FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should have no evidence of systemic infection and any identified infection should be under control before starting therapy.
Slovenian: Bolniki ne smejo kazati simptomov sistemskih okužb, kakršna koli ugotovljena okužba pa mora biti pred začetkom terapije pod nadzorom.
English: Safety profile with and without IL-2
Slovenian: Varnostni profil z IL-2 in brez njega
English: The safety and efficacy of Qarziba in children aged less than 12 months have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Qarziba pri otrocih, mlajših od 12 mesecev, še nista bili dokazani.
English: Your doctor will do blood tests and may do eye tests while you are taking this medicine.
Slovenian: Zdravnik bo opravil krvne preiskave in bo morda opravil očesni pregled v obdobju, ko jemljete to zdravilo.
English: • infection, in particular infection associated with the catheter that delivers the medicine
Slovenian: • okužba, še zlasti okužba, ki je povezana s katetrom za dovajanje zdravila
English: • oxygen deficiency
Slovenian: • pomanjkanje kisika
English: Two modes of administration are possible:
Slovenian: Možna sta dva načina dajanja zdravila:
English: It is not known if the medicine can pass into breast-milk.
Slovenian: Ni znano, ali to zdravilo prehaja v materino mleko.
English: • adequate liver function: alanine aminotransferase (ALT)/ aspartate aminotransferase (AST)
Slovenian: • ustrezna jetrna funkcija: alanin-aminotransferaza (ALT)/aspartat-aminotransferaza (AST) < 5
English: These are proteins, which specifically recognise and bind to other unique proteins in the body.
Slovenian: To so beljakovine, ki posebej prepoznajo druge edinstvene beljakovine v telesu in se vežejo nanje.
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.
Slovenian: Tveganja za posredno zmanjšanje aktivnosti CYP zaradi višjih vrednosti TNF-α in IL-6 ter zato medsebojnega delovanja v primeru sočasne uporabe drugih zdravil ni mogoče izključiti.
English: Both motor and sensory peripheral neuropathies have been reported, overall in 9% of the patients.
Slovenian: Poročali so o motorični in senzorični periferni nevropatiji, skupno pri 9 % bolnikov.
English: Treatment must be interrupted in patients who experience Grade 3 vision toxicity (i.e. subtotal vision loss per toxicity scale).
Slovenian: Zdravljenje je treba prekiniti pri bolnikih, pri katerih se razvije toksičnost za vid stopnje 3 (tj. nepopolna izguba vida glede na lestvico toksičnosti).
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:
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe.
English: The solution for infusion must be prepared under aseptic conditions.
Slovenian: Raztopino za infundiranje je treba pripraviti v aseptičnih pogojih.
English: A total of 370 patients were randomised and received treatment.
Slovenian: Skupno je bilo randomiziranih in je prejelo zdravljenje 370 bolnikov.
English: Patients should be closely monitored for anaphylaxis and allergic reactions, particularly during the first and second treatment course.
Slovenian: Bolnike je treba natančno spremljati glede pojava anafilaksije in alergijskih reakcij, še zlasti v prvem in drugem ciklu zdravljenja.
English: ≥ 20,000/µL, haemoglobin > 8.0 g/dL
Slovenian: ≥ 20.000/µl, hemoglobin > 8,0 g/dl,
English: • inflammation of the mouth and lips (stomatitis)
Slovenian: • vnetje ust in ustnic (stomatitis)
English: Given the limitation of the bioanalytical methods, data are currently insufficient to properly evaluate the impact of the formation of anti-drug antibodies on pharmacokinetic and pharmacodynamic parameters, as well as on the efficacy and safety of dinutuximab beta.
Slovenian: Zaradi omejitev bioanalitičnih metod so podatki trenutno nezadostni za ustrezno oceno vpliva nastajanja protiteles proti zdravilu na farmakokinetične in farmakodinamične parametre ter na učinkovitost in varnost dinutuksimaba beta.
English: • unable to pass urine or passing reduced urine volume
Slovenian: • nezmožnost uriniranja ali izločanje manjše količine urina kot sicer
English: Qarziba should not be used during pregnancy.
Slovenian: Zdravila Qarziba se ne sme uporabljati med nosečnostjo.
English: This has to be taken into consideration when interpreting PK parameters (Cmax, exposure, half-life) listed below.
Slovenian: To je treba upoštevati pri tolmačenju spodaj navedenih farmakokinetičnih parametrov (Cmax, izpostavljenost, razpolovni čas).
English: Once opened, Qarziba is intended for immediate use.
Slovenian: Po odprtju je zdravilo Qarziba namenjeno za takojšnjo uporabo.
English: • are allergic to dinutuximab beta or any of the other ingredients of this medicine (listed in section 6)
Slovenian: • če ste alergični na dinutuksimab beta ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: The daily dose is 10 mg/m2.
Slovenian: Dnevni odmerek je 10 mg/m2.
English: Qarziba 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 Qarziba je namenjeno samo uporabi v bolnišnici in ga je treba dajati pod nadzorom zdravnika, ki ima izkušnje z onkološkimi terapijami.
English: During and after the infusion, you will be checked regularly for infusion-related side effects.
Slovenian: Med infuzijo in po njej vas bodo redno spremljali glede neželenih učinkov, povezanih z infuzijo.
English: An effect of ADA formation on the volume of distribution was found (increase of 37% in volume).
Slovenian: Ugotovili so učinek nastajanja ADA na volumen porazdelitve (37-odstotno povečanje volumna).
English: Overall, measurable ADA titres were detected in 65 (62%) of the 105 patients examined.
Slovenian: Skupno so merljive titre protiteles proti zdravilu (anti-drug antibody - ADA) zaznali pri 65 (62 %) od 105 pregledanih bolnikov.
English: The doctor will calculate your body surface area from your height and weight.
Slovenian: Zdravnik bo izračunal vašo telesno površino na podlagi telesne višine in mase.
English: Nonopioid analgesics Nonopioid analgesics should be used permanently during the treatment, e.g. paracetamol or ibuprofen.
Slovenian: Neopioidne analgetike je treba med zdravljenjem uporabljati neprekinjeno, npr. paracetamol ali ibuprofen.
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.
Slovenian: Običajno se razvije v nekaj urah po začetku zdravljenja, o kliničnih simptomih (tj. hipotenzija, tahikardija) pa so poročali po 2 do 12 urah.
English: Effects of gender and age were not found to influence the pharmacokinetics of dinutuximab beta but data in children less than 2 years of age are very limited and insufficient to support dosing.
Slovenian: Niso ugotovili, da bi učinki spola in starosti vplivali na farmakokinetiko dinutuksimaba beta, vendar pa so podatki pri otrocih, mlajših od dveh let, zelo omejeni in ne zadoščajo za podporo odmerjanju.
English: Note that elastomeric pumps are not considered suitable in combination with in-line filters.
Slovenian: Upoštevajte, da črpalke iz elastomerov niso primerne za uporabo v kombinaciji s filtri v infuzijski liniji.
English: In case of any eye problems, patients should be referred promptly to an ophtalmology specialist.
Slovenian: V primeru težav z očmi je treba bolnike takoj napotiti na oftalmološki pregled.
English: • grade 4 hyponatremia (< 120 mEq/L) despite appropriate fluid management
Slovenian: • hiponatriemija stopnje 4 (< 120 mmol/l) kljub primernemu nadziranju tekočin,
English: • shock due to decreased body fluid volume
Slovenian: • šok zaradi zmanjšane prostornine telesnih tekočin
English: • pulse oximetry > 94% on room air
Slovenian: • pulzna oksimetrija > 94 % na sobnem zraku,
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.
Slovenian: Primere motorične ali senzorične nevropatije, ki trajajo več kot štiri dni, je treba oceniti in izključiti nevnetne vzroke zanjo, kot so napredovanje bolezni, okužbe, metabolični sindromi in sočasna zdravila.
English: Treatment with dinutuximab beta should be permanently discontinued if the following toxicities occur:
Slovenian: Zdravljenje z dinutuksimabom beta je treba trajno prekiniti, če se pojavijo naslednje toksičnosti:
English: Examples of medicines that suppress the immune system are corticosteroids used to reduce inflammation or prevent organ transplant rejection.
Slovenian: Primeri zdravil, ki zavirajo delovanje imunskega sistema, so kortikosteroidi, ki jih uporabljamo za zmanjšanje vnetja ali za preprečevanje zavrnitve presajenih organov.
English: Calculations of pharmacokinetic parameters for dinutuximab beta are based upon measurements using non-validated bioanalytical methods.
Slovenian: Izračuni farmakokinetičnih parametrov za dinutuksimab beta temeljijo na meritvah z uporabo nevalidiranih bioanalitičnih metod.
English: What Qarziba is and what it is used for
Slovenian: Kaj je zdravilo Qarziba in za kaj ga uporabljamo
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.
Slovenian: Zato je mogoče predpostaviti, da bo nastajanje ADA imelo majhen vpliv (manj kot desetodstotno zmanjšanje) na izpostavljenost v 24 urah po dajanju, v pogojih pred dosegom stanja dinamičnega ravnovesja.
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: • na zahtevo Evropske agencije za zdravila; 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 (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: • life-threatening infection (sepsis)
Slovenian: • življenjsko nevarna okužba (sepsa)
English: Neuroblastoma is a type of cancer that grows from abnormal nerve cells in the body, in particular in the glands above the kidneys.
Slovenian: Nevroblastom je vrsta raka, ki se razvija iz nenormalnih živčnih celic v telesu, še zlasti v nadledvičnih žlezah.
English: It is also used to treat neuroblastoma that has come back (relapsed) or could not be completely treated with previous therapies.
Slovenian: Uporabljamo ga tudi za zdravljenje nevroblastoma, ki se je znova pojavil (recidiv, relaps) ali ki ga s predhodnimi zdravljenji ni bilo mogoče v celoti pozdraviti.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so navedena v poglavju 6.6. 6.3 Rok uporabnosti
English: INFORMATION IN BRAILLE Qarziba
Slovenian: PODATKI V BRAILLOVI PISAVI Qarziba
English: Overall, 10% of CLS were severe (grade 3-4) and their frequency decreased over the treatment courses.
Slovenian: Skupno je bilo 10 % primerov CLS hudih (stopnja 3-4), njihova pogostnost pa se je zmanjšala v naslednjih ciklih zdravljenja.
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.
Slovenian: Neintervencijska varnostna študija po pridobitvi dovoljenja za promet (PASS): imetnik dovoljenja za promet z zdravilom mora za zbiranje podatkov o bolečinah in njihovem obvladovanju, učinku na periferni in osrednji živčni sistem, vključno s poslabšanjem vida, dolgoročni varnosti in dolgoročni učinkovitosti predložiti rezultate študije, ki temelji na podatkih, pridobljenih iz registra bolnikov z nevroblastomom z visokim tveganjem.
English: It is given into one of your veins (intravenous infusion) usually by using special tubes (catheters) and a pump.
Slovenian: Prejeli ga boste v eno od ven (intravenska infuzija), običajno po posebnih cevkah (katetri) in črpalki.
English: < 5 times upper limit of normal (ULN)
Slovenian: kratna zgornja meja normalnih vrednosti (upper limit of normal - ULN),
English: The observed Cmax levels were slightly higher (16.5 micrograms/mL) and were reached on the fifth infusion.
Slovenian: Opažene vrednosti Cmax so bile nekoliko višje (16,5 mikrogramov/ml) in so bile dosežene ob peti infuziji.
English: The most common adverse reactions were pyrexia (88%) and pain (77%) that occurred despite analgesic treatment.
Slovenian: Najpogostejša neželena učinka sta bili pireksija (88 %) in bolečina (77 %), ki sta se pojavili kljub zdravljenju z analgetiki.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če pripravljene raztopine ne uporabite takoj, je za čas shranjevanja pripravljene raztopine in za pogoje pred uporabo odgovoren uporabnik; čas ne sme biti daljši od 24 ur pri temperaturi od 2 do 8 ºC, razen če je bilo razredčenje opravljeno v nadzorovanih in validiranih aseptičnih pogojih.
English: • low blood pressure, increased heartbeat
Slovenian: • nizek krvni tlak, povišan srčni utrip
English: As they typically have a central venous catheter in situ, they are at risk of developing systemic infection.
Slovenian: Ker imajo običajno vstavljen centralni venski kateter (in situ), je tveganje za razvoj sistemske okužbe večje.
English: Renal and hepatic impairment There are no data in patients with renal and hepatic impairment (see section 5.2).
Slovenian: Okvara ledvic in jeter Ni podatkov o bolnikih z okvaro ledvic in jeter (glejte poglavje 5.2).
English: The same treatment regimen was used in a Phase II study (study 2), which enrolled 44 patients.
Slovenian: faze (študija 2), ki je vključevala 44 bolnikov.
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.
Slovenian: Model populacijske farmakokinetike je vključeval alometrično primerjavo (referenčna telesna masa je znašala 18,1 kg) za očistek in volumen porazdelitve z eksponentoma 0,75 in 1.
English: Tell your doctor if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Other intravenously co-administered agents should be delivered via a separate infusion line (see section 6.6).
Slovenian: Druga zdravila, ki se sočasno dajejo intravensko, je treba dovajati prek ločene infuzijske linije (glejte poglavje 6.6).
English: • eye problems You may notice changes to your vision.
Slovenian: Opazite lahko spremembe vida.
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.
Slovenian: Med njimi je bilo 64 % bolnikov moškega spola in 36 % ženskega spola, mediano starost je bila tri leta (od 0,6 do 20); 89 % jih je imelo tumor stopnje 4 po INSS, o amplifikaciji MYCN pa so poročali v 44 % primerov.
English: The first infusion day and course usually requires a higher dose than subsequent days and courses.
Slovenian: Običajno je na prvi dan infuzije in v prvem ciklu potreben večji odmerek kot v nadaljnjih dneh in ciklih.
English: No effects on cardiovascular functions (ECG, blood pressure) were observed in monkeys.
Slovenian: Pri opicah niso opazili učinkov na srčno-žilne funkcije (EKG, krvni tlak).
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.
Slovenian: V primeru bronhialne in/ali pljučne preobčutljivostne reakcije je priporočljiva inhalacija z adrenalinom, ki jo je treba ponoviti vsaki dve uri, skladno s kliničnim odzivom.
English: Overall, these 98 patients had primary refractory neuroblastoma (40) or relapsed neuroblastoma (49) with an additional 9 patients enrolled after first-line therapy.
Slovenian: Skupno je imelo teh 98 bolnikov primarni neodzivni nevroblastom (40) ali recidivni nevroblastom (49), dodatnih devet bolnikov pa je bilo vključenih po zdravljenju prve linije.
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).
Slovenian: Pri bolnikih z recidivno/neodzivno boleznijo in tistih, ki po zdravljenju prve linije niso dosegli popolnega odziva, je treba zdravilo Qarziba kombinirati z interlevkinom-2 (IL-2).
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 dati zdravstveni delavec, ki je pripravljen za ukrepanje v primeru hudih alergijskih reakcij, vključno z anafilaksijo, v okolju, v katerem je takoj na voljo vse potrebno za reanimacijo.
English: The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v šestih mesecih po pridobitvi dovoljenja za promet.
English: Treatment of disease before immunotherapy included intensive chemotherapy regimen followed by autologous stem cell transplantation (ASCT), radiotherapy, and surgery.
Slovenian: Zdravljenje bolezni pred imunoterapijo je vključevalo režim intenzivne kemoterapije, ki mu je sledila avtologna presaditev matičnih celic (autologous stem cell transplantation - ASCT), radioterapija in operacija.
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.
Slovenian: Hematološke toksičnosti stopnje 4, ki se do začetka naslednjega cikla zdravljenja izboljšajo najmanj do stopnje 2 ali do izhodiščnih vrednosti, ne potrebujejo prilagajanja odmerka.
English: • sudden constriction of the airways (bronchospasm, laryngospasm), rapid breathing
Slovenian: • nenadna zapora dihalnih poti (bronhospazem, laringospazem), hitro dihanje
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.
Slovenian: • Če je neprekinjena infuzija morfina potrebna več kot pet dni, je treba zdravljenje postopoma zmanjševati za 20 % na dan, po zadnjem dnevu infundiranja dinutuksimaba beta.
English: At baseline, 72 patients had measurable disease and 26 patients had no detectable disease.
Slovenian: V izhodišču je imelo 72 bolnikov merljivo bolezen, pri 26 pa bolezni ni bilo mogoče zaznati.
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]).
Slovenian: Skupna stopnja odziva (popolni odziv plus delni odziv) pri bolnikih z dokazi o bolezni v izhodišču je znašala 36 % (95 % interval zaupanja [25; 48]) in je bila ugodnejša pri bolnikih z neodzivno boleznijo (41 % [23; 57]) v primerjavi z bolniki z recidivno boleznijo (29 % [15; 46]).
English: The recommended dose is 100 mg dinutuximab beta per square metre of body surface per treatment course.
Slovenian: Priporočeni odmerek je 100 mg dinutuksimaba beta na kvadratni meter telesne površine na cikel zdravljenja.
English: • Marketing Authorisation Holder EUSA Pharma (Netherlands) B.V.
Slovenian: • Imetnik dovoljenja za promet z zdravilom EUSA Pharma (Netherlands) B.V.
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.
Slovenian: Posledično bo obdobje infundiranja podaljšano ali pa bo, če bo bolnik to ustrezno prenašal, hitrost infundiranja povečana na 3 ml/h (neprekinjena infuzija), da bo bolnik prejel celoten odmerek.
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.
Slovenian: Pri bolnikih z zmerno (stopnja 2) nevropatijo (motorična s senzorično nevropatijo ali brez nje) je treba zdravljenje prekiniti in uvesti znova, ko nevrološki simptomi izzvenijo.
English: Acute grade 3 or 4, or extensive chronic graft-versus-host disease (GvHD)
Slovenian: Akutna stopnja 3 ali 4 ali obsežna kronična reakcija presadka proti gostitelju (graft-versus-host disease - GvHD).
English: Adverse reactions are summarised in the table below.
Slovenian: Neželeni učinki so povzeti v spodnji preglednici.
English: Qarziba should not be used in women of childbearing potential not using contraception.
Slovenian: Zdravilo Qarziba se ne sme uporabljati pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: • abnormal blood or urine tests (blood cells and other components, liver function, renal function)
Slovenian: • nenormalne vrednosti krvnih ali urinskih testov (krvne celice in druge komponente, delovanje jeter, delovanje ledvic).
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).
Slovenian: Označevalci za ledvično (eGFR) in jetrno (bilirubin) funkcijo ne kažejo na povezavo z izpostavljenostjo (Cmax in AUC24h na 1. in 10. dan med desetdnevno infuzijo).
English: These included impaired visual accommodation that is correctable with eye glasses, as well as mydriasis (13%), blurred vision (3%) or photophobia (3%), which were usually reversible after treatment discontinuation.
Slovenian: Te so vključevale motnje akomodacije vida, ki jih je mogoče korigirati z očali, midriazo (13 %), zamegljen vid (3 %) ali fotofobijo (3 %); ti učinki pa so bili običajno reverzibilni po prekinitvi zdravljenja.
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
Slovenian: • neprekinjena infuzija v prvih desetih dneh vsakega cikla (skupno 240 ur) v dnevnem odmerku 10 mg/m2
English: Your doctor will further decide whether the co-administration of a second medicine, interleukin-2, is necessary for the treatment of your cancer.
Slovenian: Zdravnik se bo odločil tudi, ali je za zdravljenje vašega raka potrebno sočasno dajanje drugega zdravila, interlevkina-2.
English: Treatment should be permanently discontinued in patients experiencing any objective prolonged weakness attributable to dinutuximab beta administration.
Slovenian: Zdravljenje je treba trajno prekiniti pri bolnikih, pri katerih se razvije kakršna koli dolgotrajna objektivna šibkost, ki jo je mogoče pripisati dajanju dinutuksimaba beta.