FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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 fosfatase > 2,5 x ULN, og bilirubin > 1 x ULN.
English: Cardiac disorders
Danish: Kardiotoksicitet
English: At the median follow up time of 10 years and 5 months, TAC-treated patients had a 9% reduction in the risk of death compared to FAC-treated patients (hazard ratio = 0.91, 95% CI (0.63-1.32)).
Danish: Ved den mediane opfølgningsperiode på 10 år og 5 måneder havde TAC-behandlede patienter en 9 % lavere risiko for død sammenlignet med FAC-behandlede patienter (hazard ratio = 0,91; 95 % CI (0,63-1,32)).
English: 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).
Danish: Total overlevelse ved 10 år var også signifikant forøget med TAC i forhold til FAC (henholdsvis 76 % versus 69 %).
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Danish: Patienter i komparator-armen modtog cisplatin (P) 100 mg/m2 administreret som en 30 minutter til 3 timers intravenøs infusion på dag 1, efterfulgt af kontinuerlig intravenøs infusion af 5-fluoruracil(F) 1000 mg/m2/dag fra dag 1 til dag 5.
English: At the median follow-up was 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Danish: Ved den mediane opfølgningsperiode på 77 måneder blev der vist signifikant længere sygdoms-fri overlevelse (DFS) i TAC-armen sammenlignet med FAC-armen.
English: Nail disorders (severe: 2.6%)
Danish: Neglesygdomme (alvorlig: 2,6 %)
English: Hazard ratio (95% CI) **p-value n = 128
Danish: Hazard ratio (95 %CI) **p-værdi n = 128
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 forringe evnen til at køre bil eller betjene maskiner (se pkt.
English: Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-toTreat Analysis)
Danish: Effekt af docetaxel i indledende behandling til patienter med lokale fremskredne SCCHN (Hensigt at behandle-analyse)
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Danish: For cisplatin-dosisjustering, se tilsvarende produktresumé
English: In GEICAM 9805 study peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Danish: I studiet GEICAM 9805 forekom perifer sensorisk neuropati under behandlingen og fortsatte ind i opfølgningsperioden hos 10 patienter (1,9 %) i TAC-armen og hos 4 patienter (0,8 %) i FAC-armen.Ved afslutningen af opfølgningsperioden (median opfølgningstid på 10 år og 5 måneder) blev det observeret, at perifer sensorisk neuropati fortsatte hos 3 patienter (0,6 %) i TAC-armen og hos 1 patient (0,2 %) i FAC-armen.
English: Data from one multi-centre, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Danish: Data fra et randomiseret, kontrolleret, klinisk fase 3-multicenterstudie understøtter anvendelsen af capecitabin i kombination med docetaxel til behandling af patienter med lokal fremskreden eller metastatisk brystkræft hos hvem cytotoksisk kemoterapi med et anthracyklin, har været uden effekt.
English: 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/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Danish: Den anbefalede doxetaxel-dosis til adjuverende behandling af operabel lymfeknude-positiv og lymfeknude-negativ brystkræft er 75 mg/m2 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).
English: • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
Danish: • Hudreaktioner på injektionsstedet, betændelse eller hævelse af venen (flebitis)
English: How to use DOCETAXEL KABI
Danish: Sådan skal du bruge DOCETAXEL KABI
English: • 258 patients who received docetaxel in combination with doxorubicin.
Danish: • 258 patienter, som fik docetaxel i kombinationsbehandling med doxorubicin.
English: Nail disorders (severe: 0.8%)
Danish: Neglesygdomme (alvorlig:0,8 %)
English: Each vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Danish: Hvert hætteglas af koncentrat indeholder 0,5 ml ethanol vandfri (395 mg).
English: Myalgia (severe: 1.4%)
Danish: Myalgi (alvorlig: 1,4 %) Artralgi
English: Median TTP (months) (95% CI)
Danish: Median TTP (måneder) (95 %CI)
English: There are no data available in patients with severely impaired renal function treated with docetaxel.
Danish: Der er ingen tilgængelige data vedrørende behandling med docetaxal af patienter med alvorligt nedsat nyrefunktion.
English: Alopecia; Skin reaction (G3/4: 0.8%)
Danish: Alopeci; Hudreaktioner (G3/4: 0,8 %)
English: Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Danish: Anden primær malignitet (hyppighed ikke kendt), herunder non-Hodgkin lymfom, er blevet rapporteret, når docetaxel blev givet i kombination med andre anticancer behandlinger, der vides at være forbundet med anden primær malignitet.
English: Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Danish: Træthed (G3/4: 3,9 %); Væskeretention (alvorlig: 0,6 %)
English: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Danish: Hvert hætteglas af koncentrat indeholder 2 ml ethanol vandfri (1,58 g).
English: For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Danish: Ved dosismodifikation af cisplatin og 5-fluoruracil henvises der til de tilsvarende produktresuméer.
English: Nervous system disorders
Danish: Nervesystemet:
English: Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm3 (see section 4.2).
Danish: Behandling med docetaxel bør gentages, når neutrocyttallet igen er ≥ 1.500 celler/mm3 (se pkt.
English: Preparation of the infusion solution
Danish: Tilberedning af infusionsvæske
English: • haemorrhage
Danish: • rygsmerter
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 (0.65-1.08), 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: Cutaneous reactions
Danish: Kutane reaktioner
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Danish: Svimmelhed (G3/4: 2,3 %); Perifer motorisk neuropati (G3/4: 1,3 %)
English: 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: På basis af farmakokinetiske data med docetaxel givet som enkeltstof ved en dosis på 100 mg/m2, er den anbefalede dosis docetaxel 75 mg/m2 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.
English: No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Danish: Der blev ikke observeret nogen signifikant virkning af prednison på docetaxels farmakokinetik.
English: Tell your doctor, hospital pharmacist or nurse if you have vision problems.
Danish: Kontakt lægen, hospitalsfarmaceuten elle sundhedspersonalet, hvis du oplever problemer med dit syn.
English: 1 vial with 120 mg/6 ml
Danish: 1 hætteglas med 120 mg/6 ml.
English: Paraesthesia; Headache; Dysgeusia; Hypoaesthesia
Danish: Paræstesi; hovedpine; dysgeusi; hypoæstesi
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Danish: Asteni; periferalt ødem; pyrexi; træthed; inflammation i slimhinderne; smerter; influenzalignende symptomer; brystsmerter; kulderystelser
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Danish: • Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Til den indledende behandling af inoperabel, lokalt fremskredne pladecellecarcinom i hoved og hals (SCCHN) er den anbefalede dosis docetaxel 75 mg/m2 som en 1-times infusion, efterfulgt af 1 times infusion med cisplatin 75 mg/m2 på dag 1, efterfulgt af 5-fluoruracil som en kontinuerlig infusion på 750 mg/m2 pr. dag i fem dage.
English: DOCETAXEL KABI 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 KABI could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Danish: DOCETAXEL KABI 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: Neoplasms benign, malignant and unspecified (incl cysts and polyps) Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
Danish: cyster og polypper): Anden primær malignitet (hyppighed ikke kendt), herunder non-Hodgkin lymfom, er blevet rapporteret, når docetaxel blev givet i kombination med andre anticancer behandlinger, der vides at være forbundet med anden primær malignitet.
English: MARKETING AUTHORISATION NUMBER
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE)
English: Each vial of concentrate contains 3 ml of ethanol anhydrous (2.37 g).
Danish: Hvert hætteglas af koncentrat indeholder 3 ml ethanol vandfri (2,37 g).
English: Thrombocytopenia (G4: 1.7%)
Danish: Trombocytopeni (G4: 1,7 %)
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Danish: Opkastning (G3/4: 7,6 %); Diarré (G3/4: 6,4 %); Stomatitis (G3/4: 2 %)
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Danish: Harzard ratio: 1,122 (97,2 %CI:0.937;1,342)* Behandlingsforskel 5,4 % (95 %CI:-1,1;12,0) Behandlingsforskel 6,2 % (95 %CI:0,2;12,3)
English: • hearing impaired
Danish: • Nedsat hørelse
English: 1 vial with 80 mg/4 ml
Danish: 1 hætteglas med 80 mg/4 ml.
English: • operable node-negative breast cancer.
Danish: • operabel, lymfeknude-negativ brystkræft
English: • heart failure
Danish: • Hjertesvigt
English: Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
Danish: Stomatitis (G3/4: 1,7 %); Opkastning (G3/4: 0,8 %); Diarré (G3/4: 1,7 %)
English: 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).
Danish: Ved prostatakræft er det anbefalede præmedicineringsregime, på grund af den samtidige behandling med prednison eller prednisolon, oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxelinfusion (se pkt.
English: Median duration of response (months) (95% CI)
Danish: Gennemsnitlig varighed af respons (måneder) (95 %CI)
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Danish: Bedste respons i alt til undersøgelsesbehandling [kemoterapi +/- strålebehandling] (%) (95 %CI) ***p-værdi
English: 1 vial with 20 mg/1 ml
Danish: 1 hætteglas med 20 mg/1 ml.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet er receptpligtigt (se bilag I: Produktresumé, pkt.
English: 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.
Danish: 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 3 timers intravenøs infusion, efterfulgt af kontinuerlig intravenøs infusion af 5-fluoruracil(F) 1000 mg/m2/dag fra dag 1 til dag 4.
English: - For the treatment of head and neck cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
Danish: • Til behandling af hoved- og hals-kræft indgives DOCETAXEL KABI i kombination med cisplatin og 5- fluoruracil.
English: Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
Danish: Stomatitis (G3/4: 23,7 %); Opkastning (G3/4: 14,3 %)
English: PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning.
English: Anorexia (G3/4: 1.5%)
Danish: Anoreksi (G3/4: 1,5 %)
English: • 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/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.
Danish: • 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 dministreret som en 30 minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1000 mg/m2 som en kontinuerlig infusion fra dag 1 til dag 4.
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Danish: Neutropeni (G3/4: 63 %); Anæmi (G3/4: 10 %)
English: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Danish: Hvert hætteglas af koncentrat indeholder 4 ml ethanol vandfri (3,16 g).
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Danish: Neutropeni (G3/4: 32 %); Anæmi (G3/4: 4,9 %)
English: Anorexia (G3/4: 12.0%)
Danish: Anoreksi (G3/4:12,0 %)
English: Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel, thus facilities for the treatment of hypotension and bronchospasm should be available.
Danish: Der kan opstå overfølsomhedsreaktioner inden for få minutter efter infusion af docetaxel er påbegyndt.
English: The concentrate is a clear, colourless to pale yellow solution.
Danish: Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Koncentratet er en klar, farveløs til svag gul opløsning.
English: Anaemia (G3/4: 10.8%);
Danish: Anæmi (G3/4: 10,8 %);
English: DOCETAXEL KABI 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 KABI 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: A hazard ratio of less than 1 favoursdocetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Danish: Bedste respons i alt på undersøgelsesbehandling [kemoterapi +/- strålebehandling] (%) (95 %CI) ***p-værdi Med en hazard ratio < 1 kan docetaxel + cisplatin+5-FU anvendes med fordel * Ujusteret log-rank test ** Ujusteret log-rank test, ikke justeret efter multipel sammenligning *** Chi-square-test, ikke justeret for multipel sammenligning NA: Not Applicable
English: Data from a multi-centre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Danish: Patienter med operabel, lymfeknude-positiv brystkræft (TAX 316) Data fra et multicenter åbent randomiseret studium støtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude-positiv brystkræft og KPS > 80 % i alderen mellem 18 og 70 år.
English: At the end of the follow-up period (actual median follow-up time of 8 years), lymphoedema was observed to be ongoing in 6 TAC patients (0.8%) and 1 FAC patient (0.1%).
Danish: Ved afslutningen af opfølgningsperioden blev det observeret (median opfølgningstid på 8 år), at lymfødem fortsatte hos 6 TAC patienter (0,8 %) og hos 1 FAC patient.
English: • 92 patients treated with docetaxel in combination with trastuzumab.
Danish: • 92 patienter, som fik docetaxel i kombination med trastuzumab.
English: Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Danish: Median tid til første tilbagegang af WHO performance status var signifikant længere i TPF-armen end med PF. Smerteintensitet-scoren forbedredes under behandlingen i begge grupper, hvilket indikerer en god smertekontrol.
English: Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Danish: Træthed/svaghed (G3/4: 5 %); Perifert ødem (G3/4: 1 %);
English: DOCETAXEL KABI 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 KABI i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
English: Patients should be closely monitored for early manifestations of serious gastrointestinal toxicity (see sections 4.2, 4.4 Haematology, and 4.8).
Danish: Patienter bør overvåges nøje for tidlige tegn på alvorlig gastrointestinal toksisitet (se pkt.
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Danish: Docetaxel i kombination med trastuzumab blev undersøgt til behandling af patienter med metastatisk brystkræft, hvis tumorer var HER2-positive, og som ikke tidligere havde fået kemoterapi for metastatisk sygdom.
English: Skin and subcutaneous Alopecia (G3/4:4.0%)
Danish: Hud og subkutane væv Alopeci (G3/4: 4,0 %) Kløende udslæt
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Danish: Hver ml koncentrat til infusionsvæske, opløsning indeholder 20 mg docetaxel.
English: Dizziness;
Danish: Svimmelhed;
English: Thrombocytopenia (G3/4: 1.6%);
Danish: Trombocytopeni (G3/4:1,6 %);
English: • oral candidiasis
Danish: • Mundtørhed
English: Docetaxel is more than 95% bound to plasma proteins.
Danish: Docetaxels plasmaproteinbinding er > 95 %.
English: Patient subset
Danish: Patient fordeling
English: At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Danish: Ved afslutningen af opfølgningsperioden (faktisk median opfølgningstid på 8 år) fortsatte perifert ødem hos 19 TAC patienter (2,6 %) og hos 4 FAC patienter (0,5 %).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22nd May 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: 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.
Danish: Patienter fra TPF-armen blev behandlet med profylaktisk antibiotika med ciprofloxacin 500 mg oralt 2 gange daglig i 10 dage.
English: In TAX316 amenorrhoea that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Danish: I studiet TAX316 forekom amenorré i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden efter afsluttet kemoterapi og blev rapporteret hos 202 af 744 TAC patienter (27,2 %) og hos 125 af 736 FAC patienter (17,0 %).
English: Dehydration (G3/4: 2%)
Danish: Dehydrering (G3/4: 2
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: Myalgia (severe: 0.5%)
Danish: Myalgi (alvorlig 0,5
English: Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Danish: Der blev ikke observeret effekt af prednison på docetaxels farmakokinetik.
English: Dyspepsia;
Danish: Konstipation;
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Danish: Myalgi (G3/4: 2 %); Artralgi (G3/4: 1 %)
English: Both regimens were administered every 3 weeks.
Danish: Begge behandlingsmåder blev administreret hver 3. uge.
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Danish: Første episode: Reducer docetaxel- og 5-FU-dosis med 20 % Anden episode: Afbryd behandlingen