FrancophonIA/ELRC3.0 huggingface dataset:
English: In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2%) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Croatian: U ispitivanju TAX 316 periferna senzorna neuropatija počela je tijekom perioda liječenja te je bila prisutna i tijekom perioda praćenja u 84 bolesnika (11,3%) u TAC skupini i 15 bolesnika (2%) u FAC skupini.
English: Concentrate vial:
Croatian: Ako Docetaksel koncentrat,
English: In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
Croatian: (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti G-CSF u svim sljedećim ciklusima (npr. dani 6-15), kako bi se osigurala profilaktička zaštita.
English: Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg of docetaxel.
Croatian: Jedna bočica Docetaksel Teva 80 mg/2,88 ml koncentrata sadrži 80 mg docetaksela.
English: 3 hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
Croatian: Nakon završetka infuzije ciplatina slijedi kontinuirana infuzija 5-fluorouracilom 1000 mg/m2/dan od prvog do četvrtog dana.
English: Blood and lymphatic Neutropenia (G3/4:
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G4:
English: • Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Croatian: • Pripremljena otopina koncentrata: Dokazana kemijska i fizikalna stabilnost u primjeni je 8 sati uz čuvanje na temperaturi od 2°C do 8° C ili pri sobnoj temperaturi (ispod 25°C).
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mijalgija
English: Solvent vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Croatian: Prozirna staklena bočica od 6 ml (staklo tip I), s čepom od bromobutilne gume i s "flip-off" zatvaračem.
English: 4.1.5 Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Croatian: 4.1.5 Ostavite bočicu s pripremljenom otopinom koncentrata na sobnoj temperaturi (ispod 25°C) oko 5 minuta, a zatim provjerite je li otopina homogena i bistra (pojava pjene je uobičajena i nakon
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.72 ml (Fill: 0.88 ml)
Croatian: 0,72 ml (Punjenje: 0,88 ml)
English: You must NOT be given Docetaxel Teva:
Croatian: Docetaksel Teva se NE smije primijeniti
English: Docetaxel Teva 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: Docetaksel Teva 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: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: DODATAK II A. PROIZVOĐAČ(I) ODGOVORNA(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Croatian: Dodatkom cijelog sadržaja bočice otapala sadržaju bočice Docetaksel Teva 80 mg koncentrata za otopinu za infuziju, dobiva se pripremljena otopina koncentrata u koncentraciji od 10 mg/ml docetaksela.
English: Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Croatian: Teva je indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća nakon neuspjeha prethodne kemoterapije.
English: Gastrointestinal pain (G3/4: 1.2%); Gastrointestinal haemorrhage (G3/4:
Croatian: gastrointestinalna bol (G3/4: 1,2%); gastrointestinalno krvarenje (G3/4:
English: Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4:
Croatian: proljev (G3/4: 6,8%); ezofagitis/disfagija/ odinofagija (G3/4:
English: Docetaxel Teva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Croatian: Docetaksel Teva u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
English: Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p=0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p=0.54), docetaxel increased response rate (52% vs. 37%, p=0.01) and shortened time to response (12 weeks vs. 23 weeks, p=0.007).
Croatian: Bez utjecaja na ukupno vrijeme preživljenja (docetaksel 15 mjeseci prema doksorubicinu 14 mjeseci, p= 0,38) ili na vrijeme do progresije bolesti (docetaksel
English: Constipation (G3/4: 0.4%)
Croatian: konstipacija (G3/4: 0,4%)
English: Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Croatian: konstipacija (G3/4: 1%); abdominalna bol (G3/4: 2%); dispepsija bol u gornjem abdomenu suhoća usta
English: Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3%) in TAC arm and 4 patients (0.8%) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm.
Croatian: Astenija koja je počela u periodu liječenja i bila prisutna u periodu praćenja zabilježena je u 12 bolesnika (2,3%) u TAC skupini i u 4 bolesnika (0,8%) u FAC skupini.
English: Best overall response to chemotherapy (%) (95%CI) ***p-value
Croatian: Najbolji ukupni odgovor na kemoterapiju (%) (95% CI) ***p-vrijednost
English: • flushing, skin reactions, itching
Croatian: • navale crvenila, kožne reakcije, svrbež • stezanje u prsima, otežano disanje
English: Dyspepsia; Abdominal pain
Croatian: konstipacija; stomatitis; dispepsija; abdominalna bol
English: Number of patients Pain response rate (%) 95% CI p-value*
Croatian: Stopa smanjenja boli (%) 95% CI p-vrijednost *
English: Solvent vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Croatian: Prozirna staklena bočica od 15 ml (staklo tip I), s čepom od bromobutilne gume i sa "flip-off" zatvaračem.
English: Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Croatian: Docetaksel Teva kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
English: • The Docetaxel Teva 20 mg/0.72 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Croatian: • Docetaksel Teva 20 mg/0,72 ml bočica sadržava otopinu docetaksela u polisorbatu 80, u koncentraciji od 27,73 mg/ml.
English: There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Croatian: Starije osobe Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
English: Median overall survival (months) (95%CI)
Croatian: Ukupni medijan preživljenja (mjeseci) (95% CI)
English: Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 single agent
Croatian: Opis odabranih nuspojava kod karcinoma dojke za Docetaksel 100 mg/m2 u monoterapiji
English: 5.12 ml (Fill: 6.29 ml)
Croatian: voda za injekcije 5,12 ml (Punjenje 6,29 ml)
English: Neutropenia (G3/4: 83.5%); Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3/4: 83,5%); anemija (G3/4: 12,4%); trombocitopenija (G3/4:
English: 2.2 Solvent for Docetaxel Teva 20 mg/0.72 ml vial:
Croatian: 2.2 Bočica s otapalom za Docetaksel Teva 20 mg/0,72 ml:
English: • The solvent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Croatian: • Bočica s otapalom za Docetaksel Teva 20 mg/0,72 ml je prozirna staklena bočica od 6 ml s čepom od bromobutilne gume i "flip-off" zatvaračem.
English: Doxorubicin
Croatian: Docetaksel
English: Docetaxel Teva 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: Docetaksel Teva 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: • oesophagitis
Croatian: • Otapalo za Docetaksel
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Croatian: Tablični popis nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u kombinaciji s trastuzumabom
English: • The Docetaxel Teva 80 mg/2.88 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Croatian: • Docetaksel Teva 80 mg/2,88 ml bočica sadržava otopinu docetaksela u polisorbatu 80, u koncentraciji od 27,73 mg/ml.
English: Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Croatian: Poremećaji živčanog sustava Zabilježeni su rijetki slučajevi konvulzija ili prolaznog gubitka svijesti pri primjeni docetaksela.
English: Weight increased
Croatian: pojačano suzenje
English: Fever (G3/4: 1.2%)
Croatian: vrućica (G3/4: 1,2%)
English: 75 years of age or greater versus less than 65 years.
Croatian: bolesnika bilo je u dobi od 65 godina ili starijih, a 68 bolesnika bilo je starije od 75 godina.
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 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: If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Croatian: Ako Docetaksel Teva koncentrat, otopina koncentrata ili otopina za infuziju dođe u dodir sa sluznicom, odmah dobro i temeljito isperite vodom.
English: - For the treatment of lung cancer, Docetaxel Teva could be administered either alone or in combination with cisplatin.
Croatian: Za liječenje uznapredovalog karcinoma dojke, Docetaksel Teva se primjenjuje sam ili u kombinaciji s doksorubicinom, trastuzumabom ili kapecitabinom.
English: Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 in combination with trastuzumab
Croatian: Opis odabranih nuspojava kod karcinoma dojke za Docetaksel 100 mg/m² u kombinaciji s trastuzumabom
English: General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Croatian: Rijetko je bio zabilježen fenomenodzivne reakcijske upalne reakcije.
English: Teva Pharmaceuticals Ireland Τel: +353 51 321 740
Croatian: Τel: +353 51 321 740
English: Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Croatian: Rijetko je zabilježena pojava suzenja s ili bez konjunktivitisa,
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 80 mg/2.88 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - OTAPALO 80 mg/2,88 ml
English: VIAL LABEL - CONCENTRATE 80 mg/2.88 ml
Croatian: Teva 80 mg/2,88 ml
English: Dysgeusia (G3/4: 0%)
Croatian: limfedem (G3/4: 0%)
English: Esophagitis/dysphagia/odynophagia (G3/4: 12.0%);
Croatian: Poremećaji metabolizma i prehrane anoreksija (G3/4: 12,0%)
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: Docetaksel 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: Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Croatian: Bolesnici u TAC skupini primali su antibiotsku profilaksu s ciprofloksacinom 500 mg peroralno dvaput na dan u trajanju od 10
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/m2 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/m2 po danu u trajanju od 5
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Croatian: Tablični popis nuspojava kod karcinoma dojke za Docetaksel 75 mg/m² u kombinaciji s doksorubicinom
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Croatian: G3/4 povećanje bilirubina u krvi G3/4 povećanje alkalne fosfataze u krvi (<2,5%)
English: Cough (G3/4: 0%)
Croatian: sinkopa (G3/4: 0%)
English: • operable node-positive breast cancer • operable node-negative breast cancer
Croatian: • operabilnim karcinomom dojke i negativnim limfnim čvorovima.
English: • The Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Croatian: • Docetaksel Teva 20 mg/0,72 ml bočica je prozirna staklena bočica od 6 ml, s čepom od bromobutilne gume i "flip-off" zatvaračem.
English: Baseline cardiac assessment is recommended.
Croatian: Karnofski izvedbenom statusu.
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaksel 75 mg/m² u kombinaciji s cisplatinom
English: TCF n=221
Croatian: n = 221
English: Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Croatian: * Korigirano za višestruku usporedbu i prilagođeno faktorima stratifikacije (stadij bolesti i regija liječenja) na osnovu podataka iz populacije bolesnika koji su se mogli procijeniti.
English: • The Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Croatian: • Docetaksel Teva 80 mg/2,88 ml bočica je prozirna staklena bočica od 15 ml s čepom od bromobutilne gume i "flip-off" zatvaračem.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 20 mg/0.72 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI - OTAPALO ZA 20 mg/0,72 ml
English: • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Croatian: • 332 bolesnika koji su primali docetaksel u kombinaciji s prednizonom ili prednizolonom
English: BATCH NUMBER Lot
Croatian: *Neprilagođeni log-rang test
English: min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2
Croatian: (TCis), ili Docetaksel 75 mg/m2 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/m2 primijenjen tijekom 6
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
Croatian: • 300 bolesnika s adenokarcinomom želuca (221 bolesnik u fazi III studije i 79 bolesnika u fazi II) koji su primali docetaksel u kombinaciji s cisplatinom i 5-fluorouracilom (prikazani su klinički značajni štetni događaji povezani s liječenjem),
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 80 mg/2.88 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Croatian: UPUTE ZA PRIPREMU I PRIMJENU DOCETAKSEL TEVA 80 mg/2,88 ml KONCENTRATA I OTAPALA ZA OTOPINU ZA INFUZIJU
English: Very common adverse reactions Common adverse reactions
Croatian: Vrlo česte nuspojave Česte nuspojave
English: Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis;
Croatian: Poremećaji probavnog sustava mučnina; proljev; povraćanje;
English: Dizziness; Headache (G3/4: <1%);
Croatian: bol u udovima (G3/4: <1%);
English: 95% CI p-value*
Croatian: (95% CI) *p-vrijednost
English: At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).
Croatian: Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), limfedem je i dalje bio prisutan u 6 bolesnika (0,8%) u TAC skupini te u
English: Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel
Croatian: Docetaksel Teva 20 mg/0,72 ml koncentrat i otapalo za otopinu za infuziju docetaksel
English: Negative
Croatian: Negativan Pozitivan
English: In GEICAM 9805 study peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy 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 periferna senzorna neuropatija koja je počela tijekom perioda liječenja i dalje je bila prisutna u 10 bolesnika (1,9%) u TAC skupini i 4 bolesnika (0,8%) u FAC skupini.
English: Oral candidiasis (G3/4: <1%)
Croatian: parestezija (G3/4: <1%)
English: Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Croatian: skupinu (medijan OS: 18,6 prema 14,5 mjeseci) s rizikom smanjenja smrtnosti od 28%, p=0,0128.
English: Median progression free survival (months) (95%CI)
Croatian: Medijan preživljenja bez progresije bolesti (mjeseci) (95% CI)
English: Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Croatian: doksorubicin i ciklofosfamid (TAC režim).
English: Gastrointestinal haemorrhage (G3/4:
Croatian: Poremećaji oka konjuktivitis (G3/4:
English: 1,060 patients were randomised to receive either Docetaxel 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 cyclosphosphamide 500 mg/m2 (521 patients in
Croatian: Docetaxel 75 mg/m2 primijenjen jedan sat nakon doksorubicina 50 mg/m2 i ciklofosfamida 500 mg/m2 (539 bolesnika u TAC skupini) ili doksorubicin 50 mg/m2 nakon kojeg slijedi fluorouracil 500 mg/m2 i ciklofosfamid 500 mg/m2 (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: Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1 97007 0
Croatian: Österreich ratiopharm Arzneimittel Vertriebs-GmbH
English: Stomatitis/Pharyngitis (G3/4:
Croatian: stomatitis (G3/4:
English: Hazard ratio (95% CI) *p-value
Croatian: Omjer rizika (95% CI) *p-vrijednost
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Croatian: Tablični popis nuspojava kod karcinoma dojke za Docetaksel 75 mg/m² u kombinaciji s kapecitabinom
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4:
Croatian: proljev (G3/4: 3,4%); konstipacija (G3/4:
English: Diarrhoea (G3/4: 1.2%);
Croatian: stomatitis (G3/4: 1,7%);
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 20 mg/0.72 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Croatian: UPUTE ZA PRIPREMU I PRIMJENU DOCETAKSEL TEVA 20 mg/0,72 ml KONCENTRATA I OTAPALA ZA OTOPINU ZA INFUZIJU
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion
Croatian: Uputa o lijeku: Informacije za bolesnika Docetaksel Teva 80 mg/2,88 ml koncentrat i otapalo za otopinu za infuziju docetaksel
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 GEICAM 9805 studiji, alopecija koja je počla tijekom perioda lječenja i dalje bila prisutna tijekom perioda praćenja i zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
English: Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Croatian: Docetaksel Teva 80 mg/2,88 ml koncentrat i otapalo za otopinu za infuziju docetaksel
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Croatian: • Indukcijska kemoterapija praćena kemoradioterapijom (TAX 324)
English: Alopecia (persisting Skin disorder (G3/4:
Croatian: Poremećaji kože i potkožnog tkiva alopecija (G3/4:
English: Disease free survival
Croatian: zimica letargija
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Croatian: Opis odabranih nuspojava za Docetaksel 75 mg/m² u kombinaciji s cisplatinom i 5-fluorouracilom u terapiji adenokarcinoma želuca
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Croatian: proljev (G 3/4: 1,2%); stomatitis/faringitis (G3/4:
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 FAC patients (17.0%).
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