natgillin/translations-raw huggingface dataset:
Of 207 patients, 81 patients continued on adalimumab 40 mg every other week for 10 years.
Od 207 bolnikov jih je 81 nadaljevalo zdravljenje z adalimumabom 40 mg vsak drugi teden še 10 let.
Radiographic response
Rentgenografski odziv
In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with adalimumab compared to placebo.
Rezultati obsežnejše študije pri ankilozirajočem spondilitisu I pri 315 bolnikih so pri bolnikih, ki so dobivali adalimumab, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
Fever, bruising, bleeding or looking pale
Zvišana telesna temperatura, podplutbe, krvavitve, bledica
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.
* Note: Hefiya is currently only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
* Opomba: Zdravilo Hefiya je trenutno na voljo samo v 40 mg napolnjeni injekcijski brizgi in 40 mg napolnjenem injekcijskem peresniku.
The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel-group study in 171 children (4-17 years old) with polyarticular JIA.
Varnost in učinkovitost adalimumaba so ocenili v multicentrični randomizirani dvojno slepi študiji vzporednih skupin pri 171 otrocih (starih od 4 do 17 let) s poliartikularnim juvenilnim idiopatskim artritisom.
Figure H).
(glejte slika G).
• Store your outer carton of syringes in a refrigerator, between 2°C to 8°C.
• Zunanjo škatlo za injekcijske brizge shranjujte v hladilniku, pri temperaturi med 2 °C in 8 °C.
The combination of adalimumab and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Kombinacija adalimumaba in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARD ali antagonistov TNF”).
If these medicines do not work well enough, you will be given Hefiya to reduce the signs and symptoms of your disease.
Če ta zdravila ne bodo dovolj dobro delovala, boste dobili zdravilo Hefiya za zmanjšanje znakov in simptomov vaše bolezni.
Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Pri bolnikih, ki so dobivali adalimumab, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okužb, npr. listerioza, legioneloza in pnevmocistična okužba.
40 mg adalimumab every week week 26
40 mg adalimumaba vsak teden
Disposing of used syringes:
Odstranjevanje uporabljenih injekcijskih brizg:
The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double-masked, placebo-controlled studies (UV I and II).
Varnost in učinkovitost adalimumaba sta bili ocenjeni pri odraslih bolnikih z neinfekcijskim intermediarnim, posteriornim uveitisom in panuveitisom v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah (UV I in UV II), ki nista vključevali bolnikov z izoliranim anteriornim uveitisom.
Among those, 86 patients (75.4 %) had ACR 20 responses; 72 patients (63.2 %) had ACR 50 responses; and 41 patients (36 %) had ACR 70 responses.
Med temi je 86 bolnikov (75,4 %) imelo odziv 20 po ACR; 72 bolnikov (63,2 %) je imelo odziv 50 po ACR; in 41 bolnikov (36 %) je imelo odziv 70 po ACR.
The combination of adalimumab as well as other TNFantagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Kombiniranje adalimumaba in drugih antagonistov TNF z anakinro ali abataceptom zaradi morebitnega povečanega tveganja za okužbe, vključno z resnimi okužbami in drugimi morebitnimi farmakološkimi interakcijami, ni priporočeno.
In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84 % continued to show no radiographic progression through 144 weeks of treatment.
Pri 84 % preiskovancev, ki so dobivali adalimumab in od izhodišča do 48. tedna niso imeli rentgenografsko vidnega napredovanja (n = 102), se takšno napredovanje tudi do 144. tedna zdravljenja ni pojavilo.
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6 % and 55.7 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Opravljena je bila analiza, v kateri so vse bolnike, ki so izpadli iz študije zaradi neželenih učinkov ali nezadostne učinkovitosti, ali jim je bil povečan odmerek, obravnavali kot neodzivne; pri teh bolnikih sta bila po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov)
Infection
Okužba
The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated non-infectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Varnost in učinkovitost zdravila adalimumaba sta bili ocenjeni v randomizirani, dvojno slepi, kontrolirani študiji pri 90 pediatričnih bolnikih, starih od 2 do manj kot 18 let, z aktivnim neinfekcijskim anteriornim uveitisom, povezanim z juvenilnim idiopatskim artritisom, ki se niso odzvali na zdravljenje z metotreksatom, ki je trajalo vsaj 12 tednov.
The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year vs. 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient year vs. 0.22 per patient year.
Število hospitalizacij iz vseh razlogov v skupini, zdravljeni z adalimumabom, je bilo 0,18 na bolnikov-let proti 0,26 na bolnikov-let v placebo skupini.
There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Pri bolnikih z revmatoidnim artritisom z dolgotrajno, zelo aktivno vnetno boleznijo je zvečano osnovno tveganje za limfome in levkemijo, kar komplicira oceno tveganja.
Adults with non-infectious uveitis
Odrasli z neinfekcijskim uveitisom
Autoantibodies
Avtoprotitelesa
Rhabdomyolysis, systemic lupus erythematosus
občasni rabdomioliza, sistemski eritematozni lupus redki sindrom podoben lupusu1)
Solution for injection.
raztopina za injiciranje.
clinical response clinical remission mucosal healing steroid-free remission for ≥ 90 daysa
klinični odziv klinična remisija celjenje sluznice remisija brez steroidov za ≥ 90 dni a
Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials.
adalimumabom povezane alergijske reakcije, ki niso bile resne, so se v kliničnih študijah pojavljale občasno.
• haematoma (a solid swelling with clotted blood);
• hematom (trdna oteklina s strjeno krvjo);
Initial dose of 40 mg, followed by 40 mg given every other week starting one week after the initial dose
Začetni odmerek 40 mg, ki mu sledi odmerek 40 mg vsak drugi teden, z začetkom en teden po začetnem odmerku
It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Hefiya.
Priporočljivo je, da med zdravljenjem z zdravilom Hefiya bolnik vsak dan uporablja topikalno antiseptično čistilno sredstvo za čiščenje lezij HS.
Very common (may affect more than 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov)
Disposing of used syringes” at the end of these Instructions for Use.
Odstranjevanje uporabljenih injekcijskih brizg'' na koncu teh navodil za uporabo.
Adalimumab exposure in adolescent HS patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Izpostavljenost adalimumabu pri mladostnikih s HS je bila napovedana z uporabo populacijskega farmakokinetičnega modeliranja in simulacije, ki temelji na farmakokinetiki indikacij pri drugih pediatričnih bolnikih (psoriaza pri pediatričnih bolnikih, juvenilni idiopatski artritis, Crohnova bolezen pri pediatričnih bolnikih in artritis, povezan z entezitisom).
Adalimumab has not been studied in patients aged less than 2 years.
Študije z adalimumabom pri bolnikih mlajših od 2 let niso bile izvedene.
Hepatic or renal impairment
Okvara jeter ali ledvic
• low blood measurements for white blood cells;
• nizke krvne vrednosti za bele krvne celice;
• lichenoid skin reaction (itchy reddish-purple skin rash).
• lihenoidna reakcija kože (srbeč rdeče-vijolični kožni izpuščaj).
Antibody formation was lower when adalimumab was given together with methotrexate in comparison with use as monotherapy.
Če je bil adalimumab uporabljen skupaj z metotreksatom, je bilo nastajanje protiteles v primerjavi z monoterapijo manjše.
Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Izpostavljenost adalimumabu pri pediatričnih bolnikih z uveitisom je bila napovedana z uporabo populacijskega farmakokinetičnega modeliranja in simulacije, ki temelji na farmakokinetiki navzkrižnih indikacij pri drugih pediatričnih bolnikih (psoriaza pri pediatričnih bolnikih, juvenilni idiopatski artritis, Crohnova bolezen pri pediatričnih bolnikih in artritis, povezan z entezitisom).
Intestinal perforation1)
pnevmonitis, plevralna efuzija1)
Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Hefiya (see section 4.4).
Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Hefiya posvetujejo z ustreznim specialistom
The rate (95 % confidence interval) of non-melanoma 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 dobivali adalimumab, in 3,2 (1,3; 7,6) na 1000 bolnikov-let med kontrolnimi bolniki.
Adults with Crohn's disease
Odrasli s Crohnovo boleznijo
In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab therapy through week 156.
Pri podaljšanih študijah brez placeba se je pri zdravljenju z adalimumabom izboljšanje znakov in simptomov ohranjalo do 156. tedna.
Respiratory, thoracic and mediastinal disorders*
Bolezni dihal, prsnega koša in mediastinalnega prostora*
• pulmonary embolism (blockage in an artery of the lung);
• pljučni embolizem (zamašitev arterije v pljučih);
• vertigo (sensation of room spinning);
• vrtoglavica (občutek vrtenja prostora);
Patients received placebo, an initial dose of MTX 7.5 mg and thereafter dose increases up to week 12, with a maximum dose of 25 mg or an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
Bolniki so dobivali placebo, začetni odmerek 7,5 mg metotreksata z nadaljnjim povečevanjem odmerka do 12. tedna; do največjega odmerka 25 mg, ali začetni odmerek 80 mg adalimumaba in potem 40 mg vsak drugi teden (začenši en teden po začetnem odmerku) 16 tednov.
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 adalimumabtreated patients and 0.6 % of control-treated patients.
V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg, 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 ≥ 3 x ULN pojavilo pri 0,3 % bolnikov, zdravljenih z adalimumabom, in pri 0,6 % bolnikov v kontrolni skupini.
Thereafter, the usual dose is 20 mg every other week.
Zatem je običajni odmerek 20 mg vsak drugi teden.
Contact your pharmacist if the syringe fails any of the above mentioned checks.
Obrnite se na farmacevta, če vaš injekcijski peresnik ne ustreza kateremu izmed zgornjih pogojev.
Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Med njimi 40 bolnikov ni pokazalo napredovanja strukturne prizadetosti izražene s spremembo srednje Sharpove ocene 0,5 ali manj od začetka študije.
It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Hefiya therapy.
Za pediatrične bolnike je priporočljivo, da pred začetkom zdravljenja z zdravilom Hefiya opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
Rheumatoid arthritis
Revmatoidni artritis
After week 2, patients in both adalimumab arms received 40 mg eow.
Po 2. tednu so bolniki v obeh krakih z adalimumabom prejemali 40 mg vsak drugi teden.
At Week 16, more patients randomised to adalimumab 0.8 mg / kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg / kg eow or MTX (table 20).
V 16. tednu se je več bolnikov, ki so bili randomizirani na adalimumab 0,8 mg/kg, pozitivno odzvalo v smislu učinkovitosti (npr. PASI 75) kot tistih, ki so bili randomizirani na odmerek 0,4 mg/kg vsak drugi teden ali metotreksat (preglednica 20).
RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Študija revmatoidnega artritisa V je ocenila 799 odraslih bolnikov, ki še niso dobivali metotreksata in so imeli zmerno do zelo aktiven zgoden revmatoidni artritis (povprečno trajanje bolezni manj kot 9 mesecev).
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 vsaj enega NSAID ali s kontraindikacijo za NSAID.
solution for injection 1 pre-filled pen (SensoReady) 2 pre-filled pens (SensoReady)
1 napolnjen injekcijski peresnik (SensoReady) 2 napolnjena injekcijska peresnika (SensoReady)
• abnormal blood measurements for sodium;
• nenormalne krvne vrednosti za natrij;
General disorders and administration site conditions*
Splošne težave in spremembe na mestu aplikacije*
Hefiya is administered every other week via subcutaneous injection.
Zdravilo Hefiya se odmerja vsak drugi teden v obliki subkutane injekcije.
The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment eow for 52 weeks.
Srednje najmanjše koncentracije so se pri bolnikih, ki so 52 tednov še naprej prejemali zdravljenje z adalimumabom vsak drugi teden, ohranile.
• low blood measurements for calcium;
• nizke krvne vrednosti za kalcij;
If you have rheumatoid arthritis and you do not receive methotrexate with your Hefiya therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Če imate revmatoidni artritis in če hkrati z zdravilom Hefiya ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg adalimumaba vsak teden ali 80 mg vsak drugi teden.
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
The following side effects have been observed with adalimumab:
Med uporabo adalimumaba so opazili naslednje neželene učinke:
Figure G: hold your pen
Slika G: Držite peresnik
Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
V vseh kliničnih preskušanjih revmatoidnega artritisa so adalimumab ocenili pri več kot 3000 bolnikih.
When Hefiya 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 Hefiya se lahko pri bolnikih < 30 kg uporabi polnilni odmerek 40 mg in pri bolnikih ≥ 30 kg polnilni odmerek 80 mg en teden pred začetkom vzdrževalnegazdravljenja.
In CD study III, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Crohnovi bolezni III je 854 bolnikov po odprtem protokolu dobilo 80 mg 0. teden in 40 mg 2. teden.
If these medicines do not work well enough, you will be given Hefiya to treat your rheumatoid arthritis.
Če ta zdravila ne delujejo dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo Hefiya.
Hefiya can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Zdravilo Hefiya lahko upočasni napredovanje prizadetosti sklepnih hrustancev in kosti, ki jo povzroči bolezen, in izboljša telesno delovanje.
Patients who maintained ≥PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Bolnike, ki so imeli 33. teden ohranjen odziv PASI ≥75 in so bili v obdobju A randomizirani na aktivno terapijo, so med obdobjem C ponovno randomizirali tako, da so dodatnih 19 tednov dobivali 40 mg adalimumaba vsak drugi teden ali placebo.
Neurological events
Nevrološki zapleti
Women of child bearing potential
Ženske v rodni dobi
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 40 mg odmerek vsak drugi teden (z začetkom en teden po začetnem odmerku) ali placebo naslednjih 26 tednov, čemur je sledilo odprto zdravljenje z adalimumabom dodatnih 26 tednov.
a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab / methotrexate combination therapy using the Mann-Whitney U test.
Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann-Whitneyevim testom U.
Cleaning your injection site:
Čiščenje mesta injiciranja:
Rheumatoid arthritis is an inflammatory disease of the joints.
Revmatoidni artritis je vnetna bolezen sklepov.
o In this configuration the needle guard is
o V tej konfiguraciji je ščitnik za iglo AKTIVIRAN.
Hefiya is used in adults to treat these conditions.
Zdravilo Hefiya se uporablja za zdravljenje teh stanj pri odraslih.
After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75 % relative to baseline), entered period B and received open-label 40 mg adalimumab every other week.
PASI vsaj 75 (izboljšanje ocene PASI za vsaj 75 % glede na izhodišče), vstopili v obdobje B, med katerim so odprto dobivali 40 mg adalimumaba vsak drugi teden.
• vasculitis (inflammation of blood vessels);
• vaskulitis (vnetje krvnih žil);
• autoantibodies present in the blood;
• avtoprotitelesa prisotna v krvi;
solution for injection 1 pre-filled syringe 2 pre-filled syringes
raztopina za injiciranje 1 napolnjena injekcijska brizga 2 napolnjeni injekcijski brizgi
The recommended Hefiya 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 Hefiya med indukcijo je pri odraslih bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
Before your injection Preparing the pen
Pred injiciranjem Priprava injekcijskega peresnika
• anxiety;
• anksioznost;
(injection) Clear to slightly opalescent, colourless to slightly yellowish solution.
(injekcija) bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta raztopina
Table 3.
Preglednica 3.
Thereafter, the usual dose is 40 mg every other week.
Zatem je običajni odmerek 40 mg vsak drugi 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 adalimumab/metotreksat, glede na izhodišče 10,8, 9,2 oz. 3,9.
Do not freeze.
Ne stresajte.
Crohn's disease
Crohnova bolezen
Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Opomba: P = placebo (število rizičnih preiskovancev); A = Adalimumab (število rizičnih preiskovancev).
In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 x ULN pojavila pri 6,1 % bolnikov, zdravljenih z adalimumabom, in pri 1,3 % bolnikov v kontrolni skupini.
If these medicines do not work well enough, patients will be given Hefiya to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Če ta zdravila ne delujejo dovolj dobro, bolniki za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom, dobijo zdravilo Hefiya.
88 and 189 patients, respectively, continued to be in clinical remission.
Klinična remisija se je nadaljevala pri 88 od prvih in pri 189 od drugih bolnikov.
response placebo N=162
odziv placebo n = 162