natgillin/translations-raw huggingface dataset:
Første episode: Reducer docetaxel- og 5-FU-dosis med 20%.
First episode: reduce docetaxel and 5-FU doses by 20%.
Alopeci; Erythem; Udslæt; Neglesygdomme
Dyspnoea; Cough; Rhinorrhoea
Patienter i docetaxel-armen fik 75 mg/m² docetaxel (T) efterfulgt af 75 mg/m² cisplatin (P) efterfulgt af 750 mg/m² 5-fluoruracil (F) dagligt som kontinuerlig infusion i 5 dage.
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.
Patienter i komparatorarmen fik 100 mg/m² cisplatin (P) efterfulgt af 1.000 mg/m² 5-fluoruracil (F) dagligt 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.
G3/4 Forhøjet bilirubin i blodet (< 5%);
G3/4 Blood bilirubin increased (< 5%);
Thrombocytopeni (G4: 1,7%)
Thrombocytopenia (G4: 1.7%)
Hypersensitivitet (G3/4: 1,2%)
Hypersensitivity (G3/4: 1.2%)
Effektendepunkterne for docetaxel-armen i forhold til kontrolarmen er opsummeret i nedenstående tabel:
The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm. Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
G3/4 Forhøjet bilirubin i blodet (< 2,5%);
G3/4 Blood bilirubin increased (< 2.5%);
MedDRA systemorganklasse Meget almindelige
MedDRA system organ classes Very common adverse
Konstipation (alvorlig: Mavesmerter (alvorlig: Gastrointestinal hæmorrhage (alvorlig:
Asthenia (severe: Fluid retention (severe:
For eksempel skal der til en beregnet dosis på 140 mg docetaxel udtages 7 ml docetaxel koncentration til infusionsvæske, opløsning.
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
På basis af farmakokinetiske data med docetaxel givet som enkeltstof ved en dosis på 100 mg/m², er den anbefalede dosis docetaxel 75 mg/m² til patienter, som både har forhøjelse af transaminase (ALAT og/eller ASAT) på mere end 1,5 gange den øvre normalværdi (ULN) og af basisk phosphatase på mere end 2,5 gange den øvre normalværdi (se pkt.
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).
Patienter med en udgangsværdi for neutrofile granulocytter på < 1.500 celler/mm3.
Patients with baseline neutrophil count of < 1,500 cells/mm
Asteni; Perifert ødem; Pyrexi; Træthed; Inflammation i slimhinderne; Smerter;
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Æske indeholdende 1 eller 5 hætteglas.
Box of 1 vial, or 5 vials.
Synkope (G3/4: 0%); Neurotoksicitet (G3/4: Døsighed (G3/4: 0%)
Syncope (G3/4: 0%) Neurotoxicity (G3/4: Somnolence (G3/4:
Beskrivelse af udvalgte bivirkninger ved adjuverende behandling med docetaxel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv brystcancer (TAX 316) og lymfeknude-negativ brystcancer (GEICAM 9805)
Description of selected adverse reactions for adjuvant therapy with Docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer
• hudreaktioner på injektionsstedet, betændelse eller hævelse af venen (flebitis)
• at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
• Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) MedDRA systemorganklasse
• Induction chemotherapy followed by radiotherapy (TAX 323)
Træthed/svaghed (G3/4: 5%); Perifert ødem (G3/4: 1%)
Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Den fortyndede opløsning skal bruges inden for 6 timer og anvendes under aseptiske forhold som en 1-times infusion ved temperaturer under 25°C og under normale lysforhold.
The infusion bag solution should be used within 6 hours below 25 °C and normal lighting conditions including the one hour infusion to the patient.
Klinisk virkning og sikkerhed Brystcancer
Clinical efficacy and safety
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver ml koncentrat indeholder 20 mg docetaxel (vandfri).
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate for solution for infusion contains 20 mg of docetaxel (anhydrous).
Hvis Docetaxel Mylan koncentrat eller infusionsvæske skulle komme i berøring med huden, skal man straks vaske sig grundigt med vand og sæbe.
If Docetaxel Mylan concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
• Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Til den indledende behandling af inoperabel, lokalt fremskreden pladecellekarcinom 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-fluoruracil 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.
Behandling med docetaxel bør gentages, når neutrocyttallet igen er ≥ 1.500 celler/mm
Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm
Hvis det ikke anvendes straks, er opbevaringstider ogforhold brugerens ansvar.
If not used immediately, inuse storage times and conditions are the responsibility of the user.
Thrombocytopeni (G3/4: 3%)
Thrombocytopenia (G3/4: 3%)
Perifer sensorisk neuropati (G3: 0,4%)
Peripheral sensory neuropathy (G3: 0.4%)
Den anbefalede dosis af doxetaxel til adjuverende behandling af operabel lymfeknude-positiv og lymfeknude-negativ brystcancer, er 75 mg/m² hver 3. uge i 6 perioder, administreret 1 time efter doxorubicin 50 mg/m² og cyclophosphamid 500 mg/m² (TAC-regimen) (se også: Dosisjustering under behandling).
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m² administered 1-hour after doxorubicin 50 mg/m² and cyclophosphamide 500 mg/m² every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Patienter i komparatorarmen fik 100 mg/m² cisplatin (P) indgivet som intravenøs infusion over 30 minutter til 3 timer på førstedagen, efterfulgt af kontinuerlig intravenøs infusion af 1.000 mg/m²/dag 5-fluoruracil (F) fra dag 1 til dag 5.
Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 5.
6 ml klart, Type 1 hætteglas af glas med en bromobutyl gummiprop og aluminiumsforsegling og en plastik-afrivningshætte, der indeholder 1 ml koncentrat til infusionsvæske, opløsning.
6 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flip-off cap containing 1 ml of concentrate for solution for infusion.
Vaskulære sygdomme Luftveje, thorax og mediastinum Mave-tarmkanalen
Vascular disorders Respiratory, thoracic and mediastinal disorders
• Induktions kemoterapi efterfulgt af kemo-stråleterapi (TAX 324) Til den indledende behandling af patienter med lokalt fremskreden pladecellekarcinom 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-fluoruracil 1.000 mg/m²/dag 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.
Mediantid til første forværring af WHO-funktionsstatus var signifikant længere i TPF-armen end i PF. Smerteintensitetsscoren forbedredes under behandlingen i begge grupper, hvilket indikerer god smertebehandling.
Pain intensity score improved during treatment in both groups indicating adequate pain management.
Arytmi (G3/4: 0,7%) Hjertesvigt
Arrhythmia (G3/4: 0.7%) Cardiac failure
Tabel over bivirkninger ved adjuverende behandling med docetaxel 75 mg/m² i kombination med doxorubicin og cyclophosphamid hos patienter med lymfeknude-positiv brystcancer (TAX 316) og lymfeknude-negativ brystcancer (GEICAM 9805) - pooled data.
Tabulated list of adverse reactions in breast cancer for adjuvant therapy with docetaxel 75 mg/m² in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data.
Myalgi (G3/4: 2%); Artralgi (G3/4: 1%)
Myalgia (G3/4: 2%); Arthralgia (G3/4: 1%)
Forhøjet lakrimation (G3/4: <0,1%)
Lacrimation increased (G3/4: <0.1%)
Alopeci (G3/4: 6%); Neglesygdomme (G3/4: 2%)
Alopecia (G3/4: 6%); Nail disorders (G3/4: 2%)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ml koncentrat indeholder 20 mg docetaxel (vandfri).
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of concentrate contains 20 mg docetaxel (anhydrous).
Ved dosisjustering af cisplatin og 5-fluoruracil henvises der til de tilsvarende produktresuméer.
For cisplatin and 5-fluorouracil dose modifications, see the corresponding summary of product characteristics.
Benigne, maligne og uspecificerede tumorer (inkl.
Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hver ml koncentrat til infusionsvæske, opløsning indeholder 20 mg docetaxel (vandfri).
Each ml of concentrate for solution for infusion contains 20 mg docetaxel (anhydrous).
• betændelse i tarm, tyndtarm, perforering af tarmene
• inflammation of the colon, small intestine; intestinal perforation
Ved den mediane followup-periode på 10 år og 5 måneder havde TAC-behandlede patienter 16,5 % lavere risiko for tilbagefald sammenlignet med de patienter, der blev behandlet med FAC (hazard ratio = 0,84; 95 % CI (0,65-1,08); p = 0,1646).
At the median follow up time of 10 years and 5 months, TAC treated patients had a 16,5% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.84, 95% CI (0.65-1.08), p=0.1646).
Perifer motorisk neuropati (G3/4: 2,5%)
Peripheral motor neuropathy (G3/4: 2.5%)
Artralgi (G3/4: 0,3%); Myalgi (G3/4: 0,3%)
Arthralgia (G3/4: 0.3%); Myalgia (G3/4: 0.3%)
Infektioner (G3/4: 5%)
Infections (G3/4: 5%)
Docetaxel Mylan i kombination med cisplatin er indiceret til behandling af patienter med inoperabel lokalt fremskreden eller metastatisk ikke-småcellet lungecancer hos patienter, der ikke tidligere har fået kemoterapi mod denne tilstand.
Docetaxel Mylan 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.
Thrombocytopeni; (G3/4: 0,6%);
Thrombocytopenia (G3/4: 0.6%);
Oplysninger om opbevaring af hætteglas efter åbning og fortyndet lægemiddel, se pkt.
For storage conditions after dilution of the diluted medicinal product, see section 6.3.
EU/1/11/748/006 - 5 hætteglas
EU/1/11/748/006 - 5 vials
Patienter i docetaxel-armen fik 75 mg/m² docetaxel (T) som intravenøs infusion på førstedagen efterfulgt af 100 mg/m² cisplatin (P) indgivet som intravenøs infusion over 30 minutter til 3 timer, efterfulgt af kontinuerlig intravenøs infusion af 1.000 mg/m²/dag 5-fluoruracil (F) fra dag 1 til dag 4.
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/m²/day from day 1 to day 4.
1 hætteglas på 10 ml koncentrat indeholder 200 mg docetaxel.
One vial of 10 ml of concentrate contains 200 mg of docetaxel.
Du skal fortsætte med at tage præmedicinen i endnu 1 til 2 dage for at formindske visse bivirkninger såsom allergiske reaktioner og væskeansamlinger (hævede hænder, fødder, ben eller vægtøgning).
You will be asked to take premedication consisting of an oral corticosteroid such as dexamethasone, one day prior to Docetaxel Mylan administration and to continue for one or two days after it in order to minimise certain undesirable effects which may occur after the infusion of Docetaxel Mylan in particular allergic reactions and fluid retention (swelling of the hands, feet, legs or weight gain).
Fremstilling af infusionsvæsken
Preparation of the infusion solution
10 ml klart, Type 1 hætteglas af glas med en bromobutyl gummiprop og aluminiumsforsegling og en plastik-afrivningshætte, der indeholder 4 ml koncentrat til infusionsvæske, opløsning.
10 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flipoff cap containing 4 ml of concentrate for solution for infusion.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 10 ml
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 10 ml
Mave-tarmkanalen Stomatitis (G3/4: 5,3%); Diarre (G3/4: 4%);
Stomatitis (G3/4: 5.3%); Diarrhoea (G3/4: 4%);
Myalgi; Artralgi; Smerter i ekstremiteterne; Knoglesmerter; Rygsmerter
Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain
BATCHNUMMER
Number
15 ml klart, Type 1 hætteglas af glas med en bromobutyl gummiprop og aluminiumsforsegling og en plastik-afrivningshætte, der indeholder 10 ml koncentrat til infusionsvæske, opløsning.
15 ml clear glass Type I vial with a bromobutyl rubber stopper and aluminium seal and a plastic flipoff cap containing 10 ml of concentrate for solution for infusion.
• Hos patienter, der for anden gang udvikler grad 2-toksicitet eller første gang grad 3-toksicitet, skal behandlingen udsættes, indtil grad 0-1 nås.
• For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, and then resume treatment with docetaxel 55 mg/m².
Docetaxel Mylan i kombination med capecitabin er indiceret til behandling af patienter med lokal fremskreden eller metastatisk brystcancer efter svigt af cytotoksisk kemoterapi.
Docetaxel Mylan in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Median progressionsfri overlevelse (måneder) (95% CI)
Median progression free survival (months) (95% CI)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/748/001 - 1 hætteglas
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/001 - 1 vial
Docetaxel Mylan 200 mg/10 ml indeholder:
What Docetaxel Mylan 200 mg/10 ml contains
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Koncentrat til infusionsvæske, opløsning 1 hætteglas á 1 ml
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 1 ml
- Til behandling af hoved- og halskræft indgives docetaxel i kombination med cisplatin og 5fluoruracil.
- For the treatment of head and neck cancer, docetaxel is administered in combination with cisplatin and 5-fluorouracil.
Hypersensitivitet (G3/4: 0,6%)
Hypersensitivity (G3/4:0.6%)
EU/1/11/748/004 - 5 hætteglas
EU/1/11/748/004 - 5 vials
Docetaxel Mylan i kombination med trastuzumab er indiceret til behandling af patienter med metastatisk brystcancer, hvis tumorer overudtrykker HER2, og som ikke tidligere har fået kemoterapi mod metastatisk sygdom.
Docetaxel Mylan in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/748/003 - 1 hætteglas
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/003 - 1 vial
Tredje episode: Reducer docetaxel-dosis med 20%.
Third episode: reduce docetaxel dose by 20%.
EU/1/11/748/002 - 5 hætteglas
EU/1/11/748/002 - 5 vials
Et hætteglas indeholder 200 mg docetaxel.
One vial contains 200 mg of docetaxel.
1.060 patienter blev randomiseret til at få enten docetaxel 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.
1060 patients were randomized 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
Medmindre det er kontraindiceret, kan der til brystcancer, ikke-småcellet lungecancer, gastrisk samt hoved-halscancer gives et oralt kortikosteroid som præmedicinering, eksempelvis dexamethason 16 mg per dag (f.eks. 8 mg 2 gange dagligt).
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. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can be used (see section 4.4).
Svimmelhed (G3/4: 2,0%);
Dizziness (G3/4: 2.0%);
Der er rapporteret om knoglemarvsdepression og andre hæmatologiske bivirkninger.
Bone marrow suppression and other haematologic adverse reactions have been reported.
Hos patienter, der behandles med docetaxel som enkeltstof i dosis på 100 mg/m², som har en serumtransaminase-værdi (ALAT og/eller ASAT) på mere end 1,5 gange den øvre normalværdi samtidig med, at de serum-basiske phosphatase-værdier overstiger den øvre normalværdi 2,5 gange, er der en større risiko for udvikling af alvorlige bivirkninger.
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.
Neoplasmer benign og malign (inkl.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/748/005 - 1 hætteglas
MARKETING AUTHORISATION NUMBER(S) EU/1/11/748/005 - 1 vial
• stakåndethed
• indigestion
Beskrivelse af udvalgte bivirkninger ved behandling af brystkræft med Docetaxel 100 mg/m² i kombination med trastuzumab
Description of selected adverse reactions in breast cancer for Docetaxel 100 mg/m² in combination with trastuzumab
• Bland infusionsvæsken i infusionsposen eller -flasken ved at vippe posen.
• Mix the infusion bag or bottle manually using a rocking motion.
Docetaxel Mylan 20 mg/1 ml indeholder:
What Docetaxel Mylan 20 mg/1 ml contains
Docetaxel indgivet i kombination med trastuzumab blev undersøgt til behandling af patienter med metastatisk brystcancer og tumorer med overekspression af HER2, og som ikke tidligere havde været i kemoterapi for en metastatisk sygdom.
Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Patienter bør modtage kemo-stråleterapi efter kemoterapi.
Following chemotherapy, patients should receive chemoradiotherapy.
Bedste total respons på kemoterapi (%) (95% CI) ***p-værdi
Best overall response to chemotherapy (%) (95% CI) ***p-value
Sådan skal du bruge Docetaxel Mylan 200 mg/10 ml
How to use Docetaxel Mylan 200 mg/10 ml
Det skal du vide, før du begynder at bruge Docetaxel Mylan 200 mg/10 ml
What you need to know before you use Docetaxel Mylan 200 mg/10 ml
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Mylan 200 mg/10 ml sterilt koncentrat docetaxel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 200 mg/10 ml sterile concentrate docetaxel
Docetaxel Mylan 80 mg/4 ml indeholder:
What Docetaxel Mylan 80 mg/4 ml contains
I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m² til 75 mg/m² og/eller fra 75 mg/m² til 60 mg/m²: Hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofiltal < 500 celler/mm3 i mere end en uge, alvorlige eller kumulative kutane reaktioner eller alvorlig perifer neuropati.
Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm In patients who experienced either febrile neutropenia, neutrophil count < 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
Det skal du vide, før du begynder at bruge Docetaxel Mylan 200 mg/10 ml Sådan skal du bruge Docetaxel Mylan 200 mg/10 ml Bivirkninger
What Docetaxel Mylan 200 mg/10 ml is and what it is used for What you need to know before you use Docetaxel Mylan 200 mg/10 ml How to use Docetaxel Mylan 200 mg/10 ml Possible side effects
Perifer motorisk neuropati (G3/4: 0%)
Peripheral motor neuropathy (G3/4: 0%)
Bedste respons i alt til studie behandling [kemoterapi +/- strålebehandling] (%) (95% CI) ***p-værdi
Best overall response to study treatment [chemotherapy +/- radiotherapy] (%) (95% CI) ***p-value
Øsofagitis/dysfagi/odynofagi (G3/4: 0,7%).
Esophagitis/dysphagia/ odynophagia (G3/4:
Immunsystemet Metabolismer og ernæring Nervesystemet
Immune system disorders Metabolism and nutrition disorders Nervous system disorders
For de patienter med serum-bilirubin > øvre normalværdi og/eller ALAT og ASAT > 3,5 gange øvre normalværdi og basiske phosphataser > 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.
Det skal du vide, før du begynder at bruge Docetaxel Mylan 80 mg/4 ml
What you need to know before you use Docetaxel Mylan 80 mg/4 ml
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Docetaxel Mylan 80 mg/4 ml sterilt koncentrat docetaxel
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Mylan 80 mg/4 ml sterile concentrate docetaxel
Venøs sygdom
Hepatic impairment
Docetaxel Mylan er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikkesmåcellet lungecancer efter behandlingssvigt af tidligere kemoterapi.
Docetaxel Mylan is indicated for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of prior chemotherapy.
Vaskulære sygdomme Hedeture (G3/4: 0,5%) Hypotension (G3/4: 0%);
Vascular disorders Hot flush (G3/4: 0.5%) Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Median total overlevelse (måneder) (95% CI)
Median overall survival (months) (95% CI)
Anden episode: Reducer så docetaxel-dosis med 20%.
Second episode: then reduce docetaxel dose by 20%.
Hvert hætteglas med 4 ml koncentrat indeholder 1,58 g vandfri ethanol Alle hjælpestoffer er anført under pkt.
One vial of 4 ml of concentrate contains 1.58 g of ethanol anhydrous.