natgillin/translations-raw huggingface dataset:
Det anvendes sammen med prednison eller prednisolon (antiinflammatoriske lægemidler). • kirtelkræft i maven (gastrisk adenocarcinom) hos patienter, der endnu ikke har fået nogen behandling mod deres kræftsygdom.
It is used with prednisone or prednisolone (anti-inflammatory medicines). • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Det anvendes sammen med cisplatin og 5- fluorouracil (andre lægemidler mod kræft). • kræft i hoved - og halsregionen, når sygdommen er fremskreden.
It is used with cisplatin and 5-fluorouracil (other anticancer medicines). • head and neck cancer in patients whose cancer is advanced.
Det anvendes sammen med cisplatin og 5- fluorouracil.
It is used with cisplatin and 5-fluorouracil.
De fuldstændige oplysninger herom fremgår af produktresuméet, der ligeledes er en del af denne EPAR.
See the Summary of Product Characteristics, also part of the EPAR, for full details.
Behandling med Docetaxel Winthrop bør kun finde sted på en specialafdeling for kemoterapi under tilsyn af en læge med speciale i kemoterapi mod kræft.
Docetaxel Winthrop should be used in specialised chemotherapy wards and it should only be given under the supervision of a doctor who is qualified in the use of anticancer chemotherapy.
Docetaxel Winthrop må kun bruges, når neutrofiltallet (en type hvide blodlegemer) er mindst 1 500 celler/ mm3.
Docetaxel Winthrop is only used when the neutrophil count (a type of white blood cell) is at least 1,500 cells/ mm3.
Ved prostatakræft skal der dagen før behandlingen gives dexamethason (et antiinflammatorisk lægemiddel) til patienten.
Treatment with dexamethasone (an anti-inflammatory medicine) should be given to the patient on the day before treatment (for prostate cancer) or the day before and the two days after treatment (for other types of cancers).
Ved andre kræftformer skal dette ske dagen før behandlingen og to dage efter behandlingen.
Docetaxel Winthrop is given as a one-hour infusion every three
Docetaxel 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
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Dosis, behandlingsvarighed og kombination med andre lægemidler afhænger af den pågældende kræfttype.
The dose, length of treatment, and its use with other medicines depend on the type of cancer being treated.
Yderligere oplysninger fremgår af produktresuméet.
For more information, see the Summary of Product Characteristics.
Docetaxel blokerer cellens evne til at nedbryde det indvendige celleskelet, der gør det muligt for cellerne at dele og formere sig.
Docetaxel blocks the ability of cells to destroy the internal ‘ skeleton ’ that allows them to divide and multiply.
Docetaxel påvirker også andre celler end kræftcellerne, f. eks. blodcellerne, hvilket kan medføre bivirkninger.
Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects.
1 000 patienter med prostatakræft, 445 patienter med mavekræft og 897 patienter med kræft i hoved - og halsregionen.
Docetaxel Winthrop has been studied in a total of around 3,000 breast cancer patients, around 1,900 lung cancer patients, around 1,000 prostate cancer patients, 445 stomach cancer patients and 897 in head and neck cancer patients.
I de fleste af disse undersøgelser blev Docetaxel Winthrop kombineret med andre kræftmidler og sammenlignet med andre lægemiddelkombinationer eller med samme lægemiddelkombination uden Docetaxel Winthrop.
In most of these studies, Docetaxel Winthrop was combined with other anticancer treatments and compared with combinations of different treatments or the same treatment without Docetaxel Winthrop.
Virkningen blev hovedsagelig bedømt ud fra responsraten (dvs. den procentdel af patienterne, hos hvem sygdommen reagerede positivt på behandlingen), tiden indtil sygdommen skred frem og forlængelsen af overlevelsestiden.
The main measure of effectiveness were the response rates (percentage of patients whose cancer responded to treatment), the time taken for the disease to progress and the increase in survival time.
Dette gælder for alle fem kræfttyper (brystkræft, ikke- småcellet lungekræft, prostatakræft, kirtelkræft i maven og kræft i hoved - og halsregionen).
The addition of Docetaxel Winthrop to other anticancer treatments produced significant increases in response rates, disease progression or survival, in all five types of cancer (breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer).
Når Docetaxel Winthrop blev anvendt ved brystkræft som eneste behandling, var det mindst lige så effektivt som sammenligningslægemidlerne, undertiden mere effektivt.
Used on its own in breast cancer, Docetaxel Winthrop was at least as effective as, and sometimes more effective than the comparator medicines.
Ved lungekræft var det mere effektivt end bedste støttende behandling.
It was more effective than best supportive care therapy in lung cancer.
De hyppigste bivirkninger hos patienter, der får Docetaxel Winthrop (som ses hos flere end 1 ud af 10 patienter), er neutropeni (nedsat antal hvide blodlegemer), anæmi (nedsat antal røde blodlegemer), trombocytopeni (nedsat antal blodplader), febril neutropeni (neutropeni med feber), periferal sensorisk neuropati (skade på nerverne, der forårsager følelsesløshed, prikken og smerter i hænder og fødder), periferal motorisk neuropati (skade på nerverne, der gør det vanskeligt at koordinere bevægelser), smagsforstyrrelser, dyspnø (åndenød), stomatitis (betændelse i mundslimhinden), diarré, kvalme, opkastning, alopeci (hårtab), hudreaktioner, neglegener, myalgi (muskelsmerter), anoreksi (appetitløshed),
The most common side effects in patients receiving Docetaxel Winthrop (seen in more than 1 patient in 10) are neutropenia (reduced white blood cell counts), anaemia (reduced red blood cell counts), thrombocytopenia (low blood platelet counts), febrile neutropenia (neutropenia with fever), peripheral sensory neuropathy (damage to the nerves causing numbness, tingling and pain in the hands and feet), peripheral motor neuropathy (damage to the nerves causing difficulty co-ordinating movements), dysgeusia (taste disturbances), dyspnoea (shortness of breath), stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), vomiting, alopecia (hair loss), skin reactions, nail disorders, myalgia (muscle pain), anorexia (loss of appetite), infections, fluid retention, asthenia (weakness), pain and hypersensitivity (allergic reactions).
Den fuldstændige liste over indberettede bivirkninger ved Docetaxel Winthrop fremgår af indlægssedlen.
For the full list of all side effects reported with Docetaxel Winthrop, see the Package Leaflet.
Docetaxel Winthrop må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for docetaxel eller et af de øvrige indholdsstoffer.
Docetaxel Winthrop should not be used in people who may be hypersensitive (allergic) to docetaxel or any of the other ingredients.
Docetaxel Winthrop bør ikke anvendes til patienter med neutrofiltal under 1 500 celler/ mm3, til patienter, der er gravide eller ammer, eller til patienter med svær leversygdom.
Docetaxel Winthrop should not be used in patients who have a neutrophil count of less than 1,500 cells/ mm3, in pregnant or breast-feeding women, or in patients who have severe liver disease.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Docetaxel Winthrop opvejer risiciene ved behandling af patienter med brystkræft, ikke- småcellet lungekræft, prostatakræft, kirtelkræft i maven og pladecellekræft i hoved - og halsregionen.
The Committee for Medicinal Products for Human Use (CHMP) decided that Docetaxel Winthrop’ s benefits are greater than its risks for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and squamous cell head and neck cancer.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Docetaxel Winthrop.
The Committee recommended that Docetaxel Winthrop be given marketing authorisation.
Andre oplysninger om Docetaxel Winthrop:
Other information about Docetaxel Winthrop:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Docetaxel Winthrop til Aventis Pharma S. A den 20. april 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Winthrop to Aventis Pharma S. A. on 20 April 2007.
Den fuldstændige EPAR om Docetaxel Winthrop findes her.
The full EPAR for Docetaxel Winthrop is available here.
Hætteglas (glas)
Concentrate: vial (glass); Solvent: vial (glass)
0, 5 ml Solvens:
0.5 ml; Solvent:
2 ml Solvens:
2 ml; Solvent:
Docetaxel Winthrop 20 mg koncentrat og solvens til infusionsvæske, opløsning.
Docetaxel Winthrop 20 mg concentrate and solvent for solution for infusion
Hvert enkeltdosis- hætteglas med Docetaxel Winthrop 20 mg koncentrat indeholder docetaxel som trihydrat, svarende til 20 mg docetaxel (vandfri).
Each single-dose vial of Docetaxel Winthrop 20 mg concentrate contains docetaxel which is a trihydrate corresponding to 20 mg of docetaxel (anhydrous).
Den viskøse opløsning indeholder 40 mg/ ml docetaxel (vandfri).
The viscous solution contains 40 mg/ ml docetaxel (anhydrous).
Hvert enkeltdosis- hætteglas med solvens indeholder ethanol 13% (w/ w) i vand til injektionsvæsker.
Each single-dose vial of solvent contains 13% (w/ w) ethanol 95% in water for injection.
Docetaxel Winthrop i kombination med doxorubicin og cyclophosfamid er indiceret til adjuverende behandling af patienter med operabel lymfeknude- positiv brystkræft.
Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer.
Docetaxel Winthrop 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.
Docetaxel Winthrop 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.
Docetaxel Winthrop 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.
Docetaxel Winthrop in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
Ikke- småcellet lungekræft
Non-small cell lung cancer
Docetaxel Winthrop er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke- småcellet lungekræft efter behandlingssvigt af kemoterapi.
Docetaxel Winthrop is indicated for the treatment of patients with locally advanced or metastatic non- small cell lung cancer after failure of prior chemotherapy.
Docetaxel Winthrop 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.
Docetaxel Winthrop 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.
2 Prostatakræft
2 Prostate cancer
Docetaxel Winthrop i kombination med cisplatin og 5- fluorouracil er indiceret til behandling af patienter med metastatisk gastrisk adenocarcinom, inklusive adenocarcinom i den gastrooesophageale forbindelse, som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom.
Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
Hoved - og halskræft
Head and neck cancer
Docetaxel Winthrop i kombination med cisplatin og 5- fluorouracil er indiceret til indledende behandling af patienter med inoperable, lokale, fremskredne skællede celle- carcinoma i hoved og hals.
Docetaxel Winthrop in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
6. 6).
The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy (see section 6.6).
Medmindre det er kontraindiceret, kan der til brystkræft, ikke- småcellet lungekræft, gastrisk samt hoved- og halskræft gives et peroralt kortikosteroid som præmedicinering, eksempelvisdexamethazon 16 mg per dag (f. eks.
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.
4. 4).
8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
4. 4).
For prostate cancer, given the concurrent use of prednisone or prednisolone the recommended premedication regimen is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.4).
Docetaxel indgives som en 1- times infusion hver 3. uge.
Docetaxel is administered as a one-hour infusion every three weeks.
Dosisjustering under behandling).
Breast cancer In the adjuvant treatment of operable node-positive breast cancer, the recommended dose of docetaxel is 75 mg/ m2 administered 1-hour after doxorubicin 50 mg/ m2 and cyclophosphamide 500 mg/ m2 every 3 weeks for 6 cycles (see also Dose adjustments during treatment).
Til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft er den anbefalede dosis docetaxel i monoterapi 100 mg/ m2.
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/ m2 in monotherapy.
Som førstebehandling indgives 75 mg/ m2 doxetaxel i kombinationsbehandling med doxorubicin (50 mg/ m2).
In first-line treatment, docetaxel 75 mg/ m2 is given in combination therapy with doxorubicin (50 mg/ m2).
I kombination med trastuzumab er den anbefalede dosis af docetaxel 100 mg/ m2 hver 3. uge med en ugentlig administration af trastuzumab.
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/ m2 every three weeks, with trastuzumab administered weekly.
I pivotalforsøget blev den initiale docetaxel- infusion givet dagen efter den første dosis trastuzumab.
In the pivotal trial the initial docetaxel infusion was started the day following the first dose of trastuzumab.
Den efterfølgende docetaxel- dosis blev givet umiddelbart efter ophør af trastuzumab- infusionen, hvis trastuzumab- infusionen var veltolereret.
The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated.
Vedrørende trastuzumab- dosis og - administration, se produktresumé for trastuzumab.
For trastuzumab dose and administration, see trastuzumab summary of product characteristics.
I kombination med capecitabin er den anbefalede Docetaxel Winthrop- dosis 75 mg/ m2 hver 3. uge kombineret med capecitabin 1250 mg/ m2 to gange daglig (indenfor 30 minutter efter et måltid) i 2 uger efterfulgt af en uges pause.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/ m2 every three weeks, combined with capecitabine at 1250 mg/ m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period.
For beregning af capecitabin- dosis i overensstemmelse med legemsoverflade se capecitabin- produktresuméet.
For capecitabine dose calculation according to body surface area, see capecitabine summary of product characteristics.
Ikke- småcellet lungekræft For patienter der ikke tidligere er behandlet med kemoterapi, der behandles for ikke- småcellet lungekræft, er den anbefalede dosis af docetaxel 75 mg/ m2, straks efterfulgt af cisplatin 75 mg/ m2
For treatment
For behandling efter forudgående svigt af platinbaseret kemoterapi, er den anbefalede dosis 75 mg/ m2 givet som enkeltstof.
3 after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m² as a single agent.
Prostatakræft Den anbefalede dosis af docetaxel er 75 mg/ m2.
Prostate cancer The recommended dose of docetaxel is 75 mg/ m2.
5. 1).
Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Gastrisk adenocarcinom 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. dag, givet som en 24- timers kontinuerlig infusion i 5 dage, med start efter endt cisplatin- infusion.
Gastric adenocarcinoma 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.
Man bør anvende profylaktisk G- CSF for at nedsætte risikoen for hæmatologisk toksicitet (se også ” Dosisjustering under behandling ”).
Prophylactic G-CSF should be used to mitigate the risk of hematological toxicities (see also Dose adjustments during treatment).
Hoved- og hals- kræft Patienter skal præmedicineres med antiemetika og hydreres passende (før og efter cisplatin administration).
Head and neck cancer Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
Profylaktisk G- CSF kan anvendes til at nedsættes risikoen for hæmatologiske toksiciteter.
Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities.
Alle patienter på den docetaxel- indeholdende arm af TAX 323 og TAX 324 studierne modtog profylaktisk antibiotika.
All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Til den indledende behandling af inoperabel, lokalt fremskredne pladecellecarcinom i hoved og hals (SCCHN) er den anbefalede dosis docetaxel 75 mg/ m2 som en 1- times infusion, efterfulgt af 1 times infusion med cisplatin 75 mg/ m2 på dag 1, efterfulgt af 5- fluorouracil som en kontinuerlig infusion på 750 mg/ m2 pr. dag i fem dage.
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/ m2 as a 1 hour infusion followed by cisplatin 75 mg/ m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/ m2 per day for five days.
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/ m2 som en 1- times intravenøs infusion på dag 1, efterfulgt af cisplatin 100 mg/ m2 administreret som en 30 minutter til 3 timers infusion, efterfulgt af 5- fluorouracil 1000 mg/ m2 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/ 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.
Patienter bør modtage kemo- strålingsterapi efter kemoterapi
Following chemotherapy, patients should receive chemoradiotherapy.
Ved dosismodifikation af cisplatin og 5- fluorouracilhenvises der til de tilsvarende produktresuméer.
For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Generelt Docetaxel kan gives, når neutrocyttallet er ≥ 1. 500 celler/ mm3.
General Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/ mm3.
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.
In patients who experienced either febrile neutropenia, neutrophil < 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.
Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/ m2 bør behandlingen stoppes.
If the patient continues to experience these reactions at 60 mg/ m², the treatment should be discontinued.
Patienter, som fortsat
Adjuvant therapy for breast cancer In the pivotal trial in patients who received adjuvant therapy for breast cancer and who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 4 to 11) in all subsequent cycles.
4 havde denne reaktion, skulle forblive på G- CSF og have deres docetaxel- dosis reduceret til 60 mg/ m2.
Patients who continued to experience this reaction should remain on G-CSF and have their docetaxel dose reduced to 60 mg/ m².
Dog kan neutropeni forekomme tidligere i klinisk praksis.
4 However, in clinical practice neutropenia could occur earlier.
1) patientens risiko for at udvikle neutropeni og 2) de gældende retningslinjer.
Thus the use of G-CSF should be considered function of the neutropenic risk of the patient and current recommendations.
Patienter, som får Grad 3 - eller 4- stomatitis, bør have deres dosis reduceret til 60 mg/ m2.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/ m².
1) hos patienter med en initialdosis på 75 mg/ m2 docetaxel i kombination med cisplatin, med en minimum blodpladeværdi under den tidligere behandlingsrunde på < 25000 celler/ mm3, 2) hos patienter, der får febril neutropeni, 3) hos patienter, med alvorlig, ikke hæmatologisk toksicitet.
In combination with cisplatin For patients who are dosed initially at docetaxel 75 mg/ m2 in combination with cisplatin and whose nadir of platelet count during the previous course of therapy is < 25,000 cells/ mm3, or in patients who experience febrile neutropenia, or in patients with serious non-hematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/ m2.
For cisplatin- dosisjustering se tilsvarende produktresumé
For cisplatin dose adjustments, see the corresponding summary of product characteristics.