natgillin/translations-raw huggingface dataset:
Reproduction is authorised provided the source is acknowledged. effektiviteten af følgende behandlingskombinationer, der blev anvendt som supplement til kirurgi, sammenlignet: • kombinationen af doxorubicin og cyclophosphamid i 12 uger efterfulgt af Taxotere/ Docetaxel Winthrop i 12 uger, enten alene eller i kombination med trastuzumab • kombinationen Taxotere/ Docetaxel Winthrop, trastuzumab og carboplatin i 18 uger.
Reproduction is authorised provided the source is acknowledged. • the combination of doxorubicin and cyclophosphamide for 12 weeks, followed by Taxotere/ Docetaxel Winthrop for 12 weeks, either alone or in combination with trastuzumab; • the combination of Taxotere/ Docetaxel Winthrop, trastuzumab and carboplatin for 18 weeks.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP' s liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP afgivet en negativ udtalelse og anbefalede ikke udstedelse af markedsføringstilladelse for Taxotere/ Docetaxel Winthrop til patienter med operabel brystkræft, hvis tumorer overudtrykker HER2, i kombination med trastuzumab med eller uden carboplatin.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Taxotere/ Docetaxel Winthrop in the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
CHMP fandt grund til betænkelighed ved, at det ikke var muligt at fastslå fordelene ved de behandlingskombinationer, der omfattede Taxotere/ Docetaxel Winthrop som supplement til kirurgi, på grund af udformningen af den eneste hovedundersøgelse.
The CHMP was concerned that it was not possible to establish the benefits of the treatment combinations including Taxotere/ Docetaxel Winthrop when used in addition to surgery, because of the way the single main study was designed.
CHMP var også betænkelig ved, at virksomheden ikke fremlagde tilstrækkelige kliniske beviser, der kunne retfærdiggøre brugen af kombinationen Taxotere/ Docetaxel Winthrop, carboplatin og trastuzumab.
The CHMP was also concerned that the company did not provide sufficient clinical evidence to justify the use of the combination of Taxotere/ Docetaxel Winthrop, carboplatin and trastuzumab.
På tilbagetrækningstidspunktet var det derfor CHMP' s opfattelse, at fordelene ved Taxotere/ Docetaxel Winthrop ikke var blevet tilstrækkeligt påvist, og at de eventuelle fordele ikke opvejede de påviste risici.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Taxotere/ Docetaxel Winthrop had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Hvilke konsekvenser har tilbagetrækningen for patienter, som deltager i kliniske undersøgelser med Taxotere/ Docetaxel Winthrop?
What are the consequences of the withdrawal for patients undergoing clinical trials with Taxotere/ Docetaxel Winthrop?
Virksomheden har til CHMP oplyst, at tilbagetrækningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Taxotere/ Docetaxel Winthrop.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Taxotere/ Docetaxel Winthrop.
Hvad sker der med Taxotere/ Docetaxel Winthrop til behandling af andre typer brystkræft, ikke- småcellet lungekræft, prostatakræft, gastrisk adenocarcinom og kræft i hoved og hals?
What is happening for Taxotere/ Docetaxel Winthrop for the treatment of other types of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer?
Det får ingen konsekvenser for anvendelsen af Taxotere/ Docetaxel Winthrop til de godkendte indikationer, for hvilke benefit/ risk- forholdet forbliver uændret.
There are no consequences on the use of Taxotere/ Docetaxel Winthrop in its authorised indications, for which the balance of benefits and risks remains unchanged.
TAXOTERE 20 mg koncentrat og solvens til infusionsvæske, opløsning.
TAXOTERE 20 mg concentrate and solvent for solution for infusion
Hvert enkeltdosis- hætteglas med TAXOTERE 20 mg koncentrat indeholder docetaxel som trihydrat, svarende til 20 mg docetaxel (vandfri).
Each single-dose vial of TAXOTERE 20 mg concentrate contains docetaxel which is a trihydrate corresponding to 20 mg of docetaxel (anhydrous).
TAXOTERE i kombination med doxorubicin og cyclophosfamid er indiceret til adjuverende behandling af patienter med operabel lymfeknude- positiv brystkræft.
TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer.
TAXOTERE i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere har modtaget kemoterapi mod denne tilstand.
TAXOTERE 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.
TAXOTERE i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystkræft, som har HER2- positive tumorer, og som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom.
TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
TAXOTERE er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke - småcellet lungekræft efter behandlingssvigt af kemoterapi.
TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
TAXOTERE 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.
TAXOTERE 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.
TAXOTERE i kombination med cisplatin og 5- fluorouracil er indiceret til behandling af patienter med metastatisk gastrisk adenocarcinom, inklusive adenocarcinom i den gastrooesophageale forbindelse, som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom.
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
TAXOTERE i kombination med cisplatin og 5- fluorouracil er indiceret til indledende behandling af patienter med inoperable, lokale, fremskredne skællede celle- carcinoma i hoved og hals.
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
I kombination med capecitabin er den anbefalede TAXOTERE- dosis 75 mg/ m2 hver 3. uge kombineret med capecitabin 1250 mg/ m2 to gange daglig (indenfor 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/ m2 every three weeks, combined with capecitabine at 1250 mg/ m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period.
5 Specielle patientgrupper:
5 Special populations:
Forekomsten af de følgende bivirkninger (alle grader):
The incidence of serious adverse events was higher in the elderly patients compared to younger patients.
De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos: • 1312 og 121 patienter som fik henholdsvis 100 mg/ m2 og 75 mg/ m2 af doceraxel som enkeltstof. • 258 patienter som fik docetaxel i kombinationsbehandling med doxorubicin. • 406 patienter som fik docetaxel i kombination med cisplatin. • 92 patienter som fik docetaxel i kombination med trastuzumab. • 255 patienter som fik docetaxel i kombination med capecitabin.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: • 1312 and 121 patients who received 100 mg/ m² and 75 mg/ m² of docetaxel as a single agent respectively. • 258 patients who received docetaxel in combination with doxorubicin. • 406 patients who received docetaxel in combination with cisplatin. • 92 patients treated with docetaxel in combination with trastuzumab.
TAXOTERE 100 mg/ m² enkeltstof:
TAXOTERE 100 mg/ m² single agent
12 TAXOTERE 75 mg/ m² enkeltstof:
12 TAXOTERE 75 mg/ m² single agent
13 TAXOTERE 75 mg/ m² i kombination med doxorubicin:
13 TAXOTERE 75 mg/ m² in combination with doxorubicin
14 TAXOTERE 75 mg/ m2 i kombination med cisplatin:
14 TAXOTERE 75 mg/ m² in combination with cisplatin
15 TAXOTERE 100 mg/ m² i kombination med trastuzumab:
15 TAXOTERE 100 mg/ m² in combination with trastuzumab
16 TAXOTERE 75 mg/ m² i kombination med capecitabin:
16 TAXOTERE 75 mg/ m² in combination with capecitabine
17 TAXOTERE 75 mg/ m² i kombination med prednison eller prednisolon:
17 TAXOTERE 75 mg/ m² in combination with prednisone or prednisolone
18 TAXOTERE 75 mg/ m² i kombination med doxorubicin og cyclophosphamid:
18 TAXOTERE 75 mg/ m² in combination with doxorubicin and cyclophosphamide
19 Systemorganklasser i henhold til MedDRA - databasen Det reproduktive system og mammae
19 MedDRA System Organ classes General disorders and administration site conditions
20 TAXOTERE 75 mg/ m² i kombination med cisplatin og 5- fluorouracil til gastrisk adenocarcinoma - kræft:
20 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
Metabolisme og ernæring Infektioner og parasitære sygdomme Almene symptomer og reaktioner på administrationsstedet
Metabolism and nutrition disorders
11, 7%) Neutropenisk infektion; Infektion (G3/ 4:
11.7%)
21 TAXOTERE 75 mg/ m² i kombination med cisplatin og 5- fluorouracil (til hoved - og halskræft): • Induktions kemoterapi efterfulgt af strålebehandling (TAX 323)
• Induction chemotherapy followed by radiotherapy (TAX 323)
Meget almindelige bivirkninger ≥ 10% af patienterne
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Weight increased
Ikke almindelige bivirkninger ≥ 0, 1 til < 1% af patienterne
Cardiac disorders Blood and lymphatic system disorders
Myokardial iskæmi (G3/ 4:
Myocardial ischemia (G3/ 4:1.7%) Neutropenia (G3/ 4:
Arytmi (G3/ 4:
9.2%); Thrombocytopenia (G3/ 4:
Neutropeni (G3/ 4:
Arrhythmia (G3/ 4:
Dysgeusi/ parosmi Perifer sensorisk neuropati (G3/ 4:
Dysgeusia/ Parosmia; Dizziness Peripheral sensory neuropathy (G3/ 4:
4, 0%); Diarré (G3/ 4:
Esophagitis/ dysphagia/ 4.0%); odynophagia (G3/ 4:
2, 9%); Opkastning (G3/ 4:
Diarrhea (G3/ 4:
0, 6%); Gastrointestinale smerter; Dyspepsi; Gastrointestinale blødninger (G3/ 4:
0.6%) Abdominal pain; Dyspepsia; Gastrointestinal haemorrhage (G3/ 4:
Kløende udslæt; Tør hud; Hudafskalning (G3/ 4:
10.9%) Rash pruritic; Dry skin; Skin exfoliative (G3/ 4:
Kræftsmerter (G3/ 4:
6.3%); Neutropenic infection Cancer pain (G3/ 4:
22 • Induktions kemoterapi efterfulgt af kemo - og stråleterapi (TAX 324)
22
Cancersmerter (G3/ 4:
Cancer pain (G3/ 4:
23 Erfaringer efter markedsføring:
23
Der er rapporter om knoglemarvsdepression og andre hæmatologiske bivirkninger.
Blood and lymphatic system disorders Bone marrow suppression and other hematologic adverse reactions have been reported.
Der er rapporter om meget sjældne tilfælde af akut myeloid leukemi og myelodyplasisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutiske stoffer og/ eller radioterapi.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/ or radiotherapy.
Der er sjældne rapporter om radiation recall- fænomen.
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Adjuverende behandling
TAXOTERE in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Hazard
p=
95% CI P= Hazard 95% CI
Hazard 95% CI ratio*
0, 59- 0, 88 0, 46- 0, 82 0, 63- 1, 08
0.46-0.82 0.63-1.08
26 Flere grad 3/ 4 bivirkninger blev observeret for TAXOTERE monoterapi (55, 4%) sammenlignet med paclitaxel (23, 0%).
More grade 3/ 4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
TAXOTERE i kombination med doxorubicin
26 TAXOTERE in combination with doxorubicin
TTP = tid til progression. ” ne ” indikerer at dette ikke kunne estimeres eller ikke blev nået.
TTP = time to progression; “ ne ” indicates that it could not be estimated or it was not yet reached.
27 TAXOTERE i kombination med capecitabin
27 TAXOTERE in combination with capecitabine
Data fra et randomiseret, kontrolleret, klinisk fase 3- multicenterstudie understøtter anvendelsen af capecitabin i kombination med docetaxel til behandling af patienter med lokal fremskreden eller metastatisk brystkræft hos hvem cytotoksisk kemoterapi med et anthracyklin, har været uden effekt.
Data from one multicenter, randomised, controlled phase III clinical trial support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
28 Overlevelsesdata, median progressionstid og responsrater for forsøgets to arme arme er illustreret i nedenstående tabel:
28 Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
Gennemsnitlig tid til progression
Median Time to Progression
Sekundære endepunkter inkluderede forandring i smerter, global rating af livskvalitet med EuroQoL - 5D, lungekræft- symptom skala, og forandringer i karnosfkys performance status.
Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
30 Effekten af docetaxel ved behandling af patienter med gastrisk adenocarcinom
30 Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Behandlingen begyndte på dag 5 i hver cyklus, eller tilsvarende.
Patients on the TPF arm received antibiotic prophylaxis 31 with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
32 • Induktions kemoterapi efterfulgt af kemostråleterapi (TAX 324) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open- label fase III studie (TAX 324).
32 • 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, trial (TAX324).
33 Effekt af docetaxel i indledende behandling til patienter med lokale fremskredne SCCHN (Hensigt at behandle- analyse)
33 Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
Docetaxels clearance var ikke påvirket hos patienter med let til moderat væskeretention, og der findes ingen data for clearance hos patienter med svær væskeretention.
34 modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
6. 3 Opbevaringstid
35 6.3 Shelf-life
TAXOTERE 20 mg koncentrat til infusionsvæske, opløsning hætteglas:
TAXOTERE 20 mg concentrate for solution for infusion vial
Dette tab skyldes skumdannelse, væske, der klæber til siderne af glasset, og et restvolumen, som ikke kan udtages.
This fill volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Dette overskud sikrer, at der efter fortynding med hele indholdet af den medfølgende solvens til TAXOTERE udtages et præmixvolumen på mindst 2 ml, som indeholder 10 mg/ ml docetaxel, hvilket svarer til den mængde, der er angivet på pakningen med 20 mg per hætteglas.
This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
Tilsætning af hele indholdet fra hætteglasset med solvens til indholdet i hætteglasset med TAXOTERE 20 mg, koncentrat il infusionsvæske, opløsning, sikrer en præmixkoncentration på 10 mg/ ml docetaxel.
The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ ml docetaxel.
TAXOTERE er et antineoplastisk stof, og ligesom andre potentielle toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af TAXOTERE- opløsningerne.
TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions.
Hvis TAXOTERE infusionskoncentrat, præmix- opløsning eller infusionsvæske skulle komme på huden, så vask omgående og grundigt med sæbe og vand.
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Hvis TAXOTERE infusionskoncentrat, præmix- opløsning eller infusionsvæske skulle komme i kontakt med slimhinderne, så vask omgående og grundigt med vand.
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Tilberedning af infusionsvæsken:
36 Preparation for the intravenous administration
a) Tilberedning af TAXOTERE præmix (10 mg docetaxel/ ml)
a) Preparation of the TAXOTERE premix solution (10 mg docetaxel/ ml)
Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal TAXOTERE- æsker stå i stuetemperatur (under 25°C) i 5 minutter før brug.
If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25 °C) for 5 minutes.
Injicer derefter den beregnede mængde TAXOTERE- præmix i en 250 ml infusionspose med enten 5% glucose eller 0, 9% NaCl.
Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.
TAXOTERE infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1- times infusion ved stuetemperatur (under 25°C) og under normale lysforhold.
The TAXOTERE infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting conditions.
27. november 1995 Dato for seneste fornyelse:
27 November 1995 Date of latest renewal:
27. november 2005
27 November 2005
TAXOTERE 80 mg koncentrat og solvens til infusionsvæske, opløsning.
TAXOTERE 80 mg concentrate and solvent for solution for infusion
Hvert enkeltdosis- hætteglas med TAXOTERE 80 mg koncentrat indeholder docetaxel som trihydrat, svarende til 80 mg docetaxel (vandfri).
Each single-dose vial of TAXOTERE 80 mg concentrate contains docetaxel which is a trihydrate corresponding to 80 mg of docetaxel (anhydrous).
39 Prostatakræft
39 Prostate cancer
For behandling efter forudgående svigt af platinbaseret kemoterapi, er den anbefalede dosis 75 mg/ m2 givet som enkeltstof.
40 after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m² as a single agent.
41 havde denne reaktion, skulle forblive på G- CSF og have deres docetaxel- dosis reduceret til 60 mg/ m2.
41 However, in clinical practice neutropenia could occur earlier.
42 Specielle patientgrupper:
42 Special populations:
43 Hos de patienter, der blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (TCF), opstod der febril neutropeni og neutropenisk infektion i mindre grad, når patienterne fik profylaktisk G- CSF.
43 In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
44 Nervesystemet
44 Cardiac toxicity
45 4. 5 Interaktion med andre lægemidler og andre former for interaktion
45 4.5 Interaction with other medicinal products and other forms of interaction
De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos: • 1312 og 121 patienter som fik henholdsvis 100 mg/ m2 og 75 mg/ m2 af TAXOTERE som enkeltstof. • 258 patienter som fik docetaxel i kombinationsbehandling med doxorubicin. • 406 patienter som fik docetaxel i kombination med cisplatin. • 92 patienter som fik docetaxel i kombination med trastuzumab. • 255 patienter som fik docetaxel i kombination med capecitabin.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: • 1312 and 121 patients who received 100 mg/ m² and 75 mg/ m² of docetaxel as a single agent respectively. • 258 patients who received docetaxel in combination with doxorubicin. • 406 patients who received docetaxel in combination with cisplatin. • 92 patients treated with docetaxel in combination with trastuzumab.
46 • 332 patienter som fik docetaxel i kombination med prednison eller prednisolon (klinisk relevante behandlingsrelaterede bivirkninger er medtaget). • 744 patienter som fik docetaxel i kombination med doxorubicin og cyclophosphamid (bivirkninger til klinisk vigtig behandling er præsenteret). • 300 gastrisk adenocarcinoma- patienter (221 patienter i fase III- delen af undersøgelsen og 79 patienter i fase II- delen af undersøgelsen), som blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt). • 174 og 251 hoved - og hals- kræft- patienter, som blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
46 • 255 patients who received docetaxel in combination with capecitabine. • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). • 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
47 Der er rapporter om tilfælde af væskeretention såsom perifert ødem og sjældnere pleura- og perikardieekssudat, ascites og vægtøgning.
Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
Det perifere ødem starter sædvanligvis i underekstremiteterne og kan blive generaliseret med vægtstigning på 3 kg eller mere.
47 extremities and may become generalised with a weight gain of 3 kg or more.
49 TAXOTERE 75 mg/ m² enkeltstof:
49 TAXOTERE 75 mg/ m² single agent
50 TAXOTERE 75 mg/ m² i kombination med doxorubicin:
50 TAXOTERE 75 mg/ m² in combination with doxorubicin