FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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
English: Second episode: then reduce docetaxel dose by 20%.
Danish: Anden episode: Reducer så docetaxel-dosis med 20 %.
English: 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.
Danish: 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.
English: Oesophagitis/dysphagia/ odynophagia (G3/4: 0.6%); Abdominal pain; Dyspepsia;
Danish: Konstipation; øsofagitis/dysfagi/ odynofagi (G3/4: 0,6 %); mavesmerter;
English: Second episode: reduce docetaxel dose by 20%.
Danish: Anden episode: Reducer docetaxel-dosis med 20 %.
English: 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.
Danish: mg/m 2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m 2 pr. dag,
English: • 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)
Danish: • rødmen og hævelse på håndflader eller fodsåler, som kan få huden til at skalle af.
English: 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).
Danish: 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).
English: 80mg/4 ml One vial of 4 ml concentration contains 80 mg docetaxel.
Danish: 80 mg/4 ml Et hætteglas med 4 ml koncentrat indeholder 80 mg docetaxel.
English: Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with doxorubicin
Danish: Tabel over bivirkninger efter behandling af brystkræft med Taxespira 75 mg/m² i kombination med doxorubicin
English: 120mg/6 ml One vial of 6 ml concentrate contains 120 mg docetaxel.
Danish: 120 mg/6 ml Et hætteglas med 6 ml koncentrat indeholder 120 mg docetaxel.
English: 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.
Danish: 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.
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Danish: Se det relevante produktresumé vedrørende justering af cisplatin-dosis.
English: Taxespira 140 mg/7 ml concentrate for solution for infusion.
Danish: Taxespira 140 mg/7 ml koncentrat til infusionsvæske, opløsning Docetaxel
English: Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Danish: Ikke almindelige bivirkninger neuropati (G3/4: 4 %); Dysgeusi (alvorlig:
English: Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Danish: Median varighed af respons på kemoterapi ± strålebehandling (mdr.)
English: Weight decreased; G3/4 Blood bilirubin increased
Danish: Vægttab; G3/4 forhøjet bilirubin i blodet (9 %)
English: Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² in combination with trastuzumab
Danish: Tabel over bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m² i kombination med trastuzumab
English: 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.
Danish: 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.
English: Taxespira is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Danish: Taxespira er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungekræft efter behandlingssvigt af kemoterapi.
English: Taxespira 160 mg/8 ml concentrate for solution for infusion.
Danish: Taxespira 160 mg/8 ml koncentrat til infusionsvæske, opløsning Docetaxel
English: 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.
Danish: 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.
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by
Danish: 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.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2370 mg ethanol anhydrous per 6 ml vial.
Danish: Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 2370 mg vandfrit ethanol pr. 6 ml hætteglas.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2765 mg ethanol anhydrous per 7 ml vial.
Danish: Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 2765 mg vandfrit ethanol pr. 7 ml hætteglas.
English: Vial label
Danish: Etiket til hætteglas
English: Hypersensitivity (G3/4:
Danish: Overfølsomhed (G3/4:
English: Venous disorder (G3/4:
Danish: Venesygdomme (G3/4:
English: Nail disorders (severe: 0.8%)
Danish: Neglesygdomme (alvorlig: 0,4 %);
English: Tabulated list of adverse reactions in non-small cell lung cancer for Taxespira 75 mg/m² single agent
Danish: Tabel over bivirkninger efter behandling af ikke-småcellet lungekræft med Taxespira 75 mg/m² som enkeltstof
English: 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.
Danish: 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.
English: • dry mouth
Danish: • mundsår
English: Median survival (months) (95% CI)
Danish: Median overlevelse (måneder) (95 % CI)
English: In case of white blood cells disturbances, you may experience associated fever or infections.
Danish: Du kan få feber eller infektioner, hvis antallet af hvide blodlegemer ikke tilfredsstillende.
English: Lacrimation increased Conjunctivitis
Danish: Øget tåreflåd
English: Infusion site reaction;
Danish: Reaktioner på infusionsstedet; Smerter
English: Rash pruritus (G3/4: 0.7%); Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Danish: Kløende udslæt (G3/4: 0,7 %); neglesygdomme (G3/4: 0,7 %); hudafskalning (G3/4: 0 %)
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy (G3/4: 1.3%)
Danish: Svimmelhed (G3/4: 2,3 %); perifer motorisk neuropati (G3/4:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Taxespira 120 mg/6 ml concentrate for solution for infusion.
Danish: Taxespira 120 mg/6 ml koncentrat til infusionsvæske, opløsning Docetaxel
English: 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.
Danish: 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.
English: Gastrointestinal haemorrhage (severe:
Danish: Gastrointestinal blødning (alvorlig: 0,3
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per 1 ml vial.
Danish: Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 395 mg vandfrit ethanol pr. 1 ml hætteglas.
English: EU/1/15/1017/004 140 mg/7 ml vial x 1 vial
Danish: EU/1/15/1017/004 140 mg/7 ml hætteglas x 1 hætteglas
English: • flushing, skin reactions, itching
Danish: • rødmen, hudreaktioner, kløe
English: EU/1/15/1017/005 160 mg/8 ml vial x 1 vial
Danish: EU/1/15/1017/005 160 mg/8 ml hætteglas x 1 hætteglas
English: Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
Danish: Toksikologiske studier på gnavere har vist uønskede påvirkninger af testesfunktionen.
English: • 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.
Danish: • 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
English: Cancer pain (G3/4:
Danish: Kræftsmerter (G3/4:
English: Taxespira monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Danish: Taxespira monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
English: 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).
Danish: 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).
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3160 mg ethanol anhydrous per 8 ml vial.
Danish: Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 3160 mg vandfrit ethanol pr. 8 ml hætteglas.
English: 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).).
Danish: 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)).
English: Sclerodermal-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Danish: Ved behandling med docetaxel er der rapporteret om sklerodermi-lignende forandringer, som oftest forudgået af perifert lymfødem.
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger efter behandling af gastrisk adenokarcinom med Taxespira 75 mg/m² i kombination med cisplatin og 5-fluorouracil
English: This is equivalent to 40 ml of beer or17 ml of wine.
Danish: Dette svarer til 40 ml øl eller 17 ml vin.
English: Lacrimation increased (G3/4: 0%)
Danish: Øget tåreflåd (G3/4: 0 %)
English: Lacrimation increased (G3/4:
Danish: Øget tåreflåd (G3/4:
English: 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.
Danish: 186 patienter blev randomiseret til at få docetaxel (100 mg/m2) med eller uden trastuzumab.
English: Description of selected adverse reactions in breast cancer for Taxespira 100 mg/m 2 single agent
Danish: Beskrivelse af udvalgte bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m 2 som enkeltstof
English: Median duration of response (months) (95% CI)
Danish: Median responsvarighed (måneder) (95 % CI)
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1580 mg ethanol anhydrous per 4 ml vial.
Danish: Dette lægemiddel indeholder 50 % vol. vandfrit ethanol (alkohol), dvs. op til 1580 mg vandfrit ethanol pr. 4 ml hætteglas.
English: EU/1/15/1017/003 120 mg/6 ml vial x 1 vial
Danish: EU/1/15/1017/003 120 mg/6 ml hætteglas x 1 hætteglas
English: Tabulated list of adverse reactions in head and neck cancer for Taxespira 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger efter behandling af hoved- og halskræft med Taxespira 75 mg/m² i kombination med cisplatin og 5-fluorouracil
English: Psychiatric disorders Nervous system disorders
Danish: Metabolisme og ernæring Psykiske forstyrrelser Nervesystemet
English: Tabulated list of adverse reactions in breast cancer for Taxespira 75 mg/m² in combination with capecitabine
Danish: Tabel over bivirkninger efter behandling af brystkræft med Taxespira 75 mg/m² i kombination med capecitabin
English: In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every
Danish: 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).
English: Taxespira 80 mg/4 ml concentrate for solution for infusion.
Danish: Taxespira 80 mg/4 ml koncentrat til infusionsvæske, opløsning Docetaxel
English: 0.8%); Gastrointestinal pain (G3/4: 1.2%);
Danish: Dyspepsi (G3/4: 0,8 %); gastrointestinale smerter (G3/4: 1,2 %); gastrointestinal blødning (G3/4: 0,4
English: Abdominal pain upper; Dry mouth
Danish: Øvre mavesmerter; mundtørhed
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Danish: 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.
English: Pharyngolaryngeal pain (G3/4: 2%) Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
Danish: Dyspnø (G3/4: 1 %); hoste (G3/4: < 1 %); epistaxis (G3/4: <1 %)
English: • For capecitabine dose modifications, see capecitabine summary of product characteristics.
Danish: • Se det relevante produktresumé vedrørende justering af capecitabin-dosis.
English: Peripheral motor neuropathy (G3/4:
Danish: Perifer motorisk neuropati (G3/4: 0 %)
English: Adjusted hazard ratio (95% CI) *p-value
Danish: Justeret hazard ratio (95 % CI) *p-værdi
English: EU/1/15/1017/002 80 mg/4 ml vial x 1 vial
Danish: EU/1/15/1017/002 80 mg/4 ml hætteglas x 1 hætteglas
English: EU/1/15/1017/001 20 mg/1 ml vial x 1 vial
Danish: EU/1/15/1017/001 20 mg/1 ml hætteglas x 1 hætteglas
English: 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).
Danish: 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).
English: 7.8%); Diarrhoea (G3/4: 6.2%);
Danish: Diarré (G3/4: 6,4 %);
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Danish: Epistaxis (G3/4: 0 %); dyspnø (G3/4: 0,6 %); hoste (G3/4: 0
English: Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4:
Danish: Diarré (G3/4: 19,7 %); kvalme (G3/4: 16 %); stomatitis (G3/4:
English: Number of patients in TAC group
Danish: Undergruppe Antal patienter
English: Diarrhoea (G3/4:
Danish: Mavesmerter (G3/4:
English: 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).
Danish: 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).
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Danish: Perifer motorisk neuropati (G3/4: 0,4 %)
English: Nausea (G3/4: 9.6%); Vomiting (G3/4:
Danish: Mave-tarm-kanalen Kvalme (G3/4: 9,6 %); Opkastning (G3/4: 7,6 %);
English: 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Danish: 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.
English: For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Danish: Se trastuzumabs produktresumé vedrørende justering af trastuzumab-dosis.
English: 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).
Danish: 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).
English: Neutropenia (G3/4:
Danish: Hudreaktion (G3/4:
English: Tabulated list of adverse reactions in breast cancer for Taxespira 100 mg/m² single agent
Danish: Tabel over bivirkninger efter behandling af brystkræft med Taxespira 100 mg/m² som enkeltstof
English: 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).
Danish: 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).
English: Myalgia (severe:
Danish: Myalgi (alvorlig: 0,5
English: Exfoliative rash (G3/4: 0.3%)
Danish: Eksfoliativt udslæt (G3/4: 0,3
English: Lacrimation increased (G3/4: <0.1%)
Danish: Øget tåreflåd (G3/4: 0,6 %)
English: Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Danish: Mave-tarm-kanalen Stomatitis (G3/4: 5,3 %); Diarré (G3/4: 4 %);
English: Thrombocytopenia (G4: 0.2%)
Danish: Trombocytopeni (G3/4: 3 %)
English: Hazard ratio: (95% CI) *p-value
Danish: Hazard ratio: (95 % CI) *p-værdi
English: Dermatitis; Rash erythematous (G3/4: <1%); Nail discolouration;
Danish: Dermatitis; erythematøst udslæt (G3/4: < 1 %); misfarvning af negle; onykolyse (G3/4: 1 %)
English: Constipation;
Danish: Alopeci;
English: Gastrointestinal pain (G3/4: 1.0%); Oesophagitis/dysphagia/odynophagia (G3/4: 0.7%)
Danish: øofagitis/dysfagi/odynofagi (G3/4: 0,7 %)
English: Hazard ratio (95% CI) *p-value
Danish: Hazard ratio (95 % CI) *p-værdi
English: Hazard ratio: (95% CI) **p-value
Danish: Hazard ratio: (95 % CI) **p-værdi
English: Alopecia; Nail disorders (severe:
Danish: Hud og subkutane væv Alopeci (persisterende: <
English: Cardiac left ventricular function decrease (G3/4:
Danish: Nedsat venstre ventrikelfunktion (G3/4: 0,3
English: Taxespira 20 mg/1 ml concentrate for solution for infusion.
Danish: Taxespira 20 mg/1 ml koncentrat til infusionsvæske, opløsning Docetaxel i.v.
English: Hazard ratio (95% CI) **p-value
Danish: Hazard ratio (95 % CI) **p-værdi
English: Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m 2.
Danish: I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m 2 til 75 mg/m 2 og/eller fra 75
English: Lethargy; Pain
Danish: Letargi; smerter
English: • If you have any further questions, ask your doctor, hospital pharmacist or nurse.
Danish: • Spørg lægen, apotekspersonalet på hospitalet eller sundhedspersonalet, hvis der er mere, du vil
English: If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
Danish: I kombination med cisplatin og 5-fluorouracil Docetaxel-dosis bør reduceres fra 75 til 60 mg/m2, hvis der trods anvendelse af G-CSF opstår: 1) febril neutropeni, 2) prolongeret neutropeni eller 3) neutropenisk infektion.
English: 1.2%); Oedema (G3/4:
Danish: 23,7 %); opkastning (G3/4: 14,3
English: Ear and labyrinth disorders Cardiac disorders
Danish: Øre og labyrint Hjerte