natgillin/translations-raw huggingface dataset:
Kontakt lægen, hospitalsfarmaceuten eller sundhedspersonalet, hvis du har hjerteproblemer.
Tell your doctor, hospital pharmacist or nurse if you have heart problems.
Forhøjet lakrimation; konjunktivitis
Lacrimation increased; Conjunctivitis
I kombination med capecitabin er den anbefalede DOCETAXEL KABI-dosis 75 mg/m2 hver 3. uge kombineret med capecitabin 1250 mg/m2 to gange daglig (indenfor 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/m2 every three weeks, combined with capecitabine at 1250 mg/m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period.
Median varighed af respons til kemoterapi ± strålebehandling (måneder) (95 %CI)
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Der er rapporter om anafylaktisk shock, i nogle tilfælde letale.
Some cases of anaphylactic shock, sometimes fatal, have been reported.
445 patienter med KPS > 70 blev behandlet med enten docetaxel (T) (75 mg/m2 på dag 1) i kombination med cisplatin (C) (75 mg/m2 på dag 1) og 5-fluoruracil (F) (750 mg/m2 pr. dag i 5 dage) eller cisplatin (100 mg/m2 på dag 1) og 5-fluoruracil (1000 mg/m2 pr. dag i 5 dage).
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
• lavt blodtryk Mere alvorlige reaktioner kan forekomme.
• low blood pressure.
I studiet GEICAM9805 udviklede 3 patienter (0,6%) i TAC-armen og 3 patienter (0,6%) i FAC-armen kongestivt hjertesvigt i opfølgningsperioden.
In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær prostatakræft blev undersøgt i et randomiseret multicenter fase III-studium.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multi-centre phase III study.
Neutropeni (G4: 54,2 %);
Neutropenia (G4: 54.2%);
Neutropenisk infektion; Infektion (G3/4: 11,7 %)
Neutropenic infection; Infection (G3/4: 11.7%)
Hos de patienter, der tidligere havde fået behandling med anthracyclin uden effekt, blev docetaxel sammenlignet med kombinationsbehandling med mitomycin C og vinblastine (12 mg/m2 hver 6. uge og 6 mg/m2 hver 3. uge).
In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
• Docetaxel 75 mg/m2 hver 3. uge i 10 behandlingsrunder.
• Docetaxel 75 mg/m2 every 3 weeks for 10 cycles.
Hos patienter, der blev behandlet med docetaxel i kombination med doxorubicin og cyclophosphamid (TAC), opstod febril neutropeni og/eller neutropenisk infektion sjældnere, når patienterne fik primær G-CSF-profylakse.
In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
Begge regimer blev administreret en gang hver 3. uge i 6 cykler.
Both regimens were administered once every 3 weeks for 6 cycles.
Det skal du vide, før du begynder at bruge DOCETAXEL KABI
What you need to know before you use DOCETAXEL KABI
Der blev vist signifikant længere sygdoms-fri overlevelse i TAC-armen end FAC-armen.
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
• 406 patienter, som fik docetaxel i kombination med cisplatin.
• 406 patients who received docetaxel in combination with cisplatin.
Hos et beskedent antal patienter (n = 23) med en klinisk kemi, der tydede på en let til moderat nedsat leverfunktion (ASAT og ALAT ≥ 1,5 gange øvre normalværdi og basisk fosfatase ≥ 2,5 gange øvre normalværdi), var clearance nedsat med gennemsnitlig 27 %.
In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥ 1.5 times the ULN associated with alkaline phosphatase ≥ 2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
I dette kliniske studium randomiseredes 255 patienter til behandling med docetaxel (75 mg/m² som en 1-times intravenøs infusion hver 3. uge) og capecitabin (1250 mg/m2 to gange daglig i 2 uger efterfulgt af en uges pause).
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
• Næseflåd, betændelse i hals og næse, hoste
• nasal drainage; inflammation of the throat and nose; cough
Indberetning af bivirkninger
Reporting of adverse effects
• Ved behandling af prostatakræft kan DOCETAXEL KABI indgives i kombination med prednison eller prednisolon.
- For the treatment of prostate cancer, DOCETAXEL KABI is administered in combination with prednisone or prednisolone.
Hypotension; Hypertension; Hæmoragi
Hypertension; Haemorrhage
o Hvert hætteglas er til engangsbrug og skal anvendes straks efter åbning.
• Each vial is for single use and should be used immediately after opening.
Strålepneumonitis er blevet rapporteret hos patienter i samtidig strålebehandling.
Cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Livskvalitetsparamte
Quality of life parameters
Der er rapporter om mindre hyppige, alvorlige reaktioner såsom udslæt efterfulgt af afskalning, der sjældent førte til afbrydelse eller ophør med docetaxel-behandlingen (se pkt.
Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Co-administrationen af docetaxel, doxorubicin og cyclophosphamid påvirkede ikke deres farmakokinetik.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Et åbent multicenter randomiseret fase III-studie blev udført for at sammenligne docetaxel monoterapi med paclitaxel i behandlingen af fremskreden brystkræft hos patienter, hvis tidligere behandling havde inkluderet et antracyklin.
An open-label, multi-centre, randomised phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
I kombination med capecitabin anbefales det at reducere startdosis af capecitabin til 75 % hos patienter på 60 år eller ældre (se produktresumé for capecitabin).
In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
- Øvrige indholdsstoffer: polysorbat 80, ethanol vandfri (se afsnit 2) og citronsyre vandfri (til pHjustering)
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and anhydrous citric acid (for pH adjustment).
Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1491 patienter randomiseret til enten at få enten docetaxel 75 mg/m2 administreret en time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (TAC-arm), eller doxorubicin 50 mg/m2, fulgt af fluoruracil 500 mg/ m2 og cyclophosphamid 500 mg/m2 (FAC-arm).
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Vaskulære sygdomme: Venøse tromboemboliske tilfælde er sjældent rapporteret.
Vascular disorders Venous thromboembolic events have rarely been reported.
Det er påvist, at docetaxel er både embryo-og føtotoksisk hos kaniner og rotter, samt at de nedsætter fertiliteten hos rotter.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats (see section 5.3).
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).
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.
Patienter i behandling med TCF bør have profylaktisk G-CSF for at nedsætte risikoen for kompliceret neutropeni (febril neutropeni, prolongeret neutropeni eller neutropenisk infektion).
Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
• Ved behandling af lungekræft kan DOCETAXEL KABI enten indgives alene eller i kombination med cisplatin.
- For the treatment of lung cancer, DOCETAXEL KABI could be administered either alone or in combination with cisplatin.
DOCETAXEL KABI i kombination med capecitabin
DOCETAXEL KABI in combination with capecitabine
Arytmi (ikke alvorlig)
Arrhythmia (no severe)
Dette regime blev administreret hver 3. uge i 4 cyklusser.
This regimen is administered every 3 weeks for 4 cycles.
Derfor er den anbefalede dosis docetaxel 75mg/m2 til de patienter, der har forhøjet leverfunktionstest (LFT), og LFT skal måles ved start og før hver behandlingscyklus (se pkt.
Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/m2 and LFTs should be measured at baseline and before each cycle (see section 4.2).
Citronsyre, vandfri (pH-justering)
Anhydrous citric acid (pH adjustment)
o Bland infusionsposen- eller flasken manuelt med vippende bevægelser.
• Mix the infusion bag or bottle manually using a rocking motion.
Fase I-studier har undersøgt docetaxels farmakokinetiske egenskaber hos kræftpatienter efter indgift af 20- 115 mg/m2.
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20115 mg/m2 in phase I studies.
Dette regime administreres hver 3. uge i 3 cyklusser.
This regimen is administered every 3 weeks for 3 cycles.
DOCETAXEL KABI i kombination med cisplatin og 5-fluoruracil er indiceret til indledende behandling af patienter med inoperable, lokale, fremskredne skællede celle-carcinoma i hoved og hals.
DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
Patienter med en udgangsværdi for neutrofile granulocytter på < 1.500 celler/mm3.
Patients with baseline neutrophil count of < 1,500 cells/mm3.
For cisplatin- og 5-fluoruracil-dosis justeringer: Se tilsvarende produktresumé.
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
I nogle tilfælde (hyppighed ikke kendt) er permanent hårtab observeret.
In some cases (frequency not known)
Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter):
Very common (may affect more than 1 in 10 people):
Hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion blev reduceret hos patienter der fik primær G- CSF-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).
Bivirkningerne for docetaxel kan blive mere alvorlige, når docetaxel gives i kombination med andre kemoterapeutiske midler.
The severity of adverse events of docetaxel may be increased when docetaxel is given in combination with other chemotherapeutic agents.
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).
Sjældne (kan forekomme hos op til 1 ud af 1.000 patienter):
Rare (may affect up to 1 in 1,000 people):
DOCETAXEL KABI i kombination med cisplatin og 5-fluoruracil er indiceret til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom i den gastrooesophageale forbindelse, som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
DOCETAXEL KABI in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
o Fra et mikrobiologisk synspunkt skal rekonstituering/fortynding ske under kontrollerede og aseptiske forhold, og lægemidlet skal anvendes straks.
• From a microbiological point of view, reconstitution /dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
Stigningen i overlevelse set i armen med ugentlig docetaxel var ikke statistisk signifikant sammenlignet med mitxantron kontrol-armen.
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:
Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med DOCETAXEL KABI 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 DOCETAXEL KABI 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
DOCETAXEL KABI i kombination med doxorubicin og cyclophosphamid: Adjuverende behandling
DOCETAXEL KABI in combination with doxorubicin and cyclophosphamide: adjuvant therapy
• Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) MedDRA Systemorganklasser
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 20 mg docetaxel vandfri.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg docetaxel anhydrous.
Amenorré (G3/4: NA)
Amenorrhoea (G3/4: NA)
Almene symptomer og reaktioner på administrationsstedet: Der er sjældne rapporter om radiation recall-fænomen.
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Efter tilsætning til infusionspose
Once added to the infusion bag
Effekt af docetaxel i indledende behandling til patienter med inoperable, lokale fremskredne SCCHN (Hensigt at behandle-analyse)
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
1218 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/m2 administreret i løbet af 30-60 minutter hver 3. uge (TCis), docetaxel 75 mg/m2 som en 1-times infusion i kombination med carboplatin (AUC 6 mg/ml per min) administreret i løbet af 30-60 minutter hver 3. uge, vinorelbin (V) 25 mg/ m2 administreret i løbet af 6 til 10 minutter på dag 1, 8, 15, 22 efterfulgt af cisplatin 100 mg/m2 administreret på dag 1 af cyklusser gentaget hver 4. uge (VCis).
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/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Neutropeni (G3/4: 32 %);
Neutropenia (G3/4: 32%);
Forekomsten af tilbagefald ved 10 år var reduceret hos de patienter, som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 39 % versus 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).
Total overlevelse (Primær endepunkt) Median overlevelsestid (måneder)
Median survival (months)
Din læge vil beregne din legemsoverflade i m2
Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Asteni (alvorlig: 12,4 %); Væskeretention (alvorlig: 0,8 %); smerter
Asthenia (severe: 12.4%); Fluid retention (severe: 0.8%);Pain
Myelodysplastisk syndrom blev rapporteret hos 2 ud af 744 TAC-patienter (0,3 %) og hos 1 ud af 736 FAC-patienter (0,1 %).
Myelodysplastic syndrome was reported in 2 of 744 TAC patients (0.3%) and in 1 of 736 FAC patients (0.1%).
Øvre mavesmerter; Tør mund
Abdominal pain upper; Dry mouth
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).
Meget almindelige bivirkninger
Very common adverse reactions
Kvalme; diarré; opkastning; konstipation; stomatitis; dyspepsi; mavesmerter
Nausea; Diarrhoea; Vomiting; Constipation; Stomatitis; Dyspepsia;
• For capecitabin dosis-justeringer, se capecitabins produktresumé.
• For capecitabine dose modifications, see capecitabine summary of product characteristics.
Væskeretention (alvorlig: 6,5 %) Asteni (alvorlig: 11,2 %); smerter
Fluid retention (severe: 6.5%); Asthenia (severe: 11.2%); Pain
• Ved behandling af metastatisk gastrisk kræft indgives DOCETAXEL KABI i kombination med cisplatin og 5-fluoruracil.
- For the treatment of metastatic gastric cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
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. dag, givet som en 24-timers kontinuerlig infusion i 5 dage, med start efter endt cisplatin-infusion.
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.
• 255 patienter, som fik docetaxel i kombination med capecitabin.
• 255 patients who received docetaxel in combination with capecitabine.
Tabel over bivirkninger ved adjuverende behandling med DOCETAXEL KABI 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknudenegativ (GEICAM 9805) brystkræft - pooled data:
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with DOCETAXEL KABI 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
TAC-behandlede patienter havde 32 % lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard ratio = 0,68; 95 % CI (0,49-0,93); p = 0,01).
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
En multicenter, åben, randomiseret undersøgelse har evalueret sikkerhed og effekt af docetaxel til behandling af patienter med metastatisk gastrisk adenokarcinom, inklusive adenokarcinom af den gastrooesophagele forbindelse.
A multi-centre, 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.
Graviditet, amning og frugtbarhed Spørg din læge til råds, før du tager nogen form for medicin.
Ask your doctor for advice before being given any medicine.
Patienter i docetaxel-armen fik docetaxel (T) 75 mg/m2 efterfulgt af cisplatin (P) 75 mg/m2 efterfulgt af 5fluoruracil 750 mg/m2 daglig som en kontinuerlig infusion i 5 dage.
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.
Du eller dine pårørende kan også indberette bivirkninger via det nationale rapporteringssystem anført i Appendiks V
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Pyrexi (G3/4: 1 %);
Pyrexia (G3/4: 1%);
• Lungefibrose (ardannelse og fortykkelse i lungerne samt åndenød)
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
DOCETAXEL KABI i kombination med doxorubicin
DOCETAXEL KABI in combination with doxorubicin
Infektion (G3/4: 3,6 %) Neutropenisk infektion
Infection (G3/4: 6.3%); Neutropenic infection
På den anden side viste AC-armen en hyppigere forekomst af alvorlig anæmi (15,8 % versus 8,5 %) end AT-armen og tillige en hyppigere forekomst af alvorlig hjertetoksicitet: Hjerteinsufficiens (3,8 % versus 2,8 %), total LVEF-nedsættelse > 20 % (13,1 % versus 6,1 %), total LVEF-nedsættelse > 30 % (6,2 % versus 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%).
• Næseblod
• bleeding from the nose
95 %CI p-værdi
95% CI p-value*
1 hætteglas med 180 mg/9 ml.
1 vial with 180 mg/9 ml
Alopeci (G3/4: 4,0 %)
Alopecia (G3/4: 4.0%)
Der foreligger ingen data for patienter med nedsat leverfunktion i kombinationsbehandling ved andre indikationer.
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
Nedsættelsen af risikoen for progression var 32,1 % og blev associeret med en signifikant længere TTP (p = 0,0004) til fordel for TCF-armen.Overlevelse i alt var også signifikant længere (p = 0,0201) til fordel for TCFarmen med en nedsættelse af risikoen for død på 22,7 %.
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.
Opbevaringsforhold efter fortynding af lægemidlet, se pkt.
For storage conditions of the diluted medicinal product, see section 6.3.