natgillin/translations-raw huggingface dataset:
• If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Humira. 
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki prizadene izolacijsko plast okoli živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobivate zdravilo
• Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection. 
• Ne poskušajte si zdravila injicirati, dokler popolnoma ne obvladate priprave in dajanja injekcije.
Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection. 
Ne poskušajte si zdravila injicirati, dokler popolnoma ne obvladate priprave in dajanja injekcije.
• swollen face, hands, feet 
• oteklost obraza, dlani in stopal
Humira is used to treat psoriatic arthritis in adults. 
Zdravilo Humira se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
• Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, 
• aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis,
The recommended Humira dose is 80 mg at Week 0 followed by 40 mg every other week starting at Week 1 via subcutaneous injection. 
Priporočeni odmerek zdravila Humira je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
• After injecting Humira, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist. 
• Po injiciranju zdravila Humira takoj zavrzite odrabljeni napolnjeni injekcijski peresnik v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
Depending on your child's response, your child's doctor may increase the dose frequency to 20 mg every week. 
Glede na odziv vašega otroka mu lahko njegov zdravnik poveča pogostnost odmerjanja na 20 mg vsak teden.
If it is cloudy or discoloured or has flakes or particles in it, you must not use it. Do not use a pre-filled pen that is frozen or if it has been left in direct sunlight. 
Če je motna, obarvana ali vsebuje kosme ali delce, je ne smete uporabiti.
Cap 1 
Preglednica 1.
If your child gets any side effects, talk to your child's doctor or pharmacist. 
Če vaš otrok dobi kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom ali s farmacevtom.
On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Humira. 
V redkih primerih so pri bolnikih, ki dobivajo zdravilo Humira, opazili specifično in resno obliko limfoma.
• If your child takes Humira the risk of getting lymphoma, leukaemia, or other cancers may increase. 
• Če vaš otrok uporablja zdravilo Humira, se mu lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
Humira is used to treat rheumatoid arthritis in adults. 
Zdravilo Humira se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
Table 13: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks 
Preglednica 13: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
• cutaneous vasculitis (inflammation of blood vessels in the skin) 
• kožni vaskulitis (vnetje krvnih žil v koži)
Humira is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age. 
Zdravilo Humira se uporablja za zdravljenje hidradenitis suppurativa pri odraslih in mladostnikih,
• While still holding the syringe upright at the graduated area, remove the vial adapter with the vial by twisting the vial adapter off with the other hand. 
Medtem brizgo še vedno držite na delu z merilom in pokonci, odstranite adapter za vialo in vialo tako, da z drugo roko adapter za vialo zasučete z brizge.
There is limited safety experience of surgical procedures in patients treated with Humira. 
Operacije Izkušnje z varnostjo operacij pri bolnikih, zdravljenih z zdravilom Humira, so omejene.
Your doctor may increase the dose frequency to 20 mg every week. 
Vaš zdravnik lahko poveča pogostnost odmerjanja na 20 mg vsak teden.
No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in paediatric patients with plaque psoriasis. 
Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z zdravilom Humira pri pediatričnih bolnikih s psoriazo v plakih.
What the Humira pre-filled syringe with automatic needle guard looks like and contents of the pack 
Izgled zdravila Humira napolnjena injekcijska brizga z avtomatskim ščitnikom za iglo in vsebina pakiranja
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1). 
Priporočljivo je, da se vsako leto ocenijo koristi in tveganja nadaljnega dolgotrajnega zdravljenja (glejte poglavje 5.1).
• pulmonary embolism (bloackage in an artery of the lung); 
• pljučni embolizem (zamašitev arterije v pljučih);
Week 12 Week 24 ASAS 70 Week 2 
ASASa 20 2. teden 12. teden 24. teden ASAS 50 2. teden 12. teden 24. teden ASAS 70 2. teden 12. teden 24. teden
When Humira therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy. 
40 mg in pri bolnikih ≥ 30 kg polnilni odmerek 80 mg en teden pred začetkom vzdrževalnega zdravljenja.
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 7). 
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili radiografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 7).
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel; 
• razširitev v steni večje arterije, vnetje in krvni strdek v veni, zamašitev žile;
Humira 40 mg solution for injection in single-use vial (type I glass), fitted with rubber stoppers, aluminium crimps and flip-off seals. 
Zdravilo Humira 40 mg raztopina za injiciranje v viali (steklo tipa I) za enkratno uporabo, opremljeni z gumijastim zamaškom, aluminijsko obrobo in dvižno zaporko.
Hold the grey body of the pre-filled pen with one hand. 
Z eno roko primite sivo telo napolnjenega injekcijskega peresnika.
• Rheumatoid arthritis, 
• revmatoidni artritis,
Humira is indicated for the treatment of Crohn's disease in children aged 6 to 17 years. 
Zdravilo Humira je namenjeno za zdravljenje Crohnove bolezni pri otrocih, starih 6 do 17 let.
Ulcerative colitis is an inflammatory disease of the large intestine. 
Ulcerozni kolitis je vnetna bolezen debelega črevesa.
Wipe the injection site in a circular motion with the alcohol pad. 
o S krožnim gibom obrišite injekcijsko mesto s priloženim alkoholnim zložencem.
Humira is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. 
Zdravilo Humira je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri odraslih bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
Humira is used to treat hidradenitis suppurativa in adolescents from 12 years of age. 
Zdravilo Humira se uporablja za zdravljenje hidradenitis suppurativa pri mladostnikih, starejših od
If your child takes Humira the risk of getting lymphoma, leukemia, or other cancers may increase. 
Če vaš otrok uporablja zdravilo Humira, se mu lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
• Rheumatoid arthritis 
• revmatoidnega artritisa
All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at Week 0 and 80 mg at Week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg. 
Vsi bolniki so nezaslepljeno prejeli indukcijsko zdravljenje v odmerku glede na njihovo začetno telesno maso: 160 mg v 0. tednu in 80 mg v 2. tednu bolniki z ≥ 40 kg ter 80 mg in 40 mg v tem vrstnem redu bolniki z < 40 kg.
The results for the 40 mg every other week dose are summarised in Table 4. 
Rezultati odmerka 40 mg vsak drugi teden so strnjeni v preglednici 4.
• severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable. 
• hude kronične luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
• 1 pre-filled pen for patient use with 2 alcohol pads (1 spare) 
• 1 napolnjen injekcijski peresnik z 2 alkoholnima zložencema (1 dodatni)
The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week two weeks later. 
Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg (kot dve 40 mg injekciji v enem dnevu) na začetku, čemur sledi 40 mg vsak drugi teden dva tedna kasneje.
• a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel 
• razširitev v steni večje arterije, vnetje in krvni strdek v veni, zamašitev žile
• Do not use the pre-filled syringe if the liquid is cloudy or has particles 
• Napolnjene injekcijske brizge ne uporabite, če je tekočina motna ali vsebuje delce
Humira treated patients showed statistically significant improvements at Week 26 compared with placebo in the DLQI. 
Pri bolnikih, zdravljenih z zdravilom Humira, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi z placebom.
No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during a Humira trial in paediatric patients with chronic plaque psoriasis. 
Pri 77 pediatričnih bolnikih v preskušanju zdravila Humira pri pediatričnih bolnikih s kronično psoriazo v plakih z izpostavljenostjo 80,0 bolnikov-let niso opazili malignomov.
• swollen face, hands, feet; 
• oteklost obraza, dlani in stopal,
• erythema multiforme (inflammatory skin rash) 
• multiformni eritem (vnetni kožni izpuščaj)
In patients not given concomitant methotrexate, the incidence was 13.5% (24/178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate. 
13,5 % (24/178 bolnikov), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 7 % (14 od 198 bolnikov).
All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Humira. 
Pred zdravljenjem z zdravilom Humira in med zdravljenjem z njim je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
• oral infections (including tooth infections and cold sores); 
• okužbe ustne votline (vključno z okužbami zob in herpesom);
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 days * p < 0.001 for Humira versus placebo pairwise comparisons of proportions ** p < 0.02 for Humira versus placebo pairwise comparisons of proportions Of those receiving corticosteroids at baseline 
Bolniki v remisiji brez steroidov ≥ 90 dnia * p < 0,001 za parne primerjave razmerij Humire proti placebu ** p < 0,02 za parne primerjave razmerij Humire proti placebu a Od teh, ki so dobivali kortikosteroide ob začetku
Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 g/ml. 
Po subkutanem dajanju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z ne-radiografskim aksialnim spondiloartritisom je bila povprečna (±SD) najmanjša koncentracija v stanju dinamičnega ravnovesja (merjena v 68. tednu) 8,0 ± 4,6 µg/ml.
Vertigo and visual impairment may occur following administration of Humira (see section 4.8). 
Po dajanju zdravila Humira se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
• trouble breathing, swallowing 
• težave pri dihanju, požiranju
Do not touch the area again before injecting. 
o Predela se pred injiciranjem ne dotikajte več.
• oral infections (including tooth infections and cold sores) 
• okužbe ustne votline (vključno z okužbami zob in herpesom)
If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. 
Če se pri vas razvijejo novi simptomi srčnega popuščanja ali se ti poslabšajo (na primer kratka sapa ali otekanje nog), morate nemudoma obvestiti svojega zdravnika.
• skin infections (including cellulitis and shingles) 
• okužbe kože (vključno s celulitisom in pasovcem)
The double-blind period was followed by an open-label period during which patients receive Humira 40 mg every other week subcutaneously for up to an additional 144 weeks. 
Dvojno slepi periodi je sledila odprta perioda, v kateri so bolniki prejemali zdravilo Humira 40 mg vsak drug teden subkutano do dodatnih
Sustained Remission 
Avtoimunska dogajanja
• pulmonary embolism (blockage in an artery of the lung) 
• pljučni embolizem (zamašitev arterije v pljučih)
• systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems) 
• sistemski eritematozni lupus (vključno z vnetjem kože, srca, pljuč, sklepov in drugih organskih sistemov)
In Period A, patients received placebo or Humira at an initial dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every week starting at Week 4 to Week 11. 
V obdobju A so bolniki prejeli placebo ali zdravilo Humira v začetnem odmerku 160 mg v 0. tednu, nato 80 mg v 2. tednu in 40 mg vsak teden od vključno 4. tedna do 11. tedna.
There is limited safety experience in patients undergoing arthroplasty while receiving Humira. 
Izkušnje z varnostjo pri bolnikih, ki so jim med zdravljenjem z zdravilom Humira opravili artroplastiko, so omejene.
Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 
Zdravilo Humira je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom pri bolnikih, starih 6 let in več, ki so se neustrezno odzvali ali so intolerantni za običajno zdravljenje
After completing the injection, place a cotton ball or gauze pad on the skin over the injection site. 
Po zaključenem injiciranju položite na mesto injiciranja blazinico vate ali zloženec iz gaze.
• Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis 
• aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis
Humira can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. 
Zdravilo Humira lahko zmanjša število vozličev in ognojkov, ki jih povzroča ta bolezen.
First dose of 40 mg, followed by 40 mg one week later. 
Prvi odmerek je 40 mg, kateremu sledi 40 mg en teden kasneje.
A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with Humira. 
Pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovo boleznijo, ulceroznem kolitisom in hidradenitis suppurativa so opazili tudi naglo znižanje koncentracij CRP po zdravljenju z zdravilom Humira.
In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment. 
Pri odraslih bolnikih s psoriazo je bila povprečna koncentracija v stanju dinamičnega ravnovesja med monoterapijo z adalimumabom 40 mg vsak drugi teden 5 μg/ml.
1 sterile vial adapter 
1 sterilni adapter za vialo 2 alkoholna zloženca
Humira 80 mg solution for injection in pre-filled pen Humira 80 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe. 
Humira 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Humira 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki ga uporabi bolnik, vsebuje napolnjeno injekcijsko brizgo.
• If you have or develop demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive or continue to receive Humira. 
• Če imate ali pa se pri vas razvija demielinizirajoča bolezen, kot je multipla skleroza, bo zdravnik presodil, ali lahko dobivate oziroma tudi še nadalje dobivate zdravilo Humira.
In patients with polyarticular JIA who were 2 to < 4 years old or aged 4 and above weighing < 15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/ml (71.2% CV) with concomitant methotrexate. 
Pri bolnikih s poliartikularnim JIA, starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg, ki so prejemali adalimumab v odmerku 24 mg/m2, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja 6,0 ± 6,1 µg/ml (KV 101 %) med uporabo adalimumaba brez metotreksata in 7,9 ± 5,6 µg/ml (KV 71,2 %) med sočasno uporabo metotreksata.
In adult patients with uveitis, a loading dose of 80 mg adalimumab on Week 0 followed by 40 mg adalimumab every other week starting at Week 1, resulted in mean steady-state concentrations of approximately 8 to 10 g/mL. 
Pri odraslih bolnikih z uveitisom je polnilni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil povprečno koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
• Polyarticular juvenile idiopathic arthritis, 
• poliartikularni juvenilni idiopatski artritis,
• Psoriatic arthritis 
• psoriatičnega artritisa
Throw the cap away. 
Pokrovček zavrzite.
If these medicines do not work well enough, your child will be given Humira to treat his/her polyarticular juvenile idiopathic arthritis. 
Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa prejel zdravilo Humira.
Minimum, median and maximum dose 
Izhodiščno število bolnikov n (%) Najmanjši, srednji in največji odmerek
Low Dose 20/10 mg eow N = 95 
Majhni odmerek 20/10 mg vsak teden dan N=95
The needle cover, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste. 
V gospodinjske odpadke lahko zavržete pokrovček igle, alkoholni zloženec, blazinico vate ali zložene gaze, omot in embalažo.
• It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. 
• Zelo je pomembno, da zdravniku poveste, če ste že kdaj imeli tuberkulozo ali ste bili v tesnem stiku s kom, ki je imel tuberkulozo.
In addition cases of non-melanoma skin cancer have been observed in patients taking Humira. 
Poleg tega so pri bolnikih, zdravljenih z zdravilom Humira, opazili primere nemelanomskega kožnega raka.
Placebo/MTXHumira/MTX (95% Confidence Interval p-value 
Zdravilo Humira/MTX 40 mg vsak drugi teden placebo/MTXzdravilo Humira/MTX (95 % interval zaupanjab)
Humira treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at Week 24) compared with 0.0 ± 1.9; (p< 0.001) in the Humira group (at Week 48). 
(povprečje ± standardni odklon) 0,8 ± 2,5 v skupini s placebom (po 24 tednih) in 0,0 ± 1,9; (p < 0,001) v skupini z zdravilom Humira (po 48 tednih).
• Your belly (abdomen) at least 5 cm from your belly button (navel) 
• na trebuhu; najmanj 5 cm oddaljeno od popka
Table 19 Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission Standard Dose 40/20 mg eow 
Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
• Do not hold or pull the plunger when removing the needle cover 
• Pri odstranjevanju pokrovčka igle ne držite in ne potegnite bata.
Surgery 
Okence
Your child's doctor may increase the dose frequency to 20 mg every week. 
Zdravnik vašemu otroku lahko poveča pogostnost odmerjanja na 20 mg vsak teden.
• The following instructions explain how to give your child a subcutaneous injection of Humira using the pre-filled syringe. 
• Naslednja navodila pojasnjujejo, kako vašemu otroku subkutano injicirate zdravilo Humira z napolnjeno injekcijsko brizgo.
At Week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in Table 25. 
V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1:1 bodisi v vzdrževalni režim z majhnim odmerkom ali vzdrževalni režim s standardnim odmerkom, kot kaže preglednica 25.
Solution for injection 1 pre-filled syringe 1 alcohol pad 
raztopina za injiciranje 1 napolnjena injekcijska brizga 1 alkoholni zloženec
Enthesitis-related arthritis Age or body weight 
Artritis, povezan z entezitisom Starost ali telesna masa
Worsening or new onset of psoriasis(including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia1), 
pogosti poslabšanje ali pojav psoriaze (vključno s palmoplantarno pustularno psoriazo)1), urtikarija,
Humira 40 mg solution for injection in pre-filled pen Humira 40 mg solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe. 
Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Zdravilo Humira 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki ga uporabi bolnik, vsebuje napolnjeno injekcijsko brizgo.
There is no relevant use of Humira in patients aged less than 2 years for this indication. 
Uporaba zdravila Humira pri bolnikih, starih manj kot 2 leti, za to indikacijo ni primerna.
If you take Humira the risk of getting lymphoma, leukemia, or other cancers may increase. 
Če uporabljate zdravilo Humira, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
• Ulcerative colitis and 
• ulcerozni kolitis in
Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients) 
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom
• There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker. 
• Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNF, so bili primeri raka, ki niso bili limfomi.
No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during Humira trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis). 
Pri 249 pediatričnih bolnikih z juvenilnim idiopatskim artritisom (s poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), ki so bili med preskušanji zdravila Humira zdravilu izpostavljeni 655,6 bolnikov-let, niso ugotovili nobenega malignoma.
Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks 
Preglednica 18: Študija pri psoriazi II (CHAMPION)
• high blood measurements for white blood cells 
• visoke krvne vrednosti za bele krvne celice