FrancophonIA/ELRC3.0 huggingface dataset:
English: Naxcel has been investigated in pigs with respiratory diseases caused by various bacteria or in pigs suffering from severe lameness, fever or other clinical signs of septicaemia, polyarthritis (inflammation of the joints) or polyserositis (inflammation of the internal body membranes) associated with Streptococcus suis infection.
Danish: Naxcel er blevet undersøgt hos svin med luftvejssygdomme forårsaget af forskellige bakteriearter eller hos svin, der led af svær halten, feber eller andre kliniske tegn på septikæmi (blodforgiftning), polyarthritis (betændelse i led) eller polyserositis (betændelse på de serøse flader) i forbindelse med Streptococcus suis-infektioner.
English: In these trials, Naxcel was either used on its own or compared with another authorised antibiotic (amoxicillin) or with placebo (a dummy treatment without any active substance).
Danish: I disse undersøgelser blev Naxcel enten anvendt som monoterapi eller sammenlignet med et andet godkendt antibiotikum (amoxicillin) eller placebo (en uvirksom behandling, der ikke indeholder et aktivt stof).
English: What is Naxcel used for?
Danish: Hvad anvendes Naxcel til?
English: In cattle, Naxcel is used to treat foot rot (an infection of the feet) and acute puerperal metritis (an infection of the womb occurring after calving) in cases where treatment with another antimicrobial has failed.
Danish: Hos kvæg anvendes Naxcel til behandling af klovbyld (en klovinfektion) og af akut puerperal metritis (en infektion i maven, som indtræffer efter kælvning) i tilfælde, hvor behandling med et andet antimikrobielt stof har været uden resultat
English: How has Naxcel been studied?
Danish: Hvordan blev Naxcel undersøgt?
English: How does Naxcel work?
Danish: Hvordan virker Naxcel?
English: What benefit has Naxcel shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Naxcel?
English: • hair loss: in most cases normal hair growth should return.
Danish: • Hårtab: Ide fleste tilfælde vil normal hårvækst vende tilbage.
English: A final analysis was performed with an actual median follow-up of 96 months.
Danish: Der blev udført en endelig analyse med en aktuel median opfølgning på 96 måneder.
English: This is because Docetaxel Zentiva or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Danish: Dette er fordi Docetaxel Zentiva eller den anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.
English: DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
Danish: DFS data var ikke statistisk signifikant men blev alligevel forbundet med en positiv tendens til fordel for TAC.
English: Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Zentiva.
Danish: Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene helbredstilstand og din reaktion på Docetaxel Zentiva.
English: Harmful for those suffering from alcoholism.
Danish: Kan være skadelig for alkoholikere.
English: 1Full analysis set (intent-to-treat)
Danish: Fuldt analysesæt (intent to treat)
English: 2 Estimated median survival
Danish: Estimeret median overlevelse.
English: Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnofsky performance status.
Danish: Sekundære endepunkter inkluderede forandring i smerter, global rating af livskvalitet med EuroQoL5D, lungekræft-symptom skala, og forandringer i karnosfkys performance status.
English: Before each treatment with Docetaxel Zentiva, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Zentiva.
Danish: Før hver behandling med Docetaxel Zentiva, vil du få taget blodprøver for at få kontrolleret, om du har nok blodceller og den nødvendige leverfunktion til at få Docetaxel Zentiva.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: The safety and efficacy of Docetaxel Zentiva in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Danish: Docetaxel Zentivas sikkerhed og virkning ved nasofaryngealt karcinom hos børn i alderen 1 måned til under 18 år er endnu ikke klarlagt.
English: Docetaxel Zentiva will be administered to you by a healthcare professional.
Danish: Docetaxel Zentiva vil blive administreret af personale med en sundhedsfaglig uddannelse.
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in the older people.
Danish: Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre personer.
English: Progressive disease as best overall response (%) *Unstratified log rank test
Danish: Progressiv sygdom som bedste overlevelse respons (%) *Ustratificerede logrank test
English: It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Zentiva infusion solution.
Danish: Det er vigtigt at læse hele denne vejledning inden fremstilling af Docetaxel Zentiva infusionsvæske.
English: Second primary malignancies (including acute myeloid leukaemia, myelodysplastic syndrome and non-Hodgkin lymphoma) may occur several months or years after docetaxel-containing therapy.
Danish: Anden primær malignitet (herunder akut myeloid leukæmi, myelodysplastisk syndrom og non-Hodgkin lymfom) kan forekomme flere måneder eller år efter behandling med docetaxel.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy , because Docetaxel Zentiva may be harmful for the unborn baby.
Danish: Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge effektiv prævention under behandlingen, fordi Docetaxel Zentiva kan skade det ufødte barn.
English: 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).
Danish: Almene symptomer og reaktioner på administrationsstedet Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/m og median-tiden til reversibilitet af væskeretention var 16,4 uger (range 0 til 42 uger).
English: The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up time point, and 91.3 % in the TAC arm and 89 % in the FAC arm, at the 10-year follow-up time point.
Danish: Overlevelsesprocenten var 93,7 % i TAC-armen og 91,4 % i FAC-armen ved tidspunktet for 8-årsopfølgning, og 91,3 % i TAC-armen og 89 % i FAC-armen ved tidspunktet for 10årsopfølgning.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA Not applicable.
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: You must not breast-feed while you are treated with Docetaxel Zentiva.
Danish: Du må ikke amme, mens du behandles med Docetaxel Zentiva.
English: A total of 1776 male patients were allocated to the treatment armss of interest:
Danish: I alt blev 1776 mandlige patienter tildelt behandlingsarmen af interesse:
English: You may also have flu-like symptoms at the same time, such as fever, chills or aching muscles.)
Danish: Du kan også have influenzalignende symptomer på samme tid, såsom feber, kulderystelser eller ømme muskler.)
English: Older people patients treated with TCF should be closely monitored.
Danish: Ældre patienter, som behandles med TCF, bør monitores nøje.
English: Docetaxel Zentiva contains alcohol.
Danish: Docetaxel Zentiva indeholder alkohol.
English: The incidence of serious adverse events was higher in the older people patients compared to younger patients.
Danish: Forekomsten af alvorlige bivirkninger var højere i gruppen med de ældre patienter i forhold til gruppen med de yngre patienter.
English: What Docetaxel Zentiva contains - The active substance is docetaxel (as trihydrate).
Danish: Docetaxel Zentiva indeholder - Aktivt stof: docetaxel (som trihydrat).
English: See also section “Docetaxel Zentiva contains ethanol (alcohol)” below.
Danish: Se også punktet ”Docetaxel Zentiva indeholder ethanol (alkohol)” nedenfor.
English: More patients aged ≥65 years in the docetaxel arm reported hypersensitivity reaction, neutropenia, anemia, fluid retention, dyspnea, and nail changes when compared to the patients aged less than 65 years.
Danish: Flere patienter i alderen ≥ 65 år, i docetaxel-armen, rapportede overfølsomhedsreaktioner, neutropeni, anæmi, væskeretention, dyspnø, og negleforandringer, når sammenlignet med patienter i alderen yngre end 65 år.
English: Grade1 (includes grade not assessed)
Danish: Histologisk grad Grad 1 (inklusiv grader, der ikke er fastsat) Grad 2
English: If you are a man being treated with Docetaxel Zentiva 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.
Danish: Hvis du er mand og i behandling med Docetaxel Zentiva, rådes du til ikke at avle et barn under og 6 måneder efter behandling samt til at søge vejledning om opbevaring af sæd inden behandling, fordi docetaxel kan nedsætte den mandlige fertilitet.
English: Docetaxel Zentiva was administered as a 1-hour infusion, all other medicinal products were given intravenously on day 1 every three weeks.
Danish: Docetaxel Zentiva blev administreret som infusion over 1 time, alle andre lægemidler blev givet intravenøst på dag 1 hver 3. uge.
English: Date of latest renewal: 20 April 2012
Danish: Dato for første tilladelse: 20. april 2007 Dato for seneste fornyelse: 20. april 2012
English: The amount of alcohol in this medicinal product may alter the effects of other medicines.
Danish: Mængden af alkohol i dette lægemiddel kan påvirke effekten af andre lægemidler.
English: Acute myeloid leukaemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
Danish: Akut myeloid leukæmi og myelodysplastisk syndrom er blevet rapporteret (hyppighed ikke almindelig) i pivotale kliniske studier med brystkræft med TACregime.
English: If signs and symptoms suggestive of these reactions appear, discontinuation of docetaxel should be considered.
Danish: Hvis der synes tegn og symptomer, der tyder på disse reaktioner, bør seponering af docetaxel overvejes.
English: • if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
Danish: • hvis du er allergisk (overfølsom) overfor docetaxel eller nogle af de andre indholdsstoffer i Docetaxel Zentiva (angivet i punkt 6),
English: More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Danish: Flere grad 3/4 bivirkninger blev observeret for Docetaxel Zentiva monoterapi (55,4 %) sammenlignet med paclitaxel (23,0 %).
English: For combination with ADT and with prednisone or prednisolone (STAMPEDE study), adverse events occurring over the 6 cycles of treatment with docetaxel and having at least 2% higher incidence in the docetaxel treatment arm by comparison to the control arm, are presented, using the CTCAE grading scale.
Danish: I kombinationer med androgen deprivationsbehandling og med prednison eller prednisolon (STAMPEDE studie) præsenteres bivirkninger, der forekommer i de 6 cyklusser af behandlingen med docetaxel og med mindst 2 % højere forekomst i docetaxel-behandlingsarmen, til sammenligning med kontrolarmen, under anvendelse af CTCAE-klasseficeringskalaen.
English: • acute myeloid leukaemia and myelodysplastic syndrome (types of blood cancer) may occur in patients who are treated with docetaxel together with certain other anticancer treatments.
Danish: • Akut myeloid leukæmi og myelodysplastisk syndrom (typer af blodkræft) kan forekomme hos patienter, som behandles med docetaxel sammen med visse andre behandlinger mod kræft.
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance status 0 or 1, were randomised to one of two treatment arms.
Danish: I dette studie blev 358 patienter med inoperabelt, lokalt fremskreden SCCHN og WHO funktionsstatus 0 eller 1, randomiseret i en af to behandlingsarme.
English: Docetaxel Zentiva will be given by infusion into one of your veins (intravenous use).
Danish: Docetaxel Zentiva gives som infusion i en blodåre (intravenøs anvendelse).
English: Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC.
Danish: * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdoms-fri overlevelse, sammenlignet med FAC.
English: 256 patients were randomised to treatment with docetaxel alone (100 mg/m2 as a 1 hour intravenous infusion every 3 weeks).
Danish: 256 patienter blev randomiseret til behandling med docetaxel alene (100 mg/ m som 1 times intravøs infusion hver 3. uge).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om Docetaxel Zentiva findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: - AGEP symptoms may include a red, scaly widespread rash with bumps under the swollen skin (including your skin folds, trunk, and upper extremities) and blisters accompanied by fever.
Danish: - AGEP symptomer kan omfatte et rødt skællende udbredt udslæt med knopper under den hævede hud (herunder dine hudfolder, mave og øvre ekstremiteter) og blærer ledsaget af feber.
English: Tumour response rate (%) 95% CI p-value* †Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
Danish: Stratificeret log rank test *Tærskel for statististiskl signifikans =0,0175 **PSA: Prostata-Specific Antigen
English: G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
Danish: G-CSF blev anvendt som sekundær profylakse hos 19,3 % af patienterne
English: The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Danish: Posen med infusionsopløsningen skal bruges inden for 6 timer ved opbevaring under 25 °C inklusive den time, patienten får infusionen.
English: TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = oestrogen receptor PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Danish: TAC = docetaxel, doxorubicin og cyclophosphamid FAC = 5-fluoruracil, doxorubicin and cyclophosphamid CI = Konfidensinterval; ER = østrogenreceptor PR = progesteronreceptor a ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm
English: 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.
Danish: 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.g/ml.
English: The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to follow-up before).
Danish: Den endelige analyse blev udført, da alle patienter havde nået deres 10 års opfølgningsbesøg (medmindre de havde en DFS hændelse eller tidligere udgik afopfølgning).
English: The most commonly reported adverse reactions of Docetaxel Zentiva alone are: decrease in the number of red blood cells or white blood cells, alopecia, nausea, vomiting, sores in the mouth, diarrhoea and tiredness.
Danish: De mest almindelige bivirkninger af Docetaxel Zentiva givet alene er: Fald i antallet af røde og hvide blodlegemer, hårtab, kvalme, opkastning, sår i munden, diarré og træthed.
English: România S.C. ZENTIVA S.A.
Danish: S.C. ZENTIVA S.A.
English: Disease-free survival (DFS) was the primary efficacy endpoint and overall survival (OS) was the secondary efficacy endpoint.
Danish: Sygdoms-fri overlevelse (DFS) var det primære effektendepunkt og total overlevelse (OS) var det sekundære effektendepunkt.
English: Docetaxel Zentiva must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Danish: Docetaxel Zentiva må IKKE anvendes, hvis du er gravid eller planlægger at blive gravid, medmindre din læge udtrykkelig ønsker det.
English: Docetaxel Zentiva in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with:
Danish: Docetaxel Zentiva i kombination med doxorubicin og cyclophosphamid er indiceret til adjuverende behandling af patienter med:
English: Docetaxel Zentiva contains ethanol (alcohol)
Danish: Docetaxel Zentiva indeholder ethanol (alkohol)
English: 95% CI p-valuea* a Time to event variables: Stratified log-rank test.
Danish: a Tid til hændelsesvariabler: stratificeret log-rank test.
English: Do not use this medicine after the expiry date which is stated on outer carton and on the label of the vial after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In patients who were 75 years of age or older, when compared to younger patients, neutropenia, anemia, diarrhea, dyspnea and upper respiratory tract infection were reported with a greater incidence (at least 10% higher).
Danish: I patienter, som var 75 år eller ældre, blev der rapporteret en højere forekomst af neutropeni, anæmi, diarré, dyspnø, og infektioner i de øvre luftveje, sammenlignet med yngre patienter (mindst 10 % højere).
English: What you need to know before you use Docetaxel Zentiva
Danish: Det skal du vide, før du begynder at bruge Docetaxel Zentiva
English: Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m2 and 113 l, respectively.
Danish: Gennemsnitsværdierne for den totale clearence og steady-state distributionsvolumen var henholdsvis 21 l/h/m og 113 l. Den interindividuelle variation i totalclearance var ca 50 %.
English: In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
Danish: In vivo er docetaxels aktivitet uafhængig af behandlingsregimet og har eksperimentielt vist et bredt spektrum af antineoplastisk aktivitet over for murine og transplanterede humane tumorer.
English: The severity of adverse events of Docetaxel Zentiva may be increased when Docetaxel Zentiva is given in combination with other chemotherapeutic agents.
Danish: Alvorligheden af bivirkningerne ved Docetaxel Zentiva kan forøges, når Docetaxel Zentiva gives i kombination med andre kemoterapeutiske lægemidler.
English: The updated analysis was performed when all patients had reached their 10-year (median follow up time of 10 years and 5 months) follow-up visit (unless they had a DFS event or were lost to follow-up previously).
Danish: Den opdaterede analyse blev udført, da alle patienter havde nået deres 10-års (median opfølgningstid var 10 år og 5 måneder) opfølgningsbesøg (medmindre de havde DFS eller tidligere var udgået fraopfølgning).
English: When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Danish: Ved kombination med docetaxel,var carboplatins clearence ca. 50 % højere end de værdier, der tidligere er rapporteret for carboplatin-monoterapi.
English: All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Danish: Alt materiale, som har været brugt i forbindelse med fortynding og infusion, skal destrueres i overensstemmelse med lokale retningslinjer.
English: In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks, with trastuzumab administered weekly.
Danish: I kombination med trastuzumab er den anbefalede dosis af docetaxel 100 mg/m hver 3. uge med en ugentlig administration af trastuzumab.
English: PR = progesterone receptor a ER/PR-negative or Grade 3 or tumour size >5 cm
Danish: ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm
English: Menopausal status
Danish: Menopausal status Præ-menopausal Post-menopausal
English: The name of this medicine is Docetaxel Zentiva.
Danish: Medicinen hedder Docetaxel Zentiva.
English: Method and route of administration
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: If the vials are stored under refrigeration, allow the required number of boxes of Docetaxel Zentiva concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
Danish: Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal pakninger med Docetaxel Zentiva koncentrat til infusionsvæske, opløsning, stå ved stuetemperatur (under 25°C) i 5 minutter før brug.
English: Severe skin problems such as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Acute Generalized Exanthematous Pustulosis (AGEP) have been reported with Docetaxel Zentiva: - SJS/TEN symptoms may include blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash.
Danish: Alvorlige hudproblemer såsom, Stevens-Johnson syndrom (SJS), toksisk epidermal nekrolyse (TEN) og akut generaliseret eksantematøs pustulose (AGEP) er blevet rapporteret med Docetaxel Zentiva: - SJS/TEN symptomer kan omfatte blærer, afskrælning eller blødning på dele af huden (herunder dine læber, øjne, mund, næse, kønsorganer, hænder eller fødder) med eller uden udslæt.
English: Docetaxel Zentiva as single agent
Danish: Docetaxel Zentiva som enkeltstof
English: 3 years
Danish: 3. uge
English: Metastatic hormone-sensitive prostate cancer The recommended dose of docetaxel is 75 mg/m2 every 3 weeks for 6 cycles.
Danish: Metastatisk hormonfølsom prostatakræft Den anbefalede dosis af docetaxel er 75 mg/m hver 3. uge i 6 perioder.
English: In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Danish: I studiet GEICAM9805 udviklede 3 patienter (0,6 %) i TAC-armen og 3 patienter (0,6 %) i FACarmen kongestivt hjertesvigt i opfølgningsperioden.
English: Hazard ratio (95% CI) **p-value A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Log rank test *** Chi-square test
Danish: Med en hazard ratio < 1 kan docetaxel + cisplatin+5-FU anvendes med fordel *Cox model (tilpasning til primær tumor, T og N kliniske stadier og PSWHO) **Logrank test *** Chi-square-test
English: Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/or hearing loss have been reported.
Danish: Der er rapporter om sjældne tilfælde af ototoksicitet, nedsat hørelse og/eller tab af hørelse.
English: There is no relevant use of Docetaxel Zentiva in the paediatric population in the indications breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma.
Danish: Der er ingen relevant anvendelse af Docetaxel Zentiva i den pædiatriske population til indikationerne brystkræft, ikke-småcellet lungekræft, prostatakræft, gastrisk karcinom samt hoved- og halskræft med undtagelse af type II og III lavt differentieret nasofaryngealt karcinom..
English: In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m2.
Danish: tilfælde af grad 4-trombocytopeni bør dosis af docetaxel reduceres fra 75 mg/m til 60 mg/m
English: In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Danish: Som førstebehandling indgives 75 mg/m doxetaxel i kombinationsbehandling med doxorubicin (50 mg/m