natgillin/translations-raw huggingface dataset:
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. 
U ispitivanju TAX 316 periferna senzorna neuropatija počela je tijekom perioda liječenja te je bila prisutna i tijekom perioda praćenja u 84 bolesnika (11,3%) u TAC skupini i 15 bolesnika (2%) u FAC skupini.
Taxespira 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. 
Taxespira u kombinaciji s trastuzumabom indicirana je za liječenje bolesnika s metastatskim karcinomom dojke i prekomjerno izraženim HER2, koji nisu ranije primali kemoterapiju za metastatsku bolest.
Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle. 
• Koristeći kalibriranu štrcaljku s pričvršćenom iglom od 21G, aseptički uvucite potrebnu količinu koncentrata za otopinu za infuziju.
Myalgia (G3/4: 0.6%) 
aritmija (G3/4: 0,6%)
Number of patients PSA** response rate (%) 
Broj bolesnika PSA** stopa odgovora (%) 95% CI p-vrijednost*
Contraindications for other medicinal products also apply, when combined with docetaxel. 
Kad se docetaksel primjenjuje u kombinaciji s drugim lijekovima, potrebno je uzeti u obzir i kontraindikacije tih drugih lijekova.
20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel. 
20 mg/ 1 ml Jedna bočica od 1 ml koncentrata sadrži 20 mg docetaksela.
Taxespira 120 mg/6 ml concentrate for solution for infusion. 
Taxespira 120 mg/6 ml koncentrat za otopinu za infuziju docetaksel
Name and address of the manufacturers responsible for batch release Hospira UK Limited 
Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet
Arrhythmia (G3/4: 1.0%) 
Srčani poremećaji aritmija (G3/4: 1.0%)
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 
Iz pivotalnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje adenokarcinoma želuca, isključeni su bolesnici s ALT i/ili AST > 1,5 × GGN te alkalnom fosfatazom > 2,5 × GGN i bilirubinom > 1 × GGN.
Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 in combination with trastuzumab 
Opis odabranih nuspojava kod karcinoma dojke za Taxespira 100 mg/m² u kombinaciji s trastuzumabom
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period and 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. 
U ispitivanju GEICAM 9805 amenoreja, koja je počela tijekom perioda liječenja i bila prisutna u periodu praćenja, zabilježena je u 18 bolesnica (3,4%) u TAC skupini i u 5 bolesnica (1,0%) u FAC skupini.
Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² in combination with trastuzumab 
Tablični popis nuspojava kod karcinoma dojke za Taxespira 100 mg/m² u kombinaciji s trastuzumabom
Fever (G3/4: 1.2%) 
povraćanje (G3/4: 1,2%)
EU/1/15/1017/005 160 mg/8 ml vial x 1 vial 
EU/1/15/1017/005 160 mg/8 ml bočica x 1 bočica
Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. 
Taxespira u kombinaciji s kapecitabinom indicirana je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
Taxespira 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. 
Taxespira u kombinaciji s doksorubicinom indicirana je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
3 -hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 
Nakon završetka infuzije ciplatina slijedi kontinuirana infuzija 5-fluorouracilom 1000 mg/m2/dan od prvog do četvrtog dana.
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial, equivalent to 80 ml of beer or 33 ml wine. 
Ovaj lijek sadrži 50 vol% etanola (alkohola), tj. do 3160 mg bezvodnog etanola po 8 ml bočice, što odgovara 80 ml piva ili 33 ml vina.
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%). 
U ispitivanju TAX 316 astenija, koja je počela tijekom perioda liječenja te bila prisutna u periodu praćenja nakon završetka kemoterapije, zabilježena je u 236 od 744 bolesnika (31,7%) u TAC skupini te u 180 od 736 bolesnika (24,5%) u FAC skupini.
9.9%); Fluid retention (severe: 0.7%); 
Opći poremećaji i reakcije na mjestu primjene retencija tekućine (teška: 0,8%);
EU/1/15/1017/004 140 mg/7 ml vial x 1 vial 
EU/1/15/1017/004 140 mg/7 ml bočica x 1 bočica
Infection associated with G4 neutropenia (G3/4: 4.6%) 
Infekcije i infestacije infekcija (G3/4: 3,6%)
Taxespira 20 mg/1 ml concentrate for solution for infusion 
Taxespira 20 mg/1 ml koncentrat za otopinu za infuziju
80mg/4 ml One vial of 4 ml concentration contains 80 mg docetaxel. 
80 mg/ 4 ml Jedna bočica od 4 ml koncentrata sadrži 80 mg docetaksela.
In GEICAM 9805 study, peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm. 
U ispitivanju GEICAM 9805 periferna senzorna neuropatija koja je počela tijekom perioda liječenja i dalje je bila prisutna u periodu praćenja u 10 bolesnika (1,9%) u TAC skupini i 4 bolesnika (0,8%) u FAC skupini.
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anyhdrous per 4 ml vial, equivalent to 40 ml of beer or 17 ml wine. 
Ovaj lijek sadrži 50 vol% etanola (alkohola), tj. do 1580 mg bezvodnog etanola po 4 ml bočice, što odgovara 40 ml piva ili 17 ml vina.
There are limited data available in patients >70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide. 
Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
Cough (G3/4: 0%) 
limfedem (G3/4: 0%)
Taxespira 80 mg/4 ml concentrate for solution for infusion. 
Taxespira 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
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%). 
U ispitivanju TAX 316 limfedem, koji se pojavio tijekom perioda liječenja te bio prisutan u periodu praćenja nakon završetka kemoterapije, zabilježen je u 11 od 744 bolesnika (1,5%) u TAC skupini te u 1 od 736 bolesnika (0,1%) u FAC skupini.
Peripheral sensory neuropathy (G3/4: 0.8%) 
Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 8,7%)
EU/1/15/1017/003 120 mg/6 ml vial x 1 vial 
EU/1/15/1017/003 120 mg/6 ml bočica x 1 bočica
Weight increased (G3/4: 0%); Weight decreased (G3/4: 
Pretrage porast tjelesne težine (G3/4: 0%); gubitak tjelesne težine (G3/4: 0,2%)
Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm. 
Astenija, koja se pojavila u periodu liječenja i bila prisutna u periodu praćenja, zabilježena je u 12 bolesnika (2,3%) u TAC skupini i u 4 bolesnika (0,8%) u FAC skupini.
Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy. 
Taxespira kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
For trastuzumab dose and administration, see trastuzumab summary of product characteristics. 
O dozi i primjeni trastuzumaba, pogledati sažetak opisa svojstava lijeka za trastuzumab.
140mg/7 ml One vial of 7 ml concentration contains 140 mg docetaxel. 
140 mg/7 ml Jedna bočica sa 6 ml koncentrata sadrži 140 mg docetaksela.
Arrhythmia (G3/4: 
povraćanje (G3/4:
160mg/8 ml One vial of 8 ml concentration contains 160 mg docetaxel. 
160 mg/8 ml Jedna bočica sa 6 ml koncentrata sadrži 160 mg docetaksela.
Peripheral motor neuropathy (G3/4: 2.5%) 
periferna motorna neuropatija (G3/4: 0%)
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml, equivalent to 10 ml of beer or 4 ml wine. 
Ovaj lijek sadrži 50 vol% etanola (alkohola), tj. do 395 mg bezvodnog etanola po 1 ml bočice, što odgovara 10 ml piva ili 4 ml vina.
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial, equivalent to 70 ml of beer or 29 ml wine. 
Ovaj lijek sadrži 50 vol% etanola (alkohola), tj. do 2765 mg bezvodnog etanola po 7 ml bočice, što odgovara 70 ml piva ili 29 ml vina.
Dry skin; Desquamation 
Poremećaji kože i potkožnog tkiva suhoća kože; deskvamacija
Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with doxorubicin 
Tablični popis nuspojava kod karcinoma dojke za Taxespira 75 mg/m² u kombinaciji s doksorubicinom
Nausea (G3/4: 5%); Stomatitis (G3/4: 
Poremećaji probavnog sustava mučnina (G3/4: 5,0%); stomatitis (G3/4:
95% CI p-value 
Omjer hazarda 95% CI p-vrijednost
Pfizer Polska Sp. z o.o. 
Pfizer bv
Gastric adenocarcinoma The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 
Preporučena doza docetaksela je 75 mg/m2 u obliku jednosatne infuzije, nakon čega slijedi infuzija
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).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 (0.65-1.08), p=0.1646). 
Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik povrata bolesti smanjio se za 16,5 % u odnosu na bolesnike liječene u FAC skupini (omjer hazarda =0 ,84, 95% CI (0,65-1,08), p=0,1646).
Stomatitis/Pharyngitis (G3/4: 
konstipacija; ezofagitis/disfagija/ odinofagija (G3/4:
Infusion site reaction; 
Opći poremećaji i reakcije na mjestu primjene reakcije na mjestu primjene infuzije;
Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² in combination with cisplatin 
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Taxespira 75 mg/m² u kombinaciji s cisplatinom
Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%) 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u udovima (G3/4: <1%); bol u leđima (G3/4: 1%)
Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 single agent 
Opis odabranih nuspojava kod karcinoma dojke za Taxespira 100 mg/m 2 u monoterapiji
Pharyngolaryngeal pain (G3/4: 2%) Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); 
Poremećaji živčanog sustava disgeuzija (G3/4: <1%); parestezija (G3/4: <1%)
Median OS (months) (95% CI) 
MedijanTTP (mjeseci) (95% CI)
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine. 
Ovaj lijek sadrži 50 vol% etanola (alkohola), tj. do 2370 mg bezvodnog etanola po 6 ml bočice, što odgovara 60 ml piva ili 25 ml vina.
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 140 mg/7 ml concentrate for solution for infusion, which contains only 1 vial). 
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 140 mg/7 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
• 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/m administered as a 30-minute to 
• Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324) Za indukcijsko liječenje bolesnika s lokalno uznapredovalim (tehnički neresektabilnim, male vjerojatnosti kirurške izlječivosti, a s ciljem očuvanja organa) karcinomom skvamoznih stanica glave i vrata (engl.
EU/1/15/1017/001 20 mg/1 ml vial x 1 vial 
EU/1/15/1017/001 20 mg/1 ml bočica x 1 bočica
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. 
U ispitivanju GEICAM 9805 alopecija koja je počela tijekom perioda liječenja i dalje bila prisutna tijekom perioda praćenja zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
120mg/6 ml One vial of 6 ml concentration contains 120 mg docetaxel. 
120 mg/ 6 ml Jedna bočica od 6 ml koncentrata sadrži 120 mg docetaksela.
• oral candidiasis (thrush) 
• oralna kandidijaza
Description of selected adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m 2 in combination with cisplatin and 5-fluorouracil 
Opis odabranih nuspojava za Taxespira 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
General disorders and administration site conditions In study TAX316, peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%). 
U ispitivanju TAX 316 periferni edem, koji se pojavio tijekom perioda liječenja te bio prisutan u periodu praćenja nakon završetka kemoterapije, zabilježen je u 119 od 744 bolesnika (16,0%) u TAC skupini i 23 od 736 bolesnika (3,1%) u FAC skupini.
Gastrointestinal haemorrhage (G3/4: 
Poremećaji oka konjunktivitis (G3/4:
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial). 
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
This regimen is administered every 3 weeks for 4 cycles. 
Liječenje se ponavlja svaka 3 tjedna kroz 4 ciklusa.
120mg/6 ml One vial of 6 ml concentrate contains 120 mg docetaxel. 
120 mg/6 ml Jedna bočica sa 6 ml koncentrata sadrži 120 mg docetaksela.
Single use vials. 
Bočice za jednokratnu primjenu.
Arrhythmia (no severe) 
Srčani poremećaji aritmija (ne teška)
Immune system disorders Metabolism and nutrition disorders Nervous system disorders 
Poremećaji mišićnokoštanog sustava i vezivnog tkiva Poremećaji reproduktivnog sustava i dojki
Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² single agent 
Tablični popis nuspojava kod karcinoma dojke za Taxespira 100 mg/m² u monoterapiji
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial). 
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
EU/1/15/1017/002 80 mg/4 ml vial x 1 vial 
EU/1/15/1017/002 80 mg/4 ml bočica x 1 bočica
Outer Carton 
Vanjska kutija
General disorders and administration site conditions Investigations 
Opći poremećaji i reakcije na mjestu primjene
Pfizer Kft. Tel: + 36 1 488 37 00 
Tel: + 36 1 488 37 00
Rash pruritic; Dry skin; Skin exfoliative (G3/4: 
Poremećaji kože i potkožnog tkiva eksfolijativni osip (G3/4:
Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%) 
promjene noktiju (G3/4: 0,7%); eksfolijacija kože (G3/4: 0%)
Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with capecitabine 
Tablični popis nuspojava kod karcinoma dojke za Taxespira 75 mg/m² u kombinaciji s kapecitabinom
Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² single agent 
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Taxespira 75 mg/m² u monoterapiji
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe: 
Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 1,2%); disgeuzija (G3/4: 0%)
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m dnevno tijekom 5 dana.
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial). 
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
Neutropenia (G4: 54.2%); Anaemia (G3/4: 10.8%); Thrombocytopenia (G4: 1.7%) 
51,5%); anemija (G3/4: 6,9%); trombocitopenija (G4:
Pfizer Corporation Austria Ges.m.b.H. 
Hospira Enterprises B.V.
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial). 
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Taxespira 120 mg/6 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 
(1-3, 4+), randomiziran je 1491 bolesnik u skupine koje će primati ili docetaksel 75 mg/m 2 primijenjen jedan sat nakon doksorubicina 50 mg/m 2 i ciklofosfamida 500 mg/m 2 (TAC skupina) ili doksorubicin
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer. 
U bolesnika koje primaju docetaksel, doksorubicin i ciklofosfamid (TAC) kao adjuvantnu terapiju u liječenju karcinoma dojke, treba razmotriti primarnu profilaksu s G-CSF.
Tumour response rate (%) 95% CI p-value* 
Broj bolesnika Stopa smanjenja boli (%) 95% CI p-vrijednost*
Fluid retention (severe/life-threatening: 1%) 
retencija tekućine (teška/opasna
Lacrimation increased (G3/4: 
Poremećaji oka pojačano suzenje (G3/4:
• For the treatment of lung cancer, Taxespira could be administered either alone or in 
• Za liječenje karcinoma pluća Taxespira se primjenjuje sam ili u kombinaciji s cisplatinom.
Best overall response to chemotherapy (%) 
Najbolji ukupni odgovor na kemoterapiju (%) (95% CI) ***p-vrijednost
Infections (G3/4: 5%) 
trombocitopenija (G3/4: 3%)
This regimen is administered every 3 weeks for 3 cycles. 
Liječenje se primjenjivalo svaka 3 tjedna, tijekom 3 ciklusa.
Lymphoedema (G3/4: 
dermatitis eritematozni osip (G 3/4:
Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/odynophagia (G3/4: 0.7%) 
konstipacija (G3/4: 1,0%); gastrointestinalna bol (G3/4:
Adjusted hazard ratio (95% CI) *p-value 
Prilagođeni omjer hazarda (95% CI) *p-vrijednost
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil 
Tablični popis nuspojava za Taxespira 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
Hazard ratio: (95% CI) **p-value 
Omjer hazarda: (95% CI) **p-vrijednost
Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 
proljev (G3/4: 3,4%); konstipacija (G3/4:
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 4. 
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 nakon čega je slijedio cisplatin (P) 75 mg/m 2 te 5-fluorouracil (F) 750 mg/m dnevno u obliku kontinuirane infuzije tijekom 5 dana.
256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks). 
Za liječenje docetakselom u monoterapiji (100 mg/m u obliku jednosatne intravenske infuzije svaka 3 tjedna) bilo je randomizirano 256 bolesnika.
Peripheral sensory neuropathy Peripheral motor neuropathy 
Poremećaji živčanog sustava periferna senzorna neuropatija (G 3:
Pfizer GEP, S.L. 
Pfizer AB
Alopecia (persisting: <3%); Skin disorder (G3/4: 0.6%); Nail disorders (G3/4: 0.4%) 
Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa (G3/4: 0%); dispneja (G3/4: 0,6%); kašalj (G3/4: 0%)
Venous disorder (G3/4: 
Poremećaji probavnog sustava dispepsija (G3/4:
• If you get any side effects talk to your doctor, hospital pharmacist or nurse. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, bolničkog ljekarnika ili medicinsku sestru.
Tabulated list of adverse reactions in head and neck cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil 
Tablični popis nuspojava za Taxespira 75 mg/m 2 u kombinaciji s cisplatinom i 5-fluorouracilom za terapiju karcinoma glave i vrata
Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%); 
Poremećaji probavnog sustava mučnina (G 3/4: 2,4%); proljev (G 3/4: 1,2%); stomatitis/faringitis (G3/4:
Disease free survival 
Preživljenje bez znakova bolesti
Taxespira 20 mg/1 ml concentrate for solution for infusion. 
Taxespira 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel i.v.
Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%) 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija (G3/4: 0,3%) mialgija (G3/4: 0,3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy. 
Pri primjeni docetaksela u kombinaciji s drugim citostaticima i/ili radioterapijom, zabilježeni su slučajevi akutne mijeloične leukemije i mijelodisplastičnog sindroma.