FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 17.5 mg of dinutuximab in 5 mL.
Croatian: Svaka bočica sadrži 17,5 mg dinutuksimaba u 5 mL koncentrata.
English: Common side effects (may affect up to 1 in 10 people): - weight loss, weight gain - chills - headache - feeling tired, irritable - constipation, blood in stools - damage to the nerves around the body which may affect movement - blurred vision, being sensitive to light, the pupils of your eyes staying large (‘dilated') - not being able to urinate, blood or protein in your urine
Croatian: - oštećenje živaca po tijelu koji mogu utjecati na kretanje - zamućen vid, osjetljivost na svjetlo, proširenje zjenica - nemogućnost mokrenja, krv ili proteini u Vašoj mokraći
English: • If symptoms recur, discontinue dinutuximab, GM-CSF, and IL-2 for remaining courses.
Croatian: • Ako se simptomi ponovno pojave, prekinuti primjenu dinutuksimaba, GM-CSF-a i IL-2 za preostale cikluse.
English: Pain Grade 4
Croatian: Bol 4. stupnja
English: 1 mL of concentrate contains 3.5 mg of dinutuximab.
Croatian: 1 mL koncentrata sadrži 3,5 mg dinutuksimaba.
English: Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).
Croatian: godina, koji su prethodno primali indukcijsku kemoterapiju i postigli barem djelomični odgovor, nakon čega je slijedila mijeloablacijska terapija i transplantacija autolognih matičnih stanica (ASCT, engl.
English: Each mL of concentrate contains 3.5 mg of dinutuximab.
Croatian: Svaki mL koncentrata sadrži 3,5 mg dinutuksimaba.
English: sodium, calcium, phosphates, or high level of glucose.
Croatian: - odstupanja u krvnim nalazima poput niske razine magnezija, glukoze, visoke razine kiselina ili kreatinina.
English: Intravenous use after dilution
Croatian: Primjena u venu nakon razrjeđivanja NAČIN PRIMJENE LIJEKA
English: Table 5 summarizes adverse drug reactions reported when dinutuximab was administered in combination with GM-CSF, IL-2, and isotretinoin.
Croatian: Tablica 5 sadrži sažetak nuspojava na lijek prijavljenih kada je dinutuksimab primijenjen u kombinaciji s GM-CSF-om, IL-2, i izotretinoinom.
English: Recurrence
Croatian: Doziranje
English: • If symptoms resolve the following day, resume dinutuximab at tolerated
Croatian: • Ako se simptomi ponovno pojave, prekinuti primjenu dinutuksimaba,
English: • Discontinue dinutuximab and GM-CSF or IL-2 for that day.
Croatian: • Prekinuti primjenu dinutuksimaba i GM-CSF-a ili IL-2 za taj dan.
English: Polysorbate 20 (E 432)
Croatian: Popis pomoćnih tvari histidin polisorbat 20 (E 432) natrijev klorid voda za injekcije
English: • Proceed with subsequent planned dinutuximab and GM-CSF or IL-2 courses.
Croatian: • Nastaviti sa sljedećim planiranim ciklusima dinutuksimaba i GM-CSF-a ili IL-2.
English: • Resume dinutuximab at 0.875 mg/m2/h once BP is stable.
Croatian: • Nastaviti s primjenom infuzije dinutuksimaba brzinom od 0,875 mg/m2/sat kad krvni tlak bude stabilan.
English: Each 5 mL vial contains 17.5 mg of dinutuximab.
Croatian: Svaka bočica od 5 ml sadrži 17,5 mg dinutuksimaba.
English: • Resume GM-CSF or IL-2 the following day at 50 % of the dose if BP remains stable.
Croatian: • Nastaviti sljedećeg dana primjenu 50% doze GM-CSF-a ili IL-2 ako krvni tlak ostane stabilan.
English: This means it is essentially ‘sodiumfree'.
Croatian: To znači da sadrži zanemarive količine natrija.
English: • Discontinue dinutuximab, GM-CSF, and IL-2 for remaining courses.
Croatian: • Prekinuti primjenu dinutuksimaba, GM-CSF-a i IL-2 za preostale cikluse.
English: Table 4: Dose modification guidance for the management of treatment-emergent adverse reactions during administration of dinutuximab in combination with GM-CSF, IL-2 and isotretinoin.
Croatian: Tablica 4 : Smjernice za prilagodbu doze za zbrinjavanje nuspojava nastalih tijekom liječenja dinutuksimabom u kombinaciji s GM-CSF-om, IL-2 i izotretinoinom Alergijske reakcije
English: 1 Includes preferred terms abdominal pain, abdominal pain upper, arthralgia, back pain, bladder pain, bone pain, chest pain, facial pain, gingival pain, musculoskeletal chest pain, myalgia, neck pain, neuralgia, oropharyngeal pain, pain, pain in extremity, and proctalgia.
Croatian: bol u mjehuru, bol u kostima, bol u prsima, bol u području lica, bol u desnima, mišićno-koštana bol u prsima, mialgija, bol u vratu, neuralgija, bol u ustima i ždrijelu, bol, bol u ekstremitetima i proktalgija.
English: Water for injections
Croatian: Koncentrat za otopinu za infuziju
English: • Discontinue dinutuximab and GM-CSF or IL-2 for that course.
Croatian: • Prekinuti primjenu dinutuksimaba i GM-CSF-a ili IL-2 za taj ciklus.
English: • If GM-CSF is not tolerated at 50 % of the dose, administer dinutuximab alone for the remainder of the course.
Croatian: • Ako se GM-CSF ne podnosi pri 50% doze, primijeniti samo dinutuksimab
English: • Resume dinutuximab infusion at 0.875 mg/m2/h.
Croatian: • Nastaviti primjenu infuzije dinutuksimaba brzinom od 0,875 mg/m2/sat.
English: Febrile neutropenia
Croatian: - zatajenje bubrega
English: Adverse reactions reported for subjects receiving dinutuximab in combination with GM-CSF, IL-2, and isotretinoin are summarised in Table 5.
Croatian: Nuspojave prijavljene za ispitanike koji primaju dinutuksimab u kombinaciji s GM-CSF-om, IL-2 i izotretinoinom su prikazane u Tablici 5. Ove su nuspojave prikazane prema MedDRA klasifikaciji organskih sustava i učestalosti.
English: • Immediately discontinue dinutuximab and intravenous GM-CSF or IL-2.
Croatian: • Odmah prekinuti primjenu dinutuksimaba i intravenskog GM-CSF-a ili IL-2.
English: Endocrine disorders
Croatian: Endokrini poremećaji hipertireoza
English: • Discontinue dinutuximab and intravenous GM-CSF or IL-2.
Croatian: • Prekinuti primjenu dinutuksimaba i intravenskog GM-CSF-a ili IL-2.
English: Hypomagnesaemia, acidosis, hypoglycaemia,
Croatian: Poremećaji metabolizma hipokalijemija,
English: • Discontinue dinutuximab and GM-CSF or IL-2 for remainder of course.
Croatian: • Prekinuti primjenu dinutuksimaba i GM-CSF-a ili IL-2 za ostatak ciklusa.
English: Uncommon side effects (may affect up to 1 in 100 people ): - unequal pupils - fluid in or around the lungs - kidney failure - over-active thyroid - serum sickness - an illness similar to an allergy - abnormal heart rhythm - swelling in the back part of the brain (Posterior Reversible Encephalopathy Syndrome) - symptoms may include high blood pressure, headache, fits, change in vision or behaviour, feeling drowsy or tired.
Croatian: - oticanje u stražnjem dijelu mozga (sindrom posteriorne reverzibilne encefalopatije) - simptomi mogu uključivati visoki krvni tlak, glavobolju, napadaje, promjene vida ili ponašanja, osjećaj omamljenosti ili umora.
English: See leaflet for further information.
Croatian: Za dodatne informacije vidjeti Uputu o lijeku.
English: Constipation, lower gastrointestinal haemorrhage
Croatian: Poremećaji probavnog sustava konstipacija, krvarenje iz donjeg dijela gastrointestinalnog trakta
English: Peripheral oedema, chills, fatigue, irritability Injection site reaction
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija, bol1, edem lica periferni edem, zimica, umor, razdražljivost, reakcija na mjestu injekcije
English: • Resume GM-CSF or IL-2 the following day at 50 % of the dose if BP
Croatian: • Nastaviti sljedećeg dana primjenu 50% doze GM-CSF-a ili IL-2 ako krvni
English: Subsequent courses
Croatian: Sljedeći ciklusi
English: It is recommended that women of childbearing potential use contraception for 6 months after discontinuation of treatment with Unituxin.
Croatian: Preporučuje se da žene reproduktivne dobi koriste kontracepciju
English: • Discontinue dinutuximab and GM-CSF or IL-2.
Croatian: • Prekinuti primjenu dinutuksimaba i GM-CSF-a ili IL-2.
English: Pregnancy
Croatian: Imunogenost
English: • Permanently discontinue dinutuximab and GM-CSF or IL-2.
Croatian: • Trajno prekinuti primjenu dinutuksimaba i GM-CSF-a ili IL-2.
English: What Unituxin contains - The active substance is dinutuximab.
Croatian: - Djelatna tvar je dinutuksimab.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava anemija febrilna neutropenija atipični hemolitički uremički sindrom
English: Cytokine release syndrome
Croatian: preosjetljivost sindrom otpuštanja citokina serumska bolest
English: Unituxin 3.5 mg/mL sterile concentrate dinutuximab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Unituxin 3,5 mg/mL sterilni koncentrat dinutuksimab
English: Grade 4(life-threatening) Onset of symptoms
Croatian: 4. stupnja (opasno po život)
English: hypertension
Croatian: Dojenje
English: - higher risk of getting infections especially from the devices used to give you the medicine, blood or gut infections - skin problems where the injection was given, a red rash with small bumps - abnormal blood tests such as low levels of magnesium, glucose, high level of acids or creatinine.
Croatian: - povećan rizik od infekcija, osobito od pomagala korištenih za primjenu lijeka, infekcije krvi ili crijevne infekcije
English: Your name:
Croatian: Vaše ime:
English: de la Industria, 30 Alcobendas
Croatian: Avda. de la Industria, 30 Alcobendas
English: Doctor's phone number:
Croatian: Broj telefona liječnika:
English: Population (Number)
Croatian: Populacija (broj)
English: 28108 Madrid SPAIN
Croatian: 28108 Madrid ŠPANJOLSKA
English: Doctor's name (who prescribed Olumiant):
Croatian: Ime liječnika (koji je propisao Olumiant):
English: Long-term safety evaluations are ongoing.
Croatian: U tijeku su ocjene dugoročne sigurnosti.
English: At present it is not known whether this is clinically relevant.
Croatian: Trenutno nije poznato je li to klinički značajno.
English: - Do not take a double dose to make up for a forgotten tablet.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu tabletu.
English: Other intrinsic Factors
Croatian: Ostali intrinzični faktori
English: C-reactive protein
Croatian: C-reaktivni protein
English: Olumiant is to be taken once daily with or without food and may be taken at any time of the day.
Croatian: Olumiant se primjenjuje jedanput na dan, uz hranu ili bez nje, a može se uzeti u bilo koje doba dana.
English: You can take the tablets either with or without food.
Croatian: Tablete možete uzimati s hranom ili bez nje.
English: VTE reporting rate is increasing.
Croatian: Stopa prijavljivanja VTE-a je u porastu.
English: You may get some of the side effects described in section 4.
Croatian: Mogu se pojaviti neke od nuspojava opisanih u dijelu 4.
English: Nausea was most frequent during the first 2 weeks of treatment.
Croatian: Mučnina se najčešće javljala tijekom prva 2 tjedna liječenja.
English: What Olumiant is and what it is used for
Croatian: Što je Olumiant i za što se koristi
English: The safety and efficacy of Olumiant in children and adolescents aged 0 to 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Olumiant u djece i adolescenata u dobi od 0 do 18 godina još nisu ustanovljene.
English: Active tuberculosis should also be ruled out.
Croatian: Treba isključiti i aktivnu tuberkulozu.
English: Table 4: Response, Remission and Physical Function Study
Croatian: Tablica 4: Odgovor, remisija i tjelesna funkcija Ispitivanje
English: Therefore, no dose adjustment is needed based on these patient factors.
Croatian: Stoga nije potrebno prilagođavati dozu na temelju tih faktora.
English: c Includes changes detected during laboratory monitoring (see text below).
Croatian: c Uključuje promjene utvrđene tijekom laboratorijskog praćenja (vidjeti tekst u nastavku).
English: The guide for healthcare professionals shall contain the following key elements:
Croatian: Vodič za zdravstvene radnike sadržavat će sljedeće ključne elemente:
English: Olumiant can be used alone or together with some other medicines, such as methotrexate.
Croatian: Olumiant se može uzimati sam ili zajedno s nekim drugim lijekovima, kao što je metotreksat.
English: There was no change in the LDL/HDL ratio.
Croatian: Nije bilo promjena u omjeru LDL/HDL.
English: Olumiant is not for use in children and adolescents under 18 years old because there is no information on use in this age group.
Croatian: Olumiant nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina jer nema podataka o primjeni u toj dobnoj skupini.
English: Swelling face (n=23) and urticaria (n=20) were also frequently reported.
Croatian: Oticanje lica (n=23) i urtikarija (n=20) također su često prijavljeni.
English: Most cases were transient and did not require treatment discontinuation.
Croatian: Većina slučajeva bila je prolazne prirode i nije zahtijevala prekid liječenja.
English: The majority of these patients (n = 94) were co-treated with methotrexate.
Croatian: Većina tih bolesnika (n = 94) istodobno se liječila metotreksatom.
English: • Physical function (HAQ-DI)
Croatian: • Tjelesna funkcija (HAQ-DI)
English: In July 2019 VTE reporting rate was 0,13% compared to 0,09% in February 2019.
Croatian: U srpnju 2019. godine stopa prijavljivanja VTE-a iznosila je 0,13%, dok je u veljači 2019. godine iznosila 0,09%.
English: If the medicine is working well, your doctor may decide the dose can be reduced.
Croatian: Ako lijek bude dobro djelovao, liječnik može odlučiti smanjiti dozu.
English: Your doctor may give you a lower dose of 2 mg once a day, particularly if you are over 75 years old or if you have an increased risk of infections.
Croatian: Liječnik će Vam možda propisati nižu dozu od 2 mg jedanput na dan, osobito ako imate više od 75 godina ili ako imate povećan rizik od infekcija.
English: • lecithin (soya) (E322)
Croatian: • lecitin (soja) (E322)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, genotoksičnosti i kancerogenog potencijala.
English: • A cough that won't go away, night sweats, and weight loss.
Croatian: • kašalj koji ne prolazi, noćno znojenje i gubitak tjelesne težine.
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.
Croatian: Uzimajući u obzir informacije koje je dostavio nositelj odobrenja, najmanje jedan dio nespecificiranih događaja doista je bio sistemske prirode, ali ih zbog ograničenih informacija nije moguće pravilno kategorizirati.
English: • Radiographic progression (mTSS)
Croatian: • Radiografska progresija (mTSS)
English: Age ≥ 65 years or ≥ 75 years has no effect on baricitinib exposure (Cmax and AUC).
Croatian: Dob od ≥ 65 godina ili ≥ 75 godina ne utječe na izloženost baricitinibu (Cmax i AUC).
English: Remission and low disease activity
Croatian: Remisija i niska aktivnost bolesti
English: Other medicines and Olumiant
Croatian: Drugi lijekovi i Olumiant
English: Treatment may be initiated once values have improved above these limits (see section 4.4).
Croatian: Liječenje može započeti nakon što se vrijednosti vrate iznad tih granica (vidjeti dio 4.4).
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first Authorisation: 13 February 2017
Croatian: Datum prvog odobrenja: 13. veljače 2017.
English: Pharmacotherapeutic group: Selective immunosuppressants, ATC code: L04AA37
Croatian: Farmakoterapijska skupina: Selektivni imunosupresivi; ATK oznaka: L04AA37
English: Including data from a long-term extension study, remission and low disease activity rates were maintained for at least 2 years.
Croatian: Uključujući podatke iz dugoročnog produžetka ispitivanja, stope remisije i niske aktivnosti bolesti održale su se tijekom najmanje 2 godine.
English: • titanium dioxide (E171)
Croatian: • titanijev dioksid (E171)
English: All patients who completed these studies were eligible to enrol in a long term extension study for up to 4 years continued treatment.
Croatian: Svi bolesnici koji su završili ta ispitivanja mogli su sudjelovati u dugoročnom produžetku ispitivanja, u kojem se liječenje nastavilo tijekom razdoblja do 4 godine.
English: Greater rates of remission compared to placebo were observed as early as week 4.
Croatian: Više stope remisije u odnosu na placebo primijećene su već u 4. tjednu.
English: • macrogol
Croatian: • makrogol
English: See section 4.2 for dose recommendations.
Croatian: Vidjeti dio 4.2 za preporuke za doziranje.
English: What you need to know before you take Olumiant
Croatian: Što morate znati prije nego počnete uzimati Olumiant
English: To help you remember to take Olumiant, you may find it easier to take it at the same time every day.
Croatian: Da biste se lakše sjetili uzeti lijek Olumiant, pokušajte ga uzimati svaki dan u isto vrijeme.
English: Patients over 18 years of age were eligible to participate.
Croatian: U ispitivanju su mogli sudjelovati bolesnici stariji od 18 godina.
English: Inform your doctor immediately if you get symptoms of infection, such as:
Croatian: Odmah obavijestite svog liječnika ako primijetite simptome infekcije, kao što su:
English: Adverse events were comparable to those seen at lower doses and no specific toxicities were identified.
Croatian: Nuspojave su bile usporedive s onima primijećenima pri nižim dozama i nisu utvrđene nikakve specifične toksičnosti.
English: Olumiant should not be given to patients with active TB.
Croatian: Olumiant se ne smije davati bolesnicima s aktivnim TBC-om.
English: The majority of patients maintained low disease activity or remission based on CDAI score:
Croatian: U većine se bolesnika održala niska aktivnost bolesti ili remisija prema CDAI rezultatu:
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.
Croatian: Nadalje, pozitivan dechallenge (npr. jedan slučaj kategoriziran kao sistemski događaj) te pozitivan dechallenge i rechallenge (npr. jedan slučaj kategoriziran kao nespecificiran događaj) također govore u prilog tome da bi baricitinib mogao uzrokovati sistemske događaje.
English: Continued, durable response rates were observed, with ACR20/50/70 responses maintained for at least 2 years including the long-term extension study.
Croatian: Primijećene su postojane i dugotrajne stope odgovora, a odgovori ACR20/50/70 održali su se tijekom najmanje 2 godine, uključujući i dugoročni produžetak ispitivanja.
English: From the 316 events retrieved as of 13 May 2019, 78 were categorised as systemic/oedema and 38 were categorised as non-specific.
Croatian: Od 316 događaja utvrđenih do 13. svibnja 2019. godine, njih 78 svrstano je u kategoriju sistemskih događaja/edema, dok je njih 38 svrstano u kategoriju nespecificiranih događaja.
English: You and your doctor should decide if you will breast-feed or use Olumiant.
Croatian: Vi i Vaš liječnik trebate odlučiti hoćete li dojiti ili uzimati Olumiant.
English: In clinical trials, there were no confirmed cases of rhabdomyolysis.
Croatian: U kliničkim ispitivanjima nije bilo potvrđenih slučajeva rabdomiolize.
English: No metabolites were quantifiable in plasma.
Croatian: plazmi nije bilo mjerljivih količina metabolita.
English: If you take more Olumiant than you should, contact your doctor.
Croatian: Ako ste uzeli više lijeka Olumiant nego što ste trebali, javite se svom liječniku.
English: The tablets are rounded and have hollow sides to help you pick them up.
Croatian: Tablete su zaobljene i imaju udubljenja kako biste ih mogli lakše uhvatiti.
English: Talk to your doctor or pharmacist before and during treatment with Olumiant if you: - have an infection, or if you often get infections.
Croatian: Obratite se svom liječniku ili ljekarniku prije i tijekom liječenja lijekom Olumiant: - ako imate infekciju ili ako često imate infekcije.
English: This document contains important information you should be aware of before and during treatment with Olumiant.
Croatian: Ovaj dokument sadrži važne informacije s kojima morate biti upoznati prije i tijekom liječenja lijekom Olumiant.
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.
Croatian: Osim toga, rekurentni DVT i posljedični PE koji su opaženi u rujnu 2018. godine u bolesnika koji je nastavio liječenje baricitinibom nakon prvog nastupa DVT-a također potvrđuju moguću povezanost između primjene baricitiniba i nastupa VTE-a.
English: QR code to be included + www.olumiant.eu
Croatian: Uključiti QR kod+ www.olumiant.eu
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.
Croatian: Ako se ne sjetite zaboravljene doze cijeli dan, preskočite propuštenu dozu i sutradan uzmite samo jednu dozu u uobičajeno vrijeme.
English: These effects can help you to do normal daily activities and so improve the health-related quality of life for patients with rheumatoid arthritis.
Croatian: Vam pomoći da obavljate uobičajene svakodnevne aktivnosti i tako poboljšati kvalitetu života vezanu uz zdravlje u bolesnika s reumatoidnim artritisom.
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:
Croatian: Nositelj odobrenja pobrinut će se da u svakoj državi članici u kojoj će Olumiant biti na tržištu svi zdravstveni radnici za koje se očekuje da će propisivati Olumiant dobiju edukacijski materijal za liječnike, koji mora sadržavati:
English: Patients who discontinued or received rescue therapy were considered as non-responders thereafter.
Croatian: Bolesnici koji su prestali primjenjivati lijek ili koji su primili spasonosnu terapiju nakon toga smatrali su se bolesnicima bez odgovora.
English: Frequency estimate: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000
Croatian: Procjena učestalosti: vrlo često (≥ 1/10), često (≥1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100).
English: Baricitinib is approximately 50 % bound to plasma proteins.
Croatian: Približno 50% baricitiniba veže se za proteine u plazmi.
English: The rate of serious infections remained stable during long term exposure.
Croatian: Stopa ozbiljnih infekcija ostala je stabilna tijekom dugotrajnog izlaganja.
English: • Tell your doctor immediately if you become (or wish to become) pregnant.
Croatian: • Odmah obavijestite svog liječnika ako zatrudnite (ili želite zatrudnjeti)
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
Croatian: • Znakove i simptome infekcija, uključujući opće simptome, a osobito znakove i simptome tuberkuloze i herpesa zoster, te upozorenje da bolesnici moraju odmah potražiti liječničku pomoć ako se pojave znakovi ili simptomi koji ukazuju na infekciju.
English: Infection such as shingles, which may affect up to 1 in 10 people:
Croatian: Infekcije poput herpesa zoster, koje se mogu javiti u do 1 na 10 osoba:
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).
Croatian: Olumiant se može primjenjivati u monoterapiji ili u kombinaciji s metotreksatom (vidjeti dijelove 4.4, 4.5 i 5.1 za dostupne podatke o različitim kombinacijama).
English: Olumiant is contraindicated during pregnancy (see section 4.3).
Croatian: Olumiant je kontraindiciran u trudnoći (vidjeti dio 4.3).