FrancophonIA/ELRC3.0 huggingface dataset:
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE 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 ml per vial.
Croatian: Ovo punjenje u suvišku osigurava da, nakon razrjeđivanja s cjelokupnim sadržajem priloženog otapala za TAXOTERE, minimalni iskoristivi volumen pripremljene otopine koncentrata od 8 ml sadržava 10 mg/ml docetaksela, što odgovara deklariranoj količini od 80 mg/2 ml po bočici.
English: Concentrate for solution for infusion 1 vial
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 1 bočica
English: TAXOTERE 160 mg/8 ml concentrate for solution for infusion docetaxel
Croatian: TAXOTERE 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
English: Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
Croatian: gastrointestinalna bol (G3/4: 1,2%); gastrointestinalno krvarenje (G3/4:
English: Diarrhoea grade 4 First episode: reduce docetaxel and 5-FU doses by 20%.
Croatian: Proljev stupnja 4 Prva epizoda: smanjiti doze docetaksela i 5-FU za 20 % Druga epizoda: prekinuti liječenje
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 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 (TAXOTERE 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
English: • The solvent for TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a transparent colourless flip-off cap.
Croatian: • Bočica s otapalom za TAXOTERE 20 mg/0,5 ml je prozirna staklena bočica od 7 ml s transparentnim bezbojnim "flip-off" zatvaračem.
English: TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Croatian: TAXOTERE u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
English: 4.2.3 Mix the infusion bag or bottle manually using a rocking motion.
Croatian: 4.2.3 Promiješajte sadržaj infuzijske vrećice ili boce polukružnim (ljuljajućim) pokretima.
English: • Docetaxel 75 mg/m every 3 weeks for 10 cycles.
Croatian: • Docetaksel 75 mg/m2 svaka 3 tjedna tijekom 10 ciklusa.
English: This medicinal product contains 13% (w/w) ethanol 95% v/v (alcohol), i.e. up to 932 mg ethanol 95% v/v per solvent vial, equivalent to 23 ml of beer or 9.5 ml wine.
Croatian: Ovaj lijek sadrži 13% (m/m) 95%-tnog V/V etanola (alkohola), odnosno do 932 mg 95%-tnog V/V etanola po bočici otapala, što odgovara količini od 23 ml piva ili 9,5 ml vina.
English: Alopecia; Nail disorders (no severe)
Croatian: Poremećaji kože i potkožnog tkiva alopecija; poremećaji noktiju (ne teški)
English: Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² in combination with trastuzumab
Croatian: Opis odabranih nuspojava kod karcinoma dojke za TAXOTERE 100 mg/m² u kombinaciji s trastuzumabom
English: In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736
Croatian: U ispitivanju TAX 316 amenoreja koja je počela tijekom perioda liječenja te je i dalje bila prisutna u periodu praćenja nakon završetka kemoterapije zabilježena je u 202 od 744 bolesnice (27,2%) u TAC
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3/4: 32%); anemija (G3/4: 4,9%)
English: TAXOTERE 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: TAXOTERE 160 mg/8 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 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 (TAXOTERE 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
English: 15 ml clear glass (type I) vial with a blue aluminium seal and blue plastic flip-off cap containing 8 ml of concentrate.
Croatian: Prozirna staklena bočica od 15 ml (staklo tip I) s 8 ml koncentrata, s plavim aluminijskim prstenom i plavim plastičnim "flip-off" zatvaračem.
English: 7 ml clear glass (type I) vial with a green aluminium seal and a green plastic flip-off cap containing 1 ml of concentrate.
Croatian: Prozirna staklena bočica od 7 ml (staklo tip I) s 1 ml koncentrata, sa zelenim aluminijskim prstenom i zelenim plastičnim "flip-off" zatvaračem.
English: Aseptically withdraw the required amount of TAXOTERE 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 TAXOTERE koncentrata za otopinu za infuziju.
English: 95% CI p-value
Croatian: 95% CI p- vrijednost
English: • Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: • Zatim, odjednom injicirajte (jedno injiciranje) potrebni volumen koncentrata u infuzijsku vrećicu ili bocu od 250 ml koja sadrži ili 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
English: - If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: Nausea (G3/4: 5.0%); Stomatitis (G3/4:
Croatian: Poremećaji probavnog sustava mučnina (G3/4: 5,0%); stomatitis (G3/4:
English: Dyspnoea (G3/4: 1%); Cough (G3/4: < 1%);
Croatian: dispneja (G3/4: 1%); kašalj (G3/4: <1%); epistaksa (G3/4: <1%)
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 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: • The solvent for TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.
Croatian: • Bočica s otapalom za TAXOTERE 80 mg/2 ml je prozirna staklena bočica od 15 ml s transparentnim bezbojnim "flip-off" zatvaračem.
English: Metastatic castration-resistant prostate cancer
Croatian: Metastatski karcinom prostate rezistentan na kastraciju
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 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 (TAXOTERE 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
English: • Each TAXOTERE 20 mg/0.5 ml vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.61 ml).
Croatian: • Jedna TAXOTERE 20 mg/0,5 ml bočica sadržava 0,5 ml otopine docetaksela u polisorbatu 80, koncentracije 40 mg/ml (volumen punjenja 24,4 mg/0,61 ml).
English: Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis;
Croatian: Poremećaji probavnog sustava mučnina; proljev; povraćanje; konstipacija; stomatitis; dispepsija; abdominalna bol
English: Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone
Croatian: Tablični popis nuspojava kod metastatskog karcinoma prostate rezistentnog na kastraciju za TAXOTERE 75 mg/m² u kombinaciji s prednizonom ili prednizolonom MedDRA klasifikacija organskih sustava
English: • Each TAXOTERE 80 mg/2 ml vial contains 2.0 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/2.36 ml).
Croatian: • Jedna TAXOTERE 80 mg/2 ml bočica sadržava 2,0 ml otopine docetaksela u polisorbatu 80, koncentracije 40 mg/ml (volumen punjenja 94,4 mg/2,36 ml).
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Croatian: Dodatkom cijelog sadržaja bočice otapala sadržaju bočice TAXOTERE 20 mg/0,5 ml koncentrata za otopinu za infuziju, dobiva se pripremljena otopina koncentrata u koncentraciji od 10 mg/ml docetaksela.
English: Venous disorder (G3/4:
Croatian: Krvožilni poremećaji venski poremećaji (G3/4:
English: 2 ml (Fill 2.36 ml)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 ml (Punjenje 2,36 ml)
English: What TAXOTERE looks like and contents of the pack TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution.
Croatian: TAXOTERE 20 mg/0,5 ml koncentrat za otopinu za infuziju je prozirna, viskozna, žuta do smeđežuta otopina.
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours over express 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: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = eostrogen receptor
Croatian: TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanosti;
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 80 mg/2 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Croatian: Dodatkom cijelog sadržaja bočice otapala sadržaju bočice TAXOTERE 80 mg/2 ml koncentrata za otopinu za infuziju, dobiva se pripremljena otopina koncentrata u koncentraciji od 10 mg/ml docetaksela.
English: (539 patients in TAC arm), or doxorubicin
Croatian: (TAC skupina) ili doksorubicin
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 100 mg/m² in combination with trastuzumab
Croatian: Tablični popis nuspojava kod karcinoma dojke za TAXOTERE 100 mg/m² u kombinaciji s trastuzumabom
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta oštećenje sluha
English: TAXOTERE 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: TAXOTERE 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: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Croatian: Poremećaji probavnog sustava mučnina (G3/4: 9,6%); povraćanje (G3/4: proljev (G3/4: 6,4%); stomatitis (G3/4: 2%)
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Croatian: Poremećaji kože i potkožnog tkiva alopecija; poremećaji noktiju (teški: 0,4%); kožna reakcija (ne teška)
English: Nausea (G3/4: 5%); Stomatitis (G3/4:
Croatian: Poremećaji probavnog sustava mučnina (G3/4: 5%); stomatitis (G3/4:
English: TAXOTERE 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: TAXOTERE 20 mg/1 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: TAXOTERE 20 mg/1 ml concentrate for solution for infusion docetaxel
Croatian: TAXOTERE 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
English: 13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 6 ml (Fill 7.33 ml)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 13% (m/m) 95%-tnog etanola u vodi za injekcije (za detaljnije informacije vidjeti uputu o lijeku) 6 ml (Punjenje 7,33 ml)
English: Oedema
Croatian: osip
English: 7 ml clear glass Type I vial with a green flip-off cap.
Croatian: Prozirna staklena bočica od 7 ml (staklo tip I), sa zelenim "flip-off" zatvaračem.
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Croatian: Opći poremećaji i reakcije na mjestu primjene letargija (G3/4: 3,4%); pireksija (G3/4: 0,6%); retencija tekućine; edem
English: TAXOTERE monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Croatian: TAXOTERE kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 75 mg/m² in combination with doxorubicin
Croatian: Tablični popis nuspojava kod karcinoma dojke za TAXOTERE 75 mg/m² u kombinaciji s doksorubicinom
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/0.5 ml CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE
Croatian: UPUTE ZA PRIPREMU I PRIMJENU TAXOTERE 20 mg/0,5 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU TE OTAPALA ZA TAXOTERE
English: Lymphoedema
Croatian: Kapecitabin
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 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: TAXOTERE 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: TAXOTERE 80 mg/4 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: 13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 1.5 ml (Fill 1.98 ml)
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 13% (m/m) 95%-tnog etanola u vodi za injekcije (za detaljnije informacije vidjeti uputu o lijeku) 1,5 ml (Punjenje 1,98 ml)
English: Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: periferna motorna neuropatija (G3/4: 2%)
English: What TAXOTERE looks like and contents of the pack TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution.
Croatian: TAXOTERE 80 mg/2 ml koncentrat za otopinu za infuziju je prozirna, viskozna, žuta do smeđežuta otopina.
English: Hypotension (G3: 0%)
Croatian: Srčani poremećaji hipotenzija (G3: 0%)
English: Pain in extremity (G3/4: < 1%); Back pain (G3/4: 1%)
Croatian: bol u udovima (G3/4: <1%); bol u leđima (G3/4: 1%)
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, multi-centre, open-label, randomised study (TAX323).
Croatian: • Indukcijska kemoterapija praćena radioterapijom (TAX 323) Sigurnost 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: 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: 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: Myalgia (severe: 1.4%) Arthralgia
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva mialgija (teška: 1,4%) artralgija
English: If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Croatian: Ako TAXOTERE koncentrat ili otopina za infuziju dođu u dodir s kožom, to mjesto odmah dobro i temeljito isperite sapunom i vodom.
English: Tabulated list of adverse reactions in non-small cell lung cancer for TAXOTERE 75 mg/m² in combination with cisplatin
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za TAXOTERE 75 mg/m² u kombinaciji s cisplatinom
English: A study of
Croatian: Provedeno je ispitivanje
English: TAXOTERE 80 mg/4 ml concentrate for solution for infusion docetaxel
Croatian: TAXOTERE 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
English: As with all parenteral products, TAXOTERE infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Croatian: Kao što je slučaj sa svim parenterainim pripravcima, TAXOTERE otopina za infuziju mora se vizualno provjeriti prije primjene, a otopine koje sadrže precipitat ne smiju se koristiti.
English: 4.2.2 Inject the required premix volume into a 250 ml 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 infuzijsku vrećicu ili bocu od 250 ml, koja sadrži 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
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 od GGN, nema preporuka za smanjenje doze te se docetaksel ne smije primijeniti osim ako to nije striktno indicirano.
English: Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m² in all subsequent cycles (see sections 4.4 and 4.8).
Croatian: Bolesnicima u kojih se pojavi febrilna neutropenija i/ili neutropenijska infekcija, u svim sljedećim ciklusima treba smanjiti dozu docetaksela na 60 mg/m
English: Patients with baseline neutrophil count of < 1,500 cells/mm
Croatian: Bolesnici s početnim brojem neutrofila  1500 stanica/mm
English: Anaemia (G3/4: 3%); Neutropenia (G3/4:
Croatian: Poremećaji krvi i limfnog sustava anemija (G3/4: 3%); neutropenija (G3/4:
English: Hearing impaired (G3/4: 0%)
Croatian: Poremećaji oka pojačano suzenje (G3/4: 0%)
English: Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Croatian: Poremećaji kože i potkožnog tkiva alopecija;eritem; osip; poremećaji noktiju
English: In TAXOTERE 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici TAXOTERE 80 mg/4 ml, koncentracija docetaksela iznosi 20 mg/ml.
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: Data from a multi-centre open label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS  80%, between 18 and 70 years of age.
Croatian: TAXOTERE u kombinaciji s doksorubicinom i ciklofosfamidom: adjuvantno liječenje Bolesnici s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima (TAX 316) Podaci iz multicentričnog, otvorenog, randomiziranog ispitivanja podupiru primjenu docetaksela za adjuvantno liječenje bolesnika s operabilnim karcinomom dojke i pozitivnim limfnim čvorovima te s KPS > 80%, u dobi od 18 do 70 godina.
English: Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Croatian: Ubrizgajte potrebni volumen pripremljene otopine koncentrata u infuzijsku vrećicu ili bocu od 250 ml, koja sadrži 5 %-tnu otopinu glukoze ili 0,9 %-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
English: Progression Free Survival Median (months) 95% CI
Croatian: Preživljenje bez napretka Medijan (mjeseci) 95% CI
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 8ºC.
English: TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel
Croatian: TAXOTERE 80 mg/2 ml koncentrat i otapalo za otopinu za infuziju docetaksel
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for TAXOTERE 75 mg/m in combination with cisplatin and 5-fluorouracil
Croatian: Opis odabranih nuspojava za TAXOTERE 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
English: In TAXOTERE 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici TAXOTERE 20 mg/1 ml, koncentracija docetaksela iznosi 20 mg/ml.
English: As with all parenteral products, TAXOTERE 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 TAXOTERE i TAXOTERE otopine za infuziju moraju biti vizualno provjerene prije primjene, a otopine koje sadrže precipitat ne smiju se koristiti.
English: More than one vial of 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 s pripremljenom otopinom koncentrata kako bi se dobila potrebna doza za bolesnika.
English: TAXOTERE 160 mg/8 ml concentrate for solution for infusion.
Croatian: NAZIV LIJEKA TAXOTERE 160 mg/8 ml koncentrat za otopinu za infuziju
English: Single-use vials - discard unused contents appropriately.
Croatian: OD LIJEKA, AKO JE POTREBNO Bočice za jednokratnu uporabu - neiskorišteni lijek treba odgovarajuće zbrinuti.
English: Pharyngolaryngeal pain (G3/4:
Croatian: Srčani poremećaji ishemija miokarda (G3/4:
English: Cautions for use in castration-resistant prostate cancer Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study(TAX 327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Croatian: Od 333 bolesnika koji su docetaksel primali svaka tri tjedna u studiji liječenja karcinoma prostate, 209 bolesnika bilo je u dobi od 65 godina ili stariji, a 68 bolesnika bilo je starije od 75 godina.