natgillin/translations-raw huggingface dataset:
I studiet TAX 316 forekom lymfødemi i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden efter afsluttet kemoterapi og blev rapporteret hos 11 af 744 TAC patienter (1,5 %) og hos 1 af 736 FAC patienter (0,1 %). 
In study TAX316 lymphoedema that started during the treatment period and persisted into the followup period after the end of chemotherapy was reported in 11 of 744 TAC patients (1.5%) and 1 of 736 FAC patients (0.1%).
Metabolisme og ernæring Nervesystemet 
Metabolism and nutrition disorders Nervous system disorders
Vaskulære sygdomme Hedeture (G3/4: 0,5 %) Hypotension (G3/4: 0 %); flebitis (G3/4: 0 
Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%); Phlebitis (G3/4:
• synkebesvær eller smerter ved synkning 
• difficulty or painful swallowing
Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning 
Taxespira 20 mg/1 ml concentrate for solution for infusion
For at kunne udtage den korrekte dosis til patienten kan det være nødvendigt at anvende mere end et hætteglas med Taxespira koncentrat til infusionsvæske, opløsning. 
More than one vial of Taxespira concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
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 arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Tabel over bivirkninger efter behandling af ikke-småcellet lungekræft med Taxespira 75 mg/m² i kombination med cisplatin 
Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² in combination with cisplatin
Docetaxel blev elimineret både i urin og fæces efter cytocrom P-450-medieret oxidativ metabolisering af tert-butyl-estergruppen. 
Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Se produktresuméet for trastuzumab for yderligere oplysninger. 
For more details see summary of product characteristics of trastuzumab.
Letargi (G3/4: 3,4 %); pyreksi (G3/4: 0,6 %); væskeretention; ødem 
Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
I studiet GEICAM 9805 blev det observeret, at amenorré, som forekom i løbet af behandlingsperioden, og fortsatte ind i opfølgningsperioden, fortsat blev observeret hos 18 patienter (3,4 %) i TAC-armen og hos 5 patienter (1,0 %) i FAC-armen. 
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period and was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
tilfælde af grad 4-trombocytopeni bør dosis af docetaxel reduceres fra 75 mg/m til 60 mg/m Patienterne bør ikke genbehandles med efterfølgende cyklusser af docetaxel, før neutrofil-tallet gendannes til et niveau på > 1.500 celler/mm 3, og blodplader gendannes til et niveau på > 100.000 
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500cells/mm 3 and platelets recover to a level >100,000 cells/mm 3.
Anden episode: Reducer så docetaxel-dosis med 20 %. 
Second episode: then reduce docetaxel dose by 20%.
Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol), dvs. op til 3160 mg vandfri ethanol pr. 8 ml hætteglas, svarende til 80 ml øl eller 33 ml vin. 
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial, equivalent to 80 ml of beer or 33 ml wine.
Konstipation; øsofagitis/dysfagi/ odynofagi (G3/4: 0,6 %); mavesmerter; 
Oesophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain; Dyspepsia;
Anden episode: Reducer docetaxel-dosis med 20 %. 
Second episode: reduce docetaxel dose by 20%.
mg/m 2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m 2 pr. dag, 
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.
• rødmen og hævelse på håndflader eller fodsåler, som kan få huden til at skalle af. 
• redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
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).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).
80 mg/4 ml Et hætteglas med 4 ml koncentrat indeholder 80 mg docetaxel. 
80mg/4 ml One vial of 4 ml concentration contains 80 mg docetaxel.
Tabel over bivirkninger efter behandling af brystkræft med Taxespira 75 mg/m² i kombination med doxorubicin 
Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with doxorubicin
120 mg/6 ml Et hætteglas med 6 ml koncentrat indeholder 120 mg docetaxel. 
120mg/6 ml One vial of 6 ml concentrate contains 120 mg docetaxel.
Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol), dvs. op til 1580 mg vandfri ethanol pr. 4 ml hætteglas, svarende til 40 ml øl eller 17 ml vin. 
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anyhdrous per 4 ml vial, equivalent to 40 ml of beer or 17 ml wine.
Se det relevante produktresumé vedrørende justering af cisplatin-dosis. 
For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Taxespira 140 mg/7 ml koncentrat til infusionsvæske, opløsning Docetaxel 
Taxespira 140 mg/7 ml concentrate for solution for infusion.
Ikke almindelige bivirkninger neuropati (G3/4: 4 %); Dysgeusi (alvorlig: 
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Median varighed af respons på kemoterapi ± strålebehandling (mdr.) 
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Vægttab; G3/4 forhøjet bilirubin i blodet (9 %) 
Weight decreased; G3/4 Blood bilirubin increased
Tabel over bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m² i kombination med trastuzumab 
Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² in combination with trastuzumab
Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol), dvs. op til 395 mg vandfri ethanol pr. 1 ml hætteglas, svarende til 10 ml øl eller 4 ml vin. 
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml, equivalent to 10 ml of beer or 4 ml wine.
Taxespira er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungekræft efter behandlingssvigt af kemoterapi. 
Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Taxespira 160 mg/8 ml koncentrat til infusionsvæske, opløsning Docetaxel 
Taxespira 160 mg/8 ml concentrate for solution for infusion.
Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol), dvs. op til 2765 mg vandfri ethanol pr. 7 ml hætteglas, svarende til 70 ml øl eller 29 ml vin. 
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial, equivalent to 70 ml of beer or 29 ml wine.
Patienterne i docetaxel-armen fik docetaxel (T) 75 mg/m efterfulgt af 5-fluoruracil 750 mg/m2 dagligt 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
Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 2370 mg vandfrit ethanol pr. 6 ml hætteglas. 
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial.
Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 2765 mg vandfrit ethanol pr. 7 ml hætteglas. 
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial.
Etiket til hætteglas 
Vial label
Overfølsomhed (G3/4: 
Hypersensitivity (G3/4:
Venesygdomme (G3/4: 
Venous disorder (G3/4:
Neglesygdomme (alvorlig: 0,4 %); 
Nail disorders (severe: 0.8%)
Tabel over bivirkninger efter behandling af ikke-småcellet lungekræft med Taxespira 75 mg/m² som enkeltstof 
Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² single agent
Taxespira i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystkræft, som har HER2-positive tumorer, og som ikke tidligere har fået kemoterapi mod metastatisk sygdom. 
Taxespira in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
• mundsår 
• dry mouth
Median overlevelse (måneder) (95 % CI) 
Median survival (months) (95% CI)
Du kan få feber eller infektioner, hvis antallet af hvide blodlegemer ikke tilfredsstillende. 
In case of white blood cells disturbances, you may experience associated fever or infections.
Øget tåreflåd 
Lacrimation increased Conjunctivitis
Reaktioner på infusionsstedet; Smerter 
Infusion site reaction;
Kløende udslæt (G3/4: 0,7 %); neglesygdomme (G3/4: 0,7 %); hudafskalning (G3/4: 0 %) 
Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Svimmelhed (G3/4: 2,3 %); perifer motorisk neuropati (G3/4: 
Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Dette lægemiddel indeholder 50 % vol. vandfri ethanol (alkohol), dvs. op til 2370 mg vandfri ethanol pr. 6 ml hætteglas, svarende til 60 ml øl eller 25 ml vin. 
This medicine contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial, equivalent to 60 ml of beer or 25 ml wine.
I studiet GEICAM 9805 forekom perifer sensorisk neuropati under behandlingen og fortsatte ind i opfølgningsperioden hos 10 patienter (1,9 %) i TAC-armen og hos 4 patienter (0,8 %) i FAC-armen. 
In GEICAM 9805 study, peripheral sensory neuropathy that started during the treatment period persisted into the follow-up period in 10 patients (1.9%) in TAC arm and 4 patients (0.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), peripheral sensory neuropathy was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning Docetaxel 
Taxespira 120 mg/6 ml concentrate for solution for infusion.
Koncentrationen af docetaxel er 20 mg/ml i hætteglas med Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml og 160 mg/8 ml. 
In Taxespira 20 mg/1 ml, 80 mg/4 ml, 120 mg/6 ml, 140 mg/7 ml and 160 mg/8 ml vials the concentration of docetaxel is 20 mg/ml.
Gastrointestinal blødning (alvorlig: 0,3 
Gastrointestinal haemorrhage (severe:
Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 395 mg vandfrit ethanol pr. 1 ml hætteglas. 
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml vial.
EU/1/15/1017/004 140 mg/7 ml hætteglas x 1 hætteglas 
EU/1/15/1017/004 140 mg/7 ml vial x 1 vial
• rødmen, hudreaktioner, kløe 
• flushing, skin reactions, itching
EU/1/15/1017/005 160 mg/8 ml hætteglas x 1 hætteglas 
EU/1/15/1017/005 160 mg/8 ml vial x 1 vial
Toksikologiske studier på gnavere har vist uønskede påvirkninger af testesfunktionen. 
Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
• Induktionskemoterapi 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/m 2 som en 1-times infusion efterfulgt af 
• 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/m 2 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.
Kræftsmerter (G3/4: 
Cancer pain (G3/4:
Taxespira monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi. 
Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Docetaxel forlængede mediantiden indtil progression (24,6 uger vs. 15,6 uger; p < 0,01) og medianoverlevelsen (15,3 måneder vs. 12,7 måneder; p = 0,03) uden at påvirke det primære endepunkt (32 % vs. 25 %, p = 0,10), samlet respons rate (32 % vs. 25 %, p = 0,10). 
Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p <0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 3160 mg vandfrit ethanol pr. 8 ml hætteglas. 
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial.
Patienterne havde operabel, lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år)). 
50 mg/m 2 and cyclophosphamide 500 mg/m 2 (539 patients in TAC arm), or doxorubicin 50 mg/m 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).).
Ved behandling med docetaxel er der rapporteret om sklerodermi-lignende forandringer, som oftest forudgået af perifert lymfødem. 
Sclerodermal-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Tabel over bivirkninger efter behandling af gastrisk adenokarcinom med Taxespira 75 mg/m² i kombination med cisplatin og 5-fluorouracil 
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Dette svarer til 40 ml øl eller 17 ml vin. 
This is equivalent to 40 ml of beer or17 ml of wine.
Øget tåreflåd (G3/4: 0 %) 
Lacrimation increased (G3/4: 0%)
Øget tåreflåd (G3/4: 
Lacrimation increased (G3/4:
186 patienter blev randomiseret til at få docetaxel (100 mg/m2) med eller uden trastuzumab. 
One hundred eighty six patients were randomized to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Beskrivelse af udvalgte bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m 2 som enkeltstof 
Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 single agent
Median responsvarighed (måneder) (95 % CI) 
Median duration of response (months) (95% CI)
Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 1580 mg vandfrit ethanol pr. 4 ml hætteglas. 
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anhydrous per 4 ml vial.
EU/1/15/1017/003 120 mg/6 ml hætteglas x 1 hætteglas 
EU/1/15/1017/003 120 mg/6 ml vial x 1 vial
Tabel over bivirkninger efter behandling af hoved- og halskræft med Taxespira 75 mg/m² i kombination med cisplatin og 5-fluorouracil 
Tabulated list of adverse reactions in head and neck cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Metabolisme og ernæring Psykiske forstyrrelser Nervesystemet 
Psychiatric disorders Nervous system disorders
Tabel over bivirkninger efter behandling af brystkræft med Taxespira 75 mg/m² i kombination med capecitabin 
Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with capecitabine
I dette kliniske studie randomiseredes 255 patienter til behandling med docetaxel (75 mg/m² som en 1times intravenøs infusion hver 3. uge) og capecitabin (1.250 mg/m² to gange dagligt 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
Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning Docetaxel 
Taxespira 80 mg/4 ml concentrate for solution for infusion.
Dyspepsi (G3/4: 0,8 %); gastrointestinale smerter (G3/4: 1,2 %); gastrointestinal blødning (G3/4: 0,4 
0.8%); Gastrointestinal pain (G3/4: 1.2%);
Øvre mavesmerter; mundtørhed 
Abdominal pain upper; Dry mouth
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 140 mg/7 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas). 
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 140 mg/7 ml concentrate for solution for infusion, which contains only 1 vial).
I studiet GEICAM 9805 fortsatte alopeci, som forekom i løbet af behandlingsperioden, ind i opfølgningsperioden og blev fortsat observeret hos 49 patienter (9,2 %) i TAC-armen og hos 35 patienter (6,7 %) i FAC-armen. 
In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
I komparator-armen af studiet fik patienterne cisplatin (P) 100 mg/m2 efterfulgt af 5-fluoruracil (F) 1.000 mg/m2 (PF) dagligt i 5 dage. 
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Dyspnø (G3/4: 1 %); hoste (G3/4: < 1 %); epistaxis (G3/4: <1 %) 
Pharyngolaryngeal pain (G3/4: 2%) Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
• Se det relevante produktresumé vedrørende justering af capecitabin-dosis. 
• For capecitabine dose modifications, see capecitabine summary of product characteristics.
Perifer motorisk neuropati (G3/4: 0 %) 
Peripheral motor neuropathy (G3/4:
Justeret hazard ratio (95 % CI) *p-værdi 
Adjusted hazard ratio (95% CI) *p-value
EU/1/15/1017/002 80 mg/4 ml hætteglas x 1 hætteglas 
EU/1/15/1017/002 80 mg/4 ml vial x 1 vial
EU/1/15/1017/001 20 mg/1 ml hætteglas x 1 hætteglas 
EU/1/15/1017/001 20 mg/1 ml vial x 1 vial
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 160 mg/8 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas). 
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Diarré (G3/4: 6,4 %); 
7.8%); Diarrhoea (G3/4: 6.2%);
Epistaxis (G3/4: 0 %); dyspnø (G3/4: 0,6 %); hoste (G3/4: 0 
Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Diarré (G3/4: 19,7 %); kvalme (G3/4: 16 %); stomatitis (G3/4: 
Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4:
Undergruppe Antal patienter 
Number of patients in TAC group
Mavesmerter (G3/4: 
Diarrhoea (G3/4:
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas). 
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Perifer motorisk neuropati (G3/4: 0,4 %) 
Peripheral sensory neuropathy (G3/4: 0.8%)
Mave-tarm-kanalen Kvalme (G3/4: 9,6 %); Opkastning (G3/4: 7,6 %); 
Nausea (G3/4: 9.6%); Vomiting (G3/4:
1 times infusion med cisplatin 75 mg/m 2 på dag 1, efterfulgt af 5-fluoruracil som en kontinuerlig infusion på 750 mg/m2 pr. dag i fem dage. 
5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Se trastuzumabs produktresumé vedrørende justering af trastuzumab-dosis. 
For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas). 
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Hudreaktion (G3/4: 
Neutropenia (G3/4:
Tabel over bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m² som enkeltstof 
Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² single agent
Anvend IKKE andre lægemidler med docetaxel bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning, som kun indeholder kun 1 hætteglas). 
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Taxespira 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Myalgi (alvorlig: 0,5 
Myalgia (severe:
Eksfoliativt udslæt (G3/4: 0,3 
Exfoliative rash (G3/4: 0.3%)
Øget tåreflåd (G3/4: 0,6 %) 
Lacrimation increased (G3/4: <0.1%)
Mave-tarm-kanalen Stomatitis (G3/4: 5,3 %); Diarré (G3/4: 4 %); 
Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Trombocytopeni (G3/4: 3 %) 
Thrombocytopenia (G4: 0.2%)
Hazard ratio: (95 % CI) *p-værdi 
Hazard ratio: (95% CI) *p-value
Dermatitis; erythematøst udslæt (G3/4: < 1 %); misfarvning af negle; onykolyse (G3/4: 1 %) 
Dermatitis; Rash erythematous (G3/4: <1%); Nail discolouration;
Alopeci; 
Constipation;
øofagitis/dysfagi/odynofagi (G3/4: 0,7 %) 
Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/odynophagia (G3/4: 0.7%)
Hazard ratio (95 % CI) *p-værdi 
Hazard ratio (95% CI) *p-value
Hazard ratio: (95 % CI) **p-værdi 
Hazard ratio: (95% CI) **p-value
Hud og subkutane væv Alopeci (persisterende: < 
Alopecia; Nail disorders (severe:
Nedsat venstre ventrikelfunktion (G3/4: 0,3 
Cardiac left ventricular function decrease (G3/4:
Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning Docetaxel i.v. 
Taxespira 20 mg/1 ml concentrate for solution for infusion.
Hazard ratio (95 % CI) **p-værdi 
Hazard ratio (95% CI) **p-value
I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m 2 til 75 mg/m 2 og/eller fra 75 
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m 2.
Letargi; smerter 
Lethargy; Pain