natgillin/translations-raw huggingface dataset:
Table 9: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Tablica 9: Indukcija kliničkog odgovora i remisija u UNITI-1 i UNITI 2 UNITI-1*
• Do not use the pre-filled syringe if it is dropped without the needle cover in place.
• Nemojte upotrijebiti napunjenu štrcaljku ako je pala bez zaštitne kapice igle.
Talk to your doctor about when you will have your injections and follow-up appointments.
Razgovarajte s liječnikom o tome kada ćete primati injekcije i kada morate doći na preglede u svrhu praćenja.
At week 8, after a single intravenous induction dose, the change in SES-CD score was greater in the ustekinumab group (n = 155, mean change = -2.8) than in the placebo group (n = 97, mean change = -0.7, p = 0.012).
U 8. tjednu, nakon jedne intravenske uvodne doze, promjena u SESCD skoru bila je veća u skupini s ustekinumabom (n = 155, srednja vrijednost promjene = -2,8) nego u placebo skupini (n = 97, srednja vrijednost promjena = -0,7, p = 0,012).
No new safety concerns were identified in this study extension with up to 2 years of treatment in patients with Crohn's Disease.
U ovom produžetku ispitivanja uz liječenje u trajanju do 2 godine nisu utvrđeni nikakvi novi problemi vezani uz sigurnost primjene lijeka u bolesnika s Crohnovom bolesti.
In patients with Crohn's disease and ulcerative colitis, variability in ustekinumab clearance was affected by body weight, serum albumin level, sex, and antibody to ustekinumab status while body weight was the main covariate affecting the volume of distribution.
U bolesnika s Crohnovom bolesti i ulceroznim kolitisom na varijabilnost klirensa ustekinumaba utjecala je tjelesna težina, razina albumina u serumu, spol i status protutijela na ustekinumab dok je tjelesna težina bila glavna kovarijata koja je imala utjecaj na volumen distribucije.
No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving STELARA.
Nisu provedena ispitivanja koja bi uključila bolesnike s anamnezom maligne bolesti ili koja nastavljaju liječenje bolesnika u kojih se pojavila maligna bolest tijekom liječenja STELAROM.
Paediatric plaque psoriasis (6 years and older)
Pedijatrijska plak psorijaza (6 godina i stariji)
Fistula Response
Odgovor fistule
In Crohn's disease and ulcerative colitis intravenous induction studies, no events of anaphylaxis or other serious infusion reactions were reported following the single intravenous dose.
U ispitivanjima uvodnog intravenskog liječenja Crohnove bolesti i ulceroznog kolitisa, nisu bili prijavljeni događaji anafilaksije ili druge ozbiljne reakcije na infuziju nakon jedne intravenske doze.
Durable Remission is defined as partial Mayo remission at ≥80% of all visits prior to Week 44 and in partial Mayo remission at last visit (Week 44).
Dugotrajna remisija definirana je kao djelomična remisija prema Mayo rezultatu pri ≥ 80% svih posjeta prije 44.tjedna i djelomična remisija prema Mayo rezultatu pri posljednjem posjetu (44.tjedan).
• When the plunger is pushed as far as it will go, continue to keep the pressure on the plunger head, take out the needle and let go of the skin (see Figure 6)
• Kada je klip pritisnut do kraja, nastavite pritiskati glavu klipa, izvucite iglu i pustite kožu (pogledajte sliku 6).
Table 4 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 (PHOENIX 2)
Tablica 4. Sažetak kliničkog odgovora u Ispitivanju psorijaze 1 (PHOENIX 1) i Ispitivanju psorijaze 2 (PHOENIX 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 in Crohn's Disease and ulcerative colitis (see section 4.2 for information on paediatric use).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka ustekinumaba u jednoj ili više podskupina pedijatrijske populacije za Crohnovu bolest i ulcerozni kolitis (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
• You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
• Možete pritisnuti komadić vate ili gaze na mjesto primjene injekcije i držati 10 sekundi.
In a population pharmacokinetic analysis using data from patients with psoriasis, body weight was found to be the most significant covariate affecting the clearance of ustekinumab.
U farmakokinetičkoj analizi populacije koristeći podatke bolesnika s psorijazom, utvrđeno je da je tjelesna težina najznačajnija kovarijata koja utječe na klirens ustekinumaba.
No pharmacokinetic data are available in patients with impaired renal or hepatic function.
Nisu dostupni farmakokinetički podaci za bolesnike s oštećenjem bubrega ili jetre.
• Bleeding, bruising, hardness, swelling and itching where the injection is given
• krvarenje, modrice, otvrdnuće, oticanje i svrbež na mjestu primjene injekcije
In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA.
U ispitivanjima psorijatičnog artritisa, istodobno primijenjen MTX nije imao utjecaj na sigurnost ili djelotvornost STELARE.
Improvements in FACIT scores were maintained through week 52.
Poboljšanja FACIT bodova održana su kroz 52 tjedna.
• the solution is not frozen.
• da otopina nije smrznuta.
• Do not remove the stopper
• Nemojte ukloniti čep.
Nominally significant (p < 0.001)
Nominalno značajno (p < 0,001)
p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with placebo (PBO).
p < 0,001 za ustekinumab 45 mg ili 90 mg u usporedbi s placebom (PBO).
The pharmacokinetics of ustekinumab were generally comparable between Asian and non-Asian patients with psoriasis and ulcerative colitis.
Farmakokinetika ustekinumaba bila je općenito usporediva kod bolesnika s psorijazom i ulceroznim kolitisom azijskog i ne-azijskog porijekla.
The median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight (≤ 100 kg) in the 45 mg group.
Medijan najniže serumske koncentracije ustekinumaba kod bolesnika veće tjelesne težine (> 100 kg) u grupi od 90 mg mogla se usporediti s bolesnicima niže tjelesne težine (≤ 100 kg) u grupi s 45 mg.
Choose two different sites for these injections (for example one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
Za te injekcije odaberite dva različita mjesta primjene (na primjer jednu injekciju u desno bedro, a drugu injekciju u lijevo bedro) i primijenite injekcije točno jednu za drugom.
Hypersensitivity and infusion reactions
Reakcije preosjetljivosti i reakcije na infuziju
Make sure you tell your doctor about any illness you have before each treatment.
Svakako obavijestite liječnika o svim bolestima koje imate prije svake primjene lijeka.
• Stelara is given by injection under the skin (subcutaneously)
• Stelara se daje injekcijom pod kožu (supkutano).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Ako niste sigurni odnosi li se bilo što od gore navedenog na Vas, razgovarajte sa svojim liječnikom ili ljekarnikom prije nego što upotrijebite Stelaru.
Concentrate for Solution for infusion 130 mg/26 mL
Koncentrat za otopinu za infuziju 130 mg/26 ml
In psoriasis studies, the safety and efficacy of STELARA in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
U ispitivanjima psorijaze, sigurnost i djelotvornost primjene STELARE u kombinaciji s imunosupresivima, uključujući biološke lijekove, ili fototerapiju nisu ispitivani.
During the placebo controlled period through week 12, the efficacy of both the recommended and half of the recommended dose groups were generally comparable at the primary endpoint (69.4% and 67.6% respectively) although there was evidence of a dose response for higher level efficacy criteria (e.g. PGA of cleared (0), PASI 90).
Tijekom placebom kontroliranog razdoblja kroz 12. tjedan, djelotvornost u primarnom ishodu (69,4% odnosno 67,6%) je općenito bila usporediva u obje skupine, s preporučenom dozom i s polovinom preporučene doze, premda je postojao dokaz o odgovoru na dozu za višu razinu kriterija učinkovitosti (npr. PGA čisti (0), PASI 90).
90 mg ustekinumab every 8 weeks
90 mg ustekinumaba svakih 8 tjedana
• There may be a small amount of blood or liquid at the injection site.
• Na mjestu uboda injekcije može se pojaviti malo krvi ili tekućine.
You must look out for certain signs of illness while you are taking Stelara.
Morate paziti na određene znakove bolesti za vrijeme korištenja Stelare.
By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.
Vežući se na zajedničku p40 podjedinicu IL-12 i IL-23, ustekinumab može imati klinički učinak na psorijazu, na psorijatični artritis, na Crohnovu bolest i na ulcerozni kolitis kroz prekid Th1 i Th17 citokinskih putova koji su u središtu patologije ovih bolesti.
Serum ustekinumab concentrations in paediatric psoriasis patients 12-17 years of age (CADMUS) treated with half of the recommended weight-based dose were generally lower than those in adults.
Serumske koncentracije ustekinumaba kod pedijatrijskih bolesnika s psorijazom u dobi od 12 do 17 godina (CADMUS) liječenih s pola preporučene doze temeljene na tjelesnoj težini bile su općenito niže od onih kod odraslih bolesnika.
• During treatment, the first dose of approximately 6 mg/kg Stelara will be given by your doctor through a drip in a vein in your arm (intravenous infusion).
• Tijekom liječenja, prvu dozu od otprilike 6 mg/kg Stelare primijenite će Vam liječnik putem infuzije kap po kap (drip) u venu ruke (infuzija u venu).
In this study, 29.1% of the patients had an inadequate initial response (primary non-responders), 69.4% responded but lost response (secondary non-responders), and 36.4% were intolerant to antiTNFα therapies.
U ovom ispitivanju, 29,1% bolesnika imalo je neadekvatan inicijalni odgovor (primarno nisu odgovorili), 69,4% ih je odgovorilo ali su izgublili odgovor (sekundarno nisu odgovorili), a 36,4% ih nije podnosilo anti-TNFα terapiju.
Common: Oropharyngeal pain Uncommon: Nasal congestion Rare: Allergic alveolitis, eosinophilic pneumonia Very rare: Organising pneumonia*
Manje često: kongestija nosa Rijetko: alergijski alveolitis, eozinofilna upala pluća Vrlo rijetko: organizirajuća upala pluća*
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.
U placebom kontroliranom razdoblju tih kliničkih ispitivanja stopa infekcije bila je 1,36 po bolesnik-godini praćenja za bolesnike liječene ustekinumabom, te 1,34 kod bolesnika u placebo grupi.
If an anaphylactic or other serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of STELARA should be discontinued (see section 4.8).
Ako se pojavi anafilaktička ili druge ozbiljne reakcije preosjetljivosti, potrebno je započeti s odgovarajućim liječenjem i primjena STELARE mora se prekinuti (vidjeti dio 4.8).
In patients who failed conventional therapy, but not a biologic
U bolesnika neuspješno liječenih konvencionalnom, ali ne i biološkom terapijom
In Study 1 previous treatment with anti-tumour necrosis factor (TNF)α agent was not allowed.
U ispitivanju 1, prethodno liječenje anti-(TNF)α lijekovima nije bilo dozvoljeno.
If infection has been excluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment (see section 4.8).
Ako je infekcija isključena te dijagnoza potvrđena, ukinite ustekinumab te uvedite prikladno liječenje (vidjeti dio 4.8).
The overall safety profile was similar for patients with psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
Ukupni sigurnosni profil bio je sličan za bolesnike s psorijazom, psorijatičnim artritisom, Crohnovom bolesti i ulceroznim kolitisom.
• If the seal is broken.
• Ako je uništen zaštitni poklopac.
Dose linearity
Linearnost doza
Additionally in Crohn's disease, clearance was affected by C-reactive protein, TNF antagonist failure status and race (Asian versus non-Asian).
Nadalje, kod Crohnove su bolesti na klirens utjecali i C-reaktivni protein, neuspjeh liječenja antagonistima TNF-a i rasa (Azijci naspram ostalih).
No data are available on the secondary transmission of infection by live vaccines in patients receiving STELARA.
Podaci o sekundarnoj transmisiji infekcije primjenom živih cjepiva u bolesnika koji se liječe STELAROM nisu poznati.
Choose two different sites for these injections (e.g. one injection in the right thigh and the other injection in the left thigh), and give the injections one right after the other.
Za te injekcije odaberite dva različita mjesta primjene (npr. jednu injekciju u desno bedro, a drugu injekciju u lijevo bedro) i primijenite injekcije točno jednu za drugom.
Check the pre-filled syringe(s) to make sure
Provjerite napunjenu štrcaljku (ili štrcaljke) kako biste bili sigurni
Caution should be exercised when considering the use of STELARA in patients with a chronic infection or a history of recurrent infection (see section 4.3).
Mora se biti oprezan kod razmatranja primjene STELARE u bolesnika s kroničnom infekcijom ili rekurentnom infekcijom u anamnezi (vidjeti dio 4.3).
• Used syringes and needles should be placed in a puncture-resistant container, like a sharps container.
• Upotrijebljene štrcaljke i igle moraju se odložiti u spremnik koji se ne može probušiti, poput spremnika za oštre predmete.
Psoriasis or Psoriatic Arthritis
Psorijaza ili psorijatični artritis
The safety data described below reflect exposure in adults to ustekinumab in 14 phase 2 and phase 3 studies in 6,709 patients (4,135 with psoriasis and/or psoriatic arthritis, 1,749 with Crohn's disease and 825 patients with ulcerative colitis).
Niže opisani podaci o sigurnosti primjene odražavaju izloženost odraslih bolesnika ustekinumabu u 14 ispitivanja faze II i III u 6709 bolesnika (4135 s psorijazom i/ili psorijatičnim artritisom, 1749 s Crohnovom bolesti i 825 bolesnika s ulceroznim kolitisom).
The median steady-state trough concentration ranged from 0.21 μg/mL to 0.26 μg/mL (45 mg) and from 0.47 μg/mL to 0.49 μg/mL (90 mg).
Medijan stabilne najniže koncentracije kretao se od 0,21 μg/ml do 0,26 μg/ml (45 mg) te od 0,47 μg/ml do 0,49 μg/ml (90 mg).
• Pull the needle cover straight off and throw it away.
• Povucite zaštitnu kapicu s igle tako da ju ravno povučete s igle i bacite ju.
• Take the pre-filled syringe(s) out of the refrigerator.
• Uzmite napunjenu štrcaljku (ili štrcaljke) iz hladnjaka.
• the vial is not damaged and the seal is not broken
• da bočica nije oštećena, a zaštitni poklopac nije slomljen
The proportion of patients with a PGA score of cleared (0) or minimal (1) at week 12 was 77.3%.
Udio bolesnika kod kojih je u 12. tjednu zabilježen PGA skor čist (0) ili minimalan (1) iznosio je 77,3%.
The median CL/F in patients with weight > 100 kg was approximately 55% higher compared to patients with weight ≤ 100 kg.
Medijan CL/F kod bolesnika težine > 100 kg bio je približno 55% viši u usporedbi s bolesnicima s težinom ≤ 100 kg.
Approximately 50% of the patients had failed at least 1 prior anti-TNF therapy (of which 48% were primary non-responders) and 17% had failed at least 1 anti-TNFα therapy and vedolizumab.
Približno 50% bolesnika imalo je najmanje 1 neuspješnu prethodnu anti-TNFα terapiju (od kojih 48% nije ostvarilo primarni odgovor), a njih 17% bilo je neuspješno liječeno najmanje jednom anti-TNFα terapijom i vedolizumabom.
Corticosteroid-free clinical remission is defined as patients in clinical remission and not receiving corticosteroids at Week 44.
Klinička remisija bez kortikosteroida definirana je kao klinička remisija u bolesnika koji ne prima kortikosteroide u 44.tjednu.
The median tmax values of ustekinumab following a single subcutaneous administration of either 45 mg or 90 mg in patients with psoriasis were comparable to those observed in healthy subjects.
Medijan tmax vrijednosti ustekinumaba nakon jedne supkutane primjene 45 mg ili 90 mg kod bolesnika s psorijazom mogle su se usporediti s onima uočenim kod zdravih ispitanika.
Tell your doctor or get emergency medical help straight away if you notice any of the following signs.
Recite svom liječniku ili odmah pozovite hitnu medicinsku pomoć ako primjetite bilo koji od sljedećih znakova.
The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
Lijek se ne smije primijeniti ako je otopina promijenila boju ili je zamućena ili ako su prisutne strane čestice.
The formation of anti-ustekinumab antibodies is associated with both increased clearance and reduced efficacy of ustekinumab, except in patients with Crohn's disease or ulcerative colitis where no reduced efficacy was observed.
Nastanak protutijela na ustekinumab povezan je s povećanim klirensom i smanjenom djelotvornošću ustekinumaba, osim u bolesnika s Crohnovom bolešću ili ulceroznim kolitisom, kod kojih nije opažena smanjena djelotvornost.
STELARA 130 mg is for intravenous use only.
STELARA 130 mg je samo za intravensku primjenu.
53% of these patients were either non-responsive, intolerant, or had a contraindication to other systemic therapy.
53% od tih bolesnika ili nije reagiralo, nije podnosilo ili je imalo kontraindikacije na drugu sustavnu terapiju.
• When the plunger is pushed as far as it will go, take out the needle and let go of the skin
• Kada je klip pritisnut do kraja, izvucite iglu iz kože i pustite kožu.
EDTA disodium salt dihydrate L-histidine
EDTA dinatrijeva sol dihidrat L-histidin
What Stelara is and what it is used for What you need to know before you use Stelara How to use Stelara
Što je Stelara i za što se koristi Što morate znati prije nego počnete primjenjivati Stelaru Kako primjenjivati Stelaru
Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology.
Ustekinumab je potpuno ljudsko IgG1κ monoklonsko protutijelo protiv interleukina (IL)-12/23 proizvedeno u mišjoj staničnoj liniji mijeloma primjenom tehnologije rekombinantne DNK.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg body weight.
• Ukoliko je Vaša tjelesna težina manja od 60 kg, preporučena doza je 0,75 mg Stelare po kilogramu tjelesne težine.
Some patients who received STELARA in clinical studies developed cutaneous and non-cutaneous malignancies (see section 4.8).
U nekih bolesnika koji su primali STELARU u kliničkim ispitivanjima, razvile su se kožne i ne-kožne maligne bolesti (vidjeti dio 4.8).
• Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings (see Figure 5)
• Primjenite cijelu količinu lijeka gurajući klip, sve dok glava klipa ne bude potpuno između krilaca štitnika igle (pogledajte sliku 5).
Additionally on the basis of clinical trial data in patients with ulcerative colitis, a positive exposure-response relationship was established between trough concentrations, and clinical remission and mucosal healing.
Nadalje, na temelju podataka iz kliničkih ispitivanja u bolesnika s ulceroznim kolitisom utvrđena je pozitivna veza između izloženosti i odgovora, tj. između najnižih koncentracija i kliničke remisije te cijeljenja sluznice.
It is unknown whether ustekinumab is excreted in human breast milk.
Nije poznato izlučuje li se ustekinumab u majčino mlijeko u ljudi.
• Do not touch the needle or let the needle touch anything
• Nemojte odložiti štrcaljku ili dopustiti da igla da bilo što dotakne.
Ustekinumab has been shown to improve signs and symptoms, and health related quality of life in paediatric patients 6 years and older with plaque psoriasis.
Ustekinumab je pokazao poboljšanje znakova i simptoma, te kvalitete života povezane sa zdravljem kod pedijatrijskih bolesnika s plak psorijazom u dobi od 6 godina i starijih.
At 1 year (week 52), 89% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 63% of patients re-randomised to placebo (treatment withdrawal) (p < 0.001).
U 1. godini (52. tjedan), 89% bolesnika ponovno randomiziranih na održavanje liječenja, imalo je odgovor PASI 75, u usporedbi sa 63% bolesnika ponovno randomiziranih na placebo (prekid liječenja) (p < 0,001).
The median V/F in patients with weight > 100 kg was approximately 37% higher as compared to patients with weight ≤ 100 kg.
Medijan V/F kod bolesnika težine > 100 kg bio je približno 37% viši u usporedbi s bolesnicima težine ≤ 100 kg.
STELARA, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
STELARA, primijenjena samostalno ili u kombinaciji s MTX, indicirana je za liječenje aktivnog psorijatičnog artritisa u odraslih bolesnika kada odgovor na prethodne nebiološke antireumatske lijekove koji modificiraju tijek bolesti (engl. disease-modifying anti-rheumatic drug, DMARD) nije bio odgovarajući (vidjeti dio 5.1).
The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis, or prior exposure to anti-TNFα agents, in patients with psoriatic arthritis or Crohn's disease or by prior exposure to biologics (i.e. anti-TNFα agents and/or vedolizumab) in patients with ulcerative colitis.
Na farmakokinetiku ustekinumaba nije utjecala istodobna primjena MXT, NSAIL, 6-merkaptopurina, azatioprina i oralnih kortikosteroida kod bolesnika s psorijatičnim artritisom, Crohnovom bolesti ili ulceroznim kolitisom, kao ni prethodna izloženost anti-TNFα lijekovima kod bolesnika s psorijatičnim artritisom ili Crohnovom bolesti ili prethodna izloženost biološkim lijekovima (npr. anti-TNFα lijekovima i/ili vedolizumabu) kod bolesnika s ulceroznim kolitisom.
Ustekinumab demonstrated a statistically significant decrease in the rate of progression of structural damage compared to placebo, as measured by change from baseline to week 24 in the total modified vdH-S score (mean ± SD score was 0.97 ± 3.85 in the placebo group compared with 0.40 ± 2.11 and 0.39 ± 2.40 in the ustekinumab 45 mg (p < 0.05) and 90 mg (p < 0.001) groups, respectively).
Ustekinumab je pokazao statistički značajan pad brzine progresije strukturnih oštećenja u usporedbi s placebom, mjereno promjenom u odnosu na početnu vrijednost do 24. tjedna u ukupnom modificiranom vdH-S bodu (srednja vrijednost ± SD bod bio je 0,97 ± 3,85 u placebo skupini u usporedbi s 0,40 ± 2,11 i 0,39 ± 2,40 u skupini s 45 mg (p < 0,05) odnosno 90 mg (p < 0,001) ustekinumaba.
Paediatric patients 6 years and older with plaque psoriasis The safety of ustekinumab has been studied in two phase 3 studies of paediatric patients with moderate to severe plaque psoriasis.
Pedijatrijski bolesnici s plak psorijazom u dobi od 6 godina i stariji Sigurnost ustekinumaba ispitana je u dvama ispitivanjima faze 3 provedenima u pedijatrijskih bolesnika s umjerenom do teškom plak psorijazom.
Serious infections occurred at the rate of 0.03 per patient-year of follow-up in ustekinumab-treated patients (30 serious infections in 930 patient-years of follow-up) and 0.03 in placebo-treated patients (15 serious infections in 434 patient-years of follow-up) (see section 4.4).
Ozbiljne infekcije javile su se u stopi od 0,03 po bolesnik-godini praćenja za bolesnike liječene ustekinumabom (30 ozbiljnih infekcija u 930 bolesnik-godina praćenja), te 0,03 kod bolesnika u placebo grupi (15 ozbiljnih infekcija u 434 bolesnik-godine praćenja) (vidjeti dio 4.4).