natgillin/translations-raw huggingface dataset:
Prednisons virkning på farmakokinetikken for docetaxel administreret med standard dexamethasonpræmedicinering er undersøgt hos 42 patienter.
The effect of prednisone on the pharmacokinetics of docetaxel administered with standard dexamethasone premedication has been studied in 42 patients.
Overfølsomhedsreaktioner opstod generelt inden for få minutter efter starten af docetaxelinfusionen og reaktionerne var ofte milde til moderate.
Hypersensitivity reactions have generally occurred within a few minutes following the start of the infusion of docetaxel and were usually mild to moderate.
3 patienter (2 %), der fik docetaxel, ophørte med behandlingen grundet væskeretention, hvorimod 15 patienter (9 %), der fik doxorubicin, stoppede behandlingen grundet hjertetoksicitet (3 tilfælde af fatal hjerteinsufficiens).
Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Amenorré fortsatte under opfølgning hos 121 patienter ud af de 202 patienter med amenorré ved slutningen af kemoterapien i studiet TAX 316.
Amenorrhoea was observed to be ongoing during follow-up in 121 patients out of the 202 patients with amenorrhoea at the end of the chemotherapy in study TAX316.
Docetaxel Teva Pharma vil blive administreret af personale med en sundhedsfaglig uddannelse.
Docetaxel Teva Pharma will be administered to you by a healthcare professional.
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 cyclosporine, terfenadine, ketoconazole, erythromycin and troleandomycin.
Reaktioner på infusionsstedet; Smerter
Infusion site reaction; Pain
Behandlingsforskel: 7,1 % [95 % CI: 0,7; 13,5] *: rettet for multiple sammenligninger og justeret for stratification-faktorer (stadie af sygdommen og behandlingsregion), baseret på beregnelig patientpopulation.
Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Svære negleforandringer er karakteriseret ved hypo- eller hyperpigmentering og sommetider smerter og onykolyse.
Severe nail disorders are characterised by hypo- or hyperpigmentation and sometimes pain and onycholysis.
Mekanismen bag denne interaktion er ritonavirs hæmning af CYP3A4, der er det primære isoensym i metaboliseringen af docetaxel.
The mechanism behind this interaction is a CYP3A4 inhibition, the main isoenzyme involved in docetaxel metabolism by ritonavir.
- Øvrige indholdsstoffer: Polysorbat 80 og 25,1 % (w/w) vandfri ethanol.
- The other ingredients are polysorbate 80 and 25.1% (w/w) anhydrous ethanol.
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær metastatisk prostatakræft blev undersøgt i et randomiseret multicenter fase IIIstudie.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter Phase III study.
Docetaxels Teva Pharmas sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt.
The safety and efficacy of Docetaxel Teva Pharma in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Reaktionerne var karakteriseret ved udslæt inklusive lokale udbrud, hovedsagelig på fødder og hænder (inklusive svært hånd- og fodsyndrom), men også arme, ansigt og thorax.
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.
In vitro-forsøg har vist, at docetaxel ødelægger det mikrotubulære netværk i celler, som er essentielle for mitosen og cellulære funktioner i interfasen.
Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Docetaxel Teva Pharma må ikke anvendes efter udløbsdatoen, som er anført på karton og hætteglas.
Docetaxel Teva Pharma should not be used after the expiry date shown on the carton and vials.
I docetaxel - plus trastuzumabarmen havde 64 % modtaget en tidligere behandling med antracyklin som adjuverende behandling sammenlignet med 55 % i docetaxel-armen alene.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Hypotension; Hypertension; Hæmoragi
Hypotension; Hypertension Haemorrhage
Forekomsten af de følgende bivirkninger (alle grader): letargi, 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.
Neutropenisk infektion
Neutropenic infection;
Fald i blodtrykket, uregelmæssig eller hurtig hjerterytme
• decrease in blood pressure; irregular or rapid heart beat
I studiet TAX 316 oplevede 26 patienter (3,5 %) i TAC-armen og 17 patienter (2,3 %) i FAC-armen kongestivt hjertesvigt.
In study TAX316, 26 patients (3.5%) in the TAC arm and 17 patients (2.3%) in the FAC arm experienced congestive heart failure.
Derimod kræver svære overfølsomhedsreaktioner såsom svær hypotension, bronkospasme eller generaliseret udslæt/erytem øjeblikkelig afbrydelse af docetaxelinfusion og passende terapi.
However, severe reactions, such as severe hypotension, bronchospasm or generalised rash/erythema require immediate discontinuation of docetaxel and appropriate therapy.
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.
Symptomatisk hjertesvigt blev rapporteret hos 2,2 % af patienterne, som modtog docetaxel plus trastuzumab i forhold til 0 % af de patienter, som fik docetaxel alene.
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Ikke almindelige (kan forekomme hos op til 1 ud af 100 patienter)
Uncommon (may affect up to 1 in 100 people):
Docetaxel fandtes in vitro at være cytotoksisk over for forskellige murine og humane tumorcellelinjer samt over for humane tumorceller fra frisk udtagne humane tumorer i klonogene assays.
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Docetaxel Teva Pharma må IKKE anvendes, hvis du er gravid, medmindre det klart er anvist af din
Docetaxel Teva Pharma must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Docetaxel Teva Pharma er ordineret af din læge til behandling af fremskreden brystkræft, specielle former for lungekræft (ikke-småcellet lungekræft) og prostatakræft: - Ved behandling af fremskreden brystkræft kan Docetaxel Teva Pharma indgives alene.
Docetaxel Teva Pharma has been prescribed by your doctor for the treatment of advanced breast cancer, special forms of lung cancer (non-small cell lung cancer) and prostate cancer: - For the treatment of advanced breast cancer, Docetaxel Teva Pharma could be administered alone.
I de 2 her nævnte fase III-studier viste docetaxel den samme sikkerhedsprofil, som tidligere blev set i fase II-studierne (se pkt.
During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Docetaxel Teva Pharma gives som infusion i en vene (intravenøs anvendelse).
Docetaxel Teva Pharma will be given by infusion into one of your veins (intravenous use).
Tilfælde af tåresekretion med eller uden konjunktivitis, da der er sjældne rapporter om tilfælde af obstruktion af tårekanalerne, som resulterede i usædvanlig kraftigt tåreflod.
Cases of lacrimation with or without conjunctivitis, as cases of lachrymal duct obstruction resulting in excessive tearing have been rarely reported.
Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/m og mediantiden til reversibilitet af væskeretention var 16,4 uger (interval 0 til 42 uger).
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m2 and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks).
Almene symptomer og reaktioner på administrationsstedet I studiet TAX 316 fortsatte perifert ødem hos 19 patienter ud af de 119 patienter med perifert ødem i TAC-armen og hos 4 patienter ud af de 23 patienter med perifert ødem i FAC-armen.
General disorders and administration site conditions In study TAX316, peripheral oedema was observed to be ongoing in 19 patients out of the 119 patients with peripheral oedema in the TAC arm and 4 patients out of the 23 patients with peripheral oedema in the FAC arm.
Immunsystemet Der er rapporter om anafylaktisk shock, i nogle tilfælde fatale.
Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Efter 10 års follow-up i TAX 316-studiet blev akut leukæmi rapporteret hos 4 ud af 744 TACpatienter og hos 1 ud af 736 FAC-patienter.
After 10 years of follow up in study TAX316, acute leukaemia was reported in 4 of 744 TAC patients and in 1 of 736 FAC patients.
Ældre personer Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre personer.
Based on a population pharmacokinetic analysis, there are no special instructions for use in older people.
In vivo er docetaxels aktivitet uafhængig af behandlingsregimet og har eksperimentelt vist et bredt spektrum af antitumoraktivitet over for fremskredne murine og transplanterede humane tumorer.
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Ved en median opfølgningtid på 77 måneder forekom akut leukæmi hos 1 ud af 532 (0,2 %) patienter, som fik docetaxel, doxorubicin og cyclofosfamid i GEICAM 9805-studiet.
At a median follow-up time of 77 months, acute leukaemia occurred in 1 of 532 (0.2%) patients who received docetaxel, doxorubicin, and cyclophosphamide in the GEICAM 9805 study.
Hjerte Sjældne tilfælde af myokardieinfarkt er rapporteret.
Cardiac disorders Rare cases of myocardial infarction have been reported.
I studiet TAX 316 blev alopecia, der persisterede ind i follow-up perioden efter endt kemoterapi, rapporteret hos hos 687 TAC-patienter og 645 FAC-patienter.
In study TAX316, alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 TAC patients and 645 FAC patients.
Docetaxels clearance i kombinationsterapi med cisplatin var sammenlignelig med det observerede ved monoterapi.
Clearance of docetaxel in combination therapy with cisplatin was similar to that observed following monotherapy.
Docetaxel har vist sig at være mutagent in vitro i mikronucleus- og kromosom-aberrationstesten i CHO-K1-celler, samt in vivo i mikronucleustesten i mus.
Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Milde til moderate neurosensoriske symptomer er karakteriseret ved paræstesi, dysæstesi eller smerter inklusive brændende fornemmelser.
Mild to moderate neuro-sensory signs are characterised by paresthesia, dysesthesia or pain including burning.
I tidligere kemoterapi skal anthracyklin eller et alkylerende stof have været anvendt.
Previous chemotherapy should have included an anthracycline or an alkylating agent.
332 patienter, som fik docetaxel i kombination med prednison eller prednisolon (klinisk relevante behandlingsrelaterede bivirkninger er medtaget).
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
Skønt mulige in vivo-interaktioner mellem docetaxel og anden samtidigt administreret lægemiddel ikke er undersøgt formelt, har in vitrointeraktionsstudier 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 medicinal products has not been investigated formally, in vitro interactions with tightly protein-bound drugs such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Flere grad 3/4 bivirkninger blev observeret for docetaxel monoterapi (55,4 %) sammenlignet med paclitaxel (23,0 %).
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Du må ikke amme, mens du behandles med Docetaxel Teva Pharma.
You must not breast-feed while you are treated with Docetaxel Teva Pharma.
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 og MedDRA-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 and the MedRA terms.
Docetaxels plasmaproteinbinding er mere end 95 %.
Docetaxel is more than 95% bound to plasma proteins.
Dette er fordi Docetaxel Teva Pharma eller den anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.
This is because Docetaxel Teva Pharma or the other medicine may not work as well as expected and you may be more likely to get a side effect.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 21st January 2011
Der er ingen relevant anvendelse af docetaxel Teva Pharma i den pædiatriske population til indikationerne brystkræft, ikke-småcellet lungekræft og prostatakræft.
There is no relevant use of Docetaxel Teva Pharma in the paediatric population in the indications breast cancer, non-small cell lung cancer and prostate cancer.
De mest almindelige bivirkninger ved Docetaxel Teva Pharma givet alene er: fald i antallet af røde og hvide blodlegemer, hårtab, kvalme, opkastning, sår i munden, diarré og træthed.
The most commonly reported adverse reactions of Docetaxel Teva Pharma alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Kontakt specielt lægen, hvis du får diarré, sår i munden, følelsesløshed, stikken og prikkende fornemmelser eller feber, og giv lægen resultatet af dine blodprøver.
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him results of your blood tests.
Må ikke opbevares ved temperaturer over 25 °C.
Do not store above 25°C .
Docetaxel Teva Pharma hætteglas må ikke opbevares ved temperaturer over 25 ºC og skal beskyttes mod lys.
Docetaxel Teva Pharma vials should not be stored above 25°C and should be protected from light.
Forhøjet tåresekretion; Konjunktivitis
Lacrimation increased; Conjunctivitis
Hvis du er mand og i behandling med Docetaxel Teva Pharma, rådes du til ikke at blive far til et barn under og 6 måneder efter behandlingen og til at søge vejledning om opbevaring af sæd inden behandlingen, fordi docetaxel kan nedsætte den mandlige fertilitet.
If you are a man being treated with Docetaxel Teva Pharma you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because docetaxel may alter male fertility.
For cisplatin-dosisjustering se tilsvarende produktresumé.
For cisplatin dose adjustments, see the corresponding summary of product characeteristics.
449 patienter blev randomiseret til enten at modtage docetaxel monoterapi 100 mg/m givet som 1 times infusion eller paclitaxel 175 mg/m givet som en infusion over 3 timer.
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
Behandlingsforskel: 6,2 % [95 % CI: 0,2; 12,3]
Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og hætteglassene.
This medicine should not be used after the expiry date which is stated on the carton and vials.
Docetaxel øgede responsraten (33 % mod 12 %, p < 0,0001), forlængede tiden til progression (19 uger mod 11 uger, p = 0,0004), samt forlængede overlevelsen (11 måneder mod 9 måneder, p = 0,01).
Docetaxel increased response rate (33% vs. 12%, p<0.0001), prolonged time to progression (19 weeks vs. 11 weeks, p=0.0004) and prolonged overall survival (11 months vs. 9 months, p=0.01).
Fortæl det altid til lægen eller hospitalsfarmaceut, hvis du bruger anden medicin eller har brugt det for nylig.
Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft er den anbefalede dosis docetaxel i monoterapi 100 mg/m
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy.
Fjern sprøjten og bland miksturen manuelt ved at vende hætteglasset gentagne gange i mindst 45 sekunder.
Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
Docetaxel må ikke anvendes hos patienter med en udgangsværdi for neutrofile granulocytter på < 1.500 celler/mm
Docetaxel must not be used in patients with baseline neutrophil count of <1,500 cells/mm3.
Behandlingsforskel: 5,4 % [95 % CI: -1,1; 12,0]
Treatment difference: 5.4% [95% CI: -1.1; 12.0]
Der er rapporteret kliniske tilfælde, hvor der var en tilsvarende stigning i docetaxels toksicitet, når det blev kombineret med ritonavir.
Clinical cases consistent with an increase in docetaxel toxicity were reported when it was combined with ritonavir.
Perifer sensorisk neuropati fortsatte under opfølgning hos 10 patienter ud af 84 patienter med perifersensorisk neuropati ved slutningen af kemoterapien i det lymfeknude-positive brystkræftstudie (TAX316).
Peripheral sensory neuropathy was observed to be ongoing during follow-up in 10 patients out of the 84 patients with peripheral sensory neuropathy at the end of the chemotherapy in the node positive breast cancer study (TAX316).
Interstitiel lungesygdom (betændelse i lungerne, der forårsager hoste og vejrtrækningsbesvær.
• interstitial lung disease (inflammation of the lungs causing coughing and difficulty breathing.
Efter administration af docetaxel 100 mg/m givet som infusion over 1 time fandtes den gennemsnitlige maksimale plasmakoncentration at være 3,7 mg/ml med et AUC på 4,6 h.μg/ml.
Following the administration of a 100 mg/m2 dose given as a one hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Hovedpine (G3/4: < 1 %); Perifer neuropati
Headache (G3/4: <1%); Neuropathy peripheral
Alvorligheden af bivirkningerne ved Docetaxel Teva Pharma kan forøges, når Docetaxel Teva Pharma gives i kombination med andre kemoterapeutiske lægemidler.
The severity of adverse events of Docetaxel Teva Pharma may be increased when Docetaxel Teva Pharma is given in combination with other chemotherapeutic agents.
Mænd, som er i behandling med docetaxel, tilrådes derfor ikke at blive fædre til børn under og op til 6 måneder efter behandling, samt til at søge vejledning vedrørende opbevaring af sæd inden behandling.
Therefore, men being treated with docetaxel are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment.
På grund af risiko for skadelige påvirkninger af barnet, skal amning derfor ophøre under behandling med docetaxel.
Consequently, because of the potential for adverse reactions in nursing infants, breast feeding must be discontinued for the duration of docetaxel therapy.
For patienter, behandlet med docetaxel, doxorubicin og cyclofosfamid (TAC), kræver risikoen for forsinket myelodysplasi eller myolid leukæmi hæmatologisk opfølgning.
In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Neutropenisk infektion (grad 3
Neutropenic infection Neutropenic infection (Grade 3-4)
Hævelse forårsaget af mangelfuld drænage af lymfe
• swelling caused by faulty lymphatic drainage
Docetaxel Teva Pharma i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatakræft.
Docetaxel Teva Pharma in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
174 og 251 hoved- og halskræftpatienter, som blev behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
• 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).
Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
Ask your pharmacist how to throw away medicines no longer used.
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 docetaxelenkeltbehandling.
There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Der er begrænsede tilgængelige data vedrørende anvendelse af docetaxel i kombination med doxorubicin og cyclofosfamid til patienter over 70 år.
There are limited data available in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
Der var mindre brug af smertestillende morfika (p < 0,01), smertestillende ikke-morfika (p < 0,01), anden sygdomsrelateret medicin (p = 0,06) og strålebehandling (p < 0,01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/m end hos patienterne, der fik bedste palliative behandling.
There was less use of morphinic analgesic (p<0.01), non-morphinic analgesics (p<0.01), other disease related medications (p=0.06) and radiotherapy (p<0.01) in patients treated with docetaxel at 75 mg/m² compared to those with BSC.
Følelsesløshed eller stikkende og prikkende fornemmelse eller smerter i led eller muskler
• feeling of numbness or pins and needles or pain in the joints or muscles
4.1 Fremstilling af Docetaxel Teva Pharma præmixopløsning (10 mg docetaxel/ml)
Preparation of the Docetaxel Teva Pharma premix solution (10 mg docetaxel/ml)
Medicinen hedder Docetaxel Teva Pharma.
The name of this medicine is Docetaxel Teva Pharma.