FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking these results into consideration, Hefiya is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Slovenian: Z upoštevanjem teh ugotovitev je zdravilo Hefiya priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4.2).
English: PGA: clear/minimal
Slovenian: PGA: čisto/minimalno
English: These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and / or gold salts.
Slovenian: Terapije so vključevale metotreksat, leflunomid, hidroksiklorokin, sulfasalazin in/ali soli zlata.
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to < 4 years.
Slovenian: Zvišanja ALT ≥ 3 x ULN se niso pojavila v preskušanju faze 3 z adalimumabom pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 2 do < 4 leta.
English: Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
Slovenian: V študiji HS-II (PIONEER II) je bilo ocenjenih 326 bolnikov v dveh obdobjih zdravljenja.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 19).
Slovenian: Ocena psoriaze nohtov je vključevala prilagojeni indeks izrazitosti psoriaze nohtov (mNAPSI - Modified Nail Psoriasis Severity Index), zdravnikovo globalno oceno psoriaze nohtov (PGA-F - Physician's Global Assessment of Fingernail Psoriasis) in indeks izrazitosti psoriaze nohtov (NAPSI - Nail Psoriasis Severity Index) (glejte preglednico 19).
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Slovenian: Primarna končna točka študije revmatoidnega artritisa V je bil odstotek bolnikov, ki so do 52. tedna dosegli odziv ACR 50.
English: RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Slovenian: V študiji revmatoidnega artritisa IV je bila v prvi vrsti ocenjena varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let.
English: During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm.
Slovenian: V 52 tednih študij UC-I in UC-II so opazili nižjo stopnjo hospitalizacije iz vseh razlogov in hospitalizacije, povezane z ulceroznim kolitisom, pri skupini, zdravljeni z adalimumabom, v primerjavi s placebo skupino.
English: Allergic reaction
Slovenian: Alergijska reakcija
English: • heart attack;
Slovenian: • srčni napad;
English: Children and adolescents with Crohn's disease
Slovenian: Otroci in mladostniki s Crohnovo boleznijo
English: • Look at the expiration date (EXP) on your syringe.
Slovenian: • Poglejte datum izteka roka uporabnosti (EXP) na injekcijski brizgi.
English: Avoid areas with scars or stretch marks.
Slovenian: Izogibajte se predelom z brazgotinami ali strijami.
English: • facial oedema (swelling) associated with allergic reactions;
Slovenian: • edem (otekanje) obraza, povezan z alergijskimi reakcijami;
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
Slovenian: V študiji revmatoidnega artritisa III se je pri večini bolnikov, ki so dosegli izboljšanje telesne funkcije in so nadaljevali zdravljenje, to izboljšanje ohranilo vseskozi do 520. tedna (120. meseca) odprte faze zdravljenja.
English: Hefiya is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Slovenian: Zdravilo Hefiya se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih zdravila, ki se nanašajo na kožo, in zdravljenje z UV-svetlobo niso dovolj dobro delovali ali pa niso primerni.
English: 19.3 % of patients had continued baseline oral antibiotic therapy during the study.
Slovenian: 19,3 % bolnikov je nadaljevalo izhodiščno zdravljenje s peroralnimi antibiotiki.
English: Hefiya can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Slovenian: Zdravilo Hefiya je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
English: 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 non-melanoma skin cancers is approximately 8.5 per 1,000 patient years.
Slovenian: Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene nadaljevalne študije z medianim trajanjem približno 3,3 leta s 6427 bolniki in prek 26439 bolnikov let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 8,5 na 1000 bolnikov-let.
English: Hefiya is used to treat
Slovenian: Zdravilo Hefiya se uporablja za zdravljenje
English: Health-related quality of life and physical function were assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in RA study III.
Slovenian: Z zdravjem povezano kakovost življenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih študijah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v študiji revmatoidnega artritisa III vnaprej določena primarna končna točka po 52 tednih.
English: 40 mg every other week
Slovenian: 40 mg vsak drugi teden
English: If you have mild heart failure and you are being treated with Hefiya, your heart failure status must be closely monitored by your doctor.
Slovenian: Če imate blago srčno popuščanje in se zdravite z zdravilom Hefiya, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
English: • symptoms of nerve root compression (including low back pain and leg pain);
Slovenian: • simptomi stisnjenja živčnih korenin (vključno z bolečino v spodnjem delu hrbta in nogah);
English: Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists.
Slovenian: Glede na naravo neželenih dogodkov, opaženih pri kombiniranem zdravljenju z etanerceptom in anakinro, lahko podobne toksičnosti nastanejo tudi pri uporabi anakinre in drugih antagonistov TNF.
English: Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Slovenian: Zdravniku takoj povejte, če se pri vas pojavijo simptomi, kot so spremembe vida, šibkost rok ali nog ali pa odrevenelost ali mravljinčenje v katerem koli delu telesa.
English: You may cover the injection site with a small adhesive bandage, if needed.
Slovenian: Na mesto injiciranja si lahko po potrebi nalepite majhen obliž.
English: 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.
Slovenian: 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.
English: Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Slovenian: Adalimumaba niso preučevali pri bolnikih z artritisom, povezanim z entezitisom, starih manj kot 6 let.
English: Hefiya may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Hefiya ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Slovenian: Pri okužbah je šlo predvsem za nazofaringitis, okužbo zgornjih dihal in sinusitis.
English: Included in your carton is:
Slovenian: V škatli je priloženo:
English: You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure E).
Slovenian: Uporabite lahko tudi spodnji del trebuha, vendar ne predela 5 cm okrog popka (glejte sliko E).
English: In Study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
Slovenian: V študiji UV I so opazili statistično pomembne razlike v korist adalimumaba v primerjavi s placebom za vsako od komponent neuspeha zdravljenja.
English: The results for the 40 mg every other week dose are summarised in table 7.
Slovenian: Rezultati odmerka 40 mg vsak drugi teden so strnjeni v preglednici 7.
English: • ankylosing spondylitis,
Slovenian: • ankilozirajočega spondilitisa,
English: • Do not throw away any medicines via wastewater or household waste.
Slovenian: • Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
English: The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage of patients who achieved an ACR 20 response at week 24 or 26.
Slovenian: Primarna končna točka v študijah revmatoidnega artritisa I, II in III ter sekundarna končna točka v študiji revmatoidnega artritisa IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.
English: Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk).
Slovenian: Opomba: P# = Placebo (število dogodkov/število rizičnih preiskovancev); A# = Adalimumab (število dogodkov/število rizičnih preiskovancev).
English: Table 28 response, remission and mucosal healing in study UC-II (percent of patients)
Slovenian: Preglednica 28 odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)
English: Radiographs of hands, wrists, and feet were obtained at baseline and week 24 during the double-blind period when patients were on adalimumab or placebo and at week 48 when all patients were on open-label adalimumab.
Slovenian: Rentgenske posnetke dlani, zapestij in stopal so naredili izhodiščno in 24. teden med dvojno slepim obdobjem, med katerim so bolniki dobivali adalimumab ali placebo, in 48. teden, ko so vsi bolniki odprto dobivali adalimumab.
English: Amongst those who responded (Pediatric ACR 30) at week 24 (n = 27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Slovenian: Med tistimi, ki so se odzvali (Pediatric ACR 30) 24. teden (n = 27 od 30 bolnikov), se je odziv Pediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali adalimumab.
English: A single Hefiya pre-filled syringe / pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Slovenian: Posamezna napolnjena injekcijska brizga ali napolnjen injekcijski peresnik zdravila Hefiya se lahko shranjuje pri temperaturi do največ 25 ºC za obdobje do 14 dni.
English: 10, 20 and 25 mg
Slovenian: 10, 20 in 25 mg
English: ACR responses in PsA study I were similar with and without concomitant methotrexate therapy.
Slovenian: Odzivi ACR v študiji pri psoriatičnem artritisu I so bili podobni ob sočasni terapiji z metotreksatom in brez nje.
English: adalimumab / M TX n = 268
Slovenian: adalimumab/ MTX n = 268
English: Infections and infestations*
Slovenian: Infekcijske in parazitske bolezni*
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84 %) patients in the adalimumab group who remained in the study.
Slovenian: Izboljšanje v številu aktivnih sklepov z artritisom se je ohranilo v obdobju odprtega preskušanja po 156. tednu pri 26 od 31 (84 %) bolnikov, ki so ostali v študiji in ki so prejemali adalimumab.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hefiya.
Slovenian: Bolnike je zato treba pred, med in po zdravljenju z zdravilom Hefiya natančno kontrolirati glede okužb, vključno s tuberkulozo.
English: In rheumatoid arthritis, methotrexate is continued while using Hefiya.
Slovenian: Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila Hefiya nadaljuje.
English: You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure D).
Slovenian: Uporabite lahko tudi spodnji del trebuha, vendar ne predela 5 cm okrog popka (glejte sliko D).
English: 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).
Slovenian: Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjevi 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).
English: During treatment with Hefiya, other concomitant therapies (e.g., corticosteroids and / or immunomodulatory agents) should be optimised.
Slovenian: Med zdravljenjem z zdravilom Hefiya je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
English: 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.
Slovenian: 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.
English: Axial spondyloarthritis
Slovenian: Aksialni spondiloartritis
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
English: Store in a refrigerator (2°C-8°C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: • 80 mg at week 0 and 40 mg at week 2 ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Slovenian: • 80 mg v 0. tednu in 40 mg v 2. tednu ≥ 40 kg • 80 mg v 0. tednu in 40 mg v 2. tednu
English: Improvement in health-related quality of life and physical function was maintained during the open- label extension through week 156.
Slovenian: Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih študijah brez placeba ohranjalo do 156. tedna.
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Hefiya treatment.
Slovenian: Ženske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom Hefiya.
English: 79 (73.1) a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Slovenian: 79 (73,1) a, b a p < 0,001 adalimumab v primerjavi s placebom b p < 0,001 adalimumab v primerjavi z metotreksatom c p < 0,01 adalimumab v primerjavi s placebom d p < 0,05 adalimumab v primerjavi z metotreksatom
English: 5 How to store Hefiya Contents of the pack and other information Instructions for use
Slovenian: 5 Shranjevanje zdravila Hefiya Vsebina pakiranja in dodatne informacije Navodila za uporabo
English: • raised liver enzymes.
Slovenian: • zvišani jetrni encimi.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Slovenian: Z rentgenskim slikanjem je bilo dokazano, da adalimumab upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularno, simetrično podvrsto bolezni (glejte poglavje 5.1) in izboljša telesno funkcijo.
English: There is limited experience in the initiation of treatment with adalimumab alone.
Slovenian: O začetku zdravljenja samo z adalimumabom so izkušnje omejene.
English: Failure to respond to treatment for Crohn's disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Slovenian: Zapora tankega črevesa Če se bolnik ne odzove na zdravljenje Crohnove bolezni, lahko to pomeni, da ima stalno fibrotično strikturo, zaradi katere utegne biti potrebno kirurško zdravljenje.
English: • if you drop your syringe, do not use it if it looks damaged, or if you dropped it with the needle cap removed.
Slovenian: • če injekcijsko brizgo spustite, je ne uporabite, če je videti poškodovana ali če ste jo spustili z odstranjenim pokrovčkom za iglo.
English: There are no clinical trials with adalimumab in adolescent patients with HS.
Slovenian: Kliničnih študij z adalimumabom pri mladostnikih s HS ni.
English: Hefiya 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).
Slovenian: Zdravilo Hefiya 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).
English: There are no data available comparing adalimumab and MTX beyond 16 weeks of therapy.
Slovenian: Podatkov za primerjavo adalimumaba in metotreksata med več kot 16-tedenskim zdravljenjem ni.
English: • inflammation of the skin (such as eczema);
Slovenian: • vnetje kože (kot je ekcem);
English: Alternatively, if a patient has stopped Hefiya and signs and symptoms of disease recur, Hefiya may be re-administered.
Slovenian: Če bolnik neha uporabljati zdravilo Hefiya, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo Hefiya znova uvesti.
English: TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and / or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Slovenian: Antagonisti tumorje nekrotizirajočega faktorja (TNF), z adalimumabom vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barré- jevim sindromom.
English: • bacterial infections;
Slovenian: • bakterijske okužbe;
English: Improved physical function continued during the open label extension up to week 136.
Slovenian: Izboljšanje telesnega delovanja je trajalo še med odprto nadaljevalno študijo do 136. tedna.
English: Non-infectious uveitis in adults and children
Slovenian: Neinfekcijski uveitis pri odraslih in otrocih
English: • neurological infections (including viral meningitis);
Slovenian: • nevrološke okužbe (vključno z virusnim meningitisom);
English: • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Slovenian: • Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
English: Hefiya may have a minor influence on your ability to drive, cycle or use machines.
Slovenian: Zdravilo Hefiya ima lahko blag vpliv na sposobnost vožnje, kolesarjenja ali upravljanja strojev.
English: Treatment with Hefiya may result in the formation of autoimmune antibodies.
Slovenian: Zdravljenje z zdravilom Hefiya lahko povzroči nastanek avtoimunskih protiteles.
English: In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
Slovenian: V predvidenem kohortnem registru je bilo vključenih 257 žensk z revmatoidnim artritisom (RA) ali Crohnovo boleznijo (CB), zdravljenih z adalimumabom vsaj v prvem trimesečju nosečnosti, in 120
English: • reactivation of hepatitis B infection;
Slovenian: • reaktivacija okužbe s hepatitisom B;
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov
English: After proper training in injection technique, patients may self-inject with Hefiya if their physician determines that it is appropriate and with medical follow-up as necessary.
Slovenian: Bolniki, ki se naučijo pravilnega postopka injiciranja, si zdravilo Hefiya lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab.
Slovenian: Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih z adalimumabom, ni.
English: • do not use the pen if either the seal on the outer carton or the safety seal on the pen is broken.
Slovenian: • ne uporabljate injekcijskega peresnika, če je pečat zunanje škatle ali varnostni pečat na peresniku zlomljen;
English: Patients induced with 160 / 80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18 % vs. 9 % respectively, p = 0.031) and study UC-II (17 % vs. 9 % respectively, p = 0.019).
Slovenian: Bolniki, ki so za indukcijo dobili 160/80 mg adalimumaba, so 8. teden v primerjavi s placebom dosegli klinično remisijo v statistično značilno večjem odstotku tako v študiji UC-I (18 % v primerjavi z 9 %, p = 0,031) kot v študiji UC-II (17 % v primerjavi z 9 %, p = 0,019).
English: Study nraxSpA I evaluated patients with active nr-axSpA.
Slovenian: Študija nr-axSpA I je proučila bolnike z aktivnim nr-axSpA.
English: d score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab c based on rank analysis d
Slovenian: < 0,001c ocena erozij ocena ZSŠd a metotreksat b 95 % intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom c na podlagi analize rangov d zožitev sklepne špranje
English: 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).
Slovenian: 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 (DLQI
English: An embryo-foetal developmental toxicity / perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg / kg (9-17 monkeys / group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Slovenian: Cynomologous z odmerki 0,30 in 100 mg/kg (od 9 do 17 opic na skupino) in ni pokazala znakov okvare plodov zaradi adalimumaba.