FrancophonIA/ELRC3.0 huggingface dataset:
English: • Risk of foetal malformation o Language on teratogenicity of upadacitinib in animals o Details on how to reduce the risk of exposure during pregnancy for women of childbearing potential based on the following: upadacitinib is contraindicated during pregnancy, women of childbearing potential should be advised to use effective contraception both during treatment and for 4 weeks after the final dose of upadacitinib treatment, and to advise patients to inform their HCP immediately if they think they could be pregnant or if pregnancy is confirmed.
Slovenian: • Tveganje za malformacije ploda o informacije o teratogenosti upadacitiniba pri živalih, o podrobnejše informacije o tem, kako zmanjšati tveganje izpostavljenosti med nosečnostjo za ženske v rodni dobi na podlagi sledečega: upadacitinib je med nosečnostjo kontraindiciran, ženskam v rodni dobi je treba svetovati uporabo učinkovite kontracepcije med zdravljenjem in še 4 tedne po zadnjem prejetem odmerku upadacitiniba, bolnicam je treba svetovati tudi, da svojega zdravnika nemudoma obvestijo, če mislijo, da so noseče, ali v primeru potrjene nosečnosti.
English: • increased levels of liver enzymes, shown by blood tests (sign of liver problems)
Slovenian: • zvišanje jetrnih encimov; pokaže se na preiskavah krvi (znak težav z jetri)
English: • feeling sick in the stomach (nausea)
Slovenian: • slabost v želodcu (siljenje na bruhanje)
English: The pharmacokinetics of upadacitinib have not yet been evaluated in a paediatric population (see section 4.2).
Slovenian: Farmakokinetike upadacitiniba v pediatrični populaciji še niso ovrednotili (glejte poglavje 4.2).
English: Moreover, upadacitinib treated patients reported significant improvements in fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) compared to placebo.
Slovenian: Poleg tega so bolniki, zdravljeni z upadacitinibom, poročali o značilnih izboljšanjih glede utrujenosti, merjeni z oceno FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue), v primerjavi z bolniki, ki so prejemali placebo.
English: • thrush in the mouth (white patches in the mouth)
Slovenian: • glivična okužba v ustih (bele lise v ustih)
English: If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, upadacitinib therapy should be interrupted until this diagnosis is excluded.
Slovenian: Če se med rutinsko obravnavo bolnika zvišata ALT ali AST in obstaja sum na okvaro jeter zaradi zdravila, je treba zdravljenje z upadacitinibom prekiniti, dokler ta diagnoza ni izključena.
English: • increase in an enzyme called creatine kinase, shown by blood tests
Slovenian: • zvišanje encima, imenovanega kreatin-kinaza; pokaže se na preiskavah krvi
English: The above side effects are uncommon (may affect up to 1 in 100 people).
Slovenian: Zgoraj navedeni neželeni učinki so občasni (pojavijo se lahko pri največ 1 od 100 oseb).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.
Slovenian: Predklinični podatki o varnosti na osnovi običajnih študij farmakološke varnosti ne kažejo posebnega tveganja za človeka.
English: Inhibition of progression of structural joint damage was assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score, at weeks 24/26 and week 48 in SELECT-EARLY and SELECT-COMPARE.
Slovenian: Zavrtje napredovanja strukturne prizadetosti sklepov so v SELECT-EARLY in SELECT-COMPARE ocenjevali z modificirano celotno Sharpovo oceno (mTSS) in njenimi elementi, oceno erozij in oceno zožitve sklepne špranje po 24/26 tednih in 48 tednih.
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before taking this medicine.
Slovenian: Če dojite ali nameravate dojiti, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: Treatment with upadacitinib 15 mg resulted in significantly greater inhibition of the progression of structural joint damage compared to placebo in combination with MTX in SELECT-COMPARE and as monotherapy compared to MTX in SELECT-EARLY (Table 5).
Slovenian: Zdravljenje s 15 mg upadacitiniba je doseglo značilno večje zavrtje napredovanja strukturne prizadetosti sklepov kot placebo v kombinaciji z MTX v SELECT-COMPARE in kot monoterapija v primerjavi z MTX v SELECT-EARLY (preglednica 5).
English: The JAK family of enzymes contains four members, JAK1, JAK2, JAK3 and TYK2 which work in pairs to phosphorylate and activate signal transducers and activators of transcription (STATs).
Slovenian: Družina encimov JAK obsega štiri člane, JAK1, JAK2, JAK3 in TYK2, ki delujejo v parih,
English: Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2).
Slovenian: Zdravljenja se ne sme začeti, ali ga je treba začasno prekiniti, če se bolniku med rutinsko obravnavo pojavi AŠN < 1 x 109 celic/l, AŠL < 0,5 x 109 celic/l ali hemoglobin < 8 g/dl (glejte poglavje 4.2).
English: What RINVOQ looks like and contents of the pack
Slovenian: Izgled zdravila RINVOQ in vsebina pakiranja
English: Upadacitinib 15 mg treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.
Slovenian: Zvišanje lipidov Zdravljenje s 15 mg upadacitinibom je bilo povezano z zvišanjem vrednosti lipidov, ki je bilo odvisno od odmerka, vključno z zvišanjem celokupnega holesterola, trigliceridov, holesterola LDL in holesterola HDL.
English: Renal impairment has no clinically relevant effect on upadacitinib exposure.
Slovenian: Okvara ledvic ni klinično pomembno vplivala na izpostavljenost upadacitinibu.
English: • Risk of serious and opportunistic infections including TB o Language on the risk of infections during treatment with upadacitinib o Details on how to reduce the risk of infection with specific clinical measures (what laboratory parameters should be used to initiate upadacitinib, screening for TB, and getting patients immunised as per local guidelines, and interruption of upadacitinib if an infection develops) o Language on avoidance of live vaccines (i.e., Zostavax) prior to and during upadacitinib treatment o Details to advise patients on signs/symptoms of infection to be aware of, so that patients can seek medical attention quickly.
Slovenian: • Tveganje za resne in oportunistične okužbe, vključno s tuberkulozo o informacije o tveganju za pojav okužb med zdravljenjem z upadacitinibom, o podrobnejše informacije o tem, kako zmanjšati tveganje za pojav okužb s specifičnimi kliničnimi ukrepi (katere laboratorijske parametre je treba upoštevati pri uvedbi zdravljenja z upadacitinibom, presejanje za tuberkulozo in imunizacija bolnikov skladno z lokalnimi smernicami ter prenehanje uporabe upadacitiniba v primeru razvoja okužbe), o informacije o izogibanju uporabe živih cepiv (npr. Zostavax) pred in med zdravljenjem z upadacitinibom, o podrobnejše informacije o svetovanju bolnikom glede znakov/simptomov okužbe, na katere morajo biti pozorni, da lahko hitro poiščejo medicinsko pomoč.
English: Upadacitinib AUC was 18%, 33%, and 44% higher in subjects with mild (estimated glomerular filtration rate 60 to 89 mL/min/1.73 m2), moderate (estimated glomerular filtration rate 30 to 59 mL/min/1.73 m2), and severe (estimated glomerular filtration rate 15 to 29 mL/min/1.73 m2) renal impairment, respectively, compared to subjects with normal renal function.
Slovenian: V primerjavi s preiskovanci z normalnim delovanjem ledvic je bila AUC upadacitiniba pri preiskovancih z blago okvaro ledvic (ocenjena hitrost glomerularne filtracije od 60 do 89 ml/min/1,73 m2) 18 % večja, z zmerno okvaro ledvic (ocenjena hitrost glomerularne filtracije od 30 do 59 ml/min/1,73 m2) 33 % večja in s hudo okvaro ledvic (ocenjena hitrost glomerularne filtracije od 15 do 29 ml/min/1,73 m2) 44 % večja.
English: How to store RINVOQ 6.
Slovenian: Shranjevanje zdravila RINVOQ 6.
English: Treatment with upadacitinib was associated with a small, transient increase in mean ALC from baseline up to Week 36 which gradually returned to at or near baseline levels with continued treatment.
Slovenian: Zdravljenje z upadacitinibom je bilo povezano z majhnim, prehodnim povečanjem povprečnega AŠL od izhodišča do 36. tedna; to povečanje se je med nadaljevanjem zdravljenja vrnilo na izhodiščno raven ali blizu nje.
English: Your doctor will test you for tuberculosis before starting RINVOQ and may retest during treatment
Slovenian: Zdravnik vam bo pred uvedbo zdravljenja z zdravilom RINVOQ opravil testiranje za tuberkulozo; takšno testiranje vam lahko med zdravljenjem ponovi.
English: • medicines that affect your immune system (such as azathioprine, ciclosporin and tacrolimus)
Slovenian: • zdravila, ki vplivajo na imunski sistem (npr. azatioprin, ciklosporin in takrolimus).
English: There are limited data on the use of upadacitinib in subjects with severe renal impairment (see section 5.2).
Slovenian: Podatki o uporabi upadacitiniba pri osebah s hudo okvaro ledvic so omejeni (glejte poglavje 5.2).
English: Inhibition of IL-6 induced STAT3 and IL-7 induced STAT5 phosphorylation
Slovenian: Zavrtje IL-6 je izzvalo fosforilacijo STAT3, zavrtje IL-7 pa fosforilacijo STAT5.
English: If you take more RINVOQ than you should
Slovenian: Če ste vzeli večji odmerek zdravila RINVOQ, kot bi smeli
English: Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Slovenian: Velikost pakiranja: 1 plastenka (30 tablet s podaljšanim sproščanjem) ali 3 plastenke (90 tablet s podaljšanim sproščanjem).
English: There are limited data in patients aged 75 years and older.
Slovenian: Podatki za bolnike, stare 75 let in več, so omejeni.
English: • Core tablet: microcrystalline cellulose, mannitol, tartaric acid, hypromellose, silica colloidal anhydrous, magnesium stearate.
Slovenian: • Jedro tablete: mikrokristalna celuloza, manitol, vinska kislina, hipromeloza, silicijev dioksid (koloidni, brezvodni), magnezijev stearat.
English: Cases of bacterial meningitis have been reported in patients receiving upadacitinib.
Slovenian: Pri bolnikih, ki so prejemali upadacitinib, so poročali o primerih bakterijskega meningitisa.
English: No active metabolites have been identified for upadacitinib.
Slovenian: Aktivnih presnovkov upadacitiniba niso identificirali.
English: Coadministration with CYP3A4 inducers
Slovenian: Sočasna uporaba z induktorji CYP3A4
English: Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy, although evidence is limited.
Slovenian: S statinskim zdravljenjem se je zvišani holesterol LDL znižal na vrednosti pred zdravljenjem, toda dokazov je malo.
English: Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, patients undergoing major surgery, and prolonged immobilisation.
Slovenian: Dejavniki tveganja, ki jih je potrebno upoštevati pri oceni tveganja za GVT/PE pri posameznem bolniku, so višja starost, debelost, GVT/PE v anamnezi, načrtovani večji operativni posegi pri bolniku in dolgotrajna imobilizacija.
English: Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with upadacitinib.
Slovenian: Bolnike je treba med zdravljenjem z upadacitinibom in po njem skrbno spremljati glede znakov in simptomov okužbe.
English: Upadacitinib is contraindicated during pregnancy (see section 4.3).
Slovenian: Upadacitinib je med nosečnostjo kontraindiciran (glejte poglavje 4.3).
English: Animal studies do not indicate effects with respect to fertility (see section 5.3).
Slovenian: Študije na živalih ne kažejo vplivov na plodnost (glejte poglavje 5.3).
English: If you forget to take RINVOQ
Slovenian: Če ste pozabili vzeti zdravilo RINVOQ
English: • Risk of herpes zoster o Language on the risk of herpes zoster during treatment with upadacitinib o Details to advise patients on signs/symptoms of infection to be aware of, so that patients can seek medical attention quickly.
Slovenian: • Tveganje za herpes zoster o informacije o tveganju za herpes zoster med zdravljenjem z upadacitinibom, o podrobnejše informacije o svetovanju bolnikom glede znakov/simptomov okužbe, na katere morajo biti pozorni, da lahko hitro poiščejo medicinsko pomoč.
English: Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical studies (see section 4.8).
Slovenian: V kliničnih študijah so poročali o reaktivaciji virusov, vključno s primeri reaktivacije virusa herpesa (npr. herpes zoster) (glejte poglavje 4.8).
English: Patients who were positive for hepatitis B surface antigen or hepatitis B virus DNA were excluded from clinical studies.
Slovenian: ki so bili pozitivni na plaščne antigene hepatitisa B ali na DNA virusa hepatitisa B, niso bili vključeni v klinične študije.
English: The primary analysis for each of these studies included all randomised subjects who received at least 1 dose of study drug, and non-responder imputation was used for categorical endpoints.
Slovenian: Primarna analiza vsake od teh študij je obsegala vse randomizirane preiskovance, ki so prejeli vsaj
English: Upadacitinib plasma exposures are proportional to dose over the therapeutic dose range.
Slovenian: Plazemska izpostavljenost upadacitinibu je v območju terapevtskih odmerkov sorazmerna odmerku.
English: • cold sores (herpes simplex)
Slovenian: • herpes na ustnicah (herpes simpleks)
English: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
Slovenian: Prilagoditev odmerka pri bolnikih z blago (Child-Pugh A) ali zmerno (Child-Pugh B) okvaro jeter ni potrebna (glejte poglavje 5.2).
English: Key outcome measures
Slovenian: Ključne mere izida
English: Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin and phenytoin), which may lead to reduced therapeutic effect of upadacitinib.
Slovenian: Med izpostavljenostjo močnim induktorjem CYP3A4 (kot sta npr. rifampin in fenitoin) se izpostavljenost upadacitinibu zmanjša in to lahko zmanjša terapevtski učinek upadacitiniba.
English: RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in multipacks of 84 comprising 3 cartons, each containing 28 prolonged-release tablets.
Slovenian: Zdravilo RINVOQ je na voljo v pakiranjih, ki vsebujejo 28 ali 98 tablet s podaljšanim sproščanjem, in multipakiranjih s 84 tabletami s podaljšanim sproščanjem; multipakiranja so sestavljena iz 3 kartonskih škatel, od teh vsaka vsebuje 28 tablet s podaljšanim sproščanjem.
English: Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.
Slovenian: Upadacitinib je treba previdno uporabljati pri bolnikih, ki kronično prejemajo močne zaviralce CYP3A4.
English: On background csDMARDs
Slovenian: Ob osnovnih csDMARD
English: Talk to your doctor or pharmacist before and during treatment with RINVOQ if:
Slovenian: Pred zdravljenjem z zdravilom RINVOQ in med zdravljenjem z njim se posvetujte z zdravnikom ali farmacevtom:
English: Microcrystalline cellulose Hypromellose Mannitol
Slovenian: Mikrokristalna celuloza Hipromeloza
English: Upadacitinib had no relevant effect on atorvastatin Cmax or on plasma exposures of ortho-hydroxyatorvastatin (major active metabolite for atorvastatin).
Slovenian: Upadacitinib ni pomembno vplival na Cmax atorvastatina ali plazemsko izpostavljenost ortohidroksiatorvastatinu (glavnemu aktivnemu presnovku atorvastatina).
English: Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.
Slovenian: Med zdravljenjem z upadacitinibom je bila pojavnost zvišanja jetrnih encimov večja kot med uporabo placeba.
English: The recommended dose of upadacitinib is 15 mg once daily.
Slovenian: Odmerjanje Priporočeni odmerek upadacitiniba je 15 mg enkrat na dan.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants ATC code: not yet assigned
Slovenian: Farmakoterapevtska skupina: imunosupresivi, selektivni imunosupresivi.
English: RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, each pack contains 1 bottle (30 tablet pack) or 3 bottles (90 tablet pack).
Slovenian: Zdravilo RINVOQ je na voljo v plastenkah s sušilnim sredstvom; plastenke vsebujejo 30 tablet s podaljšanim sproščanjem in vsako pakiranje vsebuje 1 plastenko (pakiranje s 30 tabletami) ali 3 plastenke (pakiranje z 90 tabletami).
English: • Clinical remission (DAS28-CRP)
Slovenian: • Klinična remisija (DAS28-CRP)
English: Upadacitinib should be used with caution in patients with severe renal impairment.
Slovenian: Upadacitinib je treba pri bolnikih s hudo okvaro ledvic uporabljati previdno.
English: • Adalimumab 40 mg
Slovenian: • 40 mg adalimumaba
English: Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis were reported with upadacitinib.
Slovenian: Od oportunističnih okužb so med uporabo upadacitiniba poročali o tuberkulozi, multidermatomskem herpesu zostru, oralni kandidozi/kandidozi požiralnika in o kriptokokozi.
English: If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines, one of which will usually be methotrexate.
Slovenian: boste morda najprej dobili druga zdravila, od katerih je eno po navadi metotreksat.
English: In a clinical study, coadministration of upadacitinib with ketoconazole resulted in 70% and 75% increases in upadacitinib Cmax and AUC, respectively.
Slovenian: V klinični študiji je sočasna uporaba upadacitiniba in ketokonazola povečala Cmax upadacitiniba za 70 % in njegovo AUC za 75 %.
English: Administration of multiple 30 mg once daily doses of upadacitinib (a dose that is twice the recommended upadacitinib dose) to healthy subjects had a limited effect on midazolam (sensitive drug substrate for CYP3A) plasma exposures (26% decrease in midazolam AUC and Cmax), indicating that upadacitinib 30 mg once daily may have a weak induction effect on CYP3A.
Slovenian: Možni vpliv upadacitiniba na farmakokinetiko drugih zdravil Uporaba večkratnih dnevnih odmerkov 30 mg upadacitiniba enkrat na dan (to je odmerek, ki je dvakrat tolikšen kot je priporočeni odmerek upadacitiniba) je pri zdravih osebah malo vplivala na plazemsko izpostavljenost midazolamu (ki je občutljiv substrat CYP3A) (26-odstotno zmanjšanje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of 49 tablets (for the 98 pack)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Notranja škatla z 49 tabletami (za pakiranje z 98 tabletami)
English: In a human radiolabeled study, unchanged upadacitinib accounted for 79% of the total radioactivity in plasma while the main metabolite (product of monooxidation followed by glucuronidation) accounted for 13% of the total plasma radioactivity.
Slovenian: celotne radioaktivnosti v plazmi, glavni presnovek (nastal z monooksidacijo in nadaljnjo glukuronidacijo) pa 13 % celotne radioaktivnosti v plazmi.
English: RINVOQ 15 mg prolonged-release tablets are purple, oblong, biconvex tablets imprinted on one side with ‘a15'.
Slovenian: 15-mg tablete zdravila RINVOQ s podaljšanim sproščanjem so vijoličaste, podolgovate, na obeh straneh izbočene tablete, ki imajo na eni strani vtisnjeno oznako "a15".
English: The overall long-term rate of infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies (2,630 patients) was 93.7 events per 100 patient-years.
Slovenian: Celotni dolgoročni delež okužb je bil v skupini s 15 mg upadacitiniba v vseh petih kliničnih študijah 3. faze (2.630 bolnikov) 93,7 dogodka na 100 bolnik-let.
English: Upadacitinib Cmax was unchanged in subjects with mild hepatic impairment and 43% higher in subjects with moderate hepatic impairment compared to subjects with normal liver function.
Slovenian: Cmax upadacitiniba je bila pri preiskovancih z blago okvaro jeter nespremenjena, pri preiskovancih z zmerno okvaro jeter pa 43 % večja kot pri tistih z normalnim delovanjem jeter.
English: Foil Cutting Tool - on the cap of the bottle
Slovenian: Pripomoček za rezanje folije - na pokrovčku plastenke
English: In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, increases in CPK values were observed.
Slovenian: V študijah, ki so bile kontrolirane s placebom in v katerih so bolniki kot osnovo prejemali DMARD, so v obdobju do 12/14 tednov opažali zvišanje vrednosti CPK.
English: Across the Phase 3 studies, the efficacy seen with upadacitinib 15 mg QD was generally similar to that observed with upadacitinib 30 mg QD.
Slovenian: V študijah 3. faze je bila učinkovitost 15 mg upadacitiniba enkrat na dan na splošno podobna uspešnosti 30 mg upadacitiniba enkrat na dan.
English: The proportion of patients with no radiographic progression (mTSS change ≤ 0) was significantly higher with upadacitinib 15 mg in both studies.
Slovenian: (sprememba mTSS ≤ 0) je bil s 15 mg upadacitiniba v obeh študijah značilno večji.
English: Week 24b/26c
Slovenian: 24. tedenb/26c
English: Blood CPK increased ALT increased AST increased Weight increased * URTI includes: acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection ** Herpes simplex includes oral herpes
Slovenian: Povečanje telesne mase *Okužbe zgornjih dihal vključujejo: akutni sinuzitis, laringitis, nazofaringitis, orofaringealno bolečino, faringitis, faringotonzilitis, rinitis, sinuzitis, tonzilitis, virusno okužbo zgornjih dihal.
English: Physical function response and health-related outcomes Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in a significantly greater improvement in physical function compared to all comparators as measured by HAQ-DI (see Table 6).
Slovenian: Zdravljenje s 15 mg upadacitiniba samega ali v kombinaciji s csDMARD je doseglo značilno večje izboljšanje telesnega delovanja, merjeno s HAQ-DI, kot vsa primerjalna zdravila (glejte preglednico 6).
English: In clinical trials, upadacitinib was administered without regard to meals (see section 4.2).
Slovenian: V kliničnih preskušanjih so upadacitinib uporabljali ne glede na obroke (glejte poglavje 4.2).
English: Remove the cap from the bottle by pushing down and while still pushing, turn the cap anti-clockwise.
Slovenian: Pokrovček odstranite s plastenke tako, da ga pritisnete navzdol in ga med pritiskanjem zasučete v smeri, nasprotni urinemu kazalcu.
English: If you stop taking RINVOQ
Slovenian: Če ste prenehali jemati zdravilo RINVOQ
English: Malignancies were observed in clinical studies of upadacitinib.
Slovenian: V kliničnih študijah upadacitiniba so opažali maligne bolezni.
English: Absolute Neutrophil Count (ANC)
Slovenian: Absolutno število nevtrofilcev (AŠN)
English: RINVOQ 15 mg prolonged-release tablets
Slovenian: RINVOQ 15 mg tablete s podaljšanim sproščanjem
English: Treatment with upadacitinib was associated with decreases from baseline in mean hsCRP levels as early as Week 1 which were maintained with continued treatment.
Slovenian: Zdravljenje z upadacitinibom je bilo povezano z znižanjem povprečne ravni hsCRP od izhodišča že po
English: Upadacitinib should not be given to patients with active TB (see section 4.3).
Slovenian: Bolniki z aktivno TB ne smejo dobiti upadacitiniba (glejte poglavje 4.3).
English: Upadacitinib had no effect on fertility in male or female rats at doses up to 50 mg/kg/day in males and 75 mg/kg/day in females in a fertility and early embryonic development study.
Slovenian: V študiji plodnosti in zgodnjega embrionalnega razvoja upadacitinib ni vplival na plodnost podganjih samcev ali samic v odmerkih do 50 mg/kg/dan pri samcih in do 75 mg/kg/dan pri samicah.
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Bottle Label
Slovenian: PODATKI NA VMESNI OVOJNINI Nalepka na plastenki