FrancophonIA/ELRC3.0 huggingface dataset:
English: Ask your pharmacist how to dispose of medicines no longer required.
Slovenian: O odstranjevanju neuporabljenih zdravil se posvetujte s farmacevtom.
English: Docefrez is supplied as single-dose vials.
Slovenian: Docefrez je na voljo v vialah z enim odmerkom.
English: 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.
Slovenian: 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.
English: • Each solvent vial of Docefrez 20 mg contains 1 ml of 35.4% w/w Ethanol in Polysorbate 80
Slovenian: • Vsaka viala topila docefreza 20 mg vsebuje 1 ml 35,4 % etanola v polisorbatu 80
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m2 as a single agent.
Slovenian: Za zdravljenje po neuspehu predhodne, na platini osnovane kemoterapije, je priporočeni odmerek 75 mg/m v monoterapiji.
English: Instructions for reconstitution
Slovenian: Navodila za pripravo raztopine
English: Infection (G3/4: 7.8%)
Slovenian: Okužba (S3/4: 7,8 %)
English: Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Slovenian: Bolnike s hudim zastajanjem tekočine, npr. s plevralnim izlivom, perikardialnim izlivom ali ascitesom,
English: 2.1 Docefrez 80 mg powder vials
Slovenian: 2.1 Docefrez 80 mg viala s praškom
English: 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.
Slovenian: 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.
English: Musculoskeletal and connective tissue
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva
English: 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).
Slovenian: Prašek Docefrez 80 mg je bel do snežno bel liofoliziran prašek, ki vsebuje 80 mg (plus 18% prenapolnjenosti: 94,4 mg) docetaxela (brez vode)).
English: België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Slovenian: België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V.
English: Patients with operable node-positive breast cancer
Slovenian: - z operabilnim rakom dojke s pozitivnimi bezgavkami
English: 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.
Slovenian: Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo zdravila Docetaksel za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami,
English: Breast cancer
Slovenian: Bolečina zaradi raka
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Slovenian: Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z-namenom-zdravljenja)
English: Alopecia; Skin reaction (G3/4:
Slovenian: Alopecija, kožna reakcija (S3/4:
English: • 1312 and 121 patients who received 100 mg/ m2 and 75 mg/m2 of docetaxel as a single agent respectively.
Slovenian: • 1312 bolnikih, ki so v monoterapiji prejemali 100 mg/m2 docetaksela, 121 pa jih je prejemalo 75
English: Thrombocytopenia (G3/4: 0.6%); Febrile neutropenia
Slovenian: Trombocitopenija, (S3/4: 0,6 %), febrilna nevtropenija
English: 1 WHAT DOCEFREZ IS AND WHAT IT IS USED FOR
Slovenian: Kaj je zdravilo Docefrez in za kaj ga uporabljamo 2.
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Slovenian: Nevtropenija (S3/4: 32 %), anemija (S3/4: 4,9 %)
English: 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).
Slovenian: 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).
English: 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.
Slovenian: ki so prejemale TAC, in 51,2% bolnic, ki so prejemale FAC.
English: 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.
Slovenian: 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
English: Dyspnoea; Cough;
Slovenian: • zadihanost, kašelj*;
English: Median duration of response (months) (95% CI)
Slovenian: Mediano trajanje odziva (meseci) (95 % IZ)
English: Neutropenia (G3/4: 32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Slovenian: febrilna nevtropenija (vključuje nevtropenijo, povezano z zvišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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,
English: 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).
Slovenian: - za zmanjšanje alergijskih reakcij ali zadrževanje tekočine (predhodno zdravljenje s peroralnim kortikosteroidom kot je na primer dexamethasone);
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 2.1 Docefrez 20 mg powder vials
Slovenian: 2.1 Docefrez 20 mg viala s praškom
English: Solvent for Docefrez 80 mg
Slovenian: OVOJNINAH Etiketa viale raztopila za Docefrez 80 mg
English: Neutropenic infection; Infection (G3/4: 11.7%)
Slovenian: Infekcijske in parazitske bolezni Nevtropenična okužba, okužba (S3/4: 11,7 %)
English: • Induction chemotherapy followed by radiotherapy(TAX323).
Slovenian: • Indukcijska kemoterapija in nato radioterapija (TAX323)
English: Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805) Without primary G-CSF prophylaxis (n = 111) n (%)
Slovenian: (GEICAM 9805) Brez primarne profilakse z G-CSF (n = 111) n (%)
English: 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).
Slovenian: 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)).
English: • redness and swelling of the palms of your hands or soles of your feet which may cause skin to peel
Slovenian: • rdečica in otekanje dlani ali podplatov na nogah, kar lahko povzroči lupljenje kože (se lahko pojavi tudi na rokah, obrazu ali telesu)*;
English: • decrease in blood pressure (hypotension), heart failure; irregular heart beat (arrhythmia)
Slovenian: • znižanje krvnega tlaka (hipotenzia), srčne okvare; neredni srčni utrip (aritmija); • suha usta, težavno ali boleče požiranje, vnetje požiralnika (oesophagitis);
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel
Slovenian: Med monoterapijo z docetakselom so zabeležili več neželenih učinkov 3. ali 4. stopnje (55,4 %) kot med terapijo s paklitakselom (23,0 %).
English: Polysorbate 80
Slovenian: Brezvodni etanol Polisorbat 80
English: Docetaxel is an antineosplastic agent and, as with other potentially cytotoxic compounds, caution should be exercised when preparing docetaxel solutions.
Slovenian: Docetaksel je antineoplastično sredstvo, zato je tako kot pri ravnanju z drugimi morebitno citotoksičnimi učinkovinami potrebna previdnost pri pripravi raztopin docetaksela.
English: The solvent contains 35.4% w/w ethanol and polysorbate 80.
Slovenian: Raztopina vsebuje 35,4 % etanola in polisorbata 80.
English: Myocardial ischemia (G3/4: 1.7%)
Slovenian: Miokardna ishemija (S3/4: 1,7 %)
English: Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%)
Slovenian: Disgevzija (S3/4: < 1 %), parestezije (S3/4: < 1 %)
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: There are limited data available in patients >70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Slovenian: Podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah starih > 70 let je malo.
English: • 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.
Slovenian: • 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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).
English: A hazard ratio of less than 1 favors Docetaxel +Cisplatin+5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Slovenian: *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Log-rank test ***Hi - kvadrat test
English: 1-year Survival (%)
Slovenian: mediana preživetja (meseci) 1-letno preživetje (%)
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Slovenian: Mialgija (S3/4: 2 %), artralgija (S3/4: 1 %)
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%)
Slovenian: Dispneja (S3/4: 1 %), kašelj (S3/4: < 1 %), epistaksa (S3/4: < 1 %)
English: Solvent for Docefrez 80 mg, Powder for Solution for Infusion
Slovenian: Raztopilo za docefrez 80 mg, prašek za raztopino za infuzijo
English: • 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.
Slovenian: • Indukcijska kemoterapija in nato radioterapija (TAX323) 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.
English: • muscle aches and pains; back pain or bone pain*
Slovenian: • obarvanost nohtov*, ki se lahko začnejo cepiti; • bolečine v mišicah; bolečine hrbta ali bolečine v kosteh*;
English: Somnolence (G3/4: 0%)
Slovenian: somnolenca (S3/4; 0 %)
English: 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 75 mg/m2 (see sections 4.4 and 5.2).
Slovenian: 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, 75
English: 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.
Slovenian: 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
English: Oral candidiasis (G3/4: <1%)
Slovenian: Oralna kandidoza (S3/4: < 1 %)
English: MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA
English: Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Slovenian: Docefrez v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
English: 4.8 Undesirable effects
Slovenian: Možni neželeni učinki
English: • Each vial of Docefrez 80 mg contains 80 mg docetaxel (anhydrous) (plus 18% overfill: 94.4 mg
Slovenian: • Vsaka viala Docefrez 80 mg vsebuje 80 mg docetaxela (brez vode) (plus 18% prenapolnjenosti: 94,4 mg docetaxela).
English: Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Slovenian: Docefrez je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
English: • Each solvent vial of Docefrez 80 mg contains 4 ml of 35.4% w/w ethanol in Polysorbate 80.
Slovenian: • Vsaka viala topila docefreza 80 mg vsebuje 1 ml 35,4% etanola v polisorbatu 80
English: Infection (G3/4: 5.7%)
Slovenian: Okužba (S3/4: 5,7 %)
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Slovenian: Artralgija (S3/4: 0,3 %), mialgija (S3/4: 0,3 %)
English: Docetaxel in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Slovenian: Docefrez je indiciran v kombinaciji s trastuzumabom za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo čezmerno izražen HER2 in ki predhodno niso bile zdravljene s kemoterapijo za metastatsko bolezen.
English: - if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docefrez - if your number of white blood cells is too low - if you have severe liver disease
Slovenian: če ste alergični na (preobčutljivi za) docetaksel ali katerokoli sestavino zdravila Docefrez.
English: Alopecia (G3/4: 4.0%)
Slovenian: Alopecija (S3/4: 4,0 %)
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours over express HER2, and who previously had not received chemotherapy for metastatic disease.
Slovenian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 80 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Embalaža 80 mg
English: Take special care with Docefrez
Slovenian: Z Docefrez-om bodite izredno previdni
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and
Slovenian: • 174 in 251 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).
English: Peripheral sensory neuropathy (G3/4: 1.2%)
Slovenian: periferna senzorična nevropatija (S3/4: 1,2 %)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 20 mg
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Embalaža 20 mg
English: Solvent vial: 4 ml clear, colourless solution supplied in a glass vial with a grey non-latex rubber stopper and a brown aluminium seal.
Slovenian: Viala z vehiklom: 4 ml čistega, brezbarvnega vehikla v stekleni viali s sivim gumijastim pokrovom brez lateksa in rjavim aluminijastim zamaškom.
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Slovenian: Nevtropenija (S3/4: 63 %), anemija (S3/4: 10 %)
English: Store in a refrigerator
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Hranite v hladilniku.
English: HOW TO STORE DOCEFREZ
Slovenian: Sestavine Docefrez
English: Discontinue treatment if these toxicities persist (see section
Slovenian: Če ti toksični učinki trajajo, zdravljenje prekinite (glejte poglavje 4.4).
English: Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil for head and neck cancer
Slovenian: Docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
English: • one single-dose powder vial with 20 mg docetaxel (plus 22% overfill: 24.4 mg), and
Slovenian: • viala z enim odmerkom praška, to je 20 mg docetaksela (plus 22% dodatka celotni vsebini: 24,4 mg)
English: Nausea; Diarrhoea;
Slovenian: Letargija, bolečine
English: G3/4 Blood bilirubin increased (2.1%);
Slovenian: Zvečanje bilirubina v krvi S3/4 (2,1 %),
English: Solvent vial: 1 ml clear, colourless solution supplied in a glass vial with a grey non-latex rubber stopper and a blue aluminium seal.
Slovenian: Viala z vehiklom: 1 ml čistega, brezbarvnega vehikla v stekleni viali s sivim gumijastim pokrovom brez lateksa in modrim aluminijastim zamaškom.
English: Peripheral sensory neuropathy (G3: 4.1%);
Slovenian: Periferna senzorična nevropatija (S3: 4,1 %),
English: Anorexia (G3/4:0.6%)
Slovenian: Anoreksija (S3/4: 0,6 %)
English: (95% CI) ***p-value Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value A hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Slovenian: Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin + fluorouracil *Nekorigirani log-rang test **Nekorigirani log-rang test, nekorigiran za multiple primerjave ***Test hi-kvadrat, nekorigiran za multiple primerjave NP - ni podatka
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Slovenian: Mialgija (S3/4: 0,7 %), artralgija (S3/4: 0,2 %)
English: • Each vial of Docefrez 20 mg contains 20 mg docetaxel (anhydrous) (plus 22% overfill: 24.4 mg
Slovenian: • Vsaka viala Docefrez 20 mg vsebuje 20 mg docetaksela (brez vode) (plus 22% prenapolnjenosti: 24,4 mg docetaksela).
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Slovenian: Driska 4. stopnje Prvi pojav: zmanjšajte odmerka docetaksela in 5-FU za 20 %.
English: Anaemia (G3/4: 3%); Neutropenia (G3/4:
Slovenian: Anemija (S3/4: 3 %), nevtropenija (S3/4:
English: Preclinical data
Slovenian: Končna točka
English: • inflammation of the colon, small intestine; intestinal perforation
Slovenian: • vnetje debelega črevesa, tankega črevesa; črevesna perforacija;