FrancophonIA/ELRC3.0 huggingface dataset:
English: If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25°C) for 5 minutes.
Danish: Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal TAXOTERE-æsker stå i stuetemperatur (under 25°C) i 5 minutter før brug.
English: 7 ml clear glass Type I vial with a green flip-off cap.
Danish: 7 ml klart Type I-hætteglas med en grøn afrivningshætte.
English: In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide
Danish: Den anbefalede doxetaxel-dosis til adjuverende behandling af operabel lymfeknude-positiv og lymfeknude-negativ brystkræft er 75 mg/m hver 3. uge i 6 perioder, administreret 1 time efter doxorubicin 50 mg/m og cyclophosphamid 500 mg/m
English: - For the treatment of head and neck cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.
Danish: • Til behandling af hoved- og hals-kræft indgives TAXOTERE i kombination med cisplatin og 5fluoruracil.
English: What TAXOTERE looks like and contents of the pack TAXOTERE concentrate for solution for infusion is a pale yellow to brownish-yellow solution.
Danish: TAXOTERE koncentrat til infusionsvæske, opløsning er en lys gul til brunliggul opløsning.
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Danish: Hver karton indeholder et hætteglas med 8 ml koncentrat (160 mg) docetaxel.
English: TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion is a clear viscous, yellow to brownyellow solution containing 40 mg/ml docetaxel (anhydrous) in polysorbate 80 and citric acid.
Danish: TAXOTERE 20 mg, koncentrat til infusionsvæske, opløsning, er en klar viskøs, gul til brunliggul opløsning, som indeholder 40 mg/ml docetaxel (vandfri) i polysorbat 80.
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED TAXOTERE 160 mg/8 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: Docetaxel should be administered when the neutrophil count is  1,500 cells/mm In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m to 75 mg/m and/or from 75 to
Danish: Docetaxel kan gives, når neutrocyttallet er  1.500 celler/mm I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m til 75 mg/m og/eller fra
English: VIAL LABEL / TAXOTERE 160 mg/8 ml
Danish: HÆTTEGLAS ETIKET/TAXOTERE 160 mg/8ml
English: Gastrointestinal haemorrhage (G3/4:
Danish: Gastrointestinale blødninger (G3/4:
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Danish: Letargi (G3/4: 3,4 %); Pyreksi (G3/4: 0,6 %); Væskeretention; Ødem
English: Solvent vial contains 1.5 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 1.98 ml).
Danish: Hætteglasset indeholder 1,5 ml af en 13 % ethanol opløsning i vand til injektionsvæsker (indhold: 1,98 ml).
English: Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Danish: Hver karton indeholder et hætteglas med 1 ml koncentrat (20 mg) docetaxel.
English: CARTON/TAXOTERE 80 mg/2 ml
Danish: KARTON/TAXOTERE 80 MG/2 ml
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.
Danish: Solvens til TAXOTERE 20 mg/0,5 ml er i et 7 ml klart hætteglas med en gennemsigtig, farveløs afrivningshætte.
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Danish: Bedste respons i alt til studiebehandling [kemoterapi +/- strålebehandling] (%) (95 %CI) ***p-værdi
English: Nausea (G3/4: 2.4%);
Danish: Kvalme (G3/4: 2,4 %);
English: One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Danish: 1 hætteglas på 8 ml koncentrat indeholder 160 mg docetaxel.
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/0.5 ml CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED TAXOTERE 20 mg/0,5 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING OG SOLVENS TIL TAXOTERE
English: Lacrimation increased (G3/4:
Danish: Forhøjet lakrimation (G3/4:
English: Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Danish: Hver karton indeholder et hætteglas med 4 ml koncentrat (80 mg) docetaxel.
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.
Danish: Dette overskud sikrer, at der efter fortynding med hele indholdet af den medfølgende solvens til TAXOTERE kan udtages et præmix-volumen på mindst 2 ml, som indeholder 10 mg/ml docetaxel, hvilket svarer til den mængde, der er angivet på pakningen på 20 mg/0,5 ml per hætteglas.
English: Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Danish: Lad hætteglasset med præmix stå i stuetemperatur (under 25°C) i 5 minutter og kontroller så, at opløsningen nu er homogen og klar.
English: • The solvent for TAXOTERE composition is a 13% w/w solution of ethanol 95% in water for injections.
Danish: • Sammensætningen af solvens til TAXOTERE er en 13 % (w/w) opløsning af ethanol 95 % i sterilt vand.
English: Description of selected adverse reactions in breast cancer for TAXOTERE 100 mg/m² in combination with trastuzumab
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med TAXOTERE 100 mg/m² i kombination med trastuzumab:
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).
Danish: Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (TAXOTERE 20 mg/1 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
English: The solvent for TAXOTERE is a 13% w/w solution of ethanol 95% in water for injections.
Danish: Solvens (opløsningsvæske) til TAXOTERE er en 13 % (w/w) opløsning af ethanol 95% i vand til injektionsvæsker.
English: TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Danish: TAXOTERE er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungekræft efter behandlingssvigt af kemoterapi.
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.
Danish: Dette overskud sikrer, at der efter fortynding med hele indholdet af den medfølgende solvens til TAXOTERE kan udtages et præmix-volumen på mindst 8 ml, som indeholder 10 mg/ml docetaxel, hvilket svarer til den mængde, der er angivet på pakningen på 80 mg/2 ml per hætteglas.
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 75 mg/m² in combination with doxorubicin
Danish: Tabel over bivirkninger ved behandling af brystkræft med TAXOTERE 75 mg/m² i kombination med doxorubicin:
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.
Danish: Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol) dvs. op til 1,58 g vandfri ethanol pr. hætteglas, svarende til 40 ml øl eller 17 ml vin.
English: Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Danish: Anæmi (G3/4: 9,2 %); Trombocytopeni (G3/4:
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (TAXOTERE 160 mg/8 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
English: Tabulated list of adverse reactions in non-small cell lung cancer for TAXOTERE 75 mg/m² single agent
Danish: Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med TAXOTERE 75 mg/m² enkeltstof:
English: • The TAXOTERE 20 mg/0.5 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
Danish: TAXOTERE 20 mg/0,5 ml hætteglas indeholder en opløsning af docetaxel i polysorbat 80 med en koncentration på 40 mg/ml.
English: To be taken into account in pregnant or breast-feeding women, in children and in high-risk groups such as patients with liver disease, or epilepsy.
Danish: Skal tages i betragtning hos gravide og ammende kvinder, hos børn og hos patienter i højrisikogruppe, såsom patienter med leversygdom eller epilepsi.
English: • Induction chemotherapy followed by radiotherapy (TAX 323)
Danish: • Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) Systemorganklasser i henhold til MedDRAdatabasen
English: Alopecia; Erythema; Rash; Nail disorders
Danish: Alopeci; erythema; udslæt; neglesygdomme
English: 13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 6 ml (Fill 7.33 ml)
Danish: 13 % (w/w) ethanol 95 % i vand til injektionsvæsker 6 ml 6 ml (påfyldt 7,33 ml)
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
Danish: Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol) dvs. op til 3,16 g vandfri ethanol pr. hætteglas, svarende til 80 ml øl eller 33 ml vin.
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Danish: Mave-tarmkanalen Kvalme (G3/4: 13,9 %); Stomatitis (G3/4:
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED TAXOTERE 20 mg/1 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Danish: Bør overvejes hos gravide og ammende kvinder, børn samt patienter i høj-risiko grupper såsom patienter med leversygdom, eller epilepsi.
English: In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Danish: I studiet TAX316 forekom amenorré i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden efter afsluttet kemoterapi og blev rapporteret hos 202 af 744 TAC patienter (27,2 %) og 125 af 736 FAC patienter (17,0 %).
English: Tabulated list of adverse reactions in non-small cell lung cancer for TAXOTERE 75 mg/m² in combination with cisplatin
Danish: Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med TAXOTERE 75 mg/m² i kombination med cisplatin:
English: OUTER CARTON / TAXOTERE 80 mg/4 ml
Danish: YDERKARTON/TAXOTERE 80 mg/4 ml
English: One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Danish: 1 hætteglas på 1 ml koncentrat indeholder 20 mg docetaxel.
English: After 10 years of follow-up in GEICAM 9805 study, acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Danish: Efter 10 års opfølgning i GEICAM9805-studiet forekom akut leukæmi hos 1 ud af 532 (0,2%) patienter i TAC-armen.
English: Cancer pain (G3/4:
Danish: Cancersmerter (G3/4:
English: The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 80 mg/2 ml vial ensures a premix concentration of 10 mg/ml docetaxel.
Danish: Tilsætningen af hele indholdet fra hætteglasset med solvens til indholdet af TAXOTERE 80 mg/2 ml hætteglasset sikrer en præmix-koncentration på 10 mg/ml docetaxel.
English: If you develop severe skin reactions or any of the reactions listed above, immediately contact your doctor or healthcare professional.
Danish: Kontakt straks lægen eller sundhedspersoner, hvis du oplever alvorlige hudreaktioner eller nogen af reaktionerne nævnt ovenfor.
English: - The other ingredients are polysorbate 80 and citric acid.
Danish: - Øvrigt indholdstof: polysorbat 80 og citronsyre.
English: 2.1 TAXOTERE 80 mg/2 ml vial
Danish: 2.1 TAXOTERE 80 mg/2 ml hætteglas:
English: VIAL LABEL / TAXOTERE 20 mg/1 ml
Danish: HÆTTEGLAS ETIKET/TAXOTERE 20 mg/1 ml
English: • 1312 and 121 patients who received 100 mg/m² and 75 mg/m² of docetaxel as a single agent respectively.
Danish: De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos: • 1312 og 121 patienter, som fik henholdsvis 100 mg/m og 75 mg/m af doceraxel som enkeltstof.
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.
Danish: Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol) dvs. op til 395 mg vandfri ethanol pr. hætteglas, svarende til 10 ml øl eller 4 ml vin.
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).
Danish: Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (TAXOTERE 80 mg/4 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
English: TAXOTERE 160 mg/8 ml concentrate for solution for infusion docetaxel
Danish: TAXOTERE 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m followed by cisplatin (P) 75 mg/m followed by
Danish: Patienter i docetaxel-armen fik docetaxel (T) 75 mg/m efterfulgt af cisplatin (P) 75 mg/m efterfulgt af 5-fluoruracil 750 mg/m daglig som en kontinuerlig infusion i 5 dage.
English: 2.1 TAXOTERE 20 mg/0.5 ml vial
Danish: 2.1 TAXOTERE 20 mg/0,5 ml hætteglas:
English: • The TAXOTERE 20 mg/0.5 ml vial is a 7 ml clear glass vial with a green flip-off cap.
Danish: TAXOTERE 20 mg/0,5 ml hætteglas er et 7 ml klart hætteglas med en grøn afrivningshætte.
English: TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion docetaxel intravenous use
Danish: TAXOTERE 20 mg/0,5 ml koncentrat til infusionsvæske, opløsning docetaxel Intravenøs anvendelse
English: Concentrate vial: Polysorbate 80 Citric acid.
Danish: Koncentrat i hætteglas: polysorbat 80, citronsyre.
English: As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: Som ved alle andre parenterale produkter, skal både TAXOTERE præmix og infusionsvæske kontrolleres for uklarheder, og opløsninger med udfældning skal i givet fald kasseres.
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Danish: Oesophagitis/dysfagi/ odynofagi (G3/4:
English: TAXOTERE monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Danish: TAXOTERE monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
English: One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Danish: 1 hætteglas på 4 ml koncentrat indeholder 80 mg docetaxel.
English: Nausea (G3/4: 0.6%); Stomatitis (G3/4:
Danish: Mave-tarmkanalen Kvalme (G3/4: 0,6 %); Stomatitis (G3/4:
English: If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Danish: Hvis TAXOTERE infusionskoncentrat eller infusionsvæske skulle komme på huden, så vask omgående og grundigt med sæbe og vand.
English: Package leaflet: Information for the patient TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel
Danish: Indlægseddel: Information til brugeren TAXOTERE 80 mg/2 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED TAXOTERE 80 mg/4 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for TAXOTERE 75 mg/m in combination with cisplatin and 5-fluorouracil
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med TAXOTERE 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: FORMULATION
Danish: SAMMENSÆTNING
English: Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p < 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Danish: Docetaxel forlængede median-tiden til progression (24,6 uger vs 15,6 uger; p < 0,01) og medianoverlevelse (15,3 måneder vs 12,7 måneder; p = 0,03) uden at påvirke det primære endepunkt (32 % vs 25 %, p = 0,10), samlet respons rate (32 % vs 25 %, p = 0,10).
English: Median overall survival (months) 95% CI
Danish: Median samlede overlevelse (måneder) 95% CI
English: Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%);
Danish: Konstipation (alvorlig: 0,2 %); Mavesmerter (alvorlig: 1 %);
English: 23 of 736 FAC patients (3.1%).
Danish: Det blev observeret hos 119 af 744 TAC patienter (16,0 %) og hos 23 af 736 FAC patienter (3,1 %).
English: Neutropenic infection (Grade 3-4)
Danish: Neutropeni (grad 4) Febril neutropeni Neutropenisk infektion Neutropenisk infektion (grad 3-4)
English: For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Danish: Vedrørende dosisjusteringer for trastuzumab: Se produktresuméet for trastuzumab.
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.
Danish: TAXOTERE 20 mg/0,5 ml koncentrat til infusionsvæske, opløsning, er en klar viskøs, gul til brunliggul opløsning.
English: 13% (w/w) ethanol 95% in water for injections (see leaflet for further information) 1.5 ml (Fill 1.98 ml)
Danish: 13 % (w/w) ethanol 95 % i vand til injektionsvæsker 1,5 ml (påfyldt 1,98 ml)
English: TAXOTERE 160 mg/8 ml sterile concentrate docetaxel
Danish: TAXOTERE 160 mg/8 ml sterilt koncentrat docetaxel intravenøs anvendelse
English: Nausea (G3/4: 5%); Stomatitis (G3/4:
Danish: Mave-tarmkanalen Kvalme (G3/4: 5 %); Stomatitis (G3/4:
English: PREPARATION GUIDE FOR USE WITH TAXOTERE 80 mg/2 ml CONCENTRATE FOR SOLUTION FOR INFUSION AND SOLVENT FOR TAXOTERE
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED TAXOTERE 80 mg/2 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING OG OPLØSNINGSVÆSKE TIL TAXOTERE
English: TAXOTERE 20 mg/1 ml concentrate for solution for infusion docetaxel
Danish: TAXOTERE 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Danish: Luftveje, thorax og mediastinum Epistaxis; pharyngolaryngeal smerte; nasopharyngitis; dyspnø; hoste; næseflåd
English: In TAXOTERE 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentration af docetaxel i TAXOTERE 160 mg/8 ml er 20 mg/ml.
English: TAXOTERE 80 mg/2 ml concentrate for solution for infusion docetaxel intravenous use
Danish: TAXOTERE 80 mg/2 ml koncentrat til infusionsvæske, opløsning docetaxel intravenøs anvendelse
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 100 mg/m² in combination with trastuzumab
Danish: Tabel over bivirkninger ved behandling af brystkræft med TAXOTERE 100 mg/m² i kombination med trastuzumab:
English: • acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Danish: cyster og polypper) Der er rapporter om tilfælde af akut myeloid leukæmi og myelodysplastisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutika og/eller radioterapi.
English: Anaemia (G3/4: 3%); Neutropenia (G3/4:
Danish: Blod og lymfesystem Anæmi (G3/4: 3 %); Neutropeni (G3/4:
English: Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4:
Danish: Neutropeni (G3/4: 83,2 %); Trombocytopeni (G3/4: 8,8 %); Febril neutropeni
English: As with all parenteral products, TAXOTERE infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: Som ved alle andre parenterale lægemidler skal TAXOTERE infusionsvæske kontrolleres visuelt for uklarheder, og opløsninger med udfældning skal kasseres.
English: TAXOTERE 80 mg/4 ml concentrate for solution for infusion docetaxel
Danish: TAXOTERE 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Tabulated list of adverse reactions in breast cancer for TAXOTERE 75 mg/m² in combination with capecitabine
Danish: Tabel over bivirkninger ved behandling af brystkræft med TAXOTERE 75 mg/m² i kombination med capecitabin:
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m as a 1 hour infusion followed by cisplatin 75 mg/m over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m per day for five days.
Danish: • Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Til den indledende behandling af inoperabel, lokalt fremskredne pladecellecarcinom i hoved og hals (SCCHN) er den anbefalede dosis docetaxel 75 mg/m som en 1-times infusion, efterfulgt af
English: • As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: • Som ved alle andre parenterale produkter, skal TAXOTERE infusionsvæske kontrolleres visuelt for uklarheder, og opløsninger med udfældning skal i givet fald kasseres.
English: If TAXOTERE concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis TAXOTERE infusionskoncentrat eller infusionsvæske skulle komme i kontakt med slimhinderne, så vask omgående og grundigt med vand.
English: Vomiting (G3: 1%)
Danish: Opkast (G3: 1%)
English: Oral candidiasis
Danish: Mave-tarmkanalen
English: Progression Free Survival Median (months) 95% CI
Danish: Progressionfri overlevelse Median (måneder) 95% CI
English: Lethargy (G3-4: 2%) Flu-like symptoms (G3: 0%) Asthenia (G3: 0%) Fluid retention
Danish: Letargi (G3-4: 2%) Influenzalignende symptomer (G3: 0%)
English: 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.
Danish: Injicer derefter den beregnede mængde TAXOTERE-præmix i en 250 ml infusionspose med enten 5 % glucoseinfusionsvæske eller natriumchloridinfusionsvæske 9 mg/ml (0,9 %).
English: TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion docetaxel
Danish: TAXOTERE 80 mg/2 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
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.
Danish: TAXOTERE 80 mg/2 ml koncentrat til infusionsvæske, opløsning, er en klar viskøs, gul til brunliggul opløsning.