FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
Danish: Patienter i komparatorarmen fik 100 mg/m² cisplatin (P) indgivet som intravenøs infusion over 30 minutter til 3 timer på førstedagen, efterfulgt af kontinuerlig intravenøs infusion af 1.000 mg/m²/dag 5-fluoruracil (F) fra dag 1 til dag 5.
English: 6 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flip-off cap containing 1 ml of concentrate for solution for infusion.
Danish: 6 ml klart, Type 1 hætteglas af glas med en bromobutyl gummiprop og aluminiumsforsegling og en plastik-afrivningshætte, der indeholder 1 ml koncentrat til infusionsvæske, opløsning.
English: Vascular disorders Respiratory, thoracic and mediastinal disorders
Danish: Vaskulære sygdomme Luftveje, thorax og mediastinum Mave-tarmkanalen
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m² as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m² administered as a 30-minute to 3-hour infusion, followed by 5-fluorouracil 1000 mg/m²/day as a continuous infusion from day 1 to day 4.
Danish: • Induktions kemoterapi efterfulgt af kemo-stråleterapi (TAX 324) Til den indledende behandling af patienter med lokalt fremskreden pladecellekarcinom i hoved og hals (SCCHN) (ikke muligt af resektere, lav sandsynlighed for kirurgisk helbredelse samt med bevarelse af organer som mål), er den anbefalede dosis docetaxel 75 mg/m² som en 1-times intravenøs infusion på dag 1, efterfulgt af cisplatin 100 mg/m² administreret som en 30-minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1.000 mg/m²/dag som en kontinuerlig infusion fra dag 1 til dag 4.
English: Pain intensity score improved during treatment in both groups indicating adequate pain management.
Danish: Mediantid til første forværring af WHO-funktionsstatus var signifikant længere i TPF-armen end i PF. Smerteintensitetsscoren forbedredes under behandlingen i begge grupper, hvilket indikerer god smertebehandling.
English: Arrhythmia (G3/4: 0.7%) Cardiac failure
Danish: Arytmi (G3/4: 0,7%) Hjertesvigt
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data.
Danish: Tabel over bivirkninger ved adjuverende behandling med docetaxel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv brystcancer (TAX 316) og lymfeknude-negativ brystcancer (GEICAM 9805) - pooled data.
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Danish: Myalgi (G3/4: 2%); Artralgi (G3/4: 1%)
English: Lacrimation increased (G3/4: <0.1%)
Danish: Forhøjet lakrimation (G3/4: <0,1%)
English: Alopecia (G3/4: 6%); Nail disorders (G3/4: 2%)
Danish: Alopeci (G3/4: 6%); Neglesygdomme (G3/4: 2%)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel (anhydrous).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml koncentrat indeholder 20 mg docetaxel (vandfri).
English: For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Danish: Ved dosisjustering af cisplatin og 5-fluoruracil henvises der til de tilsvarende produktresuméer.
English: Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).
Danish: Hver ml koncentrat til infusionsvæske, opløsning indeholder 20 mg docetaxel (vandfri).
English: • inflammation of the colon, small intestine; intestinal perforation
Danish: • betændelse i tarm, tyndtarm, perforering af tarmene
English: At the median follow up time of 10 years and 5 months, TAC treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Danish: Ved den mediane followup-periode på 10 år og 5 måneder havde TAC-behandlede patienter 16,5 % lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard ratio = 0,84; 95 % CI (0,65-1,08); p = 0,1646).
English: Peripheral motor neuropathy (G3/4: 2.5%)
Danish: Perifer motorisk neuropati (G3/4: 2,5%)
English: Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Danish: Artralgi (G3/4: 0,3%); Myalgi (G3/4: 0,3%)
English: Infections (G3/4: 5%)
Danish: Infektioner (G3/4: 5%)
English: Docetaxel Mylan 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.
Danish: Docetaxel Mylan i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-småcellet lungecancer hos patienter, der ikke tidligere har fået kemoterapi mod denne tilstand.
English: Thrombocytopenia (G3/4: 0.6%);
Danish: Thrombocytopeni; (G3/4: 0,6%);
English: For storage conditions after dilution of the diluted medicinal product, see section 6.3.
Danish: Oplysninger om opbevaring af hætteglas efter åbning og fortyndet lægemiddel, se pkt.
English: EU/1/11/748/006 - 5 vials
Danish: EU/1/11/748/006 - 5 hætteglas
English: Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
Danish: Patienter i docetaxel-armen fik 75 mg/m² docetaxel (T) som intravenøs infusion på førstedagen efterfulgt af 100 mg/m² cisplatin (P) indgivet som intravenøs infusion over 30 minutter til 3 timer, efterfulgt af kontinuerlig intravenøs infusion af 1.000 mg/m²/dag 5-fluoruracil (F) fra dag 1 til dag 4.
English: One vial of 10 ml of concentrate contains 200 mg of docetaxel.
Danish: 1 hætteglas på 10 ml koncentrat indeholder 200 mg docetaxel.
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Mylan 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 Mylan 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 såsom allergiske reaktioner og væskeansamlinger (hævede hænder, fødder, ben eller vægtøgning).
English: Preparation of the infusion solution
Danish: Fremstilling af infusionsvæsken
English: 10 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flipoff cap containing 4 ml of concentrate for solution for infusion.
Danish: 10 ml klart, Type 1 hætteglas af glas med en bromobutyl gummiprop og aluminiumsforsegling og en plastik-afrivningshætte, der indeholder 4 ml koncentrat til infusionsvæske, opløsning.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 10 ml
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Danish: Mave-tarmkanalen Stomatitis (G3/4: 5,3%); Diarre (G3/4: 4%);
English: Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain
Danish: Myalgi; Artralgi; Smerter i ekstremiteterne; Knoglesmerter; Rygsmerter
English: Number
Danish: BATCHNUMMER
English: 15 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flipoff cap containing 10 ml of concentrate for solution for infusion.
Danish: 15 ml klart, Type 1 hætteglas af glas med en bromobutyl gummiprop og aluminiumsforsegling og en plastik-afrivningshætte, der indeholder 10 ml koncentrat til infusionsvæske, opløsning.
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: Docetaxel Mylan in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Danish: Docetaxel Mylan i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystcancer efter svigt af cytotoksisk kemoterapi.
English: Median progression free survival (months) (95% CI)
Danish: Median progressionsfri overlevelse (måneder) (95% CI)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/001 - 1 vial
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/748/001 - 1 hætteglas
English: What Docetaxel Mylan 200 mg/10 ml contains
Danish: Docetaxel Mylan 200 mg/10 ml indeholder:
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 1 ml
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 1 ml
English: - For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Danish: - Til behandling af hoved- og halskræft indgives docetaxel i kombination med cisplatin og 5fluoruracil.
English: Hypersensitivity (G3/4:0.6%)
Danish: Hypersensitivitet (G3/4: 0,6%)
English: EU/1/11/748/004 - 5 vials
Danish: EU/1/11/748/004 - 5 hætteglas
English: Docetaxel Mylan 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 Mylan i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystcancer, hvis tumorer overudtrykker HER2, og som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/003 - 1 vial
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/748/003 - 1 hætteglas
English: Third episode: reduce docetaxel dose by 20%.
Danish: Tredje episode: Reducer docetaxel-dosis med 20%.
English: EU/1/11/748/002 - 5 vials
Danish: EU/1/11/748/002 - 5 hætteglas
English: One vial contains 200 mg of docetaxel.
Danish: Et hætteglas indeholder 200 mg docetaxel.
English: 1060 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin
Danish: 1.060 patienter blev randomiseret til at få enten docetaxel 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: 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 brystcancer, ikke-småcellet lungecancer, gastrisk samt hoved-halscancer gives et oralt kortikosteroid som præmedicinering, eksempelvis dexamethason 16 mg per dag (f.eks. 8 mg 2 gange dagligt).
English: Dizziness (G3/4: 2.0%);
Danish: Svimmelhed (G3/4: 2,0%);
English: Bone marrow suppression and other haematologic adverse reactions have been reported.
Danish: Der er rapporteret om knoglemarvsdepression og andre hæmatologiske bivirkninger.
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 phosphatase-værdier overstiger den øvre normalværdi 2,5 gange, er der en større risiko for udvikling af alvorlige bivirkninger.
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Danish: Neoplasmer benign og malign (inkl.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/005 - 1 vial
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/748/005 - 1 hætteglas
English: • indigestion
Danish: • stakåndethed
English: Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med Docetaxel 100 mg/m² i kombination med trastuzumab
English: • Mix the infusion bag or bottle manually using a rocking motion.
Danish: • Bland infusionsvæsken i infusionsposen eller -flasken ved at vippe posen.
English: What Docetaxel Mylan 20 mg/1 ml contains
Danish: Docetaxel Mylan 20 mg/1 ml indeholder:
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Danish: Docetaxel indgivet i kombination med trastuzumab blev undersøgt til behandling af patienter med metastatisk brystcancer og tumorer med overekspression af HER2, og som ikke tidligere havde været i kemoterapi for en metastatisk sygdom.
English: Following chemotherapy, patients should receive chemoradiotherapy.
Danish: Patienter bør modtage kemo-stråleterapi efter kemoterapi.
English: Best overall response to chemotherapy (%) (95% CI) ***p-value
Danish: Bedste total respons på kemoterapi (%) (95% CI) ***p-værdi
English: How to use Docetaxel Mylan 200 mg/10 ml
Danish: Sådan skal du bruge Docetaxel Mylan 200 mg/10 ml
English: What you need to know before you use Docetaxel Mylan 200 mg/10 ml
Danish: Det skal du vide, før du begynder at bruge Docetaxel Mylan 200 mg/10 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 200 mg/10 ml sterile concentrate docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Mylan 200 mg/10 ml sterilt koncentrat docetaxel
English: What Docetaxel Mylan 80 mg/4 ml contains
Danish: Docetaxel Mylan 80 mg/4 ml indeholder:
English: Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm 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
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, neutrofiltal < 500 celler/mm3 i mere end en uge, alvorlige eller kumulative kutane reaktioner eller alvorlig perifer neuropati.
English: What Docetaxel Mylan 200 mg/10 ml is and what it is used for What you need to know before you use Docetaxel Mylan 200 mg/10 ml How to use Docetaxel Mylan 200 mg/10 ml Possible side effects
Danish: Det skal du vide, før du begynder at bruge Docetaxel Mylan 200 mg/10 ml Sådan skal du bruge Docetaxel Mylan 200 mg/10 ml Bivirkninger
English: Peripheral motor neuropathy (G3/4: 0%)
Danish: Perifer motorisk neuropati (G3/4: 0%)
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Danish: Bedste respons i alt til studie behandling [kemoterapi +/- strålebehandling] (%) (95% CI) ***p-værdi
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Danish: Øsofagitis/dysfagi/odynofagi (G3/4: 0,7%).
English: Immune system disorders Metabolism and nutrition disorders Nervous system disorders
Danish: Immunsystemet Metabolismer og ernæring Nervesystemet
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 phosphataser > 6 gange øvre normalværdi, kan det ikke anbefales at reducere dosis.
English: What you need to know before you use Docetaxel Mylan 80 mg/4 ml
Danish: Det skal du vide, før du begynder at bruge Docetaxel Mylan 80 mg/4 ml
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 80 mg/4 ml sterile concentrate docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Mylan 80 mg/4 ml sterilt koncentrat docetaxel
English: Hepatic impairment
Danish: Venøs sygdom
English: Docetaxel Mylan is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Danish: Docetaxel Mylan er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungecancer efter behandlingssvigt af tidligere kemoterapi.
English: Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Danish: Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4: 0%);
English: Median overall survival (months) (95% CI)
Danish: Median total overlevelse (måneder) (95% CI)
English: Second episode: then reduce docetaxel dose by 20%.
Danish: Anden episode: Reducer så docetaxel-dosis med 20%.
English: One vial of 4 ml of concentrate contains 1.58 g of ethanol anhydrous.
Danish: Hvert hætteglas med 4 ml koncentrat indeholder 1,58 g vandfri ethanol Alle hjælpestoffer er anført under pkt.
English: Docetaxel Mylan 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 Mylan i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystcancer, som ikke tidligere har fået kemoterapi mod denne tilstand.
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 followup i GEICAM9805-studiet forekom akut leukæmi hos 1 ud af 532 (0,2%) patienter i TAC-armen.
English: What Docetaxel Mylan 80 mg/4 ml is and what it is used for What you need to know before you use Docetaxel Mylan 80 mg/4 ml How to use Docetaxel Mylan 80 mg/4 ml Possible side effects
Danish: Det skal du vide, før du begynder at bruge Docetaxel Mylan 80 mg/4 ml Sådan skal du bruge Docetaxel Mylan 80 mg/4 ml Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 20 mg/1 ml sterile concentrate docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Mylan 20 mg/1 ml sterilt koncentrat docetaxel
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Danish: Letargi (G3/4: 3,4%) Pyreksi (G3/4: 0,6%) Væskeretention Ødem
English: In GEICAM 9805 study, alopecia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm.
Danish: I studiet GEICAM9805 persisterede alopeci ind i followup-perioden (median followup-tid var 10 år og 5 måneder) og blev fortsat observeret hos 49 patienter (9,2%) i TAC-armen og hos 35 patienter (6,7%) i FAC-armen.
English: Second episode: reduce docetaxel dose by 20%.
Danish: Anden episode: Reducer docetaxel-dosis med 20%.
English: How to use Docetaxel Mylan 80 mg/4 ml
Danish: Sådan skal du bruge Docetaxel Mylan 80 mg/4 ml
English: What Docetaxel Mylan 20 mg/1 ml is and what it is used for What you need to know before you use Docetaxel Mylan 20 mg/1 ml How to use Docetaxel Mylan 20 mg/1 ml Possible side effects
Danish: Det skal du vide, før du begynder at bruge Docetaxel Mylan 20 mg/1 ml Sådan skal du bruge Docetaxel Mylan 20 mg/1 ml Bivirkninger
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
Danish: • 300 gastrisk adenokarcinoma-patienter (221 patienter i fase III-delen af studiet og 79 patienter i fase II-delen af studiet), som blev behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (klinisk relevante behandlingsrelaterede bivirkninger er nævnt).
English: Mix the infusion bag or bottle manually using a rocking motion.
Danish: Indholdet i infusionsposen eller -flasken blandes ved at vippe posen/flasken.
English: Myalgia (G3/4: 0.6%)
Danish: Myalgi (G3/4: 0,6%)
English: If Docetaxel Mylan concentrate or solution for infusion should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis Docetaxel Mylan-koncentratet eller infusionsvæsken kommer i kontakt med slimhinderne, skylles der straks grundigt med vand.
English: What you need to know before you use Docetaxel Mylan 20 mg/1 ml
Danish: Det skal du vide, før du begynder at bruge Docetaxel Mylan 20 mg/1 ml
English: One vial contains 80 mg of docetaxel.
Danish: Et hætteglas indeholder 80 mg docetaxel.
English: Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]* Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Danish: 10,1 Hazard Ratio: 1,122 [97,2% CI: 0,937; 1,342]*
English: Myalgia (G3/4: 0.4%)
Danish: Myalgi (G3/4: 0,4%)
English: Peripheral sensory neuropathy (G3/4:
Danish: Febril neuropeni (G3/4:
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Mylan 200 mg/10 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Docetaxel Mylan 200 mg/10 ml koncentrat til infusionsvæske, opløsning
English: Psychiatric disorders Nervous system disorders Eye disorders Cardiac disorders
Danish: Metabolisme og ernæring Psykiske forstyrrelser Nervesystemet Øjne
English: How to use Docetaxel Mylan 20 mg/1 ml
Danish: Sådan skal du bruge Docetaxel Mylan 20 mg/1 ml
English: One vial contains 20 mg of docetaxel.
Danish: Et hætteglas indeholder 20 mg docetaxel.
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m in combination with cisplatin and 5-fluorouracil
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel 75 mg/m² i kombination med cisplatin og 5-fluoruracil
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² single agent:
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel 100 mg/m² enkeltstof:
English: Peripheral motor neuropathy (G3/4: 0.4%)
Danish: Perifer motorisk neuropati (G3/4: 0,4%)
English: Median duration of response (months) (95% CI)
Danish: Medianvarighed af respons (måneder) (95% CI)
English: Docetaxel as single agent
Danish: Docetaxel som monoterapi