natgillin/translations-raw huggingface dataset:
Denne fremgangsmåde gælder, uanset hvor patienten befinder sig i behandlingscyklus. • Ved ethvert efterfølgende tegn på toksicitet eller ved grad 4- toksicitet seponeres docetaxel - behandling.
In combination with capecitabine • For capecitabine dose modifications, see capecitabine summary of product characteristics. • For patients developing the first appearance of a Grade 2 toxicity, which persists at the time of the next docetaxel/ capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose. • For patients developing the second appearance of a Grade 2 toxicity, or the first appearance of a Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, then resume treatment with docetaxel 55 mg/ m². • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Se produktresuméet for trastuzumab.
For trastuzumab dose modifications, see trastuzumab summary of product characteristics.
1) febril neutropeni, 2) prolongeret neutropeni, 3) eller neutropenisk infektion.
In combination with cisplatin and 5-fluorouracil 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.
I tilfælde af efterfølgende episoder med kompliceret neutropeni, bør dosis af docetaxel reduceres fra 60 mg/ m2 til 45 mg/ m2.
If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/ m2.
I tilfælde af grad 4- trombocytopeni bør dosis af docetaxel reduceres fra 75 mg/ m2 til 60 mg/ m2.
In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/ m2.
Patienter bør ikke genbehandles med efterfølgende cyklusser af docetaxel indtil neutrofil- antallet gendannes til et niveau > 1. 500 celler/ mm3 og blodplader gendannes til et niveau > 100. 000 celler/ mm3.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level > 1,500 cells/ mm3 and platelets recover to a level > 100,000 cells/ mm3.
Afbryd behandlingen, hvis disse toksiciteter varer ved (se pkt.
Discontinue treatment if these toxicities persist.
4. 4).
(See section 4.4).
De anbefalede dosis- modifikationer for gastrointestinal toksicitet hos patienter behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (5- FU):
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Toksicitet Diarré grad 3
Diarrhea grade 3
Reducer 5- FU- dosis med 20% Anden episode:
First episode: reduce 5-FU dose by 20%.
Reducer så docetaxel- dosis med 20%
Second episode: then reduce docetaxel dose by 20%.
Diarré grad 4
Diarrhea grade 4
Reducer docetaxel - og 5- FU- dosis med 20% Anden episode:
First episode: reduce docetaxel and 5-FU doses by 20%.
Afbryd behandlingen
Second episode: discontinue treatment.
Stomatitis/ mucositis grad 3
Stomatitis/ mucositis grade 3
Stop kun 5- FU i alle efterfølgende cyklusser Tredje episode:
Second episode: stop 5-FU only, at all subsequent cycles.
Reducer docetaxel- dosis med 20%
Third episode: reduce docetaxel dose by 20%.
Stomatitis/ mucositis grad 4
Stomatitis/ mucositis grade 4
Stop kun 5- FU i alle efterfølgende cyklusser Anden episode:
First episode: stop 5-FU only, at all subsequent cycles.
Reducer docetaxel- dosis med 20%
Second episode: reduce docetaxel dose by 20%.
Se tilsvarende produktresumé.
For cisplatin and 5-fluorouracil dose adjustments, see the corresponding summary of product characteristics.
Til patienter, som i SCCHN pivotalstudiet udviklede kompliceret neutropeni (inklusive prolongeret neutropeni, febril neutropeni eller infektion), blev G- CSF anbefalet som profylakse (f. eks. dag 6- 15) i alle efterfølgende cyklusser.
In the pivotal SCCHN trials patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
5 Specielle patientgrupper:
5 Special populations
4. 4 og pkt.
Patients with hepatic impairment 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).
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.
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.
I sådanne tilfælde bør docetaxel kun anvendes på tvingende indikation.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical trial excluded patients with ALT and/ or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Erfaringen med behandling af børn og unge er begrænset.
Children and adolescents The experience in children is limited.
Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre.
Elderly Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Produktresumé for capecitabin)
In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
Docetaxel må ikke anvendes hos patienter med en udgangsværdi for neutrofile granulocytter på < 1. 500 celler/ mm3.
Docetaxel must not be used in patients with baseline neutrophil count of < 1,500 cells/ mm3.
Docetaxel må ikke anvendes til gravide eller ammende.
Docetaxel must not be used in pregnant or breast-feeding women.
4. 2 og 4. 4).
Docetaxel must not be used in patients with severe liver impairment since there is no data available (see sections 4.2 and 4.4).
Medmindre det er kontraindiceret, kan der til brystkræft og ikke- småcellet lungekræft gives et peroralt kortikosteroid som præmedicinering, eksempelvis dexamethasone 16 mg per dag i 3 dage (f. eks.
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e. g.
Dette kan nedsætte forekomst og sværhedsgrad af væskeretention og sværhedsgraden af overfølsomhedsreaktioner (se pkt.
8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
4. 2).
For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Neutrocyt- lavpunkt sås efter gennemsnitligt 7 dage, men intervallet kan være kortere hos patienter, der tidligere har fået en kraftigt virkende behandling.
Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
4. 2).
Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/ mm3 (see section 4.2).
4. 2).
In the case of severe neutropenia (< 500 cells/ mm3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2).
6 Hos de patienter, der blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (TCF), opstod der febril neutropeni og neutropenisk infektion i mindre grad, når patienterne fik profylaktisk G- CSF.
6 In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
Patienter i behandling med TCF bør have profylaktisk G- CSF for at nedsætte risikoen for kompliceret neutropeni (febril neutropeni, prolongeret neutropeni eller neutropenisk infektion).
Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
4. 2 og 4. 8).
Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Der bør derfor være adgang til behandling af hypotension og bronkospasmer.
Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel, thus facilities for the treatment of hypotension and bronchospasm should be available.
Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, eller bronkospasme eller generaliseret udslæt/ erythem, øjeblikkelig afbrydelse af docetaxel- infusion og passende terapi.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/ erythema require immediate discontinuation of docetaxel and appropriate therapy.
4. 2).
Severe symptoms such as eruptions followed by desquamation which lead to interruption or discontinuation of docetaxel treatment were reported (see section 4.2).
Bivirkningerne kan omfatte toksisk dødsfald inklusive sepsis og maveblødning, som kan blive fatal, febril neutropeni, infektioner, trombocytopeni, stomatitis og asteni.
In patients treated with docetaxel at 100 mg/ m2 as single agent who have serum transaminase levels (ALT and/ or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia.
4. 2).
Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/ m2 and LFTs should be measured at baseline and before each cycle (see section 4.2).
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.
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.
I kombinationsbehandling med cisplatin og 5- fluorouracil til behandling af patienter med gastrisk adenocarcinom ekskluderede pivotalstudiet patienter med ALT og/ eller AST > 1, 5 gange ULN associeret med alkalisk phosphatase > 2, 5 gange ULN, og bilirubin > 1 gange ULN.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical trial excluded patients with ALT and/ or AST > 1.5 × ULN associated with alkaline phosphatase > 2.5 × ULN, and bilirubin > 1 x ULN; for these patients, no dose-reductions can be recommended and docetaxel should not be used unless strictly indicated.
Hos disse patienter kan det ikke anbefales at reducere dosis.
No data are available in patients with hepatic impairment treated by docetaxel in combination in the other indications.
I sådanne tilfælde bør docetaxel kun anvendes på tvingende indikation.
Patients with renal impairment
Der foreligger ingen data for patienter med nedsat leverfunktion i kombinationsbehandling ved andre indikationer.
There are no data available in patients with severely impaired renal function treated with docetaxel.
Patienter med nedsat nyrefunktion
Nervous system
Der er ingen tilgængelige data vedrørende behandling med docetaxal af patienter med alvorligt nedsat nyrefunktion.
The development of severe peripheral neurotoxicity requires a reduction of dose (see section 4.2).
7 Nervesystemet
7 Cardiac toxicity
4. 8).
This may be moderate to severe and has been associated with death (see section 4.8).
Hjertefunktionen bør yderligere monitoreres under behandlingen (f. eks. hver 3. måned) med henblik på at identificere patienter, som udvikler hjerte - dysfunktion.
Cardiac function should be further monitored during treatment (e. g. every three months) to help identify patients who may develop cardiac dysfunction.
Svangerskabsforebyggende midler skal anvendes under behandlingen og i mindst 3 måneder efter seponering.
Contraceptive measures must be taken during and for at least three months after cessation of therapy.
4. 2).
Additional cautions for use in adjuvant treatment of breast cancer Complicated neutropenia For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Gastrointestinale reaktioner Symptomer såsom tidlig abdominal smerte og ømhed, feber, diarré, med eller uden neutropeni, kan være tidlige manifestationer på alvorlig gastrointestinal toksicitet og bør evalueres og behandles med det samme.
Gastrointestinal reactions Symptoms such as early abdominal pain and tenderness, fever, diarrhea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Kongestive hjertesvigt Patienter bør monitoreres for symptomer på kongestive hjertesvigt under behandlingen og under follow- up- perioden.
Congestive heart failure Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Leukemi For patienter, behandlet med docetaxel, doxorubicin og cyclophosfamid (TAC), kræver risikoen for forsinket myelodysplasi eller myolid leukemi hæmatologisk opfølgning.
Leukemia In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires haematological follow-up.
5. 1).
Patients with 4+ nodes The benefit/ risk ratio for TAC in patients with 4+ nodes was not defined fully at the interim analysis (see section 5.1).
Ældre Der er ingen tilgængelige data vedrørende anvendelse af docetaxel i kombination med doxorubicin og cyclophosfamid til patienter over 70 år.
Elderly There are no data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Hyppigheden af relateret feber, diarré, anoreksi og perifere ødemer var ≥ 10% højere hos patienter som var 75 år eller ældre end hos patienter under 65 år.
The incidence of related fever, diarrhea, anorexia, and peripheral edema occurred at rates ≥ 10% higher in patients who were 75 years of age or greater versus less than 65 years.
Blandt 300 patienter (221 patienter i fase III- delen af undersøgelsen og 79 patienter i fase II- delen af undersøgelsen), som fik behandling med docetaxel i kombination med cisplatin og 5- fluorouracil i undersøgelsen af gastrisk kræft, var 74 patienter 65 år eller ældre og 4 patienter var 75 år eller ældre.
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Lethargi, stomatitis, neutropenisk infektion opstod ≥ 10% oftere hos de patienter, som var 65 år eller derover end hos de yngre patienter.
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients.
Ældre patienter, som behandles med TCF, bør monitores nøje.
Elderly patients treated with TCF should be closely monitored.
8 4. 5 Interaktion med andre lægemidler og andre former for interaktion
8 4.5 Interaction with other medicinal products and other forms of interaction
In vitro- studier har vist, at docetaxels metabolisme kan ændres ved samtidig medicinering med stoffer, som inducerer, hæmmer eller metaboliseres (og således hæmmer enzymet kompetitivt) af cytochrom P450 3A, f. eks ciclosporin, terfenadin, ketokonazol, erythromycin og troleandromycin.
In vitro studies have shown that the metabolism of docetaxel may be modified by the concomitant administration of compounds which induce, inhibit or are metabolised by (and thus may inhibit the enzyme competitively) cytochrome P450-3A such as ciclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Skønt mulige in vivo- interaktioner mellem docetaxel og anden samtidig administreret medicin ikke er undersøgt formelt, har in vitro- interaktions - studier med kraftigt proteinbundne stoffer såsom erythromycin, difenhydramin, propranolol, propafenon, fenytoin, salicylat, sulfamethoxazol og natriumvalproat, ikke påvirket docetaxels proteinbinding.
Although the possible in vivo interaction of docetaxel with concomitantly administered medication has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Co- administrationen af docetaxel, doxorubicin og cyclophosfamid påvirkede ikke deres farmakokinetik.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
50% højere end de værdier, der tidligere er rapporteret for carboplatin monoterapi.
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Docetaxel bør administreres med forsigtighed til patienter, som er i samtidig behandling med potente CYP3A4- hæmmere (f. eks. protease- hæmmere som ritonavir, azol antimykotika som ketokonazol eller itrakonazol).
Docetaxel should be administered with caution in patients concomitantly receiving potent CYP3A4 inhibitors (e. g. protease inhibitors like ritonavir, azole antifungals like ketoconazole or itraconazole).
Et interaktionsstudie udført hos patienter, som var i behandling med ketokonazol og docetaxel viste, at clearance af docetaxel blev reduceret til halvdelen på grund af ketokonazol, sandsynligvis fordi metabolismen af docetaxel involverer CYP3A4 som den største (eneste) metaboliske omsætningsvej.
A drug interaction study performed in patients receiving ketoconazole and docetaxel showed that the clearance of docetaxel was reduced by half by ketoconazole, probably because the metabolism of docetaxel involves CYP3A4 as a major (single) metabolic pathway.
Det er påvist, at docetaxel er både embryo- og føtotoksisk hos kaniner og rotter, samt at de nedsætter fertiliteten hos rotter.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.
Docetaxel må derfor ikke anvendes til gravide.
Therefore, docetaxel must not be used during pregnancy.
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 Winthrop som enkeltstof. • 258 patienter som fik docetaxel i kombinationsbehandling med doxorubicin. • 406 patienter som fik docetaxel i kombination med cisplatin. • 92 patienter som fik docetaxel i kombination med trastuzumab. • 255 patienter som fik docetaxel i kombination med capecitabin.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: • 1312 and 121 patients who received 100 mg/ m² and 75 mg/ m² of docetaxel as a single agent respectively. • 258 patients who received docetaxel in combination with doxorubicin. • 406 patients who received docetaxel in combination with cisplatin. • 92 patients treated with docetaxel in combination with trastuzumab.
9 • 332 patienter som fik docetaxel i kombination med prednison eller prednisolon (klinisk relevante behandlingsrelaterede bivirkninger er medtaget). • 744 patienter som fik docetaxel i kombination med doxorubicin og cyclophosphamid (bivirkninger til klinisk vigtig behandling er præsenteret). • 300 gastrisk adenocarcinoma- patienter (221 patienter i fase III- delen af undersøgelsen og 79 patienter i fase II- delen af undersøgelsen), som blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt). • 174 og 251 hoved - og hals- kræft- patienter, som blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
9 • 255 patients who received docetaxel in combination with capecitabine. • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). • 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
Disse reaktioner blev beskrevet under brug af NCI Common Toxicity Criteria (grad 3 = G3; grad 3 - 4 = G3/ 4; grad 4 = G4) og COSTART- termerne.
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/ 4; grade 4 = G4) and the COSTART terms.
Hyppigheder defineres som: meget almindelig (≥ 1/ 10); almindelig (≥ 1/ 100, < 1/ 10); ikke almindelig (≥ 1/ 1000, < 1/ 100); sjælden (≥ 1/ 10. 000, < 1/ 1000); meget sjælden (< 1/ 10. 000).
Frequencies are defined as: very common (≥ 1/ 10), common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000).
Neutropeni (som var reversibel og ikke kumulativ, median- dagen til nadir var 7 dage og median- varigheden af alvorlig neutropeni (< 500 celler/ mm3) var 7 dage), anæmi, alopeci, kvalme, opkastning, stomatitis, diarré og asteni.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/ mm3) was 7 days), anemia, alopecia, nausea, vomiting, stomatitis, diarrhea and asthenia.
Der var en forøget forekomst af meget alvorlige bivirkninger (40% mod 31%) og grad 4 alvorlige bivirkninger (34% mod 23%) i kombinationsarmen trastuzumab sammenlignet med docetaxel enkeltbehandling.
23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Produktresuméet for capecitabin).
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥ 5%) reported in a phase III trial in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics).
4. 2 og 4. 4).
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Reaktionerne var ofte associerede med kløe.
Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Udbruddene opstår ofte inden for en uge efter docetaxel- infusion.
Eruptions generally occurred within one week after the docetaxel infusion.