FrancophonIA/ELRC3.0 huggingface dataset:
English: All 3 regimens were administered in combination with prednisone or prednisolone 5 mg twice daily, continuously.
Croatian: Sva tri kemoterapijska protokola primjenjivala su se u kombinaciji s prednizonom ili prednizolonom u dozi od 5 mg dva puta dnevno kontinuirano.
English: (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
Croatian: Docetaksel je povećao stopu terapijskog odgovora (33% prema 12%, p<0,0001), produljio vrijeme do progresije bolesti (19 tjedana prema 11 tjedana, p=0,0004) i produljio ukupno preživljenje (11 mjeseci prema 9 mjeseci, p=0,01).
English: - For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.
Croatian: - Za liječenje karcinoma prostate docetaksel se primjenjuje u kombinaciji s prednizonom ili prednizolonom.
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/ pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Croatian: Rijetko su zabilježeni akutni respiratorni distres sindrom, intersticijska pneumonija/pneumonitis, intersticijska bolest pluća, plućna fibroza te respiratorno zatajenje, u nekim slučajevima sa smrtnim ishodom.
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: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Croatian: G3/4 AST povišen G3/4 povećanje alkalne fosfataze u krvi
English: • 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, multicentre open-label, phase III study (TAX324).
Croatian: • Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324) 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: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Croatian: U ovoj studiji randomizirano je 255 bolesnika za liječenje docetakselom (75 mg/m2 u obliku jednosatne intravenske infuzije svaka tri tjedna) i kapecitabinom (1250 mg/m2 dvaput dnevno tijekom dva tjedna nakon čega slijedi jedan tjedan pauze).
English: EXP: Shelf life in infusion bag: see the leaflet.
Croatian: Rok valjanosti lijeka u infuzijskoj vrećici: vidjeti uputu o lijeku.
English: For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m2 as a single agent.
Croatian: Za liječenje nakon neuspjeha prethodne kemoterapije temeljene na platini, preporučuje se doza od 75 mg/m2 u monoterapiji.
English: (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Croatian: U bolesnika koji su primali docetaksel u dozi od 100 mg/m2 kao jedinu terapiju te imali vrijednosti transaminaza (ALT i/ili AST) u serumu više od 1,5 puta veće od GGN, te serumsku alkalnu fosfatazu više od 2,5 puta veću od GGN, postoji viši rizik od razvoja teških nuspojava poput toksične smrti uključujući sepsu i gastrointestinalno krvarenje koje može biti fatalno, febrilne neutropenije, infekcije, trombocitopenije, stomatitisa i astenije.
English: Docetaxel in combination with trastuzumab
Croatian: Docetaksel u kombinaciji s trastuzumabom
English: Constipation (severe: 0.2%); Abdominal pain (severe: 1%); Gastrointestinal haemorrhage (severe: 0.3%)
Croatian: 0,2%); abdominalna bol (teška: 1%); gastrointestinalno krvarenje (teško 0,3%)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 20 mg docetaksela.
English: In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m2 every 3 weeks).
Croatian: U bolesnika koji su neuspješno liječeni alkilirajućim agensima, docetaksel se uspoređivao s doksorubicinom (75 mg/m2 svaka tri tjedna).
English: A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m2 as a 1 hour infusion or paclitaxel 175 mg/m2 as a 3 hour infusion.
Croatian: Ukupno 449 bolesnika dobivalo je ili docetaksel 100 mg/m2 u jednosatnoj infuziji kao monoterapiju ili paklitaksel 175 mg/m2 u trosatnoj infuziji.
English: Marketing Authorisation Holder Accord Healthcare S.L.U.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet Accord Healthcare S.L.U.
English: A multicentre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Croatian: Provedena je multicentrična, randomizirana studija otvorenog tipa da bi se procijenila sigurnost primjene i djelotvornost docetaksela u liječenju bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji prije toga nisu primali kemoterapiju za metastatsku bolest.
English: Docetaxel in combination with doxorubicin
Croatian: Docetaksel u kombinaciji s doksorubicinom
English: • Induction chemotherapy followed by radiotherapy (TAX323) 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, multicenter, open-label, randomised study (TAX323).
Croatian: • Indukcijska kemoterapija praćena radioterapijom (TAX 323) Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s karcinomom skvamoznih stanica glave i vrata (SCCHN) procjenjivala se u fazi III multicentrične, randomizirane studije otvorenog tipa (TAX323).
English: Data from one multicentre, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Croatian: Rezultati jedne multicentrične, randomizirane, kontrolirane, kliničke studije faze III podupiru primjenu docetaksela u kombinaciji s kapecitabinom za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspješne citotoksične terapije koja je uključivala i antracikline.
English: In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Croatian: Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8°C.
English: Each box contains one vial of 8 ml concentrate.
Croatian: Jedno pakiranje sadrži po jednu bočicu s 8 ml koncentrata.
English: Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-treat analysis)
Croatian: Djelotvornost docetaksela u indukcijskom liječenju bolesnika s inoperabilnim lokalno uznapredovalim SCCHN (analiza podataka bolesnika predviđenih za liječenje [Intent-to-Treat])
English: Very common (may affect more than 1 in 10 people):
Croatian: Vrlo često (javljaju se u više od 1 na 10 osoba):
English: You must not breast-feed while you are treated with docetaxel.
Croatian: Ne smijete dojiti tijekom liječenja docetakselom.
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: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Croatian: Prijavljeni su slučajevi cistoidnog edema makule u bolesnika koji su liječeni docetakselom.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava prijavljivanja: navedenog u Dodatku V.
English: More than one vial of Docetaxel Accord concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Croatian: Ponekad je potrebno upotrijebiti više od jedne bočice Docetaxel Accorda koncentrata za otopinu za infuziju kako bi se dobila potrebna doza za bolesnika.
English: Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Croatian: (uključujući teški sindrom šaka/stopalo), ali i na rukama, licu ili grudnom košu, a često su bile povezane sa svrbežom.
English: Docetaxel Accord 20 mg/1 ml contains
Croatian: Docetaxel Accord 20 mg/1 ml sadrži
English: • Mix the infusion bag manually using a rocking motion.
Croatian: • Promiješajte sadržaj infuzijske vrećice ručno, polukružnim (ljuljajućim) pokretima.
English: Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
Croatian: anemija (G3/4: 9,4%); febrilna neutropenija; trombocitopenija (G4: 0,8%)
English: Docetaxel Accord 160 mg/8 ml contains
Croatian: Docetaxel Accord 160 mg/8 ml sadrži
English: In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to
Croatian: Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu, dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8ºC.
English: - For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin.
Croatian: - Za liječenje karcinoma pluća docetaksel se primjenjuje sam ili u kombinaciji s cisplatinom.
English: • Each vial is for single use and should be used immediately after opening.
Croatian: • Svaka bočica namijenjena je za jednokratnu primjenu te se treba primijeniti odmah nakon otvaranja.
English: Read the package leaflet before use Single use vial
Croatian: Prije uporabe pročitati uputu o lijeku Bočica za jednokratnu uporabu
English: Docetaxel Accord 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.
Croatian: Docetaxel Accord 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.
English: Mix the infusion bag manually using a rocking motion.
Croatian: Promiješajte sadržaj infuzijske vrećice ručno polukružnim (ljuljajućim) pokretima.
English: Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Croatian: U bolesnika koji se istodobno liječe radioterapijom prijavljeni su slučajevi radijacijskog pneumonitisa.
English: The concentrate is a clear pale yellow to brownish-yellow solution.
Croatian: Koncentrat je bistra svijetložuta do smeđežuta otopina.
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: Za adjuvantno liječenje operabilnog karcinoma dojke s pozitivnim i negativnim limfnim čvorovima, preporučena doza docetaksela od 75 mg/m2 primjenjuje se 1 sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 svaka tri tjedna tijekom 6 ciklusa (TAC protokol; vidjeti također
English: - For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Croatian: - Za liječenje metastatskog karcinoma želuca docetaksel se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
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
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: Syncope (G3/4: 0%); Neurotoxicity (G3/4: Somnolence (G3/4: 0%)
Croatian: sinkopa (G3/4: 0%) neurotoksičnost (G3/4:0%); somnolencija (G3/4:
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Croatian: • Indukcijska kemoterapija nakon koje slijedi radioterapija (TAX 323) Za indukcijsko liječenje neoperabilnog, lokalno uznapredovalog karcinoma skvamoznih stanica glave i vrata (engl. squamous cell carcinoma of the head and neck, SCCHN) preporučena doza docetaksela iznosi 75 mg/m2 u obliku jednosatne infuzije, nakon čega slijedi jednosatna infuzija 75 mg/m2 cisplatina prvi dan.
English: Tabulated list of adverse reactions in breast cancer 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 MedDRA klasifikacija organskih sustava
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 perioda 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: 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 sadržava oralni deksametazon u dozi od 8 mg 12 sati, 3 sata i jedan sat prije infuzije docetaksela (vidjeti dio 4.4).
English: Docetaxel in combination with capecitabine
Croatian: Docetaksel u kombinaciji s kapecitabinom
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 (0.64-1.08), p=0.1646).
Croatian: 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).
English: Use the medicine immediately after it is added into the infusion bag.
Croatian: Nakon dodavanja lijeka u infuzijsku vrećicu, odmah upotrijebite pripremljenu otopinu.
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 (engl. left ventricular ejection fraction, LVEF) > 20% (13,1% prema 6,1%), apsolutno smanjenje istisne frakcije lijeve klijetke (LVEF) > 30% (6,2% prema 1,1%).
English: Docetaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
Croatian: Docetaxel Accord u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje.
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 twice daily) 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: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-treat analysis)
Croatian: Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN (analiza podataka bolesnika predviđenih za liječenje [Intent-to-Treat]) Ishod
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 većim od GGN te serumskom 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: Docetaxel Accord 80 mg/4 ml contains
Croatian: Docetaxel Accord 80 mg/4 ml sadrži
English: An open-label, multicentre, randomised 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: If Docetaxel Accord concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako Docetaxel Accord koncentrat ili infuzijska otopina dođu u dodir sa sluznicom, odmah temeljito isperite vodom.
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks,
Croatian: U kombinaciji s trastuzumabom preporučena doza docetaksela iznosi 100 mg/m2 svaka tri tjedna, dok se trastuzumab primjenjuje svaki tjedan.
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
English: MARKETING AUTHORISATION NUMBER EU/1/12/769/001
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/769/001
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial
Croatian: Koncentrat za otopinu za infuziju 1 bočica
English: In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatment initiated (see section
Croatian: U slučaju da se dijagnosticira cistoidni edem makule potrebno je prekinuti liječenje docetakselom te početi odgovarajuću terapiju (vidjeti dio 4.8.).
English: 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.
Croatian: Preporučena doza docetaksela je 75 mg/m2 u obliku jednosatne infuzije, nakon čega slijedi infuzija 75 mg/m2 cisplatine u trajanju od 1 do 3 sata (oboje samo na dan 1), Nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m2 po danu u trajanju od 5
English: Data from a multicentre 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: 1Full analysis set (intent-to-treat)
Croatian: 1 potpuna analiza (podataka bolesnika predviđenih za liječenje [intent-to-treat]) 2 procijenjeni medijan preživljenja
English: Not applicable.
Croatian: NP- nije primjenjivo
English: Do not couple the infusion solution to the infusion set for more than 6 hours when stored at 25°C.
Croatian: Neka infuzijska otopina ne bude priključena na infuzijski set više od 6 sati na temperaturi od 25°C.
English: Dysgeusia (G3/4: < 1%); Paraesthesia (G3/4: < 1%)
Croatian: Poremećaji živčanog sustava disgeuzija (G3/4: <1%); parestezija (G3/4: <1%)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product which contains only 1 vial of concentrate.
Croatian: NE KORISTITI druge lijekove s docetakselom koji se sastoje od dvije bočice (koncentrata i otapala) s ovim lijekom koji sadrži samo 1 bočicu koncentrata.
English: Docetaxel infusion solution is supersaturated and may therefore crystallize over time.
Croatian: Infuzijska otopina docetaksela je prezasićena i stoga može kristalizirati tijekom vremena.
English: DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Croatian: NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Docetaxel Accord 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).