FrancophonIA/ELRC3.0 huggingface dataset:
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC.
Slovak: Po 10 rokoch sledovania v štúdii GEICAM 9805 sa vyskytla akútna leukémia u 1 z 532 (0,2
English: In study TAX316 lymphoedema that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%).
Slovak: V štúdii TAX316 lymfedém, ktorý sa začal počas liečby a pretrvával do obdobia sledovania po skončení chemoterapie, bolo hlásených u 11 zo 744 pacientov TAC (1,5%) a 1 z 736 pacientov v skupine FAC (0,1%).
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.
Slovak: DOCETAXEL KABI v kombinácii s trastuzumabom je indikovaný na liečbu pacientok s metastatickým karcinómom prsníka, u ktorých nádory nadmerne exprimujú HER2, a ktoré sa predtým nepodrobili chemoterapii pre metastatické ochorenie.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Slovak: 1/10 000 až < 1/1 000); veľmi zriedkavé (<
English: Unopened vial 2 years.
Slovak: 2-ročné prežívanie
English: Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Slovak: Docetaxel sa vylúčil v priebehu 7 dní močom aj stolicou, a to po oxidačnej metabolizácii terciárnej butylesterovej skupiny, sprostredkovanej cytochrómom P450.
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.
Slovak: Na indukčnú liečbu pacientov s lokálne pokročilým (technicky neresekovateľným, malá pravdepodobnosť chirurgickej liečby a s cieľom zachovania orgánu) skvamocelulárnym karcinómom hlavy a krku (SCCHN) je odporúčaná dávka docetaxelu 75 mg/m2 ako 1-hodinová intravenózna infúzia v deň 1, potom nasleduje cisplatina v dávke 100 mg/m2 podávaná ako 30minútová až 3-hodinová infúzia a potom nasleduje 5-fluóruracil v dávke 1 000 mg/m2/deň ako kontinuálna infúzia od dňa 1 do dňa 4.
English: Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Slovak: %) ukončili liečbu pre retenciu tekutín, zatiaľ čo 15 pacientok liečených doxorubicínom (9
English: Skin reaction (G3/4: 5.9%);
Slovak: Kožné reakcie (v 5,9 % G3/4)
English: Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Slovak: pacientov, ktorí dostávali docetaxel v kombinácii s trastuzumabom v porovnaní s 0 % pacientov liečených docetaxelom v monoterapii.
English: As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Slovak: Existuje potenciálne nebezpečenstvo významnej interakcie, preto si súbežná liečba pacientov týmito liekmi vyžaduje zvýšenú opatrnosť.
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Slovak: 9 % zníženie rizika úmrtia v porovnaní s pacientkami liečenými FAC (hazard ratio = 0,91, 95 % IS (0,63-1,32)).
English: Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm.
Slovak: Asténia, ktorá sa začala počas liečebného obdobia a pretrvávala v sledovanom období, sa pozorovala u 12 pacientov (2,3%) v skupine TAC a u 4 pacientov (0,8%) v skupine FAC.
English: Peripheral motor neuropathy (G3/4: 0%)
Slovak: Periférna motorická neuropatia (v 0 % G3/4)
English: • As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Slovak: Rovnako ako pri všetkých parenterálnych liekoch sa musí infúzny roztok pred použitím vizuálne skontrolovať.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mg/9 ml OTHER Cytotoxic
Slovak: OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH 180 mg/9 ml
English: Diarrhoea grade 3
Slovak: Stomatitída/mukozitída stupeň 3
English: Skin reaction (G3/4: 0.2%)
Slovak: Kožné reakcie (v 0,2 % G3/4)
English: Docetaxel is a substance derived from the needles of yew trees.
Slovak: Docetaxel je látka izolovaná z ihličia tisu.
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.
Slovak: Pacientom v skupine s docetaxelom sa podávala intravenózna infúzia 75 mg/m2 docetaxelu (T) v 1. deň, po ktorej nasledovala cisplatina (P) v dávke 100 mg/m2 podávaná vo forme 30-minútovej až 3-hodinovej intravenóznej infúzie a potom nasledovala kontinuálna intravenózna infúzia 5-fluóruracilu (F) v dávke 1 000 mg/m2/deň
English: Anorexia (G3/4: 0.6%)
Slovak: Anorexia (v 0,6 % G3/4)
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Slovak: Ak teraz užívate alebo ste v poslednom čase užívali ďalšie lieky, vrátane liekov, ktorých výdaj nie je viazaný na lekársky predpis, povedzte to svojmu lekárovi alebo nemocničnému lekárnikovi.
English: Psychiatric disorders Insomnia Nervous system disorders
Slovak: Anorexia Poruchy nervového Periférna senzorická
English: G3/4 Blood alkaline phosphatase increased
Slovak: Vzostup alkalickej fosfatázy v krvi G3/4
English: DOCETAXEL KABI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Slovak: DOCETAXEL KABI je indikovaný na liečbu pacientov s lokálne pokročilým alebo metastatickým nemalobunkovým karcinomóm pľúc po zlyhaní predchádzajúcej chemoterapie.
English: Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Slovak: TAC sa profylakticky podávali antibiotiká - ciprofloxacín v dávke 500 mg perorálne dvakrát denne počas 10 dní od 5. dňa každého cyklu alebo iná ekvivalentná terapia.
English: The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Slovak: Výskyt nasledujúcich nežiaducich účinkov (všetkých stupňov): letargia, stomatitída, neutropenická infekcia bol o ≥
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Slovak: Tieto reakcie sa opisujú pomocou NCI Common Toxicity Criteria (obvyklé kritériá toxicity) (stupeň 3 =
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Slovak: V kombinácii s cisplatinou a 5-fluóruracilom na liečbu pacientov s adenokarcinómom žalúdka, boli z pivotnej klinickej štúdie vylúčení pacienti s hladinou ALT a/alebo AST > 1,5-násobok ULN v spojení s hladinou alkalickej fosfatázy >
English: For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Slovak: Modifikácie dávky trastuzumabu sa nachádzajú v súhrne charakteristických vlastností trastuzumabu.
English: Somnolence (G3/4: 0%)
Slovak: Somnolencia (v 0 % G3/4)
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Slovak: U pacientov liečených docetaxelom boli hlásené prípady cystoidného makulárneho edému (CME).
English: Infection (G3/4: 5.7%)
Slovak: Infekcia (v 5,7 % G3/4)
English: Very common adverse reactions Common adverse reactions subcutaneous tissue disorders disorders
Slovak: Veľmi časté nežiaduce reakcie Časté nežiaduce reakcie neutropenická sepsa Poruchy metabolizmu avýživy Anorexia Psychické poruchy
English: DOCETAXEL KABI in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Slovak: DOCETAXEL KABI v kombinácii s doxorubicínom je indikovaný na liečbu pacientok s lokálne pokročilým alebo metastatickým karcinómom prsníka, ktoré sa predtým nepodrobili cytotoxickej liečbe tohto stavu.
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Slovak: Informácie o úprave dávky cisplatiny sú uvedené v príslušnom súhrne charakteristických vlastností.
English: Docetaxel pharmacokinetics in the presence of prednisone was studied in patients with metastatic prostate cancer.
Slovak: U pacientov s metastatickým karcinómom prostaty sa skúmala farmakokinetika docetaxelu za prítomnosti prednizónu.
English: Uncommon adverse reactions neuropathy (G3/4: 1.2%) neuropathy (G3/4: 0.4%)
Slovak: Menej časté nežiaduce reakcie neuropatia (v 1,2 % G3/4)
English: Infections (G3/4: 5%)
Slovak: Infekcie (v 5 % G3/4)
English: Thrombocytopenia (G4: 0.2%)
Slovak: Trombocytopénia (v 0,2 % G4)
English: The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Slovak: 0,0058) v režime s docetaxelom (medián OS: 70,6 mesiacov) v porovnaní s PT (medián OS: 30,1 mesiacov), pričom redukcia rizika mortality v porovnaní s PF bola 30 % (HR =
English: Neutropenia (G4: 76.4%);
Slovak: Neutropénia (v 76,4
English: Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p= 0.007).
Slovak: 0,38) alebo čas do progresie (docetaxel 27 týždňov oproti doxorubicínu 23 týždňov, p =
English: Patients with liver impairment
Slovak: Pacienti s poruchou funkcie obličiek
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.
Slovak: Docetaxel v kombinácii s trastuzumabom sa sledoval pri liečbe pacientok s metastatickým karcinómom prsníka s nadmernou expresiou HER2 a ktoré sa predtým nepodrobili chemoterapii metastatického ochorenia.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg/8 ml OTHER Cytotoxic
Slovak: OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH 160 mg/8 ml
English: Each box contains one vial of 9 ml concentrate (180 mg docetaxel).
Slovak: Každá škatuľa obsahuje 9 ml koncentrátu (180 mg docetaxelu).
English: Docetaxel increased response rate (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p= 0.0004) and prolonged overall survival (11 months vs. 9 months, p= 0.01).
Slovak: 0,0001), čas do progresie sa predĺžil (19 týždňov oproti 11 týždňov p =
English: Peripheral sensory neuropathy (G3/4: 0.6%)
Slovak: Periférna senzorická neuropatia (v 0,6 % G3/4)
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Slovak: V štúdii GEICAM 9805, amenorea, ktorá sa začala počas liečebného obdobia a pretrvávala v sledovanom období, sa pozorovalo jej pokračovanie u 18 pacientov (3,4%) v skupine TAC a 5 pacientov (1,0%) v skupine FAC.
English: Myalgia (G3/4: 0.6%)
Slovak: Myalgia (v 0,6 % G3/4)
English: 61352 Bad Homburg v.d.Höhe Germany
Slovak: Strasse 1, Bad Homburg v.d.H. 61352, Nemecko
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736FAC patients(87.6%).. At the end of the follow-up period actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Slovak: V štúdii TAX316 sa u 687 z 744 pacientov (92,3%) v skupine TAC a u 645 z 736 pacientov (87,6%) v skupine FAC zaznamenala alopécia pretrvávajúca až do sledovaného obdobia po ukončení chemoterapie.
English: DOCETAXEL KABI in combination with capecitabine
Slovak: DOCETAXEL KABI v kombinácii s kapecitabínom
English: Number of patients PSA** response rate (%)
Slovak: Počet pacientov Pomer odpovedí nádoru (%)
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.
Slovak: DOCETAXEL KABI v kombinácii s kapecitabínom je indikovaný na liečbu pacientok s lokálne pokročilým alebo metastatickým karcinómom prsníka po zlyhaní cytotoxickej chemoterapie.
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).
Slovak: Bezpečnosť a účinnosť docetaxelu v indukčnej liečbe pacientov s lokálne pokročilým skvamocelulárnym karcinómom hlavy a krku (SCCHN) sa vyhodnocovala v randomizovanej, multicentrickej, otvorenej klinickej štúdii fázy III (TAX324).
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to DOCETAXEL KABI administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of DOCETAXEL KABI in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Slovak: Požiadajú vás, aby ste jeden deň pred podaním DOCETAXEL KABI absolvovali premedikáciu pozostávajúcu z perorálnych (užívaných ústami) kortikosteroidov ako je dexametazón a pokračovali v nej ešte jeden alebo dva dni po podaní DOCETAXEL KABI.
English: For trastuzumab dose and administration, see trastuzumab summary of product characteristics.
Slovak: Dávkovanie a podávanie trastuzumabu si pozrite v súhrne charakteristických vlastností trastuzumabu.
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.
Slovak: DOCETAXEL KABI v kombinácii s cisplatinou je indikovaný na liečbu pacientov s neoperovateľným, lokálne pokročilým alebo metastatickým nemalobunkovým karcinómom pľúc, ktorí sa predtým nepodrobili chemoterapeutickej liečbe tohto stavu.
English: At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Slovak: Na konci obdobia sledovania (skutočný medián času sledovania 8 rokov) sa pozorovala asténia u 29 pacientov v skupine TAC (3,9%) a 16 pacientov v skupine
English: Hazard ratio: (95% CI) **p-value
Slovak: Hazard ratio: (95 % IS)
English: In some cases (frequency not known)
Slovak: V niektorých prípadoch (frekvencia nie je známa) sa pozorovala trvalá strata vlasov.
English: Myocardial ischemia (G3/4: 1.7%)
Slovak: Ischémia myokardu (v 1,7
English: There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Slovak: O používaní docetaxelu v kombinácii s doxorubicínom a cyklofosfamidom u pacientov vo veku > 70 rokov je k dispozícii iba obmedzené množstvo údajov.
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Slovak: Každá škatuľa obsahuje 8 ml koncentrátu (160 mg docetaxelu).
English: Each box contains one vial of 6 ml concentrate (120 mg docetaxel).
Slovak: Každá škatuľa obsahuje 6 ml koncentrátu (120 mg docetaxelu).
English: A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Slovak: (75 mg/m2 v deň 1) a 5-fluóruracilom (F) (750 mg/m2 denne počas 5 dní) alebo cisplatinou (100 mg/m2 v 1.deň) a 5-fluóruracilom (1 000 mg/m2 denne počas 5 dní).
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).
Slovak: Bezpečnosť a účinnosť docetaxelu v indukčnej liečbe pacientov so skvamocelulárnym karcinómom hlavy a krku (SCCHN) sa vyhodnocovala v multicentrickej, otvorenej, randomizovanej klinickej štúdii fázy III (TAX 323).
English: Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide.
Slovak: U pacientov liečených docetaxelom v kombinovaných režimoch vrátane doxorubicínu, 5-fluóruracilu a/ alebo cyklofosfamidu bola hlásená ventrikulárna arytmia vrátane komorovej tachykardie (frekvencia neznáma), niekedy smrteľná.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion
Slovak: LIEKOVÁ FORMA A OBSAH
English: Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Slovak: Každá škatuľa obsahuje 4 ml koncentrátu (80 mg docetaxelu).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
Slovak: OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH 120 mg/6 ml
English: DOCETAXEL KABI in combination with platinum agents in chemotherapy-naïve patients
Slovak: DOCETAXEL KABI v kombinácii s derivátmi platiny u pacientov bez predchádzajúcej chemoterapie
English: Skin exfoliative (G3/4: 0.6%)
Slovak: Exfoliácia kože (v 0,6 % G3/4)
English: Dry skin ; Desquamation
Slovak: Suchá koža
English: Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Slovak: Ženám vo fertilnom veku liečeným docetaxelom sa má odporučiť zabrániť otehotneniu.
English: In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Slovak: V štúdii TAX316 sa periférna senzorická neuropatia začala počas liečby a pretrvávala v období sledovania u 84 pacientov (11,3%) v skupine TAC a 15 pacientov (2%) v skupine FAC.
English: Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Slovak: Opis vybraných nežiaducich reakcií pri karcinóme prsníka pre DOCETAXEL KABI 100 mg/m² v kombinácii s trastuzumabom
English: status
Slovak: PODMIENKY
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%).
Slovak: V TAX316 sa začala amenorea počas liečby a pretrvávala v sledovanom období po ukončení chemoterapie, bola hlásená u 202 zo 744 pacientov TAC (27,2%) a 125 z 736 pacientov v skupine FAC
English: Lacrimation increased (G3/4: 0%)
Slovak: Zvýšená lakrimácia (v 0 % G3/4)
English: How to store DOCETAXEL KABI
Slovak: Ako uchovávať DOCETAXEL KABI
English: Cardiac toxicity
Slovak: Kardiotoxicita
English: Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Slovak: V kľúčových klinických štúdiach týkajúcich sa karcinómu prsníka s režimom TAC bola hlásená akútna myeloidná leukémia a myelodysplastický syndróm (frekvencia menej časté).
English: Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Slovak: Každá škatuľa obsahuje 1 ml koncentrátu (20 mg docetaxelu).
English: Tabulated list of adverse reactions in prostate cancer for DOCETAXEL KABI 75 mg/m² in combination with prednisone or prednisolone
Slovak: Tabuľkový zoznam nežiaducich reakcií pri karcinóme prostaty pre DOCETAXEL KABI 75 mg/m² v kombinácii s prednizónom alebo prednizolónom
English: One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Slovak: Jedna 8 ml injekčná liekovka obsahuje 160 mg docetaxelu.
English: • hearing impaired
Slovak: • poškodenie sluchu
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml OTHER Cytotoxic
Slovak: OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH 20 mg/1 ml
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2.37 g ethanol anhydrous per vial, equivalent to 60 ml of beer or 24 ml wine.
Slovak: Tento liek obsahuje 50 % (objemových percent) bezvodého etanolu (alkohol), čo je až do 2,37 g bezvodého etanolu/injekčná liekovka, čo zodpovedá 60 ml piva alebo 24 ml vína.
English: Disposal
Slovak: Likvidácia:
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
Slovak: NÁZOV LIEKU DOCETAXEL KABI 180 mg/9 ml infúzny koncentrát
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Slovak: Pri podávaní docetaxelu v kombinácii s protikanceróznou liečbou, o ktorej je známe, že je spojená s druhými primárnymi malignitami, boli hlásené druhé primárne malignity (frekvencia neznáma) vrátane non-Hodgkinovho lymfómu.
English: One vial of 9 ml of concentrate contains 180 mg of docetaxel.
Slovak: Jedna 9 ml injekčná liekovka obsahuje 180 mg docetaxelu.
English: You must not be given DOCETAXEL KABI
Slovak: Nepoužívajte DOCETAXEL KABI