natgillin/translations-raw huggingface dataset:
The effects of IL-12 or IL-23 on the regulation of CYP450 enzymes were evaluated in an in vitro study using human hepatocytes, which showed that IL-12 and/or IL-23 at levels of 10 ng/mL did not alter human CYP450 enzyme activities (CYP1A2, 2B6, 2C9, 2C19, 2D6, or 3A4; see section 4.5).
Študija humanih hepatocitov in vitro, v kateri so ocenjevali učinke IL-12 ali IL-23 na regulacijo encimov CYP450, je pokazala, da IL-12 in/ali IL-23 v koncentracijah 10 ng/ml nista vplivala na aktivnost humanih encimov CYP450 (CYP1A2, 2B6, 2C9, 2C19, 2D6, ali 3A4; glejte poglavje 4.5).
Crohn's Disease
Crohnova bolezen
The primary endpoint was the proportion of patients who achieved a PGA score of cleared (0) or minimal (1) at week 12.
Primarni cilj je bil delež bolnikov, ki so v 12. tednu dosegli oceno PGA čisto (0) ali minimalno (1).
• Pull on the syringe plunger to fill the syringe with the amount of liquid prescribed by your doctor
• Vlecite bat brizge, da se bo brizga napolnila s količino tekočine, ki vam jo je predpisal zdravnik.
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.
Nastanek protiteles proti ustekinumabu povezujejo s povečanim očistkom in zmanjšano učinkovitostjo ustekinumaba, razen pri bolnikih s Crohnovo boleznijo ali ulceroznim kolitisom, pri katerih niso opazili zmanjšane učinkovitosti.
Detailed instructions for use are provided in the package leaflet.
Podrobnejša navodila so navedena v navodilu za uporabo.
Ustekinumab 2 doses (week 0 and week 4) 45 mg
ustekinumab 2 odmerka (teden 0 in 4) 45 mg
Steady state ustekinumab concentration was achieved by the start of the second maintenance dose.
Koncentracije ustekinumaba v stanju dinamičnega ravnovesja so bile dosežene pred drugim vzdrževalnim odmerkom.
Common: Back pain, myalgia, arthralgia
Pogosti: bolečine v hrbtu, mialgija, artralgija
The rate of infection was 0.91 per patient-year of follow-up in ustekinumab-treated patients, and the rate of serious infections was 0.02 per patient-year of follow-up in ustekinumab-treated patients (199 serious infections in 11,581 patient-years of follow-up) and serious infections reported included pneumonia, anal abscess, cellulitis, diverticulitis, gastroenteritis and viral infections.
Pogostnost okužb je bila 0,91 na bolnikov-let spremljanja za bolnike, zdravljene z ustekinumabom, pogostnost resnih okužb pa je znašala 0,02 na bolnikov-let spremljanja tudi za bolnike, zdravljene z ustekinumabom (199 resnih okužb na 11.581 bolnikov-let spremljanja) in med poročanimi resnimi okužbami so bili pljučnica, analni absces, celulitis, divertikulitis, gastroenteritis in virusne okužbe.
• There may be a small amount of blood or liquid at the injection site.
• Morda bo iz mesta injiciranja priteklo nekaj kapelj krvi ali tekočine.
Nominally significant (p < 0.05)
nominalno statistično značilno (p < 0,05)
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).
Dolgotrajna remisija je definirana kot parcialna remisija po kriterijih Mayo pri ≥ 80% vseh študijskih obiskov pred 44. tednom in parcialna remisija po kriterijih Mayo pri zadnjem obisku (v 44. tednu).
Improvements in PGA, PASI, CDLQI and PedsQL were maintained through week 52 (Table 7).
Izboljšanje ocene PGA, PASI, CDLQI in PedsQL se je ohranilo do 52. tedna (Preglednica 7).
Enrolled patients had to have failed conventional therapy (corticosteroids or immunomodulators) or at least one biologic (a TNFα antagonist and/or vedolizumab).
Vključeni bolniki so morali imeti anamnezo neuspešnega konvencionalnega zdravljenja (s kortikosteroidi ali imunomodulatorji) ali neuspešnega zdravljenja z najmanj enim biološkim zdravilom (z zaviralcem TNFα in/ali vedolizumabom).
If you don't know the amount or type of syringe needed, contact your healthcare provider for further instruction.
Če ne veste, koliko zdravila je treba izvleči iz viale ali kakšno brizgo potrebujete, se za dodatna navodila obrnite medicinsko ali negovalno osebje.
Similar results were seen with each dose of ustekinumab.
Pri vseh odmerkih ustekinumaba so dobili podobne rezultate.
These treatments may also weaken part of the immune system.
Tudi ta zdravila lahko zmanjšajo delovanje imunskega sistema.
STELARA is available in a 1 vial pack.
Zdravilo STELARA je na voljo v pakiranjih z 1 vialo.
Hypersensitivity and infusion reactions
Preobčutljivostne in infuzijske reakcije
Dose linearity
Linearnost odmerkov
Over 70% and 40% of the patients in both studies had enthesitis and dactylitis at baseline, respectively.
Več kot 70% in 40% bolnikov v obeh študijah je imelo entezitis oziroma daktilitis na začetku zdravljenja.
Stelara 130 mg concentrate for solution for infusion will be given to you by your doctor, through a drip in the vein of your arm (intravenous infusion) over at least one hour.
Zdravilo Stelara 130 mg koncentrat za raztopino za infundiranje vam bo dal zdravnik v obliki kapljične infuzije v eno od ven na roki (intravenska infuzija), ki bo trajala najmanj eno uro.
Shedding of skin - increase in redness and shedding of skin over a larger area of the body may be symptoms of erythrodermic psoriasis or exfoliative dermatitis, which are serious skin conditions.
Luščenje kože - močna pordelost in zvečano luščenje kože večjega dela telesa so lahko simptomi eritrodermične psoriaze ali eksfoliativnega dermatitisa, ki sta hudi obolenji kože.
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.
Izberite dve različni mesti za injiciranje (na primer eno na desnem stegnu in drugo na levem stegnu) in si dajte injekciji eno za drugo.
Systemic and respiratory hypersensitivity reactions
Sistemske in dihalne preobčutljivostne reakcije
These medicines work by weakening part of the immune system.
Ta zdravila zmanjšujejo delovanje imunskega sistema.
The container of this medicinal product contains latex rubber.
Vsebnik zdravila vsebuje gumo.
• Redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis).
• pordelost in luščenje kože večjega dela telesa, ki ga lahko spremljata srbenje ali bolečina (eksfoliativni dermatitis).
• Antiseptic wipes and other supplies can be disposed of in your garbage.
• Antiseptične zložence in druge pripomočke lahko zavržete med gospodinjske odpadke.
However, you and your doctor may decide that you may inject Stelara yourself.
Vi in vaš zdravnik pa se bosta morda odločila, da si lahko zdravilo Stelara injicirate tudi sami.
• Redness and pain where the injection is given
• pordelost in bolečina na mestu injiciranja zdravila
As part of the monitoring of the patient's psoriasis, physicians should be alert for symptoms of erythrodermic psoriasis or exfoliative dermatitis.
Med spremljanjem bolnika s psoriazo mora biti zdravnik pozoren na simptome eritrodermične psoriaze ali eksfoliativnega dermatitisa.
The clinical development program consisted of one intravenous induction study (referred to as UNIFI-I) with treatment of up to 16 weeks followed by a
Klinični razvojni program je obsegal eno študijo intravenskega indukcijskega zdravljenja (z nazivom UNIFI-I) s trajanjem zdravljenja do 16 tednov.
PsARC responses were maintained through weeks 52 and 100.
Odzivi PsARC so se ohranili do 52. in do 100. tedna.
Approximately 60% of the patients had prior exposure to conventional systemic therapy or phototherapy.
Približno 60% bolnikov se je že zdravilo s konvencionalno sistemsko terapijo ali fototerapijo.
Approximately 43% of the patients had prior exposure to conventional systemic therapy or phototherapy.
Približno 43% bolnikov se je že zdravilo s konvencionalno sistemsko terapijo ali fototerapijo.
Median volume of distribution during the terminal phase (Vz) following a single intravenous administration to patients with psoriasis ranged from 57 to 83 mL/kg.
Mediana vrednost porazdelitvenega volumna v končni fazi (Vz) po enkratni intravenski injekciji zdravila bolnikom s psoriazo je bila od 57 do 83 ml/kg.
• Pull the needle cover straight off and throw it away.
• Potegnite pokrovček z igle in ga zavrzite.
Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breast-feeding to the child and the benefit of STELARA therapy to the woman.
Zaradi morebitnih neželenih učinkov ustekinumaba pri dojenčkih se je treba odločiti, ali naj mati med zdravljenjem in do 15 tednov po njem preneha dojiti ali naj se raje preneha zdraviti z zdravilom STELARA, ob upoštevanju koristi dojenja za otroka in koristi zdravljenja z zdravilom STELARA za mater.
• The active substance is ustekinumab.
• Zdravilna učinkovina je ustekinumab.
Patients may subsequently be dosed every 8 weeks or every 12 weeks according to clinical judgment (see section 5.1).
V nadaljevanju zdravljenja je mogoče bolnikom odmerjati zdravilo na 8 tednov ali na 12 tednov v skladu s klinično presojo (glejte poglavje 5.1).
STELARA treatment is to be initiated with a single intravenous dose based on body weight.
Zdravljenje z zdravilom STELARA je treba začeti z enkratnim intravenskim odmerkom glede na telesno maso.
In PsA Study 1 (PSUMMIT I) and PsA Study 2 (PSUMMIT II), 80% and 86% of the patients, respectively, had been previously treated with DMARDs.
Približno 80% bolnikov iz 1. študije PsA (PSUMMIT 1) in 86% bolnikov iz 2. študije PsA (PSUMMIT 2) je bilo že zdravljenih z DMARDs.
As early as Week 2, the earliest scheduled study visit, and at each visit thereafter, a higher proportion of ustekinumab patients had no rectal bleeding or achieved normal stool frequency as compared with placebo patients.
Že po 2 tednih, torej pri prvem rednem študijskem obisku, in nato pri vseh obiskih je bil delež bolnikov, ki niso imeli krvavitev iz danke ali so dosegli normalno frekvenco odvajanja blata, večji v skupini z ustekinumabom kot v skupini bolnikov s placebom.
Additionally in Crohn's disease, clearance was affected by C-reactive protein, TNF antagonist failure status and race (Asian versus non-Asian).
Dodatno so pri bolnikih s Crohnovo boleznijo na očistek ustekinumaba vplivali C-reaktivni protein, status neuspešnosti zdravljenja z zaviralci TNF in rasa (pripadniki azijskega v primerjavi s pripadniki neazijskega porekla).
The calculated volume should be rounded to the nearest 0.01 mL and administered using a 1 mL graduated syringe.
Izračunani volumen zaokrožite na najbližjih 0,01 ml in odmerite z 1-ml injekcijsko brizgo.
• Do not touch this area again before giving the injection.
• Tega mesta se ne smete ponovno dotakniti pred injiciranjem zdravila.
10 people)
10 bolnikov).
Patients receiving STELARA may receive concurrent inactivated or non-live vaccinations.
Bolniki, ki prejemajo zdravilo STELARA, lahko v tem času prejmejo inaktivirana ali mrtva cepiva.
• In some patients, after the first injection under the skin, 90 mg Stelara may be given every 8 weeks.
• Nekateri bolniki lahko po prvi podkožni injekciji 90 mg zdravila Stelara prejmejo na vsakih 8 tednov.
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.
Izberite dve različni mesti za injiciranje (npr. eno na desnem stegnu in drugo na levem stegnu) in si dajte injekciji eno za drugo.
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).
Resne okužbe so se pojavljale s pogostnostjo 0,03 na bolnikov-let spremljanja pri bolnikih, zdravljenih z ustekinumabom (30 resnih okužb na 930 bolnikov-let spremljanja), in s pogostnostjo 0,03 pri bolnikih, ki so prejemali placebo (15 resnih okužb na 434 bolnikov-let spremljanja) (glejte poglavje 4.4).
p = 0.012 for ustekinumab 45 mg in comparison with etanercept.
p = 0,012 za ustekinumab v odmerku 45 mg v primerjavi z etanerceptom.
The impact of these covariates was within ±20% of the typical or reference value of the respective PK parameter, thus dose adjustment is not warranted for these covariates.
Vpliv teh sospremenljivk je bil znotraj ± 20% običajnih ali referenčnih vrednosti posameznega farmakokinetičnega parametra, zato prilagajanje odmerjanja zaradi teh sospremenljivk ni potrebno.
SC
bc
The clinical development program consisted of two 8-week intravenous induction studies (UNITI-1 and UNITI-2) followed by a 44 week subcutaneous randomized withdrawal maintenance study (IM-UNITI) representing 52 weeks of therapy.
Klinični razvojni program je bil sestavljen iz dveh 8-tedenskih študij intravenske indukcije zdravila (UNITI-1 in UNITI-2), ki jima je sledila 44-tedenska randomizirana študija odtegnitve zdravljenja in vzdrževanja odgovora pri subkutanem odmerjanju (IM-UNITI), kar skupaj predstavlja 52 tednov zdravljenja.
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 dokazano izboljšal znake in simptome ter z zdravjem povezano kakovost življenja pri pediatričnih bolnikih s psoriazo s plaki, starih 12 let in več.
• Do not hold by the plunger head, plunger, needle guard wings, or needle cover
• Brizge ne držite za glavo bata, bat, krila ščitnika igle, ali pokrovček igle.
Also tell your doctor if you have any open cuts or sores as they might get infected.
Zdravniku morate tudi povedati, če imate kakršno koli ureznino ali rano, ker bi se le-ta lahko okužila.
Concentrate for Solution for infusion 130 mg/26 mL
koncentrat za raztopino za infundiranje 130 mg/26 ml
During the long term extension of Psoriasis Study 2 (PHOENIX 2), adult patients treated with STELARA for at least 3.5 years mounted similar antibody responses to both pneumococcal polysaccharide and tetanus vaccines as a non-systemically treated psoriasis control group.
Med dolgotrajnim podaljšanjem 2. študije psoriaze pri odraslih (PHOENIX 2) je bil imunski odziv (pri bolnikih, ki so se zdravili z zdravilom STELARA vsaj 3,5 let) tako na pnevmokokne polisaharide kot na cepivo proti tetanusu podoben kot v kontrolni skupini bolnikov s psoriazo, ki niso prejemali sistemskega zdravljenja.
Among patients who entered the study extension, clinical remission and response were generally maintained through week 92 for both patients who failed TNF-therapies and those who failed conventional therapies.
Med bolniki, ki so bili vključeni v podaljšano študijo jih je večina vzdrževala klinično remisijo in odziv na zdravljenje do 92 tedna, kar velja za bolnike pri katerih je bilo neuspešno zdravljenje z zaviralci TNF in za bolnike z neuspešnim konvencionalnim zdravljenjem.
The pharmacokinetics of ustekinumab were generally comparable between Asian and non-Asian patients with psoriasis and ulcerative colitis.
Farmakokinetika ustekinumaba je bila pri bolnikih s psoriazo in ulceroznim kolitisom azijskega in ne-azijskega porekla v glavnem primerljiva.
After proper training in subcutaneous injection technique, patients or their caregivers may inject STELARA if a physician determines that it is appropriate.
Po ustreznem usposabljanju o subkutanem injiciranju si lahko bolniki sami injicirajo zdravilo STELARA ali jim ga injicirajo njihovi skrbniki, če zdravnik presodi, da je to primerno in zagotovi tudi spremljanje bolnika.
Table 4 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 (PHOENIX 2)
Preglednica 4: Povzetek rezultatov kliničnega odziva v 1. študiji psoriaze (PHOENIX 1) in v 2. študiji psoriaze (PHOENIX 2)
This includes exposure to STELARA in the controlled and non-controlled periods of the clinical studies for at least 6 months or 1 year (4,577 and 3,253 patients respectively with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis) and exposure for at least 4 or 5 years (1,482 and 838 patients with psoriasis respectively).
Vključeni so tudi bolniki, ki so bili v nadzorovanih in nenadzorovanih obdobjih kliničnih študij izpostavljeni zdravilu STELARA najmanj 6 mesecev ali 1 leto (4.577 in 3.253 bolnikov s psoriazo, psoriatičnim artritisom, Crohnovo boleznijo ali ulceroznim kolitisom) in tisti, ki so mu bili izpostavljeni najmanj 4 ali 5 let (1.482 in 838 bolnikov s psoriazo).
The primary endpoint for both induction studies was the proportion of subjects in clinical response (defined as a reduction in CDAI score of ≥ 100 points) at week 6.
Primarni cilj obeh študij indukcije je bil delež bolnikov, ki so dosegli klinični odziv po 6 tednih (klinični odziv je definiran kot zmanjšanje indeksa CDAI za ≥ 100 točk).
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).
Spodaj navedeni podatki o varnosti zdravila temeljijo na stopnjah izpostavljenosti ustekinumabu v 14 študijah faze 2 in 3 pri 6.709 odraslih bolnikih (4.135 bolnikih s psoriazo in/ali psoriatičnim artritisom, 1.749 bolnikih s Crohnovo boleznijo in 825 bolnikih z ulceroznim kolitisom).
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).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z ustekinumabom za eno ali več podskupin pediatrične populacije s Crohnovo boleznijo in ulceroznim kolitisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Clinical remission is defined as CDAI score < 150; Clinical response is defined as reduction in CDAI score by at least 100 points or being in clinical remission
Klinična remisija je definirana kot CDAI < 150; Klinični odziv je definiran kot zmanjšanje CDAI za vsaj 100 točk ali pa, da je dosegel klinično remisijo.
The effects of Stelara in pregnant women are not known.
Vpliv tega zdravila na nosečnice ni znan.
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).
V 8. tednu po enkratnem infuzijskem indukcijskem odmerku je bila sprememba indeksa SES-CD večja v skupini, ki je prejemala ustekinumab (n = 155, povprečna sprememba = -2,8) kot v skupini, ki je prejemala placebo (n = 97, povprečna sprememba = -0,7, p = 0,012).
What Stelara is and what it is used for
Kaj je zdravilo Stelara in zakaj ga uporabljamo
Justification for not including in Braille accepted.
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
Prepare the dose: • Take the cap off the top of the vial (see Figure 3)
Pripravite odmerek: • Snemite pokrovček z viale (glejte Sliko 3).
Inject the dose:
Injicirajte si odmerek zdravila:
Psoriasis or Psoriatic Arthritis
Psoriaza ali psoriatični artritis
Loss of response was defined as a CDAI score ≥ 220 points and a ≥ 100 point increase from the CDAI score at baseline.
Izguba odziva je bila definirana kot vrednost indeksa CDAI ≥ 220 točk in izboljšanje indeksa CDAI za ≥ 100 točk glede na izhodiščno vrednost.
• Moderate to severe ulcerative colitis - in adults
• zmerno do močno aktivnega ulceroznega kolitisa - pri odraslih
Nominally significant (p < 0.001)
nominalno statistično značilno (p < 0,001)
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.
o nizek krvni tlak, ki lahko povzroči vrtoglavico ali omotico, o otekanje obraza, ustnic, ust ali žrela.
Table 8 Summary of primary and secondary endpoints at week 12 and week 52 Paediatric psoriasis study (CADMUS Jr.) (Age 6-11) Week 12
Preglednica 8 Povzetek primarnih in sekundarnih ciljev v 12. in 52. tednu Študija pediatrične psoriaze (CADMUS Jr.) (6-11 let) 12. teden
• 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)
• Ko ste bat potisnili do konca, še naprej pritiskajte na glavo bata, izvlecite iglo iz kože ter spustite kožno gubo (glejte Sliko 6).
The medicinal product should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
Zdravila ne smete uporabljati, če je raztopina obarvana ali motna ali če so v njej vidni tuji delci.
STELARA has no or negligible influence on the ability to drive and use machines.
Zdravilo STELARA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
44 week subcutaneous randomized withdrawal maintenance study (referred to as UNIFI-M) representing at least 52 weeks of therapy.
Tej študiji je sledila 44-tedenska randomizirana študija subkutanega vzdrževalnega zdravljenja in odtegnitve zdravljenja (z nazivom UNIFI-M), kar skupaj predstavlja najmanj 52 tednov zdravljenja.
Thus, caution should be exercised when considering the use of STELARA in these patients.
Če razmišljate o uporabi zdravila STELARA pri teh bolnikih, je torej potrebna previdnost.
• Push the plunger with your thumb as far as it will go to inject all of the liquid.
• S palcem potisnite bat do konca in injicirajte vso tekočino.
In patients with Crohn's disease and ulcerative colitis, treatment with ustekinumab resulted in a decrease in inflammatory markers including C-Reactive Protein (CRP) and fecal calprotectin during the induction phase, which were then maintained throughout the maintenance phase.
Zdravljenje z ustekinumabom je pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom med indukcijsko fazo zmanjšalo prisotnost vnetnih markerjev, vključno s C-reaktivnim proteinom (CRP) in fekalnim kalprotektinom, kar se je ohranilo skozi celotno vzdrževalno fazo.
The formation of anti-ustekinumab antibodies is associated with increased clearance of ustekinumab in patients with Crohn's disease or ulcerative colitis.
Nastanek protiteles proti ustekinumabu povezujejo s povečanim očistkom ustekinumaba pri bolnikih s Crohnovo boleznijo ali ulceroznim kolitisom.
Approximately 48% of the patients had failed 1 prior anti-TNF therapy and 52% had failed 2 or 3 prior anti-TNFα therapies.
Pri približno 48% bolnikov je bilo neuspešno 1 predhodno zdravljenje z zaviralci TNFα in pri 52% 2 ali 3 predhodna zdravljenja z zaviralci TNFα.
In Study 2, the majority of patients (58%, n = 180) had been previously treated with one or more anti-TNFα agent(s), of whom over 70% had discontinued their anti-TNFα treatment for lack of efficacy or intolerance at any time.
V 2. študiji je bila večina (58%, n = 180) bolnikov že zdravljenih z enim ali več zaviralci TNFα, 70% teh bolnikov je zdravljenje zaradi pomankanja učinkovitosti ali intolerance prekinilo.
In the population pharmacokinetic analyses of the phase 3 studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
V analizi populacijske farmakokinetike na podlagi študij faze 3 so raziskovali vpliv zdravil, ki jih najpogosteje sočasno uporabljamo pri bolnikih s psoriazo (vključno s paracetamolom, ibuprofenom, acetilsalicilno kislino, metforminom, atorvastatinom in levotiroksinom), na farmakokinetiko ustekinumaba.