FrancophonIA/ELRC3.0 huggingface dataset:
English: A study in the subcutaneous program was conducted to investigate the effect of withdrawal (three months) and restart of abatacept subcutaneous treatment on immunogenicity.
Slovenian: V okviru programa subkutane uporabe zdravila je bila izvedena študija, ki je raziskovala vpliv prekinitve (tri mesece) in ponovne uvedbe subkutanega zdravljenja z abataceptom na imunogenost.
English: Look at the liquid in the syringe (Figure 2).
Slovenian: Preverite tekočino v injekcijski brizgi (slika 2).
English: The increased incidence of lymphomas and mammary tumours observed in mice treated with abatacept may have been associated with decreased control of murine leukaemia virus and mouse mammary tumour virus, respectively, in the presence of long-term immunomodulation.
Slovenian: Večja pojavnost limfomov in tumorjev mlečne žleze pri miših, ki so prejemale abatacept, je lahko povezana z zmanjšanim nadzorom virusa mišje levkemije in virusa mišjega tumorja mlečne žleze (mouse mammary tumour virus) v prisotnosti dolgotrajne imunomodulacije.
English: Study VII: Safety of abatacept in patients with or without washout of previous TNF-inhibitor therapy
Slovenian: Študija VII: Varnost abatacepta pri bolnikih z ali brez faze izpiranja po predhodnem zdravljenju z zaviralcem TNF
English: HAQc Disability Index
Slovenian: Indeks nezmožnosti HAQc
English: Proportion (%) of polyarticular JIA patients with ACRP responses or inactive disease at end of short-term period (4 months) Ages 2 to 17 years n=219
Slovenian: Preglednica 9: Delež (%) bolnikov s poliartikularnim JIA z ACRP odzivom ali neaktivno boleznijo ob koncu kratkoročnega obdobja (4 meseci) Starost 2 do 17 let n=219
English: The primary endpoint for both PsA-I and PsA-II was the proportion of patients achieving ACR 20 response at Week 24 (day 169).
Slovenian: Primarni cilj obeh študij, študije PsA-I in študije PsA-II, je bil delež bolnikov z doseženim odzivom ACR 20 v 24. tednu (169. dan).
English: ACR30 65 ACR50 50 ACR70 28 ACR90 13 Inactive disease
Slovenian: ACRP30 ACRP50 ACRP70 ACRP90 ACRP100 neaktivna bolezen*
English: If neurological symptoms suggestive of PML occur during ORENCIA therapy, treatment with ORENCIA should be discontinued and appropriate diagnostic measures initiated.
Slovenian: Če se med zdravljenjem z zdravilom ORENCIA pojavijo nevrološki simptomi, ki kažejo na PML, je treba zdravljenje z zdravilom ORENCIA prekiniti in izvesti ustrezne diagnostične preiskave.
English: ORENCIA increases the risk of getting infections.
Slovenian: Zdravilo ORENCIA poveča tveganje za okužbe.
English: Exploratory studies to assess the effect of abatacept on the antibody response to vaccination in healthy subjects as well as the antibody response to influenza and pneumococcal vaccines in rheumatoid arthritis patients suggested that abatacept may blunt the effectiveness of the immune response, but did not significantly inhibit the ability to develop a clinically significant or positive immune response.
Slovenian: Raziskovalne študije za oceno učinka abatacepta tako na protitelesni odziv na cepljenje pri zdravih osebah kot tudi protitelesni odziv na cepljenje proti gripi in pnevmokokom pri bolnikih z revmatoidnim artritisom so pokazale, da abatacept lahko zmanjša učinkovitost imunskega odziva, vendar pa ni pomembneje zavrl sposobnosti za razvoj klinično pomembnega ali pozitivnega imunskega odziva.
English: Information on the relative safety in a clinical trial versus infliximab is summarised in section 5.1.
Slovenian: Podatki o relativni varnosti v kliničnih preskušanjih v primerjavi z infliksimabom so povzeti v poglavju 5.1.
English: Look closely to make sure that the amount of liquid in the pre-filled syringe is at or just above the fill line for your prescribed dose:
Slovenian: Skrbno poglejte in se prepričajte, da tekočina v napolnjeni injekcijski brizgi sega do ali le nekoliko nad oznako, ki označuje predpisani odmerek:
English: Proportion of patients with ACR responses at week 24 in studies PsA-I and PsA-II
Slovenian: Delež bolnikov z odzivi ACR v 24. tednu v študijah PsA-I in PsA-II Študija PsA-Ia
English: 5 How to store ORENCIA 6.
Slovenian: 5 Shranjevanje zdravila ORENCIA 6.
English: SC bioavailability (F) increased by 28% and the absorption rate constant (KA) was higher in pJIA patients than RA patients.
Slovenian: Biološka uporabnost (F) pri subkutani uporabi je večja za 28%, konstanta hitrosti absorpcije (KA) pa je pri bolnikih s pJIA višja kot pri bolnikih z RA.
English: Three patients had SAEs (postoperative wound infection, H1N1 influenza, and myocardial ischemia in 1 patient each) that were not considered related to the study drug.
Slovenian: Pri treh bolnikih so poročali o resnih neželenih učinkih (pooperativna okužba rane, influenca H1N1 in ishemija miokarda, vsak od teh učinkov pri 1 bolniku), ki pa niso bili povezani s študijskim zdravilom.
English: It is unknown whether abatacept is excreted in human milk.
Slovenian: Ni znano, ali se abatacept izloča v materino mleko.
English: STEP 2: Choose and prepare your injection site
Slovenian: KORAK: Izbira in priprava mesta za injiciranje
English: Inadequate response to TNF Inhibitor
Slovenian: Nezadosten odziv na zaviralec TNF
English: d Reduction in HAQ-DI of ≥ 0.3 units from baseline.
Slovenian: d Zmanjšanje indeksa HAQ-DI za ≥ 0,3 enote od izhodišča.
English: the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.
Slovenian: zdravljenje močno aktivne in progresivne bolezni pri odraslih bolnikih z revmatoidnim artritisom, ki se predhodno še niso zdravili z metotreksatom.
English: Inject: push the plunger with your thumb as far as it will go.
Slovenian: Injiciranje: s palcem potisnite bat do konca.
English: Start of ORENCIA Treatment:
Slovenian: Začetek zdravljenja z zdravilom ORENCIA:
English: Always keep your Sharps container out of reach of children and animals.
Slovenian: Posodo za odstranjevanje ostrih predmetov vedno shranjujte izven dosega otrok in živali.
English: Of the 54 patients withdrawn from ORENCIA during the doubleblind period for up to 6 months, none had an infusion reaction upon re-initiation of ORENCIA.
Slovenian: Pri nobenem od 54 bolnikov, pri katerih je bilo zdravljenje z zdravilom ORENCIA med dvojno slepim obdobjem prekinjeno za do 6 mesecev, se po ponovni uvedbi zdravljenja z zdravilom ORENCIA ni pojavila infuzijska reakcija.
English: The results from studies II, III, and VI are shown in Table 7.
Slovenian: Rezultati iz študij II, III in VI so prikazani v preglednici 7.
English: Excipient with known effect sodium: 0.375 mmol (8.625 mg) per vial
Slovenian: Pomožna snov z znanim učinkom natrij: 0,375 mmol (8,625 mg) na vialo
English: Your doctor will advise you on the duration of treatment and what other medicines you may continue to take while on ORENCIA.
Slovenian: Zdravnik vam bo povedal kako dolgo bo trajalo zdravljenje in katera druga zdravila lahko med zdravljenjem z zdravilom ORENCIA jemljete še naprej.
English: From a microbiological point of view, the reconstituted solution should be diluted immediately.
Slovenian: Z mikrobiološkega stališča je treba raztopino razredčiti takoj po rekonstituciji.
English: Pharmacokinetics of abatacept for subcutaneous injection have been studied in patients 2 to 17 years of age.
Slovenian: Farmakokinetiko abatacepta pri subkutanem injiciranju so preučevali pri bolnikih, starih od 2 do 17 let.
English: The efficacy and safety of abatacept were assessed in two randomised, double-blind, placebocontrolled trials (studies PsA-I and PsA-II) in adult patients, age 18 years and older.
Slovenian: Učinkovitost in varnost abatacepta so vrednotili v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih (študiji PsA-I in PsA-II) pri odraslih bolnikih, starih 18 let in starejših.
English: The geometric mean estimate (90% confidence interval) for the bioavailability of abatacept following subcutaneous administration relative to intravenous administration is 78.6% (64.7%, 95.6%).
Slovenian: Geometrijska srednja ocena (90% interval zaupanja) za biološko uporabnost abatacepta po subkutani uporabi v primerjavi z intravensko uporabo je 78,6% (64,7%; 95,6%).
English: Abatacept has been shown to be present in rat milk.
Slovenian: Pri podganah so dokazali prisotnost abatacepta v mleku.
English: Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.
Slovenian: Zdravnik vam bo povedal kako dolgo bo trajalo zdravljenje in katera druga zdravila, vključno z drugimi imunomodulirajočimi zdravili, če sploh katero, lahko med zdravljenjem z zdravilom ORENCIA jemljete še naprej.
English: If the dose is missed by more than three days, the patient should be instructed when to take the next dose based on medical judgment (condition of the patient, status of disease activity, etc).
Slovenian: Če je od predvidenega dneva injiciranja minilo več kot tri dni, mora o dajanju naslednjega odmerka zdravila presoditi zdravnik (na osnovi stanja bolnika, statusa aktivnosti bolezni ipd.).
English: Release Needle Guard: slowly lift your thumb from the plunger to activate the needle guard.
Slovenian: Sprostitev varovala za iglo: palec počasi dvignite z bata, da se aktivira varovalo za iglo.
English: In the 2 to 5 year age cohort, 39 (84.8%) patients completed 2 years.
Slovenian: V kohorti bolnikov, starih od 2 do 5 let, je 2-letno obdobje zaključilo 39 (84,8 %) bolnikov.
English: Health-related quality of life was assessed by the SF-36 questionnaire at 6 months in studies I, II, and III and at 12 months in studies I and II.
Slovenian: Z zdravstvenim stanjem povezana kvaliteta življenja je bila v študijah I, II in III ovrednotena s SF36 vprašalnikom (SF-36 questionnaire) po 6 mesecih, v študijah I in II pa tudi po 12 mesecih.
English: Administration of live vaccines to infants exposed to abatacept in utero is not recommended for 14 weeks following the mother's last exposure to abatacept during pregnancy.
Slovenian: Pri dojenčkih, ki so bili in utero izpostavljeni abataceptu, cepljenje z živimi cepivi ni priporočljivo 14 tednov po zadnji izpostavljenosti matere abataceptu med nosečnostjo.
English: ORENCIA solution for injection is injected under the skin (subcutaneous use).
Slovenian: Zdravilo ORENCIA raztopina za injiciranje se vbrizga pod kožo (subkutana uporaba).
English: Medicinal products which affect the immune system, including ORENCIA, may affect host defences against infections and malignancies, and affect vaccination responses.
Slovenian: Zdravila, ki vplivajo na imunski sistem, vključno z zdravilom ORENCIA, lahko oslabijo obrambni mehanizem proti okužbam in novotvorbam ter vplivajo na odziv na cepljenje.
English: You will find detailed instructions for the preparation and administration of ORENCIA at the end of this leaflet (see "Important instructions for use").
Slovenian: Podrobna navodila za pripravo in aplikacijo zdravila ORENCIA so na voljo na koncu tega navodila (glejte “Pomembna navodila za uporabo").
English: No dose recommendations can be made.
Slovenian: Priporočenih odmerkov ne moremo navesti.
English: Remove the needle from the skin and let go of the surrounding skin.
Slovenian: Iglo izvlecite iz kože in spustite okoliško stisnjeno kožo.
English: In the substudy 108 subjects were randomised 1:1 in double blinded fashion to receive abatacept at doses approximating 10 mg/kg (ABA 10) or 5 mg/kg (ABA 5).
Slovenian: Podštudija je vključevala 108 oseb, ki so bile randomizirane v razmerju 1:1, na dvojno slepi način, tako, da so prejemale abatacept v odmerku približno 10 mg/kg (ABA 10) ali 5 mg/kg (ABA 5).
English: ORENCIA contains the active substance abatacept, a protein produced in cell cultures.
Slovenian: Zdravilo ORENCIA vsebuje zdravilno učinkovino abatacept, ki je beljakovina, pridobljena na celičnih kulturah.
English: Because there is a higher incidence of infections and malignancies in the elderly in general, caution should be used when treating the elderly (see section 4.8).
Slovenian: Ker je pojavnost okužb in novotvorb pri starostnikih na splošno večja, je pri zdravljenju starostnikov potrebna previdnost (glejte poglavje 4.8).
English: The efficacy response over time in this study appeared consistent with studies that included an intravenous loading dose, however, the effect of no intravenous load on the onset of efficacy has not been formally studied.
Slovenian: V tej študiji je bila učinkovitost s časom podobna kot v študijah, ki so vključevale začetni intravenski odmerek, vendar pa vpliva neuporabe začetnega intravenskega odmerka na nastop učinka niso formalno raziskovali.
English: Always handle the ORENCIA syringe carefully, especially when you are around other people, and children.
Slovenian: Z zdravilom ORENCIA v napolnjeni injekcijski brizgi morate vedno rokovati previdno, še posebej v prisotnosti drugih oseb in otrok.
English: A. Check the expiry date and batch number on the carton The expiry date can be found on the ORENCIA carton and on each syringe.
Slovenian: A. Preverite datum izteka roka uporabnosti zdravila in številko serije na ovojnini Datum izteka roka uporabnosti zdravila je naveden na škatli zdravila ORENCIA in na vsaki injekcijski brizgi.
English: No clinical impact of these antibody responses was detected, and no safety concerns were observed upon reinitiation of abatacept therapy.
Slovenian: Kliničnega pomena tega protitelesnega odziva niso ugotovili, pri ponovni uvedbi zdravljenja z abataceptom pa niso opazili težav z varnostjo.
English: Other reactions potentially associated with hypersensitivity to the medicinal product, such as hypotension, urticaria, and dyspnea, that occurred within 24 hours of ORENCIA infusion, were uncommon.
Slovenian: Druge reakcije, ki bi lahko bile povezane s preobčutljivostjo na zdravilo, kot so hipotenzija, urtikarija in dispneja, ter so se pojavile v 24 urah po infundiranju zdravila ORENCIA, so bile po pogostnosti občasne.
English: b 61% of patients were previously treated with TNF inhibitor.
Slovenian: b 61% bolnikov se je predhodno zdravilo z zaviralcem TNF.
English: The efficacy of subcutaneous abatacept in children 2 to 17 years of age is based on pharmacokinetic exposure and extrapolation of established efficacy from intravenous abatacept in pJIA patients and subcutaneous abatacept in adult patients with RA, and is supported by data from an ongoing clinical study.
Slovenian: Učinkovitost subkutane uporabe abatacepta pri otrocih, starih od 2 do 17 let, temelji na farmakokinetični izpostavljenosti in ekstrapolaciji ugotovljene učinkovitosti pri intravenski uporabi abatacepta pri bolnikih s pJIA in subkutane uporabe abatacepta pri odraslih bolnikih z RA, podprta pa je tudi s podatki iz klinične študije, ki še poteka.
English: In rats, abatacept had no undesirable effects on male or female fertility.
Slovenian: Pri podganah abatacept ni imel neželenih učinkov na plodnost samcev ali samic.
English: Before you are given ORENCIA, your doctor will examine you for tuberculosis or do a skin test. if you have viral hepatitis tell your doctor.
Slovenian: Pred začetkom zdravljenja z zdravilom ORENCIA vas bo zdravnik pregledal na tuberkulozo ali pa izvedel kožni test. če imate virusni hepatitis, to povejte svojemu zdravniku.
English: Antibodies directed against the abatacept molecule were assessed by ELISA assays in 3,985 rheumatoid arthritis patients treated for up to 8 years with abatacept.
Slovenian: Protitelesa proti molekuli abatacepta so z ELISA testi ugotavljali pri 3.985 bolnikih z revmatoidnim artritisom, ki so se z abataceptom zdravili do 8 let.
English: The GDH-PQQ based glucose monitoring systems may react with the maltose present in ORENCIA, resulting in falsely elevated blood glucose readings on the day of infusion.
Slovenian: Sistemi za merjenje glukoze, ki temeljijo na GDH-PQQ, lahko reagirajo z maltozo, prisotno v zdravilu ORENCIA, kar ima za posledico lažno povečane odčitke koncentracije krvnega sladkorja na dan infundiranja.
English: Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
Slovenian: Rekonstitucijo in redčenje je treba izvesti v skladu s pravili dobre prakse.
English: *Note: the figure shows the 50 mg pre-filled syringe Proceed to Step 3
Slovenian: *Opomba: slika prikazuje 50 mg napolnjeno injekcijsko brizgo Nadaljujte s 3. korakom.
English: Do not speed up the warming process in way, such as using the microwave or placing the syringe in warm water.
Slovenian: Ne pospešujte postopka segrevanja, na primer z uporabo mikrovalovne pečice ali namakanjem injekcijske brizge v toplo vodo.
English: Your doctor will advise you on suitable methods.
Slovenian: Ustrezno obliko kontracepcije vam bo svetoval zdravnik.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Slovenian: V primeru prevelikega odmerjanja priporočamo, da se bolnika nadzira glede pojava katerega koli znaka ali simptoma neželenih učinkov in uvede ustrezno simptomatsko zdravljenje.
English: Serious infections were reported in 0.8% (1/119), 3.4% (4/116) and 0% (0/116) patients.
Slovenian: O resnih okužbah so poročali pri 0,8 % (1/119), 3,4 % (4/116) in 0 % (0/116) bolnikov.
English: When receiving ORENCIA, patients that require blood glucose monitoring should be advised to consider methods that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods.
Slovenian: Bolnikom, ki potrebujejo merjenje koncentracije krvnega sladkorja, je treba svetovati, da naj med zdravljenjem z zdravilom ORENCIA uporabljajo teste, ki ne reagirajo z maltozo, npr. testi na osnovi glukoza dehidrogenaza nikotin adenin dinukleotidne (GDH-NAD), glukoza oksidazne ali glukoza heksokinazne metode.
English: The side effects experienced in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those experienced in adults as described above, with the following differences:
Slovenian: Neželeni učinki o katerih so poročali pri otrocih in mladostnikih s poliartikularnim juvenilnim idiopatskim artritisom so podobni kot pri odraslih, ki so opisani zgoraj, z naslednjimi izjemami:
English: The results from studies II, III, and VI are shown in Table 6.
Slovenian: Rezultati iz študij II, III in VI so prikazani v preglednici 6.
English: e DAS28-CRP Remission is defined as a DAS28-CRP score < 2.6 f Per protocol data is presented in table.
Slovenian: e DAS28-CRP remisija je opredeljena kot ocena DAS28-CRP < 2,6 f Podatki po protokolu so predstavljeni v preglednici.
English: * n = 119 for Abatacept SC + MTX; n = 116 for MTX
Slovenian: * n = 119 za abatacept s.c. + MTX; n = 116 za MTX
English: Dose selection: see section 3 ‘How to use ORENCIA' of the Package Leaflet
Slovenian: Določitev odmerka: glejte poglavje 3 ‘Kako uporabljati zdravilo ORENCIA' v navodilu za uporabo.
English: In study IV, there were 37 patients with COPD treated with intravenous abatacept and 17 treated with placebo.
Slovenian: V študiji IV je 37 bolnikov s KOPB prejemalo abatacept intravensko, 17 pa placebo.
English: The most frequently reported autoimmune-related disorders other than the indication being studied during the cumulative period were psoriasis, rheumatoid nodule, and Sjogren's syndrome.
Slovenian: Bolezni, povezane z avtoimunskimi procesi, razen raziskovane indikacije, o katerih so v kumulativnem obdobju poročali najpogosteje, so bile psoriaza, revmatoidni vozlič in Sjögrenov sindrom.
English: DO NOT use if past the expiry date.
Slovenian: NE uporabljajte po datumu izteka roka uporabnosti.
English: Two patients (2/117, 1.7%) using the SC prefilled pen experienced local injection site reactions.
Slovenian: Pri dveh bolnikih (2/117; 1,7 %), ki sta s.c. uporabljala napolnjen injekcijski peresnik, so poročali o pojavu lokalnih reakcij na mestu injiciranja.
English: Have the syringe ready for use immediately after you have prepared your injection site.
Slovenian: Injekcijsko brizgo imejte pripravljeno, da jo boste lahko uporabili takoj po pripravi mesta za injiciranje.
English: 50 mg 25 kg to less than 50kg 87.5mg 50 kg or more
Slovenian: 50 mg 25 kg do manj kot 50kg 87,5mg 50 kg ali več
English: The safety and efficacy of ORENCIA in children below 2 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila ORENCIA pri otrocih, mlajših od 2 let, nista bili dokazani.
English: Your doctor may start your ORENCIA treatment with or without a one-time dose of powder for concentrate for solution for infusion (given to you into a vein, usually in your arm, over a period of 30 minutes).
Slovenian: Zdravnik lahko zdravljenje z zdravilom ORENCIA uvede z enkratnim odmerkom zdravila v obliki praška za koncentrat za raztopino za infundiranje (ki ga boste prejeli v žilo, običajno na roki, v obliki 30 minutne infuzije) ali brez njega.
English: For ITT; n=736, 721 for subcutaneous (SC) and intravenous (IV) abatacept,
Slovenian: Za vse vključene bolnike: n=736 za subkutano (s.c.) uporabo abatacepta in n=721 za intravensko (i.v.)
English: Paediatric pJIA population
Slovenian: Pediatrična populacija s pJIA
English: All injection site reactions were described as mild to moderate (hematoma, pruritus, or erythema) and generally did not necessitate drug discontinuation.
Slovenian: Vse reakcije na mestu injiciranja so bile opisane kot blage do zmerne (hematom, srbenje ali rdečina), zdravljenja pa zaradi njih običajno ni bilo treba prekiniti.
English: ORENCIA lessens the immune system's attack on normal tissues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis.
Slovenian: Zdravilo ORENCIA zmanjšuje napad imunskega sistema na normalna tkiva tako, da vpliva na imunske celice (imenovane limfociti T), ki sodelujejo pri razvoju revmatoidnega artritisa.
English: Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Slovenian: Ker so analize imunogenosti specifične za zdravilo, primerjava med odstotki protiteles pri uporabi tega zdravila in uporabi drugih zdravil ni primerna.
English: The efficacy and safety of intravenous abatacept were assessed in randomised, double-blind, placebocontrolled clinical trials in adult patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Slovenian: Učinkovitost in varnost intravenske uporabe abatacepta so vrednotili v randomiziranih, dvojno slepih, s placebom nadzorovanih kliničnih preskušanjih pri odraslih bolnikih z aktivnim revmatoidnim artritisom, diagnosticiranim po kriterijih Ameriškega združenja za revmatologijo (ACR - American College of Rheumatology).
English: Description of selected adverse reactions Infections
Slovenian: Opis izbranih neželenih učinkov Okužbe
English: Check the expiry date printed on the label.
Slovenian: Preverite datum izteka roka uporabnosti, ki je naveden na nalepki.
English: Before you use the pre-filled syringe for the first time, make sure your doctor, nurse or pharmacist shows you the right way to use it.
Slovenian: Poskrbite, da vam pred prvo uporabo napolnjene injekcijske brizge zdravnik, medicinska sestra ali farmacevt pokaže njeno pravilno uporabo.
English: P-valuea
Slovenian: P-vrednosta
English: At a dose of 200 mg/kg, representing 11-fold a human exposure at 10 mg/kg based on AUC, limited changes in immune function (a 9-fold increase in the mean T-cell-dependent antibody response in female pups and inflammation of the thyroid of 1 female pup out of 10 male and 10 female pups evaluated at this dose) were observed.
Slovenian: Pri odmerku 200 mg/kg, kar je na osnovi AUC 11-krat večja izpostavljenost od izpostavljenosti človeka pri odmerku 10 mg/kg, so opazili omejene spremembe imunske funkcije (9-kratno povečanje srednjega T-celičnega protitelesnega odziva pri mladičih ženskega spola in vnetje ščitnice pri 1 mladiču ženskega spola od 10 mladičev moškega in 10 mladičev ženskega spola, pri katerih je bil ta odmerek ovrednoten).