FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you are given Apealea Do not use Apealea if you:
Croatian: Što morate znati prije nego počnete primati lijek Apealea
English: For patients with moderate to severe impairment (total bilirubin > 1.5 to ≤ 5 × ULN and AST ≤ 10 × ULN), a 20% reduction in dose is recommended.
Croatian: U slučaju bolesnika koji imaju umjereno do teško oštećenje funkcije jetre (ukupni bilirubin od > 1,5 do ≤ 5 × GGN i AST ≤ 10 × GGN) preporučuje se smanjenje doze za 20 %.
English: Patients who can become pregnant should use effective contraception during treatment with Apealea and for six months afterwards.
Croatian: Bolesnice u reproduktivnoj dobi trebaju koristiti učinkovitu kontracepciju tijekom liječenja i šest mjeseci nakon prestanka liječenja lijekom Apealea.
English: The infusion site reactions observed include pain, phlebitis, discolouration, redness, oedema and rash.
Croatian: Zabilježene reakcije na mjestu primjene infuzije jesu bol, flebitis, diskoloracija kože, crvenilo, edem i osip.
English: Protect from direct and/or bright light throughout the preparation process.
Croatian: Tijekom postupka pripreme zaštitite otopinu od izravne ili jake svjetlosti.
English: Paclitaxel is distributed equally between plasma and blood as described in published in vitro data.
Croatian: Kako je opisano u objavljenim in vitro podatcima, paklitaksel se jednako distribuira u plazmi i krvi.
English: The plasma levels of unbound paclitaxel, i.e. the concentration that represents pharmacologically active paclitaxel in the body, were demonstrated to be bioequivalent (Cmax and AUC) after administration of albumin-bound paclitaxel and Apealea.
Croatian: Nakon primjene paklitaksela vezanog na albumin i lijeka Apealea dokazano je da su plazmatske razine nevezanog paklitaksela, tj. koncentracija koja predstavlja farmakološki aktivan paklitaksel u tijelu, bioekvivalentne (Cmax i AUC).
English: • clopidogrel: a medicine that reduces the chances of getting blood clots
Croatian: • klopidogrel (lijek za smanjenje rizika od nastanka krvnih ugrušaka)
English: Care should be taken to avoid accidental administration into the surrounding tissue during intravenous administration.
Croatian: Tijekom intravenske primjene potrebno je pripaziti kako bi se izbjegla slučajna primjena u okolno tkivo.
English: In the ITT population, the hazard ratios for PFS in the subgroups of patients with first relapse and second relapse were 0.80 (95% CI: 0.66;0.97) and 1.04 (95% CI: 0.74;1.47), respectively.
Croatian: U ITT populaciji, omjer hazarda za preživljenje bez progresije bolesti u podskupini bolesnica s prvim relapsom iznosio je 0,80 (95 % CI: 0,66; 0,97), a u podskupini s drugim relapsom iznosio je 1,04 (95 % CI: 0,74; 1,47).
English: There were more reports of infusion site pain in the group receiving paclitaxel micellar as compared to the group treated with solvent-based paclitaxel (8% and 1%, respectively).
Croatian: Zabilježen je veći broj prijava boli na mjestu primjene infuzije u skupini koja je primala micelarni paklitaksel (8 %), u usporedbi sa skupinom koja je liječena paklitakselom u otopini (1 %).
English: Patients were treated every three weeks for six cycles, either with Apealea 250 mg/m2 given as a 1-hour intravenous infusion (N = 391) or with solvent-based paclitaxel 175 mg/m2 given as a 3-hour infusion (N = 391).
Croatian: Apealea u dozi od 250 mg/m2 koja se davala kao intravenska infuzija tijekom jednog sata (N = 391) ili primjenom paklitaksela u otopini u dozi od 175 mg/m2 koja se davala kao infuzija tijekom tri sata (N = 391).
English: Abdominal pain, constipation, abdominal pain upper, flatulence, dry mouth, stomatitis
Croatian: abdominalna bol, konstipacija, bol u gornjem dijelu abdomena, flatulencija, suha usta, stomatitis
English: • vaginal bleeding
Croatian: • vaginalno krvarenje
English: The hazard ratios for OS in patients with first and second relapse were 0.98 (95% CI: 0.79;1.21) and 1.18 (95% CI: 0.79;1.75), respectively.
Croatian: Omjer hazarda za ukupno preživljenje u bolesnica s prvim relapsom iznosio je 0,98 (95 % CI: 0,79; 1,21), a u bolesnica s drugim relapsom iznosio je 1,18 (95 % CI: 0,79; 1,75).
English: Intravenous administration
Croatian: Intravenska primjena
English: Renal excretion accounts for a minor part, less than 15% of the dose.
Croatian: Manji dio, manje od 15 % doze, uklanja se bubrežnim izlučivanjem.
English: Other associated reactions were reported in 10% of the patients and were mostly (98%) mild to moderate (CTCAE grade ≤ 2).
Croatian: bolesnika te su uglavnom (98 %) bile blage do umjerene (≤ 2. stupanj prema CTCAE-u).
English: In the absence of in vivo studies addressing inhibition of CYP2B6 and CYP2C9, the concomitant use of Apealea and substances metabolised primarily by these CYP enzymes should be exercised with caution.
Croatian: CYP2C9, potrebno je oprezno postupati pri istodobnoj primjeni lijeka Apealea i tvari koje se primarno metaboliziraju putem tih CYP enzima.
English: • blurred vision, eye discomfort or irritation, watery eyes
Croatian: • zamućen vid, nelagoda u oku ili iritacija oka, suzne oči
English: If patients experience nausea, vomiting and diarrhoea following the administration of Apealea, they may be treated with antiemetics and/or antidiarrhoeal agents.
Croatian: Ako nakon primjene lijeka Apealea bolesnici osjećaju mučninu, povraćaju i imaju proljev, može ih se liječiti antiemeticima ili lijekovima protiv proljeva.
English: • efavirenz, nevirapine, ritonavir, saquinavir, indinavir, nelfinavir: medicines to treat HIV
Croatian: • cimetidin (lijek za smanjenje želučane kiseline) • efavirenz, nevirapin, ritonavir, sakvinavir, indinavir, nelfinavir (lijekovi za liječenje infekcije
English: b Can persist beyond 6 months of paclitaxel discontinuation.c c As reported in the post-marketing surveillance of paclitaxel.
Croatian: b Može se nastaviti javljati nakon više od šest mjeseci od prekida primjene paklitaksela.c
English: Paclitaxel (solvent-based)
Croatian: Paklitaksel (u otopini)
English: • low muscle tone, facial palsy
Croatian: • smanjen tonus mišića, paraliza lica
English: If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Croatian: Ako otopina dođe u dodir sa sluznicom, sluznicu je potrebno temeljito isprati vodom.
English: Patients should not be treated with subsequent cycles until neutrophils recover to ≥ 1.5 × 109/L and platelets recover to ≥ 100 × 109/L.
Croatian: Bolesnike se ne smije nastaviti liječiti sljedećim ciklusima primjene lijeka sve dok broj neutrofila ne poraste na ≥ 1,5 × 109/l, a broj trombocita na ≥ 100 × 109/l.
English: b The dose of carboplatin should be reduced by 1 AUC unit for treatment cycles following the occurrence of febrile neutropenia or low platelet count (< 75 × 109/L).
Croatian: b Dozu karboplatina u ciklusima liječenja nakon pojave febrilne neutropenije ili niskog broja trombocita (< 75 × 109/l) treba smanjiti za 1 AUC.
English: • skin inflammation with blisters
Croatian: • upala kože s plikovima
English: • lung inflammation, influenza, tonsil inflammation
Croatian: • upala pluća, gripa, upala krajnika
English: Administration in patients with hepatic impairment defined as total bilirubin > 1 to ≤ 5 × ULN and AST ≤ 10 × ULN (see section 4.2) should therefore be performed with caution and they should be closely monitored with regard to increased liver impairment and myelosuppression.
Croatian: Stoga je potreban oprez prilikom primjene lijeka u bolesnika s oštećenjem funkcije jetre koja je određena kao ukupni bilirubin od > 1 do ≤ 5 × GGN i AST ≤ 10 × GGN (vidjeti dio 4.2), a bolesnika treba pomno pratiti u pogledu povećanog oštećenja funkcije jetre i mijelosupresije.
English: In particular, tell your doctor or nurse before you are given Apealea if you are using:
Croatian: Prije uzimanja lijeka Apealea osobito recite svom liječniku ili medicinskoj sestri ako primjenjujete:
English: • diarrhoea, nausea, vomiting
Croatian: • proljev, mučnina, povraćanje
English: Infections and infestations Uncommon: Sepsis, abscess, pneumonia, influenza, respiratory tract infection viral, herpes simplex, infusion site cellulitis, tonsillitis, urinary tract infection, skin infection, cystitis
Croatian: Manje često: sepsa, apsces, pneumonija, gripa, virusna infekcija respiratornog trakta, herpes simplex, celulitis na mjestu primjene infuzije, tonzilitis, infekcija mokraćnog sustava, infekcija kože, cistitis
English: Therefore, frequent complete blood cell counts should be performed during treatment with Apealea.
Croatian: Stoga tijekom liječenja lijekom Apealea treba često kontrolirati kompletnu krvnu sliku.
English: Overall Paclitaxel Carboplatin Overall Paclitaxel Carboplatin
Croatian: Vrsta premedikacije Ukupno Paklitaksel Karboplatin Ukupno Paklitaksel Karboplatin Kortikosteroidi
English: After preparation, each millilitre of solution contains 1 mg of paclitaxel (micellar).
Croatian: Nakon pripreme lijeka jedan mililitar otopine sadrži 1 mg paklitaksela (micelarni paklitaksel).
English: A population pharmacokinetics study with albumin-bound paclitaxel demonstrated that patients with mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 × ULN) have an elimination rate in the normal range.
Croatian: U ispitivanju populacijske farmakokinetike pri primjeni paklitaksela vezanog na albumin dokazano je da je brzina eliminacije u bolesnika s blagim oštećenjem funkcije jetre (ukupni bilirubin od > 1 do ≤ 1,5 × GGN) u normalnom rasponu.
English: • severe reactions at the site of infusion
Croatian: • teške reakcije na mjestu primjene infuzije • alergijska reakcija
English: Other metabolites are 3'-p-hydroxypaclitaxel and 6α,3'-p-dihydroxypaclitaxel.
Croatian: Drugi su metaboliti 3'-p-hidroksipaklitaksel i
English: In the intention-to-treat (ITT) population (n = 789), the hazard ratios for PFS and OS were 0.85 (95% CI: 0.72;1.00) and 1.02 (95% CI: 0.85;1.22), respectively.
Croatian: U populaciji bolesnica predviđenih za liječenje (engl. intentionto-treat, ITT) (n = 789) omjer hazarda za preživljenje bez progresije bolesti iznosio je 0,85 (95 % CI: 0,72; 1,00), a za ukupno preživljenje 1,02 (95 % CI: 0,85; 1,22).
English: • low blood levels of potassium, magnesium or sodium
Croatian: • niske razine kalija, magnezija ili natrija u krvi
English: Dose reduction:
Croatian: Smanjenje doze:
English: Oedema peripheral, pain, pyrexia, chest discomfort, hyperthermia, face oedema
Croatian: periferni edem, bol, pireksija, nelagoda u prsima, hipertermija, edem lica
English: Non-inferiority analyses on PFS and OS in a randomised trial in patients with recurrent epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (PP population)a
Croatian: Tablica 4. Analize neinferiornosti za preživljenje bez progresije bolesti i ukupno preživljenje u randomiziranom ispitivanju u bolesnica s recidivirajućim epitelnim rakom jajnika, primarnim rakom peritoneuma i rakom jajovoda (PP populacija)a
English: If particles, precipitates, discolouration (orange) or opalescence are observed, the solution should be discarded.
Croatian: talog, promjena boje (narančasta) ili opalescencija, otopinu treba baciti.
English: However, a population pharmacokinetics study of 168 patients (86 males and 82 females) treated with solvent-based paclitaxel has been reported.
Croatian: zabilježeno je ispitivanje populacijske farmakokinetike kojim je obuhvaćeno 168 bolesnika
English: • coma, feeling very sleepy, drowsy and/or being deeply unresponsive
Croatian: • koma, snažan osjećaj pospanosti, omamljenosti ili naglašen izostanak reakcije na podražaje
English: Musculoskeletal and connective tissue disorders Arthralgia occurred in 19% of patients and myalgia in 10%.
Croatian: Artralgija se pojavila u 19 % bolesnika, a mijalgija u 10 % bolesnika.
English: Frequency not known (cannot be estimated from the available data):
Croatian: < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Neoplasms benign, malignant and unspecified (incl.
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine
English: • increased sweating, cold sweat
Croatian: • pojačano znojenje, hladan znoj • suha koža, poremećaj noktiju
English: Hypotension, flushing, phlebitis, vein pain, hyperaemia
Croatian: hipotenzija, crvenilo, flebitis, bol u veni, hiperemija
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE
English: See leaflet for further information.
Croatian: Dodatne informacije potražite u uputi o lijeku.
English: Reconstitution of the medicinal product
Croatian: Rekonstitucija lijeka
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba):
English: Immune system disorders Common:
Croatian: Poremećaji imunosnog sustava
English: Swirl the vial in an upright position for approximately for 20 seconds.
Croatian: Držeći bočicu u uspravnom položaju 20 sekundi miješajte otopinu kružnim pokretima.
English: Figure 3.
Croatian: PRILOG III.
English: After reconstitution, each mL of solution contains 1 mg of paclitaxel (micellar).
Croatian: Nakon rekonstitucije jedan ml otopine sadrži 1 mg paklitaksela (micelarni paklitaksel).
English: − sodium hydroxide (for pH adjustment) See section 2 “Apealea contains sodium”.
Croatian: Vidjeti dio 2. „Apealea sadrži natrij”.
English: • nosebleed, allergic inflammation inside the nose, runny nose
Croatian: • krvarenje iz nosa, alergijske upale u nosu, hunjavica • kašalj
English: Anaemia as serious adverse event occurred in 5% of the patients, thrombocytopenia and leukopenia in 3% and 6% of the patients, respectively.
Croatian: Anemija kao ozbiljan štetan događaj pojavila se u 5 % bolesnika, trombocitopenija u
English: Uncommon: Circulatory collapse, venous thrombosis, vasculitis, thrombosis, hypertension, deep vein thrombosis, lymphoedema, phlebitis superficial, thrombophlebitis, blood pressure fluctuation, haemorrhage, angiopathy, hot flush, pallor
Croatian: Manje često: cirkulatorni kolaps, venska tromboza, vaskulitis, tromboza, hipertenzija, tromboza dubokih vena, limfedem, površinski flebitis, tromboflebitis, fluktuacija krvnog tlaka, krvarenje, angiopatija,
English: Excipients: N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt, N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt, sodium hydroxide.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: Natrijeva sol metil estera N-(sav-trans-retinoil)-L-cisteinske kiseline, natrijeva sol metil estera N-(13-cis-retinoil)-L-cisteinske kiseline, natrijev hidroksid.
English: Uncommon: Haemarthrosis, musculoskeletal discomfort, sensation of heaviness
Croatian: Manje često: hemartroza, mišićno-koštana nelagoda, osjećaj težine
English: No clinical studies in patients with hepatic impairment have been undertaken with Apealea (see sections 4.2 and 4.4).
Croatian: Oštećenje funkcije jetre Nisu provedena klinička ispitivanja lijeka Apealea u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.2 i 4.4).
English: Nausea (38%), vomiting (22%) and diarrhoea (15%) were among the most commonly reported adverse reactions in the study.
Croatian: Poremećaji probavnog sustava Najčešće nuspojave zabilježene u okviru ispitivanja bile su mučnina (38 %), povraćanje (22 %) i proljev (15 %).
English: Nervous system disorders grade ≥ 2 peripheral sensory neuropathy or grade ≥ 2 motor neuropathy
Croatian: ≥ 2. stupnja ili motorička neuropatija ≥ 2.
English: • reactions at the infusion site such as pain, inflammation, discolouration, redness, swelling,
Croatian: • reakcije na mjestu primjene infuzije kao što su bol, upala, promjena boje, crvenilo, oteklina, trnci, osip, krvarenje.
English: Each carton contains 1 glass vial with powder equivalent to 60 mg of paclitaxel.
Croatian: Jedna kutija sadrži 1 staklenu bočicu s količinom praška koja odgovara 60 mg paklitaksela.
English: Patients with severe renal impairment (GFR < 30 mL/min) should not be treated with paclitaxel (see section 5.2).
Croatian: Bolesnike s teškim oštećenjem funkcije bubrega (GFR < 30 ml/min) ne smije se liječiti paklitakselom
English: Apealea has been given as monotherapy in a total of 132 patients at doses ranging between 90 mg/m2 in a 3-week regimen to weekly doses of 250 mg/m2 for various indications.
Croatian: Lijek Apealea primijenjen je kao monoterapija u ukupno 132 bolesnika u rasponu doza od 90 mg/m2
English: a Includes the following preferred terms: infusion site phlebitis, infusion site pain, injection site reaction, injection site inflammation, infusion site erythema, injection site extravasation, infusion site reaction, injection site oedema.
Croatian: a Uključuje sljedeće preporučene pojmove: flebitis na mjestu primjene infuzije, bol na mjestu primjene infuzije, reakcija na mjestu injiciranja, upala na mjestu injiciranja, eritem na mjestu primjene infuzije, ekstravazacija na mjestu injiciranja, reakcija na mjestu primjene infuzije, edem na mjestu injiciranja.
English: • pus in body tissue
Croatian: • nakupljanje gnoja u tkivu
English: Q3W 175 mg/m2 + carboplatin (N = 333)
Croatian: Paklitaksel u otopini svaka 3 tjedna 175 mg/m2 + karboplatin (N = 333)
English: d Includes the following preferred terms: infusion site pain, infusion site phlebitis, infusion site reaction, infusion site discolouration, infusion site erythema, infusion site extravasation, infusion site inflammation, infusion site oedema, infusion site paraesthesia, infusion site irritation, and infusion site rash.
Croatian: d Obuhvaća sljedeće preporučene pojmove: bol na mjestu primjene infuzije, flebitis na mjestu primjene infuzije, reakcija na mjestu primjene infuzije, diskoloracija na mjestu primjene infuzije, eritem na mjestu primjene infuzije, ekstravazacija na mjestu primjene infuzije, upala na mjestu primjene infuzije, edem na mjestu primjene infuzije, parestezija na mjestu primjene infuzije, nadraženost na mjestu primjene infuzije i osip na mjestu primjene infuzije.
English: In the pivotal clinical study, patients were either treated with Apealea (paclitaxel micellar) at a dose of 250 mg/m2 in combination with carboplatin or with solvent-based paclitaxel at a dose of 175 mg/m2 in combination with carboplatin (N = 391 in each arm).
Croatian: U okviru ključnog kliničkog ispitivanja bolesnici su liječeni dozom lijeka Apealea (micelarni paklitaksel) od 250 mg/m2 u kombinaciji s karboplatinom ili dozom paklitaksela u otopini od
English: Thereby, non-inferiority was shown in the ITT population for PFS, but not for OS. At the time of analysis of the OS data, death had occurred in 56% of the patients in the group treated with paclitaxel micellar compared to 60% in the group treated with solvent-based paclitaxel (ITT population).
Croatian: U vrijeme analize podataka o ukupnom preživljenju, došlo je do smrti 56 % bolesnica liječenih micelarnim paklitakselom, u usporedbi sa 60 % u skupini liječenoj paklitakselom u otopini
English: Listing of adverse reactions System Organ Class
Croatian: Tablica 2. Popis nuspojava Klasifikacija organskih sustava
English: Uncommon: Hyponatraemia, hypokalaemia, hypomagnesaemia,
Croatian: Manje često: hiponatrijemija, hipokalemija, hipomagnezijemija, dehidracija, smanjeni apetit
English: − formation of blood clots
Croatian: − stvaranje krvnih ugrušaka − upala krvnih žila
English: Apealea is given to you by a doctor or nurse by a slow drip (infusion) into a vein.
Croatian: Liječnik ili medicinska sestra primjenjuju lijek Apealea kao sporu intravensku infuziju (drip).
English: infection
Croatian: anoreksija
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: Fertility
Croatian: tinitus
English: Read the package leaflet before use.
Croatian: NAČIN I PUT(EVI) PRIMJENE Prije uporabe pročitajte uputu o lijeku.
English: • inflammation of the stomach lining, abdominal discomfort or bloating, lower abdominal pain
Croatian: • upala želučane ovojnice, nelagoda ili nadutost u trbuhu, bol u donjem dijelu trbuha
English: Pronounced hair loss of ≥ 50% is expected for the majority of patients who experience alopecia.
Croatian: očekuje se u većini bolesnika u kojih se pojavi alopecija.
English: Talk to your doctor or nurse, if you are not sure if any of the above applies to you.
Croatian: Odmah razgovarajte sa svojim liječnikom ili medicinskom sestrom ako primijetite bilo što od sljedećeg:
English: N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt Sodium hydroxide (for pH adjustment)
Croatian: Natrijeva sol metil estera N-(sav-trans-retinoil)-L-cisteinske kiseline Natrijeva sol metil estera N-(13-cis-retinoil)-L-cisteinske kiseline natrijev hidroksid (za prilagodbu pH vrijednosti)
English: Type of premedication
Croatian: Način primjene
English: • breathing difficulties, nasal congestion
Croatian: • teškoće s disanjem, začepljenost nosa
English: The mean unbound fraction of paclitaxel (fu) varied between 5.2% and 4.3% over time after Apealea infusion.
Croatian: Nakon infuzije lijeka Apealea srednja vrijednost udjela nevezanog paklitaksela (fu) s vremenom se kretala između 5,2 % i 4,3 %.
English: In contrast, patients with moderate hepatic impairment (total bilirubin > 1.5 to ≤ 3 × ULN) and severe hepatic impairment (total bilirubin > 3 to ≤ 5 × ULN) had a 22% or a 26% reduction in paclitaxel elimination rate, respectively.
Croatian: Nasuprot tome, u bolesnika s umjerenim oštećenjem funkcije jetre (ukupni bilirubin od > 1,5 do ≤ 3 × GGN) zabilježeno je smanjenje u brzini eliminacije paklitaksela od 22 %, a u bolesnika s teškim oštećenjem funkcije jetre (ukupni bilirubin od
English: Alopecia was observed in 45% of patients and was abrupt in onset.
Croatian: U 45 % bolesnika zabilježena je alopecija koja je naglo nastupila.
English: The reconstituted solution for infusion is a clear, greenish-yellow solution.
Croatian: Rekonstituirana otopina za infuziju bistra je otopina zelenožute boje.
English: In this limited number of patients, anorexia, fatigue, myalgia, arthralgia, peripheral sensory neuropathy, and diarrhoea were observed more frequently compared to patients younger than 65 years.
Croatian: U usporedbi s bolesnicama koje su mlađe od 65 godina, u ovom ograničenom broju bolesnica češće su uočene pojave anoreksije, umora, mijalgije, artralgije, periferne senzorne neuropatije i proljeva.
English: Hypersensitivity Uncommon: Anaphylactic shock, drug hypersensitivity
Croatian: Manje često: anafilaktički šok, preosjetljivost na lijek
English: Forest plot for PFS by relapse (PP population)
Croatian: Slika 4. Grafikon raspona pouzdanosti za ukupno preživljenje prema relapsu (PP populacija)
English: An open, randomised, multicentre study was conducted in 789 women with recurrent epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer to compare Apealea (paclitaxel micellar) in combination with carboplatin with solvent-based paclitaxel in combination with carboplatin.
Croatian: Lijek Apealea (micelarni paklitaksel) u kombinaciji s karboplatinom uspoređen je s paklitakselom u otopini u kombinaciji s karboplatinom u otvorenom, randomiziranom, multicentričnom ispitivanju koje je obuhvatilo 789 žena s recidivirajućim epitelnim rakom jajnika, primarnim rakom peritoneuma i rakom jajovoda.
English: • urinary tract infection, inflammation of the bladder
Croatian: • infekcija mokraćnog sustava, upala mokraćnog mjehura
English: Uncommon: Cardiac arrest, cardiac failure chronic, cyanosis, atrial fibrillation, sinus tachycardia, palpitations, sinus bradycardia
Croatian: atrijska fibrilacija, sinusna tahikardija, palpitacije, sinusna bradikardija
English: Very common: Astheniaa, fatiguea, infusion site reactiona,d Common:
Croatian: astenijaa, umora, reakcije na mjestu primanja infuzijea,d
English: Neutropenia resolved to ≥ 1.5 × 109/L before the next course of treatment.
Croatian: Prije sljedećeg ciklusa liječenja neutropenija se povukla na ≥ 1,5 × 109/l.
English: Because of potential serious adverse reactions in children being breastfed, Apealea is contraindicated during lactation.
Croatian: lijek Apealea kontraindiciran je tijekom laktacije.