natgillin/translations-raw huggingface dataset:
It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA.
Priporočljivo je, da živih virusnih ali živih bakterijskih cepiv (na primer cepiva z Bacillusom Calmette-Guérin - BCG) ne dajete v času zdravljenja z zdravilom STELARA.
Similar disease severity was also seen in Psoriasis Study 3.
Značilnosti bolezni so bile podobne tudi v 3. študiji psoriaze.
In Psoriasis Study 1 maintenance of PASI 75 was significantly superior with continuous treatment compared with treatment withdrawal (p < 0.001).
V 1. študiji psoriaze je bilo ohranjanje PASI 75 bistveno boljše pri neprekinjenem zdravljenju kot pri prenehanju zdravljenja (p < 0,001).
• Put the vial on a flat surface.
• Vialo položite na ravno površino.
Check the number of vials and prepare the materials:
Preverite število vial in si vse pripravite:
Psoriasis Study 2 (PHOENIX 2) evaluated 1,230 patients.
V 2. študiji psoriaze (PHOENIX 2) so ovrednotili 1.230 bolnikov.
Efficacy results presented for UNIFI-I and UNIFI-M were based on central review of endoscopies.
Prikazani rezultati za oceno učinkovitosti iz študij UNIFI-I in UNIFI-M temeljijo na ocenah centralnega pregleda endoskopij.
Take the vial(s) out of the refrigerator.
Vialo (viali) vzemite iz hladilnika.
Psoriasis Study 1 (PHOENIX 1) evaluated 766 patients.
V 1. študiji psoriaze (PHOENIX 1) so ovrednotili podatke za 766 bolnikov.
• If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na ustekinumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
All patients, in particular those greater than 60 years of age, patients with a medical history of prolonged immunosuppressant therapy or those with a history of PUVA treatment, should be monitored for the appearance of non-melanoma skin cancer (see section 4.8).
Vse bolnike, še posebno pa bolnike, starejše od 60 let, bolnike, ki so dolgo časa prejemali imunosupresive ali tiste, ki so prejemali zdravljenje s PUVA, je treba spremljati zaradi možnosti pojava nemelanomskega kožnega raka (glejte poglavje 4.8).
It is unknown whether ustekinumab is excreted in human breast milk.
Ni znano, ali se ustekinumab izloča v materino mleko pri človeku.
Treatment of latent tuberculosis infection should be initiated prior to administering STELARA.
Zdravljenje latentne tuberkulozne okužbe je treba začeti še pred uporabo zdravila STELARA.
• Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button)
• Primerna mesta za injiciranje zdravila so zgornji del stegna ali trebuh (abdomen), in sicer najmanj 5 cm stran od popka.
Push it slowly and evenly, keeping the skin gently pinched
Bat potiskajte počasi in enakomerno ter pri tem nežno stiskajte kožo v gubo.
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
V primeru prevelikega odmerjanja je priporočljivo, da bolnika spremljate, da bi lahko ugotovili morebitne znake in simptome neželenih učinkov ter jim takoj uvedli ustrezno simptomatsko zdravljenje.
Week 12 2 doses (week 0 and week 4)
12. teden 2 odmerka (v tednu 0 in 4)
The solution is clear to slightly opalescent, colourless to light yellow and may contain a few small translucent or white particles of protein.
Raztopina je bistra do rahlo opalescentna in brezbarvna do svetlo rumena ter lahko vsebuje nekaj majhnih prosojnih ali belih beljakovinskih delcev.
Your doctor may decide that you should not use Stelara until the infection goes away.
Zdravnik se lahko odloči, da zdravila Stelara ne smete jemati, dokler traja okužba.
If you forget to use Stelara
Če ste pozabili uporabiti zdravilo Stelara
• Do not mix Stelara with other liquids for injection
• Zdravila Stelara ne smete mešati z drugimi tekočinami za injiciranje.
Your body weight
Vaša telesna masa
• the solution in the pre-filled syringe is not frozen.
• da raztopina v napolnjeni injekcijski brizgi ni zmrznjena.
Impact of weight on pharmacokinetics
Vpliv telesne mase na farmakokinetiko
These may be signs of infections such as chest infections, or skin infections or shingles that could have serious complications.
To so lahko znaki okužbe spodnjih dihal, okužbe kože ali pasavec, zaradi katerih lahko pride do resnih zapletov.
• If possible, do not use areas of skin that show signs of psoriasis
• Če je mogoče, zdravila ne injicirajte na mesta, ki kažejo znake psoriaze.
• Slowly take your thumb off the plunger head to allow the empty syringe to move up until the entire needle is covered by the needle guard, as shown by Figure 7:
• Počasi umaknite palec z glave bata, da se prazna brizga pomakne navzgor, dokler ni cela igla prekrita s ščitnikom, kot je prikazano na Sliki 7:
CDLQI: The CDLQI is a dermatology instrument to assess the effect of a skin problem on the health-related quality of life in the paediatric population.
CDLQI: CDLQI je dermatološki pripomoček za oceno učinka težav s kožo na z zdravjem povezane kakovosti življenja pri pediatrični populaciji.
Antibodies to ustekinumab may develop during ustekinumab treatment and most are neutralising.
Med zdravljenjem z ustekinumabom se lahko razvijejo protitelesa proti ustekinumabu, ki so večinoma nevtralizirajoča.
In general, the adverse events reported in these two studies with safety data up to 1 year were similar to those seen in previous studies in adults with plaque psoriasis.
Na splošno so bili poročani neželeni učinki v teh dveh študijah (z vključenimi podatki o varnosti do 1 leta) podobni neželenim učinkom, poročanim v študijah psoriaze s plaki pri odraslih.
How much Stelara is given Your doctor will decide how much Stelara you need to use and for how long.
Koliko zdravila Stelara uporabimo Zdravnik bo presodil, koliko zdravila Stelara potrebujete in kako dolgo ga boste jemali.
The final volume in the infusion bag should be 250 mL.
Končni volumen v infuzijski vrečki mora biti 250 ml. Nežno premešajte.
If you are the parent or caregiver who will give Stelara to a child, please read this information carefully.
Če ste starš ali skrbnik, ki bo zdravilo Stelara dajal otroku, vas prosimo, da navodilo skrbno preberete.
Similarly, significant improvements were seen in Psoriasis Study 2 at week 4 and 12, which were sustained through week 24.
Podobna statistično značilna izboljšanja so dokazali v 2. študiji psoriaze v 4. in 12. tednu, trajala pa so tudi v 24. tednu.
Animal studies have shown excretion of ustekinumab at low levels in breast milk.
Študije na živalih so pokazale izločanje ustekinumaba v materino mleko v majhnih koncentracijah.
The primary endpoint was the percentage of patients who achieved American College of Rheumatology (ACR) 20 response at week 24.
Primarni končni rezultat je bil delež bolnikov, ki so po 24. tednih dosegli odziv 20 po merilih Ameriškega revmatološkega združenja (ACR - American College of Rheumatology criteria).
Patients receiving STELARA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
Bolnike, ki prejemajo zdravilo STELARA, je treba natančno spremljati, da bi pri njih lahko ugotovili znake in simptome aktivne tuberkuloze, tako med zdravljenjem kot po njem.
Choose an injection site (see Figure 2)
Izberite mesto injiciranja (glejte Sliko 2)
As a precautionary measure, it is preferable to avoid the use of STELARA in pregnancy.
Kot varnostni ukrep se je med nosečnostjo bolje izogibati uporabi zdravila STELARA.
Children and adolescents aged 6 years or older
Otroci in mladostniki, stari 6 let in več
Let the vial stand for about half an hour.
Vialo pustite na sobni temperaturi približno pol ure.
Patients with each subtype of PsA were enrolled, including polyarticular arthritis with no evidence of rheumatoid nodules (39%), spondylitis with peripheral arthritis (28%), asymmetric peripheral arthritis (21%), distal interphalangeal involvement (12%) and arthritis mutilans (0.5%).
Vključeni so bili bolniki z vsemi podtipi PsA, vključno poliartikularnim artritisom brez revmatoidnih vozličev (39%), spondilitisom s perifernim artritisom (28%), asimetričnim perifernim artritisom (21%), distalnimi interfalangealnimi zapleti (12%) in artritisom mutilansom (0,5%).
Ask your doctor if you are not sure.
Če niste prepričani, vprašajte svojega zdravnika.
Serious side effects Some patients may have serious side effects that may need urgent treatment.
Pri nekaterih bolnikih se lahko pojavijo tudi resni neželeni učinki, zaradi katerih je potrebno nujno zdravljenje.
What you need to know before you use Stelara
Kaj morate vedeti, preden boste uporabili zdravilo Stelara
Serious hypersensitivity reactions have been reported in the postmarketing setting, in some cases several days after treatment.
Pri uporabi v obdobju trženja zdravila so poročali o resnih preobčutljivostnih reakcijah, ki so se (v nekaterih primerih) pojavile več dni po aplikaciji zdravila.
Patients enrolled PGA
Vključeni bolniki PGA
At week 12, placebo treated patients crossed over to receive ustekinumab.
V 12. tednu so bolniki, ki so prejemali placebo prešli na zdravljenje z ustekinumabom.
Plaque psoriasis is a skin condition that causes inflammation affecting the skin and nails.
Psoriaza s plaki je kožna bolezen, ki povzroči vnetje kože in nohtov.
100 people)
100 bolnikov).
The primary endpoint for the induction study was the proportion of subjects in clinical remission at week 8.
Primarni cilj opazovanja v študiji indukcijskega zdravljenja je bil delež preiskovancev v klinični remisiji po 8 tednih.
Patients randomised PGA
Randomizirani bolniki PGA
It is not known whether STELARA may affect allergy immunotherapy.
Ni znano ali zdravilo STELARA lahko vpliva na imunoterapijo proti alergiji.
In patients who have responded to treatment with STELARA, corticosteroids may be reduced or discontinued in accordance with standard of care.
Pri bolnikih, ki so se odzvali na zdravljenje z zdravilom STELARA, bo morda treba zmanjšati odmerek kortikosteroida ali ga ukiniti, skladno z ustaljeno klinično prakso.
• Wash your hands very well with soap and warm water
• Z milom in toplo vodo si temeljito umijte roke.
Endoscopic appearance of the mucosa was evaluated in 252 patients with eligible baseline endoscopic disease activity in a substudy.
V podštudiji so ocenjevali endoskopski izgled sluznice pri 252 bolnikih z razpoložljivo endoskopsko oceno aktivnosti bolezni ob izhodišču.
Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).
Uporabite lahko le infuzijske komplete, opremljene z linijskim sterilnim, apirogenim filtrom, ki minimalno veže beljakovine (velikost por 0,2 mikrometra).
Of those patients, 9% of patients who were initially randomized to the recommended induction dose achieved clinical remission and 58% achieved clinical response at Week 16.
Izmed teh bolnikov je 9% bolnikov, ki so bili sprva randomizirani na priporočeni indukcijski odmerek, v 16. tednu doseglo klinično remisijo, 58% pa klinični odziv.
Week 28 3 doses (week 0, week 4 and week 16) PBO 45 mg 90 mg 45 mg 90 mg
28. teden 3 odmerki (v tednih 0, 4 in 16) PBO 45 mg 90 mg 45 mg 90 mg
Concomitant doses of oral corticosteroids, immunomodulators, aminosalicylates and antibiotics were permitted and 75% of patients continued to receive at least one of these medications.
Dovoljeno je bilo sočasno odmerjanje peroralnih kortikosteroidov, imunomodulatorjev, aminosalicilatov in antibiotikov in 75% bolnikov je nadaljevalo s sočasnim prejemanjem vsaj enega od teh zdravil.
• Remove the needle from the vial
• Izvlecite iglo iz viale.
• If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see section 6 ‘What Stelara looks like and contents of the pack').
• če je tekočina obarvana ali motna ali če v njej plavajo drugi tuji delci (glejte poglavje 6, ‘Izgled zdravila Stelara in vsebina pakiranja');
In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
V študijah psoriaze varnosti in učinkovitosti zdravila STELARA v kombinaciji z imunosupresivi, vključno z biološkimi zdravili ali fototerapijo, še niso ovrednotili.
The induction studies included 1409 (UNITI-1, n = 769; UNITI-2 n = 640) patients.
V študiji indukcije UNITI-1 in UNITI-2 so vključili 1.409 bolnikov (UNITI-1 n = 769; UNITI-2 n = 640).
Patients who have not shown adequate response at 8 weeks after the first subcutaneous dose, may receive a second subcutaneous dose at this time (see section 5.1).
Bolniki, pri katerih ni zadostnega odziva 8 tednov po prvem subkutanem odmerku, lahko takrat prejmejo drugi subkutani odmerek (glejte poglavje 5.1).
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Bolnikom naročite, naj se posvetujejo z zdravnikom, če se pojavijo znaki ali simptomi, ki kažejo na okužbo.
Corticosteroid-free clinical remission is defined as patients in clinical remission and not receiving corticosteroids at Week 44.
Klinična remisija brez kortikosteroidov je definirana kot bolniki, ki so v 44. tednu v klinični remisiji in ne prejemajo kortikosteroidov.
The syringe, needle and vial must never be re-used.
Injekcijske brizge, igle in viale ne smete ponovno uporabiti.
Patients with body weight > 100 kg
Bolniki s telesno maso > 100 kg
STELARA has not been evaluated in patients who have undergone allergy immunotherapy.
Zdravila STELARA niso preskušali pri bolnikih, ki so prejeli imunoterapijo proti alergiji.
• Gently pinch the cleaned skin between your thumb and index finger.
• Nežno stisnite očiščeno kožo s palcem in kazalcem.
Following the recommended intravenous induction dose, median peak serum ustekinumab concentration, observed 1 hour after the infusion, was 126.1 μg/mL in patients with Crohn's disease and 127.0 µg/mL in patients with ulcerative colitis.
Po priporočenem začetnem intravenskem indukcijskem odmerku je bila 1 uro po infuziji največja mediana serumska koncentracija ustekinumaba 126,1 μg/ml pri bolnikih s Crohnovo boleznijo in 127,0 µg/ml pri bolnikih z ulceroznim kolitisom.
Structural damage in both hands and feet was expressed as change in total van der Heijde-Sharp score (vdH-S score), modified for PsA by addition of hand distal interphalangeal joints, compared to baseline.
Strukturne spremembe dlani in stopal so bile izražene kot spremembe celokupne ocene po metodi Heijde-Sharp (rezultat vdH-S), modificirane za PsA z dodatkom distalnih interfalangealnih sklepov dlani v primerjavi z začetno vrednostjo.
Patients receiving ustekinumab experienced significantly more improvements in work productivity as assessed by greater reductions in overall work impairment and in activity impairment as assessed by the WPAI-GH questionnaire than patients receiving placebo.
Pri bolnikih, ki so prejemali ustekinumab, je prišlo do občutnega izboljšanja delovne storilnosti z ozirom na večje zmanjšanje odsotnosti z dela in zmanjšane aktivnosti, ocenjenih z vprašalnikom WPAI-GH, kot pri bolnikih, ki so prejemali placebo.
There is no apparent correlation between the presence of anti-ustekinumab antibodies and the occurrence of injection site reactions.
Prav tako niso opazili očitne povezave med nastankom protiteles in pojavom reakcije na mestu injiciranja.
• Moderate to severe Crohn's disease - in adults
• zmerno do močno aktivne Crohnove bolezni - pri odraslih
Responses observed in the ustekinumab treated groups were similar in patients receiving and not receiving concomitant MTX, and were maintained through weeks 52 and 100.
Odzivi v skupininah bolnikov, ki so prejemale ustekinumab so bili podobni odzivu pri bolnikih, ki so/niso prejemali MTX sočasno in so se ohranili do 52. in do 100. tedna.
Carcinogenicity studies were not performed with ustekinumab due to the lack of appropriate models for an antibody with no cross-reactivity to rodent IL-12/23 p40.
Študije kancerogenosti ustekinumaba niso bile opravljene, ker ni ustreznih modelov protiteles brez navzkrižne reaktivnosti na glodalske IL-12/23 p40.
If a patient develops a serious infection, the patient should be closely monitored and STELARA should not be administered until the infection resolves.
Če bolnik dobi resno okužbo, ga morate pozorno spremljati in mu zdravila STELARA ne smete več dajati, dokler okužba ne izzveni.
51% of patients had failed or were intolerant to a biologic.
Pri 51% bolnikov je bilo neuspešno predhodno zdravljenje z biološkim zdravilom ali pa ga niso prenašali.
• If you are having any other treatment for psoriasis and/or psoriatic arthritis - such as another immunosuppressant or phototherapy (when your body is treated with a type of ultraviolet (UV) light).
• če jemljete katero koli drugo zdravilo za zdravljenje psoriaze in/ali psoriatičnega artritisa, kot so drug imunosupresiv ali fototerapijo (obsevanje telesa s posebno ultravijolično (UV) svetlobo).
PedsQL: The PedsQL Total Scale Score is a general health-related quality of life measure developed for use in children and adolescent populations.
PedsQL: PedsQL je splošno merilo za z zdravjem povezano kakovost življenja pri otrocih in mladostnikih.
Concomitant doses of oral corticosteroids, immunomodulators, and aminosalicylates were permitted and 90% of patients continued to receive at least one of these medications.
Dovoljeno je bilo sočasno odmerjanje peroralnih kortikosteroidov, imunomodulatorjev in aminosalicilatov in 90% bolnikov je nadaljevalo s sočasnim prejemanjem vsaj enega od teh zdravil.
If you have ulcerative colitis you will first be given other medicines.
Če imate ulcerozni kolitis, se boste najprej zdravili z drugimi zdravili.
In the placebo-controlled period of these clinical studies, the rate of infection was 1.36 per patient-year of follow-up in ustekinumab-treated patients, and 1.34 in placebo-treated patients.
V s placebom nadzorovanem obdobju teh kliničnih študij je bila pogostnost okužb 1,36 na bolnikov-let spremljanja pri bolnikih, zdravljenih z ustekinumabom, oziroma 1,34 pri bolnikih, zdravljenih s placebom.
In these patients, clinical remission was achieved in 41.4% of patients 16 weeks after dose adjustment.
Pri 41,4% teh bolnikov je bila klinična remisija dosežena 16 tednov po prilagoditvi odmerjanja.
All patients were followed for up to 76 weeks following first administration of study treatment.
Vse bolnike so spremljali do 76 tednov po prvem prejemu preučevanega zdravila.
• Bleeding, bruising, hardness, swelling and itching where the injection is given
• krvavitve, potpludbe, zatrdlina, otekanje in srbenje na mestu injiciranja zdravila
• Tooth infections
• okužba zob
Anti-tuberculosis therapy should also be considered prior to initiation of STELARA in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Pred začetkom zdravljenja z zdravilom STELARA je treba zdravljenje tuberkuloze uvesti tudi pri bolnikih z latentno ali aktivno tuberkulozo v anamnezi, pri katerih ni mogoče potrditi, da so opravili ustrezen cikel zdravljenja.
(see section 4.4).
(glejte Sliko 4).
Long term treatment with STELARA does not suppress the humoral immune response to pneumococcal polysaccharide or tetanus vaccines (see section 5.1).
Dolgotrajno zdravljenje z zdravilom STELARA ne zavira humoralnega imunskega odziva na pnevmokokne polisaharide ali cepivo proti tetanusu (glejte poglavje 5.1).
Efficacy (defined as PGA 0 or 1) was observed as early as the first post-baseline visit at week 4 and the proportion of subjects who achieved a PGA score of 0 or 1 increased through week 16 and then remained relatively stable through week 52.
Učinkovitost (definirano z oceno PGA 0 ali 1) so opazili že pri prvem obisku po začetku zdravljenja (4. teden) in delež bolnikov, ki so dosegli oceno PGA 0 ali 1, se je povečeval do 16. tedna in nato ostal relativno stabilen do 52. tedna.
3 years.
3 leta Ne zamrzujte.
Signs include: o difficulty breathing or swallowing o low blood pressure, which can cause dizziness or light-headedness o swelling of the face, lips, mouth or throat.
Znaki so: o težave pri dihanju ali požiranju, o nizek krvni tlak, ki lahko povzroči vrtoglavico ali omotico, o otekanje obraza, ustnic, ust ali žrela.
Check the number of pre-filled syringes and prepare the materials:
Preverite število napolnjenih injekcijskih brizg in si vse pripravite:
(kg) may start on a dose of 90 mg instead of 45 mg.
100 kilogramov (kg), lahko prejmejo 90 mg namesto 45 mg.
In patients with psoriasis, exfoliative dermatitis has been reported following ustekinumab treatment (see section 4.8).
Pri bolnikih s psoriazo so po zdravljenju z ustekinumabom poročali o eksfoliativnem dermatitisu (glejte poglavje 4.8).
• Plaque psoriasis - in adults and children aged 6 years and older
• psoriaza s plaki pri odraslih in otrocih, starih 6 let in več
Live vaccines should not be given concurrently with STELARA (see section 4.4).
Živih cepiv se ne sme dajati sočasno z zdravilom STELARA (glejte poglavje 4.4).
• Clean the stopper with an antiseptic swab
• Očistite zamašek z antiseptičnim zložencem.
No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Farmakokinetični podatki o bolnikih z zmanjšanim delovanjem ledvic ali jeter niso na voljo.
Patients with a CDLQI > 1 at baseline
Bolniki s CDLQI > 1 ob izhodišču
The infusion solution is to be composed of the number of vials of STELARA 130 mg as specified in Table 1 (see section 6.6 for preparation).
Infuzijska raztopina zdravila STELARA 130 mg se pripravi iz števila vial, kot je navedeno v Preglednici 1 (za pripravo glejte poglavje 6.6).
Population pharmacokinetic analysis showed that there was a trend towards a higher clearance of ustekinumab in patients who tested positive for antibodies to ustekinumab.
Analiza populacijske farmakokinetike je pokazala nagnjenost k večjemu očistku ustekinumaba pri bolnikih, ki so imeli pozitiven izvid preiskave na protitelesa proti ustekinumabu.
Clinical Remission** In patients who failed conventional therapy, but not a biologic d49% (50/102)
Klinična remisija** pri bolnikih z neuspešnim konvencionalnim zdravljenjem, ne pa neuspešnim zdravljenjem z biološkim zdravilom d 49% (50/102)
• Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
• Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom.
The primary endpoint in these studies was the proportion of patients who achieved PASI 75 response from baseline at week 12 (see Tables 4 and 5).
Primarni končni rezultat v teh študijah je bil delež bolnikov, ki so od začetka študije do 12. tedna dosegli odziv PASI 75 (glejte Preglednici 4 in 5).
Maintenance of clinical remission through Week 44 is defined as patients in clinical remission through Week 44 among patients in clinical remission at maintenance baseline.
Ohranjena klinična remisija do 44. tedna je definirana kot bolniki, ki so v klinični remisiji do 44. tedna, izmed bolnikov, ki so bili v klinični remisiji ob izhodišču vzdrževalnega zdravljenja.
Patients who lose response on dosing every 12 weeks may benefit from an increase in dosing frequency to every 8 weeks (see section 5.1, section 5.2).
Bolnikom, ki so izgubili odziv pri odmerjanju na 12 tednov, lahko koristi zvečanje pogostosti odmerjanja na vsakih 8 tednov (glejte poglavji 5.1 in 5.2).
The European Medicines Agency has deferred the obligation to submit the results of studies with ustekinumab in one or more subsets of the paediatric population with juvenile idiopathic arthritis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z ustekinumabom za eno ali več podskupin pediatrične populacije z juvenilnim idiopatskim artritisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).