FrancophonIA/ELRC3.0 huggingface dataset:
English: Asthenia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 12 patients (2.3%) in TAC arm and 4 patients (0.8%) in FAC arm. At the end of the follow-up period, asthenia was observed to be ongoing in 2 patients (0.4%) in TAC arm, and in 2 patients (0.4%) in FAC arm.
Danish: Asteni, som forekom i løbet af behandlingsperioden, fortsatte ind i opfølgningsperioden og blev fortsat observeret hos 12 patienter (2,3%) i TAC-armen og hos 4 patienter (0,8%) i FAC-armen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.72 ml (Fill: 0.88 ml)
Danish: 0,72 ml (påfyldningsvolumen: 0,88 ml)
English: Docetaxel Teva 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 Teva i kombination med doxorubicin er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, som ikke tidligere har modtaget kemoterapi mod denne tilstand.
English: • One vial of concentrate and,
Danish: • Et hætteglas med koncentrat
English: Peripheral sensory neuropathy (G3/4: 8.7%)
Danish: Perifer sensorisk neuropati (G3/4: 8,7 %).
English: The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Danish: compartment farmakokinetisk model, med halveringstider for α-, β- og γ-faserne på henholdsvis 4
English: Median TTP (months) (95%CI)
Danish: Median TTP (måneder) (95 %CI)
English: Constipation (severe:
Danish: Neglesygdomme (alvorlig
English: Positive
Danish: Negativ Positiv
English: • Docetaxel Teva 20 mg/0.72 ml concentrate for solution for infusion vial 6 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: • Docetaxel Teva 20 mg/0,72 ml koncentrat til infusionsvæske, opløsning hætteglas 6 ml klart Type I-hætteglas med en brombutylgummiprop og en afrivningshætte.
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² in combination with cisplatin
Danish: Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med Docetaxel 75 mg/m² i kombination med cisplatin
English: Best overall response (CR + PR) to chemotherapy (%) (95%CI) ***p-value
Danish: Bedste respons i alt (CR + PR) på kemoterapi (%) (95 %CI) ***p-værdi
English: Docetaxel Teva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Danish: Docetaxel Teva monoterapi er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft efter behandlingssvigt af cytotoksisk terapi.
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 mg af en 27,73 mg/ml docetaxel-opløsning i polysorbat 80 (indeholder 24,4 mg/0,88 ml).
English: • Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: • Docetaxel Teva 80 mg/2,88 ml koncentrat til infusionsvæske, opløsning.hætteglas 15 ml klart Type I-hætteglas med brombutylgummiprop og en afrivningshætte.
English: Anaemia (G3/4: 6.9%); Thrombocytopenia (G4:
Danish: Anæmi (G3/4: 6,9 %); Trombocytopeni (G4: 0,5 %)
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 Docetacel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv (TAX 316) og lymfeknudenegativ (GEICAM 9805) brystkræft - pooled data:
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4:
Danish: Synkope (G3/4: Neurotoksicitet (G3/4: 0 %);
English: • one 6 ml clear glass vial with a flip-off cap containing 1.28 ml of solvent.
Danish: Hver æske indeholder: et 6 ml klart hætteglas med afrivningshætte indeholdende 0,72 ml koncentrat og et 6 ml klart hætteglas med afrivningshætte indeholdende 1,28 ml solvens.
English: If Docetaxel Teva concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis Docetaxel-infusionskoncentrat, præmix-opløsning eller infusionsvæske skulle komme i kontakt med slimhinderne, så vask omgående og grundigt med vand.
English: What you need to know before you use Docetaxel Teva
Danish: Det skal du vide, før du begynder at tage Docetaxel Teva Du må ikke få Docetaxel Teva
English: Nausea (G3/4: 13.9%); Stomatitis (G3/4:
Danish: Kvalme (G3/4: 13,9 %); Stomatitis (G3/4:
English: Alopecia; Erythema; Rash; Nail disorders
Danish: Alopeci; erytem; udslæt; neglesygdomme
English: Pain in extremity (G3/4: <1%); Back pain (G3/4: 1%)
Danish: Smerter i ekstremiteterne (G3/4: Rygsmerter (G3/4: 1 %);
English: Best overall response (CR + PR) to study treatment [chemotherapy +/chemoradiotherapy] (%) (95%CI) ***p-value
Danish: Bedste respons i alt (CR + PR) på studiebehandling [kemoterapi +/strålebehandling] (%) (95 %CI) ***p-værdi
English: Common (may affect up to 1 in 10 people):
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 patienter)
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: Thrombocytopenia (G4: 0.2%)
Danish: Trombocytopeni (G4: 0,8 %)
English: 4.1 Preparation of the Docetaxel Teva premix solution (10 mg docetaxel/ml)
Danish: FORBEREDELSE TIL DEN INTRAVENØSE ADMINISTRATION 4.1 Fremstilling af Docetaxel Teva præmix-opløsning (10 mg docetaxel/ml)
English: You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Teva 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 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.
English: Vomiting (G3/4: 8.4%); Diarrhoea (G3/4: 6.8%); Esophagitis/dysphagia/ odynophagia (G3/4:
Danish: Diarré (G3/4: 6,8 %); Øsofagitis/dysfagi/odynofagi (G3/4: Konstipation (G3/4:
English: Vomiting (G3/4: 4%); Constipation (G3/4: 1%); Abdominal pain (G3/4: 2%); Dyspepsia
Danish: Kvalme (G3/4: 6 %); Opkastning (G3/4: 4 %); Konstipation (G3/4: 1 %); Mavesmerter (G3/4: 2 %); Dyspepsi
English: Patient subset
Danish: Patientfordeling
English: Docetaxel Teva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Danish: Docetaxel Teva er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungekræft efter behandlingssvigt af kemoterapi.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.88 ml (Fill: 3.40 ml)
Danish: 2,88 ml (påfyldningsvolumen: 3,40 ml)
English: Median overall survival (months) (95%CI)
Danish: Median overlevelse i alt (måneder) (95 %CI)
English: Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg of docetaxel.
Danish: Hvert hætteglas Docetaxel Teva 20 mg/0,72 ml koncentrat indeholder 20 mg docetaxel.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 80 mg/2.88 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED DOCETAXEL TEVA 80 mg/2,88 ml KONCENTRAT OG SOLVENS TIL INFUSIONSVÆSKE, OPLØSNING
English: What Docetaxel Teva is and what it is used for What you need to know before you use Docetaxel Teva How to use Docetaxel Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Docetaxel Teva Sådan skal du tage Docetaxel Teva Bivirkninger
English: 1.28 ml (Fill: 1.71 ml)
Danish: vand til injektionsvæske 1,28 ml (påfyldningsvolumen: 1,71 ml)
English: • one 15 ml clear glass vial with a flip-off cap containing 5.12 ml of solvent.
Danish: Hver æske indeholder: et 15 ml klart hætteglas med afrivningshætte indeholdende 2,88 ml koncentrat og et 15 ml klart hætteglas med afrivningshætte indeholdende 5,12 ml solvens.
English: Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
Danish: Hypotension (G3/4: 0 %) Flebitis (G3/4: 0 %)
English: Nausea (G3/4: 5.0%); Stomatitis (G3/4:
Danish: Kvalme (G3/4: 5,0 %); Stomatitis (G3/4:
English: 2.2 Solvent for Docetaxel Teva 20 mg/0.72 ml vial:
Danish: Solvens til Docetaxel Teva 20 mg/0,72 ml
English: Docetaxel Teva 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 Teva i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystkræft, som har HER2-positive tumorer, og som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom.
English: PREPARATION GUIDE FOR USE WITH DOCETAXEL TEVA 20 mg/0.72 ml CONCENTRATE AND SOLVENT FOR SOLUTION FOR INFUSION
Danish: FREMSTILLINGSVEJLEDNING TIL BRUG VED DOCETAXEL TEVA 20 mg/0,72 ml KONCENTRAT OG SOLVENS TIL INFUSIONSVÆSKE, OPLØSNING
English: Nausea (G3/4: 0.6%); Stomatitis (G3/4:
Danish: Kvalme (G3/4: 0,6 %); Stomatitis (G3/4:
English: Adjusted hazard ratio (95% CI) *p-value
Danish: Tilpasset hazard ratio (95 % CI) *p-værdi
English: 2.2 Solvent for Docetaxel Teva 80 mg/2.88 ml vial:
Danish: Solvens til Docetaxel Teva 80 mg/2,88 ml
English: Teva Pharmaceuticals Ireland Τel: +353 51 321 740
Danish: Τel: +353 51 321 740
English: Nausea (G3/4: 5%); Stomatitis (G3/4:
Danish: Kvalme (G3/4: 5 %); Stomatitis (G3/4:
English: Stomatitis/mucositis grade 3 First episode: reduce 5-FU dose by 20%.
Danish: Stomatitis/mucositis grad 3 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 % Stomatitis/mucositis grad 4 Første episode: Stop kun 5-FU i alle efterfølgende cyklusser Anden episode: Reducer docetaxel-dosis med 20 %
English: • The solvent for Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: • Hætteglas med solvens til Docetaxel Teva 80 mg/2,88 ml er et 15 ml klart hætteglas med brombutylgummiprop og afrivningshætte.
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: • Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med pladecellecarcinom i hovedet og halsen (SCCHN) blev evalueret i et fase III, multicenter, åbent, randomiseret studie (TAX323).
English: Alopecia (persisting Skin disorder (G3/4:
Danish: Alopeci (persisterende<3 %); Hudtoksicitet (G3/4:
English: Dysgeusia (G3/4: Peripheral sensory neuropathy (G3/4:
Danish: Dysgeusi/parosmi Perifer sensorisk neuropati (G3/4:
English: Myalgia (G3/4: 0.4%)
Danish: Myalgi (G3/4:0,4 %)
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: • The Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: • Docetaxel Teva 20 mg/0,72 ml hætteglas er et 6 ml klart hætteglas med brombutylgummiprop og afrivningshætte.
English: • The Docetaxel Teva 80 mg/2.88 ml vial is a 15 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: • Docetaxel Teva 80 mg/2,88 ml hætteglas er et 15 ml klart hætteglas med brombutylgummiprop og afrivningshætte.
English: Docetaxel Teva 80 mg/2.88 ml concentrate for solution for infusion docetaxel
Danish: Docetaxel Teva 80 mg/2,88 ml, koncentrat til infusionsvæske, opløsning docetaxel
English: • The solvent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Danish: • Hætteglas med solvens til Docetaxel Teva 20 mg/0,72 ml hætteglas er et 6 ml klart hætteglas med brombutylgummiprop og afrivningshætte.
English: Fluid retention (severe: Asthenia (severe: Pain
Danish: Væskeretention (alvorlig: 6,5 %) Asteni (alvorlig smerter
English: TCF n=221
Danish: n=221
English: Docetaxel was administered as a 1-hour infusion; all other medicinal products were given as intravenous bolus on day one.
Danish: Alle andre lægemidler blev givet som intravenøs bolus på dag 1.
English: Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel
Danish: Docetaxel Teva 20 mg/0,72 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
English: Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Danish: Docetaxel Teva 80 mg/2,88 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
English: Skin exfoliative (G3/4:
Danish: Eksfoliativt udslæt (G3/4:
English: Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
Danish: Diarré (G3/4: 6,4 %); Stomatitis (G3/4: 2 %)
English: • blood clots
Danish: • Blodpropper.
English: Neutropenia (G3/4: 83.5%); Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Danish: Neutropeni (G3/4: 83,2 %); Trombocytopeni (G3/4: 8,8 %); Febril neutropeni.
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) 1,000 mg/m²/day from day 1 to day 4.
Danish: Patienter i docetaxel-armen modtog docetaxel (T) 75 mg/m2 ved intravenøs infusion på dag 1, efterfulgt af cisplatin (P) 100 mg/m2 administreret som en 30 minutter til
English: Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg of docetaxel.
Danish: Hvert hætteglas med Docetaxel Teva 80 mg/2,88 ml koncentrat indeholder 80 mg docetaxel.
English: Lymphoedema (G3/4:
Danish: Dysgeusi (G3/4:
English: Anaemia (G3/4:
Danish: Anoreksi (G3/4:
English: H-2100 Gödöllő, Táncsics Mihály út 82
Danish: H-2100 Gödöllő
English: • flushing, skin reactions, itching
Danish: • Rødme, hudreaktioner, kløe,
English: Infection (G3/4: 3.6%) Neutropenic infection
Danish: Infektioner og parasitære sygdomme Infektion (G3/4: 3,6 %) Neutropenisk infektion
English: Esophagitis/dysphagia/odynophagia (G3/4: 12.0%);
Danish: Øsofagitis/dysfagi/ odynofagi (G3/4: 0,6 %); Gastrointestinale smerter;
English: If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
Danish: Docetaxel-dosis bør reduceres fra 75 til 60 mg/m2, hvis der trods anvendelse af G-CSF opstår febril neutropeni, prolongeret neutropeni eller neutropenisk infektion.
English: Neutropenia (G3/4: 32%);
Danish: Neutropeni (G3/4: 32 %); Febril
English: Conjunctivitis (G3/4:
Danish: Konjunktivitis (G3/4:
English: Epistaxis (G3/4: 0%);
Danish: Hudafskalning (G3/4: 0 %).
English: Tabulated list of 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: In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm 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: 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/mm i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.
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: In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2%) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Danish: I studiet TAX316 forekom perifer sensorisk neuropati i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden hos 84 patienter (11,3 %) i TAC-armen og hos 15 patienter (2 %) i FAC-armen.
English: If Docetaxel concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Danish: Hvis Docetaxel Tevakoncentratet, præmix-opløsningen eller infusionsvæsken skulle komme i berøring med slimhinderne, skal man straks skylle grundigt med vand.
English: Abdominal pain (severe 1%);
Danish: Neglesygdomme (alvorlig 0,7 %);
English: Constipation (G3/4: 0.4%)
Danish: Neglesygdomme (G3/4: 0,4 %)
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Danish: Indlægsseddel: Information til patienten Docetaxel Teva 80 mg/2,88 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
English: Alopecia (G3/4: 4.0%)
Danish: Alopeci (G3/4: 4,0 %) Kløende udslæt
English: Lethargy (G3/4: 4.0%);
Danish: Arytmi (G3/4: 2,0 %)
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel
Danish: Indlægsseddel: Information til patienten Docetaxel Teva 20 mg/0,72 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
English: Vomiting (G3/4: 1.2%)
Danish: Opkastning (G3/4: 1,2 %)
English: Asthenia (severe: 9.9%); Fluid retention (severe:
Danish: Asteni (alvorlig 9,9 %); Væskeretention (alvorlig 0,7 %);
English: Tell your doctor, hospital pharmacist or nurse if you have heart problems.
Danish: - Kontakt lægen hospitalsfarmaceuten eller sundhedspersonalet, hvis en bivirkning bliver værre,
English: Stomatitis (G3/4: 20.7%);
Danish: Diarré (G3/4: 19,7 %);
English: Dyspepsia (G3/4:
Danish: Stomatitis (G3/4:
English: Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Danish: På basis af farmakokinetiske data med docetaxel givet som enkeltstof ved en dosis på 100 mg/m2, er den anbefalede dosis docetaxel 75 mg/m2 til patienter, som både har forhøjelse af transaminase
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) 1,000 mg/m²/day from day 1 to day 5.
Danish: 3 timers intravenøs infusion på dag 1, efterfulgt af kontinuerlig intravenøs infusion af 5-fluoruracil(F) 1.000 mg/m2/dag fra dag 1 til dag 5.
English: Nail disorders (G3/4: 2%)
Danish: Neglesygdomme (G3/4: 2 %)
English: Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4:
Danish: Neutropeni (G3/4: 83,5 %); Anæmi (G3/4:
English: Arrhythmia (G3/4:
Danish: Lymfødem (G3/4:
English: Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Danish: Kløende udslæt (G3/4: 0,7 %); Neglesygdomme (G3/4: 0,7 %);
English: Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² single agent MedDRA system organ classes
Danish: Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med Docetaxel 75 mg/m²
English: intestinal perforation.
Danish: Hjertetoksicitet
English: Scleroderma-like changes usually preceded by peripheral lymphoedema 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: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg docetaxel.
Danish: Et hætteglas Docetaxel Teva 80 mg/2,88 ml koncentrat indeholder 80 mg docetaxel.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg docetaxel.
Danish: Hvert hætteglas med Docetaxel Teva 20 mg/0,72 ml koncentrat indeholder 20 mg docetaxel.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 20 mg/0.72 ml
Danish: ETIKET TIL HÆTTEGLAS - SOLVENS TIL 20 mg/0,72 ml
English: 5.12 ml (Fill: 6.29 ml)
Danish: vand til injektionsvæsker 5,12 ml (påfyldningsvolumen: 6,29 ml)
English: Abdominal pain (severe: 1%);
Danish: Asteni (alvorlig: Væskeretention (alvorlig 1,2 %); Smerter
English: PF).
Danish: CF
English: Constipation (G3/4:
Danish: Svimmelhed (G3/4:
English: Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%); Fluid retention (G3/4:
Danish: Asteni (G3/4: 10,0 %); Pyreksi (G3/4: NA);
English: Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSØFRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
English: Amenorrhoea (G3/4: NA)
Danish: Det reproduktive system og mammae Amenorré (G3/4: NA)
English: Gastrointestinal haemorrhage (G3/4:
Danish: Hudafskalning (G3/4:
English: Median TTP (months) (95% CI)
Danish: Gennemsnitlig TTP (måneder) (95 % CI)
English: Diarrhoea (G3/4: 6.8%);
Danish: Kvalme (G3/4: 16 %);
English: Weight increased (G3/4: 0%);
Danish: Nedsat hørelse (G3/4: 0 %).
English: Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Danish: Diarré (G3/4: 2,9 %); Opkastning (G3/4:
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Danish: Ikke almindelige bivirkninger fagi/odynofagi (G3/4: Konstipation (G3/4:
English: Vizimpro is available as tablets (15, 30 and 45 mg).
Danish: Vizimpro fås som tabletter (15, 30 og 45 mg).
English: Further information on Vizimpro can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Danish: Yderligere information om Vizimpro findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
English: The patient should normally take a 45-mg tablet once a day, at around the same time every day, for as long as they benefit from it and the side effects are tolerable.
Danish: Patienterne bør normalt tage en tablet à 45 mg én gang dagligt på omtrent samme tidspunkt hver dag, så længe de har gavn af den, og bivirkningerne er tålelige.
English: Before starting treatment, the presence of mutations in the EGFR gene should be confirmed by appropriate tests.
Danish: Før påbegyndelse af behandlingen bør tilstedeværelsen af mutationer i EGFR-genet bekræftes ved relevante test.
English: Other information about Vizimpro
Danish: Andre oplysninger om Vizimpro