natgillin/translations-raw huggingface dataset:
Efter 10 års opfølgning i TAX 316-studiet blev akut leukæmi rapporteret hos 3 ud af 744 TACpatienter (0,4 %) og hos 1 ud af 736 FAC-patienter (0,1 %).
After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Patienter i TPF-armen fik antibiotisk profylakse med ciprofloxacin 500 mg oralt 2 gange dagligt i 10 dage, startende på dag 5 i hver cyklus, eller tilsvarende.
Patients on the TPF arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Der er rapporter om tilfælde af væskeretention såsom perifert ødem og sjældnere pleura- og perikardieekssudat, ascites og vægtøgning.
Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
• næseblod
• bleeding from the nose
G3/4 Forhøjet ASAT (0,5 %); G3/4 Forhøjet alkalisk fosfatase i blodet (0,3 %)
G3/4 AST increased (0.5%); G3/4 Blood alkaline phosphatase increased (0.3%)
• Ved behandling af lungekræft kan Taxespira indgives enten alene eller i kombination med
• For the treatment of lung cancer, Taxespira could be administered either alone or in
G3/4 Forhøjet ASAT
G3/4 AST increased
Reduktion af risikoen for progression var 32,1 % og blev associeret med en signifikant længere TTP (p = 0,0004) til fordel for TCF-armen.
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm. OS was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
Lægemidlets handelsnavn er docetaxel.
Its common name is docetaxel.
Primær G-CSF-profylakse bør overvejes til patienter, som får adjuverende behandling med TAC for brystkræft, for at nedsætte risikoen for kompliceret neutropeni (febril neutropeni, forlænget neutropeni eller neutropenisk infektion).
Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Den anbefalede dosis af docetaxel er 75 mg/m2 som en 1-times infusion, efterfulgt af cisplatin 75
Gastric adenocarcinoma The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin
Myokardieiskæmi (G3/4: 1,7 %)
Myocardial ischemia (G3/4:1.7%)
Ventrikulær arytmi inklusive ventrikulær takykardi (undertiden dødelig) er rapporteret hos patienter behandlet med docetaxel i kombinationsregimer inklusive doxorubicin, 5-fluorouracil og/eller cyclofosfamid (se pkt.
Ventricular arrhythmia including ventricular tachycardia (sometimes fatal) has been reported in patients treated with docetaxel in combination regimens including doxorubicin, 5-fluorouracil and/or cyclophosphamide (see section 4.8).
• hudreaktioner på injektionsstedet, betændelse (flebitis) eller hævelse af venen
• at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
Data fra et åbent, randomiseret multicenterstudie understøtter anvendelsen af Taxespira som adjuverende behandling til patienter med operabel, lymfeknude-negativ brystkræft, der er egnede til kemoterapi.
Data from a multicenter open label randomized trial support the use of Taxespira for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
cyster og polypper) Der er rapporter om tilfælde af akut myeloid leukæmi og myelodysplastisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutika og/eller strålebehandling.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy.
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.
Data from one multicenter, 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.
Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med Taxespira 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft
Description of selected adverse reactions for adjuvant therapy with Taxespira 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
160 mg/8 ml indeholder 8 ml koncentrat.
160mg/8 ml contains 8 ml of concentrate.
Dette regimen administreres hver 3. uge i 3 cyklusser.
This regimen is administered every 3 weeks for 3 cycles.
• betændelse i lungerne, der forårsager hoste og vejrtrækningsbesvær (interstitiel lungesygdom).
• interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Dette svarer til 80 ml øl eller 33 ml vin.
This is equivalent to 80 ml of beer or 33 ml of wine.
• Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) Docetaxels sikkerhed og effekt i induktionsbehandlingen af patienter med pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et åbent, randomiseret fase III-multicenterstudie (TAX 323).
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Det blev observeret, at amenorré fortsatte ved afslutningen af opfølgningsperioden (median opfølgningstid på 8 år) hos 121 af 744 TAC-patienter (16,3 %) og hos 86 FAC-patienter (11,7 %).
Amenorrhea was observed to be ongoing at the end of the follow-up period (median follow-up time of 8 years) in 121 patients of 744 TAC patients (16.3 %) and 86 FAC patients
Hyppigheden af grad 4neutropeni, febril neutropeni og neutropenisk infektion blev reduceret hos patienter, der fik primær GCSF-profylakse (se pkt.
The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
140 mg/7 ml indeholder 7 ml koncentrat.
140mg/7 ml contains 7 ml of concentrate.
20 mg/1 ml indeholder 1 ml koncentrat.
20mg/1 ml contains 1 ml of concentrate.
• Ved behandling af hoved- og halskræft kan Taxespira indgives i kombination med cisplatin og 5-fluorouracil.
• For the treatment of head and neck cancer, Taxespira is administered in combination with cisplatin and 5-fluorouracil.
I alt
In case of
Dehydrering (G3/4: 2 %)
Dehydration (G3/4: 2%)
Øget tåreflåd; konjunktivitis
Lacrimation increased; Conjunctivitis
På den anden side viste AC-armen en hyppigere forekomst af alvorlig anæmi (15,8 % vs. 8,5 %) end AT-armen og tillige en hyppigere forekomst af alvorlig hjertetoksicitet: kongestivt hjertesvigt (3,8 % vs. 2,8 %), absolut LVEF-nedsættelse > 20 % (13,1 % vs. 6,1 %), absolut LVEF-nedsættelse > 30 % (6,2 % vs. 1,1 %).
In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥20% (13.1% versus 6.1%), absolute LVEF decrease ≥30% (6.2% versus 1.1%).
• Induktionskemoterapi efterfulgt af kemo-strålebehandling (TAX 324)
• Induction chemotherapy followed by chemoradiotherapy (TAX 324)
Neutropeni (G3/4: 32 %); anæmi (G3/4: 4,9 %)
Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Patienter i komparator-armen fik 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) 1.000 mg/m²/dag fra dag 1 til dag 5.
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) 1,000 mg/m²/day from day 1 to day 5.
Hos de patienter, der tidligere havde fået behandling med alkylerende stoffer uden effekt, blev docetaxel sammenlignet med doxorubicin (75 mg/m² hver 3. uge).
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/m² every 3 weeks).
• 258 patienter, som fik docetaxel i kombination med doxorubicin.
• 258 patients who received docetaxel in combination with doxorubicin.
Infektion (G3/4: 3,3 %)
Infection (G3/4: 3.3%)
Taxespira i kombination med platinmidler til patienter, der ikke tidligere behandlet med kemoterapi 1,218 patienter med inoperabel ikke-småcellet lungekræft stadium IIIB eller IV med KPS på 70 % eller mere, og som ikke tidligere havde fået kemoterapi mod denne tilstand, blev i et fase III-studie randomiseret til enten docetaxel (T) 75 mg/m2 administreret som 1-times infusion umiddelbart efterfulgt af cisplatin (Cis) 75 mg/m 2 administreret i løbet af 30-60 minutter hver 3. uge (TCis),
Taxespira in combination with platinum agents in chemotherapy-naïve patients In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
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) 1.000 mg/m²/dag fra dag 1 til dag 4.
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) 1,000 mg/m²/day from day 1 to day 4.
Dette svarer til 10 ml øl eller 4 ml vin.
This is equivalent to 10 ml of beer or 4 ml of wine.
Ved prostatakræft er det anbefalede præmedicineringsregimen, på grund af den samtidige behandling med prednison eller prednisolon, oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxelinfusion (se pkt.
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Efter anbrud af hætteglasset
After opening of the vial
Vaskulære sygdomme Luftveje, thorax og mediastinum
Vascular disorders Respiratory, thoracic and mediastinal disorders
Stigningen i overlevelse set i armen med ugentlig docetaxel var ikke statistisk signifikant sammenlignet med kontrolarmen på mitoxantron.
The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
G3/4 Forhøjet bilirubin i blodet (< 2,5 %);
G3/4 Blood bilirubin increased (<2.5%);
Hvis koncentratet med Taxespira kommer i kontakt med slimhinder, afvaskes området straks grundigt med vand.
If Taxespira concentrate should come into contact with mucous membranes, wash immediately and thoroughly with water.
I studiet TAX 316 blev alopeci, der fortsatte ind i opfølgningsperioden efter endt kemoterapi, rapporteret hos 687 ud af 744 TAC-patienter (92,3 %) og hos 645 ud af 736 FAC-patienter (87,6 %).
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%).
Et åbent, randomiseret multicenterstudie blev gennemført for at undersøge sikkerheden og effekten af docetaxel til behandling af patienter med metastatisk gastrisk adenokarcinom, herunder adenokarcinom i den gastroøsofageale forbindelse.
A multicenter, open-label, randomized 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.
• operabel, lymfeknude-positiv brystkræft • operabel, lymfeknude-negativ brystkræft
• operable node-positive breast cancer
, og mediantiden indtil reversibilitet af væskeretention var 16,4 uger (interval 0 til 42 uger).
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
FREMSTILLINGSVEJLEDNING TIL TAXESPIRA 20 KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
PREPARATION GUIDE FOR USE WITH TAXESPIRA CONCENTRATE FOR SOLUTION FOR INFUSION
Udvikling af svær perifer neurotoksicitet kræver reduktion af dosis (se pkt.
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
G3/4 Forhøjet bilirubin i blodet (< 2 %)
G3/4 Blood bilirubin increased (<2%)
• hjertesvigt
• heart failure
Fortæl det altid til lægen eller apotekspersonalet på hospitalet, hvis du bruger anden medicin eller har gjort det for nylig.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Første episode: Reducer docetaxel- og 5-FU-dosis med 20 %.
First episode: reduce docetaxel and 5-FU doses by 20%.
Tabel over bivirkninger ved adjuverende behandling med Taxespira 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknudenegativ (GEICAM 9805) brystkræft - samlede data
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with Taxespira 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Pakningsstørrelse:
Pack size:
Forekomsten af tilbagefald efter 10 år var reduceret hos de patienter, som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 39 % vs. 45 %).
Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
120 mg/6 ml indeholder 6 ml koncentrat.
120mg/6 ml contains 6 ml of concentrate.
Synkope (G3/4: 0 %); neurotoksicitet (G3/4: 0 %); somnolens (G3/4:
Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%); Somnolence (G3/4: 0%)
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.
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.
I begge arme fik patienter med ER + og/eller PR+ tumorer 20 mg tamoxifen én gang dagligt i op til 5 år efter den sidste kemoterapicyklus.
In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
Resumé af sikkerhedsprofilen for alle indikationer De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos:
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Hvis det kommer i kontakt med slimhinder, afvaskes området straks grundigt med vand.
If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
140 mg/7 ml Hvert hætteglas med 7 ml koncentrat indeholder 3,5 ml vandfri ethanol (2765 mg).
140mg/7 ml Each 7 ml vial of concentrate contains 3.5 ml of ethanol anhydrous (2765 mg).
Ved den mediane opfølgningsperiode på 10 år og 5 måneder havde TAC-behandlede patienter en 9 % lavere risiko for dødsfald sammenlignet med FAC-behandlede patienter (hazard ratio = 0,91; 95 % CI
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)).
Hætteglas med 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml og 160 mg/8 ml fås i pakninger med et enkelt hætteglas.
Vials containing 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml are available in packs containing a single vial.
Smerter i ekstremiteter (G3/4: < 1 %); rygsmerter (G3/4: 1 %)
Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%)
Behandling med docetaxel bør gentages, når neutrofiltallet igen er ≥ 1.500 celler/mm
Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm
I kombination med capecitabin er den anbefalede docetaxel-dosis 75 mg/m 2 hver 3. uge kombineret med capecitabin 1250 mg/m2 to gange dagligt (inden for 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by a 1-week rest period.
Patienter, der får TCF, bør monitoreres nøje (se pkt.
Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Ved afslutningen af opfølgningsperioden (faktisk median opfølgningstid på 8 år) fortsatte perifert ødem hos 19 TAC patienter og hos 4 FAC patienter (0,5 %).
At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 TAC patients and 4 FAC patients (0.5%).
Dette svarer til 70 ml øl eller 29 ml vin.
This is equivalent to 70 ml of beer or 29 ml of wine.
• nedsat hørelse
• hearing impaired
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 (TAC-regimen) (se også: Dosisjustering under behandling).
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/m 2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Feber (G3/4: 1,2 %)
Fever (G3/4: 1.2%)
ikke vurderede grader)
Grade1 (includes grade not assessed)
Arthralgi (G3/4: 0,3 %); myalgi (G3/4: 0,3 %)
Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
• muskelømhed og -smerter, rygsmerter eller knoglesmerter
• muscle aches and pains; back pain or bone pain
Hver ml koncentrat indeholder 20 mg docetaxel (som trihydrat).
Each ml of concentrate contains 20 mg docetaxel (as trihydrate).
• Induktionskemoterapi efterfulgt af kemo-strålebehandling (TAX 324) Docetaxels sikkerhed og effekt i induktionsbehandlingen af patienter med lokalt fremskreden pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et åbent, randomiseret fase IIImulticenterstudie (TAX 324).
• Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Ved slutningen af opfølgningsperioden (faktisk median opfølgningstid var 8 år) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9 %) og hos 16 FAC-patienter (2,2 %).
At the end of the follow-up period (actual median follow-up time of 8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
• Ved behandling af prostatakræft kan Taxespira indgives i kombination med prednison eller
• For the treatment of prostate cancer, Taxespira is administered in combination with prednisone
Taxespira 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.
Taxespira 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.
Hver 1 ml koncentrat indeholder 20 mg docetaxel (som trihydrat).
Each 1 ml of concentrate contains 20 mg docetaxel (as trihydrate).
MedDRA-systemorganklasse Meget almindelige
MedDRA system organ classes
120 mg/6 ml Hvert hætteglas med 6 ml koncentrat indeholder 3 ml vandfri ethanol (2370 mg).
120mg/6 ml Each 6 ml vial of concentrate contains 3 ml of ethanol anhydrous (2370 mg).
Median TTP (måneder) (95 % CI)
Median TTP (months) (95% CI)
Dette svarer til 60 ml øl eller 25 ml vin.
This is equivalent to 60 ml of beer or 25 ml of wine.
Median progressionsfri overlevelse (måneder) (95 % CI)
Median progression free survival (months) (95% CI)
Immunsystemet Metabolisme og ernæring Nervesystemet
Immune system disorders Metabolism and nutrition disorders Nervous system disorders
20 mg/1 ml Hvert hætteglas med 1 ml koncentrat indeholder 0,5 ml vandfri ethanol (395 mg).
20mg/1 ml Each 1 ml vial of concentrate contains 0.5 ml of ethanol anhydrous (395 mg).
Tabel over bivirkninger efter behandling af prostatakræft med Taxespira 75 mg/m² i kombination med prednison eller prednisolon
Tabulated list of adverse reactions in prostate cancer for Taxespira 75 mg/m² in combination with prednisone or prednisolone
4.2 og 4.4).
3 (see section 4.2).
Trombocytopeni (G4:
Thrombocytopenia (G3/4:
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 på grund af metastatisk sygdom.
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.
Taxespira i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
Taxespira in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
• Induktionskemoterapi efterfulgt af kemo-strålebehandling (TAX 324) Til den indledende behandling af patienter med lokalt fremskreden pladecellecarcinom i hoved og hals (SCCHN) (ikke muligt at 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/m 2 administreret som en 30 minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1000 mg/m2 som en kontinuerlig infusion fra dag
• 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/m administered as a 30-minute to
Dyspnø (alvorlig: 2,7
Dyspnoea (severe:
Anoreksi (G3/4: 0,6 %)
Anorexia (G3/4: 0.6%)