natgillin/translations-raw huggingface dataset:
Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period,
Limfedem koji je počeo tijekom perioda liječenja bio je i dalje prisutan u periodu praćenja u 5 bolesnika (0,9%) u TAC skupini i u 2 bolesnika (0,4%) u FAC skupini.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju Jedna bočica s 8 ml koncentrata sadrži 160 mg docetaksela.
Both regimens were administered once every 3 weeks for 6 cycles.
Oba kemoterapijska protokola primjenjivala su se svaka tri tjedna,tijekom 6 ciklusa.
Number of patients PSA** response rate (%) 95% CI p-value*
PSA** stopa odgovora (%) 95% CI p- vrijednost *
severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m2.
Bolesnicima koji razviju febrilnu neutropeniju, imaju broj neutrofila manji od 500 stanica/mm3 dulje od tjedan dana, razviju teške ili kumulativne kožne reakcije ili tešku perifernu neuropatiju tijekom liječenja docetakselom, dozu docetaksela treba smanjiti sa 100 mg/m2 na 75 mg/m2 i/ili sa 75 mg/m2 na 60 mg/m2.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju Jedna bočica koncentrata sadrži 4 ml bezvodnog etanola (3,16 g).
Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m2 kao 30-minutnu do trosatnu intravensku infuziju na dan 1, nakon čega je slijedila kontinuirana intravenska infuzija 5-fluorouracila (F) 1000 mg/m2
50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
50 vol% bezvodnog etanola (alkohol), odnosno do 3,16 g bezvodnog etanola po bočici, što odgovara količini od 80 ml piva ili 33 ml vina.
Paraesthesia; Headache; Dysgeusia; Hypoaesthesia
Poremećaji živčanog sustava parestezija; glavobolja; disgeuzija; hipoestezija
Hazard ratio (TAC/FAC) (95% CI)
Omjer hazarda (TAC/FAC)
Common (may affect up to 1 in 10 people):
Često (javljaju se u do 1 na 10 osoba):
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and an orange flip-off cap, containing 1 ml of concentrate.
Docetaxel Accord 20 mg/1 ml koncentrat za otopinu za infuziju Prozirna staklena bočica (staklo tip I), s fluorotec plus (etilen-tetrafluoroetilen film) gumenim čepom i aluminijskim zatvaračem i narančastom „flip-off „ zaštitnom kapicom, koja sadrži 1 ml koncentrata.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 8 ml of concentrate.
Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju Prozirna staklena bočica (staklo tip I), s fluorotec plus (etilen-tetrafluoroetilen film) gumenim čepom i aluminijskim zatvaračem i crvenom „flip-off „ zaštitnom kapicom, koja sadrži 8 ml koncentrata.
Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Zabilježeni su rijetki slučajevi enterokolitisa, uključujući kolitis, ishemijski kolitis i neutropenijski enterokolitis s potencijalnim smrtnim ishodom (nepoznata učestalost).
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Docetaxel Accord 20 mg/1 ml koncentrat za otopinu za infuziju Jedna bočica s 1 ml koncentrata sadrži 20 mg docetaksela.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel
Docetaxel Accord 20 mg/1ml koncentrat za otopinu za infuziju Docetaxel Accord 80 mg/4 ml koncentrat za otopinu za infuziju Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Ovaj lijek sadrži 50 vol% bezvodnog etanola (alkohol), odnosno do 395 mg bezvodnog etanola po bočici, što odgovara količini od 10 ml piva ili 4 ml vina.
If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Ako dođe u dodir sa sluznicom, odmah temeljito isperite vodom.
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 Accord 80 mg/4 ml concentrate for solution for infusion Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Docetaxel Accord 80 mg/4 ml koncentrat za otopinu za infuziju Jedna bočica koncentrata sadrži 2 ml bezvodnog etanola (1,58 g).
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Razlika u liječenju: 5,4% [95% CI: -1,1; 12,0]
DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 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 (Docetaxel Accord 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
Peripheral motor neuropathy (G3/4:
periferna motorna neuropatija (G 3/4:
Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m2 every 3 weeks.
Provedena su dva randomizirana, komparativna ispitivanja faze III u kojima su sudjelovali bolesnici s metastatskim karcinomom dojke, od kojih je 326 bilo neuspješno liječeno alkilirajućim agensima, a 392 antraciklinima.
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.
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.
Tabulated list of adverse reactions in prostate cancer for docetaxel 75 mg/m2 in combination with prednisone or prednisolone
Tablični popis nuspojava kod karcinoma prostate za docetaksel 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
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 ispitivanju GEICAM 9805 akutna leukemija pojavila se u 1 od 532 bolesnika (0,2%) u TAC skupini.
One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Jedna bočica od 8 ml koncentrata sadržava 160 mg docetaksela.
DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 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 (Docetaxel Accord 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
EU/1/12/769/002
EU/1/12/769/001 EU/1/12/769/002 EU/1/12/769/003
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg twice daily) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Za karcinome dojke i karcinome nemalih stanica pluća premedikacija se sastoji od oralnog kortikosteroida, poput 16 mg deksametazona dnevno (primjerice, 8 mg dvaput dnevno) tijekom tri dana s početkom primjene jedan dan prije primjene docetaksela, osim u slučaju kad je to kontraindicirano.
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Ako se otopina ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u uporabi su odgovornost korisnika, a ne bi smjeli biti duži od 6 sati pri temperaturi ispod 25oC, uključujući u to i jednosatnu infuziju Fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu, dokazana je do 48 sati u ne-PVC vrećici kada se čuvaju pri temperaturi od 2ºC do 8ºC.
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) 1000 mg/m²/day from day 1 to day 4.
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 intravenskom. infuzijom na dan 1 nakon čega je slijedio cisplatin (P) 100 mg/m2 primijenjen kao 30-minutna do 3-satna intravenska infuzija praćena kontinuiranom intravenskom infuzijom 5-fluorouracila (F) 1000 mg/m2 dnevno od dana 1 do dana 4. Liječenje se primjenjivalo svaka 3 tjedna, tijekom 3 ciklusa.
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Docetaxel Accord 80 mg/4 ml koncentrat za otopinu za infuziju Jedna bočica s 4 ml koncentrata sadrži 80 mg docetaksela.
Docetaxel Accord 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 Accord u kombinaciji s trastuzumabom indiciran je za liječenje bolesnika s metastatskim karcinomom dojke i prekomjerno izraženim HER2, koji nisu ranije primali kemoterapiju za metastatsku bolest.
Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Docetaxel Accord je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion
Docetaxel Accord 20 mg/1 ml koncentrat za otopinu za infuziju Docetaxel Accord 80 mg/4 ml koncentrat za otopinu za infuziju Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju
In Docetaxel Accord vial the concentration of docetaxel is 20 mg/ml.
U bočici lijeka DocetaxelAccord koncentracija docetaksela iznosi 20 mg/ml.
Uncommon (may affect up to 1 in 100 people):
Manje često (javljaju se u do 1 na 100 osoba):
MARKETING AUTHORISATION NUMBER EU/1/12/769/003
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/769/002
BATCH NUMBER Lot:
BROJ SERIJE Broj serije:
Docetaxel infusion solution is supersaturated, therefore may crystallise over time.
Infuzijska otopina docetaksela je prezasićena, stoga tijekom vremena može doći do kristalizacije.
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion docetaxel
Docetaxel Accord 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
- For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
- Za liječenje karcinoma glave i vrata docetaksel se primjenjuje u kombinaciji s cisplatinom i 5
One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Jedna bočica od 4 ml koncentrata sadržava 80 mg docetaksela.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 160 mg/8 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Accord 160 mg/8 ml sterilni koncentrat docetaksel i.v. primjena
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel
Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 20 mg/1 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Accord 20 mg/1 ml sterilni koncentrat docetaksel i.v. primjena
You must not be given Docetaxel Accord
Docetaxel Accord se ne smije primijeniti:
Gastrointestinal pain (G3/4: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
konstipacija (G3/4: 1,0%); gastrointestinalna bol (G3/4: ezofagitis/disfagija/odinofagija (G3/4: 0,7%)
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Pomoćna tvar s poznatim učinkom Docetaxel Accord 20 mg/1 ml koncentrat za otopinu za infuziju Jedna bočica koncentrata sadrži 0,5 ml bezvodnog etanola (395 mg).
Docetaxel Accord 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 Accord u kombinaciji s cisplatinom indiciran je za liječenje bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća, koji nisu ranije primali kemoterapiju za tu bolest.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel.
NAVOĐENJE DJELATNE(IH) TVARI Jedan ml koncentrata sadrži 20 mg docetaksela.
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Jedna bočica s 1 ml koncentrata sadrži 20 mg docetaksela.
1060 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
1060 bolesnika randomizirano je u skupine koje su primale ili docetaksel 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).
Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Docetaxel Accord u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
50 vol% bezvodnog etanola (alkohol), odnosno do 395 mg bezvodnog etanola po bočici, što odgovara količini od 10 ml piva ili 4 ml vina.
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
Each box contains one vial of 4 ml concentrate.
Jedno pakiranje sadrži po jednu bočicu s 1 ml koncentrata, Jedno pakiranje sadrži po jednu bočicu s 4 ml koncentrata.
Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Poremećaji probavnog sustava mučnina (G 3/4: 0,6%); stomatitis (G3/4: proljev (G 3/4: 2,9%); povraćanje (G3/4:
G3/4 Blood alkaline phosphatase increased (<
G3/4 povećanje bilirubina u krvi G3/4 povećanje alkalne fosfataze u krvi (<2,5%)
lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Na kraju perioda praćenja limfedem je i dalje bio prisutan u 4 bolesnika (0,8%) u TAC skupini te u 1 bolesnika (0,2%) u FAC skupini.
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
The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR USE WITH DOCETAXEL ACCORD CONCENTRATE FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU ZA PRIMJENU DOCETAXEL ACCORD KONCENTRATA ZA OTOPINU ZA INFUZIJU
In Docetaxel Accord 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici lijeka Docetaxel Accord od 20 mg/1 ml, koncentracija docetaksela iznosi 20 mg/ml.
Musculoskeletal and connective tissue disorders
Poremećaji mišićnokoštanog sustava i vezivnog tkiva mijalgija
Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Docetaxel Accord kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 80 mg/4 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Accord 80 mg/4 ml sterilni koncentrat docetaksel i.v. primjena
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Rijetko je bio zabilježen fenomen odzivne reakcijske upalne reakcije.
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
hipotenzija (G3/4: 0%); flebitis (G3/4: 0%)
Nausea (G3/4: 9.6%); Vomiting (G3/4:
proljev (G3/4: 6,2%); povraćanje (G3/4:
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion docetaxel
Docetaxel Accord 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
osip praćen svrbežom (G3/4: promjene noktiju (G3/4: 0,7%); eksfolijacija kože (G3/4: 0%)
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
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
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
Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4: Febrile neutropenia
Poremećaji krvi i limfnog sustava neutropenija (G3/4: 83,5%); anemija (G3/4: 12,4%); trombocitopenija (G3/4: febrilna neutropenija
Docetaxel Accord 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 Accord u kombinaciji s doksorubicinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Docetaksel u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju
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
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
Dysgeusia/Parosmia (G3/4: 0.4%);
Česte nuspojave klijetke (G3/4: 0,3%)
Diarrhoea (G3/4: 1.2%);
bol izazvana karcinomom (G3/4: 1,2%)
Dizziness (G3/4: Peripheral motor neuropathy (G3/4:
Poremećaji živčanog sustava disgeuzija (G3/4: periferna senzorna neuropatija (G3/4:
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%);
Poremećaji probavnog sustava mučnina (G3/4: 3,3%); stomatitis (G3/4: 1,7%); povraćanje (G3/4: 0,8%); proljev (G3/4: 1,7%)
Lacrimation increased (G3/4:
pojačano suzenje (G3/4:
patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Nakon stratifikacije prema broju pozitivnih limfnih čvorova (1-3, 4+), randomiziran je 1491 bolesnik u skupine koje će primati ili docetaksel 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (TAC skupina) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg (FAC skupina).
In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm.
U ispitivanju GEICAM 9805 periferni edem koji je počeo tijekom perioda liječenja te je bio prisutan u periodu praćenja u 4 bolesnika (0,8%) u TAC skupini te u 2 bolesnika (0,4%) u FAC skupini.
Alopecia; Erythema; Rash; Nail disorders
Poremećaji kože i potkožnog tkiva alopecija;eritem; osip; poremećaji noktiju
In GEICAM 9805 study alopecia that started during the treatment period and persisted into the follow-up 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 ispitivanju, 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.