FrancophonIA/ELRC3.0 huggingface dataset:
English: Delay of next cycle Apealea/carboplatin
Slovenian: Odlog naslednjega cikla zdravila Apealea/karboplatina
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
Slovenian: Analiza neinferiornosti za PFS in OS v randomiziranem preskušanju pri bolnicah s ponavljajočim se epitelijskim rakom jajčnikov, primarnim peritonealnim rakom in rakom jajcevodov (populacija PP)a
English: Peripheral sensory neuropathy and peripheral neuropathy are very common adverse reactions.
Slovenian: Periferna senzorična nevropatija in periferna nevropatija sta zelo pogosta neželena učinka.
English: Minor symptoms such as flushing or skin reactions do not require interruption of therapy.
Slovenian: Pri blagih simptomih, kot sta rdečica ali kožne reakcije, zdravljenja ni treba prekiniti.
English: The formation of these metabolites is catalysed by CYP2C8 and CYP3A4.
Slovenian: Tvorbo teh presnovkov katalizirata CYP2C8 in CYP3A4.
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).
Slovenian: Farmakokinetiko paklitaksela so raziskovali pri 22 bolnicah s čvrstimi tumorji po enournem infundiranju zdravila Apealea (ravni odmerkov od 90 do 275 mg/m2).
English: Patients who can become pregnant should use effective contraception during treatment with Apealea and for six months afterwards.
Slovenian: Bolnice, ki lahko zanosijo, morajo med zdravljenjem z zdravilom Apealea in še šest mesecev pozneje uporabljati učinkovito kontracepcijo.
English: Because of potential serious adverse reactions in children being breastfed, Apealea is contraindicated during lactation.
Slovenian: Zaradi potencialno resnih neželenih učinkov na otroke, ki se dojijo, je zdravilo Apealea med dojenjem kontraindicirano.
English: • efavirenz, nevirapine, ritonavir, saquinavir, indinavir, nelfinavir: medicines to treat HIV
Slovenian: • efavirenz, nevirapin, ritonavir, sakvinavir, indinavir, nelfinavir: zdravila za zdravljenje okužbe z virusom HIV;
English: • fever, pain, chills, weakness or other signs of infection
Slovenian: • zvišana telesna temperatura, bolečine, mrzlica, šibkost ali drugi znaki okužbe;
English: Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation.
Slovenian: Paklitaksel je zdravilo proti mikrotubulom, ki pospešuje sestavljanje mikrotubulov iz tubulinskih dimerov in stabilizira mikrotubule, tako da preprečuje njihovo depolimerizacijo.
English: If patients experience nausea, vomiting and diarrhoea following the administration of Apealea, they may be treated with antiemetics and/or antidiarrhoeal agents.
Slovenian: Če se pri bolnicah po dajanju zdravila Apealea pojavijo navzea, bruhanje in driska, se lahko zdravijo z antiemetiki in/ali antidiaroiki.
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).
Slovenian: O perifernih nevropatijah (vključno s prednostnimi izrazi periferna nevropatija, periferna motorična nevropatija, periferna senzomotorična nevropatija, periferna senzorična nevropatija, polinevropatija in polinevropatija pri maligni bolezni) so poročali pri 29 % bolnic; večinoma (v 98 % primerov) so bile blage do zmerne (stopnja ≤ 2 po CTCAE).
English: Clinically relevant pharmacokinetic interaction has been observed between paclitaxel and cisplatin.
Slovenian: Opazili so klinično pomembno farmakokinetično medsebojno delovanje paklitaksela s cisplatinom.
English: • fluoxetine: a medicine to treat depression
Slovenian: • fluoksetin: zdravilo za zdravljenje depresije;
English: The mean unbound fraction of paclitaxel (fu) varied between 5.2% and 4.3% over time after Apealea infusion.
Slovenian: Povprečni nevezan delež paklitaksela se je gibal med 5,2 in 4,3 % glede na čas po infundiranju zdravila Apealea.
English: In case of discolouration (orange), discard the vial.
Slovenian: V primeru spremembe barve (oranžna) vialo zavrzite.
English: Dose adjustments and delays during treatment
Slovenian: Prilagoditve odmerkov in odlog zdravljenja
English: − nerve disorder in arms and legs which causes tingling, numbness or burning pain*
Slovenian: − motnje živcev v rokah in nogah, ki povzročajo mravljinčenje, omrtvelost ali pekočo bolečino;*
English: Other metabolites are 3'-p-hydroxypaclitaxel and 6α,3'-p-dihydroxypaclitaxel.
Slovenian: Druga dva presnovka sta 3'-p-hidroksipaklitaksel in 6α,3'-p-dihidroksipaklitaksel.
English: • cimetidine: a medicine to reduce stomach acid
Slovenian: • cimetidin: zdravilo za zmanjšanje količine želodčne kisline;
English: Care should be taken to avoid accidental administration into the surrounding tissue during intravenous administration.
Slovenian: Ravnati je treba previdno, da se med intravenskim dajanjem prepreči neželeno dajanje v sosednje tkivo.
English: Apealea contains a mixture of two retinoic acid derivatives as excipients.
Slovenian: Zdravilo Apealea kot pomožni snovi vsebuje zmes dveh derivatov retinojske kisline.
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.
Slovenian: Preobčutljivost Večina preobčutljivostnih reakcij, povezanih z zdravilom Apealea, je blagih do zmernih in se kažejo predvsem kot bolezni kože in podkožja ter splošne težave in spremembe na mestu aplikacije, vendar pa so poročali tudi o resnih preobčutljivostnih reakcijah, vključno z anafilaktičnim šokom.
English: − allergic reactions, such as breathing difficulties, fainting, swelling of the face, itching, feeling hot, chills, particularly during your infusion.
Slovenian: − alergijske reakcije, kot so oteženo dihanje, omedlevica, otekel obraz, srbenje, občutek vročine, mrzlica, zlasti med infundiranjem.
English: Alopecia was observed in 45% of patients and was abrupt in onset.
Slovenian: Alopecijo so opazili pri 45 % bolnic, pojavila se je nenadoma.
English: Apealea is supplied as a greenish-yellow to yellow powder in a glass vial with a rubber stopper and aluminium seal.
Slovenian: Zdravilo Apealea je na voljo kot zelenkasto rumen do rumen prašek v stekleni viali z gumijastim zamaškom in aluminijasto zaporko.
English: • low level of white blood cells called neutrophils
Slovenian: • nizka raven belih krvničk, imenovanih nevtrofilci;
English: All
Slovenian: Vsi
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).
Slovenian: Pri bolnicah s skupno količino bilirubina > 5 × ULN ali AST > 10 × ULN podatki ne zadoščajo za priporočilo za odmerjanje (glejte poglavji 4.4 in 5.2).
English: Unopened vials: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Neodprte viale: Shranjujte v hladilniku (2-8 °C).
English: Infusion-associated reactions
Slovenian: Reakcije, povezane z infuzijo
English: In the study, 35% of the patients in the paclitaxel micellar group and 30% of the patients in the solvent-based paclitaxel group, respectively, received GCSF to treat neutropenia.
Slovenian: V študiji je 35 % bolnic v skupini, ki je prejemala micelarni paklitaksel, in 30 % bolnic v skupini, ki je prejemala paklitaksel na osnovi topila, prejelo GCSF za zdravljenje nevtropenije.
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.
Slovenian: CYP2B6 in CYP2C9, je treba pri sočasni uporabi zdravila Apealea in snovi, ki jih presnavljajo primarno ti encimi CYP, ravnati previdno.
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%).
Slovenian: Na podlagi kombiniranih podatkov iz študij samostojnega zdravljenja so bili zelo pogosti neželeni učinki in učinki posebnega pomena: nevtropenija (45 %), utrujenost (37 %), levkopenija (33 %), alopecija (30 %), navzea (27 %), reakcija na mestu infundiranjaa (23 %), periferna senzorična nevropatija (20 %), driska (17 %), astenija (15 %), pireksija (12 %), zaprtje (12 %), artralgija (12 %), parestezija (11 %),
English: Very common: Neutropeniaa Common:
Slovenian: Zelo pogosti: nevtropenijaa Pogosti:
English: After reconstitution, the solution contains 1 mg/mL of paclitaxel formulated as micellar nanoparticles.
Slovenian: Po rekonstituciji raztopina vsebuje 1 mg/ml paklitaksela v obliki micelarnih nanodelcev.
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.
Slovenian: Iz maloštevilnih podatkov je razvidno, da sta se Cmax in AUC linearno povečevala po enournem infundiranju zdravila Apealea v odmerkih od 150 do 275 mg/m2.
English: In addition, a study with a crossover design compared total and unbound paclitaxel concentrations in plasma after a 1-hour infusion of Apealea 260 mg/m2 with those after a 1-hour infusion of albumin-bound paclitaxel at the same dose.
Slovenian: Poleg tega so v študiji z navzkrižno zasnovo primerjali koncentracije skupnega in nevezanega paklitaksela v plazmi po enournem infundiranju zdravila Apealea v odmerku 260 mg/m2 s koncentracijami po enournem infundiranju enakega odmerka paklitaksela, vezanega na albumin.
English: For safety data comparing the results of combination treatment with Apealea (paclitaxel micellar)/carboplatin and solvent-based paclitaxel/carboplatin, see section 4.8.
Slovenian: Za varnostne podatke in primerjavo rezultatov kombiniranega zdravljenja z zdravilom Apealea (micelarnim paklitakselom)/karboplatinom in paklitakselom na osnovi topila/karboplatinom glejte poglavje 4.8.
English: In vitro and in vivo studies have demonstrated that paclitaxel is a substrate for the efflux protein P-glycoprotein.
Slovenian: Študije in vitro ter in vivo so pokazale, da je paklitaksel substrat za iztočni beljakovinski prenašalec P-glikoprotein.
English: • low blood levels of potassium, magnesium or sodium
Slovenian: • nizke ravni kalija, magnezija ali natrija;
English: Very common: Anorexia
Slovenian: Zelo pogosti: anoreksija Občasni:
English: Paclitaxel causes myelosuppression (primarily neutropenia).
Slovenian: Paklitaksel povzroča mielosupresijo (ki se primarno kaže kot nevtropenija).
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Citotoksično.
English: Greenish-yellow to yellow powder.
Slovenian: Zelenkasto rumen do rumen prašek.
English: For Apealea, dose reductions of initially 50 mg/m2 and additionally 25 mg/m2 should be considered for subsequent courses (see Table 1).
Slovenian: Pri zdravilu Apealea je treba pri nadaljnjih ciklih razmisliti o zmanjšanju odmerkov, najprej za 50 mg/m2 in dodatno za 25 mg/m2 (glejte preglednico 1).
English: • brain damage, abnormal fluid accumulation within the brain
Slovenian: • možganske poškodbe, nenormalno kopičenje tekočine v možganih;
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).
Slovenian: Podatkov o uporabi zdravila Apealea pri bolnicah, ki niso bele rase, je malo, trenutni podatki pa ne zadoščajo za priporočilo dodatnih prilagoditev odmerkov (glejte poglavje 4.4).
English: Treatment should be directed at the major anticipated toxicities, which are nausea, vomiting, diarrhoea, myelosuppression, peripheral sensory neuropathy and peripheral neuropathy.
Slovenian: Zdravljenje je treba usmeriti na glavne pričakovane toksičnosti, tj. navzeo, bruhanje, drisko, mielosupresijo, periferno senzorično nevropatijo in periferno nevropatijo.
English: Tel +46 18 50 54 40 e-mail: med-info@oasmia.com
Slovenian: E-pošta: med-info@oasmia.com
English: It should not be interchanged with other paclitaxel formulations.
Slovenian: Ne sme se zamenjevati z drugimi zdravili s paklitakselom.
English: Therefore, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 (e.g. ketoconazole and other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, ritonavir, saquinavir, indinavir, and nelfinavir) because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.
Slovenian: da zavirajo CYP2C8 ali CYP3A4 (npr. ketokonazol in druga protiglivična zdravila iz skupine imidazolov, eritromicin, fluoksetin, gemfibrozil, klopidogrel, cimetidin, ritonavir, sakvinavir, indinavir in nelfinavir), saj se lahko zaradi večje izpostavljenosti paklitakselu poveča njegova toksičnost.
English: Patients that have total bilirubin > 5 × ULN or AST > 10 × ULN should not be treated with paclitaxel.
Slovenian: Bolnice, pri katerih je skupna količina bilirubina > 5 × ULN ali AST > 10 × ULN, se ne smejo zdraviti s paklitakselom.
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.
Slovenian: Paklitaksel ni namenjen za uporabo pri pediatrični populaciji za indikacije epitelijskega raka jajčnikov, primarnega peritonealnega raka in raka jajcevodov.
English: Apealea is not recommended for patients with severely reduced liver or kidney function.
Slovenian: Zdravilo Apealea ni priporočljivo pri bolnicah, ki imajo močno okvarjeno delovanje jeter ali ledvic;
English: The major route of excretion of paclitaxel-derived material in humans is the faeces, where 6α-hydroxypaclitaxel constitutes the main material.
Slovenian: Glavna pot izločanja materiala, ki se tvori iz paklitaksela, pri ljudeh je blato, pri čemer je glavni material 6α-hidroksipaklitaksel.
English: The risk of myelosuppression is increased due to the combination use with carboplatin.
Slovenian: Zaradi kombinirane uporabe s karboplatinom je povečano tveganje za mielosupresijo.
English: Apealea should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents.
Slovenian: Zdravilo Apealea sme pripraviti in dajati le osebje, ki je ustrezno usposobljeno za ravnanje s citotoksičnimi zdravili.
English: The most common clinically significant adverse reactions associated with the use of Apealea are neutropenia, gastrointestinal disorders, peripheral neuropathy, arthralgia/myalgia, and infusion site reactions.
Slovenian: Najpogostejši klinično pomembni neželeni učinki, povezani z uporabo zdravila Apealea, so nevtropenija, bolezni prebavil, periferna nevropatija, artralgija/mialgija ter reakcije na mestu infundiranja.
English: In vitro studies using human microsomes have shown these derivatives to have inhibitory activity on CYP2B6, CYP2C8, CYP2C9, and to a lesser extent on CYP2D6.
Slovenian: Študije in vitro s humanimi mikrosomi so pokazale, da ti derivati učinkujejo zaviralno na CYP2B6, CYP2C8 in
English: Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer (see section 5.1).
Slovenian: Zdravilo Apealea je v kombinaciji s karboplatinom indicirano za zdravljenje odraslih bolnic s prvim recidivom epitelijskega raka jajčnikov, primarnega peritonealnega raka ali raka jajcevodov, občutljivih za platino (glejte poglavje 5.1).
English: Patients received premedication prior to infusion of solvent-based paclitaxel, paclitaxel micellar and carboplatin as summarised in Table 3 below.
Slovenian: Bolnice so pred infundiranjem paklitaksela na osnovi topila, micelarnega paklitaksela in karboplatina prejele premedikacijo, kot je spodaj navedeno v preglednici 3.
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.
Slovenian: Ni poročil o tem, da bi druge učinkovine lahko izpodrinile paklitaksel, vezan na beljakovino, poleg tega zaradi nizkih molarnih koncentracij paklitaksela v plazmi ni verjetno, da bi ta izpodrinil druge učinkovine.
English: The non-inferiority criterion was met for OS in the PP population with the upper bound limit of the one-sided 97.5% CI for the associated hazard ratio being less than 1.185 (Table 4; Figures 1 and 2).
Slovenian: Merilo neinferiornosti je bilo za OS v populaciji PP izpolnjeno z zgornjo mejo enostranskega 97,5odstotnega-IZ za povezano razmerje ogroženosti manj kot 1,185 (preglednica 4; sliki 1 in 2).
English: Hepatic impairment has no effect on mean paclitaxel Cmax.
Slovenian: Okvara jeter nima vpliva na povprečno vrednost Cmax za paklitaksel.
English: Very common: Arthralgiaa, myalgiaa Common:
Slovenian: Zelo pogosti: artralgijaa, mialgijaa
English: Most hypersensitivity reactions related to Apealea were mild to moderate (see section 4.4).
Slovenian: Preobčutljivostne reakcije Večina preobčutljivostnih reakcij, povezanih z zdravilom Apealea, je bila blagih do zmernih (glejte poglavje 4.4).
English: Apealea should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.
Slovenian: Zdravilo Apealea se daje pod nadzorom usposobljenega onkologa na oddelkih, ki so specializirani za dajanje citotoksičnih zdravil.
English: Name and address of the manufacturer(s) responsible for batch release
Slovenian: SPROŠČANJE SERIJ Ime in naslov proizvajalec (proizvajalci), odgovornega (odgovornih) za sproščanje serij
English: Any unused medicine or waste material should be disposed of in accordance with local requirements.
Slovenian: Vsa neuporabljena zdravila ali odpadni material zavrzite v skladu z lokalnimi predpisi.
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.
Slovenian: Da bi preprečili neželeno dajanje v sosednje tkivo in zagotovili intravenski vnos celotnega odmerka, pred dajanjem in po njem splaknite infuzijski sistem in kateter/kanilo.
English: • clopidogrel: a medicine that reduces the chances of getting blood clots
Slovenian: • klopidogrel: zdravilo za zmanjšanje verjetnosti nastanka krvnih strdkov;
English: The biotransformation and elimination of paclitaxel have been reported in published studies; paclitaxel is mainly eliminated by hepatic metabolism and biliary excretion.
Slovenian: V objavljenih študijah so poročali o biotransformaciji in izločanju paklitaksela; ta se izloča predvsem z jetrno presnovo in izločanjem z žolčem.
English: It is important to flush the infusion set and catheter/cannula before and after the administration using the solution for reconstitution in order to avoid accidental administration into the surrounding tissue and to ensure administration of the complete dose.
Slovenian: Pomembno je, da pred uporabo in po njej izplaknete infuzijski sistem in kateter/kanilo z raztopino za rekonstitucijo, da preprečite neželeno dajanje v sosednje tkivo in zagotovite vnos celotnega odmerka.
English: To reach room temperature, let the vials stand protected from light for approximately 15 to 20 minutes not above 25 °C.
Slovenian: Da se viale segrejejo na sobno temperaturo, jih za približno 15 do 20 minut postavite na temperaturo do 25 °C in poskrbite, da so zaščitene pred svetlobo.
English: A population pharmacokinetics study with albumin-bound paclitaxel demonstrated that patients with mild and moderate renal impairment (creatinine clearance ≥ 30 to < 90 mL/min) have an elimination rate similar to that of patients with normal renal function.
Slovenian: Farmakokinetična študija pri skupini bolnic, ki so prejemale paklitaksel, vezan na albumin, je pokazala, da imajo bolnice z blago in zmerno okvaro ledvic (očistek kreatinina ≥ 30 do < 90 ml/min) podobno stopnjo izločanja kot bolnice z normalnim delovanjem ledvic.
English: Apealea may cause side effects such as tiredness or dizziness that may reduce your ability to drive or use machines.
Slovenian: Zdravilo Apealea lahko povzroči neželene učinke, kot sta utrujenost ali omotica, ki lahko zmanjšajo vašo sposobnost upravljanja vozil in strojev.
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).
Slovenian: V osrednji klinični študiji so bolnice prejemale bodisi zdravilo Apealea (micelarni paklitaksel) v odmerku 250 mg/m2 v kombinaciji s karboplatinom bodisi paklitaksel na osnovi topila v odmerku 175 mg/m2 v kombinaciji s karboplatinom (N = 391 v posameznem kraku).
English: The reconstituted solution for infusion is a clear, greenish-yellow solution.
Slovenian: Rekonstituirana raztopina za infundiranje je bistra, zelenkasto rumena raztopina.
English: Approximately 86% of patients experienced adverse reactions.
Slovenian: Neželeni učinki so se pojavili pri približno 86 % bolnic.
English: Clear type I glass vial with a silicon coated butyl rubber stopper, an aluminium overseal and a plastic flip-off cap containing powder equivalent to 60 mg of paclitaxel.
Slovenian: Prozorna steklena viala tipa I z gumijastim zamaškom, prevlečenim s silikonom, aluminijasto zaporko in plastično dvižno zaporko, ki vsebuje količino praška, ki ustreza 60 mg paklitaksela.
English: Apealea should be administered first, then carboplatin.
Slovenian: Najprej se da zdravilo Apealea in nato karboplatin.
English: Ensure that the solution is clear and place a light protective-bag over the EVA infusion bag.
Slovenian: Prepričajte se, da je raztopina bistra in nato prek vrečke za infundiranje iz EVA namestite vrečko za zaščito pred svetlobo.
English: Due to negative pressure in the vial, pressure must be equilibrated by a needle or a spike before and during injection of the solution for reconstitution.
Slovenian: Ker je tlak v viali negativen, ga je treba pred injiciranjem in med injiciranjem raztopine za rekonstitucijo izravnati z iglo ali prebodom.
English: All other adverse reactions Any grade 4 toxicity
Slovenian: Vsaka toksičnost stopnje 4 Prenehajte zdravljenje Vsaka toksičnost stopnje 3,
English: What Apealea looks like and contents of the pack
Slovenian: Izgled zdravila Apealea in vsebina pakiranja
English: Median months (95% CI)
Slovenian: Mediana v mesecih (95-% IZ)
English: Kaplan-Meier curve of PFS (PP population)
Slovenian: Kaplan-Meierjeva krivulja PFS (populacija PP)
English: The terminal half-life of paclitaxel after Apealea infusion varied about 5-fold between the subjects, 5-23 hours.
Slovenian: Končni razpolovni čas paklitaksela po infundiranju zdravila Apealea se je med bolnicami razlikoval približno petkratno in je znašal 5-23 ur.
English: − breathing difficulties
Slovenian: − oteženo dihanje;
English: Possible dose reductions:
Slovenian: Možna zmanjšanja odmerka:
English: • liver inflammation or disorder, raised liver enzyme in your blood
Slovenian: • vnetje ali okvara jeter, zvišana vrednost jetrnih encimov v krvi;