natgillin/translations-raw huggingface dataset:
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.
In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p<0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
V študiji pri psoriazi I so 33. teden ''izgubo ustreznega odziva'' zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov, ki so še naprej dobivali adalimumab (p < 0,001).
Placebo/ MTXa
placebo/MTXa adalimumab/MTX
Table 12: Radiographic Mean Changes at week 52 in RA Study V
Preglednica 12: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
• DO NOT re-cap the needle.
• Pokrovčka NE nameščajte nazaj na iglo.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/007
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1319/007
RA Study IIIa**
Študija revmatoidnega artritisa IIIa**
Step 3 - Partially open syringe and needle packaging Partially peel open the syringe package from the end closest to the white plunger rod.
Delno odprite ovojnino injekcijske brizge tako, da jo odlepite od konca, ki je najbližji belemu nosilcu bata.
Follow the steps below carefully each time you inject Hulio:
Pri vsakem injiciranju zdravila Hulio natančno sledite naslednjim korakom:
• 1 pre-filled syringe
• 1 napolnjen injekcijski peresnik;
Hulio 40 mg/0.8 ml solution for injection
IME ZDRAVILA Hulio 40 mg/0,8 ml raztopina za injiciranje
If a faster response is required, your child's doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.
Če je potreben hitrejši odziv, lahko zdravnik vašemu otroku predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
Follow the below steps carefully each time you inject Hulio pre-filled syringe:
Pri vsakem injiciranju zdravila Hulio v napolnjeni injekcijski brizgi natančno sledite naslednjim korakom:
Low Dose 20/10 mg eow N = 95
Majhni odmerek 20/10 mg vsak drugi teden N = 95
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.
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.
CD Study II: Infliximab Experienced Patients
Študija pri Crohnovi bolezni I: Bolniki, ki še niso dobivali infliksimaba
In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 μg/ml during the induction period.
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg adalimumaba 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, v obdobju indukcije najmanjšo koncentracijo v serumu približno 5,5 µg/ml.
Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali sindrom, podoben lupusu, pojavili pri 2 od 3441 bolnikov, zdravljenih z adalimumabom.
EU/1/18/1319/006 6 pack
EU/1/18/1319/003 6 pakiranj
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
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.
Step 13 - Squeeze injection site
13. korak - Stisnite injekcijsko mesto.
The recommended Hulio 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).
Priporočena shema odmerjanja zdravila Hulio 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).
Fill Marker
Pokrovček igle
These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week 12.
To kaže, da lahko nadaljnje vzdrževalno zdravljenje do 12. tedna koristi nekaterim bolnikom, ki se ne odzovejo do 4. tedna.
2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion 3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post
1 vrednost p za primerjavo standardnega odmerka proti majhnemu odmerku 2 Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva.
Hulio 40 mg solution for injection (injection) in vials is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml clear or slightly opalescent, colourless to pale brownish-yellow solution.
Zdravilo Hulio 40 mg raztopina za injiciranje (injekcija) v vialah je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,8 ml bistre ali rahlo opalescentne, brezbarvne do rahlo rjavorumene raztopine.
The recommended dose of Hulio for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Priporočeno odmerjanje zdravila Hulio za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
Hulio 40 mg solution for injection in pre-filled pen Hulio 40 mg solution for injection in single-use pre-filled pen containing a pre-filled syringe.
Zdravilo Hulio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki vsebuje napolnjeno injekcijsko brizgo.
The recommended dose of Hulio is an initial dose of 80 mg (two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Priporočeno odmerjanje zdravila Hulio je začetni odmerek 80 mg (dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
The recommended dose of Hulio for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Priporočeni začetni odmerek zdravila Hulio za odrasle bolnike z uveitisom je 80 mg, čemur sledi 40 mg odmerek vsak drugi teden, ki se ga začne dajati en teden po začetnem odmerku.
The recommended Hulio dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Priporočena shema odmerjanja zdravila Hulio pri odraslih bolnikih s hidradenitis suppurativa (HS) je na začetku 160 mg na 1. dan (aplicirano v obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (aplicirano v obliki dveh 40 mg injiciranj v enem dnevu).
Step 3 - Prepare injection site Wipe the skin at the chosen injection site with an alcohol swab.
Očistite kožo na izbranem injekcijskem mestu z alkoholnim zložencem.
Discontinuation of Hulio 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 Hulio.
• increased sweating;
• povečano potenje;
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 deluje dovolj dobro, lahko otrokov zdravnik poveča odmerek na 40 mg vsak teden ali 80 mg vsak drugi teden.
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:
Hulio is administered via subcutaneous injection.
Zdravilo Hulio se uporablja kot subkutana injekcija.
• inflammation of blood vessels;
• vnetje krvnih žil;
In 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 bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo adalimumaba v serumu približno 12 µg/ml.
The usual dose regimen is 80 mg initially (as two 40 mg injections in one day), followed by 40 mg two weeks later.
Običajni začetni odmerek je 80 mg (dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
6 months 12 months
6 mesec ev
At 10 years, 79 of 207 patients originally treated with 40 mg adalimumab every other week were evaluated radiographically.
Po 10 letih so rentgenografsko ocenili 79 od 207 bolnikov, ki so bili zdravljeni s 40 mg adalimumaba vsak drugi teden.
ACR 70 week 12 week 24
ACR 70 12. teden 24. teden np np
Children and adolescents from 6 to 17 years of age weighing 15 kg to less than 30 kg: The recommended dose of Hulio is 20 mg every other week.
Otroci in mladostniki z artritisom, povezanim z entezitisom Otroci in mladostniki, stari od 6 do 17 let, ki tehtajo od 15 kg do manj kot 30 kg: Priporočeni odmerek zdravila Hulio je 20 mg vsak drugi teden.
p-valuea pvalueb pvaluec
vrednost pa vrednost pb vrednost pc
Hulio 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml clear or slightly opalescent, colourless to pale brownish-yellow solution.
Zdravilo Hulio 40 mg raztopina za injiciranje (injekcija) v napolnjenem injekcijskem peresniku je na voljo kot sterilna raztopina 40 mg adalimumaba, raztopljenega v 0,8 ml bistre ali rahlo opalescentne, brezbarvne do rahlo rjavo-rumene raztopine.
Week 104 56.0% 49.3%
104. teden 56,0 % 49,3 % 69,4 % 0,002 < 0,001 0,140
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with adalimumab and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11,9 % prejemnikov adalimumaba in 8,1 % prejemnikov placeba in primerjalnega zdravila, ki so imeli izhodiščno negativne titre protijedrnih protiteles.
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 deluje dovolj dobro, lahko zdravnik poveča odmerek na 40 mg vsak teden ali 80 mg vsak drugi teden.
If a faster effect is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week.
Če je potreben hitrejši učinek, vam zdravnik lahko predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje in potem 40 mg vsak drugi teden.
The recommended dose of Hulio is an initial dose of 40 mg, followed by 40 mg one week later, Thereafter the usual dose is 40 mg every other week.
Priporočeni odmerek zdravila Hulio je začetni odmerek 40 mg, ki mu sledi 40 mg en teden kasneje.
Follow the steps below carefully each time you inject Hulio pre-filled pen:
Pri vsakem injiciranju zdravila Hulio v napolnjenem injekcijskem peresniku natančno sledite naslednjim korakom:
Plunger Rod
Nosilec bata
• DO NOT shake the syringe.
• NE iztiskajte zračnih mehurčkov.
Ask your doctor or nurse if there is anything you do not understand.
Če česa ne razumete, vprašajte zdravnika ali medicinsko sestro.
The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Odrasli z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa Običajni začetni odmerek za odrasle z neinfekcijskim uveitisom je 80 mg (kot dve injekciji v enem dnevu), čemur sledi odmerek 40 mg, ki se ga daje vsak drugi teden, z začetkom en teden po začetnem odmerku.
The usual Hulio dose for adults with ulcerative colitis is 160 mg initially (given as four 40 mg injections in one day, or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later, and then 40 mg every other week.
Običajni začetni odmerek zdravila Hulio pri odraslih z ulceroznim kolitisom je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje, nato pa 40 mg vsak drugi teden.
• skin flushing;
• zardevanje kože;
o DO NOT use the syringe if past the expiry date.
◦ Injekcijske brizge NE uporabljajte, če je rok uporabnosti že potekel.
6 months 6.7% 52.4% 8.2% 22.1% 9.5% 39.1% 12 months
52. teden 62,6 % 54,4 % 72,8 % 0,013 < 0,001 0,043
• irregular heart beat;
• neenakomerno bitje srca;
Children and adolescents from 2 to 17 years of age weighing 10 kg to less than 30 kg: The recommended dose of Hulio is 20 mg every other week.
Otroci in mladostniki s poliartikularnim juvenilnim idiopatskim artritisom Otroci in mladostniki, stari od 2 do 17 let, ki tehtajo od 10 kg do manj kot 30 kg: Priporočeni odmerek zdravila Hulio je 20 mg vsak drugi teden.
Check with child's doctor before receiving any vaccines.
Preden opravite kakršno koli cepljenje, se posvetujte z otrokovim zdravnikom.
The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same day) two weeks later.
Običajni začetni odmerek pri hidradenitis suppurativa je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan v dveh zaporednih dnevih), ki mu sledi odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
Patients who achieved sustained remission for at least 12 weeks
Bolnike, ki so imeli 33. teden ohranjen odziv
It is important to tell your child's doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems.
Pomembno je, da otrokovemu zdravniku poveste, če se pri vašem otroku pojavijo simptomi, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160/80 mg or 80/40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg.
Pediatrični bolniki z zmerno do hudo Crohnovo boleznijo so odvisno od njihove telesne mase (več ali manj kot 40 kg) dobivali odprt začetni odmerek adalimumaba 160/80 mg v 0. tednu ali 80/40 mg v 2. tednu.
ASDASc Inactive Disease
Disease Activity Index)
• If your child has psoriasis, DO NOT inject into any raised,
• Če ima vaš otrok psoriazo, NE injicirajte v izbočene, debele, pordele ali luskave predele kože ali lezije.
Standard dose
Majhni odmerek Standardni odmerek
Also this medicine contains less than 1 mmol of sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje tudi manj kot 1 mmol natrija (23 mg) na vialo, kar v bistvu pomeni ''brez natrija''.
Treatment with Hulio must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom Hulio prekiniti.
6 months 13.3% 65.1% 19.1% 46.0% 29.5% 63.3% 12 months
52. teden 45,9 % 41,2 % 61,6 % < 0,001 < 0,001 0,317
Low dose
Začetni odmerek
Week 52 27.2% 25.9%
52. teden 27,2 % 25,9 % 45,5 % < 0,001 < 0,001 0,656
Children or adolescents from 6 to 17 years weighing 40 kg or more:
Otroci ali mladostniki, stari od 6 do 17 let, ki tehtajo 40 kg ali več:
***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
2, 12 in 24 tednih a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis
Adalimumabb n=113
adalimum abb n = 113
Table 12: Ped ACR 30 Responses in the JIA study
Odziv »Ped ACR« 30
Step 4 - Uncap vial and wipe vial stopper Pop off the white plastic cap from the vial to expose the vial stopper.
4. korak - Odstranite pokrovček z viale in obrišite zaporko viale.
thick, red, or scaly skin patches, or lesions.
modrice, krvavitve, bledica.
Hulio therapy should not be continued in patients failing to respond within this time period.
Pri bolnikih, ki se v tem času ne odzovejo, zdravljenja z zdravilom Hulio ni priporočljivo nadaljevati.
Hulio Dose for Paediatric Patients with Uveitis Patient Weight
Preglednica 5: Odmerjanje zdravila Hulio pri pediatričnih bolnikih z uveitisom
STATEMENT OF ACTIVE SUBSTANCE(S) 0.8 ml vial contains 40 mg adalimumab.
NAVEDBA ENE ALI VEČ UČINKOVIN 0,8 ml viala vsebuje 40 mg adalimumaba.
Also this medicine contains less than 1 mmol of sodium (23 mg) per pre-filled syringe, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje tudi manj kot 1 mmol natrija (23 mg) v napolnjeni injekcijski brizgi, kar v bistvu pomeni, ''brez natrija''.
Keep the syringe in the outer carton in order to protect from light.
Peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
After injection, if slight bleeding occurs from the injection site, lightly press a gauze or cotton ball against the site for a few seconds.
V tem primeru z gazo ali kosmom vate nekaj sekund rahlo pritiskajte na injekcijsko mesto.
RA Study Ia**
Študija revmatoidnega artritisa Ia**