FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents LIBTAYO should not be used in children and adolescents below 18 years of age.
Croatian: Djeca i adolescenti LIBTAYO se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina.
English: ALT: alanine aminotransferase; AST: aspartate aminotransferase; ULN: upper limit of normal.
Croatian: ALT: alanin aminotransferaza; AST: aspartat aminotransferaza; GGN: gornja granica normale.
English: If diluted solution is not administered immediately, it may be stored temporarily either:
Croatian: Ako se razrijeđena otopina ne primijeni odmah, može se privremeno čuvati:
English: 31st October
Croatian: 31. listopada
English: 95% CI for ORR Complete response (CR)
Croatian: 95% CI za ORR Potpuni odgovor b
English: In particular, tell your doctor if you are taking or have ever taken any of the following medicines:
Croatian: Osobito je važno da kažete svom liječniku ako uzimate ili ste ikada uzimali neki od sljedećih lijekova:
English: • LIBTAYO can harm your unborn baby.
Croatian: • LIBTAYO može naškoditi nerođenom djetetu.
English: All patients recovered from the infusion-related reaction.
Croatian: Svi su se bolesnici oporavili od reakcije na infuziju.
English: • bruises on the skin or bleeding.
Croatian: • modrice na koži ili krvarenje
English: The study should be conducted according to an agreed protocol.
Croatian: Ispitivanje treba provesti prema dogovorenom planu ispitivanja.
English: LIBTAYO works by helping your immune system fight your cancer.
Croatian: LIBTAYO djeluje tako da pomaže Vašem imunosnom sustavu da se bori protiv raka.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka treba jasno zabilježiti.
English: Cemiplimab exposure is similar across all age groups (see sections 5.1 and 5.2).
Croatian: Izloženost cemiplimabu slična je u svim dobnim skupinama (vidjeti dijelove 5.1 i 5.2).
English: Do not stop treatment of LIBTAYO unless you have discussed this with your doctor.
Croatian: Nemojte prekinuti liječenje lijekom LIBTAYO ako o tome prethodno niste razgovarali sa svojim liječnikom.
English: It is important that you keep this Patient Alert Card and show it to your partner or caregivers.
Croatian: Važno je da čuvate Karticu s upozorenjima za bolesnika i da je pokažete svom partneru ili njegovateljima.
English: 12 months
Croatian: 12 mjeseci
English: • you are allergic to cemiplimab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na cemiplimab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Inflammation may cause serious damage to your body.
Croatian: Upala može ozbiljno naškoditi organizmu.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Your doctor will decide how much LIBTAYO you will receive and how many treatments you will need.
Croatian: Vaš će liječnik odlučiti koliko lijeka LIBTAYO ćete primiti i koliko će se puta lijek primijeniti.
English: The recommended dose of LIBTAYO is 350 mg.
Croatian: Preporučena doza lijeka LIBTAYO je 350 mg.
English: Time to response Median (months) range (min:max)
Croatian: Vrijeme do odgovora Medijan (mjeseci) raspon (min.:maks.)
English: • The patient alert card shall contain the following key messages:
Croatian: • Kartica s upozorenjima za bolesnika mora sadržavati sljedeće ključne poruke:
English: The safety and efficacy of LIBTAYO in children and adolescents below the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka LIBTAYO u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Overall survival does not require central review.
Croatian: Za podatke o ukupnom preživljenju nije potrebna središnja ocjena.
English: Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Ireland
Croatian: Regeneron Ireland DAC Europa House, Harcourt Centre Harcourt Street, Dublin 2, Irska
English: This being a conditional marketing authorisation and pursuant to Article 14a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Croatian: Budući da je ovo uvjetno odobrenje za stavljanje lijeka u promet, sukladno članku 14-a stavku 4. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Efficacy and PD-L1 status
Croatian: Djelotvornost i status ekspresije PD-L1
English: It is known that antibodies (including IgG4) are secreted in human milk; a risk to the breast-feeding newborns/infants cannot be excluded.
Croatian: Poznato je da se protutijela (uključujući IgG4) izlučuju u majčino mlijeko pa se ne može isključiti rizik za novorođenče/dojenče.
English: No neutralizing antibodies have been observed.
Croatian: Nisu opažena neutralizirajuća protutijela.
English: Results are presented from 193 patients in Study 1540.
Croatian: Prikazani su rezultati za 193 bolesnika u ispitivanju 1540.
English: Other medicines and LIBTAYO
Croatian: Drugi lijekovi i LIBTAYO
English: Overall survival a, c, d
Croatian: Ukupno preživljenjea, c, d 12 mjeseci
English: Based on Kaplan Meier estimates d.
Croatian: c. Na temelju procjena prema Kaplan-Meieru.
English: 31st March
Croatian: 31. ožujka
English: After opening Once opened, the medicinal product should be diluted and infused immediately.
Croatian: Nakon otvaranja Lijek se nakon otvaranja mora odmah razrijediti i infundirati.
English: This is because stopping your treatment may stop the effect of the medicine.
Croatian: Naime, prekid liječenja mogao bi zaustaviti djelovanje lijeka.
English: Cemiplimab is expected to degrade to small peptides and individual amino acids.
Croatian: Očekuje se da će se cemiplimab razgraditi u malene peptide i pojedinačne aminokiseline.
English: Treatment must be initiated and supervised by physicians experienced in the treatment of cancer.
Croatian: Liječenje moraju započeti i nadzirati liječnici s iskustvom u liječenju raka.
English: These medicines may interfere with the effect of LIBTAYO.
Croatian: Ti lijekovi mogu utjecati na učinak lijeka LIBTAYO.
English: Thyroid disorders can occur at any time during the treatment.
Croatian: Poremećaji štitnjače mogu nastupiti u bilo kojem trenutku tijekom liječenja.
English: Grade 4 or confirmed SJS or TEN
Croatian: 4. stupanj ili potvrđen SJS ili TEN
English: • a cancer medicine called idelalisib • medicines that make your immune system weak - examples include corticosteroids, such as prednisone.
Croatian: • lijek za rak koji se zove idelalisib • lijekove koji oslabljuju imunosni sustav - primjerice kortikosteroide, kao što je prednizon.
English: What LIBTAYO is and what it is used for
Croatian: Što je LIBTAYO i za što se koristi
English: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
Croatian: Stevens-Johnsonov sindrom (SJS) ili toksičnu epidermalnu nekrolizu (TEN)
English: There was no evidence of an altered pharmacokinetic or safety profile with anti-cemiplimab antibody development.
Croatian: Nije bilo dokaza promjena u farmakokinetičkom ili sigurnosnom profilu kod razvoja protutijela na cemiplimab.
English: LIBTAYO does not contain a preservative.
Croatian: LIBTAYO ne sadrži konzervans.
English: The following information is intended for healthcare professionals only:
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: Upute za uporabu
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego primite ovaj lijek.
English: The relationship between PD-L1 status and efficacy was analysed post-hoc in patients with available tissue samples.
Croatian: Povezanost između statusa ekspresije PD-L1 i djelotvornosti analizirala se post-hoc u bolesnika za koje su bili dostupni tkivni uzorci.
English: No clinical data are available on the possible effects of cemiplimab on fertility.
Croatian: Nisu dostupni klinički podaci o mogućim učincima cemiplimaba na plodnost.
English: For a full list of patients excluded from clinical trials, see section 5.1.
Croatian: Za cjeloviti popis bolesnika koji nisu bili uključeni u klinička ispitivanja vidjeti dio 5.1.
English: In the absence of data, cemiplimab should be used with caution in these populations after careful evaluation of the balance of benefits and risks for the patient.
Croatian: Zbog nedostatka podataka, u tim populacijama cemiplimab treba primjenjivati uz oprez nakon pažljive ocjene omjera koristi i rizika za pojedinog bolesnika.
English: The information in this Package Leaflet can be found in the Patient Alert Card you have been given by your doctor.
Croatian: Informacije iz ove upute o lijeku pronaći ćete i u Kartici s upozorenjima za bolesnika koju ste dobili od svog liječnika.
English: Nervous system disorders: Meningitis a
Croatian: Poremećaji živčanog sustava: meningitis a
English: Median (range) (months)
Croatian: Medijan (raspon, mjeseci)
English: Recommended treatment modifications
Croatian: Preporučene prilagodbe liječenja
English: • If you think you may be allergic, or you are not sure, talk to your doctor before you are given LIBTAYO.
Croatian: • Ako mislite da biste mogli biti alergični ili ako niste sigurni, obratite se svom liječniku prije nego što primite LIBTAYO.
English: Cemiplimab is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the clinical benefit outweighs the potential risk.
Croatian: Primjena cemiplimaba ne preporučuje se u trudnica i žena reproduktivne dobi koje ne koriste učinkovitu kontracepciju, osim u slučajevima kada klinička korist nadmašuje mogući rizik.
English: Cemiplimab clearance after the first dose is approximately 0.33 l/day.
Croatian: Klirens cemiplimaba nakon prve doze iznosi približno 0,33 l na dan.
English: Table 1:
Croatian: Tablica 1:
English: The physician will provide the Patient Alert Card to each patient.
Croatian: Liječnik mora svakom bolesniku dati Karticu s upozorenjima za bolesnika.
English: The final concentration of the diluted solution should be between 1 mg/ml to 20 mg/ml.
Croatian: Konačna koncentracija razrijeđene otopine treba biti između 1 mg/ml i 20 mg/ml.
English: Prior to launch of LIBTAYO in each Member State, the 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 nego što se LIBTAYO stavi u promet, nositelj odobrenja mora u svakoj državi članici s nacionalnim nadležnim tijelom dogovoriti sadržaj i format edukacijskog programa, uključujući načine komunikacije, oblike distribucije i sve druge aspekte programa.
English: There are no available data on the use of cemiplimab in pregnant women.
Croatian: Nema dostupnih podataka o primjeni cemiplimaba u trudnica.
English: No dose reductions are recommended.
Croatian: Ne preporučuje se smanjenje doze.
English: The MAH shall ensure that in each Member State where LIBTAYO is marketed, all healthcare professionals and patients/carers who are expected to prescribe and use LIBTAYO have access to/are provided with the following educational package: - A patient guide - A patient alert card
Croatian: Nositelj odobrenja mora se pobrinuti da se u svakoj državi članici u kojoj će se LIBTAYO staviti u promet svi zdravstveni radnici i bolesnici/njegovatelji za koje se očekuje da će propisivati odnosno primjenjivati LIBTAYO imaju pristup/dobiju sljedeći edukacijski paket: - Vodič za bolesnika - Karticu s upozorenjima za bolesnika
English: Absorption Cemiplimab is administered via the intravenous route and hence is completely bioavailable.
Croatian: Apsorpcija Cemiplimab se primjenjuje intravenskim putem i stoga je njegova bioraspoloživost potpuna.
English: • Central nervous system problems (such as meningitis)
Croatian: • tegobe koje zahvaćaju središnji živčani sustav (kao što je meningitis)
English: All prescribers of LIBTAYO should be familiar with the educational materials and inform the patients about the Patient Alert Card explaining what to do should they experience any symptom of immunerelated adverse reactions and infusion-related reactions.
Croatian: Svi liječnici koji propisuju LIBTAYO moraju biti upoznati s edukacijskim materijalima i informirati bolesnike o Kartici s upozorenjima za bolesnika, u kojoj se objašnjava što trebaju učiniti ako primijete bilo koji simptom imunološki uzrokovanih nuspojava i reakcija na infuziju.
English: Efficacy results for Study 1540 are presented in Table 3.
Croatian: Rezultati za djelotvornost iz ispitivanja 1540 prikazani su u Tablici 3.
English: Steady-state exposure is achieved after approximately 4 months of treatment.
Croatian: Izloženost u stanju dinamičke ravnoteže postiže se nakon približno 4 mjeseca liječenja.
English: LIBTAYO acts on your immune system and may cause inflammation in parts of your body (see the conditions listed in ‘Look out for side effects' in section 2).
Croatian: LIBTAYO djeluje na imunosni sustav i može uzrokovati upalu u određenim dijelovima tijela (pogledajte stanja navedena u odlomku „Pripazite na nuspojave“ u dijelu 2).
English: No dose adjustment is recommended for elderly patients.
Croatian: Ne preporučuje se prilagođavati dozu u starijih bolesnika.
English: If patients with locally advanced disease showed sufficient response to treatment, surgery with curative intent was permitted.
Croatian: Ako su bolesnici s lokalno uznapredovalom bolešću ostvarili dovoljno dobar odgovor na liječenje, mogli su se podvrgnuti kurativnom kirurškom zahvatu.
English: The MAH should investigate biomarkers in order to confirm that PD-L1 expression is not predictive of efficacy.
Croatian: Nositelj odobrenja treba ispitati biološke biljege kako bi potvrdio da ekspresija PD-L1 nije pretkazatelj djelotvornosti.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of cemiplimab (see “Description of selected adverse reactions” below).
Croatian: Većina se njih, uključujući teške reakcije, povukla nakon uvođenja odgovarajuće terapije ili prekida primjene cemiplimaba (vidjeti dio „Opis odabranih nuspojava“ u nastavku).
English: o A warning message for health care professionals treating the patient at any time, including in conditions of emergency, that the patient is treated with LIBTAYO.
Croatian: o Upozorenje svim zdravstvenim radnicima koji u bilo kojem trenutku liječe bolesnika (uključujući u hitnim slučajevima) da se bolesnik liječi lijekom LIBTAYO.
English: Grade 3 or 4 (hyperglycaemia)
Croatian: 3. ili 4. stupanj (hiperglikemija)
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: The selected adverse reactions described below are based on safety of cemiplimab in 591 patients in uncontrolled clinical studies.
Croatian: Odabrane nuspojave opisane u nastavku temelje se na podacima o sigurnosti cemiplimaba prikupljenima u 591 bolesnika u nekontroliranim kliničkim ispitivanjima.
English: The effect of hepatic impairment on the exposure of cemiplimab was evaluated by population PK analysis.
Croatian: Utjecaj oštećenja jetrene funkcije na izloženost cemiplimabu ocjenjivao se u populacijskoj farmakokinetičkoj analizi.
English: L-histidine
Croatian: L-histidin
English: As reported in the literature, PD-1 / PD-L1 signalling pathway plays a role in sustaining pregnancy by maintaining immunological tolerance and studies have shown that PD-1 receptor blockade results in early termination of pregnancy.
Croatian: U literaturi se navodi da signalizacija putem PD-1/PD-L1 igra ulogu u očuvanju trudnoće time što održava imunotoleranciju, a ispitivanja su pokazala da blokada receptora PD-1 dovodi do ranog prekida trudnoće.
English: • at room temperature up to 25°C for no more than 8 hours from the time of preparation.
Croatian: • na sobnoj temperaturi do 25°C tijekom najviše 8 sati od trenutka pripreme.
English: As with all therapeutic proteins, there is a potential for immunogenicity with cemiplimab.
Croatian: Kao i svi terapijski proteini, cemiplimab može imati imunogeno djelovanje.
English: Store in the original container in order to protect from light.
Croatian: Čuvati u originalnom spremniku radi zaštite od svjetlosti.
English: Patients excluded from clinical studies
Croatian: Bolesnici koji nisu bili uključeni u klinička ispitivanja
English: From time of preparation by diluting in an intravenous bag, LIBTAYO can be stored before use for no more than 8 hours at temperatures up to 25°C, and no more than 24 hours in a refrigerator (2°C to 8°C).
Croatian: Nakon što se LIBTAYO pripremi razrjeđivanjem u vrećici za intravensku primjenu, može se prije primjene čuvati najviše 8 sati na temperaturi do 25°C, odnosno najviše 24 sata u hladnjaku (2°C - 8°C).
English: o A reminder that all known or suspected adverse drug reactions (ADRs) can also be reported to local regulatory authorities.
Croatian: o podsjetnik da se sve poznate nuspojave lijeka ili sumnje na njih mogu prijaviti i lokalnim nadležnim tijelima.
English: These immune-related reactions may involve any organ system.
Croatian: Te imunološki uzrokovane nuspojave mogu zahvatiti bilo koji organski sustav.
English: • you have had an organ transplant
Croatian: • ako Vam je presađen organ
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies.
Croatian: Farmakoterapijska skupina: Antineoplastici, monoklonska protutijela.
English: Hyperthyroidism should be managed according to standard medical practice (see section 4.2).
Croatian: Hipertireozu treba liječiti u skladu sa standardnom medicinskom praksom (vidjeti dio 4.2).
English: Patients should be monitored for signs and symptoms of pneumonitis.
Croatian: Bolesnike treba nadzirati zbog moguće pojave znakova i simptoma pneumonitisa.
English: Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing foetus resulting in foetal death (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da inhibicija puta PD-1/PD-L1 može povećati rizik od imunološki posredovanog odbacivanja ploda u razvoju i tako dovesti do njegove smrti (vidjeti dio 5.3).
English: • Do not co-administer other medicines through the same infusion line.
Croatian: • Nemojte istodobno primjenjivati druge lijekove istom infuzijskom linijom.
English: Some inflammatory conditions may also lead to death and need treatment, or you may need to stop treatment with LIBTAYO.
Croatian: Neka upalna stanja mogu dovesti i do smrti te zahtijevaju liječenje, a možda ćete morati i prekinuti liječenje lijekom LIBTAYO.
English: • Problems in other parts of the body.
Croatian: • tegobe koje zahvaćaju druge dijelove tijela
English: Among patients with mCSCC, 76.5% had distant metastases, and 22.6% had only nodal metastases.
Croatian: Među bolesnicima s metastatskim planocelularnim karcinomom kože, njih 76,5% imalo je udaljene metastaze, dok je njih 22,6% imalo samo metastaze u limfnim čvorovima.
English: • It is not known if LIBTAYO passes into your breast milk.
Croatian: • Nije poznato izlučuje li se LIBTAYO u majčino mlijeko.
English: d. Myocarditis is a composite term that includes autoimmune myocarditis and myocarditis.
Croatian: Miokarditis je skupni pojam koji obuhvaća autoimuni miokarditis i miokarditis.
English: Women of childbearing potential should use effective contraception during treatment with cemiplimab and for at least 4 months after the last dose of cemiplimab.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja cemiplimabom i još najmanje 4 mjeseca nakon posljednje doze tog lijeka.
English: A population PK analysis suggests that the following factors have no clinically significant effect on the exposure of cemiplimab: age, gender, body weight, race, cancer type, albumin level, mild hepatic impairment and renal impairment.
Croatian: Populacijska farmakokinetička analiza ukazuje na to da sljedeći faktori nemaju klinički značajnog utjecaja na izloženost cemiplimabu: dob, spol, tjelesna težina, rasa, vrsta raka, vrijednost albumina, blago oštećenje jetrene funkcije i oštećenje bubrežne funkcije.
English: In Study 1540, patients received cemiplimab until progression of disease, unacceptable toxicity or completion of planned treatment [3 mg/kg every 2 weeks for 96 weeks or 350 mg every 3 weeks for 54 weeks].
Croatian: U ispitivanju 1540 bolesnici su primali cemiplimab do progresije bolesti, pojave neprihvatljive toksičnosti ili završetka planiranog liječenja (3 mg/kg svaka 2 tjedna tijekom 96 tjedana ili 350 mg svaka 3 tjedna tijekom 54 tjedna).
English: The most common immune-related adverse reactions were hypothyroidism (7.1%), pneumonitis (3.7%), immune-related skin adverse reactions (2.0%), hyperthyroidism (1.9%) and hepatitis (1.9%) (see “Description of selected adverse reactions” below, Special warnings and precautions for use in section 4.4 and Recommended treatment modifications in section 4.2).
Croatian: Najčešće imunološki uzrokovane nuspojave bile su hipotireoza (7,1%), pneumonitis (3,7%), imunološki uzrokovane kožne nuspojave (2,0%), hipertireoza (1,9%) i hepatitis (1,9%) (vidjeti dio „Opis odabranih nuspojava“ u nastavku, dio 4.4 Posebna upozorenja i mjere opreza pri uporabi te preporučene prilagodbe liječenja u dijelu 4.2).
English: Permanently discontinue
Croatian: Trajno prekinuti liječenje
English: The within dosing interval half-life at steady state is 19.4 days.
Croatian: Poluvijek unutar intervala doziranja u stanju dinamičke ravnoteže iznosi 19,4 dana.
English: • LIBTAYO is given as a drip into a vein (intravenous infusion).
Croatian: • LIBTAYO se primjenjuje kao drip u venu (intravenskom infuzijom).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with cemiplimab in all subsets of the paediatric population in the treatment of all conditions included in the category of malignant neoplasms, except haematopoietic and lymphoid tissue (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja cemiplimaba u svim podskupinama pedijatrijske populacije u liječenju svih stanja uključenih u kategoriju zloćudnih novotvorina, osim novotvorina hematopoetskog i limfoidnog tkiva (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: o The importance of carrying the Patient Alert Card at all times and to show it at all medical visits to healthcare professionals other than the prescriber (e.g. emergency healthcare professionals).
Croatian: o napomenu da je važno da bolesnik uvijek sa sobom nosi Karticu s upozorenjima za bolesnika i da je pokaže prilikom svih posjeta zdravstvenim radnicima osim propisivača (npr. osoblju hitne službe).
English: Clinical activity was observed regardless of tumour PD-L1 expression status.
Croatian: Klinička aktivnost opažena je neovisno o statusu tumorske ekspresije PD-L1.
English: • It is important that you keep the Patient Alert Card with you during treatment.
Croatian: • Važno je da tijekom liječenja sa sobom nosite Karticu s upozorenjima za bolesnika.