natgillin/translations-raw huggingface dataset:
Docetaxel Accord 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.
Docetaxel Accord 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.
Konstipation (alvorlig: 0,2 %); Mavesmerter (alvorlig: 1 %);
Constipation (severe: 0.2%); Abdominal pain (severe: 1%); Gastrointestinal haemorrhage (severe: 0.3%)
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.
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.
Der er udført to randomiserede, sammenlignende fase III-studier med docetaxel doseret hver 3. uge i den anbefalede dosis på 100 mg/m2 til patienter med metastatisk brystkræft.
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.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Accord 20 mg/1 ml sterilt koncentrat docetaxel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 20 mg/1 ml sterile concentrate docetaxel
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: 0.07%)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml koncentrat indeholder 20 mg docetaxel.
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel.
Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning 1 hætteglas på 8 ml koncentrat indeholder 160 mg docetaxel.
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Medmindre det er kontraindiceret, kan der til brystkræft og ikke-småcellet lungekræft gives et peroralt kortikosteroid som præmedicinering, eksempelvis dexamethasone 16 mg per dag i 3 dage (f.eks. 8 mg 2 gange daglig).
For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg twice daily) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Konstipation (G3/4: 1,0 %); Gastrointestinale smerter (G3/4: Oesophagitis/dysfagi/odynofagi (G3/4: 0,7 %)
Gastrointestinal pain (G3/4: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
Docetaxel Accord er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter behandlingssvigt af kemoterapi.
Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning 1 hætteglas på 1 ml koncentrat indeholder 20 mg docetaxel.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med docetaxel 100 mg/m² i kombination med trastuzumab:
Description of selected adverse reactions in breast cancer for docetaxel 100 mg/m2 in combination with trastuzumab
Du skal fortsætte med at tage præmedicinen i endnu 1 til 2 dage for at formindske visse bivirkninger, som kan forekomme efter infusionen af Docetaxel Accord.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Accord 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 Docetaxel Accord in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Hazard ratio (TAC/FAC)
Hazard ratio (TAC/FAC) (95% CI)
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.
Patients with hepatic impairment 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).
Anvend ikke andre docetaxel-lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
• Hos patienter, der for anden gang udvikler grad 2-toksicitet eller første gang grad 3-toksicitet, skal behandlingen udsættes, indtil grad 0-1 nås.
• For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1 and then resume treatment with docetaxel 55 mg/m2.
Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med docetaxel 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
Description of selected adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Hyppigheden kan variere alt efter kombinationen af de lægemidler, du får.
Between infusions of docetaxel the following may occur, and the frequency may vary with the combinations of medicines that are received
Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning Hvert hætteglas med koncentrat indeholder 4 ml vandfri ætanol (3,16 mg).
Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
For at kunne udtage den korrekte dosis til patienten, kan det være nødvendigt at anvende mere end et hætteglas Docetaxel Accord koncentrat til infusionsvæske, opløsning.
More than one vial of Docetaxel Accord concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Et hætteglas på 8 ml koncentrat indeholder 160 mg docetaxel.
One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Docetaxel Accord 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.
Docetaxel Accord 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.
Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med docetaxel 75 mg/m² i kombination med cisplatin:
Tabulated list of adverse reactions in non-small cell lung cancer for docetaxel 75 mg/m2 in combination with cisplatin
Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning Klart glas (type I) hætteglas med fluorotec plus (ethylentetrafluoroethylenfilm) gummilukning og aluminiumforsegling og en orange afrivningshætte, indeholdende 1 ml koncentrat.
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and an orange flip-off cap, containing 1 ml of concentrate.
Bedste respons i alt til studie behandling [kemoterapi +/- strålebehandling] (%) (95 %CI) ***p-værdi
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4: Flebitis (G3/4: 0 %)
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Docetaxel Accord 160 mg/8 ml leveres i et 10 ml klart glashætteglas med fluorotec plus gummilukning og aluminiumforsegling og en rød afrivningshætte.
Docetaxel Accord 160 mg/8 ml is supplied in a 10 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
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).
• 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, multicentre open-label, phase III study (TAX324).
Anvend ikke andre docetaxel-lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/ m2
256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Anvend ikke andre docetaxel-lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Accord 80 mg/4 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
DO NOT use other docetaxel medicines consisting of 2 vials (concentrate and solvent) with this medicine (Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial
I de følgende tilfælde bør docetaxel-dosis reduceres til 65 mg/ m2 i de følgende behandlingsrunder: 1) hos patienter med en initialdosis på 75 mg/m2 docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på < 25000 celler/mm3,2) hos patienter, der får febril neutropeni, 3) hos patienter, med alvorlig, ikke-hæmatologisk toksicitet.
In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Docetaxel Accord 80 mg/4 ml koncentrat til infusionsvæske, opløsning 1 hætteglas på 4 ml koncentrat indeholder 80 mg docetaxel.
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Docetaxel Accord 20 mg/1 ml leveres i et 5 ml klart glashætteglas med fluorotec plus gummilukning og aluminiumforsegling og en orange afrivningshætte.
Docetaxel Accord 20 mg/1 ml is supplied in a 5 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and an orange flip-off cap.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Accord 160 mg/8 ml sterilt koncentrat docetaxel intravenøs anvendelse
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 160 mg/8 ml sterile concentrate docetaxel
Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft for docetaxel 100 mg/m² enkeltstof
Description of selected adverse reactions in breast cancer for docetaxel 100 mg/m2 single agent
Docetaxel Accord 80 mg/4 ml koncentrat til infusionsvæske, opløsning Klart glas (type I) hætteglas med fluorotec plus (ethylentetrafluoroethylenfilm) gummilukning og aluminiumforsegling og en rød afrivningshætte, indeholdende 4 ml koncentrat.
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Clear glass (type I) vial with fluorotec plus (ethylene tetrafluoroethylene film) rubber stopper and aluminium seal and a red flip-off cap, containing 4 ml of concentrate.
Smerter i ekstremiteterne (G3/4: Rygsmerter (G3/4: 1 %);
Pain in extremity (G3/4: < 1%); Back pain (G3/4: 1%)
Efter 10 års opfølgning i GEICAM9805-studiet forekom akut leukæmi hos 1 ud af 532 (0,2%) patienter i TAC-armen.
After 10 years of follow-up in GEICAM 9805 study acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm No cases were reported in patients in FAC arm No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
I slutningen af opfølgningsperioden blev lymfødem observeret at være vedvarende hos 4 patienter (0,8 %) i TAC-armen og hos 1 patient (0,2 %) i FACarmen.
lymphoedema was observed to be ongoing in 4 patients (0.8%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Docetaxel Accord 160 mg/8 ml indeholder 50 % vol. vandfri ætanol (alkohol), dvs. op til 3,16 g vandfri ætanol pr. hætteglas, svarende til 80 ml øl eller 33 ml vin.
50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 33 ml wine.
Docetaxel Accord 80 mg/4 ml indeholder 50 % vol. vandfri ætanol (alkohol), dvs. op til 1,58 g vandfri ætanol pr. hætteglas, svarende til 40 ml øl eller 17 ml vin.
50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med docetaxel 75 mg/m² enkeltstof:
Tabulated list of adverse reactions in non-small cell lung cancer for docetaxel 75 mg/m2 single agent
Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion docetaxel
Et hætteglas på 1 ml koncentrat indeholder 20 mg docetaxel.
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Accord 80 mg/4 ml sterilt koncentrat docetaxel intravenøs anvendelse
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 80 mg/4 ml sterile concentrate docetaxel
Tabel over bivirkninger ved behandling af brystkræft med docetaxel 75 mg/m² i kombination med capecitabin:
Tabulated list of adverse reactions in breast cancer for docetaxel 75 mg/m2 in combination with capecitabine
Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion docetaxel
Koncentrationen af docetaxel i Docetaxel Accord 20 mg/1 ml er 20 mg/ml
Docetaxel Accord 20 mg/1 ml contains
Luftveje, thorax og mediastinum Epistaxis; pharyngolaryngeal smerte; nasopharyngitis; dyspnø; hoste; næseflåd
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis;
FREMSTILLINGSVEJLEDNING TIL BRUG VED DOCETAXEL ACCORD KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
The following information is intended for healthcare professionals only: PREPARATION GUIDE FOR USE WITH DOCETAXEL ACCORD CONCENTRATE FOR SOLUTION FOR INFUSION
Et hætteglas på 4 ml koncentrat indeholder 80 mg docetaxel.
One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Tabel over bivirkninger ved behandling af brystkræft med docetaxel 100 mg/m² i kombination med trastuzumab:
Tabulated list of adverse reactions in breast cancer for docetaxel 100 mg/m2 in combination with trastuzumab
Hver karton indeholder et hætteglas med 4 ml koncentrat Hver karton indeholder et hætteglas med 8 ml koncentrat
Each box contains one vial of 8 ml concentrate.
Docetaxel Accord 80 mg/4 ml leveres i et 5 ml klart glashætteglas med fluorotec plus gummilukning og aluminiumforsegling og en rød afrivningshætte.
Docetaxel Accord 80 mg/4 ml is supplied in a 5 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
Asteni (alvorlig: 12,4 %); Væskeretention (alvorlig: Smerter
Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%); Pain
Docetaxel Accord 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel
NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion docetaxel
Tabel over bivirkninger ved behandling af brystkræft med docetaxel 75 mg/m² i kombination med doxorubicin:
Tabulated list of adverse reactions in breast cancer for docetaxel 75 mg/m2 in combination with doxorubicin
• 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/m2 som en 1-times intravenøs infusion på dag 1, efterfulgt af cisplatin 100 mg/m2 administreret som en 30 minutter til
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/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 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.
Docetaxel Accord monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
Docetaxel Accord monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Tabel over bivirkninger ved behandling af hoved- og halskræft med docetaxel 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
Tabulated list of adverse reactions in head and neck cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Docetaxel i kombination med trastuzumab
Docetaxel in combination with trastuzumab
Stomatitis (G3/4: 1,7 %); Opkastning (G3/4: 0,8 %); Diarré (G3/4: 1,7 %)
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%);
Kløende udslæt (G3/4: 0,7 %); Neglesygdomme (G3/4: 0,7 %); Hudafskalning (G3/4: 0 %)
Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning Hvert hætteglas med koncentrat indeholder 2 ml vandfri ætanol (1,58 mg).
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Neglesygdomme (G3/4: 2 %)
Stomatitis (G3/4: 2%)
Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1491 patienter randomiseret til enten at få enten docetaxel 75 mg/m2 administreret en time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (TAC-arm), eller doxorubicin 50 mg/m2, fulgt af fluoruracil 500 mg/ m2 og cyclophosphamid 500 mg/m2 (FAC-arm).
patients were randomised 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).
Tabel over bivirkninger ved behandling af gastrisk adenokarcinom med docetaxel 75 mg/m² ikombination med cisplatin og 5-fluoruracil:
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Mave-tarmkanalen Stomatitis (G3/4: Diarré (G3/4: 4 %);
Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Myalgi (G3/4: 0,7 %); Artralgi (G3/4: 0,2 %)
Myalgia (G3/4: 0.7%); Arthralgia (G3/4:
Hjælpestof(fer), som behandleren skal være opmærksom på Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning Hvert hætteglas med koncentrat indeholder 0,5 ml vandfri ætanol (395 mg).
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Hud og subkutane væv Alopeci; Hudlidelser (G3/4:
Alopecia ( persisting: Skin disorder (G3/4:
Første episode: Reducer docetaxel- og 5-FU-dosis med 20 % Anden episode: Afbryd behandlingen
Diarrhoea grade 4 First episode: reduce docetaxel and 5-FU doses by 20%.
Mave-tarmkanalen Kvalme (G3/4: 9,6 %); Opkastning (G3/4:
Nausea (G3/4: 9.6%); Vomiting (G3/4:
Letargi
Arthralgia
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) BEMÆRK: Klar til tilsætning til infusionsvæske.
CAUTION: Ready to add to infusion solution
Væskeretention G3/4: Ødemer (G3/4: 1,2%)
Fluid retention (severe: Fever (G3/4: 1.2%)
ENDEPUNKT
Endpoint
Konstipation (G3/4:
Constipation (G3/4:
Patienter i docetaxel-armen fik docetaxel (T) 75 mg/m2 ved intravenøs infusion på dag 1, efterfulgt af cisplatin (P) 100 mg/m2 administreret som en 30 minutter til
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Docetaxel Accord 20 mg/1 ml indeholder 50 % vol. vandfri ætanol (alkohol), dvs. op til 395 mg vandfri ætanol pr. hætteglas, svarende til 10 ml øl eller 4 ml vin.
50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Tabel over bivirkninger ved behandling af brystkræft med docetaxel 100 mg/m² enkeltstof:
Tabulated list of adverse reactions in breast cancer for docetaxel 100 mg/m2 single agent
Trombocytopeni; (G3/4: 0,6 %); Febril neutropeni
Thrombocytopenia (G3/4: Febrile neutropenia
I studiet GEICAM 9805 blev det observeret, at perifert ødem, som forekom i løbet af behandlingsperiden, fortsatte ind i opfølgningsperioden hos 4 patienter (0,8 %) i TAC-armen og hos 2 patienter (0,4 %) i FAC-armen.
In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Dysgeusi/parosmi Perifer sensorisk neuropati (G3/4: 0,6 %)
Peripheral sensory neuropathy (G3/4: 0.6%)
Forhøjet lakrimation (G3/4: 0 %)
Weight increased (G3/4: 0%);
Dette regime blev administreret hver 3. uge i 4
This regimen is administered every
Feber (G3/4: 1,2 %)
(G3/4: 1.2%)
Diarré (G3/4: 19,7 %);
Diarrhoea (G3/4: 1.7%)
4.4 og pkt.
3 weeks for 4 cycles.
95 %CI P = Hazard ratio*
95% CI p-value*
Opbevar dette lægemiddel utilgængeligt for børn.
How to store Docetaxel Accord Keep this medicine out of the sight and reach of children.
Svimmelhed (G3/4:
Vomiting (G3/4:
Arytmi (G3/4: 0,7 %) Hjertesvigt
Arrhythmia (G3/4: 0.7%)