natgillin/translations-raw huggingface dataset:
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).
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%)