FrancophonIA/ELRC3.0 huggingface dataset:
English: Docetaxel Zentiva 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 Zentiva i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystkræft, hvis tumorer overudtrykker HER2, og som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
English: Tabulated list of adverse reactions in metastatic castration-resistant prostate cancer for Docetaxel Zentiva 75 mg/m² in combination with prednisone or prednisolone
Danish: Tabel over bivirkninger ved behandling af metastatisk kastrationsresistent prostatakræft med Docetaxel Zentiva 75 mg/m² i kombination med prednison eller prednisolon:
English: Data from a multi-centre open label randomised trial support the use of Docetaxel Zentiva for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy .
Danish: Data fra et multicenter, åbent, randomiseret studium støtter anvendelsen af Docetaxel Zentiva som adjuverende behandling til patienter med operabel, lymfeknude-negativ brystkræft, der er egnede til kemoterapibehandling.
English: • ADT + docetaxel 75 mg/m² given at the beginning of ADT, administered every 3 weeks for 6 cycles
Danish: • androgen deprivationsbehandling + docetaxel 75 mg/m² i begyndelsen af androgen deprivationsbehandlingen, administeret hver 3. uge i 6 perioder
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: Dette lægemiddel indeholder 50 % vol. ethanol, vandfri (alkohol) dvs. op til 395 mg ethanol, vandfri pr. hætteglas, svarende til 10 ml øl eller 4 ml vin.
English: If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4).
Danish: ritonavir, saquinavir, telithromycin og voriconazol) ikke kan undgås, er tæt klinisk overvågning nødvendig, og justering af docetaxeldosis kan være hensigtsmæssig under behandling med potente CYP3A4-hæmmere (se pkt.
English: Docetaxel Zentiva 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 Zentiva i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-småcellet lungekræft hos patienter, der ikke tidligere har fået kemoterapi mod denne tilstand.
English: Docetaxel Zentiva 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 Zentiva i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
English: 1000 mg/m2 per day for 5 days.
Danish: (PF) daglig i 5 dage.
English: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
Danish: Hjælpestoffer som behandleren skal være opmærksom på: Hvert hætteglas med koncentrat indeholder 4 ml ethanol, vandfri (3,16 g).
English: What Docetaxel Zentiva looks like and contents of the pack Docetaxel Zentiva concentrate for solution for infusion is a pale yellow to brownish-yellow solution.
Danish: Docetaxel Zentiva koncentrat til infusionsvæske, opløsning er en lys gul til brunliggul opløsning.
English: Docetaxel Zentiva in combination with trastuzumab
Danish: Docetaxel Zentiva i kombination med trastuzumab
English: • Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
Danish: • Udtag aseptisk den ønskede mængde Docetaxel Zentiva koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle.
English: As the benefit observed in patient with 4+ nodes was not statistically significant on disease-free survival (DFS) and overall survival (OS), the positive benefit/risk ratio for TAC in patients with 4+ nodes was not fully demontrated at the final analysis (see section 5.1).
Danish: Da fordelene hos patienter med 4+ lymfeknuder ikke var statistisk signifikante for sygdoms-fri overlevelse (DFS) og total overlevelse (OS), blev det positive fordel/risiko forhold for TAC-patienter med 4+ lymfeknuder ikke fuldt demonstreret i den endelige analyse (se pkt.
English: G3/4 AST increased G3/4 Blood alkaline phosphatase increased
Danish: G3/4 Forhøjet bilirubin i blodet (< 5 %);G3/4 forhøjet alkalisk fosfatase i blodet
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Danish: 1218 patienter med inoperabel ikke-småcellet lungekræft stadium IIIB eller IV med KPS på 70 % eller mere og som ikke tidligere havde fået kemoterapi mod denne tilstand, blev i et fase III-studie randomiseret til enten docetaxel (T) 75 mg/m administreret som 1-times infusion umiddelbart efterfulgt af cisplatin (Cis) 75 mg/m administreret i løbet af 30-60 minutter hver 3. uge (TCis),
English: • As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Danish: • Som ved alle andre parenterale produkter, skal Docetaxel Zentiva infusionsvæske kontrolleres visuelt for uklarheder, og opløsninger med udfældning skal i givet fald kasseres.
English: Citric acid
Danish: Ethanol, vandfri Citronsyre
English: Tabulated list of adverse reactions for adjuvant therapy with Docetaxel Zentiva 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 Zentiva 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft - pooled data:
English: Third episode: reduce docetaxel dose by 20%.
Danish: Første episode: Reducer 5-FU-dosis med 20 % Anden episode: Reducer så docetaxel-dosis med 20 %
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%);
Danish: Letargi (G3/4: 3,4 %); Pyreksi (G3/4: 0,6 %);
English: At the end of the follow-up period (actual median follow-up time of 8 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 var8 år) blev alopeci fortsat observeret hos 29 TAC-patienter (3,9 %) og hos 16 FAC-patienter (2,2 %).
English: Adjusted hazard ratio 95% CI p-value*
Danish: Justeret hazard ratio 95% CI p-værdi*
English: Description of selected adverse reactions for adjuvant therapy with Docetaxel Zentiva 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
Danish: Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med Docetaxel Zentiva 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknude-negativ (GEICAM 9805) brystkræft
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel as trihydrate.
Danish: Hver ml koncentrat indeholder 20 mg docetaxel som trihydrat.
English: Docetaxel Zentiva 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 Zentiva 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: 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: hos patienter med en initialdosis på 75 mg/m docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på < 25000 celler/mm
English: Docetaxel Zentiva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Danish: Docetaxel Zentiva er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungekræft efter behandlingssvigt af kemoterapi.
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 15 patienter (2 %) i FAC-armen.
English: Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Danish: Dysgeusi (G3/4: 0,6 %); Perifer sensorisk neuropati (G3/4: <
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelige ( kan forekomme hos op til 1 ud af 100 patienter):
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Zentiva 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 Zentiva 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 Zentiva.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED Docetaxel Zentiva 160 mg/8 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm).
Danish: Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1491 patienter randomiseret til enten at få enten docetaxel 75 mg/m administreret en time efter doxorubicin
English: More than one vial of Docetaxel Zentiva concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Danish: For at kunne udtage den korrekte dosis til patienten, kan det være nødvendigt at anvende mere end et hætteglas Docetaxel Zentiva koncentrat til infusionsvæske, opløsning.
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Zentiva 20 mg/1 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 160 mg/8 ml
Danish: YDERKARTON/Docetaxel Zentiva 160 mg/8 ml
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
English: First episode: reduce 5-FU dose by 20%.
Danish: Første episode: Reducer docetaxel- og 5-FU-dosis med 20 % Anden episode: Afbryd behandlingen
English: Haematology
Danish: CYTOTOKSISK
English: Docetaxel Zentiva in combination with platinum agents in chemotherapy-naïve patients
Danish: Docetaxel Zentiva i kombination med platinmidler hos patienter der ikke tidligere er behandlet med kemoterapi
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 20 mg/1 ml
Danish: YDERKARTON/Docetaxel Zentiva 20 mg/1 ml
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED Docetaxel Zentiva 20 mg/1 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 100 mg/m² i kombination med trastuzumab:
English: DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
Danish: Anvend ikke andre docetaxel lægemidler bestående af 2 hætteglas (koncentrat og solvens) sammen med dette lægemiddel (Docetaxel Zentiva 80 mg/4 ml koncentrat til infusionsvæske, opløsning, som kun indeholder 1 hætteglas).
English: PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 80 mg/4 ml
Danish: YDERKARTON/Docetaxel Zentiva 80 mg/4 ml
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin
Danish: Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin:
English: Package leaflet: Information for the patient Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Danish: Indlægseddel: Information til brugeren Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Package leaflet: Information for the patient Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Danish: Indlægseddel: Information til brugeren Docetaxel Zentiva 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² single agent
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft for Docetaxel Zentiva 100 mg/m² enkeltstof
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with capecitabine
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 75 mg/m² i kombination med capecitabin:
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² single agent
Danish: Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med Docetaxel Zentiva 75 mg/m² enkeltstof:
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED Docetaxel Zentiva 80 mg/4 ml KONCENTRAT TIL INFUSIONSVÆSKE, OPLØSNING
English: Docetaxel Zentiva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Danish: Docetaxel Zentiva monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af kemoterapi.
English: The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Danish: 75 mg/m 2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m pr.
English: In Docetaxel Zentiva 160 mg/8 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentration af docetaxel i Docetaxel Zentiva 160 mg/8 ml er 20 mg/ml.
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with doxorubicin
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 75 mg/m² i kombination med doxorubicin:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel
Danish: Docetaxel Zentiva 20 mg/1 ml sterilt koncentrat docetaxel
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Danish: Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Package leaflet: Information for the patient Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Danish: Indlægseddel: Information til brugeren Docetaxel Zentiva 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel
English: • Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/m2 as a 1 hour infusion followed by cisplatin 75 mg/m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/m2 per day for five days.
Danish: • Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Til den indledende behandling af inoperabel, lokalt fremskredne pladecellecarcinom i hoved og hals (SCCHN) er den anbefalede dosis docetaxel 75 mg/m som en 1-times infusion, efterfulgt af
English: Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel Zentiva 100 mg/m² i kombination med trastuzumab:
English: The recommended dose of docetaxel is 75 mg/m2.
Danish: Metastatisk kastrationsresistent prostatakræft Den anbefalede dosis af docetaxel er 75 mg/m2.
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: 75 mg/m til 60 mg/m 2: Hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter < 500 celler/mm i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Danish: Docetaxel Zentiva 20 mg/1 ml koncentrat til infusionsvæske, opløsning docetaxel
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Danish: Docetaxel Zentiva 80 mg/4 ml koncentrat til infusionsvæske, opløsning docetaxel
English: Abdominal pain (severe: 1%);
Danish: Konstipation (alvorlig: 0,2 %); Mavesmerter (alvorlig: 1 %);
English: You must not be given Docetaxel Zentiva:
Danish: Brug ikke Docetaxel Zentiva
English: Pre-Menopausal
Danish: Mave-tarmkanalen
English: Infection associated with G4 neutropenia (G3/4: 4.6%)
Danish: Neutropenisk infektion (G3/4: 2,6%)
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion.
Danish: Docetaxel Zentiva 160 mg/8 ml koncentrat til infusionsvæske, opløsning.
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 docetaxel (T) 75 mg/m ved intravenøs infusion på dag 1, efterfulgt af cisplatin (P) 100 mg/m administreret som en 30 minutter til
English: Vomiting (G3/4: 1.2%)
Danish: Feber (G3/4: 1,2 %)
English: 1060 patients were randomised to receive either Docetaxel Zentiva 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 cyclophosphamide 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: Patienterne havde operabel, lymfeknude-negativ brystkræft med høj risiko for tilbagefald ifølge 1998 St. Gallen-kriterierne (tumorstørrelse > 2 cm og/eller negative østrogenreceptorer (ER) og progesteronreceptorer (PR) og/eller høj histologisk/nukleær grad (grad 2 til 3) og/eller alder < 35 år).
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: In Docetaxel Zentiva 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentration af docetaxel i Docetaxel Zentiva 80 mg/4 ml er 20 mg/ml.
English: In Docetaxel Zentiva 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentration af docetaxel i Docetaxel Zentiva 20 mg/1 ml er 20 mg/ml.
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Danish: Arytmi (G3/4: 0,2 %); Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4:
English: Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Danish: eller cisplatin (100 mg/m på dag 1) og 5-fluoruracil (1000 mg/m pr. dag i 5 dage).
English: Alopecia (persisting: Skin disorder (G3/4:
Danish: Hud og subkutane væv Alopeci; Hudlidelser (G3/4:
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger ved behandling af hoved- og halskræft med Docetaxel Zentiva 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: Baseline cardiac assessment is recommended
Danish: INFORMATION I BRAILLE SKRIFT
English: In Docetaxel Zentiva 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml.
Danish: Koncentrationen af docetaxel i Docetaxel Zentiva 80 mg/4 ml er 20 mg/ml