natgillin/translations-raw huggingface dataset:
In rat and rabbit reproductive toxicology studies, baricitinib was shown to reduce foetal growth/weight and produce skeletal malformations (at exposures of approximately 10 and 39 times the human exposure, respectively).
V študijah vpliva na sposobnost razmnoževanja pri podganah in kuncih so ugotovili, da baricitinib zmanjša rast/telesno maso zarodka in povzroča deformacije okostja (pri izpostavljenostih, ki so približno 10- in 39-kratniki izpostavljenosti pri človeku).
You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.
Če zanosite, morate obvestiti svojega zdravnika, saj se zdravila Olumiant med nosečnostjo ne sme uporabljati.
Olumiant should be used with caution in patients with risk factors for DVT/PE, such as older age, obesity, a medical history of DVT/PE, or patients undergoing surgery and immobilisation.
Zdravilo Olumiant je treba uporabljati previdno pri bolnikih z dejavniki tveganja za razvoj GVT/PE, kot so na primer starost, debelost, GVT/PE v anamnezi, ali pri bolnikih,
Lipid elevations
Zvišanje lipidov
Mean serum IgG, IgM, and IgA values decreased by 12 weeks after starting treatment with Olumiant, and remained stable at a lower value than baseline through at least 104 weeks.
Povprečne serumske vrednosti IgG, IgM in IgA so se v 12. tednu po začetku zdravljenja z zdravilom Olumiant znižale in ostale stabilne, z nižjo vrednostjo od izhodiščne, še najmanj 104 tednov.
All patients on background MTX
Vsi bolniki so prejemali osnovno zdravljenje z MTX
Infection such as shingles, which may affect up to 1 in 10 people:
Okužbe, kot je pasasti izpuščaj (pojavijo se lahko pri največ 1 od 10 bolnikov):
In vitro, baricitinib is a substrate for CYP3A4, OAT3, Pgp, BCRP and MATE2-K, and may be a clinically relevant inhibitor of the transporter OCT1 (see section 4.5).
In vitro je baricitinib substrat za CYP3A4, OAT3, Pgp, BCRP in MATE2-K ter je morda klinično pomemben zaviralec prenašalca OCT1 (glejte poglavje 4.5).
The proportion of patients achieving a clinically significant improvement (HAQ-DI ≥ 0.30) was also higher with Olumiant compared to placebo or MTX at week 12 (Table 4).
Delež bolnikov, ki so dosegli klinično pomembno izboljšanje (HAQ-DI ≥ 0,30) je bil prav tako višji v primerjavi zdravila Olumiant s placebom ali MTX v 12. tednu (Preglednica 4).
Treatment should be interrupted if ALC < 0.5 x 109 cells/L and may be restarted once ALC return above this value
Zdravljenje je treba prekiniti, če je ALC < 0,5 x 109 celic/l in ga je mogoče znova uvesti, ko se raven ALC vrne nad to vrednost.
Potential for other medicinal products to affect the pharmacokinetics of baricitinib
Potencial drugih zdravil za vpliv na farmakokinetiko baricitiniba
Olumiant is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Uporaba zdravila Olumiant ni priporočljiva pri bolnikih s hudo okvaro jeter (glejte poglavje 5.2).
Therefore, the PRAC requests the MAH to update section 4.4 of the SmPC to modify the wording on “Venous Thromboembolism” to indicate that if clinical features of DVT/PE occur, baricitinib treatment should be discontinued and to update section 4.8 of the SmPC to add the adverse reaction pulmonary embolism and deep vein thrombosis with a frequency not known.
Zato odbor PRAC od imetnika dovoljenja za promet z zdravilom zahteva, da posodobi poglavje 4.4 povzetka glavnih značilnosti zdravila in besedilo o »Venski trombemboliji« spremeni z navedbo, da je treba v primeru pojava kliničnih značilnosti GVT/PE zdravljenje z baricitinibom ukiniti, ter da posodobi poglavje 4.8 povzetka glavnih značilnosti zdravila in vanj doda neželena učinka pljučno embolijo in globoko vensko trombozo z neznano pogostnostjo.
Olumiant can reduce your body's ability to fight infections and may make an existing infection worse or increase the chance of you getting a new infection - have, or have previously had, tuberculosis.
Zdravilo Olumiant lahko zmanjša sposobnost vašega telesa za obrambo pred okužbami in lahko poslabša obstoječo okužbo ali pa poveča verjetnost, da boste dobili novo okužbo.
Co-administration with OAT3 inhibitors
Sočasno dajanje z zaviralci OAT3
Coadministration of baricitinib with ciclosporin (Pgp/BCRP inhibitor) or methotrexate (substrate of several transporters including OATP1B1, OAT1, OAT3, BCRP, MRP2, MRP3, and MRP4) resulted in no clinically meaningful effects on baricitinib exposure.
Sočasno dajanje baricitiniba in ciklosporina (zaviralca Pgp/BCRP) ali metotreksata (substrata za več prenašalcev, vključno z OATP1B1, OAT1, OAT3, BCRP, MRP2, MRP3 in MRP4) ni povzročilo klinično pomembnih učinkov na izpostavljenost baricitinibu.
• Increased LDL cholesterol ≥ 3.36 mmol/L: 33.6 % vs. 10.3 %, respectively
• zvišan LDL-holesterol ≥ 3,36 mmol/l: 33,6 % v primerjavi z 10,3 %
Therefore, the PRAC requests the MAH to update of section 4.4 of the SmPC to add a warning on hypersensitivity and to update of Section 4.8 to add the adverse reactions “rash” with a frequency common and “swelling of the face, urticaria” with a frequency uncommon.
Zato odbor PRAC od imetnika dovoljenja za promet z zdravilom zahteva, da posodobi poglavje 4.4 povzetka glavnih značilnosti zdravila in vanj doda opozorilo o preobčutljivosti ter da posodobi poglavje 4.8 in vanj doda neželeni učinek »izpuščaj« s pogostnostjo »pogosti« in »otekanje obraza, urtikarija« s pogostnostjo »občasni«.
In a pre- and postnatal development study, decreased pup weights and decreased postnatal survival were observed at exposures 4 and 21 times, respectively, the human exposure.
V študijah prenatalnega in postnatalnega razvoja podgan so opazili manjše telesne mase in nižje postnatalno preživetje mladičev pri izpostavljenostih, ki ustrezajo 4- in 21-kratniku izpostavljenosti za človeka.
Coadministration of baricitinib with fluconazole (moderate CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (strong CYP3A inducer) resulted in no clinically meaningful changes to baricitinib exposure.
Sočasno dajanje baricitiniba in flukonazola (zmernega zaviralca CYP3A/CYP2C19/CYP2C9) ali rifampicina (močnega induktorja CYP3A) ni povzročilo klinično pomembnih sprememb v izpostavljenosti baricitinibu.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so dokazale vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) less than 0.5 x 109 cells/L, an absolute neutrophil count (ANC) less than 1 x 109 cells/L, or who have a haemoglobin value less than 8 g/dL.
Zdravljenja se ne sme uvesti pri bolnikih, pri katerih je absolutno število limfocitov (ALC- absolute lymphocyte count) manjše od 0,5 x 109 celic/l, absolutno število nevtrofilcev (ANC- absolute neutrophil count) manjše od 1 x 109 celic/l, ali pri katerih je vrednost hemoglobina nižja od 8 g/dl.
For up to 52 weeks, the frequency of ALT and AST elevations ≥ 3 x ULN were greater for the combination treatment of methotrexate and Olumiant (7.5 % and 3.8 %) compared to methotrexate alone (2.9 % and 0.5 %) or Olumiant alone (1.9 % and 1.3 %).
obdobju do 52 tednov je bila pogostnost zvišanj ALT in AST na ≥ 3-kratnik ULN višja pri kombiniranem zdravljenju z metotreksatom in zdravilom Olumiant (7,5 % in 3,8 %) v primerjavi s samim metotreksatom (2,9 % in 0,5 %) ali samim zdravilom Olumiant (1,9 % in 1,3 %).
• Increased triglycerides ≥ 5.65 mmol/L: 0.4 % vs. 0.5 %, respectively
• zvišani trigliceridi ≥ 5,65 mmol/l: 0,4 % v primerjavi z 0,5 %
Mean absolute lymphocyte count increased by 1 week after starting treatment with Olumiant, returned to baseline by week 24, and then remained stable through at least 104 weeks.
Povprečno absolutno število limfocitov se je 1. teden po začetku zdravljenja z zdravilom Olumiant povečalo, se do 24. tedna vrnilo na izhodiščno raven in ostalo stabilno najmanj 104 tednov.
Contents of the pack and other information
Shranjevanje zdravila Olumiant Vsebina pakiranja in dodatne informacije
Lipid parameters should be assessed approximately 12 weeks following initiation of Olumiant therapy and thereafter patients should be managed according to international clinical guidelines for hyperlipidaemia.
Približno 12 tednov po uvedbi zdravljenja z zdravilom Olumiant je treba oceniti parametre lipidov in glede na vrednosti bolnike obravnavati v skladu z mednarodnimi kliničnimi smernicami za zdravljenje hiperlipidemije.
Opportunistic infections related to demodicosis (mange) were observed in dogs at exposures approximately 7 times the human exposure.
Pri psih so pri približno sedemkratniku izpostavljenosti pri človeku opazili oportunistične okužbe, povezane z demodikozo
- The other ingredients are: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, mannitol, iron oxide red (E172), lecithin (soya) (E322), macrogol, poly (vinyl alcohol), talc and titanium dioxide (E171).
magnezijev stearat, manitol, rdeči železov oksid (E172), (sojin) lecitin (E322), makrogol,
Treatment should be interrupted if Hb < 8 g/dL and may be restarted once Hb return above this value
Zdravljenje je treba prekiniti, če je Hb < 8 g/dl in ga je mogoče znova uvesti,
Administration of baricitinib resulted in a dose dependent inhibition of IL-6 induced STAT3 phosphorylation in whole blood from healthy subjects with maximal inhibition observed 2 hours after dosing which returned to near baseline by 24 hours.
Zaviranje z IL-6 inducirane fosforilacije proteina STAT3 Dajanje baricitiniba je povzročilo od odmerka odvisno zaviranje z IL-6 inducirane fosforilacije proteina STAT3 v polni krvi zdravih oseb, pri čemer so največje zaviranje opazili 2 uri po odmerjanju,
No data are available on the response to vaccination with live vaccines in patients receiving baricitinib.
Cepljenje Pri bolnikih, ki prejemajo baricitinib, ni podatkov o odzivu na cepljenje z živimi cepivi.
Most infections were mild to moderate in severity.
Resnost večine okužb je bila blaga do zmerna.
• Additional Patient Alert Cards
• dodatne opozorilne kartice za bolnika
RA-BEAM MTX-IR patients
RA-BEAM Bolniki, zdravljeni z MTX-IR
• The purpose and use of the Patient Alert Card
• namen in uporabo opozorilne kartice za bolnika.
1 Patients who had received less than 3 doses of Methotrexate (MTX); naïve to other conventional or biologic DMARDs
1Bolniki, ki so prejeli manj kot 3 odmerke metotreksata (MTX); predhodno niso bili zdravljeni z drugimi konvencionalnimi ali biološkimi imunomodulirajočimi protirevmatičnimi zdravili.
Each tablet contains 2 or 4 milligrams of baricitinib.
Ena tableta vsebuje 2 ali 4 miligrame baricitiniba.
If you have reduced kidney function, the recommended dose of Olumiant is 2 mg once a day.
Če je delovanje vaših ledvic oslabljeno, je priporočeni odmerek zdravila Olumiant 2 mg enkrat na dan.
Modified Total Sharp Score, mean change from baseline:
Modificirana celotna Sharpova ocena, povprečna sprememba od izhodišča:
Reporting rates for Olumiant compared to placebo for the infection-related ADRs were: Upper respiratory tract infections (14.7 % vs. 11.7 %), urinary tract infections (3.4 % vs. 2.7 %), gastroenteritis (1.6 % vs. 0.8 %), herpes simplex (1.8 % vs. 0.7 %), and herpes zoster (1.4 % vs. 0.4 %).
okužbe zgornjih dihalnih poti (14,7 % v primerjavi z 11,7 %), okužbe sečil (3,4 % v primerjavi z 2,7 %), gastroenteritis (1,6 % v primerjavi z 0,8 %), herpes simpleks (1,8 % v primerjavi z 0,7 %) in herpes zoster (1,4 % v primerjavi z 0,4 %).
No association was observed between increased platelet counts and adverse events of a thrombotic nature.
Povezave med povečanim številom krvnih ploščic in neželenimi učinki trombotske narave niso opazili.
In controlled studies, for up to 16 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) were observed in 1.4 % and 0.8 % of patients treated with Olumiant, compared to 1.0 % and 0.8 % respectively of patients treated with placebo.
V nadzorovanih študijah so v obdobju do 16 tednov opazili zvišanje alanin-aminotransferaze (ALT) in aspartat-aminotransferaze (AST) na ≥ 3-kratnik zgornje meje normalnih vrednosti (ULN) pri 1,4 % in 0,8 % bolnikov, zdravljenih z zdravilom Olumiant, v primerjavi z 1,0 % in 0,8 % bolnikov, ki so prejemali placebo.
A total of 3,464 patients were treated with Olumiant in clinical studies in rheumatoid arthritis representing 4214 patient-years of exposure.
Skupno so z zdravilom Olumiant v kliničnih študijah revmatoidnega artritisa zdravili 3.464 bolnikov,
The recommended dose is 2 mg once daily in patients with creatinine clearance between 30 and 60 mL/min.
Priporočeni odmerek pri bolnikih z očistkom kreatinina med 30 in 60 ml/min je 2 mg enkrat na dan.
If increases in ALT or AST are observed during routine patient management and drug-induced liver injury is suspected, Olumiant should be temporarily interrupted until this diagnosis is excluded.
Če se ob redni obravnavi bolnika pokažejo zvišanja ALT ali AST in se pojavi sum na okvaro jeter, povzročeno z zdravili, je treba zdravljenje z zdravilom Olumiant začasno prekiniti, dokler ta diagnoza ni izključena.
Talk to your doctor or pharmacist before and during treatment with Olumiant if you: - have an infection, or if you often get infections.
Opozorila in previdnostni ukrepi Pred začetkom zdravljenja z zdravilom Olumiant ali med zdravljenjem z njim se posvetujte z zdravnikom ali farmacevtom, če: - imate okužbo ali če ste nagnjeni k okužbam.
If you take more Olumiant than you should, contact your doctor.
Če ste vzeli večji odmerek zdravila Olumiant, kot bi smeli Če ste vzeli večji odmerek zdravila Olumiant, kot bi smeli, se posvetujte z zdravnikom.
In treatment-naïve patients, combination with methotrexate resulted in increased frequency of hepatic transaminase elevations compared with baricitinib monotherapy (see section 4.8).
Pri predhodno nezdravljenih bolnikih je kombinacija z metotreksatom povzročila povečano pogostnost zvišanj jetrne transaminaze v primerjavi z baricitinibom v monoterapiji (glejte poglavje 4.8).
In controlled studies, for up to 16 weeks, the following rates were observed for Olumiant vs. placebo:
V nadzorovanih študijah so v obdobju do 16 tednov opazili naslednje deleže za zdravilo Olumiant v primerjavi s placebom:
In RA-BEAM, treatment with Olumiant resulted in significant improvement in patient and physician global assessments, HAQ-DI, pain assessment and CRP at Weeks 12, 24 and 52 compared to adalimumab.
V študiji RA-BEAM je zdravljenje z zdravilom Olumiant v primerjavi z adalimumabom povzročilo pomembno izboljšanje globalnih ocen z vidika bolnika in zdravnika, HAQ-DI, ocene bolečine in CRP v 12., 24. in 52. tednu.
In clinical pharmacology studies, coadministration of baricitinib with the CYP3A substrates simvastatin, ethinyl oestradiol, or levonorgestrel resulted in no clinically meaningful changes in the PK of these medicinal products.
V študijah klinične farmakologije sočasno dajanje baricitiniba s substrati CYP3A simvastatinom, etinilestradiolom ali levonorgestrelom ni povzročilo nikakršnih klinično pomembnih sprememb v farmakokinetiki teh zdravil.
If a patient develops herpes zoster, Olumiant treatment should be temporarily interrupted until the episode resolves.
Če se pri bolniku razvije herpes zoster, je treba zdravljenje z zdravilom Olumiant začasno prekiniti, dokler epizoda ne mine.
The mean ratios of Cmax in patients with mild and moderate renal impairment to patients with normal renal function are 1.16 (90 %CI: 0.92-1.45) and 1.46 (90 %CI: 1.17-1.83), respectively.
Povprečna razmerja vrednosti Cmax med bolniki z blago in zmerno okvaro ledvic ter bolniki z normalnim delovanjem ledvic so 1,16 (90-odstotni IZ: 0,92-1,45) in 1,46 (90-odstotni IZ: 1,17-1,83).
Herpes zoster, Herpes simplexb Gastroenteritis Urinary tract infections Pneumonia
Infekcijske in parazitske bolezni okužbe zgornjih dihalnih potia herpes zoster, herpes simpleksb gastroenteritis okužbe sečil pljučnica
From the 316 events retrieved as of 13 May 2019, 78 were categorised as systemic/oedema and 38 were categorised as non-specific.
Med 316 učinki, pridobljenimi do 13. maja 2019, jih je bilo 78
INFORMATION IN BRAILLE Olumiant 4 mg
PODATKI V BRAILLOVI PISAVI Olumiant 4 mg
INFORMATION IN BRAILLE Olumiant 2 mg
PODATKI V BRAILLOVI PISAVI Olumiant 2 mg
In controlled studies, for up to 16 weeks, increases in CPK values were common.
Kreatin fosfokinaza (CPK- Creatine phosphokinase) V nadzorovanih študijah so bila v obdobju do 16 tednov zvišanja vrednosti CPK pogosta.
In studies which included both doses, a dose-relationship was observed with increased total cholesterol ≥ 5.17 mmol/L reported in 48.8 %, 34.7 % and 17.8 % of patients up to 16 weeks in the 4 mg, 2 mg and placebo groups, respectively.
V študijah, ki so vključevale oba odmerka, so o opaženi povezanosti odmerka z zvišanim skupnim holesterolom ≥ 5,17 mmol/l v obdobju do 16 tednov poročali pri 48,8 % bolnikov v skupini s 4 mg, 34,7 % bolnikov v skupini z 2 mg in pri 17,8 % bolnikov v skupini s placebom.
The mean ratios of AUC in patients with mild and moderate renal impairment to patients with normal renal function are 1.41 (90 % CI: 1.15-1.74) and 2.22 (90 % CI: 1.81-2.73), respectively.
Povprečna razmerja AUC med bolniki z blago in zmerno okvaro ledvic ter bolniki z normalnim delovanjem ledvic so 1,41 (90-odstotni IZ: 1,15-1,74) in 2,22 (90-odstotni IZ: 1,81-2,73).
Renal function was found to significantly affect baricitinib exposure.
Dokazali so, da delovanje ledvic pomembno vpliva na izpostavljenost baricitinibu.
If you are taking probenecid, the recommended dose of Olumiant is 2 mg once a day - injectable anti-rheumatic medicine - medicines which are used to control the body's immune response, such as azathioprine,
Če jemljete probenecid, je priporočeni odmerek zdravila Olumiant 2 mg enkrat na dan. - protirevmatična zdravila za injiciranje.
• croscarmellose sodium
• premreženi natrijev karmelozat
The pattern and incidence of elevation in ALT/AST remained stable over time including in the longterm extension study.
Vzorec in incidenca zvišanja ALT/AST sta ostala stabilna dlje časa, vključno z dolgoročno podaljšano študijo.
The effect of Olumiant on progression of structural joint damage was evaluated radiographically in studies RA-BEGIN, RA-BEAM and RA-BUILD and assessed using the modified Total Sharp Score (mTSS) and its components, the erosion score and joint space narrowing score.
RA-BEGIN, RA-BEAM inRA-BUILD in ga ovrednotili s pomočjo modificirane celotne Sharpove ocene (mTSS) in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
The risks and benefits of treatment with Olumiant should be carefully considered prior to initiating therapy in patients with active, chronic or recurrent infections (see section 4.2).
Pri bolnikih z aktivnimi, kroničnimi ali ponavljajočimi se okužbami je treba pred uvedbo zdravljenja skrbno pretehtati tveganja in koristi zdravljenja z zdravilom Olumiant (glejte poglavje 4.2).
Polyvinylchloride/aluminium/oriented polyamide - aluminium perforated unit dose blisters in cartons of 28 x 1 or 84 x 1 film-coated tablets.
Perforirani pretisni omoti s posameznimi odmerki iz polovinilklorida/aluminija/orientiranega poliamida in aluminija v škatlah s po 28 x 1 ali 84 x 1 filmsko obloženo tableto.
Treatment should be started by a doctor experienced in the diagnosis and treatment of rheumatoid arthritis.
Kako jemati zdravilo Olumiant Zdravljenje mora uvesti zdravnik, ki ima izkušnje z diagnostiko in zdravljenjem revmatoidnega artritisa.
Neutropaenia
Nevtropenija
Greater rates of remission compared to placebo were observed as early as week 4.
Že v 4. tednu po začetku zdravljenja so v primerjavi s placebom opazili večje stopnje remisije.
The PK of baricitinib is linear with respect to time.
Farmakokinetika baricitiniba je glede na čas linearna.
• At week 48: 57/73 (78 %) continuing 4 mg vs. 51/86 (59 %) reduced to 2 mg (p ≤ 0.05)
• V 48. tednu: 57/73 (78 %) bolnikov, ki so nadaljevali z jemanjem odmerka 4 mg, v primerjavi z 51/86 (59 %) bolnikov, ki so jemali zmanjšan odmerek 2 mg (p ≤ 0,05).
Baricitinib is associated with an increased rate of infections such as upper respiratory tract infections compared to placebo (see section 4.8).
Baricitinib je v primerjavi s placebom povezan s povečano stopnjo okužb, kot so okužbe zgornjih dihalnih poti (glejte poglavje 4.8).
• Contact details of the prescriber
• kontaktne podatke zdravnika, ki je predpisal zdravilo.
In all studies, patients treated with Olumiant 4 mg once daily had statistically significantly higher ACR20, ACR50 and ACR70 response at 12 weeks compared to placebo, MTX or adalimumab (see Table 4).Time to onset of efficacy was rapid across measures with significantly greater responses seen as early as week 1.
V vseh študijah so imeli bolniki, zdravljeni z zdravilom Olumiant 4 mg enkrat na dan, v 12. tednu statistično značilno višji odziv ACR20, ACR50 in ACR70 v primerjavi s placebom, MTX ali adalimumabom (glejte Preglednico 4).
How to store Olumiant
Shranjevanje zdravila Olumiant
Common side effects (may affect up to 1 in 10 people): - cold sores (herpes simplex) - infection causing a sick stomach or diarrhoea (gastroenteritis) - urinary infection - pneumonia - high number of platelets (cells involved in blood clotting), shown by blood test - feeling sick in the stomach (nausea) - high levels of liver enzymes, shown by blood test - rash
- okužba, ki povzroča siljenje na bruhanje ali drisko (gastroenteritis) - okužba sečil - pljučnica - visoko število krvnih ploščic (celic, ki sodelujejo pri strjevanju krvi), ki jih pokaže krvna preiskava - siljenje na bruhanje (navzea) - visoke ravni jetrnih encimov, ki jih pokaže krvna preiskava - izpuščaj
- If you have any further questions, ask your doctor, or pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
An imbalance in reports of VTE with 0% (EAIR of 0,0) for placebo vs. 0,53% (EAIR of 1,3) for baricitinib 4-mg was noted in placebo-controlled trials.
(EAIR 0,0) pri placebu v primerjavi z 0,53 % (EAIR 1,3) pri baricitinibu 4 mg. Pogostnost poročil o
In vitro, baricitinib is not an inhibitor of OAT1, OAT2, OAT3, organic cationic transporter (OCT) 2, OATP1B1, OATP1B3, BCRP, MATE1 and MATE2-K at clinically relevant concentrations.
In vitro baricitinib ni zaviralec OAT1, OAT2, OAT3, prenašalca organskih kationov (OCT- organic cationic transporter) OCT2, OATP1B1, OATP1B3, BCRP, MATE1 in MATE2-K v klinično pomembnih koncentracijah.
EU/1/16/1170/001 (14 film-coated tablets) EU/1/16/1170/002 (28 film-coated tablets) EU/1/16/1170/003 (28 x 1 film-coated tablets) EU/1/16/1170/004 (35 film-coated tablets) EU/1/16/1170/005 (56 film-coated tablets) EU/1/16/1170/006 (84 film-coated tablets) EU/1/16/1170/007 (84 x 1 film-coated tablets) EU/1/16/1170/008 (98 film-coated tablets)
EU/1/16/1170/001 (14 filmsko obloženih tablet) EU/1/16/1170/002 (28 filmsko obloženih tablet) EU/1/16/1170/003 (28 x 1 filmsko obložena tableta) EU/1/16/1170/004 (35 filmsko obloženih tablet) EU/1/16/1170/005 (56 filmsko obloženih tablet) EU/1/16/1170/006 (84 filmsko obloženih tablet) EU/1/16/1170/007 (84 x 1 filmsko obložena tableta) EU/1/16/1170/008 (98 filmsko obloženih tablet)
Pharmacodynamic interactions
Farmakodinamična medsebojna delovanja
• At week 12: 234/251 (93 %) continuing 4 mg vs. 207/251 (82 %) reduced to 2 mg (p ≤ 0.001)
• V 12. tednu: 234/251 (93 %) bolnikov, ki so nadaljevali z jemanjem odmerka 4 mg, v primerjavi s 207/251 (82 %) bolnikov, ki so jemali zmanjšan odmerek 2 mg (p ≤ 0,001).
Olumiant 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.
4.1 Terapevtske indikacije Zdravilo Olumiant je indicirano za zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, pri katerih odziv na zdravljenje z enim ali več imunomodulirajočimi protirevmatičnimi zdravili ni zadosten ali pa teh zdravil ne prenašajo.