FrancophonIA/ELRC3.0 huggingface dataset:
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, multi-centre, open-label, randomised study (TAX323).
Slovenian: • Indukcijska kemoterapija in nato radioterapija (TAX 323) Varnost in učinkovitost docetaxel za indukcijsko zdravljenje bolnikov sskvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji faze III (TAX323).
English: Nail disorders (severe:
Slovenian: spremembe nohtov (hude:
English: Nervous system disorders
Slovenian: Bolezni živčevja periferna senzorična
English: Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Slovenian: Zdravilo Docetaxel Zentiva 80 mg/4 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: A total of 1776 male patients were allocated to the treatment arms of interest:
Slovenian: V terapevtski skupini je bilo skupaj vključenih 1776 moških:
English: Docetaxel Zentiva 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 Docetaxel Zentiva 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: Alopecia; Skin reaction (G3/4:
Slovenian: Bolezni kože in podkožja alopecija, kožna reakcija (S3/4:
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
Slovenian: • Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Za indukcijsko zdravljenje bolnikov z lokalno napredovalim (neresektabilen, majhna verjetnost kirurške ozdravitve, ohranitev organa) skvamoznoceličnim karcinomom glave in vratu (SCCHN) je priporočen odmerek docetaksela 75 mg/m2 v obliki enourne intravenske infuzije 1. dan, ki mu sledi cisplatin 100 mg/m2 v 30-minutni do 3-urni infuziji in nato stalna intravenska infuzija 5-fluorouracila
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Slovenian: Najboljši celotni odziv na proučevano zdravljenje [kemoterapija +/- radioterapija] (%) (95 % interval zaupanja) ***p-vrednost
English: Docetaxel Zentiva 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 Docetaxel Zentiva v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Slovenian: Pogosti neželeni učinki Občasni neželeni učinki nevropatija (S3: 4,1 %), periferna motorična nevropatija (S3/4: 4 %), disgevzija (huda:
English: If signs and symptoms suggestive of these reactions appear, discontinuation of docetaxel should be considered.
Slovenian: Če se pojavijo hudi kožni neželeni učinki, je treba razmisliti o prekinitvi zdravljenja.
English: • Standard of care + docetaxel 75 mg/m², administered every 3 weeks for 6 cycles
Slovenian: • standardna oskrba + docetaksel 75 mg/m2 na 3 tedne 6 ciklusov.
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%); bruhanje (S3/4: 0,8%); driska (S3/4: 1,7%)
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Zentiva administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Zentiva in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Slovenian: Namen tega je minimaliziranje določenih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila Docetaxel Zentiva, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
English: Efficacy results or the docetaxel arm versus the control arm are summarized in the following table:
Slovenian: Končna učinkovitost rok z docetaksel v primerjavi s kontrolno roko je povzeta v spodnji tabeli:
English: Description of selected adverse reactions for adjuvant therapy with Docetaxel Zentiva 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 Docetaxel Zentiva 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: Peripheral sensory neuropathy (≥G3: 2%)a
Slovenian: Bolezni živčevja periferna senzorična nevropatija (≥ 3. st.: 2 %)a glavobol omotica
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Docetaxel Zentiva 160 mg/8 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Docetaxel Zentiva in combination with trastuzumab
Slovenian: Zdravilo Docetaxel Zentiva v kombinaciji s trastuzumabom
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Slovenian: hipotenzija (S3/4: 0 %) flebitis (S3/4: 0 %)
English: Tabulated list of adverse reactions for adjuvant therapy with Docetaxel Zentiva 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 Docetaxel Zentiva 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: Myalgia
Slovenian: MeDRA
English: Failure-Free survivalb Median (months)
Slovenian: Preživetje brez napredovanja bolezni Mediana (meseci)
English: Docetaxel Zentiva 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 Docetaxel Zentiva v kombinaciji z doksorubicinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
English: 7 ml clear glass (type I) vial with a magenta aluminium seal and a magenta plastic flip-off cap containing 4 ml of concentrate.
Slovenian: 7 ml viala iz prozornega stekla tipa I s škrlatno rdečo aluminijasto zaporko in s škrlatno dvižno zaporko s 4 ml koncentrata.
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Slovenian: Učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z inoperabilnim lokalno napredovanim SCCHN (analiza z namenom zdravljenja)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Docetaxel Zentiva 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Myocardial ischemia (G3/4:1.7%)
Slovenian: Srčne bolezni miokardna ishemija (S3/4: 1,7%)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Docetaxel Zentiva 80 mg/4 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S3/4: 0,8 %)
English: Docetaxel Zentiva is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Slovenian: Zdravilo Docetaxel Zentiva je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
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, doksorubicinom in ciklofosfamidom (TAC), pride v poštev profilaksa z G-CSF.
English: 95% CI p-valuea a p-value calculated from the likelihood ratio test and adjusted for all stratification factors (except center and planned hormone therapy) and stratified by trial period b Failure-free survival: time from randomization to first evidence of at least one of: biochemical failure (defined as a rise in PSA of 50% above the within-24-week nadir and above 4 ng/mL and confirmed by retest or treatment); progression either locally, in lymph nodes, or in distant metastases; skeletal-related event; or death from prostate cancer.
Slovenian: biokemičnega neuspeha (opredeljenega kot zvišanje PSA za 50 % nad 24-tedensko obdobje znotraj najnižje vrednosti in nad 4 ng/ml ter potrjenega s ponovnim testiranjem ali z zdravljenjem); napredovanja bodisi lokalno, v bezgavkah ali oddaljenih metastaz; skeletnega dogodka; smrti zaradi raka prostate.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 160 mg/8 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA / Docetaxel Zentiva 160 mg/8 ml
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Docetaxel Zentiva 20 mg/1 ml koncentrat za raztopino za infundiranje
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion.
Slovenian: IME ZDRAVILA Docetaxel Zentiva 160 mg/8 ml koncentrat za raztopino za infundiranje
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion
Slovenian: IME ZDRAVILA Docetaxel Zentiva 80 mg/4 ml koncentrat za raztopino za infundiranje
English: 95% CI p-valuea*
Slovenian: 95 % IZ vrednost pa*
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 20 mg/1 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA / Docetaxel Zentiva 20 mg/1 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaxel Zentiva 160 mg/8 ml sterilni koncentrat docetaksel intravenska uporaba
English: In Docetaxel Zentiva 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu Docetaxel Zentiva 160 mg/8 ml vialah je koncentracija docetaksela 20 mg/ml.
English: 95% CI p-value*
Slovenian: (95 % IZ) ***p-vrednost
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaxel Zentiva 20 mg/1 ml sterilni koncentrat docetaksel intravenska uporaba
English: Docetaxel Zentiva in combination with platinum agents in chemotherapy-naïve patients
Slovenian: Zdravilo Docetaxel Zentiva v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
English: How to store Docetaxel Zentiva
Slovenian: Shranjevanje zdravila Docetaxel Zentiva
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Slovenian: okužba povezana z nevtropenijo S4 (S3/4;
English: Myalgia (G3/4: 0.6%)
Slovenian: aritmija (S3/4: 0,6%)
English: Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for DOCETAXEL 75 mg/m² in combination with prednisone prednisolone and ADT (STAMPEDE study)
Slovenian: Za bolnike z lokalno napredovalim ali metastatskim hormonsko občutljivim rakom prostate z velikim tveganjem so v preglednici prikazani neželeni učinki za zdravilo Docetaxel Zentiva 75 mg/m2 v kombinaciji s prednizonom ali prednizolonom in ADT (študija STAMPEDE) Organski sistemi po
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 80 mg/4 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA / Docetaxel Zentiva 80 mg/4 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 80 mg/4 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaxel Zentiva 80 mg/4 ml sterilni koncentrat docetaksel intravenska uporaba
English: Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Slovenian: Bolezni živčevja disgevzija (S3/4: periferna senzorična nevropatija (S3/4:
English: Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for Docetaxel Zentiva 75 mg/m² in combination with prednisone or prednisolone
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaxel Zentiva 75 mg/m2 pri metastatskem, proti kastraciji odpornim rakom prostate v kombinaciji s prednizonom ali prednizolonom
English: Progression Free Survival Median (months) 95% CI
Slovenian: Preživetje brez neuspehab Mediana (meseci) 95 % IZ
English: Cautions for use in gastric adenocarcinoma cancer Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Slovenian: Previdnost pri uporabi pri adenokarcinomu želodca Med 300 bolniki (221 bolnikov v III. fazi študije in 79 bolnikov v II.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: Navodilo za uporabo Docetaxel Zentiva 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
English: - If you get any side effects, talk to your doctor, hospital pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: If you get any side effects , talkto your doctor, hospital pharmacist or nurse.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: Navodilo za uporabo Docetaxel Zentiva 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: Navodilo za uporabo Docetaxel Zentiva 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
English: Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m2 in combination with trastuzumab
Slovenian: Opis izbranih neželenih učinkov zdravljenja z zdravilom Docetaxel Zentiva 100 mg/m2 pri raku dojke v kombinaciji z trastuzumabom
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: 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: Anorexia
Slovenian: artralgija
English: In Docetaxel Zentiva 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V Docetaxel 20 mg/1 ml vialah je koncentracija docetaksela 20 mg/ml.
English: What Docetaxel Zentiva looks like and contents of the pack Docetaxel Zentiva concentrate for solution for infusion is a pale yellow to brownish-yellow solution.
Slovenian: Zdravilo Docetaxel Zentiva koncentrat za raztopino za infundiranje je bledorumena do rjavkastorumena raztopina.
English: Lacrimation increased; Conjunctivitis
Slovenian: Očesne bolezni zvečano solzenje; konjunktivitis
English: Amenorrhoea (G3/4: NA)
Slovenian: motnja solzenja (S3/4: <
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Slovenian: Opis izbranih neželenih učinkov zdravljenja z zdravilom Docetaxel Zentiva 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
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: In Docetaxel Zentiva 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu Docetaxel Zentiva 80 mg/4 ml vialah je koncentracija docetaksela 20 mg/ml.
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
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with doxorubicin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaxel Zentiva 75 mg/m2 pri raku dojke v kombinaciji z doksorubicinom
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaxel Zentiva 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
English: Alopecia (G3/4: 10.9%) Rash pruritic; Dry skin;
Slovenian: Bolezni kože in podkožja alopecija (S3/4: 4,0 %), pruritičen izpuščaj suha koža , luščenje
English: In some cases (frequency not known)
Slovenian: V nekaterih primerih (pogostnost neznana) so opazili trajno izgubo las.
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaxel Zentiva 75 mg/m² pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Slovenian: V študiji GEICAM 9805 so nadaljnjo prisotnost alopecije, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja zabeležili pri 49 bolnicah (9,2 %) v kraku TAC in pri 35 bolnicah (6,7 %) v kraku FAC.
English: Efficacy of docetaxel in the induction treatment of patientswith locally advanced SCCHN (Intent-toTreat Analysis)
Slovenian: Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza znamenomzdravljenja)
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with capecitabine
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaxel Zentiva 75 mg/m2 pri raku dojke v kombinaciji s kapecitabinom
English: Docetaxel Zentiva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Slovenian: Zdravilo Docetaxel Zentiva v monoterapiji je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Očesne bolezni zvečano solzenje, konjunktivitis
English: PV-Romania@zentiva.com
Slovenian: Romania@zentiva.com
English: (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: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml koncentrata vsebuje 20 mg docetaksela v obliki trihidrata.
English: Dizziness (G3/4: Peripheral motor neuropathy (G3/4:
Slovenian: omotica (S3/4: 2,0 %), periferna motorična nevropatija (S3/4:
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Slovenian: Splošne težave in spremembe na mestu aplikacije zastajanje tekočine (hudo: astenija (huda: 11,2 %), bolečine reakcija na mestu infundiranja, nekardialne bolečine v prsih (hude: 0,4 %)
English: Alopecia (G3: 3%)a Nail changes (G3: 1%)
Slovenian: Bolezni kože in podkožja alopecija (3. st.: 3 %)a spremembe nohtov (3. st.: 1 %)
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Slovenian: pruritični izpuščaj (S3/4: 0,7 %), spremembe nohtov (S3/4:
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom Docetaxel Zentiva 75 mg/m2 pri nedrobnoceličnem pljučnem raku v kombinaciji s cisplatinom
English: Progressive disease as best overall response (%) *Unstratified log rank test
Slovenian: 2-letna ocena (%) razmerje tveganja (95 % IZ) *vrednost p celotni delež odziva (popolni odziv +delni odziv) (%) vrednost p napredujoča bolezen kot najboljši celotni odziv (%) *nestratificirani log-rang test