FrancophonIA/ELRC3.0 huggingface dataset:
English: VIAL LABEL / TAXOTERE 20 mg/1 ml
Slovenian: NALEPKA NA VIALI/TAXOTERE 20 mg/1 ml
English: • oral candidiasis
Slovenian: • oralna kandidoza
English: The concentrate is supplied in a 7 ml clear colourless glass vial with a green aluminium seal and a green plastic flip-off cap.
Slovenian: Koncentrat je opremljen v 7-ml prozorni brezbarvni viali iz stekla tipa I z zeleno aluminijasto zaporko in z zeleno dvižno zaporko.
English: SOLVENT for TAXOTERE
Slovenian: Shranjevanje zdravila TAXOTERE
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Slovenian: En ml koncentrata za raztopino za infundiranje vsebuje 20 mg docetaksela.
English: • Each TAXOTERE 80 mg/2 ml vial contains 2.0 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/2.36 ml).
Slovenian: • Ena viala zdravila TAXOTERE 80 mg/2 ml vsebuje 2,0 ml raztopine docetaksela 40 mg/ml v polisorbatu 80 (polnilni volumen: 94,4 mg/2,36 ml).
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 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: • The TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a red flip-off cap.
Slovenian: • Viala zdravila TAXOTERE 80 mg/2 ml je 15-ml viala iz prozornega stekla z rdečo dvižno zaporko.
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Slovenian: Splošne težave in spremembe na mestu aplikacije astenija, periferni edemi, pireksija, utrujenost, vnetje sluznice, bolečine, gripi podobna bolezen, bolečine v prsih, mrzlica letargija
English: TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Slovenian: Zdravilo TAXOTERE je indiciran za zdravljenje bolnikov z lokalno napredovalim ali metastatskim nedrobnoceličnim pljučnim rakom, pri katerih predhodna kemoterapija ni bila uspešna.
English: FAC patients (17.0%).
Slovenian: in pri 5 bolnicah (1,0 %) v kraku FAC.
English: • Each TAXOTERE 20 mg/0.5 ml vial contains 0.5 ml of a 40 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.61 ml).
Slovenian: • Ena viala zdravila TAXOTERE 20 mg/0,5 ml vsebuje 0,5 ml raztopine docetaksela 40 mg/ml v polisorbatu 80 (polnilni volumen: 24,4 mg/0,61 ml).
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 20 mg/1 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: • The TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a green flip-off cap.
Slovenian: • Viala zdravila TAXOTERE 20 mg/0,5 ml je 7-ml viala iz prozornega stekla z zeleno dvižno zaporko.
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Slovenian: Bolezni živčevja periferna senzorična nevropatija (S3: 4,1 %), periferna motorična nevropatija (S3/4: 4 %), disgevzija (huda:
English: TAXOTERE in combination with platinum agents in chemotherapy-naïve patients
Slovenian: Zdravilo TAXOTERE v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
English: • The TAXOTERE 20 mg/0.5 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
Slovenian: • Viala zdravila TAXOTERE 20 mg/0,5 ml vsebuje raztopino docetaksela v polisorbatu 80 v koncentraciji 40 mg/ml.
English: - If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Slovenian: - Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: Hazard ratio (95% CI) **p-value 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: Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Log-rank test ***Hi - kvadrat test
English: Peripheral sensory neuropathy (≥G3: 2%)
Slovenian: Bolezni živčevja periferna senzorična nevropatija (≥ 3. st.: 2 %)a glavobol omotica
English: If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, z bolnišničnim farmacevtom ali z medicinsko sestro.
English: • Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: • Potem jo vbrizgajte preko ene injekcije (en odmerek) v 250-ml infuzijsko vrečko ali steklenico, ki vsebuje 5 % raztopino glukoze ali raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje.
English: VIAL/TAXOTERE 80 mg/2 ml
Slovenian: VIALA/TAXOTERE 80 mg/2 ml
English: Vomiting (G3/4: 3%)
Slovenian: trombocitopenija (S3/4: 3 %)
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
Slovenian: TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid
English: For metastatic castration-resistant prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Slovenian: Pri zdravljenju metastatskega, proti kastraciji odpornega raka prostate, v primeru sočasne uporabe prednizona ali prednizolona, je priporočena premedikacija peroralni deksametazon 8 mg, 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (prosimo, glejte poglavje 4.4).
English: TAXOTERE 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 TAXOTERE v kombinaciji z doksorubicinom je indiciran za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke, ki zaradi te bolezni še niso prejemale citotoksične terapije.
English: Following the administration of a 100 mg/m dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml.
Slovenian: 3,7 µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
English: Adjusted hazard ratio 95% CI p-valuea
Slovenian: Prilagojeno razmerje ogroženosti 95 % IZ
English: TAXOTERE 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 TAXOTERE 160 mg/8 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: • Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
Slovenian: • S kalibrirano brizgo, opremljeno z iglo 21G, aseptično odvzemite potrebno količino koncentrata za raztopino za injiciranje.
English: • haemorrhage
Slovenian: • vnetje požiralnika
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Slovenian: NE UPORABLJAJTE drugih zdravil, ki vsebujejo docetaksel z 2 vialama (koncentrat in vehikel) s tem zdravilom (Taxotere 80 mg/4 ml koncentrat za raztopino za infundiranje, ki vsebuje samo 1 vialo).
English: Metastatic castration-resistant prostate cancer The recommended dose of docetaxel is 75 mg/m2.
Slovenian: Priporočeno odmerjanje docetaksela je 75 mg/m2.
English: In TAXOTERE 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V zdravilu TAXOTERE 160 mg/8 ml vialah je koncentracija docetaksela 20 mg/ml.
English: Myalgia (severe: 1.4%) Arthralgia
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija (huda: 1,4 %) artralgija
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Slovenian: Zdravilo vsebuje 50 vol % brezvodnega etanola (alkohol), kar ustreza 1,58 g brezvodnega etanola na vialo; kar ustreza 40 ml piva ali 17 ml vina.
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Slovenian: Bolezni prebavil navzea (S3/4: 3,3 %), stomatitis (S3/4: 1,7 %), bruhanje (S3/4: 0,8 %), driska (S3/4: 1,7 %)
English: VIAL LABEL / TAXOTERE 80 mg/4 ml
Slovenian: NALEPKA NA VIALI/TAXOTERE 80 mg/4 ml
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Slovenian: Najboljši celotni odziv (CR + PR) na raziskovano terapijo [kemoterapija +/kemoradioterapija] (%) (95 % IZ) ***Vrednost p
English: Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
Slovenian: Priprava za intravensko aplikacijo a) Priprava osnovne raztopine zdravila TAXOTERE (10 mg docetaksela/ml)
English: Each blister pack of TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion contains:
Slovenian: En pretisni omot zdravila TAXOTERE 20 mg/0,5 ml koncentrat in vehikel za raztopino za infundiranje vsebuje:
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) 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/m as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m 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: 2 ml (Fill 2.36 ml)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 ml (polnitev 2,36 ml)
English: • operable node-positive breast cancer
Slovenian: • operabilnim rakom dojke s pozitivnimi bezgavkami
English: Anorexia (G3/4: 1%); Decreased appetite
Slovenian: Presnovne in prehranske motnje anoreksija (S3/4: 1 %), zmanjšan apetit dehidracija (S3/4: 2 %),
English: 95% CI p-valuea
Slovenian: 95 % IZ p =
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).
Slovenian: • Indukcijska kemoterapija in nato kemoradioterapija (TAX324) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomizirani multicentrični odprti študiji III. faze (TAX324).
English: Cautions for use in gastric adenocarcinoma cancer Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Slovenian: fazi študije), ki so jih zdravili z docetakselom v kombinaciji s cisplatinom in 5-fluorouracilom v študiji raka želodca, je bilo 74 bolnikov starih 65 let ali več, 4 pa so bili stari 75 let ali več.
English: Each blister pack of TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion contains:
Slovenian: En pretisni omot zdravila TAXOTERE 80 mg/2 ml koncentrat in vehikel za raztopino za infundiranje vsebuje:
English: • blood clots
Slovenian: • krvni strdki
English: Venous disorder (G3/4:
Slovenian: Žilne bolezni venske motnje (S3/4:
English: Infection (G3/4: 3.6%) Neutropenic infection
Slovenian: Infekcijske in parazitske bolezni okužba (S3/4: 3,6 %) nevtropenična okužba
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg/0.5 ml per vial.
Slovenian: Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za zdravilo TAXOTERE to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 2 ml osnovne raztopine z 10 mg/ml docetaksela, kar ustreza označeni količini 20 mg/0,5 ml na vialo.
English: Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm
Slovenian: Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1.500 celic/mm3.
English: Thrombocytopenia (G4:
Slovenian: trombocitopenija (S4:
English: 13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 1.5 ml (Fill 1.98 ml)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 13 % (m/m) 95 % etanol v vodi za injekcije (za dodatne informacije glejte navodilo za uporabo) 1,5 ml (polnjenje 1,98 ml)
English: TAXOTERE 80 mg/2 ml concentrate for solution for infusion docetaxel intravenous use
Slovenian: TAXOTERE 80 mg/2 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: Lacrimation increased (G3/4: <0.1%)
Slovenian: motnja solzenja (S3/4: <0,1 %)
English: Discontinue treatment if these toxicities persist (see section 4.4).
Slovenian: zdravljenje prekinite (glejte poglavje 4.4).
English: Constipation (severe:
Slovenian: vnetje požiralnika (hud:
English: Neutropenia (G3/4:
Slovenian: Preobčutljivost (S3/4:
English: TAXOTERE 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 Taxotere 20 mg/1 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: Myocardial ischemia (G3/4:1.7%)
Slovenian: Srčne bolezni miokardna ishemija (S3/4: 1,7 %)
English: TAXOTERE 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 Taxotere 80 mg/4 ml koncentrat za raztopino za infundiranje NE POTREBUJE predhodnega redčenja z vehiklom in je pripravljen za dodajanje raztopini za infundiranje.
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg/2 ml per vial.
Slovenian: Po razredčenju s celotno vsebino spremljajoče viale z vehiklom za zdravilo TAXOTERE to prepolnjenje zagotavlja, da je mogoče izvleči najmanj 8 ml osnovne raztopine z 10 mg/ml docetaksela, kar ustreza označeni količini 80 mg/2 ml na vialo.
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 (alkohol), kar ustreza 359 mg brezvodnega etanola na vialo; kar ustreza 10 ml piva ali 4 ml vina.
English: Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 pri metastatskem, proti kastraciji odpornim rakom prostate v kombinaciji s prednizonom ali prednizolonom
English: TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion docetaxel intravenous use
Slovenian: TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje docetaksel intravenska uporaba
English: Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis;
Slovenian: Bolezni prebavil navzea, driska, bruhanje, zaprtje, stomatitis, dispepsija, bolečine v trebuhu
English: Somnolence (G3/4: 0%)
Slovenian: limfedem (S3/4: 0 %)
English: Patients on the comparator arm received cisplatin (P) 100 mg/m followed by 5-fluorouracil (F)
Slovenian: Bolniki v primerjalnem kraku so dobivali cisplatin (P) 100 mg/m2 v
English: Docetaxel increased response rate (33% vs. 12%, p < 0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p = 0.0004) and prolonged overall survival (11 months vs. 9 months, p = 0.01).
Slovenian: z 11 tedni, p = 0,0004) in podaljšal celotno preživetje (11 mesecev v prim.
English: 4.2.2 Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: 4.2.2 Potrebno količino osnovne raztopine vbrizgajte v 250-ml infuzijsko vrečko ali steklenico, v kateri je 5 % raztopina glukoze ali 9 mg/ml (0,9 %) raztopina natrijevega klorida za infundiranje.
English: Concentrate for solution for infusion (sterile concentrate).
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Koncentrat je, bledorumena do rjavkastorumena raztopina.
English: TAXOTERE in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Slovenian: Rak dojke Zdravilo TAXOTERE v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
English: Dysgeusia (G3/4: < 1%); Pareaesthesia (G3/4: < 1%)
Slovenian: Bolezni živčevja disgevzija (S3/4: < 1 %), parestezije (S3/4: < 1 %)
English: If signs and symptoms suggestive of these reactions appear discontinuation of docetaxel should be considered.
Slovenian: Če se pojavijo hudi kožni neželeni učinki, je treba razmisliti o prekinitvi zdravljenja.
English: Aseptically withdraw the required amount of TAXOTERE 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 zdravila TAXOTERE.
English: 7 ml clear glass Type I vial with a transparent colourless flip-off cap.
Slovenian: 7-ml viala iz prozornega stekla tipa I s prosojno, brezbarvno dvižno zaporko.
English: TAXOTERE 160 mg/8 ml concentrate for solution for infusion docetaxel
Slovenian: TAXOTERE 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
English: Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² in combination with trastuzumab
Slovenian: Opis izbranih neželenih učinkov zdravljenja z zdravilom TAXOTERE 100 mg/m2 pri raku dojke v kombinaciji s trastuzumabom
English: 13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 6 ml (Fill 7.33 ml)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 13 % (m/m) 95 % etanol v vodi za injekcije (za dodatne informacije glejte navodilo za uporabo) 6 ml (polnjenje 7,33 ml)
English: Metastatic hormone-sensitive prostate cancer The recommended dose of docetaxel is 75 mg/m every 3 weeks for 6 cycles.
Slovenian: Priporočeni odmerek docetaksela je 75 mg/m2 na 3 tedne 6 ciklusov.
English: What TAXOTERE looks like and contents of the pack TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution.
Slovenian: Zdravilo TAXOTERE 20 mg/0,5 ml koncentrat za raztopino za infundiranje je bistra viskozna, rumena do rjavo-rumena raztopina.
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = eostrogen receptor PR = progesterone receptor a
Slovenian: TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Slovenian: pruritični izpuščaj (S3/4: 0,7 %), spremembe nohtov (S3/4: eksfoliacija kože (S3/4: 0 %)
English: Tabulated list of adverse reactions in head and neck cancer for TAXOTERE 75 mg/m² in combination with cisplatin and 5-fluorouracil
Slovenian: Tabelarični prikaz neželenih učinkov zdravljenja z zdravilom TAXOTERE 75 mg/m2 pri raku glave in vratu v kombinaciji s cisplatinom in 5-fluorouracilom
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: Navodilo za uporabo TAXOTERE 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
English: OUTER CARTON / TAXOTERE 160 mg/8 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA / TAXOTERE 160 mg/8 ml
English: In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Slovenian: V študiji GEICAM 9805 so nadaljnjo prisotnost amenoreje, ki se je začela med obdobjem zdravljenja i je trajala v obdobje spremljanja, zabeležili pri 18 bolnicah (3,4 %) v kraku TAC in pri 5 bolnicah (1,0 %) v kraku FAC.
English: Dyspnea (G3: 1%) Coughing (G3: 0%) Upper respiratory tract infection (G3: 1%)
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja (3. st.: 1 %) kašelj (3. st.: 0 %) okužba zgornjih dihal (3. st.:
English: multi
Slovenian: Celotno
English: • one single-dose vial of solvent.
Slovenian: • eno vialo z enim odmerkom vehikla.
English: The concentrate is a clear viscous, yellow to brown-yellow solution.
Slovenian: koncentrat in vehikel za raztopino za infundiranje Koncentrat je bistra, viskozna, rumena do rjavo-rumena raztopina.
English: What TAXOTERE looks like and contents of the pack TAXOTERE 80 mg/2 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution.
Slovenian: Zdravilo TAXOTERE 80 mg/2 ml koncentrat za raztopino za infundiranje je bistra viskozna, rumena do rjavo-rumena raztopina.
English: • The solvent for TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a transparent colourless flip-off cap.
Slovenian: • Viala z vehiklom za zdravilo TAXOTERE 20 mg/0,5 ml je 7-ml steklena viala iz prozornega stekla s prosojno, brezbarvno dvižno zaporko.
English: TAXOTERE 160 mg/8 ml sterile concentrate docetaxel
Slovenian: TAXOTERE 160 mg/8 ml sterilni koncentrat docetaksel intravenska uporaba
English: More than one vial of concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Slovenian: Za odmerek, ki ga potrebuje bolnik, je lahko potrebna več kot ena viala koncentrata za raztopino za infundiranje.
English: Single-use vials - discard unused contents appropriately.
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI Navedba smiselno ni potrebna.