natgillin/translations-raw huggingface dataset:
Do not split, crush, chew or break the tablet before swallowing as it may change how much medicine gets into your body.
Preden tableto zaužijete, je ne smete razdeliti, zdrobiti, zgristi ali prelomiti: to namreč lahko vpliva na to, koliko zdravila vstopi v vaše telo.
Push down to make a hole in the foil and move the cutting tool round the edge of the foil to continue cutting the foil.
Potisnite navzdol, da boste naredili luknjo v folijo in pomikajte pripomoček za rezanje okrog roba folije, da jo boste še naprej prerezali.
Like all medicines, RINVOQ can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo RINVOQ neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Following single dose administration of [14C]-upadacitinib immediate-release solution, upadacitinib was eliminated predominantly as the unchanged parent substance in urine (24%) and faeces (38%).
Po enkratnem odmerku raztopine [14C]-upadacitiniba s takojšnim sproščanjem se je upadacitinib pretežno izločil kot nespremenjena matična snov v urinu (24 %) in blatu (38 %).
• Low disease activity (CDAI)
• Nizka aktivnost bolezni (CDAI)
In vitro, upadacitinib is a substrate for the efflux transporters P-gp and BCRP.
In vitro je upadacitinib substrat iztočnih prenašalcev P-gp in BCRP.
Immunomodulatory medicinal products may increase the risk of malignancies, including lymphoma.
Imunomodulirajoča zdravila lahko povečajo tveganje za maligne bolezni, vključno z limfomi.
Week 24e/26f
Teden 24e/26f
The European Medicines Agency has deferred the obligation to submit the results of studies with RINVOQ in one or more subsets of the paediatric population in chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and 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 zdravilom RINVOQ za eno ali več podskupin pediatrične populacije s kroničnim idiopatskim artritisom (vključno z revmatoidnim artritisom, psoriatičnim artritisom, spondiloartritisom in juvenilnim idiopatskim artritisom) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Upadacitinib is a selective and reversible JAK inhibitor.
Upadacitinib je selektiven in reverzibilen zaviralec JAK.
Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.
Pri bolnikih, ki se zdravijo z upadacitinibom, je treba dejavnike tveganja (npr. hipertenzijo, hiperlipidemijo) obravnavati kot del standardne oskrbe.
When you have taken your tablet, put the cap back on and close the bottle.
Ko imate tableto, namestite pokrovček nazaj in plastenko zaprite.
Mean CPK values increased by 4 weeks with a mean increase of 60 U/L at 12 weeks and then remained stable at an increased value thereafter including with extended therapy.
Povprečne vrednosti CPK so se zvišale do 4 tednov; povprečno zvišanje je bilo 60 e/l po 12 tednih in je nato ostalo stabilno na zvišani vrednosti, vključno s podaljšanim zdravljenjem.
Dose related increases in foetal resorptions associated with post-implantation losses at 25 and 75 mg/kg/day in this study in rats were attributed to the developmental/teratogenic effects of upadacitinib.
Z odmerkom povezana povečanja resorpcij plodov, ki so bila povezana s poimplantacijskimi izgubami ob odmerkih 25 in 75 mg/kg/dan v tej študiji na podganah, so pripisali razvojnim/teratogenim učinkom upadacitiniba.
• you have cancer - because your doctor will have to decide if you can still be given RINVOQ
• če imate raka - zdravnik bo namreč moral odločiti, ali lahko kljub temu prejemate zdravilo
Talk to your doctor or get medical help straight away if you get any signs of infection such as:
Resni neželeni učinki Takoj se posvetujte z zdravnikom ali poiščite zdravniško pomoč, če se vam pojavijo kakšni znaki okužbe, na primer:
Overall, both low disease activity and clinical remission rates were consistent across patient populations, with or without MTX.
V celoti sta bila tako delež nizke aktivnosti kot delež klinične remisije med populacijami dosledna tako z MTX kot brez njega.
• with underlying conditions that may predispose them to infection.
• z osnovnimi boleznimi, ki lahko povečajo nagnjenost k okužbam.
If a patient becomes pregnant while taking upadacitinib the parents should be informed of the potential risk to the foetus.
Če bolnica med jemanjem upadacitiniba zanosi, je treba starše seznaniti z možnim tveganjem za plod.
RINVOQ is used to treat adults with rheumatoid arthritis.
Zdravilo RINVOQ se uporablja za zdravljenje odraslih oseb z revmatoidnim artritisom.
The brochure also informs on steps which can be taken to reduce a patient's risk for key safety aspects of upadacitinib.
Vodnik seznanja tudi z ukrepi, ki jih je mogoče uporabiti za zmanjševanje ključnih varnostnih tveganj pri uporabi upadacitiniba.
Treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Zdravljenje je treba prekiniti, če se bolniku pojavi kakšna resna okužba, in sicer za čas, dokler okužba ni obvladana.
Janus Kinases (JAKs) are intracellular enzymes that transmit cytokine or growth factor signals involved in a broad range of cellular processes including inflammatory responses, hematopoiesis and immune surveillance.
Janusove kinaze (JAK) so znotrajcelični encimi, ki prenašajo signale citokinov ali rastnih faktorjev, vključene v širok nabor celičnih procesov, vključno z vnetnim odzivom, hematopoezo in imunskim nadzorom.
Tablet contents:
Vsebina tablete:
Treatment with upadacitinib should be initiated and supervised by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Zdravljenje z upadacitinibom morajo uvesti in nadzorovati zdravniki, ki imajo izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa.
Multipack: 84 (3 packs of 28) prolonged-release tablets
Multipakiranje: 84 (3 pakiranja po 28) tablet s podaljšanim sproščanjem
Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins.
Zdravnika morate obvestiti, če se vam pojavijo boleča oteklost noge, bolečine v prsih ali težko dihanje, kajti to so lahko znaki krvnih strdkov v venah.
If you take more RINVOQ than you should, contact your doctor.
Če ste vzeli večji odmerek zdravila RINVOQ, kot bi smeli, se posvetujte z zdravnikom.
Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies).
Približno 90 % upadacitiniba v sistemskem obtoku se odstrani v 24 urah po uporabi (v okviru odmerkov,
What RINVOQ is and what it is used for 2.
Kaj je zdravilo RINVOQ in za kaj ga uporabljamo 2.
Coadministration of upadacitinib with a high-fat meal had no clinically relevant effect on upadacitinib exposures (increased AUC by 29% and Cmax by 39%).
Sočasna uporaba upadacitiniba z zelo mastnim obrokom ni klinično pomembno vplivala na izpostavljenost upadacitinibu (povečanje AUC za 29 % in Cmax za 39 %).
The presence of at least 6 tender and 6 swollen joints and evidence of systemic inflammation based on elevation of hsCRP was required at baseline.
Izhodiščno je bila zahtevana prisotnost vsaj 6 bolečih in 6 oteklih sklepov in znaki sistemskega vnetja na podlagi zvišanja hsCRP.
JAK1 is important in inflammatory cytokine signals while JAK2 is important for red blood cell maturation and JAK3 signals play a role in immune surveillance and lymphocyte function.
JAK1 je pomembna pri vnetnih citokinskih signalih, JAK2 za dozorevanje eritrocitov, JAK3 pa ima vlogo pri imunskem nadzoru in delovanju limfocitov.
In human cellular assays, upadacitinib preferentially inhibits signalling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.
V človeških celičnih preizkusih upadacitinib prednostno in z večjo selektivno funkcionalnostjo zavira signaliziranje preko JAK1 ali JAK1/3 v primerjavi s citokinskimi receptorji, ki signalizirajo preko parov JAK2.
Consider the risks and benefits of treatment prior to initiating upadacitinib in patients:
Tveganja in koristi zdravljenja je treba pred uvedbo upadacitiniba pretehtati pri bolnikih:
Some patients receiving RINVOQ have developed skin cancers
Nekaterim bolnikom, ki so prejemali zdravilo RINVOQ, se je pojavil rak kože.
Pneumonia Herpes zoster Herpes simplex** Oral candidiasis
Herpes zoster Herpes simpleks** Oralna kandidoza
RINVOQ may be used as monotherapy or in combination with methotrexate.
Zdravilo RINVOQ se lahko uporablja kot samostojno zdravljenje (monoterapija) ali v kombinaciji z metotreksatom.
Among patients in the controlled studies with baseline values below the specified limits, the following frequencies of patients were observed to shift to above the specified limits on at least one occasion during 12/14 weeks (including patients who had an isolated elevated value):
V nadzorovanih študijah so med bolniki, ki so imeli izhodiščne vrednosti pod specificiranimi mejami, opažali naslednje pogostnosti premikov nad specificirane meje ob vsaj eni priložnosti med obdobjem 12/14 tednov (vključno z bolniki, ki so imeli le eno samo zvišano vrednost):
Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of upadacitinib.
Ženskam v rodni dobi je treba naročiti, da morajo med zdravljenjem in še 4 tedne po zadnjem odmerku upadacitiniba uporabljati učinkovito kontracepcijo.
• The active substance is upadacitinib.
• Učinkovina je upadacitinib.
Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172)
Črni železov oksid (E172) Rdeči železov oksid (E172)
Contents of the pack and other information What RINVOQ contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo RINVOQ
The tablets are provided in blisters or bottles.
Tablete so na voljo v pretisnih omotih ali plastenkah.
If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Če se pojavijo klinične manifestacije GVT/PE, je treba zdravljenje z upadacitinibom prekiniti, bolnike takoj ovrednotiti in slediti mora ustrezno zdravljenje.
Patients who were positive for hepatitis C antibody and hepatitis C virus RNA were excluded from clinical studies.
Bolniki, ki so bili pozitivni na protitelesa proti hepatitisu C in RNA virusa hepatitisa C, niso bili vključeni v klinične študije.
Following administration of upadacitinib to lactating rats, the concentrations of upadacitinib in milk over time generally paralleled those in plasma, with approximately 30-fold higher exposure in milk relative to maternal plasma.
Po uporabi upadacitiniba pri doječih podganah je bila koncentracija upadacitiniba v mleku skozi čas na splošno vzporedna koncentraciji v plazmi; izpostavljenost v mleku je bila približno 30-krat večja v primerjavi z materino plazmo.
• low white blood cell counts shown in blood tests
• majhno število belih krvnih celic; pokaže se na preiskavah krvi
RINVOQ has no effect on the ability to drive and use machines.
Zdravilo RINVOQ ne vpliva na sposobnost upravljanja vozil in strojev.
• you have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism).
• če ste v preteklosti imeli krvne strdke v venah nog (globoka venska tromboza) ali pljučih (pljučna embolija).
• medicines to treat tuberculosis (such as rifampicin)
• zdravila za zdravljenje tuberkuloze (npr. rifampicin)
• you have an infection (fever, sweating, or chills, shortness of breath, warm, red, or painful skin or sores on your body, feeling tired, cough, burning sensation when you pass urine or passing urine more often than normal, severe headache with stiff neck), or if you have ever had an infection that keeps coming back - RINVOQ can reduce your body's ability to fight infections and so may worsen an infection that you already have, or make it more likely for you to get a new infection
• če imate kakšno okužbo (zvišano telesno temperaturo, znojenje ali mrzlico, težko dihate, imate toplo, pordelo ali bolečo kožo ali razjede na telesu, ste utrujeni, kašljate, imate pekoč občutek pri odvajanju vode ali odvajate vodo pogosteje, kot je normalno, hud glavobol z otrdelim vratom), ali če ste kdaj imeli kakšno okužbo, ki se ponavlja - zdravilo RINVOQ lahko zmanjša sposobnost telesa za premagovanje okužb in na ta način lahko poslabša okužbo, ki jo že imate,
This is to check for a low red blood cell count (anaemia), low white blood cell count (neutropaenia or lymphopaenia), high blood fat (cholesterol) or high levels of liver enzymes.
Z njimi bodo preverili, ali imate majhno število rdečih krvnih celic (anemijo), majhno število belih krvnih celic (nevtropenijo ali limfopenijo), zvišane maščobe v krvi (holesterol) ali zvišane jetrne encime.
RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Zdravilo RINVOQ je indicirano za zdravljenje zmernega do hudega revmatoidnega artritisa pri odraslih bolnikih, ki se niso ustrezno odzvali na zdravljenje z enim ali več imunomodulirajočimi antirevmatiki (DMARD - disease-modifying anti-rheumatic drugs) ali teh zdravil ne prenašajo.
The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo redno PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
Treatment should be interrupted if Hb is < 8 g/dL and may be restarted once Hb returns above this value
Zdravljenje je treba prekiniti, če se Hb zmanjša na < 8 g/dl, in ga je mogoče znova začeti, ko se Hb vrne nad to vrednost.
Upadacitinib has no or negligible influence on the ability to drive and use machines.
Upadacitinib nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila https://www.ema.europa.eu/en.
• Film coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide, iron oxide red (E172), iron oxide black (E172).
• Filmska obloga: poli(vinil alkohol), makrogol, smukec, titanov dioksid, rdeči železov oksid (E172), črni železov oksid (E172).
• medicines to treat Cushing's syndrome (such as ketoconazole)
• zdravila za zdravljenje Cushingovega sindroma (npr. ketokonazol).
CR DAS28-CRP <2.6 (% of patients)
CR DAS28-CRP < 2,6 (% bolnikov)
In clinical studies, treatment was interrupted in response to ANC < 1,000 cells/mm3 (see section 4.2).
V kliničnih študijah so zdravljenje prekinili, če se je AŠN zmanjšalo na < 1.000 celic/mm3 (glejte poglavje 4.2).
No data are available on the response to vaccination with live or inactivated vaccines in patients receiving upadacitinib.
O odzivu na cepljenje z živimi ali inaktiviranimi cepivi pri bolnikih, ki so prejemali upadacitinib, ni podatkov.
Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.
Presejanje za virusni hepatitis in nadzor glede reaktivacije je treba izvesti pred začetkom zdravljenja z upadacitinibom in ga izvajati med zdravljenjem s tem zdravilom.
Compared to adalimumab, significantly higher rates of low disease activity were achieved at week 12 in SELECT-COMPARE.
Po 12 tednih so bile dosežene značilno višje stopnje nizke aktivnosti bolezni kot z adalimumabom v SELECT-COMPARE.
Rheumatoid arthritis patients have an increased risk for cardiovascular disorders.
Bolniki z revmatoidnim artritisom imajo povečano tveganje za nastanek srčno-žilnih bolezni.
There are no or limited data on the use of upadacitinib in pregnant women.
Podatkov o uporabi upadacitiniba pri nosečnicah ni ali pa jih je malo.
No dose adjustment is required in patients with mild or moderate renal impairment.
Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro ledvic ni potrebna.
What you need to know before you take RINVOQ 3.
Kaj morate vedeti, preden boste vzeli zdravilo RINVOQ 3.
Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.
Če se jetrni encimi zvišajo, je priporočljivo takoj preiskati vzrok za to, da bi ugotovili možne primere z zdravilom povzročene okvare jeter.
Evaluate at baseline and thereafter according to routine patient management.
Ocenite izhodiščno, pozneje pa glede na rutinsko vodenje bolnika.
Other medicines and RINVOQ
Druga zdravila in zdravilo RINVOQ
If these medicines do not work well enough, you will be given RINVOQ either alone or in combination with methotrexate to treat your rheumatoid arthritis.
Če ta zdravila ne bodo delovala dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo RINVOQ, bodisi samo bodisi v kombinaciji z metotreksatom.
• with a history of a serious or an opportunistic infection
• ki imajo v anamnezi kakšno resno ali oportunistično okužbo,
What you need to know before you take RINVOQ Do not take RINVOQ
Kaj morate vedeti, preden boste vzeli zdravilo RINVOQ Ne jemljite zdravila RINVOQ
• you have recently had or plan to have a vaccination (immunisation) - this is because live vaccines are not recommended while using RINVOQ
• če ste kdaj imeli hepatitis B ali C. • če ste nedavno opravili kakšno cepljenje (imunizacijo), ali če cepljenje načrtujete - med uporabo zdravila RINVOQ namreč ni priporočljivo dobiti živih cepiv.
Abbreviations: ACR20 (or 50) = American College of Rheumatology ≥20% (or ≥50%) improvement;
Okrajšave: ACR20 (ali 50) = izboljšanje za ≥ 20 % (ali ≥ 50 %) po American College of Rheumatology;
• medicines to treat fungal infections (such as itraconazole, posaconazole or voriconazole)
• zdravila za zdravljenje glivičnih okužb (npr. itrakonazol, posakonazol ali vorikonazol)
The pharmacologic activity of upadacitinib is attributed to the parent molecule.
Farmakološka aktivnost upadacitiniba gre na račun matične molekule.
QR code to be included For more information and support on taking RINVOQ go to www.rinvoq.eu
Vstavite QR-kodo Za več informacij in za podporo v zvezi z jemanjem zdravila RINVOQ obiščite www.rinvoq.eu
It is unknown whether upadacitinib/metabolites are excreted in human milk.
Ni znano, ali se upadacitinib ali njegovi presnovki pri človeku izločajo v materino mleko.
LDA DAS28-CRP ≤3.2 (% of patients)
LDA DAS28-CRP ≤ 3,2 (% bolnikov)
• A patient alert card
• Opozorilno kartico za bolnika
Patients should be monitored for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Bolnike je treba nadzorovati glede znakov in simptomov TB; to velja tudi za bolnike, ki so imeli pred uvedbo zdravljenja negativen izvid testiranja za latentno TB.
If hepatitis B virus DNA is detected while receiving upadacitinib, a liver specialist should be consulted.
Če je DNA virusa hepatitisa B ugotovljena med zdravljenjem z upadacitinibom, se je treba posvetovati s specialistom hepatologom.
The maximal inhibition was observed 1 hour after dosing which returned to near baseline by the end of dosing interval.
Največje zavrtje so opažali 1 uro po uporabi odmerka; zavrtje se je do konca odmernega intervala vrnilo skoraj na izhodiščno raven.
The decreases in neutrophil counts remained stable at a lower value than baseline over time including with extended therapy.
Zmanjšanje števila nevtrofilcev je skozi čas ostalo stabilno na nižji vrednosti od izhodiščne, vključno s podaljšanim zdravljenjem.
Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Za bolnike, ki imajo večje tveganje za raka kože, so priporočljivi redni pregledi kože.
What RINVOQ is and what it is used for
Kaj je zdravilo RINVOQ in za kaj ga uporabljamo
Treatment Group
Terapevtska skupina
Upadacitinib was teratogenic in both rats and rabbits.
Upadacitinib je bil teratogen tako pri podganah kot pri kuncih.
Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in improvements in individual ACR components, including tender and swollen joint counts, patient and physician global assessments, HAQ-DI, pain assessment and hsCRP.
Zdravljenje s 15 mg upadacitiniba samega ali v kombinaciji s csDMARD je doseglo izboljšanja posameznih elementov ACR, vključno s številom bolečih in oteklih sklepov, bolnikovo in zdravnikovo globalno oceno, HAQ-DI, oceno bolečin in hsCRP.
In healthy volunteers, the administration of upadacitinib (immediate release formulation) resulted in a dose- and concentration-dependent inhibition of IL-6 (JAK1/JAK2) - induced STAT3 and IL-7 (JAK1/JAK3)-induced STAT5 phosphorylation in whole blood.
Pri zdravih prostovoljcih je uporaba upadacitiniba (oblike s takojšnjim sproščanjem) povzročila od odmerka in koncentracije odvisno zavrtje z IL-6 (JAK1/JAK2) izzvane fosforilacije STAT3 in z IL-7
Approximately 34% of upadacitinib dose was excreted as metabolites.
Približno 34 % odmerka upadacitiniba se je izločilo v obliki presnovkov.
Steady-state plasma concentrations are achieved within 4 days with minimal accumulation after multiple once-daily administrations.
Koncentracija v plazmi doseže stanje dinamičnega ravnovesja v 4 dneh; kopičenje je po večkratni uporabi enkrat na dan minimalno.
Do not stop taking RINVOQ unless your doctor tells you to stop taking it.
Ne prenehajte jemati zdravila RINVOQ, če vam tega ne naroči zdravnik.
Rheumatoid arthritis is a disease that causes inflamed joints.
Revmatoidni artritis je bolezen, ki povzroči vnetje sklepov.
If you are a woman of child-bearing potential, you must use effective contraception to avoid becoming pregnant while taking RINVOQ and for at least 4 weeks after your last dose of RINVOQ.
Če ste ženska v rodni dobi, morate za preprečitev nosečnosti med jemanjem zdravila RINVOQ in vsaj še 4 tedne po zadnjem odmerku zdravila RINVOQ uporabljati učinkovito kontracepcijo.
The objective of the programme is to increase awareness of HCPs and patients on the risks of serious and opportunistic infections including TB, herpes zoster, foetal malformation (pregnancy risk), MACE, and VTEs and how to manage these risks.
Cilj programa je povečanje ozaveščenosti zdravstvenih delavcev in bolnikov glede tveganj za resne in oportunistične okužbe, vključno s tuberkulozo (TB), herpes zoster, malformacije ploda (tveganje v času nosečnosti), pomembne neželene srčno-žilne dogodke (MACE - Major Adverse Cardiovascular Events) in vensko tromboembolijo (VTE) ter kako ovladovati ta tveganja.
Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk (see section 5.3).
Farmakodinamični in toksikološki podatki, ki so na voljo za živali, so pokazali izločanje upadacitiniba v mleku (glejte poglavje 5.3).
In the clinical studies, upadacitinib treated patients reported significant improvements in patientreported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score compared to placebo and MTX.
V kliničnih študijah so bolniki, zdravljeni z upadacitinibom, poročali o značilnih izboljšanjih kakovosti življenja po navedbi bolnika, merjeni z oceno telesnega elementa vprašalnika SF-36 (Short Form (36) Health Survey Physical Component Score), v primerjavi z bolniki, ki so prejemali placebo in MTX.
Treatment with upadacitinib was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol (see section 4.8).
Zdravljenje z upadacitinibom je bilo povezano z zvišanjem vrednosti lipidov, vključno z zvišanjem celokupnega holesterola, holesterola v lipoproteinih nizke gostote (LDL) in holesterola v lipoproteinih visoke gostote (HDL) (glejte poglavje 4.8).