FrancophonIA/ELRC3.0 huggingface dataset:
English: Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Danish: Lokoregional behandling med stråling blev givet enten med en konventionel fraktion (1,8 Gy-2,0 Gy en gang daglig, 5 dage om ugen til en total dosis på 66 til 70
English: 1060 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
Danish: 1.060 patienter blev randomiseret til at få enten docetaxel 75 mg/m2 administreret 1 time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (539 patienter i TAC-armen) eller doxorubicin 50 mg/m2 efterfulgt af fluoruracil 500 mg/m2 og cyclophosphamid 500 mg/m2 (521 patienter i FAC-armen) som adjuverende behandling.
English: • As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: • Som ved alle andre parenterale lægemidler skal Docetaxel Accord infusionsvæske kontrolleres visuelt for uklarheder, og opløsninger med udfældning skal kasseres.
English: A multicentre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Danish: En multicenter, åben, randomiseret studie har evalueret sikkerhed og effekt af docetaxel til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom af den gastrooesophagele forbindelse.
English: Stomatitis/Pharyngitis (G3/4: Vomiting (G3/4: 1.2%)
Danish: Stomatitis/Pharyngitis (G3/4: Opkastning (G3/4: 1,2 %)
English: Fluid retention (severe: Asthenia (severe: 11.2%); Pain
Danish: Væskeretention (alvorlig: 6,5 %) Asteni (alvorlig: 11,2 %); smerter
English: - For the treatment of metastatic gastric cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Danish: • Ved behandling af metastatisk gastrisk kræft indgives docetaxel i kombination med cisplatin og 5fluoruracil.
English: Read the package leaflet before use Single use vial
Danish: Læs indlægssedlen inden brug.
English: Docetaxel Accord 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, docetaxel could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Danish: Docetaxel Accord 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:
English: Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Danish: Der er rapporteret sjældne tilfælde af enterocolitis, herunder colitis, iskæmisk colitis og neutropenisk enterocolitis med en potentielt dødelig udgang (hyppighed ikke kendt).
English: Dyspnoea (severe: 2.7%)
Danish: Neglesygdomme (alvorlig: 2,6 %)
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks,
Danish: I kombination med trastuzumab er den anbefalede dosis af docetaxel 100 mg/m2 hver 3. uge med en ugentlig administration af trastuzumab.
English: The amount of alcohol in this medicinal product and the side effects of the product may impair the ability to drive or use machines (see sections 4.4 and 4.8).
Danish: Mængden af alkohol i dette lægemiddel og bivirkningerne ved lægemidlet kan nedsætte evnen til at føre motorkøretøj eller betjene maskiner (se pkt.
English: What Docetaxel Accord is and what it is used for What you need to know before you use Docetaxel Accord How to use Docetaxel Accord Possible side effects
Danish: Det skal du vide, før du begynder at bruge Docetaxel Accord Sådan skal du bruge Docetaxel Accord Bivirkninger
English: • 1,312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent respectively.
Danish: De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos: • 1.312 og 121 patienter, som fik henholdsvis 100 mg/m2 og 75 mg/m2 af doceraxel som enkeltstof.
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product which contains only 1 vial of concentrate.
Danish: Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel, der kun indeholder 1 hætteglas med koncentrat.
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Danish: Bemærk, at dette sandsynligvis er underestimeret, da docetaxel alene ved en dosis på 100 mg/m2 er kendt for at resultere i neutropeni hos
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 16.5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.64-1.08), p=0.1646).
Danish: Ved den mediane opfølgningsperiode på 10 år og 5 måneder havde TAC-behandlede patienter 16,5 % lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard ratio = 0,84; 95 % CI (0,65-1,08); p = 0,1646).
English: Mix the infusion bag manually using a rocking motion.
Danish: Bland manuelt opløsningen i infusionsposen med vippende bevægelser.
English: Following chemotherapy, patients should receive chemoradiotherapy.
Danish: Patienter bør modtage kemostrålingsterapi efter kemoterapi
English: Tabulated list of adverse reactions in prostate cancer for docetaxel 75 mg/m2 in combination with prednisone or prednisolone
Danish: Tabel over bivirkninger ved behandling af prostatakræft med docetaxel 75 mg/m² i kombination med prednison eller prednisolon:
English: Surgical resection was allowed following chemotherapy, before or after radiotherapy.
Danish: Kirurgisk resektion blev tilladt efter kemoterapi,
English: • From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske forhold og lægemidlet bør anvendes umiddelbart herefter.
English: • Mix the infusion bag manually using a rocking motion.
Danish: • Bland manuelt opløsningen i infusionposen med vippende bevægelser.
English: Lymphoedema that started during the treatment period persisted into the follow-up period in 5 patients (0.9%) in TAC arm and 2 patients (0.4 %) in FAC arm. At the end of the follow-up period,
Danish: Lymfødem, der forekom i behandlingsperioden, fortsatte i opfølgningsperioden hos 5 patienter (0,9 %) i TAC-armen og 2 patienter (0,4 %) i FAC-armen.
English: Dyspnoea;
Danish: Dyspepsi;
English: • Then, inject via a single injection (one shot) into a 250 ml infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: • Injicer via en enkelt injektion (et stik) den nødvendige mængde Docetaxel Accord koncentrat til infusionsvæske, opløsning i en 250 ml infusionspose indeholdende enten en 5 % glucoseinfusionsvæske eller en 0,9 % natriumchloridinfusionsvæske.
English: 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.
Danish: 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.
English: Docetaxel Accord in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Danish: Docetaxel Accord i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-småcellet lungekræft hos patienter, der ikke tidligere har fået kemoterapi mod denne tilstand.
English: • operable node-negative breast cancer .
Danish: • operabel, lymfeknude-negativ brystkræft
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: Somnolence (G3/4: 0%)
Danish: Synkope (G3/4: 0 %) Neurotoksicitet (G3/4: Døsighed (G3/4: 0 %)
English: - The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid anhydrous.
Danish: - Øvrige indholdsstoffer: polysorbat 80, vandfri ætanol (pkt.
English: Do not couple the infusion solution to the infusion set for more than 6 hours when stored at 25°C.
Danish: Infusionsopløsningen må ikke være forbundet med infusionssættet i mere end 6 timer ved opbevaring ved 25°C.
English: What Docetaxel Accord looks like and contents of the pack Docetaxel Accord concentrate for solution for infusion is a clear pale yellow to brownish-yellow solution.
Danish: Docetaxel Accord koncentrat til infusionsvæske, opløsning er en klar, lys gul til brunliggul opløsning.
English: Docetaxel Accord in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Danish: Docetaxel Accord i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Danish: Patienter i docetaxel-armen fik docetaxel (T) 75 mg/m2 efterfulgt af cisplatin (P) 75 mg/m2 efterfulgt af 5-fluoruracil 750 mg/m2
English: This medicinal product contains 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.
Danish: Dette lægemiddel indeholder 50 % vol. vandfri ætanol (alkohol), dvs. op til 395 mg vandfri ætanol pr. hætteglas, svarende til 10 ml øl eller 4 ml vin.
English: Metabolism and nutrition disorders Cases of electrolyte imbalance have been reported.
Danish: Tilfælde af elektrolytforstyrrelser er rapporteret.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion
Danish: Indlægseddel: Information til brugeren Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning Docetaxel Accord 80 mg/4 ml koncentrat til infusionsvæske, opløsning Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
English: - For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Danish: • Til behandling af hoved- og hals-kræft indgives docetaxel i kombination med cisplatin og 5fluoruracil.
English: 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.
Danish: 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.
English: Constipation (severe: 0.2%); Abdominal pain (severe: 1%); Gastrointestinal haemorrhage (severe: 0.3%)
Danish: Konstipation (alvorlig: 0,2 %); Mavesmerter (alvorlig: 1 %);
English: For patients with serum bilirubin levels > ULN and/or ALT and AST > 3.5 times the ULN concurrent with serum alkaline phosphatase levels > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Danish: For de patienter med serum-bilirubin > øvre normalværdi og/eller ALAT og ASAT > 3,5 gange øvre normalværdi og basiske fosfataser > 6 gange øvre normalværdi, kan det ikke anbefales at reducere dosis.
English: 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/m2 til patienter med metastatisk brystkræft.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Accord 20 mg/1 ml sterile concentrate docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Accord 20 mg/1 ml sterilt koncentrat docetaxel
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe: 0.07%)
Danish: Perifer sensorisk neuropati (G3: 4,1 %); Perifer motorisk neuropati (G3/4: 4 %) Dysgeusi (alvorlig:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml koncentrat indeholder 20 mg docetaxel.
English: Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Danish: Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning 1 hætteglas på 8 ml koncentrat indeholder 160 mg docetaxel.
English: 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).
Danish: 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).
English: Gastrointestinal pain (G3/4: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%)
Danish: Konstipation (G3/4: 1,0 %); Gastrointestinale smerter (G3/4: Oesophagitis/dysfagi/odynofagi (G3/4: 0,7 %)
English: Docetaxel Accord is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Danish: Docetaxel Accord er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter behandlingssvigt af kemoterapi.
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Danish: Docetaxel Accord 20 mg/1 ml koncentrat til infusionsvæske, opløsning 1 hætteglas på 1 ml koncentrat indeholder 20 mg docetaxel.
English: Description of selected adverse reactions in breast cancer for docetaxel 100 mg/m2 in combination with trastuzumab
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med docetaxel 100 mg/m² i kombination med trastuzumab:
English: 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).
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 Docetaxel Accord.
English: Hazard ratio (TAC/FAC) (95% CI)
Danish: Hazard ratio (TAC/FAC)
English: 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).
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: 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).
Danish: 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).
English: • 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.
Danish: • Hos patienter, der for anden gang udvikler grad 2-toksicitet eller første gang grad 3-toksicitet, skal behandlingen udsættes, indtil grad 0-1 nås.
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med docetaxel 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: Between infusions of docetaxel the following may occur, and the frequency may vary with the combinations of medicines that are received
Danish: Hyppigheden kan variere alt efter kombinationen af de lægemidler, du får.
English: Docetaxel Accord 160 mg/8 ml concentrate for solution for infusion Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Danish: Docetaxel Accord 160 mg/8 ml koncentrat til infusionsvæske, opløsning Hvert hætteglas med koncentrat indeholder 4 ml vandfri ætanol (3,16 mg).
English: More than one vial of Docetaxel Accord concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Danish: 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.
English: One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Danish: Et hætteglas på 8 ml koncentrat indeholder 160 mg docetaxel.
English: 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.
Danish: 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.
English: Tabulated list of adverse reactions in non-small cell lung cancer for docetaxel 75 mg/m2 in combination with cisplatin
Danish: Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med docetaxel 75 mg/m² i kombination med cisplatin:
English: 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.
Danish: 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.
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Danish: Bedste respons i alt til studie behandling [kemoterapi +/- strålebehandling] (%) (95 %CI) ***p-værdi
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Danish: Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4: Flebitis (G3/4: 0 %)
English: 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.
Danish: Docetaxel Accord 160 mg/8 ml leveres i et 10 ml klart glashætteglas med fluorotec plus gummilukning og aluminiumforsegling og en rød afrivningshætte.
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, multicentre open-label, phase III study (TAX324).
Danish: 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: 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).
Danish: 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).
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Danish: 256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/ m2
English: 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).
Danish: 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).
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning.
English: 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.
Danish: 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.
English: Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Danish: Docetaxel Accord 80 mg/4 ml koncentrat til infusionsvæske, opløsning 1 hætteglas på 4 ml koncentrat indeholder 80 mg docetaxel.