FrancophonIA/ELRC3.0 huggingface dataset:
English: If you miss a dose or if you forget to give your child a dose, take or give the missed dose as soon as possible with food and then take or give the next scheduled dose at its regular time.
Croatian: Ako ste propustili dozu ili ste zaboravili svom djetetu dati dozu, uzmite ili dajte propuštenu dozu čim prije s hranom, a potom uzmite ili dajte sljedeću dozu prema rasporedu u uobičajeno vrijeme.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, (RMP) koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet te svim sljedećim dogovorenim ažuriranim verzijama RMP-a..
English: Hepatic impairment: atazanavir is metabolised and eliminated primarily by the liver.
Croatian: Oštećenje funkcije jetre: Atazanavir se metabolizira i eliminira prvenstveno putem jetre.
English: Additional infant formula, beverage or food may be given after consumption of the entire mixture.
Croatian: 4. Dodatnu dojenačku formulu, piće ili hranu može se dati nakon što je uzeta cjelokupna mješavina.
English: As a general rule, it is recommended that HIV infected women not breast-feed their infants in order to avoid transmission of HIV.
Croatian: Kao opće pravilo, preporučuje se da žene zaražene HIVom ne doje svoju dojenčad kako bi se izbjegao prijenos HIV-a.
English: It should always be used with a low dose of ritonavir and in combination with other anti-HIV medicines.
Croatian: Potrebno ga je uvijek uzimati s niskom dozom ritonavira i u kombinaciji s drugim lijekovima za liječenje HIV-a.
English: The compound selectively inhibits the virus-specific processing of viral Gag-Pol proteins in HIV-1 infected cells, thus preventing formation of mature virions and infection of other cells.
Croatian: Taj spoj selektivno inhibira za virus specifičnu obradu virusnih proteina Gag-Pol u stanicama zaraženima virusom HIV-1 te tako sprječava stvaranje zrelih viriona i infekciju drugih stanica.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Croatian: Relevantni primjeri uključuju citomegalovirusni retinitis, generalizirane i/ili fokalne mikobakterijske infekcije i upalu pluća uzrokovanu s Pneumocystis jirovecii.
English: If it is almost time for your or your child's next dose, do not take or give the missed dose.
Croatian: Ako je uskoro vrijeme da Vi i Vaše dijete primite -sljedeću dozu, nemojte uzeti ili dati propuštenu dozu.
English: - The active substance is atazanavir.
Croatian: - Djelatna tvar je atazanavir.
English: For details on preparation and administration of the REYATAZ oral powder and Instructions for Use, see section 6.6.
Croatian: Za detalje o pripremi i primjeni REYATAZ oralnog praška i Upute za primjenu vidjeti dio 6.6.
English: After mixing with food or beverage, mixture may be stored for up to 1 hour at temperatures not above 30°C.
Croatian: Nakon miješanja s hranom ili pićem, mješavina se može čuvati do najviše 1 sata, na temperaturi od najviše 30°C.
English: REYATAZ may affect how well your kidneys work.
Croatian: REYATAZ može utjecati na to kako dobro rade vaši bubrezi.
English: Take REYATAZ capsules with food (a meal or a substantial snack).
Croatian: Uzimajte REYATAZ kapsule s hranom (uz obrok ili obilniji međuobrok).
English: If withdrawal of ritonavir is medically warranted under restrictive conditions (see section 4.4), special attention should be given to atazanavir interactions that may differ in the absence of ritonavir (see information below Table 2).
Croatian: Ako je izostavljanje ritonavira medicinski neophodno, pod ograničenim uvjetima (vidjeti dio 4.4.), posebnu pozornost treba obratiti na interakcije koje mogu biti drugačije u odsustvu ritonavira (vidjeti informacije navedene ispod Tablice 2).
English: The entire dosage of REYATAZ oral powder (mixed in the liquid infant formula, beverage or food) is administered within one hour of preparation (the mixture can be left at room stored at temperatures not above 30°C during this period).
Croatian: 3. Cjelokupna doza REYATAZ oralnog praška (pomiješana s tekućom dojenačkom formulom, pićem ili hranom) primjenjuje se unutar jednog sata od pripreme (mješavina se može ostaviti na sobnoj temperaturi do najviše 30°C tijekom tog razdoblja).
English: In pregnant rabbits, gross lesions of the stomach and intestines were observed in dead or moribund does at maternal doses 2 and 4 times the highest dose administered in the definitive embryodevelopment study.
Croatian: U skotnih ženki kunića opažene su velike lezije na želucu i crijevima u mrtvih ženki kunića ili ženki kunića na umoru pri maternalnim dozama koje su bile 2 ili 4 puta veće od najviše doze primijenjene u zaključnom ispitivanju embrionalnog razvoja.
English: Systemic lidocaine, Quinidine
Croatian: Sistemski lidokain, Kinidin
English: ≥100,000 copies/ml
Croatian: ≥100 000 kopija /ml
English: There are other medicines that may not mix with REYATAZ.
Croatian: Postoje i drugi lijekovi koji se ne smiju miješati s lijekom REYATAZ.
English: REYATAZ capsules must be taken with ritonavir and have to be taken with food.
Croatian: REYATAZ kapsule moraju se uzimati s ritonavirom i treba ih uzimati s hranom.
English: LIST OF EXCIPIENTS Excipients: contains lactose (see leaflet for further information).
Croatian: 3. POPIS POMOĆNIH TVARI Pomoćne tvari: sadrži laktozu (vidjeti uputu za dodatne informacije).
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnikase traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog uDodatku V.
English: REYATAZ given without ritonavir should not be used in pregnant patients given that it could result of suboptimal exposure of particular concern for the mother infection and vertical transmission.
Croatian: REYATAZ se bez ritonavira ne smije primjenjivati u trudnica jer to može dovesti do suboptimalne izloženosti lijeku, što je osobito problematično s obzirom na majčinu infekciju i vertikalni prijenos.
English: REYATAZ once daily dose ritonavir once daily dose at least 5 to less than 15
Croatian: Doza ritonavira jedanput na dan najmanje 5 do manje od 15
English: Other medicines and REYATAZ
Croatian: Drugi lijekovi i REYATAZ
English: After mixing the oral powder with food or drinks, it may be stored at room temperature (not above 30oC) for up to 1 hour.
Croatian: Nakon miješanja oralnog praška s hranom ili pićem, može se čuvati na sobnoj temperaturi (ne iznad 30oC) do najviše 1 sata.
English: Add an additional tablespoon in the container, mix and feed to your child again.
Croatian: Dodajte dodatnu jušnu žlicu hrane u spremnik, promiješajte i ponovno nahranite dijete.
English: Immunosuppressants Cyclosporin Tacrolimus Sirolimus
Croatian: Imunosupresivi Ciklosporin Takrolimus Sirolimus
English: For children who are able to drink from a cup, REYATAZ oral powder must be taken with food or drinks.
Croatian: Za djecu koja mogu piti iz čaše, REYATAZ oralani prašak mora se uzeti s hranom ili pićem.
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Croatian: Može Vam naškoditi ako bolujete od fenilketonurije rijetkog genetskog poremećaja kod kojeg dolazi do nakupljanja fenilalanina jer ga tijelo ne može ukloniti na odgovarajući način.
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted)
Croatian: Atazanavir, primijenjen 1 sat nakon ddI+d4T (natašte)
English: Antiviral activity in vitro: atazanavir exhibits anti-HIV-1 (including all clades tested) and anti-HIV-2 activity in cell culture.
Croatian: Antivirusno djelovanje in vitro: Atazanavir u staničnoj kulturi ima anti-HIV-1 (uključujući sve ispitane skupine) i anti-HIV-2 djelovanje.
English: No recommendation regarding dose reduction can be made; therefore, caution should be exercised if REYATAZ is coadministered with clarithromycin.
Croatian: Ne može se dati preporuka za sniženje doze; stoga je potreban oprez kad se REYATAZ primjenjuje istovremeno s klaritromicinom.
English: If REYATAZ is co-administered with parenteral midazolam, it should be done in an intensive care unit (ICU) or similar setting which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Croatian: Ako se REYATAZ primjenjuje istovremeno s parenteralnim midazolamom, to treba učiniti u jedinici intenzivnog liječenja (JIL) ili sličnom mjestu koje omogućuje pažljiv klinički nadzor i odgovarajuće zbrinjavanje u slučaju respiratorne depresije i/ili produžene sedacije.
English: CD4 Mean Change from Baseline, cells/mm3 All patients 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60)
Croatian: CD4 prosječna promjena od početne vrijednosti, stanice/mm3 Svi bolesnici 110 (n=83) 122 (n=60) 121 (n=94) 154 (n=60)
English: Cardiac monitoring is recommended based on the presence of clinical findings (e.g., bradycardia).
Croatian: Preporučuje se nadzor srčane funkcije na temelju kliničkih znakova (npr. bradikardije).
English: It should be ensured that the patient eats or drinks all the infant formula, beverage or food that contains the powder.
Croatian: Potrebno je osigurati da bolesnik pojede ili popije u potpunosti dojenačku formulu, hranu ili piće koje sadrži prašak.
English: Assessment of the pharmacokinetics, safety, tolerability, and efficacy of REYATAZ is based on data from the open-label, multicenter clinical trial AI424-020 conducted in patients from 3 months to 21 years of age.
Croatian: Procjena farmakokinetike, sigurnosti, podnošljivosti i djelotvornosti lijeka REYATAZ temelji se na podacima iz multicentričnog kliničkog ispitivanja otvorenog tipa AI424-020 koje je provedeno u bolesnika u dobi od 3 mjeseca do 21 godine.
English: If the patient has developed SJS or DRESS associated with the use of REYATAZ, REYATAZ may not be restarted.
Croatian: Ako je bolesnik razvio SJS ili DRESS povezan s primjenom lijeka REYATAZ, REYATAZ se možda neće ponovno uvesti u terapiju.
English: - The other ingredients are aspartame (E951), sucrose and orange vanilla flavour.
Croatian: - Drugi sastojci su. aspartam (E951), saharoza i aroma naranče ivanilije.
English: Renal impairment: in healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
Croatian: Oštećenje funkcije bubrega: U zdravih je ispitanika eliminacija neizmijenjenog atazanavira putem bubrega iznosila približno 7% primijenjene doze.
English: At Week 48 there were 134 paediatric patients aged 3 months to less than 11 years that received REYATAZ oral powder with ritonavir that were evaluated for efficacy.
Croatian: U 48. tjednu bilo je 134 pedijatrijska bolesnika u dobi od 3 mjeseca do manje od 11 godina koji su primali REYATAZ oralni prašak s ritonavirom kojima je procijenjena djelotvornost.
English: - The other ingredients are crospovidone, lactose monohydrate, and magnesium stearate.
Croatian: - Drugi sastojci su krospovidon, laktoza hidrat i magnezijev stearat.
English: For inclusion in both trials, treatment-naive patients had to have genotypic sensitivity to REYATAZ and two NRTIs, and treatment-experienced patients had to have documented genotypic and phenotypic sensitivity at screening to REYATAZ and at least 2 NRTIs.
Croatian: Za uključenje u oba ispitivanja bolesnici koji prethodno nisu bili liječeni morali su imati genootipsku osjetljivost na REYATAZ i dva NRTI-ja i bolesnici koji su prethodno bili liječeni, morali su prilikom probira imati dokumentiranu genotipsku i fenotipsku osjetljivost na REYATAZ i barem 2 NRTI-ja.
English: Add another 15 ml of the drink, mix and have the child drink the mixture.
Croatian: Dodajte dodatnih 15 ml pića, promiješajte i dajte djetetu da popije.
English: None of the de novo substitutions (see Table 4) are specific to atazanavir and may reflect reemergence of archived resistance on atazanavir + ritonavir in Study 045 treatment-experienced population.
Croatian: Niti jedna od de novo supstitucija (vidjeti tablicu 4) nije specifična za atazanavir i može odražavati ponovnu pojavu stare rezistencije na atazanavir s ritonavirom u prethodno liječene populacije u Ispitivanju 045.
English: Linearity/non-linearity: the pharmacokinetics of atazanavir were evaluated in healthy adult volunteers and in HIV infected patients; significant differences were observed between the two groups.
Croatian: Linearnost/ne-linearnost: Farmakokinetika atazanavira procijenjena je u zdravih odraslih dobrovoljaca i bolesnika zaraženih HIV-om; između te dvije skupine opažene su značajne razlike.
English: Based on data obtained with other boosted PIs and ketoconazole, where ketoconazole AUC showed a 3-fold increase, REYATAZ/ritonavir is expected to increase ketoconazole or itraconazole concentrations.
Croatian: Na temelju podataka dobivenih s drugim pojačanim inhibitorima proteaze i ketokonazola, gdje je AUC ketokonazola pokazivao trostruko povećanje, očekuje se da će REYATAZ s ritonavirom povećati koncentraciju ketokonazola ili itrakonazola.
English: See the "Instructions for use" at the end of the package leaflet for how to prepare and give a dose of REYATAZ oral powder.
Croatian: Pogledajte "Upute za uporabu" o lijeku na kraju ove upute za pripremu i primjenu doze REYATAZ oralnog praška.
English: Excipient with known effect: 63 mg of aspartame; 1305.15 mg of sucrose per sachet (1.5 g oral powder).
Croatian: Pomoćna tvar s poznatim učinkom: 63 mg aspartama, 1305,15 mg saharoze po vrećici (1,5 g oralnog praška).
English: Table 5: Efficacy Outcomes in Study 138 a Parameter
Croatian: Tablica 5: Ishodi djelotvornosti u Ispitivanju 138 a Parametar
English: If you have any questions on how to prepare or give a dose of REYATAZ oral powder, talk to your doctor, pharmacist or nurse.
Croatian: U slučaju dodatnih pitanja o pripremi i primjeni doze REYATAZ oralnog praška obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Skin rash, itching that may occasionally be severe has been reported.
Croatian: Osip na koži, prijavljen je svrbež koji ponekad može biti težak.
English: Preparing and giving the medicine with liquid infant formula using a medicine cup or small container and oral syringe (ask your pharmacist for an oral syringe):
Croatian: Priprema i primjena lijeka s tekućom dojenačkom formulom korištenjem medicinske čaše ili malog spremnika i oralne štrcaljke (zatražite od svog ljekarnika oralnu štrcaljku):
English: During attempts to overcome the decreased exposure by increasing the dose of REYATAZ or other protease inhibitors with ritonavir, a high frequency of liver reactions was seen.
Croatian: Tijekom pokušaja da se prevlada smanjena izloženost povećanjem doze lijeka REYATAZ ili drugih inhibitora proteaze s ritonavirom, opažena je velika učestalost jetrenih reakcija.
English: REYATAZ 300 mg with ritonavir 100 mg may not provide sufficient exposure to atazanavir, especially when the activity of atazanavir or the whole regimen may be compromised due to drug resistance.
Croatian: REYATAZ od 300 mg s ritonavirom od 100 mg možda neće osigurati dovoljnu izloženost atazanaviru, osobito kad djelovanje atazanavira ili cijelog terapijskog protokola može biti promijenjeno zbog rezistencije na lijek.
English: Yellowing of your skin or the white part of your eyes caused by high levels of bilirubin in your blood has been commonly reported.
Croatian: Često je prijavljeno žutilo kože ili bjeloočnica koje je uzrokovano povišenim razinama bilirubina u Vašoj krvi.
English: REYATAZ should not be used in children less than 3 months because of safety concerns especially taking into account the potential risk of kernicterus.
Croatian: REYATAZ se ne smije primijenjivati u djece mlađe od 3 mjeseca zbog sigurnosnih razloga, osobito kada se uzme u obzir mogući rizik od kernikterusa.
English: Do not use this medicine after the expiry date which is stated on the label, carton or blister.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici, kutiji ili blisteru.
English: Table 5: Efficacy Outcomes in Study 138 a
Croatian: Tablica 5: Ishodi djelotvornosti u Ispitivanju 138 a
English: Symptoms of gallbladder problems may include pain in the right or middle upper stomach area, nausea, vomiting, fever or yellowing your skin or the white part of your eyes.
Croatian: Simptomi problema sa žučnim kamencima mogu uključivati bol u desnom ili srednjem gornjem dijelu trbuha, mučninu, povraćanje, vrućicu ili žutilo kože ili bjeloočnica.
English: Assessment of the pharmacokinetics, safety, tolerability, and virologic response of REYATAZ oral powder was based on data from two open-label, multicenter clinical trials.
Croatian: Procjena farmakokinetike, sigurnosti, podnošljivosti i virološkog odgovora REYATAZ oralnog praška temeljena je na podacima dva otvorena multicentirična klinička ispitivanja:
English: Pregnancy and Postpartum
Croatian: Trudnoća i postpartalno razdoblje
English: One pack size is available: 1 carton with 30 sachets.
Croatian: Dostupno je pakiranje: 1 kutija s 30 vrećica
English: absence of prior virologic failure undetectable viral load during the last 6 months under current regimen viral strains not harbouring HIV resistance associated mutations (RAMs) to current regimen.
Croatian: izostanak prethodnog virološkog neuspjeha nemjerljivo virusno opterećenje tijekom posljednjih 6 mjeseci liječenja trenutnim režimom virusni sojevi koji nisu nositelji mutacija povezanih s rezistencijom HIV-a na trenutni režim liječenja.
English: REYATAZ 100 mg hard capsules REYATAZ 150 mg hard capsules REYATAZ 200 mg hard capsules REYATAZ 300 mg hard capsules
Croatian: REYATAZ 100 mg tvrde kapsule REYATAZ 150 mg tvrde kapsule REYATAZ 200 mg tvrde kapsule REYATAZ 300 mg tvrde kapsule
English: Table 7: Efficacy Outcomes (paediatric patients 6 years to less than 18 years of age) at Week 48 (Study AI424-020)
Croatian: Tablica 7: Ishodi djelotvornosti (pedijatrijski bolesnici u dobi od 6 godina do manje od 18 godina) u 48. tjednu (Ispitivanje AI424-020)
English: In a multiple-dose study in HIVinfected patients dosed with 400 mg of atazanavir once daily with a light meal for 12 weeks, atazanavir was detected in the cerebrospinal fluid and semen.
Croatian: U ispitivanju višestrukih doza u bolesnika zaraženih HIV-om koji su primali doze od 400 mg atazanavira jedanput na dan uz lagani obrok tijekom 12 tjedana, atazanavir je otkriven u cerebrospinalnom likvoru i sjemenu.
English: 100 mg a Ritonavir capsules, tablets or oral solution.
Croatian: 100 mg a Ritonavir kapsule, tablete ili oralna otopina.
English: Assessment of adverse reactions for REYATAZ is based on safety data from clinical studies and postmarketing experience.
Croatian: Procjena nuspojava lijeka REYATAZ temelji se na podacima o sigurnosti iz kliničkih ispitivanja i iskustvu nakon stavljanja lijeka u promet.
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Croatian: Tijekom liječenja HIV infekcije moguće je povaćanje tjelesne težine i povišenje razina lipida i glukoze u krvi.
English: a Atazanavir peak concentrations and AUCs were found to be approximately 26-40% higher during the postpartum period (4-12 weeks) than those observed historically in HIV infected, non-pregnant patients.
Croatian: Utvrđeno je da su vršne koncentracije i AUC atazanavira približno 26-40% više tijekom postpartalnog razdoblja (412 tjedana) od onih prethodno opaženih u bolesnica zaraženih HIV-om koje nisu bile trudne.
English: a Number of patients with paired genotypes classified as virological failures (HIV RNA ≥ 400 copies/ml).
Croatian: a Broj bolesnika s uparenim genotipovima klasificiranih kao virološki neuspjeh (HIV RNK ≥ 400 kopija/ml).
English: If you forget to take REYATAZ
Croatian: Ako ste zaboravili uzeti REYATAZ
English: Metabolism: studies in humans and in vitro studies using human liver microsomes have demonstrated that atazanavir is principally metabolised by CYP3A4 isozyme to oxygenated metabolites.
Croatian: Ispitivanja u ljudi i ispitivanja in vitro na mikrosomima ljudske jetre pokazala su da se atazanavir prvenstveno metabolizira putem izoenzima CYP3A4 do oksigeniranih metabolita.
English: REYATAZ oral powder contains 1305.15 mg of sucrose per sachet.
Croatian: REYATAZ oralni prašak sadrži 1305,15 mg saharoze po vrećici.
English: During this time, postpartum patients should follow the same dose recommendation as for nonpregnant patients, including those for co-administration of medicinal products known to affect atazanavir exposure (see section 4.5).
Croatian: Tijekom ovog vremena, bolesnice u postpartalnom razdoblju trebaju nastaviti s istom dozom kakva se preporučuje bolesnicama koje nisu trudne, uključujući one koje istovremeno primaju lijekove za koje se zna da utječu na izloženost atazanaviru (vidjeti dio 4.5).
English: AI424-451 (PRINCE II): In paediatric patients from 3 months to less than 11 years of age In these studies, 155 patients (59 antiretroviral-naive and 96 antiretroviral-experienced) received once daily REYATAZ oral powder and ritonavir, in combination with two NRTIs.
Croatian: AI424-451 (PRINCE II): U pedijatrijskih bolesnika u dobi od 3 mjeseca do manje od 11 godina U tim ispitivanjima 155 bolesnika (59 koji prethodno nisu bili liječeni antiretrovirusnim lijekovima i 96 onih koji su prethodno bili liječeni antiretrovirusnim lijekovima) primalo je jednom dnevno REYATAZ oralni prašak i ritonavir u kombinaciji s dva NRTI-ja.
English: The withdrawal of ritonavir from the boosted regimen of REYATAZ is not recommended, but may be considered in adults patients at the dose of 400 mg once daily with food only under the following combined restrictive conditions:
Croatian: Iako se izostavljanje ritonavira iz pojačanog režima liječenja lijekom REYATAZ ne preporučuje, ono se može razmotriti u odraslih bolesnika uz dozu od 400 mg jedanput na dan primijenjenu s hranom, ali samo ako su zadovoljeni svi sljedeći restriktivni uvjeti:
English: Table 8: Efficacy Outcomes for oral powder (paediatric patients at least 3 months of age and weighing at least 5 kg) at Week 48 (Studies AI424-397 and AI424-451) Parameter
Croatian: Tablica 8: Ishodi djelotvornosti za oralni prašak (pedijatrijski bolesnici u dobi od namanje 3 mjeseca i tjelesne težine od najmanje 5kg) u 48. tjednu (Isptivanje AI424-397 i AI424-451)
English: If you accidentally take more REYATAZ capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Croatian: Ako slučajno uzmete više REYATAZ kapsula nego što je preporučio Vaš liječnik, odmah se obratite liječniku ili potražite savjet u najbližoj bolnici.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy Swords Laboratories T/A Lawrence Laboratories, Unit 12, The Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare, Ireland
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet Bristol-Myers Squibb S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italija Swords Laboratories T/A Lawrence Laboratories, Unit 12, The Distribution Centre, Shannon Industrial Estate, Shannon, Co.
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Croatian: Pojava autoimunih poremećaja (poput Gravesove bolesti i autoimunog hepatitisa) također je bila prijavljena; međutim, prijavljeno vrijeme do nastanka je jako varijabilno, te ovi događaji mogu nastati puno mjeseci nakon početka liječenja (vidjeti dio 4.4.).