FrancophonIA/ELRC3.0 huggingface dataset:
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Humira should be promptly discontinued.
Slovenian: Če se bolniku pojavijo znaki ali simptomi, kot so npr. zvišana telesna temperatura, splošno slabo počutje, hujšanje, znojenje, kašelj, dispneja in/ali pljučni infiltrati ali druge resne sistemske bolezni (s spremljajočim šokom ali brez njega), je treba posumiti na invazivno glivično okužbo.
English: Your doctor may prescribe another strength of Humira if you need a different dose.
Slovenian: Zdravnik vam lahko predpiše drugo jakost zdravila Humira, če boste potrebovali drugačen odmerek.
English: • reduction in blood platelets which increases risk of bleeding or bruising
Slovenian: • zmanjšanje števila krvnih ploščic, kar poveča tveganje krvavitev ali podplutb
English: Upon completion of the first 104 weeks, 497 patients enrolled in an open-label extension phase in which 40 mg of Humira was administered every other week up to 10 years.
Slovenian: Po zaključenih prvih 104 tednih, so 497 bolnikov vključili v odprto nadaljevalno fazo, med katero so še do 10 let dobivali 40 mg zdravila Humira vsak drugi teden.
English: • abnormal muscle breakdown
Slovenian: • brazgotinjenje • neobičajen razpad mišic
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg)
Slovenian: Hidradenitis suppurativa pri mladostnikih (starejših od 12 let, ki tehtajo najmanj 30 kg)
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in Humira-treated patients through Week 156 and Week 104, respectively.
Slovenian: Statistično izboljšanje znakov vnetja, merjenih s C-reaktivnim proteinom z veliko občutljivostjo (hsCRP) in z magnetno resonanco (MRI) sakroiliakalnih sklepov in hrbtenice, se je ohranilo pri bolnikih, zdravljenih z zdravilom Humira, do 156. tedna oz. do 104. tedna, v tem zaporedju.
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg Humira was administered every other week.
Slovenian: Po koncu obeh študij so 383 bolnikov vključili v odprto nadaljevalno študijo, med katero so bolniki dobivali 40 mg zdravilo
English: The safety profile for patients with HS treated with Humira weekly was consistent with the known safety profile of Humira.
Slovenian: Varnostni profil za bolnike s HS, ki so bili vsak teden zdravljeni z zdravilom Humira, je v skladu z znanim varnostnim profilom zdravila Humira.
English: Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of Humira and MTX compared to Humira alone.
Slovenian: Celotni odzivi so bili med zdravljenjem s kombinacijo zdravila Humira in metotreksata na splošno boljši in pri manj bolnikih so se pojavila protitelesa kot med zdravljenjem samo z zdravilom Humira.
English: • nerve root compression (including low back pain and leg pain)
Slovenian: • stisnjenje živčnih korenin (vključno z bolečino v spodnjem delu hrbta in nogah)
English: If you do not respond well enough to these medicines, you will be given Humira to treat your rheumatoid arthritis.
Slovenian: Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo Humira.
English: 3) Injecting Humira
Slovenian: 3) Injiciranje zdravila Humira
English: • cancer that affects the lymph system;
Slovenian: • rak, ki zajame limfni sistem;
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX-treated.
Slovenian: V odprti uvajalni fazi so bolnike stratificirali v dve skupini: zdravljene z metotreksatom in zdravljene brez metotreksata.
English: The efficacy of Humira was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Slovenian: Učinkovitost zdravila Humira je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali > 20 % zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
English: Your doctor may tell you to stop using Humira for some time.
Slovenian: Vaš zdravnik vam bo morda povedal, da za nekaj časa prenehate z uporabo zdravila Humira.
English: Humira (N = 30)
Slovenian: Zdravilo Humira (n = 30)
English: In patients with non-radiographic axial spondyloarthritis, anti-adalimumab antibodies were identified in 8/152 subjects (5.3%) who were treated continuously with adalimumab.
Slovenian: Pri bolnikih z ne-radiografskim aksialnim spondiloartritisom so protitelesa proti adalimumabu odkrili pri 8/152 preiskovancev (5,3 %), ki so jih neprekinjeno zdravili z adalimumabom.
English: 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 (20/10 mg, weekly).
Slovenian: Pri bolnikih, ki so prešli iz režima vsak drugi teden na režim vsak teden, so bile povprečne (±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, tedensko).
English: The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Humira za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
English: Your child may first be given other disease-modifying medicines, such as methotrexate.
Slovenian: Vaš otrok bo morda najprej prejel druga imunomodulirajoča zdravila, npr. metotreksat.
English: Press the plum activator button and count slowly for 10 seconds.
Slovenian: Pritisnite na škrlaten sprožilni gumb in počasi štejte
English: Injecting Humira
Slovenian: Injiciranje zdravila Humira
English: Humira 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 phototherapies.
Slovenian: Zdravilo Humira je indicirano za zdravljenje hude kronične 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 fototerapije.
English: • expiry (EXP) date has passed
Slovenian: • je pretekel rok uporabnosti (EXP)
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at Week 12 and 24, respectively.
Slovenian: V odprti podaljšani študiji je odziv PASI 75 v 12. oziroma 24. tednu doseglo 26,4 % (92/349) oziroma 37,8 % (132/349) bolnikov, ki so jim zaradi odziva PASI pod 50 % odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden.
English: • Remove cap from needle syringe, being careful not to touch the needle or let it touch any surface.
Slovenian: • Odstranite pokrovček z igle na brizgi; pazite, da se igle pri tem ne dotaknete in da se z njo česa ne dotaknete.
English: 5How to store Humira Contents of the pack and other information Injecting Humira
Slovenian: 5 Shranjevanje zdravila Humira Vsebina pakiranja in dodatne informacije Injiciranje zdravila Humira
English: The pivotal controlled studies involved 6,089 patients receiving Humira and 3,801 patients receiving placebo or active comparator during the controlled period.
Slovenian: Kontrolirane študije, ki podpirajo vlogo za pridobitev dovoljenja za promet, so vključevale 6089 bolnikov, ki so med kontroliranim obdobjem dobivali zdravilo Humira, in 3801 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
English: With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection (see below).
Slovenian: Ko ste pripravljeni na začetek injiciranja (glejte spodaj), s palcem ali kazalcem enkrat pritisnite škrlatni gumb na vrhu.
English: Usually, Humira is used with methotrexate.
Slovenian: Zdravilo Humira ponavadi uporabljamo z metotreksatom.
English: In patients not given concomitant methotrexate, the incidence was 25.6% (22/86) compared to 5.9% (5/85) when adalimumab was used as add-on to methotrexate.
Slovenian: Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 25,6 % (22/86) bolnikov, pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 5,9 % (5/85) bolnikov.
English: The safety and efficacy of Humira was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Slovenian: Varnost in učinkovitost zdravila Humira sta bili ocenjeni v randomizirani, dvojno slepi, kontrolirani študiji pri 90 pediatričnih bolnikih, starih od 2 do manj kot 18 let, z aktivnim neinfekcijskim anteriornim uveitisom, povezanim z juvenilnim idiopatskim artritisom, ki se niso odzvali na zdravljenje z metotreksatom, ki je trajalo vsaj 12 tednov.
English: • facial oedema (swelling of the face)
Slovenian: • edem obraza (otekanje obraza)
English: • neurological infections (including viral meningitis)
Slovenian: • nevrološke okužbe (vključno z virusnim meningitisom)
English: years.
Slovenian: 6 let.
English: Excipients: mannitol, polysorbate 80 and water for injections.
Slovenian: Pomožne snovi: manitol, polisorbat 80 in voda za injekcije.
English: Patients received an initial dose of 80 mg Humira followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label Humira treatment for an additional 26 weeks.
Slovenian: Bolniki so prejeli začetni odmerek 80 mg zdravila Humira, ki mu je sledil 40 mg odmerek vsak drugi teden (z začetkom en teden po začetnem odmerku) ali placebo naslednjih 26 tednov, čemur je sledilo odprto zdravljenje z zdravilom Humira dodatnih 26 tednov.
English: In paediatric uveitis, there is no experience in the treatment with Humira without concomitant treatment with methotrexate.
Slovenian: Izkušenj z zdravilom Humira pri zdravljenju uveitisa pri pediatričnih bolnikih brez sočasnega zdravljenja z metotreksatom ni.
English: Humira n=274
Slovenian: Zdravilo Humira n = 274
English: You may first be given other disease-modifying medicines, such as methotrexate.
Slovenian: Morda boste najprej dobili druga imunomodulirajoča zdravila, npr. metotreksat.
English: • shortness of breath with physical activity or upon lying down or swelling of the feet
Slovenian: • težko dihanje ob telesni dejavnosti ali med ležanjem ali otekanje nog
English: Humira is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Slovenian: Zdravilo Humira je indicirano za zdravljenje kroničnega, neinfekcijskega, anteriornega uveitisa pri bolnikih, starejših od 2 let, ki se niso ustrezno odzvali ali ne prenašajo konvencionalnega zdravljenja, ali pri katerih konvencionalno zdravljenje ni primerno.
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of Humira and azathioprine/6-mercaptopurine compared with Humira alone.
Slovenian: V študijah Crohnove bolezni pri odraslih so pri sočasni uporabi zdravila Humira in azatioprina/6merkaptopurina opazili večjo incidenco malignih in resnih z okužbo povezanih neželenih dogodkov kot pri zdravljenju samo z zdravilom Humira.
English: It is important to tell your doctor if your child has had or has a serious heart condition.
Slovenian: Pomembno je, da zdravniku poveste, če je vaš otrok imel ali ima kakšno resno bolezen srca.
English: In adult patients with non-infectious uveitis, anti-adalimumab antibodies were identified in 4.8% (12/249) of patients treated with adalimumab.
Slovenian: Pri odraslih bolnikih z neinfekcijskim uveitisom so bila protitelesa proti adalimumabu odkrita pri 4,8 % (12/249) bolnikov, ki so jih zdravili z adalimumabom.
English: • At least 3 cm from your child's last injection site
Slovenian: • najmanj 3 cm oddaljeno od otrokovega prejšnjega mesta injiciranja.
English: • high blood measurements for lactate dehydrogenase
Slovenian: • visoke krvne vrednosti za laktat dehidrogenazo
English: • intestinal perforation (hole in the intestine)
Slovenian: • intestinalna perforacija (predrtje črevesa)
English: • Only use each pre-filled syringe for one injection.
Slovenian: • Vsak napolnjen injekcijski peresnik uporabite le za eno injiciranje.
English: People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukemia (a cancer that affects the blood and bone marrow).
Slovenian: Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (rak, ki prizadene limfatični sistem) in levkemijo (rak, ki prizadene kri in kostni mozeg).
English: blood lactate dehydrogenase increased
Slovenian: zvišanje laktat dehidrogenaze v krvi
English: Your symptoms may return upon discontinuation.
Slovenian: Vaši simptomi se lahko po prekinitvi zdravljenja povrnejo.
English: If you received Humira while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last dose you received during pregnancy.
Slovenian: Če ste prejemali zdravilo Humira med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil takšno okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
English: 4) Throwing away supplies
Slovenian: 4) Kako zavreči ostanke
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Slovenian: (20,1 %) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9,4 %)
English: Most patients continued on Humira after the infection resolved.
Slovenian: Večina bolnikov je po ozdravitvi okužbe nadaljevala zdravljenje z zdravilom Humira.
English: Week 52 62.6% 54.4% 72.8% 0.013 < 0.001 0.043 Week 104 56.0% 49.3% 69.4% 0.002 < 0.001 0.140 ACR 50
Slovenian: 52. teden 62,6 % 54,4 % 72,8 % 0,013 < 0,001 0,043 104. teden 56,0 % 49,3 % 69,4 % 0,002 < 0,001 0,140
English: Puh/Tel: +358 (0)10 2411 200
Slovenian: AbbVie Oy Puh/Tel: +358 (0)10 2411 200
English: Table 29 Time to Treatment Failure in Studies UV I and UV II
Slovenian: Preglednica 29 Čas do neuspeha zdravljenja v študijah UV I in UV II
English: In controlled and open label adult and paediatric studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Slovenian: V kontroliranih in odprtih študijah pri odraslih in otrocih z zdravilom Humira so poročali o resnih okužbah (vključno s smrtno nevarnimi, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
English: Immunosuppressant therapy could only be discontinued at or after Week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits
Slovenian: 2Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva.
English: • Crohn's disease
Slovenian: • Crohnove bolezni
English: and
Slovenian: e
English: 40 mg every other week
Slovenian: 40 mg vsaki drugi teden
English: o One 1 ml syringe (1)
Slovenian: Guillain-Barré sindrom)1)
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with Humira compared to placebo (Table 14).
Slovenian: Rezultati po 12. tednu so pokazali statistično pomembno izboljšanje znakov in simptomov aktivnega nr-axSpA pri bolnikih, ki so bili zdravljeni z zdravilom Humira v primerjavi s placebom (preglednica14).
English: • sensation of heart beating rapidly
Slovenian: • občutek hitrega bitja srca
English: The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.3 per 1,000 patient treatment years, respectively (see section 4.4).
Slovenian: Ugotovljeni delež nemelanomskih rakov je približno 0,2 na 1000 bolnikov-let zdravljenja in limfomov približno 0,3 na 1000 bolnikov-let zdravljenja(glejte poglavje 4.4).
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases.
Slovenian: Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom sta vnetni bolezni.
English: Each pack contains 1, 2 or 6 pre-filled syringes for patient use with 1, 2 or 6 alcohol pads, respectively.
Slovenian: Eno pakiranje vsebuje 1, 2 oz. 6 napolnjenih injekcijskih brizg za bolnikovo uporabo z 1, 2 oz. 6 alkoholnimi zloženci.
English: • Ulcerative colitis
Slovenian: • ulceroznega kolitisa
English: Pull the Plum-coloured Cap 2 straight off.
Slovenian: Odstranite škrlaten pokrovček (2).
English: In Study nr-axSpA I, Humira 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 Humira and 6.5 for those on placebo) who have had an inadequate response to or intolerance to  1 NSAIDs, or a contraindication for NSAIDs.
Slovenian: Uporabo zdravila Humira 40 mg 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 (srednja vrednost aktivnosti bolezni [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] je bila 6,4 pri bolnikih zdravljenih z zdravilom Humira in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali vsaj enega NSAID ali s kontraindikacijo za NSAID.
English: Then give your child's next dose as you would have on the originally scheduled day, had you not forgotten a dose.
Slovenian: Nato dajte vašemu otroku naslednji odmerek, kot bi ga uporabili po prvotnem urniku, če ne bi pozabili odmerka.
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using Humira.
Slovenian: V primeru neinfekcijskega uveitisa se kortikosteroidi ali druga zdravila, ki zavirajo imunski sistem lahko še nadalje uporabljajo ob uporabi zdravila Humira.
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Humira/methotrexate combination therapy versus methotrexate monotherapy and Humira monotherapy at Week 52, which was maintained through Week 104.
Slovenian: V študiji revmatoidnega artritisa V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji z zdravilom Humira in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji z zdravilom Humira; to se je ohranilo do 104. tedna.
English: Humira is administered via subcutaneous injection.
Slovenian: Zdravilo Humira se uporablja kot subkutana injekcija.
English: Hypersensitivity, allergies (including seasonal allergy)
Slovenian: pogosti občasni redki preobčutljivost, alergije (vključno s sezonsko alergijo)
English: Humira is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Slovenian: Zdravilo Humira je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
English: The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among Humira-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Slovenian: Delež (95 % interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) na 1000 bolnikov-let med bolniki, ki so dobivali zdravilo Humira, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
English: Table 14 Efficacy Response in Placebo-Controlled Study nr-axSpA I
Slovenian: Preglednica 14 Odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I
English: Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila otrokovega zdravnika ali farmacevta.
English: The long halflife of adalimumab should be taken into consideration if a surgical procedure is planned.
Slovenian: Če je predviden kirurški poseg, je treba upoštevati dolg razpolovni čas adalimumaba.
English: At Week 12, a significantly higher proportion of patients treated with Humira versus placebo achieved HiSCR.
Slovenian: V 12. tednu je statistično pomembno večji delež bolnikov, ki so prejemali zdravilo Humira, doseglo klinični odziv (HiSCR) v primerjavi z bolniki, ki so prejemali placebo.
English: • elevated bilirubin measurement (liver blood test)
Slovenian: • povečane vrednosti bilirubina (krvni test jetrne funkcije)
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia)
Slovenian: • okužbe dihalnega trakta (vključno s prehladom, izcedkom iz nosu, okužbo sinusov, pljučnico)
English: The mean (±SD) serum adalimumab trough concentrations achieved at Week 4 were 15.7 ± 6.6 g/ml for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 g/ml for patients < 40 kg (80/40 mg).
Slovenian: Povprečne (±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).
English: Note: P# = Placebo (Number of Events/Number at Risk); A# = HUMIRA (Number of Events/Number at Risk).
Slovenian: Opomba: P# = placebo (število dogodkov/število rizičnih preiskovancev); A# = HUMIRA (število dogodkov/število rizičnih preiskovancev).