FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Docetaksel Teva infuzijska otopina mora se upotrijebiti unutar 4 sata nakon priprave i to uz aseptičku primjenu jednosatnom intravenskom infuzijom pri sobnoj temperaturi (ispod 25°C) i uobičajenom osvjetljenju.
English: • one 6 ml clear glass vial with a flip-off cap containing 1.28 ml of solvent.
Croatian: • jednu prozirnu staklenu bočicu od 6 ml s "flip-off" zatvaračem koja sadržava 1,28 ml otapala.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/2.88 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 80 mg/2,88 ml
English: For breast, non-small cell lung, gastric, and head and neck 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 be used (see section 4.4).
Croatian: Kod karcinoma dojke, karcinoma nemalih stanica pluća, karcinoma želuca i karcinoma glave i vrata kao premedikacija primjenjuju se oralni kortikosteroidi poput deksametazona, u dozi od 16 mg/dan tijekom 3 dana (primjerice, 8 mg dvaput na dan), pri čemu premedikaciju treba početi jedan dan prije primjene docetaksela, ako to nije kontraindicirano (vidjeti dio 4.4).
English: 4.2.2 Inject the required premix volume into a 250 ml non-PVC infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: 4.2.2 Ubrizgajte potrebni volumen pripremljene otopine koncentrata u ne-PVC infuzijsku vrećicu od 250 ml, koja sadrži 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
English: Description of selected 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
Croatian: Opis odabranih 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
English: Single-use vials.
Croatian: Bočice za jednokratnu uporabu.
English: 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.
Croatian: 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
English: 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.
Croatian: Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m2 nakon čega je slijedio cisplatin (P) 75 mg/m2 te 5-fluorouracil (F) 750 mg/m2 na dan u obliku kontinuirane infuzije tijekom 5 dana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 20 mg/0.72 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 20 mg/0,72 ml
English: Grade 3
Croatian: Proljev stupnja 3
English: The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
Croatian: Težina nuspojava Docetaksel Teva može se povećati kada se daje u kombinaciji s drugim kemoterapeuticima.
English: Tel: +44 1977 628 500
Croatian: Teva UK Limited Tel: +44 1977 628 500
English: Solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
Croatian: Bočica s otapalom sadržava 5,12 ml vode za injekcije (volumen punjenja 6,29 ml).
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis)
Croatian: Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: - For the treatment of metastatic gastric cancer, Docetaxel Teva is administered in combination with cisplatin and 5-fluorouracil.
Croatian: - Za liječenje uznapredovalog karcinoma želuca Docetaksel Teva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
English: Oesophagitis / dysphagia / odynophagia (G3/4: 0.7%)
Croatian: ezofagitis/disfagija/odinofagija (G3/4: 0,7%)
English: 2.1 Docetaxel Teva 20 mg/0.72 ml vial:
Croatian: 2.1 Docetaksel Teva 20 mg/0,72 ml bočica:
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Croatian: 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.
English: Solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Croatian: Bočica s otapalom sadržava 1,28 ml vode za injekcije (volumen punjenja 1,71 ml).
English: 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.
Croatian: 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.
English: 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%).
Croatian: 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.
English: 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%).
Croatian: 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
English: 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).
Croatian: 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),
English: Docetaxel Teva in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Croatian: Docetaksel Teva u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: Naziv i adrese proizvođača odgovornih za puštanje serije lijeka u promet
English: 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.
Croatian: 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.
English: Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4:
Croatian: konstipacija (G3/4: 1,0%); gastrointestinalna bol (G3/4:
English: Preparation for the intravenous administration a) Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Croatian: Priprema za primjenu u venu a) Priprema Docetaksel Teva otopine koncentrata (10 mg docetaksela/ml)
English: Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Croatian: Priprema Docetaksel Teva otopine koncentrata (10 mg docetaksela/ml)
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: Combination therapy
Croatian: Kombinirana terapija Doksorubicin
English: What the solvent vial contains:
Croatian: Što bočica s otapalom sadrži:
English: 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
Croatian: 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
English: 1.28 ml (Fill: 1.71 ml)
Croatian: voda za injekcije 1,28 ml (Punjenje: 1,71 ml)
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: 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%)
Croatian: 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.
English: 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).
Croatian: Najčešće nuspojave (≥ 5%) povezane s kombiniranim liječenjem s kapecitabinom zabilježene su u ispitivanju faze III u bolesnika s karcinomom dojke nakon neuspješnog liječenja antraciklinima
English: Diarrhoea grade 3
Croatian: Stomatitis/mukozitis stupnja 3
English: Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Croatian: [95% CI: 0,2; 12,3]
English: Hypertension; Haemorrhage
Croatian: disgeuzija; hipoestezija
English: Tumour response rate (%) 95% CI p-value* †Stratified log-rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Croatian: * prag statističke značajnosti = 0,0175 ** PSA: prostata-specifični antigen
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija; periferni edem; pireksija; umor; upala sluznice; bol; bolest slična gripi; bol u prsnom košu;
English: Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance=0.0175 **PSA: Prostate-Specific Antigen
Croatian: * prag statističke značajnosti = 0,0175 ** PSA: prostata specifični antigen
English: Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%);
Croatian: Poremećaji probavnog sustava proljev (G 3/4: 19,7%); mučnina (G 3/4: 16%);
English: Each solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
Croatian: • Jedna bočica otapala sadrži 5,12 ml vode za injekcije (volumen punjenja 6,29 ml).
English: Best overall response (CR + PR) to chemotherapy (%) (95%CI) ***p-value
Croatian: Najbolji ukupni odgovor (CR + PR) na kemoterapiju (%) (95% CI) ***p- vrijednost
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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%).
Croatian: 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.
English: Solvent vial: Water for injections
Croatian: Otapalo voda za injekcije
English: Hazard ratio: 1.032 [95% CI: 0.876; 1.216]
Croatian: Omjer rizika: 1,032 [95% CI: 0,876; 1,216]
English: Median PFS (months) (95% CI)
Croatian: Medijan PFS (mjeseci) (95% CI)
English: Vomiting (G3/4: 8.4%);
Croatian: povraćanje (G3/4: 8,4%);
English: If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Croatian: 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.
English: The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were
Croatian: 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.
English: 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.
Croatian: 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.
English: Lacrimation increased Conjunctivitis
Croatian: Poremećaji oka pojačano suzenje konjuktivitis
English: For those patients with serum bilirubin >ULN and/or
Croatian: Za bolesnike s vrijednostima serumskog bilirubina >
English: Neoplasms benign,
Croatian: docetaksela kao monoterapiju,
English: Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Croatian: Tablični popis nuspojava kod karcinoma prostate za Docetaksel 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
English: Grade 2
Croatian: Gradus 2 Gradus 3
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORNAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: 2.1 Docetaxel Teva 80 mg/2.88 ml vial:
Croatian: 2.1 Docetaksel Teva 80 mg/2,88 ml bočica:
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Croatian: promjene noktiju (G3/4: 0,7%); eksfolijacija kože (G3/4: 0%)
English: 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.
Croatian: 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.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 20 mg/0.72 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - KONCENTRAT 20 mg/0,72 ml
English: 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).
Croatian: 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
English: Each box contains one Docetaxel Teva vial (80 mg/2.88 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
Croatian: Jedna kutija sadrži jednu bočicu Docetaksel Teva (80 mg/2,88 ml) i jednu bočicu otapala za
English: Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
Croatian: Jedna kutija sadrži jednu bočicu Docetaksel Teva (20 mg/0,72 ml) i jednu bočicu otapala za
English: 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).
Croatian: 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).
English: Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
Croatian: Rabeći štrcaljku s iglom, aseptički izvucite cjelokupni sadržaj bočice otapala za Docetaksel
English: 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.
Croatian: 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.
English: 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).
Croatian: Bočica sadrži 2,88 ml otopine docetaksela u polisorbatu 80, koncentracije 27,73 mg/ml (volumen punjenja 94,4 mg/3,40 ml).
English: PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Croatian: 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.
English: 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.
Croatian: 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.
English: Lacrimation increased; Conjunctivitis
Croatian: Poremećaji oka pojačano suzenje; konjuktivitis
English: Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg of docetaxel.
Croatian: Jedna bočica Docetaksel Teva 20 mg/0,72 ml koncentrata sadrži 20 mg docetaksela.
English: 3 weeks for 4 cycles.
Croatian: tijekom 5 ciklusa.
English: 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.
Croatian: 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.
English: • Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p=0.0138.
Croatian: • Vrijeme do progresije bolesti (TTP) bilo je značajno dulje u AT skupini naspram AC skupine,