natgillin/translations-raw huggingface dataset:
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 ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST > 1,5 x ULN ter hkrati alkalno fosfatazo > 2,5 x ULN in bilirubinom > 1 x ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
A
s
1Full analysis set (intent-to-treat)
1celotna množica za analizo (z-namenom-zdravljenja) 2 ocenjeno mediano preživetje
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM POGOJI ALI OMEJITVE GLEDE OBSKRBE IN UPORABE, PREDPISANI IMETNIKU DOVOLJENJA ZA PROMET Z ZDRAVILOM Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
The solution in the infusion bag or bottle should be allowed to mix manually using a rocking motion.
Raztopino v infuzijski vrečki ali steklenici lahko ročno premešate z nagibanjem sem in tja.
Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Docefrez v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
In combination with capecitabine
kombinaciji s kapecitabinom
Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Docefrez je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim hormonsko neodzivnim rakom prostate.
1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years).
bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
Lacrimation increased
Močnejše solzenje
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 5fluorouracil (1000 mg/m2 na dan, 5 dni).
Lacrimation increased Conjunctivitis
Močnejše solzenje, konjunktivitis
Dyspnoea (severe 2.7%)
Dispneja (huda: 2,7 %)
Neutropenia (G4:76.4%) Anaemia (G3/4: 8.9%); Febrile neutropenia
Nevtropenija (S4: 76,4 anemija (S3/4: 8,9 %), febrilna nevtropenija
The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Pri bolnikih, zdravljenih s Herceptinom in docetakselom, je bila večja tudi incidenca febrilne nevtropenije/nevtropenične sepse (23 % v primerjavi s 17 % pri bolnikih,
Docetaxel+Cis+5-FU n=177
Docetaksel+ Cis+5-FU n = 177
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Docefrez may be harmful for the unborn baby.
Med zdravljenjem s tem zdravilom ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito.
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.
EuroQoL-5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
Best overall response to chemotherapy (%) (95%CI) ***p-value
Najboljši celotni odziv na kemoterapijo (%) (95 % IZ) ***p-vrednost
The volume of concentrate (24 mg/ml docetaxel) corresponding to the required dose (mg) for the patient should be withdrawn (from the appropriate number of vials) using graduated syringes fitted with a needle.
Z graduiranimi injekcijskimi brizgami z iglo izvlecite količino koncentrata (24 mg/ml docetaksela), ki ustreza potrebnemu odmerku (mg) za bolnika (iz ustreznega števila vial).
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).
Docetaksel ni vplival na primarno končno točko, celotni delež odziva (32 % v primerjavi s 25 %, p = 0,10), podaljšal pa je mediani čas do napredovanja bolezni (24,6 tedna v primerjavi s 15,6 tedna, p <
Anorexia (G3/4: 1%); Decreased appetite
Presnovne in prehranske motnje Anoreksija (S3/4: 1 %), zmanjšan apetit
Docetaxel 75 mg/m² in combination with capecitabine
Docetaksel 75 mg/m2 v kombinaciji s kapecitabinom
3 HOW TO USE DOCEFREZ
Kako uporabljati zdravilo Docefrez
Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Navzea (S3/4: 13,9 %), stomatitis (S3/4:
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
You must not breast-feed while using Docefrez.
Med zdravljenjem s Docefrezom NE smete dojiti.
Number of patients Median survival (months) 95% CI
Število bolnikov Mediana preživetja (meseci) 95 % IZ
There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other disease-related medications (p=0.06) and radiotherapy (p<0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/m2, so rabili manj morfinskih analgetikov (p < 0,01), nemorfinskih analgetikov (p < 0,01), drugih z boleznijo povezanih zdravil (p = 0,06) in radioterapije (p < 0,01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
Prophylactic G-CSF may be used to mitigate the risk of haematological toxicities.
Za zmanjšanje tveganja za hematološke toksične učinke se lahko profilaktično uporabi GCSF.
Overall survival at 5 years was also significantly increased with TAC compared to FAC (87% versus 81%, respectively) i.e. an absolute reduction of the risk of death by 6% (p=0.008).
Tudi celotno preživetje pri 5 letih je bilo značilno povečano pri TAC v primerjavi z FAC (87 % proti 81 %) t.j.
Non-small Cell Lung Cancer
Nedrobnocelični pljučni rak
Infection (G3/4: 3.6%) Neutropenic infection
Okužba (S3/4: 3,6 %) Nevtropenična okužba
Headache (G3/4: <1%); Neuropathy peripheral
Omotica, glavobol (S3/4: < 1 %), periferna nevropatija
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.
Radiation recall phenomena have rarely been reported.
Redko so poročali o pojavu pomnjenja obsevanja.
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).
Sicer pa je s preizkusom dokazano, da se kemična in fizična obstojnost pripravljene raztopine ohrani 8 ur, če je shranjena med 2°C in 8°C ali na sobni temperaturi (manj kot 25°C).
Docetaxel in combination with capecitabine
Docefrez v kombinaciji s kapecitabinom
Reconstituted solution The reconstituted solution contains 24 mg/ml docetaxel and should be used immediately after preparation.
Pripravljena raztopina Pripravljena raztopina vsebuje 24 mg/ml docetaksela in jo je treba uporabiti takoj po pripravi.
• one single-dose solvent vial with 4 ml solvent for docefrez (35.4% (w/w) ethanol in polysorbate 80) .
• ena viala za vehikel z enim odmerkom s 4 ml vehikla za zdravilo Docefrez (35,4 % (m/m) etanola v polisorbatu 80).
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 (F) 1000 mg/m2 na dan 5 dni.
5-fluorouracil (clinically important treatment related adverse events are presented).
(predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
Docetaxel every 3 weeks
Docetaksel vsake 3 tedne
Dehydration (G3/4: 2%);
Dehidracija (S3/4: 2 %),
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg docetaxel (anhydrous)
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 80 mg docetaxel (brez vode)
Docetaxel + Cis + 5-FU n = 255
Docetaksel + Cis + 5FU n = 255
The overfill ensures that after dilution with the entire extractable volume of the accompanying solvent vial for Docefrez, there is a minimal extractable reconstituted solution of 0.84 ml containing 20 mg docetaxel (anhydrous).
Prenapolnjenje zagotavlja, da je po razredčitvi s celotnim izločljivim volumnom raztopine viale z vehiklom za Docefrez, minimalen izločljivi volumen 0,84 ml, ki vsebuje 20 mg docetaksela (brez vode).
Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Reakcija na mestu infundiranja, nekardialne bolečine v prsih (hude
The overfills are included to ensure that, after dilution with the entire volume of the accompanying solvent vial, the minimum extractable volume of reconstituted concentrate containing 20 mg or 80 mg docetaxel, respectively, may be withdrawn from the vial.
Dodatek vsebine v viali zagotavlja, da je mogoče po razredčenju s celotno vsebino priložene viale z vehiklom iz viale izvleči najmanjšo prostornino pripravljenega koncentrata z 20 mg oziroma 80 mg docetaksela, ki jo je mogoče ekstrahitati.
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced
Učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov z inoperabilnim lokalno
After reconstitution, each vial contains an extractable volume of approx 0.84 ml concentrate, corresponding to approximately 20 mg docetaxel.
Po pripravi vsebuje vsaka viala izvlečeno količino koncentrata, približno 0,84 ml, kar ustreza približno
Patients on the docetaxel arm received docetaxel 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.
Ask your pharmacist how to dispose of medicines no longer required.
O odstranjevanju neuporabljenih zdravil se posvetujte s farmacevtom.
Docefrez is supplied as single-dose vials.
Docefrez je na voljo v vialah z enim odmerkom.
Each pack of Docefrez 80 mg powder for concentrate for solution for infusion contains one single-dose vial of docetaxel (anhydrous) (80 mg with corresponding fill of 94.4 mg as lyophilised powder) and a corresponding single-dose vial with 4.0 ml of solvent consisting of 35.4% (w/w) of Ethanol (anhydrous) in Polysorbate 80.
Vsako pakiranje praška Docefrez 80 mg za koncentrat za raztopino za infundiranje vsebuje vialo z enim odmerkom docetaksela (brez vode) (80 mg s polnjenjem 94,4 mg kot liofoliziran prašek in ustrezno vialo z enim odmerkom z 4,0 ml raztopine sestavljene iz 35,4% (t/t) etanola (brez vode) v polisorbatu 80.
• Each solvent vial of Docefrez 20 mg contains 1 ml of 35.4% w/w Ethanol in Polysorbate 80
• Vsaka viala topila docefreza 20 mg vsebuje 1 ml 35,4 % etanola v polisorbatu 80
For treatment 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/m v monoterapiji.
Instructions for reconstitution
Navodila za pripravo raztopine
Infection (G3/4: 7.8%)
Okužba (S3/4: 7,8 %)
Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Bolnike s hudim zastajanjem tekočine, npr. s plevralnim izlivom, perikardialnim izlivom ali ascitesom,
2.1 Docefrez 80 mg powder vials
2.1 Docefrez 80 mg viala s praškom
Each pack of Docefrez 20 mg powder for concentrate for solution for infusion contains one single-dose vial of docetaxel (anhydrous) (20 mg with corresponding fill of 24.4 mg as lyophilised powder) and a corresponding single-dose vial with 1 ml of solvent consisting of 35.4% (w/w)of Ethanol (anhydrous) in Polysorbate 80.
Vsako pakiranje praška Docefrez 20 mg za koncentrat za raztopino za infundiranje vsebuje vialo z enim odmerkom docetaksela (brez vode) (20 mg s polnjenjem 24,4 mg kot liofoliziran prašek in ustrezno vialo z enim odmerkom 1 ml raztopine sestavljene iz 35,4 % (t/t) etanola (brez vode) v polisorbatu 80.
Musculoskeletal and connective tissue
Bolezni mišično-skeletnega sistema in vezivnega tkiva
The Docefrez 80 mg powder is a white to off white lyophilised powder containing 80 mg (plus 18% overfill: 94.4 mg) of docetaxel (anhydrous).
Prašek Docefrez 80 mg je bel do snežno bel liofoliziran prašek, ki vsebuje 80 mg (plus 18% prenapolnjenosti: 94,4 mg) docetaxela (brez vode)).
Patients with operable node-positive breast cancer
- z operabilnim rakom dojke s pozitivnimi bezgavkami
Data from a multicenter open label randomized trial support the use of docetaxel 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 za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami,
Breast cancer
Bolečina zaradi raka
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z-namenom-zdravljenja)
Alopecia; Skin reaction (G3/4:
Alopecija, kožna reakcija (S3/4:
• 1312 and 121 patients who received 100 mg/ m2 and 75 mg/m2 of docetaxel as a single agent respectively.
• 1312 bolnikih, ki so v monoterapiji prejemali 100 mg/m2 docetaksela, 121 pa jih je prejemalo 75
Thrombocytopenia (G3/4: 0.6%); Febrile neutropenia
Trombocitopenija, (S3/4: 0,6 %), febrilna nevtropenija
1 WHAT DOCEFREZ IS AND WHAT IT IS USED FOR
Kaj je zdravilo Docefrez in za kaj ga uporabljamo 2.
Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Nevtropenija (S3/4: 32 %), anemija (S3/4: 4,9 %)
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3% of patients who received TAC and 51.2% of patients who received FAC.
ki so prejemale TAC, in 51,2% bolnic, ki so prejemale FAC.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije
Dyspnoea; Cough;
• zadihanost, kašelj*;
Median duration of response (months) (95% CI)
Mediano trajanje odziva (meseci) (95 % IZ)
Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
febrilna nevtropenija (vključuje nevtropenijo, povezano z zvišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
Docetaxel 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.
Docefrez v kombinaciji s cisplatinom je indiciran za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
Based on pharmacokinetic data with docetaxel at 100 mg/m2 as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is
Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m2 je priporočljivi odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo normalnega območja (ULN) in alkalno fosfatazo nad 2,5-kratno ULN,
Your doctor may prescribe you other medicines before or during treatment with Docefrez: - to minimise allergic reactions and fluid retention (pre-treatment with an oral corticoid such as dexamethasone), - to stimulate your bone marrow to produce more blood cells (e.g. filgrastim).
- za zmanjšanje alergijskih reakcij ali zadrževanje tekočine (predhodno zdravljenje s peroralnim kortikosteroidom kot je na primer dexamethasone);
Docefrez 80 mg powder and solvent for concentrate for solution for infusion: Powder vial: Docefrez is a white lyophilised powder, supplied in a colourless glass vial with a grey non-latex rubber stopper and a red aluminium seal.
Prašek in vehikel Docefrez 80 mg za pripravo koncentrataza raztopino infundiranjee: Viala s praškom: Docefrez je bel liofoliziran prašek, v brezbarvni stekleni viali s sivim gumijastim pokrovom brez lateksa in rdečim aluminijastim zamaškom.
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 study (TAX323).
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).
2.1 Docefrez 20 mg powder vials
2.1 Docefrez 20 mg viala s praškom
Solvent for Docefrez 80 mg
OVOJNINAH Etiketa viale raztopila za Docefrez 80 mg
Neutropenic infection; Infection (G3/4: 11.7%)
Infekcijske in parazitske bolezni Nevtropenična okužba, okužba (S3/4: 11,7 %)
• Induction chemotherapy followed by radiotherapy(TAX323).
• Indukcijska kemoterapija in nato radioterapija (TAX323)
Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805) Without primary G-CSF prophylaxis (n = 111) n (%)
(GEICAM 9805) Brez primarne profilakse z G-CSF (n = 111) n (%)
The Docefrez 20 mg powder is a white to off white lyophilised powder containing 20 mg (plus 22% overfill: 24.4 mg) of docetaxel (anhydrous).
Prašek Docefrez 20 mg ml je bel do snežno bel liofoliziran prašek, ki vsebuje 20 mg (plus 22 % prenapolnjenosti: 24,4 mg) docetaksela (brez vode)).
• redness and swelling of the palms of your hands or soles of your feet which may cause skin to peel
• rdečica in otekanje dlani ali podplatov na nogah, kar lahko povzroči lupljenje kože (se lahko pojavi tudi na rokah, obrazu ali telesu)*;
• decrease in blood pressure (hypotension), heart failure; irregular heart beat (arrhythmia)
• znižanje krvnega tlaka (hipotenzia), srčne okvare; neredni srčni utrip (aritmija); • suha usta, težavno ali boleče požiranje, vnetje požiralnika (oesophagitis);
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel
Med monoterapijo z docetakselom so zabeležili več neželenih učinkov 3. ali 4. stopnje (55,4 %) kot med terapijo s paklitakselom (23,0 %).
Polysorbate 80
Brezvodni etanol Polisorbat 80
Docetaxel is an antineosplastic agent and, as with other potentially cytotoxic compounds, caution should be exercised when preparing docetaxel solutions.
Docetaksel je antineoplastično sredstvo, zato je tako kot pri ravnanju z drugimi morebitno citotoksičnimi učinkovinami potrebna previdnost pri pripravi raztopin docetaksela.
The solvent contains 35.4% w/w ethanol and polysorbate 80.
Raztopina vsebuje 35,4 % etanola in polisorbata 80.
Myocardial ischemia (G3/4: 1.7%)
Miokardna ishemija (S3/4: 1,7 %)
Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%)
Disgevzija (S3/4: < 1 %), parestezije (S3/4: < 1 %)
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or below 25°C and for the final solution for infusion for 4 hours at room temperature.
Kemična in fizikalna stabilnost pripravljene (rekonstituirane) raztopine je 8 ur pri shranjevanju pri temperaturi med 2 °C in 8 °C ali pod 25°C in za končno raztopino za infuzijo 4 ure pri sobni temperaturi.
Docefrez 20 mg powder and solvent for concentrate for solution for infusion: Powder vial: Docefrez is a white lyophilised powder, supplied in a colourless glass vial with a grey non-latex rubber stopper and a green aluminium seal.
Prašek in vehikel Docefrez 20 mg za pripravo koncentrataza raztopino infundiranjee: Viala s praškom: Docefrez je bel liofoliziran prašek, v brezbarvni stekleni viali s sivim gumijastim pokrovom brez lateksa in zelenim aluminijastim zamaškom.
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 bolnicah starih > 70 let je malo.
• The Docefrez 20 mg vial contains a white to off white lyophilised powder in a 5 ml tubular colourless glass vial with 20 mm grey rubber stopper and sealed with dark green flip-off aluminium seal.
• Viala Docefrez 20 mg vsebuje bel do sivo bel liofoliziran prašek, v 5 ml cevasti brezbarvni viali z 20 mm sivim pokrovom in zaprto s temno zelenim aluminijastim tesnilom.
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.