natgillin/translations-raw huggingface dataset:
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Težina nuspojava Docetaksel Teva može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
Solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
Bočica s otapalom sadržava 5,12 ml vode za injekcije (volumen punjenja 6,29 ml).
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
4.2.4 The Docetaxel Teva infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
4.2.4 Docetaksel Teva infuzijska otopina mora se upotrijebiti unutar 4 sata nakon pripreme i to uz aseptičku primjenu jednosatnom intravenskom infuzijom pri sobnoj temperaturi (ispod 25°C) i uobičajenom osvjetljenju.
As with all parenteral products, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Kao što je slučaj sa svim parenteralnim pripravcima, pripremljena otopina koncentrata i otopina za infuziju Docetaksel Teva moraju biti vizualno provjerene prije primjene, a otopine koje sadrže precipitat ne smiju se koristiti.
- For the treatment of metastatic gastric cancer, Docetaxel Teva is administered in combination with cisplatin and 5-fluorouracil.
- Za liječenje uznapredovalog karcinoma želuca Docetaksel Teva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
Oesophagitis / dysphagia / odynophagia (G3/4: 0.7%)
ezofagitis/disfagija/odinofagija (G3/4: 0,7%)
2.1 Docetaxel Teva 20 mg/0.72 ml vial:
2.1 Docetaksel Teva 20 mg/0,72 ml bočica:
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/m2 nakon čega je slijedio 5-fluorouracil (F) 1000 mg/m2 na dan tijekom 5 dana.
Solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Bočica s otapalom sadržava 1,28 ml vode za injekcije (volumen punjenja 1,71 ml).
This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.72 ml per vial.
Ovo punjenje u suvišku osigurava da, nakon razrjeđivanja s cjelokupnim sadržajem priloženog otapala za docetaksel, minimalni iskoristivi volumen pripremljene otopine koncentrata od 2 ml sadržava 10 mg/ml docetaksela, što odgovara deklariranoj količini od 20 mg/0,72 ml po bočici.
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 studiji TAX 316, alopecija koja je i dalje bila prisutna tijekom 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.
Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients (11.7%).
Amenoreja je i dalje bila prisutna na kraju perioda praćenja (medijan vremena praćenja iznosio je 8 godina) u 121 od 744 bolesnica (16,3%) u
Hepatic impairment In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
U malog broja bolesnika (n=23), gdje su klinički biokemijski podaci pokazivali lagano ili srednje oštećenje jetrene funkcije (ALT, AST ≥ 1,5 puta od GGN te alkalna fosfataza ≥ 2,5 puta od GGN),
Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Docetaksel Teva u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
Name and address of the manufacturer(s) responsible for batch release
Naziv i adrese proizvođača odgovornih za puštanje serije lijeka u promet
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) 1,000 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 na dan od dana 1 do dana 5.
Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4:
konstipacija (G3/4: 1,0%); gastrointestinalna bol (G3/4:
Preparation for the intravenous administration a) Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Priprema za primjenu u venu a) Priprema Docetaksel Teva otopine koncentrata (10 mg docetaksela/ml)
Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Priprema Docetaksel Teva otopine koncentrata (10 mg docetaksela/ml)
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
U bolesnika liječenih u TAC skupini, rizik povrata bolesti smanjio se za 32% u odnosu na bolesnike u FAC skupini (omjer rizika = 0,68, 95% CI (0,49-0,93), p = 0,01).
Data from a multi-centre open-label randomised trial support the use of Docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu Docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
Combination therapy
Kombinirana terapija Doksorubicin
What the solvent vial contains:
Što bočica s otapalom sadrži:
Tabulated list of adverse reactions for adjuvant therapy with Docetaxel 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 Docetaksel 75 mg/m2 u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima - skupni podaci
1.28 ml (Fill: 1.71 ml)
voda za injekcije 1,28 ml (Punjenje: 1,71 ml)
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).
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).
This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2.88 ml per vial.
Ovo punjenje u suvišku osigurava da, nakon razrjeđivanja s cjelokupnim sadržajem priloženog otapala, minimalni iskoristivi volumen pripremljene otopine koncentrata od 8 ml sadržava 10 mg/ml docetaksela, što odgovara deklariranoj količini od 80 mg po bočici.
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%)
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.
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
Najčešće nuspojave (≥ 5%) povezane s kombiniranim liječenjem s kapecitabinom zabilježene su u ispitivanju faze III u bolesnika s karcinomom dojke nakon neuspješnog liječenja antraciklinima
Diarrhoea grade 3
Stomatitis/mukozitis stupnja 3
Treatment difference: 6.2% [95% CI: 0.2; 12.3]
[95% CI: 0,2; 12,3]
Hypertension; Haemorrhage
disgeuzija; hipoestezija
Tumour response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
* prag statističke značajnosti = 0,0175 ** PSA: prostata-specifični antigen
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 prsnom košu;
Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
* prag statističke značajnosti = 0,0175 ** PSA: prostata specifični antigen
Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%);
Poremećaji probavnog sustava proljev (G 3/4: 19,7%); mučnina (G 3/4: 16%);
Each solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
• Jedna bočica otapala sadrži 5,12 ml vode za injekcije (volumen punjenja 6,29 ml).
Best overall response (CR + PR) to chemotherapy (%) (95%CI) ***p-value
Najbolji ukupni odgovor (CR + PR) na kemoterapiju (%) (95% CI) ***p- vrijednost
For patients with serum bilirubin levels >ULN and/or ALT and AST >3.5 times the ULN concurrent with serum alkaline phosphatase levels >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
U bolesnika s razinama serumskog bilirubina > GGN i/ili ALT i AST > 3,5 x GGN te serumskom alkalnom fosfatazom > 6 x GGN, nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80.
Docetaksel Teva 20 mg/0,72 ml koncentrat za otopinu za infuziju bistra je viskozna, žuta do žutosmeđa otopina koja sadrži 27,73 mg/ml docetaksela u polisorbatu 80.
At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), periferni edem je i dalje bio prisutan u 19 bolesnika (2,6%) u TAC skupini, odnosno u 4 bolesnika (0,5%) u FAC skupini.
Solvent vial: Water for injections
Otapalo voda za injekcije
Hazard ratio: 1.032 [95% CI: 0.876; 1.216]
Omjer rizika: 1,032 [95% CI: 0,876; 1,216]
Median PFS (months) (95% CI)
Medijan PFS (mjeseci) (95% CI)
Vomiting (G3/4: 8.4%);
povraćanje (G3/4: 8,4%);
If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Ako Docetaksel Teva koncentrat, pripremljena otopina koncentrata ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah treba dobro i temeljito isprati sapunom i vodom.
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were
Incidencija vrućice, proljeva, anoreksije i perifernog edema povezanih s uzimanjem lijeka bila je ≥10% viša u bolesnika u dobi od 75 godina i starijih u odnosu na mlađe od 65 godina.
ALT and AST >3.5 times the ULN associated with alkaline phosphatase >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
GGN i/ili vrijednostima ALT i AST > 3,5 većim puta od GGN te alkalnom fosfatazom > 6 puta većom od GGN, nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
Lacrimation increased Conjunctivitis
Poremećaji oka pojačano suzenje konjuktivitis
For those patients with serum bilirubin >ULN and/or
Za bolesnike s vrijednostima serumskog bilirubina >
Neoplasms benign,
docetaksela kao monoterapiju,
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
Grade 2
Gradus 2 Gradus 3
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) ODGOVORNAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
2.1 Docetaxel Teva 80 mg/2.88 ml vial:
2.1 Docetaksel Teva 80 mg/2,88 ml bočica:
This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 181 mg ethanol, anhydrous per concentrate vial, equivalent to 4.6 ml beer or 1.9 ml wine.
Ovaj lijek sadrži 50 vol% bezvodnoga etanola (alkohola), odnosno do 395 mg bezvodnoga etanola po bočici, što odgovara količini od 10 ml piva ili 4 ml vina po bočici.
Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel in polysorbate 80.
Docetaksel Teva 80 mg/2,88 ml koncentrat za otopinu za infuziju bistra je viskozna, žuta do žutosmeđa otopina koja sadrži 27,73 mg/ml docetaksela u polisorbatu 80.
Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
promjene noktiju (G3/4: 0,7%); eksfolijacija kože (G3/4: 0%)
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) 1,000 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 na dan od dana 1 do dana 4. Liječenje se primjenjivalo svaka 3 tjedna, tijekom 3 ciklusa.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 20 mg/0.72 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - KONCENTRAT 20 mg/0,72 ml
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
preporučena doza docetaksela od 75 mg/m2 primjenjuje se 1 sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 svaka 3 tjedna tijekom 6 ciklusa (TAC protokol) (vidjeti također
Each box contains one Docetaxel Teva vial (80 mg/2.88 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
Jedna kutija sadrži jednu bočicu Docetaksel Teva (80 mg/2,88 ml) i jednu bočicu otapala za
Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
Jedna kutija sadrži jednu bočicu Docetaksel Teva (20 mg/0,72 ml) i jednu bočicu otapala za
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multi-centre, open-label, randomised study (TAX323).
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).
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
Rabeći štrcaljku s iglom, aseptički izvucite cjelokupni sadržaj bočice otapala za Docetaksel
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Dodatkom cijelog sadržaja bočice otapala sadržaju bočice Docetaksel Teva 20 mg/0,72 ml koncentrata za otopinu za infuziju, dobiva se pripremljena otopina koncentrata u koncentraciji od 10 mg/ml docetaksela.
This vial contains 2.88 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/3.40 ml).
Bočica sadrži 2,88 ml otopine docetaksela u polisorbatu 80, koncentracije 27,73 mg/ml (volumen punjenja 94,4 mg/3,40 ml).
PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
ER = estrogenski receptor PR = progesteronski receptor a ER/PR-negativni ili gradus 3 ili veličina tumora >5 cm Omjer rizika procijenjen je po Cox modelu proporcionalnog rizika s liječenom skupinom kao faktorom.
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 BID) 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 na dan (primjerice, 8 mg dvaput na dan) tijekom 3 dana s početkom primjene jedan dan prije primjene docetaksela, osim u slučaju kad je to kontraindicirano.
Lacrimation increased; Conjunctivitis
Poremećaji oka pojačano suzenje; konjuktivitis
Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg of docetaxel.
Jedna bočica Docetaksel Teva 20 mg/0,72 ml koncentrata sadrži 20 mg docetaksela.
3 weeks for 4 cycles.
tijekom 5 ciklusa.
Docetaxel Teva 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.
Docetaksel Teva 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.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p=0.0138.
• Vrijeme do progresije bolesti (TTP) bilo je značajno dulje u AT skupini naspram AC skupine,
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.
Concentrate vial:
Ako Docetaksel koncentrat,
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
(uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti G-CSF u svim sljedećim ciklusima (npr. dani 6-15), kako bi se osigurala profilaktička zaštita.
Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg of docetaxel.
Jedna bočica Docetaksel Teva 80 mg/2,88 ml koncentrata sadrži 80 mg docetaksela.
3 hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
Nakon završetka infuzije ciplatina slijedi kontinuirana infuzija 5-fluorouracilom 1000 mg/m2/dan od prvog do četvrtog dana.
Blood and lymphatic Neutropenia (G3/4:
Poremećaji krvi i limfnog sustava neutropenija (G4:
• Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
• Pripremljena otopina koncentrata: Dokazana kemijska i fizikalna stabilnost u primjeni je 8 sati uz čuvanje na temperaturi od 2°C do 8° C ili pri sobnoj temperaturi (ispod 25°C).
Musculoskeletal and connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva mijalgija
Solvent vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Prozirna staklena bočica od 6 ml (staklo tip I), s čepom od bromobutilne gume i s "flip-off" zatvaračem.
4.1.5 Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
4.1.5 Ostavite bočicu s pripremljenom otopinom koncentrata na sobnoj temperaturi (ispod 25°C) oko 5 minuta, a zatim provjerite je li otopina homogena i bistra (pojava pjene je uobičajena i nakon
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.72 ml (Fill: 0.88 ml)
0,72 ml (Punjenje: 0,88 ml)
You must NOT be given Docetaxel Teva:
Docetaksel Teva se NE smije primijeniti
Docetaxel Teva 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.
Docetaksel Teva 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.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
DODATAK II A. PROIZVOĐAČ(I) ODGOVORNA(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Dodatkom cijelog sadržaja bočice otapala sadržaju bočice Docetaksel Teva 80 mg koncentrata za otopinu za infuziju, dobiva se pripremljena otopina koncentrata u koncentraciji od 10 mg/ml docetaksela.
Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Teva je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
Gastrointestinal pain (G3/4: 1.2%); Gastrointestinal haemorrhage (G3/4:
gastrointestinalna bol (G3/4: 1,2%); gastrointestinalno krvarenje (G3/4:
Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4:
proljev (G3/4: 6,8%); ezofagitis/disfagija/ odinofagija (G3/4:
Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Docetaksel Teva u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p=0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p=0.54), docetaxel increased response rate (52% vs. 37%, p=0.01) and shortened time to response (12 weeks vs. 23 weeks, p=0.007).
Bez utjecaja na ukupno vrijeme preživljenja (docetaksel 15 mjeseci prema doksorubicinu 14 mjeseci, p= 0,38) ili na vrijeme do progresije bolesti (docetaksel
Constipation (G3/4: 0.4%)
konstipacija (G3/4: 0,4%)
Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
konstipacija (G3/4: 1%); abdominalna bol (G3/4: 2%); dispepsija bol u gornjem abdomenu suhoća usta