FrancophonIA/ELRC3.0 huggingface dataset:
English: High-risk neuroblastoma was based on the patient age (greater than 12 months) and tumour stage at diagnosis and / or the presence of biological risk factors, such as MYCN amplification.
Slovenian: Nevroblastom z visokim tveganjem je temeljil na bolnikovi starosti (več kot 12 mesecev) in stopnji tumorja ob diagnozi in/ali prisotnosti bioloških faktorjev tveganja, kot npr. amplifikacija MYCN.
English: In particular, tell your doctor or nurse if you have recently received: - medicines called ‘corticosteroids' - these can affect the activity of your immune system which is important for Unituxin to work.
Slovenian: Obvestite svojega zdravnika ali medicinsko sestro še posebno, če ste pred kratkim jemali: - zdravila, imenovana »kortikosteroidi« - ti lahko vplivajo na delovanje imunskega sistema, kar je pomembno za učinkovanje zdravila Unituxin.
English: • You will be given isotretinoin to take by mouth for the last 14 days of each course.
Slovenian: • Izotretinoin boste jemali skozi usta zadnjih 14 dni posameznega cikla.
English: • Problems with your eyes - tell your doctor or nurse if you notice any problems with your eyes or changes to your vision.
Slovenian: • Težave z očmi - obvestite svojega zdravnika ali medicinsko sestro, če opazite katere koli težave z očmi ali spremembe vida.
English: Unituxin is used to treat ‘high-risk neuroblastoma' in babies, children and adolescents aged 12 months to 17 years old.
Slovenian: Zdravilo Unituxin uporabljamo za zdravljenje »nevroblastoma z visokim tveganjem« pri dojenčkih, otrocih in mladostnikih, starih od 12 mesecev do 17 let.
English: No interaction studies have been performed.
Slovenian: Študij interakcij niso izvedli.
English: Originally reported terms have been coded to preferred terms (using the Medical Dictionary for Regulatory Activities [MedDRA]).
Slovenian: Prvotno uporabljeni izrazi so bili zamenjani s priporočenimi izrazi v skladu z medicinskim slovarjem za regulatorne aktivnosti [MedDRA]).
English: Prior to starting each treatment course, refer to Table 3 for a list of criteria that must be evaluated.
Slovenian: Preden začnete posamezni terapevtski cikel, upoštevajte Preglednico 3 za seznam kriterijev, ki jih je treba oceniti.
English: Isotretinoin3
Slovenian: izotretinoin3
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Iz mikrobiološkega vidika je treba zdravilo uporabiti takoj.
English: When Unituxin attaches to the GD2 on the cancer cells, the patient's immune system starts to attack these cells and kill them.
Slovenian: Ko se zdravilo Unituxin pritrdi na GD2 rakastih celic, začne imunski sistem bolnika napadati te celice in jih pobije.
English: Additional adverse reactions characteristic of an allergic response were also reported - including anaphylactic reaction (18 %) and bronchospasm (4 %).
Slovenian: Navedeni so bili tudi dodatni neželeni učinki v obliki alergijskih reakcij, vključno z anafilaktičnimi reakcijami (18 %) in bronhospazmom (4 %).
English: No clinical signs of CNS toxicity were observed.
Slovenian: Znaki CNS toksičnosti niso bili opaženi.
English: • Administer supportive measures (see section 4.4).
Slovenian: • Nudite podporne ukrepe (glejte poglavje 4.4).
English: It is not recommended to use systemic corticosteroid medicinal products due to possible interference with immune activation which is necessary for the therapeutic action of dinutuximab.
Slovenian: Uporaba zdravil s sistemskimi kortikosteroidi ni priporočljiva zaradi možne interference z imunsko aktivacijo, ki je potrebna za terapevtski učinek dinutuksimaba.
English: Patients were aged 11 months to 15 years and had previously achieved at least a partial response to induction chemotherapy, followed by ASCT and radiotherapy.
Slovenian: Bolniki so bili stari od 11 mesecev do 15 let in so prej dosegli vsaj delni odgovor na indukcijsko kemoterapijo, kateri sta sledili ASCT in radioterapija.
English: During courses (months) 1, 3 and 5
Slovenian: Med cikli (meseci) 1, 3 in 5
English: If patients meet criteria for discontinuation of these medications, treatment may continue with isotretinoin as clinically indicated.
Slovenian: Če bolnik izpolnjuje pogoje za prekinitev jemanja teh zdravil, se zdravljenje lahko nadaljuje z izotretinoinom, kot je klinično indicirano.
English: Each carton contains one vial.
Slovenian: Vsaka ovojnina vsebuje eno vialo.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER United Therapeutics Europe, Ltd.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM United Therapeutics Europe, Ltd.
English: If morphine is not tolerated, then fentanyl or hydromorphone may be utilised.
Slovenian: Če bolnik ne prenaša morfina, se lahko uporabi fentanil ali hidromorfon.
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na vsebniku poleg oznake EXP.
English: Other medicines and Unituxin
Slovenian: Druga zdravila in Unituxin
English: Due to overlapping signs and symptoms, it was not possible to distinguish between infusion reactions and hypersensitivity/allergic reactions in some cases.
Slovenian: Zaradi prekrivajočih se znakov in simptomov v določenih primerih ni bilo mogoče razlikovati med infuzijskimi reakcijami in preobčutljivostjo oz. alergijskimi reakcijami.
English: Systemic infections
Slovenian: Sistemske okužbe
English: Dinutuximab2
Slovenian: dinutuksimab2
English: Patients should have no evidence of systemic infection and any identified infection should be under control before beginning therapy.
Slovenian: Bolniki ne smejo kazati simptomov sistemskih okužb in katera koli ugotovljena okužba pred začetkom terapije pa mora biti nadzorovana.
English: If necessary, its use must be limited to the first 100 days after ASCT, as immunoglobulin may interfere with dinutuximab-dependent cellular cytotoxicity.
Slovenian: Če so potrebni, je treba uporabo omejiti na prvih 100 dni po ASCT, ker imunoglobulin lahko vpliva na celično citotoksičnost dinutuksimaba.
English: Severe pain (Grade 3 or 4) occurs most frequently during the first 4-day course of dinutuximab, often subsiding over time with subsequent courses.
Slovenian: Hude bolečine (stopnja 3 ali 4) se najpogosteje pojavijo v prvih štirih dneh cikla z dinutuksimabom in se običajno ublažijo med naslednjimi cikli.
English: • It is recommended to use contraception for 6 months after discontinuation of this medicine.
Slovenian: • Priporočeno je, da 6 mesecev po prenehanju zdravljenja s tem zdravilom uporabljate kontracepcijo.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Unituxin 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 Unituxin za eno ali več podskupin pediatrične populacije z nevroblastomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within six months following authorisation.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v šestih mesecih po pridobitvi dovoljenja za promet.
English: Intravenous immunoglobulin
Slovenian: Intravenski imunoglobulin
English: In animals, fertility studies have not been conducted; however in male and female rats, no adverse effects on reproductive organs were observed (see section 5.3).
Slovenian: Študij o plodnosti pri živalih niso izvedli, vendar pa pri miših ženskega in moškega spola niso bili opaženi neželeni učinki na reproduktivne organe (glejte poglavje 5.3).
English: Unituxin will be given to you in five of the six courses.
Slovenian: Zdravilo Unituxin boste jemali v petih od šestih ciklov.
English: Therefore caution should be taken when both medicinal products are combined (see section 4.4).
Slovenian: Zato je potrebna previdnost ob uporabi kombinacije obeh zdravil (glejte poglavje 4.4).
English: Unituxin has been shown to delay the progression or relapse of the disease and to increase survival.
Slovenian: Dokazano je, da zdravilo Unituxin zavira napredovanje oziroma ponoven pojav bolezni in povečuje preživetje.
English: Depending on the severity of the allergic reaction, the rate of infusion should be reduced or treatment discontinued.
Slovenian: Glede na resnost alergijske reakcije je potrebno zmanjšati hitrost infuzije oziroma prekiniti zdravljenje.
English: • Allergic reactions, which may be severe (anaphylactic reactions), or other reactions to the infusion - Tell your doctor or nurse straight away if you have any kind of reaction during or after the infusion.
Slovenian: • Alergijske reakcije, ki so lahko hude (anafilaktične reakcije) ali druge reakcije na infuzijo nemudoma obvestite svojega zdravnika ali medicinsko sestro, če se pojavi katera koli reakcija med infuzijo ali po njej.
English: It is recommended that vasopressor therapy is also administered if necessary to restore an adequate perfusion pressure.
Slovenian: Priporoča se, da se daje tudi vazopresorska podpora, če je potrebno ponovno vzpostaviti primerni tlak.
English: See section 2 for further information about sodium.
Slovenian: Glejte poglavje 2 za dodatne informacije o natriju.
English: Table 3: Clinical criteria that must be evaluated prior to the start of each treatment course of Unituxin
Slovenian: Preglednica 3: Klinični kriteriji, ki jih je treba oceniti pred začetkom posameznega cikla zdravljenja z zdravilom Unituxin
English: The complete dosing regimen is outlined in Table 1 and Table 2.
Slovenian: Celotni režim odmerjanja je naveden v Preglednici 1 in Preglednici 2.
English: Patients should have an ophthalmic examination before initiating therapy and be monitored for visual changes.
Slovenian: Bolniki morajo na oftalmološki pregled preden začnejo s terapijo in jih je treba spremljati glede sprememb vida.
English: During courses (months) 2 and 4
Slovenian: Med cikli (meseci) 2 in 4
English: The primary efficacy outcome measure was investigator-assessed event-free survival (EFS) defined as time from randomization to the first occurrence of relapse, progressive disease, secondary malignancy, or death.
Slovenian: Primarni cilj študije je bilo s strani raziskovalca ocenjeno preživetje brez bolezenskih dogodkov (EFS), opredeljeno kot čas randomizacije do prvega pojava relapsa, progresivne bolezni, sekundarnega malignoma ali smrti.
English: • Delay course initiation until systemic infection or sepsis has resolved.
Slovenian: • Odložite začetek cikla zdravljenja, dokler sistemska infekcija ali sepsa ni odpravljena.
English: Unituxin is restricted to hospital-use only and must be administered under the supervision of a physician experienced in the use of oncological therapies.
Slovenian: Zdravilo Unituxin je namenjeno samo uporabi v bolnici in pod nadzorom zdravnika, ki ima izkušnje z onkološkimi terapijami.
English: The infusion duration may be extended up to 20 hours to help minimise reactions during infusion that do not respond adequately to other supportive measures.
Slovenian: Trajanje infuzije se lahko podaljša do 20 ur za zmanjšanje reakcij med infundiranjem, ki se ne odzovejo primerno na ostale podporne ukrepe.
English: Keep the vial in the outer carton in order to protect from light.
Slovenian: Vialo za zdravilo shranjujte v zunanji ovojnini, da jo zaščitite pred svetlobo.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik.
English: - The other ingredients are histidine, polysorbate 20 (E 432), sodium chloride and water for injection.
Slovenian: - Druge sestavine zdravila so histidin, polisorbat 20 (E 432), natrijev klorid in voda za injekcije.
English: One carton contains one vial.
Slovenian: Ena ovojnina vsebuje eno vialo.
English: Dinutuximab was administered to cynomolgous monkeys resulting in effects on the cardiovascular system, which consisted of moderate increases in blood pressure (one of three animals) and heart rate (two of three animals).
Slovenian: Dinutuksimab je bil apliciran opicam Cynomolgus, kar je povzročilo učinke na kardiovaskularnem sistemu v obliki zmernega povišanja krvnega tlaka (v eni od treh živali) in srčnega utripa (v deh od treh živali).
English: The mean (± standard deviation) maximum plasma concentration observed after the 4th infusion was 11.5 (± 2.3) mcg/mL.
Slovenian: Povprečna (± standardni odklon) koncentracija dinutuksimab v plazmi po četrti infuziji je bila 11,5 (± 2,3) mcg/ml.
English: The incidence of antibody formation is highly dependent on the sensitivity and the specificity of the assay and for these reasons, comparison of the incidence of antibodies to dinutuximab with the incidence of antibodies to other products may be misleading.
Slovenian: Incidenca formiranja protiteles je v veliki meri odvisna od občutljivosti in specifičnosti poskusa, zato je lahko primerjava med incidenco protiteles na dinutuksimab in incidenco protiteles na druga zdravila zavajajoča.
English: Unituxin has major influence on the ability to drive and use machines.
Slovenian: Zdravilo Unituxin ima močan vpliv na sposobnost vožnje in upravljanja s stroji.
English: The dose may be subsequently increased (up to a maximum of 60 mg/kg/day or 3600 mg/day) as needed for pain management.
Slovenian: Odmerek se nato po potrebi lahko poveča (do največ 60 mg/kg/dan ali 3600 mg/dan) za lajšanje bolečin.
English: It must be administered by a healthcare professional prepared to manage severe allergic reactions including anaphylaxis in an environment where full resuscitation services are immediately available.
Slovenian: Zdravilo mora aplicirati zdravnik, ki je pripravljen za ukrepanje v primeru hudih alergijski reakcij, vključno z anafilaksijo, v okolju, kjer je na voljo vse potrebno za reanimacijo.
English: The geometric mean clearance was estimated at 0.025 L/hr and increased with body size.
Slovenian: Izločanje Povprečno geometrično izločanje je bilo ocenjeno na 0,25 l/uro in se je povečalo s telesno velikostjo.
English: It should be administered by intravenous infusion over 10 hours.
Slovenian: Treba ga je dajati kot intravensko infuzijo po 10 ur.
English: In a population pharmacokinetic analysis, the geometric mean volume of distribution at steady state was estimated at 5.2 L.
Slovenian: Pri farmakokinetični populacijski analizi je bil geometrični povprečni volumen porazdelitve v stanju dinamičnega ravnovesja 5.2 l.
English: Additionally, in vivo studies demonstrate that dinutuximab either alone or in combination with IL-2 can partially inhibit tumour growth in mice.
Slovenian: Poleg tega so študije in vivo dokazale, da dinutuksimab sam ali v kombinaciji z IL-2 lahko delno inhibira rast tumorja v miših.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at ambient conditions (less than 25°C).
Slovenian: Kemična in fizikalna stabilnost med uporabo sta bili dokazani za 24 ur na sobni temperaturi (manj kot 25 °C).
English: The most frequently occurring (more than 30% of patients) adverse reactions reported during the neuroblastoma studies were hypotension (67 %), pain (66 %), hypersensitivity (56 %), pyrexia (53 %), urticaria (49 %), capillary leak syndrome (45 %), anaemia (45 %), hypokalaemia (41 %), platelet count decreased (40 %), hyponatraemia (37 %), alanine aminotransferase increased (35 %), decreased lymphocyte count (34%) and decreased neutrophil count (31%).
Slovenian: Najbolj pogosti neželeni učinki (več kot 30 % bolnikov) o katerih so poročali v študijah nevroblastoma so hipotenzija (67 %), bolečine (66 %), preobčutljivost (56 %), pireksija (53 %), urtikarija (49 %), sindrom kapilarnih razpok (45 %), anemija (45 %), hipokalemija (41 %), zmanjšanje števila trombocitov (40 %), hiponatremija (37 %), povišanje alanin-aminotransferaze (35 %), zmanjšanje števila limfocitov (34 %) in zmanjšanje števila nevtrofilov (31 %).
English: Pregnancy There are no data from the use of dinutuximab in pregnant women.
Slovenian: Podatkov o uporabi dinutuksimaba pri nosečnicah ni.
English: Dinutuximab reacts specifically with the ganglioside GD2, which is highly expressed on the surface of neuroblastoma cells and minimally expressed on the surface of normal human neurons, peripheral pain fibres, and skin melanocytes.
Slovenian: Dinutuksimab reagira specifično z gangliozidom GD2, ki je močno izražen na površini celic nevroblastoma in minimalno izražen na površini normalnih humanih nevronov, perifernih bolečinskih vlaken in kožnih melanocitov.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Slovenian: V primeru prevelikega odmerjanja je treba pri bolnikih natančno spremljati znake ali simptome neželenih učinkov in izvesti primerno simptomatično terapijo.
English: Peripheral sensory neuropathy was reported in 3% of patients and peripheral motor neuropathy in 2% of patients; less than 1% of patients experienced serious peripheral neuropathy.
Slovenian: Do periferne senzorne nevropatije je prišlo pri 3 % bolnikov, do periferne motorične nevropatije pa pri 2 % bolnikov, medtem ko je do resne periferne nevropatije prišlo pri manj kot 1 % bolnikov.
English: It is recommended that antihistamine medicinal product be repeated every 4-6 hours as required during infusion of Unituxin.
Slovenian: Priporoča se, da se dajanje antihistaminika ponovi vsakih 4-6 ur, kot je zahtevano med infuzijo zdravila Unituxin.
English: Symptomatic and/or systolic BP less than 70 mmHg or a decrease that is more than 15% below baseline Onset of symptoms
Slovenian: Simptomatski in/ali sistolični krvni tlak pod 70 mmHg ali upadanje, ki je več kot 15 % pod standardno mejo Nastop simptomov
English: In male and female rats, administration of dinutuximab resulted in no adverse effects on reproductive organs at exposures that were at least 60-fold higher than those observed clinically.
Slovenian: Aplikacija dinutuksimaba podganam moškega in ženskega spola ni povzročilo neželenih učinkov na reproduktivne organe pri izpostavljenosti, ki je bila najmanj 60-krat višja od klinične izpostavljenosti.
English: What Unituxin is and what it is used for 2.
Slovenian: Kaj je zdravilo Unituxin in za kaj ga uporabljamo 2.
English: These medicines will be given to you over six courses.
Slovenian: Ta zdravila boste jemali v šestih ciklih zdravljenja.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC16
Slovenian: Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC16
English: Chemical and physical in-use stability has been demonstrated at ambient conditions (less than 25 °C).
Slovenian: Kemična in fizikalna stabilnost med uporabo sta bili dokazani pri sobni temperaturi (manj kot 25 °C).
English: Depending on the severity of the allergic reaction, the rate of infusion should be reduced or treatment discontinued (see sections 4.2 and 4.8).
Slovenian: Glede na resnost alergijske reakcije je potrebno zmanjšati hitrost infuzije oziroma prekiniti zdravljenje (glejte poglavji 4.2 in 4.8).
English: See section 4 for a full list of known side effects.
Slovenian: Glejte poglavje 4 za popoln seznam znanih neželenih učinkov.
English: From a microbiological point of view, unless the method of opening/reconstituting/dilution precludes the risks of microbial contamination, the product should be used immediately.
Slovenian: Iz mikrobiološkega vidika je razredčeno raztopino treba uporabiti takoj, razen če metoda odpiranja/ obnavljanja/redčenja ne preprečuje tveganja mikrobiološke kontaminacije.
English: • If symptoms resolve that day, resume the next day with premedication in the intensive care setting (see section 4.4).
Slovenian: • Če simptomi izzvenijo tisti dan, naslednji dan ponovno začnite premedikacijo v intenzivni negi (glejte poglavje 4.4).
English: • Low blood pressure - this may make you feel dizzy or faint.
Slovenian: • Nizek krvni tlak - ta lahko povzroča omotico ali omedlevico.
English: Clear, colourless liquid.
Slovenian: Prozorna, brezbarvna tekočina.
English: The infusion duration may be extended up to 20 hours to help minimise reactions during infusion (see sections 4.4 and 4.8) that do not respond adequately to other supportive measures.
Slovenian: Trajanje infuzije se lahko podaljša do 20 ur za zmanjšanje reakcij med infundiranjem (glejte poglavji 4.4 in 4.8), ki se ne odzovejo primerno na ostale podporne ukrepe.
English: These changes were noted to be very slight to slight in severity and recovered or tended to recover following the cessation of dosing.
Slovenian: Resnost teh sprememb je bila zmerna do zelo zmerna, do okrevanja oz. izboljševanja pa je prišlo po prekinitvi odmerjanja.
English: From a microbiological point of view, the diluted solution should be used immediately.
Slovenian: Iz mikrobiološkega vidika je razredčeno raztopino treba uporabiti takoj.
English: During course (month) 6
Slovenian: Med ciklom (mesecem) 6
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Slovenian: V posamezni skupini pogostnosti so neželeni učinki predstavljeni po podajoči resnosti.
English: Data from 409 subjects participating in several neuroblastoma studies and having samples available for the determination of human anti-chimeric antibodies (HACA) demonstrated that 71 (17%) developed binding antibodies and 15 (4%) developed a neutralising antibody response.
Slovenian: Podatki 409 bolnikov, ki so sodelovali v številnih študijah o nevroblastomu in pri katerih so razpolagali z vzorci za določitev humanih antihimernih protiteles (HACA- human anti-chimeric antibodies), so pokazali, da jih je 71 (17 %) razvilo vezna protitelesa, 15 (4 %) pa odziv nevtraliziranja protiteles.
English: It is administered on Days 4-7 during Courses 1, 3, and 5 (each course lasting approximately 24 days) and on Days 8-11 during Courses 2 and 4 (each course lasting approximately 28 days).
Slovenian: Daje se od 4. do 7. dne med cikli 1,3 in 5 (vsak cikel traja približno 24 dni) in od 8. do 11. dne med cikloma 2 in 4 (vsak cikel traja približno 28 dni).
English: • IL-2 is given as a drip into one of your veins for four days in a row (continuous infustion) - for the first four days of the first week and the first four days of the second week of each course.
Slovenian: • IL-2 boste jemali v obliki kapalne infuzije v žilo štiri dni zaporedoma (kontinuirana infuzija) - prve štiri dni v prvem tednu in prve štiri dni v drugem tednu posameznega cikla.
English: If required for persistent pain, ibuprofen should be administered orally every 6 hours between doses of paracetamol.
Slovenian: Če bolečine ne popustijo, je treba dati peroralno ibuprofen vsakih 6 ur med odmerki paracetamola.
English: In this study, 27 children with high-risk neuroblastoma (age: 3.9 ± 1.9 years) received up to 5 cycles of Unituxin at 17.5 mg/m2/day as an intravenous infusion over 10 to 20 hours for 4 consecutive days every 28 days.
Slovenian: V tej študiji je 27 otrok z nevroblastomom z visokim tveganjem (starost 3,9 ± 1,9 let) prejelo do 5 ciklov zdravila Unituxin po 17,5 mg/m2/dan v obliki intravenske infuzije v času 10 do 20 ur, 4 zaporedne dni vsakih 28 dni.
English: Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures.
Slovenian: Zdravilo Unituxin je treba ukiniti, če bolečine ni mogoče primerno nadzorovati kljub zmanjšanju hitrosti infuzije in vzpostavitvi vseh podpornih ukrepov.