FrancophonIA/ELRC3.0 huggingface dataset:
English: 1060 patients were randomised to receive either DOCETAXEL KABI 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 FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size > 2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age < 35 years).).
Swedish: 1060 patienter randomiserades till att erhålla antingen DOCETAXEL KABI 75 mg/m2 administrerat 1 timme efter doxorubicin 50 mg/m2 och cyklofosfamid 500 mg/m2 (539 patienter i TACarmen) eller doxorubicin 50 mg/m2 följt av fluorouracil 500 mg/m2 och cyklofosfamid 500 mg/m2 (521 patienter i FAC-armen) som adjuvant behandling vid operabel nodnegativ bröstcancer hos patienter med hög återfallsrisk enl.
English: 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.
Swedish: Efter 10 års uppföljning i GEICAM studien, utvecklades akut leukemi hos 1 av 532 (0,2%) patienter i TAC-armen.
English: This regimen is administered every 3 weeks for 3 cycles.
Swedish: Denna behandlingsregim administreras var 3:e vecka i 3 cykler.
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Swedish: Tala om för läkare eller apotekspersonal om du tar eller nyligen har tagit andra läkemedel, även receptfria sådana för att DOCETAXEL KABI eller den andra medicinen kanske inte verkar så bra som förväntat och för att det är mer troligt att du får en biverkan.
English: Myalgia (severe: 0.5%)
Swedish: Myalgi (svår 0,5%)
English: Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Swedish: Sällsynta fall av dehydrering har rapporterats till följd av gastrointestinala besvär såsom enterokolit och gastrointestinal perforation.
English: Median duration of response (months) (95% CI)
Swedish: Median varaktighet av respons (månader) (95% CI)
English: Dehydration (G3/4: 2%)
Swedish: Dehydrering (G3/4: 2%);
English: Complicated neutropenia
Swedish: Svåra neutropenier
English: Each vial of concentrate contains 3 ml of ethanol anhydrous (2.37 g).
Swedish: Varje injektionsflaska av koncentratet innehåller 3 ml vatttenfri etanol (2,37 g).
English: Number of patients Median survival (months) 95% CI
Swedish: Antalet patienter Överlevnad i median (månader) 95% CI
English: 1 vial with 80 mg/4 ml
Swedish: 1 injektionsflaska med 4 ml = 80 mg
English: Respiratory disorders
Swedish: Vätskeretention
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.
Swedish: • Induktionsbehandling med cytostatika följt av radioterapi (TAX 323) Vid induktionsbehandling av inoperabel lokalt avancerad skivepitelcancer i huvud- och hals regionen, rekommenderas dosen 75 mg/m2 docetaxel givet som en en-timmes infusion, följt av cisplatin 75 mg/m2, som en en-timmes infusion dag ett, följt av 5-fluorouracil 750 mg/m2 givet som en kontinuerlig infusion under 5 dagar.
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.
Swedish: Patienter i docetaxelarmen erhöll decotaxel (T) 75 mg/m² som intravenös infusion dag 1 följt av cisplatin (P) 100 mg/m² administrerat som en 30-minuters till 3timmars intravenös infusion, följt av kontinuerlig intravenös infusion med 5fluorouracil (F) 1000 mg/m²/dag från dag 1 till dag 4.
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.
Swedish: Docetaxel i kombination med trastuzumab har studerats för behandling av patienter med metastaserad bröstcancer vilkas tumörer överuttrycker HER2 och som tidigare inte fått kemoterapi mot metastaserad sjukdom.
English: After opening of the vial
Swedish: Efter öppnandet av injektionsflaskan
English: • 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, multi-centre, open-label, randomised study (TAX323).
Swedish: • Induktionsbehandling med cytostatika följt av radioterapi (TAX323) Säkerheten och effekten av docetaxel vid induktionsbehandling av patienter med avancerad skivepitelcancer i huvud-halsregionen utvärderades i en fas III, multicenter, öppen, randomiserad studie (TAX323).
English: Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Swedish: Neutropeni (G3/4: 32%); Anemi (G3/4: 4,9%)
English: Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Swedish: Asteni; perifert ödem; pyrexi; trötthet; slemhinneinflammation; smärta; influensaliknande symtom; bröstsmärta; frossa
English: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Swedish: Varje injektionsflaska av koncentratet innehåller 4 ml vatttenfri etanol (3,16 g).
English: • muscle aches and pains; back pain or bone pain
Swedish: • muskelsmärta eller värk; ryggvärk eller skelettsmärta
English: General disorders and administration site conditions
Swedish: Allmänna symtom och/eller symtom vid administrationsstället
English: - For the treatment of metastatic gastric cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
Swedish: - Vid behandling av magsäckscancer ges DOCETAXEL KABI i kombination med cisplatin och 5-fluorouracil.
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).
Swedish: Vid median uppföljningstid på 10 år och 5 månader, visade patienter behandlade i TAC-armen en 16,5%-ig reduktion av risken för återfall jämfört med de som behandlades med FAC (riskkvot = 0,84, 95% CI (0,65-1,08), p = 0,1646).
English: Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Swedish: Docetaxel eliminerades både i urin och faeces efter cytokrom P450-medierad oxidativ metabolism av tert-butyl-ester-gruppen.
English: • indigestion
Swedish: • andfåddhet
English: Somnolence (G3/4: 0%)
Swedish: Somnolens (G3/4 : 0%)
English: Thrombocytopenia (G3/4: 3%)
Swedish: Trombocytopeni (G3/4: 3%)
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.
Swedish: Din läkare har ordinerat DOCETAXEL KABI för behandling av bröstcancer, speciella former av lungcancer (icke-småcellig lungcancer) prostatacancer, magsäckscancer eller huvud- halscancer:
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.
Swedish: Överkänslighetsreaktioner kan inträffa inom några minuter efter att infusionen av docetaxel påbörjats.
English: G3/4 Blood alkaline phosphatase increased
Swedish: G3/4 bilirubin stegring G3/4 stegring av alkaliska fosfataser
English: Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
Swedish: INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1,
English: Infections (G3/4: 5%)
Swedish: Infektioner (G3/4: 5%)
English: Anorexia (G3/4: 12.0%)
Swedish: Anorexi (G3/4: 12,0%)
English: Anaemia (G3/4: 20.9%);
Swedish: Anemi (G3/4: 20,9%);
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.
Swedish: • Induktionsbehandling med cytostatika följt av kemoradioterapi (TAX 324) Vid induktionsbehandling av lokalt avancerad (icke resektabel, låg sannolikhet för kirurgisk bot, organsparande syfte) skivepitelcancer i huvud- och halsregionen, rekommenderas dosen 75 mg/m2 docetaxel givet som en en-timmes infusion, följt av cisplatin 100 mg/m2, som en 30minuters till 3-timmars infusion dag ett, följt av 5-fluorouracil 1000 mg/m2 givet som en kontinuerlig infusion från dag 1 till dag 4.
English: 1 vial with 120 mg/6 ml
Swedish: 1 injektionsflaska med 6 ml = 120 mg
English: Median PFS (months) (95% CI)
Swedish: Median PFS (månader) (95% CI)
English: Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Swedish: Neutropeni (G3/4: 63%); Anemi (G3/4: 10%)
English: Dysgeusia/Parosmia (G3/4: 0.4%);
Swedish: Dysgeusi/Parosmi (G3/4: 0,4%);
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Swedish: Hazard ratio: 1,222 [97,2% CI: 0,937; 1,342]* Skillnad i behandling: 5,4% [95% CI: -1,1; 12,0] Skillnad i behandling: 6,2% [95% CI: 0,2; 12,3]
English: Anaemia (G3/4: 10.8%);
Swedish: Anemi (G3/4: 10,8%);
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Swedish: Bästa totalt svar på studiebehandling [kemoterapi +/radioterapi] (%) (95% CI) ***p- värde
English: Best overall response to chemotherapy (%) (95% CI) ***p-value
Swedish: Bästa totalt svar på kemoterapi (%) (95% CI) ***p- värde
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Swedish: Myalgi (G3/4: 2%); Artralgi (G3/4: 1%)
English: • 92 patients treated with docetaxel in combination with trastuzumab.
Swedish: • 92 patienter som erhöll docetaxel i kombination med trastuzumab.
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.
Swedish: DOCETAXEL KABI i kombination med capecitabin är indicerat för behandling av patienter med lokalt avancerad eller metastaserad bröstcancer efter svikt på cytostatikabehandling.
English: Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Swedish: Varje injektionsflaska av koncentratet innehåller 4,5 ml vatttenfri etanol (3,55 g).
English: Dose adjustments during treatment
Swedish: Dosjustering under behandling
English: DOCETAXEL KABI 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.
Swedish: DOCETAXEL KABI i kombination med trastuzumab är indicerat för behandling av patienter med metastaserad bröstcancer vilkas tumörer överuttrycker HER2 och som inte tidigare fått kemoterapi mot metastaserad sjukdom.
English: Anorexia (G3/4: 11.7%)
Swedish: Anorexi (G3/4: 11,7%)
English: Tabulated list of adverse reactions in prostatecancer for DOCETAXEL KABI 75 mg/m² in combination with prednisone or prednisolone
Swedish: Tabell över biverkningar vid prostatacancer för DOCETAXEL KABI 75 mg/m2 i kombination med prednison eller prednisolon
English: Number of patients Tumor response rate (%) 95% CI p-value*
Swedish: Antalet patienter Tumör svarsfrekvens (%) 95% CI p-värde*
English: Infection (G3/4: 3.3%)
Swedish: Infektion (G3/4: 3,3%)
English: Median TTP (months) (95% CI)
Swedish: Median TTP (månader) (95% CI)
English: Renal insufficiency and renal failure have been reported.
Swedish: Nedsatt njurfunktion och njursvikt har rapporterats.
English: Anorexia (G3/4: 1.5%)
Swedish: Anorexi (G3/4: 1,5%)
English: Alopecia; Erythema; Rash; Nail disorders
Swedish: Alopeci; erytem; hudutslag; nagelförändringar
English: Thrombocytopenia (G4: 0.2%)
Swedish: Trombocytopeni (G4:0,5%)
English: Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm.
Swedish: Asteni som uppkom under behandlingsperioden och kvarstod i uppföljningsperioden observerades hos 12 patienter (2,3%) i TAC-armen och 4 patienter (0,8%) i FAC-armen.
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Swedish: Reaktion på infusionsstället; bröstsmärta utan hjärtpåverkan (svår
English: What DOCETAXEL KABI contains - The active substance is docetaxel anhydrous.
Swedish: Den aktiva substansen är vattenfri docetaxel.
English: First episode: reduce docetaxel and 5-FU doses by 20%.
Swedish: Diarré grad 4 Första episoden: reducera docetaxel och 5-FU med 20%.
English: You should usually receive your infusion once every 3 weeks.
Swedish: Vanligtvis ges DOCETAXEL KABI-infusionen en gång var tredje vecka.
English: Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Swedish: Epistaxis; faryngolaryngeal smärta; nasofaryngit; dyspné; hosta; rinorré
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Swedish: Artralgi (G3/4: 0,3%); Myalgi (G3/4: 0,3%)
English: • ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat, severe shortness of breath, dizziness, and/or fainting).
Swedish: • minskad halt av natrium, kalium, magnesium och /eller kalcium i blodet (störningar i elektrolytbalansen).ventrikelarytmi eller ventrikulär takykardi (yttrar sig som oregelbundna och/eller snabba hjärtslag, svår andnöd, yrsel och/eller svimning).
English: Median progression free survival (months) (95% CI)
Swedish: Median progressionsfri överlevnad (månader) (95% CI)
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%).
Swedish: Vid slutet av uppföljningsperioden (den faktiska median uppföljningstiden på 8 år) var perifert ödem kvarstående hos 19 TAC-patienter (2,6%) och hos 4 FAC-patienter ( 0,5%).
English: Peripheral motor neuropathy (G3/4: 2.5%)
Swedish: Perifer motorisk neuropati (G3/4: 2,5%)
English: Peripheral sensory neuropathy (G3/4: 8.7%)
Swedish: Perifer sensorisk neuropati (G3/4: 8,7%)
English: Peripheral sensory neuropathy (G3/4: 1.2%);
Swedish: Perifer sensorisk neuropati (G3/4: 1,2%);
English: Oesophagitis (severe: 0.4%)
Swedish: Esofagit (svår 0,4%)
English: Stomatitis (G3/4: 4.0%); Diarrhoea (G3/4: 2.9%); Vomiting (G3/4: 0.6%)
Swedish: Stomatit (G3/4: 4,4%); Diarré (G3/4: 2,9%); Kräkning (G3/4: 0,6%)
English: Anorexia (G3/4: 0.6%)
Swedish: Anorexi (G3/4: 0,6%)
English: Peripheral motor neuropathy (G3/4: 0%)
Swedish: Perifer motorisk neuropati (G3/4: 0%)
English: Very common adverse reactions Common adverse reactions disorders
Swedish: Mycket vanliga biverkningar Vanliga biverkningar
English: Pre-Menopausal
Swedish: Premenopausal
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.
Swedish: DOCETAXEL KABI i kombination med cisplatin är indicerat för behandling av patienter med icke resektabel, lokalt avancerad eller metastaserad icke-småcellig lungcancer som tidigare ej behandlats med cytostatika för denna sjukdom.
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, multi-centre open-label, phase III, study (TAX324).
Swedish: • Induktionsbehandling med cytostatika följt av kemoradioterapi (TAX324) Säkerheten och effekten av docetaxel vid induktionsbehandling av patienter med lokalt avancerad skivepitelcancer i huvud-halsregionen utvärderades i en fas III, multicenter, öppen, randomiserad studie (TAX323).
English: One vial of 9 ml of concentrate contains 180 mg of docetaxel.
Swedish: En injektionsflaska med 9 ml koncentrat innehåller 180 mg docetaxel.
English: • insomnia
Swedish: • sömnlöshet
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
Swedish: I studie TAX316 observerades kvarstående alopeci vid uppföljning efter avslutad kemoterapi hos 687 av 744 TAC-patienter (92,3%) och 645 av 736 FAC-patienter (87,6%).
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Swedish: Myalgi (G3/4: 0,7%); Artralgi (G3/4: 0,2%)
English: Pain in extremity (G3/4: < 1%); Back pain (G3/4: 1%)
Swedish: Smärta i extremiteterna (G3/4: Ryggsmärta (G3/4: 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.
Swedish: Till patienter med serumbilirubin högre än övre normalvärdesgränsen och/eller ALAT och ASAT-värden på mer än 3,5 gånger den övre normalvärdesgränsen samtidigt med alkaliska fosfataser högre än 6 gånger den övre normalvärdesgränsen, kan ingen rekommendation angående dosreduktion ges och docetaxel bör ej användas om inte strikt indikation föreligger.
English: DOCETAXEL KABI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Swedish: DOCETAXEL KABI är indicerat för behandling av patienter med lokalt avancerad eller metastaserad icke-småcellig lungcancer, efter behandlingssvikt på tidigare kemoterapi.
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Swedish: För dosjustering för cisplatin se produktresumé för cisplatin.
English: One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Swedish: En injektionsflaska med 8 ml koncentrat innehåller 160 mg docetaxel.
English: DOCETAXEL KABI 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.
Swedish: DOCETAXEL KABI i kombination med doxorubicin är indicerat för behandling av patienter med lokalt avancerad eller metastaserande bröstcancer som tidigare inte behandlats med cytostatika för denna sjukdom.
English: Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
Swedish: Trombocytopenia; (G3/4: 0,6%); Febril neutropeni
English: In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2 %) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Swedish: I studie TAX316 uppkom perifer sensorisk neuropati under behandlingsperioden och kvarstod i uppföljningsperioden hos 84 patienter (11,3%) i TAC-armen och 15 patienter (2%) i FAC-armen.
English: 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).
Swedish: Vid mediantiden för uppföljning på77 månader var total överlevnad längre i TAC-armen, i vilken TAC-behandlade patienter hade en 24%-ig minskning av dödsrisken jämfört med FAC (hazard ratio = 0,76; 95% CI(0,46-1,26); p = 0,29).
English: Myalgia (G3/4: 0.4%)
Swedish: Myalgi (G3/4: 0,4%)
English: In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients(87.6%).
Swedish: I studie TAX316 observerades alopeci vid uppföljning efter avslutad kemoterapi hos 687 av 744 TACpatienter (92,3%) och 645 av 736 FAC-patienter (87,6%).
English: Number of patients PSA** response rate (%) 95% CI p-value*
Swedish: Antalet patienter PSA** svarsfrekvens (%) 95% CI p-värde*
English: Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
Swedish: Bästa totalt svar (CR + PR) på kemoterapi (%) (95% CI) ***p-värde
English: Each box contains one vial of 9 ml concentrate (180 mg docetaxel).
Swedish: Varje kartong innehåller en injektionsflaska med 9 ml koncentrat (180 mg docetaxel).
English: Hypersensitivity (G3/4: 2.5%)
Swedish: Överkänslighetsreaktion er (G3/4: 2,5%)
English: - For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL
Swedish: - Vid behandling av bröstcancer i tidigt skede med eller utan lymfkörtelengagemang kan DOCETAXEL KABI ges i kombination med doxorubicin och cyklofosfamid.
English: Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Swedish: Anemi (G3/4: 12,4%); Trombocytopeni (G3/4:
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%);
Swedish: Esofagit/dysfagit/odynofa gi (G3/4: 0,6 %);
English: In study TAX316 lymphoedema that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%).
Swedish: I studie TAX316 uppkom lymfödem under behandlingsperioden och kvarstod i uppföljningsperioden efter avslutad kemoterapi hos 11 av 744 TAC-patienter (1,5%) och hos 1 av 736 FAC-patienter (0,1%).
English: Median overall survival (months) (95% CI)
Swedish: Median total överlevnad (månader) (95% CI)
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for DOCETAXEL KABI 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Swedish: Beskrivning av utvalda biverkningar vid adenocarcinom i magsäcken för DOCETAXEL KABI 75 mg/m2 i kombination med cisplatin och 5-fluorouracil
English: Dizziness
Swedish: Ljuskänsligt
English: Lymphoedema (G3/4: 0%)
Swedish: Lymfödem (G3/4: 0%)
English: Each box contains one vial of 6 ml concentrate (120 mg docetaxel).
Swedish: Varje kartong innehåller en injektionsflaska med 6 ml koncentrat (120 mg docetaxel).
English: Fluid retention (severe: 6.5%); Asthenia (severe: 11.2%); Pain
Swedish: Väskeretention (svår Asteni (svår 11,2%); Smärta
English: DOCETAXEL KABI monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Swedish: DOCETAXEL KABI monoterapi är indicerat för behandling av patienter med lokalt avancerad eller metastaserande bröstcancer efter svikt på tidigare cytostatikabehandling.
English: One vial of 6 ml of concentrate contains 120 mg of docetaxel.
Swedish: En injektionsflaska med 6 ml koncentrat innehåller 120 mg docetaxel.
English: Myalgia (G3/4: 0.6%)
Swedish: Myalgi (G3/4: 0,6%)
English: Fever (G3/4: 1.2%)
Swedish: Feber (G3/4: 1,2%)
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Swedish: Varje kartong innehåller en injektionsflaska med 8 ml koncentrat (160 mg docetaxel).