FrancophonIA/ELRC3.0 huggingface dataset:
English: In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Slovenian: V študiji TAX316 se je kongestivno srčno popuščanje pojavilo 26 bolnicam (3,5 %) v kraku s TAC in 17 bolnicam (2,3 %) v kraku s FAC.
English: Both regimens were administered every 3 weeks.
Slovenian: Obe shemi so aplicirali enkrat na 3 tedne.
English: Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Slovenian: Ženskam v rodni dobi, ki dobivajo docetaksel, je treba odsvetovati nosečnost; če zanosijo, morajo o tem takoj obvestiti lečečega zdravnika.
English: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Slovenian: Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 0,5 ml brezvodnega etanola (395 mg).
English: Patients should be monitored for second primary malignancies (see section 4.8).
Slovenian: Bolnike je treba kontrolirati glede drugih primarnih malignomov (glejte poglavje
English: 1Full analysis set (intent-to-treat)
Slovenian: 1 celotna množica za analizo (z-namenom-zdravljenja) 2 ocenjeno mediano preživetje
English: - For the treatment of prostate cancer, DOCETAXEL KABI is administered in combination with prednisone or prednisolone.
Slovenian: - Za zdravljenje raka prostate se zdravilo DOCETAKSEL KABI lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Slovenian: Bolniki v kraku z docetakselom so prejeli docetaksel (T) 75 mg/m2, ki mu je sledil cisplatin (P) 75 mg/m2, temu pa 5-fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Slovenian: Za prilagoditve odmerjanja cisplatina glejte ustrezen povzetek glavnih značilnosti zdravila.
English: It was shown that docetaxel was embryotoxic and fetotoxic in rats and rabbits.
Slovenian: Dokazano je, da je docetaksel pri podganah in kuncih embriotoksičen in fetotoksičen.
English: Data from a multi-centre open-label randomised trial support the use of DOCETAXEL KABI for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Slovenian: Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo zdravila DOCETAKSEL KABI za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Slovenian: Bolniki v primerjalnem kraku so dobili cisplatin (P) 100 mg/m2, ki mu je sledil 5-fluorouracil 1000 mg/m2 (F) na dan 5 dni.
English: Docetaxel + Cis + 5-FU n = 177
Slovenian: Docetaksel + Cis + 5-FU n = 177
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test
Slovenian: Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin + fluorouracil.
English: Capecitabine
Slovenian: Kapecitabin
English: The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
Slovenian: Povečanje v preživetju opazovano pri kraku tedenskega docetaksela ni bilo statistično značilno v primerjavi z mitoksantronovem kontrolnem kraku zdravljenja.
English: For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Slovenian: Pri zdravljenju raka prostate, v primeru sočasne uporabe prednizona ali prednizolona, je priporočena premedikacija peroralni deksametazon 8 mg, 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (prosimo, glejte poglavje 4.4).
English: Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
Slovenian: Mielodisplastični sindrom so zabeležili pri 2 od 744 bolnic, ki so prejemale TAC (0,3 %), in pri 1 od 736 bolnic, ki so prejemale FAC (0,1 %).
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Slovenian: Povprečni celotni telesni očistek je bil 21 l/h/m2, volumen porazdelitve v stanju dinamičnega ravnovesja pa 113 l. Interindividualno variiranje celotnega telesnega očistka je bilo približno 50 %.
English: Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Slovenian: Bolnice je med terapijo in v obdobju nadzora po terapiji potrebno kontrolirati glede simptomov kongestivnega srčnega popuščanja.
English: 1 vial with 20 mg/1 ml
Slovenian: 1 viala z 20 mg/1 ml
English: Each vial of concentrate contains 3 ml of ethanol anhydrous (2.37 g).
Slovenian: Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 3 ml brezvodnega etanola (2,37 g).
English: In both arms, after the last cycle of chemotherapy, patients with positive oestrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Slovenian: V obeh krakih so bolnice s pozitivnimi estrogenskimi in/ali progesteronskimi receptorji po zadnjem ciklu kemoterapije do 5 let dobivale tamoksifen 20 mg na dan. Adjuvantna radioterapija je bila predpisana v skladu z veljavnimi smernicami v sodelujočih ustanovah.
English: Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69% of patients who received TAC and 72% of patients who received FAC.
Slovenian: Dobilo jo je 69 % bolnic, ki so prejemale TAC, in 72 % bolnic, ki so prejemale FAC.
English: There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Slovenian: Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnikih starih > 70 let je malo.
English: • flushing, skin reactions, itching
Slovenian: • vročinski oblivi, kožne reakcije, srbenje,
English: What DOCETAXEL KABI looks like and contents of the pack DOCETAXEL KABI concentrate for solution for infusion is a clear, colourless to pale yellow solution.
Slovenian: Izgled zdravila DOCETAKSEL KABI in vsebina pakiranja Zdravilo DOCETAKSEL KABI koncentrat za raztopino za infundiranje je bistra, brezbarvna do bledorumena raztopina.
English: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Slovenian: Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 4 ml brezvodnega etanola (3,16 g).
English: G3/4 Blood bilirubin increased (2.1%); G3/4 ALT increased (1.3%)
Slovenian: Preiskave zvečanje bilirubina v krvi S3/4 (2,1 %), zvečanje ALT S3/4
English: • alteration in sense of taste
Slovenian: • spremenjeno okušanje,
English: Docetaxel is a substance derived from the needles of yew trees.
Slovenian: Docetaksel je substanca, pridobljena iz iglic tise.
English: Aseptically withdraw the required amount of DOCETAXEL KABI concentrate for solution for infusion using a calibrated syringe.
Slovenian: S kalibrirano brizgo aseptično odvzemite potrebno količino koncentrata za raztopino za infundiranje zdravila DOCETAKSEL KABI.
English: Skin and subcutaneous tissue
Slovenian: Bolezni kože in podkožja
English: The severity of adverse events of DOCETAXEL KABI may be increased when DOCETAXEL KABI is given in combination with other chemotherapeutic agents.
Slovenian: Izrazitost neželenih učinkov zdravila DOCETAKSEL KABI se lahko poveča, če dobivate zdravilo DOCETAKSEL KABI v kombinaciji z drugimi kemoterapevtiki.
English: Neutropenic infection; Infection (G3/4: 11.7%)
Slovenian: Infekcijske in parazitske bolezni nevtropenična okužba, okužba (S3/4: 11,7 %)
English: This regimen is administered every 3 weeks for 3 cycles.
Slovenian: Ta terapevtska shema se uporablja vsake 3 tedne po 3 cikle.
English: MARKETING AUTHORISATION NUMBER
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
English: • 92 patients treated with docetaxel in combination with trastuzumab.
Slovenian: • 92 bolnikih, ki so prejemale docetaksel v kombinaciji s trastuzumabom.
English: Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Slovenian: Z docetakselom sta bili v priporočenem odmerku in shemi 100 mg/m2 na 3 tedne opravljeni dve randomizirani primerjalni študiji III. faze, ki sta vključevali bolnice z metastatskim rakom dojke, in sicer 326 bolnic po neuspešnem alkilirajočem in 392 po neuspešnem antraciklinskem zdravljenju.
English: Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S3: 3,7 %), periferna motorična nevropatija (S3/4: 2 %)
English: Hypersensitivity (no severe)
Slovenian: Bolezni imunskega sistema preobčutljivost (nobene hude)
English: Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: < 0.1%)
Slovenian: Bolezni živčevja disgevzija (S3/4: 0,6 %), periferna senzorična nevropatija (S3/4: < 0,1 %)
English: DOCETAXEL KABI in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Slovenian: Zdravilo DOCETAKSEL KABI je v kombinaciji s cisplatinom indiciran za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Slovenian: Docetaksel so v kombinaciji s trastuzumabom raziskali za zdravljenje bolnic z metastatskim rakom dojke, ki so imele na tumorju hiperekspresijo HER2 in prej še niso dobivale kemoterapije za metastatsko bolezen.
English: At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in
Slovenian: Na koncu spremljanja (dejanski mediani čas spremljanja 10 let in 5 mesecev) ni imela kongestivnega srčnega popuščanja (KSP)
English: 1 vial with 80 mg/4 ml
Slovenian: 1 viala z 80 mg/4 ml
English: Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
Slovenian: zaprtje (hudo: 0,2 %), bolečine v trebuhu (hude: 1 %), gastrointestinalna krvavitev (huda: 0,3 %)
English: No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Slovenian: Ne v eni ne v drugi terapevtski skupini niso odkrili nobenega primera mielodisplastičnega sindroma.
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Slovenian: Najboljši celotni odziv na proučevano zdravljenje [kemoterapija +/- radioterapija] (%) (95 % IZ) ***p-vrednost
English: At the median follow-up time of 77 months overall survival (OS) was also longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Slovenian: Po mediano 77 mesecih spremljanja je bilo tudi celokupno preživetje v kraku TAC daljše: tveganje za smrt je bilo med prejemnicami TAC za 24 % manjše kot med prejemnicami FAC (razmerje ogroženosti = 0,76, 95 % IZ 0,46-1,26, p = 0,29).
English: In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
Slovenian: s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
English: • indigestion
Slovenian: • nespečnost,
English: Cancer pain (G3/4: 1.2%)
Slovenian: bolečina zaradi raka (S3/4: 1,2 %)
English: At the median follow-up was 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Slovenian: Po mediano 77 mesecih spremljanja je bilo dokazano, da je preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
English: Peripheral motor neuropathy (G3/4: 2.5%)
Slovenian: periferna motorična nevropatija (S3/4: 2,5 %)
English: • Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomised, multi-centre open-label, phase III, study (TAX324).
Slovenian: • Indukcijska kemoterapija in nato kemoradioterapija (TAX324) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomizirani multicentrični odprti študiji III. faze (TAX324).
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Slovenian: • 300 bolnikih z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II.
English: What DOCETAXEL KABI contains - The active substance is docetaxel anhydrous.
Slovenian: Kaj vsebuje zdravilo DOCETAKSEL KABI: - Učinkovina je brezvodni docetaksel.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Slovenian: Bolniki v primerjalnem kraku so dobivali cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji 1. dan in nato stalno intravensko infuzijo 5-fluorouracila (F) 1000 mg/m2/dan od 1. do 5. dneva.
English: Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Slovenian: Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 4,5 ml brezvodnega etanola (3,55 g).
English: Skin and subcutaneous Alopecia (G3/4:4.0%)
Slovenian: Bolezni kože in podkožja alopecija (S3/4: 4,0 %)
English: Neutropenia is the most frequent adverse reaction of docetaxel.
Slovenian: Najpogostejši neželeni učinek docetaksela je nevtropenija.
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija
English: Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
Slovenian: Bolezni prebavil navzea, driska, bruhanje, zaprtje, stomatitis, dispepsija, bolečine v trebuhu
English: • Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multi-centre, open-label, randomised study (TAX323).
Slovenian: • Indukcijska kemoterapija in nato radioterapija (TAX323) Varnost in učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji faze III (TAX323).
English: Peripheral sensory neuropathy (G3/4: 8.7%)
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S3/4: 8,7 %)
English: Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed.
Slovenian: Na udih (dlaneh in podplatih) so opažali lokalen kožni eritem z edemi in poznejšo deskvamacijo.
English: Infection (G3/4: 6.3%); Neutropenic infection
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4: 6,3 %), nevtropenična okužba
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Slovenian: omotica (S3/4: 2,3 %), periferna motorična nevropatija (S3/4: 1,3 %)
English: • oral candidiasis
Slovenian: • oralna kandidoza,
English: At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Slovenian: Na koncu spremljanja (dejanski mediani čas spremljanja 8 let) je v kraku TAC periferne edeme še vedno imelo 19 bolnic (2,6 %), v kraku FAC pa 4 bolnice (0,5
English: Skin reaction (G3/4: 5.9%); Nail disorders (severe: 2.6%)
Slovenian: Bolezni kože in podkožja alopecija, kožna reakcija (S3/4: 5,9 %), spremembe nohtov (hude: 2,6 %)
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Slovenian: Bolniki v kraku z docetakselom so dobili docetaksel (T) 75 mg/m2 v intravenski infuziji 1. dan, ki mu je sledil cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji in nato stalna intravenska infuzija 5-fluorouracila (F) 1000 mg/m2/dan od 1. do 4. dneva.
English: Paraesthesia; Headache; Dysgeusia; Hypoaesthesia
Slovenian: Bolezni živčevja parestezije, glavobol, disgevzija, hipestezija
English: - If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: - For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL
Slovenian: - Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjo bezgavk se zdravilo DOCETAKSEL KABI lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
Slovenian: • Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Za indukcijsko zdravljenje bolnikov z lokalno napredovalim (neresektabilen, majhna verjetnost kirurške ozdravitve, ohranitev organa) skvamoznoceličnim karcinomom glave in vratu (SCCHN) je priporočen odmerek docetaksela 75 mg/m2 v obliki enourne intravenske infuzije 1. dan, ki mu sledi cisplatin 100 mg/m2 v 30-minutni do 3-urni infuziji in nato stalna intravenska infuzija 5-fluorouracila 1000 mg/m2/dan od 1. do 4. dneva.
English: Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients (11.7%).
Slovenian: Na koncu spremljanja (mediani čas spremljanja 8 let) so amenorejo še vedno opažali pri 121 od 744 bolnic v kraku TAC (16,3 %) in pri 86 bolnicah v kraku FAC (11,7 %).
English: Reversible cutaneous reactions have been observed and were generally considered as mild to moderate.
Slovenian: Pojavljale so se reverzibilne, praviloma blage do zmerne kožne reakcije.
English: TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Slovenian: nobena bolnica v kraku TAC in 1 bolnica v kraku TAC je umrla zaradi dilatativne kardiomiopatije, še trajajoče KSP pa so zabeležili pri 1 bolnici (0,2 %) v kraku FAC.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel anhydrous.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata vsebuje 20 mg brezvodnega docetaksela.
English: Docetaxel + Cis + 5-FU n = 255
Slovenian: Docetaksel + Cis + 5-FU n = 255
English: DOCETAXEL KABI in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Slovenian: Zdravilo DOCETAKSEL KABI je v kombinaciji s trastuzumabom indiciran za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo čezmerno izražen HER2 in ki predhodno niso bile zdravljene s kemoterapijo za metastatsko bolezen.
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Slovenian: Po 10 letih spremljanja v študiji TAX316 so akutno levkemijo zabeležili pri 3od 744 bolnic, ki so prejemale TAC (0,4 %), in pri 1 od 736 bolnic, ki so prejemale FAC (0,1%).
English: After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Slovenian: Po 10 letih spremljanja v študiji TAX316 so akutno levkemijo zabeležili pri 3 od 744 bolnic, ki so prejemale TAC (0,4 %), in pri 1 od 736 bolnic, ki so prejemale FAC (0,1 %).
English: DOCETAXEL KABI in combination with capecitabine
Slovenian: DOCETAKSEL KABI v kombinaciji s kapecitabinom
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in bolezni dojk:
English: Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4: 2,4 %), nevtropenična okužba (S3/4: 2,6 %)
English: The pharmacokinetics of docetaxel were not altered by the age or sex of the patient.
Slovenian: Starost in spol bolnika nista spremenila farmakokinetike docetaksela.
English: Arrhythmia (no severe)
Slovenian: Srčne bolezni aritmija (nobene hude)
English: Arrhythmia (G3/4: 1.0%)
Slovenian: Srčne bolezni aritmija (S3/4: 1,0 %)
English: G3/4 ALT increased
Slovenian: zvečanje ALT S3/4
English: In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Slovenian: V študiji TAX316 so amenorejo, ki se je pojavila med obdobjem zdravljenja in je trajala še med obdobjem spremljanja po koncu kemoterapije, zabeležili pri 202 od 744 bolnic v kraku TAC (27,2 %) in pri 125 od 736 bolnic v kraku FAC (17,0 %).
English: One vial of 9 ml of concentrate contains 180 mg of docetaxel.
Slovenian: Ena viala z 9 ml koncentrata vsebuje 180 mg docetaksela.
English: Neutropenia (G4: 51.5%); Anaemia (G3/4: 6.9%); Thrombocytopenia (G4: 0.5%)
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S4: 51,5 %), anemija (S3/4: 6,9 %), trombocitopenija (S4: 0,5 %)
English: Alopecia; Skin reaction (G3/4: 0.8%)
Slovenian: Bolezni kože in podkožja alopecija, kožna reakcija (S3/4: 0,8 %)
English: • weight gain or loss.
Slovenian: • povečanje ali zmanjšanje telesne mase.
English: DOCETAXEL KABI in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Slovenian: Zdravilo DOCETAKSEL KABI je v kombinaciji s kapecitabinom indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
English: The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Slovenian: Docetaksel, doksorubicin in ciklofosfamid pri sočasni aplikaciji ne vplivajo na farmakokinetiko drug drugega.
English: Dysgeusia (G3/4: < 1%); Paraesthesia (G3/4: < 1%)
Slovenian: Bolezni živčevja disgevzija (S3/4: < 1 %), parestezije (S3/4: < 1 %)