FrancophonIA/ELRC3.0 huggingface dataset:
English: If hypotension occurs, this can be repeated, or intravenous albumin or packed red blood cells can be administered as clinically indicated.
Slovenian: Če pride do hipotenzije, se postopek lahko ponovi oz. se lahko da intravenski albumin ali pakirane eritrocite, kot je klinično indicirano.
English: Plasma concentrations of dinutuximab, especially trough levels, tended to be lower in patients with HACA.
Slovenian: Koncentracije dinutuksimaba v plazmi, še posebej tik pred naslednjim odmerkom, so bili nižji pri bolnikih s HACA.
English: Peripheral neuropathy Grade 2 peripheral motor neuropathy
Slovenian: Stopnja 2 periferna motorična nevropatija
English: In clinical trials, scheduled dinutuximab doses of up to 120 mg/m2 (60 mg/m2/day) have been administered with an adverse reaction profile similar to that described in section 4.8.
Slovenian: V kliničnih preskušanjih so bili aplicirani odmerki dinutuksimaba do 120 mg/m2 (60 mg/m2/dan), s profilom neželenih učinkov, podobnem tistemu, ki je opisan v poglavju 4.8.
English: What you need to know before you are given Unituxin 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Unituxin 3.
English: Systemic infection or sepsis Grade 3 or 4
Slovenian: Sistemska infekcija ali sepsa Stopnja 3 ali 4
English: Dinutuximab (or the murine monoclonal antibody 14.18) has been administered to mice, rabbits, rats, and dogs in single- or repeat-dose regimens that exceed the dose that is used clinically.
Slovenian: Dinutuksimab (oz. mišje monoklonsko protitelo 14.18) je bil apiciran mišim, kuncem, podganam in psom v posameznih odmerkih ali v ponavljajočih se odmerkih, ki presegajo klinično uporabljeni odmerek.
English: Dinutuximab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by ubiquitous proteolytic enzymes.
Slovenian: Biotransformacija Dinutuksimab je protein, katerega predvidena presnovna pot je razgraditev v majhne peptide in individualne aminokisline prek ubikvitarnih proteolitičnih encimov.
English: There is insufficient information on the excretion of dinutuximab in human milk.
Slovenian: Ni dovolj podatkov o izločanju dinutuksimaba v materino mleko.
English: • If symptoms resolve that day, resume the next day with premedication in the intensive care setting.
Slovenian: • Če simptomi izzvenijo tisti dan, naslednji dan ponovno začnite premedikacijo v intenzivni negi.
English: To reduce the risk of the cancer coming back, Unituxin is given at the last stage of the treatment to eliminate small amounts of disease which may still be present after the cancer has responded to chemotherapy, surgery, and an autologous (self-donating) blood cell transplant.
Slovenian: Za preprečevanje ponovnega pojava raka se zdravilo Unituxin daje v zadnji stopnji zdravljenja za uničenje ostankov bolezni, ki so morda še vedno prisotni po tem, ko se je rak odzval na kemoterapijo, kirurški poseg in avtologno presaditev (lastnih) krvnih celic.
English: Pre-medication should always be considered before starting each infusion (see section 4.4).
Slovenian: Pred začetkom posamezne infuzije je treba vedno upoštevati premedikacijo (glejte poglavje 4.4).
English: Immunoglobulin must not be given within two weeks before and one week after completing each course of Unituxin.
Slovenian: Imunoglobulina se ne sme dajati dva tedna pred in en teden po zaključku posameznega cikla z zdravilom Unituxin.
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli zdravilo, tudi če ste ga dobili brez recepta.
English: • Any kind of pain: in the stomach, throat, chest, face, hands, feet, legs or arms (such as numbness, tingling or burning) back, neck, joint, bone, muscle, mouth, eye, genitals.
Slovenian: • katere koli bolečine: v želodcu, grlu, prsih, na obrazu, dlaneh, stopalih, nogah ali rokah (na primer odrevenelost, mravljinčenje ali skelenje), hrbtu, v vratu, sklepu, kosteh, mišicah, ustih, očesu,
English: In addition, it has been shown to induce both antibody dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity in vitro.
Slovenian: Poleg tega je bilo dokazano, da povzroča bodisi od protiteles odvisno celično posredovano citotoksičnost (ADCC- antibody dependent cell-mediated cytotoxicity) bodisi od komplementa odvisno cititoksičnost in vitro.
English: Hence, this medicinal product is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Zdravila ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: • Pain - tell your doctor or nurse if you get any pain.
Slovenian: • Bolečine - obvestite svojega zdravnika ali medicinsko sestro, če čutite bolečine.
English: It is recommended to administer oral metolazone or intravenous furosemide every 6-12 hours as required.
Slovenian: Priporoča se peroralno dajanje metolazona ali intravenskega furosemida vsakih 6-12 ur, če je potrebno.
English: Unituxin is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).
Slovenian: Zdravilo Unituxin je indicirano za zdravljenje nevroblastoma z visokim tveganjem pri bolnikih, starih od 12 mesecev do 17 let, ki so že prejeli indukcijsko kemoterapijo in dosegli vsaj delni odgovor, po katerem so prejeli še mieloablacijsko terapijo in avtologno presaditev matičnih celic (ASCT- autologous stem cell transplantation).
English: Capillary leak syndrome Grade 3 (severe) Onset of symptoms
Slovenian: Sindrom kapilarnih razpok Stopnja 3 (resna) Nastop simptomov
English: As this medicinal product is used in combination with GM-CSF, IL-2, and isotretinoin, it is difficult to ascertain the causal relationship of each adverse reaction to a particular medicinal product.
Slovenian: V kolikor se to zdravilo uporablja v kombinaciji z GM-CSF, IL-2 in izotretinoinom, je težko ugotoviti vzročno povezavo posameznih neželenih učinkov z določenim zdravilom.
English: It is recommended that treatment for such reactions include hydrocortisone administered by intravenous bolus, and epinephrine administered by intravenous bolus once every 3-5 minutes as necessary according to clinical response.
Slovenian: Priporoča se, da zdravljenje tovrstnih reakcij vključuje hidrokortizon, apliciran v obliki intravenskega bolusa, in epinefrin, apliciran v obliki intravenskega bolusa, vsakih 3-5 minut, kot je treba glede na klinični odgovor.
English: • If signs and symptoms resolve rapidly with the above measures, dinutuximab infusion may be resumed at a rate of 0.875 mg/m2/h.
Slovenian: • Če znaki in simptomi hitro izginejo po zgornjih ukrepih, se lahko ponovno daje infuzija dinutuksimaba s hitrostjo 0,875 mg/m2/h.
English: • Resume infusion at the original rate.
Slovenian: • Ponovno vzpostavite prvotno hitrost infuzije.
English: Atrial fibrillation, ventricular arrhythmia
Slovenian: atrijska fibrilacija, ventrikularna aritmija
English: Unequal pupils
Slovenian: - neenakomerni zenici
English: • If blood pressure (BP) remains stable for at least 2 hours, resume GM
Slovenian: • Če krvni tlak ostane stabilen najmanj 2 uri po ponovnem dajanju GM
English: Non-clinical studies demonstrate that dinutuximab-induced neurotoxicity is likely due to the induction of mechanical allodynia that may be mediated by reactivity of dinutuximab with GD2 antigen located on the surface of peripheral nerve fibres and/or myelin.
Slovenian: Neklinične študije so dokazale, da nevrotoksičnost, ki jo povzroča dinutuksimab, verjetno nastane zaradi sprožitve mehanske alodinije, ki se lahko posreduje prek reaktivnosti dinutuksimab z antigenom GD2 na površini perifernih živčnih vlaken in/ali mielina.
English: Do not use this medicine if you notice any particulate matter or discolouration prior to administration.
Slovenian: Ne uporabljajte tega zdravila, če pred jemanjem opazite katere koli znake kvarjenja ali obarvanje.
English: It is not recommended to use intravenous immunoglobulin after ASCT.
Slovenian: Uporaba intravenskega imunoglobulina po avtologni presaditvi matičnih celic (ASCT) ni priporočljiva.
English: (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100).
Slovenian: Kategorije pogostnosti so navedene kot sledi: zelo pogosti (≥1/10); pogosti ((≥1/100 do <1/10); občasni (≥1/1.000 do <1/100).
English: The infusion is started at a dose rate of 0.875 mg/m2/h and continued at this rate for 30 minutes; the rate is then increased to 1.75 mg/m2/h and continued at this rate for the remainder of the infusion, if tolerated.
Slovenian: Začetna hitrost infundiranja je 0,875 mg/m2/h in jo je treba obdržati 30 minut, nato je treba povečati hitrost na 1,75 mg/m2/h in nadaljevati pri tej hitrosti preostali del cikla zdravljenja, če ga bolnik prenaša.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek.
English: Refer to section 4.2 for advice on tapering off or discontinuation of this medicinal product.
Slovenian: Za nasvete glede znižanja odmerka ali prekinitve zdravljenja s tem zdravilom glejte poglavje 4.2.
English: These studies support the current dinutuximab dosing regimen of 17.5 mg/m2/day administered for four consecutive days during five monthly courses.
Slovenian: Te študije podpirajo trenutni režim odmerjanja 17,5 mg/m2/dan, štiri zaporedne dni v petih mesečnih ciklih.
English: • Delay initiation of first course until alanine aminotransferase (ALT) is less than 5 times upper limit of normal (ULN).
Slovenian: • Odložite začetek prvega cikla zdravljenja, dokler alanin-aminotransferaza (ALT) ni < 5 x višja od zgornje meje normalnih vrednosti (ULN - upper limit of normal).
English: 6.6 Special precautions for disposal and other handling The exact volume of Unituxin concentrate for solution for infusion required for the patient dose (see section 4.2) must be injected into a 100 mL bag of sodium chloride 9 mg/mL (0.9 %) solution for injection.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Točen volumen zdravila Unituxin koncentrat za raztopino za infundiranje, potreben za bolnikov odmerek (glejte poglavje 4.2), je treba injicirati v 100 mililitrsko vrečko natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje.
English: During the last two weeks in each of the six courses, subjects in both the control and the dinutuximab immunotherapy arms were also given oral isotretinoin at a dose of 160 mg/m2/day (given as 80 mg/m2 twice daily).
Slovenian: V zadnjih dveh tednih vsakega od šestih ciklov so bolniki tako v kontrolni skupini kot v skupini imunoterapije z dinutuksimabom peroralno prejemali izotretinoin v odmerku 160 mg/m2/dan (odmerek po 80 mg/m2 dvakrat na dan).
English: Warnings and precautions
Slovenian: Posebna opozorila in previdnostni ukrepi
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 17.5 mg/5 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 17,5 mg/5 ml
English: • Unituxin is given as a drip into one of your veins - for about 10 hours each day for four days.
Slovenian: • Zdravilo Unituxin boste jemali v obliki kapalne infuzije v žilo - približno 10 ur na dan, štiri dni.
English: Unopened vial
Slovenian: Zaprta viala
English: • Delay initiation of first course until absolute phagocyte count (APC) is at least 1,000/μL.
Slovenian: • Odložite začetek prvega cikla zdravljenja, dokler absolutna vrednost fagocitov (APC - absolute phagocyte count) ni najmanj 1.000/µl.
English: Like all medicines, this medicine, which is given with GM-CSF, IL-2 and isotretinoin can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo, ki se uporablja skupaj z GM-CSF, IL-2 in izotretinoinom, neželene učinke, vendar pa se ti ne pojavijo pri vseh bolnikih.
English: It is administered in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and isotretinoin.
Slovenian: Daje se v kombinaciji z granulocitno-makrofagne kolonije stimulirajočim faktorjem (GMCSF), interleukinom-2 (IL-2) in izotretinoinom.
English: Grade 4(life-threatening) Onset of symptoms
Slovenian: Stopnja 4 (življenje ogrožajoča) Nastop simptomov
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Slovenian: Če imate katero koli nadaljnje vprašanje v zvezi z uporabo tega zdravila, se posvetujte s svojim zdravnikom ali medicinsko sestro.
English: Pre-medication should always be considered before starting each infusion.
Slovenian: Pred začetkom posamezne infuzije je treba vedno upoštevati premedikacijo.
English: • Problems with your nerves - you may notice numbness, tingling or burning in your hands, feet, legs or arms, reduced sensation or weakness with movement (peripheral neuropathy).
Slovenian: • Živčne težave - lahko boste občutili odrevenelost, mravljinčenje ali skelenje v dlaneh, stopalih, nogah ali rokah, zmanjšano občutljivost ali oslabelost pri gibanju (periferna nevropatija).
English: They help the immune system to target certain cells, such as cancer cells, by ‘sticking' to them.
Slovenian: Ta delujejo podobno kot protitelesa, ki jih telo naravno proizvaja in pomagajo imunskemu sistemu ciljati določene celice, kot so na primer rakaste celice, s tem, da se »prilepijo« nanje.
English: If any of the above apply to you (or you are not sure), talk to your doctor or nurse before being given Unituxin.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se pred uporabo zdravila Unituxin posvetujte z zdravnikom ali z medicinsko sestro.
English: Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures (see sections 4.2 and 4.8).
Slovenian: Zdravilo Unituxin je treba ukiniti, če bolečine ni mogoče primerno nadzorovati kljub zmanjšanju hitrosti infuzije in vzpostavitvi vseh podpornih ukrepov (glejte poglavji 4.2 in 4.8).
English: The clinical study report should be submitted by PASS: In order to better characterise the safety and immunogenicity of Unituxin and its impact on drug exposure, the applicant should conduct and submit the results of a safety study.
Slovenian: PASS: Za lažjo določitev varnosti in imunogenosti zdravila Unituxin ter njegovega vpliva na izpostavljenost zdravlni učinkovini mora predlagatelj voditi in predložiti rezultate varnostne študije.
English: Grade 3 or 4 Onset of symptoms
Slovenian: Stopnja 3 ali 4 Nastop simptomov
English: • If it is possible for you to become pregnant and you are not using contraception, talk to your doctor before being given this medicine.
Slovenian: • Če obstaja možnost, da zanosite, in ne uporabljate kontracepcije, se posvetujte s svojim zdravnikom,
English: Antihistamine premedication (e.g. hydroxyzine or diphenhydramine) should be administered by intravenous injection approximately 20 minutes before starting each dinutuximab infusion.
Slovenian: Premedikacijo z antihistaminiki (npr. hidroksizin ali difenhidramin) je treba izvajati v obliki intravenske injekcije približno 20 minut pred začetkom vsake infuzije dinutuksimaba.
English: Unituxin is used with three other medicines: - Isotretinoin - GM-CSF - IL-2
Slovenian: Zdravilo Unituxin se uporablja s tremi drugimi zdravili, imenovanimi: - izotretinoin - GM-CSF - IL-2
English: Epinephrine (adrenaline) and hydrocortisone for intravenous administration should be immediately available at the bedside during administration of dinutuximab to manage life-threatening allergic reactions.
Slovenian: Med dajanjem dinutuksimaba morata biti epinefrin (adrenalin) in hidrokortizon za intravensko dajanje takoj na razpolago ob bolniški postelji za obvladovanje življenjsko nevarnih alergijskih reakcij.
English: The recommended dose is 17.5 mg/m2.
Slovenian: Običajen odmerek je 17,5 mg/m2.
English: Following ASCT, 226 subjects were randomly assigned 1:1 to either a standard therapy arm (six courses of isotretinoin) or a dinutuximab immunotherapy arm (five courses of dinutuximab in combination with alternating GM-CSF and IL-2; combined with isotretinoin concurrently for six courses).
Slovenian: Po ASCT je bilo 226 bolnikov randomiziranih v razmerju 1:1 standardni terapevtski skupini (šest ciklov izotretinoina) oz. skupini imunoterapije z dinutuksimabom (pet ciklov dinutuksimaba v kombinaciji izmenično z GM-CSF ali IL-2; kombinirano hkrati z izotretinoinom za šest ciklov).
English: Unituxin is a cancer medicine that contains the active substance dinutuximab.
Slovenian: Unituxin je zdravilo proti raku, ki vsebuje zdravilno učinkovino dinutuksimab.
English: Characteristic symptoms and signs include hypotension, generalized oedema, ascites, dyspnoea, pulmonary oedema and acute renal failure associated with hypoalbuminaemia and haemoconcentration.
Slovenian: Značilni simptomi in znaki vključujejo hipotenzijo, splošen edem, ascites, dispnejo, pljučni edem in akutno odpoved ledvic v povezavi s hipoalbuminemijo in hemokoncentracijo.
English: What Unituxin looks like and contents of the pack
Slovenian: Videz zdravila Unituxin in vsebina pakiranja
English: • Delay course initiation until dyspnoea at rest has been resolved and/or peripheral oxygen saturation is at least 94 % on room air. Renal dysfunction
Slovenian: • Odložite začetek cikla zdravljenja, dokler dispneja med mirovanjem ni odpravljena in/ali je periferna nasičenost s kisikom v sobnem zraku najmanj 94 %.
English: GM-CSF was administered at a dose of 250 μg/m2/day during Courses 1, 3, and 5 and dosed daily for 14 days.
Slovenian: GM-CSF se je dajal v odmerku 250 μg/m2/dan med cikli 1, 3 in 5, dnevno za 14 dni.
English: What you need to know before you are given Unituxin
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Unituxin
English: Ibuprofen should not be administered if there is evidence of thrombocytopenia, bleeding, or renal dysfunction.
Slovenian: Ibuprofena se ne sme dajati v primeru trombocitopenije, krvavenja ali motenj v delovanju ledvic.
English: Unituxin should not be administered as an intravenous push or bolus.
Slovenian: Zdravilo Unituxin se ne sme dajati kot intravensko hitro infuzijo ali bolus.
English: Non-interventional post authorisation safety study (PASS): In order to evaluate the long-term safety outcomes of dinutuximab in high-risk neuroblastoma patients (including central and peripheral nervous system, prevalence of organ dysfunction, long-term effects on growth and endocrine development, hearing loss, cardiac toxicity and survival data) the applicant should conduct and submit the results of a safety registry.
Slovenian: Do datuma tveganjem (vključno s centralnim in perifernim živčnim sistemom, prevladujočim nedelovanjem organov, dolgotrajnimi učinki na rast in endokrini razvoj, izgubo sluha, srčno toksičnostjo in podatki o preživetju), mora predlagatelj voditi in predložiti rezultate registra o varnosti.
English: Unituxin is to be administered by intravenous infusion over five courses at a daily dose of 17.5 mg/m2.
Slovenian: Zdravilo Unituxin se daje z intravensko infuzijo v petih ciklih zdravljenja z dnevnim odmerkom 17,5 mg/m2.
English: If tolerated, increase GM-CSF or IL-2 to full dose the next day.
Slovenian: Če ga prenaša, povišajte GM-CSF ali IL-2 do celotnega odmerka naslednji dan.
English: • If patient has CNS metastases, delay course initiation and give platelet transfusion to maintain platelet count at least 50,000/μL.
Slovenian: • Če ima bolnik metastaze na osrednjem živčnem sistemu, odložite začetek cikla zdravljenja in dajte transfuzijo trombocitov, da se število trombocitov ohrani na najmanj 50.000/µl.
English: Long-term overall survival was evaluated with 5 years of follow up after the EFS analysis and continued to demonstrate a survival advantage for patients who received dinutuximab immunotherapy compared to those who received isotretinoin alone.
Slovenian: Dolgoročno splošno preživetje je bilo ocenjeno s petletnim sledenjem po EFS analizi in je dokazalo večje možnosti preživetja pri bolnikih, zdravljenih z imunoterapijo z dinutuksimabom v primerjavi z bolniki, zdravljenimi samo z izotretinoinom.
English: 5.3 Preclinical safety data
Slovenian: 5.3 Predklinični podatki o varnosti Splošna toksičnost
English: Unituxin will be given to you by a doctor or nurse while you are in hospital.
Slovenian: Zdravilo Unituxin vam bo dal zdravnik ali medicinska sestra, ko boste v bolnišnici, v obliki kapalne infuzije v žilo (intravenska infuzija).
English: • For IL-2 courses, administer IL-2 at 50 % of the dose starting the next day and continue for the remainder of the course.
Slovenian: • Za cikle zdravljenja z IL-2, aplicirajte 50 % odmerka IL-2, začenši z naslednjim dnem in nadaljujte za ostali del cikla.
English: See section 4 for more information about pain side effects.
Slovenian: Glejte poglavje 4 za dodatne informacije o bolečinah, ki so posledica neželenih učinkov.
English: Patients typically have a central venous catheter in situ and as a consequence of prior ASCT are likely to be immunocompromised during therapy, and therefore, at risk of developing systemic infection.
Slovenian: Bolniki imajo ponavadi centralni venski kateter in situ in zaradi avtologne presaditve matičnih celic je med terapijo oslabljen njihov imunski sistem, zato je tveganje za sistemske okužbe večje.
English: Laboratory test abnormalities
Slovenian: Nenormalni rezultati laboratorijskih testov
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before being given this medicine.
Slovenian: Nosečnost • Če ste ali mislite, da ste noseči oz. načrtujete zanositev, se posvetujte s svojim zdravnikom ali medicinsko sestro, preden uporabite to zdravilo.
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat)
English: Serum sickness
Slovenian: Serumska bolezen
English: No non-clinical studies to evaluate the potential of dinutuximab to cause carcinogenicity, genotoxicity, or developmental and reproductive toxicity have been conducted.
Slovenian: Neklinične študije za oceno karcinogenega in genotoksičnega potenciala dinutuksimaba, ter vpliva na sposobnost razmnoževanja niso bile izvedene.
English: • Rapid swelling of the arms, legs and other parts of your body, rapid drop in blood pressure, lightheadedness and breathing difficulties (Capillary Leak Syndrome).
Slovenian: • hitro otekanje rok, nog in drugih delov telesa, nenaden padec krvnega tlaka, omotičnost in težave z dihanjem (sindrom kapilarnih razpok);
English: • GM-CSF is given as either an injection under the skin or as a drip into one of your veins each day for
Slovenian: • GM-CSF boste prejeli ali kot podkožno injekcijo ali kot kapalno infuzijo v žilo vsak dan, 14 dni.
English: The 5 year estimates of OS were 74 % for dinutuximab immunotherapy compared to 57 % for isotretinoin alone (log-rank test p = 0.030).
Slovenian: Petletne ocene splošnega preživetja so bile 74 % za imunoterapijo z dinutuksimabom v primerjavi z 57 % za terapijo izključno z izotretinoinom (log-rank test p = 0,030).
English: Human IgG is known to be secreted in human milk.
Slovenian: Humana protitelesa IgG se izločajo v materino mleko.
English: These adverse reactions are presented by MedDRA system organ class and frequency.
Slovenian: Ti neželeni učinki so predstavljeni v skladu z organskimi sistemi in pogostnostjo po MedDRA.
English: Patients should be monitored for signs and symptoms of infusion reactions for 4 hours after the completion of the Unituxin infusion.
Slovenian: Bolnike je treba 4 ure po zaključku infuzije zdravila Unituxin spremljati za znake in simptome infuzijskih reakcij.
English: Electrolyte abnormalities have been reported in patients who received Unituxin (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo Unituxin, so se pojavile nenormalne vrednosti elektrolitov (glejte poglavje 4.8).