FrancophonIA/ELRC3.0 huggingface dataset:
English: Most had an initial diagnosis of INSS stage 4 disease without MYCN amplification (16% of the subjects had MYCN amplified tumours and in 14% this information was missing).
Slovenian: Večina jih je imela začetno diagnozo bolezni stopnje 4 po INSS (International Neuroblastoma Staging System - mednarodni sistem stopenj nevroblastoma) brez amplifikacije MYCN (16 % udeležencev je imelo z genom MYCN amplificirane tumorje, pri 14 % pa tega podatka ni bilo).
English: Psychiatric disorders agitation, anxiety
Slovenian: Psihiatrične motnje agitacija, anksioznost
English: Prior to the treatment of relapsed neuroblastoma, your treating physician will stabilise any actively progressing disease by other suitable measures.
Slovenian: Pred zdravljenjem recidivnega nevroblastoma bo vaš lečeči zdravnik stabiliziral morebitno aktivno napredujočo bolezen z drugimi primernimi ukrepi.
English: Laboratory abnormalities Regulatory monitoring of liver function and electrolytes is recommended.
Slovenian: Nenormalni rezultati laboratorijskih testov Priporočljivo je spremljanje jetrne funkcije in elektrolitov.
English: Qarziba is for intravenous infusion.
Slovenian: Zdravilo Qarziba je namenjeno za intravensko infundiranje.
English: • pain in the stomach, throat, chest, face, hands, feet, legs, arms, back, neck, joint, or muscles
Slovenian: • bolečine v želodcu, grlu, prsih, na obrazu, v dlaneh, stopalih, nogah, rokah, hrbtu, vratu, sklepih ali mišicah
English: • or five daily infusions of 20 mg/m2 administered over 8 hours, on the first 5 days of each course
Slovenian: • ali pet dnevnih infuzij po 20 mg/m2, danih v osmih urah, prvih pet dni vsakega cikla.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Qarziba in one or more subsets of the paediatric population in neuroblastoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Qarziba za eno ali več podskupin pediatrične populacije pri zdravljenju nevroblastoma (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • formation of blood clots in the small blood vessels (disseminated intravascular coagulation)
Slovenian: • nastanek krvnih strdkov v majhnih krvnih žilah (diseminirana intravaskularna koagulacija)
English: Severe eye disorders were also reported including ophthalmoplegia (2%) and optic atrophy.
Slovenian: Poročali so tudi o hudih očesnih boleznih, vključno z oftalmoplegijo (2 %) in optično atrofijo.
English: Qarziba will be given to you in five treatment courses of 35 days and the infusion will last 5 or 10 days in the beginning of each course.
Slovenian: Zdravilo Qarziba vam bodo dajali v petih ciklih zdravljenja, ki obsegajo 35 dni, infuzija pa bo trajala 5 ali 10 dni na začetku vsakega cikla.
English: The effects of dinutuximab beta on fertility in humans are unknown.
Slovenian: Učinki dinutuksimaba beta na plodnost pri ljudeh niso znani.
English: Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures.
Slovenian: Pred zdravljenjem recidivnega nevroblastoma je treba morebitno aktivno napredujočo bolezen stabilizirati z drugimi ustreznimi ukrepi.
English: After reaching steady state, no difference in exposure is predicted, with and without ADA formation.
Slovenian: Po dosegu dinamičnega ravnovesja ne predvidevamo razlike v izpostavljenosti, niti ob nastajanju ADA niti brez njega.
English: The safety of dinutuximab beta has been evaluated in 514 patients with high-risk and relapsed/refractory neuroblastoma, who received it as a continuous infusion (98) or as repeated daily infusions (416).
Slovenian: Varnost dinutuksimaba beta so ocenjevali pri 514 bolnikih z nevroblastomom z visokim tveganjem ter z recidivnim ali neodzivnim nevroblastomom, ki so zdravilo prejemali v obliki neprekinjene infuzije (98) ali kot ponavljajoče se vsakodnevne infuzije (416).
English: • tissue swelling (in the face, lip, around the eye, in the lower limbs)
Slovenian: • otekanje tkiva (obraza, ustnic, okrog oči, v spodnjih okončinah)
English: The solution should be administered via a peripheral or central intravenous line.
Slovenian: Raztopino je treba dati prek periferne ali centralne intravenske linije.
English: The bone marrow changes were slight to severe and recovered after cessation of dosing.
Slovenian: Spremembe kostnega mozga so bile majhne do hude in so se izboljšale po prekinitvi odmerjanja.
English: In the case of overdose, patients should be carefully observed for signs or symptoms of adverse reactions and supportive care administered, as appropriate.
Slovenian: V primeru prevelikega odmerjanja je treba pri bolnikih natančno spremljati znake ali simptome neželenih učinkov in uvesti primerno podporno zdravljenje.
English: Survival rates (event-free survival, overall survival) are presented by type of disease in Table 1.
Slovenian: Stopnje preživetja (preživetje brez bolezenskih dogodkov, skupno preživetje) so predstavljene po vrsti bolezni v preglednici 1.
English: Dilated pupils with sluggish light reflex +/- photophobia
Slovenian: Razširjene zenice s počasnim refleksom na svetlobo +/fotofobija
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC
English: The patient specific daily dose of Qarziba is calculated based on body surface area (see section 4.2).
Slovenian: Dnevni odmerek zdravila Qarziba za posameznega bolnika se izračuna na podlagi njegove telesne površine (glejte poglavje 4.2).
English: • agitation, anxiety
Slovenian: • agitacija, anksioznost
English: • decreased weight, loss of fluids (dehydration)
Slovenian: • izguba telesne mase, izguba tekočin (dehidracija).
English: Mean plasma Cmax levels (around 12 micrograms/mL) were reached on the last day of infusion.
Slovenian: Povprečne vrednosti Cmax v plazmi (približno 12 mikrogramov/ml) so bile dosežene zadnji dan infundiranja.
English: The individual dose is determined based on the body surface area and should be a total of 100 mg/m2 per course.
Slovenian: Posamezni odmerek se določi na podlagi telesne površine in mora skupaj znašati 100 mg/m2 na cikel.
English: Dinutuximab beta has major influence on the ability to drive and use machines.
Slovenian: Zdravilo Dinutuksimab beta ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
English: Therefore, your doctor will give you an appropriate pain treatment starting 3 days before and continuing during use of Qarziba.
Slovenian: Zato vam bo zdravnik dajal ustrezna zdravila za obvladovanje bolečine tri dni pred začetkom zdravljenja in ves čas uporabe zdravila Qarziba.
English: Mean plasma Cmax levels, observed during 8-hour infusions (20 mg/m2/day on five consecutive days), were determined in another study (n=15).
Slovenian: Povprečne vrednosti Cmax v plazmi, ki so jih opazili med osemurnimi infuzijami (20 mg/m2/dan v petih zaporednih dneh), so bile ugotovljene v drugi študiji (n = 15).
English: No animal data are available on teratogenicity or embryotoxicity.
Slovenian: Podatki o teratogenosti in embriotoksičnosti pri živalih niso na voljo.
English: It is recommended that a 0.22 micrometre in-line filter is used during infusion.
Slovenian: Med infuzijo je priporočljiva uporaba 0,22-mikrometrskega filtra v infuzijski liniji.
English: If your doctor considers co-administration of interleukin-2, it will be given twice, by injection under the skin, each time for 5 consecutive days (before and during treatment with Qarziba).
Slovenian: Če se bo zdravnik odločil za sočasno dajanje interlevkina-2, vam ga bodo dali dvakrat, z injiciranjem pod kožo, vsakokrat po pet zaporednih dni (pred zdravljenjem z zdravilom Qarziba in med njim).
English: The pharmacokinetics of dinutuximab beta, based on 10-day continuous intravenous infusion of 10 mg/m2/day (equal to a total dose of 100 mg/m2/course) were evaluated in studies 1 and 2.
Slovenian: Farmakokinetika dinutuksimaba beta je bila na podlagi desetdnevne neprekinjene intravenske infuzije odmerka 10 mg/m2/dan (kar je enako skupnemu odmerku 100 mg/m2/cikel) ocenjena v študijah 1 in 2.
English: The exposure (Cmax and AUC24h on day 1 and day 10 during a 10-day infusion) is predicted to be similar in subjects with ages less than or equal to 12 years and decreases slightly for older, heavier subjects.
Slovenian: Predvidena izpostavljenost (Cmax in AUC24h na 1. in 10. dan med desetdnevno infuzijo) naj bi bila podobna pri bolnikih s starostjo, starih 12 let ali manj, in naj bi se nekoliko zmanjševala pri starejših in težjih bolnikih.
English: It was combined with 13-cis retinoic in most patients and with IL-2 in 307 patients.
Slovenian: Pri večini bolnikov so zdravljenje kombinirali s 13-cis-retinoidno kislino, pri 307 bolnikih pa z IL-2.
English: • With continuous infusion, in response to the patient's pain perception, it may be possible to wean off morphine over 5 days by progressively decreasing its dosing rate (e.g. to 0.02 mg/kg/hour, 0.01 mg/kg/hour, 0.005 mg/kg/hour).
Slovenian: • Pri neprekinjeni infuziji je glede na bolnikovo dojemanje bolečine dajanje morfina mogoče prekiniti v petih dneh, tako da postopno zmanjšate hitrost odmerjanja morfina (npr. na 0,02 mg/kg/h, 0,01 mg/kg/h, 0,005 mg/kg/h).
English: For 8-hour daily infusions, the solution is administered at a rate of approximately 13 mL per hour.
Slovenian: Za osemurne dnevne infuzije se raztopina daje s hitrostjo približno 13 ml na uro.
English: A population pharmacokinetic modelling approach was used to investigate the influence of covariates.
Slovenian: Za preučevanje vpliva sospremenljivk je bil uporabljen pristop modeliranja populacijske farmakokinetike.
English: Based on the physician's evaluation of the severity of adverse drug reactions to dinutuximab beta, patients may undergo a dose reduction of 50% or a temporary interruption of the infusion.
Slovenian: Glede na zdravnikovo oceno izraženosti neželenih reakcij na dinutuksimab beta bo pri bolnikih odmerek zdravila morda zmanjšan za 50 % ali pa bo infuzija začasno prekinjena.
English: Due to their immunosuppressive activity, concomitant treatment with corticosteroids is not recommended within 2 weeks prior to the first treatment course until 1 week after the last treatment course with dinutuximab beta, except for life-threatening conditions.
Slovenian: Zaradi njihovega imunosupresivnega delovanja sočasno zdravljenje s kortikosteroidi v dveh tednih pred prvim ciklom zdravljenja do enega tedna po zadnjem ciklu zdravljenja z dinutuksimabom beta ni priporočljivo, razen v primeru življenjsko nevarnih stanj.
English: Haematologic toxicities
Slovenian: Hematološke toksičnosti
English: It is recommended that women of childbearing potential use contraception for 6 months after discontinuation of treatment with dinutuximab beta.
Slovenian: Priporočljivo je, da ženske v rodni dobi uporabljajo kontracepcijo šest mesecev po prekinitvi zdravljenja z dinutuksimabom beta.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/4.5 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 20 mg/4,5 ml
English: It is recommended that treatment for such reactions include prednisolone administered by intravenous bolus, and epinephrine administered by intravenous bolus every 3 to 5 minutes as necessary, according to clinical response.
Slovenian: Priporoča se, da zdravljenje tovrstnih reakcij vključuje prednizolon, dan v obliki intravenskega bolusa, in adrenalin, dan v obliki intravenskega bolusa, vsakih 3-5 minut, skladno s kliničnim odzivom.
English: • prolonged grade 2 peripheral motor neuropathy
Slovenian: • daljša periferna motorična nevropatija stopnje 2,
English: Dinutuximab beta is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzmes.
Slovenian: Dinutuksimab beta je beljakovina, katera predvidena presnovna pot je razgraditev v majhne peptide in posamične aminokisline s pomočjo ubikvitarnih proteolitičnih encimov.
English: • a condition in which some of the small veins in the liver are obstructed (veno-occlusive disease)
Slovenian: • stanje, pri katerem so nekatere majhne vene v jetrih zamašene (venska okluzivna bolezen)
English: After weaning off intravenous morphine, in case of severe neuropathic pain, oral morphine sulphate (0.2 to 0.4 mg/kg every 4 to 6 hours) can be administered on demand.
Slovenian: Po prekinitvi intravenskega dajanja morfina je v primerih hude nevropatske bolečine mogoče po potrebi peroralno dati morfinijev sulfat (od 0,2 to 0,4 mg/kg vsakih 4 do 6 ur).
English: Cytokine release syndrome frequently manifests itself within minutes to hours of initiating the first infusion and is characterised by systemic symptoms such as fever, hypotension and urticaria.
Slovenian: Sindrom sproščanja citokinov se običajno pojavi v nekaj minutah ali urah po uvedbi prve infuzije, zanj pa so značilni sistemski simptomi, kot so povišana telesna temperatura, hipotenzija in urtikarija.
English: Qarziba is used to treat neuroblastoma that has a high risk of coming back after a series of treatments, which include a stem cell transplantation for rebuilding the immune system.
Slovenian: Zdravilo Qarziba uporabljamo za zdravljenje nevroblastoma, pri katerem obstaja veliko tveganje za njegov ponovni pojav po nizu zdravljenj, ki vključujejo presaditev matičnih celic za ponovno vzpostavitev imunskega sistema.
English: First-line patients who received autologous stem cell transplantation In study 3, patients with high-risk neuroblastoma were enrolled after they had received induction chemotherapy and achieved at least a partial response, then myeloablative therapy and stem cell transplantation.
Slovenian: Bolniki prve linije, ki so prejeli avtologno presaditev matičnih celic V študijo 3 so bili bolniki z nevroblastomom z visokim tveganjem vključeni po tem, ko so prejeli indukcijsko kemoterapijo in dosegli vsaj delni odziv, po čemer so prejeli še mieloablacijsko terapijo in presaditev matičnih celic.
English: Patients are likely to be immunocompromised as a result of prior therapies.
Slovenian: Bolniki imajo zaradi predhodnih zdravljenj zelo verjetno oslabljen imunski sistem.
English: Before receiving Qarziba, you will have blood tests to check your liver, lung, renal and bone marrow functions.
Slovenian: Preden boste prejeli zdravilo Qarziba, bodo pri vas opravili krvne preiskave, s katerimi bodo preverili delovanje vaših jeter, pljuč, ledvic in kostnega mozga.
English: It is recommended that antihistamine administration be repeated every 4 to 6 hours as required during dinutuximab infusion.
Slovenian: Priporoča se, da se dajanje antihistaminika med infuzijo dinutuksimaba ponovi vsakih 4-6 ur, kot je potrebno.
English: Diluted solution (solution for infusion)
Slovenian: Razredčena raztopina (raztopina za infundiranje)
English: Clear Type I glass vial (6 mL) with a halobutyl rubber stopper and aluminium flip-off cap, containing a minimum extractable volume of 4.5 mL concentrate for solution for infusion.
Slovenian: Prozorna viala (6 ml) iz stekla tipa I z zamaškom iz halobutilne gume in aluminijasto zaporko „flipoff“, ki vsebuje najmanjšo ekstraktibilno prostornino 4,5 ml koncentrata za raztopino za infundiranje.
English: Cytokine release syndrome was also reported in 32% of the patients.
Slovenian: Pri 32 % bolnikov so poročali tudi o sindromu sproščanja citokinov.
English: The development of anti-drug antibodies is a class effect of monoclonal chimeric antibodies.
Slovenian: Razvoj protiteles na zdravilo je učinek skupine monoklonskih himernih protiteles.
English: The combination of Qarziba with IL-2 increases the risk of adverse drug reactions compared to Qarziba without IL-2, especially for pyrexia (92% vs. 79%), CLS (50% vs. 25%), pain related to dinutuximab beta (75% vs. 63%), hypotension (43% vs. 26%), and peripheral neuropathy (14% vs. 7%), respectively.
Slovenian: Kombinacija zdravila Qarziba z IL-2 poveča tveganje za pojav neželenih učinkov, v primerjavi z zdravilom Qarziba brez IL-2, še zlasti za pireksijo (92 % v primerjavi z 79 %), CLS (50 % v primerjavi s 25 %), bolečino, povezano z dinutuksimabom beta (75 % v primerjavi s 63 %), hipotenzijo (43 % v primerjavi s 26 %) in periferno nevropatijo (14 % v primerjavi s 7 %).
English: Anaphylactic reactions may occur as early as within a few minutes of the first infusion with dinutuximab beta and are commonly associated with bronchospasm and urticaria.
Slovenian: Anafilaktične reakcije se lahko pojavijo že v nekaj minutah po začetku prve infuzije dinutuksimaba beta in so pogosto povezane z bronhospazmom in urtikarijo.
English: Occurrence of a severe infusion related reaction (including CRS) requires immediate discontinuation of dinutuximab beta therapy and may necessitate emergency treatment.
Slovenian: Če se pojavijo hude reakcije, povezane z infundiranjem (vključno s CRS), je treba takoj prekiniti zdravljenje z dinutuksimabom beta in po potrebi uvesti nujne ukrepe.
English: Qarziba has several side effects that may affect your ability to drive and use machines.
Slovenian: Zdravilo Qarziba ima več neželenih učinkov, ki lahko vplivajo na vašo sposobnost upravljanja vozil in strojev.
English: The solution for infusion should be administered via a peripheral or central intravenous line.
Slovenian: Raztopino za infundiranje je treba dati prek periferne ali centralne intravenske linije.
English: No non-clinical studies to evaluate the potential of dinutuximab beta to cause carcinogenicity, genotoxicity or developmental and reproductive toxicity have been conducted.
Slovenian: Neklinične študije za oceno karcinogenega in genotoksičnega potenciala dinutuksimaba beta ter njegovega vpliva na razvoj in reproduktivno toksičnost niso bile izvedene.
English: In the repeat-dose toxicity studies in Guinea pigs and cynomolgus monkeys, no adverse effects of dinutuximab beta were observed on reproductive organs at exposure levels above clinical levels.
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih, opravljenih na morskih prašičkih in javanskih makakih, niso opazili neželenih učinkov dinutuksimaba beta na reproduktivne organe pri ravneh izpostavljenosti, ki so presegale klinične ravni.
English: The most frequent hypersensitivity reactions included hypotension (39%), urticaria (18%) and bronchospasm (4%).
Slovenian: Preobčutljivostne reakcije, ki so se pojavljale najpogosteje, so vključevale hipotenzijo (39 %), urtikarijo (18 %) in bronhospazem (4 %).
English: Pain typically occurs during the first infusion of dinutuximab beta and decreases over the treatment courses.
Slovenian: Bolečine se tipično pojavijo med prvo infuzijo dinutuksimaba beta in se zmanjšajo v naslednjih ciklih zdravljenja.
English: Qarziba contains dinutuximab beta, which belongs to a group of medicines called ‘monoclonal antibodies'.
Slovenian: Zdravilo Qarziba vsebuje dinutuksimab beta, ki spada v skupino zdravil, imenovanih „monoklonska protitelesa“.
English: Other intravenously co-administered agents should be delivered via a separate infusion line.
Slovenian: Druga zdravila, ki se sočasno dajejo intravensko, je treba dovajati prek ločene infuzijske linije.
English: Capillary leak syndrome (CLS)
Slovenian: Sindrom povečane prepustnosti kapilar (CLS)
English: • dilated pupils or abnormal pupil reactions
Slovenian: • razširjene zenice ali nenormalne reakcije zenic
English: For moderate neuropathic pain, oral tramodol may be administered.
Slovenian: Pri zmerni nevropatski bolečini je mogoče peroralno dati tramadol.
English: Neurotoxicity associated to dinutuximab beta is likely due to the induction of mechanical allodynia that may be mediated by the reactivity of dinutuximab beta with the GD2 antigen located on the surface of peripheral nerve fibres and myelin.
Slovenian: Nevrotoksičnost, povezana z dinutuksimabom beta, verjetno nastane zaradi sprožitve mehanske alodinije, ki je lahko posledica reagiranja dinutuksimaba beta z antigenom GD2 na površini perifernih živčnih vlaken in mielina.
English: For continuous infusions, any medical device suitable for infusion at a rate of 2 mL per hour can be applied, e.g. syringe infusion pumps/infusors, electronic ambulatory infusion pumps.
Slovenian: Za neprekinjene infuzije je mogoče uporabiti kateri koli medicinski pripomoček, ki je primeren za infundiranje s hitrostjo 2 ml na uro, npr. infuzijske črpalke z brizgo/infuzorje, elektronske ambulantne infuzijske črpalke.
English: Additionally, in vivo studies demonstrated that dinutuximab beta could suppress liver metastasis in a syngeneic liver metastasis mouse model.
Slovenian: Poleg tega so študije in vivo pokazale, da lahko dinutuksimab beta zavira jetrne metastaze v singenskem mišjem modelu jetrnih metastaz.
English: If IL-2 is combined with dinutuximab beta, it should be given as subcutaneous injections for 5 consecutive days twice during each course.
Slovenian: Če se IL-2 daje v kombinaciji z zdravilom dinutuksimabom beta, ga je treba dati v obliki subkutanih injekcij pet zaporednih dni, dvakrat v vsakem ciklu zdravljenja.
English: Study 1 N=15
Slovenian: Študija 1 N = 15
English: In order to evaluate the long-term survival effect of dinutuximab, the MAH will submit at least 5-year survival data for patients included in studies APN311-202 and APN311-302.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora za oceno dolgotrajnih učinkov dinutuksimaba na preživetje predložiti podatke o najmanj petletnem preživetju bolnikov, vključenih v študiji APN311-202 in APN311-302.
English: • leakage from small blood vessels (capillary leak syndrome) Leakage of blood components from small blood vessels may cause rapid swelling in arms, legs and other parts of the body.
Slovenian: • iztekanje iz kapilar (sindrom povečane prepustnosti kapilar) Uhajanje komponent krvi skozi stene kapilar lahko povzroči hitro otekanje rok, nog in drugih delov telesa.
English: The patient-specific daily dose of Qarziba is calculated based on body surface area.
Slovenian: Dnevni odmerek zdravila Qarziba za posameznega bolnika se izračuna na podlagi njegove telesne površine.
English: Antihistamine premedication (e.g. diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab beta infusion.
Slovenian: Premedikacijo z antihistaminiki (npr. difenhidraminom) je treba dati v obliki intravenske injekcije približno 20 minut pred začetkom vsake infuzije dinutuksimaba beta.
English: You may only use Qarziba if your doctor assesses that benefits outweigh risks for a foetus.
Slovenian: Zdravilo Qarziba lahko uporabljate le, če zdravnik presodi, da koristi zdravila odtehtajo tveganja za plod.
English: Findings of note included changes (decrease) in thymus weight as well as bone marrow changes (atrophy affecting myeloid and erythroid precursor cell lines).
Slovenian: Pomembna odkritja so vključevala spremembe (zmanjšanje) mase priželjca in spremembe kostnega mozga (atrofija, ki vpliva na mieloidne in eritroidne prekurzorske celične linije).
English: Other frequent adverse reactions were hypersensitivity (63%), vomiting (57%), diarrhoea (51%), capillary leak syndrome (40%) and hypotension (39%).
Slovenian: Drugi pogosti neželeni učinki so bili preobčutljivost (63 %), bruhanje (57 %), driska (51 %), sindrom kapilarnega prepuščanja (40 %) in hipotenzija (39 %).
English: Dinutuximab beta has been administered to male and female juvenile Guinea pigs, as well as male and female young cynomolgus monkeys, as repeat-dose regimens that exceeded the recommended clinical dose.
Slovenian: Dinutuksimab beta so dajali nedoraslim samcem in samicam morskih prašičkov in mladim samcem in samicam javanskih makakov v ponavljajočih odmerkih, ki so presegali priporočeni klinični odmerek.
English: • The other ingredients are histidine, sucrose, polysorbate 20, water for injections, hydrochloric acid (for pH adjustment).
Slovenian: • Druge sestavine zdravila so histidin, saharoza, polisorbat 20, voda za injekcije, klorovodikova kislina (za uravnavanje pH).