FrancophonIA/ELRC3.0 huggingface dataset:
English: For metastatic hormone-sensitive prostate cancer, irrespective of the concurrent use of prednisone or prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg 12 hours, 3 hours, and 1 hour before docetaxel infusion (see section 4.4).
Danish: Ved metastatisk hormonfølsom prostatakræft, er det anbefalede præmedicineringsregime, uanset samtidig anvendelse af prednison eller prednisolon, oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxel-infusion (se pkt.
English: The safety and efficacy of docetaxel administered at the beginning of androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer were evaluated in a randomised Phase III multi-centre study (CHAARTED).
Danish: Sikkerheden og effekten af docetaxel administreret i begyndelsen af androgen deprivationsbehandling hos patienter med metastatisk hormonfølsom prostatakræft blev evalueret i et randomiseret fase III multicenter studie (CHAARTED).
English: • Docetaxel 75 mg/m every 3 weeks for 10 cycles.
Danish: • Docetaxel 75 mg/m hver 3. uge i 10 behandlingsrunder.
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Danish: For cisplatin-dosisjustering se tilsvarende produktresumé
English: Alopecia (G3/4: 6%); Nail disorders (G3/4: 2%)
Danish: Alopeci (G3/4: 6 %); Neglesygdomme (G3/4: 2 %)
English: Anorexia (G3/4:
Danish: Anoreksi (G3/4:
English: • operable node-negative breast cancer
Danish: • operabel, lymfeknude-negativ brystkræft
English: TAXOTERE 20 mg/1 ml sterile concentrate docetaxel
Danish: TAXOTERE 20 mg/1 ml sterilt koncentrat docetaxel
English: The concentrate is supplied in a 7 ml clear colourless glass vial with a magenta aluminium seal and a magenta plastic flip-off cap.
Danish: Koncentratet leveres i et 7 ml klart, farveløst hætteglas med en magenta aluminiumforsegling og en magenta plastik-afrivningshætte.
English: Alopecia (G3/4: 10.9%) Rash pruritic; Dry skin;
Danish: Hud og subkutane væv Alopeci (G3/4: 10,9 %) Kløende udslæt; Tør hud;
English: Excipient with known effect: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Danish: Hjælpestoffer som behandleren skal være opmærksom på: Hvert hætteglas med koncentrat indeholder 4 ml ethanol, vandfri (3,16 g).
English: 95% CI p-value
Danish: 95 %CI p-værdi
English: Dehydration (G3/4: 2%)
Danish: Dehydrering (G3/4: 2 %);
English: In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
Danish: På den anden side viste AC-armen en hyppigere forekomst af alvorlig anæmi (15,8 % versus 8,5 %) end AT-armen og tillige en hyppigere forekomst af alvorlig hjertetoksicitet: Hjerteinsufficiens (3,8 % versus 2,8 %), total LVEF-nedsættelse > 20 % (13,1 % versus 6,1 %), total LVEF-nedsættelse > 30 % (6,2 % versus 1,1 %).
English: Each blister pack of TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion contains:
Danish: Hver blisterpakning med TAXOTERE 20 mg/0,5 ml koncentrat og solvens til infusionsvæske, opløsning, indeholder:
English: Tumour response rate (%) 95% CI p-value*
Danish: Tumor-response rate (%) 95 %CI p-værdi*
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Danish: Asteni; periferalt ødem; pyrexi; træthed; inflammation i slimhinderne; smerter; influenza-lignende symptomer; brystsmerter; kulderystelser
English: • The TAXOTERE 80 mg/2 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
Danish: • TAXOTERE 80 mg/2 ml hætteglas indeholder en opløsning af docetaxel i polysorbat 80 med en koncentration på 40 mg/ml.
English: Cautions for use in castration-resistant prostate cancer Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study(TAX 327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Danish: Forsigtighedsregler ved behandling af kastrationsresistent prostatakræft Ud af 333 patienter behandlet med docetaxel hver tredje uge i et prostatakræftstudium (TAX 327), var 209 patienter 65 år eller derover og 68 patienter var ældre end 75 år.
English: • Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomised study (TAX323).
Danish: • Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med pladecellecarcinom i hovedet og halsen (SCCHN) blev evalueret i et fase III, multicenter, åbent, randomiseret studie (TAX323).
English: Dysgeusia (G3/4: 0%)
Danish: Dysgeusi (G3/4: 0 %)
English: The infusion solution should be used within 4 hours at room temperature (below 25°C).
Danish: Infusionsvæsken skal bruges indenfor 4 timer ved stuetemperatur (under 25ºC).
English: Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM STUDY.
Danish: Tabellen nedenfor viser, at hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion var lavere hos patienter, der fik G-CSF profylaktisk, efter det blev gjort obligatorisk i TACarmen i GEICAM-studiet.
English: What TAXOTERE is and what it is used for What you need to know before you use TAXOTERE How to use TAXOTERE
Danish: Det skal du vide, før du begynder at bruge TAXOTERE Sådan skal du bruge TAXOTERE Bivirkninger
English: • The solvent for TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.
Danish: • Solvens til TAXOTERE 80 mg/2 ml er i et 15 ml klart hætteglas med en gennemsigtig, farveløs afrivningshætte.
English: 4.2.4 The TAXOTERE 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: 4.2.4 TAXOTERE infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1-times infusion ved stuetemperatur (under 25ºC) og under normale lysforhold.
English: 13% (w/w) ethanol 95% in water for injections Fill: 7.33 ml
Danish: 13 % (w/w) ethanol 95 % i vand til injektionsvæsker Indhold: 7,33 ml
English: 13% (w/w) ethanol 95% in water for injections Fill: 1.98 ml
Danish: 13 % (w/w) ethanol 95 % i vand til injektionsvæsker Indhold: 1,98 ml
English: Solvent vial contains 6 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 7.33 ml).
Danish: Hætteglasset indeholder 6 ml af en 13 % ethanol opløsning 95% i vand til injektionsvæsker (indhold: 7,33 ml).
English: Hypersensitivity (G3-4: 1%)
Danish: Overfølsomhed (G3-4: 1%)
English: Special populations:
Danish: Specielle patientgrupper:
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Danish: Hazard ratio: 1,122 (97,2 %CI:0.937;1,342)* Behandlingsforskel 5,4 % (95 %CI:-1,1;12,0) Behandlingsforskel 6,2 % (95 %CI:0,2;12,3)
English: Weight increased (G3/4:
Danish: Vægtforøgelse (G3/4:
English: The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap.
Danish: Koncentratet leveres i et 15 ml klart, farveløst hætteglas med en blå aluminiumforsegling og en blå plastik-afrivningshætte.
English: Aseptically withdraw the required amount of TAXOTERE concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.
Danish: Udtag aseptisk den ønskede mængde TAXOTERE koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle.
English: Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone
Danish: Tabel over bivirkninger ved behandling af metastatisk kastrationsresistent prostatakræft med TAXOTERE 75 mg/m² i kombination med prednison eller prednisolon:
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.
Danish: Koncentratet leveres i et 7 ml klart, farveløst hætteglas med en grøn aluminiumforsegling og en grøn plastik-afrivningshætte.
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.
Danish: TAXOTERE 80 mg/4 ml koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske.
English: Anorexia (G3/4: 11.7%)
Danish: Anoreksi (G3/4: 11,7 %)
English: Skin reaction (no severe)
Danish: Hudreaktioner (ikke alvorlig)
English: Hypersensitivity (G3/4: 1.7%)
Danish: Overfølsomhed (G3/4: 1,7 %)
English: Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm3 (see section 4.2).
Danish: Behandling med docetaxel bør gentages, når neutrocyttallet igen er  1.500 celler/mm (se pkt.
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).
Danish: • Hver TAXOTERE 80 mg/2 ml hætteglas indeholder 2 ml af en 40 mg/ml docetaxel opløsning i polysorbat 80 (indeholder 94,4 mg/2,36 ml).
English: Thrombocytopenia (G3/4:
Danish: Trombocytopeni (G3/4:
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between + 2°C and + 8°C or at room temperature (below 25°C).
Danish: Dog har præmixen vist sig kemisk og fysisk stabil i en 8 timers periode, når den blev opbevaret enten ved temperatur mellem +2 °C og +8 °C eller ved stuetemperatur (under 25 ºC).
English: Thrombocytopenia (G3/4: 3%)
Danish: Trombocytopeni (G3/4: 3 %)
English: • The TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a red flip-off cap.
Danish: • TAXOTERE 80 mg/2 ml hætteglas er et 15 ml klart hætteglas med en rød afrivningshætte.
English: Peripheral sensory neuropathy (G3/4: 1.2%);
Danish: Perifer sensorisk neuropati (G3/4: 1,2 %);
English: Diarrhoea (G3/4: 1.2%);
Danish: Diarré (G3/4: 1,2 %);
English: Each box contains one TAXOTERE vial (20 mg/0.5 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
Danish: Hver karton indeholder en blisterpakning med et TAXOTERE hætteglas (20 mg) og et tilsvarende hætteglas med solvens til TAXOTERE.
English: 1 vial of TAXOTERE 80 mg/2 ml concentrate for solution for infusion 80 mg docetaxel in 2 ml polysorbate 80 (40 mg/ml) Fill: 94.4 mg/2.36 ml
Danish: 1 hætteglas TAXOTERE 80 mg/2 ml koncentrat til infusionsvæske, opløsning 80 mg docetaxel i 2 ml polysorbat 80 (40 mg/ml) Indhold: 94,4 mg/2,36 ml
English: In addition, 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.
Danish: Endvidere er den fysiske og kemiske stabilitet af infusionsvæsken tilberedt som anbefalet i infusionsposer uden indhold af PVC påvist at være op til 48 timer ved opbevaring mellem 2 °C og 8 °C.
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.
Danish: Den fysiske og kemiske stabilitet af infusionsvæsken tilberedt som anbefalet i infusionsposer uden indhold af PVC er påvist at være op til 48 timer ved opbevaring mellem 2 °C og 8 °C.
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).
Danish: • Induktions kemoterapi efterfulgt af kemostråleterapi (TAX 324) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open-label fase III-studie (TAX 324).
English: This fill volume has been established during the development of TAXOTERE 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 indhold er blevet fastlagt under udvikling af TAXOTERE for at kompensere for væsketab ved fremstilling af præmixen.
English: Mix the infusion bag or bottle manually using a rocking motion.
Danish: Bland manuelt opløsningen i infusionsposen eller -flasken med vippende bevægelser.
English: TAXOTERE in combination with platinum agents in chemotherapy-naïve patients
Danish: TAXOTERE i kombination med platinmidler hos patienter der ikke tidligere er behandlet med kemoterapi
English: • one single-dose vial of concentrate,
Danish: • et enkeltdosis hætteglas koncentrat
English: Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25C.
English: What solvent vial contains 13% (w/w) ethanol 95% (see section 2) in water for injections.
Danish: Hætteglas med solvens indeholder 13 % (w/w) ethanol 95 % (se punkt 2) i vand til injektionsvæsker
English: TAXOTERE 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.
Danish: TAXOTERE i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystkræft, hvis tumorer overudtrykker HER2, og som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
English: In patients treated with docetaxel at 100 mg/m as single agent who have serum transaminase levels (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: 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 fosfatase-værdier overstiger den øvre normalværdi 2,5 gange, er der en større risiko for udvikling af alvorlige bivirkninger.
English: Hand-foot syndrome (G3/4:
Danish: Hånd- og fodsyndrom (G3/4:
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to TAXOTERE 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 TAXOTERE in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Danish: Du skal fortsætte med at tage præmedicinen i endnu 1 til 2 dage for at formindske visse bivirkninger, som kan forekomme efter infusionen af TAXOTERE.
English: The European Medicines Agency has waived the obligation to submit the results of studies with TAXOTERE in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med TAXOTERE i alle undergrupper af den pædiatriske population ved brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk adenokarcinom og hoved- og halskræft med undtagelse af type II og type III lavt differentieret nasofaryngealt karcinom (se pkt.
English: combined with capecitabine at 1250 mg/m twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Danish: I kombination med capecitabin er den anbefalede TAXOTERE-dosis 75 mg/m hver 3. uge kombineret med capecitabin 1250 mg/m to gange daglig (indenfor 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
English: 7 ml clear glass (type I) vial with a magenta aluminium seal and a magenta plastic flip-off cap containing 4 ml of concentrate.
Danish: 7 ml klart glas (type I) hætteglas indeholdende 4 ml koncentrat med en magenta afrivningshætte.
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.
Danish: TAXOTERE i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere har fået kemoterapi mod denne tilstand.
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).
Danish: Ved metastatisk kastrationsresistent prostatakræft er det anbefalede præmedicineringsregime, på grund af den samtidige behandling med prednison eller prednisolon, oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxel-infusion (se pkt.
English: OUTER CARTON / TAXOTERE 160 mg/8 ml
Danish: YDERKARTON/TAXOTERE 160 mg/8 ml
English: SOLVENT for TAXOTERE 80 mg/2 ml
Danish: Solvens til TAXOTERE 80 mg/2 ml
English: 4.1.1 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: 4.1.1 Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal TAXOTERE æsker stå i stuetemperatur (under 25ºC) i 5 minutter før brug.
English: Description of selected adverse reactions for adjuvant therapy with TAXOTERE 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 TAXOTERE 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft:
English: Diarrhoea grade 4 First episode: reduce docetaxel and 5-FU doses by 20%.
Danish: Første episode: Reducer docetaxel- og 5-FU-dosis med 20 %
English: What TAXOTERE concentrate vial contains - The active substance is docetaxel (as trihydrate).
Danish: TAXOTERE koncentrat hætteglas indeholder - Aktivt stof: docetaxel (som trihydrat).
English: If the vials are stored under refrigeration, allow the required number of boxes of TAXOTERE concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Danish: Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal pakninger med TAXOTERE koncentrat til infusionsvæske, opløsning, stå ved stuetemperatur (under 25°C) i 5 minutter før brug.
English: 1 vial of TAXOTERE 20 mg/0.5 ml concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ml) Fill: 24.4 mg/0.61 ml
Danish: 1 hætteglas TAXOTERE 20 mg/0,5 ml koncentrat til infusionsvæske, opløsning 20 mg docetaxel i 0,5 ml polysorbat 80 (40 mg/ml) Indhold: 24,4 mg/0,61 ml
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).
Danish: Hver TAXOTERE 20 mg/0,5 ml hætteglas indeholder 0,5 ml af en 40 mg/ml docetaxelopløsning i polysorbat 80 (indeholder 24,4 mg/0,61 ml).
English: 7 ml clear glass (type I) vial with a green aluminium seal and a green plastic flip-off cap containing 1 ml of concentrate.
Danish: 7 ml klart glas (type I) hætteglas indeholdende 1 ml koncentrat med en grøn afrivningshætte.
English: The concentrate is a pale yellow to brownish-yellow solution.
Danish: Koncentratet er en lys gul til brunliggul opløsning.
English: Solvent vial
Danish: Lever og galdeveje
English: OUTER CARTON / TAXOTERE 20 mg/1 ml
Danish: YDERKARTON/TAXOTERE 20 mg/1 ml
English: The required volume of TAXOTERE concentrate for solution for infusion must be injected 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.
Danish: Den nødvendige mængde TAXOTERE koncentrat til infusionsvæske, opløsning, skal via en enkelt injektion (et skud) injiceres i en 250 ml infusionspose eller -flaske indeholdende enten en 5 % glucoseinfusionsvæske eller en 0,9 % natriumchloridinfusionsvæske.
English: Febrile neutropenia (G3/4: NA)
Danish: Febril neuropeni (G3/4: NA)
English: Dysgeusia (G3/4: < 1%); Pareaesthesia (G3/4: < 1%)
Danish: Dysgeusi (G3/4: < 1 %); Paræsthesi (G3/4: < 1 %)
English: TAXOTERE 80 mg/2 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 80 mg/2 ml, koncentrat til infusionsvæske, opløsning er en klar viskøs, gul til brunliggul opløsning, som indeholder 40 mg/ml docetaxel (vandfri) i polysorbat 80.
English: Tabulated list of adverse reactions for adjuvant therapy with TAXOTERE 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Danish: Tabel over bivirkninger ved adjuverende behandling med TAXOTERE 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknudenegativ (GEICAM 9805) brystkræft - pooled data:
English: Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Danish: Der er udført to randomiserede, sammenlignende fase III-studier med docetaxel doseret hver 3. uge i den anbefalede dosis på 100 mg/m til patienter med metastatisk brystkræft.
English: SOLVENT for TAXOTERE 20 mg/0.5 ml
Danish: Solvens til TAXOTERE 20 mg/0,5 ml
English: 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m 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/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m 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 per min) administreret i løbet af 30-60 minutter hver 3. uge, vinorelbin (V) 25 mg/ m administreret i løbet af 6
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 25ºC) og kontroller så, at opløsningen er homogen og klar.
English: TAXOTERE 160 mg/8 ml concentrate for solution for infusion.
Danish: TAXOTERE 160 mg/8 ml koncentrat til infusionsvæske, opløsning.
English: The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Danish: Hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion blev reduceret hos patienter der fik primær GCSF-profylakse (se pkt.
English: CARTON/TAXOTERE 20 mg/0.5 ml
Danish: KARTON/TAXOTERE 20 MG/0,5 ml