FrancophonIA/ELRC3.0 huggingface dataset:
English: Most of these side effects usually disappear over time after the end of Portrazza therapy.
Croatian: Većina tih nuspojava obično s vremenom nestaje nakon završetka terapije lijekom Portrazza.
English: • Immediately and permanently discontinue treatment with necitumumab.
Croatian: • Odmah i trajno prekinuti liječenje necitumumabom.
English: This leaflet was last revised in <{month YYYY}>.
Croatian: Ova uputa je zadnji puta revidirana u <{mjesec GGGG}>.
English: No overall differences in efficacy between arms were observed in patients above 70 years of age.
Croatian: Sveukupno nisu primijećene razlike u djelotvornosti između liječenih skupina u bolesnika starijih od 70 godina.
English: See also section 4 for the symptoms of blood clots.
Croatian: Pogledajte i dio 4. za simptome krvnih ugrušaka.
English: Median age was 62 (32-86), 83 % of patients were men; 83.5 % were Caucasian; and 91 % were smokers.
Croatian: 62 godine (32 - 86), 83% bolesnika bili su muškarci, 83,5% njih bili su bijelci, a 91% pušači.
English: Special attention should be given to patients with clinical evidence of concomitant infectious conditions including early signs of active infections.
Croatian: Potrebno je posvetiti posebnu pozornost bolesnicima s kliničkim dokazima istodobnih infektivnih stanja, uključujući rane znakove aktivne infekcije.
English: • Decrease infusion rate by 50 % for the duration of infusion.b
Croatian: • Smanjiti brzinu infuzije za 50% tijekom preostalog trajanja infuzije.b
English: Your doctor will discuss with you whether you need any preventive measures.
Croatian: Vaš će liječnik razgovarati s Vama o tome trebate li poduzeti bilo kakve preventivne mjere.
English: Patients and physicians should be aware of signs and symptoms of thromboembolism.
Croatian: Bolesnici i liječnici moraju biti upoznati sa znakovima i simptomima tromboembolije.
English: It is recommended that the prepared dosing solution be used immediately in order to minimize the risk of microbial contamination.
Croatian: Preporučuje se pripremljenu otopinu primijeniti odmah, kako bi se minimizirao rizik od mikrobnog onečišćenja.
English: Demographics and baseline characteristics were balanced between arms.
Croatian: Demografske i početne značajke bile su ujednačene među skupinama.
English: This includes medicines obtained without a prescription and herbal medicines.
Croatian: uključujući one koje ste nabavili bez recepta i biljne lijekove.
English: a MedDRA preferred term (Version 16).
Croatian: a Preporučeni pojam prema MedDRA klasifikaciji (verzija 16)
English: The majority of skin reactions developed during the first cycle of treatment and resolved within 17 weeks after onset (see also section 4.4).
Croatian: Većina kožnih reakcija razvila se tijekom prvog ciklusa liječenja, a povukla se unutar 17 tjedana nakon nastupa (vidjeti i dio 4.4).
English: Pre-emptive treatment for skin reaction was not permitted prior to the beginning of the second treatment cycle.
Croatian: Preventivno liječenje zbog mogućeg razvoja kožne reakcije nije bilo dopušteno prije početka drugog ciklusa liječenja.
English: Store protected from light.
Croatian: Lijek čuvati zaštićen od svjetlosti.
English: The skin effects were consistent with the known class effects of EGFR inhibitors.
Croatian: Učinci na kožu bili su u skladu s poznatim učincima skupine inhibitora EGFR-a.
English: Treatment of any infection should be initiated according to local standards.
Croatian: Liječenje bilo koje infekcije treba započeti sukladno lokalnim standardima Starije osobe
English: - Infections If you have signs of infection before start of treatment please tell your doctor.
Croatian: Ako prije početka liječenja imate znakove infekcije, obavijestite o tome svog liječnika.
English: Contraceptive measures or abstinence are recommended.
Croatian: Preporučuju se kontracepcijske mjere ili apstinencija.
English: Progressively decreasing serum magnesium levels occur frequently (81.3%) and may lead to severe Hypomagnesaemia (18.7%) (see also section 4.8).
Croatian: Često (81,3%) dolazi do progresivnog pada vrijednosti magnezija u serumu, što može uzrokovati tešku hipomagnezijemiju (18,7%) (vidjeti i dio 4.8).
English: Venous blood clots are likely to occur in approximately 8 out of 100 patients.
Croatian: Venski krvni ugrušci vjerojatno će se javiti u približno 8 od 100 bolesnika.
English: No dose adjustment is necessary for these subpopulations.
Croatian: Nije potrebno prilagođavati dozu u tim potpopulacijama.
English: The onset of events occurred mainly during the first cycle of treatment.
Croatian: One su se uglavnom javljale tijekom prvog ciklusa liječenja.
English: The skin rash commonly resembles acne and often involves the face, upper chest and back, but can affect any area of the body.
Croatian: Kožni osip obično nalikuje aknama i često zahvaća lice, gornji dio prsa i leđa, ali može zahvatiti bilo koji dio tijela.
English: A tumour was considered to be EGFRexpressing if at least one stained cell could be identified.
Croatian: Smatralo se da tumor eksprimira EGFR ako se mogla identificirati najmanje jedna obojena stanica.
English: Recommendations for the management of infusion-related and skin reactions are provided in tables 1 and 2.
Croatian: Preporuke za zbrinjavanje reakcija na infuziju i kožnih reakcija navedene su u Tablicama 1 i 2.
English: Elderly No dose reductions other than those recommended for all patients are necessary (see sections 4.4 and
Croatian: Nisu potrebna druga smanjenja doze osim onih preporučenih za sve bolesnike (vidjeti dijelove 4.4
English: Table 2 - Management recommendations for skin reactions Toxicity gradea
Croatian: Tablica 2 - Preporuke za zbrinjavanje kožnih reakcija Stupanj toksičnostia
English: America, Europe, and Australia vs. South America, South Africa, and India vs. Eastern Asia])
Croatian: [Sjeverna Amerika, Europa i Australija naspram Južne Amerike, Južne Afrike i Indije naspram Istočne
English: Skin reactions may occur in approximately 80 out of 100 patients who take Portrazza and are usually mild to moderate.
Croatian: Kožne reakcije Kožne reakcije mogu se javiti u približno 80 od 100 bolesnika koji uzimaju lijek Portrazza, a obično su blage do umjerene naravi.
English: It is administered as an intravenous infusion over approximately 60 minutes via an infusion pump.
Croatian: Primjenjuje se u obliku intravenske infuzije tijekom približno 60 minuta uz pomoć infuzijske pumpe.
English: Your doctor will discuss with you whether you need any preventive measures or early treatment.
Croatian: Vaš će liječnik razgovarati s Vama o tome trebate li poduzeti bilo kakve preventivne mjere ili primiti rano liječenje.
English: The materials will address the risks concerning arterial / venous thromboembolic events and cardiorespiratory disorders.
Croatian: Materijali će govoriti o rizicima od arterijskih / venskih tromboembolijskih događaja i kardiorespiratornih poremećaja.
English: • Permanently discontinue if patients experience Grade 3 skin induration/fibrosis.
Croatian: • Trajno prekinuti primjenu ako bolesnik razvije kožnu induraciju/fibrozu 3. stupnja.
English: The MAH shall ensure that in each Member State where Portrazza (necitumumab) is marketed, all physicians (i.e. oncologists) are notified about the key conditions for the safe use of necitumumab.
Croatian: Nositelj odobrenja mora osigurati da u svakoj državi članici u kojoj se Portrazza (necitumumab) nalazi na tržištu svi liječnici (tj. onkolozi) budu obaviješteni o ključnim uvjetima za sigurnu primjenu necitumumaba.
English: If a decreased infusion rate is indicated, the infusion duration should not exceed 2 hours.
Croatian: Ako je indicirana smanjena brzina infuzije, infuzija ne smije trajati dulje od 2 sata.
English: Contraceptive measures or abstinence are recommended (see section 4.6).
Croatian: Preporučuju se kontracepcijske mjere ili apstinencija (vidjeti dio 4.6).
English: Necitumumab recognises and binds specifically to a protein on the surface of some cancer cells.
Croatian: Necitumumab prepoznaje i specifično se vezuje za protein na površini nekih stanica raka.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži
English: Permanently discontinue if symptoms do not resolve to Grade ≤ 2 after holding for 2 consecutive cycles (6 weeks)
Croatian: Trajno prekinuti liječenje ako se simptomi ne ublaže do ≤ 2. stupnja nakon odgode liječenja za 2 uzastopna ciklusa (6 tjedana).
English: The ECOG PS was 0 for 31.5 %, 1 for 59.7 %, and 2 for 9 % of patients; over 50 % had metastatic disease at more than 2 sites.
Croatian: Funkcionalni ECOG status iznosio je 0 u 31,5% bolesnika, 1 u 59,7% bolesnika te 2 u 9% bolesnika; više od 50% bolesnika imalo je metastatsku bolest na više od 2 sijela.
English: b The table reflects the frequency of ADRs during the chemotherapy phase of study treatment in which Portrazza+GC was directly compared with GC.
Croatian: . b Tablica odražava učestalost nuspojava na lijek tijekom kemoterapijske faze ispitivanja, u kojoj su se Portrazza + GC izravno uspoređivali s GC.
English: Kaplan Meier plot of overall survival (ITT population)
Croatian: Slika 1 Kaplan-Meierova krivulja ukupnog preživljenja (ITT populacija)
English: Based on animal models, epidermal growth factor receptor (EGFR) is involved in prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo.
Croatian: Prema životinjskim modelima, receptor epidermalnog faktora rasta (EGFR) sudjeluje u prenatalnom razvoju i može biti presudan za normalnu organogenezu, proliferaciju i diferencijaciju embrija u razvoju.
English: If these levels are too low, your doctor may prescribe appropriate supplements.
Croatian: Ako su te vrijednosti preniske, liječnik će Vam možda propisati odgovarajuće nadomjeske.
English: What you need to know before you are given Portrazza
Croatian: Što morate znati prije nego počnete primati lijek Portrazza
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC22
Croatian: Farmakoterapijska skupina: Antineoplastici, monoklonska protutijela, ATK oznaka: L01XC22 Mehanizam djelovanja
English: What you need to know before you are given Portrazza 3.
Croatian: Što morate znati prije nego počnete primati lijek Portrazza 3.
English: See section 4 for more details about skin reactions.
Croatian: Pogledajte dio 4. za više informacija o kožnim reakcijama.
English: Portrazza should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus.
Croatian: Portrazza se ne smije primjenjivati u trudnoći niti u žena koje ne koriste učinkovitu kontracepciju, osim u slučajevima kada moguća korist od liječenja opravdava mogući rizik za plod.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1084/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1084/001
English: Prompt electrolyte repletion is recommended, as appropriate.
Croatian: Preporučuje se hitno nadomještanje elektrolita prema potrebi.
English: Adverse events observed included headache, vomiting and nausea and were consistent with the safety profile at the recommended dose.
Croatian: Primijećeni štetni događaji uključivali su glavobolju, povraćanje i mučninu, što je bilo u skladu sa sigurnosnim profilom zabilježenim kod primjene preporučene doze.
English: The highest dose of necitumumab studied clinically in a human dose-escalation Phase 1 study is 1,000 mg once a week or once every other week.
Croatian: Najveća klinički ispitivana doza necitumumaba u ispitivanju povećanja doze za ljude faze 1 iznosila je 1000 mg jedanput na tjedan ili jedanput svaka dva tjedna.
English: See also section 2 under “Warnings and precautions”.
Croatian: Pogledajte i odlomak 'Upozorenja i mjere opreza' u dijelu 2.
English: Patients underwent radiographic assessment of disease status every six weeks, until radiographic documentation of progressive disease (PD).
Croatian: U bolesnika se svakih šest tjedana provodilo radiografsko ocjenjivanje statusa bolesti, sve dok radiografijom nije dokumentirana njezina progresija.
English: A pre-planned exploratory analysis performed after the primary analysis, determined clinical efficacy outcome according to the level of tumour EGFR protein expression.
Croatian: Unaprijed planiranom eksploracijskom analizom, koja je provedena nakon primarne analize, utvrđen je ishod za kliničku djelotvornost prema razini tumorske ekspresije proteina EGFR.
English: The major efficacy outcome measure was overall survival (OS) and the supportive efficacy outcome measure was progression-free survival (PFS).
Croatian: Glavna mjera ishoda za djelotvornost bilo je ukupno preživljenje (engl. overall survival, OS), dok je potporna mjera ishoda za djelotvornost bilo preživljenje bez progresije bolesti (engl. progression-free survival, PFS).
English: Animal studies to assess fertility directly have not been conducted (see section 5.3).
Croatian: Nisu provedena ispitivanja na životinjama radi izravne ocjene učinaka na plodnost (vidjeti dio 5.3).
English: Portrazza may also cause changes in the results of blood tests.
Croatian: Portrazza može uzrokovati i promjene u nalazima krvnih pretraga.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Portrazza in all subsets of the paediatric population in non-small cell lung cancer (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Portrazza u svim podskupinama pedijatrijske populacije za rak pluća nemalih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: These include low blood levels of magnesium, calcium, potassium or phosphate.
Croatian: One uključuju niske krvne vrijednosti magnezija, kalcija, kalija ili fosfata.
English: Portrazza is given in combination with the medicines gemcitabine and cisplatin for up to 6 cycles and then it is given on its own.
Croatian: Portrazza se daje u kombinaciji s lijekovima gemcitabin i cisplatin tijekom najviše 6 ciklusa, a nakon toga se primjenjuje samostalno.
English: Necitumumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Croatian: Necitumumab je humano IgG1 monoklonsko protutijelo proizvedeno u mišjim (NS0) stanicama tehnologijom rekombinantne DNK.
English: Do not breast-feed your baby during treatment with Portrazza and for at least 4 months after you receive the last dose, as this medicine may harm the growth and development of your baby.
Croatian: Ne smijete dojiti dijete tijekom liječenja lijekom Portrazza i još najmanje 4 mjeseca nakon posljednje doze jer ovaj lijek može štetno utjecati na rast i razvoj Vašeg djeteta.
English: Toxicity gradea
Croatian: Stupanj toksičnostia
English: Abbreviations: C = cisplatin; G = gemcitabine.
Croatian: Kratice: C = cisplatin; G = gemcitabin.
English: Population pharmacokinetic analysis suggested age, gender, and race had no effect on the pharmacokinetics of necitumumab, while CL and volume of distribution had a less than proportional positive correlation with body weight.
Croatian: Populacijska farmakokinetička analiza pokazala je da dob, spol i rasa ne utječu na farmakokinetiku necitumumaba, dok su klirens i volumen distribucije bili u manje nego proporcionalnoj pozitivnoj korelaciji s tjelesnom težinom.
English: Skin reactions were reported in approximately 78 % of patients and mainly presented as acneiform rash, dermatitis acneiform, dry skin, pruritus, skin fissures, paronychia and palmar-plantar erythrodysaesthesia syndrome.
Croatian: Kožne reakcije prijavljene su u približno 78% bolesnika, a uglavnom su se manifestirale kao akneiformni osip, akneiformni dermatitis, suha koža, pruritus, kožne fisure, paronihija i sindrom palmarno-plantarne eritrodizestezije.
English: No drug-drug interactions were observed between Portrazza and gemcitabine/cisplatin.
Croatian: Nisu primijećene interakcije između lijeka Portrazza i gemcitabina/cisplatina.
English: If you have an infusion-related reaction during treatment, your drip will be slowed down and future doses will also be given more slowly.
Croatian: Ako Vam se tijekom liječenja pojavi reakcija na infuziju, ukapavanje će se usporiti, a nakon toga će se i sve ostale doze primjenjivati sporije.
English: Portrazza is used in combination with other anti-cancer medicines for the treatment of adults with certain type of lung cancer at an advanced stage (squamous non-small cell lung cancer), whose cancer cells have the EGFR protein on their surface.
Croatian: Portrazza se koristi u kombinaciji s drugim lijekovima za liječenje raka za liječenje odraslih osoba s određenom vrstom raka pluća u uznapredovaloj fazi (planocelularni rak pluća nemalih stanica), čije stanice imaju protein EGFR na svojoj površini.
English: Brief exposure to ambient light is acceptable while preparation and administration is taking place.
Croatian: Prihvatljivo je kratkotrajno izlaganje sobnoj svjetlosti tijekom pripreme i primjene lijeka.
English: The large majority of patients (95.2% of evaluable patients; n = 935) had tumor samples expressing EGFR protein; 4.8% (n = 47) were not detectable for EGFR protein expression.
Croatian: Velika većina bolesnika (95,2% bolesnika koji su zadovoljili kriterije za uključivanje u analizu; n = 935) imala je uzorke tumora koji su eksprimirali protein EGFR; 4,8% bolesnika (n = 47) nije imalo mjerljivu ekspresiju EGFR proteina.
English: Use of post-study systemic therapy was similar in the 2 arms (47.3 % in the Portrazza+GC arm and 44.7 % in the GC arm).
Croatian: Primjena sistemske terapije nakon ispitivanja bila je slična u obje skupine (47,3% u skupini koja je primala lijek Portrazza + GC te 44,7% u skupini koja je primala GC).
English: The majority of infusion-related reactions developed after the first or second administration of necitumumab.
Croatian: Većina reakcija na infuziju razvila se nakon prve ili druge primjene necitumumaba.
English: Prior to each necitumumab infusion, premedication for possible skin reactions must be considered (see section 4.4).
Croatian: Prije svake infuzije necitumumaba mora se razmotriti premedikacija zbog mogućih kožnih reakcija (vidjeti dio 4.4).
English: Although modeling results suggest that the disposition of necitumumab was statistically dependent on body weight, simulations indicated that weight-based dosing would not significantly decrease PK variability.
Croatian: Iako rezultati modeliranja ukazuju na to da je dispozicija necitumumaba statistički ovisila o tjelesnoj težini, simulacije su pokazale da doziranje na temelju tjelesne težine neće značajno smanjiti farmakokinetičku varijabilnost.
English: The protein is known as epidermal growth factor receptor (EGFR).
Croatian: Taj se protein naziva receptorom epidermalnog faktora rasta (engl. epidermal growth factor receptor,
English: In patients with detectable EGFR protein expression, there was no trend observed for increased efficacy with increasing levels of EGFR expression.
Croatian: U bolesnika s mjerljivom ekspresijom EGFR proteina nije primijećen trend povećanja djelotvornosti s porastom razine ekspresije EGFR-a.
English: Severe infusion-related reactions were reported in 0.4 % of patients.
Croatian: Teške reakcije na infuziju prijavljene su u 0,4% bolesnika.
English: The most common serious adverse reactions (Grade ≥3) observed in necitumumab-treated patients are skin reactions (6.3 %) and venous thromboembolic events (4.3 %).
Croatian: Najčešće ozbiljne nuspojave (≥ 3. stupnja) primijećene u bolesnika liječenih necitumumabom su kožne reakcije (6,3%) i venski tromboembolijski događaji (4,3%).
English: Human IgG1 is known to cross the placenta; therefore, necitumumab has the potential to be transmitted from the mother to the developing foetus.
Croatian: Poznato je da humani IgG1 prolazi kroz placentu; dakle, može doći do prijenosa necitumumaba s majke na plod u razvoju.
English: Of the ITT population, 982 patients (89.8%) were evaluable for an EGFR protein expression analysis by immunohistochemistry (IHC) using Dako PharmDx Kit.
Croatian: U ITT populaciji su 982 bolesnika (89,8%) zadovoljila kriterije za uključivanje u analizu ekspresije proteina EGFR, koja se provodila imunohistokemijom (engl. immunohistochemistry, IHC) uz pomoć dijagnostičkog seta Dako PharmDx Kit.
English: Other body proteins (called growth factors) can attach to the EGFR and stimulate the cancer cell to grow and divide.
Croatian: Drugi proteini u tijelu (koji se nazivaju faktorima rasta) mogu se pričvrstiti za EGFR te potaknuti rast i dijeljenje stanice raka.
English: a Grade per NCI-CTCAE, Version 3.0
Croatian: aStupanj prema verziji 3.0 NCI-CTCAE kriterija.
English: Portrazza and gemcitabine were administered on days 1 and 8 of each 3-week treatment cycle, and cisplatin was administered on day 1 of each 3-week treatment cycle.
Croatian: Portrazza i gemcitabin primjenjivali su se 1. i 8. dana svakog 3-tjednog ciklusa liječenja, dok se cisplatin primjenjivao 1. dana svakog 3-tjednog ciklusa liječenja.
English: • Temporarily withhold, for a maximum of 6 weeks following Day 1 of the most recent treatment cycle, until symptoms resolve to Grade ≤ 2.
Croatian: • Privremeno odgoditi primjenu - za najviše 6 tjedana počevši od 1. dana posljednjeg ciklusa liječenja - dok se simptomi ne ublaže do ≤ 2. stupnja.
English: Cardiorespiratory arrest or sudden death was reported in 2.8% (15/538) of patients treated with necitumumab in combination with gemcitabine and cisplatin compared to 0.6% (3/541) of patients treated with chemotherapy alone.
Croatian: Kardiorespiratorni zastoj ili iznenadna smrt prijavljeni su u 2,8% (15/538) bolesnika liječenih necitumumabom u kombinaciji s gemcitabinom i cisplatinom u odnosu na 0,6% (3/541) bolesnika liječenih samo kemoterapijom.
English: Patients may be advised to apply moisturiser, sunscreen and topical steroid cream to face, hands, feet, neck, back and chest.
Croatian: Bolesnicima se može savjetovati da sredstvo za ovlaživanje kože, kremu za zaštitu od sunca i topikalnu steroidnu kremu nanesu na lice, šake, stopala, vrat, leđa i prsa.
English: No animal studies have been specifically conducted to evaluate the effect of necitumumab on reproduction and foetal development; however, based on its mechanism of action and animal models where EGFR expression is disrupted, necitumumab may cause foetal harm or developmental anomalies.
Croatian: Nisu provedena specifična ispitivanja na životinjama kojima bi se ocijenio učinak necitumumaba na reprodukciju i razvoj ploda; međutim, s obzirom na mehanizam djelovanja i životinjske modele u kojima je ekspresija EGFR-a poremećena, necitumumab bi mogao uzrokovati oštećenje ploda ili razvojne anomalije.
English: Symptoms of severe skin reactions may include acne-like skin conditions and skin rash.
Croatian: Simptomi teških kožnih reakcija mogu uključivati kožne bolesti nalik aknama i kožni osip.
English: What Portrazza looks like and contents of the pack Portrazza 800 mg concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow liquid in a glass vial with a rubber stopper.
Croatian: Kako Portrazza izgleda i sadržaj pakiranja Portrazza 800 mg koncentrat za otopinu za infuziju (sterilni koncentrat) je bistra do blago opalescentna te bezbojna do blijedo žuta tekućina u staklenoj bočici s gumenim čepom.
English: Necitumumab should not be administered to patients with multiple risk factors for thromboembolic events unless the benefits outweigh the risks to the patient.
Croatian: Necitumumab se ne smije primjenjivati bolesnicima s višestrukim faktorima rizika za tromboembolijske događaje, osim ako koristi nadmašuju rizike za bolesnika.
English: - Cardiorespiratory disorders
Croatian: Kardiorespiratorni poremećaji
English: Name and address of the manufacturer(s) responsible for batch release Lilly, S.A.
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Lilly, S.A.
English: Infections
Croatian: - Infekcije