FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Uporabo adalimumaba 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 adalimumabom in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali vsaj enega NSAID ali s kontraindikacijo za NSAID.
English: AMGEVITA 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 AMGEVITA 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: Important: Always keep the sharps disposal container out of the sight and reach of children.
Slovenian: Pomembno: Vsebnik za ostre odpadke vedno shranjujte nedosegljivega otrokom!
English: Each pack contains 1, 2, 4 or 6 single use SureClick pre-filled pens.
Slovenian: Eno pakiranje vsebuje 1, 2, 4 ali 6 40 mg napolnjenih injekcijskih peresnikov SureClick.
English: Talk to your doctor or pharmacist before using AMGEVITA:
Slovenian: Pred začetkom uporabe zdravila AMGEVITA se posvetujte s svojim zdravnikom ali s farmacevtom:
English: Patients were randomised to receive either 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Slovenian: Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m2 telesne površine adalimumaba do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION AMGEVITA 40 mg injection adalimumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE AMGEVITA 40 mg injekcija adalimumab s.c.
English: Table 25.
Slovenian: Preglednica 25.
English: AMGEVITA is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with AMGEVITA.
Slovenian: Priporoča se, da med zdravljenjem z zdravilom AMGEVITA bolnik vsakodmevno izpira HS lezije s topikalnim antiseptikom.
English: In all cases, use a new pre-filled pen.
Slovenian: V vseh teh primerih uporabite nov napolnjen injekcijski peresnik.
English: 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.
Slovenian: 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.
English: AMGEVITA is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom pri bolnikih, starih 6 let in več, ki so se neustrezno odzvali ali so intolerantni za kovencionalno zdravljenje (glejte poglavje 5.1).
English: The recommended AMGEVITA induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Slovenian: Priporočena shema odmerjanja zdravila AMGEVITA med indukcijo je pri odraslih bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
English: Low dose
Slovenian: Majhen odmerek
English: The usual dose of AMGEVITA is 20 mg every other week with methotrexate.
Slovenian: Običajni odmerek zdravila AMGEVITA je 20 mg vsak drugi teden z metotreksatom.
English: AMGEVITA 40 mg solution for injection in pre-filled pen (SureClick) Solution for injection (injection).
Slovenian: AMGEVITA 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku (SureClick) raztopina za injiciranje (injekcija).
English: • 80 mg at week 0 and 40 mg at week 2
Slovenian: • 80 mg v 0.tednu in 40 mg v 2.tednu
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Slovenian: Varnost in učinkovitost adalimumaba so v randomiziranih, dvojno slepih študijah raziskali pri odraslih bolnikih s kronično psoriazo v plakih (zajete ≥ 10 % telesne površine ter indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
English: Anaphylaxis1)
Slovenian: angioedem1),
English: Step 4: Finish K. Discard the used pre-filled pen and the yellow cap.
Slovenian: 4. korak: Zaključek K. Uporabljeni napolnjeni injekcijski peresnikin rumeni pokrovček igle odvrzite.
English: The posology of AMGEVITA in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Slovenian: Kliničnih študij z adalimumabom pri mladostnikih s HS ni. Odmerjanje zdravila AMGEVITA pri teh bolnikih je bilo določeno na podlagi farmakokinetičnega modeliranja in simulacije (glejte poglavje 5.2).
English: In controlled phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Slovenian: V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 x ULN pojavila pri 6,1 % bolnikov zdravljenih z adalimumabom, in pri 1,3 % bolnikov v kontrolni skupini.
English: Pack sizes of one, two, four or multipack of six (3x2) pre-filled syringes.
Slovenian: Velikosti pakiranj po ena, dve, štiri ali skupno pakiranje po šest (3x2) napolnjenih injekcijskih brizg.
English: If you do not respond well enough to these medicines, you will be given AMGEVITA to reduce the signs and symptoms of your Crohn's disease.
Slovenian: Če se nanje ne boste odzvali dovolj, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo AMGEVITA.
English: 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.
Slovenian: V študijah Chronove 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.
English: Discontinuation of Immunomodulators2
Slovenian: 26. teden 52. teden Prenehanje z imunomodulatorji2
English: The usual dose of AMGEVITA is 40 mg every other week with methotrexate.
Slovenian: Običajni odmerek zdravila AMGEVITA je 40 mg vsak drugi teden z metotreksatom.
English: The recommended dose of AMGEVITA 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 AMGEVITA za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
English: Table 22.
Slovenian: Preglednica 22.
English: The 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 14 days.
Slovenian: Napolnjena injekcijska brizga ali napolnjen injekcijski peresnik se lahko shranjujeta pri temperaturi največ do 25°C za obdobje do 14 dni.
English: ● Do not remove the finger flange.
Slovenian: ● Ne odstranjujte oprijemala za prste.
English: In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
Slovenian: Poleg tega so pri bolnikih, zdravljenih z adalimumabom, opazili primere nemelanomskega kožnega raka.
English: If you do not respond well enough to these medicines, you will be given AMGEVITA to reduce the signs and symptoms of your disease.
Slovenian: Če se na ta zdravila ne boste dovolj dobro odzivali, boste prejeli zdravilo AMGEVITA za zmanjšanje znakov in simptomov vaše bolezni.
English: ● Do not twist or bend the yellow cap.
Slovenian: ● Ne sučite ali upogibajte rumenega pokrovčka igle.
English: AMGEVITA is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje ankilozirajočega spondilitisa in aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis pri odraslih.
English: 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.
Slovenian: Delež (95 % interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
English: In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Slovenian: V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m2 (do največ 40 mg) adalimumaba vsak drugi teden.
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 µg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 µg/mL with concomitant methotrexate.
Slovenian: Po dajanju 24 mg/m2 (do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 μg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 μg/ml med sočasno uporabo metotreksata.
English: 506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p < 0.001, adalimumab versus placebo Table 18.
Slovenian: PGA: čisto/minimalno 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
English: The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, and for patients with psoriatic arthritis is 40 mg given every other week as a single dose.
Slovenian: Običajni odmerek za odrasle z revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za ankilozirajoči spondilitis in za bolnike s psoriatičnim artritisom je 40 mg vsak drugi teden v enkratnem odmerku.
English: 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.
Slovenian: Med temi kožnimi raki je bil delež (95 % interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
English: Your doctor should test you for HBV. AMGEVITA can cause reactivation of HBV in people who carry this virus.
Slovenian: Zdravilo AMGEVITA lahko pri nosilcih HBV povzroči reaktivacijo tega virusa.
English: AMGEVITA is used to treat rheumatoid arthritis in adults.
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL PRE-FILLED SYRINGE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA ZA NAPOLNJENO INJEKCIJSKO BRIZGO
English: Patients were then retreated with adalimumab 0.8 mg/kg every other week for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9% (15 of 19 subjects) and PGA clear or minimal of 52.6% (10 of 19 subjects).
Slovenian: tednov, pri čemer so bile opažene stopnje odziva podobne kot v prejšnjem dvojno slepem obdobju: odziv PASI 75 pri 78,9 % (15 od 19 oseb) in PGA čisto ali minimalno pri 52,6 % (10 od 19 oseb).
English: Table 24.
Slovenian: Preglednica 24.
English: Carriers of HBV who require treatment with AMGEVITA should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Slovenian: Nosilce HBV, ki potrebujejo zdravljenje z zdravilom AMGEVITA, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
English: 79 (73.1) a, b a p < 0.001 adalimumab versus placebo b p < 0.001 adalimumab versus methotrexate c p < 0.01 adalimumab versus placebo d p < 0.05 adalimumab versus methotrexate
Slovenian: PGA: čisto/minimalno 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: Medicine Make sure the medicine in the window is clear and colourless to slightly yellow.
Slovenian: Prepričajte se, da je zdravilo v okencu bistro in brezbarvno do rahlo rumenkasto.
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: AMGEVITA 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 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki se ne odzovejo zadostno na običajno zdravljenje, vključno s kortikosteroidi in 6merkaptopurinom (6-MP) ali azatioprinom (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
English: AMGEVITA Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
Slovenian: Odmerjanje zdravila AMGEVITA pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom Masa bolnika
English: Used syringe barrel
Slovenian: Uporabljeni valj brizge
English: AMGEVITA 20 mg solution for injection in pre-filled syringe EU/1/16/1164/001 - 1 pack
Slovenian: AMGEVITA 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/16/1164/001 - 1 brizga
English: Table 26.
Slovenian: Preglednica 26.
English: Week 4 Clinical remission Clinical response (CR-100) All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001 ** p < 0.01
Slovenian: Vse vrednosti p so za parne primerjave deležev med adalimumabom in placebom * p < 0,001
English: Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Slovenian: 40 mg vsak drugi teden Adalimumaba niso preučevali pri bolnikih z artritisom, povezanim z entezitisom, starih manj kot 6 let.
English: Children and adolescents from 2 years of age weighing 30 kg or more The usual dose of AMGEVITA is 40 mg every other week with methotrexate.
Slovenian: Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več Običajni odmerek zdravila AMGEVITA je 40 mg vsak drugi teden z metotreksatom.
English: Statistically significant increases (improvement) from baseline to week 26 and 52 in body mass index and height velocity were observed for both treatment groups.
Slovenian: V obeh skupinah so opazili statistično pomembno povečanje (izboljšanje) indeksa telesne mase in hitrosti rasti od začetka študije do 26. in 52. tedna.
English: Table 27.
Slovenian: Preglednica 27.
English: The recommended dose of AMGEVITA for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila AMGEVITA pri bolnikih z ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS in pri bolnikih s psoriatičnim artritisom je 40 mg adalimumaba, apliciran v enkratni subkutani injekciji vsak drugi teden.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific 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
Slovenian: 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).
English: 4 pre-filled syringes.
Slovenian: 4 napolnjene injekcijske brizge.
English: AMGEVITA Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Slovenian: Odmerjanje zdravila AMGEVITA pri bolnikih z artritisom, povezanim z entezitisom
English: All doses/schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to month 6 compared to placebo and in RA study III the same was seen at week 52.
Slovenian: V vseh štirih študijah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi odmerki/shemami adalimumaba izboljšal statistično značilno bolj kot s placebom; v študiji revmatoidnega artritisa III so isto ugotovili po 52 tednih.
English: INFORMATION IN BRAILLE AMGEVITA 40 mg pen
Slovenian: PODATKI V BRAILLOVI PISAVI AMGEVITA 40 mg brizga
English: Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Slovenian: Adalimumab je bil ocenjen v multicentrični, randomizirani, dvojno slepi klinični študiji, ki je bila zasnovana za oceno učinkovitosti in varnosti uvodnega in vzdrževalnega zdravljenja z odmerki, odvisnimi od telesne mase (< 40 kg ali ≥ 40 kg) pri 192 pediatričnih bolnikih med 6. in 17.
English: Rare (may affect up to 1 in 1,000 people)
Slovenian: Redki (pojavijo se lahko pri naveč 1 od 1.000 bolnikov)
English: Paediatric ACR 30 responses in the JIA study
Slovenian: Odzivi “Pediatric ACR 30” v študiji pri juvenilnem idiopatskem artritisu
English: Corticosteroid taper was permitted after week
Slovenian: Po 8. tednu je bilo dovoljeno postopno zmanjševanje kortikosteroida.
English: ACR responses in RA study V (percent of patients)
Slovenian: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov) Odziv
English: Table 21.
Slovenian: Preglednica 21.
English: All subjects received open-label induction therapy at a dose based on their baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Slovenian: Vsi bolniki so prejeli odprto uvodno zdravljenje v odmerku glede na njihovo začetno telesno maso: 160 mg v 0. tednu in 80 mg v 2. tednu bolniki z ≥ 40 kg ter 80 mg in 40 mg v tem vrstnem redu bolniki z < 40 kg.
English: Placebo Adalimumab 40 mg weekly
Slovenian: Placebo adalimumab 40 mg vsak drugi teden
English: 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.
Slovenian: 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.
English: PROBABILITY OF NO FLARE
Slovenian: VERJETNOST, DA DO ZAGONA NE PRIDE
English: ● Do not remove the yellow cap from the pre-filled pen yet.
Slovenian: ● Ne odstranite še rumenega pokrovčka z napolnjenega injekcijskega peresnika.
English: Use a new AMGEVITA pre-filled syringe.
Slovenian: Uporabite novo napolnjeno injekcijsko brizgo zdravila AMGEVITA.
English: AMGEVITA Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Slovenian: Odmerjanje zdravila AMGEVITA pri pediatričnih bolnikih s psoriazo v plakih Masa bolnika
English: AMGEVITA 40 mg solution for injection in pre-filled syringe EU/1/16/1164/002 - 1 pack
Slovenian: AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/16/1164/002 - 1 brizga
English: The pen is a single use, disposable, handheld, mechanical injection device.
Slovenian: Peresnik je mehanski pripomoček za injiciranje za enkratno uporabo, za zavrženje po enkratni uporabi in za ročno uporabo.
English: INFORMATION IN BRAILLE AMGEVITA 20 mg syringe
Slovenian: PODATKI V BRAILLOVI PISAVI AMGEVITA 20 mg brizga
English: In CD study I, 299 TNF-antagonist naïve patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Slovenian: V študiji pri Crohnovi bolezni I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg adalimumab 0. teden in 80 mg 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
English: Important: Keep the skin pinched while injecting.
Slovenian: Pomembno: Med injiciranjem držite kožo stisnjeno v kožno gubo.