natgillin/translations-raw huggingface dataset:
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised 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 cyclophosphamide 500 mg/m2 (FAC arm).
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
Hazard ratio (95% CI) **p-value A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Log rank test *** Chi-square test
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Logrank test ***Hi - kvadrat test
Patients with baseline neutrophil count of < 1,500 cells/mm3.
Bolnikih z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
- If you have any further questions, ask your doctor, your hospital pharmacist or nurse.
- Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
MARKETING AUTHORISATION NUMBER EU/1/07/384/005
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/07/384/005
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.
Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetaksel 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v 3
Data from a multi-centre open label randomised trial support the use of Docetaxel Zentiva for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo zdravila Docetaxel Zentiva za adjuvantno zdravljenje bolnic z operabilnim rakom dojke z negativnimi bezgavkami, primernih za prejemanje kemoterapije.
A multi-centre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Opravljena je bila multicentrična, odprta, randomizirana študija za oceno varnosti in učinkovitosti docetaxel pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
MARKETING AUTHORISATION NUMBER EU/1/07/384/004
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/07/384/004
Cases of cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel.
Pri zdravljenju z docetakselom so poročali o kožnem eritematoznem lupusu, o buloznih erupcijah, npr. o multiformnem eritemu in o hudih kožnih neželenih učinkih kot so Stevens-Johnsonov sindrom (SJS), toksična epidermalna nekroliza (TEN) in akutna generalizirana eksantemska pustuloza (AGEP).
Docetaxel Zentiva is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Zentiva solutions.
Docetaxel Zentiva je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin zdravila Docetaxel Zentiva potrebna previdnost.
How to use Docetaxel Zentiva
Kako uporabljati zdravilo Docetaxel Zentiva
There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
V kombinacijski roki s trastuzumabom je prišlo do povečane incidence resnih neželenih učinkov (40 % proti 31 %) in neželenih učinkov stopnje 4 (34 % proti 23 %) v primerjavi z monoterapijo z docetakselom .
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml koncentrata vsebuje 20 mg docetaksela v obliki trihidrata.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
V ključni klinični študiji docetaksela v kombinaciji s cisplatinom in 5-fluorouracilom pri bolnikih z adenokarcinomom želodca so izključili bolnike z ALT in/ali AST > 1,5 × ULN ter hkrati alkalno fosfatazo > 2,5 × ULN in bilirubinom > 1 x ULN; pri teh bolnikih ni mogoče priporočiti zmanjšanja odmerka in docetaksela se ne sme uporabljati, če ni strogo indiciran.
Median overall survival (months)
Mediano celokupno preživetje (meseci)
Neutropenic infection (Grade 3-4)
Nevtropenična okužba (3.-4.
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
MARKETING AUTHORISATION NUMBER EU/1/07/384/003
ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/07/384/003
Neutropenic infection; Infection (G3/4: 11.7%)
Infekcijske in parazitske bolezni nevtropenična okužba; okužba (S3/4: 11,7 %)
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaxel (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).
Dose adjustment Diarrhoea grade 3 First episode: reduce 5-FU dose by20%.
Prilagoditev odmerka driska 3. stopnje Prvi pojav: zmanjšajte odmerek 5-FU za 20 %.
Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Bolezni dihal, prsnega koša in mediastinalnega prostora V redkih primerih so bili opisani akutni respiracijski distres sindrom in primeri, , intersticijske pljučnice/pnevmonitis, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, ki so bili včasih usodni.
Docetaxel Zentiva in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Zdravilo Docetaxel Zentiva je v kombinaciji s prednizonom ali prednizolonom indiciran za zdravljenje bolnikov z metastatskim proti kastraciji odpornim rakom prostate.
Docetaxel + Cis + 5-FU n = 177
Končna točka docetaksel + Cis + 5-FU n = 177
Disease-free survival (DFS) was the primary efficacy endpoint and overall survival (OS) was the secondary efficacy endpoint.
Preživetje brez bolezni (DFS-Disease-free-survival) je bilo primarni, celokupno preživetje (OS-Overall survival) pa sekundarni opazovani dogodek učinkovitosti.
Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Letargija (G3/4: 3,4 %) pireksija (S3/4:0,6 %); retenca tekočine; edem
• operable node- positive breast cancer
• operabilnim rakom dojke s pozitivnimi bezgavkami
Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Zdravilo Docetaxel Zentiva 160 mg/8 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
Oral candidiasis Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
astenija (3. st.: 0 %) zastajanje tekočine zvišana telesna temperatura (3. st.: 1 %) oralna kandidoza hipokalciemija (3. st.: 0 %) hipofosfatemija (3.-4. st.: 1 %) hipokaliemija (3. st.: 0 %)
Aseptically withdraw the required amount of Docetaxel Zentiva concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
S kalibrirano brizgo, opremljeno z iglo 21G, aseptično odvzemite potrebno količino koncentrata za raztopino za infundiranje zdravila Docetaxel Zentiva.
Docetaxel Zentiva 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.
Zdravilo Docetaxel Zentiva 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.
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Bolniki v kraku z docetakselom so prejelidocetaksel (T) 75 mg/m2, ki mu je sledil cisplatin (P) 75 mg/m2, temu pa 5-fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dosereduction can be recommended and docetaxel should not be used unless strictly indicated.
Pri bolnikih, ki imajo serumski bilirubin > ULN in/ali ALT in AST > 3,5-kratno ULN ter hkrati alkalno fosfatazo > 6-kratno ULN, ni mogoče priporočiti zmanjšanja odmerka; pri teh bolnikih se docetaksela ne sme uporabljati, če ni strogo indiciran.
Docetaxel Zentiva in combination with doxorubicin
Zdravilo Docetaxel Zentiva v kombinaciji z doksorubicinom
Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Zdravilo Docetaxel Zentiva 20 mg/1 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
Docetaxel Zentiva in combination with capecitabine
Zdravilo Docetaxel Zentiva v kombinaciji s kapecitabinom
• 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).
• 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).
Nail disorders (severe:
spremembe nohtov (hude:
Nervous system disorders
Bolezni živčevja periferna senzorična
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.
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.
A total of 1776 male patients were allocated to the treatment arms of interest:
V terapevtski skupini je bilo skupaj vključenih 1776 moških:
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.
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.
Alopecia; Skin reaction (G3/4:
Bolezni kože in podkožja alopecija, kožna reakcija (S3/4:
• 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.
• 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
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Najboljši celotni odziv na proučevano zdravljenje [kemoterapija +/- radioterapija] (%) (95 % interval zaupanja) ***p-vrednost
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.
Zdravilo Docetaxel Zentiva v kombinaciji s kapecitabinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije.
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Pogosti neželeni učinki Občasni neželeni učinki nevropatija (S3: 4,1 %), periferna motorična nevropatija (S3/4: 4 %), disgevzija (huda:
If signs and symptoms suggestive of these reactions appear, discontinuation of docetaxel should be considered.
Če se pojavijo hudi kožni neželeni učinki, je treba razmisliti o prekinitvi zdravljenja.
• Standard of care + docetaxel 75 mg/m², administered every 3 weeks for 6 cycles
• standardna oskrba + docetaksel 75 mg/m2 na 3 tedne 6 ciklusov.
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Bolezni prebavil navzea (S3/4: 3,3%); stomatitis (S3/4: 1,7%); bruhanje (S3/4: 0,8%); driska (S3/4: 1,7%)
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).
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).
Efficacy results or the docetaxel arm versus the control arm are summarized in the following table:
Končna učinkovitost rok z docetaksel v primerjavi s kontrolno roko je povzeta v spodnji tabeli:
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
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)
Peripheral sensory neuropathy (≥G3: 2%)a
Bolezni živčevja periferna senzorična nevropatija (≥ 3. st.: 2 %)a glavobol omotica
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).
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).
Docetaxel Zentiva in combination with trastuzumab
Zdravilo Docetaxel Zentiva v kombinaciji s trastuzumabom
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
hipotenzija (S3/4: 0 %) flebitis (S3/4: 0 %)
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
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.
Myalgia
MeDRA
Failure-Free survivalb Median (months)
Preživetje brez napredovanja bolezni Mediana (meseci)
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.
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.
7 ml clear glass (type I) vial with a magenta aluminium seal and a magenta plastic flip-off cap containing 4 ml of concentrate.
7 ml viala iz prozornega stekla tipa I s škrlatno rdečo aluminijasto zaporko in s škrlatno dvižno zaporko s 4 ml koncentrata.
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z inoperabilnim lokalno napredovanim SCCHN (analiza z namenom zdravljenja)
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).
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).
Myocardial ischemia (G3/4:1.7%)
Srčne bolezni miokardna ishemija (S3/4: 1,7%)
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).
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).
Peripheral sensory neuropathy (G3/4: 0.8%)
Bolezni živčevja periferna senzorična nevropatija (S3/4: 0,8 %)
Docetaxel Zentiva is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Zdravilo Docetaxel Zentiva je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
Pri bolnicah, ki prejemajo adjuvantno zdravljenje raka dojke z docetakselom, doksorubicinom in ciklofosfamidom (TAC), pride v poštev profilaksa z G-CSF.
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.
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.
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 160 mg/8 ml
PODATKI NA ZUNANJI OVOJNINI ŠKATLA / Docetaxel Zentiva 160 mg/8 ml
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion
IME ZDRAVILA Docetaxel Zentiva 20 mg/1 ml koncentrat za raztopino za infundiranje
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion.
IME ZDRAVILA Docetaxel Zentiva 160 mg/8 ml koncentrat za raztopino za infundiranje
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion
IME ZDRAVILA Docetaxel Zentiva 80 mg/4 ml koncentrat za raztopino za infundiranje
95% CI p-valuea*
95 % IZ vrednost pa*
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 20 mg/1 ml
PODATKI NA ZUNANJI OVOJNINI ŠKATLA / Docetaxel Zentiva 20 mg/1 ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaxel Zentiva 160 mg/8 ml sterilni koncentrat docetaksel intravenska uporaba
In Docetaxel Zentiva 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
V zdravilu Docetaxel Zentiva 160 mg/8 ml vialah je koncentracija docetaksela 20 mg/ml.
95% CI p-value*
(95 % IZ) ***p-vrednost
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaxel Zentiva 20 mg/1 ml sterilni koncentrat docetaksel intravenska uporaba
Docetaxel Zentiva in combination with platinum agents in chemotherapy-naïve patients
Zdravilo Docetaxel Zentiva v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
How to store Docetaxel Zentiva
Shranjevanje zdravila Docetaxel Zentiva
Infection associated with G4 neutropenia (G3/4: 4.6%)
okužba povezana z nevtropenijo S4 (S3/4;
Myalgia (G3/4: 0.6%)
aritmija (S3/4: 0,6%)
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)
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
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 80 mg/4 ml
PODATKI NA ZUNANJI OVOJNINI ŠKATLA / Docetaxel Zentiva 80 mg/4 ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 80 mg/4 ml sterile concentrate docetaxel
IME ZDRAVILA IN POT(I) UPORABE Docetaxel Zentiva 80 mg/4 ml sterilni koncentrat docetaksel intravenska uporaba
Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Bolezni živčevja disgevzija (S3/4: periferna senzorična nevropatija (S3/4:
Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for Docetaxel Zentiva 75 mg/m² in combination with prednisone or prednisolone
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
Progression Free Survival Median (months) 95% CI
Preživetje brez neuspehab Mediana (meseci) 95 % IZ