FrancophonIA/ELRC3.0 huggingface dataset:
English: • That Olumiant use is associated with hyperlipidaemia; prescribers should monitor the patient's lipid parameters and manage the hyperlipidaemia, if detected.
Slovenian: • da je uporaba zdravila Olumiant povezana s hiperlipidemijo; zdravniki, ki predpisujejo zdravilo morajo spremljati bolnikove parametre lipidov in zdraviti hiperlipidemijo, če jo zaznajo.
English: The JAK/STAT pathway has been shown to be involved in cell adhesion and cell polarity which can affect early embryonic development.
Slovenian: Dokazali so, da pot JAK/STAT sodeluje pri celični adheziji in polarnosti celic, s čimer lahko vpliva na zgodnji razvoj zarodka.
English: Please remove this portion of the patient leaflet and keep it with you.
Slovenian: Odtrgajte ta del navodila za uporabo in ga shranite pri sebi.
English: In patients with rheumatoid arthritis, decreases in serum C-reactive protein (CRP) were observed as early as 1 week after starting treatment with Olumiant and were maintained throughout dosing.
Slovenian: C-reaktivni protein Pri bolnikih z revmatoidnim artritisom so znižanja serumskega C-reaktivnega proteina (CRP) opazili že v 1. tednu po začetku zdravljenja z zdravilom Olumiant in so se ohranila ves čas odmerjanja.
English: The prodrug leflunomide rapidly converts to teriflunomide which is a weak OAT3 inhibitor and therefore may lead to an increase in baricitinib exposure.
Slovenian: Predzdravilo leflunomid se hitro pretvori v teriflunomid, ki je šibak zaviralec OAT3 in lahko zato povzroči povečanje izpostavljenosti baricitinibu.
English: Do not take Olumiant: - if you are allergic to baricitinib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na baricitinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Administration with meals was not associated with a clinically relevant effect on exposure.
Slovenian: Dajanja zdravila ob obrokih niso povezali s klinično pomembnim učinkom na izpostavljenost.
English: If a planned pregnancy is considered, Olumiant treatment should be stopped.
Slovenian: Če razmišljajo o načrtovani nosečnosti, je treba zdravljenje z zdravilom Olumiant prekiniti.
English: b Combined term (eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes).
Slovenian: b Skupni izraz (herpetični ekcem, herpes simpleks, očesni herpes simpleks, ustni herpes).
English: A decision must be made whether to discontinue breast-feeding or to discontinue Olumiant therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Treba se je odločiti, ali naj mati med zdravljenjem preneha dojiti ali prekine zdravljenje z zdravilom Olumiant, pri čemer je treba upoštevati koristi dojenja za otroka in koristi zdravljenja za mater.
English: For most patients, changes in immunoglobulins occurred within the normal reference range.
Slovenian: Pri večini bolnikov je do sprememb imunoglobulinov prišlo v okviru normalnega referenčnega območja.
English: The tablets are rounded and have hollow sides to help you pick them up.
Slovenian: Tablete so zaobljene in imajo vdolbino na obeh straneh, da jih lažje primete.
English: Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy.
Slovenian: Zvišanja ravni LDL-holesterola so se kot odziv na zdravljenje s statini znižala na ravni pred zdravljenjem.
English: Summary of key outcome measures
Slovenian: Povzetek meril ključnih izidov
English: In a clinical pharmacology study, approximately 75 % of the administered dose was eliminated in the urine, while about 20 % of the dose was eliminated in the faeces.
Slovenian: V študiji klinične farmakologije se je približno 75 % danega odmerka izločilo z urinom, približno 20 % oodmerka pa se je izločilo z blatom.
English: In treatment-naïve patients, the combination of Olumiant with potentially hepatotoxic medicinal products, such as methotrexate, resulted in increased frequency of these elevations.
Slovenian: Pri bolnikih, ki predhodno niso bili zdravljeni, je kombinacija zdravila Olumiant s potencialno hepatotoksičnimi zdravili, kot je npr. metotreksat, povzročila povečano pogostnost teh zvišanj.
English: In isolated enzyme assays, baricitinib inhibited the activities of JAK1, JAK2, Tyrosine Kinase 2 and JAK3 with IC50 values of 5.9, 5.7, 53 and > 400 nM, respectively.
Slovenian: V analizah izoliranih encimov je baricitinib inhibiral dejavnost JAK1, JAK2, tirozin kinaze 2 in JAK3 z vrednostmi IC50 5,9; 5,7; 53 in > 400 nM, v tem zaporedju.
English: Improvements were seen as early as Week 1 and, in studies RA-BEGIN and RA-BEAM, this was maintained for up to 52 weeks.
Slovenian: Izboljšanja so opazili že v 1. tednu in so se v študijah RA-BEGIN in RA-BEAM ohranila do 52. tedna.
English: This could be a sign of a herpes zoster infection.
Slovenian: To je lahko znak okužbe z virusom herpes zoster.
English: To help you remember to take Olumiant, you may find it easier to take it at the same time every day.
Slovenian: Da si boste lažje zapomnili, kdaj morate vzeti zdravilo Olumiant, ga poskusite jemati vsak dan ob istem času.
English: • Do not take Olumiant if you are pregnant or suspect you may be pregnant.
Slovenian: • Ne jemljite zdravila Olumiant, če ste noseči, ali če menite, da bi lahko bili noseči.
English: Since dedicated interaction studies have not been conducted, caution should be used when leflunomide or teriflunomide are given concomitantly with baricitinib.
Slovenian: Ker namenske študije medsebojnega delovanja niso bile opravljene, je pri sočasnem dajanju leflunomida ali teriflunomida z baricitinibom potrebna previdnost.
English: VTE reporting rate is increasing.
Slovenian: VTE narašča.
English: • iron oxide red (E172)
Slovenian: • rdeči železov oksid (E172)
English: The clinical data are insufficient to assess the potential incidence of malignancies following exposure to baricitinib.
Slovenian: Kliničnih podatkov za oceno možne incidence malignih bolezni po izpostavljenosti baricitinibu ni dovolj.
English: You may need blood tests before you start Olumiant, or while you are taking it, to check if you have 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, to ensure that treatment with Olumiant is not causing problems.
Slovenian: Morda boste morali pred začetkom jemanja ali med jemanjem zdravila Olumiant opraviti krvne preiskave, s katerimi bodo preverili, ali imate nizko število rdečih krvnih celic (anemija), nizko število belih krvnih celic (nevtropenija ali limfopenija), visoko raven krvnih maščob (holesterol) ali visoke ravni jetrnih encimov, da se bodo prepričali, da vam zdravljenje z zdravilom Olumiant ne bo povzročalo težav.
English: Following oral administration, baricitinib is rapidly absorbed with a median tmax of approximately 1 hour (range 0.5 - 3.0 h) and an absolute bioavailability of approximately 79 % (CV = 3.94 %).
Slovenian: Po peroralnem dajanju se baricitinib hitro absorbira z medianim časom tmax približno 1 ure (razpon 0,5-3,0 ure) in z absolutno biološko razpoložljivostjo približno 79 % (CV = 3,94 %).
English: RA-BUILD cDMARD-IR patients
Slovenian: RA-BUILD Bolniki, zdravljeni s cDMARD-IR
English: Concomitant use of the OAT3 inhibitors ibuprofen and diclofenac may lead to increased exposure of baricitinib, however their inhibition potential of OAT3 is less compared to probenecid and thus a clinically relevant interaction is not expected.
Slovenian: Sočasna uporaba zaviralcev OAT3 ibuprofena in diklofenaka lahko povzroči povečano izpostavljenost baricitinibu, vendar pa je njun potencial za zaviranje OAT3 manjši v primerjavi z probenecidom, zato ni pričakovati klinično pomembnega medsebojnega delovanja.
English: 12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia
Slovenian: 12 tednov po uvedbi zdravljenja in nato v skladu z mednarodnimi kliničnimi smernicami za zdravljenje hiperlipidemije.
English: Absolute Neutrophil Count (ANC)
Slovenian: Absolutno število nevtrofilcev (ANC)
English: If a patient becomes pregnant while taking Olumiant the parents should be informed of the potential risk to the foetus.
Slovenian: Če bolnica zanosi med jemanjem zdravila Olumiant, je treba bodoče starše obvestiti o potencialnih tveganjih za zarodek.
English: Laboratory measures and monitoring guidance
Slovenian: Laboratorijske meritve in smernice za spremljanje
English: Your doctor may check for levels of fat in the blood, such as cholesterol, while you are taking Olumiant.
Slovenian: bo vaš zdravnik morda preverjal ravni maščob v krvi, npr. holesterol.
English: Baricitinib was detected in the milk of lactating rats.
Slovenian: Baricitinib so zaznali v mleku podgan v obdobju laktacije.
English: • Morning Joint Stiffness
Slovenian: • Jutranja okorelost sklepov
English: If clinical features of DVT/PE occur, Olumiant treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Slovenian: Če se pojavijo klinične značilnosti GVT/PE, je treba zdravljenje z zdravilom Olumiant ukiniti, bolnike pa je treba takoj oceniti in uvesti ustrezno zdravljenje.
English: A dose of 2 mg once daily may also be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering (see section 5.1).
Slovenian: O odmerku 2 mg enkrat na dan je mogoče razmisliti tudi pri bolnikih, ki so z odmerkom 4 mg enkrat na dan dosegli trajen nadzor nad aktivnostjo bolezni in so primerni za zmanjševanje odmerka (glejte poglavje 5.1).
English: Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma.
Slovenian: Imunomodulatorji lahko tveganje za maligne bolezni, vključno z limfomom, povečajo.
English: • magnesium stearate
Slovenian: • magnezijev stearat
English: Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
English: Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus RNA, were allowed to participate.
Slovenian: Bolniki, ki so bili pozitivni na protitelesa hepatitisa C in negativni na virusno RNA hepatitisa C, so lahko sodelovali.
English: Treatment with Olumiant 4 mg resulted in a statistically significant inhibition of progression of structural joint damage (Table 5).
Slovenian: Zdravljenje z zdravilom Olumiant 4 mg je povzročilo statistično značilno upočasnitev napredovanja strukturne prizadetosti sklepov (Preglednica 5).
English: Olumiant is contraindicated during pregnancy (see section 4.3).
Slovenian: Uporaba zdravila Olumiant je med nosečnostjo kontraindicirana (glejte poglavje 4.3).
English: Janus kinases (JAKs) are enzymes that transduce intracellular signals from cell surface receptors for a number of cytokines and growth factors involved in haematopoiesis, inflammation and immune function.
Slovenian: Janus kinaze (JAK) so encimi, ki pretvarjajo znotrajcelične signale receptorjev na celični površini za številne citokine in rastne dejavnike, ki sodelujejo pri hematopoezi, vnetju in imunskem delovanju.
English: As of 01 July 2019, 114 VTEs have been reported in 102 cases from post-marketing reports.
Slovenian: obdobju trženja so do 1. julija 2019 poročali o 114 pojavih VTE pri 102 primerih.
English: In a long-term extension study, patients from Studies RA-BEAM, RA-BUILD and RA-BEACON who achieved sustained low disease activity or remission (CDAI ≤ 10) after at least 15 months of treatment with Olumiant 4 mg once daily were re-randomized 1:1 in a double-blind manner to continue 4 mg once daily or reduce dose to 2 mg once daily.
Slovenian: V dolgoročni podaljšani študiji so bili bolniki iz študij RA-BEAM, RA-BUILD in RA-BEACON, ki so dosegli trajno nizko aktivnost bolezni ali remisijo (CDAI ≤ 10) po najmanj 15 mesecih zdravljenja z zdravilom Olumiant 4 mg, danim enkrat na dan, znova randomizirani v razmerju 1 : 1 na dvojno slep način in so nadaljevali z jemanjem odmerka 4 mg enkrat na dan ali pa so jemali zmanjšan odmerek
English: RA-BEGIN (52 weeks)
Slovenian: RA-BEGIN (52 tednov)
English: Treatment group
Slovenian: Skupine zdravljenja
English: If HBV DNA is detected, a liver specialist should be consulted to determine if treatment interruption is warranted.
Slovenian: Če zaznamo DNA HBV, se je treba posvetovati s specialistom za jetrne bolezni, ki bo odločil, ali je prekinitev zdravljenja upravičena.
English: On the basis of the scientific conclusions for baricitinib the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing baricitinib is unchanged subject to the proposed changes to the product information
Slovenian: Na podlagi znanstvenih zaključkov za baricitinib odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) baricitinib, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: 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.
Slovenian: 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.
English: Cytochrome P450 enzymes
Slovenian: Encimi citokroma P450
English: Herpes zoster was reported more commonly in patients ≥ 65 years of age who had previously been treated with both biologic and conventional DMARDs.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Information for Patients about OLUMIANT® (baricitinib)
Slovenian: Informacije za bolnike o zdravilu OLUMIANT® (baricitinib)
English: 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.
Slovenian: 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.
English: Baricitinib is a selective and reversible inhibitor of Janus kinase (JAK)1 and JAK2.
Slovenian: Baricitinib je selektiven in reverzibilen zaviralec Janus kinaz (JAK-Janus Associated Kinases) JAK1 in JAK2.
English: QR code to be included + www.olumiant.eu
Slovenian: Vključena bo koda QR+ www.olumiant.eu
English: RA-BEACON TNF-IR patients
Slovenian: RA-BEACON Bolniki, zdravljeni s TNF-IR
English: Swelling face (n=23) and urticaria (n=20) were also frequently reported.
Slovenian: (n = 23) in urtikariji (n = 20).
English: Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase', which is involved in inflammation.
Slovenian: Zdravilo Olumiant deluje tako, da zmanjšuje dejavnost encima v telesu, imenovanega »Janus kinaza«, ki sodeluje pri vnetju.
English: It is unknown whether baricitinib/metabolites are excreted in human milk.
Slovenian: Ni znano, ali se baricitinib/presnovki izločajo v materino mleko.
English: 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.
Slovenian: 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.
English: RA-BUILD (24 weeks)
Slovenian: RA-BUILD (24 tednov)
English: Available pharmacodynamic/toxicological data in animals have shown excretion of baricitinib in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamski/toksikološki podatki iz študij na živalih kažejo, da se baricitinib izloča v mleku samic (glejte poglavje 5.3).
English: 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.
Slovenian: 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.
English: The presence of at least 6 tender and 6 swollen joints was required at baseline.
Slovenian: V izhodišču je bila za vključitev potrebna prisotnost najmanj 6 bolečih in 6 oteklih sklepov.
English: Within the intracellular signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which activate gene expression within the cell.
Slovenian: 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.
English: 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
Slovenian: 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
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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
English: No relevant differences regarding efficacy and safety were observed in subgroups defined by types of concomitant DMARDs used in combination with baricitinib.
Slovenian: V povezavi z učinkovitostjo in varnostjo v podskupinah, določenih z vrstami sočasnih imunomodulirajočih protirevmatičnih zdravil, uporabljenih v kombinaciji z baricitinibom, niso opazili pomembnih razlik.
English: Olumiant is not recommended for use in patients with creatinine clearance < 30 mL/min (see section 5.2).
Slovenian: Uporaba zdravila Olumiant ni priporočljiva pri bolnikih z očistkom kreatinina < 30 ml/min (glejte poglavje 5.2).
English: 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.
Slovenian: 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.
English: Body weight, sex, race, and ethnicity did not have a clinically relevant effect on the PK of baricitinib.
Slovenian: Telesna masa, spol, rasa in etnično poreklo niso imeli klinično pomembnega učinka na farmakokinetiko baricitiniba.
English: Animal studies indicate that baricitinib may have an adverse effect on bone development in utero at higher dosages.
Slovenian: Študije na živalih kažejo, da ima lahko baricitinib v visokih odmerkih neželen učinek na razvoj kosti in utero.
English: Driving and using machines Olumiant has no effect on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Olumiant nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Absolute Lymphocyte Count (ALC)
Slovenian: Absolutno število limfocitov (ALC)
English: 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).
Slovenian: 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).
English: For Olumiant, the most common serious infections were herpes zoster, and cellulitis.
Slovenian: Pri zdravilu Olumiant sta bili najpogostejši resni okužbi herpes zoster in celulitis.
English: • That the patient may need to have their cholesterol level checked during treatment
Slovenian: • da bo pri bolniku med zdravljenjem morda treba preverjati raven holesterola.
English: 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.
Slovenian: 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.
English: Treatment should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Slovenian: Zdravljenje morajo uvesti zdravniki, ki imajo izkušnje z diagnostiko in zdravljenjem revmatoidnega artritisa.
English: 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.
Slovenian: 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.
English: Significant increases (> 5 x ULN) occurred in 0.8 % of patients treated with Olumiant and 0.3 % of patients treated with placebo.
Slovenian: 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.
English: Use with live, attenuated vaccines during, or immediately prior to, Olumiant therapy is not recommended.
Slovenian: Uporaba živih oslabljenih cepiv med ali neposredno pred zdravljenjem z zdravilom Olumiant ni priporočljiva.
English: Prior to initiating Olumiant, it is recommended that all patients be brought up to date with all immunisations in agreement with current immunisation guidelines.
Slovenian: Priporočljivo je, da pred začetkom zdravljenja z zdravilom Olumiant vsi bolniki opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje.
English: Patients should be managed according to international clinical guidelines for hyperlipidaemia
Slovenian: Bolnike je treba obravnavati v skladu z mednarodnimi kliničnimi smernicami za zdravljenje hiperlipidemije.
English: 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:
Slovenian: 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: