natgillin/translations-raw huggingface dataset:
This medicinal product contains 20.0 mg sorbitol. 
To zdravilo vsebuje 20,0 mg sorbitola.
Steroid-free remission for ≥ 90 daysa 
Remisija brez steroidov za ≥ 90 dnia
The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab: 
Opisani simptomi so lahko znaki naslednjih neželenih učinkov, ugotovljenih med uporabo adalimumaba:
At week 12 and week 24, PaedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach. 
12. teden je bil odziv Paed ACR 30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. 
Zdravilo Imraldi je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
This injection should not be mixed in the same syringe or vial with any other medicine. 
Raztopine ne smete v isti brizgi ali viali mešati z nobenim drugim zdravilom.
a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor b 2-sided P value from log rank test c NE = not estimable. 
a RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem b 2-stranska vrednost p testa log-rank c NE = ni mogoče oceniti.
The active ingredient in Imraldi, adalimumab, is a monoclonal antibody. 
Učinkovina v zdravilu Imraldi, adalimumab, je monoklonsko protitelo.
Follow this instruction guide carefully, and soon you will develop a routine for injecting confidently. 
Natančno se ravnajte po teh navodilih in kmalu boste povsem obvladali postopek injiciranja.
Biogen Portugal Sociedade Farmacêutica, Unipessoal, Lda 
Portugal Biogen Portugal Sociedade Farmacêutica,
• serious infections 
• resne okužbe
• Place the syringe on your clean work surface. 
• Položite brizgo na čisto delovno površino.
Ped ACR 30 response (n/N) 
Odziv »Paed ACR« 30 (n/N)
Place the container on your work surface. 
Položite vsebnik za odpadke na delovno površino.
Hidradenitis Suppurativa Clinical Response (HiSCR)a 
Klinični odziv pri hidradenitis suppurativa (HiSCR)a
• intestinal perforation; 
• intestinalna perforacija;
hepatic steatosis, 
jetrna steatoza,
Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II) 
Slika 2 Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednu (študija UV I) ali 2. tednu (študija UV II)
Imraldi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1). 
Zdravilo Imraldi je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
Place greenbase, press down, and hold 
Zeleno osnovo položite na kožo, pritisnite navzdol in držite
Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment. 
Med 68 bolniki iz skupine namenjene prenehanju zdravljenja, pri katerih je prišlo do ponovnega zagona bolezni, jih je 65 zaključilo 12 tednov trajajoče rešilno zdravljenje z zdravilom adalimumab, od tega jih je 37 (56,9 %) po 12 tednih ponovne odprte faze zdravljenja ponovno doseglo remisijo (ASDAS < 1,3).
The primary efficacy endpoint in both studies was ´time to treatment failure´. 
Primarni opazovani dogodek kot merilo učinkovitosti je bil v obeh študijah "čas do neuspeha zdravljenja".
Study nr-axSpA II was a treatment withdrawal study in active nr-axSpA patients who achieved remission during open-label treatment with adalimumab. 
Študija nr-axSpA II je bila študija prenehanja zdravljenja pri bolnikih z aktivnim nr-axSpA, ki so med zdravljenjem z zdravilom adalimumab v odprti fazi zdravljenja dosegli remisijo.
In the open-label extension for RA study III, most patients who were ACR responders maintained response when followed for up to 10 years. 
V odprtem podaljšanju študije revmatoidnega artritisa III se je večina bolnikov, ki so se odzvali na ACR, odzivala še naprej v času sledenja do 10 let.
In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Imraldi. 
V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem, lahko še nadalje uporabljajo ob uporabi zdravila Imraldi.
If you press the syringe plunger slowly, it may make your injection more comfortable. 
Če bat injekcijske brizge potiskate počasneje, bo injiciranje morda manj neprijetno.
506 (62.2)b a Percent of patients achieving PASI 75 response was calculated as centre-adjusted rate b p<0.001, adalimumab vs. placebo 
506 (62,2)b a Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center b p < 0,001, adalimumab v primerjavi s placebom
• Imraldi can be used during breast-feeding. 
• Zdravilo Imraldi se lahko uporablja med dojenjem.
Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg /kg/day or 10 mg/day maximum). 
Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil in/ali prednizona (≤ 0,2 mg/kg/dan ali največ 10 mg/dan).
Significant improvements at week 16 from baseline compared to placebo (studies I and II) and MTX (study II) were demonstrated in the DLQI (Dermatology Life Quality Index). 
Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti življenja (DLQIDermatology Life Quality Index).
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Imraldi. 
Bolnike je zato treba pred, med in po zdravljenju z zdravilom Imraldi natančno kontrolirati glede okužb, vključno s tuberkulozo.
Do not remove the needle cap before you are ready to inject. 
Pokrovček za iglo odstranite šele, ko ste pripravljeni na injiciranje.
There is limited experience in the initiation of treatment with Imraldi alone. 
O začetku zdravljenja samo z zdravilom Imraldi so izkušnje omejene.
What Imraldi looks like and contents of the pack 
Izgled zdravila Imraldi in vsebina pakiranja
After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 ml/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks. 
Po odmerkih 0,5 mg/kg (~40 mg) je bil očistek od 11 do 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze približno dva tedna.
Patients participating in studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week. 
Bolniki, vključeni v študiji HS-I in HS-II, so bili primerni za vključitev v odprto podaljšano študijo, pri kateri so prejemali 40 mg adalimumaba vsak teden.
PASI 75b PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumab 0.8 mg/kg versus MTX 
PGA: čisto/minimalnoc a MTX = metotreksat b P = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX c P = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
All patients received a 2-week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15. 
Vsi bolniki so ob začetku študije prejeli 2-tedenski standardizirani odmerek prednizolona 60 mg/dan, čemur je sledil obvezen program postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 15. tedna.
If new areas of damaged skin appear during or after therapy or if existing marks or areas of damage change appearance, tell your doctor. 
Če se med zdravljenjem ali po njem pojavijo nova področja poškodovane kože ali če se spremeni videz obstoječih znamenj ali poškodovanih področij, morate to povedati zdravniku.
After proper training in injection technique, patients may self-inject with Imraldi if their physician determines that it is appropriate and with medical follow-up as necessary. 
Bolniki, ki se naučijo pravilnega postopka injiciranja, si zdravilo Imraldi lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
This includes any possible side effects not listed in this leaflet (See section 4). 
Posvetujte se tudi, če opazite katere koli neželene učinke, ki niso navedeni v tem navodilu (glejte poglavje 4).
• In addition, cases of non-melanoma skin cancer have been observed in patients taking Imraldi. 
• Poleg tega so pri bolnikih, zdravljenih z zdravilom Imraldi, opazili primere nemelanomskega kožnega raka.
Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I). 
Večje izboljšanje v 12. tednu so pokazali glede na izhodiščno vrednost v primerjavi s placebom glede z zdravjem povezane kakovosti življenja, specifične za kožo, merjene z dermatološkim indeksom kakovosti življenja (“Dermatology life quality index” (DLQI), v študijah HS-I in HS-II), glede bolnikovega splošnega zadovoljstva z zdravljenjem z zdravilom, merjenem z vprašalnikom o zadovoljstvu z zdravljenjem z zdravilom (“Treatment Satisfaction Questionnaire - medication” (TSQM), v študijah HS-I in HS-II), in glede telesnega zdravja, merjenega s seštevkom telesnih komponent v vprašalniku SF-36 (“Short Form Health Survey" (SF-36) v študiji HS-I).
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for control treated patients. 
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, kontroliranim delom študij, ki podpirajo vlogo za pridobitev dovoljenja za promet, je bil 5,9 % v skupini, ki je prejemala adalimumab, in 5,4 % v kontrolni skupini.
Improvement in health-related quality of life and physical function was maintained during the openlabel extension through week 156. 
Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih študijah brez placeba ohranjalo do 156. tedna.
• facial oedema associated with allergic reactions; 
• edem obraza, povezan z alergijskimi reakcijami;
When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and nonmelanoma skin cancers is approximately 8.5 per 1,000 patient years. 
Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene nadaljevalne študije z medianim trajanjem približno 3,3 leta s 6.427 bolniki in prek 26.439 bolnikov-let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 8,5 na 1.000 bolnikov-let.
• symptoms of nerve root compression(including low back pain and leg pain); 
• simptomi stisnjenja živčnih korenin (vključno z bolečino v spodnjem delu hrbta in nogah);
• For example, if the prescribed dose is 0.5 ml, DO NOT push the white plunger rod past the 0.5 ml position. 
• Če je npr. predpisani odmerek 0,5 ml, NE POTISNITE belega nosilca bata čez položaj 0,5 ml.
DO NOT rub the injection site. 
NE DRGNITE mesta injiciranja.
Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50 % reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline). 
Zmanjšanje inflamatornih lezij in preprečevanje poslabšanja abscesov in fistul z izcedkom so ocenili z rezultatom kliničnega odziva pri hidradenitis suppurativa (HiSCR - Hidradenitis Suppurativa Clinical Response; najmanj 50-% zmanjšanje skupnega števila abscesov in inflamatornih nodulov brez povečanja števila abscesov in fistul z izcedkom glede na izhodiščno število).
Patients who develop a new infection while undergoing treatment with Imraldi, should be monitored closely and undergo a complete diagnostic evaluation. 
Bolnike, pri katerih se med zdravljenjem z zdravilom Imraldi pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
36.8 % (14/38) 64.9 % (24/37)b 43.3 % (13/30) 71.4 % (20/28)c Median time to disease flare >32 weeks 
36,8 % (14/38) 64,9 % (24/37)b 43,3 % (13/30) 71,4 % (20/28)c
Inspect medicine & expiration date 
Preverite zdravilo in datum izteka roka uporabnosti
It is important to tell your doctor if you have had or have a serious heart condition. 
Pomembno je, da zdravniku poveste, če ste imeli ali imate kakšno resno bolezen srca.
Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day). 
Študija UV I je ovrednotila 217 bolnikov z aktivnim uveitisom kljub zdravljenju s kortikosteroidi (prednizolon peroralno v odmerku 10 do 60 mg/dan).
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤18 years of age), including adalimumab in the post marketing setting. 
Med obdobjem trženja so bili opisani malignomi (nekateri s smrtnim izidom) pri otrocih, mladostnikih in mladih odraslih (starih do 22 let), ki so dobivali antagoniste TNF, vključno z adalimumabom (začetek zdravljenja v starosti ≤ 18 let).
Peel the package just far enough to expose the yellow syringe connector. 
Odlepite ovojnino ravno toliko, da odkrijete rumeni konektor za brizgo.
Adalimumab/MTX 40 mg every other week 
Adalimumab/MTX 40 mg vsak drugi teden
BCVA was either improved or maintained (< 5 letters deterioration) in 88.4 % of the eyes at week 78. 
(poslabšanje ostrine vida < 5 črk) pri 88,4 % očeh v 78. tednu.
Gently pinch your skin and insert the needle all the way at about a 45-degree angle. 
Nežno stisnite kožo s prsti in vanjo potisnite vso iglo pod kotom približno 45 stopinj.
• Peel the cover off the vial adapter package but do not take out the vial adapter. 
• Odlepite prekrivno folijo z ovojnine adapterja za vialo, vendar adapterja ne vzemite ven.
• With one quick, short motion, push needle all the way into skin. 
• S hitrim, kratkim gibom iglo v celoti zabodite v kožo.
• Push the white plunger rod to inject the liquid medication until the syringe is empty. 
• Potisnite beli nosilec bata, da boste injicirali tekoče zdravilo, dokler ne bo brizga prazna.
DO NOT try to reinsert the white plunger rod. 
NE POSKUŠAJTE belega nosilca bata vstaviti nazaj noter.
If you take off the needle cap before you are ready to inject, do not put the needle cap back on. 
Če snamete pokrovček za iglo, preden ste pripravljeni na injiciranje, ga ne poskušajte znova natakniti.
Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease. 
Študija UV II je ovrednotila 226 bolnikov z inaktivnim uveitisom, ki je že na začetku zahteval kronično zdravljenje s kortikosteroidi (prednizolon peroralno 10 do 35 mg/dan) za nadzor njihove bolezni.
Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with adalimumab. 
Kljub profilaktičnemu zdravljenju za tuberkulozo so se pri bolnikih, zdravljenih z adalimumabom, pojavili primeri reaktivacije tuberkuloze.
You should record the date when the pen is first removed from refrigerator, and the date after which it should be discarded. 
Zapisati si morate datum, ko je bil peresnik vzet iz hladilnika, in datum, po katerem ga je potrebno zavreči.
Patients treated with Imraldi should be given the Patient Reminder Card. 
Bolniki, ki se zdravijo z zdravilom Imraldi, morajo dobiti Opozorilno kartico za bolnika.
- If your child has a severe infection, including tuberculosis (see “Warnings and precautions”). 
- če ima vaš otrok hudo okužbo, vključno s tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Imraldi injection. 
• Premisliti morate o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še 5 mesecev po zadnjem zdravljenju z zdravilom Imraldi.
Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents. 
Z adalimumabom niso bile narejene niti raziskave kancerogenosti, niti standardne ocene plodnosti ter poporodne toksičnosti, in sicer zato, ker ni ustreznih modelov za protitelo z omejeno navzkrižno reaktivnostjo z glodavskim TNF, in zaradi nastanka nevtralizirajočih protiteles pri glodavcih.
Approximately twice the proportion of patients in the placebo group in the first 12 weeks of studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively). 
Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjavi s tistimi, ki so bili v skupini z adalimumabom, v prvih 12. tednih študije HS-I in HS-II, doživelo poslabšanje abscesov (23,0 % v primerjavi z 11,4 %, v tem zaporedju) in fistul z izcedkom (30,0 % v primerjavi s 13,9 %, v tem zaporedju).
Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. 
Luskavica v plakih je vnetna bolezen kože, pri kateri nastajajo rdeče, kosmičaste, krastave lise na koži, pokrite s srebrnimi luskami.
After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75 % relative to baseline), entered period B and received open-label 40 mg adalimumab every other week. 
Po 16 tednih zdravljenja so bolniki, ki so dosegli odziv PASI vsaj 75 (izboljšanje ocene PASI za vsaj 75 % glede na izhodišče), vstopili v obdobje B, med katerim so odprto dobivali 40 mg adalimumaba vsak drugi teden.
Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods. 
V študiji HS-I (PIONEER I) je bilo ocenjenih 307 bolnikov v dveh obdobjih zdravljenja.
Children, adolescents and adults with enthesitis-related arthritis 
Otroci, mladostniki in odrasli z artritisom, povezanim z entezitisom
Imraldi is intended for treatment of: 
Zdravilo Imraldi je namenjeno za zdravljenje:
Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood. 
Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom, sta vnetni bolezni sklepov, ki se ponavadi pojavita v otroštvu.
A single Imraldi pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 28 days. 
Imraldi se lahko shranjuje pri temperaturi največ do 25 ºC za obdobje do 28 dni.
• Put the syringe with needle, vial and vial adapter into a special sharps container. 
• Odložite brizgo z iglo, vialo in adapter za vialo v poseben vsebnik za ostre predmete.
SPARCC MRI Spined,j a Assessments in SpondyloArthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab 
SPARCC MRI hrbtenjačed,j a ASAS = ocena v spondiloartritičnem mednarodnem združenju (Assessments in Spondyloarthritis International Society) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index) c ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease Activity Score) d povprečna sprememba od začetka zdravljenja e N = 91 placebo in N = 87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/l) g N = 73 placebo in N = 70 adalimumab h SPARCC = Kanadski raziskovalni konzorcij za spondiloartritis (Spondyloarthritis Research
If you stop using Imraldi 
Če ste prenehali uporabljati zdravilo Imraldi
• Remove one box containing, one syringe, one vial adapter, one vial, two alcohol pads and one needle from the carton. 
• Odprite eno škatlo, ki vsebuje eno brizgo, en adapter za vialo, eno vialo, dva alkoholna zloženca in eno iglo.
• SLOWLY pull the white plunger rod out to 0.1 ml beyond the prescribed dose. 
• POČASI potegnite beli nosilec bata ven, do 0,1 ml preko predpisanega odmerka.
After 5 years of adalimumab therapy, 74.0 % (37/50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46/50) of patients continued to be in clinical response per PCDAI. 
Po 5 letih zdravljenja z adalimumabom se je glede na PCDAI klinična remisija nadaljevala pri 74,0 % (37/50) od 50 bolnikov, ki so ostali v študiji, klinični odziv pa se je nadaljeval pri 92,0 % (46/50) bolnikov, ki so ostali v študiji.
Treatment with Imraldi may result in the formation of autoimmune antibodies. 
Zdravljenje z zdravilom Imraldi lahko povzroči nastanek avtoimunskih protiteles.
 Do not remove the cap just yet! 
 Pokrovčka za iglo še ne odstranite takoj!
Imraldi can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment. 
Zdravilo Imraldi je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
• Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV infection or if you think you might be at risk of contracting HBV. 
• Zdravniku morate povedati, če ste nosilec virusa hepatitisa B (HBV), če imate aktivno okužbo s HBV ali če mislite, da bi se lahko nalezli HBV.
• Do not use a damaged syringe. 
• Ne uporabite poškodovane injekcijske brizge.
• DO NOT pull the white plunger rod completely out of the syringe. 
• NE POTEGNITE belega nosilca bata popolnoma iz brizge.
The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥220 and ≤450) in randomised, double blind, placebo-controlled studies. 
Varnost in učinkovitost adalimumaba so ocenili pri več kot 1.500 bolnikih z zmerno do zelo aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group. 
Z indukcijskima shemama 160/80 mg in 80/40 mg so do 8. tedna ugotovili podobne deleže remisij; neželeni učinki so bili pogostejši v skupini s shemo 160/80 mg.
• Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash); 
• sindrom Stevens-Johnson (zgodnji znaki vključujejo slabo počutje, povišano telesno temperaturo, glavobol in izpuščaj);