aktivnim poliartikularnim ali poliartikularnim juvenilnim idiopatskim artritisom, z različnimi tipi začetka JIA
English: p < 0.01
Slovenian: * p < 0,001 ** p < 0,01
English: • If you received Humira while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Humira dose you received during pregnancy.
Slovenian: • Če ste prejemali zdravilo Humira med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil takšno okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
English: In controlled trials of Humira (initial doses of 160 mg at Week 0 and 80 mg at Week 2, followed by 40 mg every week starting at Week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of Humira-treated patients and 0.6% of control-treated patients.
Slovenian: V kontroliranih preskušanjih z zdravilom Humira (v začetnem odmerku 160 mg, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu) pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 0,3 % bolnikov, zdravljenih z zdravilom Humira, in pri 0,6 % bolnikov v kontrolni skupini.
English: Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Slovenian: Psoriatični artritis je vnetje sklepov, povezano s kožno luskavico.
English: Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: Zdravilo Humira je indicirano za zdravljenje aktivne zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
English: The Humira vial is a glass vial containing a solution of adalimumab.
Slovenian: Viala z zdravilom Humira je steklena viala, ki vsebuje raztopino adalimumaba.
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Slovenian: Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
English: Wipe your skin by using the enclosed alcohol pad, using a circular motion.
Slovenian: S krožnim gibom obrišite kožo s priloženim alkoholnim zložencem.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
Slovenian: demielinizacijske bolezni (npr.optični nevritis,
English: Pull the Grey Cap 1 straight off.
Slovenian: Odstranite siv pokrovček (1).
English: • 80 mg at Week 0 and 40 mg at Week 2
Slovenian: • 80 mg v 0. tednu in 40 mg v 2. tednu
English: Week 26 Week 52 p value for Standard Dose versus Low Dose comparison.
Slovenian: 1p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing 30 kg or more
Slovenian: Mladostniki s hidradenitis suppurativa stari od 12 do 17 let, ki tehtajo 30 kg ali več
English: All doses/schedules of Humira in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at Week 52.
Slovenian: V vseh štirih študijah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi odmerki/shemami zdravila Humira izboljšal statistično značilno bolj kot s placebom; v študiji revmatoidnega artritisa III so isto ugotovili po 52 tednih.
English: Patients remained on stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and or prednisone ( 0.2 mg /kg/day or 10 mg/day maximum).
Slovenian: Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil (NSPVZ) in/ali prednizona (≤ 0,2 mg/kg/dan ali največ 10 mg/dan).
English: • Severe allergic reaction with shock;
Slovenian: • hude alergijske reakcije s šokom;
English: In the OL LI phase all patients received 24 mg/m up to a maximum of 40 mg Humira every other week for 16 weeks.
Slovenian: V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m2 (do največ 40 mg) zdravila Humira vsak drugi teden.
English: Packs of:
Slovenian: Pakiranja:
English: The double-blind period is followed by an open-label (OL) period during which patients received 24 mg/m2 BSA of Humira up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Slovenian: Obdobju dvojno slepega preskušanja je sledilo obdobje odprtega preskušanja, v katerem so bolniki prejemali 24 mg/m2 telesne površine zdravila Humira do največjega posamičnega odmerka 40 mg vsak drugi teden subkutano do največ 192 tednov.
English: The patients received 24 mg/m2 body surface area (BSA) of Humira up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Slovenian: Bolniki so vsaj 24 tednov prejemali zdravilo Humira v odmerku 24 mg/m2 telesne površine (in do največ 20 mg) vsak drugi teden kot enkraten odmerek v subkutani injekciji.
English: • low blood measurements for calcium
Slovenian: • nizke krvne vrednosti za kalcij
English: Humira 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Slovenian: s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa - Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6,3), ki se niso odzvali ustrezno na konvencionalno terapijo.
English: The recommended dose of Humira is 40 mg every other week.
Slovenian: Priporočeni odmerek zdravila Humira je 40 mg vsak drugi teden.
English: • At least 3 cm from your last injection site
Slovenian: • najmanj 3 cm oddaljeno od prejšnjega mesta injiciranja.
English: Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Slovenian: Poliartikularni juvenilni idiopatski artritis je vnetna bolezen sklepov.
English: Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: Zdravilo Humira je indicirano za zdravljenje aktivne zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
English: Humira may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Humira ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Placebo N=107
Slovenian: Odziv placebo n = 107
English: Humira was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Slovenian: V vseh kliničnih preskušanjih revmatoidnega artritisa so zdravilo Humira ocenili pri več kot 3000 bolnikih.
English: • abnormal blood measurements for sodium
Slovenian: • nenormalne krvne vrednosti za natrij
English: Humira 40 mg/0.8 ml solution for injection
Slovenian: Humira 40 mg/0,8 ml raztopina za injiciranje
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg Humira on Week 0 followed by 80 mg on Week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/ml at Week 2 and Week 4.
Slovenian: Pri odraslih bolnikih s hidradenitis suppurativa doseže odmerek 160 mg zdravila Humira na 0. teden, ki mu sledi 80 mg zdravila Humira 2. teden, najnižjo koncentracijo adalimubaba v serumu pred naslednjim odmerkom približno 7 do 8 µg/ml v 2. tednu in v 4. tednu.
English: Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks Placebo N=53 n (%)
Slovenian: Rezultati učinkovitosti po 16 tednih placebo n = 53 n (%)
English: Humira can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.
Slovenian: Zdravilo Humira lahko upočasni napredovanje prizadetosti sklepov, ki jo povzroči vnetna bolezen, in jim lahko pomaga, da se bolj prosto gibljejo.
English: RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Slovenian: Študija revmatoidnega artritisa V je ocenila 799 odraslih bolnikov, ki še niso dobivali metotreksata in so imeli zmerno do hudo aktiven zgoden revmatoidni artritis (povprečno trajanje bolezni manj kot 9 mesecev).
English: Humira has not been studied in patients aged less than 2 years.
Slovenian: Študije z zdravilom Humira pri bolnikih mlajših od 2 let niso bile izvedene.
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 21).
Slovenian: V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 21).
English: • Cases of non-melanoma skin cancer have been observed in patients taking Humira.
Slovenian: • Pri bolnikih, zdravljenih z zdravilom Humira, so opazili primere nemelanomskega kožnega raka.
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ml (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg/ml (47.7% CV) with concomitant methotrexate.
Slovenian: Po uporabi 24 mg/m2 (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih od 4 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med uporabo adalimumaba brez metotreksata 5,6 ± 5,6 µg/ml (koeficient variacije 102 %) in med uporabo z metotreksatom 10,9 ± 5,2 µg/ml (koeficient variacije 47,7 %).
English: Table 8 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks Placebo N=398 n (%)
Slovenian: Rezultati učinkovitosti po 16 tednih placebo n = 398 n (%)
English: The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritisfrom 2 years of age is based on body weight (Table 1).
Slovenian: Priporočeni odmerek zdravila Humira pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
English: If a faster response is required, the doctor may prescribe a first dose of 80 mg, followed by 40 mg two weeks later.
Slovenian: Če je potreben hitrejši odziv, lahko zdravnik predpiše začetni odmerek 80 mg, ki mu sledi 40 mg dva tedna kasneje.
English: ACR 20 Week 12 Week 24
Slovenian: ACR 20 12. teden 24. teden np np
English: In patients not given concomitant methotrexate, the incidence was 13.6% (3/22), compared to 8.3% (2/24) when adalimumab was used as add-on to methotrexate.
Slovenian: Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 13,6 % (3/22) bolnikov, pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 8,3 % (2/24) bolnikov.
English: • elevated liver enzymes.
Slovenian: • zvišani jetrni encimi.
English: The safety and efficacy of Humira were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised doubleblind study (Psoriasis Study III).
Slovenian: Varnost in učinkovitost zdravila Humira so raziskali tudi v randomizirani dvojno slepi študiji pri odraslih bolnikih z zmerno do hudo kronično psoriazo v plakih s sočasno psoriazo na dlaneh in/ali stopalih, ki so bili kandidati za sistemsko zdravljenje (Študija pri psoriazi III).
English: White Needle Sleeve
Slovenian: Bel tulec igle
English: ACR 70 Week 12 Week 24
Slovenian: ACR 70 12. teden 24. teden np np
English: In controlled trials of Humira (initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Humira-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of Humira-treated patients and 2.4% of control-treated patients.
Slovenian: V kontroliranih preskušanjih z zdravilom Humira (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri odraslih bolnikih z uveitisom, ki so trajala do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih zdravljenih z zdravilom Humira in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 2,4 % bolnikov zdravljenih z zdravilom Humira in pri 2,4 % bolnikov v kontrolni skupini.
English: In RA study IV, the ACR 20 response of patients treated with Humira plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Slovenian: Humira in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
English: Carriers of HBV who require treatment with Humira should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Slovenian: Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Humira, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving Humira.
Slovenian: Pri bolnikih, ki so dobivali zdravilo Humira, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okužb, npr. listerioza, legioneloza in pnevmocistična okužba.
English: Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Slovenian: 40 bolnikov ni pokazalo napredovanja strukturne prizadetosti izražene s spremembo srednje Sharpove ocene 0,5 ali manj od začetka študije.
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
Slovenian: V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 17).
English: Rheumatoid arthritis Rheumatoid arthritis is an inflammatory disease of the joints.
Slovenian: Revmatoidni artritis Revmatoidni artritis je vnetna bolezen sklepov.
English: At Week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 11).
Slovenian: V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine na koži, povezane s HS (glejte preglednico 11).
English: • sensation of heart beating irregularly such as skipped beats
Slovenian: • občutek neenakomernega bitja srca kot je preskakovanje utripov
English: Total Sharp Score Erosion score 3.7 (2.7-4.7) 1.7 (1.0-2.4) 0.8 (0.4-1.2) < 0.001 0.0082 < 0.001 JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) 0.5 (0-1.0) < 0.001 0.0037 0.151 a p-value is from the pairwise comparison of methotrexate monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test. p-value is from the pairwise comparison of Humira monotherapy and Humira/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Slovenian: ACR 50 52. teden 45,9 % 41,2 % 61,6 % < 0,001 < 0,001 0,317 104. teden 42,8 % 36,9 % 59,0 % < 0,001 < 0,001 0,162 ACR 70 52. teden 27,2 % 25,9 % 45,5 % < 0,001 < 0,001 0,656 104. teden 28,4 % 28,1 % 46,6 % < 0,001 < 0,001 0,864 a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z zdravilom Humira/metotreksat z Mann-Whitneyevim testom U. b Vrednost p se nanaša na parno primerjavo monoterapije z zdravilom Humira in kombinirane terapije z zdravilom Humira/metotreksat z Mann-Whitneyevim testom U. c Vrednost p se nanaša na parno primerjavo monoterapije z zdravilom Humira in monoterapije z metotreksat z Mann-Whitneyevim testom U.
English: Contains 2 cartons each for a single injection only Each carton contains:
Slovenian: raztopina za injiciranje Vsebuje 2 škatli, vsaka škatla je namenjena enkratnemu injiciranju.
English: Humira was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Slovenian: Zdravilo Humira je bilo ocenjeno v multicentrični, randomizirani, dvojno slepi klinični študiji, ki je bila zasnovana za oceno učinkovitosti in varnosti indukcijskega in vzdrževalnega zdravljenja z odmerki, odvisnimi od telesne mase (< 40 mg ali ≥ 40 mg) pri 192 pediatričnih bolnikih med 6. in 17.
English: • There have been very rare cases of certain kinds of cancer in children and adult patients taking Humira or other TNF blockers.
Slovenian: • Med bolniki (otroci in odraslimi), ki so jemali zdravilo Humira ali druge zaviralce TNF, so se pojavili zelo redki primeri določenih vrst raka.