natgillin/translations-raw huggingface dataset:
Olumiant may be used as monotherapy or in combination with methotrexate (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Zdravilo Olumiant se lahko uporablja v monoterapiji ali v kombinaciji z metotreksatom (glejte poglavja 4.4, 4.5 in 5.1 za razpoložljive podatke o različnih kombinacijah).
Taking into account information provided by MAH, at least part of non-specific events were indeed systemic however due the limited information it is not possible to categorise them properly.
Z upoštevanjem informacij, ki jih je predložil imetnik dovoljenja za promet z zdravilom, je bil vsaj določen delež nespecifičnih učinkov dejansko sistemskih, vendar jih zaradi omejenih informacij ni mogoče pravilo razvrstiti.
The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.
Vpliva zvišanj teh parametrov lipidov na srčnožilno obolevnost in smrtnost niso določili.
You should not use Olumiant while breast-feeding as it is not known if this medicine passes into milk.
Zdravila Olumiant ne smete uporabljati, ko dojite, saj ni znano, ali to zdravilo prehaja v materino mleko.
Consequently, estimates of the glomerular filtration rate based on serum creatinine may be slightly reduced, without actual loss of renal function or the occurrence of renal adverse events.
Posledično so lahko ocene stopnje glomerulne filtracije, ki temeljijo na serumskem kreatininu, nekoliko nižje, brez dejanskega zmanjšanja delovanja ledvic ali pojava neželenih učinkov na ledvice.
The main objectives of the programme are to make the prescribers aware of the risks associated with the product's use, and to highlight specific risk minimisation measures to be performed before and during the treatment with Olumiant.
Glavni cilji programa so opozoriti zdravnike, ki predpisujejo zdravilo na tveganja, povezana z uporabo zdravila, ter poudariti posebne ukrepe za zmanjševanje tveganj, ki jih je treba izvesti pred zdravljenjem z zdravilom Olumiant in med njim.
• lecithin (soya) (E322)
• (sojin) lecitin (E322)
Patients who discontinued or received rescue therapy were considered as non-responders thereafter.
Bolniki, pri katerih je bilo zdravljenje prekinjeno ali ki so prejeli rešilno zdravljenje, so bili v nadaljevanju upoštevani kot neodzivni na zdravljenje.
Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Neželeni učinki Ocena pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100).
Since there were no effects on spermatogenesis (as assessed by histopathology) or semen/sperm endpoints in male rats, the decreased overall mating performance was likely the result of these female effects.
Ker učinkov na spermatogenezo (kot so ocenili s histopatološkimi postopki) ali opazovanih dogodkov v zvezi s semenčicami/spermo podganjih samcev ni bilo, je bila nižja skupna uspešnost parjenja najverjetneje posledica teh učinkov na samice.
BEACON (24 weeks)
BEACON (24 tednov)
Rare cases of lymphoproliferative disorders have been reported.
Poročali so o redkih primerih limfoproliferativnih bolezni.
• Low disease activity and Remission (SDAI)
• Nizka aktivnost bolezni in remisija (SDAI)
Patients with hepatitis B surface antibody and hepatitis B core antibody, without hepatitis B surface antigen, were also allowed to participate; such patients should be monitored for expression of hepatitis B virus (HBV) DNA.
Bolniki s površinskim protitelesom hepatitisa B in z jedrnim protitelesom hepatitisa B ter brez površinskega antigena hepatitisa B so prav tako lahko sodelovali; take bolnike je treba spremljati glede izražanja DNA virusa hepatitisa B (HBV).
From the 316 events included for review from post-marketing reports, rash (n=95) was the most frequently reported event.
Med 316 učinki, vključenimi v pregled poročil iz obdobja trženja, so najpogosteje poročali o izpuščaju (n = 95).
Baricitinib may be a clinically relevant inhibitor of OCT1, however there are currently no known selective OCT1 substrates for which clinically significant interactions might be predicted.
Baricitinib je morda klinično pomemben zaviralec OCT1, vendar pa trenutno ni znanih selektivnih substratov OCT1, za katere bi lahko predvideli klinično pomembna medsebojna delovanja.
• Radiographic progression (mTSS)
• Radiografsko napredovanje bolezni (mTSS)
- Do not take a double dose to make up for a forgotten tablet.
- Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
• titanium dioxide (E171)
• titanov dioksid (E171)
Analyses of erosion and joint space narrowing scores were consistent with the overall scores.
Analize erozij in ocen zožitve sklepne špranje so bile skladne s skupnimi ocenami.
• That Olumiant increases the potential risk of infections.
• da zdravilo Olumiant povečuje možno tveganje za okužbe.
No metabolites were quantifiable in plasma.
V plazmi ni bilo mogoče količinsko določiti nobenega presnovka.
Olumiant 2 mg film-coated tablets EU/1/16/1170/001
Olumiant 2 mg filmsko obložene tablete EU/1/16/1170/001
Abbreviations: QD = Once daily; Q2W = Once every 2 weeks; SC = Subcutaneously; ACR = American College of Rheumatology; SDAI = Simplified Disease Activity Index; HAQ-DI = Health Assessment Questionnaire-Disability Index; mTSS = modified Total Sharp Score
Razlaga kratic: QD = enkrat na dan; Q2W = enkrat vsaka 2 tedna; s.c. = subkutano; ACR = Ameriško združenje za revmatologijo (American College of Rheumatology); SDAI = Poenostavljen indeks aktivnosti bolezni (Simplified Disease Activity Index); HAQ-DI = Vprašalnik za oceno zdravstvenega stanja - indeks nezmožnosti (Health Assessment Questionnaire-Disability Index); mTSS = modificirana celotna Sharpova ocena (modified Total Sharp Score)
Vaccine study
Študija cepiva
In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
V primeru prevelikega odmerka je priporočljivo spremljati bolnika za pojav znakov in simptomov neželenih učinkov.
In particular, tell your doctor or pharmacist before taking Olumiant if you are taking: - probenecid (for gout), since this medicine may increase the levels of Olumiant in your blood.
Še zlasti morate zdravnika ali farmacevta pred jemanjem zdravila Olumiant obvestiti, če jemljete: - probenecid (za zdravljenje protina), saj lahko to zdravilo poveča ravni zdravila Olumiant v vaši krvi.
< 1 x 109 cells/L.
< 1 x 109 celic/l.
The safety, efficacy and pharmacokinetics of baricitinib have not yet been established in a paediatric population (see section 4.2).
Varnosti, učinkovitosti in farmakokinetike baricitiniba v pediatrični populaciji še niso dokazali (glejte poglavje 4.2).
• A cough that won't go away, night sweats, and weight loss.
• kašelj, ki ne mine, nočno potenje in izguba telesne mase.
The European Medicines Agency has deferred the obligation to submit the results of studies with Olumiant in one or more subsets of the paediatric population in chronic idiopathic arthritis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Olumiant za eno ali več podskupin pediatrične populacije, za zdravljenje kroničnega idiopatskega artritisa (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The efficacy and safety of Olumiant once daily was assessed in 4 Phase III randomised, double-blind, multicentre studies in patients with moderate to severe active rheumatoid arthritis diagnosed according to the ACR/EULAR 2010 criteria (see Table 3).
Učinkovitost in varnost zdravila Olumiant enkrat na dan so ocenjevali v štirih randomiziranih, dvojno slepih, multicentričnih študijah III. faze pri bolnikih z zmernim do hudim aktivnim revmatoidnim artritisom, diagnosticiranim v skladu z merili ACR/EULAR 2010 (glejte Preglednico 3).
The majority of patients who lost their low disease activity or remission status after dose reduction could regain disease control after the dose was returned to 4 mg.
Večina bolnikov, ki je po zmanjšanju odmerka izgubila status nizke aktivnosti bolezni ali remisije, je znova dosegla nadzor nas boleznijo, ko so njihov odmerek spet dvignili na 4 mg.
Other medicines and Olumiant
Druga zdravila in zdravilo Olumiant
Lipid parameters
Parametri lipidov
There are no adequate data from the use of baricitinib in pregnant women.
V zvezi z uporabo baricitiniba pri nosečnicah ni zadostnih podatkov.
Patients who develop adverse reactions should receive appropriate treatment.
Bolniki, pri katerih se razvijejo neželene učnike, morajo prejeti ustrezno zdravljenje.
• That the Patient Alert Card should be carried by the patient at any time and to share it with other healthcare professionals involved in their treatment.
• da mora bolnik imeti opozorilno kartico za bolnika vedno pri sebi in jo pokazati vsem zdravstvenim delavcem, ki so vključeni v njegovo zdravljenje.
• That Olumiant should not be taken while pregnant and that women should inform their doctor should they become (or wish to become) pregnant
• da se zdravila Olumiant med nosečnostjo ne sme jemati in da morajo ženske obvestiti zdravnika, če zanosijo (ali če želijo zanositi).
However, in clinical studies, treatment was interrupted in response to ANC
Vendar pa so v kliničnih študijah zdravljenje prekinili, če je bila vrednost ANC
What Olumiant is and what it is used for What you need to know before you take Olumiant How to take Olumiant
Kaj je zdravilo Olumiant in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Olumiant Kako jemati zdravilo Olumiant
14 film-coated tablets 28 film-coated tablets 35 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 28 x 1 film-coated tablets 84 x 1 film-coated tablets
14 filmsko obloženih tablet 28 filmsko obloženih tablet 35 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet 98 filmsko obloženih tablet 28 x 1 filmsko obložena tableta 84 x 1 filmsko obložena tableta
The majority of patients maintained low disease activity or remission based on CDAI score:
Pri večini bolnikov se je na podlagi ocene CDAI ohranila nizka aktivnost bolezni ali remisija:
By reducing the activity of this enzyme, Olumiant helps to reduce pain, stiffness and swelling in your joints, tiredness, and helps to slow damage to the bone and cartilage in the joints.
Z zmanjšanjem delovanja tega encima zdravilo Olumiant pomaga zmanjšati bolečino, okorelost in otekanje vaših sklepov ter utrujenost in pomaga upočasniti pojav poškodb na kosteh in hrustancu v sklepih.
Monitoring Guidance
Smernice za spremljanje
For the total population, pneumococcal vaccination resulted in a satisfactory IgG immune response in 68.0 % (95 % CI: 58.4 %, 76.2 %) of the patients.
V celotni populaciji je cepivo proti pnevmokoku povzročilo zadovoljiv imunski odgovor IgG pri 68,0 % (95-odstotni IZ: 58,4 %, 76,2 %) bolnikov.
Infections: Olumiant may make an existing infection worse or increase the chance of you getting a new infection or increase the chance of viral reactivation.
Okužbe: Zdravilo Olumiant lahko poslabša obstoječo okužbo ali poveča možnost, da dobite novo okužbo oziroma poveča možnost za reaktivacijo virusa.
Potential for baricitinib to affect the pharmacokinetics of other medicinal products
Potencialni vpliv baricitiniba na farmakokinetiko drugih zdravil
A risk to newborns/infants cannot be excluded and Olumiant should not be used during breast-feeding.
Tveganja za novorojenčka/dojenčka ne moremo izključiti, zato se zdravila Olumiant v obdobju dojenja ne sme uporabljati.
The recommended dose is 4 mg once a day.
Priporočeni odmerek je 4 mg enkrat na dan.
Infections reported with Olumiant treatment included Herpes zoster.
Okužbe, o katerih so poročali pri zdravljenju z zdravilom Olumiant, so vključevale herpes zoster.
You and your doctor should decide if you will breast-feed or use Olumiant.
Skupaj z zdravnikom se boste odločili, ali boste dojili ali pa jemali zdravilo Olumiant.
• That Olumiant use is associated with hyperlipidaemia; prescribers should monitor the patient's lipid parameters and manage the hyperlipidaemia, if detected.
• da je uporaba zdravila Olumiant povezana s hiperlipidemijo; zdravniki, ki predpisujejo zdravilo morajo spremljati bolnikove parametre lipidov in zdraviti hiperlipidemijo, če jo zaznajo.
The JAK/STAT pathway has been shown to be involved in cell adhesion and cell polarity which can affect early embryonic development.
Dokazali so, da pot JAK/STAT sodeluje pri celični adheziji in polarnosti celic, s čimer lahko vpliva na zgodnji razvoj zarodka.
Please remove this portion of the patient leaflet and keep it with you.
Odtrgajte ta del navodila za uporabo in ga shranite pri sebi.
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.
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.
The prodrug leflunomide rapidly converts to teriflunomide which is a weak OAT3 inhibitor and therefore may lead to an increase in baricitinib exposure.
Predzdravilo leflunomid se hitro pretvori v teriflunomid, ki je šibak zaviralec OAT3 in lahko zato povzroči povečanje izpostavljenosti baricitinibu.
Do not take Olumiant: - if you are allergic to baricitinib or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na baricitinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Administration with meals was not associated with a clinically relevant effect on exposure.
Dajanja zdravila ob obrokih niso povezali s klinično pomembnim učinkom na izpostavljenost.
If a planned pregnancy is considered, Olumiant treatment should be stopped.
Če razmišljajo o načrtovani nosečnosti, je treba zdravljenje z zdravilom Olumiant prekiniti.
b Combined term (eczema herpeticum, herpes simplex, ophthalmic herpes simplex, oral herpes).
b Skupni izraz (herpetični ekcem, herpes simpleks, očesni herpes simpleks, ustni herpes).
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.
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.
For most patients, changes in immunoglobulins occurred within the normal reference range.
Pri večini bolnikov je do sprememb imunoglobulinov prišlo v okviru normalnega referenčnega območja.
The tablets are rounded and have hollow sides to help you pick them up.
Tablete so zaobljene in imajo vdolbino na obeh straneh, da jih lažje primete.
Elevations in LDL cholesterol decreased to pre-treatment levels in response to statin therapy.
Zvišanja ravni LDL-holesterola so se kot odziv na zdravljenje s statini znižala na ravni pred zdravljenjem.
Summary of key outcome measures
Povzetek meril ključnih izidov
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.
V študiji klinične farmakologije se je približno 75 % danega odmerka izločilo z urinom, približno 20 % oodmerka pa se je izločilo z blatom.
In treatment-naïve patients, the combination of Olumiant with potentially hepatotoxic medicinal products, such as methotrexate, resulted in increased frequency of these elevations.
Pri bolnikih, ki predhodno niso bili zdravljeni, je kombinacija zdravila Olumiant s potencialno hepatotoksičnimi zdravili, kot je npr. metotreksat, povzročila povečano pogostnost teh zvišanj.
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.
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.
Improvements were seen as early as Week 1 and, in studies RA-BEGIN and RA-BEAM, this was maintained for up to 52 weeks.
Izboljšanja so opazili že v 1. tednu in so se v študijah RA-BEGIN in RA-BEAM ohranila do 52. tedna.
This could be a sign of a herpes zoster infection.
To je lahko znak okužbe z virusom herpes zoster.
To help you remember to take Olumiant, you may find it easier to take it at the same time every day.
Da si boste lažje zapomnili, kdaj morate vzeti zdravilo Olumiant, ga poskusite jemati vsak dan ob istem času.
• Do not take Olumiant if you are pregnant or suspect you may be pregnant.
• Ne jemljite zdravila Olumiant, če ste noseči, ali če menite, da bi lahko bili noseči.
Since dedicated interaction studies have not been conducted, caution should be used when leflunomide or teriflunomide are given concomitantly with baricitinib.
Ker namenske študije medsebojnega delovanja niso bile opravljene, je pri sočasnem dajanju leflunomida ali teriflunomida z baricitinibom potrebna previdnost.
VTE reporting rate is increasing.
VTE narašča.
• iron oxide red (E172)
• rdeči železov oksid (E172)
The clinical data are insufficient to assess the potential incidence of malignancies following exposure to baricitinib.
Kliničnih podatkov za oceno možne incidence malignih bolezni po izpostavljenosti baricitinibu ni dovolj.
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.
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.
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 %).
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 %).
RA-BUILD cDMARD-IR patients
RA-BUILD Bolniki, zdravljeni s cDMARD-IR
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.
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.
12 weeks after initiation of treatment and thereafter according to international clinical guidelines for hyperlipidaemia
12 tednov po uvedbi zdravljenja in nato v skladu z mednarodnimi kliničnimi smernicami za zdravljenje hiperlipidemije.
Absolute Neutrophil Count (ANC)
Absolutno število nevtrofilcev (ANC)
If a patient becomes pregnant while taking Olumiant the parents should be informed of the potential risk to the foetus.
Če bolnica zanosi med jemanjem zdravila Olumiant, je treba bodoče starše obvestiti o potencialnih tveganjih za zarodek.
Laboratory measures and monitoring guidance
Laboratorijske meritve in smernice za spremljanje
Your doctor may check for levels of fat in the blood, such as cholesterol, while you are taking Olumiant.
bo vaš zdravnik morda preverjal ravni maščob v krvi, npr. holesterol.
Baricitinib was detected in the milk of lactating rats.
Baricitinib so zaznali v mleku podgan v obdobju laktacije.
• Morning Joint Stiffness
• Jutranja okorelost sklepov
If clinical features of DVT/PE occur, Olumiant treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Če se pojavijo klinične značilnosti GVT/PE, je treba zdravljenje z zdravilom Olumiant ukiniti, bolnike pa je treba takoj oceniti in uvesti ustrezno zdravljenje.
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).
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).
Immunomodulatory medicinal products may increase the risk of malignancies including lymphoma.
Imunomodulatorji lahko tveganje za maligne bolezni, vključno z limfomom, povečajo.
Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
Patients, who were positive for hepatitis C antibody but negative for hepatitis C virus RNA, were allowed to participate.
Bolniki, ki so bili pozitivni na protitelesa hepatitisa C in negativni na virusno RNA hepatitisa C, so lahko sodelovali.
Treatment with Olumiant 4 mg resulted in a statistically significant inhibition of progression of structural joint damage (Table 5).
Zdravljenje z zdravilom Olumiant 4 mg je povzročilo statistično značilno upočasnitev napredovanja strukturne prizadetosti sklepov (Preglednica 5).
Olumiant is contraindicated during pregnancy (see section 4.3).
Uporaba zdravila Olumiant je med nosečnostjo kontraindicirana (glejte poglavje 4.3).
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.
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.
As of 01 July 2019, 114 VTEs have been reported in 102 cases from post-marketing reports.
obdobju trženja so do 1. julija 2019 poročali o 114 pojavih VTE pri 102 primerih.
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.
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
RA-BEGIN (52 weeks)
RA-BEGIN (52 tednov)
Treatment group
Skupine zdravljenja
If HBV DNA is detected, a liver specialist should be consulted to determine if treatment interruption is warranted.
Če zaznamo DNA HBV, se je treba posvetovati s specialistom za jetrne bolezni, ki bo odločil, ali je prekinitev zdravljenja upravičena.
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
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.