natgillin/translations-raw huggingface dataset:
Median TTP (måneder) (95 %CI) 
Median TTP (months) (95% CI)
Der er ingen tilgængelige data vedrørende behandling med docetaxal af patienter med alvorligt nedsat nyrefunktion. 
There are no data available in patients with severely impaired renal function treated with docetaxel.
Alopeci; Hudreaktioner (G3/4: 0,8 %) 
Alopecia; Skin reaction (G3/4: 0.8%)
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. 
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.
Træthed (G3/4: 3,9 %); Væskeretention (alvorlig: 0,6 %) 
Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Hvert hætteglas af koncentrat indeholder 2 ml ethanol vandfri (1,58 g). 
Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
Ved dosismodifikation af cisplatin og 5-fluoruracil henvises der til de tilsvarende produktresuméer. 
For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Nervesystemet: 
Nervous system disorders
Behandling med docetaxel bør gentages, når neutrocyttallet igen er ≥ 1.500 celler/mm3 (se pkt. 
Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm3 (see section 4.2).
Tilberedning af infusionsvæske 
Preparation of the infusion solution
• rygsmerter 
• haemorrhage
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). 
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).
Kutane reaktioner 
Cutaneous reactions
Svimmelhed (G3/4: 2,3 %); Perifer motorisk neuropati (G3/4: 1,3 %) 
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
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. 
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).
Der blev ikke observeret nogen signifikant virkning af prednison på docetaxels farmakokinetik. 
No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Kontakt lægen, hospitalsfarmaceuten elle sundhedspersonalet, hvis du oplever problemer med dit syn. 
Tell your doctor, hospital pharmacist or nurse if you have vision problems.
1 hætteglas med 120 mg/6 ml. 
1 vial with 120 mg/6 ml
Paræstesi; hovedpine; dysgeusi; hypoæstesi 
Paraesthesia; Headache; Dysgeusia; Hypoaesthesia
A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
Asteni; periferalt ødem; pyrexi; træthed; inflammation i slimhinderne; smerter; influenzalignende symptomer; brystsmerter; kulderystelser 
Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
• 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. 
• 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.
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: 
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.
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. 
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.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) 
MARKETING AUTHORISATION NUMBER
Hvert hætteglas af koncentrat indeholder 3 ml ethanol vandfri (2,37 g). 
Each vial of concentrate contains 3 ml of ethanol anhydrous (2.37 g).
Trombocytopeni (G4: 1,7 %) 
Thrombocytopenia (G4: 1.7%)
Opkastning (G3/4: 7,6 %); Diarré (G3/4: 6,4 %); Stomatitis (G3/4: 2 %) 
Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
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) 
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
• Nedsat hørelse 
• hearing impaired
1 hætteglas med 80 mg/4 ml. 
1 vial with 80 mg/4 ml
• operabel, lymfeknude-negativ brystkræft 
• operable node-negative breast cancer.
• Hjertesvigt 
• heart failure
Stomatitis (G3/4: 1,7 %); Opkastning (G3/4: 0,8 %); Diarré (G3/4: 1,7 %) 
Stomatitis (G3/4: 1.7%); Vomiting (G3/4: 0.8%); Diarrhoea (G3/4: 1.7%)
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. 
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).
Gennemsnitlig varighed af respons (måneder) (95 %CI) 
Median duration of response (months) (95% CI)
Bedste respons i alt til undersøgelsesbehandling [kemoterapi +/- strålebehandling] (%) (95 %CI) ***p-værdi 
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
1 hætteglas med 20 mg/1 ml. 
1 vial with 20 mg/1 ml
Lægemidlet er receptpligtigt (se bilag I: Produktresumé, pkt. 
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).
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. 
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.
• Til behandling af hoved- og hals-kræft indgives DOCETAXEL KABI i kombination med cisplatin og 5- fluoruracil. 
- For the treatment of head and neck cancer, DOCETAXEL KABI is administered in combination with cisplatin and 5-fluorouracil.
Stomatitis (G3/4: 23,7 %); Opkastning (G3/4: 14,3 %) 
Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%)
LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning. 
PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate).
Anoreksi (G3/4: 1,5 %) 
Anorexia (G3/4: 1.5%)
• 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. 
• 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.
Neutropeni (G3/4: 63 %); Anæmi (G3/4: 10 %) 
Neutropenia (G3/4: 63%); Anaemia (G3/4: 10%)
Hvert hætteglas af koncentrat indeholder 4 ml ethanol vandfri (3,16 g). 
Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Neutropeni (G3/4: 32 %); Anæmi (G3/4: 4,9 %) 
Neutropenia (G3/4: 32%); Anaemia (G3/4: 4.9%)
Anoreksi (G3/4:12,0 %) 
Anorexia (G3/4: 12.0%)
Der kan opstå overfølsomhedsreaktioner inden for få minutter efter infusion af docetaxel er påbegyndt. 
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.
Koncentrat til infusionsvæske, opløsning (sterilt koncentrat) Koncentratet er en klar, farveløs til svag gul opløsning. 
The concentrate is a clear, colourless to pale yellow solution.
Anæmi (G3/4: 10,8 %); 
Anaemia (G3/4: 10.8%);
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. 
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.
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 
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
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. 
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.
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. 
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%).
• 92 patienter, som fik docetaxel i kombination med trastuzumab. 
• 92 patients treated with docetaxel in combination with trastuzumab.
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. 
Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Træthed/svaghed (G3/4: 5 %); Perifert ødem (G3/4: 1 %); 
Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
DOCETAXEL KABI i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi. 
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.
Patienter bør overvåges nøje for tidlige tegn på alvorlig gastrointestinal toksisitet (se pkt. 
Patients should be closely monitored for early manifestations of serious gastrointestinal toxicity (see sections 4.2, 4.4 Haematology, and 4.8).
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. 
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.
Hud og subkutane væv Alopeci (G3/4: 4,0 %) Kløende udslæt 
Skin and subcutaneous Alopecia (G3/4:4.0%)
Hver ml koncentrat til infusionsvæske, opløsning indeholder 20 mg docetaxel. 
Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Svimmelhed; 
Dizziness;
Trombocytopeni (G3/4:1,6 %); 
Thrombocytopenia (G3/4: 1.6%);
• Mundtørhed 
• oral candidiasis
Docetaxels plasmaproteinbinding er > 95 %. 
Docetaxel is more than 95% bound to plasma proteins.
Patient fordeling 
Patient subset
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 %). 
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%).
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22nd May 2012
Patienter fra TPF-armen blev behandlet med profylaktisk antibiotika med ciprofloxacin 500 mg oralt 2 gange daglig i 10 dage. 
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.
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 %). 
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%).
Dehydrering (G3/4: 2 
Dehydration (G3/4: 2%)
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. 
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.
Myalgi (alvorlig 0,5 
Myalgia (severe: 0.5%)
Der blev ikke observeret effekt af prednison på docetaxels farmakokinetik. 
Prednisone No effect of prednisone on the pharmacokinetics of docetaxel was observed.
Konstipation; 
Dyspepsia;
Myalgi (G3/4: 2 %); Artralgi (G3/4: 1 %) 
Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Begge behandlingsmåder blev administreret hver 3. uge. 
Both regimens were administered every 3 weeks.
Første episode: Reducer docetaxel- og 5-FU-dosis med 20 % Anden episode: Afbryd behandlingen 
First episode: reduce docetaxel and 5-FU doses by 20%.
2-års estimat (%) Hazard ratio (95 %CI) *p-værdi 
2-year estimate (%) Hazard ratio (95% CI) *p-value
Antal patienter Tumor-response rate (%) 95 %CI p-værdi* 
Number of patients Tumor response rate (%) 95% CI p-value*
• Hos patienter, der for anden gang udvikler grad 2-toksicitet eller første gang grad 3-toksicitet, skal behandlingen udsættes, indtil grad 0-1 nås. 
• For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1 and then resume treatment with docetaxel 55 mg/m².
Udvikling af alvorlig perifer neurotoksicitet kræver en dosisreduktion (se pkt. 
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
1.060 patienter blev randomiseret til at få enten DOCETAXEL KABI 75 mg/m2 administreret 1 time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (539 patienter i TAC-armen) eller doxorubicin 50 mg/m2 efterfulgt af fluoruracil 500 mg/m2 og cyclophosphamid 500 mg/m2 (521 patienter i FAC-armen) som adjuverende behandling. 
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).).
• Fordøjelsesbesvær 
• indigestion
Hvert hætteglas af koncentrat indeholder 4,5 ml ethanol vandfri (3,55 g). 
Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Antal patienter Smerte-response rate (%) 95 %CI p-værdi* 
Number of patients Pain response rate (%) 95% CI p-value*
Hos patienter, der behandles med docetaxel som enkeltstof i dosis på 100 mg/m2, som har en serumtransaminase-værdi (ALAT og/eller ASAT) på mere end 1,5 gange den øvre normalværdi samtidig med, at de serum-basiske fosfatase-værdier overstiger den øvre normalværdi 2,5 gange, er der en større risiko for udvikling af alvorlige bivirkninger. 
In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
Infektion associeret med G4-neutropeni (G3/4: 
Infection associated with G4 neutropenia (G3/4: 4.6%)
Asteni, som forekom i løbet af behandlingsperioden, fortsatte ind i opfølgningsperioden og blev fortsat observeret hos 12 patienter (2,3 %) i TAC-armen og hos 4 patienter (0,8 %) i FAC-armen. 
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.
Median progression fri overlevelse (måneder) (95 %CI) 
Median progression free survival (months) (95% CI)
Infektioner (G3/4: 5 %) 
Infections (G3/4: 5%)
DOCETAXEL KABI koncentrat til infusionsvæske, opløsning er en klar, farveløs til svag gul opløsning. 
What DOCETAXEL KABI looks like and contents of the pack DOCETAXEL KABI concentrate for solution for infusion is a clear, colourless to pale yellow solution.
Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med DOCETAXEL KABI 75 mg/m2 i kombination med cisplatin og 5-fluorouractil 
Description of selected adverse reactions in gastric adenocarcinoma cancer for DOCETAXEL KABI 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Perifer sensorisk neuropati (G3/4: 8,7 %) 
Peripheral sensory neuropathy (G3/4: 8.7%)
I studiet TAX 316 forekom asteni i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden efter afsluttet kemoterapi og blev rapporteret hos 236 af 744 TAC patienter (31,7 %) og hos 180 af 736 FAC patienter (24,5 %). 
In study TAX316 asthenia that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).
Du skal fortsætte med at tage præmedicinen i endnu 1 til 2 dage for at formindske visse bivirkninger, som kan forekomme efter infusionen af DOCETAXEL KABI. 
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to DOCETAXEL KABI administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of DOCETAXEL KABI in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Stomatitis (G3/4: 18 %); Diarré (G3/4: 14 %); Kvalme 
Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%);
Perifer motorisk neuropati (G3/4: 2,5 %) 
Peripheral motor neuropathy (G3/4: 2.5%)
Almindelige (kan forekomme hos op til 1 ud af 10 patienter): 
Common (may affect up to 1 in 10 people):
Øget tåresekretion (G3/4: < 0,1 %); 
Lacrimation increased (G3/4: < 0.1%)
Dysgeusi (G3/4: 0,6 %); Perifer sensorisk neuropati (G3/4: < 
Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: < 0.1%)
Alopeci; erythema; udslæt; neglesygdomme 
Alopecia; Erythema; Rash; Nail
Luftveje, thorax og mediastinum Epistaxis; pharyngolaryngeal smerte; nasopharyngitis; dyspnø; 
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Artralgi (G3/4: 0,3 %); Myalgi (G3/4: 0,3 %) 
Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Efter 10 års opfølgning i GEICAM 9805-studiet forekom akut leukæmi hos 1 ud af 532 (0,2%) patienter i TAC-armen. 
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.
Anæmi (G3/4: 8,9 %); Febril neutropeni 
Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
• Synkebesvær eller smerter ved synkning 
• difficulty or painful swallowing
Ved slutningen af opfølgningsperioden (faktisk median opfølgningstid var 8 år) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9%) og 16 FAC-patienter (2,2%). 
At the end of the follow-up period (actual median follow-up time of8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2,2%).
Alle andre lægemidler blev givet som intravenøs bolus på dag 1. 
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.