natgillin/translations-raw huggingface dataset:
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%)
Tiden indtil progressiv sygdom var længere i kombinationsarmen med docetaxel + capecitabin 
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p <0.0001).
Tumor-responsrate (%) 95 % CI p-værdi* 
Tumour response rate (%) 95% CI p-value*
Bedste overordnede respons på forsøgsbehandling [kemoterapi +/- strålebehandling] (%) (95 % CI) ***p-værdi 
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Patienter, som får TAC, bør monitoreres omhyggeligt (se pkt. 
Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8).
Hver ml opløsning indeholder 20 mg docetaxel (som trihydrat). 
Each ml of solution contains 20 mg of docetaxel (as trihydrate).
• trykken for brystet, vejrtrækningsbesvær 
• chest tightness; difficulty in breathing
160 mg/8 ml Hvert hætteglas med 8 ml koncentrat indeholder 4 ml vandfri ethanol (3160 mg). 
160mg/8 ml Each 8 ml vial of concentrate contains 4 ml of ethanol anhydrous (3160 mg).
Svimmelhed (G3/4: 2,0 %); perifer motorisk neuropati (G3/4: 0,4 %) 
Dizziness (G3/4: 2.0%); Peripheral motor neuropathy (G3/4: 0.4%)
• smagsforstyrrelser 
• alteration in sense of taste
Ved slutningen af kemoterapi fik patienter, hvis sygdomstilstand ikke var forværret, strålebehandling i 7 uger med et interval på mindst 4 uger og maksimalt 7 uger, udført efter fastlagte retningslinjer (TPF/RT). 
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/RT).
Ved slutningen af kemoterapi fik patienter, hvis sygdomstilstand ikke var forværret, strålebehandling i 7 uger med et interval på mindst 4 uger og maksimalt 7 uger, udført efter fastlagte retningslinjer (PF/RT). 
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/RT).
• ardannelse og fortykkelse i lungerne sammen med stakåndethed (lungefibrose) 
• pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
docetaxel 75 mg/m 2 som en 1-times infusion i kombination med carboplatin (AUC 6 mg/ml pr. min.) administreret i løbet af 30-60 minutter hver 3. uge, vinorelbin (V) 25 mg/m 2 administreret i løbet af 6 
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/m administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m 2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Letargi (G3/4: 19,0 %); feber (G3/4: 2,3 %); 
Lethargy (G3/4: 19.0%); Fever (G3/4: 2.3%);
Asteni (alvorlig: 9,9 %); Væskeretention (alvorlig: 0,7 %); 
9.9%); Fluid retention (severe: 0.7%);
Du skal straks informere din læge, hvis du bliver gravid under behandlingen. 
If pregnancy occurs during your treatment, you must immediately inform your doctor.
Beskrivelse af udvalgte bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m 2 i kombination med trastuzumab 
Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 in combination with trastuzumab
Indgivelseshyppighed 
Frequency of administration
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. 
Patients with hepatic impairment 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 2 (see sections 4.4 and 5.2).
For patienter med serum-bilirubin > øvre normalværdi og/eller ALAT og ASAT > 3,5 gange øvre normalværdi og basiske fosfataser > 6 gange øvre normalværdi kan det ikke anbefales at reducere dosis. 
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.
80 mg/4 ml Hvert hætteglas med 4 ml koncentrat indeholder 2 ml vandfri ethanol (1580 mg). 
80mg/4 ml Each 4 ml vial of concentrate contains 2 ml of ethanol anhydrous (1580 mg).
Vægtstigning (G3/4: 0 %); vægttab (G3/4: 
Weight increased (G3/4: 0%); Weight decreased (G3/4:
Det primære endepunkt for effekt i dette studie (OS) var signifikant længere (log-rank-test, p=0,0058) i det regimen, der indeholdt docetaxel sammenlignet med PF (median OS: henholdsvis 70,6 vs. 30,1 måneder) med en reduktion af risikoen for mortalitet på 30 % sammenlignet med PF (hazard ratio (HR) = 0,70, 95 % konfidensinterval (CI) = 0,54-0,90) og med en samlet median opfølgningstid på 41,9 måneder. 
versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Dosisjustering under behandling 
Dose adjustments during treatment
Du skal fortsætte med at tage præmedicineringen i yderligere 1 til 2 dage for at mindske visse bivirkninger, som kan opstå efter infusion af Taxespira. 
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Taxespira 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 Taxespira in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
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 study TAX316 amenorrhoea that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 202 of 744 TAC patients (27.2%) and 125 of 736 FAC patients (17.0%).
Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning Taxespira 140 mg/7 ml koncentrat til infusionsvæske, opløsning Taxespira 160 mg/8 ml koncentrat til infusionsvæske, opløsning 
Taxespira 20 mg/1 ml concentrate for solution for infusion Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
Der kan opstå overfølsomhedsreaktioner kan opstå 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.
Overfølsomhed (G3/4: 0,6 %) 
Hypersensitivity (G3/4: 0.6%)
Bedste overordnede respons (CR + PR) på kemoterapi (%) (95 % CI) ***p-værdi 
Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
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.
Patienter med nedsat leverfunktion 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. 
Patients with liver impairment 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.
Median OS (måneder) (95 % CI) 
Median OS (months) (95% CI)
Tredje episode: Reducer docetaxel-dosis med 20 %. 
Third episode: reduce docetaxel dose by 20%.
Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning Taxespira 140 mg/7 ml koncentrat til infusionsvæske, opløsning Taxespira 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel 
Taxespira 80 mg/4 ml concentrate for solution for infusion Taxespira 120 mg/6 ml concentrate for solution for infusion Taxespira 140 mg/7 ml concentrate for solution for infusion Taxespira 160 mg/8 ml concentrate for solution for infusion
80 mg/4 ml indeholder 4 ml koncentrat. 
80mg/4 ml contains 4 ml of concentrate
Bedste overordnede respons (CR + PR) på forsøgsbehandling [kemoterapi +/- kemostrålebehandling] (%) (95 % CI) ***p-værdi 
Best overall response (CR + PR) to study treatment [chemotherapy +/- chemoradiotherapy] (%) (95%CI) ***p-value
Taxespira i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere har fået kemoterapi mod denne tilstand. 
Taxespira 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.
20 mg/1 ml Et hætteglas med 1 ml koncentrat indeholder 20 mg docetaxel. 
20mg/1 ml One vial of 1 ml of concentrate contains 20 mg docetaxel.
Reaktioner på infusionsstedet; Ikkehjerterelaterede brystsmerter (alvorlig: 
Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Total overlevelse efter 10 år var også signifikant forøget med TAC i forhold til FAC (henholdsvis 76 % vs. 69 %). 
OS at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
140 mg/7 ml Et hætteglas med 7 ml koncentrat indeholder 140 mg docetaxel. 
140mg/7 ml One vial of 7 ml concentration contains 140 mg docetaxel.
Beskrivelse af udvalgte bivirkninger efter behandling af gastrisk adenokarcinom med Taxespira 75 mg/m2 i kombination med cisplatin og 5-fluorouracil 
Description of selected adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m 2 in combination with cisplatin and 5-fluorouracil
G3/4 Forhøjet alkalisk fosfatase i blodet (< 2,5 
G3/4 Blood alkaline phosphatase increased
• svamp i mundhulen (trøske) 
• haemorrhage (bleeding)
• For 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/m
I studiet TAX316 forekom perifer sensorisk neuropati i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden hos 84 patienter (11,3 %) i TAC-armen og hos 15 patienter (2 %) i FAC-armen. 
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.
160 mg/8 ml Et hætteglas med 8 ml koncentrat indeholder 160 mg docetaxel. 
160mg/8 ml One vial of 8 ml concentration contains 160 mg docetaxel.
Der er ingen tilgængelige data vedrørende behandling med docetaxal af patienter med alvorligt nedsat nyrefunktion. 
Patients with renal impairment There are no data available in patients with severely impaired renal function treated with docetaxel.
Asteni, som forekom i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden og blev fortsat observeret hos 12 patienter (2,3 %) i TAC-armen og 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.
Medmindre det er kontraindiceret, kan der til brystkræft og ikke-småcellet lungekræft gives et peroralt kortikosteroid som præmedicinering, eksempelvis dexamethason 16 mg pr. dag i 3 dage (f.eks. 8 mg 2 gange daglig). 
For breast, non-small cell lung, gastric, and head and neck cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).