FrancophonIA/ELRC3.0 huggingface dataset:
English: Chromosomal aberrations have also been detected in in vivo studies in mice and monkeys.
Croatian: Kromosomske aberacije također su uočene u in vivo ispitivanjima na miševima i majmunima.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se nositelju odobrenja za stavljanje lijeka u promet:
English: • are allergic to paclitaxel or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na paklitaksel ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.),
English: Further, it has been demonstrated that peripheral neuropathies can persist beyond 6 months of paclitaxel discontinuation.
Croatian: Nadalje, pokazano je kako se periferne neuropatije mogu nastaviti javljati nakon više od šest mjeseci od prekida primjene paklitaksela.
English: In some of the cases, the patients had previously been exposed to cardiotoxic medicinal products such as doxorubicin or had underlying cardiac history.
Croatian: U nekim od tih slučajeva bolesnici su u prošlosti bili izloženi kardiotoksičnim lijekovima kao što je doksorubicin ili su imali već postojeću anamnezu bolesti srca.
English: The model indicated that a 0.2 m2 increase in BSA would lead to a 9% increase in the elimination rate.
Croatian: Na temelju modela naznačeno je da bi povećanje tjelesne površine (BSA) od 0,2 m2 dovelo do povećanja brzine eliminacije od 9 %.
English: Patients experiencing severe reactions should not be re-challenged with paclitaxel.
Croatian: bolesnika s teškim reakcijama ne smije se ponovno primjenjivati paklitaksel.
English: • blood poisoning
Croatian: • trovanje krvi
English: The solution should be clear and greenish-yellow without visible particles or precipitates.
Croatian: Otopina mora biti bistra i zelenožute boje, bez vidljivih čestica ili taloga.
English: There is very little information available on whether the elimination of paclitaxel differs between races.
Croatian: Dostupno je vrlo malo informacija o tome razlikuje li se brzina eliminacije paklitaksela ovisno o rasi.
English: Apealea in children and adolescents aged 0−17 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Apealea u djece i adolescenata u dobi od 0 do 17 godina nisu utvrđene.
English: Limited data are available on use in patients ≥ 75 years.
Croatian: Dostupni su ograničeni podatci o primjeni u bolesnika ≥ 75 godina.
English: • low body temperature
Croatian: • niska tjelesna temperatura
English: Protect from light and allow the vial to stand for three to five minutes.
Croatian: Zaštitite bočicu od svjetlosti i ostavite je da odstoji tri do pet minuta.
English: Standard dose:
Croatian: Standardna doza:
English: However, compatibility with DEHP-containing administration sets has not been demonstrated.
Croatian: Međutim, nije dokazana kompatibilnost sa setovima za primjenu koji sadrže DEHP.
English: Apealea contains a mixture of two retinoic acid derivatives as excipients.
Croatian: Apealea sadrži mješavinu dvaju derivata retinoatne kiseline kao pomoćnih tvari.
English: Withhold treatment until symptoms resolve to grade ≤ 1
Croatian: Obustaviti liječenje dok se simptomi ne povuku na ≤ 1. stupanj
English: No pharmacologically active metabolite has been found.
Croatian: Nije utvrđeno postojanje farmakološki aktivnog metabolita.
English: With regard to age, the population model indicated an approximate 5% decline in paclitaxel elimination rate for each 10-year increase in age compared to the median age of 56 years of the study.
Croatian: U pogledu dobi, populacijski model upućivao je na približno smanjenje u brzini eliminacije paklitaksela od 5 % za svako povećanje dobi od deset godina, u usporedbi s medijanom dobi ispitanika od 56 godina.
English: The paclitaxel infusion was followed by carboplatin after an interval of 30 minutes in both treatment arms.
Croatian: Nakon infuzije paklitaksela primijenjen je karboplatin nakon intervala od 30 minuta u obje liječene skupine.
English: Infusion site reactions, such as pain, phlebitis, and erythema, were seen in 12% of patients (see section 4.4).
Croatian: Reakcije na mjestu primjene infuzije, kao što su bol, flebitis i eritem, bile su opažene u 12 % bolesnika (vidjeti dio 4.4).
English: Palmar-plantar erythrodysesthesia syndromec
Croatian: Sindrom palmarno-plantarne eritrodisestezijec
English: There were no differences in Eastern Cooperative Oncology Group (ECOG) performance score between the two study groups at any time during or after treatment (mainly score 0 or 1).
Croatian: Funkcionalno stanje prema ljestvici Istočne kooperativne skupine za onkologiju (ECOG) bilo je jednako u objema skupinama u svakom trenutku tijekom i nakon liječenja (rezultat je uglavnom bio 0 ili 1).
English: • skin infections, including infections at the infusion site
Croatian: • infekcije kože, uključujući infekcije na mjestu primjene infuzije
English: Withhold treatment until recovery
Croatian: Obustaviti liječenje do oporavka
English: To reach room temperature, let the vials stand protected from light for approximately 15 to 20 minutes not above 25 °C.
Croatian: Kako bi dosegle sobnu temperaturu, zaštitite bočice od svjetlosti i ostavite ih da odstoje otprilike 15 do 20 minuta na temperaturi ne višoj od 25 °C.
English: The solution should be injected during approximately one minute towards the inner wall of the vial and not directly onto the powder as this will result in foaming.
Croatian: Otopinu treba injicirati tijekom približno jedne minute i usmjeriti je prema unutarnjoj stijenci bočice, a ne izravno na prašak jer će nastati pjena.
English: * Solutions containing both Ca2+ and Mg2+ should have a total (combined) concentration of Ca2+ and Mg2+ within the range of 1.0 to 3.5 mmol/L.
Croatian: * Otopine koje sadrže i Ca2+ i Mg2+ trebaju sadržavati ukupnu (kombiniranu) koncentraciju Ca2+ i Mg2+ u rasponu od 1,0 do 3,5 mmol/l.
English: • disturbed blood clotting mechanisms in the body
Croatian: • poremećaj mehanizma zgrušavanja krvi u tijelu
English: Paraesthesia and hypoaesthesia were the most common ones.
Croatian: Najčešće su bile parestezija i hipoestezija.
English: − breathing difficulties
Croatian: − teškoće s disanjem
English: Paclitaxel at doses below the human therapeutic dose was associated with low fertility and foetal toxicity in rats.
Croatian: Paklitaksel u dozama nižim od terapijskih doza u ljudi povezuje se s niskom plodnošću i fetalnom toksičnošću u štakora.
English: The tissue distribution is extensive, with a volume of distribution on the terminal elimination phase of about 155 L/m2 corresponding to about 280 L for an average patient with a body surface area of 1.8 m2.
Croatian: Paklitaksel se široko distribuira u tkivima, a volumen distribucije u terminalnoj fazi eliminacije iznosi otprilike 155 l/m2, što odgovara otprilike 280 l u prosječnog bolesnika s tjelesnom površinom od 1,8 m2.
English: The median number of cycles with administration of GCSF was 3 (1;6) and the mean value 3.1, each in both groups.
Croatian: Medijan broja ciklusa uz primjenu G-CSF-a bio je 3 (1; 6), a srednja vrijednost 3,1 u obje skupine.
English: Patients with low neutrophil count should be made aware of the increased risk of infections.
Croatian: Bolesnike s niskim brojem neutrofila potrebno je upozoriti na povećan rizik od infekcija.
English: Uncommon: Alanine aminotransferase increased a See Description of selected adverse reactions.
Croatian: Manje često: povišena razina alanin aminotransferaze a Vidjeti dio Opis odabranih nuspojava.
English: The high interindividual variability in clearance is believed to be a consequence of variability in hepatic enzyme activity.
Croatian: Smatra se da je velika varijabilnost između pojedinih bolesnika posljedica varijabilnosti u aktivnosti jetrenih enzima.
English: Binding of paclitaxel to both albumin and α1-acid glycoprotein has been reported, but other binding proteins such as lipoproteins might be important.
Croatian: Zabilježeno je vezivanje paklitaksela na albumin i α1-kiseli glikoprotein, no mogli bi biti važni i drugi vezujući proteini, kao što su lipoproteini.
English: The reconstituted product should not be diluted.
Croatian: Rekonstituirani lijek ne smije se razrjeđivati.
English: The reduced dose may be escalated to the dose for patients with normal hepatic function if the patient is tolerating the treatment for at least two cycles (see sections 4.4 and 5.2).
Croatian: Smanjena doza može se povećati do doze za bolesnike s normalnom funkcijom jetre ako se u najmanje dvama ciklusima pokaže da bolesnik podnosi liječenje (vidjeti dijelove 4.4 i 5.2).
English: During and after infusion of Apealea, paclitaxel rapidly leaves the plasma compartment with a distribution half-life of about 0.6 hours.
Croatian: Tijekom i nakon infuzije lijeka Apealea paklitaksel brzo napušta plazmatski odjeljak, a poluvijek distribucije iznosi otprilike 0,6 sati.
English: Limited data are available on use in patients ≥ 75 years (2% of the patients in the study).
Croatian: Dostupni su ograničeni podatci o primjeni u bolesnica s ≥ 75 godina (2 % bolesnica u ispitivanju).
English: • a heart rhythm disorder causing irregular rapid activity in the upper heart chambers
Croatian: • poremećaj srčanog ritma koji uzrokuje nepravilne brze kontrakcije gornjih komora srca
English: Apealea is used to treat the following cancers in adults, in combination with another medicine called carboplatin:
Croatian: Lijek Apealea primjenjuje se za liječenje sljedećih karcinoma u odraslih osoba, u kombinaciji s drugim lijekom naziva karboplatin:
English: • difficulty producing voice sounds
Croatian: • teškoće u nastanku glasa
English: Moderate cases may require premedication with corticosteroids, antihistamines and/or H2 antagonists for the following treatment cycles.
Croatian: U umjerenim slučajevima može biti potrebna premedikacija kortikosteroidima, antihistaminicima ili H2 antagonistima u sljedećim ciklusima liječenja.
English: Breast-feeding must be discontinued for the duration of therapy.
Croatian: Dojenje se mora prekinuti za vrijeme trajanja liječenja.
English: • blood vessel disorders, such as:
Croatian: • poremećaji krvnih žila kao što su:
English: Paclitaxel affects or stops growth of rapidly dividing cells, such as tumour cells.
Croatian: Paklitaksel utječe na rast ili zaustavlja rast stanica koje se brzo dijele, kao što su tumorske stanice.
English: The biotransformation and elimination of paclitaxel have been reported in published studies; paclitaxel is mainly eliminated by hepatic metabolism and biliary excretion.
Croatian: Biotransformacija i eliminacija paklitaksela zabilježene su u objavljenim ispitivanjima; paklitaksel se uglavnom eliminira jetrenim metabolizmom i izlučivanjem putem žuči.
English: The solution should be administered by an intravenous infusion over approximately one hour (120−140 drops/min).
Croatian: Otopinu treba primijeniti putem intravenske infuzije u trajanju od otprilike jednog sata (120 do 140 kapi/min).
English: • sensation of heaviness in the legs
Croatian: • osjećaj težine u nogama
English: First
Croatian: Prvi
English: In view of this, and of the potential for frailty and co-morbidities, elderly patients should be carefully monitored.
Croatian: kao i na potencijalnu osjetljivost i komorbiditete, starije bolesnike treba pozorno pratiti.
English: The proportions of patients treated at first or second relapse were then equal in both treatment groups (76% were treated at first relapse and 24% at second relapse).
Croatian: Udio bolesnica koje su liječene nakon prvog ili drugog relapsa bio je tada jednak u objema liječenim skupinama (76 % bolesnica liječeno je nakon prvog relapsa, a 24 % nakon drugog relapsa).
English: • deafness, inner ear disorder, ringing in the ears
Croatian: • gluhoća, poremećaj unutarnjeg uha, zvonjava u ušima
English: The dose-dependency of frequency and severity of neurotoxicity was not studied for Apealea, but has been observed for other paclitaxel formulations in other indications.
Croatian: Ovisnost o dozi u pogledu učestalosti i težine neurotoksičnosti nije ispitivana za lijek Apealea, ali je zapažena za druge formulacije paklitaksela u drugim indikacijama.
English: Women of childbearing potential must use effective contraception during treatment and for six months afterwards.
Croatian: Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i šest mjeseci nakon završetka liječenja.
English: • lack of white and red blood cells, and blood platelets
Croatian: • nedostatak bijelih i crvenih krvnih stanica i krvnih pločica
English: • ketoconazole, or other medicines to treat fungal infections
Croatian: • ketokonazol ili druge lijekove za liječenje gljivičnih infekcija
English: Neutropenia is a dose-dependent and dose-limiting adverse reaction.
Croatian: Neutropenija je ovisna o dozi i nuspojava je koja ograničava dozu.
English: Likewise, total plasma clearance varied about 5-fold from 8 to 41 L/hour.
Croatian: Slično tome, vrijednost ukupnog klirensa plazme razlikovala se za otprilike pet puta, od 8 od 41 l/sat.
English: Of the 391 patients with ovarian cancer in the randomised study who received Apealea in combination with carboplatin, 13% were between 65 and 74 years old.
Croatian: Od 391 bolesnice s rakom jajnika koje su u okviru randomiziranog ispitivanja primale lijek Apealea u kombinaciji s karboplatinom, 13 % bolesnica bilo je u dobi od 65 do 74 godine.
English: Inject the required amount of reconstituted Apealea into an empty, sterile ethylene-vinyl acetate (EVA) bag.
Croatian: Potrebnu količinu rekonstituiranog lijeka Apealea injicirajte u praznu i sterilnu etilenvinilacetatnu (EVA) vrećicu.
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Croatian: Teška preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 (vidjeti dio 4.4).
English: Paclitaxel should not be used during pregnancy unless the clinical condition requires this treatment.
Croatian: Paklitaksel se ne smije primjenjivati tijekom trudnoće, osim ako je zbog kliničkog stanja trudnice potrebno liječenje paklitakselom.
English: Based on literature data, no clinically relevant pharmacokinetic interaction between paclitaxel and carboplatin is expected.
Croatian: Na temelju podataka iz literature, ne očekuju se klinički relevantne farmakokinetičke interakcije između paklitaksela i karboplatina.
English: • primary peritoneal cancer - a cancer of the cells lining the space between the wall of the belly and the internal organs
Croatian: • primarni rak peritoneuma - rak stanica ovojnice koja oblaže prostor između trbušne stijenke i unutarnjih organa
English: • epithelial ovarian cancer - a cancer of the ovary, the organ that produces a woman's egg cells
Croatian: • epitelni rak jajnika - rak jajnika, organa koji proizvodi jajne stanice žene
English: • fever, pain, chills, weakness or other signs of infection
Croatian: • vrućica, bol, zimica, slabost ili drugi znakovi infekcije
English: Paclitaxel causes myelosuppression (primarily neutropenia).
Croatian: Paklitaksel uzrokuje mijelosupresiju (primarno neutropeniju).
English: Apealea is supplied as a greenish-yellow to yellow powder in a glass vial with a rubber stopper and aluminium seal.
Croatian: Apealea se isporučuje kao prašak zelenožute do žute boje u staklenoj bočici s gumenim čepom i aluminijskim prstenom.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • lack of appetite
Croatian: • gubitak apetita
English: The mean age was 56 years of age in both treatment groups (range 26-81).
Croatian: Srednja vrijednost dobi u objema liječenim skupinama bila je 56 godina (raspon godina od 26 do 81).
English: The carcinogenic activity of paclitaxel has not been studied.
Croatian: Kancerogeno djelovanje paklitaksela nije ispitivano.
English: When reconstituted, this medicinal product contains up to approximately 1.6 g sodium per dose (0.9 g/m2 BSA; 3.6 mg per mL), equivalent to 80% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Nakon rekonstitucije ovaj lijek sadrži do otprilike 1,6 g natrija po dozi (0,9 g/m2 BSA; 3,6 mg po ml), što odgovara 80 % maksimalnog dnevnog unosa od 2 g natrija prema preporukama Svjetske zdravstvene organizacije (SZO) za odraslu osobu.
English: Severe reactions, such as hypotension requiring treatment, dyspnoea requiring bronchodilators, angioedema or generalised urticaria require immediate discontinuation of paclitaxel and initiation of symptomatic treatment.
Croatian: U slučaju teških reakcija, kao što su hipotenzija koju je potrebno liječiti, dispneja koja zahtijeva primjenu bronhodilatatora, angioedem ili generalizirana urtikarija, potrebno je odmah prekinuti primjenu paklitaksela i započeti simptomatsko liječenje.
English: It should not be interchanged with other paclitaxel formulations.
Croatian: Ne smije se zamijeniti drugim formulacijama paklitaksela.
English: Neutropenia as a serious adverse reaction occurred in 29% of the patients and febrile neutropenia occurred in 3% of the patients.
Croatian: Neutropenija kao ozbiljna nuspojava pojavila se u 29 % bolesnika, a febrilna neutropenija pojavila se u 3 % bolesnika.
English: Apealea is not recommended during pregnancy, as paclitaxel may cause serious birth defects.
Croatian: Primjena lijeka Apealea ne preporučuje se tijekom trudnoće jer paklitaksel može uzrokovati teške urođene mane.
English: Compatibility with administration sets made of DEHP-free PVC (i.e. polyvinyl chloride without the plasticizer di-(2-ethylhexyl) phthalate) has been demonstrated.
Croatian: Dokazana je kompatibilnost sa setovima za primjenu od PVC-a bez DEHP-a (tj. od polivinilklorida koji ne sadrži plastifikator di-(2-etilheksil)ftalat).
English: • brain damage, abnormal fluid accumulation within the brain
Croatian: • oštećenje mozga, abnormalno nakupljanje tekućine u mozgu
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C to 8 °C in lactated and acetated Ringer's solution and for 4 hours at 2 °C to 8 °C in sodium chloride 9 mg/mL (0.9%) solution when protected from light.
Croatian: Kemijska i fizikalna stabilnost u primjeni dokazana je za razdoblje od 24 sata pri temperaturi od 2 °C do 8 °C u otopini Ringerova laktata ili Ringerova acetata te za razdoblje od 4 sata pri temperaturi od 2 °C do 8 °C u 0,9 %-tnoj (9 mg/ml) otopini natrijeva klorida, uz zaštitu od svjetlosti.
English: Apealea should be reconstituted using either one of the three suitable solutions for reconstitution and according to the following steps:
Croatian: Lijek Apealea potrebno je rekonstituirati s jednom od tri prikladne otopine za rekonstituciju te prema sljedećim koracima:
English: The corresponding median number of cycles (min;max) for the two groups were 6 (1;12) and 6 (1;9), respectively.
Croatian: Medijan broja ciklusa (min; maks) u prvoj skupini bio je 6 (1; 12), a u drugoj 6 (1; 9).
English: • swelling of ankles, feet, face or fingers
Croatian: • oticanje zglobova, stopala, lica ili prstiju.
English: Continue to swirl the vial until the powder is completely dissolved.
Croatian: Nastavite kružnim pokretima miješati otopinu u bočici sve dok se prašak potpuno ne otopi.
English: After reconstitution, this medicine contains approximately up to 1.6 g sodium (component of cooking salt) per dose.
Croatian: Nakon rekonstitucije ovaj lijek sadrži do otprilike 1,6 g natrija (glavni sastojak kuhinjske soli) po dozi.
English: Paclitaxel has been shown in vitro to be a substrate for the influx transporter proteins OATP1B3 and OATP1A2.
Croatian: Paklitaksel se in vitro pokazao kao supstrat proteinskih prijenosnika za unos OATP1B3 i OATP1A2.
English: The formation of these metabolites is catalysed by CYP2C8 and CYP3A4.
Croatian: Stvaranje tih metabolita katalizirano je pomoću CYP2C8 i CYP3A4.
English: There are no reports of active substances able to displace protein-bound paclitaxel, nor is paclitaxel a likely candidate as a displacer of other active substances given its low molar concentrations in plasma.
Croatian: Nema prijavljenih djelatnih tvari koje mogu istisnuti paklitaksel koji je vezan na protein niti je vjerojatno da bi paklitaksel mogao istisnuti druge djelatne tvari s obzirom na njegove niske molarne koncentracije u plazmi.
English: The powder should be greenish-yellow to yellow.
Croatian: Prašak treba biti zelenožute do žute boje.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanjima provedenima na životinjama utvrđena je reproduktivna toksičnost (vidjeti dio 5.3).
English: • herpes simplex (a viral infection), viral airways infections
Croatian: • herpes simplex (virusna infekcija), virusne infekcije dišnih putova
English: Alopecia is a very common adverse reaction and occurs early in treatment.
Croatian: Alopecija je vrlo česta nuspojava i javlja se u ranoj fazi liječenja.
English: Patients who experience severe pain or other reactions to the infusion of Apealea are recommended to be considered for a central venous catheter.
Croatian: U bolesnika koji osjećaju jaku bol ili imaju druge reakcije na infuziju lijeka Apealea preporučuje se razmatranje centralnog venskog katetera.
English: On average, the paclitaxel elimination rate was 20% higher in males compared to in females.
Croatian: Brzina eliminacije paklitaksela u muškaraca bila je u prosjeku za 20 % veća nego u žena.
English: Paclitaxel is suspected to cause serious birth defects when administered during pregnancy.
Croatian: Postoji sumnja da paklitaksel uzrokuje ozbiljne urođene mane ako se primjenjuje tijekom trudnoće.
English: Apealea should not be interchanged with other paclitaxel formulations.
Croatian: Apealea se ne smije zamijeniti drugim formulacijama paklitaksela.
English: Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, efavirenz, nevirapine) is not recommended because efficacy may be compromised because of lower paclitaxel exposures.
Croatian: Primjena paklitaksela istodobno s lijekovima za koje je utvrđeno da induciraju CYP2C8 ili CYP3A4 (primjerice rifampicin, karbamazepin, fenitoin, efavirenz, nevirapin) ne preporučuje se jer djelotvornost može biti kompromitirana zbog manje izloženosti paklitakselu.
English: Median time to death or disease progression [months] (95% CI)
Croatian: Medijan vremena do smrti ili progresije bolesti [u mjesecima] (95 % CI)
English: Most of the patients enrolled in the study had ECOG performance status of 0 or 1 (≥ 96%), in similar proportions between the treatment arms.
Croatian: Većina bolesnica koje su sudjelovale u ispitivanju imale su status općeg zdravlja prema ECOG-u 0 ili 1 (≥ 96 %), i to u sličnom omjeru u objema liječenim skupinama.
English: Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Croatian: Prijavljena je i diseminirana intravaskularna koagulacija (DIK), često u vezi sa sepsom ili zatajenjem više organa.
English: Withhold treatment until recovery to < grade 2
Croatian: Obustaviti liječenje do oporavka na < 2. stupanj
English: For patients with total bilirubin > 5 × ULN or AST > 10 × ULN, there are insufficient data to permit dosage recommendations (see sections 4.4 and 5.2).
Croatian: Za bolesnike u kojih je ukupni bilirubin > 5 × GGN ili AST > 10 × GGN nema dovoljno podataka na temelju kojih bi se omogućile preporuke doza (vidjeti dijelove 4.4 i 5.2).
English: Gastrointestinal adverse reactions are very common.
Croatian: Gastrointestinalne nuspojave vrlo su česte.