natgillin/translations-raw huggingface dataset:
Lacrimation increased Conjunctivitis
Poremećaji oka pojačano suzenje konjunktivitis
Following chemotherapy, patients should receive chemoradiotherapy.
Nakon kemoterapije bolesnici se moraju liječiti
Hypotension (G3/4:
hipotenzija (G3/4:
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.
U bolesnika s razinama serumskog bilirubina > GGN i/ili ALT i AST > 3,5 puta od GGN te serumskom alkalnom fosfatazom > 6 puta od GGN, nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Nema podataka o primjeni docetaksela u kombiniranoj terapiji u bolesnika s oštećenjem jetre u ostalim indikacijama.
Patients previously treated with chemotherapy with or without radiotherapy In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and OS were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
U ispitivanju faze III, vrijeme do progresije bolesti (12,3 tjedna prema 7 tjedana) i ukupno preživljenje bilo je u ranije liječenih bolesnika značajno dulje s docetakselom u dozi od 75 mg/m2 u usporedbi s najboljom potpornom terapijom (BSC).
Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm
Bolesnici se mogu ponovno liječiti docetakselom kad se broj neutrofila oporavi na razinu ≥ 1500 stanica/mm
Diarrhoea grade 4
Proljev stupnja 4
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)
Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m2 prvi dan)
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%).
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), alopecija je i dalje bila prisutna u 29 bolesnika u TAC skupini (3,9%) i 16 bolesnika u FAC skupini (2,2 %).
G3/4 Blood bilirubin increased (<5%); G3/4 Blood alkaline phosphatase increased (<4%); G3/4 AST increased (<3%); G3/4 ALT increased (<2%)
G3/4 povećanje alkalne fosfataze u krvi (<4%); G3/4 povećanje AST
3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
(1250 mg/m2 dvaput dnevno tijekom 2 tjedna nakon čega slijedi jedan tjedan pauze).
At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 TAC patients and 4 FAC patients (0.5%).
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), periferni edem je i dalje bio prisutan u 19 bolesnika u TAC skupini, odnosno u 4 bolesnika (0,5%) u FAC skupini.
Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value
Najbolji ukupni odgovor (CR + PR) na liječenje tijekom studije [kemoterapija +/- kemoradioterapija] (%) (95%CI) ***p-vrijednost
Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Opći poremećaji i reakcije na mjestu primjene reakcija na mjestu primjene infuzije; bol u prsima nekardiološke etiologije (teška: 0,4%)
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
• razviti i kada se docetaksel primjenjuje istodobno s radioterapijom)
Taxespira 20 mg/1 ml concentrate for solution for infusion Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Taxespira 20 mg/1 ml koncentrat za otopinu za infuziju Taxespira 80 mg/4 ml koncentrat za otopinu za infuziju Taxespira 120 mg/6 ml koncentrat za otopinu za infuziju Taxespira 140 mg/7 ml koncentrat za otopinu za infuziju Taxespira 160 mg/8 ml koncentrat za otopinu za infuziju
• tiredness or flu-like symptoms
• umor; ili simptomi nalik gripi
• operable node-positive breast cancer
• operabilnim karcinomom dojke i pozitivnim limfnim čvorovima
Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Taxespira 80 mg/4 ml koncentrat za otopinu za infuziju Taxespira 120 mg/6 ml koncentrat za otopinu za infuziju Taxespira 140 mg/7 ml koncentrat za otopinu za infuziju Taxespira 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
160mg/8 ml Each 8 ml vial of concentrate contains 4 ml of ethanol anhydrous (3160 mg).
160 mg/8 ml Jedna bočica sa 8 ml koncentrata sadrži 4 ml bezvodnog etanola (3160 mg).
The cycles were repeated every 3 weeks for 3 cycles.
Liječenje se ponavlja svaka 3 tjedna kroz 3 ciklusa.
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%).
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina) limfedem je i dalje bio prisutan u 6 bolesnika (0,8%) u TAC skupini te u 1 bolesnika (0,1%) u FAC skupini.
Abdominal pain (G3/4: 0.4%)
abdominalna bol (G3/4: 0,4%)
If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Ako dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
80mg/4 ml Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580 mg).
80 mg/4 ml Jedna bočica s 4 ml koncentrata sadrži 2 ml bezvodnog etanola (1580 mg).
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Najbolji ukupni odgovor na liječenje tijekom studije [kemoterapija +/- radioterapija] (%) (95% CI) ***p-vrijednost
Vascular disorders Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja
After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%)patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Nakon 10 godina praćenja u GEICAM 9805 ispitivanju akutna leukemija pojavila se u 1 od 532 bolesnika (0,2%) u TAC skupini.
Preparation of the infusion solution
Priprema infuzijske otopine
80mg/4 ml contains 4 ml of concentrate
80 mg/ 4 ml sadrži 4 ml koncentrata.
Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
Najbolji ukupni odgovor (CR + PR) na kemoterapiju (%) (95% CI) ***p-vrijednost
Patients with renal impairment There are no data available in patients with severely impaired renal function treated with docetaxel.
Ne postoje dostupni podaci o liječenju docetakselom bolesnika s teškim oštećenjem bubrega.
At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik od smrti smanjio se za 9% u odnosu na bolesnike u FAC skupini (omjer hazarda= 0,91, 95% CI (0,63
Tabulated list of adverse reactions in prostate cancer for Taxespira 75 mg/m² in combination with prednisone or prednisolone
Tablični popis nuspojava kod karcinoma prostate za Taxespira 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Taxespira je indicirana za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
In study TAX316 amenorrhoea that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
U ispitivanju TAX 316 amenoreja, koja je počela tijekom perioda liječenja te koja je i dalje bila prisutna u periodu praćenja nakon završetka kemoterapije, zabilježena je u 202 od 744 bolesnice (27,2%) u TAC skupini te u 125 od 736 bolesnica (17,0%) u FAC skupini.
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.
Primarni ishod djelotvornosti u ovom ispitivanju, ukupno preživljenje (OS) bilo je značajno dulje (log-rank test, p=0,0058) u skupini liječenoj docetakselom u usporedbi s PF (medijan OS: 70,6 prema 30,1 mjesec), s 30% smanjenja smrtnosti u usporedbi s PF (omjer hazarda (HR) = 0,70, 95% interval pouzdanosti (CI) = 0,54-0,90) uz ukupni medijan praćenja od 41,9 mjeseci.
Taxespira 140 mg/7 ml concentrate for solution for infusion.
Taxespira 140 mg/7 ml koncentrat za otopinu za infuziju docetaksel
Ischemia myocardial
Poremećaji uha i labirinta ishemija miokarda
The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
Produljenje preživljenja u skupini koja je primala docetaksel tjedno nije bio statistički značajan u usporedbi sa kontrolnom skupinom koja je primala mitoksantron.
• For the treatment of prostate cancer, Taxespira is administered in combination with prednisone
• Za liječenje karcinoma prostate Taxespira se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
U kombinaciji s kapecitabinom, preporučena doza docetaksela je 75 mg/m 2 svaka tri tjedna u kombinaciji s kapecitabinom u dozi od 1250 mg/m dvaput dnevno (unutar pola sata nakon obroka) u trajanju od 2 tjedna, nakon čega slijedi tjedan dana stanke.
Myalgia (severe:
ezofagitis (težak:
Aseptically withdraw the required amount of Taxespira concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Koristeći kalibriranu štrcaljku s pričvršćenom iglom od 21G, aseptički uvucite potrebnu količinu Taxespira koncentrata za otopinu za infuziju.
Taxespira 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.
Taxespira u kombinaciji s cisplatinom indicirana je za liječenje bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća, koji nisu ranije primali kemoterapiju za tu bolest.
Second episode: reduce docetaxel dose by 20%.
Druga epizoda: smanjiti dozu docetaksela za 20%.
Taxespira 160 mg/8 ml concentrate for solution for infusion.
Taxespira 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Docetaksel u kombinaciji s trastuzumabom ispitivao se u liječenju bolesnika s metastatskim karcinomom dojke i pojačanom ekspresijom HER2 koji nisu ranije primali kemoterapiju za metastatsku bolest.
Respiratory disorders
Oštećenje jetre
Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
Poremećaji dišnog sustava, prsišta i sredoprsja Poremećaji probavnog sustava konstipacija (teška: 0,2%); abdominalna bol (teška: 1%); gastrointestinalno krvarenje (teško 0,3%)
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Sažetak profila sigurnosti primjene lijeka za sve indikacije Nuspojave koje su moguće ili vjerojatno povezane s primjenom docetaksela zabilježene su u:
If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Ako primijetite bilo koju nuspojavu potrebno je obavijestiti iječnika, bolničkog ljekarnika ili medicinsku sestru.
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%)