natgillin/translations-raw huggingface dataset:
Effekt af docetaxel i indledende behandling til patienter med inoperable, lokale fremskredne SCCHN (Hensigt at behandle-analyse):
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Hos et beskedent antal patienter (n = 23) med en klinisk kemi, der tydede på en let til moderat nedsat leverfunktion (ALAT og ASAT ≥ 1,5 gange øvre normalværdi og basisk fosfatase ≥ 2,5 gange øvre normalværdi), var clearance nedsat med gennemsnitlig 27 % (se pkt.
Hepatic impairment In a small number of patients (n=23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
Graviditet og amning og frugtbarhed
Pregnancy, breast-feeding and fertility
Docetaxel Teva i kombination med cisplatin og 5-fluoruracil er indiceret til behandling af patienter med metastatisk gastrisk adenocarcinom, inklusive adenocarcinom i den gastroøsofageale forbindelse, som ikke tidligere har modtaget kemoterapi mod metastatisk sygdom.
Docetaxel Teva 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.
I kombination med capecitabin anbefales det at reducere startdosis af capecitabin til 75 % hos patienter på 60 år eller ældre (Se 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).
445 patienter med KPS > 70 blev behandlet med enten docetaxel (T) (75 mg/m2 på dag 1) i kombination med cisplatin (C) (75 mg/m2 på dag 1) og 5-fluoruracil (F) (750 mg/m2 pr. dag i 5 dage) eller cisplatin (100 mg/m2 på dag 1) og 5-fluoruracil (1.000 mg/m2 pr. dag i 5 dage).
A total of 445 patients with KPS>70 were treated with either docetaxel (T) (75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1,000 mg/m2 per day for 5 days).
• Hvert hætteglas med solvens indeholder 1,28 ml vand til injektionsvæsker (påfyldningsvolumen: 1,71 ml).
• Each solvent vial contains 1.28 ml of water for injections (fill volume: 1.71 ml).
• et hætteglas (2,88 ml) med koncentrat (80 mg docetaxel),
• one vial (2.88 ml) of concentrate (80 mg of docetaxel),
4.2.2 Injicer derefter den beregnede mængde præmix i en 250 ml ikke-PVC-infusionspose ellerflaske med enten 5 % glucoseinfusionsvæske eller natriumchloridinfusionsvæske 9 mg/ml (0,9 %).
4.2.2 Inject the required premix volume into a 250 ml non-PVC infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
I henhold til den beregnede dosis udtrykt i mg udtages det tilsvarende volumen præmix indeholdende 10 mg/ml docetaxel aseptisk med en gradueret sprøjte.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
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).
Gennemsnitlig tid til progression
Median duration of response
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 medicine, including medicines obtained without a prescription.
Hvert hætteglas med koncentrat indeholder 25,1 % (w/w) vandfri ethanol (181 mg af vandfri ethanol).
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (181 mg of anhydrous ethanol).
I dette kliniske studium randomiseredes 255 patienter til behandling med docetaxel (75 mg/m² som en 1-times intravenøs infusion hver 3. uge) og capecitabin (1.250 mg/m2 to gange daglig i 2 uger efterfulgt af en uges pause).
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1,250 mg/m2 twice daily for 2 weeks followed by 1-week rest period).
Som ved alle andre parenterale produkter, skal både Docetaxel Teva-præmix og -infusionsvæske kontrolleres for uklarheder, og opløsninger med udfældning skal i givet fald kasseres.
As with all parenteral products, Docetaxel Teva premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
N=224
CF n=224
Hyppigheden af grad 4 neutropeni, febril neutropeni og neutropenisk infektion blev reduceret hos patienter, der fik primær GCSF-profylakse (se pkt.
The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
• et hætteglas a 0,72 ml koncentrat (20 mg docetaxel),
• one vial of 0.72 ml concentrate (20 mg of docetaxel),
Ved afslutningen af opfølgningsperioden (median opfølgningstid på 10 år og 5 måneder) blev det observeret, at amenorré fortsatte hos 7 patienter (1,3 %) i TAC-armen og hos 4 patienter (0,8 %) i FAC-armen.
in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
Total overlevelse ved 10 år var også signifikant forøget med TAC i forhold til FAC (henholdsvis 76 % versus 69 %).
Overall survival at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p=0.002).
Asteni; perifert ødem; pyrexi; træthed; inflammation i slimhinderne; smerter; influenzalignende symptomer; brystsmerter; kulderystelser
Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Co-administrationen af docetaxel, doxorubicin og cyclofosfamid påvirkede ikke deres farmakokinetik.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their co-administration.
Luftveje, thorax og mediastinum Akut respiratorisk åndedrætsbesvær og tilfælde af interstitial pneumoni/ pneumonitis, interstitiel lungesygdom, pulmonar fibrose og respirationssvigt, sommetider letale, er rapporteret sjældent.
Acute respiratory distress syndrome and cases of interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure sometimes fatal have rarely been reported.
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 anemia (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%).
1.060 patienter blev randomiseret til at få enten Docetaxel Teva 75 mg/m2 administreret 1 time efter doxorubicin 50 mg/m2 og cyclophosphamid 500 mg/m2 (539 patienter i TAC-armen) eller doxorubicin 50 mg/m2 efterfulgt af fluoruracil 500 mg/m2 og cyclophosphamid 500 mg/m2 (521 patienter i FAC-armen) som adjuverende behandling.
1,060 patients were randomised to receive either Docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in
• For capecitabin dosisjusteringer, se capecitabins produktresumé.
• For capecitabine dose modifications, see capecitabine summary of product characteristics.
Docetaxel i kombination med doxorubicin og cyclofosfamid: Adjuverende behandling
Docetaxel in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Sådan skal du tage Docetaxel Teva
How to store Docetaxel Teva
Almene symptomer og reaktioner på administrationsstedet Reaktionerne ved infusionsstedet var almindeligvis milde og bestod af hyperpigmentering, inflammation, rødmen eller tørhed, flebitis eller blodudtrækninger og hævelse af venen.
Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein.
• trykken for brystet, besvær med at trække vejret,
• chest tightness; difficulty in breathing
Hvert hætteglas med koncentrat indeholder vandfri ethanol 25,1 % (w/w) vandfri ethanol (723 mg af vandfri ethanol).
Each vial of concentrate contains 25.1% (w/w) anhydrous ethanol (723 mg of anhydrous ethanol).
- Ved behandling af metastatisk gastrisk kræft indgives Docetaxel Teva i kombination med cisplatin og 5-fluoruracil.
- For the treatment of metastatic gastric cancer, Docetaxel Teva is administered in combination with cisplatin and 5-fluorouracil.
Et multicenter, åbent, randomiseret studie har evalueret sikkerhed og effekt af docetaxel til behandling af patienter med metastatisk gastrisk adenocarcinom, inklusive adenocarcinom af den gastroøsofageale forbindelse.
A multi-centre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal Docetaxel Teva-æsker stå i stuetemperatur (under 25 °C) i 5 minutter før brug.
If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.
2.1 Docetaxel Teva 20 mg/0,72 ml hætteglas:
2.1 Docetaxel Teva 20 mg/0.72 ml vial:
• Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse
Obligation to conduct post-authorisation measures Not applicable
Data fra et multicenter, åbent, randomiseret forsøg støtter anvendelsen af Docetacel Teva 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 Docetaxel for the adjuvant treatment of patients with operable node-negative breast cancer eligible to receive chemotherapy.
minutter til 3 timers infusion, efterfulgt af 5-fluoruracil 1000 mg/m pr. dag som en kontinuerlig infusion fra dag 1 til dag 4.
3 hour infusion, followed by 5-fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4.
4.1.1 Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal Docetaxel Teva-æsker stå i stuetemperatur (under 25 °C) i 5 minutter før brug.
4.1.1 If the vials are stored under refrigeration, allow the required number of Docetaxel Teva boxes to stand at room temperature (below 25°C) for 5 minutes.
Efter stratificering i henhold til antallet af positive lymfeknuder (1-3, 4+), blev 1.491 patienter randomiseret til enten at få enten docetaxel 75 mg/m2 administreret en time efter doxorubicin 50 mg/m2 og cyclofosfamid 500 mg/m2 (TAC arm), eller doxorubicin 50 mg/m2, fulgt af fluoruracil 500 mg/m2og cyclofosfamid 500 mg/m2 (FAC arm).
After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (FAC arm).
Docetaxel Teva (angivet i punkt 6)
Teva (listed in section 6).
PSA**-responsrate (%) 95 % CI p-værdi*
PSA** response rate (%) 95% CI p-value*
Alopeci (G3/4: 4,0 %).
Alopecia (G3/4: 4.0%).
I studiet TAX 316 blev alopeci, der fortsatte ind i opfølgningsperioden efter endt kemoterapi, rapporteret hos 687 ud af 744 TAC-patienter (92,3%) og hos 645 ud af 736 FAC-patienter (87,6%).
In study TAX316 alopecia persisting into the follow-up period after the end of chemotherapy was reported in 687 of 744 TAC patients (92.3%) and 645 of 736 FAC patients (87.6%).
docetaxel 75 mg/m som en 1-times infusion i kombination med carboplatin (AUC 6 mg/ml pr. min) administreret i løbet af 30-60 minutter hver 3. uge eller vinorelbin (V) 25 mg/ m2 administreret i løbet af 6 til 10 minutter på dag 1, 8, 15, 22 efterfulgt af cisplatin 100 mg/m2 administreret på dag 1 af cyklusser gentaget hver 4. uge (VCis).
min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
For cisplatin-dosisjustering se tilsvarende produktresumé.
For cisplatin dose adjustments, see the corresponding summary of product characteristics.
Solvens hætteglas: vand til injektionsvæsker
Solvent vial: Water for injections
4.2.4 Docetaxel Teva 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.
4.2.4 The Docetaxel Teva 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.
I studiet GEICAM9805 blev det observeret, at amenorré, som forekom i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden fortsat blev observeret hos 18 patienter (3,4%) i TAC-armen og hos 5 patienter (1,0%) i FAC-armen.
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4%) in TAC arm and 5 patients (1.0%)
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, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10% higher in patients who were
Ved den mediane followup-periode på 77 måneder var den totale overlevelse (OS) længere i TACarmen, hvor TAC-behandlede patienter havde 24 % lavere risiko for død sammenlignet med FACbehandlede patienter (hazard ratio = 0,76; 95 % CI (0,46-1,26; p=0,29).
At the median follow-up time of 77 months, overall survival (OS) was longer in the TAC arm with TAC-treated patients having a 24% reduction in the risk of death compared to FAC (hazard ratio = 0.76, 95% CI (0.46-1.26, p = 0.29).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - 80 mg/2,88 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 80 mg/2.88 ml
Dosisjustering under behandling Generelt
Dose adjustments during treatment
I kombinationsbehandling med cisplatin og 5-fluoruracil til behandling af patienter med gastrisk adenocarcinom ekskluderede det kliniske pivotalstudie patienter med ALAT og/eller ASAT > 1,5 gange øvre normalværdi associeret med alkalisk fosfatase > 2,5 gange øvre normalværdi, og bilirubin > 1 gange øvre normalværdi.
In combination with cisplatin and 5-fluorouracil for the treatment of patients with gastric adenocarcinoma, the pivotal clinical study 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.
Docetaxel Teva-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 Docetaxel Teva 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.
Dette lægemiddel indeholder 25,1 % vol. ethanol, vandfri (alkohol) dvs. op til 723 mg ethanol, vandfri pr. hætteglas, svarende til 18,3 ml øl eller 7,6 ml vin.
This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 723 mg ethanol, anhydrous per concentrate vial, equivalent to 18.3 ml beer or 7.6 ml wine.
1.218 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/m2 administreret som 1-times infusion umiddelbart efterfulgt af cisplatin (Cis) 75 mg/m2 administreret i løbet af 30-60 minutter hver 3. uge (TCis),
In a phase III study, 1,218 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/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.
- Aktivt stof: Docetaxel.
What Docetaxel Teva concentrate vial contains: - The active substance is docetaxel.
4.1.2 Med en sprøjte med påsat kanyle udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til Docetaxel Teva ved at holde hætteglasset på skrå.
4.1.2 Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
Anæmi (G3/4: 9,4 %); Febril neutropeni; Trombocytopeni (G4: 0,8 %)
Anaemia (G3/4: 9.4%); Febrile neutropenia; Thrombocytopenia (G4: 0.8%)
Konstipation (G3/4: 1,0 %); Gastrointestinale smerter (G3/4:
Constipation (G3/4: 1.0 %); Gastrointestinal pain (G3/4:
2.1 Docetaxel Teva 80 mg/2,88 ml hætteglas:
2.1 Docetaxel Teva 80 mg/2.88 ml vial:
Dette lægemiddel indeholder 25,1 % vol. ethanol, vandfri (alkohol) dvs. op til 181 mg ethanol, vandfri pr. hætteglas, svarende til 4,6 ml øl eller 1,9 ml vin.
This medicinal product contains 25.1 % (w/w) ethanol, anhydrous (alcohol), i.e. up to 181 mg ethanol, anhydrous per concentrate vial, equivalent to 4.6 ml beer or 1.9 ml wine.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE - 20 mg/0,72 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON - 20 mg/0.72 ml
Dysgeusi/parosmi (G3/4: 0,4 %);
Dysgeusia/Parosmia (G3/4: 0.4%);
Hver karton indeholder et Docetaxel Teva hætteglas (80 mg/2,88 ml) og et tilsvarende hætteglas med solvens til Docetaxel Teva.
Each box contains one Docetaxel Teva vial (80 mg/2.88 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
I sammenligningsarmen af studiet fik patienterne cisplatin (P) 100 mg/m2 efterfulgt af 5-fluoruracil (F) 1000 mg/m2 daglig i 5 dage.
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F) 1000 mg/m2 per day for 5 days.
Tabel over bivirkninger ved behandling af prostatakræft med Docetaxel 75 mg/m² i kombination med prednison eller prednisolon
Tabulated list of adverse reactions in prostate cancer for Docetaxel 75 mg/m² in combination with prednisone or prednisolone
Dette volumen er blevet fastlagt under udviklingen af docetaxel for at kompensere for væsketab ved fremstillingen af præmixen(se pkt.
This volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix (see section 4) due to foaming, adhesion to the walls of the vial and "dead-volume".
Hyppigheden af bivirkninger listet nedenfor er fastlagt under anvendelse af de følgende betegnelser:
Frequencies are defined as:
Dette volumen er blevet fastlagt under udviklingen af docetaxel for at kompensere for væsketab ved fremstillingen af præmixen (se pkt.
This fill volume has been established during the development of docetaxel to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Perifer motorisk neuropati (G3/4:
Peripheral motor neuropathy (G3/4:
Hver karton indeholder et Docetaxel Teva hætteglas (20 mg/0,72 ml) og et tilsvarende hætteglas med solvens til Docetaxel Teva.
Each box contains one Docetaxel Teva vial (20 mg/0.72 ml) and one corresponding solvent for Docetaxel Teva vial in a carton.
Den samtidige administration af docetaxel, doxorubicin og cyclofosfamid påvirkede ikke deres farmakokinetik.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Træthed (G3/4: 3,9 %); Væskeretention (alvorlig 0,6 %)
Fatigue (G3/4: 3.9%); Fluid retention (severe: 0.6%)
Smerte-responsrate (%) 95 % CI p-værdi*
Number of patients Pain response rate (%) 95% CI p-value*
Anæmi (G3/4: 3 %); Neutropeni (G3/4:
Anaemia (G3/4: 3%); Neutropenia (G3/4:
For modifikationer af doser af cisplatin og 5-fluoruracil: Se tilsvarende produktresumé.
For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Neutropeni (G3/4:
Neutropenia (G3/4:
Patienter i docetaxel-armen modtog docetaxel (T) 75 mg/m2 efterfulgt af cisplatin (P) 75 mg/m2 efterfulgt af 5-fluoruracil (F) 750 mg/m2
Patients on the docetaxel arm received docetaxel (T) 75 mg/m2 followed by cisplatin (P) 75 mg/m2 followed by 5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days.
Docetaxel Teva 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 Teva 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.
Immunsystemet Der er rapporter om anafylaktisk shock, i nogle tilfælde fatale.
Some cases of anaphylactic shock, sometimes fatal, have been reported.
Myelodysplastisk syndrom blev ikke diagnosticeret i nogen af behandlingsgrupperne.
in TAC arm. No cases were reported in patients in FAC arm. No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
- Til behandling af hoved- og halskræft indgives Docetaxel Teva i kombination med cisplatin og 5-fluoruracil.
- For the treatment of head and neck cancer, Docetaxel Teva is administered in combination with cisplatin and 5-fluorouracil.
Ved afslutningen af opfølgningsperioden (faktisk median opfølgningstid på 8 år) fortsatte perifert ødem hos 19 TAC patienter (2,6 %) og hos 4 FAC patienter (0,5 %).
At the end of the follow-up period (actual median follow-up time of 8 years), peripheral oedema was ongoing in 19 TAC patients (2.6%) and 4 FAC patients (0.5%).
Hætteglas med solvens 15 ml klart Type I-hætteglas med brombutyl-gummiprop og en afrivningshætte.
Solvent vial 15 ml clear glass Type I vial with a bromobutyl rubber stopper and a flip-off cap.
Med en sprøjte udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til Docetaxel Teva ved at holde hætteglasset på skrå.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Teva vial by partially inverting the vial.
Dette regime blev administreret hver 3.
This regimen is administered every