FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Consider the risks and benefits of treatment prior to initiating upadacitinib in patients:
Slovenian: Tveganja in koristi zdravljenja je treba pred uvedbo upadacitiniba pretehtati pri bolnikih:
English: Some patients receiving RINVOQ have developed skin cancers
Slovenian: Nekaterim bolnikom, ki so prejemali zdravilo RINVOQ, se je pojavil rak kože.
English: Pneumonia Herpes zoster Herpes simplex** Oral candidiasis
Slovenian: Herpes zoster Herpes simpleks** Oralna kandidoza
English: RINVOQ may be used as monotherapy or in combination with methotrexate.
Slovenian: Zdravilo RINVOQ se lahko uporablja kot samostojno zdravljenje (monoterapija) ali v kombinaciji z metotreksatom.
English: 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):
Slovenian: 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):
English: Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of upadacitinib.
Slovenian: Ženskam v rodni dobi je treba naročiti, da morajo med zdravljenjem in še 4 tedne po zadnjem odmerku upadacitiniba uporabljati učinkovito kontracepcijo.
English: • The active substance is upadacitinib.
Slovenian: • Učinkovina je upadacitinib.
English: Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172)
Slovenian: Črni železov oksid (E172) Rdeči železov oksid (E172)
English: -0.5 -0.8h -0.3 -0.7g -0.3 -0.6g -0.3 -0.6g,i
Slovenian: -0,5 -0,8h -0,3 -0,7g -0,3 -0,6g -0,3 -0,6g,h -0,5 -0,2 -0,4g
English: Contents of the pack and other information What RINVOQ contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo RINVOQ
English: The tablets are provided in blisters or bottles.
Slovenian: Tablete so na voljo v pretisnih omotih ali plastenkah.
English: If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Slovenian: Če se pojavijo klinične manifestacije GVT/PE, je treba zdravljenje z upadacitinibom prekiniti, bolnike takoj ovrednotiti in slediti mora ustrezno zdravljenje.
English: Patients who were positive for hepatitis C antibody and hepatitis C virus RNA were excluded from clinical studies.
Slovenian: Bolniki, ki so bili pozitivni na protitelesa proti hepatitisu C in RNA virusa hepatitisa C, niso bili vključeni v klinične študije.
English: 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.
Slovenian: 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.
English: • low white blood cell counts shown in blood tests
Slovenian: • majhno število belih krvnih celic; pokaže se na preiskavah krvi
English: RINVOQ has no effect on the ability to drive and use machines.
Slovenian: Zdravilo RINVOQ ne vpliva na sposobnost upravljanja vozil in strojev.
English: • you have had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism).
Slovenian: • če ste v preteklosti imeli krvne strdke v venah nog (globoka venska tromboza) ali pljučih (pljučna embolija).
English: • medicines to treat tuberculosis (such as rifampicin)
Slovenian: • zdravila za zdravljenje tuberkuloze (npr. rifampicin)
English: • 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
Slovenian: • 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,
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo redno PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
English: Treatment should be interrupted if Hb is < 8 g/dL and may be restarted once Hb returns above this value
Slovenian: 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.
English: Upadacitinib has no or negligible influence on the ability to drive and use machines.
Slovenian: Upadacitinib nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila https://www.ema.europa.eu/en.
English: • Film coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide, iron oxide red (E172), iron oxide black (E172).
Slovenian: • Filmska obloga: poli(vinil alkohol), makrogol, smukec, titanov dioksid, rdeči železov oksid (E172), črni železov oksid (E172).
English: • medicines to treat Cushing's syndrome (such as ketoconazole)
Slovenian: • zdravila za zdravljenje Cushingovega sindroma (npr. ketokonazol).
English: CR DAS28-CRP <2.6 (% of patients)
Slovenian: CR DAS28-CRP < 2,6 (% bolnikov)
English: In clinical studies, treatment was interrupted in response to ANC < 1,000 cells/mm3 (see section 4.2).
Slovenian: V kliničnih študijah so zdravljenje prekinili, če se je AŠN zmanjšalo na < 1.000 celic/mm3 (glejte poglavje 4.2).
English: No data are available on the response to vaccination with live or inactivated vaccines in patients receiving upadacitinib.
Slovenian: O odzivu na cepljenje z živimi ali inaktiviranimi cepivi pri bolnikih, ki so prejemali upadacitinib, ni podatkov.
English: Screening for viral hepatitis and monitoring for reactivation should be performed before starting and during therapy with upadacitinib.
Slovenian: Presejanje za virusni hepatitis in nadzor glede reaktivacije je treba izvesti pred začetkom zdravljenja z upadacitinibom in ga izvajati med zdravljenjem s tem zdravilom.
English: Compared to adalimumab, significantly higher rates of low disease activity were achieved at week 12 in SELECT-COMPARE.
Slovenian: Po 12 tednih so bile dosežene značilno višje stopnje nizke aktivnosti bolezni kot z adalimumabom v SELECT-COMPARE.
English: Rheumatoid arthritis patients have an increased risk for cardiovascular disorders.
Slovenian: Bolniki z revmatoidnim artritisom imajo povečano tveganje za nastanek srčno-žilnih bolezni.
English: There are no or limited data on the use of upadacitinib in pregnant women.
Slovenian: Podatkov o uporabi upadacitiniba pri nosečnicah ni ali pa jih je malo.
English: No dose adjustment is required in patients with mild or moderate renal impairment.
Slovenian: Prilagoditev odmerka pri bolnikih z blago ali zmerno okvaro ledvic ni potrebna.
English: What you need to know before you take RINVOQ 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo RINVOQ 3.
English: Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury.
Slovenian: Če se jetrni encimi zvišajo, je priporočljivo takoj preiskati vzrok za to, da bi ugotovili možne primere z zdravilom povzročene okvare jeter.
English: Evaluate at baseline and thereafter according to routine patient management.
Slovenian: Ocenite izhodiščno, pozneje pa glede na rutinsko vodenje bolnika.
English: Other medicines and RINVOQ
Slovenian: Druga zdravila in zdravilo RINVOQ
English: 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.
Slovenian: Če ta zdravila ne bodo delovala dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo RINVOQ, bodisi samo bodisi v kombinaciji z metotreksatom.
English: • with a history of a serious or an opportunistic infection
Slovenian: • ki imajo v anamnezi kakšno resno ali oportunistično okužbo,
English: What you need to know before you take RINVOQ Do not take RINVOQ
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo RINVOQ Ne jemljite zdravila RINVOQ
English: • you have recently had or plan to have a vaccination (immunisation) - this is because live vaccines are not recommended while using RINVOQ
Slovenian: • 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.
English: Abbreviations: ACR20 (or 50) = American College of Rheumatology ≥20% (or ≥50%) improvement;
Slovenian: Okrajšave: ACR20 (ali 50) = izboljšanje za ≥ 20 % (ali ≥ 50 %) po American College of Rheumatology;
English: • medicines to treat fungal infections (such as itraconazole, posaconazole or voriconazole)
Slovenian: • zdravila za zdravljenje glivičnih okužb (npr. itrakonazol, posakonazol ali vorikonazol)
English: The pharmacologic activity of upadacitinib is attributed to the parent molecule.
Slovenian: Farmakološka aktivnost upadacitiniba gre na račun matične molekule.
English: QR code to be included For more information and support on taking RINVOQ go to www.rinvoq.eu
Slovenian: Vstavite QR-kodo Za več informacij in za podporo v zvezi z jemanjem zdravila RINVOQ obiščite www.rinvoq.eu
English: It is unknown whether upadacitinib/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se upadacitinib ali njegovi presnovki pri človeku izločajo v materino mleko.
English: LDA DAS28-CRP ≤3.2 (% of patients)
Slovenian: LDA DAS28-CRP ≤ 3,2 (% bolnikov)
English: • A patient alert card
Slovenian: • Opozorilno kartico za bolnika
English: 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.
Slovenian: 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.
English: If hepatitis B virus DNA is detected while receiving upadacitinib, a liver specialist should be consulted.
Slovenian: Če je DNA virusa hepatitisa B ugotovljena med zdravljenjem z upadacitinibom, se je treba posvetovati s specialistom hepatologom.
English: The maximal inhibition was observed 1 hour after dosing which returned to near baseline by the end of dosing interval.
Slovenian: Največje zavrtje so opažali 1 uro po uporabi odmerka; zavrtje se je do konca odmernega intervala vrnilo skoraj na izhodiščno raven.
English: The decreases in neutrophil counts remained stable at a lower value than baseline over time including with extended therapy.
Slovenian: Zmanjšanje števila nevtrofilcev je skozi čas ostalo stabilno na nižji vrednosti od izhodiščne, vključno s podaljšanim zdravljenjem.
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Slovenian: Za bolnike, ki imajo večje tveganje za raka kože, so priporočljivi redni pregledi kože.
English: What RINVOQ is and what it is used for
Slovenian: Kaj je zdravilo RINVOQ in za kaj ga uporabljamo
English: Treatment Group
Slovenian: Terapevtska skupina
English: Upadacitinib was teratogenic in both rats and rabbits.
Slovenian: Upadacitinib je bil teratogen tako pri podganah kot pri kuncih.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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
English: Approximately 34% of upadacitinib dose was excreted as metabolites.
Slovenian: Približno 34 % odmerka upadacitiniba se je izločilo v obliki presnovkov.
English: Steady-state plasma concentrations are achieved within 4 days with minimal accumulation after multiple once-daily administrations.
Slovenian: Koncentracija v plazmi doseže stanje dinamičnega ravnovesja v 4 dneh; kopičenje je po večkratni uporabi enkrat na dan minimalno.
English: Do not stop taking RINVOQ unless your doctor tells you to stop taking it.
Slovenian: Ne prenehajte jemati zdravila RINVOQ, če vam tega ne naroči zdravnik.
English: Rheumatoid arthritis is a disease that causes inflamed joints.
Slovenian: Revmatoidni artritis je bolezen, ki povzroči vnetje sklepov.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk (see section 5.3).
Slovenian: Farmakodinamični in toksikološki podatki, ki so na voljo za živali, so pokazali izločanje upadacitiniba v mleku (glejte poglavje 5.3).
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: The most frequent serious infections reported with upadacitinib included pneumonia and cellulitis (see section 4.8).
Slovenian: Med najpogostejšimi resnimi okužbami, o katerih so poročali med uporabo upadacitiniba, sta bili pljučnica in celulitis (glejte poglavje 4.8).
English: Tell your doctor if you get a painful skin rash with blisters as these can be signs of shingles
Slovenian: Zdravnika morate obvestiti, če se vam pojavi boleč kožni izpuščaj z mehurji, kajti to so lahko znaki pasovca.
English: CDAI ≤10 (% of patients)
Slovenian: CDAI ≤ 10 (% bolnikov)
English: Table 3: Clinical trials summary Study name Population (n) Treatment arms
Slovenian: Ime študije Populacija (n) Terapevtske skupine
English: Upadacitinib is metabolised mainly by CYP3A4.
Slovenian: Upadacitinib se v glavnem presnavlja s CYP3A4.
English: • medicines to treat bacterial infections (such as clarithromycin)
Slovenian: • zdravila za zdravljenje bakterijskih okužb (npr. klaritromicin).
English: The risks and benefits of upadacitinib treatment should be considered prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing upadacitinib therapy in patients who develop a malignancy.
Slovenian: Upoštevati je potrebno tveganja in koristi zdravljenja z upadacitinibom, preden takšno zdravljenje začnete pri bolnikih z znano maligno boleznijo (razen uspešno zdravljenega nemelanomskega raka kože), ali ko presojate o nadaljevanju zdravljenja z upadacitinibom pri bolnikih, ki se jim pojavi maligna bolezen.
English: Following oral administration of upadacitinib prolonged-release formulation, upadacitinib is absorbed with a median Tmax of 2 to 4 hours.
Slovenian: Po peroralni uporabi oblike upadacitiniba s podaljšanim sproščanjem se upadacitinib absorbira z medianim Tmax od 2 do 4 ure.
English: Do not chew, crush or break the tablet.
Slovenian: Tablet ne grizite, ne drobite in ne lomite.
English: Mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment has no clinically relevant effect on upadacitinib exposure.
Slovenian: Blaga (Child-Pugh A) in zmerna (Child-Pugh B) okvara jeter ni klinično pomembno vplivala na izpostavljenost upadacitinibu.
English: Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smart phone.
Slovenian: Podrobne in posodobljene informacije o zdravilu so vam na voljo, če s pametnim telefonom skenirate
English: Upadacitinib Cmax was similar in subjects with normal and impaired renal function.
Slovenian: Cmax upadacitiniba je bila pri preiskovancih z normalnim in okvarjenim delovanjem ledvic podobna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle Carton (30 and 90 pack)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za plastenko (30 in 90 v pakiranju)
English: Potential for upadacitinib to affect the pharmacokinetics of other medicinal products
Slovenian: Možni vpliv drugih zdravil na farmakokinetiko upadacitiniba
English: Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - aluminium calendar blisters in packs containing 28 or 98 prolonged-release tablets, or multipacks containing 84 (3 packs of 28) prolongedrelease tablets.
Slovenian: Polivinilklorid/polietilen/poliklorotrifluoroetilen-aluminijski koledarski pretisni omoti v pakiranjih, ki vsebujejo 28 ali 98 tablet s podaljšanim sproščanjem, ali multipakiranjih, ki vsebujejo 84 (3 pakiranja po 28) tablet s podaljšanim sproščanjem.
English: Table 6: Mean change from baseline in HAQ-DIa,b Study
Slovenian: Preglednica 6: Povprečna sprememba HAQ-DI od izhodiščaa,b
English: Modified Total Sharps Score, mean change from baseline
Slovenian: Modificirana celotna Sharpova ocena, povprečna sprememba od izhodišča
English: This is because some medicines may reduce how well RINVOQ works or may increase the risk of getting side effects.
Slovenian: Nekatera zdravila namreč lahko poslabšajo delovanje zdravila RINVOQ ali povečajo tveganje za neželene učinke.
English: Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no effect on upadacitinib plasma exposures.
Slovenian: Metotreksat in zdravila, ki vplivajo na pH (npr. antacidi in zaviralci protonske črpalke), ne vplivajo na plazemsko izpostavljenost upadacitinibu.
English: Upadacitinib should not be used during breast-feeding.
Slovenian: Upadacitiniba se med obdobjem dojenja ne sme uporabljati.
English: Turn the cap over and place the cutting tool near the edge of the foil seal.
Slovenian: Obrnite pokrovček in namestite pripomoček za rezanje ob rob zapečatene folije.
English: If a patient develops herpes zoster, interruption of upadacitinib therapy should be considered until the episode resolves.
Slovenian: Če se bolniku pojavi herpes zoster, je treba razmisliti o prekinitvi zdravljenja z upadacitinibom, dokler ta epizoda ne mine.
English: HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Slovenian: Plastenke iz HDPE s sušilnim sredstvom in polipropilensko zaporko v škatli, ki vsebuje 30 tablet s podaljšanim sproščanjem.
English: • General introductory language that the HCP measure contains important information to assist the discussion with patients when prescribing upadacitinib.
Slovenian: • Splošen uvodni del, ki vsebuje pomembne informacije za zdravstvene delavce, ki so v pomoč pri pogovoru z bolniki, katerim zdravnik predpiše upadacitinib.
English: The patient information pack should contain:
Slovenian: Paket izobraževalnih gradiv za bolnika mora vsebovati: