natgillin/translations-raw huggingface dataset:
If you forget to give your child an injection, you should inject the next dose of Hulio as soon as you remember.
Če pozabite dati svojemu otroku injekcijo zdravila Hulio, mu morate odmerek zdravila Hulio injicirati takoj, ko se spomnite.
Hulio is administered every other week via subcutaneous injection.
Zdravilo Hulio se odmerja vsak drugi teden v obliki subkutane injekcije.
If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Če vam je zdravnik povedal, da imate (ali ima vaš otrok) intoleranco za nekatere sladkorje, ali če so vam odkrili dedno intoleranco za fruktozo (HFI), redko genetsko bolezen, pri kateri telo ne more razgraditi fruktoze, se posvetujte s svojim zdravnikom, preden začnete jemati (ali začne vaš otrok jemati) to zdravilo.
Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Hulio for patients with polyarticular juvenile idiopathic arthritis from 2 years, of age is based on body weight (Table 1).
Poliartikularni juvenilni idiopatski artritis od 2. leta starosti Priporočeni odmerek zdravila Hulio pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14).
Rezultati so v 12. tednu pokazali statistično pomembno izboljšanje znakov in simptomov aktivnega nraxSpA pri bolnikih, ki so bili zdravljeni z adalimumabom v primerjavi s placebom (preglednica 14).
What Hulio is and what it is used for What you need to know before giving your child Hulio How to use Hulio
Kaj je zdravilo Hulio in za kaj ga uporabljamo Kaj morate vedeti, preden bo vaš otrok prejel zdravilo Hulio Kako uporabljati zdravilo Hulio Možni neželeni učinki
Time to Treatment Failure in Studies UV I and UV II
Preglednica 24: Čas do neuspeha zdravljenja v študijah UV I in UV II
• 1 sharps disposal container (not included in Hulio pack)
• 1 vsebnik za odlaganje ostrih predmetov (ni priložen pakiranju zdravila Hulio);
By week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Rezultati do 68. tedna so pokazali statistično značilno izboljšanje znakov in simptomov aktivnega nr axSpA pri bolnikih, ki so neprekinjeno prejemali adalimumab, v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
General disorders and administration site conditions*
Splošne težave in spremembe na mestu aplikacije:*
Use one of the alcohol pads to wipe the stopper and then place the vial on a flat surface.
Uporabite enega od alkoholnih zložencev in z njim obrišite zaporko.
Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 18,9, izhodiščna zdravnikova globalna ocena (PGA - Physician's Global Assessment) pa je segala od ''zmerne'' (53 % vključenih preiskovancev) do ''hude'' (41 %) in ''zelo hude'' (6 %).
Table 7: Distribution of patients by age and adalimumab dose received during the OL LI phase
Preglednica 7: Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo
Hulio is used to treat children and adolescents aged 2 to 17 years with chronic non-infectious uveitis who have inflammation affecting the front of the eye.
Zdravilo Hulio se uporablja za zdravljenje otrok in mladostnikov, starih od 2 do 17 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
Hulio is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Zdravilo Hulio se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih zdravila, nanesena na kožo, in zdravljenje z UV-svetlobo niso dovolj dobro delovali ali pa niso primerni.
• Hulio can be used during breast-feeding.
Zdravilo Hulio se lahko uporablja med dojenjem.
In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 14 and 15).
V študijah psoriaze I in II je bila primarna končna točka delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 14 in 15).
Keep this Patient Reminder Card with you or your child at all times and for 4 months after your child's last injection of Hulio.
To opozorilno kartico za bolnika imejte vedno pri sebi ali naj jo ima pri sebi vaš otrok, kar velja še 4 mesece po zadnji injekciji zdravila Hulio, ki jo otrok prejme.
Preparing the Hulio dose for injection
Priprava odmerka zdravila Hulio za injiciranje
For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Hulio should be promptly discontinued.
Če se pri bolniku pojavijo znaki in simptomi, kot so zvišana telesna temperatura, splošno slabo počutje, hujšanje, znojenje, kašelj, dispneja in/ali pljučni infiltrati ali druga resna sistemska bolezen s sočasnim šokom ali brez njega, je treba posumiti na invazivno glivično okužbo.
This risk may increase if your lung function is reduced.
Tveganje je lahko večje, če imate oslabljeno delovanje pljuč.
What Hulio is and what it is used for What you need to know before you use Hulio How to use Hulio
Kaj je zdravilo Hulio in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Hulio Kako uporabljati zdravilo Hulio Možni neželeni učinki
JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Ocena erozij Ocena ZSŠd a metotreksat b 95 % intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom c na podlagi analize rangov d zožitev sklepne špranje
The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Varnost in učinkovitost adalimumaba so raziskali v randomiziranih, dvojno slepih študijah, kontroliranih s placebom, in v odprti podaljšani študiji pri odraslih bolnikih z zmerno do hudo obliko hidradenitis suppurativa (HS), ki imajo intoleranco, kontraindikacijo ali se ne odzovejo zadovoljivo na vsaj 3-mesečno preskušanje sistemske antibiotične terapije.
Your child's doctor may decide to stop treatment.
Morda se bo odločil, da otrokovo zdravljenje prekine.
Vaccine
Cepljenje
Hulio is used to treat hidradenitis suppurativa in adults, and adolescents from 12 years of age.
Zdravilo Hulio se uporablja za zdravljenje hidradenitis suppurativa pri odraslih in mladostnikih, starejših od 12 let.
The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Delež (95-% interval zaupanja) nemelanomskih kožnih rakov je bil 8,8 (6,0; 13,0) na 1000 bolnikov-let med bolniki, ki so prejemali adalimumab, in 3,2 (1,3; 7,6) na 1000 bolnikov-let med kontrolnimi bolniki.
Gently squeeze the injection site to create a raised area, and hold that area firmly.
Nežno stisnite kožo na injekcijskem mestu, da se površina dvigne, in jo čvrsto držite.
• pale complexion, dizziness, persistent fever, bruising or bleeding very easily.
• bledica, omotica, dolgotrajno zvišana telesna temperatura, hiter nastanek podplutb ali krvavitve.
When Hulio therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Na začetku zdravljenja z zdravilom Hulio se lahko pri bolnikih < 30 kg uporabi polnilni odmerek 40 mg in pri bolnikih ≥ 30 kg polnilni odmerek 80 mg en teden pred začetkom vzdrževalnega zdravljenja.
In CD Study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
V tej študiji je 854 bolnikov po odprtem protokolu dobilo 80 mg 0. teden in 40 mg 2. teden.
The recommended Hulio induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Priporočena shema odmerjanja zdravila Hulio med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivno Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
In CD Study I and CD Study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD Study III as well among the adalimumab treatment groups compared to the placebo group.
Študiji pri Crohnovi bolezni I in II sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, randomiziranih na shemi z adalimumabom 80/40 mg in 160/80 mg v primerjavi s placebom; razliko 26. in 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija pri Crohnovi bolezni III.
EU/1/18/1319/001 1 pack EU/1/18/1319/002 2 pack EU/1/18/1319/003 6 pack
EU/1/18/1319/004 1 pakiranje EU/1/18/1319/005 2 pakiranji EU/1/18/1319/006 6 pakiranj
• trouble breathing or swallowing;
• težave pri dihanju ali požiranju;
Hulio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Zdravilo Hulio je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
Table 17: Ps Study I (REVEAL) - Efficacy Results at 16 weeks Placebo N=398 n (%)
Preglednica 17: Študija pri psoriazi I (REVEAL) - Rezultati učinkovitosti po 16 tednih placebo n = 398 n (%)
• itching, inflammation of the skin (including eczema);
• srbenje, vnetje kože (vključno z ekcemom);
Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Zdravilo Hulio je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
Table 11: Distribution of patients by age and adalimumab dose received during the OL LI
Preglednica 11: Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo
Hepatosplenic T-cell lymphoma1) Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
redki levkemija1) neznana pogostnost hepatosplenični T-celični limfom1), karcinom Merklovih celic (nevroendokrini karcinom kože)1)
Note: P = Placebo (Number at Risk); H = adalimumab (Number at Risk).
Opomba: P = placebo (število rizičnih preiskovancev); H = adalimumab (število rizičnih preiskovancev)
• Check the expiry date printed on the vial.
• Preverite rok uporabnosti zdravila, ki je natisnjen na viali.
Preparing the Hulio injection
Priprava injekcije zdravila Hulio
Hulio is intended for the treatment of the following inflammatory diseases: - rheumatoid arthritis; - polyarticular juvenile idiopathic arthritis; - enthesitis-related arthritis; - ankylosing spondylitis; - axial spondyloarthritis without radiographic evidence of ankylosing spondylitis; - psoriatic arthritis; - psoriasis; - hidradenitis suppurativa; - Crohn's disease; - ulcerative colitis; - non-infectious uveitis in adults and children.
Zdravilo Hulio je namenjeno za zdravljenje naslednjih vnetnih bolezni: - revmatoidnega artritisa, - poliartikularnega juvenilnega idiopatskega artritisa, - artritisa, povezanega z entezitisom, - ankilozirajočega spondilitisa, - aksialnega spondiloartritisa brez radiografskega dokaza za ankilozirajoči spondilitis, - psoriatičnega artritisa, - luskavice (psoriaze), - hidradenitis suppurativa, - Crohnove bolezni, - ulceroznega kolitisa, - neinfekcijskega uveitisa pri odraslih in otrocih.
Amongst those who responded at week 16 (n=144), the Pediatric ACR 30/50/70/90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi ''Pediatric ACR'' 30/50/70/90 v odprti podaljšani fazi ohranili do 6 let pri tistih, ki so ves čas študije dobivali adalimumab.
If these medicines do not work well enough, you will be given Hulio.
Če ta zdravila ne delujejo dovolj dobro, boste dobili zdravilo Hulio.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - VIAL MULTIPACK (WITH BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - VEČKRATNO PAKIRANJE VIAL (Z MODRIM OKENCEM)
If your child has mild heart failure and are being treated with Hulio, your child's heart failure status must be closely monitored by the doctor.
Če ima vaš otrok blago srčno popuščanje in se zdravi z zdravilom Hulio, mora zdravnik natančno nadzorovati stanje srčnega popuščanja pri otroku.
Hulio Dose for Paediatric Patients with Crohn's disease
Preglednica 4: Odmerjanje zdravila Hulio pri pediatričnih bolnikih s Crohnovo boleznijo
Recheck the doctor's prescription for the correct prescribed amount.
Ponovno preverite, kolikšno količino je predpisal zdravnik.
• Take a single vial box out of the fridge at least 30 minutes before you intend to use it to allow the contents to reach room temperature.
• Škatlo z eno vialo vzemite iz hladilnika najmanj 30 minut pred predvideno uporabo, da se vsebina segreje na sobno temperaturo.
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab /methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Po 52 oz. 104 tednih zdravljenja je bil v skupini s kombinirano terapijo z adalimumabom in metotreksatom odstotek bolnikov brez napredovanja bolezni (sprememba prilagojene Sharpove ocene od izhodišča ≤ 0,5) značilno večji (63,8 % oz. 61,2 %) kot v skupinah, ki sta prejemali monoterapijo z metotreksatom (37,4 % in 33,5 %, p < 0,001) ali monoterapijo z adalimumabom (50,7 %, p < 0,002, oz. 44,5 %, p < 0,001).
If you have mild heart failure and you are being treated with Hulio your heart failure status must be closely monitored by your doctor.
Če imate blago srčno popuščanje in se zdravite z zdravilom Hulio, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
Patients who had been randomised to placebo in Period A were assigned to receive adalimumab 40 mg every week in period B.
Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdobju B prejemali adalimumab 40 mg vsak teden.
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali > 20 % zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
Table 16: ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Preglednica 16: Odziv ACR v študijah psoriatičnega artritisa, kontroliranih s placebom (odstotek bolnikov)
The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 μg/ml for patients ≥ 40 kg (160/80 mg) and 10.6±6.1 μg/ml for patients < 40 kg (80/40 mg).
Povprečne (± SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 µg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6,1 µg/ml pri bolnikih < 40 kg (80/40 mg).
SPARCCh MRI Sacroiliac Jointsd,i
SPARCCh MRI sakroiliakalnih sklepovd, i
If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or a rash, do not inject more Hulio and contact your doctor immediately since, in rare cases, these reactions can be life-threatening.
Če imate alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Hulio ne injicirajte več in se takoj posvetujte z zdravnikom, saj so v redkih primerih te reakcije lahko življenjsko ogrožajoče.
Hulio is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Zdravilo Hulio se uporablja za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih zdravila, nanesena na kožo, in zdravljenje z UV-svetlobo niso dovolj dobro delovali ali pa niso primerni.
• Do not give Hulio to children with plaque psoriasis below the age of 4 years.
• Zdravila Hulio ne smete dati otroku s psoriazo v plakih, če je star manj kot 4 leta.
The usual dose regimen is 40 mg initially, followed by 20 mg two weeks later.
Običajni začetni odmerek je 40 mg, ki mu sledi 20 mg dva tedna kasneje.
• If your child receives Hulio during her pregnancy, her baby may have a higher risk for getting an infection.
Če vaš otrok prejema zdravilo Hulio med nosečnostjo, ima lahko njegov dojenček povečano tveganje za okužbo.
Each pre-filled syringe is for single-use only and contains one 40 mg dose of adalimumab.
Vsaka napolnjena injekcijska brizga je namenjena samo za enkratno uporabo in vsebuje en 40 mg odmerek adalimumaba.
Placebo / MTXc n=60
placebo/M TXc n = 60
If these medicines do not work well enough, you will be given Hulio to treat your rheumatoid arthritis.
Če ta zdravila ne delujejo dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo Hulio.
The following side effects have been observed with adalimumab:
Pri uporabi adalimumaba so bili ugotovljeni naslednji neželeni učinki:
Adalimumab has not been studied in patients aged less than 2 years.
Študije z adalimumabom pri bolnikih, mlajših od 2 let, niso bile izvedene.
o DO NOT use the vial if past the expiry date.
◦ Viale NE uporabljajte, če je rok uporabnosti že potekel.
• If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Hulio.
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Hulio posvetujte s svojim zdravnikom.
In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 18).
Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden, kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 18).
o DO NOT use other heat sources such as a microwave oven or hot water to warm the vial.
◦ Za segrevanje viale NE uporabljajte nobenih drugih virov toplote, kot je mikrovalovna pečica ali vroča voda.
Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Opazili so tudi statistično in klinično pomembno izboljšanje parametrov kakovosti življenja (vključno z IMPACT III) glede na začetek študije.
Rhabdomyolysis, systemic lupus erythematosus
občasni rabdomioliza, sistemski eritematozni lupus redki sindrom, podoben lupusu1)
Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Bolniki so prejemali adalimumab v odmerkih 0,8 mg/kg vsak drugi teden (do 40 mg), 0,4 mg/kg vsak drugi teden (do 20 mg) ali 0,1-0,4 mg/kg metotreksata na teden (do 25 mg).
Step 6 - Insert needle into site
6. korak - Iglo zabodite v mesto.
In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
V odprti podaljšani študiji je v 12. tednu odziv PASI 75 doseglo 92 od 349 (26,4 %) bolnikov in v 24. tednu 132 od 349 (37,8 %) bolnikov, ki so jim zaradi odziva PASI pod 50 % odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden.
Anti-adalimumab antibodies may develop during adalimumab treatment.
Med zdravljenjem z adalimumabom lahko nastanejo protitelesa proti adalimumabu.
• If your child have an infection, including long-term or localised infection (for example, leg ulcer) consult your child's doctor before starting Hulio.
• Če ima vaš otrok okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Hulio posvetujte z otrokovim zdravnikom.
In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Uporabo adalimumaba 40 mg vsak drugi teden so proučili v randomizirani, 12 tednov trajajoči, dvojno slepi, s placebom kontrolirani študiji nr-axSpA I pri 185 bolnikih z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] je bila 6,4 pri bolnikih, zdravljenih z adalimumabom, in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali ≥ 1 NSAID ali s kontraindikacijo za NSAID.