FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Sočasna uporaba MTX, NSAID, 6-merkaptopurina, azatioprina in peroralnih kortikosteroidov pri bolnikih s psoriatičnim artritisom, Crohnovo boleznijo ali ulceroznim kolitisom ali predhodna izpostavljenost zaviralcem TNFα pri bolnikih s psoriatičnim artritisom ali Crohnovo boleznijo ali predhodna izpostavljenost biološkim zdravilom (zaviralcem TNFα in/ali vedolizumabu) pri bolnikih z ulceroznim kolitisom ni vplivala na farmakokinetiko ustekinumaba.
English: Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with specificity to the shared p40 protein subunit of human cytokines interleukin (IL)-12 and IL-23.
Slovenian: Ustekinumab je popolnoma človeško monoklonsko protitelo IgG1κ, ki se specifično veže na p40, skupno proteinsko podenoto človeških citokinov interlevkinov (IL)-12 in IL-23.
English: • Common signs of an allergic reaction include skin rash and hives (these may affect up to 1 in 100 people).
Slovenian: • Pogosti znaki alergijske reakcije vključujejo kožni izpuščaj in koprivnico (pojavijo se lahko pri največ 1 od 100 bolnikov).
English: A higher proportion of patients treated with ustekinumab who had spondylitis with peripheral arthritis as their primary presentation, demonstrated 50 and 70 percent improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores compared with placebo at week 24.
Slovenian: Večjemu deležu bolnikov s spondilitisom s perifernim artritisom je zdravljenje z ustekinumabom izboljšalo oceno po Bathovem indeksu aktivnosti ankilozirajočega spondilitisa (BASDAI-Bath Ankylosing Spondylitis Disease Activity Index) za 50% in 70% v primerjavi s placebom po 24 tednih.
English: p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with placebo (PBO).
Slovenian: p < 0,001 za odmerek 45 mg ali 90 mg ustekinumaba v primerjavi s placebom (PBO).
English: If infection has been excluded and diagnosis is confirmed, discontinue ustekinumab and institute appropriate treatment (see section 4.8).
Slovenian: Ob prisotnosti okužbe in potrjeni diagnozi, je treba zdravljenje z ustekinumabom prekiniti in uvesti primerno zdravljenje (glejte poglavje 4.8).
English: PGA of cleared (0) or minimal
Slovenian: PGA čisto (0) ali minimalno
English: Any unused product remaining in the syringe should be thrown away.
Slovenian: Neuporabljeno zdravilo, ki ostane v brizgi je treba zavreči.
English: The median time to reach the maximum serum concentration (tmax) was 8.5 days after a single 90 mg subcutaneous administration in healthy subjects.
Slovenian: Pri zdravih preizkušancih je bila mediana vrednost časa do doseganja največje serumske koncentracije (tmax) po enkratni 90 mg subkutani injekciji zdravila 8,5 dni.
English: A combined endpoint of histo-endoscopic mucosal healing defined as subjects having both mucosal healing and histologic healing was evaluated at week 8 of UNIFI-I and week 44 of UNIFI-M.
Slovenian: Kombiniran cilj opazovanja histološko endoskopske zacelitve sluznice, ki je bil definiran kot bolniki, pri katerih je prišlo tako do zacelitve sluznice kot histološke zacelitve, so ocenjevali v 8. tednu študije UNIFI-I in v 44. tednu študije UNIFI-M.
English: In these studies, 2.2% of 785 placebo treated patients and 1.9% of 790 patients treated with the recommended dose of ustekinumab reported adverse events occurring during or within an hour of the infusion.
Slovenian: V teh študijah je o neželenih učinkih med infuzijo ali v eni uri po infuziji poročalo 2,2% od 785 bolnikov, zdravljenih s placebom in 1,9% od 790 bolnikov, zdravljenih s priporočenim odmerkom ustekinumaba.
English: 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).
Slovenian: Po enem letu (52. teden) je 89% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za vzdrževalno zdravljenje, pokazalo odziv PASI 75, v primerjavi s 63% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za prejemanje placeba (prenehanje zdravljenja) (p < 0,001).
English: If you do not respond well enough or are intolerant to these medicines, you may be given Stelara to reduce the signs and symptoms of your disease.
Slovenian: Če odziv na zdravljenje s temi zdravili ni bil zadosten ali jih niste prenašali, lahko zdravnik za zmanjšanje znakov in simptomov bolezni uvede zdravljenje z zdravilom Stelara.
English: Do not touch the plunger while you do this
Slovenian: Pri tem se ne dotikajte bata.
English: Dispose of your sharps container according to your local regulations
Slovenian: Te posode odstranite skladno z lokalnimi predpisi.
English: • When the plunger is pushed as far as it will go, take out the needle and let go of the skin
Slovenian: • Ko ste bat potisnili do konca, vzemite iglo ven in spustite kožo.
English: 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.
Slovenian: Pri 29,1% bolnikov v tej študiji je bil začetni odziv na zdravljenje z zaviralci TNFα nezadosten (primarno neodzivni bolniki), 69,4% bolnikov se je sprva odzvalo, a so odziv izgubili (sekundarno neodzivni bolniki), 36,4% bolnikov pa zdravljenja ni prenašalo.
English: Serum ustekinumab concentrations in paediatric psoriasis patients 6 to 17 years of age, treated with the recommended weight-based dose were generally comparable to those in the adult psoriasis population treated with the adult dose.
Slovenian: Serumske koncentracije ustekinumaba pri pediatričnih bolnikih s psoriazo, starih 6 do 17 let, zdravljenih s priporočenim odmerkom glede na telesno maso so bile v splošnem primerljive s tistimi pri odrasli populaciji bolnikov s psoriazo, ki so prejemali priporočeni odmerek za odrasle.
English: Crohn's Disease and Ulcerative Colitis
Slovenian: Crohnova bolezen in ulcerozni kolitis
English: At week 12, subjects treated with ustekinumab showed clinically meaningful improvements in their psoriasis and health related quality of life (Table 8).
Slovenian: V 12. tednu so pri preiskovancih, zdravljenih z ustekinumabom ugotovili klinično pomembnejše izboljšanje psoriaze in izboljšanje z zdravjem povezane kakovosti življenja (Preglednica 8).
English: • Psoriatic arthritis - in adults
Slovenian: • psoriatični artritis pri odraslih
English: In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of STELARA.
Slovenian: V študijah Crohnove bolezni in ulceroznega kolitisa sočasna uporaba imunosupresivov ali kortikosteroidov ni vplivala na varnost ali učinkovitost zdravila STELARA.
English: No adverse effects on female fertility indices were observed using an analogous antibody to IL-12/23 in mice.
Slovenian: Pri miših niso opazili nobenih neželenih učinkov na pokazatelje plodnosti pri samicah pri uporabi analognega protitelesa IL-12/23.
English: Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials- discard 52 mL, for 3 vials discard 78 mL, for 4 vials- discard 104 mL).
Slovenian: Iz 250 ml infuzijske vrečke odvzemite volumen 9 mg/ml (0,9%) raztopine natrijevega klorida, ki ustreza volumnu zdravila STELARA, ki ga boste dodali (za eno vialo zdravila STELARA odvzemite in zavrzite 26 ml natrijevega klorida, za dve viali 52 ml, za 3 viale 78 ml, za 4 viale 104 ml).
English: 61% of these patients were either non-responsive, intolerant, or had a contraindication to other systemic therapy.
Slovenian: 61% teh bolnikov se bodisi ni odzvalo na drugo sistemsko zdravljenje, ga niso prenašali ali pa so imeli kontraindikacije zanj.
English: The proportion of patients achieving a clinically significant improvement in fatigue (4 points in FACIT-F) was also significantly greater in the ustekinumab groups compared with placebo.
Slovenian: Tudi delež bolnikov, ki so dosegli klinično pomembno izboljšanje utrujenosti (4 točke po FACIT-F), je bil pomembno večji v skupini z ustekinumabom.
English: STELARA is available in a 1 vial pack or a pack of 1 pre-filled syringe.
Slovenian: Zdravilo STELARA je na voljo v pakiranjih z 1 vialo ali v pakiranjih z 1 napolnjeno injekcijsko brizgo.
English: Table 9: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Slovenian: Preglednica 9: Indukcija kliničnega odziva in klinične remisije v študijah UNITI-1 in UNITI-2 UNITI-1*
English: Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology.
Slovenian: Ustekinumab je popolnoma človeško monoklonsko protitelo IgG1κ proti interlevkinu (IL)-12/23, izdelano v celični liniji mišjega plazmocitoma s tehnologijo rekombinantne DNA.
English: Table 3: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Slovenian: Preglednica 3: Indukcija kliničnega odziva in klinične remisije v študijah UNITI-1 in UNITI-2 UNITI-1*
English: These improvements were maintained in ustekinumab-treated patients in UNIFI-M through week 44.
Slovenian: Ta izboljšanja so se pri bolnikih, zdravljenih z ustekinumabom v študiji UNIF-M, ohranila do 44. tedna.
English: The needle cover on the syringe in the STELARA pre-filled syringe is manufactured from dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
Slovenian: Pokrovček za iglo napolnjene injekcijske brizge vsebuje naravno gumo (lateks), ki lahko povzroči alergijske reakcije pri posameznikih s preobčutljivostjo na lateks.
English: Stelara contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Slovenian: Zdravilo STELARA vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: 49% of patients had failed conventional therapy, but not a biologic (of which 94% where biological-naïve).
Slovenian: Pri 49% bolnikov je bilo neuspešno predhodno konvencionalno zdravljenje, ne pa zdravljenje z biološkim zdravilom (med temi bolniki jih 94% predhodno ni prejemalo biološkega zdravila).
English: • The needle cover should not be removed until you are ready to inject the dose
Slovenian: • Pokrovčka ne snemajte z igle, dokler niste pripravljeni za injiciranje odmerka.
English: * Following response to IV ustekinumab.
Slovenian: * po odzivu na intravenski odmerek ustekinumaba.
English: Clinical response and remission were significant as early as week 3 in ustekinumab treated patients and continued to improve through week 8.
Slovenian: Razlika v deležu kliničnih odzivov in remisij je bila pri bolnikih, ki so prejemali ustekinumab, statistično značilna že v 3. tednu in se je povečevala do 8. tedna.
English: At 18 months (week 76), 84% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 19% of patients re-randomised to placebo (treatment withdrawal).
Slovenian: Po 18. mesecih (76. teden) je imelo 84% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za vzdrževalno zdravljenje, odziv PASI 75, v primerjavi z 19% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za prejemanje placeba (prenehanje zdravljenja).
English: • If you have any new or changing lesions within psoriasis areas or on normal skin.
Slovenian: • če so se pojavili novi plaki ali je prišlo do sprememb obtoječih plakov na področjih kože, kjer ste imeli psoriazo, ali na zdravi koži.
English: No data are available on the secondary transmission of infection by live vaccines in patients receiving STELARA.
Slovenian: O sekundarnem prenosu okužb z živimi cepivi pri bolnikih, ki prejemajo zdravilo STELARA ni podatkov.
English: • Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings (see Figure 5)
Slovenian: • Injicirajte vse zdravilo tako, da pritiskate na bat dokler glava bata ni med aktivacijskimi nastavki ščitnika igle (glejte Sliko 5).
English: Patients previously treated with anti-TNFα agents who received ustekinumab achieved a greater response at week 24 than patients receiving placebo (ACR 20 response at week 24 for 45 mg and 90 mg was 37% and 34%, respectively, compared with placebo 15%; p < 0.05), and responses were maintained through week 52.
Slovenian: Bolniki, ki so že bili zdravljeni z zaviralci TNFα in so prejemali ustekinumab so po 24 tednih zdravljenja dosegli večji odziv v primerjavi z bolniki, ki so prejemali placebo (odziv ACR 20 v 24. tednu za 45 mg in 90 mg je bil 37% in 34%, v primerjavi s 15% pri placebu; p < 0,05).
English: • After the starting intravenous dose, you will have the next dose of 90 mg Stelara by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks therafter.
Slovenian: • Po začetnemu intravenskem odmerku boste naslednji, 90 mg odmerek zdravila STELARA prejeli pod kožo (subkutana injekcija) 8 tednov kasneje, nadaljnje odmerke pa boste prejemali na vsakih 12 tednov.
English: The first subcutaneous dose should be given at week 8 following the intravenous dose.
Slovenian: Prvi subkutani odmerek je treba injicirati 8 tednov po intravenskem odmerku.
English: • If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg body weight.
Slovenian: • Če tehtate manj kot 60 kg, je priporočeni odmerek zdravila Stelara 0,75 mg na kg telesne mase.
English: Table 5: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Slovenian: Preglednica 5: Povzetek glavnih kazalcev učinkovitosti v študiji UNIFI-I (po 8 tednih) Placebo
English: Some types of vaccines (live vaccines) should not be given while using Stelara.
Slovenian: Med uporabo zdravila Stelara vam ne smejo dati nekaterih cepiv (živa cepiva).
English: If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment.
Slovenian: Če ste pozabili ali zamudili dogovorjeni termin, da bi prejeli zdravilo, se čimprej dogovorite za naslednjega.
English: For patients with a body weight > 100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter.
Slovenian: Pri bolnikih s telesno maso > 100 kg je začetni odmerek 90 mg (subkutana injekcija), ki mu sledi 90 mg odmerek čez 4 tedne in nato na vsakih 12 tednov.
English: What Stelara is and what it is used for What you need to know before you use Stelara How Stelara will be given Possible side effects
Slovenian: Kaj je zdravilo Stelara in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Stelara Kako uporabljati zdravilo Stelara Možni neželeni učinki
English: Table 2 List of adverse reactions System Organ Class
Slovenian: Preglednica 2: Seznam neželenih učinkov Organski sistem
English: Malignancies excluding non-melanoma skin cancers were reported in 62 patients in 11,561 patient-years of follow-up (incidence of 0.54 per 100 patientyears of follow-up for ustekinumab-treated patients).
Slovenian: O malignomu, z izjemo nemelanomskega kožnega raka, so poročali pri 62 bolnikih na 11.561 bolnikov-let spremljanja (incidenca 0,54 na 100 bolnikov-let spremljanja za bolnike, zdravljene z ustekinumabom).
English: Table 11: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Slovenian: Preglednica 11: Povzetek glavnih kazalcev učinkovitosti v študij UNIFI-I (po 8 tednih) Placebo
English: Table 3 List of adverse reactions System Organ Class
Slovenian: Preglednica 3: Seznam neželenih učinkov Organski sistem
English: • Do not remove the needle cover from the pre-filled syringe until instructed to do so
Slovenian: • Ne snemajte pokrovčka igle z napolnjene injekcijske brizge, dokler ni to zahtevano v navodilu.
English: For the posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the STELARA solution for injection (vial) and solution for injection in pre-filled syringe SmPC.
Slovenian: Za odmerjanje vseh naslednjih subkutanih odmerkov glejte poglavje 4.2 povzetka glavnih značilnosti zdravila STELARA raztopina za injiciranje (viala) in STELARA raztopina za injiciranje v napolnjeni injekcijski brizgi.
English: 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).
Slovenian: Uporaba ustekinumaba statistično značilno zmanjša hitrost napredovanja strukturnih sprememb v primerjavi s placebom v 24. tednu, merjeno s spremembo celokupne vrednosti modificiranega rezultata vdH-S (v skupini s placebom je znašala povprečna vrednost ± SD 0,97 ± 3,85, v primerjavi z 0,40 ± 2,11 in 0,39 ± 2,40 za skupini, ki sta prejemali 45 mg (p < 0,05) oziroma 90 mg (p < 0,001) ustekinumaba).
English: STELARA 45 mg and 90 mg vials or pre-filled syringes are for subcutaneous injection only.
Slovenian: Zdravilo STELARA v obliki 45 mg in 90 mg vial ali napolnjenih injekcijskih brizg je namenjeno samo subkutanemu injiciranju.
English: In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA.
Slovenian: V študijah psoriatričnega artritisa sočasno jemanje MTX ni vplivalo na varnost ali učinkovitost zdravila STELARA.
English: How to use Stelara
Slovenian: Kako uporabljati zdravilo Stelara
English: PGA of cleared (0) or minimal (1)
Slovenian: PGA čisto (0) ali minimalno (1) PGA čisto (0)
English: • Stelara is given by injection under the skin (subcutaneously)
Slovenian: • Zdravilo Stelara dajemo z injiciranjem pod kožo (subkutano).
English: STELARA should be administered at Weeks 0 and 4, then every 12 weeks thereafter.
Slovenian: Zdravilo STELARA je treba odmerjati ob tednu 0 in 4, nato pa na vsakih 12 tednov.
English: Frequency: Adverse reaction
Slovenian: Pogostnost: neželeni učinek
English: The safety and efficacy of STELARA in children with psoriasis less than 6 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established.
Slovenian: Učinkovitosti in varnosti zdravila STELARA pri otrocih s psoriazo, mlajših od 6 let, ali pri otrocih s psoriatičnim artritisom, mlajših od 18 let, niso ugotovili.
English: A TNFα antagonist and/or vedolizumab.
Slovenian: zaviralecTNFα in/ali vedolizumab.
English: Table 1 Initial intravenous dosing of STELARA Body weight of patient at the time of dosing
Slovenian: Preglednica 1 Začetno intravensko odmerjanje zdravila STELARA Telesna masa bolnika ob odmerjanju
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Slovenian: Če niste gotovi, ali se katera od zgornjih trditev nanaša na vaš primer, se pogovorite z zdravnikom ali farmacevtom, preden začnete uporabljati zdravilo Stelara.
English: In patients with Crohn's disease and ulcerative colitis, based on observed data and population PK analyses, randomized subjects who lost response to treatment had lower serum ustekinumab concentrations over time compared with subjects who did not lose response.
Slovenian: Pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom so bile glede na podatke na osnovi opazovanj in rezultate analize populacijske farmakokinetike sčasoma koncentracije ustekinumaba v serumu nižje pri randomiziranih preiskovancih, pri katerih je prišlo do izgube odziva na zdravljenje, kot pri tistih preiskovancih, pri katerih ni prišlo do izgube odziva.
English: • Push the needle into the pinched skin
Slovenian: • Iglo vbodite v kožno gubo.
English: The proportion of patients with a PGA score of cleared (0) or minimal (1) and the proportion achieving PASI 75 showed separation between the ustekinumab treated group and placebo at the first post-baseline visit at week 4, reaching a maximum by week 12.
Slovenian: Delež bolnikov z oceno PGA čisto (0) ali minimalno (1) in delež bolnikov, ki so dosegli PASI 75 je v prvem obisku po začetku zdravljenja (4. teden) pokazal razliko med skupino, ki je prejemala ustekinumab in skupino, ki je prejemala placebo, največjo razliko pa v 12. tednu.
English: • Empty vials, antiseptic wipes, and other supplies can be disposed of in your garbage.
Slovenian: • Prazne viale, zložence in druge pripomočke lahko zavržete med gospodinjske odpadke.
English: • The doctor will work out the right dose for you, including the amount (volume) of Stelara to be injected to give the right dose.
Slovenian: • Zdravnik bo določil za vas pravi odmerek zdravila Stelara, vključno s količino zdravila
English: Approximately 11% of the patients had prior exposure to biologics.
Slovenian: Z biološkimi zdravili pa se je že zdravilo približno 11% bolnikov.
English: p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with etanercept.
Slovenian: p < 0,001 za ustekinumab v odmerku 45 mg ali 90 mg v primerjavi z etanerceptom.
English: 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.
Slovenian: V študijah indukcijskega zdravljenja Crohnove bolezni in ulceroznega kolitisa z intravenskim zdravljenjem po enkratnem intravenskem odmerku niso poročali o nobenem dogodku anafilakse ali hude infuzijske reakcije.
English: • Turn the vial and the syringe upside down
Slovenian: • Vialo in brizgo obrnite tako, da bo viala zgoraj.
English: Approximately 5% of the patients had prior exposure to biologics.
Slovenian: Z biološkimi zdravili se je že zdravilo približno 5% bolnikov.
English: In this case you will get training on how to inject Stelara yourself.
Slovenian: V tem primeru vas bodo poučili, kako si lahko zdravilo Stelara injicirate sami.
English: Similar proportions of adult patients developed protective levels of anti-pneumococcal and anti-tetanus antibodies and antibody titers were similar among STELARA-treated and control patients.
Slovenian: Deleža odraslih bolnikov, pri katerih je prišlo do nastanka proti-pneumokoknih in proti-tetanusnih protiteles, sta bila v skupini, ki je prejemala zdravilo STELARA in kontrolni skupini, podobna.
English: After the starting dose, you will receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks thereafter by an injection under the skin (‘subcutaneously').
Slovenian: Po začetnem odmerku boste prejeli naslednji, 90 mg odmerek zdravila Stelara čez 8 tednov, nadaljnje odmerke pa boste prejemali na vsakih 12 tednov v obliki podkožne injekcije (‘subkutano').
English: Paediatric plaque psoriasis
Slovenian: Pediatrična psoriaza s plaki
English: • Do not use the pre-filled syringe if it is dropped without the needle cover in place.
Slovenian: • Brizge ne smete uporabiti, če vam je padla in je brez pokrovčka.
English: The efficacy of ustekinumab was studied in 44 paediatric patients aged 6 to 11 years with moderate to severe plaque psoriasis in an open label, single-arm, multicenter, phase 3, study (CADMUS Jr.).
Slovenian: Učinkovitost ustekinumaba so preučevali pri 44 pediatričnih bolnikih, starih 6 do 11 let z zmerno do hudo psoriazo s plaki, v odprti, multicentični študiji faze 3 z eno skupino bolnikov (CADMUS Jr).
English: Uncommon: Cellulitis, dental infections, herpes zoster, lower respiratory tract infection, viral upper respiratory tract infection, vulvovaginal mycotic infection
Slovenian: Pogosti: okužbe zgornjih dihal, nazofaringitis Občasni: celulitis, okužbe zob, herpes zoster, okužbe spodnjih dihal, virusne okužbe zgornjih dihal, vulvovaginalne glivične okužbe, sinusitis