FrancophonIA/ELRC3.0 huggingface dataset:
English: 10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a yellow flip-off aluminium over seal containing 8 ml of concentrate.
Croatian: Prozirna bezbojna staklena bočica od 10 ml (staklo tip I) s 8 ml koncentrata, zatvorena gumenim (flurotec) čepom i žutim “flip-off” aluminijskim zaštitnim zatvaračem.
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: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija, periferni edem, pireksija, umor, upala sluznice, bol, bolest slična gripi, bol u prsima, zimica letargija
English: Farnham Road, Bordon Hampshire, GU35 0NF United Kingdom
Croatian: Hampshire, GU35 0NF
English: General disorders and administration site conditions In study TAX316 peripheral oedema that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was observed in 119 of 744 TAC patients (16.0%) and 23 of 736 FAC patients (3.1%).
Croatian: U ispitivanju TAX 316 periferni edem koji je počeo tijekom perioda liječenja te je bio prisutan u periodu praćenja nakon završetka kemoterapije zabilježen je u 119 od 744 bolesnika (16,0%) u TAC skupini i 23 od 736 bolesnika (3,1%) u FAC skupini.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 120 mg/6 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Croatian: UPUTE ZA PRIPREMU I UPOTREBU DOCETAXEL KABI 120 mg/6 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
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 DOCETAXEL KABI koncentrata kako bi se dobila potrebna doza za bolesnika.
English: DOCETAXEL KABI 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 KABI je u kombinaciji s doksorubicinom indiciran za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
English: This medicine 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% bezvodnog etanola (alkohol), odnosno do 1.58 g bezvodnog etanola po bočici, što odgovara količini od 40 ml piva ili 17 ml vina.
English: In DOCETAXEL KABI 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Croatian: U bočici DOCETAXEL KABI 20 mg/1 ml, koncentracija docetaksela iznosi 20 mg/ml.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Croatian: UPUTE ZA PRIPREMU I UPOTREBU DOCETAXEL KABI 20 mg/1 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
English: DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
Croatian: DOCETAXEL KABI 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
English: Arrhythmia (no severe)
Croatian: ezofagitis (težak:
English: Intravenous use Single-use vial.
Croatian: Za primjenu u venu.Bočica za jednokratnu uporabu.
English: 10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a orange flip-off aluminium over seal containing 9 ml of concentrate.
Croatian: Prozirna bezbojna staklena bočica od 10 ml (staklo tip I) s 9 ml koncentrata, zatvorena gumenim (flurotec) čepom i narančastim “flip-off” aluminijskimzaštitnim zatvaračem.
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Croatian: Tablični popis nuspojava kod karcinoma dojke za DOCETAXEL KABI 100 mg/m² u kombinaciji s trastuzumabom
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 32 ml wine.
Croatian: Ovaj lijek sadrži 50 vol% bezvodnog etanola (alkohol), tj. do 3.16 g bezvodnog etanola po bočici, što odgovara količini od 80 ml piva ili 32 ml vina.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DOCETAXEL KABI 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
English: Febrile neutropenia (G3/4: NA)
Croatian: Poremećaji imunološkog preosjetljivost (G3/4:
English: DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Croatian: DOCETAXEL KABI 180 mg/9 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: Peripheral sensory neuropathy (G3: 0.4%)
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G3: 0,4%)
English: DOCETAXEL KABI monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Croatian: DOCETAXEL KABI kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha citotoksične terapije.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml OTHER Cytotoxic
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 20 mg/1 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion docetaxel
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DOCETAXEL KABI 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
English: Cases of cystoid macular oedema (CMO) have been reported in patients treated with docetaxel.
Croatian: U bolesnika liječenih docetakselom prijavljeni su slučajevi cističnog edema makule.
English: Number of patients Pain response rate (%) 95% CI p-value*
Croatian: Stopa smanjenja boli (%) 95% CI p-vrijednost*
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DOCETAXEL KABI 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
English: DOCETAXEL KABI in combination with platinum agents in chemotherapy-naïve patients
Croatian: DOCETAXEL KABI u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju
English: Lacrimation increased (G3/4: 0%)
Croatian: Poremećaji oka pojačano suzenje (G3/4: 0%)
English: An open-label, multi-centre, randomised phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Croatian: Provedeno je, multicentrično randomizirano ispitivanje faze III otvorenog tipa kako bi se usporedile monoterapija docetakselom i terapija paklitakselom u liječenju uznapredovalog karcinoma dojke kod bolesnika prethodno liječenih antraciklinima.
English: DOCETAXEL KABI 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 KABI 160 mg/8 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA DOCETAXEL KABI 120 mg/6 ml koncentrat za otopinu za infuziju docetaksel
English: Treatment difference: 7.1%
Croatian: 1,7% slučajeva)
English: There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Croatian: Podaci o primjeni docetaksela u kombinaciji s doksorubicinom i ciklofosfamidom za bolesnike starije od 70 godina su ograničeni.
English: Infections (G3/4: 5%)
Croatian: Infekcije i infestacije infekcije (G3/4: 5%)
English: MARKETING AUTHORISATION NUMBER EU/1/12/770/004
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/770/004
English: Nausea (G3/4: 5.0%); Stomatitis (G3/4: 6.0%); Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Croatian: Poremećaji probavnog sustava mučnina (G3/4: 5,0%), stomatitis (G3/4: povraćanje (G3/4: proljev (G3/4: 3,4%), konstipacija (G3/4:
English: Oral candidiasis (G3/4: < 1%)
Croatian: Infekcije i infestacije oralna kandidijaza (G3/4: <1%)
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with doxorubicin
Croatian: Tablični popis nuspojava kod karcinoma dojke za DOCETAXEL KABI 75 mg/m² u kombinaciji s doksorubicinom
English: Tabulated list of adverse reactions in non-small cell lung cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin
Croatian: Tablični popis nuspojava kod karcinoma nemalih stanica pluća za DOCETAXEL KABI 75 mg/m² u kombinaciji s cisplatinom
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: Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3/4: 32%), febrilna neutropenija (uključujući neutropeniju povezanu s vrućicom i primjenom antibiotika) ili neutropenijska sepsa
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for DOCETAXEL KABI 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Croatian: Opis odabranih nuspojava za DOCETAXEL KABI 75 mg/m² u kombinaciji s cisplatinom i 5fluorouracilom u terapiji adenokarcinoma želuca
English: PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size > 5 cm
Croatian: TAC = docetaksel, doksorubicin i ciklofosfamid FAC = 5-fluorouracil, doksorubicin i ciklofosfamid CI = interval pouzdanost; ER = estrogenski receptor PR = progesteronski receptor a ER/PR-negativni ili gradus 3 ili veličina tumora >5 cm
English: Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: < 0.1%)
Croatian: Poremećaji živčanog sustava disgeusija/parosmija (G3/4: 0,4%), periferna senzorna neuropatija (G3/4: 1,2%)
English: Neutropenia (G4: 51.5%); Anaemia (G3/4: 6.9%); Thrombocytopenia (G4: 0.5%)
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G4: anemija (G3/4: 6,9%), trombocitopenija (G4: 0,5%)
English: Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
Croatian: Opis odabranih nuspojava kod karcinoma dojke za DOCETAXEL KABI 100 mg/m2 u monoterapiji
English: Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Croatian: Poremećaji probavnog sustava mučnina (G 3/4: 0,6%), stomatitis (G3/4: 4,0%), proljev (G 3/4: 2,9%), povraćanje (G3/4: 0,6%)
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a blue flip-off aluminium over seal containing 4 ml of concentrate.
Croatian: Prozirna bezbojna staklena bočica od 6 ml (staklo tip I) s 4 ml koncentrata, zatvorena gumenim (flurotec) čepom i plavim „flip-off“ aluminijskim zaštitnim zatvaračem.
English: This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.55 g ethanol anhydrous per vial, equivalent to 90 ml of beer or 36 ml wine.
Croatian: Ovaj lijek sadrži 50 vol% bezvodnog etanola (alkohol), odnosno do 3,55 g bezvodnog etanola po bočici, što odgovara količini od 90 ml piva ili 36 ml vina.
English: Median progression free survival (months) (95% CI)
Croatian: Medijan preživljenja bez progresije bolesti (mjeseci) (95% CI)
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: Anorexia (G3/4: 12.0%)
Croatian: Poremećaji metabolizma i prehrane anoreksija (G3/4: 12,0%)
English: METHOD OF ADMINISTRATION
Croatian: NAČIN IZDAVANJA LIJEKA
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Croatian: osip praćen svrbežom (G3/4: promjene noktiju (G3/4: 0,7%), eksfolijacija kože (G3/4: 0%)
English: DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Croatian: DOCETAXEL KABI 120 mg/6 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4: 0,8%)
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain;
Croatian: konstipacija, ezofagitis/disfagija/ odinofagija (G3/4: 0,6%), abdominalna bol, dispepsija, gastrointestinalno krvarenje (G3/4: 0,6%)
English: This regimen is administered every 3 weeks for 3 cycles.
Croatian: Liječenje se primjenjivalo svaka 3 tjedna tijekom 3 ciklusa.
English: This medicine 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% bezvodnog etanola (alkohol), odnosno do 395 mg bezvodnog etanola po bočici, što odgovara količini od 10 ml piva ili 4 ml vina.
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress 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 s pojačanom ekspresijom HER2 na tumorskim stanicama koji nisu ranije primali kemoterapiju za metastatsku bolest.
English: Stomatitis (G3/4: 6.0%); Vomiting (G3/4: 4.2%);
Croatian: proljev (G3/4: 6,2%), povraćanje (G3/4:
English: Dizziness;
Croatian: omaglica,
English: Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatija (G 3: 4,1%), periferna motorna neuropatija (G 3/4: 4%), disgeuzija (teška:
English: Stomatitis/mucositis grade 4 First episode: stop 5-FU only, at all subsequent cycles.
Croatian: Prva epizoda: prekinuti samo primjenu 5-FU u svim sljedećim ciklusima.
English: Patients with baseline neutrophil count of < 1,500 cells/mm3.
Croatian: Bolesnici s početnim brojem neutrofila  1500 stanica/mm3.
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with capecitabine
Croatian: Tablični popis nuspojava kod karcinoma dojke za DOCETAXEL KABI 75 mg/m² u kombinaciji s kapecitabinom
English: • flushing, skin reactions, itching
Croatian: • crvenilo praćeno osjećajem vrućine, kožne reakcije, svrbež
English: Paraesthesia; Headache; Dysgeusia; Hypoaesthesia
Croatian: Poremećaji živčanog sustava parestezija, glavobolja, disgeuzija, hipoestezija
English: Infection (G3/4: 3.6%)
Croatian: Infekcije i infestacije infekcija (G3/4: 3,6%)
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% bezvodnog etanola (alkohol), tj. do 395 mg bezvodnog etanola po bočici, što odgovara količini od 10 ml piva ili 4 ml vina.
English: DOCETAXEL KABI 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 KABI 80 mg/4 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđi vanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Croatian: Poremećaji krvi i limfnog sustava neutropenija (G3/4: 63%), anemija (G3/4: 10%)
English: DOCETAXEL KABI 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 KABI 20 mg/1 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
English: How to store DOCETAXEL KABI 6.
Croatian: Kako čuvati DOCETAXEL KABI 6. Sadržaj pakiranja i druge informacije
English: status
Croatian: Ishod
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 180 mg/9 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 KABI 180 mg/9 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
English: Tabulated list of adverse reactions in head and neck cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin and 5-fluorouracil
Croatian: Tablični popis nuspojava za DOCETAXEL KABI 75 mg/m2 u kombinaciji s cisplatinom i 5fluorouracilom za terapiju karcinoma glave i vrata
English: Infection (G3/4: 3.3%)
Croatian: Infekcije i infestacije infekcija (G3/4: 3,3%)
English: Amenorrhoea (G3/4: NA)
Croatian: dispepsija (G3/4:
English: • haemorrhage
Croatian: • probavne tegobe
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 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 KABI 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Polysorbate 80
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari polisorbat 80 etanol, bezvodni citratna kiselina, bezvodna (za podešavanje pH) 6.2 Inkompatibilnosti
English: Adjusted Hazard ratio (95% CI) *p-value
Croatian: Prilagođeni omjer hazarda (95% CI) *p-vrijednost
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Croatian: Za liječenje docetakselom u monoterapiji (100 mg/m2 u obliku jednosatne intravenske infuzije svaka 3 tjedna) bilo je randomizirano 256 bolesnika.
English: An open-label, multi centre, randomised phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Croatian: Provedena je faza III multicentričnog randomiziranog ispitivanja otvorenog tipa kako bi se usporedile monoterapija docetakselom i terapija paklitakselom u liječenju uznapredovalog karcinoma dojke kod bolesnika prethodno liječenih antraciklinima.
English: Fluid retention (severe: 6.5%); Asthenia (severe: 11.2%); Pain
Croatian: Opći poremećaji i reakcije na mjestu primjene retencija tekućine (teška: 6,5%), astenija (teška, 11,2%); bol reakcija na mjestu primjene infuzije, bol u prsima nekardiološke etiologije (teška: 0,4%)
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a green flip-off aluminium over seal containing 1 ml of concentrate.
Croatian: Prozirna, bezbojna staklena bočica od 6 ml (staklo tip I) s 1 ml koncentrata, zatvorena gumenim (flurotec) čepom i zelenim „flip-off“ aluminijskim zaštitnim zatvaračem.
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a red flip-off aluminium over seal containing 6 ml of concentrate.
Croatian: Prozirna bezbojna staklena bočica od 6 ml (staklo tip I) sa 6 ml koncentrata, zatvorena gumenim (flurotec) čepom i crvenim “filp-off” aluminijskim zaštitnim zatvaračem.
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 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 KABI 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
English: Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Croatian: Tijekom liječenja i kasnijeg praćenja bolesnike treba nadzirati zbog mogućih simptoma kongestivnog srčanog zatajivanja.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Hazard ratio (95% CI) **p-value
Croatian: Omjer hazarda (95% CI) **p-vrijednost
English: Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija (G3/4: 3%), pireksija (G3/4: 1%), umor/slabost (G3/4: 5%), periferni edem (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: 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: Very common adverse reactions Common adverse reactions disorders
Croatian: Vrlo česte nuspojave Česte nuspojave
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 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 KABI 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
English: Peripheral motor neuropathy (G3/4: 4%);
Croatian: periferna motorna neuropatija (G3/4: 2%)
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva mialgija (G3/4: 2%), artralgija (G3/4: 1%)
English: Hazard ratio (95% CI) *p-value
Croatian: Omjer hazarda (95% CI) *p-vrijednost
English: Very common adverse reactions
Croatian: Vrlo česte nuspojave
English: Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%);
Croatian: Poremećaji probavnog sustava mučnina (G3/4: 5,0%), stomatitis (G3/4:
English: DO NOT use other docetaxel medicine consisting of 2 vials (concentrate and solvent) with this medicine (DOCETAXEL KABI 120 mg/6 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 KABI 120 mg/6 ml koncentrat za otopinu za infuziju), koji sadržava samo 1 bočicu).
English: Lacrimation increased (G3/4: 0.6%)
Croatian: Poremećaji oka pojačano suzenje (G3/4: 0,6%)
English: MARKETING AUTHORISATION NUMBER EU/1/12/770/003
Croatian: BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/770/002
English: Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Croatian: proljev (G3/4: 3,4%), konstipacija (G3/4:
English: Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Croatian: Poremećaji kože i potkožnog tkiva alopecija, eritem, osip, poremećaji noktiju
English: At the end of the follow-up period (actual median follow-up time of 8 years), asthenia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Croatian: Na kraju perioda praćenja (stvarni medijan vremena praćenja iznosio je 8 godina), astenija je i dalje bila prisutna u 29 bolesnika (3,9%) u TAC skupini te u 16 bolesnika (2,2%) u FAC skupini.
English: Gastrointestinal disorders Diarrhoea (G3/4: 19.7%); Nausea (G3/4: 16%);
Croatian: gastrointestinalna bol (G3/4: 1,2%), gastrointestinalno krvarenje (G3/4: