natgillin/translations-raw huggingface dataset:
• Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) Sikkerheden og effektiviteten af docetaxel ved induktionsbehandling af patienter med pladecellekarcinom i hoved og hals (SCCHN) blev evalueret i et fase III, multicenter, open-label, randomiseret studie (TAX 323).
• 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, randomized study (TAX323).
Den fysiske og kemiske stabilitet af infusionsvæsken tilberedt som anbefalet i PVC-frie infusionsposer er påvist at være op til 48 timer ved opbevaring mellem 2°C og 8°C.
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.
Første episode: Reducer 5-FU-dosis med 20%.
First episode: reduce 5-FU dose by 20%.
Docetaxel Mylan koncentrat til infusionsvæske, opløsning er lysgul til brunlig gul.
Docetaxel Mylan concentrate for solution for infusion is a pale yellow to brownish-yellow solution.
Median TTP var 37,3 uger (95% CI: 33,4-42,1) i AT-armen og 31,9 uger (95% CI: 27,4-36,0) i AC-armen.
The median TTP was 37.3 weeks (95% CI: 33.4-42.1) in AT arm and 31.9 weeks (95% CI: 27.4-36.0) in AC arm.
Docetaxel Mylan i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatacancer.
Docetaxel Mylan in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
5 hætteglas á 10 ml
5 vials of 10 ml
• Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske forhold og lægemidlet bør anvendes umiddelbart herefter.
• From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
I alt 445 patienter med KPS > 70 blev behandlet med enten docetaxel (T) (75 mg/m² på førstedagen) i kombination med cisplatin (C) (75 mg/m² på førstedagen) og 5-fluoruracil (F) (750 mg/m² pr. dag i 5 dage) eller cisplatin (100 mg/m² på førstedagen) og 5-fluoruracil (1.000 mg/m² pr. dag i 5 dage).
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m² on day 1) in combination with cisplatin (C) (75 mg/m² on day 1) and 5-fluorouracil (F) (750 mg/m² per day for 5 days) or cisplatin (100 mg/m² on day 1) and 5-fluorouracil (1000 mg/m² per day for 5 days).
I studiet GEICAM9805 udviklede 3 patienter (0,6%) i TAC-armen og 3 patienter (0,6%) i FAC-armen kongestivt hjertesvigt i followup-perioden.
In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Almene symptomer og reaktioner på administrationsstedet Der er i sjældne tilfælde rapporteret recallfænomener i forbindelse med strålebehandling.
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
5 hætteglas á 1 ml
5 vials of 1 ml
Hos de patienter, der blev behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (TCF), opstod der febril neutropeni og neutropenisk infektion i mindre grad, når patienterne fik profylaktisk G¬CSF.
In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Medianoverlevelse (mdr.)
Median survival (months)
Infektion (G3/4: 3,6%) Neutropenisk infektion
Infection (G3/4: 3.6%) Neutropenic infection
Den totale responsrate var 59,3% (95% CI: 52,8-65,9) i AT-armen og 46,5% (95% CI: 39,8-53,2) i AC-armen.
The ORR was 59.3% (95% CI: 52.8-65.9) in AT arm versus 46.5% (95% CI: 39.8-53.2) in AC arm.
Dette regime administreres hver 3. uge i 4 cyklusser.
This regimen is administered every 3 weeks for 4 cycles.
Der blev observeret flere grad 3/4-bivirkninger ved monoterapi med docetaxel (55,4%) end paclitaxel
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
PSA** responsrate (%) 95% CI p-value*
PSA** response rate (%) 95% CI p-value*
I dette studie blev 255 patienter randomiseret til behandling med docetaxel (75 mg/m² som intravenøs infusion over 1 time hver 3. uge) og capecitabin (1.250 mg/m² 2 gange dagligt i 2 uger efterfulgt af 1 uges pause).
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m² as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m² twice daily for 2 weeks followed by 1-week rest period).
Efter den anbefalede tilsætning til infusionsposen er docetaxelinfusionsopløsningen stabil i 6 timer, hvis den opbevares under 25°C.
Once added as recommended into the non-PVC infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau > 1.500 celler/mm3 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.
Docetaxel i kombination med doxorubicin og cyclophosphamid: adjuverende behandling
Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
5 hætteglas á 4 ml
5 vials of 4 ml
Vaskulære sygdomme Der er rapporteret sjældne tilfælde af venøse tromboemboliske hændelser.
Vascular disorders Venous thromboembolic events have rarely been reported.
Der er rapporteret sjældne tilfælde af tåreproduktion med eller uden konjunktivitis, samt tilfælde af tilstoppede tårekanaler, som medfører overdreven epiphora.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Effekten af docetaxel i induktionsbehandlingen af patienter med inoperabel, lokalt fremskredent SCCHN (intent-to-treat-analyse)
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Hver ml koncentrat til infusionsvæske, opløsning indeholder 395 mg vandfri ethanol.
Each ml of concentrate for solution for infusion contains 395 mg of ethanol anhydrous.
Effekten af docetaxel i induktionsbehandlingen af patienter med lokalt fremskredent SCCHN (intentto-treat-analyse)
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis)
Docetaxel Mylan i kombination med cisplatin og 5-fluoruracil er indiceret til indledende behandling af patienter med lokalt, fremskreden pladecellekarcinom i hoved og hals.
Docetaxel Mylan in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
• træthed eller influenzalignende symptomer
• tiredness; or flu-like symptoms
I studiet GEICAM9805 persisterede amenorré ind i followup-perioden (median followup-tid var 10 år og 5 måneder) og blev fortsat observeret hos 18 patienter (3,4%) i TAC-armen og hos 5 patienter (1,0%) i FAC-armen.
In GEICAM 9805 study, amenorrhoea persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm.
Primær G¬CSF-profylakse bør overvejes til patienter, som får adjuverende behandling med TAC for brystcancer for at nedsætte risikoen for kompliceret neutropeni (febril neutropeni, prolongeret neutropeni eller neutropenisk infektion).
Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Hos patienter, der blev behandlet med docetaxel i kombination med doxorubicin og cyclophosphamid (TAC), opstod febril neutropeni og/eller neutropenisk infektion sjældnere, når patienterne fik primær G¬CSF-profylakse.
In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
For cisplatin- og 5-fluoruracil-dosisjusteringer: Se tilsvarende produktresuméer.
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
I studiet GEICAM 9805 fortsatte lymfødem hos 4 ud af 5 patienter i TAC-armen og hos 1 ud af 2 patienter i FAC-armen ved slutningen af kemoterapien, og blev ikke forbedret i followup-perioden (median followup-tid var 10 år og 5 måneder).
In study GEICAM 9805, lymphoedema was observed to be ongoing in 4 of the 5 patients in TAC arm and in 1 of the 2 patients in FAC arm at the end of the chemotherapy, and did not resolve during the follow-up period (median follow-up time of 10 years and 5 months).
Patienter, som får febril neutropeni og/eller neutropenisk infektion bør have deres docetaxel-dosis reduceret til 60 mg/m² i alle efterfølgende cyklusser (se pkt.
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m in all subsequent cycles (see sections 4.4 and 4.8).
Hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion blev reduceret hos patienter der fik primær G¬CSF-profylakse (se pkt.
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).
MedDRA systemorganklasse Meget almindelige bivirkninger
MedDRA system organ classes Very common adverse reactions
Efter stratificering i forhold til antallet af positive lymfeknuder (1-3, 4+) blev 1.491 patienter randomiseret til enten at få 75 mg/m² docetaxel 1 time efter 50 mg/m² doxorubicin og 500 mg/m² cyclophosphamid (TAC-arm), eller 50 mg/m² doxorubicin efterfulgt af 500 mg/m² fluoruracil og 500 mg/m² cyclophosphamid (FAC-arm).
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized to receive either docetaxel 75 mg/m² administered 1-hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² (TAC arm), or doxorubicin 50 mg/m² followed by fluorouracil 500 mg/m² and cyclosphosphamide 500 mg/m² (FAC arm).
Patienter i behandling med TCF bør have profylaktisk G¬CSF for at nedsætte risikoen for kompliceret neutropeni (febril neutropeni, prolongeret neutropeni eller neutropenisk infektion).
Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
I begge arme fik patienter med ER + og/eller PgR+ tumorer 20 mg tamoxifen en gang daglig i op til 5 år efter den sidste kemoterapicyklus.
In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
95% CI p-værdi† *
95% CI p-value*
• operabel, lymfeknude-positiv brystcancer
• operable node-positive breast cancer
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.
In the case of severe neutropenia (< 500 cells/mm 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).
Patienter i TAC-armen fik antibiotisk profylakse med 500 mg ciprofloxacin oralt 2 gange dagligt i 10 dage, startende på femte dagen af hver cyklus, eller tilsvarende.
Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Effektresultaterne er vist i nedenstående tabel:
Efficacy results are presented in the table below:
cyster og polypper) Der er rapporteret om tilfælde af akut myeloid leukæmi og myelodysplastisk syndrom i forbindelse med indgift af docetaxel, når lægemidlet er brugt i kombination med anden kemoterapi og/eller strålebehandling.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy
Patienter i TPF-armen fik antibiotisk profylakse med 500 mg ciprofloxacin oralt 2 gange dagligt i 10 dage, startende på femtedagen af hver cyklus eller tilsvarende.
Patients on the TPF arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Derfor er den anbefalede dosis docetaxel 75 mg/m² 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/m² and LFTs should be measured at baseline and before each cycle (see section 4.2).
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 200 mg/10 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mg/10 ml
Perifer sensorisk neuropati (G3: 3,7%); Perifer motorisk neuropati (G3/4: 2%)
Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Infektioner og parasitære sygdomme Blod og lymfesystem Neutropeni
Infections and infestations Blood and lymphatic system disorders
Docetaxel Mylan indeholder ethanol (alkohol)
Docetaxel Mylan contains ethanol
G3/4 ASAT forhøjet G3/4 Forhøjet alkalisk phosphatase i blodet
G3/4 AST increased G3/4 Blood alkaline phosphatase increased
SÆRLIG ADVARSEL OM, AT LÆGEMIDLET SKAL OPBEVARES UTILGÆNGELIGT FOR BØRN
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHT AND THE REACH OF CHILDREN Keep out of the sight and reach of children.
TAC-behandlede patienter havde 32% lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard-ratio = 0,68; 95% CI (0,49-0,93); p = 0,01).
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
I et fase III-studie blev 1.218 patienter med inoperabel, ikke-småcellet lungecancer, stadium IIIB eller IV med KPS ≥ 70%, og som ikke tidligere havde fået kemoterapi mod denne tilstand, randomiseret til enten 75 mg/m² docetaxel (T) som en infusion over 1 time umiddelbart efterfulgt af 75 mg/m² cisplatin (Cis) indgivet over 30-60 minutter hver 3. uge, 75 mg/m² docetaxel som infusion over 1 time i kombination med carboplatin (AUC 6 mg/ml/min) indgivet over 30-60 minutter hver 3. uge, eller 25 mg/m² vinorelbin (V) indgivet over 6-10 minutter på dag 1, 8, 15, 22, efterfulgt af 100 mg/m² cisplatin indgivet på førstedagen af cyklusserne og gentaget hver 4. uge.
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, docetaxel 75 mg/m² 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/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).
Medianvarighed af respons på kemoterapi +/strålebehandling (måneder) (95% CI)
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Myokardisk iskæmi (G3/4: 1,7%)
Myocardial ischemia (G3/4:1.7%)
Ved den mediane followup-periode på 77 måneder var den totale overlevelse (OS) længere i TACarmen, hvor TAC-behandlede patienter havde 24% lavere risiko for død sammenlignet med FACbehandlede 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).
Prednison Der er ikke observeret påvirkning fra prednison på docetaxels farmakokinetik.
Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Ikke-kardiale brystsmerter (alvorlig: 0,4%)
Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Diarré (G3/4: 6,2%);
Diarrhoea (G3/4: 6.2%);
Dehydrering (G3/4: 2%)
Dehydration (G3/4: 2%)
Svimmelhed (G3/4: 2,3%); Perifer motorisk neuropati (G3/4: 1,3%)
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
I kombination med capecitabin er den anbefalede docetaxel-dosis 75 mg/m² hver 3. uge kombineret med capecitabin 1250 mg/m² to gange dagligt (indenfor 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m² every three weeks, combined with capecitabine at 1250 mg/m² twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
For eksempel skal der til en beregnet dosis på 140 mg docetaxel udtages 7 ml koncentrat til infusionsvæske.
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution for infusion.
Docetaxel Mylan i kombination med cisplatin og 5-fluoruracil er indiceret til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom i den gastroøsofageale overgang, som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
Docetaxel Mylan in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Brug ikke Docetaxel Mylan:
You must not be given Docetaxel Mylan
Myalgi (alvorlig 0,5%)
Myalgia (severe: 0.5%)
G3/4 Forhøjet bilirubin i blodet (2,1%);
G3/4 Blood bilirubin increased (2.1%);
Hos patienter, som tidligere havde fået alkylerende stoffer uden effekt, blev docetaxel sammenlignet med doxorubicin (75 mg/m² hver 3. uge).
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
• Induktionskemoterapi efterfulgt af kemo-stråleterapi (TAX 324) Sikkerheden og effektiviteten af docetaxel i induktionsbehandling af patienter med lokalt fremskreden pladecellekarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, openlabel, fase III-studie (TAX 324).
• 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 randomized, multicenter open-label, phase III study (TAX324).
Median TTP (måneder) (95% CI)
Median TTP (months) (95% CI)
• operabel, lymfeknude-negativ brystcancer
• operable node-negative breast cancer
G3/4 Forhøjet alkalisk phosphatase i blodet
G3/4 Blood alkaline phosphatase increased
Pyrexi (G3/4: 1%);
Pyrexia (G3/4: 1%);
• lungefibrose (ardannelse og fortykkelse i lungerne samt åndenød)
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Anæmi (G3/4: 10,8%);
Anaemia (G3/4: 10.8%);
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 20 mg/1 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 80 mg/4 ml
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml
Fald i den kardiale venstre ventrikelfunktion (G3/4: 0,3%)
Cardiac left ventricular function decrease (G3/4: 0.3%)
Den totale overlevelse i år ti var ligeledes væsentlig højere i TAC-armen sammenlignet med FAC-armen (hhv. 76% og 69%), dvs. en absolut reduktion af risikoen for død med 7% (p=0,002).
Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
Hvert hætteglas indeholder 1 ml koncentrat.
Each vial contains 1 ml of concentrate.
Modsat udviste AC-armen højere forekomst af svær anæmi (15,8% mod 8,5%) end AT-armen samt en højere forekomst af svær hjertetoksicitet: kongestivt hjertesvigt (3,8% mod 2,8%), absolut LVEF-nedsættelse ≥ 20% (13,1% mod 6,1%), absolut LVEFnedsættelse ≥ 30% (6,2% mod 1,1%).
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%).
I kombinationsbehandling med cisplatin og 5-fluoruracil til behandling af patienter med gastrisk adenokarcinom ekskluderede pivotalstudiet patienter med ALAT og/eller ASAT > 1,5 gange ULN associeret med alkalisk phosphatase > 2,5 x ULN, og bilirubin > 1 x ULN.
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 ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Den anbefalede dosis af docetaxel er 75 mg/m² som en 1-times infusion, efterfulgt af cisplatin 75 mg/m², som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m² pr. dag, givet som en 24-timers kontinuerlig infusion i 5 dage, med start efter endt cisplatin-infusion.
The recommended dose of docetaxel is 75 mg/m² as a 1-hour infusion, followed by cisplatin 75 mg/m², as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m² per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
• Injicer via en enkelt injektion (et stik) derefter den nødvendige mængde Docetaxel Mylan koncentrat til infusionsvæske, opløsning i en 250 ml infusionspose eller -flaske indeholdende enten 5% glucoseinfusionsvæske eller 9 mg/ml (0,9%) natriumchloridinfusionsvæske.
• Then, inject via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
- Ved behandling af metastatisk gastrisk kræft indgives docetaxel i kombination med cisplatin og 5fluoruracil.
- For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Data fra et multicenter, open-label randomiseret studie støtter anvendelsen af docetaxel som adjuverende behandling til patienter med operabel lymfeknude-negativ brystcancer, der er egnede til kemoterapibehandling.
Data from a multicenter open label randomized trial support the use of docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Ved prostatacancer 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 docetaxelinfusion (se pkt.
For 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).
• For capecitabin dosisjusteringer se capecitabins produktresumé.
• For capecitabine dose modifications, see capecitabine summary of product characteristics.
Stomatitis/mucositis grad 4 Første episode: Stop kun 5-FU i alle efterfølgende cyklusser.
First episode: stop 5-FU only, at all subsequent cycles.