natgillin/translations-raw huggingface dataset:
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Pogostost recidiva pri 5 letih je
Incidence of relapses at 5 years was reduced in patients receiving TAC compared to those who received FAC (25% versus 32%, respectively) i. e. an absolute risk reduction by 7% (p = 0.001).
25 bila zmanjšana pri bolnicah, ki so prejemale TAC, v primerjavi s tistimi, ki so prejemale FAC (25% proti 32%) t. j. zmanjšanje absolutnega tveganja za 7% (p = 0, 001).
0.46-0.82 0.63-1.08
0, 59– 0, 88 0, 46– 0, 82 0, 63– 1, 08
0.29-0.70 0.66-1.33
0, 53– 0, 91 0, 29– 0, 70 0, 66– 1, 33
TAXOTERE as single agent
TAXOTERE v monoterapiji
26 TAXOTERE in combination with doxorubicin
26 TAXOTERE v kombinaciji z doksorubicinom
33.4 - 42.1) in AT arm and 31.9 weeks (95% CI:
33, 4– 42, 1) in v kraku AC 31, 9 tedna (95% IZ:
27.4 - 36.0) in AC arm. • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
27, 4– 36, 0). • Celotni delež odziva je bil v kraku AT značilno večji kot v kraku AC, p = 0, 009.
52.8 - 65.9) in AT arm versus 46.5% (95% CI:
52, 8– 65, 9) in v kraku AC 46, 5% (95% IZ:
TAXOTERE in combination with trastuzumab
TAXOTERE v kombinaciji s trastuzumabom
Docetaxel
Docetaksel1
TTP = time to progression; “ ne ” indicates that it could not be estimated or it was not yet reached.
ČDN = čas do napredovanja; “ no ” pomeni, ni bilo mogoče oceniti ali še ni doseženo.
27 TAXOTERE in combination with capecitabine
27 TAXOTERE v kombinaciji s kapecitabinom
Data from one multicenter, randomised, controlled phase III clinical trial support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Podatki multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja III. faze podpirajo uporabo docetaksela v kombinaciji s kapecitabinom za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije, ki je vključevala antraciklin.
TAXOTERE in combination with platinum agents in chemotherapy-naïve patients
TAXOTERE v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
28 Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
Podatke o preživetju, mediano časa do napredovanja in delež odziva v dveh krakih te raziskave prikazuje naslednja preglednica:
Median Time to Progression
mediana časa do napredovanja
Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Sekundarne končne točke so vključevale spremembe bolečin, celotno oceno kakovosti življenja z EuroQoL- 5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
A total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups: • Docetaxel 75 mg/ m2 every 3 weeks for 10 cycles. • Docetaxel 30 mg/ m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. • Mitoxantrone 12 mg/ m2 every 3 weeks for 10 cycles.
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60: • Docetaksel 75 mg/ m2 vsake 3 tedne, 10 ciklov. • Docetaksel 30 mg/ m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5- ih ciklih. • Mitoksantron 12 mg/ m2 vsake 3 tedne, 10 ciklov.
29
vsake
Endpoint
teden 334
Docetaxel every Docetaxel every 3 weeks week
vsake 3 tedne 337
Mitoxantrone every 3 weeks
mediana preživetja (meseci)
Number of patients Median survival (months) 95% CI Hazard ratio 95% CI p-value† * Number of patients PSA** response rate (%) 95% CI p-value* Number of patients Pain response rate (%) 95% CI p-value* Number of patients Tumor response rate (%) 95% CI p-value* † Stratified log rank test
95% IZ p- vrednost * število bolnikov odzivnost na bolečino (%) 95% IZ p - vrednost * število bolnikov odzivnost tumorja (%) 95% IZ p - vrednost *
Prostate-Specific Antigen
Stratificiran log- rang test * Prag statistične značilnosti = 0, 0175 ** PSA: prostatični specifični antigen
No statistical differences were observed between treatment groups for Global Quality of Life.
29 Med skupinami zdravljenja niso opazovali statističnih razlik po oceni globalnega vprašalnika o kvaliteti življenja (» Global Quality of Life «).
A multicenter, open-label, randomized trial, was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Opravljeno je bilo multicentrično, odprto, randomizirano preskušanje za oceno varnosti in učinkovitosti docetaksela pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
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).
Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaksel (T) (75 mg/ m2 1. dan) v kombinaciji s cisplatinom (C) (75 mg/ m2 1. dan) in 5- fluorouracilom (F) (750 mg/ m2 na dan, 5 dni), bodisi cisplatin (100 mg/ m2 1. dan) in 5 - fluorouracil (1000 mg/ m2 na dan, 5 dni).
30 Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Učinkovitost docetaksela pri zdravljenju bolnikov z adenokarcinomom želodca
• 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, multicenter, open-label, randomized trial (TAX323).
• 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 multicentričnem odprtem randomiziranemu preskušanju faze III (TAX323).
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance status 0 or 1, were randomized to one of two treatment arms.
V tej študiji so 358 bolnikov z inoperabilnim lokalno napredovalim 30 SCCHN in stanjem zmogljivosti po WHO 0 ali 1 randomizirali v enega od dveh terapevtskih krakov.
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.
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.
Patients on the TPF arm received antibiotic prophylaxis 31 with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Bolniki na kraku TPF so prejemali antibiotično profilakso s ciprofloksacinom v odmerku 500 mg peroralno dvakrat na dan 10 dni z začetkom 5. dne vsakega cikla, ali enakovredno profilakso.
Docetaxel + Cis + 5-FU
Cis+5- FU
Cis
Končna točka
+ 5-FU
Docetaksel+ Cis+5- FU
= 181 8.3
= 181
(95% CI) Adjusted Hazard ratio
(meseci) (95% IZ)
(95% CI) *p-value
(95% IZ) * p- vrednost
[chemotherapy +/ - radiotherapy] (%) (95% CI) ***p-value
zdravljenje [kemoterapija + / - radioterapija] (%) (95% IZ) *** p- vrednost
A Hazard ratio of less than 1 favors docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumor site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
(0, 52- 0, 99) (95% IZ) 0, 0457 ** p- vrednost Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5- FU * Model po Cox- u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in 31 stanje zmogljivosti po WHO) ** Log- rank test *** Hi - kvadrat test
32 • 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 randomized, multicenter open-label, phase III, trial (TAX324).
• 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 randomiziranem multicentričnem odprtem preskušanju III. faze (TAX324).
33 Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
32 Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z- namenom- zdravljenja)
Docetaxel + Cis + 5-FU n = 255
n = 255 70, 6
***p-value
*** Vrednost p Najboljši celotni odziv (CR + PR) na
34 modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajenjem tekočine podatkov ni.
Concentrate vial: polysorbate 80.
Polisorbat 80.
35 6.3 Shelf-life
34 6. 3 Rok uporabnosti
• 2 years. • Premix solution:
• 2 leti. • Osnovna raztopina:
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C). • Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25 °C).
Vendar je dokazano, da je osnovna raztopina kemično in fizikalno stabilna 8 ur, če je shranjena pri temperaturi med 2 °C in 8 °C ali pri sobni temperaturi (do 25° C). • Raztopina za infundiranje: raztopino za infundiranje je pri sobni temperaturi treba uporabiti v 4 urah (do 25° C).
TAXOTERE 20 mg concentrate for solution for infusion vial
Viala TAXOTERE 20 mg koncentrat za raztopino za infundiranje:
This fill volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Ta polnilni volumen je bil določen med razvojem TAXOTERA za nadomestitev izgube tekočine, do katere pride med pripravo osnovne mešanice zaradi penjenja, adhezije na stene viale in "mrtvega volumna".
This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za TAXOTERE to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 2 ml osnovne raztopine z 10 mg/ ml docetaksela, kar ustreza označeni količini 20 mg na vialo.
7 ml clear glass Type I vial with a transparent colourless flip-off cap.
7- ml viala iz prozornega stekla tipa I s prosojno, brezbarvno dvižno zaporko.
The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ ml docetaxel.
Dodatek celotne vsebine viale z vehiklom vsebini viale TAXOTERE 20 mg koncentrat za raztopino za infundiranje zagotavlja koncentracijo docetaksela v osnovni raztopini 10 mg/ ml.
TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions.
TAXOTERE je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin TAXOTERA potrebna previdnost.
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje TAXOTERE v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje TAXOTERE v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
36 Preparation for the intravenous administration
35 Priprava za intravensko aplikacijo
a) Preparation of the TAXOTERE premix solution (10 mg docetaxel/ ml)
a) Priprava osnovne raztopine TAXOTERA (10 mg docetaksela/ ml)
If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25 °C) for 5 minutes.
Če so viale shranjene v hladilniku, pustite potrebno število škatel TAXOTERA 5 minut stati na sobni temperaturi (do 25 °C).
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Uporabite injekcijsko brizgo z nameščeno iglo in aseptično izvlecite celotno količino vehikla za TAXOTERE iz viale tako, da vialo delno obrnete.
Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
Vbrizgajte celotno vsebino injekcijske brizge v ustrezno vialo TAXOTERA.
The TAXOTERE infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting conditions.
Aplicirati jo je treba aseptično v 1 - urni infuziji, pri sobni temperaturi (do 25 °C) in v pogojih običajne svetlobe.
As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Tako kot vsa zdravila za parenteralno uporabo je treba tudi osnovno raztopino in raztopino za infundiranje TAXOTERE pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
27 November 1995 Date of latest renewal:
27. november 1995 Datum zadnjega podaljšanja dovoljenja za promet:
TAXOTERE 80 mg concentrate and solvent for solution for infusion
TAXOTERE 80 mg koncentrat in vehikel za raztopino za infundiranje
Each single-dose vial of TAXOTERE 80 mg concentrate contains docetaxel which is a trihydrate corresponding to 80 mg of docetaxel (anhydrous).
Vsaka viala z enim odmerkom zdravila TAXOTERE 80 mg koncentrat vsebuje docetaksel v obliki trihidrata, ki ustreza 80 mg brezvodnega docetaksela.
39 Prostate cancer
38 Rak prostate
For treatment
39 Nedrobnocelični pljučni rak Pri bolnikih z nedrobnoceličnim pljučnim rakom, ki še niso bili zdravljeni s kemoterapijo, je priporočena shema odmerjanja docetaksel v odmerku 75 mg/ m2, ki mu takoj sledi cisplatin v odmerku 75 mg/ m2, apliciran 30– 60 minut.
40 after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m² as a single agent.
Za zdravljenje po neuspehu predhodne, na platini osnovane kemoterapije, je priporočeni odmerek 75 mg/ m2 v monoterapiji.
41 However, in clinical practice neutropenia could occur earlier.
V klinični praksi pa se lahko nevtropenija pojavi bolj zgodaj.
In combination with capecitabine • For capecitabine dose modifications, see capecitabine summary of product characteristics. • For patients developing the first appearance of a Grade 2 toxicity, which persists at the time of the next docetaxel/ capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose. • For patients developing the second appearance of a Grade 2 toxicity, or the first appearance of a Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, then resume treatment with docetaxel 55 mg/ m². • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
V kombinaciji s kapecitabinom • Za prilagoditve odmerka kapecitabina glejte povzetek glavnih značilnosti kapecitabina. • Pri bolnikih, pri katerih se prvič pojavijo toksični učinki 2. stopnje, ki trajajo še v času naslednjega zdravljenja z docetakselom/ kapecitabinom, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1 ter znova uporabite 100% izvirnega odmerka. • Pri bolnikih, pri katerih se drugič pojavijo toksični učinki 2. stopnje ali prvič učinki 3. stopnje kadarkoli med ciklusom zdravljenja, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1, nato zdravljenje nadaljujte z docetakselom55 mg/ m2. • V primeru vsakega ponovnega pojava toksičnih učinkov ali pojava toksičnih učinkov 4. stopnje, odmerek docetaksela prekinite.
42 Special populations:
41 Posebne skupine bolnikov:
43 In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
42 Med bolniki, ki so docetaksel prejemali v kombinaciji s cisplatinom in 5- fluorouracilom (TCF), sta se febrilna nevtropenija in nevtropenična okužba redkeje pojavili pri bolnikih, ki so profilaktično prejemali G- CSF.
44 Cardiac toxicity
43 Kardiotoksičnost
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.
Pri bolnikih zdravljenih z docetakselom vsake tri tedne, ki so bili starejši od 65 let, je bila incidenca pojavljanja z zdravljenjem povezanih sprememb na nohtih ≥ 10% večja v primerjavi z mlajšimi bolniki.
45 4.5 Interaction with other medicinal products and other forms of interaction
44 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: • 1312 and 121 patients who received 100 mg/ m² and 75 mg/ m² of docetaxel as a single agent respectively. • 258 patients who received docetaxel in combination with doxorubicin. • 406 patients who received docetaxel in combination with cisplatin. • 92 patients treated with docetaxel in combination with trastuzumab.
Podatki o neželenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so bili zbrani pri: • 1312 bolnikih, ki so v monoterapiji prejemali 100 mg/ m² docetaksela, 121 pa jih je prejemalo 75 mg/ m². • 258 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom. • 406 bolnikih, ki so prejemali docetaksel v kombinaciji s cisplatinom. • 92 bolnicah, ki so prejemale docetaksel v kombinaciji s trastuzumabom. • 255 bolnikih, ki so prejemali docetaksel v kombinaciji s kapecitabinom.
46 • 255 patients who received docetaxel in combination with capecitabine. • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). • 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). • 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). • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
45 • 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki). • 744 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki). • 300 bolnikov z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II. fazi študije), ki so prejemali docetaksel v kombinaciji s cisplatinom in 5 fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki). • 174 bolnikov z rakom glave in vratu, ki so prejemali docetaksel v kombinaciji s cisplatinom in 5- fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
47 extremities and may become generalised with a weight gain of 3 kg or more.
Periferni edemi se ponavadi začnejo na nogah in lahko postanejo generalizirani; telesna masa se lahko poveča za 3 kg ali več.
Immune system disorders
46 Bolezni imunskega sistema
TAXOTERE 100 mg/ m² single agent
TAXOTERE 100 mg/ m2 v monoterapiji
5.3%); 0.2%); Diarrhoea (G3/ 4:
4%),
4%); Abdominal pain Nausea (G3/ 4:
bolečine v trebuhu (hude:
4%); (severe:
1%),
1%); Vomiting (G3/ 4:
0, 4%)
3%) Gastrointestinal haemorrhage (severe:
bruhanje (S3/ 4:
48
4, 6%)
MedDRA System Organ classes nutrition disorders
47 Organski sistemi po MedDRA Žilne bolezni Splošne težave in spremembe na mestu aplikacije
Very common adverse reactions ≥ 10% of patients
Zelo pogosti neželeni učinki ≥ 10% bolnikov zastajanje tekočine (hudo:
Common adverse reactions ≥ 1 to < 10% of patients
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov hipotenzija, hipertenzija, krvavitev reakcija na mestu infundiranja, nekardialne bolečine v prsih (hude 0, 4%)
Infections and infestations
Bolezni imunskega sistema Preiskave
Infections (G3/ 4:
preobčutljivost (S3/ 4:
4.6%) 1.7%)
5, 3%)
0.4%) 11.2%); Pain
zvečanje bilirubina v krvi S3/ 4 (< 5%), zvečanje alkalne fosfataze v krvi S3/ 4 (< 4%), zvečanje AST S3/ 4 (< 3%), zvečanje ALT S3/ 4 (< 2%)
Immune system disorders
Bolezni krvi in limfatičnega sistema:
5.3%)
Redki: krvavitve povezane s trombocitopenijo stopnje 3/ 4
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/ 4 thrombocytopenia.
Bolezni živčevja:
Nervous system disorders Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/ m² as single agent.
Podatki o reverzibilnosti so na voljo za 35, 3% bolnikov, pri katerih so se po zdravljenju z docetakselomkot monoterapijo v odmerku 100 mg/ m2 pojavili nevrotoksični učinki.
49 TAXOTERE 75 mg/ m² single agent
48 TAXOTERE 75 mg/ m2 v monoterapiji
12.4%); Fluid retention (severe:
5%) astenija (huda 12, 4%), zastajanje tekočine (hudo:
50 TAXOTERE 75 mg/ m² in combination with doxorubicin
49 TAXOTERE 75 mg/ m2 v kombinaciji z doksorubicinom
0.4%) neuropathy (G3/ 4:
periferna motorična nevropatija (S3/ 4:
51 TAXOTERE 75 mg/ m² in combination with cisplatin
50 TAXOTERE 75 mg/ m2 v kombinaciji s cisplatinom
0.7%)
0, 7%) reakcija na mestu
9.9%);
9, 9%),
Infusion site reaction; Pain
infundiranja,
conditions
spremembe na mestu
Fluid retention (severe:
zastajanje tekočine
52 TAXOTERE 100 mg/ m² in combination with trastuzumab
51 TAXOTERE 100 mg/ m2 v kombinaciji s trastuzumabom
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
O simptomatskem srčnem popuščanju so poročali pri 2, 2% bolnikov, ki so dobivali docetaksel in trastuzumab, in pri 0% bolnikov, ki so dobivali samodocetaksel.
53 TAXOTERE 75 mg/ m² in combination with capecitabine
52 TAXOTERE 75 mg/ m2 v kombinaciji s kapecitabinom
1%)
1%),
54 TAXOTERE 75 mg/ m² in combination with prednisone or prednisolone
53 TAXOTERE 75 mg/ m2 v kombinaciji s prednizonom ali prednizolonom
55 TAXOTERE 75 mg/ m² in combination with doxorubicin and cyclophosphamide
54 TAXOTERE 75 mg/ m2 v kombinaciji z doksorubicinom in ciklofosfamidom
Peripheral motor 0.7%); neuropathy (G3/ 4:
periferna motorična
0%); Peripheral sensory Neurocortical (G3/ 4: neuropathy (G3/ 4:
0, 7%), periferna senzorična nevropatija (S3/ 4:
0.4%)
0, 7%), spremembe nohtov (S3/ 4:
Myalgia (G3/ 4:
0, 4%) mialgija (S3/ 4:
Infections and infestations
3, 2%), bolezni
3.2%); Neutropenic infection.
nevtropenična okužba.
Vasodilatation (G3/ 4:
1, 2%), periferni edemi (S3/ 4:
56 MedDRA System Organ classes General disorders and administration site conditions
55 Organski sistemi po MedDRA