FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Croatian: 4.3 Kontraindikacije Bolesnici koji u anamnezi imaju tešku ili po život opasnu preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti dio 4.4).
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 primijete simptome povezane s liječenjem koji utječu na njihovu sposobnost koncentracije i reagiranja, preporučuje se da ne upravljaju vozilima i da ne rade sa strojevima sve dok se ti učinci ne povuku.
English: Necitumumab exhibits concentration-dependent clearance.
Croatian: Necitumumab pokazuje klirens ovisan o koncentraciji.
English: The anti-cancer medicines it is combined with are gemcitabine and cisplatin.
Croatian: Lijekovi za liječenje raka s kojima se kombinira zovu se gemcitabin i cisplatin.
English: In addition, necitumumab induces EGFR internalization and degradation in vitro.
Croatian: Uz to, necitumumab inducira internalizaciju i razgradnju EGFR-a in vitro.
English: In approximately 4 out of 100 patients these side effects are likely to be severe.
Croatian: U približno 4 od 100 bolesnika te će nuspojave vjerojatno biti teške.
English: The concentrate must be diluted before use (see section 6.6).
Croatian: Koncentrat se prije primjene mora razrijediti (vidjeti dio 6.6).
English: Key elements of the physician educational material: o Importance of assessing the risks before starting treatment with necitumumab o Description of thromboembolic events including incidence rates from clinical trials o Advice that patients and physicians should be aware of signs and symptoms of thromboembolism.
Croatian: Ključni elementi edukacijskog materijala za liječnike: o Važnost procjene rizika prije započinjanja liječenja necitumumabom o Opis tromboembolijskih događaja, uključujući stope incidencije u kliničkim ispitivanjima o Preporuku da bolesnici i liječnici moraju biti svjesni znakova i simptoma tromboembolije.
English: Portrazza may cause side effects involving the skin.
Croatian: Portrazza može uzrokovati nuspojave koje zahvaćaju kožu.
English: Prepare the infusion solution using the aseptic technique to ensure the sterility of the prepared solution.
Croatian: Pripremite otopinu za infuziju aseptičnom tehnikom kako biste osigurali sterilnost pripremljene otopine.
English: Necitumumab is a recombinant human IgG1 monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 1 (EGFR) and blocks the ligand binding site, blocking activation by all known ligands and inhibiting relevant biological consequences in vitro.
Croatian: Necitumumab je rekombinantno humano IgG1 monoklonsko protutijelo koje se s velikim afinitetom i specifičnošću vezuje za receptor 1 humanog epidermalnog faktora rasta (EGFR) i blokira mjesto vezivanja liganda, čime sprječava aktivaciju potaknutu svim poznatim ligandima te inhibira značajne biološke posljedice in vitro.
English: This medicine contains 76 mg sodium per dose.
Croatian: Ovaj lijek sadrži 76 mg natrija po dozi.
English: There is no relevant use of necitumumab in the paediatric population in the non-small cell lung cancer indication.
Croatian: Nema relevantne primjene necitumumaba u pedijatrijskoj populaciji za indikaciju raka pluća nemalih stanica.
English: If not used immediately, the prepared necitumumab dosing solution must be stored at 2°C to 8°C for a duration not to exceed 24 hours, or may be held at 9°C to 25°C for up to 4 hours.
Croatian: Ako se ne primijeni odmah, pripremljena otopina necitumumaba mora se čuvati na temperaturi od 2°C do 8°C tijekom najviše 24 sata ili na temperaturi od 9°C do 25°C tijekom najviše 4 sata.
English: There has been limited experience with necitumumab overdose in human clinical trials.
Croatian: Ograničeno je iskustvo s predoziranjem necitumumabom iz kliničkih ispitivanja.
English: The most common adverse reactions were skin reactions, venous thromboembolic events and laboratory abnormalities (hypomagnesaemia and albumin-corrected hypocalcaemia).
Croatian: Najčešće nuspojave bile su kožne reakcije, venski tromboembolijski događaji i odstupanja u laboratorijskim nalazima (hipomagnezijemija i hipokalcijemija korigirana za albumin).
English: Prior to launch of Portrazza (necitumumab) in each Member State the MAH must agree about the content and format of the educational material, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: • Dodatne mjere minimizacije rizika Prije stavljanja lijeka Portrazza (necitumumab) na tržište u svakoj državi članici, nositelj odobrenja mora s nadležnim nacionalnim tijelom dogovoriti sadržaj i format edukacijskog materijala, uključujući medije komunikacije, načine distribucije i sve druge aspekte programa.
English: The important side effects of Portrazza are skin reactions and blood clots in the veins.
Croatian: Važne nuspojave lijeka Portrazza su kožne reakcije i krvni ugrušci u venama.
English: The incidence of fatal ATEs was 0.6% in the experimental arm versus 0.2% in the control arm (see also section 4.4).
Croatian: Incidencija AT događaja sa smrtnim ishodom iznosila je 0,6% u skupini koja je primala ispitivani lijek naspram 0,2% u kontrolnoj skupini (vidjeti i dio 4.4).
English: Portrazza contains the active substance necitumumab, which belongs to a group of substances called monoclonal antibodies.
Croatian: Portrazza sadrži djelatnu tvar necitumumab, koja pripada skupini lijekova koji se nazivaju monoklonskim protutijelima.
English: Patients should be carefully monitored for serum electrolytes, including serum magnesium, potassium, and calcium, prior to each necitumumab administration and after completion of necitumumab treatment, until within normal limits.
Croatian: U bolesnika treba pažljivo nadzirati serumske vrijednosti elektrolita, uključujući magnezij, kalij i kalcij, prije svake primjene i nakon završetka liječenja necitumumabom, sve dok se vrijednosti ne vrate u normalu.
English: Common (≥1/100 to <1/10)
Croatian: često (≥ 1/100 i < 1/10)
English: Monitor patients during and following the infusion for signs of hypersensitivity and infusion-related reactions with resuscitation equipment and appropriate medical resources readily available.
Croatian: Potrebno je nadzirati bolesnike tijekom i nakon infuzije zbog moguće pojave znakova reakcija preosjetljivosti i reakcija na infuziju te osigurati dostupnost opreme za oživljavanje i odgovarajućih medicinskih resursa.
English: There were no relevant differences in the distribution of demographics, disease characteristics, or the use of post-study systemic therapy between the subset of patients with detectable EGFR protein expression and the ITT population.
Croatian: Nije bilo značajnih razlika u raspodjeli demografskih podataka, značajki bolesti ni primjeni sistemske terapije nakon ispitivanja između podskupine bolesnika s mjerljivom ekspresijom EGFR proteina i
English: In the Portrazza+GC arm, 51 % of patients continued with single-agent Portrazza after completing chemotherapy.
Croatian: Portrazza + GC, 51% bolesnika je nakon završetka kemoterapije nastavilo liječenje lijekom Portrazza u monoterapiji.
English: The relative risk of VTE or ATE was approximately three-fold higher in patients with a reported history of VTE or ATE.
Croatian: Relativan rizik od VT ili AT događaja bio je približno trostruko veći u bolesnika koji su imali prijavljene VT ili AT događaje u anamnezi.
English: Mean total systemic clearance (CLtot) at steady state following 800 mg on Day 1 and Day 8 of a 21-day cycle was 0.014 l/hr (CV 39 %).
Croatian: Srednja vrijednost ukupnog sistemskog klirensa u stanju dinamičke ravnoteže nakon primjene doze od 800 mg 1. i 8. dana 21-dnevnog ciklusa iznosio je 0,014 l/h (CV: 39%).
English: For management and dose adjustments, see section 4.2.
Croatian: Za zbrinjavanje tih reakcija i prilagođavanje doze vidjeti dio 4.2.
English: The physician educational material package should also contain: o The Summary of Product Characteristics o Patient Information Leaflet
Croatian: Paket edukacijskih materijala za liječnike mora sadržavati i sljedeće: o Sažetak opisa svojstava lijeka o Uputu o lijeku
English: - Blood clots in the arteries or the veins
Croatian: - Krvni ugrušci u arterijama ili venama
English: Based on the results of the population pharmacokinetic analysis, hepatic status (as assessed by alanine aminotransferase, aspartate transaminase and total bilirubin) had no significant effect on the pharmacokinetics of necitumumab.
Croatian: Rezultati populacijske farmakokinetičke analize pokazali su da jetreni status (ocijenjen na temelju vrijednosti alanin aminotransferaze, aspartat transaminaze i ukupnog bilirubina) nije značajno utjecao na farmakokinetiku necitumumaba.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 800 mg/50 mL
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 800 mg/50 ml
English: Portrazza is for intravenous use only.
Croatian: Portrazza je namijenjena samo za intravensku primjenu.
English: In a phase 2 clinical trial investigating necitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone (106 versus 55 patients, 2:1 randomisation) as the first-line therapy in patients with Stage IV metastatic squamous NSCLC, a higher rate of death, including death due to infection, was observed for the necitumumab plus paclitaxel/carboplatin arm during the first 4 months (see also section 4.4), with a later trend towards improved survival after 4 months.
Croatian: U kliničkom ispitivanju faze 2 u kojem se ispitivao necitumumab u kombinaciji s paklitakselom i karboplatinom naspram samo paklitaksela i karboplatina (106 naspram 55 bolesnika, randomizacija u omjeru 2:1) u prvoj liniji liječenja bolesnika s metatatskim planocelularnim NSCLC-om stadija IV, opažena je povećana stopa smrti, uključujući smrt zbog infekcije, u skupini liječenoj necitumumabom plus paklitakselom/karboplatinom tijekom prva 4 mjeseca (vidjeti i dio 4.4), s kasnijim trendom prema poboljšanom preživljenju nakon 4 mjeseca.
English: They can lead to a blockage of a blood vessel in the leg.
Croatian: Mogu dovesti do blokade krvne žile u nozi.
English: Portrazza infusions should not be administered or mixed with glucose solutions.
Croatian: Infuzije lijeka Portrazza ne smiju se primjenjivati ni miješati s otopinama glukoze.
English: After dilution When prepared as directed, infusion solutions of Portrazza contain no antimicrobial preservatives.
Croatian: Kada se pripreme prema uputama, infuzijske otopine lijeka Portrazza ne sadrže antimikrobne konzervanse.
English: - Skin reactions
Croatian: - Kožne reakcije
English: Forest plot for subgroup analysis of overall survival (ITT population)
Croatian: Slika 2 Grafikon raspona pouzdanosti (engl. forest plot) za analizu ukupnog preživljenja po podskupinama (ITT populacija)
English: Excretion in milk and oral absorption is expected to be low.
Croatian: Očekuje se da će stupanj izlučivanja u majčino mlijeko i opseg apsorpcije nakon peroralne primjene biti nizak.
English: - The other ingredients are sodium citrate dihydrate (E331), citric acid anhydrous (E330), sodium chloride (see section 2 “Portrazza contains sodium”), glycine (E640), mannitol (E421), polysorbate 80 (E433) and water for injections.
Croatian: - Drugi sastojci su natrijev citrat dihidrat (E331), bezvodna citratna kiselina (E330), natrijev klorid (pogledajte odlomak 'Portrazza sadrži natrij' u dijelu 2.), glicin (E640), manitol (E421), polisorbat 80 (E433) i voda za injekcije.
English: How to store Portrazza
Croatian: Kako čuvati lijek Portrazza
English: Excipients: sodium citrate dihydrate, citric acid anhydrous, sodium chloride, glycine, mannitol, polysorbate 80 and water for injections.
Croatian: Pomoćne tvari: natrijev citrat dihidrat, bezvodna citratna kiselina, natrijev klorid, glicin, manitol, polisorbat 80 i voda za injekcije.
English: Abbreviations: GC = gemcitabine and cisplatin alone; Portrazza+GC = necitumumab plus gemcitabine and cisplatin; MedDRA = Medical Dictionary for Regulatory Activities.
Croatian: Kratice: GC = samo gemcitabin i cisplatin; Portrazza + GC = necitumumab plus gemcitabin i cisplatin; MedDRA (engl.
English: Portrazza can cause blood clots in your arteries or your veins.
Croatian: Portrazza može uzrokovati nastanak krvnih ugrušaka u arterijama ili venama.
English: 50 mL solution in a vial (Type I glass) with a chlorobutyl elastomer stopper, an aluminium seal and a polypropylene cap.
Croatian: 50 ml otopine u bočici (staklo tipa I) s čepom od klorbutilnog elastomera, aluminijskim prstenom i polipropilenskim zatvaračem.
English: Following improvement to Grade ≤ 2, resume at reduced dose of 400 mg.
Croatian: • Nakon poboljšanja do ≤ 2. stupnja, nastaviti liječenje dozom smanjenom na 400 mg.
English: Skin reactions were reported with necitumumab (see section 4.8).
Croatian: Kožne reakcije Kod primjene necitumumaba prijavljene su kožne reakcije (vidjeti dio 4.8).
English: Clear to slightly opalescent and colourless to slightly yellow liquid, with pH 6.0.
Croatian: Bistra do blago opalescentna i bezbojna do blijedo žuta otopina, pH vrijednosti 6,0.
English: The following table provides the frequency and severity of ADRs based on results from SQUIRE, a global, multicenter, two-arm, randomized Phase 3 study in adult patients with squamous NSCLC randomised to treatment with necitumumab in combination with gemcitabine/cisplatin or gemcitabine/cisplatin.
Croatian: U sljedećoj se tablici navode učestalost i težina nuspojava lijeka na temelju rezultata iz ispitivanja SQUIRE - globalnog, multicentričnog, randomiziranog ispitivanja faze 3 s dvije skupine, provedenog u odraslih bolesnika s planocelularnim rakom pluća nemalih stanica koji su bili randomizirani za liječenje necitumumabom u kombinaciji s gemcitabinom/cisplatinom ili za liječenje gemcitabinom/cisplatinom.
English: There was no relationship between immunogenicity and IRRs or treatment emergent adverse events.
Croatian: Nije postojala povezanost između imunogenosti i reakcija na infuziju ili štetnih događaja koji se se javljali tijekom liječenja.
English: The recommended dose of Portrazza is 800 mg (flat dose) administered as an intravenous infusion over 60 minutes on Days 1 and 8 of each 3-week cycle.
Croatian: Preporučena doza lijeka Portrazza je 800 mg (doza neovisna o tjelesnoj težini), a primjenjuje se intravenskom infuzijom tijekom 60 minuta 1. i 8. dana svakog 3-tjednog ciklusa.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 800 mg/ 50 mL
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 800 mg/50 ml
English: The risk of fertility impairment is unknown.
Croatian: Nije poznat rizik od štetnih učinaka na plodnost.
English: If you have a severe skin reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza.
Croatian: Ako imate tešku kožnu reakciju, liječnik će možda preporučiti prilagodbu doze lijeka Portrazza ili posve prekinuti liječenje ovim lijekom.
English: Administration of necitumumab should be carefully considered in those patients with a history of thromboembolic events (such as pulmonary embolism, deep vein thrombosis, myocardial infarction, stroke) or preexisting risk factors for thromboembolic events (such as advanced age, patients with prolonged periods of immobilisation, severely hypovolemic patients, patients with acquired or inherited thrombophilic disorders).
Croatian: Primjenu necitumumaba potrebno je pažljivo razmotriti u bolesnika koji u anamnezi imaju tromboembolijske događaje (poput plućne embolije, duboke venske tromboze, infarkta miokarda, moždanog udara) ili otprije postojeće faktore rizika za tromboembolijske događaje (poput starije dobi, dugotrajnih razdoblja imobilizacije, teške hipovolemije te stečenih ili nasljednih trombofilijskih poremećaja).
English: This should be taken into consideration by patients on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika koji su na dijeti s kontroliranim unosom natrija.
English: Talk to your doctor or nurse immediately if any of the following applies to you (or you are not sure) during or after treatment with Portrazza:
Croatian: Odmah se obratite svom liječniku ili medicinskoj sestri ako se tijekom ili nakon liječenja lijekom
English: Overall survival Number of events (n) Median - months (95 % CIa) Hazard ratio (95 % CI)b, c Two-sided log-rank p-valuec 1-year Overall survival rate (%)
Croatian: Medijan - mjeseci (95 % CIa) Omjer hazarda (95 % CI)b, c Dvostrana log-rang p-vrijednost c
English: Portrazza has no known influence on the ability to drive and use machines.
Croatian: Nema poznatih učinaka lijeka Portrazza na sposobnost upravljanja vozilima i rada sa strojevima.
English: In patients with detectable EGFR protein expression (indicated patient population), overall survival was statistically significantly improved in the Portrazza+GC Arm as compared to the GC Arm with an estimated reduction in risk of death of 21% (hazard ratio [HR] = 0.79 [0.69, 0.92]; p = 0.002) and a median OS of 11.7 months in the Portrazza+GC Arm and 10.0 months in the GC Arm. A statistically significant improvement in progression-free survival was also observed (HR = 0.84 [0.72, 0.97]; p = 0.018), with a median PFS of 5.7 months in the Portrazza+GC Arm and 5.5 months in the GC Arm.
Croatian: U bolesnika s mjerljivom ekspresijom proteina EGFR (indicirana populacija bolesnika) ukupno preživljenje se statistički značajno poboljšalo u skupini liječenoj lijekom Portrazza + GC u odnosu na skupinu koja je primala GC, uz procijenjeno smanjenje rizika od smrti za 21% (omjer hazarda [HR] = 0,79 [0,69; 0,92]; p = 0,002) i medijan OS-a od 11,7 mjeseci u skupini koja je primala lijek Portrazza + GC te 10,0 mjeseci u skupini koja je primala GC.
English: Portrazza is administered as an intravenous infusion.
Croatian: Portrazza se primjenjuje u obliku intravenske infuzije.
English: Patients received a maximum of six cycles of chemotherapy in each arm; patients in the Portrazza+GC arm who had no progression continued to receive single-agent Portrazza until disease progression, unacceptable toxicity, or withdrawal of consent.
Croatian: Bolesnici su primili najviše šest ciklusa kemoterapije u svakoj skupini; bolesnici u skupini liječenoj lijekom Portrazza + GC kojima bolest nije uznapredovala nastavili su primati lijek Portrazza kao monoterapiju do progresije bolesti, pojave neprihvatljive toksičnosti ili povlačenja pristanka za sudjelovanje u ispitivanju.
English: Women of childbearing potential have to use effective contraception during necitumumab treatment and up to 3 months after last administration of necitumumab treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja necitumumabom i do 3 mjeseca nakon posljednje primjene necitumumaba.
English: Overall, there was a low incidence of both treatment-emergent anti-drug antibodies and neutralizing antibodies among necitumumab-treated patients, and no correlation with safety outcomes in these patients.
Croatian: Sveukupno je među bolesnicima liječenima necitumumabom zabilježena niska incidencija i protutijela na lijek nastalih tijekom liječenja i neutralizirajućih protutijela, bez korelacije sa sigurnosnim ishodima u tih bolesnika.
English: Portrazza in combination with gemcitabine and cisplatin chemotherapy is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) expressing squamous non-small cell lung cancer who have not received prior chemotherapy for this condition.
Croatian: Portrazza je u kombinaciji s kemoterapijom gemcitabinom i cisplatinom indicirana za liječenje odraslih bolesnika s lokalno uznapredovalim ili metastatskim planocelularnim rakom pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC) koji eksprimira receptor epidermalnog faktora rasta (engl. epidermal growth factor receptor, EGFR), koji prethodno nisu primili kemoterapiju za tu bolest.
English: Breast-feeding should be discontinued during treatment with Portrazza and for at least 4 months after the last dose.
Croatian: Dojenje treba prekinuti tijekom liječenja lijekom Portrazza i još najmanje 4
English: Based on population pharmacokinetic approach (PopPK), the mean volume of distribution at steady state (Vss) for necitumumab was 6.97 L (CV
Croatian: Na temelju populacijskog farmakokinetičkog pristupa, srednji volumen distribucije necitumumaba u stanju dinamičke ravnoteže iznosio je 6,97 l
English: Avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Portrazza as this medicine may potentially cause harm to your unborn child. Talk to your doctor about the best contraception for you.
Croatian: Morate izbjegavati trudnoću tijekom liječenja ovim lijekom i još najmanje 3 mjeseca nakon posljednje doze lijeka Portrazza jer bi on mogao naškoditi Vašem nerođenom djetetu.
English: Manufacturer Lilly S.A., Avda de la Industria, 30, Alcobendas, Madrid, 28108, Spain
Croatian: Lilly S.A., Avda de la Industria, 30, Alcobendas, Madrid, 28108, Španjolska Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: The recommended dose of Portrazza is 800 mg on days 1 and 8 of each 3-week cycle.
Croatian: Preporučena doza lijeka Portrazza je 800 mg, a primjenjuje se 1. i 8. dana svakog 3-tjednog ciklusa.
English: The concentrate for solution for infusion must be clear to slightly opalescent and colourless to slightly yellow prior to dilution.
Croatian: Koncentrat za otopinu za infuziju mora prije razrjeđivanja biti bistar do blago opalescentan te bezbojan do blijedo žut.
English: Women of childbearing potential/contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on necitumumab and should be informed of the potential hazard to the pregnancy and foetus.
Croatian: Ženama reproduktivne dobi treba savjetovati da izbjegavaju trudnoću tijekom liječenja necitumumabom te ih treba upozoriti na moguće rizike za trudnoću i plod.
English: However, no adverse effects on male or female reproductive organs were observed in monkeys treated for 26 weeks with necitumumab.
Croatian: Međutim, u majmuna koji su primali necitumumab tijekom 26 tjedana nisu primijećeni štetni učinci na reproduktivne organe mužjaka ni ženki.
English: Hypomagnesaemia may reoccur at the same grade or worse after a dose delay.
Croatian: Nakon odgode primjene doze, može se ponovno javiti hipomagnezijemija istog ili težeg stupnja.
English: In vivo studies in cell line-derived xenograft models of human cancer, including non-small cell lung carcinoma, demonstrate that necitumumab has antitumor activity both in monotherapy and in combination with gemcitabine and cisplatin.
Croatian: Ispitivanja in vivo na ksenotransplantacijskim modelima humanog raka, uključujući karcinom pluća nemalih stanica, dobivenima iz stanične linije pokazuju da necitumumab ostvaruje antitumorsku aktivnost i u monoterapiji i u kombinaciji s gemcitabinom i cisplatinom.
English: If you have a severe infusion-related reaction, your doctor may recommend adjusting the dose of Portrazza, or stop your treatment with Portrazza.
Croatian: Ako imate tešku reakciju na infuziju, liječnik će možda preporučiti prilagodbu doze lijeka Portrazza ili posve prekinuti liječenje ovim lijekom.
English: • Stop the infusion; when the reaction has resolved to Grade ≤ 1, resume infusion at a 50 % decreased infusion rate.b
Croatian: • Zaustaviti infuziju; kada se reakcija ublaži do ≤ 1. stupnja,
English: Specific animal studies to test necitumumab for carcinogenic potential or potential to impair fertility have not been performed.
Croatian: Nisu provedena specifična ispitivanja kancerogenosti necitumumaba na životinjama, kao ni njegova potencijala da štetno utječe na plodnost.