FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, these 98 patients had primary refractory neuroblastoma (40) or relapsed neuroblastoma (49) with an additional 9 patients enrolled after first-line therapy.
Croatian: Sveukupno, tih 98 bolesnika imalo je primarni refraktorni neuroblastom (40) ili recidiv neuroblastoma (49), a dodatnih 9 bolesnika u ispitivanje se uključilo nakon prve linije liječenja.
English: You may only use Qarziba if your doctor assesses that benefits outweigh risks for a foetus.
Croatian: Qarziba smijete koristiti jedino ako vaš liječnik procijeni da koristi nadmašuju rizike za plod.
English: Qarziba has several side effects that may affect your ability to drive and use machines.
Croatian: Qarziba ima nekoliko nuspojava koje mogu utjecati na vašu sposobnost upravljanja vozilima i strojevima.
English: Calculations of pharmacokinetic parameters for dinutuximab beta are based upon measurements using non-validated bioanalytical methods.
Croatian: Izračuni farmakokinetičkih parametara za dinutuksimab beta temelje se na mjerenjima pomoću nevalidiranih bioanalitičkih metoda.
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.
Croatian: Mora ga primjenjivati zdravstveni radnik pripremljen za liječenje teških alergijskih reakcija uključujući anafilaksiju, u okruženju u kojemu je odmah dostupna sva oprema za oživljavanje.
English: During and after the infusion, you will be checked regularly for infusion-related side effects.
Croatian: Tijekom i nakon infuzije redovito će vas pregledavati zbog moguće pojave nuspojava povezanih s infuzijom.
English: Patients should have no evidence of systemic infection and any identified infection should be under control before starting therapy.
Croatian: U bolesnika ne smije biti nikakvih dokaza sistemske infekcije, a prije početka terapije svaka utvrđena infekcija trebala bi biti pod kontrolom.
English: An effect of ADA formation on the volume of distribution was found (increase of 37% in volume).
Croatian: Utvrđeno je da stvaranje protutijela na lijek ima učinak na volumen distribucije (37 %-tno povećanje volumena).
English: • life-threatening infection (sepsis)
Croatian: • infekcija opasna po život (sepsa)
English: Keep the vial in the outer carton in order to protect from light.
Croatian: Čuvajte bočicu u vanjskoj kutiji radi zaštite od svjetlosti.
English: This being a marketing authorisation under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Croatian: Budući je ovo odobrenje za stavljanje lijeka u promet u iznimnim okolnostima, sukladno članku 14. stavku 8. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog roka provesti sljedeće mjere:
English: At baseline, 72 patients had measurable disease and 26 patients had no detectable disease.
Croatian: Kao početnu vrijednost 72 bolesnika imalo je mjerljivu bolest, a 26 bolesnika nije imalo bolest koju je bilo moguće otkriti.
English: It is not known if the medicine can pass into breast-milk.
Croatian: Nije poznato može li lijek prijeći u majčino mlijeko.
English: • agitation, anxiety
Croatian: • uznemirenost, tjeskoba
English: The observed Cmax levels were slightly higher (16.5 micrograms/mL) and were reached on the fifth infusion.
Croatian: Zabilježene razine Cmax bile su malo više (16,5 mikrograma/ml), a dosegnute su u petoj infuziji.
English: Grade 4 haematologic toxicities, improving to at least Grade 2 or baseline values by start of next treatment course, do not require dose modification.
Croatian: Hematološke toksičnosti 4. stupnja, koje se poboljšaju najmanje do 2. stupnja ili početnih vrijednosti do početka sljedećeg ciklusa liječenja, ne zahtijevaju prilagodbu doze.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska protutijela, ATK oznaka: L01XC
English: • formation of blood clots in the small blood vessels (disseminated intravascular coagulation)
Croatian: • stvaranje krvnih ugrušaka u malim krvnim žilama (diseminirana intravaskularna koagulacija)
English: It is given into one of your veins (intravenous infusion) usually by using special tubes (catheters) and a pump.
Croatian: Lijek vam se daje u jednu od vena (intravenska infuzija), uobičajeno upotrebom posebnih cjevčica (kateteri) i pumpe.
English: What Qarziba looks like and contents of the pack
Croatian: Kako Qarziba izgleda i sadržaj pakiranja
English: In case of any eye problems, patients should be referred promptly to an ophtalmology specialist.
Croatian: U slučaju pojave bilo kakvih problema s očima bolesnike je potrebno odmah uputiti specijalistu oftalmologu.
English: Patients should be closely monitored for anaphylaxis and allergic reactions, particularly during the first and second treatment course.
Croatian: Bolesnike je potrebno pozorno pratiti kako bi se uočili simptomi anafilaksije i alergijskih reakcija, osobito tijekom prvog i drugog ciklusa liječenja.
English: The most common adverse reactions were pyrexia (88%) and pain (77%) that occurred despite analgesic treatment.
Croatian: Najčešće nuspojave bile su pireksija (88 %) i bol (77 %), koje su se pojavile unatoč liječenju analgeticima.
English: These included 64% male and 36% female patients with a median age of 3 years (0.6 to 20); 89% had a tumour INSS stage 4 and MYCN amplification was reported in 44% of the cases.
Croatian: Ta brojka uključivala je 64 % muških i 36 % ženskih bolesnika, čiji je medijan dobi iznosio 3 godine (0,6 do 20); 89 % ispitanika imalo je INSS 4. stadij bolesti, a MYCN amplifikacija zabilježena je u 44 % slučajeva.
English: No effects on cardiovascular functions (ECG, blood pressure) were observed in monkeys.
Croatian: U majmuna nisu zabilježeni učinci na kardiovaskularne funkcije (EKG, krvni tlak).
English: A risk for indirect reduction of CYP activity due to higher TNF-α and IL-6 levels and, therefore, interactions with concomitantly used medicinal products, cannot be excluded.
Croatian: Nije moguće isključiti rizik od neizravnog smanjenja aktivnosti enzima CYP zbog povišenih razina TNF -α i IL-6, te stoga ni od interakcija s lijekovima koji se istodobno primjenjuju.
English: • dilated pupils or abnormal pupil reactions
Croatian: • proširene zjenice ili abnormalne reakcije zjenica
English: The population pharmacokinetic model included allometric scaling (reference weight of 18.1 kg) on clearance and volume of distribution with exponents of 0.75 and 1, respectively.
Croatian: Populacijsko farmakokinetičko modeliranje uključivalo je alometričko skaliranje (referentna težina iznosila je 18,1 kg) klirensa i volumena distribucije s eksponentima od 0,75, odnosno 1.
English: Psychiatric disorders agitation, anxiety
Croatian: Psihijatrijski poremećaji agitacija, anksioznost
English: Markers for renal (eGFR) and hepatic (bilirubin) function did not show a relationship with exposure (Cmax and AUC24h on day 1 and day 10 during a 10-day infusion).
Croatian: Markeri za bubrežnu funkciju (eGFR) i funkciju jetre (bilirubin) nisu pokazali povezanost s izloženošću (Cmaxi AUC24h na 1. i 10. dan tijekom 10-dnevne infuzije).
English: Treatment of disease before immunotherapy included intensive chemotherapy regimen followed by autologous stem cell transplantation (ASCT), radiotherapy, and surgery.
Croatian: Liječenje bolesti prije imunoterapije uključivalo je režim intenzivne kemoterapije nakon čega su uslijedile transplantacija autolognih matičnih stanica (ASCT), radioterapija i operacija.
English: CLS usually develops within hours after initiation of treatment, while clinical symptoms (i.e. hypotension, tachycardia) are reported to occur after 2 to 12 hours.
Croatian: Sindrom kapilarnog curenja obično se razvija u roku od nekoliko sati nakon početka liječenja, a klinički simptomi (tj. hipotenzija, tahikardija) javljaju se nakon 2 do 12 sati.
English: What Qarziba is and what it is used for What you need to know before you use Qarziba How to use Qarziba
Croatian: Što je Qarziba i za što se koristi Što morate znati prije nego što počnete primjenjivati Qarziba Kako primjenjivati Qarziba
English: Patients are likely to be immunocompromised as a result of prior therapies.
Croatian: Postoji vjerojatnost da će bolesnici biti imunokomprimitirani, što je posljedica prethodnog liječenja.
English: • a continuous infusion over the first 10 days of each course (a total of 240 hours) at the daily dose of 10 mg/m2
Croatian: • kontinuirana infuzija tijekom prvih 10 dana svakog ciklusa (ukupno 240 sati) s dnevnom dozom od 10 mg/m2 ili
English: Other intravenously co-administered agents should be delivered via a separate infusion line (see section 6.6).
Croatian: Ostala sredstva koja se istodobno primjenjuju intravenski potrebno je dati u zasebnoj infuzijskoj liniji (vidjeti dio 6.6).
English: Non-interventional post-authorisation safety study (PASS): In order to collect data on pain and its management, effect on peripheral and central nervous system, including visual impairment, long-term safety and long-term effectiveness, the MAH should submit the results of a study based on data deriving from a registry of patients with high risk neuroblastoma.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): U svrhu prikupljanja podataka o boli i njezinom zbrinjavanju, učinku na periferni i središnji živčani sustav, uključujući poremećaje vida, dugoročnu sigurnost primjene i dugoročnu učinkovitost, nositelj odobrenja za stavljanje lijeka u promet treba predati rezultate ispitivanja na temelju podataka iz registra bolesnika s neuroblastomom visokog rizika.
English: • prolonged grade 2 peripheral motor neuropathy
Croatian: • dugotrajna periferna motorna neuropatija 2. stupnja
English: The most frequent hypersensitivity reactions included hypotension (39%), urticaria (18%) and bronchospasm (4%).
Croatian: Najčešće reakcije preosjetljivosti uključivale su hipotenziju (39 %), urtikariju (18 %) i bronhospazam (4 %).
English: Therefore, ADA formation would be predicted to have a slight impact (less than 10% decrease) on exposure within 24 hours after administration, under non-steady state conditions.
Croatian: Stoga se predviđa da stvaranje protutijela na lijek ima slab utjecaj (manje od 10 %-tno smanjenje) na izloženost u roku od 24 sata nakon primjene, u uvjetima kad nije postignuta dinamička ravnoteža.
English: • tissue swelling (in the face, lip, around the eye, in the lower limbs)
Croatian: • oticanje tkiva (na licu, usnama, oko oka, u donjim ekstremitetima)
English: Therefore, your doctor will give you an appropriate pain treatment starting 3 days before and continuing during use of Qarziba.
Croatian: Stoga će vam liječnik dati odgovarajuću terapiju protiv bolova počevši 3 dana prije i nastaviti tijekom primjene lijeka Qarziba.
English: • abnormal blood or urine tests (blood cells and other components, liver function, renal function)
Croatian: • abnormalne vrijednosti testova krvi ili urina (krvne stanice i ostale komponente, funkcija jetre,
English: • Marketing Authorisation Holder EUSA Pharma (Netherlands) B.V.
Croatian: • Nositelj odobrenja za stavljanje lijeka u promet EUSA Pharma (Netherlands) B.V.
English: Cases of motor or sensory neuropathy lasting more than 4 days must be evaluated and non-inflammatory causes, such as disease progression, infections, metabolic syndromes and concomitant medication, should be excluded.
Croatian: Slučajeve motorne ili senzorne neuropatije koja traje dulje od 4 dana potrebno je ocijeniti i isključiti neupalne uzroke kao što su napredovanje bolesti, infekcije, metabolički sindromi i istodobna primjena drugih lijekova.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek je potrebno odmah primijeniti.
English: The effects of dinutuximab beta on fertility in humans are unknown.
Croatian: Učinci dinutuksimaba beta na plodnost u ljudi nisu poznati.
English: • inflammation of the mouth and lips (stomatitis)
Croatian: • upala usta i usana (stomatitis)
English: It is recommended that antihistamine administration be repeated every 4 to 6 hours as required during dinutuximab infusion.
Croatian: Preporučuje se ponavljanje primjene antihistaminika svakih 4 do 6 sati po potrebi tijekom infuzije dinutuksimaba.
English: Qarziba should not be used in women of childbearing potential not using contraception.
Croatian: Qarziba ne smiju koristiti žene u reproduktivnoj dobi koje ne koriste kontracepciju.
English: • oxygen deficiency
Croatian: • manjak kisika
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskim stranicama Europske agencije za lijekove: http://www.ema.europa.eu.
English: INFORMATION IN BRAILLE Qarziba
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Qarziba
English: In case of bronchial and/or pulmonary hypersensitivity reaction, inhalation with epinephrine (adrenaline) is recommended and should be repeated every 2 hours, according to clinical response.
Croatian: U slučaju reakcije preosjetljivosti bronha ili pluća preporučuje se davanje inhalacije epinefrina (adrenalina), koju je potrebno ponavljati svaka 2 sata, u skladu s kliničkim odgovorom.
English: The overall response rate (complete response plus partial response) in patients with evidence of disease at baseline was 36% (95% confidence interval [25; 48]) and was more favourable in patients with refractory disease (41% [23; 57]) than in patients with relapsed disease (29% [15; 46]).
Croatian: Stopa ukupnog odgovora (potpuni odgovor plus djelomični odgovor) u bolesnika s dokazima postojanja bolesti na početku iznosila je 36 % (95-postotni interval pouzdanosti [25; 48]), a bila je povoljnija u bolesnika s refraktornom bolešću (41 % [23; 57]) nego u bolesnika s recidivom bolesti (29 % [15; 46]).
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.
Croatian: Dinutuksimab beta je protein za koji je očekivani metabolički put razgradnja do malih peptida i pojedinačnih aminokiselina posredstvom ubikvitarnih proteolitičkih enzima.
English: If you get any side effects, talk to your doctor or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, trebate obavijestiti liječnika ili medicinsku sestru.
English: Do not use medicines that suppress the immune system from 2 weeks before the first dose of Qarziba until 1 week after the last treatment course, unless prescribed by your doctor.
Croatian: Nemojte primjenjivati lijekove koji potiskuju imunosni sustav počevši 2 tjedna prije prve doze lijeka Qarziba do isteka tjedan dana nakon zadnjeg ciklusa liječenja, osim ako vam je to propisao liječnik.
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Qarziba u jednoj ili više podskupina pedijatrijske populacije za liječenje neuroblastoma (vidjeti dio 4.2. za informacije o pedijatrijskoj primjeni).
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.
Croatian: Preporučuje se da liječenje takvih reakcija uključuje prednizolon primijenjen intravenskim bolusom i epinefrin primijenjen intravenskim bolusom svakih 3 do 5 minuta po potrebi, u skladu s kliničkim odgovorom.
English: It is recommended to prepare 50 mL solution in a 50 mL syringe, or 250 mL in an infusion bag suitable for the employed infusion pump, i.e. an overfill of 2 mL (syringe) or 10 mL (infusion bag) to allow for dead volumes of the infusion systems.
Croatian: Preporučuje se priprema otopine od 50 ml u štrcaljki od 50 ml ili od 250 ml u vrećici za infuziju koja je prikladna za infuzijsku pumpu koja se koristi, to jest prepunjavanje od 2 ml (štrcaljka) ili 10 ml (vrećica za infuziju) kako bi se omogućio ukupni volumen sustava za infuziju.
English: • sudden constriction of the airways (bronchospasm, laryngospasm), rapid breathing
Croatian: • iznenadno suženje dišnih putova (bronhospazam, laringospazam), ubrzano disanje
English: Treatment should be permanently discontinued in patients experiencing any objective prolonged weakness attributable to dinutuximab beta administration.
Croatian: Liječenje je potrebno trajno prekinuti u bolesnika koji osjećaju bilo kakvu objektivnu dugotrajnu slabost koja se pripisuje primjeni dinutuksimaba beta.
English: • adequate renal function: creatinine clearance or glomerular filtration rate (GRF)
Croatian: • odgovarajuća funkcija bubrega: klirens kreatinina ili brzina glomerularne filtracije (GRF)
English: Survival rates (event-free survival, overall survival) are presented by type of disease in Table 1.
Croatian: Stope preživljenja (preživljenje bez događaja, ukupno preživljenje) predstavljene su prema vrsti bolesti u tablici 1.
English: • or five daily infusions of 20 mg/m2 administered over 8 hours, on the first 5 days of each course
Croatian: • pet dnevnih infuzija od 20 mg/m2 koje se primjenjuju tijekom 8 sati, prvih 5 dana svakog ciklusa.
English: Prior to the treatment of relapsed neuroblastoma, your treating physician will stabilise any actively progressing disease by other suitable measures.
Croatian: Prije liječenja neuroblastoma koji se vratio, vaš liječnik stabilizirat će svaku bolest koja aktivno napreduje primjenom drugih odgovarajućih mjera.
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).
Croatian: Ako vaš liječnik razmatra istodobnu primjenu interleukina-2, dobit ćete ga dvaput, injekcijom pod kožu, svaki put 5 uzastopnih dana (prije i tijekom liječenja lijekom Qarziba).
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.
Croatian: • curenje iz malih krvnih žila (sindrom kapilarnog curenja) Curenje sastavnica krvi iz malih krvnih žila može prouzročiti brzo oticanje ruku, nogu i ostalih dijelova tijela.
English: No animal data are available on teratogenicity or embryotoxicity.
Croatian: Nema podataka o teratogenosti ili embriotoksičnosti u životinja.
English: • If continous morphine infusion is required for more than 5 days, treatment should be gradually reduced by 20% per day after the last day of dinutuximab beta infusion.
Croatian: • Ako je potrebno primjenjivati kontinuiranu infuziju morfina dulje od 5 dana, liječenje je potrebno postupno smanjivati za 20 % na dan nakon posljednjeg dana davanja infuzije dinutuksimaba beta.
English: For patients with moderate (Grade 2) neuropathy (motor with or without sensory), treatment should be interrupted and may be resumed after neurologic symptoms resolve.
Croatian: U bolesnika s umjerenom (2. stupanj) neuropatijom (motorna neuropatija koja uključuje ili ne uključuje senzornu) liječenje je potrebno prekinuti, a moguće ga je ponovno nastaviti nakon nestanka neuroloških simptoma.
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.
Croatian: Qarziba koristi se za liječenje neuroblastoma, za koji postoji visok rizik od povrata nakon niza liječenja, koja uključuju transplantaciju matičnih stanica radi ponovne izgradnje imunosnog sustava.
English: As a consequence, either the infusion period is prolonged or, if tolerated by the patient, the infusion rate may be increased up to 3 mL/h (continuous infusion), in order to administer the total dose.
Croatian: Posljedično se produljuje razdoblje davanja infuzije ili je, ako to bolesnik podnosi, moguće povećati brzinu infuzije do 3 ml/h (kontinuirana infuzija) kako bi se primijenila cjelokupna doza.
English: Rapid drop in blood pressure, light-headedness and breathing difficulties are further signs.
Croatian: Brzi pad krvnog tlaka, ošamućenost i otežano disanje dodatni su znakovi.
English: In patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy, Qarziba should be combined with interleukin-2 (IL-2).
Croatian: U bolesnika koji imaju povijest recidiva neuroblastoma/refraktornog neuroblastoma te bolesnika koji nisu postigli potpun odgovor nakon prve linije terapije, Qarziba potrebno je kombinirati s interleukinom-2 (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).
Croatian: • Uz kontinuirane infuzije, kao odgovor na doživljaj boli bolesnika, moglo bi biti moguće postupno ukinuti primjenu morfina tijekom 5 dana progresivnim smanjivanjem brzine njegova doziranja (npr. na 0,02 mg/kg/sat, 0,01 mg/kg/sat, 0,005 mg/kg/sat).
English: The recommended dose is 100 mg dinutuximab beta per square metre of body surface per treatment course.
Croatian: Preporučena doza iznosi 100 mg dinutuksimaba beta po četvornom metru tjelesne površine po ciklusu liječenja.
English: • Subsequently, a dosing rate of 0.03 mg/kg/hour is recommended concomitantly with dinutuximab beta infusion.
Croatian: • Zatim, brzina doziranja od 0,03 mg/kg/sat preporučuje se istodobno s primjenom infuzije dinutuksimaba beta.
English: The patient specific daily dose of Qarziba is calculated based on body surface area (see section 4.2).
Croatian: Dnevna doza lijeka Qarziba za pojedinog bolesnika izračunava se na temelju tjelesne površine (vidjeti dio 4.2).
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).
Croatian: Sigurnost dinutuksimaba beta ocijenjena je u 514 bolesnika s neuroblastomom visokog rizika i s recidivom neuroblastoma / refraktornim neuroblastomom, koji su ga primili u obliku kontinuirane infuzije (98) ili u obliku ponavljajućih dnevnih infuzija (416).
English: What Qarziba contains
Croatian: Što Qarziba sadrži
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet prvi PSUR za ovaj lijek dostavit će unutar 6 mjeseci nakon odobrenja.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/4.5 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 20 mg/4,5 ml
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.
Croatian: Sindrom otpuštanja citokina često se manifestira u roku od nekoliko minuta do nekoliko sati nakon početka primjene prve infuzije, a karakteriziraju ga sistemski simptomi kao što su vrućica, hipotenzija i urtikarija.
English: Each carton contains 1 vial.
Croatian: U svakoj kutiji nalazi se jedna bočica.
English: Before receiving Qarziba, you will have blood tests to check your liver, lung, renal and bone marrow functions.
Croatian: Prije primanja lijeka Qarziba napravit će vam se krvne pretrage kako bi se provjerile funkcije vaše jetre, pluća, bubrega i koštane srži.