FrancophonIA/ELRC3.0 huggingface dataset:
English: No dose adjustment is required for elderly patients (≥ 65 years) (see sections 5.1 and 5.2).
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika ( ≥ 65 godina) (vidjeti dijelove 5.1 i 5.2).
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta, lijek se mora odmah upotrijebiti.
English: The metabolic pathway of nivolumab has not been characterised.
Croatian: Put metabolizma nivolumaba nije okarakteriziran.
English: Ask your doctor if you can breast-feed during or after treatment with Nivolumab BMS.
Croatian: Pitajte svog liječnika smijete li dojiti tijekom ili nakon liječenja lijekom Nivolumab BMS.
English: Thirty-one percent had progressive disease reported as the best response to their most recent prior regimen and 45% received nivolumab within 3 months of completing their most recent prior regimen.
Croatian: Trideset i jedan posto bolesnika imalo je progresivnu bolest prijavljenu kao najbolji odgovor na posljednji primijenjeni protokol, a njih 45% primilo je nivolumab unutar 3 mjeseca nakon završetka posljednjeg primijenjenog protokola.
English: 101 International Drive Portsmouth, New Hampshire
Croatian: Portsmouth, New Hampshire
English: The European Medicines Agency has deferred the obligation to submit the results of studies with nivolumab in all subsets of the paediatric population in the treatment of malignant solid tumours (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja nivolumaba u svim podskupinama pedijatrijske populacije u liječenju zloćudnih solidnih tumora (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If you have any further questions about your treatment or on the use of this medicine, ask your doctor.
Croatian: U slučaju bilo kakvih pitanja u vezi s liječenjem ili primjenom ovog lijeka, obratite se svom liječniku.
English: As with all therapeutic proteins, there is a potential for an immune response to nivolumab.
Croatian: Kao i kod svih terapijskih proteina, može se razviti imunološki odgovor na nivolumab.
English: Your doctor may give you other medicines in order to prevent complications and reduce your symptoms,
Croatian: dati druge lijekove kako bi spriječio komplikacije i ublažio simptome
English: nivolumab (n = 135)
Croatian: (n = 135)
English: Prior to launch of Nivolumab BMS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka Nivolumab BMS u promet, nositelj odobrenja za stavljanje lijeka u promet mora u svakoj državi članici s nacionalnim nadležnim tijelom dogovoriti sadržaj i format edukacijskog programa, uključujući medije komunikacije, modalitete distribucije i sve druge aspekte programa.
English: Results for growth indices, as well as teratogenic, neurobehavioral, immunological, and clinical pathology parameters throughout the 6-month postnatal period were comparable to the control group.
Croatian: Rezultati za indekse rasta kao i teratogene, neurobihevioralne, imunološke i kliničke patološke parametre tijekom 6-mjesečnog postnatalnog razdoblja bili su usporedivi s kontrolnom skupinom.
English: The majority of adverse reactions were mild to moderate (Grade 1 or 2).
Croatian: Većina nuspojava bila je blage do umjerene težine (1. ili 2. stupnja).
English: The MAH shall ensure that in each Member State where Nivolumab BMS is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use Nivolumab BMS have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja pobrinut će se da u svakoj zemlji članici u kojoj će Nivolumab BMS biti na tržištu svi zdravstveni djelatnici i bolesnici/njegovatelji za koje se očekuje da će propisivati i primjenjivati lijek Nivolumab BMS imaju pristup/dobiju sljedeći edukacijski paket:
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u
English: The PD-1 receptor is a negative regulator of T-cell activity that has been shown to be involved in the control of T-cell immune responses.
Croatian: Receptor PD-1 je negativan regulator aktivnosti T-stanica za koji se pokazalo da sudjeluje u kontroli imunoloških odgovora T-stanica.
English: It contains the active substance nivolumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Croatian: Sadrži djelatnu tvar nivolumab, koji je monoklonsko protutijelo, tj. jedna vrsta proteina oblikovana tako da prepozna specifičnu ciljnu tvar u tijelu i pričvrsti se za nju.
English: There was no evidence of altered pharmacokinetic or toxicity profile associated with anti-product-antibody development.
Croatian: Nisu pronađeni dokazi promjena u farmakokinetičkom profilu ni profilu toksičnosti koje bi bile povezane s razvojem protutijela na lijek.
English: • Signs or symptoms of the safety concern and when to seek attention from a HCP
Croatian: • Znakove i simptome pojedinih sigurnosnih problema i naputak o tome kada potražiti pomoć
English: Nivolumab BMS acts on your immune system and may cause inflammation in parts of your body.
Croatian: Nivolumab BMS djeluje na imunosni sustav i može uzrokovati upalu u nekim dijelovima tijela.
English: Key secondary efficacy outcome measures were investigator-assessed objective response rate (ORR) and progression-free survival (PFS).
Croatian: Ključne sekundarne mjere ishoda za djelotvornost bile su stopa objektivnog odgovora (engl. objective response rate, ORR) i preživljenje bez progresije bolesti (engl. progression-free survival, PFS) prema ocjeni ispitivača.
English: The educational programme is aimed at increasing the awareness about the potential immune mediated adverse events associated with Nivolumab BMS use, how to manage them and to enhance the awareness of patients or their caregivers on the signs and symptoms relevant to the early those adverse events.
Croatian: Cilj edukacijskog programa je povećati svijest o mogućim imunološki uzrokovanim nuspojavama povezanima s primjenom lijeka Nivolumab BMS, o tome kako ih zbrinuti i povećati svijest bolesnika ili njihovih njegovatelja o znakovima i simptomima koji su važni za rano prepoznavanje tih nuspojava.
English: Nivolumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Croatian: Očekuje se da će se nivolumab kataboličkim putovima razgraditi na male peptide i aminokiseline na isti način kao i endogeni IgG.
English: A risk to the breast-fed infant cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with nivolumab may occur at any time during or after discontinuation of nivolumab therapy.
Croatian: Bolesnike treba kontinuirano pratiti (najmanje 5 mjeseci nakon posljednje doze) jer kod liječenja nivolumabom nuspojave mogu nastupiti u bilo kojem trenutku tijekom ili nakon prekida terapije nivolumabom.
English: Use a separate infusion line for the infusion.
Croatian: Za infuziju upotrijebite posebnu infuzijsku liniju.
English: It is important that you keep the Alert Card with you during treatment.
Croatian: Važno je da tijekom liječenja sa sobom nosite Karticu s upozorenjima
English: In the absence of data, nivolumab should be used with caution in these populations after careful consideration of the potential risk-benefit on an individual basis.
Croatian: S obzirom na nedostatak podataka, nivolumab se u tim populacijama mora primjenjivati uz oprez nakon pažljive procjene omjera rizika i koristi za
English: Your doctor will continue giving you Nivolumab BMS for as long as you keep benefitting from it or until you no longer tolerate the treatment.
Croatian: Liječnik će Vam nastaviti davati Nivolumab BMS sve dok od njega budete imali koristi ili do trenutka kada više ne budete mogli podnositi liječenje.
English: The median age was 63 years (range: 39-85) with 44% ≥65 years of age and 11% ≥75 years of age.
Croatian: Medijan dobi iznosio je 63 godine (raspon: 39-85), uz 44% bolesnika u dobi od ≥ 65 godina i 11% u dobi od ≥ 75 godina.
English: Nivolumab is a human monoclonal antibody, as such pharmacokinetic interaction studies have not been conducted.
Croatian: Nivolumab je ljudsko monoklonsko protutijelo i stoga nisu provedena ispitivanja farmakokinetičkih interakcija.
English: The remaining offspring of nivolumab-treated females survived to scheduled termination, with no treatment-related clinical signs, alterations to normal development, organ-weight effects, or gross and microscopic pathology changes.
Croatian: Preostala mladunčad ženki liječenih nivolumabom preživjela je do planirana usmrćivanja, a tijekom tog razdoblja nisu primijećeni klinički znakovi povezani s liječenjem, promjene u normalnom razvoju, učinci na težinu organa niti makroskopske i mikroskopske patološke promjene.
English: The observed OS benefit was consistently demonstrated across subgroups of patients.
Croatian: Opaženi korisni učinci na OS dosljedno su bili dokazani u svim podskupinama bolesnika.
English: To continue the exploration of the optimal cut-off for PD-L1 positivity based on current assay method used to further elucidate its value as predictive of nivolumab efficacy.
Croatian: Nastaviti istraživati optimalnu graničnu vrijednost za pozitivan nalaz na PD-L1 prema testnoj metodi koja se trenutno koristi, radi daljnjeg rasvjetljavanja njegove vrijednosti kao pretkazatelja djelotvornosti nivolumaba.
English: The average EQ-VAS increased over time for both treatment groups, indicating better overall health status for patients remaining on treatment.
Croatian: Prosječni EQ-VAS rezultat s vremenom se povećavao u obje liječene skupine, što je ukazivalo na bolji ukupan zdravstveni status
English: • The patient alert card shall contain the following key messages:
Croatian: • Kartica s upozorenjima za bolesnika sadržavat će sljedeće ključne elemente:
English: Unless an alternate etiology has been identified, signs or symptoms of endocrinopathies should be considered immune-related.
Croatian: Ako se ne utvrdi neka druga etiologija, znakove ili simptome endokrinopatija treba smatrati imunološki uzrokovanima.
English: Before you are given Nivolumab BMS, tell your doctor if you are taking any medicines that suppress your immune system, such as corticosteroids, since these medicines may interfere with the effect of Nivolumab BMS.
Croatian: Prije nego što primite Nivolumab BMS, obavijestite svog liječnika ako uzimate bilo kakve lijekove koji potiskuju imunosni sustav, poput kortikosteroida, jer ti lijekovi mogu utjecati na djelovanje lijeka Nivolumab BMS.
English: The preliminary results show that systemic immunosuppression after starting nivolumab treatment does not appear to preclude the response on nivolumab.
Croatian: Preliminarni rezultati pokazuju da sistemska imunosupresija nakon uvođenja liječenja nivolumabom ne spriječava odgovor na nivolumab.
English: Because of potential adverse reactions such as fatigue (see section 4.8), patients should be advised to use caution when driving or operating machinery until they are certain that nivolumab does not adversely affect them.
Croatian: Zbog mogućih nuspojava poput umora (vidjeti dio 4.8), bolesnicima treba savjetovati da budu oprezni kada upravljaju vozilima ili rade sa strojevima dok ne
English: Two patients (1 with Grade 2 rash and 1 with Grade 3 rash) required permanent discontinuation of nivolumab.
Croatian: U dva se bolesnika (1 s osipom 2. stupnja i 1 s osipom 3. stupnja) liječenje nivolumabom moralo trajno prekinuti.
English: Based on its pharmacodynamic properties, nivolumab is unlikely to affect the ability to drive and use machines.
Croatian: S obzirom na farmakodinamička svojstva nivolumaba, nije vjerojatno da će on utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Grade 3 anaphylactic reaction and Grade 4 hypersensitivity were each reported in 1 patient; both of these cases led to discontinuation and resolved with treatment.
Croatian: Anafilaktička reakcija 3. stupnja i preosjetljivost 4. stupnja prijavljene su svaka u 1 bolesnika; oba ta slučaja zahtijevala su prekid primjene lijeka, a povukla su se uz liječenje.
English: Neutralising antibodies were detected in only 5 (1.0% of the total) of the positive anti-product-antibody patients.
Croatian: Neutralizirajuća protutijela pronađena su u samo 5 bolesnika (1,0% svih bolesnika) pozitivnih na protutijela na lijek.
English: No cases of overdose have been reported in clinical trials.
Croatian: U kliničkim ispitivanjima nije prijavljen nijedan slučaj predoziranja.
English: See “Description of selected adverse reactions; laboratory abnormalities” below.
Croatian: Vidjeti 'Opis odabranih nuspojava; odstupanja u laboratorijskim vrijednostima' u nastavku.
English: Nivolumab BMS must be stored in a refrigerator (2°C to 8°C).
Croatian: Nivolumab BMS se mora čuvati u hladnjaku (2°C do 8°C).
English: From a microbiological point of view, once opened, the medicinal product should be infused or diluted and infused immediately.
Croatian: S mikrobiološkog stanovišta, lijek se nakon otvaranja mora odmah infundirati ili razrijediti i
English: The prescribed dose for the patient is given in mg/kg.
Croatian: Propisana doza za bolesnika izražava se u mg/kg.
English: Study CA209017 included a limited number of patients ≥ 75 years (11 in the nivolumab group and 18 in the docetaxel group).
Croatian: U ispitivanje CA209017 bio je uključen ograničen broj bolesnika u dobi od ≥75 godina (11 u skupini liječenoj nivolumabom i 18 u skupini liječenoj docetakselom).
English: If you become pregnant while using Nivolumab BMS tell your doctor.
Croatian: Ako zatrudnite dok primate Nivolumab BMS, obavijestite o tome svog liječnika.
English: The final infusion concentration should range between 1 and 10 mg/mL.
Croatian: Konačna koncentracija infuzije mora biti u rasponu od 1 do 10 mg/ml.
English: Tumour assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter.
Croatian: Response Evaluation Criteria In Solid Tumors, RECIST) provedene su 9 tjedana nakon randomizacije, a zatim svakih 6 tjedana.
English: Although ECOG status, baseline glomerular filtration rate (GFR), albumin, body weight, and mild hepatic impairment had an effect on nivolumab CL, the effect was not clinically meaningful.
Croatian: Iako su ECOG status, početna brzina glomerularne filtracije (GFR), razina albumina, tjelesna težina i blago oštećenje jetrene funkcije utjecali na klirens nivolumaba, taj učinak nije bio klinički značajan.
English: Do not use Nivolumab BMS if you are pregnant unless your doctor specifically tells you to.
Croatian: Nemojte primati Nivolumab BMS tijekom trudnoće, osim ako Vam to izričito ne kaže Vaš liječnik.
English: Nivolumab attaches to a target protein called programmed death-1 receptor (PD-1) that can switch off the activity of T cells (a type of white blood cell that forms part of the immune system, the body's natural defences).
Croatian: Nivolumab se veže za ciljni protein koji se naziva receptorom programirane stanične smrti-1 (engl. programmed death-1 receptor, PD-1) i koji može zaustaviti aktivnost T-stanica (jedne vrste bijelih krvnih stanica koje čine dio imunosnog sustava, prirodnog obrambenog sustava tijela).
English: As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of nivolumab.
Croatian: Budući da se monoklonska protutijela ne metaboliziraju enzimima citokroma P450 (CYP) ni drugim enzimima koji metaboliziraju lijekove, ne očekuje se da će inhibicija ili indukcija tih enzima uzrokovana istodobnom primjenom drugih lijekova utjecati na farmakokinetiku nivolumaba.
English: It is available in packs containing either 1 vial of 4 mL or 1 vial of 10 mL.
Croatian: Dostupan je u pakiranjima koja sadrže 1 bočicu od 4 ml ili 1 bočicu od 10 ml.
English: Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Croatian: Lijek mora pripremiti obučeno zdravstveno osoblje u skladu s pravilima dobre prakse, osobito s obzirom na asepsu.
English: Recommendation for the use of hormone replacement therapy is provided in section 4.4.
Croatian: Preporuka za primjenu hormonske nadomjesne terapije navedena je u dijelu 4.4.
English: 31st March 2017
Croatian: 31. ožujka 2017.
English: Tell your doctor immediately if you get any of the side effects listed above.
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo koju od gore navedenih nuspojava.
English: Nivolumab BMS is a medicine used to treat advanced non-small cell lung cancer (a type of lung cancer) in adults.
Croatian: Nivolumab BMS je lijek koji se koristi za liječenje uznapredovalog raka pluća nemalih stanica (jedne vrste raka pluća) u odraslih.
English: Docetaxel (events : 113/137), median and 95% CI : 6.01 (5.13, 7.33)
Croatian: Docetaksel (događaji: 113/137), medijan i 95% CI: 6,01 (5,13; 7,33)
English: In syngeneic mouse models, blocking PD-1 activity resulted in decreased tumour growth.
Croatian: U singeničnim mišjim modelima blokiranje aktivnosti PD-1 dovelo je do smanjena rasta tumora.
English: For instructions on the handling of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rukovanju lijekom prije primjene vidjeti dio 6.6.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Although hyperparathyroidism was not reported in CA209017, immune-related hyperparathyroidism might be considered especially if associated with hypophosphataemia (reported in 6 hypercalcemic patients in this study).
Croatian: Iako u ispitivanju CA209017 nije prijavljena hiperparatireoza, može se razmotriti imunološki uzrokovana hiperparatireoza, osobito ako je povezana s hipofosfatemijom (koja je u ovom ispitivanju prijavljena u
English: 6.6 Special precautions for disposal and other handling Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Lijek mora pripremiti obučeno zdravstveno osoblje u skladu s pravilima dobre prakse, osobito s obzirom na asepsu.
English: The rate of disease-related symptom improvement, as measured by LCSS, was similar between the nivolumab group (18.5%) and the docetaxel group (21.2%).
Croatian: Stopa poboljšanja simptoma povezanih s bolešću, mjerena upitnikom LCSS, bila je slična u skupini liječenoj nivolumabom (18,5%) i onoj liječenoj docetakselom (21,2%).
English: The amount of Nivolumab BMS you will be given will be calculated based on your body weight.
Croatian: Količina lijeka Nivolumab BMS koju ćete primiti izračunat će se na temelju
English: September 2015
Croatian: 30. rujna 2015.
English: A population PK analysis suggested no difference in CL of nivolumab based on age, gender, race, tumour type, tumour size, and hepatic impairment.
Croatian: Populacijska PK analiza nije ukazala na razlike u klirensu nivolumaba na temelju dobi, spola, rase, vrste tumora, veličine tumora i oštećenje jetrene funkcije.
English: Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody (HuMAb), which binds to the programmed death-1 (PD-1) receptor and blocks its interaction with PD-L1 and PD-L2.
Croatian: Nivolumab je ljudsko imunoglobulinsko G4 (IgG4) monoklonsko protutijelo (HuMAb) koje se veže za receptor programirane stanične smrti-1 (engl. programmed death-1, PD-1) i blokira njegovu interakciju s ligandima PD-L1 i PD-L2.
English: The vials must be kept in the original package in order to protect from light.
Croatian: Bočice se moraju čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: For Grade 2 transaminase or total bilirubin elevation, nivolumab should be withheld.
Croatian: U slučaju povišenja razine transaminaza ili ukupnog bilirubina 2. stupnja, potrebno je odgoditi primjenu nivolumaba.
English: Survival benefit was observed regardless of whether patients had tumours that were designated PD-L1 negative or PDL1 positive (tumour membrane expression cut off of 1%, 5% or 10%).
Croatian: Korisni učinci na preživljenje bili su opaženi neovisno o tome jesu li bolesnici imali tumore koji se se smatrali PD-L1 negativnima ili PD-L1 pozitivnima (granična vrijednost za ekspresiju na tumorskoj membrani od 1%, 5% ili 10%).
English: Inflammation may cause serious damage to your body and some inflammatory conditions may be life-threatening and need treatment or withdrawal of nivolumab.
Croatian: Upala može ozbiljno naškoditi Vašem organizmu, a neka upalna stanja mogu biti opasna po život te zahtijevati liječenje ili prestanak primjene nivolumaba.
English: This medicine contains 2.5 mg sodium per mL of concentrate.
Croatian: Ovaj lijek sadrži 2,5 mg natrija po ml koncentrata.
English: However, based on its mechanism of action, foetal exposure to nivolumab may increase the risk of developing immune-related disorders or altering the normal immune response and immune-related disorders have been reported in PD-1 knockout mice.
Croatian: Međutim, s obzirom na mehanizam djelovanja nivolumaba, izloženost ploda ovom lijeku može povećati rizik od razvoja imunološki uzrokovanih poremećaja ili promjene normalnog imunološkog odgovora, pa su tako u miševa kojima je inaktiviran (engl. knockout) PD-1 prijavljeni imunološki uzrokovani poremećaji.
English: Nivolumab should not be resumed while the patient is receiving immunosuppressive doses of corticosteroids or other immunosuppressive therapy.
Croatian: Liječenje nivolumabom ne smije se nastaviti dok bolesnik prima imunosupresivne doze kortikosteroida ili drugog imunosupresivnog lijeka.
English: Patients with mild or moderate infusion reaction may receive nivolumab with close monitoring.
Croatian: Bolesnici s blagim ili umjerenim reakcijama na infuziju mogu primati nivolumab pod strogim
English: All prescribers of Nivolumab BMS must be familiar with the Physician Information and Management Guidelines.
Croatian: Svi liječnici koji propisuju Nivolumab BMS moraju poznavati Informacije za liječnike i Smjernice za zbrinjavanje.
English: The pharmacokinetics (PK) of nivolumab is linear in the dose range of 0.1 to 10 mg/kg.
Croatian: Farmakokinetika (PK) nivolumaba je linearna u rasponu doza od 0,1 do 10 mg/kg.
English: The active substance is nivolumab.
Croatian: Djelatna tvar je nivolumab.
English: Adverse reactions reported in the pooled dataset (n=248) of CA209017 and CA209063 are presented in Table 2.
Croatian: Prijavljene nuspojave identificirane na temelju objedinjenih podataka (n = 248) iz ispitivanja CA209017 i CA209063 prikazane su u Tablici 2.
English: By attaching to PD-1, nivolumab blocks its action and prevents it from switching off your T cells.
Croatian: Vezanjem za PD-1, nivolumab blokira njegovo djelovanje i sprječava ga da zaustavi aktivnost T-stanica.
English: If not used immediately, the solution may be stored under refrigeration conditions (2°C-8°C) and protected from light for up to 24 hours [a maximum of 4 hours of the total 24 hours can be at room temperature (20°C-25°C) and room light].
Croatian: Ako se ne primijeni odmah, otopina se može čuvati u hladnjaku (2°C-8°C), zaštićena od svjetlosti, tijekom najviše 24 sata [lijek se može čuvati na sobnoj temperaturi (20°C-25°C) i sobnoj svjetlosti tijekom najviše 4 sata od ukupna 24 sata].