natgillin/translations-raw huggingface dataset:
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Samtidig indgivelse af atazanavir og protonpumpehæmmere anbefales ikke.
4.4 Special warnings and precautions for use
Uåbnet hætteglas 12 måneder.
Unopened vial 12 months.
Andre relevante symptomatiske tiltag bør iværksættes efter behov.
Other appropriate symptomatic measures should be taken, as needed.
Resultaterne for disse endepunkter understøttede de primære endepunktsresultater.
Results on these end-points were supportive of the primary end-points results.
• hårtab (i de fleste tilfælde vil normal hårvækst vende tilbage)
• hair loss (in most cases normal hair growth should return)
Brug af handsker anbefales.
The use of gloves is recommended.
TTP = tid til progression; “ne” indikerer at den ikke kunne estimeres eller endnu ikke var nået.
TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
73% af de kutane reaktioner var reversible inden for 21 dage.
73% of the cutaneous reactions were reversible within 21 days.
- hvis du har en alvorlig leversygdom.
- if you have a severe liver disease.
Median tid til progression (uger):
Median time to progression (weeks):
I nogle tilfælde kan samtidigt tilstedeværende faktorer have bidraget til udviklingen af disse bivirkninger.
In some cases concomitant factors may have contributed to the development of these effects.
Hvis der forekommer krystaller, må opløsningen ikke længere anvendes og skal kasseres.
If crystals appear, the solution must no longer be used and shall be discarded.
• ændring eller udeblivelse af menstruationer
• change or absence of menstrual period
• feber: hvis dette forekommer, skal du straks fortælle det til din læge
• fever: if this happens you must tell your doctor immediately
I alt 70 Gy anbefales ved accelererede regimer og 74 Gy for hyperfraktionerede systemer.
A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes.
Total overlevelse (Primært endepunkt):
Overall survival (Primary end-point):
I begge arme blev livskvaliteten målt ved hjælp af EORTC-spørgeskemaet og var 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.
Der blev udført en endelig analyse med en aktuel median followup på 96 måneder.
A final analysis was performed with an actual median follow up of 96 months.
• forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver)
• raised liver enzymes (hence the need for regular blood tests).
Evalueringen af effekten og sikkerheden fokuserede udelukkende på overlevelsesendepunkter, mens succesrig organbevarelse ikke blev undersøgt formelt.
The efficacy and safety evaluation solely addressed survival endpoints and the success of organ preservation was not formally addressed.
Den totale responsrate var 6,8% hos de evaluerbare patienter, og den mediane responsvarighed 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.
Dato for første tilladelse: 31. januar 2012
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 January 2012
Instruktioner vedrørende sikker håndtering:
Recommendations for the safe handling:
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.
Der blev ikke observeret statistiske forskelle i forhold til global livskvalitet grupperne imellem.
No statistical differences were observed between treatment groups for Global Quality of Life.
I alt 1.006 patienter med KPS ≥ 60 blev randomiseret til følgende behandlingsgrupper:
A total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups:
I tilfælde af overdosering skal patienten indlægges på et specialafsnit og de vitale funktioner monitoreres nøje.
In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
- hvis antallet af hvide blodlegemer er for lavt.
Mylan - if the number of white blood cells is too low.
Operation på det primære sygdomssted og/eller hals kunne overvejes på et hvilket som helst tidspunkt efter endt CRT.
Surgery on the primary site of disease and/or neck could be considered at anytime following completion of CRT.
Docetaxels binding til mikrotubuli ændrer ikke antallet af protofilamenter.
The binding of docetaxel to microtubules does not alter the number of protofilaments.
Længden af en behandlingscyklus var 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.
Hyppigheder defineres som: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); frekvens ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Overlevelsesdata, mediantid til progression og responsrater for to af studiearmene 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:
ER/PR-negativ eller grad 3 eller tumorstørrelse >5 cm
ER/PR-negative or Grade 3 or tumor size >5 cm
Indehaveren af markedsføringstilladelsen skal fremsende PSUR'es for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Dette er fordi Docetaxel Mylan eller den anden medicin måske ikke virker så godt som forventet, og du måske nemmere får bivirkninger.
This is because Docetaxel Mylan or the other medicine may not work as well as expected and you may be more likely to get a side effect.
EXP: Læs indlægssedlen for holdbarhed af den fortyndede medicin.
EXP: Read the leaflet for the shelf life of the diluted medicine.
Et mindretal af patienter blev testet ved hjælp af fluorescens in situ hybridisering (FISH).
A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Dette lægemiddel må ikke blandes med andre lægemidler med undtagelse af dem, der nævnes i pkt.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25°C.
SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Væskeretention har ikke været forbundet med akutte episoder af oliguri eller hypotension.
Fluid retention has not been accompanied by acute episodes of oliguria or hypotension.
• ændring af farven på fingerneglene, som kan løsne sig
• change in the colour of your nails, which may detach
Den sene fase skyldes til dels den relativt langsomme efflux af docetaxel fra perifere compartments.
The late phase is due, in part, to a relatively slow efflux of docetaxel from the peripheral compartment.
Tilberedning af den intravenøse administration:
Preparation of the intravenous administration:
Din læge kan ændre dosis og dosisfrekvensen afhængig af dine blodprøver, din almene helbredstilstand og din reaktion på Docetaxel Mylan.
Your doctor may change the dose and frequency of dosing depending on your blood tests, your general condition and your response to Docetaxel Mylan.
Ved kombinationen docetaxel/carboplatin kunne der hverken påvises ækvivalent eller non-inferiør 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.
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.
• mistet appetit (anoreksi)
• loss of appetite (anorexia)
Docetaxel binder mere end 95% til plasmaproteiner.
Docetaxel is more than 95% bound to plasma proteins.
Eftersom docetaxel indgivet hver uge udviste en lidt bedre sikkerhedsprofil end docetaxel indgivet hver 3. uge, er det muligt, at nogle patienter kan have fordel af at få docetaxel 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.
Primær G¬CSF-profylakse blev gjort obligatorisk i TAC-armen, efter 230 patienter var blevet randomiseret.
Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomized.
Man bør derfor udvise forsigtighed ved samtidig medicinering med disse lægemidler på grund af risikoen for signifikant 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.
1Fuldt analysesæt (intent-to-treat)
1Full analysis set (intent-to-treat)
• 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
117 allée des parcs 69800 Saint Priest Frankrig
117 allée des parcs 69800 Saint Priest France
117 allée des Parcs F-69 800 Saint Priest Frankrig
117 allée des Parcs F-69 800 Saint Priest France
Ca. 80% af radioaktiviteten i fæces udskilles i løbet af de første 48 timer i form af en primær inaktiv metabolit, 3 mindre vigtige inaktive metabolitter og 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.
Din læge vil beregne din legemsoverflade i m² og bestemme den dosis, du skal have.
Your doctor will calculate your body surface area in square meters (m²) and will determine the dose you should receive.
Patienter bør monitoreres for symptomer på kongestivt hjertesvigt under behandlingen og under followup-perioden.
Patients should be monitored for symptoms of congestive heart failure during therapy and during the follow up period.
G¬CSF blev brugt som sekundær profylakse hos 19,3% af patienterne (10,7% af cyklusserne).
G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
Progressiv sygdom som bedste totale respons (%) * Ustratificeret log-rank test
Progressive Disease as Best Overall Response (%) *Unstratified logrank test
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.
Før hver behandling med Docetaxel Mylan, vil du få taget blodprøver for at kontrollere, om du har nok blodceller og den nødvendige leverfunktion til at kunne få Docetaxel Mylan.
Before each treatment with Docetaxel Mylan, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive Docetaxel Mylan.
Sygdomsfri overlevelse (DFS) var det primære effektendepunkt, og total overlevelse (OS) var det sekundære effektendepunkt.
Disease-free survival (DFS) was the primary efficacy endpoint and Overall survival (OS) was the secondary efficacy endpoint.
I dette studie havde 87% af patienterne sygdom, der var IHC 3+, og 95% af de inkluderede patienter havde sygdom, der var IHC 3+ og/eller FISH-positiv.
In this study, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
Lethargi
Lethargy
Undergrupper af TAC-behandlede patienter efter prospektivt definerede betydningsfulde prognostiske faktorer blev analyseret i den primære analyse (ved median followup-periode på 77 måneder) (se tabel nedenfor):
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed in the primary analysis (at the median follow-up time of 77 months) (see table below):
Du må ikke blive gravid under behandling med dette lægemiddel, og du skal bruge effektiv prævention under behandlingen, fordi Docetaxel Mylan 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 Mylan may be harmful for the unborn baby.
Ved overdosering kan der forventes forværring af bivirkningerne.
In cases of overdose, exacerbation of adverse events may be expected.
Docetaxels karcinogene potentiale er ikke undersøgt.
The carcinogenic potential of docetaxel has not been studied.
Disse bivirkninger var reversible ved afbrydelse af infusionen.
These were reversible upon discontinuation of the infusion.
Docetaxel er i udstrakt grad proteinbundet (> 95%).
Docetaxel is highly protein bound (> 95%).
Anvend lægemidlet umiddelbart efter tilsætning til den PVC-fri infusionspose.
Use immediately the medicine once added into the non-PVC infusion bag.
Farmakoterapeutisk klassifikation: antineoplastiske stoffer, taxaner, ATC-kode: L 01 CD 02
Pharmacotherapeutic group: antineoplastic agents, taxanes, ATC Code: L01CD02
Undergruppeanalyser på tværs af alder, køn og race favoriserede konsekvent TCF-armen i forhold til 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
Alt materiale, som har været brugt i forbindelse med fortynding og administration, skal destrueres i overensstemmelse med lokale retningslinjer.
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Docetaxel viste sig desuden aktivt på nogle, men ikke alle, cellelinjer, der udviste overekspression af P-glycoprotein, som er kodet af multidrug resistance (MDR) genet.
In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Docetaxel hører til gruppen af kræftmedicin, der kaldes taxaoider.
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Patienter, der får TAC, bør monitoreres nøje (se pkt 4.2 og 4.8).
Patients receiving TAC should be closely monitored (see sections 4.2 and 4.8).
24,5 Behandlingsforskel: 7.1% [95% CI: 0,7; 13,5] *: Korrigeret for flere sammenligninger og justeret for stratificeringsfaktorer (sygdomsstadie og behandlingsregion), baseret på evaluerbar patientgruppe.
Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Docetaxel Mylan vil blive administreret af personale med en sundhedsfaglig uddannelse.
Docetaxel Mylan will be administered to you by a healthcare professional.
Sekundære endepunkter omfattede smerteændring, global rating af livskvalitet af EuroQoL-5D, lungecancersymptomskala og ændringer i Karnofsky 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.
Blod og lymfesystem Sjældent: Blødningsepisoder associeret med grad 3/4 thrombocytopeni.
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia.
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.
Tilberedning af den intravenøse administration
Preparation for the intravenous administration
Patienter, der tidligere er behandlet med kemoterapi med eller uden strålebehandling
Patients previously treated with chemotherapy with or without radiotherapy
Disse reaktioner kan vise sig i forbindelse med infusionen af lægemidlet.
These reactions sometimes appear during the infusion of the medicinal product.
I løbet af disse to fase III-studier udviste docetaxel samme sikkerhedsprofil som i fase II-studierne (se pkt.
During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Mitoxantron hver tredje uge
Mitoxantrone every 3 weeks
Overordnet demonstrerer resultaterne fra studierne en positiv benefit/risk-fordeling for TAC sammenlignet med FAC.
Overall, the study results demonstrate a positive benefit risk ratio for TAC compared to FAC.
Det er vigtigt at læse hele denne vejledning inden fremstilling af Docetaxel Mylan infusionsvæske.
It is important that you read the entire contents of this guide prior to the preparation of the Docetaxel Mylan infusion solution.
* en hazard ratio på under 1 indikerer, at TAC er forbundet med en længere sygdomsfri overlevelse og total overlevelse sammenlignet med FAC.
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC.
Reduktionen af risikoen for progression var 32,1% og var forbundet med en signifikant længere TTP (p = 0,0004) til fordel for TCF-armen.
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favour of the TCF arm.
Der er rapporteret om dissemineret intravaskulær koagulation (DIC) ofte i forbindelse med sepsis eller multiorgansvigt.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Generelt indikerede resultaterne for livskvalitet og kliniske fordele konsekvent en forbedring til fordel for TCF-armen.
Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
Den primære analyse blev udført, da alle patienter havde en followup-tid på mere end 5 år (median followup-tid var 77 måneder).
The primary analysis was done when all patients had a follow-up of greater than 5 years (median follow-up time of 77 months).
Docetaxel opnår høje intracellulære koncentrationer ved længere ophold i cellen.
Docetaxel achieves high intracellular concentrations with a long cell residence time.
Kirurgisk resektion var tilladt efter kemoterapi, før eller efter strålebehandling.
Surgical resection was allowed following chemotherapy, before or after radiotherapy.
Eventuelt ubrugt præparat eller affald bør bortskaffes i overensstemmelse med lokale regler.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Funktionsstatusskalaen med underskalaerne for hoved- og hals (PSS-HN), der er designet til at måle forståelse af patientens tale, evne til at indtage føde offentligt samt normal kost, var signifikant til fordel for TPF sammenlignet med PF.
The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favour of TPF as compared to PF.
Der kan være behov for at anvende mere end ét hætteglas for at opnå den dosis, der er nødvendig for patienten.
More than one vial may be necessary to obtain the required dose for the patient.
Forsøgsgruppen omfattede patienter med teknisk inoperabel sygdom, patienter med lille sandsynlighed 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.
Forekomsten af alvorlige bivirkninger var højere i gruppen med de ældre patienter i forhold til gruppen med de yngre patienter.
The incidence of serious adverse events was higher in the older people compared to younger patients.
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.
Yderligere forsigtighedsregler for anvendelse ved adjuverende behandling af brystcancer
Additional cautions for use in adjuvant treatment of breast cancer
• rødme og hævelse af håndflader eller fodsåler, hvilket kan få huden til at skalle af (kan også forekomme på arme, ansigt eller krop)
• redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
En farmakokinetisk populationsanalyse af docetaxel er gennemført hos 577 patienter.
A population pharmacokinetic analysis has been performed with docetaxel in 577 patients.
Der er rapporteret sjældne tilfælde af dehydrering som en konsekvens af gastrointestinale lidelser, gastrointestinal perforering, iskæmisk colitis, colitis og neutropen enterocolitis.
Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Reversibilitets-data er tilgængelige hos 35,3% af de patienter, som udviklede neurotoksicitet efter docetaxel-behandling med 100 mg/m² som enkelt stof.
Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/m² as single agent.
Aktivt stof: docetaxel.
The active substance is docetaxel.
Patienter skal have terapeutisk G¬CSF straks efter, overdosering er opdaget.
Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Overlevelsesprocenten var 93,7 % i TAC-armen og 91,4 % i FAC-armen ved tidspunktet for 8-års followup, og 91,3 % i TAC-armen og 89 % i FAC-armen ved tidspunktet for 10-års followup.
The survival rate was 93.7% in the TAC arm and 91.4 % in the FAC arm, at the 8-year follow-up timepoint, and 91.3 % in the TAC arm and 89% in the FAC arm, at the 10-year follow-up timepoint.
- hvis du er allergisk over for docetaxel eller et af de øvrige indholdsstoffer i Docetaxel Mylan
- if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Docetaxel
De primære forventede komplikationer ved en overdosis vil være knoglemarvsdepression, perifer neurotoksicitet og mucositis.
The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.
Hvis det ikke anvendes straks, er opbevaringstider og -forhold brugerens ansvar og vil normalt ikke være længere end 6 timer ved opbevaring under 25°C inklusive den time, patienten får infusionen.
If not used immediately, inuse storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion.
Neutropeniske komplikationer hos patienter, der får TAC med eller uden primær G¬CSF-profylakse (GEICAM 9805)
Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Det er påvist, at docetaxel er både embryo-og føtotoksisk hos kaniner og rotter, samt at det nedsætter fertiliteten hos rotter.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats.