natgillin/translations-raw huggingface dataset:
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.
Best overall response to chemotherapy (%) (95%CI) ***p-value
Najbolji ukupni odgovor na kemoterapiju (%) (95% CI) ***p-vrijednost
• flushing, skin reactions, itching
• navale crvenila, kožne reakcije, svrbež • stezanje u prsima, otežano disanje
Dyspepsia; Abdominal pain
konstipacija; stomatitis; dispepsija; abdominalna bol
Number of patients Pain response rate (%) 95% CI p-value*
Stopa smanjenja boli (%) 95% CI p-vrijednost *
Solvent vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Prozirna staklena bočica od 15 ml (staklo tip I), s čepom od bromobutilne gume i sa "flip-off" zatvaračem.
Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Docetaksel Teva kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
• The Docetaxel Teva 20 mg/0.72 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
• Docetaksel Teva 20 mg/0,72 ml bočica sadržava otopinu docetaksela u polisorbatu 80, u koncentraciji od 27,73 mg/ml.
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Starije osobe Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
Median overall survival (months) (95%CI)
Ukupni medijan preživljenja (mjeseci) (95% CI)
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 single agent
Opis odabranih nuspojava kod karcinoma dojke za Docetaksel 100 mg/m2 u monoterapiji
5.12 ml (Fill: 6.29 ml)
voda za injekcije 5,12 ml (Punjenje 6,29 ml)
Neutropenia (G3/4: 83.5%); Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Poremećaji krvi i limfnog sustava neutropenija (G3/4: 83,5%); anemija (G3/4: 12,4%); trombocitopenija (G3/4:
2.2 Solvent for Docetaxel Teva 20 mg/0.72 ml vial:
2.2 Bočica s otapalom za Docetaksel Teva 20 mg/0,72 ml:
• The solvent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
• Bočica s otapalom za Docetaksel Teva 20 mg/0,72 ml je prozirna staklena bočica od 6 ml s čepom od bromobutilne gume i "flip-off" zatvaračem.
Doxorubicin
Docetaksel
Docetaxel Teva 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.
Docetaksel Teva u kombinaciji s doksorubicinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
• oesophagitis
• Otapalo za Docetaksel
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Tablični popis nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u kombinaciji s trastuzumabom
• The Docetaxel Teva 80 mg/2.88 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
• Docetaksel Teva 80 mg/2,88 ml bočica sadržava otopinu docetaksela u polisorbatu 80, u koncentraciji od 27,73 mg/ml.
Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Poremećaji živčanog sustava Zabilježeni su rijetki slučajevi konvulzija ili prolaznog gubitka svijesti pri primjeni docetaksela.
Weight increased
pojačano suzenje
Fever (G3/4: 1.2%)
vrućica (G3/4: 1,2%)
75 years of age or greater versus less than 65 years.
bolesnika bilo je u dobi od 65 godina ili starijih, a 68 bolesnika bilo je starije od 75 godina.
• 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 praćena radioterapijom (TAX 323) Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s karcinomom skvamoznih stanica glave i vrata (SCCHN) procjenjivala se u fazi III multicentrične, randomizirane studije otvorenog tipa (TAX323).
If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Ako Docetaksel Teva koncentrat, otopina koncentrata ili otopina za infuziju dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
- For the treatment of lung cancer, Docetaxel Teva could be administered either alone or in combination with cisplatin.
Za liječenje uznapredovalog karcinoma dojke, Docetaksel Teva se primjenjuje sam ili u kombinaciji s doksorubicinom, trastuzumabom ili kapecitabinom.
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 in combination with trastuzumab
Opis odabranih nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u kombinaciji s trastuzumabom
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Rijetko je bio zabilježen fenomenodzivne reakcijske upalne reakcije.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Rijetko je zabilježena pojava suzenja s ili bez konjunktivitisa,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 80 mg/2.88 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - OTAPALO 80 mg/2,88 ml
VIAL LABEL - CONCENTRATE 80 mg/2.88 ml
Teva 80 mg/2,88 ml
Dysgeusia (G3/4: 0%)
limfedem (G3/4: 0%)
Esophagitis/dysphagia/odynophagia (G3/4: 12.0%);
Poremećaji metabolizma i prehrane anoreksija (G3/4: 12,0%)
Data from a multi-centre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Docetaksel u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316) Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima te s KPS > 80%, u dobi od 18 do 70 godina.
Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Bolesnici u TAC skupini primali su antibiotsku profilaksu s ciprofloksacinom 500 mg peroralno dvaput na dan u trajanju od 10
The recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion, followed by cisplatin 75 mg/m2, as a 1 to 3 hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg /m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
75 mg/m2 cisplatine u trajanju od 1 do 3 sata (oboje samo na dan 1), a nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m2 po danu u trajanju od 5
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Tablični popis nuspojava kod karcinoma dojke za Docetaksel 75 mg/m² u kombinaciji s doksorubicinom
G3/4 AST increased G3/4 Blood alkaline phosphatase increased
G3/4 povećanje bilirubina u krvi G3/4 povećanje alkalne fosfataze u krvi (<2,5%)
Cough (G3/4: 0%)
sinkopa (G3/4: 0%)
• operable node-positive breast cancer • operable node-negative breast cancer
• operabilnim karcinomom dojke i negativnim limfnim čvorovima.
• The Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
• Docetaksel Teva 20 mg/0,72 ml bočica je prozirna staklena bočica od 6 ml, s čepom od bromobutilne gume i "flip-off" zatvaračem.
Baseline cardiac assessment is recommended.
Karnofski izvedbenom statusu.
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaksel 75 mg/m² u kombinaciji s cisplatinom
TCF n=221
n = 221
Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
* Korigirano za višestruku usporedbu i prilagođeno faktorima stratifikacije (stadij bolesti i regija liječenja) na osnovu podataka iz populacije bolesnika koji su se mogli procijeniti.
• The Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
• Docetaksel Teva 80 mg/2,88 ml bočica je prozirna staklena bočica od 15 ml s čepom od bromobutilne gume i "flip-off" zatvaračem.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 20 mg/0.72 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - OTAPALO ZA 20 mg/0,72 ml
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
• 332 bolesnika koji su primali docetaksel u kombinaciji s prednizonom ili prednizolonom
BATCH NUMBER Lot
*Neprilagođeni log-rang test
min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2
(TCis), ili Docetaksel 75 mg/m2 u obliku jednosatne infuzije u kombinaciji s karboplatinom (AUC 6 mg/ml u min) tijekom 30-60 min svaka 3 tjedna ili vinorelbin (V) 25 mg/m2 primijenjen tijekom 6
• 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
• 300 bolesnika s adenokarcinomom želuca (221 bolesnik u fazi III studije i 79 bolesnika u fazi II) koji su primali docetaksel u kombinaciji s cisplatinom i 5-fluorouracilom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 80 mg/2.88 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I PRIMJENU DOCETAKSEL TEVA 80 mg/2,88 ml KONCENTRATA I OTAPALA ZA OTOPINU ZA INFUZIJU
Very common adverse reactions Common adverse reactions
Vrlo česte nuspojave Česte nuspojave
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis;
Poremećaji probavnog sustava mučnina; proljev; povraćanje;
Dizziness; Headache (G3/4: <1%);
bol u udovima (G3/4: <1%);
95% CI p-value*
(95% CI) *p-vrijednost
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
Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel
Docetaksel Teva 20 mg/0,72 ml koncentrat i otapalo za otopinu za infuziju docetaksel
Negative
Negativan Pozitivan
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.
Oral candidiasis (G3/4: <1%)
parestezija (G3/4: <1%)
Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
skupinu (medijan OS: 18,6 prema 14,5 mjeseci) s rizikom smanjenja smrtnosti od 28%, p=0,0128.
Median progression free survival (months) (95%CI)
Medijan preživljenja bez progresije bolesti (mjeseci) (95% CI)
Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
doksorubicin i ciklofosfamid (TAC režim).
Gastrointestinal haemorrhage (G3/4:
Poremećaji oka konjuktivitis (G3/4:
1,060 patients were randomised to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
Docetaxel 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg/m2 (521 bolesnik u FAC skupini), kao adjuvantnu terapiju za operabilni karcinom dojke s negativnim limfnim čvorovima i visokim rizikom povrata bolesti prema kriterijima iz St. Gallena iz 1998.g. (veličina tumora >2 cm i/ili negativni ER i PR i/ili visoki histološki/nuklearni gradus (gradus 2 do 3) i/ili dob <35 godina).
Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007 0
Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Stomatitis/Pharyngitis (G3/4:
stomatitis (G3/4:
Hazard ratio (95% CI) *p-value
Omjer rizika (95% CI) *p-vrijednost
Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Tablični popis nuspojava kod karcinoma dojke za Docetaksel 75 mg/m² u kombinaciji s kapecitabinom
Myalgia (G3/4: 0.7%); Arthralgia (G3/4:
proljev (G3/4: 3,4%); konstipacija (G3/4:
Diarrhoea (G3/4: 1.2%);
stomatitis (G3/4: 1,7%);
PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 20 mg/0.72 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I PRIMJENU DOCETAKSEL TEVA 20 mg/0,72 ml KONCENTRATA I OTAPALA ZA OTOPINU ZA INFUZIJU
NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion
Uputa o lijeku: Informacije za bolesnika Docetaksel Teva 80 mg/2,88 ml koncentrat i otapalo za otopinu za infuziju docetaksel
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 GEICAM 9805 studiji, alopecija koja je počla tijekom perioda lječenja i dalje bila prisutna tijekom perioda praćenja i zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Docetaksel Teva 80 mg/2,88 ml koncentrat i otapalo za otopinu za infuziju docetaksel
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
• Indukcijska kemoterapija praćena kemoradioterapijom (TAX 324)
Alopecia (persisting Skin disorder (G3/4:
Poremećaji kože i potkožnog tkiva alopecija (G3/4:
Disease free survival
zimica letargija
Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Opis odabranih nuspojava za Docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
Nausea (G3/4: 13.9%); Stomatitis (G3/4:
proljev (G 3/4: 1,2%); stomatitis/faringitis (G3/4:
In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up 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 je i dalje bila prisutna u periodu praćenja nakon završetka kemoterapije zabilježena je u 202 od 744 bolesnice (27,2%) u TAC
Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent
Tablični popis nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u monoterapiji
Docetaxel Teva is supplied as single-dose vials.
Teva je dostupan u jednodoznim bočicama.
Primary G-CSF prophylaxis should be considered in patients who receive docetaxel, doxorubicin and cyclophosphamide (TAC) adjuvant therapy for breast cancer.
U bolesnika koji primaju docetaksel, doksorubicin i ciklofosfamid (TAC) kao adjuvantnu terapiju u liječenju karcinoma dojke, treba razmotriti primarnu profilaksu s G-CSF.
Hazard ratio (95% CI) **p-value
Omjer rizika (95% CI) **p-vrijednost
Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
vrućica (G3/4: 2,3%); retencija tekućine (teška/opasna po život: 1%)
Nausea (G3/4:13.9%);
Poremećaji probavnog sustava mučnina (G 3/4: 13,9%);
Skin reaction (G3/4:
retencija tekućine (G3/4:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva 20 mg/0.72 ml
Otapalo za Docetaksel Teva 20 mg/0,72 ml
NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion
Uputa o lijeku: Informacije za bolesnika Docetaksel Teva 20 mg/0,72 ml koncentrat i otapalo za otopinu za infuziju docetaksel
This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
27,73 mg/ml (volumen punjenja 24,4 mg/0,88 ml).
Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tablični popis nuspojava za Docetaksel 75 mg/m2 u kombinaciji s cisplatinom i 5-fluorouracilom za terapiju karcinoma glave i vrata
Syncope (G3/4: 0%); Neurotoxicity (G3/4:
(G3/4:0%); somnolencija (G3/4:
Fatigue/ weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Opći poremećaji i reakcije na mjestu primjene astenija (G3/4: 3%); pireksija (G3/4: 1%); umor/slabost (G3/4: 5%); periferni edem (G3/4: 1%)
No of positive nodes Overall
Broj pozitivnih limfnih čvorova
G3/4 Blood bilirubin increased (< 5%);
G3/4 povećanje bilirubina u krvi (<5%); G3/4 povećanje alkalne fosfataze u krvi (<4%);
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.
Na kraju perioda praćenja (medijan vremena praćenja iznosio je 10 godina i 5 mjeseci), alopecija je i dalje bila prisutna u 3 bolesnika (0,6%) u TAC skupini, te u 1 bolesnika (0,2%) u FAC skupini.
Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
prsišta i sredoprsja epistaksa (G3/4: 0%); dispneja (G3/4: 0,6%); kašalj (G3/4: 0%)
Hypersensitivity (G3/4: 1.7%)
proljev (G3/4: 1,7%)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Česte nuspojave Manje česte nuspojave
Febrile neutropenia (G3/4: NA)
vrućica (G3/4: ND);
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.88 ml (Fill: 3.40 ml)
2,88 ml (Punjenje 3,40 ml)
Nausea (G3/4: 3.3%);
stomatitis (G3/4: 23,7%);
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tablični popis nuspojava za Docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%); Fluid retention (G3/4:
Opći poremećaji i reakcije na mjestu primjene letargija (G3/4: 4,0%); pireksija (G3/4: 3,6%);
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Poremećaji krvi i limfnog sustava neutropenija (G4: 54,2%); anemija (G3/4: 10,8%); trombocitopenija (G4: 1,7 %)
Diarrhoea (G3/4: Vomiting (G3/4: 0.6%)
hipotenzija (G3/4: flebitis (G3/4: 0%)
Polysorbate 80
Koncentrat polisorbat 80 etanol, bezvodni
What the solvent vial contains: Water for injections.
Teva sadrži vodu za injekcije.
Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Najbolji ukupni odgovor (CR + PR) na liječenje tijekom studije [kemoterapija +/
Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%)
dermatitis eritematozni osip (G 3/4: <1%) promjena boje nokta; oniholiza (G 3/4: 1%)
Solvent vial: water for injections.
Teva je voda za injekcije.
Myalgia (severe: 1.4%) Arthralgia
Poremećaji mišićno koštanog sustava i vezivnog tkiva mijalgija (teška: 1,4%) artralgija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg docetaxel.
Jedana bočica s koncentratom Docetaksel Teva sadrži 80 mg/2,88 ml docetaksela.
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%)
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² single agent MedDRA system organ classes
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaksel 75 mg/m² u monoterapiji
Dry skin;
kožna toksičnost
Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Opći poremećaji i reakcije na mjestu primjene letargija (G3/4: 3,4%); pireksija (G3/4: 0,6%);
The solvent for Docetaxel Teva is water for injections.
Docetaksel Teva otopine za infuziju
2-year estimate (%) Hazard ratio (95% CI) *p-value
Medijan preživljenja (mjeseci) (95% CI) dvogodišnja procjena (%) Omjer rizika (95% CI) *p-vrijednost
Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Poremećaji krvi i limfnog sustava neutropenija (G3/4: anemija (G3/4: 9,2%); trombocitopenija (G3/4: 5,2%)
The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1-to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg /m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
SCCHN), preporučena doza docetaksela iznosi 75 mg/m2 i daje se kao jednosatna intravenska infuzija na prvi dan, nakon čega slijedi cisplatin 100 mg/m2 primjenjen kao 30-minutna do 3 satna infuzija.
• chest tightness; difficulty in breathing
• bol u trbuhu • probavne tegobe
Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain
prsišta i sredoprsja epistaksa; bol u ždrijelu i grkljanu; nazofaringitis, dispneja; kašalj; rinoreja
Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
mučnina (G 3/4: 4%); povraćanje (G 3/4: 3%)
In a phase III study, 1,218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.
Ispitivanje faze III provedeno je na 1218 bolesnika s neoperabilnim karcinomom nemalih stanica pluća stadija IIIB ili IV s KPS od 70% ili više, koji nisu ranije primali kemoterapiju za tu bolest.
At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Pri medijanu vremena praćenja od 77 mjeseci ukupno ukupno preživljenje (OS) također je bilo duže u bolesnika u TAC skupini, uz 24% smanjenje rizika od smrti u usporedbi s bolesnicima u FAC skupini