natgillin/translations-raw huggingface dataset:
• Hos 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/m².
Udvikling af alvorlig perifer neurotoksicitet kræver en dosisreduktion (se pkt.
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
1.060 patienter blev randomiseret til at få enten DOCETAXEL KABI 75 mg/m2 administreret 1 time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (539 patienter i TAC-armen) eller doxorubicin 50 mg/m2 efterfulgt af fluoruracil 500 mg/m2 og cyclophosphamid 500 mg/m2 (521 patienter i FAC-armen) som adjuverende behandling.
1060 patients were randomised to receive either DOCETAXEL KABI 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 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).).
• Fordøjelsesbesvær
• indigestion
Hvert hætteglas af koncentrat indeholder 4,5 ml ethanol vandfri (3,55 g).
Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Antal patienter Smerte-response rate (%) 95 %CI p-værdi*
Number of patients Pain response rate (%) 95% CI p-value*
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.
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.
Infektion associeret med G4-neutropeni (G3/4:
Infection associated with G4 neutropenia (G3/4: 4.6%)
Asteni, som forekom i løbet af behandlingsperioden, fortsatte ind i opfølgningsperioden og blev fortsat observeret hos 12 patienter (2,3 %) i TAC-armen og hos 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.
Median progression fri overlevelse (måneder) (95 %CI)
Median progression free survival (months) (95% CI)
Infektioner (G3/4: 5 %)
Infections (G3/4: 5%)
DOCETAXEL KABI koncentrat til infusionsvæske, opløsning er en klar, farveløs til svag gul opløsning.
What DOCETAXEL KABI looks like and contents of the pack DOCETAXEL KABI concentrate for solution for infusion is a clear, colourless to pale yellow solution.
Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med DOCETAXEL KABI 75 mg/m2 i kombination med cisplatin og 5-fluorouractil
Description of selected adverse reactions in gastric adenocarcinoma cancer for DOCETAXEL KABI 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Perifer sensorisk neuropati (G3/4: 8,7 %)
Peripheral sensory neuropathy (G3/4: 8.7%)
I studiet TAX 316 forekom asteni i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden efter afsluttet kemoterapi og blev rapporteret hos 236 af 744 TAC patienter (31,7 %) og hos 180 af 736 FAC patienter (24,5 %).
In study TAX316 asthenia that started during the treatment period and persisted into the follow-up period after the end of chemotherapy was reported in 236 of 744 TAC patients (31.7%) and 180 of 736 FAC patients (24.5%).
Du skal fortsætte med at tage præmedicinen i endnu 1 til 2 dage for at formindske visse bivirkninger, som kan forekomme efter infusionen af DOCETAXEL KABI.
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to DOCETAXEL KABI 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 DOCETAXEL KABI in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Stomatitis (G3/4: 18 %); Diarré (G3/4: 14 %); Kvalme
Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%);
Perifer motorisk neuropati (G3/4: 2,5 %)
Peripheral motor neuropathy (G3/4: 2.5%)
Almindelige (kan forekomme hos op til 1 ud af 10 patienter):
Common (may affect up to 1 in 10 people):
Øget tåresekretion (G3/4: < 0,1 %);
Lacrimation increased (G3/4: < 0.1%)
Dysgeusi (G3/4: 0,6 %); Perifer sensorisk neuropati (G3/4: <
Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: < 0.1%)
Alopeci; erythema; udslæt; neglesygdomme
Alopecia; Erythema; Rash; Nail
Luftveje, thorax og mediastinum Epistaxis; pharyngolaryngeal smerte; nasopharyngitis; dyspnø;
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Artralgi (G3/4: 0,3 %); Myalgi (G3/4: 0,3 %)
Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
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.
Anæmi (G3/4: 8,9 %); Febril neutropeni
Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
• Synkebesvær eller smerter ved synkning
• difficulty or painful swallowing
Ved slutningen af opfølgningsperioden (faktisk median opfølgningstid var 8 år) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9%) og 16 FAC-patienter (2,2%).
At the end of the follow-up period (actual median follow-up time of8 years), alopecia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2,2%).
Alle andre lægemidler blev givet som intravenøs bolus på dag 1.
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
I studiet TAX 316 forekom lymfødem 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%).
Trombocytopeni; (G3/4: 0,6 %);
Thrombocytopenia (G3/4: 0.6%);
PSA**- response rate (%) 95 %CI p-værdi*
Number of patients PSA** response rate (%) 95% CI p-value*
Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter):
Uncommon (may affect up to 1 in 100 people):
Paræsthesi (G3/4: < 1 %)
Epistaxis (G3/4: < 1%)
Bedste respons i alt til kemoterapi (%) (95 %CI) ***p-værdi
Best overall response to chemotherapy (%) (95% CI) ***p-value
Medmindre det er kontraindiceret, kan der til brystkræft og ikke-småcellet lungekræft gives et peroralt kortikosteroid som præmedicinering, eksempelvis dexamethasone 16 mg per 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).
Anoreksi (G3/4: 0.6 %)
Anorexia (G3/4: 0.6%)
Efter 10 års opfølgning i TAX 316-studiet blev akut leukæmi rapporteret hos 3 ud af 744 TACpatienter (0,4 %) og hos 1 ud af 736 FAC-patienter (0,1%).
After 10 years of follow up in study TAX316, acute leukaemia was reported in 3 of 744 TAC patients (0.4%) and in 1 of 736 FAC patients (0.1%).
Ved den mediane opfølgningsperiode på 77 måneder var den samlet overlevelse (SO) også længere i TAC- armen, hvor TAC-behandlede patienter havde 24 % lavere risiko for død sammenlignet med FAC- behandlede patienter (hazard ratio = 0,76; 95 % CI (0,46-1,26; p=0,29).
At the median follow-up time of 77 months overall survival (OS) was also longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
DOCETAXEL KABI er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter behandlingssvigt af kemoterapi.
DOCETAXEL KABI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Iskæmisk hjertesygdom
Cardiac failure
Myalgi (G3/4: 0,7 %); Artralgi (G3/4: 0,2 %)
Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Letargi (G3/4: 19,0 %); Feber (G3/4: 2,3 %);
Lethargy (G3/4: 19.0%); Fever (G3/4: 2.3%);
Hjerte:
arm.
Nedsat venstre ventrikelfunktion (G3/4: 0,3 %)
Cardiac left ventricular function decrease (G3/4: 0.3%)
Dyspnø (G3/4: 1 %); Hoste (G3/4: < 1 %);
Dyspnoea (G3/4: 1%); Cough (G3/4: < 1%);
Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 100 mg/m2 i kombination med trastuzumab
Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
For de 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 those patients with serum bilirubin > ULN and/or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Ved den mediane opfølgningsperiode på 77 måneder var den totale overlevelse (OS) længere i TACarmen, hvor TAC-behandlede patienter havde 24 % lavere risiko for død sammenlignet med FACbehandlede patienter (hazard ratio = 0,76; 95 % CI (0,46-1,26; p=0,29).
At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
Tabel over bivirkninger ved behandling af prostatakræft med DOCETAXEL KABI 75 mg/m² i kombination med prednison eller prednisolon
Tabulated list of adverse reactions in prostate cancer for DOCETAXEL KABI 75 mg/m² in combination with prednisone or prednisolone
• Smagsforstyrrelser
• alteration in sense of taste
DOCETAXEL KABI 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.
DOCETAXEL KABI 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.
Docetaxel forlængede median-tiden til progression (24,6 uger vs 15,6 uger; p < 0,01) og median- overlevelse (15,3 måneder vs 12,7 måneder;
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).
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 180 mg/9 ml ANDET Cytotoksisk
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mg/9 ml OTHER Cytotoxic
Hver æske indeholder 1 hætteglas af 9 ml (180 mg docetaxel).
Each box contains one vial of 9 ml concentrate (180 mg docetaxel).
Trombocytopeni (G4:0,5 %)
Thrombocytopenia (G4: 0.2%)
Ved afslutningen af opfølgningsperioden blev det observeret (median opfølgningstid på 8 år), at asteni fortsatte hos 29 TAC patienter (3,9 %) og hos 16 FAC patienter (2,2 %).
At the end of the follow-up period (actual median follow-up time of 8 years), asthenia was observed to be ongoing in 29 TAC patients (3.9%) and 16 FAC patients (2.2%).
Infektioner (G3/4: 3,3 %)
Infection (G3/4: 3.3%)
G3/4 Forhøjet bilirubin i blodet (9 %)
G3/4 Blood bilirubin increased (< 2%)
Forhøjet lakrimation (G3/4: 0 %)
Lacrimation increased (G3/4: 0%)
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.
Diarré (G3/4: 3,4 %); Obstipation (G3/4:0,5
Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Perifer sensorisk neuropati (G3: 0,4 %)
Peripheral sensory neuropathy (G3: 0.4%)
Hver æske indeholder 1 hætteglas af 6 ml (120 mg docetaxel).
Each box contains one vial of 6 ml concentrate (120 mg docetaxel).
Hver æske indeholder 1 hætteglas af 8 ml (160 mg docetaxel).
Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
DOCETAXEL KABI indeholder:
You must not be given DOCETAXEL KABI:
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.
Vedrørende dosisjusteringer for trastuzuma, se produktresuméet for trastuzumab.
For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 100 mg/m2 enkeltstof
Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
I de følgende tilfælde bør docetaxel-dosis reduceres til 65 mg/ m2 i de følgende behandlingsrunder: 1) hos patienter med en initialdosis på 75 mg/m2 docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på < 25000 celler/mm3 2) hos patienter, der får febril neutropeni, 3) hos patienter, med alvorlig, ikke-hæmatologisk toksicitet.
For patients who are dosed initially at docetaxel 75 mg/m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/mm3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2.
Perifer motorisk neuropati (G3/4: 0 %)
Peripheral motor neuropathy (G3/4: 0%)
Bortskaffelse:
Disposal
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 160 mg/8 ml ANDET Cytotoksisk
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg/8 ml OTHER Cytotoxic
Et hætteglas af 9 ml koncentrat indeholder 180 mg docetaxel.
One vial of 9 ml of concentrate contains 180 mg of docetaxel.
Patienter bør modtage kemo-strålingsterapi efter kemoterapi
Following chemotherapy, patients should receive chemoradiotherapy.
Brug ikke DOCETAXEL KABI
You must not be given DOCETAXEL KABI
I studiet GEICAM9805 blev det observeret, at amenorré, som forekom i løbet af behandlingsperiden 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 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.
- Aktivt stof: docetaxel vandfri.
What DOCETAXEL KABI contains - The active substance is docetaxel anhydrous.
DOCETAXEL KABI 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.
DOCETAXEL KABI 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.
Et hætteglas af 8 ml koncentrat indeholder 160 mg docetaxel.
One vial of 8 ml of concentrate contains 160 mg of docetaxel.
• Blodpropper
• blood clots.
Kvalme (G3/4: 3,3 %);
Nausea (G3/4: 3.3%);
Gastrointestinal Hæmoragi (alvorlig:
Gastrointestinal haemorrhage (severe: 0.3%)
Dysgeusi (G3/4: < 1 %); Paræsthesi (G3/4: < 1 %)
Dysgeusia (G3/4: < 1%); Paraesthesia (G3/4: < 1%)
Hver æske indeholder 1 hætteglas af 4 ml (80 mg docetaxel).
Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Forhøjet lakrimation (G3/4:0,6 %)
Lacrimation increased (G3/4: 0.6%)
UTILGÆNGELIGT FOR BØRN
NA-not applicable
Median overlevelse i alt (måneder) (95% CI)
Median overall survival (months) (95% CI)
10 ml klar, farveløs Type-I hætteglas, lukket med flurotec gummipropper og en orange flip-off aluminium kapsel, indeholdende 9 ml koncentrat.
10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a orange flip-off aluminium over seal containing 9 ml of concentrate.
• Muskelømhed og smerter, rygsmerter eller knoglesmerter
• muscle aches and pains; back pain or bone pain
Der er rapporter om knoglemarvsdepression og andre hæmatologiske bivirkninger.
Bone marrow suppression and other haematologic adverse reactions have been reported.
FREMSTILLINGSVEJLEDNING TIL BRUG FOR DOCETAXEL KABI 180 mg/9 ml, KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 180 mg/9 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Tabel over bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 75 mg/m² i kombination med capecitabin:
Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with capecitabine
I studiet TAX 316 blev alopeci, der fortsatte ind i opfølgningsperioden efter endt kemoterapi, rapporteret hos 687 af 744 TAC-patienter (92,3%) og 645 af 736 FAC-patienter (87,6%).
In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients(87.6%).
Perifer motorisk neuropati (G3/4: 0,4 %)
Peripheral motor neuropathy (G3/4: 0.4%)
Myalgi (G3/4: 0,6 %)
Myalgia (G3/4: 0.6%)
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 120 mg/6 ml ANDET Cytotoksisk
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
DOCETAXEL KABI i kombination med platinmidler hos patienter der ikke tidligere er behandlet med kemoterapi
DOCETAXEL KABI in combination with platinum agents in chemotherapy-naïve patients
Toksikologiske studier på gnavere har vist uønskede påvirkninger af testisfunktionen.
Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
Kvalme (G3/4: 5 %);
Nausea (G3/4: 5%);
LÆGEMIDLETS NAVN DOCETAXEL KABI 180 mg/9 ml koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
• Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder kan DOCETAXEL KABI anvendes i kombination med doxorubicin eller cyclophosphamid.
- For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL
G3/4 Forhøjet bilirubin i blodet (< 5 %);G3/4 forhøjet alkalisk fosfatase i blodet
G3/4 Blood alkaline phosphatase increased (< 4%);G3/4 AST increased (< 3%);
Et hætteglas af 6 ml koncentrat indeholder 120 mg docetaxel.
One vial of 6 ml of concentrate contains 120 mg of docetaxel.
5,7 %; inklusive sepsis og pneumoni, letal hos
Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
DOCETAXEL KABI monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
DOCETAXEL KABI monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Hver æske indeholder 1 hætteglas af 1 ml (20 mg docetaxel).
Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Lægemidlet indeholder 50 vol % ethanol vandfri (alkohol), dvs. op til 2,37 g (3 ml) ethanol vandfri per hætteglas svarende til 60 ml øl eller 24 ml vin.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 2.37 g ethanol anhydrous per vial of 6 ml equivalent to 60 ml of beer or 24 ml wine.
FREMSTILLINGSVEJLEDNING TIL BRUG FOR DOCETAXEL KABI 160 mg/8 ml, KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Trombocytopeni (G3/4:
Thrombocytopenia (G3/4: 3%)
• Søvnløshed
• insomnia
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 20 mg/1 ml ANDET Cytotoksisk
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml OTHER Cytotoxic
Myalgi (G3/4: 0,4 %)
Myalgia (G3/4: 0.4%)
Et hætteglas af 1 ml koncentrat indeholder 20 mg docetaxel.
One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Det er et handelsnavn for docetaxel.
Its common name is docetaxel.
INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 80 mg/4 ml ANDET Cytotoksisk
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml OTHER Cytotoxic
I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m2 til 75 mg/m2 og/eller fra 75 mg/m2 til 60 mg/m2: Hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter < 500 celler/mm3 i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.
In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
DOCETAXEL KABI 180 mg/9 ml koncentrat til infusionsvæske, opløsning docetaxel
DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
Lægemidlet indeholder 50 vol % ethanol vandfri (alkohol), dvs. op til 395 mg ethanol vandfri per hætteglas svarende til 10 ml øl eller 4 ml vin.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 395 mg ethanol anhydrous per vial, equivalent to 10 ml of beer or 4 ml wine.
Lægemidlet indeholder 50 vol % ethanol vandfri (alkohol), dvs. op til 3,16 g (4 ml) ethanol vandfri per hætteglas svarende til 80 ml øl eller 32 ml vin.
This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.16 g ethanol anhydrous per vial, equivalent to 80 ml of beer or 32 ml wine.
LÆGEMIDLETS NAVN DOCETAXEL KABI 160 mg/8 ml koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion
Median overlevelse (måneder) (95 %CI)
Median survival (months) (95% CI)
DOCETAXEL KABI 120 mg/6 ml koncentrat til infusionsvæske, opløsning docetaxel
DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
Nyre og urinveje
Cough; Rhinorrhoea
LÆGEMIDLETS NAVN DOCETAXEL KABI 20 mg/1 ml koncentrat til infusionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
Hoved-og hals-kræft
Head and neck cancer