FrancophonIA/ELRC3.0 huggingface dataset:
English: The duration of treatment may vary depending on your disease as well as from person to person and your doctor will therefore discuss with you how long you will receive Erbitux.
Croatian: Trajanje liječenja može varirati ovisno o Vašoj bolesti te od osobe do osobe i liječnik će s Vama razgovarati o tome koliko dugo trebate primati Erbitux.
English: Only in study EMR 62 202-007, a post-hoc analysis was not possible.
Croatian: Samo u ispitivanju EMR 62 202-007 post hoc analiza nije bila moguća.
English: Erbitux is used to treat two different types of cancer:
Croatian: Erbitux se koristi za liječenje dva različita tipa karcinoma:
English: Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
Croatian: Nemojte voziti niti koristiti alate ili strojeve ako osjećate simptome koji su vezani uz liječenje i koji utječu na Vašu sposobnost koncentracije i reakcije.
English: Your doctor will discuss with you whether you may need any preventive measures or early treatment.
Croatian: Liječnik će razgovarati s Vama o tome jesu li Vam potrebne preventivne mjere ili rano liječenje.
English: Diarrhoea; nausea; vomiting.
Croatian: Proljev; mučnina; povraćanje.
English: Effects on male and female fertility have not been evaluated within formal animal studies (see section 5.3).
Croatian: Učinci na mušku i žensku plodnost nisu procjenjivani unutar formalnih ispitivanja na životinjama (vidjeti dio 5.3).
English: If you notice other extensive skin alterations, please inform your doctor as soon as possible because the Erbitux dose or the time between infusions may need to be changed.
Croatian: Ako uočite druge intenzivne promjene na koži, molimo obavijestite svog liječnika čim je prije moguće jer će možda trebati promijeniti dozu Erbituxa ili vrijeme između infuzija.
English: For the subsequent weekly doses, the recommended infusion period is 60 minutes.
Croatian: Za sljedeće tjedne doze, preporučeno vrijeme infuzije je 60 minuta.
English: Detailed instructions for your doctor or your nurse on how to prepare the Erbitux infusion are included at the end of this package leaflet (see 'Handling instructions').
Croatian: Detaljne upute za Vašeg liječnika ili medicinsku sestru kako pripremiti infuziju Erbituxa uključene su na kraju ove upute (pogledajte „Uputa za rukovanje“).
English: Your doctor will discuss appropriate measures with you.
Croatian: Liječnik će s Vama razgovarati o odgovarajućim mjerama.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless opening has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika i ne bi smjeli biti dulji od 24 sata pri 2 - 8 °C, osim ako je lijek otvoren u kontroliranim i validiranim aseptičkim uvjetima.
English: It further induces the internalisation of EGFR, which can lead to downregulation of EGFR.
Croatian: To nadalje inducira internalizaciju EGFR-a, što može dovesti do smanjenja regulacije EGFRa.
English: • skin reactions typical for radiation therapy
Croatian: • kožne reakcije tipične za terapiju zračenjem
English: Several pathways have been described that may contribute to the metabolism of antibodies.
Croatian: Opisano je nekoliko puteva koji bi mogli pridonijeti metabolizmu protutijela.
English: Approximately 15% of the skin reactions are severe, including single cases of skin necrosis.
Croatian: Otprilike 15% kožnih reakcija su teške, uključujući pojedinačne slučajeve nekroze kože.
English: Date of latest renewal: 29/06/2009
Croatian: Datum posljednje obnove odobrenja: 29.06.2009.
English: Set and control the rate as explained in section 4.2.
Croatian: Postavite i kontrolirajte brzinu kako je objašnjeno u dijelu 4.2.
English: For storage conditions after opening, see section 6.3.
Croatian: Uvjete čuvanja nakon otvaranja vidjeti u dijelu 6.3.
English: Your doctor will discuss with you whether you need to consult a specialist.
Croatian: Liječnik će razgovarati s Vama o tome trebate li se obratiti specijalistu.
English: Other medicines and Erbitux
Croatian: Drugi lijekovi i Erbitux
English: Bevacizumab plus FOLFIRI
Croatian: Bevacizumab i FOLFIRI
English: Your doctor will then discuss with you the risks and benefits of using Erbitux in these situations.
Croatian: Liječnik će s Vama razmotriti rizike i koristi primjene Erbituxa u ovim situacijama.
English: They usually disappear over time after the end of Erbitux therapy.
Croatian: One obično s vremenom nestaju nakon prestanka liječenja Erbituxom.
English: The efficacy of cetuximab in paediatric patients below the age of 18 years has not been established.
Croatian: Djelotvornost cetuksimaba kod pedijatrijskih bolesnika mlađih od 18 godina nije ustanovljena.
English: Increase in liver enzyme levels (ASAT, ALAT, AP).
Croatian: Porast razina jetrenih enzima (ASAT, ALAT, AP).
English: Animal data revealed no evidence of teratogenicity.
Croatian: Podaci na životinjama nisu otkrili dokaz teratogenosti.
English: This premedication is recommended prior to all subsequent infusions.
Croatian: Ova se premedikacija preporučuje prije svih sljedećih infuzija.
English: Non-clinical data on genotoxicity and local tolerance including accidental administration by routes other than the intended infusion revealed no special hazard for humans.
Croatian: Neklinički podaci o genotoksičnosti i lokalnoj podnošljivosti uključujući i slučajnu primjenu drugim putevima osim propisanom infuzijom ne ukazuju na poseban rizik za ljude.
English: It is strongly recommended that Erbitux be given during pregnancy or to any woman not employing adequate contraception only if the potential benefit for the mother justifies a potential risk to the foetus.
Croatian: Strogo je preporučeno da se Erbitux primjenjuje tijekom trudnoće ili kod žena koje ne koriste odgovarajuću kontracepciju jedino ako potencijalna korist opravdava potencijalni rizik za plod.
English: Your doctor will decide whether treatment has to be stopped if skin reactions reappear after several dose reductions.
Croatian: Vaš liječnik će odlučiti treba li prekinuti liječenje ako se kožne reakcije ponovno pojave nakon nekoliko smanjenja doze.
English: Frequency not known: Aseptic meningitis.
Croatian: Nepoznata učestalost: Aseptični meningitis.
English: Most of these side effects develop within the first three weeks of treatment.
Croatian: Većina ovih nuspojava razvije se unutar prva tri tjedna liječenja.
English: However, dependent on the dose, an increased incidence of abortion was observed.
Croatian: Međutim, ovisno o dozi, primijećena je povećana incidencija pobačaja.
English: • inflammation of the eye lid or the front part of the eye
Croatian: • upala očnog kapka ili prednjeg dijela oka
English: A close monitoring of patients, particularly during the first administration, is required.
Croatian: Zahtijeva se pomno nadziranje bolesnika, osobito prilikom prve primjene.
English: No dose adjustment is required in older people, but the experience is limited in patients 75 years of age and above.
Croatian: Kod starijih osoba nije potrebna prilagodba doze, ali ovo je iskustvo ograničeno kod bolesnika u dobi od 75 ili više godina.
English: Overall, measurable HACA titres were noted in 3.4% of the patients studied, with incidences ranging from 0% to 9.6% in the target indication studies.
Croatian: Ukupno, mjerljivi HACA titri nađeni su kod 3,4% ispitanih bolesnika, s incidencijom u rasponu od 0% do 9,6% u ispitivanjima o indikaciji.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC06
Croatian: Farmakoterapijska skupina: antineoplastici, monoklonska protutijela, ATK oznaka: L01XC06
English: With respect to the KRAS status, tumour samples were only available from 23% of the patients (300 of 1298).
Croatian: S obzirom na KRAS status, uzorci tumora bili su dostupni samo od 23% bolesnika (300 od 1298).
English: In these patients cetuximab should be administered only after a careful assessment of benefit/risk, including alternative treatments, and only under close supervision of well trained personnel with resuscitation equipment ready.
Croatian: U tih se bolesnika cetuksimab smije primijeniti tek nakon pažljive procjene koristi i rizika, uključujući druga liječenja, i samo pod pažljivim nadzorom dobro uvježbanog osoblja sa spremnom opremom za resuscitaciju.
English: • inflammation of the lining of the intestine, mouth, and nose (in some cases severe), which may lead to nose bleeding in some patients
Croatian: • upala sluznice crijeva, usta i nosa (u nekim slučajevima teška) koja može uzrokovati krvarenje iz nosa u nekih bolesnika
English: Therefore, please make sure that you also read the package leaflet for the other medicines.
Croatian: Stoga također pročitajte i uputu za druge lijekove koje uzimate.
English: • absolute neutrophil count < 1500/mm³
Croatian: • apsolutni broj neutrofila < 1500/mm³
English: According to clinical practice guidelines prophylactic use of oral tetracyclines (6 - 8 weeks) and topical application of 1% hydrocortisone cream with moisturiser should be considered.
Croatian: U skladu sa smjernicama o kliničkoj praksi treba razmotriti profilaktičku uporabu oralnih tetraciklina (6 - 8 tjedana) i topikalnu primjenu kreme 1%-tnog hidrokortizona s ovlaživačem.
English: Erbitux does not contain any antimicrobial preservative or bacteriostatic agent.
Croatian: Erbitux ne sadrži antimikrobne konzervanse ili bakteriostatske agense.
English: If during the first infusion, an infusion-related reaction occurs within the first 15 minutes, the infusion should be stopped.
Croatian: Ako se za vrijeme davanja prve infuzije unutar prvih 15 minuta pojave reakcije povezane s infuzijom, infuziju treba zaustaviti.
English: Cetuximab does not bind to other receptors belonging to the HER family.
Croatian: Cetuksimab se ne veže na druge receptore koji pripadaju HER obitelji.
English: Contact lens use is also a risk factor for keratitis and ulceration.
Croatian: Uporaba kontaktnih leća također je čimbenik rizika za nastanak keratitisa i ulceracija.
English: No formal animal studies have been performed to establish the carcinogenic potential of cetuximab or to determine its effects on male and female fertility.
Croatian: Nisu provedena formalna ispitivanja na životinjama za određivanje kancerogenog potencijala cetuksimaba ili za određivanje njegovih učinaka na mušku i žensku plodnost.
English: Special attention is recommended for patients with reduced performance status and pre-existing cardiopulmonary disease.
Croatian: Preporučuje se obratiti posebnu pažnju kod bolesnika reduciranog općeg statusa i s prethodno postojećom kardiopulmonalnom bolešću.
English: If an infusion-related reaction develops later during the infusion or at a subsequent infusion further management will depend on its severity:
Croatian: Ako se reakcija povezana s infuzijom pojavi kasnije tijekom infuzije ili pri sljedećim infuzijama, daljnji postupak ovisit će o njenoj težini:
English: The majority of skin reactions develop within the first three weeks of therapy.
Croatian: Većina se kožnih reakcija razvije unutar prva tri tjedna liječenja.
English: Your doctor will decide whether treatment has to be stopped.
Croatian: Liječnik će odlučiti treba li prekinuti liječenje.
English: What Erbitux looks like and contents of the pack
Croatian: Kako Erbitux izgleda i sadržaj pakiranja
English: Therefore, if you experience general signs of infection such as fever and tiredness, please speak to a doctor immediately.
Croatian: Stoga, ako osjetite opće znakove infekcije kao što su vrućica i umor, molimo odmah razgovarajte s liječnikom.
English: However, dependent on the dose, an increased incidence of abortion was observed (see section 5.3).
Croatian: Međutim, ovisno o dozi uočena je povećana incidencija pobačaja (vidjeti dio 5.3).
English: Do not breast-feed your baby during the period over which you are being treated with Erbitux and for two months after the last dose.
Croatian: Nemojte dojiti svoje dijete tijekom razdoblja liječenja Erbituxom i dva mjeseca nakon zadnje doze.
English: The initial dose should be given slowly and speed of infusion must not exceed 5 mg/min (see section 4.4).
Croatian: Početnu dozu treba davati polako i brzina infuzije ne smije prijeći 5 mg/min (vidjeti dio 4.4).
English: The mean Cmax ( standard deviation) was 18555 microgram per mL.
Croatian: Srednja vrijednost Cmax ( standardno odstupanje) iznosila je 18555 mikrograma po ml.
English: However, since it does not contain any antimicrobial preservative or bacteriostatic agent, it is intended for immediate use.
Croatian: Međutim, budući da ne sadrži antimikrobna zaštitna sredstva niti bakteriostatike, trebalo bi ga odmah primijeniti.
English: Symptoms may include bronchospasm, urticaria, increase or decrease in blood pressure, loss of consciousness or shock.
Croatian: Simptomi mogu uključivati bronhospazam, urtikariju, povišenje ili sniženje krvnog tlaka, gubitak svijesti ili šok.
English: Sufficient data from pregnant or lactating women are not available.
Croatian: Nema dovoljno dostupnih podataka o trudnicama i dojiljama.
English: From a microbiological point of view, the product shall be used immediately after opening.
Croatian: S mikrobiološkog stajališta, lijek treba primijeniti odmah nakon otvaranja.
English: Cases of interstitial lung disease (ILD), including fatal cases, have been reported, with the majority of patients from the Japanese population.
Croatian: Opisani su slučajevi intersticijske bolesti pluća (engl. interstitial lung disease, ILD), uključujući slučajeve sa smrtnim ishodom, a većina bolesnika bila je iz japanske populacije.
English: If patients experience treatment-related symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Croatian: Ako bolesnici osjete simptome povezane s liječenjem koji utječu na sposobnost koncentracije i reakcije, preporučuje se da do popuštanja ovakvog učinka ne upravljaju vozilom ili strojem.
English: These reactions are commonly associated with bronchospasm and urticaria.
Croatian: Te su reakcije često povezane s bronhospazmom i urtikarijom.
English: The infusion rate must not exceed 10 mg/min.
Croatian: Brzina infuzije ne smije premašiti 10 mg/min.
English: Hypomagnesaemia (see section 4.4).
Croatian: Hipomagnezijemija (vidjeti dio 4.4).
English: It is recommended to warn patients of the possibility of such a late onset and instruct them to contact their physician if symptoms or signs of an infusion-related reaction occur.
Croatian: Preporučuje se upozoriti bolesnike o mogućnosti takvog kasnog nastupa i uputiti ih da u slučaju pojave simptoma ili znakova reakcije povezanih s infuzijom kontaktiraju svog liječnika.
English: Neutropenia and related infectious complications
Croatian: Neutropenija i povezane komplikacije radi infekcija
English: If a patient experiences an intolerable or severe skin reaction ( grade 3; Common Terminology Criteria for Adverse Events, CTCAE), cetuximab therapy must be interrupted.
Croatian: Ako bolesnik dobije nepodnošljivu ili tešku kožnu reakciju (≥ 3. stupanj; Common Terminology Criteria for Adverse Events, CTCAE) liječenje cetuksimabom mora se prekinuti.
English: Mutations of RAS genes at certain hot-spots on exons 2, 3 and 4 result in constitutive activation of RAS proteins independently of EGFR signalling.
Croatian: Mutacija gena RAS na određenim „vrućim točkama“ na eksonima 2, 3 i 4 dovodi do konstitutivne aktivacije RAS proteina neovisno o EGFR signalu.
English: • excessive growth of hair
Croatian: • prekomjerni rast kose
English: The first dose should be administered slowly and the speed must not exceed 5 mg/min whilst all vital signs are closely monitored for at least two hours.
Croatian: Prvu dozu treba primijeniti polako i brzina ne smije prijeći 5 mg/min, dok istovremeno treba pažljivo nadzirati sve vitalne znakove tijekom najmanje dva sata.
English: You are more likely to experience severe allergic reactions if you are allergic to red meat, tick bites or had positive results for certain antibodies (seen in a test).
Croatian: Imate veću vjerojatnost da dobijete teške alergijske reakcije ako ste alergični na crveno meso, ugrize krpelja ili ste imali pozitivne nalaze određenih protutijela (vidljivi na testovima).
English: There is no relevant use of Erbitux in children and adolescents.
Croatian: Ne postoji relevantna primjena u djece i adolescenata.
English: The combination of cetuximab with irinotecan compared to cetuximab alone reduced the overall risk of disease progression by 46% and significantly increased objective response rate.
Croatian: Kombinacija cetuksimaba i irinotekana u usporedbi s cetuksimabom samim smanjila je ukupan rizik progresije bolesti za 46% i značajno povećala objektivnu stopu odgovora.
English: • reduction in the number of white blood cells
Croatian: • smanjenje broja bijelih krvnih stanica
English: The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signaltransducer of EGFR.
Croatian: Proteinski produkt proto-onkogena RAS (rat sarcoma) središnji je nizvodni prijenosnik signala EGFR-a.
English: Not all vial sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine bočica.
English: Remove the needle and put the syringe into the syringe pump.
Croatian: Uklonite iglu i stavite štrcaljku u injekcijsku pumpu.
English: Once opened, Erbitux is intended for immediate use.
Croatian: Nakon otvaranja Erbitux je namijenjen za neposrednu primjenu.
English: Do not use Erbitux if you have ever had a severe hypersensitivity (allergic) reaction to cetuximab.
Croatian: Erbitux nemojte primjenjivati ako ste ikada imali tešku reakciju preosjetljivosti (alergijsku reakciju) na cetuksimab.
English: It is recommended that women do not breast-feed during treatment with Erbitux and for 2 months after the last dose, because it is not known whether cetuximab is excreted in breast milk.
Croatian: Preporučuje se da žene ne doje tijekom liječenja Erbituxom i tijekom dva mjeseca nakon posljednje doze jer nije poznato izlučuje li se cetuksimab u majčino mlijeko.
English: Frequency not known (cannot be estimated from the available data) An asterisk (*) indicates that additional information on the respective undesirable effect is provided below the table.
Croatian: Nepoznata učestalost (ne može se procijeniti iz dostupnih podataka) Zvjezdica (*) ukazuje da se za navedenu nuspojavu ispod tablice nalaze dodatni podaci.
English: There is no relevant use of cetuximab in the paediatric population in the granted indications.
Croatian: Nema relevantne primjene cetuksimaba u pedijatrijskoj populaciji u odobrenim indikacijama.
English: If you have heart problems, your doctor will discuss with you whether you can receive Erbitux in combination with other anticancer medicines, especially if you are 65 years of age or older.
Croatian: U slučaju problema sa srcem liječnik će razgovarati s Vama o tome trebate li primati Erbitux u kombinaciji s drugim lijekovima protiv karcinoma posebice ako imate 65 godina ili više.
English: • in combination with irinotecan-based chemotherapy,
Croatian: • u kombinaciji s kemoterapijom na bazi irinotekana,
English: During each infusion and for at least 1 hour afterwards, your condition will be checked regularly for early signs of a possible infusion-related side effect.
Croatian: Tijekom svake infuzije i najmanje 1 sat nakon svake infuzije Vaše će se stanje redovito provjeravati na rane znakove mogućih nuspojava povezanih s infuzijom.
English: The efficacy data on the OxMdG regimen generated in this study are summarised in the table below:
Croatian: Podaci o djelotvornosti liječenja režimom OxMdG dobiveni u ovom ispitivanju sažeti su u tablici u nastavku:
English: In rare cases, angina pectoris, myocardial infarction or cardiac arrest have been observed.
Croatian: U rijetkim slučajevima primijećeni su angina pektoris, infarkt miokarda ili srčani zastoj.
English: Please tell your doctor, if you have acute or worsening eye problems such as blurred vision, eye pain, red eyes and/or severe dry eye, if you have had such problems in the past or if you use contact lenses.
Croatian: Molimo obavijestite svog liječnika ako imate akutne probleme s očima poput zamućenog vida, boli u očima, crvenih očiju i/ili vrlo suhog oka, ako se problemi pogoršavaju, ako ste imali takve probleme u prošlosti ili koristite kontaktne leće.
English: Talk to your doctor before using Erbitux, if any of the following information is not clear.
Croatian: Recite liječniku prije nego počnete uzimati Erbitux ako vam nešto od sljedećeg nije jasno.
English: Main adverse reactions of cetuximab are skin reactions which may become severe, especially in combination with chemotherapy.
Croatian: Glavne nuspojave cetuksimaba su kožne reakcije koje mogu postati teške, naročito u kombinaciji s kemoterapijom.
English: An embryo-foetal toxicity study in Cynomolgus monkeys revealed no signs of teratogenicity.
Croatian: Embrio-fetalna studija toksičnosti kod Cynomolgus majmuna nije pokazala znakove teratogenosti.
English: Progressively decreasing serum magnesium levels occur frequently and may lead to severe hypomagnesaemia.
Croatian: Često se javlja progresivni pad razine magnezija u serumu, što može dovesti do teške hipomagnezijemije.
English: Cetuximab + CTX (N=222)
Croatian: Cetuksimab + CTX (N=222)
English: • in combination with radiation therapy for locally advanced disease,
Croatian: • u kombinaciji sa zračenjem za lokalno uznapredovalu bolest,
English: Erbitux 5 mg/mL must be prepared as follows:
Croatian: Erbitux 5 mg/ml se mora pripremiti kako slijedi:
English: What Erbitux is and what it is used for What you need to know before you use Erbitux How to use Erbitux
Croatian: Što je Erbitux i za što se koristi Što morate znati prije nego počnete primjenjivati Erbitux Kako primjenjivati Erbitux
English: Transfer the Erbitux into the prepared infusion bag.
Croatian: Prenesite Erbitux u pripremljenu infuzijsku vrećicu.
English: Immunohistochemical detection of EGFR expression was not performed since more than 90% of patients with squamous cell cancer of the head and neck have tumours that express EGFR.
Croatian: Imunohistokemijsko određivanje ekspresije EGFR-a nije provedeno budući da više od 90% bolesnika s karcinomom pločastih stanica glave i vrata imaju tumore koji iskazuju EGFR.
English: In about 15 out of 100 patients these skin reactions are likely to be severe.
Croatian: Kod oko 15 od 100 bolesnika ove bi kožne reakcije mogle biti teške.
English: Cetuximab has a long elimination half-life with values ranging from 70 to 100 hours at the target dose.
Croatian: Cetuksimab ima dugi poluvijek eliminacije s vrijednostima u rasponu 70 do 100 sati na ciljnoj dozi.
English: • a certain type of cancer of the head and neck (squamous cell cancer).
Croatian: • određenog tipa raka glave i vrata (karcinoma pločastih stanica).
English: If you experience these symptoms, please speak to a doctor immediately, because these signs may have serious consequences including life-threatening conditions.
Croatian: Ako osjetite te simptome, molimo odmah razgovarajte s liječnikom jer ti znakovi mogu imati ozbiljne posljedice, uključujući po život opasna stanja.
English: • leukocyte count < 3000/mm³
Croatian: • broj leukocita < 3000/mm³
English: Remove an adequate volume of the sodium chloride solution from the infusion bag, using an appropriate sterile syringe with a suitable needle.
Croatian: Uklonite odgovarajući volumen otopine natrijevog klorida iz infuzijske vrećice koristeći odgovarajuću sterilnu štrcaljku s prikladnom iglom.
English: Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS and NRAS (exons 2, 3, and 4) mutations (see section 4.4 and 5.1).
Croatian: Mutacijski status mora se odrediti u iskusnom laboratoriju korištenjem validirane metode testiranja za detekciju KRAS i NRAS (eksoni 2, 3 i 4) mutacija (vidjeti dijelove 4.4 i 5.1).