FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel in combination with doxorubicin
Slovenian: Docetaksel v kombinaciji z doksorubicinom
English: In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Slovenian: V kombinaciji s kapecitabinom je priporočeni odmerek docetaksela 75 mg/m2 na tri tedne, kombiniran s kapecitabinom 1.250 mg/m2 dvakrat na dan (v 30 minutah po obroku) 2 tedna, čemur sledi 1-tedenski premor.
English: Diarrhoea grade 3 First episode: reduce 5-FU dose by 20%.
Slovenian: Prilagoditev odmerka driska 3. stopnje Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product which contains only 1 vial of concentrate.
Slovenian: NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel) s tem zdravilom, ki vsebuje samo 1 vialo koncentrata.
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/m2 v monoterapiji.
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Slovenian: • plučna fibroza (brazgotinjenje in zadebelitve v pljučih, težko dihanje/kratka sapa)
English: In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m2 every 3 weeks).
Slovenian: Pri bolnicah z neuspelim alkilirajočim zdravljenjem so docetaksel primerjali z doksorubicinom (75 mg/m2 na 3 tedne).
English: • 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, randomised study (TAX323).
Slovenian: • 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 III. faze (TAX323).
English: Data from a multicentre open-label randomised 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, primernih za prejemanje kemoterapije.
English: • 1,312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent respectively.
Slovenian: • 1.312 bolnikih, ki so v monoterapiji prejemali 100 mg/m² docetaksela, 121 pa jih je prejemalo 75 mg/m².
English: Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Slovenian: Priporočene prilagoditve odmerka v primeru toksičnih učinkov pri bolnikih, ki prejemajo docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (5-FU): Toksičen učinek
English: Docetaxel Accord in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Slovenian: Zdravilo Docetaksel Accord je v kombinaciji s cisplatinom in 5-fluorouracilom indicirano za zdravljenje bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki predhodno še niso bili zdravljeni s kemoterapijo za metastatsko bolezen.
English: Tumour response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Slovenian: 95 % IZ p-vrednost†* število bolnikov odzivnost na PSA** (%) 95 % IZ p-vrednost* število bolnikov odzivnost na bolečino (%) 95 % IZ p- vrednost* število bolnikov odzivnost tumorja (%) 95 % IZ p- vrednost* †Stratificiran log-rang test *Prag statistične značilnosti = 0,0175 **PSA: prostatični specifični antigen
English: (G3/4: 1.2%)
Slovenian: (S3/4:0,2 %)
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Slovenian: V tem preskušanju so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m2 v 1-urni intravenski infuziji na 3 tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
English: Read the package leaflet before use Single use vial
Slovenian: Pred uporabo preberite priloženo navodilo!
English: mostly associated with dehydration, vomiting and pneumonia.
Slovenian: Opisani so bili primeri hiponatriemije, večinoma povezani z dehidracijo, bruhanjem in pljučnico.
English: Marketing Authorisation Holder Accord Healthcare S.L.U.
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec Imetnik dovoljenja za promet z zdravilom Accord Healthcare S.L.U.
English: 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).
Slovenian: 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).
English: For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg twice daily) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Slovenian: Pri zdravljenju raka dojke, nedrobnoceličnega pljučnega raka, raka želodca ter raka glave in vratu lahko kot premedikacijo dajemo peroralne kortikosteroide, kot je deksametazon 16 mg na dan (npr. 8 mg dvakrat na dan v trajanju treh dni, in sicer 1 dan pred aplikacijo docetaksela, razen v primeru kontraindikacij (prosimo, glejte poglavje 4.4).
English: A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m2 as a 1 hour infusion or paclitaxel 175 mg/m2 as a 3 hour infusion.
Slovenian: Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetakselom 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v
English: At the median follow-up time of 77 months, overall survival (OS) was 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).
Slovenian: 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).
English: Description of selected adverse reactions for adjuvant therapy with docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Slovenian: Opis izbranih neželenih učinkov adjuvantnega zdravljenja z zdravilom docetaksel 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805)
English: Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Accord solutions.
Slovenian: Docetaksel je zdravilo z delovanjem na novotvorbe (citostatik) in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin zdravila Docetaksel Accord potrebna previdnost.
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with docetaxel 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
Slovenian: Tabelarični prikaz neželenih učinkov adjuvantnega zdravljenja z zdravilom docetaksel 75 mg/m2 v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah z rakom dojke s pozitivnimi bezgavkami (TAX 316) in negativnimi bezgavkami (GEICAM 9805) - kumulativni podatki
English: - For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.
Slovenian: - Za zdravljenje raka prostate se docetaksel lahko uporablja v kombinaciji s prednizonom ali prednizolonom.
English: In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
Slovenian: V študiji TAX316 je alopecija trajala še naprej v obdobju spremljanja po koncu kemoterapije pri 687 od 744 bolnic, ki so prejemale TAC(92,3 %), in pri 645 od 736 bolnic, ki so prejemale FAC (87,6 %).
English: - For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Slovenian: - Za zdravljenje metastatskega raka želodca se docetaksel uporablja v kombinaciji s cisplatinom in 5fluorouracilom.
English: • operable node-negative breast cancer .
Slovenian: • z operabilnim rakom dojke z negativnimi bezgavkami.
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 (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.
English: There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medicinal products (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/m2 compared to those with BSC.
Slovenian: 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.
English: - For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Slovenian: - Za zdravljenje raka glave in vratu se docetaksel uporablja v kombinaciji s cisplatinom in 5fluorouracilom.
English: 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 (0.64-1.08), p=0.1646).
Slovenian: 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).
English: Each box contains one vial of 1 ml concentrate.
Slovenian: Ena škatla vsebuje 1 vialo z 1 ml koncentrata.
English: Patients with operable node-positive breast cancer (TAX 316) Data from a multicentre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Slovenian: Podatki multicentriče, odprte randomiziranege študije podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke, pozitivnimi bezgavkami in seštevkom po Karnofskem  80 %.
English: If you have any further questions, ask your doctor, hospital pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, s farmacevtom ali z medecinsko sestro.
English: Each box contains one vial of 8 ml concentrate.
Slovenian: Ena škatla vsebuje 1 vialo z 8 ml koncentrata.
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe: 0.07%)
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S3: 4,1 %), periferna motorična nevropatija (S3/4: 4 %), dizgevzija (huda: 0,07
English: More than one vial of Docetaxel Accord concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Slovenian: Za odmerek, ki ga potrebuje bolnik, je lahko potrebna več kot ena viala koncentrata za raztopino za infundiranje Docetaksel Accord.
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: Somnolence (G3/4: 0%)
Slovenian: sinkopa (S3/4: 0 %) nevrotoksičnost (S3/4: somnolenca (S3/4; 0 %)
English: Vascular disorders Venous thromboembolic events have rarely been reported.
Slovenian: Žilne bolezni Opisani so bili redki primeri venskih trombembolij.
English: Each box contains one vial of 4 ml concentrate.
Slovenian: Ena škatla vsebuje 1 vialo s 4 ml koncentrata.
English: (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
Slovenian: z 11 tedni, p = 0,0004) in podaljšal celotno preživetje (11 mesecev v prim.
English: • Mix the infusion bag manually using a rocking motion.
Slovenian: • Infuzijsko vrečko ročno premešajte z nagibanjem sem in tja.
English: If Docetaxel Accord concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Slovenian: Če pride koncentrat ali raztopina za infundiranje Docetaksel Accord v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
English: Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Slovenian: Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje Ena viala z 8 ml koncentrata vsebuje 160 mg docetaksela.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata vsebuje 20 mg docetaksela.
English: In Docetaxel Accord 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V Docetaksel Accord 20 mg/1 ml vialah je koncentracija docetaksela 20 mg/ml.
English: The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR USE WITH DOCETAXEL ACCORD CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: NAVODILA ZA UPORABO GLEDE PRIPRAVE KONCENTRATA ZA RAZTOPINO ZA INFUNDIRANJE DOCETAKSEL ACCORD
English: Docetaxel + Cis + 5-FU n = 177
Slovenian: Končna točka docetaksel+ Cis+5-FU n = 177
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks,
Slovenian: Za kombinacijo s trastuzumabom je priporočeni odmerek docetaksela 100 mg/m2 vsake tri tedne, s tedensko aplikacijo trastuzumaba.
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Slovenian: Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Ena viala koncentrata vsebuje 0,5 ml brezvodnega etanola (395 mg).
English: Docetaxel infusion solution is supersaturated, therefore may crystallise over time.
Slovenian: Raztopina docetaksela je prenasičena raztopina, ki lahko čez čas kristalizira.
English: 1060 patients were randomised 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
Slovenian: 1060 bolnic je bilo naključno razporejenih na prejemanje zdravila docetaksel 75 mg/m2 1 -uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (539
English: Docetaxel in combination with capecitabine
Slovenian: Docetaksel v kombinaciji s kapecitabinom
English: 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.
Slovenian: 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.
English: There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Slovenian: Starostniki podatkov o uporabi docetaksela v kombinaciji z doksorubicinom in ciklofosfamidom pri bolnicah starih > 70 let je malo.
English: • flushing, skin reactions, itching
Slovenian: • vročinski oblivi, kožne reakcije, srbenje
English: Docetaxel Accord 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: Zdravilo Docetaksel Accord v kombinaciji s cisplatinom je indicirano za zdravljenje neresektabilnega, lokalno napredovalega ali metastatskega nedrobnoceličnega pljučnega raka pri bolnikih, ki zaradi te bolezni še niso dobivali kemoterapije.
English: If Docetaxel Accord concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Slovenian: Če pride koncentrat ali raztopina za infundiranje Docetaksel Accord v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
English: 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.
Slovenian: 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.
English: Docetaxel + Cis + 5-FU n = 255
Slovenian: Končna točka docetaksel + Cis + 5-FU n = 255
English: Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period,
Slovenian: Limfedem, ki se je začel med obdobjem zdravljenja, se je med obdobjem spremljanja nadaljeval pri 5 bolnicah (0,9 %) v kraku TAC in pri 2 bolnicah (0,4 %) v kraku FAC.
English: If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
English: Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml.
Slovenian: 3,7 µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Accord Healthcare Ltd.
English: For patients with serum bilirubin levels > ULN and/or ALT and AST > 3.5 times the ULN concurrent with serum alkaline phosphatase levels > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Slovenian: 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.
English: Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Slovenian: Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje Ena viala koncentrata vsebuje 4 ml brezvodnega etanola (3,16 g).
English: Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Slovenian: Zdravilo Docetaksel Accord v kombinaciji s kapecitabinom je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
English: Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Slovenian: Opisani so redki primeri enterokolitisa, vključno s kolitisom, ishemičnim kolitisom in nevtropeničnim enterokolitisom, s potencialnim smrtnim izidom (pogostnost neznana).
English: 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
Slovenian: 50 vol % brezvodnega etanola (alkohola), kar ustreza 3,16 g brezvodnega etanola na vialo in je ekvivalentno 80 ml piva ali 33 ml vina.
English: 3 weeks for 4 cycles.
Slovenian: CF pa 4 tedne.
English: 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Slovenian: 50 vol % brezvodnega etanola (alkohola), kar ustreza 1,58 g brezvodnega etanola na vialo in je ekvivalentno 40 ml piva ali 17 ml vina.
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Slovenian: Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Ena viala z 1 ml koncentrata vsebuje 20 mg docetaksela.
English: What Docetaxel Accord contains - The active substance is docetaxel.
Slovenian: Kaj vsebuje zdravilo Docetaksel Accord Učinkovina je docetaksel.
English: Hazard ratio (TAC/FAC) (95% CI)
Slovenian: Razmerje ogroženosti (TAC/FAC)
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Slovenian: razmerje tveganj: 1,122 [97,2 % IZ: 0,937, 1,342]*
English: Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Slovenian: Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje Ena viala s 4 ml koncentrata vsebuje 80 mg docetaksela.
English: Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4: 2,4 %), nevtropenična okužba (S3/4: 2,6%).
English: 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 arm No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Slovenian: Po 10 letih spremljanja v študiji GEICAM 9805 se je akutna levkemija pojavila pri 1 od 532 (0,2 %) bolnic v kraku TAC.
English: Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Slovenian: Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje Ena viala koncentrata vsebuje 2 ml brezvodnega etanola (1,58 g).