FrancophonIA/ELRC3.0 huggingface dataset:
English: • Mitoxantrone 12 mg/m2 every 3 weeks for 10 cycles.
Danish: 6 mg/m hver 3. uge).
English: Hypersensitivity (G3/4: 1.2%)
Danish: Overfølsomhed (G3/4:1,2 %)
English: Neutropenia (Grade 4) Febrile neutropenia
Danish: Neutropeni (grad 4)
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath)
Danish: Lungefibrose (ardannelse og fortykkelse i lungerne samt åndenød) Sløret syn pga. hævet nethinde (cystoidt makulaødem)
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between +2°C and +8°C or at room temperature (below 25°C).
Danish: Dog har præmixopløsningen vist fysisk og kemisk stabilitet i en periode på 8 timer, både når den blev opbevaret mellem +2 °C og +8 °C, og når den blev opbevaret ved stuetemperatur (under 25 °C).
English: If Docetaxel Teva Pharma concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Danish: Hvis Docetaxel Teva Pharma-infusionskoncentrat, præmixopløsning eller infusionsvæske skulle komme på huden, så vask omgående og grundigt med sæbe og vand.
English: Each vial of concentrate contains 20 mg of docetaxel.
Danish: Hvert hætteglas med koncentrat indeholder 20 mg docetaxel.
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
Danish: Dette overskud sikrer, at der efter fortynding med hele indholdet af den medfølgende solvens til docetaxel hætteglas kan udtages et præmixvolumen på mindst 2 ml, som indeholder 10 mg/ml docetaxel, hvilket svarer til den mængde, der er angivet på pakningen på 20 mg pr. hætteglas.
English: Each vial of concentrate contains 80 mg of docetaxel.
Danish: Hvert hætteglas med koncentrat indeholder 80 mg docetaxel.
English: Solvent for Docetaxel Teva Pharma 80 mg vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: Solvens til Docetaxel Teva Pharma 80 mg hætteglas 15 ml klart Type I-hætteglas med brombutyl-gummiprop og en afrivningshætte.
English: Peripheral sensory neuropathy (G3: 4.1%);
Danish: Perifer sensorisk neuropati (G3: 3,7 %);
English: Febrile neutropenia (G3/4: NA)
Danish: Amenorré (G3/4: NA)
English: Dyspepsia (G3/4: 0.8%); Gastrointestinal pain (G3/4: 1.2%);
Danish: Dyspepsi (G3/4: 0,8 %) Gastrointestinal smerte (G3/4: 1,2 %) Gastrointestinal blødning (G3/4: 0,4 %)
English: This overfill ensures that after dilution with the entire contents of the accompanying solvent for docetaxel vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ml docetaxel which corresponds to the labelled amount of 80 mg per vial.
Danish: Dette overskud sikrer, at der efter fortynding med hele indholdet af den medfølgende solvens til docetaxel hætteglas kan udtages et præmixvolumen på mindst 8 ml, som indeholder 10 mg/ml docetaxel, hvilket svarer til den mængde, der er angivet på pakningen på 80 mg pr. hætteglas.
English: For breast and non-small cell lung cancer, 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 dexamethason 16 mg pr. dag i 3 dage (f.eks. 8 mg 2 gange daglig).
English: 4.2.4 The Docetaxel Teva Pharma infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25°C) and normal lighting conditions.
Danish: 4.2.4 Docetaxel Teva Pharma infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1-times infusion ved stuetemperatur (under 25 °C) og under normale
English: However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2°C and 8°C or at room temperature (below 25°C).
Danish: Dog har præmixen vist sig kemisk og fysisk stabil i en 8-timers periode, når den blev opbevaret enten ved temperatur mellem 2 °C og 8 °C eller ved stuetemperatur (under 25 ºC).
English: Endpoint every 3 weeks
Danish: Docetaxel hver 3. uge
English: Solvent for Docetaxel Teva Pharma 20 mg vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: Solvens til Docetaxel Teva Pharma 20 mg hætteglas 6 ml klart Type I-hætteglas med brombutylgummiprop og en afrivningshætte.
English: Allow the premix vial to stand for 5 minutes at room temperature (below 25°C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Danish: Lad hætteglasset med præmix stå i stuetemperatur (under 25 °C) i 5 minutter, og kontroller så, at opløsningen nu er homogen og klar.
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-butylestergruppen.
English: If Docetaxel concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis Docetaxel infusionskoncentrat, præmixopløsning eller infusionsvæske skulle komme i kontakt med slimhinderne, så vask omgående og grundigt med vand.
English: Anaemia (G3/4: 20.9%); Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4: 8.8%);
Danish: Anæmi (G3/4: 20,9 %); Neutropeni (G3/4: 83,2 %);
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: Tabulated list of adverse reactions 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 cyclofosfamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknudenegativ (GEICAM 9805) brystkræft - pooled data.
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%);
Danish: Dyspnø (G3/4: 1 %); Hoste (G3/4: < 1 %); Epistaxis (G3/4:
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Teva Pharma 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 Teva Pharma 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 Teva Pharma.
English: Patients receiving TCF should be closely monitored, (see sections 4.2 and 4.8).
Danish: Patienter, der får TCF, bør monitoreres nøje (se pkt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva Pharma 80 mg
Danish: Solvens til Docetaxel Teva Pharma 80 mg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Docetaxel Teva Pharma 20 mg
Danish: Solvens til Docetaxel Teva Pharma 20 mg
English: Rash pruritic; Dry skin;
Danish: Tør hud;
English: Fever (G3/4: 1.2%)
Danish: Ødemer (G3/4: 1,2 %)
English: • you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel Teva
Danish: Det skal du vide, før du begynder at bruge Docetaxel hvis du er allergisk (overfølsom) over for docetaxel eller nogle af de andre indholdsstoffer i hvis antallet af hvide blodlegemer er for lavt
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Danish: Må ikke opbevares ved temperaturer over 25 °C Må ikke fryses.
English: Blood and lymphatic system disorders neutropenia associated with fever and antibiotic use) or neutropenic
Danish: Neutropeni (G3/4: 32 %); Febril neutropeni (inklusive neutropeni associeret med feber og brug af antibiotika) eller neutropenisk sepsis
English: Gastrointestinal haemorrhage (G3/4: 0.6%)
Danish: Gastrointestinale blødninger (G3/4: 0,6 %)
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
Danish: 75 mg/m2: 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: Other medicines and Docetaxel Teva Pharma
Danish: Brug af anden medicin sammen med Docetaxel Pharma
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 80 mg
Danish: ETIKET TIL HÆTTEGLAS - KONCENTRAT 80 mg
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m2 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: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 80 mg
Danish: ETIKET TIL HÆTTEGLAS - SOLVENS TIL 80 mg
English: Anorexia (G3/4: 1.5%)
Danish: Anoreksi (G3/4: 1 %);
English: • Each vial contains 20 mg/0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
Danish: Hvert hætteglas indeholder 20/0,72 mg af en 27,73 mg/ml docetaxel-opløsning i polysorbat 80 (indeholder 24,4 mg/0,88 ml).
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA PHARMA 80 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED DOCETAXEL TEVA PHARMA 80 mg KONCENTRAT OG SOLVENS TIL INFUSIONSVÆSKE, OPLØSNING
English: Each box contains one Docetaxel Teva Pharma vial (80 mg) and one corresponding solvent for Docetaxel Teva Pharma vial in a carton.
Danish: Hver karton indeholder et Docetaxel Teva Pharma hætteglas (80 mg) og et tilsvarende hætteglas med
English: Each box contains one Docetaxel Teva Pharma vial (20 mg) and one corresponding solvent for Docetaxel Teva Pharma vial in a carton.
Danish: Hver karton indeholder et Docetaxel Teva Pharma hætteglas (20 mg) og et tilsvarende hætteglas med
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel 100 mg/m² i kombination med trastuzumab
English: 2.2 Solvent for Docetaxel 20 mg vial:
Danish: 2.2 Hætteglas med solvens til Docetaxel 20 mg:
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA PHARMA 20 mg CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED DOCETAXEL TEVA PHARMA 20 mg KONCENTRAT OG SOLVENS TIL INFUSIONSVÆSKE, OPLØSNING
English: Esophagitis/dysphagia/ odynophagia (G3/4: 0.6%);
Danish: Øsofagitis/dysfagi/ odynofagi (G3/4: 0,6 %); Gastrointestinale smerter;
English: Each vial contains 80 mg/2.88 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/3.40 ml).
Danish: Hvert hætteglas indeholder 80 mg af en 27,73 mg/ml docetaxel-opløsning i polysorbat 80 (indeholder 94,4 mg/3,40 ml).
English: Weight decreased; G3/4 Blood bilirubin increased
Danish: Vægttab; G3/4 Forhøjet bilirubin i blodet (9 %)
English: Tel: +44 1977 628 500
Danish: United Kingdom Teva UK Limited Tel: +44 1977 628 500
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - CONCENTRATE 20 mg
Danish: ETIKET TIL HÆTTEGLAS - KONCENTRAT 20 mg
English: Mix the infusion bag or bottle manually using a rocking motion.
Danish: Infusionsvæsken og præmix opblandes ved manuel rotation af infusionsposen.
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 (< 4 %);
English: How to store Docetaxel Teva Pharma
Danish: Sådan bliver du behandlet med Docetaxel Teva Pharma
English: Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Danish: Myalgi (G3/4: 0,7 %); Artralgi (G3/4: 0,2 %)
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 mediantiden til progression (24,6 uger vs. 15,6 uger; p < 0,01) og medianoverlevelse (15,3 måneder vs. 12,7 måneder; p = 0,03) uden at påvirke det primære endepunkt (32 % vs. 25 %, p = 0,10), samlet respons rate (32 % vs. 25 %, p = 0,10).
English: Gastrointestinal Haemorrhage (severe 0.3%)
Danish: Gastrointestinal Hæmorrhage (alvorlig
English: Pyrexia (G3/4: 1%);
Danish: Rygsmerter (G3/4: 1 %);
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 20 mg
Danish: ETIKET TIL HÆTTEGLAS - SOLVENS TIL 20 mg
English: Neutropenia (G3/4: 83.5%); Anaemia
Danish: Neutropeni (G3/4: 83,5 %); Anæmi (G3/4:
English: Tabulated list of adverse reactions in head and neck cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger ved behandling af hoved- og halskræft med Docetaxel 75 mg/m² i kombination med cisplatin og 5-fluoruracil
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with capecitabine
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel 75 mg/m² i kombination med capecitabin
English: Nausea (G3/4: 9.6%); Vomiting (G3/4: 7.6%);
Danish: Kvalme (G3/4: 9,6 %); Opkastning (G3/4:
English: Arrhythmia (G3/4: 1.0%)
Danish: Arytmi (G3/4: 1,0 %).
English: Each single dose vial of Docetaxel Teva Pharma concentrate contains 80 mg docetaxel (anhydrous).
Danish: Hvert hætteglas Docetaxel Teva Pharma koncentrat indeholder 80 mg docetaxel (vandfri).
English: • one vial (2.88 ml) of concentrate (80 mg of docetaxel),
Danish: et hætteglas (2,88 ml) med koncentrat (80 mg docetaxel), et hætteglas (5,12 ml) med solvens (vand til injektionsvæsker).
English: Intravenous use.
Danish: Infusionen tager ca.
English: Method and route of administration
Danish: Lever og galdeveje
English: • Periodic Safety Update Reports
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
English: Uncommon adverse organ classes reactions reactions reactions
Danish: Almene symptomer og reaktioner på administrationsstedet Undersøgelser
English: Neurotoxicity(G3/4: 0%); Somnolence (G3/4: 0%)
Danish: Hypotension (G3/4: 0 %); Flebitis (G3/4: 0%)
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with doxorubicin
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel 75 mg/m² i kombination med doxorubicin
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² in combination with cisplatin
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel 75 mg/m² i kombination med cisplatin
English: CLINICAL PARTICULARS
Danish: Specielle patientgrupper
English: Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
Danish: Tabel over bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva Pharma 80 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Danish: Tilsætning af hele indholdet i hætteglasset med solvens til indholdet i hætteglasset med Docetaxel Teva Pharma 80 mg koncentrat til infusionsvæske, opløsning, sikrer en præmixkoncentration på 10 mg/ml docetaxel.
English: Sclerodermal-like changes usually preceded by peripheral lymphedema have been reported with docetaxel.
Danish: Ved behandling med docetaxel er der rapporteret om sclerodermi-lignende forandringer, som ofte går forud for perifer lymfødem.
English: • The Docetaxel 20 mg vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: Docetaxel 20 mg hætteglas er et 6 ml klart hætteglas med brombutylgummiprop og afrivningshætte.
English: • The Docetaxel 80 mg vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: Docetaxel 80 mg hætteglas er et 15 ml klart hætteglas med brombutylgummiprop og afrivningshætte.
English: Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m2 single agent
Danish: Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med Docetaxel 100 mg/m² enkeltstof
English: - For the treatment of prostate cancer, Docetaxel Teva Pharma is administered in combination with prednisone or prednisolone.
Danish: - Ved behandling af prostatakræft kan Docetaxel Teva Pharma indgives i kombination med
English: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva Pharma 20 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ml docetaxel.
Danish: Tilsætning af hele indholdet i hætteglasset med solvens til indholdet i hætteglasset med Docetaxel Teva Pharma 20 mg, koncentrat til infusionsvæske, opløsning, sikrer en præmixkoncentration på 10 mg/ml docetaxel.
English: This vial contains 2.88 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 94.4 mg/3.40 ml).
Danish: Hætteglasset indeholder 2,88 ml af en opløsning af docetaxel i polysorbat 80 med en koncentration på 27,73 mg/ml (påfyldningsvolumen: 94,4 mg/3,40 ml).
English: Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
Danish: Anæmi (G3/4: 6,9 %); Trombocytopeni (G4: 0,5 %)
English: Each single-dose vial of Docetaxel Teva Pharma concentrate contains 20 mg docetaxel (anhydrous).
Danish: Hvert enkeldosishætteglas Docetaxel Teva Pharma koncentrat indeholder 20 mg docetaxel (vandfri).
English: MedDRA system organ classes Very common adverse reactions Common adverse reactions
Danish: Meget almindelige bivirkninger Almindelige bivirkninger
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%); Fluid retention (G3/4: 1.2%);
Danish: Asteni (G3/4: 10,0 %); Pyreksi (G3/4: NA %); Perifert ødem (G3/4:
English: • heart failure
Danish: Hjerteinsufficiens
English: If Docetaxel Teva Pharma concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis Docetaxel Teva Pharma-koncentratet, præmixopløsningen eller infusionsvæsken skulle komme i berøring med slimhinderne, skal man straks skylle grundigt med vand.
English: Docetaxel Teva Pharma 80 mg concentrate and solvent for solution for infusion docetaxel
Danish: Docetaxel Teva Pharma 80 mg koncentrat og solvens til infusionsvæske, opløsning docetaxel
English: Tabulated list of adverse reactions in breast cancer for Docetaxel 75 mg/m² single agent
Danish: Tabel over bivirkninger ved behandling af brystkræft med Docetaxel 75 mg/m² enkeltstof
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: The addition of the entire contents of the solvent vial to the contents of the Docetaxel Teva Pharma 20mg vial ensures a premix concentration of 10 mg/ml docetaxel.
Danish: Tilsætning af hele indholdet fra hætteglassene med solvens til indholdet af Docetaxel Teva Pharma 80 mg hætteglas sikrer en præmixkoncentration på 10 mg/ml docetaxel.
English: Docetaxel Teva Pharma 20 mg concentrate and solvent for solution for infusion docetaxel
Danish: Docetaxel Teva Pharma 20 mg koncentrat og solvens til infusionsvæske, opløsning docetaxel
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: Thrombocytopenia (G4: 1.7%)
Danish: Trombocytopeni (G4:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 20 mg
Danish: ÆSKE - 20 mg
English: This vial contains 0.72 ml of a 27.73 mg/ml solution of docetaxel in polysorbate 80 (fill volume: 24.4 mg/0.88 ml).
Danish: Hætteglasset indeholder 0,72 ml af en opløsning af docetaxel i polysorbat 80 med en koncentration på 27,73 mg/ml (påfyldningsvolumen: 24,4 mg/0,88 ml).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs
English: Thrombocytopenia (G3/4: 0.6%);
Danish: Trombocytopeni (G3/4: 0,6 %) Febril neutropeni
English: Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Danish: Letargi (G3/4: 19,0 %); Feber (G3/4: 2,3 %);
English: Alopecia; Erythema; Rash; Nail disorders
Danish: Luftveje, thorax og mediastinum Epistaxis; pharyngolaryngeal smerte; nasopharyngitis; dyspnø; hoste; næseflåd
English: Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%)
Danish: Smerter i ekstremiteterne (G3/4: < 1 %);
English: Oedema
Danish: Mundsår
English: • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
Danish: Hudreaktioner på injektionsstedet, betændelse eller hævelse af venen (flebitis) Betændelse i tarm eller tyndtarm, perforering af tarmene
English: Arrhythmia (G3/4: 0.2%)
Danish: Arytmi (G3/4: 0,2 %)
English: What Docetaxel Teva Pharma concentrate vial contains: - The active substance is docetaxel.
Danish: - Aktivt stof: Docetaxel.
English: Hypertension; Haemorrhage
Danish: Letargi; smerter
English: Epistaxis (G3/4: 0%);
Danish: Nedsat hørelse (G3/4: 0 %).
English: Myocardial ischemia (G3/4: 1.7%)
Danish: Iskæmisk hjertesygdom (G3/4: 1,7 %)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg
Danish: ÆSKE - 80 mg
English: These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4) and the COSTART and the MedDRA terms.
Danish: Disse reaktioner blev beskrevet under brug af NCI Common Toxicity Criteria (grad 3 = G3;
English: Abdominal pain (G3/4: 0.4%)
Danish: Neglesygdomme (G3/4: 0,4 %)
English: • The solvent for Docetaxel 20 mg vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: Hætteglas med solvens til Docetaxel 20 mg hætteglas er et 6 ml klart hætteglas med brombutylgummiprop og afrivningshætte.
English: How to store Docetaxel Teva Pharma Contents of the pack and other information
Danish: Docetaxel Teva Pharma koncentrat i hætteglas indeholder:
English: Syncope (G3/4: 0%);
Danish: Konstipation (G3/4: 1,0 %);
English: Eye disorders Respiratory, thoracic and mediastinal disorders
Danish: Knogler, led, muskler og bindevæv
English: BATCH NUMBER
Danish: En ml
English: • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and
Danish: 300 gastrisk adenocarcinoma-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 5fluoruracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
English: Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000
Danish: Tel: +385 1 37 20 000
English: Arrhythmia (G3/4: 0.6%)
Danish: Arytmi (G3/4: 0,6 %)