natgillin/translations-raw huggingface dataset:
Anorexia (G3/4: 1%); Decreased appetite
Poremećaji metabolizma i prehrane anoreksija (G3/4: 1%), smanjen apetit dehidracija (G3/4: 2%)
DOCETAXEL KABI in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
DOCETAXEL KABI je u kombinaciji s kapecitabinom indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha citotoksične kemoterapije.
Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Svaka kutija sadržava jednu bočicu s 8 ml koncentrata (160 mg docetaksela).
In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients(87.6%).
U ispitivanju TAX 316 alopecija koja je i dalje bila prisutna tijekom perioda praćenja nakon završetka kemoterapije zabilježena je u 687 od 744 bolesnika (92,3%) u TAC skupini i 645 od 736 bolesnika (87,6%) u FAC skupini.
Hypertension; Haemorrhage
Česte nuspojave hipoestezija
Infusion site reaction
Koncentrat za otopinu za infuziju
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg/8 ml OTHER Cytotoxic
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 160 mg/8 ml
Infection (G3/4: 7.8%)
Infekcije i infestacije infekcija (G3/4: 7,8%)
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 bilo statistički značajno u usporedbi s kontrolnom skupinom koja je primala mitoksantron.
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis)
Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN (analiza podataka bolesnika predviđenih za liječenje [Intent-to-Treat])
Fever (G3/4: 1.2%)
edem (G3/4: 1,2%)
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Jedna bočica s 1 ml koncentrata sadržava 20 mg docetaksela.
Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
Najbolji ukupni odgovor (CR + PR) na kemoterapiju (%) (95% CI) ***p- vrijednost
Tabulated list of adverse reactions in prostate cancer for DOCETAXEL KABI 75 mg/m² in combination with prednisone or prednisolone
Tablični popis nuspojava kod karcinoma prostate za DOCETAXEL KABI 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
At the median follow-up was time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Pri medijanu vremena praćenja od 77 mjeseci dokazano je značajno produljenje preživljenja bez znakova bolesti u TAC skupini u usporedbi sa bolesnicima iz FAC skupine.
Asthenia (severe: 8.1%); Fluid retention (severe: 1.2%); Pain
Opći poremećaji i reakcije na mjestu primjene astenija (teška: 8,1%), retencija tekućine (teška: 1,2%), bol reakcija na mjestu primjene infuzije
Number of patients PSA** response rate (%) 95% CI p-value*
PSA** stopa odgovora (%) 95% CI p- vrijednost*
Cardiac left ventricular function decrease (G3/4: 0.3%)
Srčani poremećaji smanjenje funkcije lijeve srčane klijetke (G3/4: 0,3%)
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
NAZIV LIJEKA DOCETAXEL KABI 180 mg/9 ml koncentrat za otopinu za infuziju
Nail disorders (severe: 0.4%); Skin reaction (no severe)
Poremećaji kože i potkožnog tkiva alopecija, poremećaji noktiju (teški: 0,4%);,kožna reakcija (ne teška)
The cycles were repeated every 3 weeks for 3 cycles.
Liječenje se ponavlja svaka 3 tjedna u 3 ciklusa.
• Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomised, multi-centre open-label, phase III, study (TAX324).
• Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX324) Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
Median survival (months) (95% CI)
Medijan preživljenja (mjeseci) (95% CI)
- 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.
DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
DOCETAXEL KABI 120 mg/6 ml koncentrat za otopinu za infuziju docetaksel
Arrhythmia (G3/4: 1.0%)
Srčani poremećaji aritmija (G3/4: 1,0%)
Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%);
sinkopa (G3/4: 0%) neurotoksičnost (G3/4:0%), somnolencija (G3/4:
Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Opis odabranih nuspojava kod karcinoma dojke za DOCETAXEL KABI 100 mg/m² u kombinaciji s trastuzumabom
95% CI p-value*
95% CI p=
You must not be given DOCETAXEL KABI
DOCETAXEL KABI se ne smije primijeniti
Peripheral motor neuropathy (G3/4: 0.4%)
periferna motorna neuropatija (G3/4: 0,4%)
DOCETAXEL KABI 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.
DOCETAXEL KABI je u kombinaciji s trastuzumabom indiciran za liječenje bolesnika s metastatskim karcinomom dojke i prekomjerno izraženim HER2, koji nisu ranije primali kemoterapiju za metastatsku bolest.
Neutropenia (Grade 4) Febrile neutropenia Neutropenic infection Neutropenic infection (Grade 3-4)
Neutropenijska infekcija (stupanj 3-4)
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
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.
To be taken into account in pregnant or breast-feeding women, in children and high-risk groups such as patients with liver disease, or epilepsy.
Potrebno jeuzeti u obzir kod trudnica ili dojilja, djece i visoko rizičnih skupina, kao što su bolesnici s bolešću jetre ili epilepsijom.
Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Poremećaji krvi i limfnog sustava neutropenija (G3/4: 32%), anemija (G3/4: 4,9%)
Contraindications for other medicinal products also apply, when combined with docetaxel.
Kad se docetaksel primjenjuje u kombinaciji s drugim lijekovima, primjenjive su i kontraindikacije tih drugih lijekova.
Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Svaka kutija sadržava jednu bočicu s 1 ml koncentrata (20 mg docetaksela).
At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 10 godina i 5 mjeseci), niti jedan bolesnik u TAC skupini nije imao CHF, 1 bolesnik u TAC skupini preminuo je zbog dilatacijske kardiomiopatije, a CHF je i dalje bio prisutan u 1 bolesnika (0,2%) u FAC skupini.
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion
NAZIV LIJEKA DOCETAXEL KABI 80 mg/4 ml koncentrat za otopinu za infuziju
Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%);
ezofagitis/disfagija/odinofagija (G3/4: 0,7%)
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 je počela 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.
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 je 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.
Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Poremećaji mišićnokoštanog sustava i mialgija (G3/4: 0,7%), artralgija (G3/4: 0,2%)
Peripheral motor neuropathy (G3/4: 0%)
periferna motorna neuropatija (G3/4: 0%)
Peripheral sensory neuropathy (G3/4: 8.7%)
Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 8,7%)
DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
DOCETAXEL KABI 180 mg/9 ml koncentrat za otopinu za infuziju docetaksel
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 120 mg/6 ml
Capecitabine
Kapecitabin
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion
NAZIV LIJEKA DOCETAXEL KABI 160 mg/8 ml koncentrat za otopinu za infuziju
Somnolence (G3/4: 0%)
limfedem (G3/4: 0%)
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2.37 g ethanol anhydrous per vial of 6 ml equivalent to 60 ml of beer or 24 ml wine.
Ovaj lijek sadrži 50 vol% bezvodnog etanola (alkohol), odnosno do 2.37 g bezvodnog etanola po bočici od 6 ml, što odgovara količini od 60 ml piva ili 24 ml vina.
Median overall survival (months) (95% CI)
Ukupni medijan preživljenja (mjeseci) (95% CI)
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.
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
NAZIV LIJEKA DOCETAXEL KABI 20 mg/1 ml koncentrat za otopinu za infuziju
• oesophagitis
• omaglica
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Poremećaji probavnog sustava mučnina (G3/4: 3,3%), stomatitis (G3/4: 1,7%), povraćanje (G3/4: 0,8%), proljev (G3/4: 1,7%)
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 je počeo tijekom perioda liječenja te je 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.
G3/4 AST increased (0.5%); G3/4 Blood alkaline phosphatase increased (0.3%)
G3/4 povećanje bilirubina u krvi (<5%), G3/4 povećanje alkalne fosfataze u krvi (<4%), G3/4 povećanje AST
Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%); Stomatitis/Pharyngitis (G3/4: 0.9%);
Poremećaji probavnog sustava mučnina (G 3/4: 2,4%), proljev (G 3/4: 1,2%), stomatitis/faringitis (G3/4:
In DOCETAXEL KABI 180 mg/9 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici DOCETAXEL KABI 180 mg/9 ml, koncentracija docetaksela iznosi 20 mg/ml.
PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 180 mg/9 ml CONCENTRATE FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I UPOTREBU DOCETAXEL KABI 180 mg/9 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
Alopecia; Skin reaction (G3/4: 0.8%)
Poremećaji kože i potkožnog tkiva alopecija, kožna reakcija (G3/4: 0,8%)
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.
Iz pivotalnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje adenokarcinoma želuca, isključeni su bolesnici s ALT i/ili AST > 1,5 x GGN te alkalnom fosfatazom > 2,5 x GGN i bilirubinom > 1 x GGN.
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion
NAZIV LIJEKA DOCETAXEL KABI 120 mg/6 ml koncentrat za otopinu za infuziju
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.
DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
DOCETAXEL KABI 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml OTHER Cytotoxic
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 80 mg/4 ml
Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Opći poremećaji i reakcije na mjestu primjene umor (G3/4: 3,9%), retencija tekućine (teška: 0,6%)
Infection (G3/4: 5.7%)
Infekcije i infestacije infekcija (G3/4: 5,7%)
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 10 bolesnika (1,9%) u TAC skupini i 4 bolesnika (0,8%) u FAC skupini.
DOCETAXEL KABI 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.
DOCETAXEL KABI je u kombinaciji s cisplatinom indiciran za liječenje bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća, koji nisu ranije primali kemoterapiju za tu bolest.
Musculoskeletal and connective tissue disorders
Poremećaji mišićnokoštanog sustava i vezivnog tkiva mialgija
Thrombocytopenia (G3/4: 3%)
trombocitopenija (G3/4: 3%)
In DOCETAXEL KABI 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici DOCETAXEL KABI 160 mg/8 ml, koncentracija docetaksela iznosi 20 mg/ml.
For trastuzumab dose and administration, see trastuzumab summary of product characteristics.
O dozi i primjeni trastuzumaba, pogledati sažetak opisa svojstva lijeka za trastuzumab.
Exfoliative rash (G3/4: 0.3%)
eksfolijativni osip (G 3/4: 0,3%)
Psychiatric disorders Insomnia Nervous system disorders
Psihijatrijski poremećaji nesanica
Venous disorder (G3/4: 0.6%)
Krvožilni poremećaji venski poremećaji (G3/4: 0,6%)
DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion docetaxel
DOCETAXEL KABI 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
- For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL
- Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, DOCETAXEL KABI se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
In DOCETAXEL KABI 120 mg/6 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici DOCETAXEL KABI 120 mg/6 ml, koncentracija docetaksela iznosi 20 mg/ml.
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2.37 g ethanol anhydrous per vial, equivalent to 60 ml of beer or 24 ml wine.
Ovaj lijek sadrži 50 vol% bezvodnog etanola (alkohol), tj. do 2.37 g bezvodnog etanola po bočici, što odgovara količini od 60 ml piva ili 24 ml vina.
Epistaxis (G3/4: < 1%)
Česte nuspojave parestezija (G3/4: <1%)
Skin and
Njemačka ili
PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I UPOTREBU DOCETAXEL KABI 160 mg/8 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
Lacrimation increased; Conjunctivitis
Poremećaji oka pojačano suzenje, konjunktivitis
In DOCETAXEL KABI 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici DOCETAXEL KABI 80 mg/4 ml, koncentracija docetaksela iznosi 20 mg/ml.
If this happens, you must tell your doctor immediately
Odmah obavijestite svog liječnika ako se to dogodi.
At the end of the follow-up period (actual median follow-up time of8 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 %).
Dyspnoea (G3/4: 1%); Cough (G3/4: < 1%);
dispneja (G3/4: 1%), kašalj (G3/4: <1%), epistaksa (G3/4: <1%)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DOCETAXEL KABI 180 mg/9 ml koncentrat za otopinu za infuziju docetaksel
10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a yellow flip-off aluminium over seal containing 8 ml of concentrate.
Prozirna bezbojna staklena bočica od 10 ml (staklo tip I) s 8 ml koncentrata, zatvorena gumenim (flurotec) čepom i žutim “flip-off” aluminijskim zaštitnim zatvaračem.
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
Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Opći poremećaji i reakcije na mjestu primjene astenija, periferni edem, pireksija, umor, upala sluznice, bol, bolest slična gripi, bol u prsima, zimica letargija
Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Hampshire, GU35 0NF
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 je počeo tijekom perioda liječenja te je 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.
PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 120 mg/6 ml CONCENTRATE FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I UPOTREBU DOCETAXEL KABI 120 mg/6 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Ponekad je potrebno upotrijebiti više od jedne bočice DOCETAXEL KABI koncentrata kako bi se dobila potrebna doza za bolesnika.
DOCETAXEL KABI in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
DOCETAXEL KABI je u kombinaciji s doksorubicinom indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine .
Ovaj lijek sadrži 50 vol% bezvodnog etanola (alkohol), odnosno do 1.58 g bezvodnog etanola po bočici, što odgovara količini od 40 ml piva ili 17 ml vina.
In DOCETAXEL KABI 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici DOCETAXEL KABI 20 mg/1 ml, koncentracija docetaksela iznosi 20 mg/ml.
PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I UPOTREBU DOCETAXEL KABI 20 mg/1 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
DOCETAXEL KABI 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
Arrhythmia (no severe)
ezofagitis (težak:
Intravenous use Single-use vial.
Za primjenu u venu.Bočica za jednokratnu uporabu.
10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a orange flip-off aluminium over seal containing 9 ml of concentrate.
Prozirna bezbojna staklena bočica od 10 ml (staklo tip I) s 9 ml koncentrata, zatvorena gumenim (flurotec) čepom i narančastim “flip-off” aluminijskimzaštitnim zatvaračem.
Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Tablični popis nuspojava kod karcinoma dojke za DOCETAXEL KABI 100 mg/m² u kombinaciji s trastuzumabom
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 32 ml wine.
Ovaj lijek sadrži 50 vol% bezvodnog etanola (alkohol), tj. do 3.16 g bezvodnog etanola po bočici, što odgovara količini od 80 ml piva ili 32 ml vina.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DOCETAXEL KABI 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
Febrile neutropenia (G3/4: NA)
Poremećaji imunološkog preosjetljivost (G3/4:
DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
DOCETAXEL KABI 180 mg/9 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
Peripheral sensory neuropathy (G3: 0.4%)
Poremećaji živčanog sustava periferna senzorna neuropatija (G3: 0,4%)
DOCETAXEL KABI monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
DOCETAXEL KABI kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha citotoksične terapije.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml OTHER Cytotoxic
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 20 mg/1 ml
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DOCETAXEL KABI 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
U bolesnika liječenih docetakselom prijavljeni su slučajevi cističnog edema makule.
Number of patients Pain response rate (%) 95% CI p-value*
Stopa smanjenja boli (%) 95% CI p-vrijednost*
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DOCETAXEL KABI 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
DOCETAXEL KABI in combination with platinum agents in chemotherapy-naïve patients
DOCETAXEL KABI u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju
Lacrimation increased (G3/4: 0%)
Poremećaji oka pojačano suzenje (G3/4: 0%)