natgillin/translations-raw huggingface dataset:
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.
Po 10 letih spremljanja v študiji GEICAM 9805 se je akutna levkemija pojavila pri 1 od 532 (0,2 %) bolnic v kraku TAC.
DOCETAXEL KABI in combination with doxorubicin
DOCETAKSEL KABI v kombinaciji z doksorubicinom
If DOCETAXEL KABI concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Če pride koncentrat ali raztopina za infundiranje zdravila DOCETAKSEL KABI v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
Tudi celotno preživetje pri 10 letih je bilo značilno povečano pri TAC v primerjavi z FAC (76 % proti 69 %) t.j.
In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m2 immediately followed by cisplatin 75 mg/m2 over 30-60 minutes.
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.
- If you have any further questions, ask your doctor, hospital pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
Rare (may affect up to 1 in 1,000 people):
Redko (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
This regimen is administered every 3 weeks for 4 cycles.
Ta terapevtska shema se uporablja vsake 3 tedne po 4 cikle.
As the benefit observed in patients with 4+ nodes was not statistically significant on DFS and OS, the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis.
Korist za preživetje brez bolezni in celokupno preživetje pri bolnicah z bezgavkami 4+ ni bila statistično značilna, zato končna analiza ni v celoti potrdila pozitivnega razmerja med koristjo in tveganjem TAC pri bolnicah z bezgavkami 4+.
The name of this medicine is DOCETAXEL KABI.
To zdravilo se imenuje DOCETAKSEL KABI.
At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Po medianem spremljanju 10 let in 5 mesecev so imele prejemnice TAC 16,5 % manjše tveganje za recidiv kot prejemnice FAC (razmerje ogroženosti = 0,84, 95 % IZ 0,65-1,08, p = 0,1646).
More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Za odmerek, ki ga potrebuje bolnik, je lahko potrebna več kot ena viala koncentrata za raztopino za infundiranje zdravila DOCETAKSEL KABI.
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Tabelarični prikaz neželenih učinkov adjuvantne terapije z zdravilom DOCETAKSEL KABI 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805) - kumulativnimi podatki:
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)).
Po medianem spremljanju 10 let in 5 mesecev so imele prejemnice TAC 9 % manjše tveganje za smrt kot prejemnice FAC (razmerje ogroženosti = 0,91, 95 % IZ 0,63-1,32).
DOCETAXEL KABI is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing the solution.
Zdravilo DOCETAKSEL KABI je zdravilo z delovanjem na novotvorbe (citostatik) in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin potrebna previdnost.
• at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
• kožne reakcije, flebitis (vnetje vene) ali otekanje na mestu injiciranja,
The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3- hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Priporočeni odmerek docetaksela je 75 mg/m2 v 1-urni infuziji, ki mu sledi cisplatin 75 mg/m2 v 1- do 3-urni infuziji (oboje samo 1. dan); temu sledi 5-fluorouracil 750 mg/m2 na dan v 24-urni stalni infuziji 5 dni, z začetkom ob koncu infuzije cisplatina.
• 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.
• Indukcijska kemoterapija in nato radioterapija (TAX 323) Za indukcijsko zdravljenje inoperabilnega lokalno napredovalega skvamoznoceličnega karcinoma glave in vratu (SCCHN - squamous cell carcinoma of the head and neck), je priporočeni odmerek docetaksela 75 mg/m2 v obliki enourne infuzije, ki ji sledi cisplatin 75 mg/m2, infundiran 1 uro dolgo, prvega dne, temu pa sledi 5-fluorouracil v obliki neprekinjene infuzije v odmerku 750 mg/m2 na dan pet dni.
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Za prilagoditve odmerjanja cisplatina in 5-fluorouracila glejte ustrezen povzetek glavnih značilnosti obeh zdravil.
Headache (G3/4: < 1%); Neuropathy peripheral
omotica, glavobol (S3/4: < 1 %), periferna nevropatija
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 2 ml brezvodnega etanola (1,58 g).
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
fazi študije), ki so jih zdravili z docetakselom v kombinaciji s cisplatinom in 5-fluorouracilom v študiji raka želodca, je bilo 74 bolnikov starih 65 let ali več, 4 pa so bili stari 75 let ali več.
For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Pri bolnikih, ki imajo serumski bilirubin > ULN in/ali ALT in AST > 3,5-kratno ULN ter hkrati alkalno fosfatazo > 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
A study of 14C-docetaxel has been conducted in three cancer patients.
Pri treh onkoloških bolnikih so opravili študijo s 14C-docetakselom.
Mild to moderate neuro-sensory signs are characterised by paraesthesia, dysesthesia or pain including burning.
Za blage do zmerne senzorične motnje so značilne parestezije, dizestezije ali bolečina s pekočim občutkom.
There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
V kombinacijskem kraku s trastuzumabom je prišlo do povečane incidence resnih neželenih učinkov (40 % proti 31 %) in neželenih učinkov stopnje 4 (34 % proti 23 %) v primerjavi z monoterapijo z docetakselom.
- For the treatment of head and neck cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
- Za zdravljenje raka glave in vratu se zdravilo DOCETAKSEL KABI uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
1 vial with 180 mg/9 ml
1 viala s 180 mg/9 ml
Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Pri bolnikih, ki so sočasno dobivali radioterapijo, so bili opisani primeri radiacijskega pnevmonitisa.
DOCETAXEL KABI in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Zdravilo DOCETAKSEL KABI je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim hormonsko neodzivnim rakom prostate.
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Za bolnike z okvaro jeter, zdravljene z docetakselom v kombinaciji pri drugih indikacijah, ni podatkov.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Redko je bilo opisano solzenje s konjunktivitisom ali brez njega ter obstrukcija solzovoda s posledičnim čezmernim solzenjem.
In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
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.
Both regimens were administered every 3 weeks.
Obe shemi so aplicirali enkrat na 3 tedne.
Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Ženskam v rodni dobi, ki dobivajo docetaksel, je treba odsvetovati nosečnost; če zanosijo, morajo o tem takoj obvestiti lečečega zdravnika.
Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 0,5 ml brezvodnega etanola (395 mg).
Patients should be monitored for second primary malignancies (see section 4.8).
Bolnike je treba kontrolirati glede drugih primarnih malignomov (glejte poglavje
1Full analysis set (intent-to-treat)
1 celotna množica za analizo (z-namenom-zdravljenja) 2 ocenjeno mediano preživetje
- For the treatment of prostate cancer, DOCETAXEL KABI is administered in combination with prednisone or prednisolone.
- Za zdravljenje raka prostate se zdravilo DOCETAKSEL KABI lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
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.
For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Za prilagoditve odmerjanja cisplatina glejte ustrezen povzetek glavnih značilnosti zdravila.
It was shown that docetaxel was embryotoxic and fetotoxic in rats and rabbits.
Dokazano je, da je docetaksel pri podganah in kuncih embriotoksičen in fetotoksičen.
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.
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.
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
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.
A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test
Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin + fluorouracil.
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:
Povečanje v preživetju opazovano pri kraku tedenskega docetaksela ni bilo statistično značilno v primerjavi z mitoksantronovem kontrolnem kraku zdravljenja.
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).
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).
Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
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 %).
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
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 %.
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Bolnice je med terapijo in v obdobju nadzora po terapiji potrebno kontrolirati glede simptomov kongestivnega srčnega popuščanja.
1 vial with 20 mg/1 ml
1 viala z 20 mg/1 ml
Each vial of concentrate contains 3 ml of ethanol anhydrous (2.37 g).
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 3 ml brezvodnega etanola (2,37 g).
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.
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.
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.
Dobilo jo je 69 % bolnic, ki so prejemale TAC, in 72 % bolnic, ki so prejemale FAC.
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnikih starih > 70 let je malo.
• flushing, skin reactions, itching
• vročinski oblivi, kožne reakcije, srbenje,
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.
Izgled zdravila DOCETAKSEL KABI in vsebina pakiranja Zdravilo DOCETAKSEL KABI koncentrat za raztopino za infundiranje je bistra, brezbarvna do bledorumena raztopina.
Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 4 ml brezvodnega etanola (3,16 g).
G3/4 Blood bilirubin increased (2.1%); G3/4 ALT increased (1.3%)
Preiskave zvečanje bilirubina v krvi S3/4 (2,1 %), zvečanje ALT S3/4
• alteration in sense of taste
• spremenjeno okušanje,
Docetaxel is a substance derived from the needles of yew trees.
Docetaksel je substanca, pridobljena iz iglic tise.
Aseptically withdraw the required amount of DOCETAXEL KABI concentrate for solution for infusion using a calibrated syringe.
S kalibrirano brizgo aseptično odvzemite potrebno količino koncentrata za raztopino za infundiranje zdravila DOCETAKSEL KABI.
Skin and subcutaneous tissue
Bolezni kože in podkožja
The severity of adverse events of DOCETAXEL KABI may be increased when DOCETAXEL KABI is given in combination with other chemotherapeutic agents.
Izrazitost neželenih učinkov zdravila DOCETAKSEL KABI se lahko poveča, če dobivate zdravilo DOCETAKSEL KABI v kombinaciji z drugimi kemoterapevtiki.
Neutropenic infection; Infection (G3/4: 11.7%)
Infekcijske in parazitske bolezni nevtropenična okužba, okužba (S3/4: 11,7 %)
This regimen is administered every 3 weeks for 3 cycles.
Ta terapevtska shema se uporablja vsake 3 tedne po 3 cikle.
MARKETING AUTHORISATION NUMBER
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
• 92 patients treated with docetaxel in combination with trastuzumab.
• 92 bolnikih, ki so prejemale docetaksel v kombinaciji s trastuzumabom.
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.
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.
Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Bolezni živčevja periferna senzorična nevropatija (S3: 3,7 %), periferna motorična nevropatija (S3/4: 2 %)
Hypersensitivity (no severe)
Bolezni imunskega sistema preobčutljivost (nobene hude)
Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: < 0.1%)
Bolezni živčevja disgevzija (S3/4: 0,6 %), periferna senzorična nevropatija (S3/4: < 0,1 %)
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.
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.
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.
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.
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
Na koncu spremljanja (dejanski mediani čas spremljanja 10 let in 5 mesecev) ni imela kongestivnega srčnega popuščanja (KSP)
1 vial with 80 mg/4 ml
1 viala z 80 mg/4 ml
Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
zaprtje (hudo: 0,2 %), bolečine v trebuhu (hude: 1 %), gastrointestinalna krvavitev (huda: 0,3 %)
No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Ne v eni ne v drugi terapevtski skupini niso odkrili nobenega primera mielodisplastičnega sindroma.
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Najboljši celotni odziv na proučevano zdravljenje [kemoterapija +/- radioterapija] (%) (95 % IZ) ***p-vrednost
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).
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).
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.
s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
• indigestion
• nespečnost,
Cancer pain (G3/4: 1.2%)
bolečina zaradi raka (S3/4: 1,2 %)
At the median follow-up was 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Po mediano 77 mesecih spremljanja je bilo dokazano, da je preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
Peripheral motor neuropathy (G3/4: 2.5%)
periferna motorična nevropatija (S3/4: 2,5 %)
• 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).
• 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).
• 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).
• 300 bolnikih z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II.
What DOCETAXEL KABI contains - The active substance is docetaxel anhydrous.
Kaj vsebuje zdravilo DOCETAKSEL KABI: - Učinkovina je brezvodni docetaksel.
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.
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.
Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Pomožne snovi z znanim učinkom Ena viala koncentrata vsebuje 4,5 ml brezvodnega etanola (3,55 g).
Skin and subcutaneous Alopecia (G3/4:4.0%)
Bolezni kože in podkožja alopecija (S3/4: 4,0 %)
Neutropenia is the most frequent adverse reaction of docetaxel.
Najpogostejši neželeni učinek docetaksela je nevtropenija.
Musculoskeletal and connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
Bolezni prebavil navzea, driska, bruhanje, zaprtje, stomatitis, dispepsija, bolečine v trebuhu
• 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).
• 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).
Peripheral sensory neuropathy (G3/4: 8.7%)
Bolezni živčevja periferna senzorična nevropatija (S3/4: 8,7 %)
Localised skin erythema of the extremities (palms of the hands and soles of the feet) with oedema followed by desquamation has been observed.
Na udih (dlaneh in podplatih) so opažali lokalen kožni eritem z edemi in poznejšo deskvamacijo.
Infection (G3/4: 6.3%); Neutropenic infection
Infekcijske in parazitske bolezni okužba (S3/4: 6,3 %), nevtropenična okužba
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
omotica (S3/4: 2,3 %), periferna motorična nevropatija (S3/4: 1,3 %)
• oral candidiasis
• oralna kandidoza,