natgillin/translations-raw huggingface dataset:
(up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/mL (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg/mL (47.7% CV) with concomitant methotrexate. 
(do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom (pJIA), starih od 4 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med uporabo adalimumaba brez metotreksata 5,6 ± 5,6 µg/ml (koeficient variacije 102 %) in med uporabo z metotreksatom 10,9 ± 5,2 µg/ml (koeficient variacije 47,7 %).
Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk). 
Opomba: P# = placebo (število dogodkov/število rizičnih preiskovancev); A# = Adalimumab (število dogodkov/število rizičnih preiskovancev).
Pediatric Uveitis 
Uveitis pri pediatričnih bolnikih
Children and adolescents from 4 to 17 years of age weighing 30 kg or more 
Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več
In adult patients with ulcerative colitis, 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. 
Pri odraslih bolnikih z ulceroznim kolitisom doseţe polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu pribliţno 12 µg/ml.
adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11). 
Pri bolnikih, ki so dobivali adalimumab in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 11) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
• Hold the syringe upward and pull the needle cap straight off (Figure N). 
Injekcijsko brizgo drţite obrnjeno navzgor in odstranite pokrovček na injekcijski igli (Slika N).
Each pre-filled syringe contains 40 mg of adalimumab in 0.8 ml of solution. 
Vsaka napolnjena brizga vsebuje 40 mg adalimumaba in 0,8 ml raztopine.
• Throw away the needle cap. 
• Pokrovček z injekcijske igle zavrzite.
All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Kromeya. 
Pred zdravljenjem z zdravilom Kromeya in med zdravljenjem z njim je treba za nemelanomskega koţnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leucopenia) have been reported with adalimumab. 
Med uporabo adalimumaba so poročali o neţelenih učinkih na hematološki sistem, vključno z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
Shaking can damage the pre-filled syringe and the medicine. 
S tem bi lahko poškodovali napolnjeno injekcijsko brizgo ali zdravilo.
The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 7. 
Preglednica 7 prikazuje porazdelitev bolnikov po starosti ter najmanjšem, srednjem in največjem odmerku, prejetem med odprto uvajalno fazo.
Patients received placebo or adalimumab at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose. 
Bolniki so prejeli placebo ali adalimumaba v začetnem odmerku 80 mg, ki mu je sledil odmerek 40 mg vsak drugi teden, z začetkom dajanja en teden po začetnem odmerku.
• cutaneous vasculitis (inflammation of blood vessels in the skin); 
• koţni vaskulitis (vnetje krvnih ţil v koţi);
Nervous system disorders* Very common 
Organski sistem po MedDRA Pogostnost
Paediatric uveitis Age or body weight 
Pediatrični uveitis Starost ali telesna masa
• Hold the -pre-filled pen so that you can see the transparent syringe housing. 
• Napolnjen injekcijski peresnik drţite tako, da vidite prozorno ohišje injekcijske brizge.
Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9 (p< 0.001) in the adalimumab group (at week 48). 
Sprememba je bila (povprečje ± standardni odklon) 0,8 ± 2,5 v skupini s placebom (po 24 tednih) in 0,0 ± 1,9; (p < 0,001) v skupini z adalimumabom (po 48 tednih).
3.1 Check the transparent syringe housing to make sure that: 
3.1 Injekcijsko brizgo preglejte in preverite, ali:
Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma** 
ploščatoceličnim karcinomom), benigni tumor občasni limfom**, tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice) maligni melanom**,
If you do not respond well enough to these medicines, you will be given Kromeya to reduce the signs and symptoms of your Crohn's disease. 
Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo Kromeya.
Renal and/or hepatic impairment 
Okvara jeter in/ali ledvic
The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 11. 
Preglednica 11 prikazuje porazdelitev bolnikov po starosti ter najmanjšem, srednjem in največjem odmerku, prejetem med odprto uvajalno fazo.
Kromeya 40 mg/0.8 mL solution for injection (injection) for paediatric use is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab. 
Zdravilo Kromeya 40 mg/0,8 ml raztopine za injiciranje v vialah za pediatrično uporabo je na voljo kot 0,8 ml sterilna, bistra, brezbarvna raztopina z 40 mg adalimumaba.
What you need to know before your child uses Kromeya 3. 
Kaj morate vedeti, preden bo vaš otrok uporabil zdravilo Kromeya Ne uporabljajte zdravila Kromeya
CD study I and CD study II induction of remission and response rates are presented in Table 21. 
Indukcijo remisije in deleţe odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje preglednica 21.
Kromeya 40 mg/0.8 mL solution for injection for paediatric use adalimumab 
Kromeya 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo adalimumab
Warning: Do not reuse a syringe in case of partial injection. 
Opozorilo: Če injicirate le del odmerka, ne smete ponovno uporabiti injekcijske brizge.
There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis. 
Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom Uporaba adalimumaba pri pediatrični populaciji za indikaciji ankilozni spodilitis in psoriatični artritis ni primerna.
• Store the pre-filled syringe in its original box to protect it from light. 
• Napolnjen injekcijski peresnik shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
The recommended dose of Kromeya for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5). 
Priporočeni odmerek zdravila Kromeya pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
- If you get any side effects, talk to your doctor or pharmacist. 
- Če opazite kateri koli neţeleni učinek, se posvetujte z zdravnikom ali farmacevtom.
The recommended dose of Kromeya for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2). 
Priporočeni odmerek zdravila Kromeya pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
Pack sizes of: - 2 pre-filled syringes, with 2 alcohol pads - 6 pre-filled syringes, with 6 alcohol pads. 
Velikost pakiranj: - 2 napolnjena injekcijska peresnika z 2 alkoholnima zloţencema - 6 napolnjenih injekcijskih peresnikov s 6 alkoholnimi zloţenci
Step 6 Give Injection 
6. korak Injicirajte zdravilo
Erosion score 
Ocena erozij Ocena ZSŠ
The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and PASI ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies. 
Varnost in učinkovitost adalimumaba so raziskali v randomiziranih, dvojno slepih študijah pri odraslih bolnikih s kronično psoriazo v plakih (zajete ≥ 10 % telesne površine ter indeksom obseţnosti in izrazitosti psoriaze PASI ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
• Keep Kromeya pre-filled syringe and the sharps disposal container out of reach and sight of children. 
• Zdravilo Kromeya napolnjena injekcijsko brizgo in zbiralnik za ostre predmete shranjujte nedosegljivo otrokom.
Possible side effects 
Neţeleni učinki
Concomitant administration of adalimumab with other biologic DMARDs (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. 
Sočasna uporaba adalimumaba z drugimi biološkimi DMARDs (tj.anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi moţnega povečanega tveganja za okuţbe, vključno z resnimi okuţbami, in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
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. 
< 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.
Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg 
Otroci in mladostniki, starejši od 2 let, ki tehtajo od 10 kg do manj kot 30 kg
4.5 Place the syringe on a clean, flat surface. 
4.5 Injekcijsko brizgo poloţite na čisto, ravno površino.
Each vial contains 40 mg of adalimumab in 0.8 ml of solution. 
Ena viala vsebuje 40 mg adalimumaba in 0,8 ml raztopine.
If these medicines do not work well enough, you will be given Kromeya to reduce the signs and symptoms of your disease. 
Če ta zdravila ne bodo dovolj delovala, boste dobili zdravilo Kromeya za zmanjšanje znakov in simptomov vaše bolezni.
Table 12 Radiographic mean changes at week 52 in RA study V 
Preglednica 12: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV). 
V vseh treh študijah (študije revmatoidnega artritisa I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti.
Kromeya is contraindicated in moderate to severe heart failure (see section 4.3). 
Pri bolnikih z zmernim do hudim srčnim popuščanjem je zdravilo Kromeya kontraindicirano (glejte poglavje 4.3).
Children and adolescents from 2 years of age weighing less than 30 kg 
Otroci in mladostniki, starejši od 2 let, ki tehtajo manj kot 30 kg
If this dose does not work well enough, your child's doctor may increase the dosage to 40 mg every week or 80 mg every other week. 
Če ta odmerek ne bo deloval dovolj dobro, lahko otrokov zdravnik odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
Warning: Do not remove the needle cap while allowing syringe to reach room temperature. 
Opozorilo: Medtem ko čakate, da se injekcijska brizga ogreje na sobno temperaturo, ne smete odstraniti pokrovčka na injekcijski igli.
Kromeya 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab. 
Zdravilo Kromeya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo kot 0,8 ml sterilna, bistra, brezbarvna raztopina z 40 mg adalimumaba.
If so, throw away the pre-filled pen in a sharps disposal container and contact your healthcare professional or pharmacist. 
V tem primeru injekcijski peresnik zavrzite v zbiralnik za ostre predmete in se obrnite na svojega zdravstvenega delavca ali farmacevta.
Vertigo and visual impairment may occur following administration of Kromeya (see section 4.8). 
Po dajanju zdravila Kromeya se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
• muscle spasms; 
• okuţbe sečil;
• reproductive tract infections; 
• okuţbe reproduktivnih organov;
Kromeya therapy should not be continued in patients failing to respond within this time period. 
Pri bolnikih, ki se v tem času ne odzovejo na zdravljenje z zdravilom Kromeya, zdravljenja ni priporočljivo nadaljevati.
Table 20 Induction of clinical remission and response (percent of patients) 
Preglednica 20 Indukcija klinične remisije in odziv (Odstotek bolnikov)
• pulmonary fibrosis (scarring of the lung); 
• pljučna fibroza (brazgotinjenje pljuč);
• It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems. 
• Pomembno je, da poveste zdravniku, če vaš otrok dobi znake okuţbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
The safety guard will slide down and lock into place to protect you from the needle (Figure Q). 
Varovalo se bo spustilo navzdol in ostalo na mestu, da se ne bi poškodovali z iglo.
Week 12 Week 24 ASAS 70 Week 2 
12. teden 4 % 24. teden 6 %
Back view 
Zadnja stran
≥ 40 kg • 80 mg at week 0 and 40 mg at week 2 
< 40 kg • 40 mg v 0. tednu in 20 mg v 2. tednu
Kromeya dose for paediatric patients with uveitis 
Odmerjanje zdravila Kromeya pri pediatričnih bolnikih z uveitisom
Pack sizes of: - 2 pre-filled pens, with 2 alcohol pads - 6 pre-filled pens, with 6 alcohol pads. 
Velikost pakiranj: - 2 napolnjeni injekcijski brizgi z 2 alkoholnima zloţencema - 6 napolnjenih injekcijskih brizg s 6 alkoholnimi zloţenci
• Top of the thighs or 
• zgornjem delu stegen ali
Tabulated list of adverse reactions 
Seznam neţelenih učinkov v preglednici
• polyarticular juvenile idiopathic arthritis 
• poliartikularni juvenilni idiopatski artritis
Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials.Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration. 
Po uporabi adalimumaba so prejeli poročila o resnih alergijskih reakcijah, vključno z anafilaksijo.
5.3 Remove the clear needle cap by pulling it straight off and throw it away. 
5.3 Odstranite prozoren pokrovček na injekcijski igli in ga zavrzite.
• paediatric plaque psoriasis 
• luskavica (psoriaza) v plakih pri pediatričnih bolnikih
This will unlock the injection button (Figure O). 
S tem boste odklenili gumb za injiciranje.
In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2. 
V študiji UC-I so 390 bolnikov, ki še niso prejemali antagonista TNF, randomizirali bodisi na placebo in 2. teden, na adalimumab 0. teden in 80 mg 2. teden, ali na 80 mg 0. teden in 40 mg 2. teden.
• any issue you had 
• kakršnihkoli teţavah,
These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, 
Zdravilo Kromeya je namenjeno za zdravljenje naslednjih vnetnih bolezni: - revmatoidni artritis, - poliartikularni juvenilni idiopatski artritis, - artritis, povezan z entezitisom, - ankilozirajoči spondilitis, - aksialni spondiloartritis brez radiografskega dokaza za ankilozirajoči spondilitis, - psoriatični artritis, - luskavica (psoriaza), - Crohnova bolezen, - ulcerozni kolitis in - neinfekcijski uveitis.
Your doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose. 
Zdravnik lahko predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
Table 20: Paediatric plaque psoriasis efficacy results at 16 weeks MTX 
Preglednica 20: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
If these medicines do not work well enough, your child will be given Kromeya to reduce the signs and symptoms of his/her disease. 
Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok dobil zdravilo Kromeya za zmanjšanje znakov in simptomov Crohnove bolezni.
Kromeya 40 mg solution for injection in pre-filled syringe adalimumab 
Kromeya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
Children and adolescents from 2 years of age weighing 30 kg or more 
Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več
RA Study III a** 
Študija revmatoidnega artritisa a**
• pull the pre-filled pen straight up and out of the packaging (Figure D). 
• injekcijski peresnik potegnite navzgor iz škatle (Slika D).
Step 3 Check the Syringe 
3. korak Preglejte injekcijsko brizgo
• Store the pre-filled pen in its original box to protect it from light. 
• Napolnjeno brizgo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
PsA study II with 12 -week duration, treated 100 patients who had an inadequate response to DMARD therapy. 
V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
5.1 Wipe the skin of your injection site with an alcohol pad to clean it (Figure K). 
5.1 Koţo na mestu injiciranja obrišite z zloţencem, prepojenim z alkoholom, da jo očistite.
Kromeya is available as a vial, a pre-filled syringe and a pre-filled pen. 
Zdravilo Kromeya je na voljo v viali, napolnjeni injekcijski brizgi in napolnjenem injekcijskem peresniku.
Your child's doctor may prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose. 
Otrokov zdravnik lahko predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
Note: P = Placebo (Number at Risk); A = Adalimumab (Number at Risk). 
Opomba: P = placebo (število rizičnih preiskovancev); A = Adalimumab (število rizičnih preiskovancev).
Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis. 
Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija z adalimumabom in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0,001) in monoterapije z adalimumabom (p < 0,001).
Read carefully these entire instructions before using your Kromeya pre-filled syringe. 
Pred uporabo zdravila Kromeya napolnjena injekcijska brizga natančno preberite celotno navodilo.
Week 12 Week 24 ASAS 50 Week 2 
2. teden 12. teden 24. teden ASAS 50 2. teden 12. teden 24. teden ASAS 70 2. teden 12. teden 24. teden
• facial oedema (swelling); 
• edem obraza (oteklina);
Table 25 Paediatric CD study Discontinuation of corticosteroids or immunomodulators and fistula remission 
Preglednica 25 Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule Standardni odmerek 40/20 mg vsak drugi teden
If this dose does not work well enough, your doctor may increase the dose frequency to 40 mg every week or 80 mg every other week. 
Če ta odmerek ne bo deloval dovolj dobro, lahko zdravnik poveča odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
Discontinuation of Kromeya therapy should be considered in patients with confirmed significant haematologic abnormalities. 
Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Kromeya.
RA study III a** 
Študija revmatoidnega artritisa III a**
Table 21 Induction of clinical remission and response (percent of patients) 
Preglednica 21: Indukcija klinične remisije in odziva (odstotek bolnikov)
ACR 20 Week 12 Week 24 
> 32 tednov 20 tednov > 32 tednov
• Only use Kromeya Vial Kit if your healthcare professional has trained you how to use it correctly. 
• Zdravilo Kromeya komplet z vialo lahko uporabljate le, če vas je zdravstveni delavec naučil,
RA Study II a** 
Študija revmatoidnega artritisa II a**
3.2 Check the label to make sure that: 
3.2 Preverite nalepko, ali:
Kromeya is administered via subcutaneous injection. 
Zdravilo Kromeya se odmerja v obliki subkutane injekcije.
Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab. 
Pri bolnikih, ki so dobivali adalimumab, so opaţali oportunistične okuţbe, vključno z invazivnimi glivičnimi okuţbami.
Transparent syringe housing 
PODATKI NA ZUNANJI OVOJNINI
Low dose 20/10 mg eow p value 
Nizek odmerek 20/10 mg vsak drugi teden p vrednost
Check with your doctor before your child receives any vaccines. 
Preden vaš otrok opravi kakršno koli cepljenje, se posvetujte z zdravnikom.
2.5 Wipe the entire vial top with an alcohol pad and throw the pad away. 
2.5 Očistite površino pod pokrovčkom z zloţencem, prepojenim z alkoholom, ki ga nato zavrţete.
Phase 
Masa
Adalimumab 40 mg eow N=109 
Adalimumab 40 mg vsak drugi teden N = 109
In case there is a need for a more rapid response to therapy, the regimen 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), 80 mg at week 2 (given as two 40 mg injections in one day), can be used with the awareness that the risk for adverse events is higher during induction. 
Če je potreben hitrejši odziv na zdravljenje, lahko uporabite shemo 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekcija v enem dnevu).
Your child's doctor may prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose. 
Otrokov zdravnik lahko predpiše začetni odmerek 80 mg, ki se ga uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
a p Value b 
vrednost p
If you get any side effects, talk to your doctor or pharmacist. 
Če opazite katerega koli izmed neţelenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
• Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections. 
• Zdravniku povejte, če je vaš otrok imel v preteklosti ponavljajoče se okuţbe ali druge bolezni,
NA 
Po
• Do not shake. 
• ne pušča,
Refer to Storage information for -how to store your unused syringe(s). 
Za navodila za shranjevanje neuporabljene injekcijske brizge (neuporabljenih injekcijskih brizg) glejte poglavje Navodila za shranjevanje.
Warning: Do not remove the clear needle cap. 
Opozorilo: Ne odstranite prozornega pokrovčka na igli.