FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Limfedem, ki se je začel med obdobjem zdravljenja, se je med obdobjem spremljanja nadaljeval pri 5 bolnicah (0,9 %) v kraku TAC in pri 2 bolnicah (0,4 %) v kraku FAC.
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%).
Slovenian: V študiji TAX316 so periferne edeme, ki so se pojavili med obdobjem zdravljenja in so trajali še med obdobjem spremljanja po koncu kemoterapije, opažali pri 119 od 744 bolnic v kraku TAC (16,0 %) in pri 23 od 736 bolnic v kraku FAC (3,1 %).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml OTHER Cytotoxic
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 20 mg/1 ml DRUGI PODATKI CITOTOKSIČNO ZDRAVILO
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.
Slovenian: V študiji GEICAM 9805 se je med zdravljenjem nastala periferna senzorična nevropatija nadaljevala še med obdobjem spremljanja pri 10 bolnicah (1,9 %) v kraku TAC in pri 4 bolnicah (0,8 %) v kraku FAC.
English: Median duration of response (months) (95% CI)
Slovenian: delež odziva (95 % IZ) mediano trajanje odziva (meseci) (95 % IZ)
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 .
Slovenian: Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza 1,58 g brezvodnega etanola na vialo in je ekvivalentno 40 ml piva ali 17 ml vina.
English: Disease free survival
Slovenian: Žilne bolezni limfedem
English: Tabulated list of adverse reactions in head and neck cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravila DOCETAKSEL KABI 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za rak glave in vratu
English: In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in TAC arm died because of dilated cardiomyopathy, and CHF was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Slovenian: Na koncu spremljanja (dejanski mediani čas spremljanja 10 let in 5 mesecev) ni imela kongestivnega srčnega popuščanja (KSP) nobena bolnica v kraku TAC in 1 bolnica v kraku TAC je umrla zaradi dilatativne kardiomiopatije, še trajajoče KSP pa so zabeležili pri 1 bolnici (0,2 %) v kraku FAC.
English: Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost (S3/4: 3,9 %), zastajanje tekočine (hudo 0,6 %)
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Slovenian: Splošne težave in spremembe na mestu aplikacije letargija (S3/4: 3,4 %), pireksija (S3/4: 0,6 %), retenca tekočine, edem
English: In DOCETAXEL KABI 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu DOCETAKSEL KABI 160 mg/8 ml vialah je koncentracija docetaksela 20 mg/ml.
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Slovenian: Bolezni prebavil navzea (S3/4: 9,6 %), bruhanje (S3/4: 7,6 %), driska (S3/4: 6,4 %), stomatitis (S3/4: 2 %)
English: In DOCETAXEL KABI 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu DOCETAKSEL KABI 80 mg/4 ml vialah je koncentracija docetaksela 20 mg/ml.
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Slovenian: *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO).
English: • insomnia
Slovenian: • omedlevica,
English: Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Slovenian: Bolezni prebavil navzea (S3/4: 0,6 %), stomatitis (S3/4: 4,0 %), diareja (S3/4: 2,9 %), bruhanje (S3/4: 0,6 %)
English: In DOCETAXEL KABI 180 mg/9 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu DOCETAKSEL KABI 180 mg/9 ml vialah je koncentracija docetaksela 20 mg/ml.
English: Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Slovenian: Ob uporabi docetaksela so opažali redke primere konvulzij ali prehodne izgube zavesti.
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.
Slovenian: 6 ml viala iz prozornega, brezbarvnega stekla tipa I, zaprta z gumijastim zamaškom in rdečo snemno (flip-off) aluminijasto prekrivno zaporko, ki vsebuje 6 ml koncentrata.
English: The concentrate is a clear, colourless to pale yellow solution.
Slovenian: koncentrat za raztopino za infundiranje (sterilni koncentrat) Koncentrat je bistra, brezbarvna do bledorumena raztopina.
English: Neutropenic complications
Slovenian: Nevtropenični zapleti:
English: Anorexia (G3/4: 12.0%)
Slovenian: Presnovne in prehranske motnje anoreksija (S3/4: 12,0 %)
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.
Slovenian: Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza 3,16 g brezvodnega etanola na vialo in je ekvivalentno 80 ml piva ali 32 ml vina.
English: Abdominal pain (G3/4: 0.4%)
Slovenian: bolečine v trebuhu (S3/4: 0,4 %)
English: DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion docetaxel
Slovenian: DOCETAKSEL KABI 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to DOCETAXEL KABI administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of DOCETAXEL KABI in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Slovenian: Namen tega je zmanjšanje določenih neželenih učinkov, ki se lahko pojavijo po infuziji zdravila DOCETAKSEL KABI, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
English: Arrhythmia
Slovenian: Dojenje
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.
Slovenian: Zdravilo DOCETAKSEL KABI 180 mg/9 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
Slovenian: DOCETAKSEL KABI 180 mg/9 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/ odynophagia (G3/4: 0.7%)
Slovenian: zaprtje (S3/4: 1,0 %), bolečine v prebavilih (S3/4: 1,0 %), ezofagitis/disfagija/odinofagija (S3/4: 0,7 %)
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.
Slovenian: Zdravilo DOCETAKSEL KABI 120 mg/6 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: Adjusted Hazard ratio (95% CI) *p-value
Slovenian: Popravljeno razmerje tveganja (95 % IZ) *p-vrednost
English: Hazard ratio (95% CI) **p-value
Slovenian: Razmerje tveganja (95 % IZ) **p-vrednost
English: G3/4 AST increased (0.5%); G3/4 Blood alkaline phosphatase increased (0.3%)
Slovenian: Preiskave zvečanje bilirubina v krvi S3/4 (< 5 %), zvečanje alkalne fosfataze v krvi S3/4
English: Tell your doctor, hospital pharmacist or nurse if you have vision problems.
Slovenian: Če imate težave z vidom, morate to povedati zdravniku, bolnišničnemu farmacevtu ali medicinski sestri.V primeru težav z vidom, zlasti zamegljenega vida, morate takoj opraviti pregled oči in vida.
English: Oral candidiasis (G3/4: < 1%)
Slovenian: Infekcijske in parazitske bolezni oralna kandidoza (S3/4: < 1 %)
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.
Slovenian: 6 ml viala iz prozornega, brezbarvnega stekla tipa I, zaprta z gumijastim zamaškom in modro snemno (flip-off) aluminijasto prekrivno zaporko, ki vsebuje 4 ml koncentrata.
English: Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S4: 91,7 %), anemija (S3/4: 9,4 %), febrilna nevtropenija, trombocitopenija (S4: 0,8 %)
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Slovenian: pruritični izpuščaj (S3/4: 0,7 %), spremembe nohtov (S3/4: 0,7 %), eksfoliacija kože (S3/4: 0 %)
English: Anorexia (G3/4: 1.5%)
Slovenian: Presnovne in prehranske motnje anoreksija (S3/4: 1,5 %)
English: Hypotension (G3/4: 0.7%)
Slovenian: Žilne bolezni hipotenzija (S3/4: 0,7 %)
English: Nervous system
Slovenian: Bolezni živčevja
English: Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
Slovenian: Opis izbranih neželenih učinkov monoterapije z zdravilom DOCETAKSEL KABI 100 mg/m2 pri raku dojke
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with capecitabine
Slovenian: Tabelarični prikaz neželenih učinkov zdravila DOCETAKSEL KABI 75 mg/m2 v kombinaciji s kapecitabinom pri raku dojke
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.
Slovenian: Zdravilo DOCETAKSEL KABI 160 mg/8 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
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.
Slovenian: Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza 3,55 g brezvodnega etanola na vialo in je ekvivalentno 90 ml piva ali 36 ml vina.
English: DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
Slovenian: DOCETAKSEL KABI 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
English: Hypersensitivity (G3/4: 1.2%)
Slovenian: Bolezni imunskega sistema preobčutljivost (S3/4: 1,2 %)
English: Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa, faringo-laringealna bolečina, nazofaringitis, dispneja, kašelj, rinoreja
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija (S3/4: 0,7 %), artralgija (S3/4: 0,2 %)
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S3/4: 63 %), anemija (S3/4: 10 %)
English: In DOCETAXEL KABI 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu DOCETAKSEL KABI 20 mg/1 ml vialah je koncentracija docetaksela 20 mg/ml.
English: Peripheral sensory neuropathy (G3/4: 1.2%)
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S3/4: 1,2 %), disgevzija (S3/4: 0 %)
English: Cardiac toxicity
Slovenian: Kardiotoksičnost
English: G3/4 Blood alkaline phosphatase increased (< 4%);G3/4 AST increased (< 3%);
Slovenian: Preiskave zvišanje bilirubina v krvi S3/4 (< 2,5 %), zvišanje alkalne fosfataze v krvi S3/4 (< 2,5 %)
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.
Slovenian: Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza 395 mg brezvodnega etanola na vialo in je ekvivalentno 10 ml piva ali 4 ml vina.
English: Median progression free survival (months) (95% CI)
Slovenian: Mediano preživetje brez napredovanja bolezni (meseci) (95 % IZ)
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
Slovenian: Tabelarični prikaz neželenih učinkov monoterapije z zdravilom DOCETAKSEL KABI 100 mg/m2 pri raku dojke
English: Alopecia; Nail disorders (no severe)
Slovenian: Bolezni kože in podkožja alopecija, spremembe nohtov (nobenih hudih)
English: Reporting of side effects
Slovenian: Učinki na prebavila
English: Disease Free Survival Hazard ratio*
Slovenian: Preživetje brez bolezni Razmerje ogroženosti*
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.
Slovenian: Zdravilo DOCETAKSEL KABI 80 mg/4 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: Venous disorder (G3/4: 0.6%)
Slovenian: Žilne bolezni venska bolezen (S3/4: 0,6 %)
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.
Slovenian: Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohola), kar ustreza 395 mg brezvodnega etanola na vialo in je ekvivalentno 10 ml piva ali 4 ml vina na vialo.
English: Alopecia (G3/4: 10.9%) Rash pruritic; Dry skin;
Slovenian: Bolezni kože in podkožja alopecija (S3/4: 4,0 %), pruritičen izpuščaj suha koža, luščenje
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.
Slovenian: Zdravilo DOCETAKSEL KABI 20 mg/1 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: DOCETAXEL KABI in combination with trastuzumab
Slovenian: DOCETAKSEL KABI v kombinaciji s trastuzumabom
English: Infection (G3/4: 5.7%)
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4: 5,7 %)
English: Very common adverse reactions Common adverse reactions disorders
Slovenian: Organski sistemi po MedDRA Zelo pogosti neželeni učinki
English: 1 vial with 120 mg/6 ml
Slovenian: 1 viala s 160 mg/8 ml
English: Ventricular arrhythmia including ventricular tachycardia (frequency not known), sometimes fatal, has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5fluorouracil and/ or cyclophosphamide.
Slovenian: Pri bolnicah, zdravljenih z docetakselom v kombiniranih shemah, ki so vključevale doksorubicin, 5fluorouracil in/ali ciklofosfamid, so poročali o prekatnih motnjah srčnega ritma, vključno s prekatno tahikardijo (pogostnost ni znana), včasih s smrtnim izidom
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4: 20.7%); Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4: 12.0%);
Slovenian: bruhanje (S3/4: 8,4 %), driska (S3/4: 6,8 %), ezofagitis/disfagija/ odinofagija (S3/4:
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel) s tem zdravilom (zdravilo DOCETAKSEL KABI 180 mg/9 ml koncentrat za raztopino za infundiranje, ki vsebuje samo eno vialo).
English: Infections (G3/4: 5%)
Slovenian: Infekcijske in parazitske bolezni okužbe (S3/4: 5 %)
English: Treatment difference: 7.1%
Slovenian: z 2,4 %), driska (7,5 % v prim.
English: Pharyngolaryngeal pain (G3/4: 2%)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora faringo-laringealna bolečina (S3/4: 2 %)
English: Diarrhoea (G3/4: 4%); Nausea (G3/4: 4%); Vomiting (G3/4: 3%)
Slovenian: Bolezni prebavil stomatitis (S3/4: 5,3 %), driska (S3/4: 4 %), navzea (S3/4: 4 %), bruhanje (S3/4: 3 %)
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Slovenian: okužba, povezana z nevtropenijo S4 (S3/4:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/770/005
English: Weight decreased; G3/4 Blood bilirubin increased
Slovenian: Preiskave zmanjšanje telesne mase, zvišanje bilirubina v krvi S3/4 (9
English: Hearing impaired (G3/4: 0%)
Slovenian: Očesne bolezni močnejše solzenje (S3/4: 0 %)
English: Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija (S3/4: 3 %), pireksija (S3/4: 1 %), utrujenost/šibkost (S3/4: 5 %), periferni edemi (S3/4: 1 %)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel) s tem zdravilom (zdravilo DOCETAKSEL KABI 160 mg/8 ml koncentrat za raztopino za infundiranje, ki vsebuje samo eno vialo).
English: Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
Slovenian: Bolezni prebavil driska (S3/4: 19,7 %), navzea (S3/4: 16 %), stomatitis (S3/4: 23,7 %), bruhanje (S3/4: 14,3 %)
English: Tell your doctor, hospital pharmacist, or nurse immediately if you have abdominal pain or tenderness, diarrhoea, rectal haemorrhage, blood in stool or fever.
Slovenian: Če imate bolečine v trebuhu, občutljiv trebuh, drisko, krvavitev iz danke, kri v blatu ali zvišano telesno temperaturo, morate o tem nemudoma obvestiti zdravnika, bolnišničnega farmacevta ali medicinsko sestro.
English: Exfoliative rash (G3/4: 0.3%)
Slovenian: eksfoliacijski izpuščaj (S3/4: 0,3 %)
English: Arrhythmia (G3/4: 0.2%)
Slovenian: Srčne bolezni aritmija (S3/4: 0,2 %)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel) s tem zdravilom (zdravilo DOCETAKSEL KABI 120 mg/6 ml koncentrat za raztopino za infundiranje, ki vsebuje samo eno vialo).
English: Very common adverse reactions
Slovenian: Zelo pogosti neželeni učinki
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Slovenian: Čas običajno ne sme preseči 6 ur na temperaturi do 25 °C; to vključuje tudi enourno infundiranje.
English: Dizziness;
Slovenian: Odlaganje:
English: Patients with operable node-negative breast cancer eligible to receive chemotherapy (GEICAM 9805) Data from a multi-centre open- label randomised trial support the use of DOCETAXEL KABI for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Slovenian: DOCETAKSEL KABI v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje Bolniki z operabilnim rakom dojke s pozitivnimi bezgavkami (TAX 316) Podatki multicentrične, odprte randomizirane študije podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke s pozitivnimi bezgavkami in seštevkom po Karnofskem ≥ 80 %.
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%);
Slovenian: Bolezni živčevja disgevzija/parozmija, periferna senzorična nevropatija (S3/4: 0,6 %)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel) s tem zdravilom (zdravilo DOCETAKSEL KABI 80 mg/4 ml koncentrat za raztopino za infundiranje, ki vsebuje samo eno vialo).
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil z docetakselom, ki vsebujejo 2 viali (koncentrat in vehikel) s tem zdravilom (zdravilo DOCETAKSEL KABI 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo eno vialo).
English: DOCETAXEL KABI monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Slovenian: Zdravilo DOCETAKSEL KABI je v monoterapiji indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.
English: • heart failure
Slovenian: • srčno popuščanje,
English: Each ml of concentrate contains 20 mg docetaxel anhydrous.
Slovenian: 1 ml koncentrata vsebuje 20 mg brezvodnega docetaksela.
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Slovenian: hipotenzija (S3/4: 0 %), vnetje žile (S3/4: 0 %)
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva mialgija (S3/4: 2 %), artralgija (S3/4: 1 %)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE DOCETAKSEL KABI 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba POSTOPEK UPORABE ZDRAVILA DATUM IZTEKA ROKA UPORABNSOTI ZDRAVILA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/770/001
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain;
Slovenian: zaprtje, ezofagitis/disfagija/ odinofagija (S3/4: 0,6 %), bolečine v trebuhu, dispepsija, krvavitev v prebavilih (S3/4: 0,6 %)
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the follow-up 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.
Slovenian: V študiji GEICAM 9805 so nadaljno prisotnost alopecije, ki se je začela med obdobjem zdravljenja in je trajala v obdobje spremljanja, zabeležili pri 49 bolnicah (9,2 %) v kraku TAC in pri 35 bolnicah (6,7 %) v kraku FAC.
English: • oesophagitis
Slovenian: • omotica,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/12/770/004
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija (S3/4: 0,3 %), mialgija (S3/4: 0,3 %)