FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rarely, serious allergic (hypersensitivity) reactions involving symptoms similar to an infusion reaction (see “Infusion reactions”) have occurred more than 24 hours after treatment and resulted in a fatal outcome.
Croatian: Vrlo su rijetko nastupile ozbiljne alergijske reakcije (preosjetljivost) koje su uključivale simptome slične infuzijskoj reakciji (pogledajte „Infuzijske reakcije“) više od 24 sata nakon liječenja i rezultirale smrtnim ishodom.
English: Do not use Vectibix:
Croatian: Nemojte primjenjivati Vectibix:
English: If Vectibix is to be used in combination with FOLFOX then it is recommended that mutational status be determined by a laboratory that participates in a RAS External Quality Assurance programme or wild-type status be confirmed in a duplicate test.
Croatian: Ako se Vectibix planira uzimati u kombinaciji s FOLFOX, protokolom, tada se preporučuje odrediti mutacijski status u laboratoriju koji sudjeluje u eksternom programu osiguranja kakvoće za RAS testiranje (RAS External Quality Assurance program) ili status divljeg tipa treba potvrditi ponovljenim testom.
English: Activating mutations in the RAS genes occur frequently in a variety of human tumours and have been implicated in both oncogenesis and tumour progression.
Croatian: Aktivirajuće mutacije u genima RAS česte su u brojnim ljudskim tumorima i sudjeluju u onkogenezi i progresiji tumora.
English: • if you have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Croatian: • ako ste ranije imali ili imate simptome intersticijskog pneumonitisa (oticanja pluća što dovodi do kašljanja i otežanog disanja) ili plućne fibroze (ožiljci i zadebljanje pluća uz nedostatak zraka)
English: In an exploratory analysis of banked tumour specimens from this study, 11 of 72 patients (15%) with wild-type RAS tumours receiving panitumumab had an objective response compared to only 1 of 95 patients (1%) with mutant RAS tumour status.
Croatian: U eksplorativnoj analizi prikupljenih uzoraka tumora iz ovog ispitivanja, 11 od 72 bolesnika (15%) s tumorima s divljim tipom RAS koji su primali panitumumab imali su objektivan odgovor u usporedbi sa samo 1 od 95 ispitanika (1%) s tumorom s mutiranim RAS statusom.
English: These toxicities infrequently led to discontinuation of Vectibix or of chemotherapy.
Croatian: Ove su toksičnosti ponekad dovele do prekida liječenja lijekom Vectibix ili kemoterapijom.
English: Clinical efficacy in combination with chemotherapy
Croatian: Klinička djelotvornost u kombinaciji s kemoterapijom
English: The solution should be colourless and may contain visible translucent-to-white, amorphous, proteinaceous particulates (which will be removed by in-line filtration).
Croatian: Otopina treba biti bezbojna i može sadržavati vidljive prozirne do bijele, amorfne, proteinske čestice (koje će se ukloniti linijskim filterom).
English: No pre- and post-natal development animal studies have been conducted with panitumumab.
Croatian: Nisu provedena nikakva pre- i postnatalna razvojna ispitivanja na životinjama s panitumumabom.
English: Patients should be periodically monitored for hypomagnesaemia and accompanying hypocalcaemia prior to initiating Vectibix treatment, and periodically thereafter for up to 8 weeks after the completion of treatment (see section 4.8).
Croatian: Bolesnike se mora periodički kontrolirati zbog hipomagnezijemije i pridružene hipokalcijemije prije početka liječenja lijekom Vectibix i periodički od tada sve do 8 tjedana nakon završetka terapije (vidjeti dio 4.8).
English: Patients may be advised to apply moisturiser and sunscreen to face, hands, feet, neck, back and chest every morning during treatment, and to apply the topical steroid to face, hands, feet, neck, back and chest every night during treatment.
Croatian: Bolesnicima se može savjetovati da nanose sredstva za ovlaživanje kože i sredstva za zaštitu od sunca na područje lica, šaka, stopala, vrata, leđa i prsa svakog jutra tijekom liječenja te da primjenjuju topikalne steroide na područje lica, šaka, stopala, vrata, leđa i prsa svake večeri tijekom liječenja.
English: Patients with interstitial pneumonitis or pulmonary fibrosis (see section 4.4).
Croatian: Bolesnici s intersticijskim pneumonitisom ili plućnom fibrozom (vidjeti dio 4.4).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu
English: The European Medicines Agency has waived the obligation to submit the results of studies with Vectibix in all subsets of the paediatric population in colorectal cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Vectibix u svim podskupinama pedijatrijske populacije s kolorektalnim karcinomom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: However, infusion reactions were more frequent with cetuximab (13% versus 3%) but electrolyte disturbances were more frequent with panitumumab, especially hypomagnesaemia (29% versus 19%).
Croatian: Međutim, infuzijske reakcije bile su učestalije uz cetuksimab (13% naspram 3%), ali poremećaji elektrolita bili su učestaliji uz panitumumab, osobito hipomagnezijemija (29% naspram 19%).
English: Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reverzibilni učinak na menstrualni ciklus i smanjenu plodnost ženki majmuna (vidjeti dio 5.3).
English: Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, proteinaceous panitumumab particles.
Croatian: Bezbojna otopina, s pH 5,6 do 6,0, koja može sadržavati poluprozirne do bijele, vidljive amorfne proteinske čestice panitumumaba.
English: All patients should be advised regarding the potential risk of panitumumab on pre- and post-natal development prior to initiation of Vectibix therapy.
Croatian: Sve bolesnike se mora upozoriti na mogući rizik panitumumaba na pre- i postnatalni razvoj prije započinjanja liječenja lijekom Vectibix.
English: Results from a cross-study comparison indicated that irinotecan-containing regimens (IFL or FOLFIRI) have no effect on the pharmacokinetics of panitumumab.
Croatian: Rezultati usporedbe između ispitivanja pokazali su da protokoli koji sadrže irinotekan (IFL ili FOLFIRI) nemaju učinak na farmakokinetiku panitumumaba.
English: You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.
Croatian: Morate obavijestiti svoga liječnika prije upravljanja vozilom ili strojevima jer neke nuspojave mogu umanjiti Vašu sposobnost sigurnog upravljanja.
English: Tell your doctor if you use contact lenses and/or have a history of eye problems such as severe dry eye, inflammation of the front part of the eye (cornea) or ulcers involving the front part of the eye.
Croatian: Obavijestite svoga liječnika ukoliko koristite kontaktne leće i/ili ste imali tegobe s očima kao što su jako suho oko, upala prednjeg dijela oka (kornea) ili vrijedovi u prednjem dijelu oka.
English: If you experience severe diarrhoea please tell your doctor or nurse since you may lose a lot of water from your body (become dehydrated) and this could damage your kidneys.
Croatian: Ako razvijete teški proljev, molimo da obavijestite svog liječnika ili medicinsku sestru, budući da tako možete izgubiti puno tekućine (postati dehidrirani), što Vam može oštetiti bubrege.
English: Because human IgG is secreted into human milk, panitumumab might also be secreted.
Croatian: Budući da se ljudski IgG izlučuje u majčino mlijeko, panitumumab bi se također mogao izlučivati.
English: Results suggest that age (21-88), gender, race, hepatic function, renal function, chemotherapeutic agents, and EGFR membrane staining intensity (1+, 2+, 3+) in tumour cells had no apparent impact on the pharmacokinetics of panitumumab.
Croatian: Prema rezultatima, dob (21-88), spol, rasa, funkcija jetre, funkcija bubrega, kemoterapeutici i intenzitet membranskog bojanja za EGFR (1+, 2+, 3+) na tumorskim stanicama nisu imali vidljivih učinaka na farmakokinetiku panitumumaba.
English: There is no clinical data to support dose adjustments in the elderly.
Croatian: Nema kliničkih podataka koji govore u prilog prilagodbe doze kod starijih bolesnika.
English: Very commonly reported adverse reactions occurring in ≥ 20% of patients were gastrointestinal disorders [diarrhoea (46%), nausea (39%), vomiting (26%), constipation (23%) and abdominal pain (23%)]; general disorders [fatigue (35%), pyrexia (21%)]; metabolism and nutrition disorders [decreased appetite (30%)]; infections and infestations [paronychia (20%)]; and skin and subcutaneous disorders [rash (47%), dermatitis acneiform (39%), pruritus (36%), erythema (33%) and dry skin
Croatian: Vrlo često prijavljivane nuspojave, koje su se javile u ≥ 20% bolesnika, bile su poremećaji probavnog sustava [proljev (46%), mučnina (39%), povraćanje (26%), konstipacija (23%) i bol u abdomenu (23%)], opći poremećaji [umor (35%), pireksija (21%)], poremećaji metabolizma i prehrane [smanjeni apetit (30%)], infekcije i infestacije [paronihija (20%)], i poremećaji kože i potkožnog tkiva [osip (47%), akneiformni dermatitis (39%), svrbež (36%), eritem (33%) i suha koža (21%)].
English: In rare cases patients may experience blistering of the skin, mouth, eyes and genitals, which may indicate a severe skin reaction called “Stevens-Johnson syndrome” or blistering of the skin, which may indicate a severe skin reaction called “toxic epidermal necrolysis”.
Croatian: U rijetkim slučajevima kod bolesnika se može pojaviti stvaranje mjehura na koži, ustima, očima i genitalijama što može ukazivati na tešku kožnu reakciju koja se naziva „Stevens-Johnsonov sindrom“ ili stvaranje mjehura na koži što može ukazivati na tešku kožnu reakciju koja se naziva „toksična epidermalna nekroliza“.
English: If a patient develops dermatologic reactions that are grade 3 (CTCAE v 4.0) or higher, or that are considered intolerable, see the recommendation for dose modification in section 4.2.
Croatian: Ako bolesnici razviju dermatološke reakcije stupnja 3 ili višeg (CTCAE v 4.0), ili koje se smatraju nepodnošljivima, pogledajte preporuku za prilagodbu doze u dijelu 4.2.
English: If you experience a severe skin reaction, your doctor may recommend an adjustment of the dose of Vectibix.
Croatian: Ukoliko dođe do pojave teške kožne reakcije, liječnik Vam može preporučiti prilagodbu doze lijeka Vectibix.
English: BRAF mutations in exon 15 were found to be prognostic of worse outcome.
Croatian: Pronađeno je da su mutacije egzona 15 gena BRAF prognostički čimbenik lošijeg ishoda.
English: If you develop a severe infection or fever as a result of skin reactions, your doctor may stop your treatment with Vectibix.
Croatian: Ako dobijete tešku infekciju ili vrućicu kao posljedicu kožne reakcije, liječnik Vam može prekinuti liječenje lijekomVectibix.
English: What Vectibix contains
Croatian: Što Vectibix sadrži
English: A total of 1,010 patients refractory to chemotherapy were randomised 1:1 to receive Vectibix or cetuximab to test whether Vectibix is non-inferior to cetuximab.
Croatian: Ukupno je 1010 bolesnika refraktornih na kemoterapiju bilo randomizirano 1:1 za primjenu lijeka Vectibix ili cetuksimaba, kako bi se ispitalo da Vectibix nije inferioran u odnosu na cetuksimab.
English: If a severe or life-threatening reaction occurs during an infusion or at any time post-infusion [e.g. presence of bronchospasm, angioedema, hypotension, need for parenteral treatment, or anaphylaxis], Vectibix should be permanently discontinued (see sections 4.3 and 4.8).
Croatian: Ako se pojavi teška ili po život opasna reakcija preosjetljivosti za vrijeme ili u bilo kojem trenutku nakon primjene infuzije (npr. prisutnost bronhospazma, angioedema, hipotenzije, potrebe za parenteralnim liječenjem ili anafilaksije), primjena lijeka Vectibix mora se trajno prekinuti (vidjeti dijelove 4.3 i 4.8).
English: The efficacy results from an analysis adjusting for potential bias from unscheduled assessments are shown in the table below.
Croatian: Rezultati analize djelotvornosti nakon prilagodbe za moguću sustavnu pogrešku zbog neplaniranih pregleda prikazani su u tablici ispod.
English: Human IgG is known to cross the placental barrier, and panitumumab may therefore be transmitted from the mother to the developing foetus.
Croatian: Poznato je da ljudski IgG prolazi kroz placentarnu barijeru te stoga i panitumumab može biti prenesen s majke na plod.
English: Doses higher than 1,000 mg should be infused over approximately 90 minutes (for handling instructions, see section 6.6).
Croatian: Doze iznad 1000 mg moraju biti primijenjene u infuziji tijekom približno 90 minuta (za upute o rukovanju, vidjeti dio 6.6).
English: Hypocalcaemia Dehydration Hyperglycaemia Hypophosphataemia
Croatian: Hipokalcijemija Dehidracija Hiperglikemija Hipofosfatemija
English: Toxic epidermal necrolysis4
Croatian: Toksična epidermalna nekroliza4
English: Withhold or discontinue Vectibix in the event of dermatologic or soft tissue toxicity associated with severe or life-threatening inflammatory or infectious complications.
Croatian: Privremeno ili trajno prekinite primjenu lijeka Vectibix u slučaju dermatološke toksičnosti ili toksičnosti za meka tkiva, povezanih s teškim ili životno opasnim upalnim ili infektivnim komplikacijama.
English: Dermatologic reactions and soft tissue toxicity
Croatian: Dermatološke reakcije i toksičnost za meka tkiva
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 se javiti na bilo kojem dijelu tijela.
English: Paronychial inflammation was associated with swelling of the lateral nail folds of the toes and fingers.
Croatian: Paronihijalna upala bila je povezana s oticanjem bočnih nabora noktiju na prstima ruku i nogu.
English: Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) mutations.
Croatian: Mutacijski status mora se odrediti u iskusnom laboratoriju korištenjem validirane metode testiranja za detekciju mutacija gena KRAS (egzoni 2, 3 i 4) i NRAS (egzoni 2, 3 i 4).
English: Symptoms may include headache, rashes, itching or hives, flushing, swelling (face, lips, mouth, around the eyes, and throat area), rapid and irregular heartbeat, fast pulse, sweating, nausea, vomiting, dizziness, difficulty breathing or swallowing, or a decrease in blood pressure that may be severe or life-threatening and, very rarely, may lead to death.
Croatian: Simptomi mogu uključivati glavobolju, osipe, svrbež ili koprivnjaču, crvenilo uz osjećaj vrućine, otok (lica, usana, usta, oko očiju i područja grla), brzi i nepravilni otkucaji srca, ubrzan puls, znojenje, mučninu, povraćanje, omaglicu, otežano disanje ili gutanje ili sniženje krvnog tlaka koje može biti teško ili životno opasno i, u vrlo rijetkim slučajevima, može dovesti do smrti.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7.
English: • cough; dyspnoea (breathing difficulties).
Croatian: • kašalj; dispneja (otežano disanje).
English: Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium.
Croatian: Jedan ml koncentrata sadrži 0,150 mmol natrija, što odgovara 3,45 mg natrija.
English: Hypersensitivity reactions occurring more than 24 hours after infusion have been reported including a fatal case of angioedema that occurred more than 24 hours after the infusion.
Croatian: Prijavljene su reakcije preosjetljivosti koje su se pojavile više od 24 sata nakon infuzije, uključujući i fatalni slučaj angioedema koji se pojavio više od 24 sata nakon infuzije.
English: Patients who have severe dermatologic reactions or soft tissue toxicity or who develop worsening reactions whilst receiving Vectibix should be monitored for the development of inflammatory or infectious sequelae (including cellulitis and necrotising fasciitis), and appropriate treatment promptly initiated.
Croatian: Bolesnike s teškim dermatološkim reakcijama ili toksičnošću za meka tkiva ili one kojima su se za vrijeme primanja lijeka Vectibix reakcije pogoršale, mora se pratiti zbog razvoja upalnih ili infekcijskih posljedica (uključujući celulitis i nekrotizirajući fasciitis) i odmah započeti odgovarajuće liječenje.
English: Mutant RAS population PFS
Croatian: Populacija s mutiranim RAS PFS
English: The observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medicinal products and underlying disease, therefore, comparison of the incidence of antibodies to other products may be misleading.
Croatian: Na uočenu incidenciju pozitivnog testa na protutijela može utjecati nekoliko čimbenika uključujući metodologiju testa, postupanje s uzorcima, vrijeme uzimanja uzoraka, istodobno primijenjeni lijekovi i osnovna bolest pa stoga usporedba pojavnosti protutijela u odnosu na druge lijekove može biti pogrešna.
English: Fertility studies conducted in female cynomolgus monkeys showed that panitumumab may produce prolonged menstrual cycle and/or amenorrhea and reduced pregnancy rate which occurred at all doses evaluated.
Croatian: Ispitivanja fertilnosti u ženki cynomolgus majmuna pokazala su da panitumumab može uzrokovati produljen menstruacijski ciklus i/ili amenoreju te smanjenu stopu trudnoće, što je primijećeno pri svim promatranim dozama.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza EXP/“Rok valjanosti“.
English: Adverse events observed included skin toxicity, diarrhoea, dehydration and fatigue and were consistent with the safety profile at the recommended dose.
Croatian: Primijećeni štetni događaji uključivali su kožnu toksičnost, proljev, dehidraciju i umor, a ti su simptomi bili u skladu sa sigurnosnim profilom preporučene doze.
English: The mean (± SD) AUC0-tau and CL were 1,306 ± 374 mcg•day/mL and 4.9 ± 1.4 mL/kg/day, respectively.
Croatian: Srednja vrijednost (± SD) AUC0-tau i vrijednost CL iznosile su 1306 ± 374 mcg•dan/ml, odnosno 4,9 ± 1,4 ml/kg/dan.
English: If these levels are too low, your doctor may prescribe you appropriate supplements.
Croatian: Ako su te vrijednosti preniske, liječnik će Vam propisati odgovarajuću nadomjesnu terapiju.
English: Data on the development of anti-panitumumab antibodies has been evaluated using two different screening immunoassays for the detection of binding anti-panitumumab antibodies (an ELISA which detects high-affinity antibodies, and a Biosensor Immunoassay which detects both high and low-affinity antibodies).
Croatian: Podaci o stvaranju anti-panitumumab protutijela potvrđeni su uporabom dvaju različitih probirnih imunotestova za detekciju vežućih anti-panitumumab protutijela (testom ELISA, koji otkriva protutijela s visokim afinitetom i testom Biosensor Immunoassay, koji otkriva protutijela s visokim i niskim afinitetom).
English: This medicinal product contains 3.45 mg sodium per mL, equivalent to 0.017% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Ovaj lijek sadrži 3,45 mg natrija po ml, što odgovara 0,017% maksimalnog preporučenog dnevnog unosa od 2 g natrija prema preporukama SZO za odraslu osobu.
English: Formal male fertility studies have not been conducted; however, microscopic evaluation of male reproductive organs from repeat-dose toxicity studies in cynomolgus monkeys at doses up to approximately 5-fold the human dose on a mg/kg basis, revealed no differences compared to control male monkeys.
Croatian: Formalna ispitivanja fertilnosti mužjaka nisu provedena, međutim, mikroskopsko proučavanje muških reproduktivnih organa tijekom ispitivanja toksičnosti ponavljanih doza u cynomolgus majmuna pri dozama do 5 puta većim od doza u ljudi u mg/kg, nisu pokazale promjene u odnosu na kontrolne mužjake.
English: The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) given once every two weeks.
Croatian: Preporučena doza lijeka Vectibix je 6 mg/kg (miligrama po kilogramu tjelesne težine) dana jedanput svaka dva tjedna.
English: • severe skin reaction with blistering of the skin (toxic epidermal necrolysis);
Croatian: • teška kožna reakcija sa stvaranjem mjehura na koži (toksična epidermalna nekroliza);
English: The addition of panitumumab to radiation, chemotherapy or other targeted therapeutic agents, in animal studies resulted in an increase in antitumour effects compared to radiation, chemotherapy or targeted therapeutic agents alone.
Croatian: Dodatak panitumumaba zračenju, kemoterapiji ili ostaloj ciljanoj terapiji u ispitivanjima na životinjama doveo je do pojačanog antitumorskog učinka u usporedbi sa zračenjem, kemoterapijom ili ciljnom terapijom bez njega.
English: Following a single-dose administration of panitumumab as a 1-hour infusion, the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner and clearance (CL) of panitumumab decreased from 30.6 to 4.6 mL/day/kg as the dose increased from 0.75 to 9 mg/kg.
Croatian: Pri jednokratnoj primjeni panitumumaba u obliku 1-satne infuzije površina ispod krivulje koncentracija-vrijeme (AUC) porasla je više nego proporcionalno dozi, a klirens (CL) panitumumaba smanjio se s 30,6 na 4,6 ml/dan/kg kako se doza povećavala s 0,75 na 9 mg/kg.
English: • inflammation of the lungs (interstitial lung disease).
Croatian: • upala pluća (intersticijska bolest pluća).
English: Vectibix must be administered as an intravenous infusion via an infusion pump.
Croatian: Vectibix se mora primijeniti intravenskom infuzijom pomoću infuzijske pumpe.
English: Panitumumab recognises and binds specifically to a protein known as epidermal growth factor receptor (EGFR), which is found on the surface of some cancer cells.
Croatian: Panitumumab prepoznaje i veže se specifično za protein poznat kao receptor epidermalnog faktora rasta (EGFR) koji se nalazi na površini nekih tumorskih stanica.
English: In the event of acute onset or worsening pulmonary symptoms, Vectibix treatment should be interrupted and a prompt investigation of these symptoms should occur.
Croatian: U slučaju akutne pojave ili pogoršanja plućnih simptoma, terapija lijekom Vectibix mora se prekinuti i hitno istražiti uzroke tih simptoma.
English: Data from an interaction study involving Vectibix and irinotecan in patients with mCRC indicated that the pharmacokinetics of irinotecan and its active metabolite, SN-38, are not altered when the medicinal products are co-administered.
Croatian: Podaci iz ispitivanja interakcija lijeka Vectibix i irinotekana kod bolesnika s mKRK-om ukazuju na to da farmakokinetika irinotekana i njegovog aktivnog metabolita, SN-38, nije izmijenjena istodobnom primjenom ovih dvaju lijekova.
English: Vectibix should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Croatian: Vectibix se mora primjenjivati s oprezom kod bolesnika s anamnezom keratitisa, ulceroznog keratitisa ili jakom suhoćom oka.