natgillin/translations-raw huggingface dataset:
Hver karton indeholder en blisterpakning med et TAXOTERE hætteglas (80 mg/2 ml) og et tilsvarende hætteglas med solvens til TAXOTERE. 
Each box contains one TAXOTERE vial (80 mg/2 ml) and one corresponding solvent for TAXOTERE vial in a blister pack.
50 mg/m og cyclophosphamid 500 mg/m 
50 mg/m followed by fluorouracil 500 mg/m and cyclophosphamide 500 mg/m
Diarré (G3: 3%) Stomatitis (G3: 0%) Forstoppelse (G3: 0%) Kvalme (G3: 1%) Dyspepsi 
Diarrhea (G3: 3%) Stomatitis (G3: 0%) Constipation (G3: 0%) Nausea (G3: 1%) Dyspepsia
Dysgeusi/parosmi (G3/4: 0,4%); 
Dysgeusia/Parosmia (G3/4: 0.4%);
Perifer sensorisk neuropati (G3: 4,1 %); Perifer motorisk neuropati (G3/4: 4 %) Dysgeusi (alvorlig: 
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Tabel over bivirkninger i højrisiko lokalt avanceret eller metastatisk hormonfølsom prostatakræft med TAXOTERE 75 mg/m² i kombination med prednison eller prednisolon og androgen deprivationsbehandling (STAMPEDE studie). 
Tabulated list of adverse reactions in high-risk locally advanced or metastatic hormone-sensitive prostate cancer for TAXOTERE 75 mg/m² in combination with prednisone or prednisolone and ADT (STAMPEDE study)
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), 
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/m as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m over
1.060 patienter blev randomiseret til at få enten TAXOTERE 75 mg/m administreret 1 time efter doxorubicin 50 mg/m og cyclophosphamid 500 mg/m 
1060 patients were randomised to receive either TAXOTERE 75 mg/m administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
Perifer sensorisk neuropati (G3: 3,7 %); Perifer motorisk neuropati (G3/4: 2 %) 
Peripheral sensory neuropathy (G3: 3.7%); Peripheral motor neuropathy (G3/4: 2%)
TAXOTERE er ordineret af din læge til behandling af bryst- eller specielle former for lungekræft (ikke-småcellet lungekræft), prostata kræft, gastrisk kræft eller hoved- og hals-kræft: 
TAXOTERE has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: - For the treatment of advanced breast cancer, TAXOTERE could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine.
Patienter bør modtage kemostrålingsterapi efter kemoterapi. 
Following chemotherapy, patients should receive chemoradiotherapy.
(TAC-arm), eller doxorubicin 50 mg/m 2, fulgt af fluoruracil 500 mg/ m og cyclophosphamid 500 mg/m 
(TAC arm), or doxorubicin 50 mg/m followed by fluorouracil 500 mg/m and cyclophosphamide 500 mg/m
Stigningen i overlevelse set i armen med ugentlig docetaxel var ikke statistisk signifikant sammenlignet med mitoxantron-kontrol-armen. 
The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
1.060 patienter blev randomiseret til at få enten TAXOTERE 75 mg/m2 administreret 1 time efter doxorubicin 50 mg/m og cyclophosphamid 500 mg/m 
1060 patients were randomised to receive either TAXOTERE 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m and cyclophosphamide 500 mg/m
Øget tåresekretion (G3/4: < 0,1 %); 
Lacrimation increased (G3/4: <0.1%)
• Vægtforøgelse eller vægttab 
• weight gain or loss
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med metastatisk kastrationsresistent prostatakræft blev undersøgt i et randomiseret multicenter fase III-studium (TAX 327). 
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with metastatic castration-resistant prostate cancer were evaluated in a randomised multi-centre phase III study (TAX 327).
Insomni (G3: 1%) 
Insomnia (G3: 1%)
4.2 Fremstilling af infusionsvæsken 
4.2 Preparation of the infusion solution
Sikkerheden og effekten af docetaxel administreret samtidig med standardpleje (androgen deprivationsbehandling) hos patienter med højrisiko lokalt avanceret eller metastatisk hormonfølsom prostatakræft, blev evalueret i et randomiseret multicenter, multiarm, multi-stage (MAMS) studie, med et gnidningsfrist fase II/III design (STAMPEDE- MRC PR08). 
The safety and efficacy of docetaxel administered concomitantly with standard of care (ADT) in patients with high-risk locally advanced or metastatic hormone-sensitive prostate cancer were evaluated in a randomised multi-centre, multi-arm multi-stage (MAMS) study with a seamless phase II/III design (STAMPEDE - MRC PR08).
Forekomsten af tilbagefald ved 10 år var reduceret hos de patienter som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 39 % versus 45 %). 
Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
TAXOTERE hætteglas: polysorbat 80, citronsyre. 
TAXOTERE vial: polysorbate 80, citric acid.
15 ml klart Type I-hætteglas med en rød afrivningshætte. 
15 ml clear glass Type I vial with a red flip-off cap.
cTid til klinisk progression = tiden fra randomisering til klinisk progression (dvs. øget symtomatisk knoglemetastaser, progression ifølge (RECIST) kriterier, eller klinisk forværring grundet kræft pr. Investigator's opinion). 
c The time to clinical progression = the time from randomization until clinical progression (i.e., increased symptoms of bone metastases; progression according to RECIST; or clinical deterioration due to cancer according to the investigator's opinion).
Den samtidige administration af docetaxel, doxorubicin og cyclophosphamid påvirkede ikke deres farmakokinitik. 
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Hvis samtidige anvendelse af en potent CYP3A4-hæmmer (f.eks. ketoconazol, itraconazol, clarithromycin, indinavir, nefazodon, nelfinavir, 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. 
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).
Anæmi (G3/4: 20,9 %); 
Anaemia (G3/4: 20.9%);
Med en sprøjte udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til TAXOTERE ved at holde hætteglasset på skrå. 
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Hver ml koncentrat til infusionsvæske indeholder 20 mg docetaxel. 
Each ml of concentrate for solution for infusion contains 20 mg docetaxel.
Data fra et multicenter, åbent, randomiseret studium støtter anvendelsen af TAXOTERE som adjuverende behandling til patienter med operabel, lymfeknude-negativ brystkræft, der er egnede til kemoterapibehandling. 
Data from a multi-centre open label randomised trial support the use of TAXOTERE for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
Solvens hætteglas: ethanol 95 % vand til injektionsvæsker. 
Ethanol 95% Water for injections.
TAXOTERE 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. 
TAXOTERE 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.
• Bland manuelt opløsningen i infusionposen eller -flasken med vippende bevægelser. 
• Mix the infusion bag or bottle manually using a rocking motion.
Hvert enkeltdosis-hætteglas med TAXOTERE 80 mg/2 ml koncentrat indeholder docetaxel (som trihydrat) svarende til 80 mg docetaxel (vandfri). 
Each single-dose vial of TAXOTERE 80 mg/2 ml concentrate contains docetaxel (as trihydrate) corresponding to 80 mg of docetaxel (anhydrous).
Justeret hazard ratio 95% CI p-værdia 
Adjusted hazard ratio 95% CI p-valuea
Hvert enkeltdosis-hætteglas med solvens indeholder 13% (w/w) ethanol 95% v/v i vand til injektionsvæsker (252 mg ethanol 95% v/v). 
Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (252 mg of ethanol 95% v/v).
Den anbefalede doxetaxel-dosis til adjuverende behandling af operabel lymfeknude-positiv og lymfeknude-negativ brystkræft er 75 mg/m hver 3. uge i 6 perioder, administreret 1 time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (TAC-regime) (se også: Dosisjustering under behandling). 
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
TAXOTERE indeholder - Aktivt stof: docetaxel (som trihydrat). 
What TAXOTERE contains - The active substance is docetaxel (as trihydrate).
Hvert enkeltdosis-hætteglas med TAXOTERE 20 mg/0,5 ml koncentrat indeholder docetaxel (som trihydrat) svarende til 20 mg docetaxel (vandfri). 
Each single-dose vial of TAXOTERE 20 mg/0.5 ml concentrate contains docetaxel (as trihydrate) corresponding to 20 mg of docetaxel (anhydrous).
Et hætteglas indeholder 80 mg/2 ml docetaxel. 
One vial contains 80 mg/2 ml docetaxel.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 
PARTICULARS TO APPEAR ON OUTER PACKAGING
Hyppigheden kan variere alt efter kombinationen af de lægemidler, du får. 
Between infusions of TAXOTERE the following may occur, and the frequency may vary with the combinations of medicines that are received
Hvert hætteglas med solvens til TAXOTERE 20 mg/0,5 ml indeholder 1,98 ml. 
• Each solvent for TAXOTERE 20 mg/0.5 ml vial contains 1.98 ml.
Hjælpestoffer som behandleren skal være opmærksom på: Hvert hætteglas med koncentrat indeholder 2 ml ethanol, vandfri (1,58 g). 
Excipient with known effect: Each vial of concentrate contains 2 ml of ethanol anhydrous (1.58 g).
I nogle tilfælde (hyppighed ikke kendt) er permanent hårtab blevet observeret. 
In some cases (frequency not known)
TAXOTERE 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 lysforhold. 
The TAXOTERE 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.
Feber (G3: 1%) Oral candidiasis Hypokalcæmi (G3: 0%) Hypofosfatæmi (G3-4: 1%) Hypokaliæmi (G3: 0%) 
Hypocalcaemia (G3: 0%) Hypophosphataemia (G3-4: 1%) Hypokalaemia (G3: 0%)
Koncentrat og solvens til infusionsvæske, opløsning. 
Concentrate and solvent for solution for infusion.
Dyspnø (G3: 1%) Hoste (G3: 0%) Infektioner i de øvre luftveje (G3: 1%) 
Dyspnea (G3: 1%) Coughing (G3: 0%) Upper respiratory tract infection (G3: 1%)
• Udtag aseptisk den ønskede mængde TAXOTERE koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle. 
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe fitted with a 21G needle.
TAXOTERE 160 mg/8 ml koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske. 
TAXOTERE 160 mg/8 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Metastatisk kastrationsresistent prostatakræft 
Metastatic castration-resistant prostate cancer
Median (måneder) 95% CI 
Median (months) 95% CI
Samlet 
PRESENTATION
Paræstesi; hovedpine; dysgeusi; hypoæstesi 
Paresthesia; Headache; Dysgeusia; Hypoaesthesia
0,2 %); Mavesmerter (alvorlig: 1 %); 
Abdominal pain (severe: 1%);
15 ml klart glas (type I) hætteglas indeholdende 8 ml koncentrat med blå aluminiumforsegling og en blå plastik-afrivningshætte. 
15 ml clear glass (type I) vial with a blue aluminium seal and blue plastic flip-off cap containing 8 ml of concentrate.
Hvert enkeltdosis-hætteglas med solvens indeholder ethanol 13% (w/w) ethanol 95% v/v i vand til injektionsvæsker (932 mg ethanol 95% v/v). 
Each single-dose vial of solvent contains 13% (w/w) ethanol 95% v/v in water for injection (932 mg of ethanol 95% v/v).
Hver ml docetaxel opløsning indeholder 40 mg (vandfrit) docetaxel. 
Each ml of docetaxel solution contains 40 mg of docetaxel (anhydrous).
• 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 af resektere, lav sandsynlighed for kirurgisk helbredelse samt med bevarelse af organer som mål), er den anbefalede dosis docetaxel 75 mg/m som en 1-times intravenøs infusion på dag 1, efterfulgt af cisplatin 100 mg/m administreret som en 30 minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1000 mg/m som en kontinuerlig infusion fra dag 1 til dag 4. 
• 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/m as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m 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.
TAXOTERE i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystkræft efter svigt af cytotoksisk kemoterapi. 
TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil-antallet gendannes til et niveau  1.500 celler/mm og blodplader gendannes til et niveau 
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/mm and platelets recover to a level > 100,000 cells/mm 3.
Hver blisterpakning med TAXOTERE 80 mg/2 ml koncentrat og solvens til infusionsvæske, opløsning, indeholder: 
Each blister pack of TAXOTERE 80 mg/2 ml concentrate and solvent for solution for infusion contains:
TAXOTERE 20 mg/1 ml koncentrat til infusionsvæske, opløsning kræver INGEN forudgående fortynding med en solvens, men er klar til tilsætning til infusionsvæske. 
TAXOTERE 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
75 mg/m 2, som en 1-3-timers infusion (begge kun på dag 1), efterfulgt af 5-fluoruracil 750 mg/m pr. 
75 mg/m 2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
• Standarpleje + docetaxel 75 mg/m², administreret hver 3. uge i 6 perioder 
• ADT + docetaxel 75 mg/m² given at the beginning of ADT, administered every 3 weeks for 6 cycles
Ved metastatisk hormonfølsom prostatakræft, er det anbefalede præmedicineringsregime, uanset samtidig anvendelse af prednison eller prednisolon, oral dexamethason 8 mg 12 timer, 3 timer og 1 time før docetaxel-infusion (se pkt. 
For metastatic hormone-sensitive prostate cancer, irrespective of the concurrent use of prednisone or prednisolone, the recommended premedication regimen is oral dexamethasone 8 mg 12 hours, 3 hours, and 1 hour before docetaxel infusion (see section 4.4).
Sikkerheden og effekten af docetaxel administreret i begyndelsen af androgen deprivationsbehandling hos patienter med metastatisk hormonfølsom prostatakræft blev evalueret i et randomiseret fase III multicenter studie (CHAARTED). 
The safety and efficacy of docetaxel administered at the beginning of androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer were evaluated in a randomised Phase III multi-centre study (CHAARTED).
• Docetaxel 75 mg/m hver 3. uge i 10 behandlingsrunder. 
• Docetaxel 75 mg/m every 3 weeks for 10 cycles.
For cisplatin-dosisjustering se tilsvarende produktresumé 
For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Alopeci (G3/4: 6 %); Neglesygdomme (G3/4: 2 %) 
Alopecia (G3/4: 6%); Nail disorders (G3/4: 2%)
Anoreksi (G3/4: 
Anorexia (G3/4:
• operabel, lymfeknude-negativ brystkræft 
• operable node-negative breast cancer
TAXOTERE 20 mg/1 ml sterilt koncentrat docetaxel 
TAXOTERE 20 mg/1 ml sterile concentrate docetaxel
Koncentratet leveres i et 7 ml klart, farveløst hætteglas med en magenta aluminiumforsegling og en magenta plastik-afrivningshætte. 
The concentrate is supplied in a 7 ml clear colourless glass vial with a magenta aluminium seal and a magenta plastic flip-off cap.
Hud og subkutane væv Alopeci (G3/4: 10,9 %) Kløende udslæt; Tør hud; 
Alopecia (G3/4: 10.9%) Rash pruritic; Dry skin;
Hjælpestoffer som behandleren skal være opmærksom på: Hvert hætteglas med koncentrat indeholder 4 ml ethanol, vandfri (3,16 g). 
Excipient with known effect: Each vial of concentrate contains 4 ml of ethanol anhydrous (3.16 g).
95 %CI p-værdi 
95% CI p-value
Dehydrering (G3/4: 2 %); 
Dehydration (G3/4: 2%)
På den anden side viste AC-armen en hyppigere forekomst af alvorlig anæmi (15,8 % versus 8,5 %) end AT-armen og tillige en hyppigere forekomst af alvorlig hjertetoksicitet: Hjerteinsufficiens (3,8 % versus 2,8 %), total LVEF-nedsættelse > 20 % (13,1 % versus 6,1 %), total LVEF-nedsættelse > 30 % (6,2 % versus 1,1 %). 
In this study, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhoea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm. On the other hand, AC arm showed a higher incidence of severe anaemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease  20% (13.1% versus 6.1%), absolute LVEF decrease  30% (6.2% versus 1.1%).
Hver blisterpakning med TAXOTERE 20 mg/0,5 ml koncentrat og solvens til infusionsvæske, opløsning, indeholder: 
Each blister pack of TAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion contains:
Tumor-response rate (%) 95 %CI p-værdi* 
Tumour response rate (%) 95% CI p-value*
Asteni; periferalt ødem; pyrexi; træthed; inflammation i slimhinderne; smerter; influenza-lignende symptomer; brystsmerter; kulderystelser 
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
• TAXOTERE 80 mg/2 ml hætteglas indeholder en opløsning af docetaxel i polysorbat 80 med en koncentration på 40 mg/ml. 
• The TAXOTERE 80 mg/2 ml vial contains a solution of docetaxel in polysorbate 80 at a concentration of 40 mg/ml.
Forsigtighedsregler ved behandling af kastrationsresistent prostatakræft Ud af 333 patienter behandlet med docetaxel hver tredje uge i et prostatakræftstudium (TAX 327), var 209 patienter 65 år eller derover og 68 patienter var ældre end 75 år. 
Cautions for use in castration-resistant prostate cancer Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study(TAX 327), 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
• Induktions kemoterapi 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). 
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomised study (TAX323).
Dysgeusi (G3/4: 0 %) 
Dysgeusia (G3/4: 0%)
Infusionsvæsken skal bruges indenfor 4 timer ved stuetemperatur (under 25ºC). 
The infusion solution should be used within 4 hours at room temperature (below 25°C).
Tabellen nedenfor viser, at hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion var lavere hos patienter, der fik G-CSF profylaktisk, efter det blev gjort obligatorisk i TACarmen i GEICAM-studiet. 
Table below shows that the incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis after it was made mandatory in the TAC arm - GEICAM STUDY.
Det skal du vide, før du begynder at bruge TAXOTERE Sådan skal du bruge TAXOTERE Bivirkninger 
What TAXOTERE is and what it is used for What you need to know before you use TAXOTERE How to use TAXOTERE
• Solvens til TAXOTERE 80 mg/2 ml er i et 15 ml klart hætteglas med en gennemsigtig, farveløs afrivningshætte. 
• The solvent for TAXOTERE 80 mg/2 ml vial is a 15 ml clear glass vial with a transparent colourless flip-off cap.
4.2.4 TAXOTERE infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1-times infusion ved stuetemperatur (under 25ºC) og under normale lysforhold. 
4.2.4 The TAXOTERE 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.
13 % (w/w) ethanol 95 % i vand til injektionsvæsker Indhold: 7,33 ml 
13% (w/w) ethanol 95% in water for injections Fill: 7.33 ml
13 % (w/w) ethanol 95 % i vand til injektionsvæsker Indhold: 1,98 ml 
13% (w/w) ethanol 95% in water for injections Fill: 1.98 ml
Hætteglasset indeholder 6 ml af en 13 % ethanol opløsning 95% i vand til injektionsvæsker (indhold: 7,33 ml). 
Solvent vial contains 6 ml of a 13% w/w solution of ethanol 95% in water for injections (fill volume: 7.33 ml).
Overfølsomhed (G3-4: 1%) 
Hypersensitivity (G3-4: 1%)
Specielle patientgrupper: 
Special populations:
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) 
Hazard Ratio: 1.122 [97.2% CI: 0.937; 1.342]*
Vægtforøgelse (G3/4: 
Weight increased (G3/4:
Koncentratet leveres i et 15 ml klart, farveløst hætteglas med en blå aluminiumforsegling og en blå plastik-afrivningshætte. 
The concentrate is supplied in a 15 ml clear colourless glass vial with a blue aluminium seal and a blue plastic flip-off cap.
Udtag aseptisk den ønskede mængde TAXOTERE koncentrat til infusionsvæske, opløsning, med en kalibreret sprøjte påsat en 21G-kanyle. 
Aseptically withdraw the required amount of TAXOTERE concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.