FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel Accord 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.
Slovenian: Zdravilo Docetaksel Accord je indicirano v kombinaciji s trastuzumabom za zdravljenje bolnic z metastatskim rakom dojke, katerih tumorji imajo čezmerno izražen HER2 in ki predhodno niso bile zdravljene s kemoterapijo za metastatsko bolezen.
English: Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Slovenian: Kemična in fizikalna stabilnost med uporabo sta dokazani za 48 ur pri temperaturi 2 do 8°C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 160 mg/8 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaksel Accord 160 mg/8 ml sterilni koncentrat docetaksel i.v.
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
Slovenian: Srčne bolezni zmanjšanje funkcije levega srčnega prekata (S 3/4: 0,3 %)
English: DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 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 (Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel
Slovenian: Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje
English: In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give any results of your blood tests to your doctor.
Slovenian: Še zlasti morate zdravniku povedati, če se pojavijo driska, razjede v ustih, občutek otrplosti ali mravljinčenja ali zvišana telesna temperatura.
English: Mix the infusion bag manually using a rocking motion.
Slovenian: Infuzijsko vrečko ročno premešajte z nagibanjem sem in tja.
English: You must not be given Docetaxel Accord
Slovenian: Zdravila Docetaksel Accord ne smete dobiti:
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 %), driska (S3/4: 2,9 %), bruhanje (S3/4: 0,6 %)
English: Description of selected adverse reactions in breast cancer for docetaxel 100 mg/m2 in combination with trastuzumab
Slovenian: Opis izbranih neželenih učinkov zdravljenja z zdravilom docetaksel 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
English: Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Slovenian: Zdravilo Docetaksel Accord je indicirano za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 20 mg/1 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaksel Accord 20 mg/1 ml sterilni koncentrat docetaksel i.v.
English: lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Slovenian: Na koncu spremljanja so limfedem še vedno opažali pri 4 bolnicah (0,8 %) v kraku TAC in pri 1 bolnici (0,2 %) v kraku FAC.
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 359 mg brezvodnega etanola na vialo in je ekvivalentno 10 ml piva ali 4 ml vina.
English: Tabulated list of adverse reactions in prostate cancer for docetaxel 75 mg/m2 in combination with prednisone or prednisolone
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 pri raku prostate v kombinaciji s prednizonom ali prednizolonom
English: FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).).
Slovenian: bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m in ciklofosfamid 500 mg/m2 (521 bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
English: The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC).
Slovenian: Kombinacija docetaksela in trastuzumaba je bila pri bolnicah učinkovita ne glede na to, ali so prej dobile adjuvantne antracikline ali ne. Glavni test za ugotavljanje HER2-pozitivnosti v tej ključni študiji je bila imunohistokemija (IHK).
English: In Docetaxel Accord vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V viali, ki vsebuje zdravilo Docetaksel Accord, je koncentracija docetaksela 20 mg/ml.
English: In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/m2 compared to Best Supportive
Slovenian: s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/m2 značilno daljša kot z najboljšo podporno oskrbo.
English: Docetaxel Accord 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.
Slovenian: Zdravilo Docetaksel Accord v kombinaciji z doksorubicinom je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
English: DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 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 (Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 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 (Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Slovenian: 1 ml koncentrata za raztopino za infundiranje vsebuje 20 mg docetaksela.
English: severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m2.
Slovenian: Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm3 za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m2 na 75 mg/m2 oz. s 75 na 60 mg/m2.
English: In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.
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: Docetaxel Accord 160 mg/8 ml is supplied in a 10 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
Slovenian: Docetaksel Accord 160 mg/8 ml je na voljo v 10 ml viali iz prozornega stekla s fluorotek plus gumijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 80 mg/4 ml sterile concentrate docetaxel
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Docetaksel Accord 80 mg/4 ml sterilni koncentrat docetaksel i.v.
English: You must not breast-feed while you are treated with docetaxel.
Slovenian: Med zdravljenjem z zdravilom Docetaksel Accord ne smete dojiti.
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and an orange flip-off cap, containing 1 ml of concentrate.
Slovenian: Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje Viala tipa I iz prozornega stekla s fluorotek plus (etilen tetrafluoroetilenskim premazom) gumijastim zamaškom in aluminijastim pokrovčkom, in oranžno zaporko, ki vsebuje 1 ml koncentrata.
English: Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 8 ml of concentrate.
Slovenian: Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje Viala tipa I iz prozornega stekla s fluorotek plus (etilen tetrafluoroetilenskim premazom) gumijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko, ki vsebuje 8 ml koncentrata.
English: Nail disorders (severe: 0.8%)
Slovenian: vnetje požiralnika (hudo: 0,4 %)
English: Aseptically withdraw the required amount of Docetaxel Accord concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Slovenian: S kalibrirano brizgo, opremljeno z iglo 21G, aseptično odvzemite potrebno količino koncentrata za raztopino za infundiranje Docetaksel Accord.
English: CAUTION: Ready to add to infusion solution
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA OPOZORILO: Že pripravljeno za dodatek raztopini za infundiranje intravenska uporaba
English: • blood clots.
Slovenian: • krvni strdki
English: Docetaxel Accord 20 mg/1 ml is supplied in a 5 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and an orange flip-off cap.
Slovenian: Docetaksel Accord 20 mg/1 ml je na voljo v 5 ml viali iz prozornega stekla s fluorotek plus gumijastim zamaškom in aluminijastim pokrovčkom, in oranžno zaporko.
English: Tabulated list of adverse reactions in breast cancer for docetaxel 100 mg/m2 in combination with trastuzumab
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
English: 4.8 Undesirable effects
Slovenian: Pogosti neželeni učinki
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Slovenian: Bolezni prebavil navzea (S3/4: 13,9 %), stomatitis (S3/4: 20,7
English: For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
Slovenian: • Indukcijska kemoterapija in nato kemoradioterapija (TAX 324) Za indukcijsko zdravljenje bolnikov z lokalno napredovalim (neresektabilen, majhna verjetnost kirurške ozdravitve, ohranitev organa) skvamoznoceličnim karcinomom glave in vratu (SCCHN) je priporočen odmerek docetaksela 75 mg/m2 v obliki enourne intravenske infuzije 1. dan, ki mu sledi cisplatin 100 mg/m2 v 30-minutni do 3-urni infuziji in nato stalna intravenska infuzija 5-fluorouracila
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.
Slovenian: Bolniki v kraku z docetakselom so dobili docetaksel (T) 75 mg/m2 v intravenski infuziji 1. dan, ki mu je sledil cisplatin (P) 100 mg/m2 v 30-minutni do 3-urni intravenski infuziji in nato stalna intravenska infuzija 5
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel
Slovenian: Docetaksel Accord 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
English: Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 of 744 TAC patients (16.3%) and 86 FAC patients
Slovenian: Na koncu spremljanja (mediani čas spremljanja 8 let) so amenorejo še vedno opažali pri 121 od 744 bolnic v kraku TAC (16,3 %) in pri 86 bolnicah v kraku FAC (11,7 %).
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Slovenian: S3/4 zvišanje AST (0,5 S3/4 zvišanje alkalne fosfataze v krvi (< 0,3
English: 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: 50 vol % brezvodnega etanola (alkohola), kar ustreza 359 mg brezvodnega etanola na vialo in je ekvivalentno 10 ml piva ali 4 ml vina.
English: Tabulated list of adverse reactions in head and neck cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Accord 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 Accord 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 Accord, zlasti alergijskih reakcij in zastajanja tekočine (otekanje dlani, stopal, nog ali zvečanje telesne mase).
English: MARKETING AUTHORISATION NUMBER EU/1/12/769/001
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/12/769/001
English: Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 4 ml of concentrate.
Slovenian: Docetaksel Accord 80 mg/4 ml koncentrat za raztopino za infundiranje Viala tipa I iz prozornega stekla s fluorotek plus (etilen tetrafluoroetilenskim premazom) gumijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko, ki vsebuje 4 ml koncentrata.
English: Docetaxel Accord 80 mg/4 ml is supplied in a 5 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
Slovenian: Docetaksel Accord 80 mg/4 ml je na voljo v 5 ml viali iz prozornega stekla s fluorotek plus umijastim zamaškom in aluminijastim pokrovčkom, in rdečo zaporko.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion docetaxel
Slovenian: Docetaksel Accord 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
English: • operable node-positive breast cancer
Slovenian: • z operabilnim rakom dojke s pozitivnimi bezgavkami.
English: Neutropenia (G4:
Slovenian: Nevtropenija (4. stopnje)
English: MARKETING AUTHORISATION NUMBER EU/1/12/769/003
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/12/769/003
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Slovenian: Opis izbranih neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
English: G3/4 Blood alkaline phosphatase increased (<
Slovenian: S 3/4 zvišanje bilirubina v krvi (< 2,5 %) S3/4 zvišanje alkalne fosfataze v krvi (< 2,5
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion docetaxel
Slovenian: Docetaksel Accord 80 mg/4ml koncentrat za raztopino za infundiranje docetaksel
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: Nadaljnjo prisotnost astenije, ki se je začela med obdobjem zdravljenja trajala v obdobje spremljanja, so zabeležili pri 12 bolnicah (2,3 %) v kraku TAC in pri 4 bolnicah (0,8 %) v kraku FAC.
English: G3/4 ALT increased
Slovenian: S3/4 zvišanje ALT (< 2
English: Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4: Febrile neutropenia
Slovenian: anemija (S3/4: 12,4 %), trombocitopenija (S3/4: 4,0 %), febrilna nevtropenija
English: Tabulated list of adverse reactions in breast cancer for docetaxel 75 mg/m2 in combination with capecitabine
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 pri raku dojke v kombinaciji s kapecitabinom
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4:
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija (S3/4: 0,7 %), artralgija (S3/4: 0,2 %)
English: Diarrhoea (G3/4:
Slovenian: Očesne bolezni konjunktivitis (S3/4:
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Slovenian: Bolezni prebavil stomatitis (S3/4: 5,3 %), driska (S3/4: 4 %), navzea (S3/4: 4 %), bruhanje (S3/4: 3 %)
English: Alopecia ( persisting: Skin disorder (G3/4:
Slovenian: Bolezni kože in podkožja alopecija, kožna reakcija (S3/4:
English: This regimen is administered every
Slovenian: To shemo so uporabljali 4
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%);
Slovenian: Bolezni prebavil navzea (S3/4: 3,3 %), stomatitis (S3/4: 1,7 %), bruhanje (S3/4: 0,8 %), driska (S3/4: 1,7 %)
English: Fluid retention (severe: Asthenia (severe: 11.2%); Pain
Slovenian: Splošne težave in spremembe na mestu aplikacije zastajanje tekočine (hudo: 6,5 %), astenija (huda: 11,2 %), bolečine reakcija na mestu infundiranja, bolečine v prsih, ki niso srčne narave (hude:
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/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Slovenian: Druga je na 3 tedne (Tcis) dobivala docetaksel 75 mg/m2 v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml•min) v 30-60 minutah, tretja pa na 4 tedne (Vcis) vinorelbin (V) 25 mg/m2 v 6-10 minutah
English: Arrhythmia (G3/4:
Slovenian: Žilne bolezni hipotenzija (S 3/4:
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 nadaljnjo 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: Docetaxel in combination with trastuzumab
Slovenian: Docetaksel v kombinaciji s trastuzumabom
English: Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Slovenian: Docetaksel v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 v kombinaciji s cisplatinom in 5-fluorouracilom za adenokarcinom želodca
English: Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
Slovenian: Bolezni krvi in limfatičnega sistema anemija (S3/4: 20,9 %), nevtropenija (S3/4: 83,2 %), trombocitopenija (S3/4: 8,8 %), febrilna nevtropenija
English: Asthenia (severe: Fluid retention (severe:
Slovenian: spremembe nohtov (hude:
English: Dizziness (G3/4: Peripheral motor neuropathy (G3/4:
Slovenian: Bolezni živčevja disgevzija (S3/4: periferna senzorična nevropatija (S 3/4:
English: In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Slovenian: V študiji GEICAM 9805 so se med zdravljenjem nastali periferni edemi nadaljevali še med obdobjem spremljanja pri 4 bolnicah (0,8 %) v kraku TAC in pri 2 bolnicah (0,4 %) v kraku FAC.
English: patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Slovenian: Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m2 (krak FAC).
English: Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Slovenian: zaprtje (S3/4: 1,0 %), bolečine v prebavilih (S3/4: 1,0 %), ezofagitis/disfagija/odinofagija (S3/4: 0,7 %)
English: Tabulated list of adverse reactions in breast cancer for docetaxel 75 mg/m2 in combination with doxorubicin
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom docetaksel 75 mg/m2 pri raku dojke v kombinaciji z doksorubicinom Organski sistemi po MedDRA
English: Nail disorders (severe: Skin reaction (no severe)
Slovenian: Bolezni kože in podkožja alopecija, spremembe nohtov (hude 0,4 %), kožna reakcija (nobene hude)
English: Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Slovenian: Zdravilo Docetaksel Accord v monoterapiji je indicirano za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, pri katerih predhodna citotoksična terapija ni bila uspešna.