FrancophonIA/ELRC3.0 huggingface dataset:
English: 2-year estimate (%) Hazard ratio (95% CI) *p-value
Danish: 2-års estimat (%) Hazard ratio (95 %CI) *p-værdi
English: Number of patients Tumor response rate (%) 95% CI p-value*
Danish: Antal patienter Tumor-response rate (%) 95 %CI p-værdi*
English: • 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.
Danish: • Hos patienter, der for anden gang udvikler grad 2-toksicitet eller første gang grad 3-toksicitet, skal behandlingen udsættes, indtil grad 0-1 nås.
English: The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Danish: Udvikling af alvorlig perifer neurotoksicitet kræver en dosisreduktion (se pkt.
English: 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).).
Danish: 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.
English: • indigestion
Danish: • Fordøjelsesbesvær
English: Each vial of concentrate contains 4.5 ml of ethanol anhydrous (3.55 g).
Danish: Hvert hætteglas af koncentrat indeholder 4,5 ml ethanol vandfri (3,55 g).
English: Number of patients Pain response rate (%) 95% CI p-value*
Danish: Antal patienter Smerte-response rate (%) 95 %CI p-værdi*
English: 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.
Danish: 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.
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Danish: Infektion associeret med G4-neutropeni (G3/4:
English: 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.
Danish: 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.
English: Median progression free survival (months) (95% CI)
Danish: Median progression fri overlevelse (måneder) (95 %CI)
English: Infections (G3/4: 5%)
Danish: Infektioner (G3/4: 5 %)
English: 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.
Danish: DOCETAXEL KABI koncentrat til infusionsvæske, opløsning er en klar, farveløs til svag gul opløsning.
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for DOCETAXEL KABI 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med DOCETAXEL KABI 75 mg/m2 i kombination med cisplatin og 5-fluorouractil
English: Peripheral sensory neuropathy (G3/4: 8.7%)
Danish: Perifer sensorisk neuropati (G3/4: 8,7 %)
English: 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%).
Danish: 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 %).
English: 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).
Danish: 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.
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%);
Danish: Stomatitis (G3/4: 18 %); Diarré (G3/4: 14 %); Kvalme
English: Peripheral motor neuropathy (G3/4: 2.5%)
Danish: Perifer motorisk neuropati (G3/4: 2,5 %)
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter):
English: Lacrimation increased (G3/4: < 0.1%)
Danish: Øget tåresekretion (G3/4: < 0,1 %);
English: Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: < 0.1%)
Danish: Dysgeusi (G3/4: 0,6 %); Perifer sensorisk neuropati (G3/4: <
English: Alopecia; Erythema; Rash; Nail
Danish: Alopeci; erythema; udslæt; neglesygdomme
English: Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea;
Danish: Luftveje, thorax og mediastinum Epistaxis; pharyngolaryngeal smerte; nasopharyngitis; dyspnø;
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Danish: Artralgi (G3/4: 0,3 %); Myalgi (G3/4: 0,3 %)
English: 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.
Danish: Efter 10 års opfølgning i GEICAM 9805-studiet forekom akut leukæmi hos 1 ud af 532 (0,2%) patienter i TAC-armen.
English: Thrombocytopenia (G3/4: 8.8%); Febrile neutropenia
Danish: Anæmi (G3/4: 8,9 %); Febril neutropeni
English: • difficulty or painful swallowing
Danish: • Synkebesvær eller smerter ved synkning
English: 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%).
Danish: 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%).
English: Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Danish: Alle andre lægemidler blev givet som intravenøs bolus på dag 1.
English: 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%).
Danish: 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 %).
English: Thrombocytopenia (G3/4: 0.6%);
Danish: Trombocytopeni; (G3/4: 0,6 %);
English: Number of patients PSA** response rate (%) 95% CI p-value*
Danish: PSA**- response rate (%) 95 %CI p-værdi*
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter):
English: Epistaxis (G3/4: < 1%)
Danish: Paræsthesi (G3/4: < 1 %)
English: Best overall response to chemotherapy (%) (95% CI) ***p-value
Danish: Bedste respons i alt til kemoterapi (%) (95 %CI) ***p-værdi
English: 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).
Danish: 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).
English: Anorexia (G3/4: 0.6%)
Danish: Anoreksi (G3/4: 0.6 %)
English: 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%).
Danish: 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%).
English: 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).
Danish: 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).
English: DOCETAXEL KABI is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Danish: DOCETAXEL KABI er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter behandlingssvigt af kemoterapi.
English: Cardiac failure
Danish: Iskæmisk hjertesygdom
English: Myalgia (G3/4: 0.7%); Arthralgia (G3/4: 0.2%)
Danish: Myalgi (G3/4: 0,7 %); Artralgi (G3/4: 0,2 %)
English: Lethargy (G3/4: 19.0%); Fever (G3/4: 2.3%);
Danish: Letargi (G3/4: 19,0 %); Feber (G3/4: 2,3 %);
English: arm.
Danish: Hjerte:
English: Cardiac left ventricular function decrease (G3/4: 0.3%)
Danish: Nedsat venstre ventrikelfunktion (G3/4: 0,3 %)
English: Dyspnoea (G3/4: 1%); Cough (G3/4: < 1%);
Danish: Dyspnø (G3/4: 1 %); Hoste (G3/4: < 1 %);
English: Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 100 mg/m2 i kombination med trastuzumab
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Tabulated list of adverse reactions in prostate cancer for DOCETAXEL KABI 75 mg/m² in combination with prednisone or prednisolone
Danish: Tabel over bivirkninger ved behandling af prostatakræft med DOCETAXEL KABI 75 mg/m² i kombination med prednison eller prednisolon
English: Phlebitis (G3/4: 0%)
Danish: Flebitis (G3/4: 0 %)
English: • alteration in sense of taste
Danish: • Smagsforstyrrelser
English: 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.
Danish: 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.
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 median-tiden til progression (24,6 uger vs 15,6 uger; p < 0,01) og median- overlevelse (15,3 måneder vs 12,7 måneder;
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 180 mg/9 ml OTHER Cytotoxic
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 180 mg/9 ml ANDET Cytotoksisk
English: Each box contains one vial of 9 ml concentrate (180 mg docetaxel).
Danish: Hver æske indeholder 1 hætteglas af 9 ml (180 mg docetaxel).
English: Thrombocytopenia (G4: 0.2%)
Danish: Trombocytopeni (G4:0,5 %)
English: 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%).
Danish: 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 %).
English: Infection (G3/4: 3.3%)
Danish: Infektioner (G3/4: 3,3 %)
English: G3/4 Blood bilirubin increased (< 2%)
Danish: G3/4 Forhøjet bilirubin i blodet (9 %)
English: Lacrimation increased (G3/4: 0%)
Danish: Forhøjet lakrimation (G3/4: 0 %)
English: 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.
Danish: Docetaxel blev elimineret både i urin og fæces efter cytocrom P-450 medieret oxidativ metabolisering af tert-butyl estergruppen.
English: Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Danish: Diarré (G3/4: 3,4 %); Obstipation (G3/4:0,5
English: Peripheral sensory neuropathy (G3: 0.4%)
Danish: Perifer sensorisk neuropati (G3: 0,4 %)
English: Each box contains one vial of 6 ml concentrate (120 mg docetaxel).
Danish: Hver æske indeholder 1 hætteglas af 6 ml (120 mg docetaxel).
English: Each box contains one vial of 8 ml concentrate (160 mg docetaxel).
Danish: Hver æske indeholder 1 hætteglas af 8 ml (160 mg docetaxel).
English: You must not be given DOCETAXEL KABI:
Danish: DOCETAXEL KABI indeholder:
English: 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.
Danish: 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.
English: For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Danish: Vedrørende dosisjusteringer for trastuzuma, se produktresuméet for trastuzumab.
English: Description of selected adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 100 mg/m2 enkeltstof
English: 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.
Danish: 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.
English: Peripheral motor neuropathy (G3/4: 0%)
Danish: Perifer motorisk neuropati (G3/4: 0 %)
English: Disposal
Danish: Bortskaffelse:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 160 mg/8 ml OTHER Cytotoxic
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 160 mg/8 ml ANDET Cytotoksisk
English: One vial of 9 ml of concentrate contains 180 mg of docetaxel.
Danish: Et hætteglas af 9 ml koncentrat indeholder 180 mg docetaxel.
English: Following chemotherapy, patients should receive chemoradiotherapy.
Danish: Patienter bør modtage kemo-strålingsterapi efter kemoterapi
English: You must not be given DOCETAXEL KABI
Danish: Brug ikke DOCETAXEL KABI
English: 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.
Danish: 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.
English: What DOCETAXEL KABI contains - The active substance is docetaxel anhydrous.
Danish: - Aktivt stof: docetaxel vandfri.
English: 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.
Danish: 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.
English: One vial of 8 ml of concentrate contains 160 mg of docetaxel.
Danish: Et hætteglas af 8 ml koncentrat indeholder 160 mg docetaxel.
English: • blood clots.
Danish: • Blodpropper
English: Nausea (G3/4: 3.3%);
Danish: Kvalme (G3/4: 3,3 %);
English: Gastrointestinal haemorrhage (severe: 0.3%)
Danish: Gastrointestinal Hæmoragi (alvorlig:
English: Dysgeusia (G3/4: < 1%); Paraesthesia (G3/4: < 1%)
Danish: Dysgeusi (G3/4: < 1 %); Paræsthesi (G3/4: < 1 %)
English: Each box contains one vial of 4 ml concentrate (80 mg docetaxel).
Danish: Hver æske indeholder 1 hætteglas af 4 ml (80 mg docetaxel).
English: Lacrimation increased (G3/4: 0.6%)
Danish: Forhøjet lakrimation (G3/4:0,6 %)
English: NA-not applicable
Danish: UTILGÆNGELIGT FOR BØRN
English: Median overall survival (months) (95% CI)
Danish: Median overlevelse i alt (måneder) (95% CI)
English: 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.
Danish: 10 ml klar, farveløs Type-I hætteglas, lukket med flurotec gummipropper og en orange flip-off aluminium kapsel, indeholdende 9 ml koncentrat.
English: • muscle aches and pains; back pain or bone pain
Danish: • Muskelømhed og smerter, rygsmerter eller knoglesmerter
English: Bone marrow suppression and other haematologic adverse reactions have been reported.
Danish: Der er rapporter om knoglemarvsdepression og andre hæmatologiske bivirkninger.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 180 mg/9 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG FOR DOCETAXEL KABI 180 mg/9 ml, KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with capecitabine
Danish: Tabel over bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 75 mg/m² i kombination med capecitabin:
English: 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%).
Danish: 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%).
English: Peripheral motor neuropathy (G3/4: 0.4%)
Danish: Perifer motorisk neuropati (G3/4: 0,4 %)
English: Myalgia (G3/4: 0.6%)
Danish: Myalgi (G3/4: 0,6 %)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 120 mg/6 ml OTHER Cytotoxic
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 120 mg/6 ml ANDET Cytotoksisk
English: DOCETAXEL KABI in combination with platinum agents in chemotherapy-naïve patients
Danish: DOCETAXEL KABI i kombination med platinmidler hos patienter der ikke tidligere er behandlet med kemoterapi
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 testisfunktionen.
English: Nausea (G3/4: 5%);
Danish: Kvalme (G3/4: 5 %);
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN DOCETAXEL KABI 180 mg/9 ml koncentrat til infusionsvæske, opløsning.
English: - For the treatment of early breast cancer with or without lymph node involvement, DOCETAXEL
Danish: • Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder kan DOCETAXEL KABI anvendes i kombination med doxorubicin eller cyclophosphamid.
English: G3/4 Blood alkaline phosphatase increased (< 4%);G3/4 AST increased (< 3%);
Danish: G3/4 Forhøjet bilirubin i blodet (< 5 %);G3/4 forhøjet alkalisk fosfatase i blodet
English: One vial of 6 ml of concentrate contains 120 mg of docetaxel.
Danish: Et hætteglas af 6 ml koncentrat indeholder 120 mg docetaxel.
English: Infections (G3/4: 5.7%; including sepsis and pneumonia, fatal in 1.7%)
Danish: 5,7 %; inklusive sepsis og pneumoni, letal hos
English: DOCETAXEL KABI monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Danish: DOCETAXEL KABI monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
English: Each box contains one vial of 1 ml concentrate (20 mg docetaxel).
Danish: Hver æske indeholder 1 hætteglas af 1 ml (20 mg docetaxel).
English: 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.
Danish: 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.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG FOR DOCETAXEL KABI 160 mg/8 ml, KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: Thrombocytopenia (G3/4: 3%)
Danish: Trombocytopeni (G3/4:
English: • insomnia
Danish: • Søvnløshed
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg/1 ml OTHER Cytotoxic
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 20 mg/1 ml ANDET Cytotoksisk
English: Myalgia (G3/4: 0.4%)
Danish: Myalgi (G3/4: 0,4 %)
English: One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Danish: Et hætteglas af 1 ml koncentrat indeholder 20 mg docetaxel.
English: Its common name is docetaxel.
Danish: Det er et handelsnavn for docetaxel.