FrancophonIA/ELRC3.0 huggingface dataset:
English: Docefrez powder and solvent for concentrate for solution for infusion is for single use only.
Danish: Docefrez-pulver og solvens til koncentrat til infusionsvæske er kun til engangsbrug
English: Dilute before use.
Danish: ANVENDELSESMÅDE Fortyndes før brugen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/630/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/10/630/002
English: The Docefrez 20 mg powder is a white to off white lyophilised powder containing 20 mg (plus 22% overfill: 24.4 mg) of docetaxel (anhydrous).
Danish: Docefrez 20 mg pulver er et hvidt til cremefarvet lyofiliseret pulver indeholdende 20 mg (plus 22 % overfyldning: 24,4 mg) docetaxel (vandfri)).
English: Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Danish: Docefrez i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi.
English: For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Danish: For cisplatin-dosismodifikationer se tilsvarende produktresumé.
English: • inflammation of the colon, small intestine; intestinal perforation
Danish: • betændelse i tyktarm, tyndtarm; tarmperforation
English: Median duration of response (months) (95% CI)
Danish: Gennemsnitlig varighed af respons (måneder) (95 % CI)
English: Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Danish: Docetaxel blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
English: Dyspnoea (severe 2.7%)
Danish: Neglesygdomme (alvorlig: 2,6 %)
English: A multicenter, open-label, randomized study, was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Danish: En multicenter, åben, randomiseret undersøgelse har evalueret sikkerhed og effekt af docetaxel til behandling af patienter med metastatisk gastrisk adenocarcinom, inklusive adenocarcinom af den gastroøsofageale forbindelse.
English: Dysgeusia (G3/4: 0.6%); Peripheral sensory neuropathy (G3/4: 0.1%)
Danish: Dysgeusi (G3/4: 0,6 %); Perifer sensorisk neuropati (G3/4: <
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of powder contains 80 mg docetaxel (anhydrous).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert enkeltdosis-hætteglas med pulver indeholder 80 mg docetaxel (vandfri).
English: The Docefrez 80 mg powder is a white to off white lyophilised powder containing 80 mg (plus 18% overfill: 94.4 mg) of docetaxel (anhydrous).
Danish: Docefrez 80 mg pulver er et hvidt til cremefarvet lyofiliseret pulver indeholdende 20 mg (plus 18 % overfyldning: 94,4 mg) docetaxel (vandfri)).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose vial of powder contains 20 mg docetaxel (anhydrous).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert enkeltdosis-hætteglas med pulver indeholder 20 mg docetaxel (vandfri).
English: 2.1 Docefrez 20 mg powder vials
Danish: 2.1 Docefrez 20 mg pulverhætteglas
English: • one single-dose powder vial with 20 mg docetaxel (plus 22% overfill: 24.4 mg), and
Danish: • et enkeltdosis-pulverhætteglas med 20 mg docetaxel (plus 22 % overfyldning: 24,4 mg) og
English: Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95%CI) ***p-value
Danish: Bedste respons ialt til undersøgelsesbehandling [kemoterapi +/- strålebehandling] (%) (95 % CI) ***p-værdi
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
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 (ALAT og/eller ASAT) på mere end 1,5 gange den øvre normalværdi og af basisk fosfatase på mere end 2,5 gange den øvre normalværdi (se pkt.
English: Weight increased (G3/4: Weight decreased (G3/4: 0.2%)
Danish: Vægtforøgelse (G3/4: Vægttab (G3/4: 0,2 %)
English: • 92 patients treated with docetaxel in combination with trastuzumab.
Danish: • 92 patienter som fik docetaxel i kombination med trastuzumab.
English: Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Danish: Docetaxel må derfor ikke anvendes til gravide.
English: • Each solvent vial of Docefrez 20 mg contains 1 ml of 35.4% w/w Ethanol in Polysorbate 80
Danish: • Hvert hætteglas Docefrez 20 mg indeholder 1 ml 35,4 % w/w ethanol i polysorbat 80.
English: België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Danish: België/Belgique/Belgien Sun Pharmaceutical Industries Europe B.V.
English: Nausea; Diarrhoea;
Danish: Letargi; Smerter
English: Preparation of the infusion solution
Danish: FORBEREDELSE TIL DEN INTRAVENØSE ADMINISTRATION
English: G3/4 AST increased G3/4 ALT increased
Danish: G3/4 ASAT forhøjet (< G3/4 ALAT forhøjet
English: 2.1 Docefrez 80 mg powder vials
Danish: 2.1 Docefrez 80 mg pulverhætteglas
English: Nail disorders (severe 0.8%)
Danish: Neglesygdomme (alvorlig: 0,8 %)
English: Infection (G3/4: 7.8%)
Danish: Infektioner (G3/4: 7,8 %)
English: Fatigue (G3/4: 3.9%); Fluid retention (severe 0.6%)
Danish: Træthed (G3/4: 3,9 %); Væskeretention (alvorlig: 0,6 %)
English: • one single-dose powder vial with 80 mg docetaxel (plus 18% overfill: 94.4 mg) and
Danish: • et enkeltdosis-pulverhætteglas med 20 mg docetaxel (plus 18 % overfyldning: 94,4 mg) og
English: Vomiting; Constipation; Stomatitis; Dyspepsia; Abdominal pain
Danish: Kvalme; diarré; opkastning; konstipation; stomatitis; dyspepsi; mavesmerter
English: Overall survival at 5 years was also significantly increased with TAC compared to FAC (87% versus 81%, respectively) i.e. an absolute reduction of the risk of death by 6% (p=0.008).
Danish: Total overlevelse ved 5 år var også signifikant forøget med TAC i forhold til FAC /henholdsvis 87 % versus 81 %).
English: Patients with operable node-positive breast cancer
Danish: • operabel, lymfeknude-positiv brystkræft
English: Docetaxel 75 mg/m² in combination with cisplatin: MedDRA system organ classes
Danish: Docefrez 75 mg/m2 i kombination med cisplatin: Systemorganklasser i henhold til MedDRAdatabasen
English: Best overall response to chemotherapy (%) (95%CI) ***p-value
Danish: Bedste respons ialt til kemoterapi (%) (95 % CI) ***p-værdi
English: Thrombocytopenia (G3/4: 4.0%);
Danish: Trombocytopeni (G3/4: 4,0 %);
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docefrez 80 mg powder for concentrate for solution for infusion Docetaxel
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docefrez 80 mg pulver til koncentrat til infusionsvæske, opløsning Docetaxel
English: Oedema peripheral (G3/4:
Danish: Perifert ødem (G3/4:
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Danish: Asteni; periferalt ødem; pyrexi; træthed; inflammation i slimhinderne; smerter; influenzalignende symptomer; brystsmerter; kulderystelser
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT
English: Contraceptive measures must be taken by both men and women during treatment and for men at least 6months after cessation of therapy (see section 4.6).
Danish: Svangerskabsforebyggende midler skal anvendes under behandlingen og i mindst 3 måneder efter seponering.
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: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 80 mg docetaxel (anhydrous)
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 80 mg docetaxel (vandfri)
English: Disposal Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Bortskaffelse Ikke anvendt lægemiddel bør destrueres i henhold til lokale retningslinjer.
English: • 1312 and 121 patients who received 100 mg/m2 and 75 mg/m2 of docetaxel as a single agent respectively.
Danish: De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos: • 1312 og 121 patienter som fik henholdsvis 100 mg/m2 og 75 mg/m2 af docetaxel som enkeltstof.
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/ m2 as a 1 hour intravenous infusion every 3 weeks).
Danish: 256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/ m2
English: EXPIRY DATE
Danish: UDLØBSDATO EXP:
English: Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours over express HER2, and who previously had not received chemotherapy for metastatic disease.
Danish: Docetaxel i kombination med trastuzumab blev undersøgt til behandling af patienter med metastatisk brystkræft, hvis tumorer var HER2-positive, og som ikke tidligere havde fået kemoterapi for metastatisk sygdom.
English: Peripheral motor neuropathy (G3/4: 0%);
Danish: Perifer motorisk neuropati (G3/4: 0 %);
English: Lacrimation increased (G3/4: 0.1%);
Danish: Øget tåresekretion (G3/4: < 0,1 %);
English: Hazard ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Danish: Hazard ratio: 1,122 (97,2 % CI: 0.937;1,342)* Behandlingsforskel 5,4 % (95 % CI: -1,1;12,0) Behandlingsforskel 6,2 % (95 % CI: 0,2;12,3)
English: Median progression free survival (months) (95%CI)
Danish: Median progression fri overlevelse (måneder) (95 % CI)
English: Each single-dose vial of powder contains 20 mg docetaxel (anhydrous).
Danish: Hvert hætteglas indeholder 20 mg docetaxel (vandfri).
English: For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Danish: For modifikationer af doser af cisplatin og 5-fluorouracil: se tilsvarende produktresumé.
English: • Each vial of Docefrez 80 mg contains 80 mg docetaxel (anhydrous) (plus 18% overfill: 94.4 mg
Danish: • Hvert hætteglas Docefrez 80 mg indeholder 80 mg docetaxel (vandfri) (plus 18 % overfyldning: 94.4 mg docetaxel).
English: Docetaxel 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: Docefrez 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: • Each vial of Docefrez 20 mg contains 20 mg docetaxel (anhydrous) (plus 22% overfill: 24.4 mg
Danish: • Hvert hætteglas Docefrez 20 mg indeholder 20 mg docetaxel (vandfri) (plus 22 % overfyldning: 24,4 mg docetaxel).
English: Stomatitis (G3/4: 23.7%); Vomiting (G3/4: 14.3%).
Danish: Stomatitis (G3/4: 23,7 %); Opkastning (G3/4: 14,3 %)
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 brystkræft og ikke-småcellet lungekræft gives et peroralt kortikosteroid som præmedicinering, eksempelvis dexamethason 16 mg per dag i 3 dage (f.eks. 8 mg 2 gange daglig).
English: • The solvent vial for Docefrez 20 mg is a 1 ml colourless type 1 tubular glass vial with 20 mm grey bromobutyl rubber stopper sealed with 20 mm dark blue flip-off aluminium seal.
Danish: • Solvenshætteglasset til Docefrez 20 mg er et 1 ml farveløst, type 1, rørformet hætteglas med 20 mm grå bromobutylgummiprop lukket med en 20 mm mørkeblå flip-off-aluminiumforsegling.
English: G3/4 Blood alkaline phosphatase increased
Danish: G3/4 Forhøjet alkalisk fosfatase i blodet (<
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: Den anbefalede dosis af docetaxel er 75 mg/m2 som en 1-times infusion, efterfulgt af cisplatin 75 mg/m2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluorouracil 750 mg/m2 pr.
English: Neutropenia (G3/4: 83.2%);
Danish: Neutropeni (G3/4: 32 %);
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 pladecellecarcinom i hoved og hals (SCCHN) (ikke muligt at 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
English: Solvent vial:
Danish: Solvenshætteglas:
English: Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
Danish: Konstipation (G3/4: 1,0 %); Gastrointestinale smerter
English: • The Docefrez 20 mg vial contains a white to off white lyophilised powder in a 5 ml tubular colourless glass vial with 20 mm grey rubber stopper and sealed with dark green flip-off aluminium seal.
Danish: • Docefrez 20 mg-hætteglasset indeholder et hvidt til cremefarvet lyofiliseret pulver i et 5 ml rørformet, farveløst hætteglas med 20 mm grå gummiprop og lukket med en mørkegrøn flip-offaluminiumforsegling.
English: • The solvent vial for Docefrez 80 mg is a 5 ml colourless type 1 tubular glass vial with 20 mm grey bromobutyl rubber stopper sealed with 20 mm brown flip-off aluminium seal.
Danish: • Solvenshætteglasset til Docefrez 80 mg er et 5 ml farveløst, type 1, rørformet hætteglas med 20 mm grå bromobutylgummiprop lukket med en 20 mm mørkeblå flip-off-aluminiumforsegling.
English: • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and
Danish: • 174 og 251 hoved- og halskræftpatienter, som blev behandlet med docetaxel i kombination med cisplatin og 5-fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
English: • dry mouth, difficulty or painful swallowing, inflammation of the gullet (oesophagitis)
Danish: • tør mund, vanskelighed ved synkning eller smerter ved synkning, betændelse i spiserøret
English: Peripheral sensory neuropathy (G3/4: 8.7%).
Danish: Perifer sensorisk neuropati (G3/4: 8,7 %)
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 fosfataser > 6 gange øvre normalværdi, kan det ikke anbefales at reducere dosis.
English: Infection (G3/4: 5.7%)
Danish: Infektion (G3/4: 5,7 %)
English: The solvent for Docefrez is a 35.4% w/w solution of ethanol (anhydrous) in polysorbate 80.
Danish: Solvensen til Docefrez er en 35,4 % w/w opløsning af ethanol (vandfri) i polysorbat 80.
English: Dysgeusia (G3/4: <1%); Paraesthesia (G3/4: <1%)
Danish: Dysgeusi (G3/4: < 1 %); Paræsthesi (G3/4: < 1 %)
English: Oesophagitis/dysphagia/odynop hagia (G3/4: 0.7%).
Danish: Øsofagitis/dysfagi/odynofagi (G3/4: 0,7 %)
English: Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
Danish: Docefrez er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungekræft efter behandlingssvigt af kemoterapi.
English: What Docefrez is and what it is used for Before you use Docefrez How to use Docefrez Possible side-effects How to store Docefrez Further information
Danish: Det skal du vide, før du begynder at bruge Docefrez Sådan skal du bruge Docefrez Bivirkninger
English: The volume of concentrate (24 mg/ml docetaxel) corresponding to the required dose (mg) for the patient should be withdrawn (from the appropriate number of vials) using graduated syringes fitted with a needle.
Danish: Med graduerede sprøjter med påsatte kanyler udtages et indhold af koncentrat (24,4 mg/ml docetaxel) svarende til den nødvendige dosis (mg) til patienten (fra det nødvendige antal hætteglas).
English: Docetaxel 75 mg/m² in combination with capecitabine
Danish: Docefrez 75 mg/m2 i kombination med capecitabin: Meget almindelige bivirkninger
English: Peripheral sensory neuropathy (G3/4: 1.2%)
Danish: Perifer sensorisk neuropati (G3/4: 1,2 %)
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Fortyndes før brug.
English: For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
Danish: Vedrørende dosismodifikasjoner for trastuzumab: se produktresuméet for trastuzumab.
English: Powder vial:
Danish: Lever og galdeveje:
English: • The Docefrez 80 mg vial contains a white to off white lyophilised powder in a 15 ml tubular colourless glass vial with 20 mm grey rubber stopper and sealed with red flip-off aluminium seal.
Danish: • Docefrez 80 mg hætteglasset indeholder et hvidt til cremefarvet lyofiliseret pulver i et 15 ml rørformet, farveløst hætteglas med 20 mm grå gummiprop og lukket med en mørkegrøn flip-offaluminiumforsegling.
English: • CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
Danish: BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 20 mg doxetaxel (anhydrous)
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 20 mg docetaxel (vandfri)
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Danish: Tal med din læge eller sygeplejerske, hvis en bivirkning bliver værre, eller hvis du bemærker bivirkninger, som ikke er nævnt i denne indlægsseddel.
English: Haemorrhage
Danish: Lymfeødem
English: After reconstitution, 1 ml of concentrate contains 24 mg docetaxel.
Danish: Efter rekonstitution indeholder 1 ml koncentrat 24 mg docetaxel.
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel bør destrueres i henhold til lokale retningslinjer.
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 median-tiden 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: NAME OF THE MEDICINAL PRODUCT Docefrez 20 mg powder and solvent for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Docefrez 20 mg pulver og solvens til koncentrat til infusionsvæske, opløsning
English: Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Danish: Luxembourg/Luxemburg Sun Pharmaceutical Industries Europe B.V.
English: 2132 JH Hoofddorp The Netherlands tel. +31 (0)23 568 5501
Danish: Holland tlf. +31 (0)23 568 5501
English: NAME OF THE MEDICINAL PRODUCT Docefrez 80 mg powder and solvent for concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Docefrez 80 mg pulver og solvens til koncentrat til infusionsvæske, opløsning
English: Lymphoedema (G3/4:
Danish: Trombocytopeni (G3/4:
English: For patients with serum bilirubin levels >ULN and/or ALT and AST >3.5 times the ULN concurrent with serum alkaline phosphatase levels >6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Danish: Hos patienter med serumbilirubin > øvre normalværdi og/eller forhøjelse af ASAT/ALAT på > 3,5 gange øvre normalværdi og samtidig forhøjelse af basisk fosfatase på > 6 gange øvre normalværdi kan det ikke anbefales at reducere dosis.
English: If docetaxel powder, reconstituted concentrate or solution for infusion should come into contact with skin, wash immediately and thoroughly with soap and water.
Danish: Hvis docetaxel-pulver, rekonstitueret koncentrat eller infusionsvæske, opløsning, kommer i kontakt med huden, skal det straks vaskes af med sæbe og vand.
English: 4.2.2 Inject the required volume of reconstituted solution into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: 4.2.2 Injicer derefter den beregnede mængde Docefrez-præmix i en 250 ml infusionspose med enten 5 % glucose eller 9 mg/ml 0,9 % NaCl.
English: Median survival (months) 95% CI
Danish: Median overlevelsestid (måneder) 95 % CI
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: Arrhythmia (G3/4:0.7%) Cardiac failure Hypotension;
Danish: Arytmi (G3/4: 0,7 %) Hjertesvigt
English: • muscle aches and pains; back pain or bone pain*
Danish: • muskelsmerter; rygsmerter eller knoglesmerte*
English: Dyspnoea (G3/4: 1%); Cough (G3/4: <1%); Epistaxis (G3/4: <1%)
Danish: Hoste (G3/4: < 1 %); Epistaxis (G3/4: < 1 %)
English: Docetaxel 75 mg/m² in combination with doxorubicin: MedDRA system organ classes
Danish: Docefrez 75 mg/m2 i kombination med doxorubicin Systemorganklasser i henhold til MedDRAdatabasen
English: 1 ml colourless type 1 glass vial with grey bromobutyl rubber stopper sealed with dark blue flip-off with aluminium seal.
Danish: 1 ml farveløst type 1-hætteglas med grå bromobutylgummiprop og mørkeblå flip-offaluminiumforsegling.
English: Number of patients PSA** response rate (%)
Danish: Antal patienter PSA**- response rate (%) 95 % CI p-værdi*
English: Nausea (G3/4: 4%);
Danish: Kvalme (G3/4: 4 %);
English: BEFORE YOU USE DOCEFREZ
Danish: SÅDAN SKAL DU BRUGE DOCEFREZ
English: In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/ m2 to 75 mg/m2 and/or from 75 to 60 mg/ m2.
Danish: I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m2 til 75 mg/m2 og/eller fra 75 mg/m2 til 60 mg/m2: hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter < 500 celler/mm3 i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.