FrancophonIA/ELRC3.0 huggingface dataset:
English: Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Slovenian: Pri bolnicah, ki prejemajo adjuvantno zdravljenje raka dojke z docetakselom, doksorubicimom in ciklofosfamidom (TAC), pride v poštev profilaksa z G-CSF.
English: One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Slovenian: Ena viala z 8 ml koncentrata vsebuje 160 mg docetaksela.
English: If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Slovenian: Če opazite katerega koli izmed neželeni učinek, se posvetujte s svojim zdravnikom, bolnišničnim farmacevtom ali medicinsko sestro.
English: Nail disorders (severe: 0.4%); Skin reaction (no severe)
Slovenian: Bolezni kože in podkožja alopecija, spremembe nohtov (hude: 0,4 %), kožna reakcija (nobene hude)
English: Median survival (months) (95% CI)
Slovenian: Mediano preživetje (meseci) (95 % IZ)
English: Third episode: reduce docetaxel dose by 20%.
Slovenian: Tretji pojav: zmanjšajte odmerek docetaksela za 20 %.
English: DOCETAXEL KABI will be administered to you by a healthcare professional.
Slovenian: Kako uporabljati zdravilo DOCETAKSEL KABI Zdravilo DOCETAKSEL KABI vam bo dal pristojni zdravstveni delavec.
English: Dehydration and pulmonary oedema have rarely been reported.
Slovenian: V redkih primerih so poročali o dehidraciji in pljučnem edemu.
English: Peripheral motor neuropathy (G3/4: 0%)
Slovenian: periferna motorična nevropatija (S3/4: 0 %)
English: Anorexia (G3/4: 1%); Decreased appetite
Slovenian: Presnovne in prehranske motnje anoreksija (S3/4: 1 %), zmanjšan apetit dehidracija (S3/4: 2 %)
English: Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
Slovenian: Najboljši celotni odziv (CR + PR) na kemoterapijo (%) (95 % IZ) ***vrednost p
English: • shortness of breath
Slovenian: • težko dihanje,
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Slovenian: Pri bolnikih zdravljenih z docetakselom so bili opisani primeri cistoidnega makularnega edema (CMO).
English: Myocardial ischemia (G3/4: 1.7%)
Slovenian: Srčne bolezni miokardna ishemija (S3/4: 1,7 %)
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms.
Slovenian: 3.-4. stopnja = S3/4; 4. stopnja = S4) in z izrazi COSTART in MedDRA.
English: At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).
Slovenian: Na koncu spremljanja (dejanski mediani čas spremljanja 8 let) so še trajajoč limfedem opažali pri 6 bolnicah v kraku TAC (0,8 %) in pri 1 bolnici v kraku FAC
English: Second episode: reduce docetaxel dose by 20%.
Slovenian: Drugi pojav: zmanjšajte odmerek docetaksela za 20 %.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Polysorbate 80
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi polisorbat 80 brezvodni etanol brezvodna citronska kislina (za uravnavanje pH)
English: Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/ or cyclophosphamide (see section 4.8).
Slovenian: Pri bolnikih, zdravljenih z docetakselom v kombiniranih shemah, ki so vključevale doksorubicin, 5fluorouracil in/ali ciklofosfamid, so poročali o prekatnih motnjah srčnega ritma, vključno s prekatno tahikardijo (včasih s smrtnim izidom) (glejte poglavje 4.8).
English: Best overall response to chemotherapy (%) (95% CI) ***p-value
Slovenian: Najboljši celotni odziv na kemoterapijo (%) (95 % IZ) ***p-vrednost
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Slovenian: razmerje tveganj: 1,122 [97,2 % IZ: 0,937, 1,342]* razlika zdravljenj: 5,4 % [95 % IZ: -1,1, 12,0] razlika zdravljenj: 6,2 % [95 % IZ: 0,2, 12,3]
English: Median overall survival (months) (95% CI)
Slovenian: Mediano celotno preživetje (meseci) (95 % IZ)
English: Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
Slovenian: trombocitopenija (S3/4: 0,6 %), febrilna nevtropenija
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mg/9 ml OTHER Cytotoxic
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 180 mg/9 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
English: In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests.
Slovenian: Še zlasti morate zdravniku povedati, če se pojavijo driska, razjede v ustih, občutek otrplosti ali mravljinčenja ali povišana telesna temperatura.
English: Peripheral motor neuropathy (G3/4: 0.4%)
Slovenian: periferna motorična nevropatija (S3/4: 0,4 %)
English: For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Slovenian: Za prilagajanje odmerka trastuzumaba prosimo, glejte povzetek glavnih značilnosti trastuzumaba.
English: Toxicity
Slovenian: Hematologija
English: Median TTP (months) (95% CI)
Slovenian: Mediano PBN (meseci) (95 % IZ)
English: DOCETAXEL KABI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Slovenian: Zdravilo DOCETAKSEL KABI je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
English: Psychiatric disorders Insomnia Nervous system disorders
Slovenian: Presnovne in prehranske motnje anoreksija Psihiatrične motnje nespečnost
English: Arrhythmia (G3/4: 0.6%)
Slovenian: aritmija (S3/4: 0,6 %)
English: Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Slovenian: Opis izbranih neželenih učinkov zdravila DOCETAKSEL KABI 100 mg/m2 v kombinaciji s trastuzumabom pri raku dojke
English: You must not breast-feed while you are treated with DOCETAXEL KABI.
Slovenian: Med zdravljenjem z zdravilo DOCETAKSEL KABI ne smete dojiti.
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
Slovenian: Srčne bolezni zmanjšanje funkcije levega srčnega prekata (S3/4: 0,3 %)
English: At the end of the follow-up period (actual median follow-up time of 8 years), asthenia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Slovenian: Na koncu obdobja spremljanja (dejanski mediani čas spremljanja 8 let) so še trajajočo alopecijo zabeležili pri 29 bolnicah (3,9 %), ki so prejemale TAC, in pri 16 bolnicah (2,2 %), ki so prejemale FAC.
English: Constipation
Slovenian: vrtoglavica
English: One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Slovenian: Ena viala z 1 ml koncentrata vsebuje 20 mg docetaksela.
English: Each box contains one vial of 9 ml concentrate (180 mg docetaxel).
Slovenian: Ena škatla vsebuje 1 vialo z 9 ml koncentrata (180 mg docetaksela).
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%);Pain
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija (huda: 12,4 %), zastajanje tekočine (hudo: 0,8 %), bolečine
English: Each box contains one vial of 6 ml concentrate (120 mg docetaxel).
Slovenian: Ena škatla vsebuje 1 vialo s 6 ml koncentrata (120 mg docetaksela).
English: Pain in extremity (G3/4: < 1%); Back pain (G3/4: 1%)
Slovenian: bolečine v udih (S3/4: < 1 %), bolečine v hrbtu (S3/4: 1 %)
English: Nausea (G3/4: 5.0%); Stomatitis (G3/4: 6.0%); Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Slovenian: Bolezni prebavil navzea (S3/4: 5,0 %), stomatitis (S3/4: 6,0 %), bruhanje (S3/4: 4,2 %), driska (S3/4: 3,4 %), zaprtje (S3/4: 0,5 %)
English: Peripheral sensory neuropathy (G3: 0.4%)
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S3: 0,4 %)
English: In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
Slovenian: V obeh krakih so bolnice s tumorji, ki so imeli pozitivne ER in/ali PgR, po zadnjem ciklu kemoterapije do 5 let prejemale tamoksifen 20 mg enkrat na dan. Adjuvantna radioterapija je bila uporabljena v skladu z veljavnimi smernicami v sodelujočih ustanovah.
English: • muscle aches and pains; back pain or bone pain
Slovenian: • bolečine v mišicah, bolečine v hrbtu ali kosteh,
English: Cystoid macular oedema (CMO) has been reported in patients treated with docetaxel.
Slovenian: Pri bolnikih zdravljenih z docetakselom je bil opisan cistoidni makularni edem (CMO).
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%);
Slovenian: sinkopa (S3/4: 0 %), nevrotoksičnost (S3/4: 0 %), somnolenca (S3/4: 0 %)
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA DOCETAKSEL KABI 20 mg/1 ml koncentrat za raztopino za infundiranje
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Slovenian: Druga je na 3 tedne (Tcis) dobivala docetaksel 75 mg/m2 v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml.min) v 30-60 minutah, tretja pa na 4 tedne (VCis) vinorelbin (V) 25 mg/m2 v 6-10 minutah 1., 8., 15. in 22. dan, ki mu je 1. dan ciklov sledil cisplatin 100 mg/m2.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg/8 ml OTHER Cytotoxic
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 160 mg/8 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
English: Asthenia (severe: 8.1%); Fluid retention (severe: 1.2%); Pain
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija (huda: 8,1 %), zastajanje tekočine (hudo: 1,2 %), bolečine reakcija na mestu infundiranja
English: One vial of 6 ml of concentrate contains 120 mg of docetaxel.
Slovenian: Ena viala s 6 ml koncentrata vsebuje 120 mg docetaksela.
English: One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Slovenian: Ena viala s 4 ml koncentrata vsebuje 80 mg docetaksela.
English: • operable node-positive breast cancer
Slovenian: • z operabilnim rakom dojke s pozitivnimi bezgavkami,
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for DOCETAXEL KABI 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Slovenian: Opis izbranih neželenih učinkov zdravila DOCETAKSEL KABI 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
English: Vascular disorders Lymphoedema Respiratory, thoracic and mediastinal disorders
Slovenian: Očesne bolezni zvečano solzenje, konjunktivitis
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95% CI) ***p-value
Slovenian: Najboljši celotni odziv (CR + PR) na raziskovano terapijo [kemoterapija +/kemoradioterapija] (%) (95 % IZ) ***vrednost p
English: 95% CI p-value*
Slovenian: 95 % IZ p =
English: Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Slovenian: Ena škatla vsebuje 1 vialo s 4 ml koncentrata (80 mg docetaksela).
English: In study TAX316 asthenia that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).
Slovenian: V študiji TAX316 so astenijo, ki se je pojavila med obdobjem zdravljenja in je trajala še med obdobjem spremljanja po koncu kemoterapije, zabeležili pri 236 od 744 bolnicah v kraku TAC (31,7 %) in pri 180 od 736 bolnicah v kraku FAC (24,5 %).
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Slovenian: Ena škatla vsebuje 1 vialo z 8 ml koncentrata (160 mg docetaksela).
English: Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Slovenian: *Razmerje ogroženosti vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA DOCETAKSEL KABI 160 mg/8 ml koncentrat za raztopino za infundiranje
English: Phlebitis (G3/4: 0%)
Slovenian: limfedem (S3/4: 0 %)
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA DOCETAKSEL KABI 120 mg/6 ml koncentrat za raztopino za infundiranje
English: Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 32 %), febrilna nevtropenija (vključuje nevtropenijo, povezano s povišano telesno temperaturo in uporabo antibiotika) ali nevtropenična sepsa
English: The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC).
Slovenian: Kombinacija docetaksela in trastuzumaba je bila pri bolnicah učinkovita ne glede na to, ali so prej dobile adjuvantne antracikline ali ne. Glavni test za ugotavljanje HER2-pozitivnosti v tej odločilni študiji je bila imunohistokemija (IHK).
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA DOCETAKSEL KABI 180 mg/9 ml koncentrat za raztopino za infundiranje
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 120 mg/6 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
English: Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Slovenian: Ena škatla vsebuje 1 vialo z 1 ml koncentrata (20 mg docetaksela).
English: DOCETAXEL KABI in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Slovenian: Zdravilo DOCETAKSEL KABI je v kombinaciji z doksorubicinom indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija, periferni edemi, pireksija, utrujenost, vnetje sluznice, bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica letargija
English: DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
Slovenian: DOCETAKSEL KABI 120 mg/6 ml koncentrat za raztopino za infundiranje docetaksel
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA DOCETAKSEL KABI 80 mg/4 ml koncentrat za raztopino za infundiranje
English: There are no data available in patients with severely impaired renal function treated with docetaxel.
Slovenian: O zdravljenju z docetakselom pri bolnikih s hudo okvaro ledvic ni podatkov.
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Slovenian: V študiji GEICAM 9805 so nadaljnjo prisotnost amenoreje, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja, zabeležili pri 18 bolnicah (3,4 %) v kraku TAC in pri 5 bolnicah (1,0 %) v kraku FAC.
English: For trastuzumab dose and administration, see trastuzumab summary of product characteristics.
Slovenian: Za odmerjanje in dajanje trastuzumaba prosimo, glejte povzetek glavnih značilnosti zdravila trastuzumaba.
English: Thrombocytopenia (G3/4: 3%)
Slovenian: trombocitopenija (S3/4: 3 %)
English: 10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a orange flip-off aluminium over seal containing 9 ml of concentrate.
Slovenian: 10 ml viala iz prozornega, brezbarvnega stekla tipa I, zaprta z gumijastim zamaškom in oranžno snemno (flip-off) aluminijasto prekrivno zaporko, ki vsebuje 9 ml koncentrata.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE DOCETAKSEL KABI 120 mg/6 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Slovenian: V študiji TAX316 se je pri 84 bolnicah (11,3 %) v kraku TAC in pri 15 bolnicah (2 %) v kraku FAC med zdravljenjem pojavila periferna senzorična nevropatija, ki je trajala še med obdobjem spremljanja.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml OTHER Cytotoxic
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 80 mg/4 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
English: Docetaxel increased response rate (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: Single-use vial.
Slovenian: Viala za enkratno uporabo.
English: In study TAX316 lymphoedema that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%).
Slovenian: V študiji TAX316 so limfedem, ki se je pojavil med obdobjem zdravljenja in je trajal še med obdobjem spremljanja po koncu kemoterapije, zabeležili pri 11 od 744 bolnic v kraku TAC (1,5 %) in pri 1 od 736 bolnic v kraku FAC (0,1 %).
English: Rare cases of ileus and intestinal obstruction have been reported.
Slovenian: Opisani so redki primeri ileusa in zapore črevesa.
English: As with other cytotoxic medicinal products, docetaxel may cause foetal harm when administered to pregnant women.
Slovenian: Pri nosečnicah uporabljeni docetaksel lahko škoduje plodu, tako kot druga citotoksična zdravila.
English: Amenorrhoea (G3/4: NA)
Slovenian: Motnje reprodukcije in dojk amenoreja (S3/4: NA)
English: Conjunctivitis (G3/4: < 0.1%)
Slovenian: motnja solzenja (S3/4: < 0,1 %)
English: At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Slovenian: Na koncu spremljanja (dejanski mediani čas spremljanja 8 let) so še trajajočo astenijo opažali pri 29 bolnicah v kraku TAC (3,9 %) in pri 16 bolnicah v kraku FAC (2,2 %).
English: 10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a yellow flip-off aluminium over seal containing 8 ml of concentrate.
Slovenian: 10 ml viala iz prozornega, brezbarvnega stekla tipa I, zaprta z gumijastim zamaškom in rumeno snemno (flip-off) aluminijasto prekrivno zaporko, ki vsebuje 8 ml koncentrata.
English: Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Slovenian: Dokazano je bilo, da je preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
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
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 645 od 736 bolnic, ki so prejemale FAC (87,6%).
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 645 od 736 bolnic, ki so prejemale FAC (87,6 %).
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Slovenian: Bolezni prebavil navzea (S3/4: 3,3 %), stomatitis (S3/4: 1,7 %), driska (S3/4: 1,7 %), bruhanje (S3/4: 0,8 %)
English: Dyspnoea (G3/4: 1%); Cough (G3/4: < 1%);
Slovenian: dispneja (S3/4: 1 %), kašelj (S3/4: < 1 %), epistaksa (S3/4: < 1 %)
English: Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%); Stomatitis/Pharyngitis (G3/4: 0.9%);
Slovenian: Bolezni prebavil navzea (S3/4: 2,4 %), driska (S3/4: 1,2 %), stomatitis/faringitis (S3/4: 0,9 %), bruhanje (S3/4: 1,2 %)
English: Hearing impaired
Slovenian: Očesne bolezni
English: Fluid retention (severe: 6.5%); Asthenia (severe: 11.2%); Pain
Slovenian: Splošne težave in spremembe na mestu aplikacije zastajanje tekočine (hudo: 6,5 %), astenija (huda: 11,2 %), bolečine reakcija na mestu infundiranja, bolečine v prsih, ki niso srčnega izvora (hude: 0,4
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora:
English: DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
Slovenian: DOCETAKSEL KABI 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
English: In DOCETAXEL KABI 120 mg/6 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu DOCETAKSEL KABI 120 mg/6 ml vialah je koncentracija docetaksela 20 mg/ml.
English: Infection (G3/4: 7.8%)
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4: 7,8 %)
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2.37 g ethanol anhydrous per vial, equivalent to 60 ml of beer or 24 ml wine.
Slovenian: Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza 2,37 g brezvodnega etanola na vialo in je ekvivalentno 60 ml piva ali 24 ml vina.
English: The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS: 70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Slovenian: Ob tem so pri shemi z docetakselom ugotovili tudi 30 % zmanjšanje tveganja umrljivosti v primerjavi s PF (razmerje ogroženosti (OR) = 0,70, 95 % interval zaupanja (IZ) = 0,54-0,90); celotni mediani čas spremljanja je bil 41,9 meseca.
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a green flip-off aluminium over seal containing 1 ml of concentrate.
Slovenian: 6 ml viala iz prozornega, brezbarvnega stekla tipa I, zaprta z gumijastim zamaškom in zeleno snemno (flip-off) aluminijasto prekrivno zaporko, ki vsebuje 1 ml koncentrata.
English: KABI (listed in section 6).
Slovenian: (navedeno v poglavju 6);
English: Cancer pain (G3/4: 0.6%)
Slovenian: bolečina zaradi raka (S3/4: 0,6 %)