FrancophonIA/ELRC3.0 huggingface dataset:
English: Taxespira in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Croatian: Taxespira u kombinaciji s prednizonom ili prednizolonom indicirana je za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
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 ispitivanju 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: Without affecting OS 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).
Croatian: 27 tjedana prema doksorubicinu 23 tjedna, p=0,54), docetaksel je povećao stopu terapijskog odgovora (52% prema 37%, p=0,01) i skratio vrijeme do odgovora (12 tjedana prema 23 tjedna, p=0,007).
English: Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 patients of 744 TAC patients (16.3 %) and 86 FAC patients
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 TAC skupini i 86 bolesnica (11,7%) u FAC skupini.
English: Peripheral motor neuropathy (G3/4:
Croatian: periferna motorna neuropatija (G3/4:
English: For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Croatian: Za karcinom prostate, uz terapiju prednizonom ili prednizolonom, preporučeni režim premedikacije sadrži oralni deksametazon u dozi od 8 mg 12 sati, 3 sata i 1 sat prije infuzije docetaksela (vidjeti dio 4.4).
English: Data from a multicenter open label randomized trial support the use of Taxespira 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 lijeka Taxespira za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
English: Vial label
Croatian: Naljepnica bočice
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Croatian: omaglica (G3/4: 2,3%); periferna motorna neuropatija (G3/4: 1,3%)
English: In Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml vials the concentration of docetaxel is 20 mg/ml.
Croatian: U bočicama Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml i 160 mg/8 ml koncentracija docetaksela je 20 mg/ml.
English: If this happens, you must tell your doctor immediately.
Croatian: Odmah obavijestite svog liječnika ako se to dogodi.
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every
Croatian: U ovom ispitivanju randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m2 u obliku jednosatne intravenske infuzije svaka 3 tjedna) i kapecitabinom
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST >1.5 × ULN associated with alkaline phosphatase >2.5 × ULN, and bilirubin >1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Croatian: Iz ključnog kliničkog ispitivanja kombinacije s cisplatinom i 5-fluorouracilom za liječenje bolesnika s adenokarcinomom želuca, isključeni su bolesnici s ALT i/ili AST više od 1,5 puta većim od GGN te alkalnom fosfatazom više od 2,5 puta većom od GGN i bilirubinom više od 1 puta većim od GGN; za te bolesnike nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
English: Taxespira in combination with platinum agents in chemotherapy-naïve patients 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/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
Croatian: Taxespira u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju Ispitivanje faze III provedeno je na 1218 bolesnika s neoperabilnim karcinomom nemalih stanica pluća stadija IIIB ili IV s KPS od 70% ili više, koji nisu ranije primali kemoterapiju za tu bolest.
English: In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥20% (13.1% versus 6.1%), absolute LVEF decrease ≥30% (6.2% versus 1.1%).
Croatian: S druge strane, AC skupina je pokazala veću incidenciju teške anemije (15,8% prema 8,5%) nego AT skupina te veću incidenciju teške srčane toksičnosti: kongestivno zatajenje srca (3,8% prema 2,8%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 30% (6,2% prema 1,1%).
English: 140mg/7 ml Each 7 ml vial of concentrate contains 3.5 ml of ethanol anhydrous (2765 mg).
Croatian: 140 mg/7 ml Jedna bočica sa 7 ml koncentrata sadrži 3,5 ml bezvodnog etanola (2765 mg).
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 dnevno), pri čemu premedikaciju treba početi jedan dan prije primjene docetaksela, ako to nije kontraindicirano (vidjeti dio 4.4).
English: 120mg/6 ml Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370 mg).
Croatian: 120 mg/6 ml Jedna bočica sa 6 ml koncentrata sadrži 3 ml bezvodnog etanola (2370 mg).
English: 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.
Croatian: 75 mg/m2 cisplatine u trajanju od 1 do 3 sata (oboje samo na 1. dan), a nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m2 po danu u trajanju od 5 dana.
English: Each ml of solution contains 20 mg of docetaxel (as trihydrate).
Croatian: Jedan ml otopine sadrži 20 mg docetaksela (u obliku docetaksel trihidrata).
English: Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%)
Croatian: omaglica (G3/4:2,0%) periferna motorna neuropatija (G3/4:0,4%)
English: Both regimens were administered once every 3 weeks for 6 cycles.
Croatian: Oba kemoterapijska protokola primjenjivala su se svaka 3 tjedna, tijekom 6 ciklusa.
English: 20mg/1 ml Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Croatian: 20 mg/1 ml Jedna bočica s 1 ml koncentrata sadrži 0,5 ml bezvodnog etanola (395 mg).
English: An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Croatian: Provedeno je multicentrično randomizirano ispitivanje faze III otvorenog tipa kako bi se usporedile monoterapija docetakselom i terapija paklitakselom u liječenju uznapredovalog karcinoma dojke kod bolesnika prethodno liječenih antraciklinima.
English: Lacrimation increased (G3/4: <0.1%)
Croatian: pojačano suzenje (G3/4: <0,1%)
English: Rare (may affect up to 1 in 1,000 people): inflammation of the colon, small intestine, which could be fatal (frequency not known);
Croatian: • upala debelog crijeva, tankog crijeva, koja može biti smrtonosna (nepoznata učestalost);
English: Lacrimation increased Conjunctivitis
Croatian: Poremećaji oka pojačano suzenje konjunktivitis
English: Following chemotherapy, patients should receive chemoradiotherapy.
Croatian: Nakon kemoterapije bolesnici se moraju liječiti
English: Hypotension (G3/4:
Croatian: hipotenzija (G3/4:
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 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.
English: No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Croatian: Nema podataka o primjeni docetaksela u kombiniranoj terapiji u bolesnika s oštećenjem jetre u ostalim indikacijama.
English: Patients previously treated with chemotherapy with or without radiotherapy In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and OS were significantly longer for docetaxel at 75 mg/m² compared to Best Supportive Care.
Croatian: U ispitivanju faze III, vrijeme do progresije bolesti (12,3 tjedna prema 7 tjedana) i ukupno preživljenje bilo je u ranije liječenih bolesnika značajno dulje s docetakselom u dozi od 75 mg/m2 u usporedbi s najboljom potpornom terapijom (BSC).
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm
Croatian: Bolesnici se mogu ponovno liječiti docetakselom kad se broj neutrofila oporavi na razinu ≥ 1500 stanica/mm
English: Diarrhoea grade 4
Croatian: Proljev stupnja 4
English: 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)
Croatian: Svih 445 bolesnika s KPS >70 liječeni su ili docetakselom (T) (75 mg/m2 prvi dan)
English: At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Croatian: Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), alopecija je i dalje bila prisutna u 29 bolesnika u TAC skupini (3,9%) i 16 bolesnika u FAC skupini (2,2 %).
English: G3/4 Blood bilirubin increased (<5%); G3/4 Blood alkaline phosphatase increased (<4%); G3/4 AST increased (<3%); G3/4 ALT increased (<2%)
Croatian: G3/4 povećanje alkalne fosfataze u krvi (<4%); G3/4 povećanje AST
English: 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Croatian: (1250 mg/m2 dvaput dnevno tijekom 2 tjedna nakon čega slijedi jedan tjedan pauze).
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 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 u TAC skupini, odnosno u 4 bolesnika (0,5%) u FAC skupini.
English: Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value
Croatian: Najbolji ukupni odgovor (CR + PR) na liječenje tijekom studije [kemoterapija +/- kemoradioterapija] (%) (95%CI) ***p-vrijednost
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Croatian: Opći poremećaji i reakcije na mjestu primjene reakcija na mjestu primjene infuzije; bol u prsima nekardiološke etiologije (teška: 0,4%)
English: Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Croatian: • razviti i kada se docetaksel primjenjuje istodobno s radioterapijom)
English: Taxespira 20 mg/1 ml concentrate for solution for infusion Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Croatian: Taxespira 20 mg/1 ml koncentrat za otopinu za infuziju Taxespira 80 mg/4 ml koncentrat za otopinu za infuziju Taxespira 120 mg/6 ml koncentrat za otopinu za infuziju Taxespira 140 mg/7 ml koncentrat za otopinu za infuziju Taxespira 160 mg/8 ml koncentrat za otopinu za infuziju
English: • tiredness or flu-like symptoms
Croatian: • umor; ili simptomi nalik gripi
English: • operable node-positive breast cancer
Croatian: • operabilnim karcinomom dojke i pozitivnim limfnim čvorovima
English: Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Croatian: Taxespira 80 mg/4 ml koncentrat za otopinu za infuziju Taxespira 120 mg/6 ml koncentrat za otopinu za infuziju Taxespira 140 mg/7 ml koncentrat za otopinu za infuziju Taxespira 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
English: 160mg/8 ml Each 8 ml vial of concentrate contains 4 ml of ethanol anhydrous (3160 mg).
Croatian: 160 mg/8 ml Jedna bočica sa 8 ml koncentrata sadrži 4 ml bezvodnog etanola (3160 mg).
English: The cycles were repeated every 3 weeks for 3 cycles.
Croatian: Liječenje se ponavlja svaka 3 tjedna kroz 3 ciklusa.
English: At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).
Croatian: Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina) limfedem je i dalje bio prisutan u 6 bolesnika (0,8%) u TAC skupini te u 1 bolesnika (0,1%) u FAC skupini.
English: Abdominal pain (G3/4: 0.4%)
Croatian: abdominalna bol (G3/4: 0,4%)
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
English: 80mg/4 ml Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580 mg).
Croatian: 80 mg/4 ml Jedna bočica s 4 ml koncentrata sadrži 2 ml bezvodnog etanola (1580 mg).
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Croatian: Najbolji ukupni odgovor na liječenje tijekom studije [kemoterapija +/- radioterapija] (%) (95% CI) ***p-vrijednost
English: Vascular disorders Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja
English: 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.
Croatian: Nakon 10 godina praćenja u GEICAM 9805 ispitivanju akutna leukemija pojavila se u 1 od 532 bolesnika (0,2%) u TAC skupini.
English: Preparation of the infusion solution
Croatian: Priprema infuzijske otopine
English: 80mg/4 ml contains 4 ml of concentrate
Croatian: 80 mg/ 4 ml sadrži 4 ml koncentrata.
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: Patients with renal impairment There are no data available in patients with severely impaired renal function treated with docetaxel.
Croatian: Ne postoje dostupni podaci o liječenju docetakselom bolesnika s teškim oštećenjem bubrega.
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Croatian: Pri medijanu vremena praćenja od 10 godina i 5 mjeseci u bolesnika liječenih u TAC skupini rizik od smrti smanjio se za 9% u odnosu na bolesnike u FAC skupini (omjer hazarda= 0,91, 95% CI (0,63
English: Tabulated list of adverse reactions in prostate cancer for Taxespira 75 mg/m² in combination with prednisone or prednisolone
Croatian: Tablični popis nuspojava kod karcinoma prostate za Taxespira 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
English: Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Croatian: Taxespira je indicirana za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
English: In study TAX316 amenorrhoea that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Croatian: U ispitivanju TAX 316 amenoreja, koja je počela tijekom perioda liječenja te koja je i dalje bila prisutna u periodu praćenja nakon završetka kemoterapije, zabilježena je u 202 od 744 bolesnice (27,2%) u TAC skupini te u 125 od 736 bolesnica (17,0%) u FAC skupini.
English: versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Croatian: Primarni ishod djelotvornosti u ovom ispitivanju, ukupno preživljenje (OS) bilo je značajno dulje (log-rank test, p=0,0058) u skupini liječenoj docetakselom u usporedbi s PF (medijan OS: 70,6 prema 30,1 mjesec), s 30% smanjenja smrtnosti u usporedbi s PF (omjer hazarda (HR) = 0,70, 95% interval pouzdanosti (CI) = 0,54-0,90) uz ukupni medijan praćenja od 41,9 mjeseci.
English: Taxespira 140 mg/7 ml concentrate for solution for infusion.
Croatian: Taxespira 140 mg/7 ml koncentrat za otopinu za infuziju docetaksel
English: Ischemia myocardial
Croatian: Poremećaji uha i labirinta ishemija miokarda
English: The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
Croatian: Produljenje preživljenja u skupini koja je primala docetaksel tjedno nije bio statistički značajan u usporedbi sa kontrolnom skupinom koja je primala mitoksantron.
English: • For the treatment of prostate cancer, Taxespira is administered in combination with prednisone
Croatian: • Za liječenje karcinoma prostate Taxespira se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
English: combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Croatian: U kombinaciji s kapecitabinom, preporučena doza docetaksela je 75 mg/m 2 svaka tri tjedna u kombinaciji s kapecitabinom u dozi od 1250 mg/m dvaput dnevno (unutar pola sata nakon obroka) u trajanju od 2 tjedna, nakon čega slijedi tjedan dana stanke.
English: Myalgia (severe:
Croatian: ezofagitis (težak:
English: Aseptically withdraw the required amount of Taxespira concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Croatian: Koristeći kalibriranu štrcaljku s pričvršćenom iglom od 21G, aseptički uvucite potrebnu količinu Taxespira koncentrata za otopinu za infuziju.
English: Taxespira 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: Taxespira u kombinaciji s cisplatinom indicirana je za liječenje bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća, koji nisu ranije primali kemoterapiju za tu bolest.
English: Second episode: reduce docetaxel dose by 20%.
Croatian: Druga epizoda: smanjiti dozu docetaksela za 20%.
English: Taxespira 160 mg/8 ml concentrate for solution for infusion.
Croatian: Taxespira 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Croatian: Docetaksel u kombinaciji s trastuzumabom ispitivao se u liječenju bolesnika s metastatskim karcinomom dojke i pojačanom ekspresijom HER2 koji nisu ranije primali kemoterapiju za metastatsku bolest.
English: Respiratory disorders
Croatian: Oštećenje jetre
English: Constipation (severe: 0.2%); Abdominal pain (severe: 1%);
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Poremećaji probavnog sustava konstipacija (teška: 0,2%); abdominalna bol (teška: 1%); gastrointestinalno krvarenje (teško 0,3%)
English: The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Croatian: Sažetak profila sigurnosti primjene lijeka za sve indikacije Nuspojave koje su moguće ili vjerojatno povezane s primjenom docetaksela zabilježene su u:
English: If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu potrebno je obavijestiti iječnika, bolničkog ljekarnika ili medicinsku sestru.
English: 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.
Croatian: 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.
English: Taxespira 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.
Croatian: Taxespira u kombinaciji s trastuzumabom indicirana je za liječenje bolesnika s metastatskim karcinomom dojke i prekomjerno izraženim HER2, koji nisu ranije primali kemoterapiju za metastatsku bolest.
English: Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
Croatian: • Koristeći kalibriranu štrcaljku s pričvršćenom iglom od 21G, aseptički uvucite potrebnu količinu koncentrata za otopinu za infuziju.
English: Myalgia (G3/4: 0.6%)
Croatian: aritmija (G3/4: 0,6%)
English: Number of patients PSA** response rate (%)
Croatian: Broj bolesnika PSA** stopa odgovora (%) 95% CI p-vrijednost*
English: Contraindications for other medicinal products also apply, when combined with docetaxel.
Croatian: Kad se docetaksel primjenjuje u kombinaciji s drugim lijekovima, potrebno je uzeti u obzir i kontraindikacije tih drugih lijekova.
English: 20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel.
Croatian: 20 mg/ 1 ml Jedna bočica od 1 ml koncentrata sadrži 20 mg docetaksela.