natgillin/translations-raw huggingface dataset:
* p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline 
* p < 0,001 za parne primerjave deležev med adalimumabom in placebom ** p < 0,02 za parne primerjave deležev med adalimumabom in placebom a od tistih, ki so izhodiščno dobivali kortikosteroide
• blockage in an artery of the lung; 
• zamašitev arterije v pljučih;
In controlled Phase 3 trials of adalimumab in patients with plaque Psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥ 3 x ULN occurred in 1.8% of adalimumabtreated patients and 1.8% of control-treated patients. 
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s psoriazo v plakih in s trajanjem kontrolnega obdobja od 12 do 24 tednov se je zvišanje ALT ≥ 3 × ULN pojavilo pri 1,8 % bolnikov, zdravljenih z adalimumabom, in pri 1,8 % bolnikov v kontrolni skupini.
In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment. 
Pri odraslih bolnikih s psoriazo je bila povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja med monoterapijo s 40 mg adalimumaba vsak drugi teden 5 µg/ml.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hulio 40 mg/0.8 ml injection adalimumab 
IME ZDRAVILA IN POT(I) UPORABE Hulio 40 mg/0,8 ml injekcija adalimumab s.c.
• Check the expiry date printed on the pen. 
• Preverite rok uporabnosti zdravila, ki je natisnjen na injekcijskem peresniku.
Placebo/MTXAdalimumab /MTX (95% Confidence Intervalb) 
40 mg vsak drugi teden placebo/MTXadalimumab/MTX (95-% interval zaupanjab)
Dose Preparation 
Priprava odmerka
The combination of Hulio and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”). 
Kombinacija zdravila Hulio in anakinre ni priporočljiva (glejte poglavje 4.4 ''Sočasna uporaba bioloških DMARD ali antagonistov TNF'').
Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/ml (without concomitant methotrexate) and 8 to 9 μg/ml (with concomitant methotrexate), respectively. 
Po subkutani uporabi 40 mg adalimumaba vsak drugi teden pri odraslih bolnikih z revmatoidnim artritisom (RA) so bile povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja približno 5 µg/ml (brez sočasne uporabe metotreksata) in od 8 do 9 µg/ml (s sočasno uporabo metotreksata).
Table 9: Radiographic Mean Changes Over 12 Months in RA Study III 
Preglednica 9: Povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
• It is important that you tell your baby's doctors and other health care professionals about your Hulio use during your pregnancy before the baby receives any vaccine. 
Pomembno je, da poveste dojenčkovemu zdravniku in drugim zdravstvenim delavcem o uporabi zdravila Hulio med nosečnostjo, preden dojenček dobi cepivo.
Step 8 - Pull plunger to draw dose + 0.1 ml Keep the plunger rod pressed down and turn the connected syringe and vial upside down. 
8. korak - Povlecite bat, da izvlečete odmerek +0,1 ml.
Table 8: Ped ACR 30 Responses in the JIA study 
Preglednica 8: Odzivi »Ped ACR« 30 v študiji juvenilnega idiopatskega artritisa Stratum
In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Hulio should be considered prior to initiating therapy (see Other opportunistic infections). 
Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom Hulio pretehtati pri bolnikih, ki so bili izpostavljeni tuberkulozi, in bolnikih, ki so potovali na območja, kjer obstaja veliko tveganje tuberkuloze ali endemičnih mikoz, npr. histoplazmoze, kokcidioidomikoze ali blastomikoze (glejte Druge oportunistične okužbe).
Table 13: Paediatric Plaque Psoriasis Efficacy Results at 16 weeks 
Preglednica 13: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
If this dose does not work well enough, your child's doctor may increase the dose frequency to 20 mg every week. 
Če ta odmerek ne deluje dovolj dobro, lahko otrokov zdravnik poveča pogostnost odmerjanja na 20 mg vsak teden.
The recommended Hulio dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection. 
Priporočeni odmerek zdravila Hulio je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
CD Study I and CD Study II induction of remission and response rates are presented in Table 22. 
Indukcijo remisije in deleže odziva v študiji Crohnove bolezni I in študiji Crohnove bolezni II prikazuje preglednica 22.
In CD Study I, 299 TNF-antagonist naive 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. 
V študiji Crohnove bolezni I je bilo 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg adalimumaba 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.
Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks. 
Preiskovanci, pri katerih je v dvojno slepem obdobju prišlo do ponovnega zagona bolezni, so kot rešilno zdravljenje prejemali adalimumab 40 mg vsak drugi teden vsaj 12 tednov.
The recommended dose of Hulio for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5). 
Priporočeni odmerek zdravila Hulio pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg: The recommended dose of Hulio is an initial dose of 20 mg, followed by 20 mg one week later, Thereafter the usual dose is 20 mg every other week. 
Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo od 15 kg do manj kot 30 kg: Priporočeni odmerek zdravila Hulio je začetni odmerek 20 mg, ki mu sledi 20 mg en teden kasneje.
Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphataemia, dehydration 
Presnovne in prehranske motnje zelo pogosti zvišanje lipidov pogosti hipokaliemija, hiperurikemija, nenormalni nivo natrija v krvi, hipokalciemija, hiperglikemija, hipofosfatemija, dehidracija
Table 23: Induction of Clinical Remission and Response (Percent of Patients) 
Preglednica 23: Indukcija klinične remisije in odziva (odstotek bolnikov)
Opportunistic infections, including invasive fungal infections have been observed in patients receiving adalimumab. 
Pri bolnikih, ki so prejemali adalimumab, so opažali oportunistične okužbe, vključno z invazivnimi glivičnimi okužbami.
The decision to stop using Hulio should be discussed with your child's doctor. 
Če je vaš otrok prenehal uporabljati zdravilo Hulio O odločitvi, da bi prenehali uporabljati zdravilo Hulio, se morate posvetovati z otrokovim zdravnikom.
In adolescent patients with inadequate response to Hulio 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered. 
Pri mladostnikih z nezadostnim odzivom na zdravilo Hulio 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
After the needle is completely inserted, let go of the site you are squeezing. 
Ko je igla v celoti v koži, spustite stisnjeno kožo.
Table 24: Maintenance of Clinical Remission and Response (Percent of Patients) 
Preglednica 24: Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
Hulio is contraindicated in moderate to severe heart failure (see section 4.3). 
Pri bolnikih z zmernim do hudim srčnim popuščanjem je zdravilo Hulio kontraindicirano (glejte poglavje 4.3).
Table 11: Radiographic Mean Changes Over 12 Months in RA Study III 
Preglednica 11: Povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
Adalimumab 40 mg eow N=814 n (%) 
adalimumab 40 mg vsak 2. teden n = 814 n (%)
• You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Hulio injection. 
Premislite o uporabi ustrezne kontracepcije za preprečitev nosečnosti in nadaljujte z njeno uporabo še najmanj 5 mesecev po tem, ko prejmete zadnjo injekcijo zdravila Hulio.
Step 16 - Dispose syringe & needle Each vial, syringe, vial adapter and needle are for single-use only. 
Vsaka viala, brizga, adapter za vialo in igla so namenjeni samo za enkratno uporabo.
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. 
Pri odraslih bolnikih s hidradenitis suppurativa doseže odmerek 160 mg adalimumaba 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, najnižjo koncentracijo adalimumaba v serumu približno 7 do 8 µg/ml v 2. tednu in v 4. tednu.
o DO NOT use the syringe if the liquid is cloudy, discoloured, or has particles in it. 
◦ Injekcijske brizge NE uporabljajte, če je tekočina motna, razbarvana ali vsebuje delce.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine. 
Ankilozirajoči spondilitis in aksialni spondiloartritis brez radiografskega dokaza o ankilozirajočem spondilitisu sta vnetni bolezni hrbtenice.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE 
PODATKI, NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - NAPOLNJENA INJEKCIJSKA BRIZGA
EU/1/18/1319/005 2 pack 
EU/1/18/1319/002 2 pakiranji
If this dose does not work well enough, your doctor may increase the dose frequency to 20 mg every week. 
Če ta odmerek ne deluje dovolj dobro, lahko zdravnik poveča pogostnost odmerjanja na 20 mg vsak teden.
56 patients (69.1%) had ACR 50 responses; and 43 patients (53.1%) had ACR 70 responses. 
Med temi je 64 bolnikov (79,0 %) imelo odziv 20 po ACR; 56 bolnikov (69,1 %) je imelo odziv 50 po ACR in 43 bolnikov (53,1 %) je imelo odziv 70 po ACR.
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 Hulio. 
Pred in med zdravljenjem z zdravilom Hulio je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so v preteklosti prejemali PUVA.
Adalimumab 40 mg eow N=108 n (%) 
adalimumab 40 mg vsak 2. teden n = 108 n (%)
No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis). 
Pri 249 pediatričnih bolnikih z juvenilnim idiopatskim artritisom (s poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), ki so bili med preskušanji adalimumaba učinkovini izpostavljeni 655,6 bolnikov-let, niso ugotovili nobenega malignoma.
If your child develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of feet), you must contact your child's doctor immediately. 
Če se simptomi srčnega popuščanja (npr. težko dihanje ali otekanje stopal) pri otroku pojavijo na novo ali se poslabšajo, se morate takoj posvetovati z otrokovim zdravnikom.
This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'. 
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v 0,8 ml odmerku, kar v bistvu pomeni ''brez natrija''.
Hulio Dose for Patients with Enthesitis-Related Arthritis Patient Weight 
Preglednica 2: Odmerjanje zdravila Hulio pri bolnikih z artritisom, povezanim z entezitisom
Table 9: ACR Responses in Placebo-Controlled Trials (Percent of Patients) 
Preglednica 9: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
Table 6: Undesirable Effects 
Preglednica 6: Neželeni učinki Organski sistem Pogostnost
Vertigo and visual impairment may occur following administration of Hulio (see section 4.8). 
Po dajanju zdravila Hulio se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
What you need to know before giving your child Hulio Do not give Hulio - If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6). 
- če je vaš otrok alergičen na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Table 7: ACR Responses in Placebo-Controlled Trials (Percent of Patients) 
Preglednica 7: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
ACR 50 week 12 week 24 
ACR 50 12. teden 24. teden np np
If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately. 
Če se simptomi srčnega popuščanja (npr. težko dihanje ali otekanje nog) pojavijo na novo ali se poslabšajo, se morate takoj posvetovati z zdravnikom.
Beyond 16 weeks, patients with inadequate response to Hulio 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week. 
Od 16. tedna dalje lahko bolnikom z nezadostnim odzivom na zdravilo Hulio 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of adalimumab-treated patients and 1.6% of control-treated patients. 
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom s trajanjem kontrolnega obdobja od 4 do 104 tedne so se zvišanja ALT ≥ 3 × ULN (Upper Limits of Normal - zgornja normalna meja) pojavila pri 3,7 % bolnikov, zdravljenih z adalimumabom, in pri 1,6 % bolnikov v kontrolni skupini.
Table 8: ACR Responses in RA Study V (percent of patients) 
Preglednica 8: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
The recommended dose of Hulio for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2). 
Priporočeni odmerek zdravila Hulio pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
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. 
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.
In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥ 3 x ULN occurred in 0.3% of adalimumab-treated patients and 0.6% of control-treated patients. 
V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg v 0. tednu, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu), pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov se je zvišanje ALT
• DO NOT inject into scars or stretch marks. 
• NE injicirajte v brazgotine ali strije.
Hulio is for subcutaneous injection. 
Zdravilo Hulio je namenjeno za subkutano injiciranje.
adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9). 
Pri bolnikih, ki so dobivali adalimumab in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 9) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
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 (DMARD).
Table 10: Radiographic Mean Changes at week 52 in RA Study V 
Preglednica 10: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
In monotherapy, some patients who experience a decrease in their response to Hulio 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week. 
Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Hulio 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi teden.
The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially, followed by 40 mg every other week starting two weeks later. 
Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg (kot dve 40 mg injekciji v enem dnevu) na začetku, čemur sledi 40 mg vsak drugi teden z začetkom dva tedna kasneje.
Some patients who experience decrease in their response to Hulio 40 mg every other week may benefit from an increase in dosage to 40 mg Hulio every week or 80 mg every other week. 
Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Hulio 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Hulio na 40 mg vsak teden ali na 80 mg vsak drugi teden.
The patients received 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks. 
Bolniki so vsaj 24 tednov prejemali adalimumab v odmerku 24 mg/m² telesne površine (in do največ 20 mg) vsak drugi teden kot enkraten odmerek v subkutani injekciji.
QUALITATIVE AND QUANTITATIVE COMPOSITION Hulio 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab. 
Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
Hulio Dose for Paediatric Patients with Plaque Psoriasis Patient Weight 
Preglednica 3: Odmerjanje zdravila Hulio pri pediatričnih bolnikih s psoriazo v plakih
Following the administration of 24 mg/m2 (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. 
Po uporabi 24 mg/m² (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, 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 sočasnega odmerjanja 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 %).
• DO NOT use the pen if the needle cap is missing or not securely attached. 
• NE uporabljajte injekcijskega peresnika, če je brez pokrovčka igle ali če pokrovček ni trdno nameščen.
Clinical response is decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the rectal bleeding subscore [RBS] ≥1 or an absolute RBS of 0 or 1; * p<0.05 for adalimumab vs. placebo pairwise comparison of proportions **p<0.001 for adalimumab vs. placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline 
Klinični odziv pomeni znižanje ocene Mayo od začetka za ≥ 3 točke in ≥ 30 % ter znižanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1.
Table 10: ACR Responses in RA Study V (percent of patients) 
Preglednica 10: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in pre-filled pen 
Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Hulio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
It is recommended that your child uses an antiseptic wash daily on the affected areas. 
Priporočljivo je, da vaš otrok na prizadetih predelih vsak dan uporabi antiseptično milo.
Preparing the pre-filled syringe 
Priprava napolnjene injekcijske brizge
Hulio 40 mg solution for injection in pre-filled syringe adalimumab 
Hulio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
Children or adolescents from 6 to 17 years weighing less than 40 kg: 
Otroci ali mladostniki, stari od 6 do 17 let, ki tehtajo manj kot 40 kg:
Step 7 - Attach syringe to vial adapter and push plunger rod Hold the syringe on the graduated area and remove it from the packaging. 
7. korak -Namestite brizgo na adapter za vialo in potisnite nosilec bata.
• 6 pre-filled syringes (with 6 alcohol pads) 
• 6 napolnjenih injekcijskih brizg (s 6 alkoholnimi zloženci)
Each Hulio pre-filled syringe contains 38.2 mg of sorbitol. 
Vsaka napolnjena injekcijska brizga zdravila Hulio vsebuje 38,2 mg sorbitola.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/004 1 pack 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1319/001 1 pakiranje
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/008 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1319/008
• DO NOT touch the vial stopper after wiping with the alcohol pad. 
• Potem, ko ste zaporko viale obrisali z alkoholnim zložencem, se zaporke NE DOTIKAJTE.
14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031 
20 tednov > 32 tednov 14 tednov a Odzivi »Ped ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo.
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.
Your child's doctor will test your child for HBV. Hulio can reactivate HBV infection in people who carry this virus. 
Zdravnik bo vašega otroka testiral na HBV.
In Period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0, 80 mg at week 2, and 40 mg every week starting at week 4 to week 11. 
V obdobju A so bolniki prejemali placebo ali adalimumab v začetnem odmerku 160 mg v 0. tednu, nato 80 mg v 2. tednu in 40 mg vsak teden od 4. tedna do 11. tedna.
Hulio is also available as a pre-filled syringe or a pre-filled pen. 
Zdravilo Hulio je na voljo tudi v napolnjeni injekcijski brizgi ali napolnjenem injekcijskem peresniku.
DO NOT twist the needle cap. 
NE VRTITE pokrovčka igle.