FrancophonIA/ELRC3.0 huggingface dataset:
English: However, studies in breast cancer patients treated with paclitaxel-containing regimens indicate a possible increased risk of neuropathy in non-Caucasian patients (see section 4.2).
Croatian: Međutim, ispitivanja kojima su obuhvaćeni bolesnici s rakom dojke u kojih je primijenjen režim liječenja koji sadrži paklitaksel upućuju na mogućnost povećanog rizika od neuropatije u bolesnika koji nisu bijele rase (vidjeti dio 4.2.).
English: − nerve disorder in arms and legs which causes tingling, numbness or burning pain*
Croatian: − poremećaj živaca u rukama i nogama koji uzrokuje trnce, utrnulost ili žareću bol.*
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalost nuspojava prikazana je redoslijedom prema sve manjoj ozbiljnosti.
English: Apealea dose for subsequent courses (mg/m2)b
Croatian: Doza lijeka Apealea u sljedećim ciklusima liječenja (mg/m2)b
English: Unopened vials: Store in a refrigerator (2 °C - 8 °C).
Croatian: Neotvorene bočice: Čuvati u hladnjaku (2 °C - 8 °C).
English: There are very limited data on the use of paclitaxel in pregnant women.
Croatian: Podatci o primjeni paklitaksela u trudnica vrlo su ograničeni.
English: For CTCAE grade ≥ 2 sensory or motor neuropathy withhold treatment until resolution to < grade 2, followed by a dose reduction for all subsequent courses (see section 4.2).
Croatian: U slučaju senzorne ili motoričke neuropatije ≥ 2. stupnja prema CTCAE-u potrebno je obustaviti liječenje do oporavka na < 2. stupanj, nakon čega slijedi smanjivanje doze za sve sljedeće cikluse liječenja (vidjeti dio 4.2.).
English: 752 28 Uppsala Sweden
Croatian: 752 28 Uppsala Švedska
English: The risk of myelosuppression is increased due to the combination use with carboplatin.
Croatian: Rizik od mijelosupresije povećan je zbog kombinirane primjene s karboplatinom.
English: Clinically relevant pharmacokinetic interaction has been observed between paclitaxel and cisplatin.
Croatian: Zabilježena je klinički relevantna farmakokinetička interakcija između paklitaksela i cisplatina.
English: * Can persist beyond 6 months of paclitaxel discontinuation.
Croatian: * Može se nastaviti javljati nakon više od šest mjeseci od prekida primjene paklitaksela.
English: Based on the published literature, in vitro studies indicate that the presence of cimetidine, ranitidine, dexamethasone, or diphenhydramine does not affect protein binding of paclitaxel.
Croatian: Na temelju objavljene literature, in vitro ispitivanja pokazuju da prisutnost cimetidina, ranitidina, deksametazona ili difenhidramina ne utječe na vezivanje paklitaksela na proteine.
English: Apealea is for intravenous use.
Croatian: Lijek Apealea namijenjen je za intravensku primjenu.
English: • carbamazepine, phenytoin: medicines to treat epilepsy and certain pain conditions
Croatian: • karbamazepin, fenitoin (lijekovi za liječenje epilepsije i određenih stanja boli)
English: Apealea contains sodium
Croatian: Apealea sadrži natrij
English: Dose adjustments and delays during treatment
Croatian: Prilagodbe doze i odgode primjene doze tijekom liječenja
English: No additional dosage reductions, other than those for all patients, are recommended for patients 65 years and older.
Croatian: Nema preporuka za dodatno smanjenje doza u bolesnika u dobi od 65 i više godina, osim onih koje se odnose na sve bolesnike.
English: In studies with Apealea, 45% of patients reported alopecia during therapy.
Croatian: provedenim ispitivanjima lijeka Apealea 45 % bolesnika prijavilo je pojavu alopecije tijekom liječenja.
English: As a result of the combined treatment, it is not possible to determine whether this observation is due to Apealea or to other factors, and delayed reactions related to paclitaxel cannot be excluded.
Croatian: Zbog kombiniranog liječenja nije moguće utvrditi temelji li se to opažanje na primjeni lijeka Apealea ili na drugim čimbenicima te se ne može se isključiti pojava odgođenih reakcija na paklitaksel.
English: Local reactions at the infusion site are very common during Apealea infusions.
Croatian: Lokalne reakcije na mjestu primjene infuzije vrlo su česte tijekom infuzije lijeka Apealea.
English: Paclitaxel was devoid of mutagenic activity in the Ames test or the Chinese hamster ovary/hypoxanthine-guanine phosphoribosyl transferase (CHO/HGPRT) gene mutation assay.
Croatian: Paklitaksel nije pokazao mutageno djelovanje u Amesovom testu ili testu mutacije gena jajnika kineskog hrčka/hipoksantin-gvanin fosforibozil transferaze (CHO/HGPRT).
English: Based on limited data, Cmax and AUC increased with dose after 1-hour infusions of Apealea in doses ranging from 150 to 275 mg/m2.
Croatian: Na temelju ograničenih podataka, Cmax i AUC povećavaju se s dozom nakon jednosatnih infuzija lijeka Apealea u dozama u rasponu od 150 do 275 mg/m2.
English: No studies have been performed to evaluate drug-drug interactions between Apealea and other medicinal products.
Croatian: Nisu provedena ispitivanja interakcije lijeka Apealea i drugih lijekova.
English: Talk to your doctor or nurse before you are given Apealea if you have:
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego što primite lijek Apealea:
English: In the clinical study, the proportion of patients receiving six treatment cycles was 81% in the group treated with paclitaxel micellar and 87% in the group receiving solvent-based paclitaxel.
Croatian: U okviru kliničkog ispitivanja udio bolesnica koje su primile šest ciklusa liječenja bio je 81 % u skupini liječenoj micelarnim paklitakselom i 87 % u skupini koja je primala paklitaksel u otopini.
English: Breast-feeding (see section 4.6).
Croatian: Dojenje (vidjeti dio 4.6.).
English: Apealea is a cancer medicine containing the active substance paclitaxel, which belongs to a group of medicines called taxanes.
Croatian: Apealea je lijek za liječenje raka koji sadrži djelatnu tvar paklitaksel, koji pripada skupini lijekova naziva taksani.
English: Apealea may cause adverse reactions such as fatigue (very common) and dizziness (common) that may affect the ability to drive or use machinery.
Croatian: Apealea može uzrokovati nuspojave kao što su umor (vrlo često) i omaglica (često), koje mogu utjecati na sposobnost vožnje i rada sa strojevima.
English: Premedication may be considered in patients who have previously experienced gastrointestinal symptoms when being treated with cytotoxic medicinal products.
Croatian: Može se razmotriti premedikacija u bolesnika koji su imali gastrointestinalne simptome pri prethodnom liječenju citotoksičnim lijekovima.
English: SE-752 28 Uppsala Sweden
Croatian: SE-752 28 Uppsala Švedska
English: Peripheral sensory neuropathy represented the most common reaction and was reported in 16% of patients.
Croatian: Najčešća reakcija bila je periferna senzorna neuropatija, koja je prijavljena u 16 % bolesnika.
English: Mutagenesis, carcinogenesis, impairment of fertility
Croatian: Mutageneza, karcinogeneza, smanjenje plodnosti
English: • low level of blood platelets or red blood cells
Croatian: • nizak broj krvnih pločica ili crvenih krvnih stanica
English: For appropriate use of carboplatin, the prescriber is advised to consult the prescribing information for carboplatin as well.
Croatian: Liječnicima koji propisuju lijek savjetuje se da za prikladnu primjenu karboplatina prouče i informacije za propisivanje karboplatina.
English: The frequency of paclitaxel-related hypersensitivity reactions was similar in both groups (5% of the patients receiving paclitaxel micellar and 7% of the patients receiving solvent-based paclitaxel), whereas a higher frequency of carboplatin-related hypersensitivity reactions was observed in the group receiving paclitaxel micellar (12% vs 7%).
Croatian: Učestalost reakcija preosjetljivosti povezanih s paklitakselom bila je slična u obje skupine (u 5 % bolesnika koji su primali micelarni paklitaksel i u 7 % bolesnika koji su primali paklitaksel u otopini), dok je veća učestalost reakcija preosjetljivosti povezanih s karboplatinom zamijećena u skupini koja je primala micelarni paklitaksel (12 % u odnosu na 7 %).
English: • pain for instance in arms, legs, breast or at site of tumour
Croatian: • bol, primjerice u rukama, nogama, prsima ili na mjestu tumora
English: • erythromycin, rifampicin: medicines to treat bacterial infections
Croatian: • eritromicin, rifampicin (lijekovi za liječenje bakterijskih infekcija)
English: Any unused medicine or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti u skladu s nacionalnim propisima.
English: Peripheral neuropathies (including the preferred terms neuropathy peripheral, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, polyneuropathy, and polyneuropathy in malignant disease) were reported in 29% of the patients and were mostly (98%) mild to moderate (CTCAE grade ≤ 2).
Croatian: Oblici periferne neuropatije (uključujući preporučene pojmove kao što su periferna neuropatija, periferna motorička neuropatija, periferna senzomotorna neuropatija, periferna senzorna neuropatija, polineuropatija i polineuropatija u slučaju zloćudne bolesti) prijavljeni su u 29 % bolesnika te su većinom (98 %) bili blagi do umjereni (≤ 2. stupanj prema CTCAE-u).
English: Each vial contains 3.77 mg (0.164 mmol) sodium.
Croatian: Jedna bočica sadrži 3,77 mg (0,164 mmol) natrija.
English: In comparison to the patients receiving solvent-based paclitaxel, there were more patients in the group receiving paclitaxel micellar who experienced haematological toxicities with grade 3 and 4.
Croatian: U usporedbi s bolesnicima koji su primali paklitaksel u otopini, u skupini koja je primala micelarni paklitaksel bilo je više bolesnika koji su imali hematološke toksičnosti 3. i 4. stupnja.
English: Peripheral sensory neuropathy and peripheral neuropathy are very common adverse reactions.
Croatian: Periferna senzorna neuropatija i periferna neuropatija vrlo su česte nuspojave.
English: Premedication was not mandated prior to infusion of paclitaxel micellar.
Croatian: Premedikacija nije bila nužna prije infuzije micelarnog paklitaksela.
English: • regular blood tests to ensure it is safe for you to continue treatment
Croatian: Tijekom liječenja pomno će se nadzirati: • nalazi redovitih krvnih pretraga kako bi se osiguralo da možete sigurno nastaviti s liječenjem
English: The frequency of undesirable effects listed in Table 2 is defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava navedenih u tablici 2 određena je u skladu sa sljedećim pravilima: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i
English: A non-inferiority analysis was conducted for PFS in the per-protocol (PP) population with pre-specified non-inferiority margin.
Croatian: Provedena je analiza neinferiornosti za preživljenje bez progresije bolesti u populaciji po protokolu (engl. per protocol, PP) s prethodno utvrđenom marginom neinferiornosti.
English: After reconstitution, each mL of solution contains up to approximately 3.60 mg (0.157 mmol) sodium.
Croatian: Nakon rekonstitucije jedan ml otopine sadrži do otprilike 3,60 mg (0,157 mmol) natrija.
English: Delayed reactions related to paclitaxel occurring during or after infusion of carboplatin cannot be excluded.
Croatian: Ne može se isključiti pojava odgođenih reakcija na paklitaksel tijekom ili nakon infuzije karboplatina.
English: • cisplatin: a medicine to treat cancer
Croatian: • cisplatin (lijek za liječenje raka).
English: No analysis of the effect of age, gender or body size on the elimination of Apealea has been undertaken.
Croatian: Utjecaj dobi, spola, rase i veličine tijela Nije provedena analiza utjecaja dobi, spola ili veličine tijela na eliminaciju lijeka Apealea.
English: In vitro studies using different cell systems have shown paclitaxel to be clastogenic inducing chromosomal aberrations, micronuclei and DNA damage.
Croatian: U in vitro ispitivanjima na različitim staničnim sustavima dokazano je klastogeno djelovanje paklitaksela, uključujući kromosomske aberacije, mikrojezgre i oštećenja DNK.
English: Apealea should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Croatian: Lijek Apealea smije se primjenjivati samo pod nadzorom kvalificiranog onkologa na odjelima koji su specijalizirani za primjenu citotoksičnih lijekova.
English: Swirl the vial again in upright position for approximately 20 seconds, then gently invert it five times.
Croatian: Ponovno kružnim pokretima miješajte otopinu tijekom približno 20 sekundi držeći bočicu u uspravnom položaju, a zatim je polako okrenite pet puta.
English: Apealea is not recommended for patients with severely reduced liver or kidney function.
Croatian: Primjena lijeka Apealea ne preporučuje se u bolesnika s teškim oblikom smanjene funkcije jetre ili bubrega.
English: Information is lacking for patients with severe renal impairment (GFR < 30 mL/min).
Croatian: Ne postoje informacije o bolesnicima s teškim oštećenjem funkcije bubrega (GFR < 30 ml/min).
English: − allergic reactions, such as breathing difficulties, fainting, swelling of the face, itching, feeling hot, chills, particularly during your infusion.
Croatian: − alergijske reakcije kao što su teškoće s disanjem, nesvjestica, oticanje lica, svrbež, osjećaj vrućine, zimica, osobito tijekom infuzije.
English: Studies in animals being treated with paclitaxel have shown decreased fertility (see section 5.3).
Croatian: U ispitivanjima na životinjama koje su liječene paklitakselom dokazana je smanjena plodnost (vidjeti dio 5.3).
English: Apealea should be administered first, then carboplatin.
Croatian: Najprije je potrebno primijeniti lijek Apealea, a zatim karboplatin.
English: Most hypersensitivity reactions related to Apealea are mild to moderate and mainly occur as skin and subcutaneous tissue disorders, general disorders and administration site conditions, but serious hypersensitivity reactions including anaphylactic shock have been reported.
Croatian: Većina reakcija preosjetljivosti povezanih s primjenom lijeka Apealea blage su do umjerene i uglavnom se javljaju kao poremećaji kože i potkožnog tkiva, opći poremećaji i reakcije na mjestu primjene, no prijavljene su i ozbiljne reakcije preosjetljivosti, uključujući anafilaktički šok.
English: The pharmacokinetics of paclitaxel were studied in 22 patients with solid tumours after 1-hour infusions of Apealea (dose levels of 90 to 275 mg/m2).
Croatian: Farmakokinetička svojstva paklitaksela ispitivana su u 22 bolesnika sa solidnim tumorima nakon jednosatne infuzije lijeka Apealea (razine doze od 90 do 275 mg/m2).
English: Treatment should be directed at the major anticipated toxicities, which are nausea, vomiting, diarrhoea, myelosuppression, peripheral sensory neuropathy and peripheral neuropathy.
Croatian: Liječenje je potrebno usmjeriti na glavne očekivane toksičnosti, a one su mučnina, povraćanje, proljev, mijelosupresija, periferna senzorna neuropatija i periferna neuropatija.
English: Pack size: 1 vial.
Croatian: Veličina pakiranja: 1 bočica.
English: Table 2 lists adverse reactions associated with the administration of Apealea in combination with carboplatin observed in a clinical study (N = 391) and adverse reactions from post-marketing experience.
Croatian: U tablici 2. navedene su nuspojave povezane s primjenom lijeka Apealea u kombinaciji s karboplatinom zabilježene u kliničkom ispitivanju (N = 391) i nuspojave zabilježene nakon stavljanja lijeka u promet.
English: Probability of progression-free survival
Croatian: Vjerojatnost preživljenja bez progresije bolesti
English: Overall, there were higher rates of serious adverse events with paclitaxel micellar (41%) than with solvent-based paclitaxel (27%).
Croatian: Općenito gledajući, zabilježena je viša stopa ozbiljnih štetnih događaja prilikom primjene micelarnog paklitaksela (41 %) u odnosu na primjenu paklitaksela u otopini (27 %).
English: This was in agreement with the mean fu after albumin-bound paclitaxel infusion which varied between 5.5% and 4.5% over time.
Croatian: To je bilo u skladu sa srednjom vrijednošću udjela nevezanog paklitaksela nakon infuzije paklitaksela vezanog na albumin, koja se tijekom vremena kretala između 5,5 % i 4,5 %.
English: Patients treated with paclitaxel and cisplatin may have an increased risk of renal failure as compared to cisplatin alone in gynaecological cancers.
Croatian: U bolesnika koji se liječe paklitakselom i cisplatinom moguć je povećan rizik od zatajenja bubrega, u usporedbi s monoterapijom cisplatinom u slučaju raka organa ginekološkog sustava.
English: PFS and OS results in the PP population are summarised in Figures 3 and 4.
Croatian: Rezultati za preživljenje bez progresije bolesti i ukupno preživljenje u PP populaciji sažeto su prikazani u slikama 3 i 4.
English: To avoid accidental administration into the surrounding tissue and to ensure intravenous delivery of the complete dose, flush the infusion set and catheter/cannula before as well as after the administration.
Croatian: Kako bi se izbjegla slučajna primjena u okolno tkivo i osigurala intravenska primjena cijele doze, potrebno je isprati set za infuziju i kateter/kanilu prije i nakon primjene.
English: Apealea is indicated to be used in combination with carboplatin (see section 4.1).
Croatian: Lijek Apealea indiciran je za primjenu u kombinaciji s karboplatinom (vidjeti dio 4.1).
English: • reduced sense of touch or sensation
Croatian: • smanjenje osjećaja dodira ili osjeta,
English: There is no relevant use of paclitaxel in the paediatric population for the indications of epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
Croatian: Nema relevantne primjene paklitaksela u pedijatrijskoj populaciji za indikacije epitelnog raka jajnika, primarnog raka peritoneuma i raka jajovoda.
English: • low level of white blood cells called neutrophils
Croatian: • niska razina bijelih krvnih stanica naziva neutrofili
English: The major route of excretion of paclitaxel-derived material in humans is the faeces, where 6α-hydroxypaclitaxel constitutes the main material.
Croatian: Glavni način izlučivanja tvari koje potječu od paklitaksela u ljudi jest putem fecesa, a 6α-hidroksipaklitaksel je glavna tvar.
English: • taste disturbance
Croatian: • poremećaj okusa
English: Dose reductions or/and delays should be considered as a result of any clinically significant adverse reaction as presented in Table 1.
Croatian: Potrebno je razmotriti smanjenje doze ili odgodu primjene doze u slučaju bilo koje od klinički značajnih nuspojava koje su prikazane u tablici 1.
English: Package leaflet: Information for the user Apealea 60 mg powder for solution for infusion paclitaxel
Croatian: Uputa o lijeku: Informacije za korisnika Apealea 60 mg prašak za otopinu za infuziju paklitaksel
English: Patients that have total bilirubin > 5 × ULN or AST > 10 × ULN should not be treated with paclitaxel.
Croatian: Bolesnike kod kojih je ukupni bilirubin > 5 × GGN ili AST > 10 × GGN ne smije se liječiti paklitakselom.
English: The usual dose is 250 mg/m2 body surface area given every three weeks for up to six treatments.
Croatian: Uobičajena je doza 250 mg/m2 tjelesne površine svaka tri tjedna tijekom najviše šest ciklusa liječenja.
English: Patients Events
Croatian: Bolesnice Događaji
English: The terminal half-life of paclitaxel after Apealea infusion varied about 5-fold between the subjects, 5-23 hours.
Croatian: Vrijednost terminalnog poluvijeka paklitaksela nakon infuzije lijeka Apealea razlikovala se između bolesnika za otprilike pet puta, od 5 do 23 sata.
English: Patients received premedication prior to infusion of solvent-based paclitaxel, paclitaxel micellar and carboplatin as summarised in Table 3 below.
Croatian: Bolesnice su primile premedikaciju prije infuzije paklitaksela u otopini, micelarnog paklitaksela i karboplatina, kako je sažeto navedeno u tablici 3. u nastavku.
English: The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4 (see section 5.2).
Croatian: Paklitaksel se metabolizira djelomično izoenzimima citokroma P450 CYP2C8 i CYP3A4 (vidjeti dio 5.2.).
English: Pharmacokinetic data for patients with total bilirubin > 5 × ULN are not available.
Croatian: Nisu dostupni podatci o farmakokinetici u bolesnika s ukupnim bilirubinom > 5 × GGN.
English: Delay of next cycle Apealea/carboplatin
Croatian: Odgoda sljedećeg ciklusa lijeka Apealea/karboplatina
English: When solvent-based paclitaxel was given after cisplatin, patients showed a more profound myelosuppression and an approximately 20% decrease in paclitaxel clearance.
Croatian: Kada se paklitaksel u otopini primjenjivao nakon cisplatina, u bolesnika je zabilježena snažnija mijelosupresija i smanjenje klirensa paklitaksela od otprilike 20 %.
English: • abnormally high levels of nitrogen-containing compounds in the blood
Croatian: • neuobičajeno visoke razine spojeva koji sadrže dušik u krvi.
English: General disorders and administration site conditions Asthenia and fatigue were very common and occurred in 23% and 11% of patients, respectively.
Croatian: Opći poremećaji i reakcije na mjestu primjene Astenija i iscrpljenost bile su vrlo česte, a pojavile su se u 23 % odnosno 11 % bolesnika.
English: There are limited data of Apealea in non-Caucasian patients and current data is insufficient to recommend additional dose adjustments (see section 4.4).
Croatian: Podatci o primjeni lijeka Apealea u bolesnika koji nisu bijele rase ograničeni su, a postojeći podatci nisu dovoljni da bi se preporučile dodatne prilagodbe doze (vidjeti dio 4.4.).
English: Possible dose reductions:
Croatian: Moguća smanjenja doze:
English: Administration sets containing a 15 µm polyamide fluid filter should be used.
Croatian: Potrebno je upotrebljavati setove za primjenu otopine koji sadrže poliamidni filter za tekućinu veličine otvora 15 µm.
English: • low blood pressure, flushing, vein inflammation, vein pain, increased blood flow to some parts of the body
Croatian: • nizak krvni tlak, naleti crvenila, upala vena, bol u veni, povećanje protoka krvi u nekim dijelovima tijela
English: • severe lack of oxygen, arising from abnormal breathing
Croatian: • težak nedostatak kisika uzrokovan poremećenim disanjem
English: • fluoxetine: a medicine to treat depression
Croatian: • fluoksetin (lijek za liječenje depresije)
English: Based on the combined data from monotherapy studies, very common adverse reactions and those of special interest were the following: neutropenia (45%), fatigue (37%), leukopenia (33%), alopecia (30%), nausea (27%), infusion site reactiona (23%), peripheral sensory neuropathy (20%), diarrhoea (17%), asthenia (15%), pyrexia (12%), constipation (12%), arthralgia (12%), paraesthesia (11%), pain (11%), vomiting (9%), myalgia (9%), peripheral motor neuropathy (5%), neuropathy (5%), neuropathy peripheral (5%), thrombocytopenia (4%), febrile neutropenia (2%), sepsis (2%), tachycardia (2%), phlebitis (2%), thrombosis (2%).
Croatian: Na temelju kombiniranih podataka iz ispitivanja primjene monoterapije, vrlo česte nuspojave i nuspojave od posebnog interesa bile su sljedeće: neutropenija (45 %), umor (37 %), leukopenija (33 %), alopecija (30 %), mučnina (27 %), reakcije na mjestu primjene infuzijea (23 %), periferna senzorna neuropatija (20 %), proljev (17 %), astenija (15 %), pireksija (12 %), konstipacija (12 %), artralgija (12 %),
English: • indigestion, disorder of bowel function, very hard stools, bloody stool
Croatian: • žgaravica, poremećaj funkcije crijeva, vrlo tvrde stolice, krvava stolica
English: − bleeding
Croatian: − krvarenje