natgillin/translations-raw huggingface dataset:
*** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
*** p < 0,001 za vse primerjave med adalimumabom in placebom * p < 0,05 za vse primerjave med adalimumabom in placebom
• Take a single pre-filled syringe out of the fridge at least 30 minutes before you intend to use it to allow the contents to reach room temperature.
• Eno napolnjeno injekcijsko brizgo vzemite iz hladilnika najmanj 30 minut pred predvideno uporabo, da se vsebina segreje na sobno temperaturo.
In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab /methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
V študiji revmatoidnega artritisa V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji z adalimumabom in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji z adalimumabom; to se je ohranilo do 104. tedna.
Hulio 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.
Zdravilo Hulio 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.
RA Study IIa**
Študija revmatoidnega artritisa IIa**
The double-blind period was followed by an openlabel period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Dvojno slepi fazi je sledila odprta faza, v kateri so bolniki prejemali adalimumab 40 mg vsak drugi teden subkutano do dodatnih 144 tednov.
Gently flip the pink needle cover over the needle and snap into place.
Previdno obrnite rožnati pokrovček igle navzgor, čez iglo, da se zaskoči na mestu.
< 40 kg • 40 mg at week 0 and 20 mg at week 2
< 40 kg • 40 mg v 0. tednu in 20 mg v 2. tednu
Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Zdravilo Hulio je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom, pri bolnikih, starih 6 let in več, ki so se nanj neustrezno odzvali ali so intolerantni za običajno zdravljenje (glejte poglavje 5.1).
Table 28: Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients) Placebo
Preglednica 28: Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Hulio treatment.
Ženske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom Hulio.
If these medicines do not work well enough, you will be given Hulio to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom, dobili zdravilo Hulio.
The combination of Hulio and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Kombinacija zdravila Hulio in abatacepta ni priporočljiva (glejte poglavje 4.4 ''Sočasna uporaba bioloških DMARD ali antagonistov TNF'').
Your child's doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual recommended dose.
Zdravnik lahko vašemu otroku predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim priporočenim odmerkom.
Fever, bruising, bleeding or looking pale
Zvišana telesna temperatura, podplutbe, krvavitve ali bledica
506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p<0.001, adalimumab vs. placebo
506 (62,2)b a Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center.
Adalimumab treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Pri bolnikih, zdravljenih z adalimumabom, so v primerjavi s placebom 24. teden ugotovili statistično značilno izboljšanje telesnega delovanja, ocenjeno s HAQ in vprašalnikom SF-36 (Short Form Health Survey).
It is important that you tell the baby's doctors and other health care professionals about Hulio use during your child's pregnancy so they can decide when your child's baby should receive any vaccine.
Zato je pomembno, da obvestite zdravnika otrokovega dojenčka in druge zdravstvene delavce, da je vaš otrok med nosečnostjo prejemal zdravilo Hulio, da se lahko odločijo, kdaj bo dojenček vašega otroka lahko prejel katero koli cepivo.
• DO NOT hold the syringe by the plunger rod.
• NE DRŽITE brizge za nosilec bata.
Table 22: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
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
JSN score 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
Seštevek JSN 2,0 (1,2-2,8) 1,3 (0,5-2,1) 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.
The recommended Hulio dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Priporočeni odmerek zdravila Hulio pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
Hulio 40 mg/0.8 ml solution for injection adalimumab
Hulio 40 mg/0,8 ml raztopina za injiciranje adalimumab
In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see Table 10).
V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom in monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 10).
Placebo Adalimumab 40 mg weekly
placebo adalimumab 40 mg vsak teden placebo adalimumab 40 mg vsak teden
In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
V odprtem podaljšanju študije revmatoidnega artritisa V je bila povprečna sprememba celotne Sharpove ocene v 10. letu pri bolnikih, ki so jih na začetku randomizirali na monoterapijo z metotreksatom, monoterapijo z adalimumabom in kombinacijo adalimumaba/metotreksata, glede na izhodišče 10,8, 9,2 oz. 3,9.
Hulio is used to treat moderate to severe plaque psoriasis in adults.
Zdravilo Hulio se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
Each pre-filled syringe or pre-filled pen contains 38.2 mg sorbitol (E420).
Ena napolnjena injekcijska brizga ali napolnjen injekcijski peresnik vsebuje 38,2 mg sorbitola (E420).
Solution for injection 1 pre-filled pen, 2 alcohol pads 2 pre-filled pens, 2 alcohol pads 6 pre-filled pens, 6 alcohol pads
1 napolnjen injekcijski peresnik, 2 alkoholna zloženca 2 napolnjena injekcijska peresnika, 2 alkoholna zloženca 6 napolnjenih injekcijskih peresnikov, 6 alkoholnih zložencev
The mean steady-state trough concentration at week 12 through week 36 were approximately 8 to 10 μg/ml during adalimumab 40 mg every week treatment.
Najnižja koncentracija v stanju dinamičnega ravnovesja je bila približno 8 do 10 µg/ml med 12. tednom in 36. tednom pri zdravljenju z odmerkom 40 mg adalimumaba vsak teden.
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.
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.
Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label adalimumab treatment for an additional 26 weeks.
Bolniki so prejeli začetni odmerek 80 mg adalimumaba, ki mu je sledil odmerek 40 mg vsak drugi teden (z začetkom en teden po začetnem odmerku), ali pa placebo 26 tednov, čemur je sledilo odprto zdravljenje z adalimumabom dodatnih 26 tednov.
If your doctor considers that methotrexate is inappropriate, Hulio can be given alone.
Če vaš zdravnik meni, da metotreksat ni primeren, lahko zdravilo Hulio dobivate samo.
Hulio 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.
Zdravilo Hulio 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.
Hulio is also available as a vial for paediatric use or a pre-filled syringe.
Zdravilo Hulio je na voljo tudi v viali za uporabo pri otrocih ali napolnjeni injekcijski brizgi.
Hulio can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Zmanjša lahko tudi bolečino, ki je pogosto povezana s to boleznijo.
Hulio is used to treat psoriatic arthritis in adults.
Zdravilo Hulio se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
If your doctor determines that methotrexate is inappropriate, Hulio can be given alone.
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Hulio dobivate samo.
Table 18: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Preglednica 18: Delež bolnikov, ki so dosegli klinični odziv (HiSCRb) v 24. in 36. tednu po spremembi zdravljenja na jemanje adalimumaba vsak teden v 12. tednu placebo (ukinitev zdravljenja) N = 73
Hulio 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).
Zdravilo Hulio 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 ustrezno na konvencionalno sistemsko HS-zdravljenje (glejte poglavji 5.1 in 5.2).
4.5 Interaction with other medicinal products and other forms of interaction Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Adalimumab so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so adalimumab jemali v monoterapiji, kot pri tistih, ki so ga jemali hkrati z metotreksatom.
The blinded period was followed by an open − label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Slepljenemu obdobju je sledilo odprto obdobje, v katerem so bolniki dobivali 40 mg adalimumaba vsak drugi teden subkutano, do dodatnih 28 tednov.
Your doctor may recommend temporarily stopping Hulio.
Vaš zdravnik bo morda priporočil, da začasno prenehate z uporabo zdravila Hulio.
Do not use this medicine after the expiry date which is stated on the label/ carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Muscle spasms (including blood creatine phosphokinase increased)
Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti mišično-skeletne bolečine pogosti mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
Their doctor may recommend temporarily stopping Hulio.
Zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Hulio.
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 (v 24 tednu) in 0,0 ± 1,9; (p < 0,001) v skupini z adalimumabom (v 48 tednu).
Hulio is used to treat ulcerative colitis in adults.
Zdravilo Hulio se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
• DO NOT touch or pull back on the plunger at any time.
• Nikoli se NE dotikajte bata in ga ne vlecite nazaj.
Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Odziv »Ped ACR« 30 (n/N)
• Check the expiry date printed on the syringe.
• Preverite rok uporabnosti zdravila, ki je natisnjen na injekcijski brizgi.
Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Zdravilo Hulio je indicirano za zdravljenje aktivne, zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS-zdravljenje (glejte poglavji 5.1 in 5.2).
Double-Blind Response at week 12
Dvojno slepa Odziv v 12. tednu placebo N = 94
Patients were randomised to receive either 24 mg/m body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m² telesne površine adalimumaba do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteku roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
If your child gets any side effects, talk to your child's doctor or pharmacist.
Če vaš otrok dobi katerega koli izmed neželenih učinkov, se posvetujte z otrokovim zdravnikom ali farmacevtom.
Standard Dose 40/20 mg eow N = 93
Standardni odmerek 40/20 mg vsak drugi teden N = 93
Hulio is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Zdravilo Hulio se uporablja za zdravljenje ankilozirajočega spondilitisa in aksialnega spondiloartritisa brez radiografskega dokaza o ankilozirajočem spondilitisu pri odraslih.
Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at week 68 was 8.0 ± 4.6 µg/ml.
Po subkutanem dajanju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z neradiografskim aksialnim spondiloartritisom je bila povprečna (± SD) najmanjša koncentracija v stanju dinamičnega ravnovesja (merjena v 68. tednu) 8,0 ± 4,6 µg/ml.
Injection syringe
raztopina za injiciranje
In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 μg/ml.
Pri odraslih bolnikih z uveitisom je polnilni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil povprečno koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
You should rotate and change the injection site each time, staying at least 3 cm from the previous site used.
Ob vsakem injiciranju izberite drugo injekcijsko mesto, ki je vsaj 3 cm od mesta prejšnje injekcije.
Gently place the syringe on a clean, flat surface.
Brizgo previdno odložite na čisto, ravno delovno površino.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hulio 40 mg injection adalimumab
IME ZDRAVILA IN POT(I) UPORABE Hulio 40 mg injekcija adalimumab s.c.
Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing at least 30 kg
Mladostniki s hidradenitis suppurativa, stari od 12 do 17 let, ki tehtajo najmanj 30 kg
If these medicines do not work well enough, your child will be given Hulio to treat his/her polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom, prejel zdravilo Hulio.
Sustained Remission
Ohranjena remisija
• DO NOT inject into skin that is red, hard, bruised, or tender.
• NE injicirajte v pordelo, zatrdelo, podpluto ali občutljivo kožo.
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
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 ** p < 0,01, adalimumab v primerjavi s placebom
≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
≥ 40 kg • 80 mg v 0. tednu in 40 mg v 2. tednu
Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in single-use pre-filled syringe with an automatic needle guard.
Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi za enkratno uporabo, opremljeni s samodejnim ščitnikom za iglo.
Each Hulio vial contains 38.2 mg of sorbitol.
Vsaka viala zdravila Hulio vsebuje 38,2 mg sorbitola.
If these medicines do not work well enough your child will be given Hulio to reduce the signs and symptoms of his/her Crohn's disease.
Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zmanjšanje znakov in simptomov Crohnove bolezni prejel zdravilo Hulio.
o DO NOT put the syringe back in the fridge after it has reached room temperature.
◦ Injekcijske brizge NE dajte nazaj v hladilnik, ko se segreje na sobno temperaturo.
In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m² (do največ 40 mg) adalimumaba vsak drugi teden.
It is important that you tell your baby's doctors and other health care professionals about your Hulio use during your pregnancy so they can decide when your baby should receive any vaccine.
Zato je pomembno, da obvestite zdravnika svojega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Hulio, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katero koli cepivo.
o DO NOT use other heat sources such as a microwave oven or hot water to warm the syringe.
◦ Za segrevanje injekcijske brizge NE uporabljajte nobenih drugih virov toplote, kot je mikrovalovna pečica ali vroča voda.
It is recommended that your child uses an antiseptic wash daily on the affected areas during treatment with Hulio.
Priporočljivo je, da vaš otrok med zdravljenjem z zdravilom Hulio na prizadetih predelih vsak dan uporabi antiseptično milo.
Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Opomba: P = Placebo (število rizičnih preiskovancev (zagon bolezni)); A = adalimumab (število rizičnih preiskovancev (zagon bolezni)).
Your child's doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual recommended dose.
Zdravnik lahko vašemu otroku predpiše začetni odmerek 80 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim priporočenim odmerkom.
The third group received 40 mg of adalimumab every other week with placebo injections on alternate weeks.
Tretja pa je vsak drugi teden dobivala 40 mg adalimumaba in injekcije placeba vsak vmesni teden.
Place the Orange Activator end of the pen onto the injection site.
Del injekcijskega peresnika z oranžnim aktivatorjem postavite na injekcijsko mesto.
Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 16 weeks.
Bolniki so prejeli začetni odmerek 80 mg adalimumaba, ki mu je sledil 40 mg odmerek vsak drugi teden (z začetkom en teden po začetnem odmerku) ali placebo 16 tednov.
At a 45° angle to the injection site, use a quick, short motion and push the needle all the way into skin.
S hitrim, kratkim gibom zabodite iglo v celoti v kožo pod kotom 45° na injekcijsko mesto.
The pre-filled syringes should be stored in the fridge (between 2°C to 8°C).
Napolnjene injekcijske peresnike shranjujte v hladilniku (pri temperaturi od 2 do 8 °C).
• Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after their last Hulio injection.
Vaš otrok naj premisli o uporabi ustrezne kontracepcije za preprečitev nosečnosti in naj nadaljuje z njeno uporabo še najmanj 5 mesecev po tem, ko prejme zadnjo injekcijo zdravila Hulio.
The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
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 obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index)  12 ali  10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
Injecting Hulio
Injiciranje zdravila Hulio