FrancophonIA/ELRC3.0 huggingface dataset:
English: Therapeutic IgG monoclonal antibodies are typically degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgGs.
Croatian: Terapijska IgG monoklonska protutijela obično se kataboličkim putovima razgrađuju na male peptide i aminokiseline na isti način kao i endogeni IgG.
English: If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.
Croatian: Ako se u bolesnika razvije takva infekcija ili ako bolesnik ne odgovara na standardnu terapiju za infekciju, potrebno ga je pažljivo nadzirati, a primjenu risankizumaba odgoditi dok se infekcija ne povuče.
English: Before injecting, patients may remove the carton from the refrigerator and allow to reach room temperature out of direct sunlight (15 to 30 minutes) without removing the pre-filled syringes from the carton.
Croatian: Prije injiciranja bolesnici mogu izvaditi kutiju iz hladnjaka i pričekati da se lijek ugrije na sobnu temperaturu bez izlaganja izravnoj sunčevoj svjetlosti (15 do 30 minuta) i bez vađenja napunjenih štrcaljki iz kutije.
English: • Your doctor, pharmacist or nurse will tell you how to return the full special disposal container
Croatian: • Vaš liječnik, ljekarnik ili medicinska sestra reći će Vam kako trebate vratiti poseban spremnik za odlaganje nakon što ga napunite.
English: This is because Skyrizi has not been studied in this age group.
Croatian: Naime, Skyrizi se nije ispitivao u toj dobnoj skupini.
English: • Do not inject into areas affected by psoriasis
Croatian: • Nemojte injicirati lijek u područja zahvaćena psorijazom.
English: Drug interactions between risankizumab and inhibitors, inducers, or substrates of drug metabolising enzymes are not expected and no dose adjustment is needed (see section 5.2).
Croatian: Ne očekuju se interakcije između risankizumaba i inhibitora, induktora ili supstrata enzima koji metaboliziraju lijekove, te nije potrebno prilagođavati dozu (vidjeti dio 5.2).
English: Over the entire psoriasis programme including long-term exposure to risankizumab, the rate of infections was 75.5 events per 100 subject-years.
Croatian: Tijekom cjelokupnog kliničkog programa psorijaze koji uključuje dugoročno izlaganje risankizumabu, stopa infekcija bila je 75,5 događaja po 100 ispitanik-godina.
English: In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Croatian: U slučaju predoziranja preporučuje se nadzirati bolesnika zbog moguće pojave znakova ili simptoma nuspojava te odmah uvesti odgovarajuće simptomatsko liječenje.
English: Of the 31 subjects from the IMMHANCE study with latent tuberculosis (TB) who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on risankizumab.
Croatian: Ni u jednoga od 31 ispitanika iz ispitivanja IMMHANCE s latentnom tuberkulozom koji nije primao profilaksu tijekom ispitivanja nije se razvila aktivna tuberkuloza tijekom trajanja praćenja liječenja risankizumabom srednje vrijednosti od 55 tjedana.
English: Week 52 249 (81.9) PASI 100
Croatian: 52. tjedan 249 (81,9) PASI 100
English: If a serious hypersensivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
Croatian: Ako nastupi ozbiljna reakcija preosjetljivosti, potrebno je odmah prekinuti primjenu risankizumaba i uvesti odgovarajuću terapiju.
English: • warm, red and painful skin, or a painful skin rash with blisters
Croatian: • topla, crvena i bolna koža ili bolan kožni osip praćen mjehurićima
English: In 270 patients who switched from adalimumab to risankizumab without a washout period, the safety profile of risankizumab was similar to that in patients who initiated risankizumab after wash out of any prior systemic therapies.
Croatian: U 270 bolesnika koji su prešli s adalimumaba na risankizumab bez razdoblja ispiranja, sigurnosni profil risankizumaba bio je sličan onome u bolesnika koji su liječenje risankizumabom započeli po razdoblju ispiranja nakon bilo koje prethodne sistemske terapije.
English: There is limited information in subjects aged ≥65 years.
Croatian: Postoje ograničene informacije o primjeni u ispitanika u dobi od ≥65 godina.
English: Table 4: Efficacy and quality of life results at week 16 in adults with plaque psoriasis in IMMVENT
Croatian: Tablica 4: Rezultati za djelotvornost i kvalitetu života u 16. tjednu za odrasle s plak psorijazom u ispitivanju IMMVENT
English: Before each injection, wipe where you will inject in a circular motion with an alcohol pad.
Croatian: Prije svake injekcije kružnim pokretima obrišite mjesto injiciranja jastučićem natopljenim alkoholom.
English: The results for the co-primary and other endpoints are presented in Table 2 and Figure 1.
Croatian: Rezultati za koprimarne i druge mjere ishoda prikazani su u Tablici 2 i na Slici 1.
English: A caregiver may also give your injections after they have been trained.
Croatian: Injekciju Vam može dati i njegovatelj nakon što prođe obuku.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of risankizumab in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni risankizumaba u trudnica ograničeni (manje od 300 ishoda trudnoća).
English: For a full dose, two injections are needed, one after the other.
Croatian: Za primjenu pune doze potrebne su dvije injekcije, koje se daju jedna za drugom.
English: Examination of age, gender, race, body weight ≤130 kg, baseline PASI score, concurrent psoriatic arthritis, previous non-biologic systemic treatment, previous biologic treatment, and previous failure of a biologic did not identify differences in response to risankizumab among these subgroups.
Croatian: Ocjena utjecaja dobi, spola, rase, tjelesne težine ≤130 kg, početnog PASI rezultata, istodobnog psorijatičnog artritisa, prethodnog nebiološkog sistemskog liječenja, prethodnog biološkog liječenja i prethodnog neuspješnog liječenja biološkim lijekom nije ukazala na razlike u odgovoru na risankizumab među tim podskupinama.
English: In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution.
Croatian: U bolesnika koji imaju kroničnu infekciju, rekurentnu infekciju u anamnezi ili poznate faktore rizika za infekciju, risankizumab je potrebno primjenjivati s oprezom.
English: • Wait to remove the needle cover until just before the injection
Croatian: • Nemojte skinuti pokrov igle sve do neposredno prije injiciranja.
English: Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Croatian: Liječenje risankizumabom ne smije se započeti u bolesnika koji imaju bilo koju klinički važnu aktivnu infekciju sve dok se infekcija ne povuče ili nije odgovarajuće liječena.
English: Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.
Croatian: Napunjena staklena štrcaljka s pričvršćenom iglom i pokrovom igle, kao sastavnim dijelom automatskog štitnika za iglu.
English: Among the few subjects (approximately 1%; 7/1,000 at week 16 and 6/598 at week 52) with high antibody titers (>128), clinical response appeared to be reduced.
Croatian: Činilo se da je među malobrojnim ispitanicima (približno 1%; 7/1000 u 16. tjednu i 6/598 u 52. tjednu) s visokim titrima protutijela (>128) klinički odgovor bio smanjen.
English: In a study of subjects with psoriasis, expression of genes associated with the IL-23/IL-17 axis was decreased in the skin after single doses of risankizumab.
Croatian: U ispitivanju provedenom u ispitanika s psorijazom, ekspresija gena povezanih s osi IL-23/IL-17 u koži bila je smanjena već nakon jedne doze risankizumaba.
English: For a full dose, 2 injections are required, one after the other.
Croatian: Za primjenu pune doze potrebne su 2 injekcije, koje se daju jedna za drugom.
English: Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Croatian: Skyrizi je indiciran za liječenje umjerene do teške plak psorijaze u odraslih koji su kandidati za sistemsku terapiju.
English: Change at Week 16 (SE)
Croatian: Promjena u 16. tjednu (SP)
English: Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Croatian: Potrebno je razmotriti antituberkuloznu terapiju prije uvođenja risankizumaba u bolesnika koji u anamnezi imaju latentnu ili aktivnu tuberkulozu, a u kojih se ne može potvrditi da su bili odgovarajuće liječeni.
English: Patients may self-inject Skyrizi after training in subcutaneous injection technique.
Croatian: Bolesnici si mogu sami injicirati Skyrizi nakon obuke o tehnici supkutanog injiciranja.
English: Hold the syringe with the covered needle pointing down, as shown.
Croatian: Uhvatite štrcaljku tako da je igla s pokrovom usmjerena prema dolje, kako je prikazano na slici.
English: Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system organ class and are based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000).
Croatian: klasifikaciji organskih sustava i sljedećim kategorijama učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); i vrlo rijetko (< 1/10 000).
English: It may contain a few translucent to white product-related particles.
Croatian: Može sadržavati nekoliko prozirnih do bijelih čestica povezanih s lijekom.
English: Skyrizi is administered by subcutaneous injection.
Croatian: Skyrizi se primjenjuje supkutanom injekcijom.
English: The pharmacokinetics of risankizumab in paediatric subjects has not been established.
Croatian: Farmakokinetika risankizumaba u pedijatrijskih ispitanika nije ustanovljena.
English: Do not rub the skin where you have injected.
Croatian: Nemojte trljati kožu na mjestu injiciranja.
English: If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.
Croatian: Ako niste sigurni, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije i tijekom liječenja lijekom Skyrizi.
English: • Keep the syringes in the carton until ready to inject
Croatian: • Štrcaljke čuvajte u kutiji dok ne budete spremni injicirati lijek.
English: • Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
Croatian: • Čuvajte Skyrizi u originalnom pakiranju kako biste zaštitili lijek od svjetlosti dok ne dođe vrijeme da ga primijenite.
English: There is no relevant use of Skyrizi in children aged below 6 years for the indication of moderate to severe plaque psoriasis.
Croatian: Nema relevantne primjene lijeka Skyrizi u djece mlađe od 6 godina za indikaciju umjerene do teške plak psorijaze.
English: Tell your doctor, pharmacist or nurse:
Croatian: Obavijestite svog liječnika, ljekarnika ili medicinsku sestru:
English: Nail Psoriasis Severity Index (NAPSI), Palmoplantar Psoriasis Severity Index (PPASI), Psoriasis Scalp Severity Index (PSSI), and Standard Error (SE) ** P < 0.01 comparing to risankizumab *** P < 0.001 comparing to risankizumab
Croatian: Psoriasis Scalp Severity Index, PSSI) i standardna pogreška (SP) ** P < 0,01 u usporedbi s risankizumabom *** P < 0,001 u usporedbi s risankizumabom
English: • feeling tired or short of breath, cough which will not go away
Croatian: • umor ili nedostatak zraka, kašalj koji ne prolazi
English: • 2 pre-filled syringes and 2 alcohol pads (included in the carton)
Croatian: • 2 napunjene štrcaljke i 2 jastučića natopljena alkoholom (uključeno u pakiranje)
English: Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smartphone.
Croatian: Sve pojedinosti i najnovije informacije o ovom lijeku možete dobiti skeniranjem QR kôda navedenog u nastavku ili na vanjskom pakiranju pametnim telefonom.
English: Week 16 89 (29.3) Week 52 173 (56.9) All comparisons of risankizumab versus ustekinumab and placebo achieved p<0.001 except for PASI 75 at week 52 in ULTIMMA-2 where p=0.001
Croatian: 16. tjedan 89 (29,3) 52. tjedan 173 (56,9) Kod svih usporedbi za risankizumab u odnosu na ustekinumab i placebo postignut je p<0,001, osim za PASI 75 u 52. tjednu ispitivanja ULTIMMA-2 gdje je p=0,001
English: Skyrizi contains sorbitol and sodium This medicine contains 68 mg sorbitol per 150 mg dose.
Croatian: Skyrizi sadrži sorbitol i natrij Ovaj lijek sadrži 68 mg sorbitola po dozi od 150 mg.
English: Nonclinical data revealed no special hazard for humans based on repeat-dose toxicity studies including safety pharmacology evaluations, and a reproductive and developmental toxicity study in cynomolgus monkeys at doses of up to 50 mg/kg/week (producing exposures of about 70 times the clinical exposure at maximum recommended human dose [MRHD]).
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja toksičnosti ponovljenih doza, uključujući ocjene sigurnosne farmakologije, ni ispitivanja reproduktivne i razvojne toksičnosti provedenog u makaki majmuna uz doze do 50 mg/kg/tjedan (kojima se postižu izloženosti približno 70 puta veće od kliničke izloženosti nakon primjene najveće preporučene doze za ljude).
English: Keep the syringe steady at the same angle.
Croatian: Držite štrcaljku nepomičnom pod istim kutom.
English: 148, Pontina Km 52 snc
Croatian: AbbVie S.r.l. 148, Pontina Km 52 snc
English: The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab.
Croatian: Većina slučajeva nije bila ozbiljna, te je bila blage do umjerene težine i nije dovela do prekida liječenja risankizumabom.
English: • 2 cotton balls or gauze pads (not included in the carton)
Croatian: • 2 komada pamučne vate ili gaze (nije uključeno u pakiranje)
English: For the second syringe, inject at least 3 cm away from the first injection.
Croatian: Sadržaj druge štrcaljke treba injicirati najmanje 3 cm od mjesta primjene prve injekcije.
English: Risankizumab may increase the risk of infection.
Croatian: Risankizumab može povećati rizik od infekcije.
English: Important information to know before you inject Skyrizi
Croatian: Važne informacije koje morate znati prije injiciranja lijeka Skyrizi
English: Co-primary endpoints No impact on health-related quality of life
Croatian: Bez utjecaja na kvalitetu života vezanu uz zdravlje
English: The exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate) and midazolam (CYP3A substrate) following risankizumab treatment were comparable to their exposures prior to risankizumab treatment, indicating no clinically meaningful drug interactions through these enzymes.
Croatian: Izloženost kofeinu (supstratu CYP1A2), varfarinu (supstratu CYP2C9), omeprazolu (supstratu CYP2C19), metoprololu (supstratu CYP2D6) i midazolamu (supstratu CYP3A) nakon liječenja risankizumabom bila je usporediva s izloženošću prije liječenja risankizumabom, što ukazuje na nepostojanje klinički značajnih interakcija s lijekovima metaboliziranim tim enzimima.
English: For PASI 90 responders at week 16, 88.4% (398/450) of subjects maintained the response at week 52.
Croatian: Među ispitanicima koji su u 16. tjednu imali odgovor PASI 90, njih 88,4% (398/450) imalo je održan odgovor i u 52. tjednu.
English: Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody selective to the interleukin (IL)-23 protein produced in Chinese Hamster Ovary cells using recombinant DNA technology.
Croatian: Risankizumab je humanizirano imunoglobulinsko G1 (IgG1) monoklonsko protutijelo selektivno za protein interleukin (IL)-23, proizvedeno u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
English: No overall differences in risankizumab exposure were observed between older and younger subjects who received risankizumab.
Croatian: Sveukupno nisu opažene razlike u izloženosti risankizumabu između starijih i mlađih ispitanika koji su primali risankizumab.
English: Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine without binding to IL12 and inhibits its interaction with the IL-23 receptor complex.
Croatian: Risankizumab je humanizirano imunoglobulinsko G1 (IgG1) monoklonsko protutijelo koje se s visokim afinitetom selektivno vezuje za podjedinicu p19 humanog citokina interleukina 23 (IL-23) bez vezivanja za IL-12 i inhibira njegovu interakciju s kompleksom receptora za IL-23.
English: Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
Croatian: Odmah obavijestite svog liječnika ili potražite liječničku pomoć ako tijekom liječenja lijekom Skyrizi primijetite bilo koji znak alergijske reakcije, kao što su:
English: Do not inject yourself with this medicine unless you have been trained by your doctor, pharmacist or nurse.
Croatian: Nemojte sami injicirati ovaj lijek ako Vam liječnik, ljekarnik ili medicinska sestra nisu pokazali kako se to radi.
English: ULTIMMA-1 and ULTIMMA-2
Croatian: ULTIMMA-1 i ULTIMMA-2
English: These conditions are generally not expected to have any significant impact on the pharmacokinetics of monoclonal antibodies and no dose adjustments are considered necessary (see section 5.2).
Croatian: U načelu se ne očekuje značajan učinak takvih oštećenja na farmakokinetiku monoklonskih protutijela, te se smatra da prilagodbe doze nisu potrebne (vidjeti dio
English: Population pharmacokinetic analyses indicated that risankizumab exposure was not impacted by concomitant medications (metformin, atorvastatin, lisinopril, amlodipine, ibuprofen, acetylsalicylate and levothyroxine) used by some subjects with plaque psoriasis during the clinical studies.
Croatian: Populacijske farmakokinetičke analize ukazale su na to da na izloženost risankizumabu nisu utjecali istodobno primijenjeni lijekovi (metformin, atorvastatin, lizinopril, amlodipin, ibuprofen, acetilsalicilat i levotiroksin) koje su neki ispitanici s plak psorijazom uzimali tijekom kliničkih ispitivanja.
English: Talk to your doctor, pharmacist or nurse if you need help
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri ako trebate pomoć.
English: The effect of risankizumab on human fertility has not been evaluated.
Croatian: Nije se procjenjivao učinak risankizumaba na plodnost ljudi.
English: Week 16 109 (35.9) Week 52 171 (56.3) DLQI 0 or 1
Croatian: 16. tjedan 109 (35,9) 52. tjedan 171 (56,3) DLQI 0 ili 1
English: Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines.
Croatian: Prije uvođenja terapije risankizumabom potrebno je razmotriti dovršetak odgovarajućih programa cijepljenja u skladu s važećim smjernicama.
English: Mutagenicity and carcinogenicity studies have not been conducted with risankizumab.
Croatian: Nisu provedena ispitivanja mutagenosti i kancerogenog potencijala risankizumaba.
English: Change at Week 52 (SE)
Croatian: Promjena u 52. tjednu (SP)
English: What Skyrizi contains
Croatian: Što Skyrizi sadrži
English: The recommended dose is 150 mg (two 75 mg injections) administered by subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.
Croatian: Preporučena doza je 150 mg (dvije injekcije od 75 mg) primijenjeno supkutanom injekcijom u 0. tjednu, 4. tjednu i zatim svakih 12 tjedana.
English: Baseline sPGA score was severe in 19.3% of subjects and moderate in 80.7% of subjects.
Croatian: Početni sPGA rezultat ukazivao je na tešku bolest u 19,3% ispitanika te umjerenu bolest u 80,7% ispitanika.
English: The two co-primary endpoints in ULTIMMA-1 and ULTIMMA-2 were the proportion of subjects who achieved 1) PASI 90 response and 2) sPGA score of clear or almost clear (sPGA 0 or 1) at week 16 versus placebo.
Croatian: ULTIMMA-1 i ULTIMMA-2 bile su udio ispitanika koji su postigli: 1) odgovor PASI 90 i 2) sPGA rezultat „čisto“ ili „gotovo čisto“ (sPGA 0 ili 1) u 16. tjednu u odnosu na placebo.
English: • You should receive training on how to inject Skyrizi before giving an injection.
Croatian: • Prije primjene morate proći obuku o tome kako injicirati lijek Skyrizi.
English: • Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
Croatian: • Nemojte injicirati lijek u kožu koja je bolna na dodir, prekrivena modricama, crvena, tvrda ili prekrivena ožiljcima ili strijama.
English: With dosing of 150 mg at week 0, week 4 and every 12 weeks thereafter, estimated steady-state peak and trough plasma concentrations are 12 and 2 µg/mL, respectively.
Croatian: Kod primjene doze od 150 mg u 0. tjednu i 4. tjednu te svakih 12 tjedana nakon toga, procijenjena vršna koncentracija u plazmi u stanju dinamičke ravnoteže iznosi 12 µg/ml, a procijenjena najniža plazmatska koncentracija 2 µg/ml.
English: This medicinal product contains 68.0 mg sorbitol per 150 mg dose.
Croatian: Ovaj lijek sadrži 68,0 mg sorbitola po dozi od 150 mg.
English: IMMVENT enrolled 605 subjects (301 randomised to risankizumab and 304 to adalimumab).
Croatian: U ispitivanje IMMVENT bilo je uključeno 605 ispitanika (301 bio je randomiziran za liječenje risankizumabom, a 304 za liječenje adalimumabom).
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na plodnost.
English: ULTIMMA-1 and ULTIMMA-2 enrolled 997 subjects (598 randomised to risankizumab 150 mg, 199 to ustekinumab 45 mg or 90 mg [according to baseline weight], and 200 to placebo).
Croatian: U ispitivanja ULTIMMA-1 i ULTIMMA-2 bilo je uključeno 997 ispitanika (598 njih bilo je randomizirano za liječenje risankizumabom u dozi od 150 mg, 199 za liječenje ustekinumabom u dozi od 45 mg ili 90 mg [ovisno o početnoj težini], a 200 za primanje placeba).
English: By blocking IL-23 from binding to its receptor, risankizumab inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines.
Croatian: Blokiranjem vezivanja IL-23 za njegov receptor, risankizumab inhibira o interleukinu-23 ovisnu staničnu signalizaciju i oslobađanje proupalnih citokina.
English: Skyrizi is available in packs containing 2 pre-filled syringes and 2 alcohol pads.
Croatian: Skyrizi je dostupan u pakiranjima koja sadrže 2 napunjene štrcaljke i 2 jastučića natopljena alkoholom.
English: Comprehensive instructions for use are provided in the package leaflet.
Croatian: Detaljne upute za uporabu navedene su u uputi o lijeku.
English: Table 2: Efficacy and quality of life results in adults with plaque psoriasis in ULTIMMA-1 and ULTIMMA-2
Croatian: Tablica 2: Rezultati za djelotvornost i kvalitetu života u odraslih s plak psorijazom u ispitivanjima ULTIMMA-1 i ULTIMMA-2
English: In a 26-week chronic toxicology study in cynomolgus monkeys at doses of up to 50 mg/kg/week (about 70 times the clinical exposure at the MRHD), there were no pre-neoplastic or neoplastic lesions observed and no adverse immunotoxicity or cardiovascular effects were noted .
Croatian: U jednom 26-tjednom ispitivanju kronične toksičnosti u makaki majmuna uz doze do 50 mg/kg/tjedan (izloženosti približno 70 puta veće od kliničke izloženosti nakon primjene najveće preporučene doze za ljude) nisu opažene nikakve preneoplastične ni neoplastične lezije, kao ni štetni imunotoksični ili kardiovaskularni učinci.