FrancophonIA/ELRC3.0 huggingface dataset:
English: • 1276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented).
Danish: 1.276 patienter (744 i TAX 316 og 532 i GEICAM 9805), som fik docetaxel i kombination med doxorubicin og cyclofosfamid (bivirkninger til klinisk vigtig behandling er præsenteret).
English: Psychiatric disorders Nervous system disorders
Danish: Psykiske forstyrrelser Nervesystemet
English: Docetaxel Teva Pharma is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Teva Pharma solutions.
Danish: Docetaxel Teva Pharma er et antineoplastisk stof, og som med andre potentielle toksiske lægemidler, skal man udvise forsigtighed ved brug og fremstilling af Docetaxel Teva Pharma-opløsninger.
English: When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Danish: DoxorubicinDocetaxel influerer ikke på clearance af doxorubicin eller plasmaniveauet af doxorubicinol (en doxorubicinmetabolit), når det anvendes i kombination.
English: 4.1.3 Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
Danish: 4.1.3 Injicer hele indholdet fra sprøjten i det tilsvarende Docetaxel Teva Pharma-hætteglas.
English: Arrhythmia (no severe)
Danish: Arytmi (ikke alvorlig);
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Danish: Infektion associeret med G4-neutropeni (G3/4: 4,6 %)
English: • redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
Danish: Hårtab (i de fleste tilfælde vil normal hårvækst vende tilbage) Rødme og hævelse af håndflader eller fodsåler, hvilket kan få huden til at skalle af (dette kan også forekomme på arme, ansigt eller krop)
English: MARKETING AUTHORISATION NUMBER EU/1/10/662/002
Danish: EU/1/10/662/002
English: Docetaxel Teva Pharma in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Danish: Docetaxel Teva Pharma i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-småcellet lungekræft hos patienter, der ikke tidligere har fået kemoterapi mod denne tilstand.
English: - For the treatment of lung cancer, Docetaxel Teva Pharma could be administered either alone or in combination with cisplatin.
Danish: - Ved behandling af lungekræft kan Docetaxel Teva Pharma enten indgives alene eller i
English: The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Danish: De mest almindeligt rapporterede bivirkninger med docetaxel var: neutropeni (som var reversibel og ikke kumulativ, median-dagen til nadir var 7 dage og median-varigheden af alvorlig neutropeni (< 500 celler/mm
English: (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Danish: Patienter med nedsat leverfunktion Hos patienter, der behandles med docetaxel som enkeltstof i dosis på 100 mg/m2, som har en serumtransaminase-værdi (ALAT og/eller ASAT) på mere end 1,5 gange den øvre normalværdi samtidig med, at de serum-basiske fosfataseværdier overstiger den øvre normalværdi 2,5 gange, er der en større risiko for udvikling af alvorlige bivirkninger, såsom toksisk dødsfald inklusive sepsis og maveblødning, som kan blive fatal, febril neutropeni, infektioner, trombocytopeni, stomatitis og asteni.
English: In the case of severe neutropenia (<500 cells/mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
Danish: 3) i mere end 7 dage i løbet af en docetaxelbehandling, anbefales det at reducere dosis i de efterfølgende cyklusser eller at tage passende symptomatiske forholdsregler (se pkt.
English: Inject the entire contents of the syringe into the corresponding Docetaxel Teva Pharma vial.
Danish: Injicer hele indholdet af sprøjten i det tilsvarende hætteglas med Docetaxel Teva Pharma.
English: Immune system disorders Metabolism and nutrition disorders
Danish: Immunsystemet Metabolisme og ernæring
English: If you get any side effects talk to your doctor, hospital pharmacist or nurse.
Danish: Indberetning af bivirkninger til Sundhedsstyrelsen Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Docetaxel should be administered when the neutrophil count is ≥1,500 cells/mm3.
Danish: Behandling med docetaxel bør gentages, når neutrofiltallet igen er ≥ 1.500 celler/mm
English: This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Danish: Dette volumen er blevet fastlagt under udviklingen af docetaxel for at kompensere for væsketab ved fremstillingen af præmixen (se pkt.
English: MARKETING AUTHORISATION NUMBER EU/1/10/662/001
Danish: EU/1/10/662/001
English: In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Danish: Hos de patienter, der tidligere havde fået behandling med anthracyklin uden effekt, blev docetaxel sammenlignet med kombinationsbehandling med mitomycin C og vinblastin (12 mg/m hver 6. uge og
English: Neutropenic infection; Infection (G3/4: 11.7%)
Danish: Neutropenisk infektion; Infektion (G3/4: 11,7 %).
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Danish: På basis af farmakokinetiske data med docetaxel givet som enkeltstof ved en dosis på 100 mg/m2, er den anbefalede dosis docetaxel 75 mg/m til patienter, som både har forhøjelse af transaminase (ALAT og/eller ASAT) på mere end 1,5 gange den øvre normalværdi og af basisk fosfatase på mere end 2,5 gange den øvre normalværdi (se pkt.
English: Acute respiratory distress syndrome and cases of interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
Danish: Akut respiratorisk åndedrætsbesvær og tilfælde af interstitial pneumoni/pneumonitis, interstitiel lungesygdom, pulmonar fibrose og respirationssvigt, sommetider letale, er rapporteret sjældent.
English: • The solvent for Docetaxel composition is water for injections.
Danish: Sammensætningen af solvens til Docetaxel er vand til injektionsvæsker
English: The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
Danish: Stigningen i overlevelse set i armen med ugentlig docetaxel var ikke statistisk signifikant sammenlignet med mitoxantron-kontrolarmen.
English: Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitital lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Danish: Akut respiratorisk distress syndrom, interstitiel pneumoni/pneumonitis, interstitiel lungesygdom, lungefibrose og respirationssvigt er blevet rapporteret og kan være associeret med dødelig udgang.
English: Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Danish: Diarré (G3/4: 6,4 %); Stomatitis (G3/4: 2 %)
English: Number of patients Pain response rate (%) 95% CI p-value*
Danish: Antal patienter Smerte-responsrate (%) 95 % CI p-værdi*
English: • 255 patients who received docetaxel in combination with capecitabine.
Danish: 255 patienter, som fik docetaxel i kombination med capecitabin.
English: As with all parenteral products, Docetaxel Teva Pharma 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 Docetaxel Teva Pharma-præmix og -infusionsvæske kontrolleres for uklarheder, og opløsninger med udfældning skal i givet fald kasseres.
English: PREPARATION FOR THE INTRAVENOUS ADMINISTRATION 4.1 Preparation of the Docetaxel Teva Pharma premix solution (10 mg docetaxel/ml) 4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Pharma boxes to stand at room temperature (below 25°C) for 5 minutes.
Danish: Tilberedning til intravenøs administration a) Tilberedning af Docetaxel Teva Pharma præmix (10 mg docetaxel/ml) Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal Docetaxel Teva Pharma-æsker stå i stuetemperatur (under 25°C) i 5 minutter før brug.
English: Solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Danish: Hætteglasset indeholder 1,28 ml vand til injektionsvæsker (påfyldningsvolumen: 1,71 ml).
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe
Danish: Perifer sensorisk neuropati (G3: 4,1 %); Perifer motorisk neuropati (G3/4: 4 %) Dysgeusi (alvorlig:
English: Each solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
Danish: Hvert hætteglas med solvens indeholder 5,12 ml vand til injektionsvæsker (påfyldningsvolumen 6,29 ml).
English: In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study excluded patients with ALT and/or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin> 1 x UNL; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Danish: I kombinationsbehandling med cisplatin og 5-fluoruracil til behandling af patienter med gastrisk adenocarcinom ekskluderede det kliniske pivotalstudie patienter med ALAT og/eller ASAT > 1,5 gange øvre normalværdi associeret med alkalisk fosfatase > 2,5 gange øvre normalværdi, og bilirubin > 1 gange øvre normalværdi.
English: Manufacturer:
Danish: enkeltstof:
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 docetaxel som enkeltstof.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT water for injections
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Solvent vial contains 5.12 ml of water for injections (fill volume: 6.29 ml).
Danish: Hætteglasset indeholder 5,12 ml vand til injektionsvæsker (påfyldningsvolumen: 6,29 ml).
English: Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasations and swelling of the vein.
Danish: Almene symptomer og reaktioner på administrationsstedet Reaktionerne ved infusionsstedet var almindeligvis milde og bestod af hyperpigmentering, inflammation, rødmen eller tørhed, flebitis eller blodudtrækninger og hævelse af venen.
English: Usual dose
Danish: Meget almindelige
English: There are no data available in patients with severely impaired renal function treated with docetaxel.
Danish: Der er ingen tilgængelige data vedrørende behandling med docetaxel af patienter med alvorligt nedsat nyrefunktion.
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Danish: Asteni; perifert ødem; pyrexi; træthed; inflammation i slimhinderne; smerter; influenzalignende symptomer; brystsmerter; kulderystelser letargi
English: Docetaxel Teva Pharma monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Danish: Docetaxel Teva Pharma monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af cytotoksisk terapi.
English: Number of patients PSA** response rate (%) 95% CI p-value*
Danish: Antal patienter PSA**-responsrate (%) 95 % CI p-værdi*
English: 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).
Danish: docetaxel 75 mg/m som en 1-times infusion i kombination med carboplatin (AUC 6 mg/ml pr. min) administreret i løbet af 30-60 minutter hver 3. uge eller vinorelbin (V) 25 mg/ m administreret i løbet af 6 til 10 minutter på dag 1, 8, 15, 22 efterfulgt af cisplatin 100 mg/m administreret på dag 1
English: Lacrimation increased Conjunctivitis
Danish: Øget tåresekretion
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Danish: Svimmelhed (G3/4: 2,3 %); Perifer motorisk neuropati (G3/4: 1,3 %).
English: • 258 patients who received docetaxel in combination with doxorubicin.
Danish: 258 patienter, som fik docetaxel i kombinationsbehandling med doxorubicin.
English: If the vials are stored under refrigeration, allow the required number of Docetaxel Teva Pharma boxes to stand at room temperature (below 25°C) for 5 minutes.
Danish: 4.1.1 Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal Docetaxel Teva Pharma æsker stå i stuetemperatur (under 25 °C) i 5 minutter før brug.
English: • infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
Danish: Meget almindelige (kan forekomme hos mere end 1 ud af 10 patienter) Infektioner, fald i antallet af røde blodlegemer (anæmi), eller hvide blodlegemer (som er vigtige
English: Oesophagitis / dysphagia / odynophagia (G3/4: 0.7%)
Danish: Øsofagitis/dysfagi/odynofagi (G3/4: 0,7 %).
English: This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Danish: Dette påfyldningsvolumen er blevet fastlagt under udvikling af docetaxel for at kompensere for væsketab ved fremstilling af præmixen.
English: • Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
Danish: Hvert hætteglas med solvens indeholder 1,28 ml vand til injektionsvæsker (påfyldningsvolumen: 1,71 ml).
English: 6.4 Special precautions for storage and other handling
Danish: 6.4 Særlige opbevaringsforhold
English: Docetaxel Teva Pharma 80 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel (anhydrous) in polysorbate 80.
Danish: Docetaxel Teva Pharma 80 mg koncentrat til infusionsvæske, opløsning, er en klar viskøs, gul til gulbrun opløsning, som indeholder 27,73 mg/ml docetaxel (vandfri) i polysorbat 80.
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Danish: Induktionskemoterapi efterfulgt af kemo- og stråleterapi (TAX 324) Systemorganklasser i henhold til
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Danish: Arthralgi (G3/4: 0,3 %); Myalgi (G3/4: 0,3 %)
English: Lethargy
Danish: Docetaxels
English: Docetaxel Teva Pharma 20 mg concentrate for solution for infusion is a clear viscous, yellow to brown-yellow solution containing 27.73 mg/ml docetaxel (anhydrous) in polysorbate 80.
Danish: Docetaxel Teva Pharma 20 mg koncentrat til infusionsvæske, opløsning, er en klar viskøs, gul til gulbrun opløsning, som indeholder 27,73 mg/ml docetaxel (vandfri) i polysorbat 80.
English: 4.1.4 Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Danish: 4.1.4 Fjern sprøjten og bland miksturen manuelt ved at vende hætteglasset gentagne gange i mindst
English: 4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva Pharma vial by partially inverting the vial.
Danish: 4.1.2 Med en sprøjte med påsat kanyle udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til Docetaxel Teva Pharma ved at holde hætteglasset på skrå.
English: Neutropenic infection (G3/4: 2.6%)
Danish: Neutropenisk infektion (G3/4: 2,6 %)
English: Anaemia (G3/4: 9.2%); Thrombocytopenia (G3/4: 5.2%)
Danish: Anæmi (G3/4: 9,2 %); Trombocytopeni (G3/4: 5,2 %)
English: Infection (G3/4: 6.3%); Neutropenic infection
Danish: Infektion (G3/4:6,3 %) Neutropenisk infektion
English: Batch:
Danish: Amning:
English: 4.1.5 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: 4.1.5 Lad præmixen stå i 5 minutter ved stuetemperatur (under 25 °C) og kontroller så, at opløsningen er homogen og klar.
English: Docetaxel Teva Pharma is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Danish: Docetaxel Teva Pharma er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter behandlingssvigt af kemoterapi.
English: Cardiac failure
Danish: Kongestivt hjertesvigt
English: • 92 patients treated with docetaxel in combination with trastuzumab.
Danish: 92 patienter, som fik docetaxel i kombination med trastuzumab.
English: Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Danish: Docetaxel i kombination med platinmidler hos patienter der ikke tidligere er behandlet med kemoterapi
English: During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people):
Danish: Følgende allergiske reaktioner ((kan forekomme hos flere end 1 ud af 10 patienter)) kan optræde trykken for brystet, besvær med at trække vejret
English: The Docetaxel Teva Pharma infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Danish: Docetaxel Teva Pharma-infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1-times infusion ved stuetemperatur (under 25 °C) og under normale lysforhold.
English: For patients with serum bilirubin levels >ULN and/or ALT and AST >3.5 times the ULN concurrent with serum alkaline phosphatase levels >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Danish: For de patienter med serum-bilirubin > øvre normalværdi og/eller ALAT og ASAT > 3,5 gange øvre normalværdi og basiske fosfataser > 6 gange øvre normalværdi, kan det ikke anbefales at reducere dosis.
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.
Danish: 1.218 patienter med inoperabel ikke-småcellet lungekræft stadium IIIB eller IV med KPS på 70 % eller mere, og som ikke tidligere havde fået kemoterapi mod denne tilstand, blev i et fase III-studie randomiseret til enten docetaxel (T) 75 mg/m administreret som 1-times infusion umiddelbart efterfulgt af cisplatin (Cis) 75 mg/m administreret i løbet af 30-60 minutter hver 3. uge (TCis),
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel 75 mg/m² i kombination med prednison eller prednisolon
English: • Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
Danish: administreret ugentlig i de første 5 uger i en 6 ugers behandlingsrunde i
English: Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas med koncentrat indeholder 25,1 % (w/w) vandfri ethanol.
English: Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Danish: Din læge vil beregne din legemsoverflade i m
English: Teva Nederland B.V. Tel: +31 800 0228 400
Danish: Tel: +31 800 0228400
English: • The Docetaxel 80 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Danish: Docetaxel 80 mg hætteglas indeholder en opløsning af docetaxel i polysorbat 80 med en koncentration på 27,73 mg/ml.
English: Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva Pharma vial by partially inverting the vial.
Danish: Med en sprøjte udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til Docetaxel Teva Pharma ved at holde hætteglasset på skrå.
English: Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4: 1.0%);
Danish: Konstipation (G3/4: 1,0 %); Gastrointestinale smerter (G3/4:
English: • The Docetaxel 20 mg vial contains a solution of docetaxel in polysorbate 80 at a concentration of 27.73 mg/ml.
Danish: Docetaxel 20 mg hætteglas indeholder en opløsning af docetaxel i polysorbat 80 med en koncentration på 27,73 mg/ml.
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.
Danish: 1.218 patienter med inoperabel ikke-småcellet lungekræft stadium IIIB eller IV med KPS på 70 % eller mere, og som ikke tidligere havde fået kemoterapi mod denne tilstand, blev i et fase III-studie administreret som 1-times infusion umiddelbart administreret i løbet af 30-60 minutter hver 3. uge (TCis), som en 1-times infusion i kombination med carboplatin (AUC 6 mg/ml pr. min) administreret i løbet af 30-60 minutter hver 3. uge eller vinorelbin (V) 25 mg/ m administreret i løbet af 6 til 10 minutter på dag 1, 8, 15, 22 efterfulgt af cisplatin 100 mg/m administreret på dag 1
English: • oral candidiasis
Danish: Mave-tarmkanalen
English: Description of selected adverse reactions for adjuvant therapy with Docetaxel 75 mg/m2 in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Danish: Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med Docetaxel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft
English: • Premix solution: Chemical and physical in-use stability has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Danish: Præmixopløsning: Kemisk og fysisk stabilitet under brug er påvist i 8 timer ved opbevaring enten mellem 2 °C og 8 °C eller ved stuetemperatur (under 25 °C).