natgillin/translations-raw huggingface dataset:
- Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Cyltezo and during treatment with Cyltezo. 
Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Cyltezo in med zdravljenjem z njim.
• Inspect Cyltezo pre-filled syringe, medication, and expiration date. 
• Preverite napolnjeno injekcijsko brizgo zdravila Cyltezo, zdravilo in datum izteka roka
≥ mNAPSI 75 
PASI ≥ 75
Prescribers should exercise caution in considering the use of Cyltezo in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Cyltezo should be considered if any of these disorders develop. 
Pri odločanju za uporabo zdravila Cyltezo pri bolnikih z obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega ali perifernega živčevja je potrebna previdnost; če se razvije katera od teh bolezni, je treba razmisliti o prenehanju zdravljenja z zdravilom Cyltezo.
> 32 weeks 
> 32 tednov 14 tednov
Cyltezo in combination with methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate. 
Zdravilo Cyltezo je v kombinaciji z metotreksatom indicirano za: ▪ Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten.
The safety and efficacy of adalimumab were assessed in two randomised, double-blind placebo-controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA). 
Varnost in učinkovitost adalimumaba so ocenili v dveh randomiziranih dvojno slepih, s placebom kontroliranih študijah pri bolnikih z ne-radiografskim aksialnim spondiloartritisom (nr-axSpA).
No ALT elevations ≥ 3 X ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque 
Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih
Adalimumab 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. 
Adalimumab 40 mg so vsak drugi teden ocenili v dveh randomiziranih 24-tedenskih dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (BASDAI, Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6,3), ki se niso odzvali ustrezno na konvencionalno terapijo.
During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95 % confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for controltreated patients). 
V kontroliranih delih ključnih preskušanj z adalimumabom pri odraslih, ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez rentgenskega dokaza za AS, psoriatičnim artritisom, psoriazo, hidradenitis suppurativa, Crohnovo boleznijo, ulceroznim kolitisom in uveitisom so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95-% interval zaupanja) 6,8 (4,4; 10,5) na 1.000 bolnikov-let med 5.291 bolniki, ki so dobivali adalimumab, in 6,3 (3,4; 11,8) na 1.000 bolnikov-let med 3.444 kontrolnimi bolniki (mediana zdravljenja pri prvih je bila 4,0 mesece in pri drugih 3,8 meseca).
Patients were then re-treated with adalimumab 0.8 mg/kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects). 
Bolniki so bili nato znova zdravljeni z adalimumabom v odmerku 0,8 mg/kg vsak drugi teden še nadaljnjih 16 tednov, pri čemer so bile opažene stopnje odziva podobne kot v prejšnjem dvojno slepem obdobju: odziv PASI 75 pri 78,9 % (15 od 19 oseb) in PGA čisto ali minimalno pri
The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7 %) in the adalimumab-treated women with RA and 5/74 (6.8 %) in the untreated women with RA (unadjusted OR 1.31, 95 % CI 0.38-4.52) and 16/152 (10.5 %) in the adalimumab-treated women with CD and 3/32 (9.4 %) in the untreated women with CD (unadjusted OR 1.14, 95 % CI 0.31-4.16). 
Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim otrokom z večjim defektom ob rojstvu, je bilo 6/69 (8,7 %) pri nosečnicah, zdravljenih z adalimumabom z RA, in 5/74 (6,8 %) pri nezdravljenih nosečnicah z RA (neprilagojeno razmerje obetov 1,31, 95 % interval zaupanja 0,38-4,52), ter 16/152 (10,5 %) pri nosečnicah, zdravljenih z adalimumabom s CB, in 3/32 (9,4 %) pri nezdravljenih nosečnicah s CB (neprilagojeno razmerje obetov 1,14, 95 % interval zaupanja 0,31-4,16).
Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk). 
Opomba: P# = placebo (število dogodkov/število rizičnih preiskovancev); A# = adalimumab (število dogodkov/število
Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral) 
zelo pogosti okužbe dihal (vključno z okužbo spodnjih in zgornjih dihal, pljučnico, sinusitisom, faringitisom, nazofaringitisom in pljučnim virusnim herpesom)
The needle cover of the syringe contains latex 
Pokrovček igle na injekcijski brizgi vsebuje lateks
Administration of Cyltezo should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. 
Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo zdravila Cyltezo prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
• swollen face, hands, feet; 
• lomljivost nohtov na rokah in nogah;
Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Cyltezo therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders. 
Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom Cyltezo in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
Patients who had been randomised to placebo in Period A were assigned to receive adalimumab 40 mg every week in Period B. 
Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdobju B prejemali adalimumab 40 mg vsak teden.
RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week. 
V študiji revmatoidnega artritisa III je bilo ocenjeno 619 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, ki se niso učinkovito odzvali na odmerke metotreksata od 12,5 do 25 mg ali niso prenašali 10 mg metotreksata vsak teden.
• In addition cases of non-melanoma skin cancer have been observed in patients taking adalimumab. 
• Poleg tega so pri bolnikih, zdravljenih z adalimumabom, opazili primere nemelanomskega kožnega raka.
Cyltezo is also used to treat severe 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. 
Zdravilo Cyltezo se uporablja tudi za zdravljenje hude 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
In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group. 
Študiji pri Crohnovi bolezni I in II sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, randomiziranih na shemi z adalimumabom 80/40 mg in 160/80 mg, v primerjavi s placebom; razliko 26. in 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija pri Crohnovi bolezni III.
However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab. 
Poleg tega so iz obdobja trženja zdravila poročali tako o jetrni odpovedi kot tudi o hudih boleznih jeter, ki lahko vodijo v jetrno odpoved, kot je hepatitis, vključno z avtoimunskim hepatitisom, pri bolnikih, ki so
The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year vs. 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient 
Število hospitalizacij iz vseh razlogov v skupini, zdravljeni z adalimumabom, je bilo 0,18 na bolnikov-let proti 0,26 na bolnikov-let v placebo skupini.
• Do not use the 40 mg pre-filled pen, if doses other than 40 mg are recommended. 
• Ne uporabljajte 40 mg napolnjenega injekcijskega peresa, če so priporočeni drugi odmerki kot
In the pivotal controlled trials in adults and children, 12.9 % of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2 % of patients receiving placebo or active control. 
V ključnih preskušanjih pri odraslih in otrocih je reakcije na mestu injiciranja (eritem in/ali srbenje, krvavitve, bolečine ali oteklost) imelo 12,9 % bolnikov, ki so dobivali adalimumab, v primerjavi s 7,2 % bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
2) Inspect pre-filled syringe 
2) Preglejte napolnjeno injekcijsko brizgo
Fever, bruising, bleeding or looking pale 
Zvišana telesna temperatura, modrice, krvavitve ali bledica
At week 52, 42.9 % of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4 % of patients receiving adalimumab monotherapy. 
Po 52. tednih je klinično remisijo (DAS28 (CRP) < 2,6) doseglo 42,9 % bolnikov, ki so dobivali kombinirano terapijo z adalimumabom/metotreksatom, 20,6 % bolnikov, ki so dobivali metotreksat v monoterapiji, in 23,4 % bolnikov, ki so dobivali adalimumab v monoterapiji.
The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA. 
Varnost in učinkovitost adalimumaba so ocenili v odprti, multicentrični študiji pri 32 otrocih (starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg) z zmernim do zelo aktivnim poliartikularnim JIA.
Cyltezo is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs. 
Zdravilo Cyltezo je indicirano za zdravljenje odraslih s hudim aksialnim spondiloartritisom brez radiografskega dokaza za AS, toda z objektivnimi znaki vnetja s povišanimi CRP in/ali MRI, ki so nezadostno reagirali na ali ne prenašajo nesteroidnih protivnetnih zdravil.
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,
• Before removing pen from skin, confirm entire dose was delivered by making sure plunger (seen in 
• Preden peresnik umaknete iz kože, potrdite, da ste injicirali celotni odmerek.
• The following instructions explain how to give yourself a subcutaneous injection of CYLTEZO using the pre-filled syringe. 
• V spodnjih navodilih je razloženo, kako si sami daste subkutano injekcijo zdravila Cyltezo z napolnjeno injekcijsko brizgo.
Full instructions for use are provided in the package A paediatric presentation is not available for patients who need to administer less than the full 40 mg dose. 
Podrobna navodila za uporabo so na voljo v Farmacevtska oblika primerna za odmerjanje pri pediatričnih bolnikih, ki potrebujejo manj kot polni
If active tuberculosis is diagnosed, Cyltezo therapy must not be initiated (see section 4.3). 
Če se odkrije aktivna tuberkuloza, se zdravljenja z zdravilom Cyltezo ne sme začeti (glejte
Significant response was first observed at week 2 and maintained through 24 weeks (Table 13). 
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do
Cyltezo 40 mg solution for injection in pre-filled syringe Cyltezo 40 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and a needle with a cap (outer part made of plastic material and inner part made of elastomer containing latex). 
Cyltezo 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Cyltezo 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) za enkratno uporabo z batnim zamaškom (butilna guma) in z iglo s pokrovčkom (zunanji del je iz plastičnega materiala in notranji del iz elastomera, ki vsebuje lateks).
The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient-years, and the observed rate of lymphomas is approximately 1.3 per 
Ugotovljeni delež nemelanomskih kožnih rakov je približno 9,6 na 1.000 bolnikov-let, ugotovljeni delež limfomov pa približno 1,3 na 1.000 bolnikov-let.
The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 μg/mL for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 μg/mL for patients 
Srednje (± SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6.1 μg/ml pri bolnikih < 40 kg (80/40 mg).
If you have rheumatoid arthritis and you do not receive methotrexate with your Cyltezo therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week. 
Če imate revmatoidni artritis in hkrati z zdravilom Cyltezo ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg adalimumaba vsak teden ali 80 mg vsak drugi teden.
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8 % and 61.2 % respectively) compared to methotrexate monotherapy (37.4 % and 33.5 % respectively, p < 0.001) and adalimumab monotherapy (50.7 %, p < 0.002 and 44.5 %, p < 0.001 
Po 52 oz. 104 tednih zdravljenja je bil v skupini s kombinirano terapijo z adalimumabom in metotreksatom odstotek bolnikov brez napredovanja bolezni (sprememba prilagojene Sharpove ocene od izhodišča ≤ 0,5) značilno večji (63,8 % oz. 61,2 %) kot v skupinah, ki sta prejemali monoterapijo z metotreksatom (37,4 % in 33,5 %, p < 0,001) ali monoterapijo z adalimumabom (50,7 %, p < 0,002, oz. 44,5 %, p < 0,001).
On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response. 
Na podlagi podatkov iz kliničnih preskušanj pri bolnikih z juvenilnim idiopatskim artritisom (JIA) (poliartikularnim idiopatskim artritisom (pJIA) in z artritisom, povezanim z entezitisom (ERA)) je bilo dokazano razmerje med izpostavljenostjo in odzivom med plazemskimi koncentracijami in
• There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers. 
• Med bolniki, otroci in odraslimi, ki so jemali adalimumab ali druge zaviralce TNFα, so se pojavili zelo redki primeri določenih vrst raka.
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 %). 
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 19,7, izhodiščna PGA pa je segala od "blage" (< 1 %), "zmerne" (48 %) in "hude" (46 %) do
In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment. 
V študijah revmatoidnega artritisa I-IV so z adalimumabom zdravljeni bolniki v primerjavi s prejemniki placeba dosegli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku
Upon completion of the first 104 weeks, 497 patients enrolled in an open-label extension phase in which 40 mg of adalimumab was administered 
Po zaključenih prvih 104 tednih, so 497 bolnikov vključili v odprto nadaljevalno fazo, med katero so še do 10 let dobivali 40 mg
• The following instructions explain how to give yourself a subcutaneous injection of CYLTEZO using the pre-filled pen. 
• V spodnjih navodilih je razloženo, kako si sami daste subkutano injekcijo zdravila Cyltezo z napolnjenim injekcijskim peresnikom.
* p < 0.05, *** p < 0.001, adalimumab versus placebo 
* p < 0.05, *** p < 0.001, adalimumab v primerjavi s placebom
Placebo 
s placebom
week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14). 
Rezultati po 12. tednu so pokazali statistično pomembno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so bili zdravljeni z adalimumabom v primerjavi s placebom (preglednica 14).
For patients who dose escalated from eow to weekly regimen, the mean (± SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg/mL (40/20 mg, weekly) and 6.7 ± 3.5 μg/mL 
Pri bolnikih, ki so prešli iz režima vsak drugi teden na režim vsak teden, so bile srednje (± SD) serumske koncentracije adalimumaba v 52. tednu 15,3 ± 11,4 μg/ml (40/20 mg, tedensko) in 6,7 ± 3,5 μg/ml (20/10 mg,
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6 % and 55.7 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks). 
Opravljena je bila analiza, v kateri so vse bolnike, ki so izpadli iz študije zaradi neželenih učinkov ali nezadostne učinkovitosti, ali jim je bil povečan odmerek, obravnavali kot neodzivne; pri teh bolnikih sta bila po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) delež odziva PASI 75 69,6 % in delež odziva PGA "čisto" ali "minimalno" 55,7 %.
If these medicines do not work well enough, patients will be given Cyltezo to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related 
Če ta zdravila ne bodo delovala dovolj dobro, bodo bolniki za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom, dobili
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly 
Tveganja in koristi neprekinjenega dolgotrajnega zdravljenja je treba periodično ovrednotiti
Adalimumab /MTX n = 207 
adalimumab/M TX n = 268
• Vaccinations: if possible children should be up to date with all vaccinations before using Cyltezo. 
• Cepljenja: če je mogoče, naj vaš otrok pred začetkom uporabe zdravila Cyltezo opravi vsa
Adalimumab 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 
Adalimumab je indiciran 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 (glejte
Time to Treatment Failure in Studies UV I and UV II 
Preglednica 29: Čas do neuspeha zdravljenja v študijah UV I in UV II
Cyltezo is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and 
Zdravilo Cyltezo je indiciran za zdravljenje hude psoriaze v plakih pri otrocih in mladostnikih od 4. leta starosti, ki so se neustrezno odzvali na ali niso ustrezni kandidati za topikalno zdravljenje in
No patients developed lupus nephritis or central nervous system symptoms. 
Pri nobenem bolniku se niso pojavili lupusni nefritis ali simptomi s strani osrednjega
Cyltezo reduces the rate of progression of joint damage as measured by X-ray and improves physical function, when given in combination with methotrexate. 
Z rentgenskim slikanjem je bilo dokazano, da zdravilo Cyltezo upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
b at Weeks 24 and 36 After Treatment Reassignment from Weekly adalimumab at Week 12 
b v 24. in 36. tednu po spremembi zdravljenja na jemanje adalimumaba vsak teden v 12. tednu placebo (ukinitev zdravljenja) n = 73
• Using your thumb, slowly push plunger down until all medication in syringe has been delivered. 
• S palcem počasi bat potiskajte navzdol, dokler ni injekcijska brizga prazna.
Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials. 
Z adalimumabom povezane alergijske reakcije, ki niso bile resne, so se v kliničnih preskušanjih pojavljale občasno.
In CD Study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2. 
V študiji pri Crohnovi bolezni III je 854 bolnikov po odprtem protokolu dobilo 80 mg 0. teden in 40 mg 2. teden.
• vertigo (sensation of the room spinning); 
• vrtoglavica (občutek vrtenja prostora);
14 weeks 
20 tednov
Assessments in SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score high sensitivity C-Reactive Protein (mg/L) Spondyloarthritis Research Consortium of Canada 
ASAS = ocena v spondiloartritičnem mednarodnem združenju (Assessments in Spondyloarthritis international Society BASDAI = Bath Ankylosing Spondylitis Disease Activity Index ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease Activity Score) povprečna sprememba od začetka zdravljenja hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/l)