natgillin/translations-raw huggingface dataset:
The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients. 
Delež (95-% interval zaupanja) nemelanomskih kožnih rakov je bil 8,8 (6,0; 13,0) na 1.000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 3,2 (1,3; 7,6) na 1.000 bolnikov-let med kontrolnimi bolniki.
Table 26 Paediatric CD Study PCDAI Clinical Remission and Response 
Študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv
Leukocytosis, thrombocytopenia Uncommon Idiopathic thrombocytopenic purpura Rare 
anemija pogosti levkocitoza, trombocitopenija občasni idiopatska trombocitopenična purpura redki pancitopenija
• If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Imraldi. 
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Imraldi posvetujte z zdravnikom.
• sensation of heart beating irregularly such as skipped beats; 
• občutek neenakomernega bitja srca, kot je preskakovanje utripov;
• vaccinations 
• cepljenja
• If your child has an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Imraldi. 
• Če ima vaš otrok kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Imraldi posvetujte z zdravnikom.
 4 pre-filled syringes, each with 1 alcohol pad  6 pre-filled syringes, each with 1 alcohol pad 
 4 napolnjenih injekcijskih brizg, vsak z 1 alkoholnim zložencem  6 napolnjenih injekcijskih brizg, vsak z 1 alkoholnim zložencem
In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51 %) were in remission at week 52. 
V študiji UC-II je bilo 21/41 bolnikov (51 %), ki so bili zdravljeni z adalimumabom in so dosegli remisijo 8. teden, v remisiji
Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks). 
Bolniki, ki so v odprti fazi dosegli trajno remisijo za vsaj 12 tednov (N = 305) (ASDAS < 1,3 v 16., 20., 24. in 28. tednu), so bili nato randomizirani tako, da so prejemali bodisi nadaljevalno zdravljenje z zdravilom adalimumab 40 mg vsak drugi teden (N = 152)
2 years. 
2. teden.
In study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥1 NSAIDs, or a contraindication for NSAIDs. 
Uporabo 40 mg adalimumaba vsak drugi teden so proučili v randomizirani, 12 tednov trajajoči, dvojno slepi, s placebom kontrolirani študiji nr-axSpA I pri 185 bolnikih z aktivnim nr-axSpA I (srednja vrednost aktivnosti bolezni [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] je bila 6,4 pri bolnikih, zdravljenih z adalimumabom, in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali vsaj enega NSAID ali s kontraindikacijo za NSAID.
• vertigo (sensation of the room spinning); 
• vrtoglavica (občutek, da se prostor vrti);
• If your child has mild heart failure and is being treated with Imraldi, his/her heart failure status must be closely monitored by your doctor. 
• Če ima vaš otrok blago srčno popuščanje in se zdravi z zdravilom Imraldi, mora zdravnik natančno nadzorovati stanje njegovega srčnega popuščanja.
EU/1/17/1216/001 1 pre-filled syringe EU/1/17/1216/002 2 pre-filled syringes EU/1/17/1216/003 4 pre-filled syringes EU/1/17/1216/004 6 pre-filled syringes 
EU/1/17/1216/001 1 napolnjena injekcijska brizga EU/1/17/1216/002 2 napolnjeni injekcijski brizgi EU/1/17/1216/003 4 napolnjene injekcijske brizge EU/1/17/1216/004 6 napolnjenih injekcijskih brizg
The recommended dose of Imraldi is an initial dose of 20 mg, followed by 20 mg one week later. 
Priporočeni odmerek zdravila Imraldi je začetni odmerek 20 mg, ki mu sledi 20 mg en teden kasneje.
Imraldi is available in packs containing 1, 2, 4 or 6 pre-filled pen(s) containing a pre-filled syringe (type I glass) with a stainless steel needle, a rigid needle shield, a rubber plunger for patient use and 2, 2, 4 or 6 alcohol pads are enclosed in packs respectively. 
Zdravilo Imraldi je na voljo v pakiranjih, ki vsebujejo 1, 2, 4 ali 6 napolnjenih injekcijskih brizg (iz stekla tipa I) z iglo iz nerjavnega jekla, rigidnim varovalom za iglo, batom iz gume, steblom bata, zaščitnim ohišjem in prirobnico za bolnikovo uporabo ter 2 ali 2, 4 oziroma 6 priloženih alkoholnih zložencev.
Age Group Number of patients at Baseline N (%) Minimum, median and maximum 
Starostna skupina Izhodiščno število bolnikov N (%)
• 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 TNFα blocker. 
• Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNFα, so bili primeri rakov, ki niso bili limfomi.
• Make sure you know the proper amount (volume) needed for dosing. 
• Preverite točen odmerek (volumen) zdravila za vašega otroka.
If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away. 
Če dobite zvišano telesno temperaturo, ki ne mine, ali če se vam zlahka pojavljajo podplutbe ali zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte z zdravnikom.
• Choose a fatty area for injection: 
• Za injiciranje izberite mesto z veliko podkožne maščobe:
DO NOT touch the area again before injecting. 
Očiščenega mesta se do injiciranja ne dotikajte več.
Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less. 
Med njimi 40 bolnikov ni pokazalo napredovanja strukturne prizadetosti, izražene s spremembo modificirane celotne Sharpove ocene 0,5 ali manj od začetka študije.
>32 weeks 
32-tedenskega obdobjaa
6 months 12 months a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate 
12 mesecev a Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega artritisa III po 24 in 52 tednih b 40 mg adalimumaba, danega vsak drugi teden.
The recommended dose of Imraldi for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. 
Priporočeni odmerek zdravila Imraldi za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
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 PedACR
Disease-related hospitalisations and surgeries were statistically significantly reduced with adalimumab compared with placebo at week 56. 
Z boleznijo povezanih hospitalizacij in operacij je bilo do 56. tedna med uporabo adalimumaba statistično značilno manj kot med uporabo placeba.
Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/ml (79% CV). 
Po dajanju adalimumaba 0,8 mg/kg (do največ 40 mg) subkutano vsak drugi teden pediatričnim bolnikom s kronično psoriazo v plakih, je bila povprečna (±SD) najmanjša koncentracija adalimumaba v stanju dinamičnega ravnovesja približno 7,4 ± 5,8 µg/ml (79 % KV).
Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab. 
Pri uporabi adalimumaba so poročali tudi o smrtnih in življenjsko ogrožajočih okužbah (vključno s sepso, oportunističnimi okužbami in TB), HBV reaktivaciji in različnih malignih obolenjih (vključno z levkemijo, limfomom in HSTCL).
Among those, 64 patients (79.0 %) had ACR 20 responses; 56 patients (69.1 %) had ACR 50 responses; and 43 patients (53.1 %) had ACR 70 responses. 
(79,0 %) imelo odziv 20 po ACR; 56 bolnikov (69,1 %) je imelo odziv 50 po ACR; in 43 bolnikov (53,1 %) je imelo odziv 70 po ACR.
• cutaneous vasculitis (inflammation of blood vessels in the skin); 
• kožni vaskulitis (vnetje krvnih žil v koži);
Hold the syringe on the graduated area and pull the syringe from its package. 
Primite brizgo na delu z merilom (graduiranem delu) in jo vzemite iz ovojnine.
Be sure to remove the vial adapter with the vial from the syringe. 
Poskrbite, da boste adapter za vialo in vialo sneli z brizge.
Discontinuation of Immunomodulators2 
Prenehanje z imunomodulatorji2
The recommended dose of Imraldi for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4). 
Priporočeni odmerek zdravila Imraldi pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
• If you are about to have surgery or dental procedures tell your doctor that you are taking Imraldi. 
• Če boste imeli kirurški poseg ali poseg na zobeh, povejte zdravniku, da jemljete zdravilo Imraldi.
Imraldi is used to treat Crohn's disease in adults and children aged 6 to 17 years. 
Zdravilo Imraldi se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do
If you accidentally inject Imraldi more frequently than you should, call your doctor or pharmacist and explain that you have taken more. 
Če ste uporabili večji odmerek zdravila Imraldi, kot bi smeli Če pomotoma injicirate zdravilo Imraldi pogosteje, kot bi smeli, se morate posvetovati z zdravnikom ali farmacevtom in razložiti, da ste uporabili večji odmerek.
The syringe inside the pen is made from type I glass with a stainless steel needle, a rigid needle shield, a rubber plunger (bromobutyl). 
Injekcijska brizga v peresniku je izdelana iz stekla tipa I in opremljena z iglo iz nerjavnega jekla, rigidnim varovalom za iglo in batom iz gume (bromobutilne).
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 adalimumab. 
Pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovo boleznijo, ulceroznim kolitisom in hidradenitis suppurativa so opazili tudi naglo znižanje koncentracij CRP po zdravljenju z adalimumabom.
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, 
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.
DO NOT wipe off the needle or the syringe. 
BRIŠITE je z igle ali brizge.
In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with adalimumab alone. 
V študijah Crohnove bolezni pri odraslih so pri sočasni uporabi adalimumaba in azatioprina/6-merkaptopurina opazili večjo incidenco malignih in resnih z okužbo povezanih neželenih dogodkov kot pri zdravljenju samo z adalimumabom.
Table 16 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients) 
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom (odstotek bolnikov)
Imraldi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. 
Zdravilo Imraldi je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki se ne odzovejo zadostno na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 18). 
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden, kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 18).
Name and address of the manufacturer(s) responsible for batch release 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij Biogen (Denmark) Manufacturing ApS
• nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body); 
• bolezni živčevja (kot je vnetje optičnega živca, ki vodi do očesa, in sindrom Guillain-Barré,
How to inject with your pre-filled syringe Gather supplies 
Kako injicirati z napolnjeno injekcijsko brizgo Pripravite pripomočke
Imraldi is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. 
Zdravilo Imraldi se uporablja za zdravljenje ankilozirajočega spondilitisa in aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis pri odraslih.
Respiratory, thoracic and mediastinal disorders* 
prsnega koša in mediastinalnega prostora*
• Do not use a damaged pen. 
• Ne uporabite poškodovanega injekcijskega peresnika.
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.
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 simptomi srčnega popuščanja (npr. težko dihanje ali otekanje nog) pojavijo na novo ali se poslabšajo, se morate takoj obrniti na zdravnika.
In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥3 ×ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients. 
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom s trajanjem kontrolnega obdobja od 4 do 104 tedne, so se zvišanja ALT ≥ 3 × ULN (Upper Limits of Normal - zgornja normalna meja) pojavila pri 3,7 % bolnikov, zdravljenih z adalimumabom, in pri 1,6 % bolnikov v kontrolni skupini.
Exposure-response relationship in paediatric population 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. 
Razmerje med izpostavljenostjo in odzivom pri pediatrični populaciji 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 PedACR
• Press plunger slowly: 
• Bat potiskajte počasi:
Mood alterations (including depression), anxiety, 
Psihiatrične motnje pogosti spremembe razpoloženja (vključno z depresijo),
Children and adolescents from 6 to 17 years of age weighing less than 40 kg The usual dose regimen is 40 mg initially followed by 20 mg two weeks later. 
Otroci in mladostniki, stari od 6 do 17 let, ki tehtajo manj kot 40 kg Običajni začetni odmerek je 40 mg, ki mu sledi 20 mg dva tedna kasneje.
In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 22). 
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden, kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 22).
Of those patients who had a response at week 8, 47 % were in response, 29 % were in remission, 41 % had mucosal healing, and 20 % were in steroid-free remission for ≥90 days at week 52. 
Od bolnikov, ki so bili odzivni v 8. tednu, jih je bilo v 52. tednu 47 % odzivnih, 29 % v remisiji, 41 %
• Store your syringe in the refrigerator, but do not freeze it. 
• Injekcijsko brizgo shranjujte v hladilniku, vendar ne sme zamrzniti.
Among those, 48 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less. 
Med temi bolniki jih 48 ni kazalo napredovanja strukturne prizadetosti, izražene s spremembo srednje celotne Sharpove ocene 0,5 ali manj od začetka študije.
Imraldi is used to treat rheumatoid arthritis in adults. 
Zdravilo Imraldi se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 
Navidezna koncentracija adalimumaba v plazmi, ki doseže polovico največje verjetnosti Ped ACR 50 odziva (EC50) je bila 3 μg/ml (95% IZ: 1-6 μg/ml).
Figure 3: Kaplan-Meier Curves Summarizing Time to Treatment Failure in the Paediatric Uveitis Study 
Slika 3: Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
The rate (95 % confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients. 
Delež (95-% interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) na 1.000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1.000 bolnikov-let v kontrolni skupini bolnikov.
Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/ml (without concomitant methotrexate) and 8 to 9 μg/ml (with concomitant methotrexate), respectively. 
Po subkutani uporabi 40 mg adalimumaba vsak drugi teden pri odraslih bolnikih z revmatoidnim artritisom (RA) so bile povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja približno 5 μg/ml (brez sočasne uporabe metotreksata) in od 8 do 9 μg/ml (s sočasno uporabo metotreksata).
HRa 
SERIJ
• non-infectious uveitis. 
• ulceroznega kolitisa in • neinfekcijskega uveitisa.
• If your child is about to have surgery or dental procedures tell your doctor that he/she is taking Imraldi. 
• Če bo vaš otrok imel kirurški poseg ali poseg na zobeh, povejte zdravniku, da jemlje zdravilo Imraldi.
A little bleeding may occur. 
Pojavi se lahko neznatna krvavitev.
***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo. 
***, ** Statistično značilno s p < 0,001 in < 0,01 (v tem zaporedju) za vse primerjave med zdravilom adalimumab in placebom.
The mean steady-state trough concentration at week 12 through week 36 were approximately 8 to 10 μg/ml during adalimumab 40 mg every week treatment. 
Najnižja koncentracija pred naslednjim odmerkom v stanju dinamičnega ravnovesja je bila približno 8 do 10 μg/ml med 12. tednom in 36. tednom pri zdravljenju z odmerkom 40 mg adalimumaba vsak teden.
The recommended dose of Imraldi is an initial dose of 40 mg, followed by 40 mg one week later. 
Priporočeni odmerek zdravila Imraldi je začetni odmerek 40 mg, ki mu sledi 40 mg en teden kasneje.
• 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.
DO NOT put these items into regular household waste. 
ODLAGAJTE jih v običajen koš za odpadke.
Imraldi 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 Imraldi 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.
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients. 
Med temi kožnimi raki je bil delež (95-% interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) na 1.000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1.000 bolnikov-let v kontrolni skupini bolnikov.
Standard Dose 40/20 mg eow N=93 
Standardni odmerek 40/20 mg vsak drugi teden N = 93