natgillin/translations-raw huggingface dataset:
Da fordelen observeret hos patienter med 4+lymfeknuder ikke var statistisk signifikant for DFS og OS, blev den positive benefit/risk fordeling for TAC hos patienter med 4+lymfeknuder ikke helt demonstreret ved den endelige analyse.
As the benefit observed in patients with 4+ nodes was not statistically significant on DFS and OS, the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demonstrated at the final analysis.
Kontakt lægen, hospitalsfarmaceuten eller sundhedspersonalet, hvis du oplever problemer med dit syn.
Tell your doctor, hospital pharmacist or nurse if you have vision problems.
(PF) daglig i 5 dage.
1000 mg/m per day for 5 days.
Hver ml koncentrat indeholder 20 mg docetaxel som trihydrat.
Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Trombocytopeni (G4:
Thrombocytopenia (G4:
Tilberedning af infusionsvæsken a) Tilberedning af TAXOTERE præmix (10 mg docetaxel/ml)
Preparation of the TAXOTERE premix solution (10 mg docetaxel/ml)
Anden episode: Reducer så docetaxel-dosis med 20 %
Second episode: reduce docetaxel dose by 20%.
Synkope (G3/4: 0 %) Neurotoksicitet (G3/4:
Syncope (G3/4: 0%); Neurotoxicity (G3/4:
Hos de patienter, der tidligere havde fået behandling med alkylerende stoffer uden effekt, blev docetaxel sammenlignet med doxorubicin (75 mg/m hver 3. uge).
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
• Lungefibrose (ardannelse og fortykkelse i lungerne samt åndenød)
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
Metastatisk hormonfølsom prostatakræft
Metastatic hormone-sensitive prostate cancer
Effekten af docetaxel-armen versus kontrol-armen hos metastatiske prostatakræft patienter er opsummeret i nedenstående tabel:
Efficacy results in metastatic prostate cancer patients for docetaxel arm versus control arm are summarized in the following table:
Effekten af docetaxel og androgen deprivationsbehandling i behandlingen af patienter med metastatisk hormonfølsom prostatakræft (CHAARTED)
Efficacy of docetaxel and ADT in the treatment of patients with metastatic hormone-sensitive prostate cancer (CHAARTED)
Konstipation (G3/4: 1,0 %); Gastrointestinale smerter (G3/4:
Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
Derfor er den anbefalede dosis docetaxel 75mg/m til de patienter, der har forhøjet leverfunktionstest (LFT), og LFT skal måles ved start og før hver behandlingscyklus (se pkt.
Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/m and LFTs should be measured at baseline and before each cycle (see section 4.2).
eller cisplatin (100 mg/m på dag 1) og 5-fluoruracil (1000 mg/m pr. dag i 5 dage).
(750 mg/m per day for 5 days) or cisplatin (100 mg/m on day 1) and 5-fluorouracil (1000 mg/m per day for 5 days).
• Mitoxantrone 12 mg/m hver 3. uge i 10 behandlingsrunder.
• Mitoxantrone 12 mg/m every 3 weeks for 10 cycles.
Et hætteglas indeholder 20 mg/0,5 ml docetaxel.
One vial contains 20 mg/0.5 ml docetaxel.
Fejlfri overlevelse: tiden fra randomiseringen til første bevis for mindst et af: biokemisk svigt (defineret som en stigning i PSA på 50 % over inden-24-ugers nadir og over 4 ng/ml og bekræftet ved omtest eller behandling); progression enten lokalt, i lymfeknuder eller i fjerne metastaser, skeletrelateret begivenhed; eller død af prostatakræft.
Adjusted hazard ratio 95% CI p-valuea a p-value calculated from the likelihood ratio test and adjusted for all stratification factors (except center and planned hormone therapy) and stratified by trial period b Failure-free survival: time from randomization to first evidence of at least one of: biochemical failure (defined as a rise in PSA of 50% above the within-24-week nadir and above 4 ng/mL and confirmed by retest or treatment); progression either locally, in lymph nodes, or in distant metastases; skeletal-related event; or death from prostate cancer.
Et stort randomiseret fase III-studie, med 429 tidligere ubehandlede patienter med metastatisk sygdom, er blevet udført med doxorubicin (50 mg/m2) i kombination med docetaxel (75 mg/
One large randomised phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
mg/m
SanofiA/S
Den viskøse opløsning indeholder 40 mg/ml docetaxel (vandfri).
The viscous solution contains 40 mg/ml docetaxel (anhydrous).
TAXOTERE i kombination med prednison eller prednisolon er indiceret til behandling af patienter med metastatisk kastrationsresistent prostatakræft.
TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
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.
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/m
Hvis den beregnede dosis er større end 200 mg docetaxel, skal der bruges et større volumen af infusionsvæsken, så man ikke overstiger en koncentration på 0,74 mg/ml.
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
• Ved behandling af metastatisk gastrisk kræft indgives TAXOTERE i kombination med cisplatin og 5-fluoruracil.
- For the treatment of metastatic gastric cancer, TAXOTERE is administered in combination with cisplatin and 5-fluorouracil.
Ved den mediane opfølgningsperiode på 77 måneder var den samlede overlevelse (OS) længere i TAC-armen, hvor TAC-behandlede patienter havde 24 % lavere risiko for død sammenlignet med FAC-behandlede patienter (hazard ratio = 0,76; 95 % CI (0,46-1,26; p=0,29).
At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1491 patienter randomiseret til enten at få enten docetaxel 75 mg/m administreret en time efter doxorubicin
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
I dette studie viste AT-armen en hyppigere forekomst af alvorlig neutropeni (90 % versus 68,6 %), febril neutropeni (33,3 % versus 10 %), infektion (8 % versus 2,4 %), diarré (7,5 % versus 1,4 %), asteni (8,5 % versus 2,4 %) og smerter ((2,4 % versus 0 %) end AC-armen.
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
Systemorganklasser i henhold til MedDRA-databasen
MedDRA system organ classes
G3/4 Forhøjet bilirubin i blodet
G3/4 Blood bilirubin increased
Hjælpestoffer som behandleren skal være opmærksom på: Hvert hætteglas med koncentrat indeholder 0,5 ml ethanol, vandfri (395 mg).
Excipient with known effect: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Hver karton indeholder en blisterpakning med et TAXOTERE hætteglas (80 mg/2 ml) og et tilsvarende hætteglas med solvens til TAXOTERE.
Each box contains one TAXOTERE vial (80 mg/2 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
50 mg/m og cyclophosphamid 500 mg/m
50 mg/m followed by fluorouracil 500 mg/m and cyclophosphamide 500 mg/m
Diarré (G3: 3%) Stomatitis (G3: 0%) Forstoppelse (G3: 0%) Kvalme (G3: 1%) Dyspepsi
Diarrhea (G3: 3%) Stomatitis (G3: 0%) Constipation (G3: 0%) Nausea (G3: 1%) Dyspepsia
Dysgeusi/parosmi (G3/4: 0,4%);
Dysgeusia/Parosmia (G3/4: 0.4%);
Perifer sensorisk neuropati (G3: 4,1 %); Perifer motorisk neuropati (G3/4: 4 %) Dysgeusi (alvorlig:
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Tabel over bivirkninger i højrisiko lokalt avanceret eller metastatisk hormonfølsom prostatakræft med TAXOTERE 75 mg/m² i kombination med prednison eller prednisolon og androgen deprivationsbehandling (STAMPEDE studie).
Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study)
1218 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),
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/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
1.060 patienter blev randomiseret til at få enten TAXOTERE 75 mg/m administreret 1 time efter doxorubicin 50 mg/m og cyclophosphamid 500 mg/m
1060 patients were randomised to receive either TAXOTERE 75 mg/m administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
Perifer sensorisk neuropati (G3: 3,7 %); Perifer motorisk neuropati (G3/4: 2 %)
Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
TAXOTERE er ordineret af din læge til behandling af bryst- eller specielle former for lungekræft (ikke-småcellet lungekræft), prostata kræft, gastrisk kræft eller hoved- og hals-kræft:
TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Patienter bør modtage kemostrålingsterapi efter kemoterapi.
Following chemotherapy, patients should receive chemoradiotherapy.
(TAC-arm), eller doxorubicin 50 mg/m 2, fulgt af fluoruracil 500 mg/ m og cyclophosphamid 500 mg/m
(TAC arm), or doxorubicin 50 mg/m followed by fluorouracil 500 mg/m and cyclophosphamide 500 mg/m
Stigningen i overlevelse set i armen med ugentlig docetaxel var ikke statistisk signifikant sammenlignet med mitoxantron-kontrol-armen.
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:
1.060 patienter blev randomiseret til at få enten TAXOTERE 75 mg/m2 administreret 1 time efter doxorubicin 50 mg/m og cyclophosphamid 500 mg/m
1060 patients were randomised to receive either TAXOTERE 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
Øget tåresekretion (G3/4: < 0,1 %);
Lacrimation increased (G3/4: <0.1%)
• Vægtforøgelse eller vægttab
• weight gain or loss
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med metastatisk kastrationsresistent prostatakræft blev undersøgt i et randomiseret multicenter fase III-studium (TAX 327).
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with metastatic castration-resistant prostate cancer were evaluated in a randomised multi-centre phase III study (TAX 327).
Insomni (G3: 1%)
Insomnia (G3: 1%)
4.2 Fremstilling af infusionsvæsken
4.2 Preparation of the infusion solution
Sikkerheden og effekten af docetaxel administreret samtidig med standardpleje (androgen deprivationsbehandling) hos patienter med højrisiko lokalt avanceret eller metastatisk hormonfølsom prostatakræft, blev evalueret i et randomiseret multicenter, multiarm, multi-stage (MAMS) studie, med et gnidningsfrist fase II/III design (STAMPEDE- MRC PR08).
The safety and efficacy of docetaxel administered concomitantly with standard of care (ADT) in patients with high-risk locally advanced or metastatic hormone-sensitive prostate cancer were evaluated in a randomised multi-centre, multi-arm multi-stage (MAMS) study with a seamless phase II/III design (STAMPEDE - MRC PR08).
Forekomsten af tilbagefald ved 10 år var reduceret hos de patienter som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 39 % versus 45 %).
Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
TAXOTERE hætteglas: polysorbat 80, citronsyre.
TAXOTERE vial: polysorbate 80, citric acid.
15 ml klart Type I-hætteglas med en rød afrivningshætte.
15 ml clear glass Type I vial with a red flip-off cap.
cTid til klinisk progression = tiden fra randomisering til klinisk progression (dvs. øget symtomatisk knoglemetastaser, progression ifølge (RECIST) kriterier, eller klinisk forværring grundet kræft pr. Investigator's opinion).
c The time to clinical progression = the time from randomization until clinical progression (i.e., increased symptoms of bone metastases; progression according to RECIST; or clinical deterioration due to cancer according to the investigator's opinion).
Den samtidige administration af docetaxel, doxorubicin og cyclophosphamid påvirkede ikke deres farmakokinitik.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Hvis samtidige anvendelse af en potent CYP3A4-hæmmer (f.eks. ketoconazol, itraconazol, clarithromycin, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin og voriconazol) ikke kan undgås, er tæt klinisk overvågning nødvendig, og justering af docetaxeldosis kan være hensigtsmæssig under behandling med potente CYP3A4-hæmmere (se pkt.
If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
Anæmi (G3/4: 20,9 %);
Anaemia (G3/4: 20.9%);
Med en sprøjte udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til TAXOTERE ved at holde hætteglasset på skrå.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Hver ml koncentrat til infusionsvæske indeholder 20 mg docetaxel.
Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Data fra et multicenter, åbent, randomiseret studium støtter anvendelsen af TAXOTERE som adjuverende behandling til patienter med operabel, lymfeknude-negativ brystkræft, der er egnede til kemoterapibehandling.
Data from a multi-centre open label randomised trial support the use of TAXOTERE for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Solvens hætteglas: ethanol 95 % vand til injektionsvæsker.
Ethanol 95% Water for injections.
TAXOTERE 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.
TAXOTERE 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.
• Bland manuelt opløsningen i infusionposen eller -flasken med vippende bevægelser.
• Mix the infusion bag or bottle manually using a rocking motion.
Hvert enkeltdosis-hætteglas med TAXOTERE 80 mg/2 ml koncentrat indeholder docetaxel (som trihydrat) svarende til 80 mg docetaxel (vandfri).
Each single-dose vial of TAXOTERE 80 mg/2 ml concentrate contains docetaxel (as trihydrate) corresponding to 80 mg of docetaxel (anhydrous).
Justeret hazard ratio 95% CI p-værdia
Adjusted hazard ratio 95% CI p-valuea
Hvert enkeltdosis-hætteglas med solvens indeholder 13% (w/w) ethanol 95% v/v i vand til injektionsvæsker (252 mg ethanol 95% v/v).
Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (252 mg of ethanol 95% v/v).
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/m2 og cyclophosphamid 500 mg/m2 (TAC-regime) (se også: Dosisjustering under behandling).
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
TAXOTERE indeholder - Aktivt stof: docetaxel (som trihydrat).
What TAXOTERE contains - The active substance is docetaxel (as trihydrate).
Hvert enkeltdosis-hætteglas med TAXOTERE 20 mg/0,5 ml koncentrat indeholder docetaxel (som trihydrat) svarende til 20 mg docetaxel (vandfri).
Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains docetaxel (as trihydrate) corresponding to 20 mg of docetaxel (anhydrous).
Et hætteglas indeholder 80 mg/2 ml docetaxel.
One vial contains 80 mg/2 ml docetaxel.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
PARTICULARS TO APPEAR ON OUTER PACKAGING
Hyppigheden kan variere alt efter kombinationen af de lægemidler, du får.
Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received
Hvert hætteglas med solvens til TAXOTERE 20 mg/0,5 ml indeholder 1,98 ml.
• Each solvent for TAXOTERE 20 mg/0.5 ml vial contains 1.98 ml.
Hjælpestoffer som behandleren skal være opmærksom på: Hvert hætteglas med koncentrat indeholder 2 ml ethanol, vandfri (1,58 g).
Excipient with known effect: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
I nogle tilfælde (hyppighed ikke kendt) er permanent hårtab blevet observeret.
In some cases (frequency not known)
TAXOTERE 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.
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.
Feber (G3: 1%) Oral candidiasis Hypokalcæmi (G3: 0%) Hypofosfatæmi (G3-4: 1%) Hypokaliæmi (G3: 0%)
Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
Koncentrat og solvens til infusionsvæske, opløsning.
Concentrate and solvent for solution for infusion.
Dyspnø (G3: 1%) Hoste (G3: 0%) Infektioner i de øvre luftveje (G3: 1%)
Dyspnea (G3: 1%) Coughing (G3: 0%) Upper respiratory tract infection (G3: 1%)
• Udtag aseptisk den ønskede mængde TAXOTERE koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle.
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
TAXOTERE 160 mg/8 ml koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske.
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.
Metastatisk kastrationsresistent prostatakræft
Metastatic castration-resistant prostate cancer
Median (måneder) 95% CI
Median (months) 95% CI
Samlet
PRESENTATION
Paræstesi; hovedpine; dysgeusi; hypoæstesi
Paresthesia; Headache; Dysgeusia; Hypoaesthesia
0,2 %); Mavesmerter (alvorlig: 1 %);
Abdominal pain (severe: 1%);
15 ml klart glas (type I) hætteglas indeholdende 8 ml koncentrat med blå aluminiumforsegling og en blå plastik-afrivningshætte.
15 ml clear glass (type I) vial with a blue aluminium seal and blue plastic flip-off cap containing 8 ml of concentrate.
Hvert enkeltdosis-hætteglas med solvens indeholder ethanol 13% (w/w) ethanol 95% v/v i vand til injektionsvæsker (932 mg ethanol 95% v/v).
Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (932 mg of ethanol 95% v/v).
Hver ml docetaxel opløsning indeholder 40 mg (vandfrit) docetaxel.
Each ml of docetaxel solution contains 40 mg of docetaxel (anhydrous).
• Induktions kemoterapi efterfulgt af kemo-stråleterapi (TAX 324) Til den indledende behandling af patienter med lokalt fremskreden pladecellecarcinom i hoved og hals (SCCHN) (ikke muligt af resektere, lav sandsynlighed for kirurgisk helbredelse samt med bevarelse af organer som mål), er den anbefalede dosis docetaxel 75 mg/m som en 1-times intravenøs infusion på dag 1, efterfulgt af cisplatin 100 mg/m administreret som en 30 minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1000 mg/m som en kontinuerlig infusion fra dag 1 til dag 4.
• 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.
TAXOTERE i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau  1.500 celler/mm og blodplader gendannes til et niveau
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm and platelets recover to a level > 100,000 cells/mm 3.
Hver blisterpakning med TAXOTERE 80 mg/2 ml koncentrat og solvens til infusionsvæske, opløsning, indeholder:
Each blister pack of TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion contains:
TAXOTERE 20 mg/1 ml koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske.
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.
75 mg/m 2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m pr.
75 mg/m 2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.