FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel Zentiva in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
Croatian: Docetaxel Zentiva u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate rezistentnim na kastraciju.
English: 3 years
Croatian: svaka 3 tjedna.
English: Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for Docetaxel Zentiva 75 mg/m² in combination with prednisone or prednisolone
Croatian: Tablični popis nuspojava kod metastatskog karcinoma prostate rezistentnog na kastraciju za Docetaxel Zentiva 75 mg/m² u kombinaciji s prednizonom ili prednizolonom
English: Data from a multi-centre open label randomised trial support the use of Docetaxel Zentiva for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Croatian: Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu lijeka Docetaxel Zentiva za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, prikladnih za liječenje kemopterapijom.
English: Efficacy of docetaxel in the induction treatment of patientswith locally advanced SCCHN (Intent-toTreat Analysis)
Croatian: Djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim SCCHN (Intent-to-treat analiza)
English: Aseptically withdraw the required amount of Docetaxel Zentiva concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Croatian: Rabeći kalibriranu štrcaljku s pričvršćenom iglom od 21G, aseptički uvucite potrebnu količinu Docetaxel Zentiva koncentrata za otopinu za infuziju.
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Croatian: (TCis), ili docetaksel 75 mg/m u obliku jednosatne infuzije u kombinaciji s karboplatinom (AUC 6 mg/ml u min) tijekom 30-60 min svaka 3 tjedna ili vinorelbin (V) 25 mg/m primijenjen tijekom 6 do 10 minuta na dan 1, 8, 15, 22, nakon čega je slijedilo davanje cisplatine 100 mg/m na dan 1 ciklusa koji se ponavljao svaka 4 tjedna (VCis).
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, multi-centre open-label, phase III study (TAX324).
Croatian: • Indukcijska kemoterapija nakon koje slijedi kemoradioterapija (TAX 324) Sigurnost i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
English: - For the treatment of metastatic gastric cancer, Docetaxel Zentiva is administered in combination with cisplatin and 5-fluorouracil.
Croatian: - Za liječenje uznapredovalog karcinoma želuca Docetaxel Zentiva se primjenjuje u kombinaciji s cisplatinom i 5-fluoruracilom.
English: Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Croatian: Poremećaji živčanog sustava disgeuzija (G3/4: periferna senzorna neuropatija (G3/4:
English: A study of 14C-docetaxel has been conducted in three cancer patients.
Croatian: C-docetaksela na tri osobe s karcinomom.
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/005
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/005
English: Oral candidiasis Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
Croatian: astenija (G3: 0%) retencija tekućine vrućica (G3: 1%) oralna kandidijaza hipokalcijemija (G3: 0%) hipofosfatemija (G3-4: 1%) hipokalijemija (G3: 0%)
English: Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for DOCETAXEL 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study)
Croatian: Tablični popis nuspojava kod visokorizičnog lokalno uznapredovalog ili metastatskog karcinoma prostate osjetljivog na hormone za DOCETAXEL ZENTIVA 75 mg/m u kombinaciji s prednizonom ili prednizolonom i terapijom deprivacije androgena (ADT) (studija STAMPEDE)
English: In some cases (frequency not known)
Croatian: U pojedinim slučajevima (nepoznata učestalost) primijećen je trajan gubitak kose
English: Docetaxel Zentiva in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Croatian: Docetaxel Zentiva u kombinaciji s trastuzumabom indiciran je za liječenje bolesnika s metastatskim karcinomom dojke i prekomjerno izraženim HER2, koji nisu ranije primali kemoterapiju za metastatsku bolest.
English: For those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dosereduction can be recommended and docetaxel should not be used unless strictly indicated.
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: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedan ml koncentrata sadržava 20 mg docetaksela u obliku docetaksel trihidrata.
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/004
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/004
English: Rare cases of ileus and intestinal obstruction have been reported.
Croatian: Zabilježeni su slučajevi insuficijencije bubrega i zatajenja bubrega.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 160 mg/8 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 160 mg/8 ml
English: MARKETING AUTHORISATION NUMBER EU/1/07/384/003
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/384/003
English: Package leaflet: Information for the patient Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Croatian: Uputa o lijeku: Informacije za bolesnika Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 160 mg/8 ml sterile concentrate docetaxel
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 160 mg/8 ml sterilni koncentrat docetaksel
English: Adjusted hazard ratio 95% CI p-value*
Croatian: Prilagođeni omjer hazarda 95% CI p-vrijednost*
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: 75 mg/m cisplatine u trajanju od 1 do 3 sata (oboje samo na dan 1), a nakon završetka infuzije cisplatina slijedi kontinuirana 24-satna infuzija 5-fluorouracila 750 mg/m po danu u trajanju od 5 dana.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 20 mg/1 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 20 mg/1 ml
English: Docetaxel Zentiva is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Croatian: Docetaxel Zentiva je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
English: In Docetaxel Zentiva 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici Docetaxel Zentiva 160 mg/8 ml, koncentracija docetaksela iznosi 20 mg/ml.
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 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 Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
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 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: Docetaxel Zentiva 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: Docetaxel Zentiva 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: Docetaxel Zentiva in combination with platinum agents in chemotherapy-naïve patients
Croatian: Docetaxel Zentiva u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 20 mg/1 ml sterilni koncentrat docetaksel
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 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Croatian: U GEICAM 9805 studiji, amenoreja je i dalje bila prisutna u periodu praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci) i zabilježena je u 18 bolesnica (3,4%) u TAC skupini i u 5 bolesnica (1,0%) u FAC skupini.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Croatian: UPUTE ZA PRIPREMU I UPOTREBU Docetaxel Zentiva 160 mg/8 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
English: Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Croatian: Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 80 mg/4 ml
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 80 mg/4 ml
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion.
Croatian: NAZIV LIJEKA Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Croatian: hipotenzija (G3/4: flebitis (G3/4: 0%)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 20 mg/1 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 Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 80 mg/4 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 Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion
Croatian: NAZIV LIJEKA Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju
English: Docetaxel Zentiva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Croatian: Docetaxel Zentiva u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
English: Alopecia; Skin reaction (G3/4:
Croatian: Poremećaji kože i potkožnog tkiva alopecija; kožna reakcija (G 3/4:
English: Skin reaction (G3/4:
Croatian: Manje česte nuspojave kožna reakcija (G3/4:
English: Peripheral sensory neuropathy (≥G3: 2%)a
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (≥G3: 2%)
English: Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Croatian: Opis odabranih nuspojava kod karcinoma dojke za Docetaxel Zentiva 100 mg/m² u kombinaciji s trastuzumabom
English: (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
Croatian: u kombinaciji sa cisplatinom (C) (75 mg/m prvi dan) i 5-fluorouracilom (F) (750 mg/m dnevno kroz
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 80 mg/4 ml sterile concentrate docetaxel
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 80 mg/4 ml sterilni koncentrat docetaksel
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 160 mg/8 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE / Docetaxel Zentiva 160 mg/8 ml
English: Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm3 (see section 4.2).
Croatian: Bolesnici se mogu ponovno liječiti docetakselom kad se broj neutrofila oporavi na razinu ≥ 1500 stanica/mm
English: Docetaxel Zentiva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Croatian: Docetaxel Zentiva u kombinaciji s doksorubicinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
English: Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Croatian: Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Croatian: Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Croatian: UPUTE ZA PRIPREMU I UPOTREBU Docetaxel Zentiva 20 mg/1 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Croatian: Tablični popis nuspojava kod karcinoma dojke za Docetaxel Zentiva 100 mg/m² u kombinaciji s trastuzumabom
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 20 mg/1 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE / Docetaxel Zentiva 20 mg/1 ml
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Croatian: UPUTE ZA PRIPREMU I UPOTREBU Docetaxel Zentiva 80 mg/4 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
English: 1060 patients were randomised to receive either Docetaxel Zentiva 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).
Croatian: (521 bolesnik u FAC skupini), kao adjuvantnu terapiju za operabilni karcinom dojke s negativnim limfnim čvorovima i visokim rizikom povrata bolesti prema kriterijima iz St. Gallena iz 1998.g. (veličina tumora >2 cm i/ili negativni ER i PR i/ili visoki histološki/nuklearni gradus (gradus 2 do 3) i/ili dob <35 godina).
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Croatian: U ispitivanju GEICAM 9805, alopecija koja je počela tijekom perioda liječenja i dalje bila prisutna tijekom perioda praćenja zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
English: Dizziness
Croatian: Raspodjela
English: Peripheral sensory neuropathy (G3/4:
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4:
English: Docetaxel Zentiva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Croatian: Docetaxel Zentiva kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
English: In Docetaxel Zentiva 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici Docetaxel Zentiva 80 mg/4 ml, koncentracija docetaksela iznosi 20 mg/ml.
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Croatian: proljev (G3/4: 6,4%); stomatitis (G3/4: 2%)
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaxel Zentiva 75 mg/m² u kombinaciji s cisplatinom
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with doxorubicin
Croatian: Tablični popis nuspojava kod karcinoma dojke za Docetaxel Zentiva 75 mg/m² u kombinaciji s doksorubicinom
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Croatian: Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
English: Nausea (G3/4: 9.6%);
Croatian: proljev (G3/4: 6,2%);
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 80 mg/4 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE / Docetaxel Zentiva 80 mg/4 ml
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with capecitabine
Croatian: Tablični popis nuspojava kod karcinoma dojke za Docetaxel Zentiva 75 mg/m² u kombinaciji s kapecitabinom
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Opis odabranih nuspojava za Docetaxel Zentiva 75 mg/m² u kombinaciji s cisplatinom i 5fluorouracilom u terapiji adenokarcinoma želuca
English: The recommended dose of docetaxel is 75 mg/m2.
Croatian: Standard liječenja + docetaksel 75 mg/m
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Croatian: Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Croatian: Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
English: Weight decreased (G3/4: 0.2%)
Croatian: abdominalna bol (G3/4: 0,4%)
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Croatian: Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m nakon čega je slijedio cisplatin (P)
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² single agent
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaxel Zentiva 75 mg/m² u monoterapiji
English: Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² single agent
Croatian: Opis odabranih nuspojava kod karcinoma dojke za Docetaxel Zentiva 100 mg/m u monoterapiji
English: Vomiting (G3: 1%)
Croatian: a promjene na noktima (G3: 1%)
English: In Docetaxel Zentiva 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici lijeka Docetaxel Zentiva 20 mg/1 ml, koncentracija docetaksela iznosi 20 mg/ml.
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G 3: periferna motorna neuropatija (G 3/4: disgeuzija (teška:
English: If you get any side effects , talkto your doctor, hospital pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Number of metastatic prostate cancer patients
Croatian: Broj bolesnika s metastatskim karcinomom prostate Medijan ukupnog preživljenja (mjeseci)
English: In Docetaxel Zentiva 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici Docetaxel Zentiva 20 mg/l ml, koncentracija docetaksela iznosi 20 mg/ml.
English: Febrile neutropenia (G3/4: NA)
Croatian: Manje česte nuspojave povraćanje (G3/4: konstipacija
English: 95% CI p-value*
Croatian: 95% CI p- vrijednost
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Tablični popis nuspojava za Docetaxel Zentiva 75 mg/m u kombinaciji s cisplatinom i 5
English: Dizziness (G3/4: Peripheral motor neuropathy (G3/4:
Croatian: omaglica (G3/4:2,0%) periferna motorna neuropatija (G3/4:0,4%)
English: 2 years
Croatian: Neotovorena bočica 2 godine
English: Infection associated with G4 neutropenia
Croatian: infekcije udružene s G4 neutropenijom (G3/4:
English: Infusion site reaction
Croatian: Opći poremećaji i reakcije na mjestu primjene