FrancophonIA/ELRC3.0 huggingface dataset:
English: Unituxin recognises and attaches to a cell surface target called ‘GD2'.
Croatian: Unituxin prepoznaje i veže se na svoj cilj na staničnoj površini koji se naziva "GD2".
English: Therefore caution should be taken when both medicinal products are combined (see section 4.4).
Croatian: Zbog toga treba biti oprezan pri kombinaciji oba lijeka (vidjeti dio 4.4.).
English: If necessary, its use must be limited to the first 100 days after ASCT, as immunoglobulin may interfere with dinutuximab-dependent cellular cytotoxicity.
Croatian: Ako je neophodno, njegova primjena mora biti ograničena na prvih 100 dana nakon ASCT-a budući da imunoglobulin može utjecati na staničnu citotoksičnost ovisnu o dinutuksimabu.
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.
Croatian: Doza se može kasnije povećati (do najviše 60 mg/kg/dan ili 3600 mg/dan) po potrebi radi zbrinjavanja boli.
English: Supplemental oxygen, respiratory support, and albumin replacement therapy should be used as necessary according to clinical response.
Croatian: Dodatni kisik, respiratornu potporu i nadomjesnu terapiju albuminom treba koristiti po potrebi prema kliničkom odgovoru.
English: Refer to section 4.2 for advice on tapering off or discontinuation of this medicinal product.
Croatian: Vidjeti dio 4.2. za savjet o postupnom snižavanju doze ili prekidu liječenja ovim lijekom.
English: Your doctor will work out your dose based on your body surface area.
Croatian: Liječnik će odrediti Vašu dozu na temelju
English: Gabapentin may be administered at the time of starting morphine premedication, at an oral dose of 10 mg/kg/day.
Croatian: Gabapentin se može primijeniti u vrijeme početka premedikacije morfinom, u peroralnoj dozi od 10 mg/kg/dan.
English: Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies, ATC code: L01XC16
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska protutijela, ATK oznaka: L01XC16 Mehanizam djelovanja
English: Patients should be monitored for signs and symptoms of infusion reactions for 4 hours after the completion of the Unituxin infusion.
Croatian: Bolesnike treba nadzirati kako bi se uočili znakovi i simptomi reakcija na infuziju tijekom 4 sata po završetku infuzije Unituxina.
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.
Croatian: • Ako je moguće da ostanete trudni i ne koristite kontracepciju, obratite se svom liječniku prije nego primite ovaj lijek.
English: The recommended dose is 17.5 mg/m2.
Croatian: Preporučena doza je 17,5 mg/m2.
English: • Delay initiation of first course until alanine aminotransferase (ALT) is less than 5 times upper limit of normal (ULN).
Croatian: • Odgoditi početak prvog ciklusa dok vrijednost alanin aminotransferaze (ALT) ne bude manja od peterostruke vrijednosti gornje granice normale (GGN).
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.
Croatian: Trajanje infuzije može biti produženo do 20 sati da bi se pomoglo umanjiti reakcije tijekom infuzije (vidjeti dijelove 4.4. i 4.8.) koje ne reagiraju odgovarajuće na druge potporne mjere.
English: Regular dosing every 4-6 hours is recommended when IL-2 is coadministered.
Croatian: Preporučuje se redovito doziranje svakih 4 do 6 sati kad se primjenjuje zajedno s IL-2.
English: • Administer supportive measures (see section 4.4).
Croatian: • Primijeniti potporne mjere (vidjeti dio 4.4.)
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.
Croatian: Dinutuksimab (ili mišje monoklonsko protutijelo 14.18) je primijenjen u miševa, kunića, štakora i pasa u režimima jednokratne ili ponovljene doze koja je bila viša od doze koja se klinički primjenjuje.
English: Tell your doctor or nurse straight away if you notice the following:
Croatian: Obratite se odmah svom liječniku ili medicinskoj sestri ako primijetite sljedeće:
English: - The other ingredients are histidine, polysorbate 20 (E 432), sodium chloride and water for injection.
Croatian: - Drugi sastojci su histidin, polisorbat 20 (E 432), natrijev klorid i voda za injekcije.
English: • If symptoms resolve that day, resume the next day with premedication in the intensive care setting (see section 4.4).
Croatian: • Ako se simptomi povuku tog dana, nastaviti sljedećeg dana s premedikacijom na odjelu intenzivne njege (vidjeti dio 4.4.).
English: One carton contains one vial.
Croatian: Jedna kutija sadrži jednu bočicu.
English: What Unituxin is and what it is used for
Croatian: Što je Unituxin i za što se koristi
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi.
English: Electrolyte abnormalities occurring in at least 25 % of patients who received Unituxin included hyponatraemia and hypokalaemia.
Croatian: Odstupanja elektrolita koja su se pojavila u najmanje 25% bolesnika koji su primili Unituxin uključivala su hiponatrijemiju i hipokalijemiju.
English: What you need to know before you are given Unituxin 3.
Croatian: Što morate znati prije nego počnete primati Unituxin 3.
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.
Croatian: Bolesnici su bili u dobi od 11 mjeseci do 15 godina i prethodno su postigli barem djelomičan odgovor na indukcijsku kemoterapiju, nakon čega je slijedila transplantacija autolognih matičnih stanica (ASCT) i radioterapija.
English: Each carton contains one vial.
Croatian: Svaka kutija sadrži jednu bočicu.
English: The geometric mean clearance was estimated at 0.025 L/hr and increased with body size.
Croatian: Geometrijska srednja vrijednost klirensa je procijenjena na 0,025 L/sat i povećava se s porastom veličine tijela.
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.
Croatian: Ne preporučuje se primjena sistemskih kortikosteroida zbog mogućeg utjecaja na imunološku aktivaciju koja je neophodna za terapijsko djelovanje dinutuksimaba.
English: Plasma concentrations of dinutuximab, especially trough levels, tended to be lower in patients with HACA.
Croatian: Koncentracije dinutuksimaba u plazmi, osobito najniže koncentracije lijeka, bile su niže u bolesnika s HACA.
English: Concentrate for solution for infusion (sterile concentrate).
Croatian: OBLIK Koncentrat za otopinu za infuziju (sterilni koncentrat).
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).
Croatian: Sigurnosna farmakologija Dinutuksimab je bio primijenjen u cinomolgus majmuna što je rezultiralo učincima na kardiovaskularni sustav, koji su se sastojali od umjerenih povećanja krvnog tlaka (u jedne od tri životinje) i brzine otkucaja srca (u dvije od tri životinje).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER United Therapeutics Europe, Ltd.
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET United Therapeutics Europe, Ltd.
English: Atrial fibrillation, ventricular arrhythmia
Croatian: fibrilacija atrija, ventrikularna aritmija
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.
Croatian: Radi smanjivanja rizika od ponovnog pojavljivanja raka, Unituxin se primjenjuje u posljednjoj fazi liječenja radi uništavanja malih količina bolesti koje još uvijek mogu biti prisutne nakon što je rak reagirao na kemoterapiju, kirurški zahvat i autolognu (s bolesnikovim vlastitim stanicama) transplantaciju krvnih stanica.
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).
Croatian: Primjenjuje se od 4. do 7. dana tijekom 1., 3. i 5. ciklusa (svaki ciklus traje otprilike 24 dana), te od 8. do 11. dana tijekom 2. i 4. ciklusa (svaki ciklus traje otprilike 28 dana).
English: See section 4 for a full list of known side effects.
Croatian: Pogledajte dio 4 za cjeloviti popis poznatih nuspojava.
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.
Croatian: Trudnoća • Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili medicinskoj sestri za savjet prije nego primite ovaj lijek.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6. 6.3. Rok valjanosti
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Unituxin has many side effects, and this will affect your ability to drive and use machines
Croatian: Unituxin ima mnoge nuspojave i to će utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: Pre-medication should always be considered before starting each infusion (see section 4.4).
Croatian: Prije početka svake infuzije uvijek treba uzeti u obzir premedikaciju (vidjeti dio 4.4.).
English: Electrolytes should be monitored daily during therapy with Unituxin.
Croatian: Elektrolite treba nadzirati svakodnevno za vrijeme terapije Unituxinom.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, korisnik je odgovoran za vrijeme čuvanja i uvjete čuvanja za vrijeme primjene.
English: Refer to section 4.4 for actions to be taken for specific adverse reactions.
Croatian: Vidjeti dio 4.4. za mjere koje treba poduzeti za pojedine nuspojave.
English: • Unituxin is given as a drip into one of your veins - for about 10 hours each day for four days.
Croatian: • Unituxin se primjenjuje infuzijom kap po kap u jednu od Vaših vena - kroz približno 10 sati svakodnevno tijekom četiri dana.
English: Do not take Unituxin if - you are allergic to dinutuximab or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na dinutuksimab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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.
Croatian: Unituxin je ograničen samo na bolničku primjenu, a mora se primjenjivati pod nadzorom liječnika s iskustvom u primjeni onkoloških terapija.
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.
Croatian: • IL-2 se primjenjuje infuzijom kap po kap u jednu od Vaših vena kroz 4 uzastopna dana (kontinuirana infuzija) - prva četiri dana prvog tjedna i prva četiri dana drugog tjedna svakog ciklusa.
English: Chemical and physical in-use stability has been demonstrated at ambient conditions (less than 25 °C).
Croatian: Dokazana je kemijska i fizikalna stabilnost u primjeni pri sobnoj temperaturi (manjoj od 25°C).
English: During course (month) 6
Croatian: Za vrijeme 6. ciklusa (mjeseca)
English: It should be administered by intravenous infusion over 10 hours.
Croatian: Treba se primijeniti intravenskom infuzijom tijekom 10 sati.
English: Unituxin is a clear, colourless solution for infusion, provided in a clear glass vial.
Croatian: Unituxin je bistra, bezbojna otopina za infuziju isporučena u prozirnoj staklenoj bočici.
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).
Croatian: Ovisno o težini alergijske reakcije, potrebno je smanjiti brzinu infuzije ili prekinuti liječenje (vidjeti dijelove 4.2. i 4.8.).
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.
Croatian: Preporučuje se da liječenje takvih reakcija uključuje hidrokortizon primijenjen intravenskim bolusom i epinefrin primijenjen intravenskim bolusom jednom svakih 3 do 5 minuta po potrebi prema kliničkom odgovoru.
English: Talk to your doctor or nurse before you are given Unituxin if: - you have ever had fits (convulsions) - you have liver problems - you have a low number of white blood cells or platelets in your blood - shown in tests - you have breathing problems such as shortness of breath when resting - you have kidney problems - you have any infections.
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite Unituxin: - ako ste ikada imali napadaje (konvulzije) - ako imate problema s jetrom - ako imate nizak broj bijelih krvnih stanica ili krvnih pločica u krvi - vidljivo iz nalaza pretraga - ako imate problema s disanjem poput nedostatka zraka u mirovanju - ako imate problema s bubrezima - ako imate bilo kakve infekcije.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at ambient conditions (less than 25°C).
Croatian: Dokazana je kemijska i fizikalna stabilnost u primjeni do 24 sata pri sobnoj temperaturi (manjoj od 25°C).
English: • Pain - tell your doctor or nurse if you get any pain.
Croatian: • Bol - obavijestite svog liječnika ili medicinsku sestru ako imate bilo kakve bolove.
English: What you need to know before you are given Unituxin
Croatian: Što morate znati prije nego počnete primati Unituxin
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Croatian: U slučaju predoziranja bolesnike treba pomno nadzirati kako bi se uočili znakovi ili simptomi nuspojava, te treba uvesti odgovarajuće simptomatsko liječenje.
English: Additionally, in vivo studies demonstrate that dinutuximab either alone or in combination with IL-2 can partially inhibit tumour growth in mice.
Croatian: Dodatno, ispitivanja in vivo pokazuju da dinutuksimab, bilo sam ili u kombinaciji s IL-2, može djelomično inhibirati rast tumora u miševa.
English: GD2 is found on the surface of neuroblastoma cells.
Croatian: GD2 se nalazi na površini stanica neuroblastoma.
English: • Delay course initiation until creatinine clearance or glomerular filtration rate (GFR) is at least 70 mL/min/1.73 m2 Systemic infection or sepsis
Croatian: • Odgoditi početak ciklusa dok klirens kreatinina ili stopa glomerularne filtracije (GFR) ne bude najmanje 70 mL/min/1,73 m2 Sistemska infekcija ili sepsa
English: Subgroup analyses of EFS and OS response indicated that patients with minimal residual disease, DNA hyperploidy, and those having received a purged bone marrow may not have benefited from dinutuximab immunotherapy.
Croatian: Analize odgovora EFS i OS po podskupinama su pokazale da bolesnici s minimalnom rezidualnom bolešću, hiperploidnom DNK i oni koji su primili pročišćenu koštanu srž možda nisu imali koristi od imunoterapije dinutuksimabom.
English: Patients should have an ophthalmic examination before initiating therapy and be monitored for visual changes.
Croatian: Bolesnici trebaju obaviti oftalmološki pregled prije početka terapije i treba ih se nadzirati zbog mogućih promjena vida.
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.
Croatian: Kao i svi lijekovi, ovaj lijek, koji se primjenjuje s GM-CSF-om, IL-2 i izotretinoinom, može uzrokovati nuspojave iako se one neće javiti kod svakoga.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 17.5 mg/5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 17,5 mg/5 ml
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.
Croatian: Epinefrin (adrenalin) i hidrokortizon za intravensku primjenu trebaju biti trenutno dostupni uz krevet tijekom primjene dinutuksimaba radi zbrinjavanja alergijskih reakcija opasnih po život.
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.
Croatian: Sistemske infekcije Bolesnici uobičajeno imaju postavljen centralni venski kateter in situ, i kao posljedica prethodne transplantacije autolognih matičnih stanica (ASCT) vjerojatno je da će biti imunokompromitirani tijekom terapije, te su zbog toga izloženi riziku od razvoja sistemske infekcije.
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.
Croatian: Dinutuksimab specifično reagira s gangliozidom GD2, koji je izrazito izražen na površini stanica neuroblastoma i minimalno izražen na površini normalnih ljudskih neurona, perifernim vlaknima za bol i kožnim melanocitima.
English: Dinutuximab is a monoclonal chimeric antibody composed of murine variable heavy and light chain regions and the human constant region for the heavy chain IgG1 and light chain kappa.
Croatian: Dinutuksimab je monoklonsko kimerično protutijelo sastavljeno od mišjih varijabilnih regija teškog i lakog lanca i ljudske konstantne regije za teški lanac IgG1 i laki kappa lanac.
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.
Croatian: U kliničkim ispitivanjima, planirane doze dinutuksimaba od najviše 120 mg/m2 (60 mg/m2/dan) su primjenjivane s profilom nuspojava sličnim onome opisanom u dijelu 4.8.
English: Paracetamol should be administered orally 20 minutes prior to starting each dinutuximab infusion, and repeated every 4-6 hours as needed.
Croatian: Paracetamol treba primijeniti peroralno 20 minuta prije početka svake infuzije dinutuksimaba te ponoviti svakih 4 do 6 sati prema potrebi.
English: Unituxin is used to treat ‘high-risk neuroblastoma' in babies, children and adolescents aged 12 months to 17 years old.
Croatian: Unituxin se koristi za liječenje "neuroblastoma visokog rizika" u dojenčadi, djece i adolescenata u dobi od
English: Ibuprofen should not be administered if there is evidence of thrombocytopenia, bleeding, or renal dysfunction.
Croatian: Ibuprofen se ne smije primjeniti ako postoje dokazi trombocitopenije, krvarenja ili poremećaja funkcije bubrega.
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.
Croatian: Event-Free Survival) prema procjeni ispitivača definirana kao vrijeme od randomizacije do prve pojave relapsa, progresivne bolesti, sekundarne zloćudne bolesti ili smrti.
English: Neurological disorders of the eye
Croatian: Neurološki poremećaji oka
English: Lidocaine infusion should be discontinued if the patient develops dizziness, perioral numbness, or tinnitus.
Croatian: Infuziju lidokaina treba prekinuti ako bolesnik razvije omaglicu, perioralnu utrnulost ili tinitus.
English: Unituxin contains sodium
Croatian: Unituxin sadrži natrij
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.
Croatian: U ovom ispitivanju, 27 djece s neuroblastomom visokog rizika (u dobi od 3,9 ± 1,9 godina) je primilo do 5 ciklusa Unituxina u dozi od 17,5 mg/m2/dan u obliku intravenske infuzije tijekom 10 do 20 sati u 4 uzastopna dana svakih 28 dana.
English: • Infections of the blood - tell your doctor if you notice fever, shaking chills, or feel faint or dizzy.
Croatian: • Infekcije krvi - obavijestite svog liječnika ako primijetite vrućicu, zimicu s drhtavicom, ili ako osjetite nesvjesticu ili omaglicu.
English: A population pharmacokinetic analysis conducted on all clinical data available suggests that the disposition of dinutuximab is not altered by age, race, gender, concomitant medications (IL-2, GM-CSF) and the presence of capillary leak syndrome, renal or hepatic impairment.
Croatian: Populacijska farmakokinetička analiza provedena na svim raspoloživim kliničkim podacima upućuje na zaključak da se raspoloživost dinutuksimaba ne mijenja zbog dobi, rase, spola, istovremene primjene drugih lijekova (IL-2, GM-CSF) i prisutnosti sindroma kapilarnog curenja, oštećenja funkcije bubrega ili jetre.
English: The mean (± standard deviation) maximum plasma concentration observed after the 4th infusion was 11.5 (± 2.3) mcg/mL.
Croatian: Srednja vrijednost (± standardna devijacija) najviše koncentracije u plazmi zabilježena nakon 4. infuzije je iznosila 11,5 (± 2,3) μg/mL.
English: United Therapeutics Europe, Ltd. Unither House
Croatian: United Therapeutics Europe, Ltd.
English: Unituxin is used with three other medicines: - Isotretinoin - GM-CSF - IL-2
Croatian: Unituxin se koristi s tri druga lijeka: - izotretinoin - GM-CSF - IL-2
English: Unituxin should be discontinued if pain is not adequately controlled despite infusion rate reduction and institution of maximum supportive measures.
Croatian: Liječenje Unituxinom treba prekinuti ako bol nije zadovoljavajuće kontrolirana unatoč smanjenju brzine infuzije i uvođenju najviših potpornih mjera.
English: Infusion reactions generally occurred during or within 24 hours of completing the Unituxin infusion.
Croatian: Reakcije na infuziju su se uglavnom pojavile tijekom ili unutar 24 sata nakon dovršetka infuzije
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V. 4.9.
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).
Croatian: Tijekom posljednja dva tjedna u svakom od šest ciklusa, ispitanicima iz kontrolne skupine i iz skupine imunoterapije dinutuksimabom je također primijenjen izotretinoin peroralno u dozi od 160 mg/m2/dan (primijenjen je u dozi od 80 mg/m2 dvaput dnevno).
English: Unituxin has major influence on the ability to drive and use machines.
Croatian: Unituxin značajno utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Electrolyte abnormalities have been reported in patients who received Unituxin (see section 4.8).
Croatian: Prijavljena su odstupanja vrijednosti elektrolita u bolesnika koji su primili Unituxin (vidjeti dio 4.8.).
English: • At the request of the European Medicines Agency;
Croatian: Nadalje, nadopunjeni RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;