FrancophonIA/ELRC3.0 huggingface dataset:
English: • Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
Croatian: • Rabeći kalibriranu štrcaljku s pričvršćenom iglom od 21G, aseptički uvucite potrebnu količinu koncentrata za otopinu za infuziju.
English: Lacrimation increased (G3/4: <0.1%)
Croatian: pojačano suzenje (G3/4: <0,1%);
English: TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with castration-resistant metastatic prostate cancer.
Croatian: TAXOTERE u kombinaciji s prednizonom ili prednizolonom indiciran je za liječenje bolesnika s metastatskim karcinomom prostate rezistentnim na kastraciju.
English: TAXOTERE in combination with platinum agents in chemotherapy-naïve patients
Croatian: TAXOTERE u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju
English: PSA** response rate (%) 95% CI p-value*
Croatian: PSA** stopa odgovora (%) 95% CI p- vrijednost *
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/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
Croatian: 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: Diarrhea (G3: 3%) Stomatitis (G3: 0%) Constipation (G3: 0%) Nausea (G3: 1%) Dyspepsia
Croatian: Poremećaji probavnog sustava proljev (G3: 3%) stomatitis (G3: 0%) konstipacija (G3: 0%) mučnina (G3: 1%) dispepsija bol u abdomenu (G3: 0%) vjetrovi povraćanje (G3: 1%)
English: CARTON/TAXOTERE 80 mg/2 ml
Croatian: KUTIJA/TAXOTERE 80 mg/2 ml
English: 7 ml clear glass Type I vial with a transparent colourless flip-off cap.
Croatian: Prozirna staklena bočica od 7 ml (staklo tip I), s transparentnim bezbojnim "flip-off" zatvaračem.
English: To be administered under the supervision of a physician experienced in the use of cytotoxic agents.
Croatian: Primjena lijeka mora biti pod nadzorom liječnika educiranog za liječenje citostaticima.
English: Excipient with known effect: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Croatian: Jedna bočica koncentrata sadržava 0,5 ml (395 mg) etanola, bezvodnog.
English: Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (932 mg of ethanol 95% v/v).
Croatian: Jedna jednodozna bočica otapala sadrži 13% (m/m) 95%-tnog V/V etanola u vodi za injekcije (932 mg 95%-tnog V/V etanola).
English: Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (252 mg of ethanol 95% v/v).
Croatian: Jedna jednodozna bočica otapala sadrži 13% (m/m) 95%-tnog V/V etanola u vodi za injekcije (252 mg 95%-tnog V/V etanola).
English: Tumour response rate (%) 95% CI p-value*
Croatian: Stopa tumorskog odgovora (%) 95% CI p-vrijednost *
English: 1 vial of TAXOTERE 80 mg/2 ml concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ml) Fill: 94.4 mg/2.36 ml
Croatian: 1 bočica TAXOTERE 80 mg/2 ml koncentrata za otopinu za infuziju 80 mg docetaksela u 2 ml polisorbata 80 (40 mg/ml) Punjenje: 94,4 mg/2,36 ml
English: TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid.
Croatian: TAXOTERE 80 mg/2 ml koncentrat za otopinu za infuziju bistra je viskozna, žuta do žutosmeđa otopina koja sadrži 40 mg/ml docetaksela (bezvodnog) u polisorbatu 80 i citratnoj kiselini.
English: If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25°C) for 5 minutes.
Croatian: Ako su bočice pohranjene u hladnjaku, izvadite potreban broj kutija lijeka TAXOTERE iz hladnjaka i ostavite ih na sobnoj temperaturi (ispod 25
English: The required volume of TAXOTERE concentrate for solution for infusion must be injected 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: Potrebni volumen TAXOTERE koncentrata za otopinu za infuziju mora se injicirati jednokratnom injekcijom (jedno injiciranje) 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.
English: Abdominal pain (G3/4:
Croatian: abdominalna bol (G3/4:
English: 2.1 TAXOTERE 20 mg/0.5 ml vial
Croatian: 2.1 TAXOTERE 20 mg/0,5 ml bočica
English: TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid.
Croatian: TAXOTERE 20 mg/0,5 ml koncentrat za otopinu za infuziju bistra je viskozna, žuta do žutosmeđa otopina koja sadrži 40 mg/ml docetaksela (bezvodnog) u polisorbatu 80 i citratnoj kiselini.
English: Solvent vial contains 6 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 7.33 ml).
Croatian: Bočica s otapalom sadržava 6 ml 13%-tne (m/m) otopine 95%-tnog etanola u vodi za injekcije (volumen punjenja 7,33 ml).
English: Hazard ratio: 1.032 [95% CI: 0.876; 1.216]
Croatian: Omjer hazarda: 1,032 [95% CI: 0,876; 1,216]
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Croatian: Ovaj lijek sadrži 50 vol% bezvodnoga etanola (alkohola), odnosno do 1,58 g bezvodnoga etanola po bočici, što odgovara količini od 40 ml piva ili 17 ml vina.
English: Acute myeloid leukaemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Croatian: Akutna mijeloična leukemija i mijelodisplastični sindrom su prijavljeni (manje česta učestalost) u pivotalnim kliničkim ispitivanjima raka dojke u kojima se primjenjivao docetaksel, doksorubicin i ciklofosfamid (TAC režim).
English: 2.1 TAXOTERE 80 mg/2 ml vial
Croatian: 2.1 TAXOTERE 80 mg/2 ml bočica
English: 1 vial of TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ml) Fill: 24.4 mg/0.61 ml
Croatian: 1 bočica TAXOTERE 20 mg/0,5 ml koncentrata za otopinu za infuziju 20 mg docetaksela u 0,5 ml polisorbata 80 (40 mg/ml) Punjenje: 24,4 mg/0,61 ml
English: • As with all parenteral products, 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, otopina za infuziju mora se vizualno provjeriti prije uporabe, a otopine koje sadrže precipitat ne smiju se koristiti.
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Croatian: Jedan ml koncentrata za otopinu za infuziju sadržava 20 mg docetaksela.
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Croatian: UPUTE ZA PRIPREMU I UPOTREBU TAXOTERE 160 mg/8 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
Croatian: Ovaj lijek sadrži 50 vol% bezvodnoga etanola (alkohola), odnosno do 3,16 g bezvodnoga etanola po bočici, što odgovara količini od 80 ml piva ili 33 ml vina.
English: • The TAXOTERE 80 mg/2 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
Croatian: • TAXOTERE 80 mg/2 ml bočica sadržava otopinu docetaksela u polisorbatu 80, u koncentraciji od 40 mg/ml.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Croatian: Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m intravenskom. infuzijom na dan 1 nakon čega je slijedio cisplatin (P) 100 mg/m primijenjen kao 30-minutna do 3-satna intravenska infuzija praćena kontinuiranom intravenskom infuzijom 5fluorouracila (F) 1000 mg/m dnevno od dana 1 do dana 4. Liječenje se primjenjivalo svaka 3 tjedna, tijekom 3 ciklusa.
English: Some cases of anaphylactic shock, sometimes fatal, have been reported.
Croatian: Poremećaji imunološkog sustava Zabilježeno je nekoliko slučajeva anafilaktičkog šoka, ponekad sa smrtnim ishodom.
English: Excipient with known effect: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Croatian: Jedna bočica koncentrata sadržava 2 ml (1,58 g) etanola, bezvodnog.
English: Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains docetaxel (as trihydrate) corresponding to 20 mg of docetaxel (anhydrous).
Croatian: Jedna jednodozna bočica TAXOTERE 20 mg/0,5 ml koncentrata sadrži docetaksel (u obliku docetaksel trihidrata) u količini koja odgovara 20 mg docetaksela (bezvodnog).
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: TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Croatian: TAXOTERE je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
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 ispitivanju GEICAM 9805 akutna leukemija pojavila se u 1 od 532 bolesnika (0,2%) u TAC skupini.
English: Anaemia (G3/4:
Croatian: aritmija (G3/4:
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = eostrogen receptor PR = progesterone receptor a
Croatian: TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanost; ER = estrogenski receptor PR = progesteronski receptor a
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4:
Croatian: sinkopa (G3/4: 0%) neurotoksičnost (G3/4:0%); somnolencija (G3/4:
English: Each blister pack of TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion contains:
Croatian: Jedno pakiranje TAXOTERE 20 mg/0,5 ml koncentrata i otapala za otopinu za infuziju sadržava:
English: combined with capecitabine at 1250 mg/m 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 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 pauze.
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Croatian: Jedna kutija sadržava 1 bočicu s 8 ml koncentrata (160 mg docetaksela).
English: Time to castration-resistant prostate cancerb Median (months)
Croatian: Broj bolesnika s metastatskim karcinomom prostate Medijan ukupnog preživljenja (mjeseci)
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: CARTON/TAXOTERE 20 mg/0.5 ml
Croatian: KUTIJA/TAXOTERE 20 mg/0,5 ml
English: For metastatic castration-resistant 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 metastatski karcinom prostate rezistentan na kastraciju, uz istodobnu terapiju prednizonom ili prednizolonom, preporučeni režim premedikacije je oralni deksametazon u dozi od 8 mg 12 sati, 3 sata i 1 sat prije infuzije docetaksela (vidjeti dio 4.4).
English: Each single-dose vial of TAXOTERE 80 mg/2 ml concentrate contains docetaxel (as trihydrate) corresponding to 80 mg of docetaxel (anhydrous).
Croatian: Jedna jednodozna bočica TAXOTERE 80 mg/2 ml koncentrata sadrži docetaksel (u obliku docetaksel trihidrata) u količini koja odgovara 80 mg docetaksela (bezvodnog).
English: The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with metastatic castration-resistant prostate cancer were evaluated in a randomised multi-centre phase III study (TAX 327).
Croatian: Sigurnost i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate rezistentnim na kastraciju u randomiziranoj multicentričnoj studiji faze III (TAX 327).
English: Dyspnea (G3: 1%) Coughing (G3: 0%) Upper respiratory tract infection (G3: 1%)
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja (G3: 1%) kašalj (G3: 0%) infekcija gornjih dišnih puteva (G3: 1%)
English: b Time to castration-resistant prostate cancer = time from randomization to PSA progression or clinical progression (i.e., increasing symptomatic bone metastases, progression per Response Evaluation Criteria in Solid Tumours (RECIST) criteria, or clinical deterioration due to cancer per the Investigator's opinion), whichever occurred first.
Croatian: PSA ili kliničke progresije bolesti (npr. porast simptomatskih metastaza u kostima, progresija bolesti prema Kriterijima ocjene odgovora kod solidnih tumora [eng.
English: Excipient with known effect: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Croatian: Jedna bočica koncentrata sadržava 4 ml (3,16 g) etanola, bezvodnog.
English: Each blister pack of TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion contains:
Croatian: Jedno pakiranje TAXOTERE 80 mg/2 ml koncentrata i otapala za otopinu za infuziju sadržava:
English: Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Croatian: Jedna kutija sadržava 1 bočicu s 1 ml koncentrata (20 mg docetaksela).
English: Solvent vial contains 1.5 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 1.98 ml).
Croatian: Bočica s otapalom sadržava 1,5 ml 13%-tne (m/m) otopine 95%-tnog etanola u vodi za injekcije (volumen punjenja 1,98 ml).
English: Alopecia; Skin reaction (G3/4: 0.8%)
Croatian: Poremećaji kože i potkožnog tkiva alopecija; kožna reakcija (G3/4: 0,8%)
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
Croatian: TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanosti
English: Paresthesia; Headache; Dysgeusia; Hypoaesthesia
Croatian: Poremećaji živčanog sustava parestezija; glavobolja; disgeuzija; hipoestezija
English: 15 ml clear glass Type I vial with a red flip-off cap.
Croatian: Prozirna staklena bočica od 15 ml (staklo tip I), s crvenim "flip-off" zatvaračem.
English: Hypersensitivity (G3-4: 1%)
Croatian: Poremećaji imunološkog sustava preosjetljivost (G3-4: 1%)
English: Dyspepsia (G3/4:
Croatian: dispepsija (G3/4:
English: Efficacy results or the docetaxel arm versus the control arm are summarized in the following table:
Croatian: Ishodi djelotvornosti za skupinu docetaksela u odnosu na kontrolnu skupini prikazani su u sljedećoj tablici:
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Croatian: Poremećaji probavnog sustava mučnina (G3/4: 3,3%); stomatitis (G3/4: 1,7%); povraćanje (G3/4: 0,8%); proljev (G3/4: 1,7%)
English: Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Croatian: Jedna kutija sadržava 1 bočicu s 4 ml koncentrata (80 mg docetaksela).
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Croatian: Ovaj lijek sadrži 50 vol% bezvodnoga etanola (alkohola), odnosno do 395 mg bezvodnoga etanola po bočici, što odgovara količini od 10 ml piva ili 4 ml vina.
English: Vomiting (G3/4: 3%)
Croatian: trombocitopenija (G3/4: 3%)
English: The solvent is a colourless solution.
Croatian: Otapalo je bezbojna otopina.
English: Insomnia (G3: 1%)
Croatian: Psihijatrijski poremećaji nesanica (G3: 1%)
English: The concentrate is supplied in a 7 ml clear colourless glass vial with a magenta aluminium seal and a magenta plastic flip-off cap.
Croatian: Pakiranje sadrži koncentrat u prozirnoj staklenoj bočici od 7 ml, sa magenta aluminijskim prstenom i magenta plastičnim "flip-off" zatvaračem.
English: Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV l ml koncentrata sadržava 20 mg docetaksela (u obliku docetaksel trihidrata).
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Croatian: Fizikalna i kemijska stabilnost otopine dokazana je, međutim, do 8 sati pri temperaturi od 2º do 8º C ili pri sobnoj temperaturi (ispod 25°C).
English: TAXOTERE 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: TAXOTERE 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: Anorexia (G3/4: 1%); Decreased appetite
Croatian: Poremećaji metabolizma i prehrane anoreksija (G3/4: 1%) smanjen apetit dehidracija (G3/4: 2%)
English: Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Croatian: Opći poremećaji i reakcije na mjestu primjene umor (G3/4: 3,9%); retencija tekućine (teška: 0,6%)
English: TAXOTERE 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: TAXOTERE 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: The concentrate is supplied in a 7 ml clear colourless glass vial with a green aluminium seal and a green plastic flip-off cap.
Croatian: Pakiranje sadrži koncentrat u prozirnoj staklenoj bočici od 7 ml, sa zelenim aluminijskim prstenom i zelenim plastičnim "flip-off" zatvaračem.
English: The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap.
Croatian: Pakiranje sadrži koncentrat u prozirnoj staklenoj bočici od 15 ml, s plavim aluminijskim prstenom i plavim plastičnim "flip-off" zatvaračem.
English: G3/4 Blood bilirubin increased (< 2.5%);
Croatian: G3/4 povećanje bilirubina u krvi G3/4 povećanje alkalne fosfataze u krvi (<2,5%)
English: In TAXOTERE 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici TAXOTERE 160 mg/8 ml, koncentracija docetaksela iznosi 20 mg/ml.
English: Description of selected adverse reactions for adjuvant therapy with Taxotere 75 mg/m 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 TAXOTERE 75 mg/m u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima
English: Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Croatian: Ako ste ovisni o alkoholu, imate epilepsiju ili oštećenje funkcije jetre, razgovarajte sa svojim liječnikom.
English: Oesophagitis (severe:
Croatian: ezofagitis (težak:
English: Preparation of the infusion solution
Croatian: Priprema otopine za intuziju
English: 7 ml clear glass (type I) vial with a magenta aluminium seal and a magenta plastic flip-off cap containing 4 ml of concentrate.
Croatian: Prozirna staklena bočica od 7 ml (staklo tip I) s 4 ml koncentrata, s magenta aluminijskim prstenom i magenta plastičnim "flip-off" zatvaračem.
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 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.5 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 2 ml sadržava 10 mg/ml docetaksela, što odgovara deklariranoj količini od 20 mg/0,5 ml po bočici.
English: - For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.
Croatian: - Za liječenje karcinoma glave i vrata TAXOTERE se primjenjuje u kombinaciji s cisplatinom i 5
English: Tabulated list of adverse reactions for adjuvant therapy with TAXOTERE 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 TAXOTERE 75 mg/m u kombinaciji s doksorubicinom i ciklofosfamidom u bolesnika s karcinomom dojke s pozitivnim (TAX 316) i negativnim (GEICAM 9805) limfnim čvorovima - skupni podaci
English: Dysgeusia (G3/4: < 1%); Pareaesthesia (G3/4: < 1%)
Croatian: Poremećaji živčanog sustava disgeuzija (G3/4: <1%); parestezija (G3/4: <1%)
English: • The TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a red flip-off cap.
Croatian: • TAXOTERE 80 mg/2 ml bočica je prozirna staklena bočica od 15 ml s crvenim "flip-off" zatvaračem.
English: • The TAXOTERE 20 mg/0.5 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
Croatian: • TAXOTERE 20 mg/0,5 ml bočica sadržava otopinu docetaksela u polisorbatu 80, u koncentraciji od 40 mg/ml.
English: This medicinal product contains 13 % (w/w) ethanol 95% v/v (alcohol), i.e. up to 252 mg ethanol 95% v/v per solvent vial, equivalent to 6 ml of beer or 2.6 ml wine.
Croatian: Ovaj lijek sadrži 13% (m/m) 95%-tnog V/V etanola (alkohola), odnosno do 252 mg 95%-tnog V/V etanola po bočici otapala, što odgovara količini od 6 ml piva ili 2,6 ml vina.
English: • The TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a green flip-off cap.
Croatian: • TAXOTERE 20 mg/0,5 ml bočica je prozirna staklena bočica od 7 ml sa zelenim "flip-off" zatvaračem.
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija (teška: 12,4%); retencija tekućine (teška: 0,8%); bol