FrancophonIA/ELRC3.0 huggingface dataset:
English: Dehydration, in particular secondary to diarrhoea or mucositis; hypocalcaemia (see section 4.4); anorexia which may lead to weight decrease.
Croatian: Dehidracija, naročito kao posljedica dijareje ili mukozitisa; hipokalcemija (vidjeti dio 4.4); anoreksija koja može dovesti do pada tjelesne težine.
English: Repeat this procedure until the calculated volume has been reached.
Croatian: Ponavljajte ovaj postupak sve dok se ne dostigne izračunati volumen.
English: These side effects may have serious consequences, in rare cases including life-threatening conditions, and require immediate attention.
Croatian: Ove nuspojave mogu imati ozbiljne posljedice, u rijetkim slučajevima opasne po život i zahtijevaju trenutnu skrb.
English: However, in this study no positive effects on PFS or OS were demonstrated in patients with KRAS wild-type tumours, either.
Croatian: Međutim, u ovom ispitivanju nisu dokazani ni pozitivni učinci na PFS ili OS u bolesnika s tumorima tipa „divljeg tipa“
English: An integrated analysis across all clinical studies showed that the pharmacokinetic characteristics of cetuximab are not influenced by race, age, gender, renal or hepatic status.
Croatian: Integrirana analiza kroz sva klinička ispitivanja pokazala je da na farmakokinetičke karakteristike cetuksimaba ne utječe rasa, dob, spol, te funkcija jetre ili bubrega.
English: To recognise early signs of such effects, your condition will be checked regularly while you receive each infusion of Erbitux and for at least 1 hour afterwards.
Croatian: Za rano prepoznavanje znakova tih učinaka liječnik će redovito provjeravati Vaše stanje dok primate svaku infuziju Erbituxa i tijekom najmanje sat vremena nakon infuzije.
English: A cytokine release syndrome (CRS) typically occurs within one hour after infusion and is less commonly associated with bronchospasm and urticaria.
Croatian: Sindrom oslobađanja citokina obično nastaje unutar jednog sata nakon infuzije i manje je često povezan s bronhospazmom i urtikarijom.
English: In very rare cases (may affect up to 1 in 10,000 people) patients may experience blistering or peeling of the skin, which may indicate a severe skin reaction called “Stevens-Johnson syndrome”.
Croatian: U vrlo rijetkim slučajevima (mogu zahvatiti do 1 na 10 000 osoba) bolesnici mogu iskusiti nastanak mjehurića na koži ili ljuštenje kože, koje mogu ukazivati na teške kožne reakcije zvane „StevensJohnson sindrom“.
English: Deep vein thrombosis.
Croatian: Duboka venska tromboza.
English: In clinical studies with doses up to 700 mg/m 2 given every 2 weeks the safety profile was consistent with that described in section 4.8.
Croatian: U kliničkim ispitivanjima s dozama do 700 mg/m tjelesne površine koje su se davale svaka 2 tjedna sigurnosni profil u skladu je s profilom opisanim u dijelu 4.8.
English: Cetuximab has not been studied in patients presenting with one or more of the following laboratory parameters:
Croatian: Cetuksimab nije ispitivan u bolesnika s jednom ili više sljedećih laboratorijskih vrijednosti:
English: EGFR signalling pathways are involved in the control of cell survival, cell cycle progression, angiogenesis, cell migration and cellular invasion/metastasis.
Croatian: Signalni putevi EGFR-a uključeni su u kontrolu staničnog preživljenja, progresije staničnog ciklusa, angiogeneze, stanične migracije i stanične invazije/metastaza.
English: Side effects of which the frequency is not known (cannot be estimated from the available data) • inflammation of the lining of the brain (aseptic meningitis)
Croatian: Nuspojave čija je učestalost nepoznata (ne može se procijeniti iz dostupnih podataka) • upala ovojnice mozga (aseptički meningitis)
English: The third experimental arm used an intermittent OxMdG or XELOX regimen without cetuximab.
Croatian: Treća eksperimentalna skupina izmjenično je upotrebljavala protokol OxMdG ili XELOX bez cetuksimaba.
English: The efficacy and safety of cetuximab have not been documented in patients with tumours where EGFR was not detected.
Croatian: Djelotvornost i sigurnost cetuksimaba nije dokumentirana kod tumora kod kojih nije pronađen EGFR.
English: In addition, significantly fewer patients treated with cetuximab received second-line therapy.
Croatian: Pored toga, znatno manje bolesnika liječenih cetuksimabom primilo je liječenje druge linije.
English: In the event of symptoms (such as dyspnoea, cough, fever) or radiographic findings suggestive of ILD, prompt diagnostic investigation should occur.
Croatian: U slučaju simptoma (kao što su dispneja, kašalj, vrućica) ili radiografskog nalaza koji upućuje na ILD, mora se bez odlaganja provesti dijagnostička pretraga.
English: Treatment with Erbitux must then be stopped.
Croatian: Liječenje Erbituxom mora se odmah prekinuti.
English: Care must be taken to ensure aseptic handling when preparing the infusion.
Croatian: Treba obratiti pozornost na to da se pri pripremi infuzije osiguraju aseptički uvjeti.
English: It is recommended to maintain this lower infusion rate in all subsequent infusions.
Croatian: Preporučuje se nastaviti smanjenom brzinom infuzije i u svim sljedećim infuzijama.
English: • in first-line in combination with FOLFOX,
Croatian: • u prvoj liniji liječenja u kombinaciji s FOLFOX-om,
English: All of these pathways involve the biodegradation of the antibody to smaller molecules, i.e. small peptides or amino acids.
Croatian: Svi su ti putevi uključivali biorazgradnju protutijela na manje molekule tj. na male peptide ili aminokiseline.
English: These signs may indicate a skin infection, which may have serious consequences including life-threatening conditions.
Croatian: Ti znakovi mogu ukazivati na infekcije kože koje mogu imati ozbiljne posljedice uključujući po život opasna stanja.
English: Treatment may only be resumed if the reaction has resolved to grade 2.
Croatian: Liječenje se smije ponovno uspostaviti samo ako se kožna reakcija vrati na razinu 2. stupnja.
English: Treatment may only be resumed at a lower dose level (200 mg/m² after the second occurrence and 150 mg/m² after the third occurrence), if the reaction has resolved to grade 2.
Croatian: Liječenje se može nastaviti manjom dozom (200 mg/m² tjelesne površine nakon drugog pojavljivanja, odnosno 150 mg/m² nakon trećeg pojavljivanja) samo ako se reakcija vratila na razinu 2. stupnja.
English: Erbitux 5 mg/mL is chemically and physically stable for up to 48 hours at 25°C, if the solution is prepared as described hereafter.
Croatian: Erbitux 5 mg/ml je fizikalno i kemijski stabilan do 48 sati na 25 °C, ako je otopina pripremljena kao što je opisano u nastavku.
English: Similar findings were also reported when cetuximab was given as add-on to XELOX in combination with bevacizumab (CAIRO2).
Croatian: Slični nalazi prijavljeni su kad se cetuksimab davao kao dodatak XELOX-u u kombinaciji s bevacizumabom (CAIRO2).
English: The main undesirable effects of cetuximab are skin reactions, which occur in more than 80% of patients, hypomagnesaemia which occurs in more than 10% of patients and infusion-related reactions, which occur with mild to moderate symptoms in more than 10% of patients and with severe symptoms in more than 1% of patients.
Croatian: Glavne nuspojave lijeka su kožne reakcije koje se pojavljuju kod više od 80% bolesnika, hipomagnezijemija koja se pojavljuje kod više od 10% bolesnika i reakcije povezane s infuzijom koje se pojavljuju s blagim do umjerenim simptomima kod više od 10% bolesnika a s teškim simptomima kod više od 1% bolesnika.
English: Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Croatian: Erbitux se mora primijeniti pod nadzorom liječnika iskusnog u primjeni antineoplastičkih lijekova.
English: Take an appropriate sterile syringe (minimum 50 mL) and attach a suitable needle.
Croatian: Uzmite odgovarajuću sterilnu štrcaljku (minimalno 50 ml) i na nju pričvrstite prikladnu iglu.
English: Dose-dependent skin alterations, starting at dose levels equivalent to those used in humans, were the major findings observed in toxicity studies with Cynomolgus monkeys (a chronic repeat-dose toxicity study and an embryo-foetal development study).
Croatian: Promjene na koži ovisne o dozi, s pojavom kod doza jednakih dozama primijenjenim na ljudima, bile su glavni zapaženi nalaz u ispitivanjima toksičnosti na majmunima Cynomolgus (ispitivanja kronične toksičnosti kod ponavljanih doza i embrio-fetalna razvojna studija).
English: It is recommended that cetuximab treatment be continued until progression of the underlying disease.
Croatian: Preporučuje se da se liječenje cetuksimabom nastavi do progresije postojeće bolesti.
English: If you notice symptoms such as occurrence or worsening of breathing difficulties, speak to a doctor immediately, especially if you also experience cough or fever.
Croatian: Ako primijetite simptome poput pojave ili pogoršanja poteškoća u disanju, odmah se obratite liječniku, posebice ako iskusite kašalj ili vrućicu.
English: In the randomised trial, the improvement in overall survival time did not reach statistical significance; however, in the follow-up treatment, nearly 50% of the patients of the cetuximab alone arm received a combination of cetuximab and irinotecan after progression of disease, which may have influenced overall survival time.
Croatian: U randomiziranom ispitivanju poboljšanje ukupnog vremena preživljenja nije doseglo statističku značajnost; međutim, u kontrolnom praćenju bolesnika, gotovo 50% bolesnika koji su primali samo cetuksimab po napredovanju bolesti dobilo je kombinaciju cetuksimaba i irinotekana, što je moglo utjecati na ukupno vrijeme preživljenja.
English: They generally resolve, without sequelae, over time following cessation of treatment if the recommended adjustments in dose regimen are followed (see section 4.4).
Croatian: Općenito se povlače bez posljedica tijekom razdoblja prekida liječenja ako se slijedi preporučeni režim prilagodbe doze (vidjeti dio 4.4).
English: Thus, a benefit-risk ratio for this combination has not yet been established.
Croatian: Stoga omjer dobrobiti i rizika za ovu kombinaciju dosada nije utvrđen.
English: If you receive Erbitux in combination with radiation therapy, treatment with Erbitux is usually started one week before radiation therapy.
Croatian: Ako Erbitux primate u kombinaciji sa zračenjem, liječenje Erbituxom obično počinje tjedan dana prije zračenja.
English: Cetuximab serum concentrations reached stable levels after three weeks of cetuximab monotherapy.
Croatian: Serumske koncentracije cetuksimaba dosegle su stabilne razine nakon tri tjedna monoterapije cetuksimabom.
English: The efficacy data generated in this study are summarised in the table below:
Croatian: Podaci o djelotvornosti izvedeni iz ovih ispitivanja prikazani su u sljedećoj tablici:
English: If you notice that already affected areas of your skin get worse, speak to a doctor immediately, especially if you also experience general signs of infection such as fever and tiredness.
Croatian: Ako primijetite pogoršanja na već inficiranim područjima kože, odmah razgovarajte s liječnikom, posebice ako ste također iskusili općenite znakove infekcije poput vrućice ili umora.
English: Calculate the required volume of Erbitux.
Croatian: Izračunajte potrebni volumen Erbituxa.
English: Overall, no clinically relevant difference between genders was observed.
Croatian: Općenito, klinički značajne razlike među spolovima nisu zamijećene.
English: Before initiation of combination treatment, contraindications for concomitantly used chemotherapeutic agents or radiation therapy must be considered.
Croatian: Prije započinjanja kombiniranog liječenja moraju se uzeti u obzir kontraindikacije za istodobno primijenjene kemoterapeutike ili zračenje.
English: Data for the XELOX regimen and the third experimental arm are not presented.
Croatian: Podaci za skupinu koja je primala XELOX i treću eksperimentalnu skupinu nisu prikazani.
English: If severe skin reactions occur a fourth time or do not resolve to grade 2 during interruption of treatment, permanent discontinuation of cetuximab treatment is required.
Croatian: Ako se teška kožna reakcija pojavi četvrti puta ili se nije vratila na razinu 2. stupnja tijekom prekida liječenja, liječenje cetuksimabom treba trajno prekinuti.
English: In uncommon cases (may affect up to 1 in 100 people) patients may experience an inflammation of the lungs (called interstitial lung disease), which may have serious consequences including lifethreatening conditions.
Croatian: U manje čestim slučajevima (mogu zahvatiti do 1 na 100 osoba) bolesnici mogu iskusiti upalu pluća (zvanu intersticijska bolest pluća) koja može imati ozbiljne posljedice, uključujući po život opasna stanja.
English: In particular a negative effect of cetuximab add-on in the RAS mutant population was observed.
Croatian: Posebice je primijećen negativan učinak dodatnog cetuksimaba na populaciju s mutiranim RASom.
English: Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid at least 1 hour prior to administration of cetuximab.
Croatian: Prije prve infuzije, bolesnik mora primiti premedikaciju antihistaminicima i kortikosteroidima najmanje jedan sat prije primjene cetuksimaba.
English: Your doctor will discuss with you whether you may need any particular supervision (see also 'Side effects in combination with other anticancer treatments' in section 4).
Croatian: Liječnik će razgovarati s Vama o tome trebate li nekakav poseban nadzor (pogledajte također „Nuspojave u kombinaciji s drugim lijekovima protiv karcinoma“ u dijelu 4).
English: If the patient experiences a mild or moderate infusion-related reaction, the infusion rate may be decreased.
Croatian: Ako bolesnik iskusi blagu ili umjerenu reakciju povezanu s infuzijom, može se smanjiti brzina infuzije.
English: What you need to know before you use Erbitux
Croatian: Što morate znati prije nego počnete primjenjivati Erbitux
English: Cetuximab has not been studied in patients with pre-existing haematological disorders (see section 4.4).
Croatian: Cetuksimab nije istraživan kod bolesnika s prethodno postojećim hematološkim poremećajima (vidjeti dio 4.4).
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Croatian: Bolesnici sa znakovima i simptomima koji ukazuju na keratitis kao što su akutna ili pogoršavajuća: upala oka, suzenje, osjetljivost na svjetlost, zamućen vid, bol u oku i/ili crvenilo oka trebaju odmah biti upućeni specijalisti oftalmologu.
English: Very rare (< 1/10,000)
Croatian: Vrlo rijetko (< 1/10 000)
English: With the second and third occurrences of severe skin reactions, cetuximab therapy must again be interrupted.
Croatian: S drugim ili trećim pojavljivanjem teških kožnih reakcija liječenje cetuksimabom mora se ponovo prekinuti.
English: A tumour was considered to be EGFR-expressing, if one stained cell could be identified.
Croatian: Smatralo se da tumor iskazuje EGFR ako je bilo moguće identificirati jednu označenu stanicu.
English: In all studies, cetuximab was administered as described in section 4.2.
Croatian: U svim je ispitivanjuma cetuksimab davan kao što je opisano u poglavlju 4.2.
English: In particular, in these patients negative effects on progression-free survival (PFS) and overall survival (OS) were seen as add-on to FOLFOX4 (see section 5.1).
Croatian: Posebice su u tih bolesnika zabilježeni negativni učinci na preživljenje bez napredovanja bolesti (PFS) i ukupno preživljenje (OS) kad se lijek koristio kao dodatak protokolu FOLFOX4 (vidjeti dio 5.1).
English: Your doctor will decide whether such pre-treatment is necessary for subsequent doses.
Croatian: Vaš će liječnik odlučiti o potrebi ovakvog predliječenja kod sljedećih doza.
English: The mean clearance was 0.022 L/h per m² body surface area.
Croatian: Srednji klirens iznosio je 0,022 l/h po m² površine tijela.
English: Monoclonal antibodies are proteins that specifically recognise and bind to other unique proteins called antigens.
Croatian: Monoklonska protutijela su bjelančevine koje specifično prepoznaju i vežu se na druge jedinstvene bjelančevine koje zovemo antigeni.
English: Electrolyte repletion is recommended, as appropriate.
Croatian: Preporučuje se odgovarajuće nadoknađivanje elektrolita.
English: Mild or moderate infusion-related side effects include:
Croatian: Blage ili umjerene nuspojave povezane s infuzijom uključuju:
English: Since Erbitux is only compatible with sterile sodium chloride 9 mg/mL (0.9%) solution for injection, it must not be mixed with other intravenously applied medicinal products.
Croatian: Budući da je Erbitux kompatibilan samo sa 0,9%-tnom (9 mg/ml) sterilnom otopinom natrijeva klorida za injekciju,ne smije se miješati s drugim lijekovima koji se primjenjuju u venu.
English: The development of human anti-chimeric antibodies (HACA) is a class effect of monoclonal chimeric antibodies.
Croatian: Razvoj humanih anti-kimernih protutijela (HACA) učinak je vezan uz razred monoklonskih kimernih protutijela.
English: • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
Croatian: • kao samostalan lijek nakon neuspjeha terapije na bazi oksaliplatina i irinotekana i kod bolesnika koji ne podnose irinotekan.
English: Hypocalcaemia may also occur; in particular in combination with platinum-based chemotherapy the frequency of severe hypocalcaemia may be increased.
Croatian: Moguća je i pojava hipokalcemije; u kombinaciji s kemoterapijom na bazi platine učestalost teške hipokalcemije može biti naročito povećana.
English: If the severe skin reaction occurred for the first time, treatment may be resumed without any change in dose level.
Croatian: Ako se teška kožna reakcija pojavila prvi puta, liječenje se može nastaviti u istoj dozi.
English: Occurrence of a severe infusion-related reaction requires immediate and permanent discontinuation of cetuximab therapy and may necessitate emergency treatment.
Croatian: Pojava teških reakcija povezanih s infuzijom zahtjeva trenutan i trajni prekid liječenja cetuksimabom i može zahtijevati i hitno liječenje.
English: The KRAS exon 2 status was recognised as predictive factor for the treatment with cetuximab in 4 of the randomised controlled studies (EMR 62 202-013, EMR 62 202-047, CA225006, and CA225025).
Croatian: Status eksona 2 KRAS-a utvrđen je kao prediktivni čimbenik liječenja cetuksimabom u 4 randomizirana kontrolirana ispitivanja (EMR 62 202-013, EMR 62 202-047, CA225006 i CA225025).
English: Pulmonary embolism; interstitial lung disease, which may be fatal (see section 4.4).
Croatian: Plućna embolija; intersticijska bolest pluća koja može imati smrtni ishod (vidjeti dio 4.4).
English: When cetuximab was administered at an initial dose of 400 mg/m 2 body surface area, the mean volume of distribution was approximately equivalent to the vascular space (2.9 L/m 2 with a range of
Croatian: Kada je cetuksimab primijenjen u početnoj dozi od 400 mg/m2 tjelesne površine, srednja vrijednost volumena distribucije bila je otprilike razmjerna vaskularnom prostoru (2,9 l/m2 s rasponom od 1,5 do
English: • increase in blood levels of certain liver enzymes
Croatian: • porast u razinama određenih jetrenih enzima u krvi
English: There is limited experience in the use of cetuximab in combination with radiation therapy in colorectal cancer.
Croatian: Ograničena su iskustva s korištenjem cetuksimaba u kombinaciji s radioterapijom u liječenju kolorektalnog karcinoma.
English: If necessary, repeat this procedure until the calculated volume has been infused.
Croatian: Ako je potrebno, ponavljajte ovaj postupak sve dok ne primijenite infuziju s izračunatim volumenom.
English: Erbitux 5 mg/mL is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6).
Croatian: Erbitux 5 mg/ml primjenjuje se intravenski putem infuzijske pumpe, obične infuzije ili injekcijske pumpe (za upute o rukovanju, vidjeti dio 6.6).
English: Chemical and physical in-use stability of Erbitux 5 mg/mL has been demonstrated for 48 hours at 25ºC, if the solution is prepared as described in section 6.6.
Croatian: Dokazana je kemijska i fizikalna stabilnost Erbituxa 5 mg/ml tijekom primjene u trajanju od 48 sati na 25 °C, ako je otopina pripremljena kao što je opisano u dijelu 6.6.
English: Anaphylactic reactions may occur as early as within a few minutes of the first infusion e.g. due to preformed IgE antibodies cross-reacting with cetuximab.
Croatian: Anafilaktičke reakcije mogu nastupiti čak u prvih nekoliko minuta prve infuzije npr. zbog prethodno stvorenih IgE protutijela koja križno reagiraju s cetuksimabom.
English: Cetuximab binds to the EGFR with an affinity that is approximately 5- to 10-fold higher than that of endogenous ligands.
Croatian: Cetuksimab se veže na EGFR afinitetom koji je otprilike 5 do 10 puta snažniji od onoga za endogene ligande.
English: The risk for secondary infections (mainly bacterial) is increased and cases of staphylococcal scalded skin syndrome, necrotising fasciitis and sepsis, in some cases with fatal outcome, have been reported (see section 4.8).
Croatian: Povećan je rizik od sekundarnih infekcija (uglavnom bakterijskih), a prijavljeni su slučajevi stafilokoknog sindroma opečene kože, nekrotizirajućeg fasciitisa i sepse, u nekim slučajevima s fatalnim ishodom (vidjeti dio 4.8).
English: Further post-hoc analyses were performed for studies EMR 62 202-013 and EMR 62 202-047, where also mutations on RAS genes (NRAS and KRAS) other than KRAS exon 2 have been determined.
Croatian: Provedene su dodatne post hoc analize ispitivanja EMR 62 202-013 i EMR 62 202-047 kojima su utvrđene i druge mutacije na RAS genima (NRAS i KRAS), osim na eksonu 2 KRAS-a.
English: More than 10 out of 100 patients are likely to experience infusion-related side effects; in more than 1 out of 100 patients these side effects are likely to be severe.
Croatian: Nuspojave povezane s infuzijom vjerojatno će se pojaviti kod više od 10 na 100 bolesnika; kod više od 1 na 100 bolesnika vjerojatno je da će ove nuspojave biti teške.
English: The appearance of HACA did not correlate with the occurrence of hypersensitivity reactions or any other undesirable effect to cetuximab.
Croatian: Pojava HACA nije korelirala s pojavom reakcija preosjetljivosti ili s nekom drugom nuspojavom cetuksimaba.
English: Results from clinical studies show a negative benefit-risk balance in tumours with RAS mutations.
Croatian: Rezultati iz kliničkih ispitivanja pokazuju negativan omjer dobrobiti i rizika kod tumora s RAS mutacijom.
English: • in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.
Croatian: • u kombinaciji s kemoterapijom na bazi platine za recidivirajuću i/ili metastatsku bolest.
English: In a phase-I study in paediatric patients (1-18 years) with refractory solid tumours, cetuximab was administered in combination with irinotecan.
Croatian: U kliničkom ispitivanju faze-I na pedijatrijskim bolesnicima (1-18 godina) s refraktornim solidnim tumorima, cetuksimab se primjenjivao u kombinaciji s irinotekanom.
English: Please also read 'Side effects concerning the skin' in section 4 for details, as some skin reactions may have serious consequences for you, including life-threatening conditions.
Croatian: Pročitajte također „Nuspojave povezane s kožom“ u dijelu 4 za pojedinosti jer neke reakcije na koži mogu imati ozbiljne posljedice za Vas uključujući i po život opasna stanja.
English: What Erbitux is and what it is used for
Croatian: Što je Erbitux i za što se koristi
English: Only patients with adequate renal and hepatic function have been investigated to date (see section 4.4).
Croatian: Do danas su istraženi samo bolesnici s urednom bubrežnom i jetrenom funkcijom (vidjeti dio 4.4).
English: If interstitial lung disease is diagnosed, cetuximab must be discontinued and the patient be treated appropriately.
Croatian: Ako se dijagnosticira intersticijska bolest pluća, cetuksimab treba ukinuti i bolesnika odgovarajuće liječiti.