natgillin/translations-raw huggingface dataset:
I alt 70 Gy blev anbefalet til accelererede regimer og 74 Gy for hyperfraktionerede systemer.
A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes.
• Hårtab (i de fleste tilfælde vil normal hårvækst vende tilbage).
• hair loss: in most cases normal hair growth should return.
En effektiv præventionsmetode skal anvendes under behandlingen.
An effective method of contraception should be used during treatment.
Infusionen tager ca. en time, mens du er på sygehuset.
The infusion will last approximately one hour during which you will be in the hospital.
Der er få rapporter om overdosering.
There were a few reports of overdose.
• Ændring eller udeblivelse af menstruationer
• change or absence of menstrual period
En primær analyse og en opdateret analyse blev udført.
One primary analysis and one updated analysis were performed.
Skadelig for patienter, der lider af alkoholisme.
Harmful for those suffering from alcoholism.
Alle patienter undtagen en patient i hver arm blev diagnosticeret med CHF mere end 30 dage efter behandlingsperioden.
All except one patient in each arm were diagnosed with CHF more than 30 days after the treatment period.
Der blev udført to interim-analyser og en endelig analyse.
Two interim analyses and one final analysis were performed.
Tilfældene var spontant reversible inden for 3 måneder.
The events were spontaneously reversible within 3 months.
Under behandlingen kan du få anden medicin til at opretholde antallet af blodcellerne.
During treatment, you may be given other medicines to maintain the number of your blood cells.
Statistisk analyse
Statistical analysis
• Tab af appetit (anoreksi)
• loss of appetite (anorexia)
Anbefalinger vedrørende sikker håndtering
Recommendations for the safe handling
I alt 1006 patienter med KPS ≥ 60 blev randomiseret i følgende behandlingsgrupper:
A total of 1006 patients with KPS ≥ 60 were randomised to the following treatment groups:
• Forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver)
• raised liver enzymes (hence the need for regular blood tests).
I begge arme var livskvaliteten målt via et EORTC-spørgeskema sammenlignelig og stabil under behandling og opfølgning.
In both arms, quality of life measured by the EORTC questionnaire was comparable and stable during treatment and follow-up.
Den første interim-analyse var planlagt til 3 år efter datoen, hvor halvdelen af tilmeldingerne til studiet var nået.
The first interim analysis was planned 3 years after the date when half of study enrolment was done.
Andre samtidige risikofaktorer kan muligvis have medvirket til udviklingen af disse virkninger.
In some cases concomitant factors may have contributed to the development of these effects.
Det perifere ødem starter sædvanligvis i underekstremiteterne og kan blive generaliseret med vægtstigning på 3 kg eller mere.
The peripheral oedema usually starts at the lower extremities and may become generalised with a weight gain of 3 kg or more.
Resumé af sikkerhedsprofilen for alle indikationer.
Summary of the safety profile for all indications
2Estimeret median overlevelse.
2 Estimated median survival
Der blev udført en endelig analyse med en aktuel median opfølgning på 96 måneder.
A final analysis was performed with an actual median follow up of 96 months.
Den skal anvendes indenfor 6 timer (inklusive en time administration af intravenøs infusion).
It should be used within 6 hours (including the one hour infusion intravenous administration).
Lægen vil måske stoppe din behandling med det samme.
Your doctor may stop your treatment immediately.
Behandlingen gentages hver 3. uge.
Treatment is repeated every three weeks.
Den primære testmetode, som blev anvendt til at bestemme HER2-positivitet i dette pivotal-studie var immunohistokemi (IHC).
The main test method used to determine HER2 positivity in this pivotal study was immunohistochemistry (IHC).
Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/m2 bør behandlingen stoppes.
If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
Din tilstand vil blive nøje kontrolleret af hospitalspersonalet under behandlingen.
The hospital staff will monitor your condition closely during treatment.
Neuromotoriske tilfælde er hovedsagligt karakteriseret ved svaghed.
Neuro-motor events are mainly characterised by weakness.
Forsigtighed anbefales hos patienter med neutropeni, især ved risiko for udvikling af gastrointestinale komplikationer.
Caution is recommended for patients with neutropenia, particularly at risk for developing gastrointestinal complications.
Patienter bør modtage terapeutisk G-CSF så snart som muligt efter overdosering er erkendt.
Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Den estimerede hazard ratio blev udregnet ved hjælp af Cox proportional hazard-model med behandlingsgruppen som faktor.
The estimated hazard ratio was using Cox proportional hazard model with treatment group as the factor.
• Reaktioner på injektionsstedet på stedet for en tidligere reaktion.
• injection site reactions at the site of a previous reaction.
MedDRA Systemorganklasser
MedDRA system organ classes
Histologisk grad
Histological grade
Hvis der opstår krystaller, må opløsningen ikke længere anvendes og skal bortskaffes.
If crystals appear, the solution must no longer be used and shall be discarded.
Perifer sensorisk
Peripheral sensory
I tilfælde af en overdosis skal patienten indlægges på en specialafdeling og de vitale funktioner skal følges nøje.
In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
Anden primær malignitet
Second primary malignancies
Væskeretention er ikke ledsaget af akutte episoder af oliguri eller hypotension.
Fluid retention has not been accompanied by acute episodes of oliguria or hypotension.
Normal dosis Dosis vil afhænge af din vægt og din almene tilstand.
The dose will depend on your weight and your general condition.
Tilfælde af permanent alopeci er rapporteret (hyppighed ikke kendt).
Cases of permanent alopecia (frequency not known) have been reported.
Mængden af alkohol i dette lægemiddel kan have virkninger på centralnervesystemet (den del af nervesystemet, der omfatter hjernen og rygmarven).
The amount of alcohol in this medicine may have effects on the central nervous system (the part of the nervous system that includes the brain and spinal cord).
Reversible kutane reaktioner blev observeret og de var almindeligvis milde til moderate.
Reversible cutaneous reactions have been observed and were generally considered as mild to moderate.
Overlevelsesdata, median progressionstid og responsrater for studiets to arme er illustreret i nedenstående tabel:
Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
Patienter bør observeres nøje med henblik på overfølsomhedsreaktioner specielt under første og anden infusion.
Patients should be observed closely for hypersensitivity reactions especially during the first and second infusions.
Hvis pulmonale symptomer udvikles eller forværres, skal patienterne overvåges nøje, undersøges omgående og sættes i passende behanding.
If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated.
1Fuldt analysesæt (intent to treat)
1Full analysis set (intent-to-treat)
Dette er fordi DOCETAXEL KABI eller den anden medicin måske ikke virker så godt som forventet, og du måske lettere får bivirkninger.
This is because DOCETAXEL KABI or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Opbevares i original yderpakning for at beskytte mod lys.
Store in the original package in order to protect from light.
Hjertefunktionen bør yderligere monitoreres under behandlingen (f.eks. hver 3. måned) med henblik på at identificere patienter, som udvikler hjertedysfunktion.
Cardiac function should be further monitored during treatment (e.g. every three months) to help identify patients who may develop cardiac dysfunction.
Den samlede overlevelsesrate var 6,8 % i de evaluerbare patienter, og median-varigheden for respons var 26,1 uge.
The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Begrænsede data fra et enkelt, ukontrolleret studie antydede en interaktion mellem docetaxel og carboplatin.
Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin.
Kirurgisk indgreb på det primære sygdomssted og/eller hals kunne overvejes når som helst efter endt CRT.
Surgery on the primary site of disease and/or neck could be considered at anytime following completion of CRT.
Hvis du får problemer med synet, særligt sløret syn, skal du straks have undersøgt dine øjne og dit syn.
In case of vision problems, in particular blurred vision, you should immediately have your eyes and vision examined.
Alopeci;
Alopecia;
Binding af docetaxel til mikrotubuli medfører ingen ændring i antallet af protofilamenter.
The binding of docetaxel to microtubules does not alter the number of protofilaments.
For docetaxel /Carboplatin-kombinationen kunne der hverken bevises ekvivalent eller noninferior effekt sammenlignet med referencebehandlingen kombination VCis.
For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Hver æske indeholder 1 hætteglas.
Each box contains one vial.
I kombination med trastuzumab, vises de bivirkninger (alle grader), som er rapporteret hos ≥ 10 %.
For combination with trastuzumab, adverse events (all grades) reported in ≥ 10% are displayed.
Uåbnet hætteglas 2 år
Unopened vial 2 years.
Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene tilstand og din reaktion på DOCETAXEL KABI.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to DOCETAXEL KABI.
I tilfælde af forstyrrelser af de hvide blodlegemer kan du få feber eller infektioner.
In case of white blood cells disturbances, you may experience associated fever or infections.
Dato for første markedsføringstilladelse: 22. maj 2012 Dato for seneste fornyelse: 23. februar 2017.
Date of latest renewal: 23 February 2017
Det er vigtigt at læse hele indholdet af denne vejledning før tilberedelse af DOCETAXEL KABI infusionsvæske.
It is important that you read the entire contents of this guide prior to the preparation of the DOCETAXEL KABI infusion solution.
• hvis du er allergisk (overfølsom) overfor docetaxel eller nogle af de andre indholdsstoffer i
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of DOCETAXEL
Kongestivt hjertesvigt (CHF)
Congestive heart failure (CHF)
Hvis dette sker, må du ikke føre motorkøretøj, bruge værktøj eller maskiner, før du har talt med din læge, sundhedspersonalet eller hospitalsfarmaceuten.
If this happens, do not drive or use any tools or machines before discussing with your doctor, nurse or hospital pharmacist.
Data for DFS var ikke statistisk signifikante, men blev alligevel forbundet med en positiv tendens til fordel for TAC.
DFS data were not statistically significant but were still associated with a positive trend in favour of TAC.
Behandlings cyklus var på 3 uger for TCF-armen og 4 uger for CF-armen.
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
”ne” indikerer at dette ikke kunne estimeres eller ikke blev nået.
TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Disse symptomer kan være de første tegn på en alvorlig mave-tarmforgiftning, som kan være dødelig.
These symptoms may be the first signs of a serious gastrointestinal toxicity, which could be fatal.
Derimod induceredes ingen mutationer i Ames test eller i en CHO/HGPRT gen mutation assay.
However, it did not induce mutagenicity in the Ames test or the CHO/HGPRT gene mutation assay.
DOCETAXEL KABI vil blive administreret af personale med en sundhedsfaglig uddannelse.
DOCETAXEL KABI will be administered to you by a healthcare professional.
• Infektioner, fald i antallet af røde blodlegemer (anæmi), eller hvide blodlegemer (som er vigtige for at bekæmpe infektioner) og blodplader
• infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
En mindre del af patienterne blev testet ved hjælp af fluoroscence in situ hybridization (FISH).
A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Anvend hætteglasset straks efter dets åbning.
Use the vial immediately after its opening.
Farmakoterapeutisk klassifikation : Antineoplastiske stoffer, plantealkaloider og andre naturprodukter, taxaner, ATC kode: L01CD 02
Pharmacotherapeutic group: antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD02
Præ-menopausal
Pre-Menopausal
Sekundære endepunkter inkluderede forandring i smerter, global rating af livskvalitet med EuroQoL5D, lungekræft-symptom skala, og forandringer i karnosfkys performance status.
Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Den sene fase skyldes til dels den relativt langsomme redistribution af docetaxel fra perifere compartments.
The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Mitoxantrone Hver 3.uge
Mitoxantrone every 3 weeks
Akut leukæmi / myelodysplastisk syndrom
Acute leukaemia / Myelodysplastic syndrome
Hvis du har yderligere spørgsmål om anvendelsen af dette lægemiddel, så spørg din læge eller sygehusfarmaceut.
If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.
Selvom et flertal af tilfældene opstod under den første eller anden behandlingsrunde med docetaxel kunne enterocolitis opstå når som helst, og medføre død så tidligt som på den første dag tilstanden indtrådte.
Although majority of cases occurred during the first or second cycle of docetaxel containing regimen, enterocolitis could develop at any time, and could lead to death as early as on the first day of onset.
Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge effektiv prævention under behandlingen, fordi DOCETAXEL KABI kan skade det ufødte barn.
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because DOCETAXEL KABI may be harmful for the unborn baby.
I tilfælde af en overdosis kan der forventes en forværring af bivirkninger.
In cases of overdose, exacerbation of adverse events may be expected.
Før hver behandling med DOCETAXEL KABI, vil du få taget blodprøver for at få kontrolleret, om du har nok blodceller og den nødvendige leverfunktion til at få DOCETAXEL KABI.
Before each treatment with DOCETAXEL KABI, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive DOCETAXEL KABI.
• Feber: Hvis dette forekommer, skal du straks fortælle det til din læge
• fever: if this happens you must tell your doctor immediately
Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og i opfølgningsperioden.
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
Disse patienter skal monitoreres tæt ved initiering af docetaxelbehandling.
These patients should be closely monitored during initiation of docetaxel therapy.
Ældre personer, som behandles med TCF, bør monitoreres nøje.
Elderly treated with TCF should be closely monitored.
Studiepopulationen bestod af patienter med teknisk uresekterbar sygdom, patienter med lav chance for kirurgisk helbredelse og patienter med bevarelse af organer som mål.
The study population comprised patients with technically unresectable disease, patients with low probability of surgical cure and patients aiming at organ preservation.
• Fald i blodtrykket, uregelmæssig eller hurtig hjerterytme
• decrease in blood pressure; irregular or rapid heart beat
Grad 1 (inklusiv grader, der ikke er fastsat)
Grade1 (includes grade not assessed)
Dette var også statistisk signifikant med en HR på 0,71; 95 % CI 0,56-0,90; log-rank test p =0,004.
This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Docetaxel hører til gruppen af kræftmedicin, der kaldes taxoider.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Febril neutropeni (inklusive neutropeni associeret med feber og brug af antibiotika) eller neutropenisk sepsis
Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
Docetaxel metaboliseres via CYP3A4, og prednison er kendt for at inducere CYP3A4.
Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Gastrointestinale reaktioner
Gastrointestinal reactions
Taget i betragtning af, at docetaxel givet hver uge gav en lidt bedre sikkehedsprofil end docetaxel administreret hver 3. uge, er det en mulighed, at nogle patienter kan have fordel af docetaxel administreret hver uge.
Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre.
Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Kontraindikationer for andre lægemidler gælder også, når disse lægemidler kombineres med docetaxel.
Contraindications for other medicinal products also apply, when combined with docetaxel.
Man bør derfor udvise forsigtighed ved samtidig medicinering med disse lægemidler på grund af risikoen for en betydelig interaktion.
As a result, caution should be exercised when treating patients with these medicinal products as concomitant therapy since there is a potential for a significant interaction.
Hormonel receptorstatus
Hormonal receptor status
Symptomer såsom tidlig abdominal smerte og ømhed, feber, diarré, med eller uden neutropeni, kan være tidlige manifestationer på alvorlig gastrointestinal toksicitet og bør evalueres og behandles med det samme.
Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Docetaxel må derfor ikke anvendes til gravide, medmindre det er tydeligt indikeret.
Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
• Ændring af neglenes farve, som også kan løsne sig
• change in the colour of your nails, which may detach
Ca 80 % af radioaktiviteten i fæces er udskilt efter 48 timer i form af en større inaktiv og tre mindre inaktive metabolitter samt meget lave koncentrationer af uomdannet lægemiddel.
About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
• hvis du har en alvorlig leverlidelse
• if you have a severe liver disease.
En TAC patient (0,1 %) og 1 FAC patient (0,1 %) døde på grund af AML i løbet af opfølgningsperioden (median opfølgningstid på 8 år).
One TAC patient (0.1%) and 1 FAC patient (0.1%) died due to AML during the follow-up period (median follow-up time of 8 years).
Forekomsten af alvorlige bivirkninger var højere i gruppen med de ældre personer i forhold til gruppen med de yngre patienter.
The incidence of serious adverse events was higher in older people compared to younger patients.
Svangerskabsforebyggende midler skal anvendes af både mænd og kvinder under behandlingen og for mænd i mindst 6 måneder efter seponering (se pkt.
Contraceptive measures must be taken by both men and women during treatment and for men at least 6 months after cessation of therapy (see section 4.6).
Gennemsnitlig tid til progression (uger)
Median time to progression (weeks):
Sjældne tilfælde af myokardieinfarkt er rapporteret.
Rare cases of myocardial infarction have been reported.
Alle patienter på den docetaxel-indeholdende arm af TAX 323 og TAX 324 studierne modtog profylaktisk antibiotika.
All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Patienter bør derfor advares om den potentielle indvirkning, som mængden af alkohol og bivirkningerne af dette lægemiddel kan have på evnen til at føre motorkøretøj eller betjene maskiner, samt frarådes at føre motorkøretøj og betjene maskiner, hvis de oplever disse bivirkninger under behandlingen.
Therefore, patients should be warned of the potential impact of the amount of alcohol and the side effects of this medicinal product on the ability to drive or use machines, and be advised not to drive or use machines if they experience these side effects during treatment.
I ca. 20% af tilfældene var der ingen risikofaktorer for akut nyresvigt såsom samtidig behandling med nefrotoksiske lægemidler og gastrointestinale sygdomme.
In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
Resultaterne af effekten er opsummeret i den følgende tabel:
Efficacy results are summarized in the following table:
Forberedelse til intravenøs administration
Preparation for the intravenous administration
Følgende allergiske reaktioner kan optræde under infusionen på hospitalet (kan forekomme hos flere end 1 ud af 10 patienter):
During the infusion at the hospital the following allergic reactions may occur (may affect more than 1 in 10 people):
Bemærk, at dette sandsynligvis er underestimeret, da docetaxel alene ved en dosis på 100 mg/m2 er kendt for at resultere i neutropeni hos 97 % af patienterne, 76 % grad 4, baseret på laveste blodtælling.
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Alderskategori 2 <35 år ≥35 år
Age category 2 <35 years ≥35 years
Fysisk og kemisk i-brug stabilitet af infusionsopløsningen fremstillet som anbefalet er endvidere påvist i op til 48 timer, når opbevaret mellem 2⁰C til 8⁰C i ikke-PVC poser.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.
Som helhed viste livskvalitet (LK) og kliniske fordele resultater i overensstemmelse med fremgang til fordel for TCF-armen.
Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
De bivirkninger, som muligvis eller sandsynligvis er relateret til anvendelsen af docetaxel, er set hos:
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
De patienter, der fik docetaxel hver 3. uge, viste signifikant længere total overlevelsese sammenlignet med dem, der fik mitoxantrone.
Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Undergruppe-analyser på tværs af alder, køn og race favoriserede samstemmende TCF-armen sammenlignet med CF-armen.
Subgroup analyses across age, gender and race consistently favoured the TCF arm compared to the CF arm.
• Hævelse af hænder, fødder eller ben
• swelling of the hands, feet, legs