natgillin/translations-raw huggingface dataset:
Severe Cutaneous Adverse Reactions (SCARs) such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel treatment.
Prijavljene su teške kožne nuspojave poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantemozne pustuloze (AGEP) kod liječenja docetakselom.
U kabelovny 130 102 37 Prague 10 Czech Republic
U kabelovny 130, 102 37 Prague 10, Češka Republika
How to store Docetaxel Zentiva
Kako čuvati Docetaxel Zentiva
MARKETING AUTHORISATION HOLDER Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Czech Republic
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zentiva k.s., U kabelovny 130, 102 37 Prague 10, Češka Republika
Dose adjustment Diarrhoea grade 3 First episode: reduce 5-FU dose by20%.
Prilagodba doze Proljev stupnja 3 Prva epizoda: smanjiti dozu 5-FU za 20%.
A total of 1776 male patients were allocated to the treatment armss of interest:
Ukupno 1776 muških bolesnika bilo je raspodijeljeno u sljedeće terapijske skupine:
- For the treatment of early breast cancer with or without lymph node involvement, Docetaxel Zentiva could be administered in combination with doxorubicin and cyclophosphamide.
- Za liječenje ranog karcinoma dojke sa ili bez zahvaćenih limfnih čvorova, Docetaxel Zentiva se primjenjuje u kombinaciji s doksorubicinom i ciklofosfamidom.
Consequently, because of the potential for adverse reactions in nursing infants, breast-feeding must be discontinued for the duration of docetaxel therapy.
Sukladno navedenom, zbog mogućih nuspojava u dojenčeta, za vrijeme liječenja docetakselom dojenje se mora prekinuti.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najčešće prijavljene nuspojave samog docetaksela su: neutropenija (koja je bila reverzibilna i nije bila kumulativna; medijan javljanja najnižih vrijednosti je bio 7 dana, a medijan trajanja teške neutropenije (<500 stanica/mm
More than one vial of Docetaxel Zentiva 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 Zentiva koncentrata za otopinu za infuziju kako bi se dobila potrebna doza za bolesnika.
Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Docetaxel Zentiva u kombinaciji s doksorubicinom i ciklofosfamidom indiciran je za adjuvantno liječenje bolesnika s:
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.
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.
- For the treatment of prostate cancer, Docetaxel Zentiva is administered in combination with prednisone or prednisolone.
- Za liječenje karcinoma prostate Docetaxel Zentiva se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Nakon 10 godina praćenja u ispitivanju TAX 316, akutna leukemija zabilježena je u 3 od 744 bolesnika u (0,4%) TAC skupini te u 1 od 736 bolesnika (0,1%) u FAC skupini.
• flushing, skin reactions, itching
• naleti vrućine, kožne reakcije, svrbež
When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Bolesnici koji su kandidati za liječenje docetakselom u kombinaciji s trastuzumabom trebaju na početku liječenja obaviti osnovne pretrage srčane funkcije.
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) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m prvi dan) u kombinaciji sa cisplatinom (C) (75 mg/m prvi dan) i 5-fluorouracilom (F) (750 mg/m dnevno kroz 5
In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
U prvoj liniji liječenja docetaksel se primjenjuje u dozi od 75 mg/m u kombinaciji s doksorubicinom (50 mg/m
If Docetaxel Zentiva concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Ako Docetaxel Zentiva koncentrat ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah dobro i temeljito isperite sapunom i vodom.
Docetaxel Zentiva in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Docetaxel Zentiva u kombinaciji s cisplatinom i 5-fluorouracilom je indiciran za liječenje bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Jedna bočica koncentrata sadržava 2 ml (1,58 g) etanola, bezvodnog.
For combination with ADT and with prednisone or prednisolone (STAMPEDE study), adverse events occurring over the 6 cycles of treatment with docetaxel and having at least 2% higher incidence in the docetaxel treatment arm by comparison to the control arm, are presented, using the CTCAE grading scale.
Za kombinaciju s terapijom deprivacije androgena (ADT) i prednizonom ili prednizolonom (studija STAMPEDE), korištenjem CTCAE ljestvice ocjenjivanja, prikazani su štetni događaji koji su se javljali tijekom 6 ciklusa liječenja docetakselom i koji su imale barem 2% veću incidenciju u skupini liječenoj docetakselom u odnosu na kontrolnu skupinu.
Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Docetaxel Zentiva u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje
Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Jedna bočica koncentrata sadržava 4 ml (3,16 g) etanola, bezvodnog.
Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
konstipacija (G3/4: 1,0%); gastrointestinalna bol (G3/4:
In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m2 immediately followed by cisplatin 75 mg/m2 over 30-60 minutes.
Za bolesnike koji nisu prethodno primali kemoterapiju za karcinom nemalih stanica pluća preporučeni režim doziranja iznosi 75 mg/m docetaksela, nakon čega odmah slijedi infuzija 75 mg/m cisplatina u trajanju od 30 do 60 minuta.
A total of 445 patients with KPS > 70 were treated with either docetaxel (T)
Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m prvi dan)
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm3 and platelets recover to a level > 100,000 cells/mm3.
2. Bolesnici ne bi smjeli primiti sljedeći ciklus docetaksela dok se broj neutrofila ne vrati na razinu od > 1500 stanica/mm 3, a broj trombocita na > 100 000 stanica/mm 3. Liječenje se mora prekinuti ako toksičnost potraje (vidjeti dio 4.4).
95% CIAdjusted hazard ratio
95% CI Prilagođeni omjer hazarda
Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with Docetaxel Zentiva: - SJS/TEN sympoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Teške kožne tegobe poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantematozne pustuloze (AGEP) prijavljene su kod primjene lijeka Docetaxel Zentiva: - Simptomi Stevens-Johnsonovog sindroma (SJS) i toksične epidermalne nekrolize TEN) mogu uključivati pojavu mjehurića, guljenje ili krvarenje bilo kojeg dijela kože (uključujući usne, oči, usta, nos, genitalije, šake ili stopala) sa ili bez pojave osipa.
Docetaxel Zentiva in combination with trastuzumab
Docetaxel Zentiva u kombinaciji s trastuzumabom
Docetaxel Zentiva is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Zentiva solutions.
Docetaxel Zentiva je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora s njime oprezno rukovati u pripremi otopine lijeka Docetaxel Zentiva.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 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 cyclophosphamide 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/m primijenjen jedan sat nakon doksorubicina 50 mg/m i ciklofosfamida 500 mg/m
- For the treatment of lung cancer, Docetaxel Zentiva could be administered either alone or in combination with cisplatin.
- Za liječenje karcinoma pluća Docetaxel Zentiva se primjenjuje sam ili u kombinaciji s cisplatinom.
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m nakon čega je slijedio cisplatin (P) 75 mg/m te 5-fluorouracil (F) 750 mg/m dnevno u obliku kontinuirane infuzije tijekom 5 dana.
• Standard of care + docetaxel 75 mg/m², administered every 3 weeks for 6 cycles
Standard liječenja + docetaksel 75 mg/m2, primijenjen svaka 3 tjedna u 6 ciklusa
In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, 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.
Docetaksel treba primjenjivati kad je broj neutrofila ≥ 1500 stanica/mm Bolesnicima koji razviju febrilnu neutropeniju, imaju broj neutrofila manji od 500 stanica/mm dulje od tjedan dana, razviju teške ili kumulativne kožne reakcije ili tešku perifernu neuropatiju tijekom liječenja docetakselom, dozu docetaksela treba smanjiti sa 100 mg/m na 75 mg/m i/ili sa 75 mg/m na 60 mg/m
b Time to castration-resistant prostate cancer = time from randomization to PSA progression or clinical progression (i.e., increasing symptomatic bone metastases, progression per Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or clinical deterioration due to cancer per the Investigator's opinion), whichever occurred first.
b Vrijeme do karcinoma prostate rezistentnog na kastraciju = vrijeme od randomizacije do povećanja PSA ili kliničke progresije bolesti (npr. porast simptomatskih metastaza u kostima, progresija bolesti prema Kriterijima ocjene odgovora kod solidnih tumora [eng.
- For the treatment of head and neck cancer, Docetaxel Zentiva is administered in combination with cisplatin and 5-fluorouracil.
- Za liječenje karcinoma glave i vrata Docetaxel Zentiva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Bolesnici u usporednoj skupini primali su cisplatin (P) 100 mg/m nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m dnevno tijekom 5 dana.
If Docetaxel Zentiva concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Ako Docetaxel Zentiva koncentrat, ili otopina za infuziju dođu u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
Cautions for use in castration-resistant prostate cancer Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study (TAX 327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Od 333 bolesnika koji su docetaksel primali svaka tri tjedna u studiji liječenja karcinoma prostate, 209 bolesnika bilo je u dobi od 65 godina ili starijih, a 68 bolesnika bilo je starije od 75 godina.
Oedema (G3/4: 1.2%)
edem (G3/4: 1,2%)
G3/4 AST increased
G3/4 ALT povišen
95% CI p-valuea*
95% CI p-vrijednosta*
Docetaxel Zentiva in combination with capecitabine
Docetaxel Zentiva u kombinaciji s kapecitabinom
If this happens, you must tell your doctor immediately
Odmah obavijestite svog liječnika ako se to dogodi
The safety and efficacy of docetaxel administered concomitantly with standard of care (ADT) in patients with high-risk locally advanced or metastatic hormone-sensitive prostate cancer were evaluated in a randomised multi-centre, multi-arm multi-stage (MAMS) study with a seamless phase II/III design (STAMPEDE - MRC PR08).
Sigurnost i djelotvornost docetaksela primijenjenog istovremeno sa standardom liječenja (terapija deprivacije androgena, ADT) u bolesnika s visokorizičnim lokalno uznapredovalim ili metastatskim karcinomom prostate osjetljivim na hormone ocijenjene su u randomiziranoj multicentričnoj studiji s više skupina i više stupnjeva (engl. multi-arm multi-stage, MAMS) s dizajnom bez prijelaza faza II/III (engl. seamless phase II/III design)(STAMPEDE - MRC PR08).
Description of selected adverse reactions for adjuvant therapy with Docetaxel Zentiva 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Opis odabranih nuspojava za adjuvantno liječenje za Docetaxel Zentiva 75 mg/m u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima
Docetaxel Zentiva in combination with doxorubicin
Docetaxel Zentiva u kombinaciji s doksorubicinom
Tabulated list of adverse reactions for adjuvant therapy with Docetaxel Zentiva 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Tablični popis nuspojava za adjuvantno liječenje za Docetaxel Zentiva 75 mg/m u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima - skupni podaci
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).
Cases of cutaneous lupus erythematosus, bullous eruptions such as erythema multiforme and severe cutaneous adverse reactions such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) and Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with docetaxel.
Pri primjeni docetaksela, zabilježeni su kožni lupus eritematodes, bulozne erupcije poput eritema multiforme i teških kožnih nuspojava poput Stevens-Johnsonovog sindroma (SJS), toksične epidermalne nekrolize (TEN) ) i akutne generalizirane egzantemozne pustuloze (AGEP).
Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
ezofagitis/disfagija/odinofagija (G3/4: 0,7%)
Docetaxel Zentiva in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Docetaxel Zentiva u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate rezistentnim na kastraciju.
3 years
svaka 3 tjedna.
Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for Docetaxel Zentiva 75 mg/m² in combination with prednisone or prednisolone
Tablični popis nuspojava kod metastatskog karcinoma prostate rezistentnog na kastraciju za Docetaxel Zentiva 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
Data from a multi-centre open label randomised trial support the use of Docetaxel Zentiva for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu lijeka Docetaxel Zentiva za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
Efficacy of docetaxel in the induction treatment of patientswith locally advanced SCCHN (Intent-toTreat Analysis)
Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN (Intent-to-treat analiza)
Aseptically withdraw the required amount of Docetaxel Zentiva concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Rabeći kalibriranu štrcaljku s pričvršćenom iglom od 21G, aseptički uvucite potrebnu količinu Docetaxel Zentiva koncentrata za otopinu za infuziju.
In a phase III study, 1218 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.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
(TCis), ili docetaksel 75 mg/m 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/m primijenjen tijekom 6 do 10 minuta na dan 1, 8, 15, 22, nakon čega je slijedilo davanje cisplatine 100 mg/m na dan 1 ciklusa koji se ponavljao svaka 4 tjedna (VCis).
• 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 (TAX 324) Sigurnost 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).
- For the treatment of metastatic gastric cancer, Docetaxel Zentiva is administered in combination with cisplatin and 5-fluorouracil.
- Za liječenje uznapredovalog karcinoma želuca Docetaxel Zentiva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Poremećaji živčanog sustava disgeuzija (G3/4: periferna senzorna neuropatija (G3/4:
A study of 14C-docetaxel has been conducted in three cancer patients.
C-docetaksela na tri osobe s karcinomom.
MARKETING AUTHORISATION NUMBER EU/1/07/384/005
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/005
Oral candidiasis Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
astenija (G3: 0%) retencija tekućine vrućica (G3: 1%) oralna kandidijaza hipokalcijemija (G3: 0%) hipofosfatemija (G3-4: 1%) hipokalijemija (G3: 0%)
Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for DOCETAXEL 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study)
Tablični popis nuspojava kod visokorizičnog lokalno uznapredovalog ili metastatskog karcinoma prostate osjetljivog na hormone za DOCETAXEL ZENTIVA 75 mg/m u kombinaciji s prednizonom ili prednizolonom i terapijom deprivacije androgena (ADT) (studija STAMPEDE)
In some cases (frequency not known)
U pojedinim slučajevima (nepoznata učestalost) primijećen je trajan gubitak kose
Docetaxel Zentiva 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 Zentiva 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.
For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dosereduction 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.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel as trihydrate.
NAVOĐENJE DJELATNE(IH) TVARI Jedan ml koncentrata sadržava 20 mg docetaksela u obliku docetaksel trihidrata.
MARKETING AUTHORISATION NUMBER EU/1/07/384/004
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/004
Rare cases of ileus and intestinal obstruction have been reported.
Zabilježeni su slučajevi insuficijencije bubrega i zatajenja bubrega.
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 160 mg/8 ml
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 160 mg/8 ml
MARKETING AUTHORISATION NUMBER EU/1/07/384/003
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/003
Package leaflet: Information for the patient Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Uputa o lijeku: Informacije za bolesnika Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 160 mg/8 ml sterilni koncentrat docetaksel
Adjusted hazard ratio 95% CI p-value*
Prilagođeni omjer hazarda 95% CI p-vrijednost*
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/m 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/m po danu u trajanju od 5 dana.
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 20 mg/1 ml
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 20 mg/1 ml
Docetaxel Zentiva is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Docetaxel Zentiva je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
In Docetaxel Zentiva 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici Docetaxel Zentiva 160 mg/8 ml, koncentracija docetaksela iznosi 20 mg/ml.