natgillin/translations-raw huggingface dataset:
• 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.
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.
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).
%) ukončili liečbu pre retenciu tekutín, zatiaľ čo 15 pacientok liečených doxorubicínom (9
Skin reaction (G3/4: 5.9%);
Kožné reakcie (v 5,9 % G3/4)
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
pacientov, ktorí dostávali docetaxel v kombinácii s trastuzumabom v porovnaní s 0 % pacientov liečených docetaxelom v monoterapii.
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)).
9 % zníženie rizika úmrtia v porovnaní s pacientkami liečenými FAC (hazard ratio = 0,91, 95 % IS (0,63-1,32)).
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.
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.
• As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Rovnako ako pri všetkých parenterálnych liekoch sa musí infúzny roztok pred použitím vizuálne skontrolovať.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mg/9 ml OTHER Cytotoxic
OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH 180 mg/9 ml
Diarrhoea grade 3
Stomatitída/mukozitída stupeň 3
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.
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
Psychiatric disorders Insomnia Nervous system disorders
Anorexia Poruchy nervového Periférna senzorická
G3/4 Blood alkaline phosphatase increased
Vzostup alkalickej fosfatázy v krvi G3/4
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.
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.
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.
Výskyt nasledujúcich nežiaducich účinkov (všetkých stupňov): letargia, stomatitída, neutropenická infekcia bol o ≥
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.
Tieto reakcie sa opisujú pomocou NCI Common Toxicity Criteria (obvyklé kritériá toxicity) (stupeň 3 =
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.
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 >
Very common adverse reactions Common adverse reactions subcutaneous tissue disorders disorders
Veľmi časté nežiaduce reakcie Časté nežiaduce reakcie neutropenická sepsa Poruchy metabolizmu avýživy Anorexia Psychické poruchy
Uncommon adverse reactions neuropathy (G3/4: 1.2%) neuropathy (G3/4: 0.4%)
Menej časté nežiaduce reakcie neuropatia (v 1,2 % G3/4)
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.
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 =
Neutropenia (G4: 76.4%);
Neutropénia (v 76,4
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).
0,38) alebo čas do progresie (docetaxel 27 týždňov oproti doxorubicínu 23 týždňov, p =
Patients with liver impairment
Pacienti s poruchou funkcie obličiek
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg/8 ml OTHER Cytotoxic
OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH 160 mg/8 ml
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).
0,0001), čas do progresie sa predĺžil (19 týždňov oproti 11 týždňov p =
Peripheral sensory neuropathy (G3/4: 0.6%)
Periférna senzorická neuropatia (v 0,6 % G3/4)
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.
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.
61352 Bad Homburg v.d.Höhe Germany
Strasse 1, Bad Homburg v.d.H. 61352, Nemecko
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%).
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.
Number of patients PSA** response rate (%)
Počet pacientov Pomer odpovedí nádoru (%)
• 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).
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).
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).
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.
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%).
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
Hazard ratio: (95% CI) **p-value
Hazard ratio: (95 % IS)
In some cases (frequency not known)
V niektorých prípadoch (frekvencia nie je známa) sa pozorovala trvalá strata vlasov.
Myocardial ischemia (G3/4: 1.7%)
Ischémia myokardu (v 1,7
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
O používaní docetaxelu v kombinácii s doxorubicínom a cyklofosfamidom u pacientov vo veku > 70 rokov je k dispozícii iba obmedzené množstvo údajov.
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).
(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).
• 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).
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).
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.
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.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion
LIEKOVÁ FORMA A OBSAH
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH 120 mg/6 ml
Skin exfoliative (G3/4: 0.6%)
Exfoliácia kože (v 0,6 % G3/4)
Dry skin ; Desquamation
Suchá koža
Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Ženám vo fertilnom veku liečeným docetaxelom sa má odporučiť zabrániť otehotneniu.
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.
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.
status
PODMIENKY
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%).
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
Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
V kľúčových klinických štúdiach týkajúcich sa karcinómu prsníka s režimom TAC bola hlásená akútna myeloidná leukémia a myelodysplastický syndróm (frekvencia menej časté).
• hearing impaired
• poškodenie sluchu
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml OTHER Cytotoxic
OBSAH V HMOTNOSTNÝCH, OBJEMOVÝCH ALEBO KUSOVÝCH JEDNOTKÁCH 20 mg/1 ml
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.
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.
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
NÁZOV LIEKU DOCETAXEL KABI 180 mg/9 ml infúzny koncentrát
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.
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.
You must not be given DOCETAXEL KABI
Nepoužívajte DOCETAXEL KABI
In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period 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 TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Na konci obdobia sledovania (skutočný medián času sledovania 10 rokov a 5 mesiacov) žiadni pacienti nemali CHF v skupine TAC a 1 pacient v skupine TAC zomrel z dôvodu dilatovanej kardiomyopatie a pozorovalo sa pokračovanie CHF u 1 pacienta (0,2%) v ramene FAC.
In GEICAM 9805 study peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
V štúdii GEICAM 9805 periférna senzorická neuropatia, ktorá sa začala počas liečby, pretrvávala v sledovanom období u 10 pacientov (1,9%) v skupine TAC a u 4 pacientov (0,8%) v skupine FAC.
1-year Survival (%)
111) n (%)
†Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
**PSA, Prostatie-Specific Angigen: Prostatický špecifický antigén
MARKETING AUTHORISATION NUMBER EU/1/12/770/004
REGISTRAČNÉ ČÍSLO EU/1/12/770/004
Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p < 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
0,10), docetaxel predlžoval medián času do progresie ochorenia (24,6 týždňov oproti 15,6 týždňov; p <
The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up time point, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up time point.
% v skupine FAC v časovom bode sledovania 8 rokov a v časovom bode sledovania 10 rokov v skupine TAC 91,3
Or
CI)
Hepatobiliary disorders
Dysgeúzia Hypestézia
Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
O liečbe docetaxelom v kombinácii pri iných indikáciách nie sú v skupine pacientov s poruchou funkcie pečene k dispozícii žiadne informácie.
In study TAX316 asthenia that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).
V štúdii TAX316 sa vyskytla asténia, ktorá sa začala počas liečby a pretrvávala v sledovanom období po ukončení chemoterapie, u 236 zo 744 pacientov v skupine TAC (31,7%) a 180 z 736 pacientov v skupine FAC
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
U pacientov liečených docetaxelom každé tri týždne bol výskyt súvisiacich zmien na nechtoch ≥
Abdominal pain (G3/4: 0.4%)
Abdominálna bolesť (v 2 % G3/4)
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion
NÁZOV LIEKU DOCETAXEL KABI 160 mg/8 ml infúzny koncentrát
First episode: reduce docetaxel and 5-FU doses by 20%.
Prvá epizóda: znížte dávky docetaxelu a 5-FU o 20 %. Druhá epizóda: prerušte liečbu.
61352 Bad Homburg v.d.Höhe
Strasse 1, Bad Homburg v.d.H.
DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
DOCETAXEL KABI 180 mg/9 ml infúzny koncentrát docetaxel
Data from a multi-centre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Údaje z multicentrickej, otvorenej, randomizovanej klinickej štúdie podporujú používanie docetaxelu v adjuvantnej liečbe pacientok s operovateľným karcinómom prsníka s pozitívnymi uzlinami a KPS ≥
Thrombocytopenia (G4: 1.7%)
Trombocytopénia (v 1,7 %
DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
DOCETAXEL KABI 160 mg/8 ml infúzny koncentrát docetaxel
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion
NÁZOV LIEKU DOCETAXEL KABI 120 mg/6 ml infúzny koncentrát
Very common adverse reactions Common adverse reactions Abdominal pain
Veľmi časté nežiaduce reakcie Časté nežiaduce reakcie Bolesť chrbta (v 1
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial with 160 mg/8 ml METHOD AND ROUTE(S) OF ADMINISTRATION Ready to add to infusion solution.
LIEKOVÁ FORMA A OBSAH Infúzny koncentrát 1 injekčná liekovka s 160 mg/8 ml
G3/4 Blood bilirubin increased (< 2%)
Vzostup bilirubínu v krvi G3/4 (v 9 %)
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Na indukčnú liečbu neoperovateľného lokálne pokročilého skvamocelulárneho karcinómu hlavy a krku (SCCHN) je odporúčaná dávka docetaxelu 75 mg/m2 ako 1-hodinová infúzia, po ktorej nasleduje 75 mg/m2 cisplatiny ako 1-hodinová infúzia v deň 1, potom nasleduje 750 mg/m2 5fluóruracilu denne ako 24-hodinová kontinuálna infúzia počas 5 dní.
Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
Abdominálna bolesť (závažná v 1
Baseline cardiac assessment is recommended.
Odporúča sa základné vyšetrenie srdca.
Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Neutropénia (v 63 % G3/4)
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Tento liek obsahuje 50 % (objemových percent) bezvodého etanolu (alkohol), čo je až do 1,58 g bezvodého etanolu/injekčná liekovka, čo zodpovedá 40 ml piva alebo 17 ml vína.
Oesophagitis (severe: 0.4%)
Ezofagitída (závažná v 0,4
Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
Trombocytopénia (v 8,8
General disorders and administration site conditions In study TAX316 peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%).
V štúdii TAX316 sa pozoroval periférny edém, ktorý sa začal počas liečby a pokračoval v sledovanom období po ukončení chemoterapie 119 z 744 pacientov s skupine TAC (16,0%) a 23 z 736 pacientov v skupine FAC (3,1%).
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 32 ml wine.
Tento liek obsahuje 50 % (objemových percent)bezvodého etanolu (alkohol), čo je až do 3,16 g bezvodého etanolu/injekčná liekovka, čo zodpovedá 80 ml piva alebo 32 ml vína.
MARKETING AUTHORISATION NUMBER EU/1/12/770/003
REGISTRAČNÉ ČÍSLO EU/1/12/770/003
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
NÁZOV LIEKU DOCETAXEL KABI 20 mg/1 ml infúzny koncentrát
The median number of cycles administered per patient was 6 (with a range of 1-16) for the TCF arm compared to 4 (with a range of 1-12) for the CF arm. Time to progression (TTP) was the primary endpoint.
16) v porovnaní so skupinou CF, kde bol medián počtu cyklov na jedného pacienta 4 (v rozmedzí 1 −
A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test
Hazard ratio menší ako 1 je v prospech kombinácie docetaxel + cisplatina + 5-FU
Hazard ratio (95% CI) *p-value
Hazard ratio (95 % IS)
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Tento liek obsahuje 50 % (objemových percent) bezvodého etanolu (alkohol), čo je až do 395 mg bezvodého etanolu/injekčná liekovka, čo zodpovedá 10 ml piva alebo 4 ml vína.
Peripheral motor neuropathy (G3/4: 2.5%)
Periférna motorická neuropatia (v 2 % G3/4)
Dizziness
Zvracanie
Best overall response to chemotherapy (%) (95% CI) ***p-value
Najlepšia celková odpoveď na chemoterapiu (%)
Anorexia (G3/4: 1.5%)
Anorexia (v 1,5
Gastrointestinal haemorrhage (G3/4: 0.6%)
Gastrointestinálne krvácanie (v 0,6 % G3/4)
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
• 332 pacientov, ktorí dostávali docetaxel v kombinácii s prednizónom alebo prednizolónom
Weight decreased; G3/4 Blood bilirubin increased
Vzostup bilirubínu v krvi G3/4
Uncommon adverse reactions disorders
Menej časté nežiaduce reakcie traktu
Stomatitis/mucositis grade 4 First episode: stop 5-FU only, at all subsequent cycles.
Prvá epizóda: ukončite len podávanie 5-FU, vo všetkých ďalších cykloch.
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
1 ml infúzneho koncentrátu obsahuje 20 mg bezvodého docetaxelu.