FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pivotal study, about a third of the patients received granulocyte colony stimulating factor (GCSF) to treat neutropenia and clinicians should consider whether individual cases could benefit from GCSF.
Slovenian: V osrednji študiji je približno tretjina bolnic prejela granulocitne kolonije stimulirajoči faktor (GCSF) za zdravljenje nevtropenije.
English: Renal excretion accounts for a minor part, less than 15% of the dose.
Slovenian: manj kot 15 % odmerka.
English: No additional dosage reductions, other than those for all patients, are recommended for patients 65 years and older.
Slovenian: Starejše osebe Pri bolnicah, starih 65 let in več, ni priporočljivo dodatno zmanjšanje odmerkov, razen tistega, ki velja za vse bolnice.
English: How Apealea is given
Slovenian: Kako se daje zdravilo Apealea
English: Limited data are available on use in patients ≥ 75 years (2% of the patients in the study).
Slovenian: O uporabi pri bolnicah, starih 75 let ali več (2 % bolnic v študiji), je voljo le malo podatkov.
English: Second dose level reduction: a Grade of the adverse reaction is defined according to Common Terminology Criteria for Adverse Events (CTCAE).
Slovenian: a Stopnja neželenih učinkov je določena v skladu s Skupnimi terminološkimi merili za neželene učinke
English: Kaplan-Meier curve of OS (PP population)
Slovenian: Kaplan-Meierjeva krivulja OS (populacija PP)
English: Mutagenesis, carcinogenesis, impairment of fertility
Slovenian: Mutagenost, rakotvornost, zmanjšana plodnost
English: • deafness, inner ear disorder, ringing in the ears
Slovenian: • gluhost, bolezen notranjega ušesa, zvenenje v ušesih;
English: Patients should not be treated with subsequent cycles until neutrophils recover to ≥ 1.5 × 109/L and platelets recover to ≥ 100 × 109/L.
Slovenian: Bolnice se ne smejo zdraviti v nadaljnjih ciklih, dokler se število nevtrofilcev ne izboljša na ≥ 1,5 × 109/l in število krvnih ploščic na ≥ 100 × 109/l.
English: No clinical studies in patients with hepatic impairment have been undertaken with Apealea (see sections 4.2 and 4.4).
Slovenian: Pri bolnicah z okvaro jeter niso izvedli kliničnih študij z zdravilom Apealea (glejte poglavji 4.2 in 4.4).
English: Swirl the vial in an upright position for approximately 20 seconds.
Slovenian: Z vialo v pokončnem položaju krožite približno 20 sekund.
English: Tell your doctor before treatment if you are pregnant, think you may be pregnant or are breast-feeding.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči, ali dojite, se pred zdravljenjem posvetujte z zdravnikom.
English: The main metabolite of paclitaxel is 6α-hydroxypaclitaxel.
Slovenian: Glavni presnovek paklitaksela je 6α-hidroksipaklitaksel.
English: Treatment delay and dose level reductions for adverse drug reactions Observationa
Slovenian: Odlog zdravljenja in zmanjšanje odmerkov pri neželenih učinkih
English: • reduced liver, kidney or heart function
Slovenian: • če imate zmanjšano delovanje jeter, ledvic ali srca.
English: No clinical studies in patients with renal impairment have been undertaken with Apealea (see section 4.2 for dose recommendations).
Slovenian: Pri bolnicah z okvaro ledvic niso izvedli kliničnih študij z zdravilom Apealea (glejte poglavje 4.2 za priporočila glede odmerkov).
English: • The active substance is paclitaxel.
Slovenian: • Učinkovina je paklitaksel.
English: In addition, paclitaxel induces microtubule bundle formation throughout the cell cycle and induces microtubule aster formation during mitosis.
Slovenian: Poleg tega paklitaksel izzove nastanek nenormalnih razporeditev ali svežnjev mikrotubulov med celotnim celičnim ciklom in multiplih aster mikrotubulov med mitozo.
English: Paclitaxel is suspected to cause serious birth defects when administered during pregnancy.
Slovenian: Domneva se, da paklitaksel povzroča resne prirojene motnje, če se daje med nosečnostjo.
English: However, paclitaxel is potentially carcinogenic based on its mechanism of action and demonstrated genotoxic activity.
Slovenian: Rakotvornosti paklitaksela niso preučevali, vendar je paklitaksel zaradi svojega mehanizma delovanja in dokazanega genotoksičnega delovanja potencialno rakotvoren.
English: • sensation of heaviness in the legs
Slovenian: • občutek težkosti nog;
English: Neutropenia occurred in 79% and 66%, leukopenia in 53% and 34%, thrombocytopenia in 18% and 10%, and anaemia in 24% and 14% of the patients in the treatment arms receiving either paclitaxel micellar or solvent-based paclitaxel, respectively.
Slovenian: Pri bolnicah, ki so prejemale micelarni paklitaksel in tistih, ki so prejemale paklitaksel na osnovi topila, se je nevtropenija pojavila pri 79 % oziroma 66 %, levkopenija pri 53 % oziroma 34 %, trombocitopenija pri 18 % oziroma 10 % ter anemija pri 24 % oziroma 14 % bolnic.
English: Breast-feeding must be discontinued for the duration of therapy.
Slovenian: Med zdravljenjem je treba dojenje prekiniti.
English: Erythema, rash, pruritus, urticaria
Slovenian: eritem, izpuščaji, pruritus, urtikarija
English: − bleeding
Slovenian: − krvavitve;
English: In the case of febrile neutropenia or low platelet count (< 75 × 109/L), the dose of carboplatin should be reduced by 1 AUC unit in the treatment cycles following recovery.
Slovenian: Pri febrilni nevtropeniji ali nizkem številu krvnih ploščic (< 75 × 109/l) je treba v ciklih zdravljenja po izboljšanju stanja odmerek karboplatina zmanjšati za eno enoto AUC.
English: Nervous system disorders grade ≥ 2 peripheral sensory neuropathy or grade ≥ 2 motor neuropathy
Slovenian: Bolezni živčevja Periferna senzorična nevropatija stopnje ≥ 2
English: Premedication may be considered in patients who have previously experienced gastrointestinal symptoms when being treated with cytotoxic medicinal products.
Slovenian: Pri bolnicah, ki so že imele gastrointestinalne simptome pri zdravljenju s citotoksičnimi zdravili, se lahko razmisli o premedikaciji.
English: • gemfibrozil: a medicine to lower blood fats
Slovenian: • gemfibrozil: zdravilo za zniževanje ravni maščob v krvi;
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).
Slovenian: Bolnice so zdravilo prejemale vsake tri tedne šest ciklov, in sicer zdravilo Apealea 250 mg/m2 v obliki enourne intravenske infuzije (N = 391) ali paklitaksel na osnovi topila 175 mg/m2 v obliki triurne infuzije (N = 391).
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.
Slovenian: V nasprotju s tem so imele bolnice z zmerno okvaro jeter (skupna količina bilirubina > 1,5 do ≤ 3 × ULN) 22-odstotno zmanjšanje stopnje izločanja paklitaksela, bolnice s hudo okvaro jeter (skupna količina bilirubina > 3 do ≤ 5 × ULN) pa 26-odstotno zmanjšanje stopnje izločanja paklitaksela.
English: The pH of lactated or acetated Ringer's solution must be in the range of 5.0 to 7.5, and acceptable ion concentrations of calcium and magnesium are listed below (Table 5).
Slovenian: Vrednost pH Ringerjeve raztopine laktata ali acetata mora biti v razponu med 5,0 in 7,5; dopustne ionske koncentracije kalcija in magnezija so navedene spodaj (preglednica 5).
English: Intravenous administration
Slovenian: intravenska uporaba
English: • increased sweating, cold sweat
Slovenian: • povečano potenje, hladen pot;
English: • pus in body tissue
Slovenian: • gnoj v telesnem tkivu;
English: The pH of lactated or acetated Ringer's solution must be in the range of 5.0 to 7.5 and acceptable ion concentrations of calcium and magnesium are listed below (Table 1).
Slovenian: Vrednost pH Ringerjeve raztopine laktata ali acetata mora biti v razponu med 5,0 in 7,5; dopustne ionske koncentracije kalcija in magnezija so navedene spodaj (preglednica 1).
English: Cytotoxic Apealea should not be interchanged with other paclitaxel formulations.
Slovenian: Zdravilo Apealea se ne sme zamenjevati z drugimi zdravili s paklitakselom.
English: Frequency Preferred term
Slovenian: Prednostni izraz
English: Very common: Astheniaa, fatiguea, infusion site reactiona,d Common:
Slovenian: Zelo pogosti: astenijaa, utrujenosta, reakcija na mestu infundiranjaa,d
English: Compared to patients with normal hepatic function, hepatically impaired patients with total bilirubin > 1.5 × ULN have an increase in mean paclitaxel AUC of approximately 20%.
Slovenian: V primerjavi z bolnicami z normalnim delovanjem jeter se je pri bolnicah z okvaro jeter, ki so imele skupno količino bilirubina > 1,5 × ULN, povprečna vrednost AUC za paklitaksel povečala za približno 20 %.
English: Using a sterile syringe, inject 60 mL of solution for reconstitution per vial.
Slovenian: S sterilno brizgo injicirajte 60 ml raztopine za rekonstitucijo v posamezno vialo.
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.
Slovenian: Farmakokinetična študija pri skupini bolnic, ki so prejemale paklitaksel, vezan na albumin, je pokazala, da imajo bolnice z blago okvaro jeter (skupna količina bilirubina > 1 do ≤ 1,5 × ULN) stopnjo izločanja v normalnem razponu.
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.
Slovenian: Amesovem testu in pri preskusu genske mutacije na jajčnikih kitajskega hrčka glede hipoksantingvanin fosforibozil transferaze (CHO/HGPRT).
English: Patients with mildly or moderately impaired renal function (glomerular filtration rate (GFR) 89−60 mL/min or GFR 59−30 mL/min, respectively) may be treated with Apealea without a dose modification.
Slovenian: Bolnice z blago (stopnja glomerulne filtracije [GFR] 89−60 ml/min) ali zmerno okvarjenim delovanjem ledvic (stopnja glomerulne filtracije [GFR] 59−30 ml/min) se lahko zdravijo z zdravilom
English: • dizziness or feeling of spinning
Slovenian: • omotica ali občutek vrtenja;
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.
Slovenian: V populaciji ITT so bila razmerja ogroženosti za PFS v podskupinah bolnic s prvim recidivom in drugim recidivom 0,80 (95-% IZ: 0,66; 0,97) oziroma 1,04 (95-% IZ: 0,74; 1,47).
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Apealea Vsebina pakiranja in dodatne informacije
English: In particular, tell your doctor or nurse before you are given Apealea if you are using:
Slovenian: Preden prejmete zdravilo Apealea, zdravnika ali medicinsko sestro zlasti obvestite, če uporabljate:
English: • high blood pressure, blood pressure changes, paleness
Slovenian: • motnje v kroženju krvi; • visok krvni tlak, spremembe krvnega tlaka, bledica;
English: Neoplasms benign, malignant and unspecified (incl.
Slovenian: Benigne, maligne in neopredeljene novotvorbe
English: Probability of progression-free survival
Slovenian: Verjetnost preživetja brez napredovanja bolezni
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.
Slovenian: Pri dajanju bolnicam z okvaro jeter, pri katerih je skupna količina bilirubina > 1 do ≤ 5 × ULN in AST ≤ 10 × ULN (glejte poglavje 4.2), je potrebna previdnost in te bolnice je treba skrbno spremljati glede poslabšanja okvare jeter in mielosupresije.
English: Cardiotoxicity
Slovenian: Kardiotoksičnost
English: • low blood pressure, flushing, vein inflammation, vein pain, increased blood flow to some parts of the body
Slovenian: • nizek krvni tlak, rdečica, vnetje ven, bolečina v venah, povečan krvni pretok v nekatere dele telesa; • oteženo dihanje, zamašen nos;
English: First dose level reduction: Possible dose reduction: Second dose level reduction:
Slovenian: prvo zmanjšanje odmerka: drugo zmanjšanje odmerka:
English: Dose-linearity could not be ascertained since a large inter-individual variability was observed.
Slovenian: Linearnosti z velikostjo odmerka zaradi velikih razlik med bolnicami ni bilo mogoče z gotovostjo potrditi.
English: Patients Events
Slovenian: Bolnice Dogodki
English: Apealea contains sodium
Slovenian: Zdravilo Apealea vsebuje natrij
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni kostno-mišičnega sistema in vezivnega tkiva
English: Paraesthesia and hypoaesthesia were the most common ones.
Slovenian: Najpogostejša neželena učinka sta bila parestezija in hipestezija.
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.
Slovenian: Razmerja ogroženosti za celokupno preživetje pri bolnicah s prvim in drugim recidivom so bila 0,98 (95-% IZ: 0,79; 1,21) oziroma 1,18 (95-% IZ: 0,79; 1,75).
English: − reddening and swelling at the site of infusion
Slovenian: − rdečica in oteklina na mestu infundiranja;
English: Febrile neutropeniaa, leukopeniaa, thrombocytopeniaa, granulocytopenia, anaemiaa
Slovenian: febrilna nevtropenijaa, levkopenijaa, trombocitopenijaa, granulocitopenija, anemijaa
English: Baseline neutrophil count < 1.5 × 109/L.
Slovenian: Izhodiščno število nevtrofilcev < 1,5 × 109/l.
English: After reconstitution of the powder, the solution for infusion is a clear, greenish-yellow solution.
Slovenian: Po rekonstituciji praška je raztopina za infundiranje bistra in zelenkasto rumene barve.
English: Musculoskeletal and connective tissue disorders Arthralgia occurred in 19% of patients and myalgia in 10%.
Slovenian: Artralgija se je pojavila pri 19 % in mialgija pri 10 % bolnic.
English: The principle measures of efficacy were progression-free survival (PFS) and overall survival (OS).
Slovenian: PFS) in celokupno preživetje (Overall Survival - OS).
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).
Slovenian: Podatki o uporabi zdravila Apealea pri bolnicah, ki niso bele rase, so omejeni, vendar študije pri bolnicah z rakom dojke, ki so se zdravile z zdravili, ki vsebujejo paklitaksel, kažejo možnost povečanega tveganja nevropatije pri bolnicah, ki niso bele rase (glejte poglavje 4.2).
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.
Slovenian: V populaciji z namenom zdravljenja (intention-to-treat - ITT) (n = 789) so bila razmerja ogroženosti za PFS 0,85 (IZ 95 %: 0,72; 1,00) in za OS 1,02 (IZ 95 %: 0,85; 1,22).
English: Information is lacking for patients with severe renal impairment (GFR < 30 mL/min).
Slovenian: Za bolnice s hudo okvaro ledvic (GFR < 30 ml/min) so informacije pomanjkljive.
English: • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel
Slovenian: • pordelost in otekanje dlani ali stopal, kar lahko povzroči luščenje kože.
English: favours Apealea favours solvent-based paclitaxel
Slovenian: Drugi v prid zdravilu Apealea v prid paklitakselu na osnovi topila
English: • weakness, tiredness
Slovenian: • šibkost, utrujenost;
English: Apealea: solvent-based paclitaxel:
Slovenian: Zdravilo Apealea: paklitaksel na osnovi topila:
English: Hypoaesthesia, dizziness, paraesthesia, peripheral motor neuropathy, dysgeusia, headache
Slovenian: hipestezija, omotica, parestezija, periferna motorična nevropatija, paragevzija, glavobol
English: If particles, precipitates, discolouration (orange) or opalescence are observed, the solution should be discarded.
Slovenian: Če opazite oborino ali spremembo barve (oranžna) ali motnost, raztopino zavrzite.
English: First dose level reduction:
Slovenian: prvo zmanjšanje odmerka:
English: • nosebleed, allergic inflammation inside the nose, runny nose
Slovenian: • krvavitev iz nosu, alergijsko vnetje v nosu, izcedek iz nosu;
English: • cardiac arrest, heart failure
Slovenian: • zastoj srca, popuščanje srca;
English: − sodium hydroxide (for pH adjustment) See section 2 “Apealea contains sodium”.
Slovenian: Glejte poglavje 2, „Zdravilo Apealea vsebuje natrij“.
English: • indigestion, disorder of bowel function, very hard stools, bloody stool
Slovenian: • prebavne motnje, motnja delovanja črevesja, zelo trdo blato, kri v blatu;
English: Very common (may affect more than 1 in 10 people):
Slovenian: zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnic):
English: Patients who experience neutropenia (neutrophil count < 1.5 × 109/L), febrile neutropenia or thrombocytopenia (platelet count < 100 × 109/L) during treatment should have the next treatment cycle delayed until neutrophil counts recover to ≥ 1.5 × 109/L and platelets recover to ≥ 100 × 109/L.
Slovenian: febrilna nevtropenija ali trombocitopenija (število krvnih ploščic < 100 × 109/l), je treba naslednji cikel zdravljenja odložiti, dokler se število nevtrofilcev ne izboljša na ≥ 1,5 × 109/l in število krvnih ploščic na ≥ 100 × 109/l.
English: The recommended dose of Apealea is 250 mg/m2 body surface area (BSA) given as an intravenous infusion over 1 hour followed by carboplatin every three weeks for six cycles.
Slovenian: Odmerjanje Priporočeni odmerek zdravila Apealea je 250 mg/m2 telesne površine; daje se v šestih ciklih vsake tri tedne z enourno intravensko infuzijo, ki ji sledi dajanje karboplatina.
English: Uncommon: Vision blurred, eye irritation, ocular discomfort, lacrimation increased
Slovenian: zamegljen vid, draženje oči, neprijeten občutek v očeh, povečano solzenje
English: Median time to death [months] (95% CI)
Slovenian: Mediani čas do smrti (v mesecih) (IZ
English: Intravenous use.
Slovenian: Intravensko dajanje
English: Oedema peripheral, pain, pyrexia, chest discomfort, hyperthermia, face oedema
Slovenian: periferni edem, bolečina, pireksija, nelagodje v prsnem košu, hipertermija, obrazni edem
English: − formation of blood clots
Slovenian: − tvorba krvnih strdkov;
English: • tissue swelling caused by excess fluid
Slovenian: • otekanje tkiv zaradi prevelike količine tekočine;
English: • a heart rhythm disorder causing irregular rapid activity in the upper heart chambers
Slovenian: • motnja srčnega ritma, ki povzroča nepravilno hitro dejavnost v srčnih preddvorih; • čutenje srčnega utripa (palpitacije), počasen srčni utrip;
English: The European Medicines Agency has waived the obligation to submit the results of studies with Apealea in all subsets of the paediatric population in the treatment of ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), peritoneal carcinoma (excluding blastomas and sarcomas) and fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours) (see section 4.2 for information on paediatric use).
Slovenian: Apealea za vse podskupine pediatrične populacije pri zdravljenju raka jajčnikov (razen rabdomiosarkoma in tumorjev zarodnih celic), peritonealnega karcinoma (razen blastomov in sarkomov) in raka jajcevodov (razen rabdomiosarkoma in tumorjev zarodnih celic) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: • previously had nausea, vomiting and diarrhoea during cancer treatment
Slovenian: • če so se pri vas med zdravljenjem raka že pojavili siljenje na bruhanje, bruhanje in driska.
English: Uncommon: Status epilepticus, coma, cerebrovascular accident, peripheral sensorimotor neuropathy, lethargy, hypotonia, neurotoxicity, polyneuropathy, polyneuropathy in malignant disease, burning sensation, somnolence, cognitive disorder, facial palsy, encephalopathy, hydrocephalus
Slovenian: epileptični status, koma, cerebrovaskularni inzult, periferna senzomotorična nevropatija, letargija, hipotonija, nevrotoksičnost, polinevropatija, polinevropatija pri maligni bolezni, pekoč občutek,
English: • feeling hot
Slovenian: • občutek vročine;
English: Uncommon: Haemarthrosis, musculoskeletal discomfort, sensation of heaviness
Slovenian: hemartroza, kostno-mišično nelagodje, občutek obteženosti
English: The infusion site reactions observed include pain, phlebitis, discolouration, redness, oedema and rash.
Slovenian: Opažene reakcije na mestu infundiranja vključujejo bolečino, flebitis, spremembo barve, rdečino, edem in izpuščaje.
English: Withhold treatment until recovery
Slovenian: Odložite zdravljenje do izboljšanja stanja
English: After reconstitution, each mL of solution contains 1 mg of paclitaxel (micellar).
Slovenian: Po rekonstituciji en ml raztopine vsebuje 1 mg (micelarnega) paklitaksela.
English: How to store Apealea
Slovenian: Shranjevanje zdravila Apealea
English: Uncommon: Angioedema, rash generalised, skin discolouration, hyperhidrosis, rash papular, dermatitis bullous, swelling face, pigmentation disorder, dry skin, cold sweat, livedo reticularis, nail disorder, pruritus allergic, skin disorder
Slovenian: angioedem, generaliziran izpuščaj, sprememba barve kože, hiperhidroza, papulozni izpuščaj, bulozni dermatitis, otekanje obraza, motnja pigmentacije, suha koža, hladen pot, retikularni livedo, bolezen nohtov, alergijski pruritus, bolezni kože
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.
Slovenian: Pomožne snovi: natrijeva sol metilnega estra N-(all-trans retinol)-L-cisteinske kisline, natrijeva sol metilnega estra N-(13-cis retinol)-L-cisteinske kisline, natrijev hidroksid.
English: Back pain, bone pain, musculoskeletal pain, muscular weakness, pain in extremity
Slovenian: bolečina v hrbtu, bolečina v kosteh, kostno-mišična bolečina, oslabelost mišic, bolečine v udih
English: Paclitaxel is excreted in human milk.
Slovenian: Paklitaksel se izloča v materino mleko.
English: One vial contains 60 mg of paclitaxel.
Slovenian: Ena viala vsebuje 60 mg paklitaksela.
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).
Slovenian: V času analize podatkov o celokupnem preživetju je bilo med bolnicami v skupini, ki je bila zdravljena z micelarnim paklitakselom, 56 % smrtnih primerov, v skupini, zdravljeni s paklitakselom na osnovi topila, pa je bilo teh primerov 60 % (populacija ITT).
English: Uncommon: Vertigo, deafness, inner ear disorder, tinnitus
Slovenian: vrtoglavica, gluhost, bolezen notranjega ušesa, tinitus
English: • severe nausea, vomiting or diarrhoea
Slovenian: • močno siljenje na bruhanje, bruhanje ali driska;
English: Dose reduction:
Slovenian: Zmanjšanje odmerka:
English: Uncommon: Circulatory collapse, venous thrombosis, vasculitis, thrombosis, hypertension, deep vein thrombosis, lymphoedema, phlebitis superficial, thrombophlebitis, blood pressure fluctuation, haemorrhage, angiopathy, hot flush, pallor
Slovenian: kolaps krvnega obtoka, venska tromboza, vaskulitis, tromboza, hipertenzija, globoka venska tromboza, limfedem, površinski flebitis, tromboflebitis, nihanje krvnega tlaka, krvavitve, angiopatija, vročinski oblivi, bledica
English: Figure 4.
Slovenian: Slika 4.
English: • depression, sleeplessness, anxiety
Slovenian: • depresija, nespečnost, tesnoba;
English: Relapse n Events
Slovenian: Recidiv n Dogodki
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.
Slovenian: rifampicin, karbamazepin, fenitoin, efavirenz in nevirapin), ni priporočljivo, saj se lahko zaradi manjše izpostavljenosti paklitakselu zmanjša učinkovitost.