FrancophonIA/ELRC3.0 huggingface dataset:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg/4 ml OTHER Cytotoxic
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 80 mg/4 ml ANDET Cytotoksisk
English: 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.
Danish: 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.
English: DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
Danish: DOCETAXEL KABI 180 mg/9 ml koncentrat til infusionsvæske, opløsning docetaxel
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN DOCETAXEL KABI 160 mg/8 ml koncentrat til infusionsvæske, opløsning.
English: Median survival (months) (95% CI)
Danish: Median overlevelse (måneder) (95 %CI)
English: DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
Danish: DOCETAXEL KABI 120 mg/6 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Cough; Rhinorrhoea
Danish: Nyre og urinveje
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN DOCETAXEL KABI 20 mg/1 ml koncentrat til infusionsvæske, opløsning.
English: Head and neck cancer
Danish: Hoved-og hals-kræft
English: DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
Danish: DOCETAXEL KABI 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
English: (95% CI) ***p-value
Danish: CI) **p-værdi
English: Peripheral sensory neuropathy (G3/4: 0.8%)
Danish: Perifer sensorisk neuropati (G3/4: 0,8 %)
English: Second episode: reduce docetaxel dose by 20%.
Danish: Første episode: Reducer 5-FU-dosis med 20 % Anden episode: Reducer så docetaxel-dosis med 20 %
English: Arrhythmia
Danish: Letargi
English: One vial of 4 ml of concentrate contains 80 mg of docetaxel.
Danish: Et hætteglas af 4 ml koncentrat indeholder 80 mg docetaxel.
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² in combination with trastuzumab
Danish: Tabel over bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 100 mg/m² i kombination med trastuzumab:
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG FOR DOCETAXEL KABI 20 mg/1 ml, KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN DOCETAXEL KABI 80 mg/4 ml koncentrat til infusionsvæske, opløsning.
English: Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain
Danish: Myalgi; artralgi; smerter i ekstremiteterne; knoglesmerter; rygsmerter
English: Weight decreased; G3/4 Blood bilirubin increased
Danish: G3/4 Forhøjet bilirubin i blodet
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG FOR DOCETAXEL KABI 80 mg/4 ml, KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: Infection (G3/4: 5.7%)
Danish: Infektioner (G3/4: 5,7
English: Dose adjustments during treatment
Danish: Dosisjustering under behandling:
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL KABI 120 mg/6 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG FOR DOCETAXEL KABI 120 mg/6 ml, KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: 10 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a yellow flip-off aluminium over seal containing 8 ml of concentrate.
Danish: 10 ml klar, farveløs Type-I hætteglas, lukket med flurotec gummipropper og en gul flip-off aluminium kapsel, indeholdende 8 ml koncentrat.
English: DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion docetaxel
Danish: DOCETAXEL KABI 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Musculoskeletal and connective bone disorders
Danish: Almindelige bivirkninger bindevæv
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a green flip-off aluminium over seal containing 1 ml of concentrate.
Danish: 6 ml klar, farveløs Type-I hætteglas, lukket med flurotec gummipropper og en grøn flip-off aluminium kapsel, indeholdende 1 ml koncentrat.
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 75 mg/m² in combination with doxorubicin
Danish: Tabel over bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 75 mg/m² i kombination med doxorubicin:
English: Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
Danish: Perifer sensorisk neuropati (G3: 4,1 %); Perifer motorisk neuropati (G3/4: 4 %) Dysgeusi (alvorlig:
English: DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
Danish: DOCETAXEL KABI 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel
English: NAME OF THE MEDICINAL PRODUCT DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN DOCETAXEL KABI 120 mg/6 ml koncentrat til infusionsvæske, opløsning.
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 1.58 g ethanol anhydrous per vial, equivalent to 40 ml of beer or 17 ml wine.
Danish: Lægemidlet indeholder 50 vol % ethanol vandfri (alkohol), dvs. op til 1,58 g (2 ml) ethanol vandfri per hætteglas svarende til 40 ml øl eller 17 ml vin.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) DOCETAXEL KABI 180 mg/9 ml koncentrat til infusionsvæske, opløsning docetaxel i.v.
English: Rash erythematous (G3/4: < 1%);
Danish: Dysgeusi (G3/4: < 1 %);
English: Pharyngolaryngeal pain (G3/4: 2%)
Danish: Luftveje, thorax og mediastinum Pharyngolaryngeale smerter (G3/4: 2 %)
English: One hundred eighty six patients were randomised to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
Danish: 186 patienter blev randomiseret til at få docetaxel (100 mg/m2) med eller uden trastuzumab.
English: Nausea (G3/4: 5%); Stomatitis (G3/4: 7.8%);
Danish: Kvalme (G3/4: 13,9 %); Stomatitis (G3/4:20,7
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a red flip-off aluminium over seal containing 6 ml of concentrate.
Danish: 6 ml klar, farveløs Type-I hætteglas, lukket med flurotec gummipropper og en rød flip-off aluminium kapsel, indeholdende 6 ml koncentrat.
English: Skin reaction (G3/4: 0.2%)
Danish: Hudreaktioner (G3/4:0,2 %)
English: Constipation
Danish: Konstipation
English: Fever (G3/4: 1.2%)
Danish: Ødemer (G3/4: 1,2%)
English: Hepatic impairment
Danish: Eksfoliativt udslæt
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) DOCETAXEL KABI 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel i.v.
English: Tabulated list of adverse reactions in gastric adenocarcinoma center for DOCETAXEL KABI 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger ved behandling af gastrisk adenokarcinom med DOCETAXEL KABI 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: • 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 randomised, multi centre open-label, phase III, study (TAX324).
Danish: 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).
English: 6 ml clear, colourless Type-I glass vial, closed with flurotec rubber stopper and a blue flip-off aluminium over seal containing 4 ml of concentrate.
Danish: 6 ml klar, farveløs Type-I hætteglas, lukket med flurotec gummipropper og en blå flip-off aluminium kapsel, indeholdende 4 ml koncentrat.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) DOCETAXEL KABI 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel i.v.
English: Tabulated list of adverse reactions in non-small cell lung cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin
Danish: Tabel over bivirkninger ved behandling af ikke små-cellet lungekræft med DOCETAXEL KABI 75 mg/m² i kombination med cisplatin:
English: Number of patients Median survival (months) 95% CI
Danish: Median overlevelsestid (måneder) 95 %CI
English: Asthenia (severe: 8.1%); Fluid retention (severe: 1.2%); Pain
Danish: Asteni (alvorlig: 8,1 %); Væskeretention (alvorlig 1,2 %);
English: Scleroderma-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Danish: Ved behandling med docetaxel er der rapporteret om sklerodermi-lignende forandringer, som oftest forudgået af perifert lymfødem.
English: DOCETAXEL KABI in combination with trastuzumab
Danish: DOCETAXEL KABI i kombination med trastuzumab
English: This medicinal product contains 50 vol % ethanol anhydrous (alcohol), i.e. up to 3.55 g ethanol anhydrous per vial, equivalent to 90 ml of beer or 36 ml wine.
Danish: Lægemidlet indeholder 50 vol % ethanol vandfri (alkohol), dvs. op til 3,55 g (4,5 ml) ethanol vandfri per hætteglas svarende til 90 ml øl eller 36 ml vin.
English: Adjusted Hazard ratio (95% CI) *p-value
Danish: Tilpasset hazard ratio (95 %CI) *p-værdi
English: Arrhythmia (G3/4: 1.0%)
Danish: Arytmi (G3/4: 1,0 %)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) DOCETAXEL KABI 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel i.v.
English: Tabulated list of adverse reactions in head and neck cancer for DOCETAXEL KABI 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger ved behandling af hoved- og halskræft med DOCETAXEL KABI 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: In DOCETAXEL KABI 180 mg/9 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentrationen er 20 mg/ml i DOCETAXEL KABI 180 mg/9 ml hætteglas.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) DOCETAXEL KABI 120 mg/6 ml koncentrat til infusionsvæske, opløsning docetaxel i.v.
English: Vomiting (G3/4: 4%);
Danish: Diarré (G3/4: 4 %);
English: Vomiting (G3/4: 4%); Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Danish: (G3/4: 6 %); Opkastning (G3/4: 4 %); Konstipation (G3/4: 1 %); Mavesmerter (G3/4: 2 %); Dyspepsi
English: DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Danish: DOCETAXEL KABI 180 mg/9 ml koncentrat til infusionsvæske, opløsning kræver INGEN fortynding med solvent og er derfor klar til at blive tilsat til infusionsvæsken.
English: • dry mouth
Danish: • Mundsår
English: • shortness of breath
Danish: • Åndedrætsbesvær
English: DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Danish: DOCETAXEL KABI 160 mg/8 ml koncentrat til infusionsvæske, opløsning kræver INGEN fortynding med solvent og er derfor klar til at blive tilsat til infusionsvæsken.
English: Cough (G3/4: 0%)
Danish: Hoste (G3/4: 0 %)
English: At the end of the follow-up period (actual median follow-up time of 10 years and 5 months), no patients had CHF in TAC arm and 1 patient in
Danish: Ved afslutningen af opfølgningsperioden (faktisk median opfølgningstid på 10 år og 5 måneder) havde ingen patienter CHF i TAC-armen og 1 patient i TAC-armen døde af dilateret kardiomyopati, og det blev observeret at CHF fortsatte hos 1 patient (0,2 %) i FAC-armen.
English: Skin and
Danish: Infektioner og
English: Hypersensitivity (G3/4: 1.7%)
Danish: Iskæmisk hjertesygdom (G3/4: 1,7 %)
English: • flushing, skin reactions, itching
Danish: • rødme i ansigtet, hudreaktioner, kløe
English: Tabulated list of adverse reactions in breast cancer for DOCETAXEL KABI 100 mg/m² single agent
Danish: Tabel over bivirkninger ved behandling af brystkræft med DOCETAXEL KABI 100 mg/m² enkeltstof:
English: Arrhythmia (G3/4: 2.0%)
Danish: Arytmi (G3/4: 2,0 %)
English: Hearing impaired (G3/4: 0%)
Danish: Nedsat hørelse (G3/4: 0 %)
English: Possible side effects
Danish: Almindelige bivirkninger
English: Vomiting (G3/4: 1.2%)
Danish: Diarré (G3/4: 1,2 %);
English: DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Danish: DOCETAXEL KABI 120 mg/6 ml koncentrat til infusionsvæske, opløsning kræver INGEN fortynding med solvent og er derfor klar til at blive tilsat til infusionsvæsken.
English: Venous disorder
Danish: Venesygdomme
English: Second episode: stop 5-FU only, at all subsequent cycles.
Danish: Første episode: Reducer 5-FU-dosis med 20 % Anden episode: Stop kun 5-FU i alle efterfølgende cyklusser Tredje episode: Reducer docetaxel-dosis med 20 %
English: DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Danish: DOCETAXEL KABI 20 mg/1 ml koncentrat til infusionsvæske, opløsning kræver INGEN fortynding med solvent og er derfor klar til at blive tilsat til infusionsvæsken.
English: DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Danish: DOCETAXEL KABI 80 mg/4 ml koncentrat til infusionsvæske, opløsning kræver INGEN fortynding med solvent og er derfor klar til at blive tilsat til infusionsvæsken.
English: Nausea (G3/4: 6%);
Danish: Kvalme (G3/4: 16 %);
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%);
Danish: Oesophagitis/dysfagi/odynofagi (G3/4: 0,7 %)
English: Peripheral motor neuropathy (G3/4: 4%);
Danish: Perifer motorisk neuropati (G3/4: 0 %);
English: In DOCETAXEL KABI 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentrationen er 20 mg/ml i DOCETAXEL KABI 20 mg/1 ml hætteglas.
English: Hazard ratio: (95% CI) *p-value
Danish: Hazard ratio: (95% CI) *p-værdi
English: Uncommon adverse reactions neuropathy (G3/4: 1.2%) neuropathy (G3/4: 0.4%)
Danish: Perifer sensorisk neuropati (G3/4: 1,2 %); Dysgeusi (G3/4: 0 %)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 180 mg/9 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: ANVEND IKKE andre docetaxel lægemidler, som består af 2 hætteglas (koncentrat og solvent) med dette lægemiddel (DOCETAXEL KABI 180 mg/9 ml koncentrat til infusionsvæske, opløsning, som indeholder 1 hætteglas).
English: Constipation (G3/4: 0.4%)
Danish: Neglesygdomme (G3/4:0,4 %)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/770/005
English: Exfoliative rash (G3/4: 0.3%)
Danish: Eksfoliativt udslæt (G3/4: 0,3 %)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: ANVEND IKKE andre docetaxel lægemidler, som består af 2 hætteglas (koncentrat og solvent) med dette lægemiddel (DOCETAXEL KABI 160 mg/8 ml koncentrat til infusionsvæske, opløsning, som indeholder 1 hætteglas).
English: Dyspnoea (G3/4: 0.6%); Cough (G3/4: 0%)
Danish: Epistaxis (G3/4: 0 %); Dyspnø (G3/4: 0,6 %); Hoste (G3/4: 0 %)
English: Between infusions of DOCETAXEL KABI the following may occur, and the frequency may vary with the combinations of medicines that are received
Danish: Følgende kan ske mellem DOCETAXEL KABI infusionerne.
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: ANVEND IKKE andre docetaxel lægemidler, som består af 2 hætteglas (koncentrat og solvent) med dette lægemiddel (DOCETAXEL KABI 80 mg/4 ml koncentrat til infusionsvæske, opløsning, som indeholder 1 hætteglas).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/770/004
English: Tabulated list of adverse reactions in non-small cell lungcancer for DOCETAXEL KABI 75 mg/m² single agent
Danish: Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med DOCETAXEL KABI 75 mg/m² enkeltstof:
English: Arrhythmia (G3/4: 0.7%)
Danish: Arytmi (G3/4: 0,7 %)
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 120 mg/6 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: ANVEND IKKE andre docetaxel lægemidler, som består af 2 hætteglas (koncentrat og solvent) med dette lægemiddel (DOCETAXEL KABI 120 mg/6 ml koncentrat til infusionsvæske, opløsning, som indeholder 1 hætteglas).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/770/001
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (DOCETAXEL KABI 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: ANVEND IKKE andre docetaxel lægemidler, som består af 2 hætteglas (koncentrat og solvent) med dette lægemiddel (DOCETAXEL KABI 20 mg/1 ml koncentrat til infusionsvæske, opløsning, som indeholder 1 hætteglas).
English: Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Danish: Første episode: Stop kun 5-FU i alle efterfølgende cyklusser Anden episode: Reducer docetaxel-dosis med 20 %
English: Arrhythmia (G3/4: 0.2%)
Danish: Vægttab (G3/4: 0,2 %)
English: Fluid retention (G3/4: 1.2); Oedema (G3/4: 1.2%)
Danish: Stomatitis/Pharyngitis (G3/4:0,9 %); Opkastning (G3/4: 1,2 %)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/770/003
English: 36.0) in AC arm.
Danish: 36 min. og 11,1 time.
English: status
Danish: ENDEPUNKT
English: Nausea (G3/4: 2.4%); Diarrhoea (G3/4: 1.2%);
Danish: Opkastning (G3/4: Diarré (G3/4: 3,4 %);
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 arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Danish: Efter 10 års opfølgning i GEICAM 9805-studiet forekom akut leukæmi hos 1 ud af 532 (0,2%) patienter i TAC-armen i GEICAM 9805-studiet.
English: Hazard ratio (95% CI) *p-value
Danish: Hazard ratio (95 %CI) *p-værdi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/770/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/12/770/002
English: In DOCETAXEL KABI 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentrationen er 20 mg/ml i DOCETAXEL KABI 80 mg/4 ml hætteglas.
English: Common adverse reactions tissue disorders
Danish: Ikke almindelige bivirkninger bindevæv
English: In DOCETAXEL KABI 120 mg/6 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentrationen er 20 mg/ml i DOCETAXEL KABI 120 mg/6 ml hætteglas.
English: Dyspepsia (G3/4: 0.8%);
Danish: Artralgi (G3/4: 0,3 %);
English: Hazard ratio (95% CI) **p-value
Danish: Hazard ratio (95% CI) **p-værdi
English: Nausea (G3/4: 5.0%); Stomatitis (G3/4: 6.0%); Vomiting (G3/4: 4.2%); Diarrhoea (G3/4: 3.4%); Constipation (G3/4: 0.5%)
Danish: Stomatitis (G3/4: 18 %); Diarré (G3/4: 14 %); Kvalme (G3/4: 6 %); Opkastning (G3/4: 4 %); Konstipation (G3/4: 1 %); Mavesmerter (G3/4: 2 %); Dyspepsi
English: Cancer pain (G3/4: 0.6%)
Danish: Hudsygdomme (G3/4:0,6%)
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Danish: - Tal med lægen eller sundhedspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Infusion site reaction; Non-cardiac chest pain (severe: 0.4%)
Danish: Ikke-kardiale brystsmerter (alvorlig:
English: Gastrointestinal haemorrhage (G3/4: 0.6%)
Danish: Tør hud; Hudafskalning (G3/4:0,6 %)
English: In DOCETAXEL KABI 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentrationen er 20 mg/ml i DOCETAXEL KABI 160 mg/8 ml hætteglas.
English: Stomatitis (G3/4: 23.7%);
Danish: Diarré (G3/4: 19,7 %);
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: 0%);
Danish: Epistaxis (G3/4: 0 %); Dyspnø (G3/4: 0,6 %);
English: Anaemia (G3/4: 8.9%);
Danish: Trombocytopeni (G3/4: 8,8 %);
English: Anaemia (G3/4: 3%); Neutropenia (G3/4: 59.2%);
Danish: Blod og lymfesystem Neutropeni (G3/4: Anæmi (G3/4: 9,2 %);
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Danish: Letargi (G3/4: 3,4 %); Pyreksi (G3/4:
English: Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Danish: Patienter, der får TCF, bør monitores nøje (se pkt.
English: Nausea (G3/4: 9.6%);
Danish: Kvalme (G3/4: 9,6
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Danish: Kløende udslæt (G3/4: 0,7 %); Neglesygdomme (G3/4: 0,7 %); Hudafskalning (G3/4: 0 %)
English: Tell them immediately if you notice any of these effects.
Danish: Hvis du får nogle af disse bivirkninger, så fortæl det straks til lægen.
English: Somnolence (G3/4: 0%)
Danish: Døsighed (G3/4: 0
English: Ref. EMEA/CHMP/466849/2009 EMEA/H/A-30/1003
Danish: ref. EMEA/714035/2009 EMEA/H/A-30/1003
English: The review was carried out under an ‘Article 30' referral1.
Danish: Undersøgelsen blev gennemført i henhold til en ‘artikel 30'-indbringelse1.
English: Also, not all Member States had authorised the medicine for use in children.
Danish: Alle medlemsstater havde heller ikke godkendt lægemidlet til børn.
English: Why was Meronem reviewed?
Danish: Hvorfor blev Meronem revurderet?
English: Meronem and associated names are authorised in the EU via national procedures.
Danish: Meronem og tilknyttede navne er godkendt i EU via nationale procedurer.
English: What is Meronem?
Danish: Hvad er Meronem?
English: The amended information to doctors and patients is available here.
Danish: Den ændrede produktinformation til patienter og fagfolk i sundhedssektoren findes her.
English: 23 October 2008
Danish: den 23. oktober 2008