FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.4 Special warnings and precautions for use
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Okužbe
English: 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.
Slovenian: Če se razvije okužba, je treba bolnika skrbno spremljati in zdravljenje z zdravilom Olumiant začasno prekiniti, če se bolnik ne odziva na standardno zdravljenje.
English: Combination with biologic DMARDs or other JAK inhibitors has not been studied.
Slovenian: Kombinacij z biološkimi imunomodulirajočimi protirevmatičnimi zdravili ali drugimi zaviralci JAK niso proučevali.
English: Physicians should advise women of child bearing potential to use contraception during treatment and for a week after its ending.
Slovenian: Zdravniki morajo ženskam v rodni dobi svetovati, naj med zdravljenjem in še teden dni po zaključku zdravljenja uporabljajo kontracepcijo.
English: The tablets contain a recessed area on each side.
Slovenian: Tablete imajo na obeh straneh vdolbino.
English: 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).
Slovenian: 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).
English: Renal elimination is the principal mechanism for baricitinib's clearance through glomerular filtration and active secretion via OAT3, Pgp, BCRP and MATE2-K.
Slovenian: Izločanje prek ledvic je primarni mehanizem očistka baricitiniba z glomerularno filtracijo in aktivnim izločanjem prek OAT3, Pgp, BCRP in MATE2-K.
English: 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.
Slovenian: 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.
English: Women of childbearing potential have to use effective contraception during and for at least 1 week after treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in vsaj 1 teden po njem uporabljati učinkovito kontracepcijo.
English: Tablet cores
Slovenian: Jedro tablete
English: 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.
Slovenian: Uporabljati morate učinkovito kontracepcijo, da med zdravljenjem z zdravilom Olumiant in vsaj še en teden po zadnjem zdravljenju z zdravilom Olumiant preprečite zanositev.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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 %).
English: The risk of malignancies including lymphoma is increased in patients with rheumatoid arthritis.
Slovenian: Tveganje za maligne bolezni, vključno z limfomom, je pri bolnikih z revmatoidnim artritisom povečano.
English: 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.
Slovenian: 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.
English: Cmax and AUC at steady state are 1.4- and 2.0-fold higher, respectively, in subjects with rheumatoid arthritis compared to healthy subjects.
Slovenian: 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.
English: For most patients, changes in lymphocyte count occurred within the normal reference range.
Slovenian: Pri večini bolnikov je do sprememb števila limfocitov prišlo v normalnem referenčnem območju.
English: Clinical Trial Summary Study name (Duration)
Slovenian: Ime študije (trajanje)
English: 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).
Slovenian: Preiskave povečana telesna masa zvišana vrednost kreatin fosfokinaze > 5 x ULNc a Skupni izraz (akutni sinusitis, epiglotitis, laringitis, nazofaringitis, orofaringealna bolečina, faringitis,
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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).
English: Decreases in red blood cell parameters were observed in mice, rats and dogs at exposures approximately 6 to 36 times the human exposure.
Slovenian: Pri miših, podganah in psih so pri približno 6- do 36-kratniku izpostavljenosti pri človeku opazili znižanja parametrov rdečih krvničk.
English: In vitro, baricitinib is a cytochrome P450 enzyme (CYP)3A4 substrate although less than 10 % of the dose is metabolised via oxidation.
Slovenian: Encimi citokroma P450 In vitro je baricitinib substrat encima citokroma P450 (CYP)3A4, čeprav se manj kot 10 % odmerka presnavlja prek oksidacije.
English: Treatment should be interrupted if ANC < 1 x 109 cells/L and may be restarted once ANC return above this value
Slovenian: 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.
English: The risk of lymphocytosis is increased in elderly patients with rheumatoid arthritis.
Slovenian: Tveganje limfocitoze je pri starejših bolnikih z revmatoidnim artritisom povečano.
English: This may be due to inhibition of creatinine secretion by baricitinib in the renal tubules.
Slovenian: Vzrok je morda v tem, da baricitinib inhibira izločanje kreatinina v ledvičnih kanalčkih.
English: Following oral administration of baricitinib, a dose-proportional increase in systemic exposure was observed in the therapeutic dose range.
Slovenian: Po peroralnem dajanju baricitiniba so opazili z odmerkom sorazmerno povečanje sistemske izpostavljenosti v razponu terapevtskih odmerkov.
English: Laboratory Measure Action
Slovenian: Laboratorijska meritev
English: 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).
Slovenian: 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).
English: 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).
Slovenian: V študijah klinične farmakologije niso opazili klinično pomembnih učinkov na izpostavljenost, ko so baricitinib dajali sočasno z digoksinom (substratom Pgp) ali metotreksatom
English: 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.
Slovenian: 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.
English: Baricitinib metabolism is mediated by CYP3A4, with less than 10 % of the dose identified as undergoing biotransformation.
Slovenian: Baricitinib se presnavlja zlasti s CYP3A4, pri čemer ugotovili, da biotransformacija poteka pri manj kot 10 % odmerka.
English: • Prescribers should screen the patients for viral hepatitis before commencing Olumiant treatment.
Slovenian: • da morajo zdravniki, ki predpisujejo zdravilo pri bolnikih opraviti presejalni pregled za virusni hepatitis, preden uvedejo zdravljenje z zdravilom Olumiant.
English: 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
Slovenian: A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Polyvinylchloride/polyethylene/polychlorotrifluoroethylene - aluminium blisters in cartons of 14, 28, 35, 56, 84 or 98 film-coated tablets.
Slovenian: Pretisni omoti iz polovinilklorida/polietilena/poliklorotrifluoroetilena in aluminija v škatlah s po 14, 28, 35, 56, 84 ali 98 filmsko obloženih tablet.
English: 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).
Slovenian: 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).
English: RA-BEAM (52 weeks)
Slovenian: RA-BEAM (52 tednov)
English: The most common concomitant DMARDs in these subjects were MTX (79% of patients), hydroxychloroquine (19%), leflunomide
Slovenian: Najbolj pogosta sočasna imunomodulirajoča protirevmatična zdravila pri teh preskušancih so bila metotreksat (79 % bolnikov), hidroksiklorokin (19 %), leflunomid (11 %), sulfasalazin (9 %).
English: Combination with biologic DMARDs or other Janus kinase (JAK) inhibitors is not recommended, as a risk of additive immunosuppression cannot be excluded.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The use of baricitinib has not been studied in patients with severe hepatic impairment.
Slovenian: Uporabe baricitiniba pri bolnikih s hudo jetrno okvaro niso proučevali.
English: In treatment naïve patients, combination with methotrexate resulted in increased frequency of infections compared to baricitinib monotherapy.
Slovenian: Pri predhodno nezdravljenih bolnikih je kombinacija z metotreksatom povzročila povečano pogostnost okužb v primerjavi z baricitinibom v monoterapiji.
English: • The Package Leaflet including the Patient Alert Card
Slovenian: • Navodilo za uporabo, vključno z opozorilno kartico za bolnika
English: In a combined male/female rat fertility study, baricitinib decreased overall mating performance (decreased fertility and conception indices).
Slovenian: V kombinirani študiji plodnosti podganjih samcev/samic je baricitinib znižal skupno uspešnost parjenja (zmanjšana plodnost in manjše število spočetij).
English: 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 %).
Slovenian: 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 %).
English: 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).
Slovenian: 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).
English: You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.
Slovenian: Če zanosite, morate obvestiti svojega zdravnika, saj se zdravila Olumiant med nosečnostjo ne sme uporabljati.
English: 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.
Slovenian: 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,
English: Lipid elevations
Slovenian: Zvišanje lipidov
English: 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.
Slovenian: 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.
English: All patients on background MTX
Slovenian: Vsi bolniki so prejemali osnovno zdravljenje z MTX
English: Infection such as shingles, which may affect up to 1 in 10 people:
Slovenian: Okužbe, kot je pasasti izpuščaj (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Treatment should be interrupted if ALC < 0.5 x 109 cells/L and may be restarted once ALC return above this value
Slovenian: 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.
English: Potential for other medicinal products to affect the pharmacokinetics of baricitinib
Slovenian: Potencial drugih zdravil za vpliv na farmakokinetiko baricitiniba
English: Olumiant is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Slovenian: Uporaba zdravila Olumiant ni priporočljiva pri bolnikih s hudo okvaro jeter (glejte poglavje 5.2).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Co-administration with OAT3 inhibitors
Slovenian: Sočasno dajanje z zaviralci OAT3
English: 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.
Slovenian: 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.
English: • Increased LDL cholesterol ≥ 3.36 mmol/L: 33.6 % vs. 10.3 %, respectively
Slovenian: • zvišan LDL-holesterol ≥ 3,36 mmol/l: 33,6 % v primerjavi z 10,3 %
English: 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.
Slovenian: 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«.
English: 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.
Slovenian: 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.
English: Coadministration of baricitinib with fluconazole (moderate CYP3A/CYP2C19/CYP2C9 inhibitor) or rifampicin (strong CYP3A inducer) resulted in no clinically meaningful changes to baricitinib exposure.
Slovenian: Sočasno dajanje baricitiniba in flukonazola (zmernega zaviralca CYP3A/CYP2C19/CYP2C9) ali rifampicina (močnega induktorja CYP3A) ni povzročilo klinično pomembnih sprememb v izpostavljenosti baricitinibu.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so dokazale vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: 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.
Slovenian: 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.
English: 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 %).
Slovenian: 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 %).
English: • Increased triglycerides ≥ 5.65 mmol/L: 0.4 % vs. 0.5 %, respectively
Slovenian: • zvišani trigliceridi ≥ 5,65 mmol/l: 0,4 % v primerjavi z 0,5 %
English: 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.
Slovenian: 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.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Olumiant Vsebina pakiranja in dodatne informacije
English: 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.
Slovenian: 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.
English: Opportunistic infections related to demodicosis (mange) were observed in dogs at exposures approximately 7 times the human exposure.
Slovenian: Pri psih so pri približno sedemkratniku izpostavljenosti pri človeku opazili oportunistične okužbe, povezane z demodikozo
English: - 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).
Slovenian: magnezijev stearat, manitol, rdeči železov oksid (E172), (sojin) lecitin (E322), makrogol,