natgillin/translations-raw huggingface dataset:
Tell your doctor if you get symptoms such as fever, wounds, feeling more tired than usual or dental problems as these can be signs of infection.
Obvestite svojega zdravnika, če se pri vas pojavijo simptomi, kot so zvišana telesna temperatura, rane, občutek večje utrujenosti kot običajno ali težave z zobmi, saj so to lahko znaki okužbe.
Cytochrome P450 enzymes
Encimi citokroma P450
Herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs.
O herpesu zostru so pogosteje poročali pri bolnikih, starih ≥ 65 let, ki so bili predhodno zdravljeni tako z biološkimi kot s konvencionalnimi imunomodulirajočimi protirevmatičnimi zdravili.
The influence of baricitinib on the humoral response to non-live vaccines was evaluated in 106 RA patients under stable treatment with baricitinib 2 or 4 mg, receiving inactivated pneumococcal or tetanus vaccination.
Vpliv baricitiniba pri humoralnem odzivu na neživa cepiva so ocenjevali pri 106 bolnikih z revmatoidnim artritisom, ki so prejemali stabilno zdravljenje z baricitinibom 2 ali 4 mg, in ki so prejeli inaktivirano cepivo proti pnevmokoku ali tetanusu.
Information for Patients about OLUMIANT® (baricitinib)
Informacije za bolnike o zdravilu OLUMIANT® (baricitinib)
Olumiant 2 mg and 4 mg are available in blister packs of 14, 28, 35, 56, 84 and 98 tablets in calendar blisters and 28 x 1 and 84 x 1 tablets in perforated unit dose blisters.
Tablete Olumiant 2 mg in 4 mg so na voljo v pretisnih omotih s po 14, 28, 35, 56, 84 in 98 tabletami v koledarskih pretisnih omotih ter 28 x 1 in 84 x 1 tableta v perforiranem pretisnem omotu s posameznimi odmerki.
Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2.
Baricitinib je selektiven in reverzibilen zaviralec Janus kinaz (JAK-Janus Associated Kinases) JAK1 in JAK2.
QR code to be included + www.olumiant.eu
Vključena bo koda QR+ www.olumiant.eu
RA-BEACON TNF-IR patients
RA-BEACON Bolniki, zdravljeni s TNF-IR
Swelling face (n=23) and urticaria (n=20) were also frequently reported.
(n = 23) in urtikariji (n = 20).
Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase', which is involved in inflammation.
Zdravilo Olumiant deluje tako, da zmanjšuje dejavnost encima v telesu, imenovanega »Janus kinaza«, ki sodeluje pri vnetju.
It is unknown whether baricitinib/metabolites are excreted in human milk.
Ni znano, ali se baricitinib/presnovki izločajo v materino mleko.
Moreover positive dechallenge (e.g. one case categorised as systemic) and positive dechallenge and rechallenge (e.g. one case categorised as non-specific) also support the view that baricitinib may cause systemic events.
Poleg tega tudi izzvenetje simptomov po prekinitvi zdravljenja (npr. en primer, razvrščen kot sistemski) ter izzvenetje simptomov po prekinitvi zdravljenja in ponovni pojav simptomov po ponovni uvedbi zdravljenja (npr. en primer, razvrščen kot nespecifičen) podpirajo stališče, da baricitinib lahko povzroča sistemske učinke.
RA-BUILD (24 weeks)
RA-BUILD (24 tednov)
Available pharmacodynamic/toxicological data in animals have shown excretion of baricitinib in milk (see section 5.3).
Razpoložljivi farmakodinamski/toksikološki podatki iz študij na živalih kažejo, da se baricitinib izloča v mleku samic (glejte poglavje 5.3).
Degeneration of the sternal growth plate was observed in some dogs, at low incidence and also in control animals, but with a dose-effect relationship regarding severity.
Pri nekaterih psih so opazili degeneracijo rastne plošče prsnice, z manjšo pojavnostjo tudi pri kontrolnih živalih, vendar pa s povezavo med odmerkom in učinkom na jakost.
The presence of at least 6 tender and 6 swollen joints was required at baseline.
V izhodišču je bila za vključitev potrebna prisotnost najmanj 6 bolečih in 6 oteklih sklepov.
Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell.
Janus kinaze na znotrajcelični signalni poti fosforilirajo in aktivirajo signalne pretvornike in aktivatorje transkripcije (STAT- signal transducers and activators of transcription), ki aktivirajo izražanje gena v celici.
Abbreviations: ADA = adalimumab; MTX = methotrexate; OLU = Olumiant; PBO = Placebo * p ≤ 0.05; ** p ≤ 0.01; *** p ≤ 0.001 vs. placebo (vs. MTX for study RA-BEGIN) † p ≤ 0.05; †† p ≤ 0.01; ††† p ≤ 0.001 vs. adalimumab
Razlaga kratic: ADA = adalimumab; MTX = metotreksat; OLU = zdravilo Olumiant; PBO = placebo * p ≤ 0,05; ** p ≤ 0,01; *** p ≤ 0,001 v primerjavi s placebom (v primerjavi z MTX za študijo RA-BEGIN) † p ≤ 0,05; †† p ≤ 0,01; ††† p ≤ 0,001 v primerjavi z adalimumabom
Studies in animals suggest that treatment with baricitinib has the potential to decrease female fertility while on treatment, but there was no effect on male spermatogenesis (see section 5.3).
Študije na živalih kažejo, da ima zdravljenje z baricitinibom potencial za zmanjšanje plodnosti pri zdravljenih samicah, niso pa opazili učinka na spermatogenezo pri samcih (glejte poglavje 5.3).
In all studies, Olumiant-treated patients reported improvements in patient-reported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score and fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F).
V vseh študijah so bolniki, zdravljeni z zdravilom Olumiant, poročali o izboljšanju kakovosti življenja z vidika bolnika, kot so jo ovrednotili s telesno komponento ocene SF-36 (Short Form (36) Health
No relevant differences regarding efficacy and safety were observed in subgroups defined by types of concomitant DMARDs used in combination with baricitinib.
V povezavi z učinkovitostjo in varnostjo v podskupinah, določenih z vrstami sočasnih imunomodulirajočih protirevmatičnih zdravil, uporabljenih v kombinaciji z baricitinibom, niso opazili pomembnih razlik.
Olumiant is not recommended for use in patients with creatinine clearance < 30 mL/min (see section 5.2).
Uporaba zdravila Olumiant ni priporočljiva pri bolnikih z očistkom kreatinina < 30 ml/min (glejte poglavje 5.2).
Six placebo-controlled studies were integrated (997 patients on 4 mg once daily and 1070 patients on placebo) to evaluate the safety of Olumiant in comparison to placebo for up to 16 weeks after treatment initiation.
Vključili so šest s placebom nadzorovanih študij (997 bolnikov je prejemalo odmerek 4 mg enkrat na dan, 1070 bolnikov pa je prejemalo placebo) za oceno varnosti zdravila Olumiant v primerjavi s placebom za obdobje največ 16 tednov po začetku zdravljenja.
Body weight, sex, race, and ethnicity did not have a clinically relevant effect on the PK of baricitinib.
Telesna masa, spol, rasa in etnično poreklo niso imeli klinično pomembnega učinka na farmakokinetiko baricitiniba.
Animal studies indicate that baricitinib may have an adverse effect on bone development in utero at higher dosages.
Študije na živalih kažejo, da ima lahko baricitinib v visokih odmerkih neželen učinek na razvoj kosti in utero.
Driving and using machines Olumiant has no effect on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Olumiant nima vpliva na sposobnost vožnje in upravljanja strojev.
Absolute Lymphocyte Count (ALC)
Absolutno število limfocitov (ALC)
Data concerning use of baricitinib with potent immunosuppressive medicinal products (e.g., azathioprine, tacrolimus, ciclosporin) are limited and caution should be exercised when using such combinations (see section 4.5).
Podatki o uporabi baricitiniba z močnimi imunosupresivi (npr. azatioprin, takrolimus, ciklosporin) so omejeni, zato je pri uporabi teh kombinacij potrebna previdnost (glejte poglavje 4.5).
For Olumiant, the most common serious infections were herpes zoster, and cellulitis.
Pri zdravilu Olumiant sta bili najpogostejši resni okužbi herpes zoster in celulitis.
• That the patient may need to have their cholesterol level checked during treatment
• da bo pri bolniku med zdravljenjem morda treba preverjati raven holesterola.
In female rats there were decreased numbers of corpora lutea and implantation sites, increased pre-implantation loss, and/or adverse effects on intrauterine survival of the embryos.
Pri podganjih samicah so opazili zmanjšano število rumenih telesc in mest implantacije, večjo izgubo pred implantacijo in/ali neželene učinke na preživetje zarodkov v maternici.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Zdravljenje morajo uvesti zdravniki, ki imajo izkušnje z diagnostiko in zdravljenjem revmatoidnega artritisa.
In a clinical pharmacology study, dosing of probenecid (an OAT3 inhibitor with strong inhibition potential) resulted in approximately a 2-fold increase in AUC(0-∞) with no change in tmax or Cmax of baricitinib.
V študiji klinične farmakologije je odmerjanje probenecida (zaviralca OAT3 z velikim potencialom za zaviranje) povzročilo približno 2-kratno povečanje AUC(0-∞) brez sprememb v tmax ali Cmax baricitiniba.
Significant increases (> 5 x ULN) occurred in 0.8 % of patients treated with Olumiant and 0.3 % of patients treated with placebo.
Do pomembnih zvišanj (> 5 x ULN) je prišlo pri 0,8 % bolnikov, zdravljenih z zdravilom Olumiant in pri 0,3 % bolnikov, ki so prejemali placebo.
Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended.
Uporaba živih oslabljenih cepiv med ali neposredno pred zdravljenjem z zdravilom Olumiant ni priporočljiva.
Prior to initiating Olumiant, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Priporočljivo je, da pred začetkom zdravljenja z zdravilom Olumiant vsi bolniki opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje.
Patients should be managed according to international clinical guidelines for hyperlipidaemia
Bolnike je treba obravnavati v skladu z mednarodnimi kliničnimi smernicami za zdravljenje hiperlipidemije.
Week 24 0.14 0.06 0.03 0.29 0.12** Week 52 0.21 0.25 0.06 0.58 0.21*** 0.19** Proportion of patients with no radiographic progressionb:
24. teden 0,14 0,06 0,03 0,29 0,12** 52. teden 0,21 0,25 0,06 0,58 0,21*** 0,19** Delež bolnikov brez radiografskih znakov napredovanjab:
4.4 Special warnings and precautions for use
4.4 Posebna opozorila in previdnostni ukrepi Okužbe
If an infection develops, the patient should be monitored carefully and Olumiant therapy should be temporarily interrupted if the patient is not responding to standard therapy.
Če se razvije okužba, je treba bolnika skrbno spremljati in zdravljenje z zdravilom Olumiant začasno prekiniti, če se bolnik ne odziva na standardno zdravljenje.
Combination with biologic DMARDs or other JAK inhibitors has not been studied.
Kombinacij z biološkimi imunomodulirajočimi protirevmatičnimi zdravili ali drugimi zaviralci JAK niso proučevali.
Physicians should advise women of child bearing potential to use contraception during treatment and for a week after its ending.
Zdravniki morajo ženskam v rodni dobi svetovati, naj med zdravljenjem in še teden dni po zaključku zdravljenja uporabljajo kontracepcijo.
The tablets contain a recessed area on each side.
Tablete imajo na obeh straneh vdolbino.
Use of baricitinib with potent immunosuppressive medicinal products such as azathioprine, tacrolimus, or ciclosporin was limited in clinical studies of baricitinib, and a risk of additive immunosuppression cannot be excluded (see section 4.4).
Uporaba baricitiniba z močnimi imunosupresivi, kot so npr. azatioprin, takrolimus ali ciklosporin, je bila v kliničnih študijah baricitiniba omejena, zato tveganja za aditivno imunosupresijo ni mogoče izključiti (glejte poglavje 4.4).
Renal elimination is the principal mechanism for baricitinib's clearance through glomerular filtration and active secretion via OAT3, Pgp, BCRP and MATE2-K.
Izločanje prek ledvic je primarni mehanizem očistka baricitiniba z glomerularno filtracijo in aktivnim izločanjem prek OAT3, Pgp, BCRP in MATE2-K.
The proportion of patients with no radiographic progression (mTSS change ≤ 0) was significantly higher with Olumiant 4 mg compared to placebo at weeks 24 and 52.
Delež bolnikov brez radiografskih znakov napredovanja (sprememba mTSS ≤ 0) je bil bistveno višji pri zdravilu Olumiant 4 mg v primerjavi s placebom v 24. in 52. tednu.
Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment.
Ženske v rodni dobi morajo med zdravljenjem in vsaj 1 teden po njem uporabljati učinkovito kontracepcijo.
Tablet cores
Jedro tablete
You should use an effective method of contraception to avoid becoming pregnant during treatment with Olumiant and for at least one week after the last Olumiant treatment.
Uporabljati morate učinkovito kontracepcijo, da med zdravljenjem z zdravilom Olumiant in vsaj še en teden po zadnjem zdravljenju z zdravilom Olumiant preprečite zanositev.
In controlled studies, for up to 16 weeks, the incidence rate of all infections (rate of patients with ≥ 1 event per 100 patient-years of exposure) was 101 with Olumiant compared to 83 in the placebo group.
V nadzorovanih študijah je v obdobju do 16 tednov stopnja pojavnosti za vse okužbe (delež bolnikov z ≥ 1 dogodkom na 100 bolnikov-let izpostavljenosti) znašala 101 za zdravilo Olumiant v primerjavi s 83 v skupini s placebom.
Mean apparent clearance (CL/F) and half-life in patients with rheumatoid arthritis was 9.42 L/hr (CV = 34.3 %) and 12.5 hrs (CV = 27.4 %), respectively.
Povprečni navidezni očistek (CL/F) in razpolovni čas pri bolnikih z revmatoidnim artritisom sta znašala 9,42 l/uro (CV = 34,3 %) in 12,5 ure (CV = 27,4 %).
The risk of malignancies including lymphoma is increased in patients with rheumatoid arthritis.
Tveganje za maligne bolezni, vključno z limfomom, je pri bolnikih z revmatoidnim artritisom povečano.
A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections.
Priporočeni odmerek zdravila Olumiant je 4 mg enkrat na dan. Odmerek 2 mg enkrat na dan je primeren za bolnike, ki so stari ≥ 75 let, in je lahko primeren za bolnike s kroničnimi ali ponavljajočimi se okužbami v anamnezi.
Cmax and AUC at steady state are 1.4- and 2.0-fold higher, respectively, in subjects with rheumatoid arthritis compared to healthy subjects.
Vrednosti Cmax and AUC v stanju dinamičnega ravnovesja sta pri bolnikih z revmatoidnim artritisom 1,4- in 2,0-krat višji kot pri zdravih preskušancih.
For most patients, changes in lymphocyte count occurred within the normal reference range.
Pri večini bolnikov je do sprememb števila limfocitov prišlo v normalnem referenčnem območju.
Clinical Trial Summary Study name (Duration)
Ime študije (trajanje)
Weight increased Creatine phosphokinase increased >5 x ULNc a Combined term (acute sinusitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, tracheitis, upper respiratory tract infection).
Preiskave povečana telesna masa zvišana vrednost kreatin fosfokinaze > 5 x ULNc a Skupni izraz (akutni sinusitis, epiglotitis, laringitis, nazofaringitis, orofaringealna bolečina, faringitis,
In addition, for both study RA-BEACON and RA-BUILD, onset of efficacy was faster and the effect size was generally larger for the 4 mg dose groups compared to 2 mg.
RA-BEACON in RA-BUILD, nastop učinkovitosti hitrejši, obseg učinka pa na splošno večji v skupinah z odmerkom 4 mg v primerjavi z odmerkom 2 mg.
In vitro, baricitinib is a substrate for organic anionic transporter (OAT)3, P-glycoprotein (Pgp), breast cancer resistance protein (BCRP) and multidrug and toxic extrusion protein (MATE)2-K.
In vitro je baricitinib substrat za prenašalec organskih anionov (OAT-organic anionic transporter)3, P-glikoprotein (Pgp), protein odpornosti pri raku dojke (BCRP-breast cancer resistance protein) in protein za ekstruzijo več zdravil in toksinov (MATE-multidrug and toxin extrusion protein) 2-K.
In all 4 studies, a significantly higher proportion of patients treated with Olumiant 4 mg compared to placebo or MTX achieved low disease activity or remission (DAS28-ESR or DAS28-hsCRP ≤ 3.2 and DAS28-ESR or DAS28-hsCRP < 2.6) at Weeks 12 and 24.
V vseh 4 študijah je v 12. in 24. tednu statistično značilno večji delež bolnikov, zdravljenih z zdravilom Olumiant 4 mg, v primerjavi s placebom ali MTX, dosegel nizko aktivnost bolezni ali remisijo (DAS28-ESR ali DAS28-hsCRP ≤ 3,2 in DAS28-ESR ali DAS28-hsCRP < 2,6).
Decreases in red blood cell parameters were observed in mice, rats and dogs at exposures approximately 6 to 36 times the human exposure.
Pri miših, podganah in psih so pri približno 6- do 36-kratniku izpostavljenosti pri človeku opazili znižanja parametrov rdečih krvničk.
In vitro, baricitinib is a cytochrome P450 enzyme (CYP)3A4 substrate although less than 10 % of the dose is metabolised via oxidation.
Encimi citokroma P450 In vitro je baricitinib substrat encima citokroma P450 (CYP)3A4, čeprav se manj kot 10 % odmerka presnavlja prek oksidacije.
Treatment should be interrupted if ANC < 1 x 109 cells/L and may be restarted once ANC return above this value
Zdravljenje je treba prekiniti, če je ANC < 1 x 109 celic/l in ga je mogoče znova uvesti, ko se raven ANC vrne nad to vrednost.
The risk of lymphocytosis is increased in elderly patients with rheumatoid arthritis.
Tveganje limfocitoze je pri starejših bolnikih z revmatoidnim artritisom povečano.
This may be due to inhibition of creatinine secretion by baricitinib in the renal tubules.
Vzrok je morda v tem, da baricitinib inhibira izločanje kreatinina v ledvičnih kanalčkih.
Following oral administration of baricitinib, a dose-proportional increase in systemic exposure was observed in the therapeutic dose range.
Po peroralnem dajanju baricitiniba so opazili z odmerkom sorazmerno povečanje sistemske izpostavljenosti v razponu terapevtskih odmerkov.
Laboratory Measure Action
Laboratorijska meritev
The RA-BEGIN Study in MTX-naïve patients is supportive for the target population of patients with an inadequate response to, or intolerance to, other DMARDs (section 4.1).
Študija RA-BEGIN, opravljena z bolniki, ki predhodno niso bili zdravljeni z metotreksatom, podpira ciljno populacijo bolnikov z nezadostnim odzivom na druga imunomodulirajoča protirevmatična zdravila ali z intoleranco na ta zdravila (poglavje 4.1).
In clinical pharmacology studies there were no clinically meaningful effects on exposure when baricitinib was coadministered with digoxin (Pgp substrate) or methotrexate (substrate of several transporters).
V študijah klinične farmakologije niso opazili klinično pomembnih učinkov na izpostavljenost, ko so baricitinib dajali sočasno z digoksinom (substratom Pgp) ali metotreksatom
Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity.
V kliničnih preskušanjih so 10 dni dajali enkratne odmerke do 40 mg in večkratne odmerke do 20 mg na dan, brez toksičnih učinkov, ki bi omejevali odmerek zdravila.
Baricitinib metabolism is mediated by CYP3A4, with less than 10 % of the dose identified as undergoing biotransformation.
Baricitinib se presnavlja zlasti s CYP3A4, pri čemer ugotovili, da biotransformacija poteka pri manj kot 10 % odmerka.
• Prescribers should screen the patients for viral hepatitis before commencing Olumiant treatment.
• da morajo zdravniki, ki predpisujejo zdravilo pri bolnikih opraviti presejalni pregled za virusni hepatitis, preden uvedejo zdravljenje z zdravilom Olumiant.
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - aluminium blisters in cartons of 14, 28, 35, 56, 84 or 98 film-coated tablets.
Pretisni omoti iz polovinilklorida/polietilena/poliklorotrifluoroetilena in aluminija v škatlah s po 14, 28, 35, 56, 84 ali 98 filmsko obloženih tablet.
Consequently, the recommended dose in patients taking OAT3 inhibitors with a strong inhibition potential, such as probenecid, is 2 mg once daily (see section 4.2).
Posledično je priporočeni odmerek za bolnike, ki jemljejo zaviralce OAT3 z velikim potencialom zazaviranje, kot je npr. probenecid, 2 mg enkrat na dan (glejte poglavje 4.2).
RA-BEAM (52 weeks)
RA-BEAM (52 tednov)
The most common concomitant DMARDs in these subjects were MTX (79% of patients), hydroxychloroquine (19%), leflunomide
Najbolj pogosta sočasna imunomodulirajoča protirevmatična zdravila pri teh preskušancih so bila metotreksat (79 % bolnikov), hidroksiklorokin (19 %), leflunomid (11 %), sulfasalazin (9 %).
Combination with biologic DMARDs or other Janus kinase (JAK) inhibitors is not recommended, as a risk of additive immunosuppression cannot be excluded.
Kombinacija z biološkimi imunomodulirajočimi protirevmatičnimi zdravili ali drugimi zaviralci Janus kinaz (JAK- Janus kinase inhibitors) ni priporočljiva, saj ni mogoče izključiti tveganja za aditivno imunosupresijo.
In placebo-controlled trials in which MTX was not required, 501 subjects randomized to baricitinib 2 mg or 4 mg received MTX as background therapy, and 303 received conventional DMARDs other than MTX (approximately half with MTX and half without).
V preskušanjih, nadzorovanih s placebom, kjer metotreksat ni bil zahtevan, je 501 preskušanec, ki je bil randomiziran v skupino z baricitinibom 2 mg ali 4 mg, prejemal metotreksat kot osnovno zdravljenje, 303 preskušanci pa so prejemali konvencionalna imunomodulirajoča protirevmatična zdravila, ki niso bila metotreksat (približno polovica z metotreksatom in polovica brez).
In RA-BEAM and RA-BUILD, treatment with Olumiant 4 mg resulted in a significant improvement in the mean duration and severity of morning joint stiffness compared to placebo or adalimumab as assessed using daily electronic patient diaries for 12 weeks.
V študijah RA-BEAM in RA-BUILD je zdravljenje z zdravilom Olumiant 4 mg povzročilo pomembno izboljšanje v povprečnem trajanju in jakosti jutranje okorelosti sklepov v primerjavi s placebom ali adalimumabom, kot so ocenili s pomočjo vsakodnevnih elektronskih dnevnikov, ki so jih bolniki uporabljali 12 tednov.
The use of baricitinib has not been studied in patients with severe hepatic impairment.
Uporabe baricitiniba pri bolnikih s hudo jetrno okvaro niso proučevali.
In treatment naïve patients, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.
Pri predhodno nezdravljenih bolnikih je kombinacija z metotreksatom povzročila povečano pogostnost okužb v primerjavi z baricitinibom v monoterapiji.
• The Package Leaflet including the Patient Alert Card
• Navodilo za uporabo, vključno z opozorilno kartico za bolnika
In a combined male/female rat fertility study, baricitinib decreased overall mating performance (decreased fertility and conception indices).
V kombinirani študiji plodnosti podganjih samcev/samic je baricitinib znižal skupno uspešnost parjenja (zmanjšana plodnost in manjše število spočetij).
The most commonly reported adverse drug reactions (ADRs) occurring in ≥ 2 % of patients treated with Olumiant monotherapy or in combination with conventional synthetic DMARDs were increased LDL cholesterol (33.6 %), upper respiratory tract infections (14.7 %) and nausea (2.8 %).
Najbolj pogosto so poročali o naslednjih neželenih učinkih, ki so se pojavili pri ≥ 2 % bolnikov, zdravljenih z zdravilom Olumiant v monoterapiji ali v kombinaciji s konvencionalnimi sintetičnimi imunomodulirajočimi protirevmatičnimi zdravili, so bili zvišan LDL-holesterol (33,6 %), okužbe zgornjih dihalnih poti (14,7 %) in navzea (2,8 %).