FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall ensure that, in each Member State where Olumiant is marketed, all healthcare professionals who are expected to prescribe Olumiant are provided with the physician educational material, which should contain:
Slovenian: MAH mora zagotoviti, da v vsaki državi članici, v kateri se zdravilo Olumiant trži, vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali zdravilo Olumiant, prejmejo izobraževalno gradivo za zdravnike, ki mora vsebovati:
English: Remission and low disease activity
Slovenian: Remisija in nizka aktivnost bolezni
English: Including data from a long-term extension study, remission and low disease activity rates were maintained for at least 2 years.
Slovenian: Vključujoč podatke iz dolgoročne podaljšane študije sta se remisija in nizka aktivnost bolezni ohranili najmanj 2 leti.
English: The rate of serious infections remained stable during long term exposure.
Slovenian: Delež resnih okužb je med dolgoročno izpostavljenostjo ostal stabilen.
English: Age ≥ 65 years or ≥ 75 years has no effect on baricitinib exposure (Cmax and AUC).
Slovenian: Starost ≥ 65 let ali ≥ 75 let nima učinka na izpostavljenost baricitinibu (Cmax in AUC).
English: Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90 % of the administered dose is expected to be eliminated within 24 hours.
Slovenian: Farmakokinetični podatki o enkratnem odmerku 40 mg pri zdravih prostovoljcih kažejo, da lahko pričakujemo, da se bo več kot 90 % danega odmerka izločilo v 24 urah.
English: Treatment may be initiated once values have improved above these limits (see section 4.4).
Slovenian: Zdravljenje se lahko uvede, ko se vrednosti dvignejo nad te meje (glejte poglavje 4.4).
English: If any serious allergic or anaphylactic reaction occurs, baricitinib should be discontinued immediately.
Slovenian: Če se pojavi kakršna koli resna alergijska ali anafilaktična reakcija, je treba baricitinib nemudoma ukiniti.
English: • Physical function (HAQ-DI)
Slovenian: • Telesna zmogljivost (HAQ-DI)
English: • Signs or symptoms of infections including general symptoms, and specifically tuberculosis and herpes zoster signs and symptoms; and a warning for the patients to seek immediate medical attention if signs or symptoms suggesting infection appear
Slovenian: • znake ali simptome okužb, vključno s splošnimi simptomi in še posebej znake in simptome tuberkuloze in herpesa zostra; ter opozorilo za bolnike, naj takoj poiščejo zdravniško pomoč, če se pojavijo znaki ali simptomi, ki kažejo na okužbo.
English: - If you forget your dose for an entire day, just skip the missed dose and take only a single dose as usual the following day.
Slovenian: - Če ste pozabili vzeti svoj odmerek za ves dan, enostavno preskočite zamujeni odmerek in kot običajno vzemite le enkratni odmerek naslednjega dne.
English: The rate of serious infections with Olumiant (1.1 %) was similar to placebo (1.2 %).
Slovenian: Delež resnih okužb pri zdravilu Olumiant (1,1 %) je bil podoben kot pri placebu (1,2 %).
English: • Fever, wounds, feeling more tired than usual, or dental problems.
Slovenian: • vročina, rane, občutek večje utrujenosti kot običajno ali težave z zobmi.
English: • The guide for healthcare professionals to support counselling of the patient
Slovenian: • vodič za zdravstvene delavce za podporo pri svetovanju bolniku
English: Continued, durable response rates were observed, with ACR20/50/70 responses maintained for at least 2 years including the long-term extension study.
Slovenian: Opazili so nadaljnje trajne stopnje odziva, pri čemer so se odzivi ACR20/50/70 ohranili najmanj 2 leti, vključno z dolgoročno podaljšano študijo.
English: Adverse events were comparable to those seen at lower doses and no specific toxicities were identified.
Slovenian: Neželeni učinki so bili primerljivi s tistimi, ki so jih opazili pri nižjih odmerkih in prepoznali niso nobene specifične toksičnosti.
English: Food intake led to a decreased exposure by up to 14 %, a decrease in Cmax by up to 18 % and delayed tmax by 0.5 hours.
Slovenian: Vnos hrane je povzročil zmanjšano izpostavljenost za do 14 %, zmanjšanje vrednosti Cmax za do 18 % in zakasnjen tmax za 0,5 ur.
English: Therefore, no dose adjustment is needed based on these patient factors.
Slovenian: Zato na podlagi teh bolnikovih dejavnikov prilagajanje odmerka ni potrebno.
English: • macrogol
Slovenian: • makrogol
English: • That Olumiant is contraindicated in pregnancy as pre-clinical data showed reduced foetal growth and malformations.
Slovenian: • da je zdravilo Olumiant v nosečnosti kontraindicirano, saj so predklinični podatki pokazali zmanjšano rast plodu in deformacije.
English: Most cases of hepatic transaminase elevations were asymptomatic and transient.
Slovenian: Večina zvišanj jetrnih transaminaz je bila asimptomatskih in prehodnih.
English: Of these, 2166 rheumatoid arthritis patients were exposed to Olumiant for at least one year.
Slovenian: Od teh je bilo 2.166 bolnikov z revmatoidnim artritisom izpostavljenih zdravilu Olumiant vsaj eno leto.
English: Before treatment initiation and thereafter according to routine patient management
Slovenian: Pred začetkom zdravljenja in nato v skladu z redno obravnavo bolnika
English: Note: Proportions of responders at each time point based on those initially randomised to treatment (N).
Slovenian: Opomba: Delež na zdravljenje odzivnih bolnikov v vsaki časovni točki na podlagi bolnikov, ki so bili v izhodišču randomizirani za zdravljenje (N).
English: You may get some of the side effects described in section 4.
Slovenian: Morda se bodo pri vas pojavili nekateri neželeni učinki, opisani v poglavju 4.
English: If you forget to take Olumiant - If you miss a dose, take it as soon as you remember.
Slovenian: Če ste pozabili vzeti zdravilo Olumiant - Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
English: There was no clear relationship between decreases in neutrophil counts and the occurrence of serious infections.
Slovenian: Niso ugotovili jasne povezave med znižanji števila nevtrofilcev in pojavom resnih okužb.
English: Moreover, recurrent DVT and subsequent PE observed September 2018 in patient who continued treatment with baricitinib after the first DVT also confirm possible relationship between use of baricitinib and occurrence of VTE.
Slovenian: Poleg tega septembra 2018 opažena ponovitev GVT in posledično PE pri bolniku, ki je nadaljeval zdravljenje z baricitinibom po prvem pojavu GVT, potrjuje morebitno povezavo med uporabo baricitiniba in pojavom VTE.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Clinical experience in patients ≥ 75 years is very limited and in these patients a starting dose of 2 mg is appropriate.
Slovenian: Klinične izkušnje pri bolnikih, starih ≥ 75 let, so zelo omejene; pri teh bolnikih je primeren začetni odmerek 2 mg.
English: Olumiant should not be given to patients with active TB.
Slovenian: Zdravila Olumiant se ne sme dajati bolnikom z aktivno TB.
English: Olumiant treatment should not be resumed until the infection resolves.
Slovenian: Zdravljenja z zdravilom Olumiant se ne sme nadaljevati, dokler okužba ni odpravljena.
English: Baricitinib modulates these signalling pathways by partially inhibiting JAK1 and JAK2 enzymatic activity, thereby reducing the phosphorylation and activation of STATs.
Slovenian: Baricitinib modulira te signalne poti tako, da delno inhibira encimsko dejavnost JAK1 in JAK2 ter na ta način zmanjša fosforilacijo in aktivacijo STAT.
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA37
Slovenian: Farmakoterapevtska skupina: zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA37
English: Patients with evidence of active hepatitis B or C infection were excluded from clinical trials.
Slovenian: Bolniki z dokazi o aktivni okužbi s hepatitisom B ali C so bili izključeni iz kliničnih preskušanj.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatli poleg oznake „EXP“.
English: Mean volume of distribution following intravenous infusion administration was 76 L, indicating distribution of baricitinib into tissues.
Slovenian: Povprečni volumen porazdelitve po dajanju z intravensko infuzijo je znašal 76 l, kar kaže na porazdelitev baricitiniba v tkiva.
English: Baricitinib is approximately 50 % bound to plasma proteins.
Slovenian: Baricitinib se v približno 50 % veže na beljakovine v plazmi.
English: Patients should be instructed to seek immediate medical attention, if signs or symptoms suggesting infection appear.
Slovenian: Bolnikom je treba svetovati, naj takoj poiščejo zdravniško pomoč, če se pojavijo znaki ali simptomi, ki kažejo na okužbo.
English: • A painful skin rash with blisters.
Slovenian: • boleč kožni izpuščaj z mehurji.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: In clinical trials, there were no confirmed cases of rhabdomyolysis.
Slovenian: V kliničnih preskušanjih niso odkrili potrjenih primerov rabdomiolize.
English: Baricitinib was teratogenic in rats and rabbits.
Slovenian: Baricitinib je deloval teratogeno pri podganah in kuncih.
English: Inform your doctor immediately if you get symptoms of infection, such as:
Slovenian: obvestite svojega zdravnika, če se pri vas pojavijo simptomi okužbe, kot so npr.:
English: Prior to launch of Olumiant in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Olumiant na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom (MAH) dogovoriti s pristojnim nacionalnim organom o vsebini in obliki izobraževalnega programa, vključno s sredstvi obveščanja, načini distribucije in vsemi drugimi vidiki programa.
English: In 43.1 % (95 % CI: 34.0 %, 52.8 %) of the patients, a satisfactory IgG immune response to tetanus vaccination was achieved.
Slovenian: Pri 43,1 % (95-odstotni IZ: 34,0 %, 52,8 %) bolnikov je bil dosežen zadovoljiv imunski odgovor IgG na cepivo proti tetanusu.
English: • That Olumiant use should be stopped in case of herpes zoster or any other infection that doesn't respond to standard treatment until the event resolves.
Slovenian: • da je treba prekiniti uporabo zdravila Olumiant v primeru herpesa zostra ali katere koli druge okužbe, ki se ne odziva na standardno zdravljenje, dokler dogodek ne mine.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.
Slovenian: Vpliva zvišanj teh parametrov lipidov na srčnožilno obolevnost in smrtnost niso določili.
English: You should not use Olumiant while breast-feeding as it is not known if this medicine passes into milk.
Slovenian: Zdravila Olumiant ne smete uporabljati, ko dojite, saj ni znano, ali to zdravilo prehaja v materino mleko.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • lecithin (soya) (E322)
Slovenian: • (sojin) lecitin (E322)
English: Patients who discontinued or received rescue therapy were considered as non-responders thereafter.
Slovenian: Bolniki, pri katerih je bilo zdravljenje prekinjeno ali ki so prejeli rešilno zdravljenje, so bili v nadaljevanju upoštevani kot neodzivni na zdravljenje.
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Slovenian: Neželeni učinki Ocena pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100).
English: 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.
Slovenian: 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.
English: BEACON (24 weeks)
Slovenian: BEACON (24 tednov)
English: Rare cases of lymphoproliferative disorders have been reported.
Slovenian: Poročali so o redkih primerih limfoproliferativnih bolezni.
English: • Low disease activity and Remission (SDAI)
Slovenian: • Nizka aktivnost bolezni in remisija (SDAI)
English: 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.
Slovenian: 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).
English: From the 316 events included for review from post-marketing reports, rash (n=95) was the most frequently reported event.
Slovenian: Med 316 učinki, vključenimi v pregled poročil iz obdobja trženja, so najpogosteje poročali o izpuščaju (n = 95).
English: 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.
Slovenian: Baricitinib je morda klinično pomemben zaviralec OCT1, vendar pa trenutno ni znanih selektivnih substratov OCT1, za katere bi lahko predvideli klinično pomembna medsebojna delovanja.
English: • Radiographic progression (mTSS)
Slovenian: • Radiografsko napredovanje bolezni (mTSS)
English: - Do not take a double dose to make up for a forgotten tablet.
Slovenian: - Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
English: • titanium dioxide (E171)
Slovenian: • titanov dioksid (E171)
English: Analyses of erosion and joint space narrowing scores were consistent with the overall scores.
Slovenian: Analize erozij in ocen zožitve sklepne špranje so bile skladne s skupnimi ocenami.
English: • That Olumiant increases the potential risk of infections.
Slovenian: • da zdravilo Olumiant povečuje možno tveganje za okužbe.
English: No metabolites were quantifiable in plasma.
Slovenian: V plazmi ni bilo mogoče količinsko določiti nobenega presnovka.
English: Olumiant 2 mg film-coated tablets EU/1/16/1170/001
Slovenian: Olumiant 2 mg filmsko obložene tablete EU/1/16/1170/001
English: 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
Slovenian: 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)
English: Vaccine study
Slovenian: Študija cepiva
English: In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
Slovenian: V primeru prevelikega odmerka je priporočljivo spremljati bolnika za pojav znakov in simptomov neželenih učinkov.
English: 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.
Slovenian: 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.
English: < 1 x 109 cells/L.
Slovenian: < 1 x 109 celic/l.
English: Haemoglobin (Hb)
Slovenian: Hemoglobin (Hb)
English: The safety, efficacy and pharmacokinetics of baricitinib have not yet been established in a paediatric population (see section 4.2).
Slovenian: Varnosti, učinkovitosti in farmakokinetike baricitiniba v pediatrični populaciji še niso dokazali (glejte poglavje 4.2).
English: • A cough that won't go away, night sweats, and weight loss.
Slovenian: • kašelj, ki ne mine, nočno potenje in izguba telesne mase.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: Other medicines and Olumiant
Slovenian: Druga zdravila in zdravilo Olumiant
English: Lipid parameters
Slovenian: Parametri lipidov
English: There are no adequate data from the use of baricitinib in pregnant women.
Slovenian: V zvezi z uporabo baricitiniba pri nosečnicah ni zadostnih podatkov.
English: Patients who develop adverse reactions should receive appropriate treatment.
Slovenian: Bolniki, pri katerih se razvijejo neželene učnike, morajo prejeti ustrezno zdravljenje.
English: • 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.
Slovenian: • da mora bolnik imeti opozorilno kartico za bolnika vedno pri sebi in jo pokazati vsem zdravstvenim delavcem, ki so vključeni v njegovo zdravljenje.
English: • That Olumiant should not be taken while pregnant and that women should inform their doctor should they become (or wish to become) pregnant
Slovenian: • da se zdravila Olumiant med nosečnostjo ne sme jemati in da morajo ženske obvestiti zdravnika, če zanosijo (ali če želijo zanositi).
English: However, in clinical studies, treatment was interrupted in response to ANC
Slovenian: Vendar pa so v kliničnih študijah zdravljenje prekinili, če je bila vrednost ANC
English: What Olumiant is and what it is used for What you need to know before you take Olumiant How to take Olumiant
Slovenian: Kaj je zdravilo Olumiant in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Olumiant Kako jemati zdravilo Olumiant
English: 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
Slovenian: 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
English: The majority of patients maintained low disease activity or remission based on CDAI score:
Slovenian: Pri večini bolnikov se je na podlagi ocene CDAI ohranila nizka aktivnost bolezni ali remisija:
English: 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.
Slovenian: 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.
English: Monitoring Guidance
Slovenian: Smernice za spremljanje
English: 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.
Slovenian: V celotni populaciji je cepivo proti pnevmokoku povzročilo zadovoljiv imunski odgovor IgG pri 68,0 % (95-odstotni IZ: 58,4 %, 76,2 %) bolnikov.
English: 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.
Slovenian: Okužbe: Zdravilo Olumiant lahko poslabša obstoječo okužbo ali poveča možnost, da dobite novo okužbo oziroma poveča možnost za reaktivacijo virusa.
English: Potential for baricitinib to affect the pharmacokinetics of other medicinal products
Slovenian: Potencialni vpliv baricitiniba na farmakokinetiko drugih zdravil
English: A risk to newborns/infants cannot be excluded and Olumiant should not be used during breast-feeding.
Slovenian: Tveganja za novorojenčka/dojenčka ne moremo izključiti, zato se zdravila Olumiant v obdobju dojenja ne sme uporabljati.
English: The recommended dose is 4 mg once a day.
Slovenian: Priporočeni odmerek je 4 mg enkrat na dan.
English: Infections reported with Olumiant treatment included Herpes zoster.
Slovenian: Okužbe, o katerih so poročali pri zdravljenju z zdravilom Olumiant, so vključevale herpes zoster.
English: You and your doctor should decide if you will breast-feed or use Olumiant.
Slovenian: Skupaj z zdravnikom se boste odločili, ali boste dojili ali pa jemali zdravilo Olumiant.