FrancophonIA/ELRC3.0 huggingface dataset:
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: Table 8 Ped ACR 30 responses in the JIA study
Slovenian: Preglednica 8 Odzivi »Ped ACR« 30 v študiji pri juvenilnem idiopatskem artritisu
English: • Continue to HOLD the pre-filled pen firmly.
Slovenian: • Napolnjen injekcijski peresnik močno DRŽITE še naprej.
English: Idacio dose for patients with enthesitis-related arthritis
Slovenian: Odmerjanje zdravila Idacio pri bolnikih z artritisom, povezanim z entezitisom
English: Idacio 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 Idacio 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: Idacio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: Zdravilo Idacio je indicirano za zdravljenje aktivne, zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
English: No ALT elevations ≥ 3 X ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Slovenian: Do nobenih zvišanj ALT ≥ 3 x ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
English: NA 4.5% 23.2% a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Slovenian: NP a Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega artritisa III po 24 in 52 tednih b 40 mg adalimumaba vsak drugi teden c MTX = metotreksat
English: Idacio is also used to treat severe plaque psoriasis in children and adolescents 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 Idacio 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, nista dovolj dobro delovala ali pa nista primerna.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Idacio 40 mg injection adalimumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Idacio 40 mg injekcija adalimumab s.c.
English: Table 18: Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Slovenian: Preglednica 18: Delež bolnikova, ki so dosegli klinični odziv (HiSCR)b v 24. in 36. tednu po spremembi zdravljenja v 12. tednu po jemanju adalimumaba vsak teden Placebo (ukinitev zdravljenja) N = 73
English: Storage information
Slovenian: Navodila za shranjevanje
English: HS Study I
Slovenian: Študija HS I
English: Idacio contains sodium
Slovenian: Zdravilo Idacio vsebuje natrij
English: It is recommended that the conduct and results of these tests are recorded in the patient reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Slovenian: Zdravniki se morajo zavedati tveganja za lažno negativne izvide tuberkulinskega kožnega testa, zlasti pri hudo bolnih ali imunsko oslabelih bolnikih.
English: ACR 20 Week 52 62.6% 54.4% 72.8% Week 104 56.0% 49.3% 69.4% ACR 50 Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 a. p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Slovenian: 52. teden 27,2 % 25,9 % 45,5 % < 0,001 < 0,001 0,656 104. teden 28,4 % 28,1 % 46,6 % < 0,001 < 0,001 0,864 a. Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U. b. Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U. c. Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann-Whitneyevim testom U.
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: • The name on the pre-filled pen says Idacio (Figure I).
Slovenian: • je na injekcijskem peresniku ime Idacio (Slika I).
English: Do not use this medicine after the expiry date which is stated on the label /carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/škatli poleg oznake “EXP”.
English: Table 22: Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Slovenian: Preglednica 22: Delež bolnikova, ki so dosegli klinični odziv (HiSCR)b v 24. in 36. tednu po spremembi zdravljenja na jemanje adalimumaba vsak teden v 12. tednu Placebo (ukinitev zdravljenja) N = 73
English: Adalimumab was assessed in a multicenter, 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 mg ali ≥ 40 mg) pri 192 pediatričnih bolnikih med 6. in 17.
English: Idacio is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo Idacio je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri odraslih bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
English: When needed (for example when you are travelling), Idacio may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Slovenian: Če je potrebno (na primer kadar potujete), lahko zdravilo Idacio hranite pri sobni temperaturi (do 25 °C) za največ 14 dni - zagotovite, da bo zaščiteno pred svetlobo.
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/mL (79% CV).
Slovenian: Po dajanju adalimumaba 0,8 mg/kg (do največ 40 mg) subkutano vsak drugi teden pediatričnim bolnikom s kronično psoriazo v plakih, so bile povprečne koncentracije adalimumaba v stanju dinamičnega ravnovesja približno 7,4 ± 5,8 µg/ml (79 % KV).
English: Adalimumab 40 mg every other week N = 70
Slovenian: Adalimumab 40 mg vsak drugi teden N = 70
English: Each box of Idacio pre-filled syringe comes with two or six syringes.
Slovenian: V vsaki škatli zdravila Idacio napolnjene injekcijske brizge sta dve ali šest injekcijskih brizg.
English: It is important that you tell your doctor if your child has symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Slovenian: Pomembno je, da zdravniku poveste, če ima vaš otrok simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi (glejte "Opozorila in previdnostni ukrepi").
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 Idacio 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 druga resna sistemska bolezen (s spremljajočim šokom ali brez njega), je treba posumiti na invazivno glivično okužbo.
English: Contents of the pack and other information What Idacio contains
Slovenian: VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo Idacio - Učinkovina je adalimumab.
English: • Do not use an Idacio pre-filled pen that has been frozen or left in direct sunlight.
Slovenian: • Zdravila Idacio napolnjen injekcijski peresnik ne uporabljajte, če je bil injekcijski peresnik zamrznjen ali dlje časa izpostavljen neposredni sončni svetlobi.
English: Idacio is 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 Idacio se uporablja 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 nista dovolj dobro delovala ali pa nista primerna.
English: 506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centeradjusted rate b p<0.001, adalimumab vs. placebo
Slovenian: 506 (62,2)b Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center.
English: The recommended Idacio dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Slovenian: Priporočeni odmerek zdravila Idacio pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
English: NAME OF THE MEDICINAL PRODUCT Idacio 40 mg/0.8 mL solution for injection for paediatric use
Slovenian: IME ZDRAVILA Idacio 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Idacio.
Slovenian: Med zdravljenjem z zdravilom Idacio je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
English: You are advised to avoid becoming pregnant and must use adequate contraception while using Idacio and for at least 5 months after the last Idacio injection.
Slovenian: Svetujemo vam, da preprečite nosečnost in uporabljate ustrezno kontracepcijsko zaščito, dokler uporabljate zdravilo Idacio in še 5 mesecev po zadnjem injiciranju zdravila Idacio.
English: Idacio dose for paediatric patients with plaque psoriasis
Slovenian: Odmerjanje zdravila Idacio pri pediatričnih bolnikih s psoriazo v plakih
English: Idacio is used to treat psoriatic arthritis in adults.
Slovenian: Zdravilo Idacio se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
English: ≥30% Reduction in skin painb N = 109
Slovenian: suppurativa (HiSCR)a ≥ 30 % zmanjšanje bolečine N = 109
English: Idacio is available as a vial, a pre-filled syringe and as a pre-filled pen.
Slovenian: Zdravilo Idacio je lahko na voljo kot viala, napolnjena injekcijska brizga in napolnjen injekcijski peresnik.
English: PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumaa 0.8 mg/kg versus MTX
Slovenian: 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
English: A 40 mg pre-filled syringe and a 40 mg pre-filled pen are also available for use.
Slovenian: Za uporabo sta na voljo tudi 40 mg napolnjena injekcijska brizga in 40 mg napolnjen injekcijski peresnik.
English: The recommended Idacio dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Idacio je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
English: Erosion score
Slovenian: Disease Activity Score)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Idacio 40 mg/0.8 mL injection adalimumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Idacio 40 mg/0,8 ml injekcija adalimumab s.c.
English: Adalimumab 40 mg weekly N = 70
Slovenian: Adalimumab 40 mg vsak teden N = 70
English: Idacio is administered via subcutaneous injection.
Slovenian: Zdravilo Idacio se uporablja kot subkutana injekcija.
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Idacio.
Slovenian: Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Idacio ali po njem doživijo znake/simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje teže, nekoliko zvišano telesno temperaturo, ravnodušnost).
English: 5.2 Clean the injection site with an alcohol pad and throw the pad away.
Slovenian: 5.2 Kožo na mestu injiciranja obrišite z zložencem, prepojenim z alkoholom, in ga zavrzite.
English: The recommended dose of Idacio for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Slovenian: Priporočeni odmerek zdravila Idacio pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
English: Idacio is used to treat ulcerative colitis in adults.
Slovenian: Zdravilo Idacio se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
English: • Keep all components of the Idacio Vial Kit and the sharps disposal container out of reach and sight of children.
Slovenian: • Pripomočke zdravila Idacio komplet z vialo in zbiralnik za ostre predmete shranjujte nedosegljivo otrokom.
English: Idacio 40 mg/0.8 mL solution for injection for paediatric use adalimumab
Slovenian: Idacio 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo adalimumab
English: What Idacio contains
Slovenian: Kaj vsebuje zdravilo Idacio
English: The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Slovenian: Kombinacija adalimumaba in tudi drugih TNF antagonistov in anakinre ali abatacepta ni priporočljiva, saj temelji na možnosti, da poveča tveganje za okužbo, vključno z resnimi okužbami in ostalimi potencialnimi farmakološkimi interakcijami.
English: JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1) a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Slovenian: a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U. b Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U. c Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann-Whitneyevim testom U.
English: • If needed, for example when traveling, the Idacio Vial Kit can be stored at room temperature for up to 14 days.
Slovenian: • Po potrebi lahko zdravilo Idacio komplet z vialo shranjujete pri sobni temperaturi do 14 dni, če na primer potujete.
English: When needed (for example when you are travelling), a single Idacio pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Slovenian: Če je potrebno (na primer kadar potujete), lahko posamezno napolnjeno injekcijsko brizgo Idacio hranite pri sobni temperaturi (do 25 ºC) za največ 14 dni - zagotovite, da bo zaščitena pred svetlobo.
English: Your healthcare provider should show you how to prepare and inject Idacio properly using the pre-filled syringe before you use it for the first time.
Slovenian: Vaš zdravstveni delavec vam mora pokazati kako pravilno pripraviti in injicirati zdravilo Idacio preden boste napolnjeno injekcijsko brizgo prvič uporabili.
English: Table 18 Ps Study II (CHAMPION) efficacy results at 16 weeks Placebo N=53 n (%)
Slovenian: b p < 0,001, adalimumab v primerjavi s placebom Preglednica 18: Študija pri psoriazi II (CHAMPION) Rezultati učinkovitosti po 16 tednih placebo n = 53 n (%)
English: If these medicines do not work well enough, your child will be given Idacio to treat his/her polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom dobil zdravilo Idacio.
English: 4.5 Place the syringe on a clean, flat surface.
Slovenian: 4.5 Injekcijsko brizgo položite na čisto, ravno površino.
English: Idacio is used to treat moderate to severe plaque psoriasis in adults.
Slovenian: Zdravilo Idacio se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
English: • Store the Idacio Vial Kit in a refrigerator between 2°C to 8°C.
Slovenian: • Zdravilo Idacio komplet z vialo shranjujte v hladilniku pri temperaturi med 2 °C in 8 °C.
English: • Store the Idacio Vial Kit in its original box to protect it from light.
Slovenian: • Zdravilo Idacio komplet z vialo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Your child is advised to avoid becoming pregnant and must use adequate contraception while using Idacio and for at least 5 months after the last Idacio injection.
Slovenian: Za vašega otroka je priporočljivo, da ne zanosi in uporablja ustrezno kontracepcijsko zaščito, dokler uporablja zdravilo Idacio in še 5 mesecev po zadnjem injiciranju zdravila Idacio.
English: Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Adalimumab so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so adalimumab jemali kot monoterapijo, kot pri tistih, ki so ga jemali hkrati z metotreksatom.
English: If you become pregnant, you should see your doctor.
Slovenian: Če zanosite, je potrebno obiskati zdravnika.
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/mL at week 2 and week 4.
Slovenian: Pri odraslih bolnikih s hidradenitis suppurativa doseže odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, najnižjo koncentracijo adalimumaba v serumu pred naslednjim odmerkom približno 7 do 8 µg/ml v 2. tednu in v 4. tednu.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Idacio 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Idacio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,8 ml enoodmerna napolnjena injekcijska brizga vsebuje 40 mg adalimumaba.
English: Table 24 Maintenance of clinical remission and response (percent of patients) Placebo
Slovenian: Preglednica 24: Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
English: Table 23 Maintenance of clinical remission and response (percent of patients) Placebo
Slovenian: Preglednica 23 Vzdrževanje klinične remisije in odziv (Odstotek bolnikov)
English: The recommended Idacio induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila Idacio med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
English: Your healthcare provider should show you how to prepare and inject Idacio properly using the vial kit before you use it for the first time.
Slovenian: Vaš zdravstveni delavec vam mora pokazati kako pravilno pripraviti in injicirati zdravilo Idacio preden boste komplet z vialo prvič uporabili.
English: A loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/mL during the induction period.
Slovenian: Polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, doseže med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.