FrancophonIA/ELRC3.0 huggingface dataset:
English: For docetaxel/carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Danish: For docetaxel/carboplatin-kombinationen kunne der hverken bevises ækvivalent eller non-inferior effekt sammenlignet med referencebehandlingen kombination VCis.
English: The effect appears to be less pronounced than in patients with 1-3 positive nodes.
Danish: Effekten synes mindre end hos patienter med 1-3 positive lymfeknuder.
English: Reduced tolerance of docetaxel may occur, even at lower doses.
Danish: Der kan forekomme nedsat tolerance af docetaxel, selv ved mindre doser.
English: It is administered through a drip into a vein (intravenous infusion) for about one hour.
Danish: Det indgives gennem et drop i en vene (intravenøs infusion) i cirka en time.
English: TTP=time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Danish: "ne" indikerer at dette ikke kunne estimeres eller ikke blev nået.
English: The solvent is a viscous, clear and colourless solution.
Danish: Solvensen er en viskøs, klar og farveløs opløsning.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Medicin må ikke hældes ud via spildevandet eller som husholdningsaffald.
English: Before each Docefrez dose, you will have blood tests to check that your blood cell counts and liver function are adequate.
Danish: Før hver dosis Docefrez får du taget blodprøver for at kontrollere, at dit blodcelletal og din leverfunktion er passende.
English: • bleeding from the nose
Danish: • blødning fra næsen
English: • change in the colour of your nails*, which may detach
Danish: • ændring af farven på fingerneglene*, som kan løsne sig
English: ≥35 years
Danish: ≥35 år
English: Vial 24 months
Danish: 24 måneder
English: From a microbiological point of view, the reconstituted solution should be used immediately.
Danish: Af mikrobiologiske årsager skal den rekonstituerede opløsning bruges straks.
English: Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin.
Danish: Begrænsede data fra et enkelt, ukontrolleret forsøg antydede en interaktion mellem docetaxel og carboplatin.
English: Gastric adenocarcinoma
Danish: Gastrisk adenocarcinom
English: 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.
Danish: I dette forsøg havde 87 % af patienterne sygdom, som var IHC 3+, og 95 % af de inkluderede patienter havde sygdom, som var IHC3+ og/eller patienterne var FISH positive.
English: Your doctor may change the dose and/or frequency of administration depending on the results of your blood tests, your general condition and the occurence of certain side effects.
Danish: Din læge kan ændre din dosis og/eller hyppigheden af indgivelsen afhængigt af resultaterne af dine blodprøver, din almindelige tilstand og forekomsten af visse bivirkninger.
English: The infusion should be used within 4 hours below 25 ºC.
Danish: Infusionsvæsken bør bruges inden for 4 timer under 25 ºC.
English: • swelling caused by fluids from the lymph nodes spreading to uncommon places
Danish: • opsvulmen fremkaldt af væsker fra lymfeknuder, der breder sig til usædvanlige steder
English: • fungal infection of the mouth (oral candidiasis)
Danish: • svampeinfektion i munden (oral candidiasis)
English: White lyophilised powder.
Danish: Hvidt lyofiliseret pulver.
English: More than one vial may be necessary to obtain the required dose for the patient.
Danish: Det kan være nødvendigt at bruge mere end ét hætteglas for at opnå den nødvendige dosis til patienten.
English: Important information about some of the ingredients of Docefrez
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Docefrez
English: • swelling of the hands, feet, legs
Danish: • opsvulmen af hænder, fødder, ben
English: Discontinue treatment if these toxicities persist (see section
Danish: Afbryd behandlingen, hvis disse toksiciteter varer ved (se pkt.
English: When Docefrez is given in combination with other anti-cancer medicines, the frequency or severity of some side effects may increase.
Danish: Hvis Docefrez gives sammen med anden medicin mod cancer, kan hyppigheden eller styrken af nogle bivirkninger øges.
English: Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table.
Danish: Overlevelsesdata, median progressionstid og responsrater for forsøgets to arme er illustreret i nedenstående tabel:
English: You should usually receive your Docefrez infusion every three weeks.
Danish: Du bør i reglen have din infusion af Docefrez hver tredje uge.
English: You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Docefrez may be harmful for the unborn baby.
Danish: Du må ikke blive gravid under behandlingen med denne medicin, og du skal anvende tilstrækkelig prævention under behandlingen, da Docefrez kan være skadelig for det ufødte barn.
English: 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.
Danish: Sekundære endepunkter inkluderede forandring i smerter, global rating af livskvalitet med EuroQoL5D, lungekræft-symptomskala, og forandringer i karnosfkys performance status.
English: Pharmacotherapeutic group: Taxanes, ATC Code: L01CD02
Danish: Farmakoterapeutisk klassifikation: Taxaner, ATC kode: L01CD 02
English: Your doctor will calculate your dose according to your body surface area in square metres (depends on weight and height) and your general condition.
Danish: Din læge vil beregne din dosis i forhold til dit kropsoverfladeareal i m² (afhænger af vægt og højde) og din almindelige tilstand.
English: Docefrez vials should be stored in a refrigerator.
Danish: Docefrez-hætteglas bør opbevares i køleskab.
English: Pre-Menopausal
Danish: Præ-Menopausal
English: Each pack contains: 1 powder vial and 1 solvent vial.
Danish: Hver pakning indeholder: 1 pulverhætteglas og 1 solvenshætteglas.
English: Like all medicines, Docefrez can cause side effects, although not everybody gets them.
Danish: Docefrez kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: ≥50 years
Danish: ≥50 år
English: • decreased number of red bloods cells (anaemia, with symptoms of such as paleness, weakness)
Danish: • fald i antallet af røde blodlegemer (anæmi, med symptomer herpå som bleghed, svaghed)
English: • decreased number of white blood cells (may make you more prone to infections)
Danish: • fald i antallet af hvide blodlegemer (kan gøre dig mere disponeret for infektioner)
English: Do not use any PVC equipment or device.
Danish: Brug ikke udstyr af PVC.
English: Women of childbearing potential /contraception:
Danish: Kvinder i den fertile alder/prævention:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hrs at 2 to 8°C, unless reconstitution and further dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis den ikke bruges med det samme, er opbevaringstider og opbevaringsforhold inden anvendelse brugerens ansvar, og det vil normalt være højst 24 timer ved mellem 2°C og 8°C, medmindre rekonstitution og yderligere fortynding er foregået under kontrollerede og godkendte aseptiske forhold.
English: Docetaxel is a lipophilic substance but it is not known whether it is excreted in human milk.
Danish: Docetaxel er et lipofil stof, men det vides ikke, om det udskilles i modermælk.
English: The incidence of serious adverse events was higher in the elderly 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: • pain in the joints or muscles
Danish: • smerte i led eller muskler
English: • raised liver enzymes (in blood tests)
Danish: • forhøjelse af leverenzymer (i blodprøver)
English: 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: Den mediane kumulative dosis til behandlingsophør var mere end 1000 mg/m2 og median-tiden til reversibilitet af væskeretention var 16,4 uger (range 0 til 42 uger).
English: PSURs The PSUR submission schedule should follow the PSUR schedule for the reference product.
Danish: Den fastsatte plan for indsendelse af PSUR skal følge den fastsatte plan for indsendelse af PSUR for referencelægemidlet.
English: Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favor of the TCF arm.
Danish: Som helhed viste livskvalitet (LK) og kliniske fordele resultater i overensstemmelse med fremgang til fordel for TCF-armen.
English: The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p=0.0004) in favor of the TCF arm.
Danish: Nedsættelsen af risikoen for progression var 32,1 % og blev associeret med en signifikant længere TTP (p = 0,0004) til fordel for TCF-armen.
English: Tell your doctor if you have: - heart problems - liver problems - kidney problems
Danish: Fortæl det altid til lægen, hvis du har: - problemer med hjertet - problemer med leveren - problemer med nyrerne
English: • loss of appetite (anorexia), weight gain or loss*
Danish: • tab af appetit (anoreksi), vægtforøgelse eller vægttab*
English: Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Danish: Der er rapporter om sjældne tilfælde af radiation pneumonitis er rapporteret hos patienter, som modtog samtidig radioterapi.
English: This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Danish: Dette var også statistisk signifikant med en HR på 0,71; 95 % CI 0,56-0,90; logrank-test p = 0,004.
English: • headache* , insomnia*
Danish: • hovedpine*, søvnløshed*
English: Subgroup analyses across age, gender and race consistently favored the TCF arm compared to the CF arm.
Danish: Undergruppe-analyser på tværs af alder, køn og race favoriserede samstemmende TCF-armen sammenlignet med CF-armen.
English: *a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
Danish: * En Hazard ratio på mindre end 1 indikerer, at TAC kan associeres med længere sygdomsfri overlevelse og længere total overlevelse sammenlignet med FAC.
English: This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25 % reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Danish: Dette regime blev administreret hver 3. uge i 4 cyklusser i tilfælde hvor der som mindstemål blev observeret mindre respons (> 25% reduktion i den bidimensionalt målte tumorstørrelse) efter 2 cyklusser.
English: • decreased number of platelets (increased risk of unexpected bleedings)
Danish: • fald i antal af blodplader (øget risiko for uventede blødninger)
English: Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Danish: De patienter, der fik docetaxel hver 3. uge, viste signifikant længere total overlevelse sammenlignet med dem, der fik mitoxantrone.
English: Medium time to progression (weeks):
Danish: Gennemsnitlig tid til progression (uger)
English: Any solution containing a precipitate should be discarded.
Danish: Opløsninger, der indeholder bundfald, skal bortskaffes.
English: Recommended dose
Danish: Anbefalet dosis:
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Danish: For opbevaringsforhold for det rekonstituerede og fortyndede lægemiddel, se pkt.
English: Overall response rate (%)
Danish: Total response rate (%)
English: Other very common side effects:
Danish: Andre meget almindelige bivirkninger:
English: Age category 2 <35 years
Danish: Alderskategori 2 <35 år
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10 May 2010
Danish: Dato for første tilladelse: 10, maj, 2010
English: Side effects marked with “*” have been reported when Docefrez was given in combination.
Danish: Bivirkninger markeret med “*” er bivirkninger, er indberettet når Docefrez blev givet i kombination med anden medicin.
English: Congestive Heart Failure (CHF) has been reported in 18 of 1276 patiens during the follow-up period.
Danish: Hjerteinsufficiens er rapporteret hos 18 ud af 1.276 patienter i opfølgningsperioden.
English: Previous therapy should have included an anthracycline.
Danish: Tidligere behandling skal have omfattet et anthracyclin.
English: The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Danish: Paediatric population The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
English: Docefrez contains the active substance docetaxel.
Danish: Docefrez indeholder det aktive stof docetaxel.
English: Your doctor may prescribe you other medicines before or during treatment with Docefrez: - to minimise allergic reactions and fluid retention (pre-treatment with an oral corticoid such as dexamethasone), - to stimulate your bone marrow to produce more blood cells (e.g. filgrastim).
Danish: Din læge kan ordinere dig anden medicin før eller under behandlingen med Docefrez: - for at minimere allergiske reaktioner og væskeophobning (forbehandling med oral kortikoid som dexamethason), - for at stimulere din knoglemarv til at producere flere blodlegemer (f.eks. filgrastim).
English: Overall response rate (CR+PR) (%) p-value
Danish: Respons rate ialt (CR+PR) (%) p-værdi
English: Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Danish: Toksisk død forekom hos 1 patient i AT-armen (hjerteinsufficiens) og i 4 patienter i ACarmen (1 på grund af septisk shock og 3 på grund af hjerteinsufficiens).
English: PREPARATION FOR INTRAVENOUS ADMINISTRATION Do not use any PVC equipment or device.
Danish: FORBEREDELSE TIL DEN INTRAVENØSE ADMINISTRATION Brug ikke udstyr af PVC.
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: Post-Menopausal * Hazard ratio (TAC/FAC) på mindre end 1 indikerer, at der er en sammenhæng mellem TAC og en længere sygdomsfri overlevelse, sammenlignet med FAC.
English: Age category 1 <50 years
Danish: Alderskategori 1 <50 år
English: The beneficial effect of TAC was not proven in patients with 4 and more positive nodes (37% of the population) at the interim analysis stage.
Danish: Den gavnlige effekt af TAC blev ikke bevist hos patienter med 4 eller flere positive lymfeknuder (37 % af patienterne) ved tidspunktet for interim-analyse.
English: Peripheral sensory neuropathy was observed to be ongoing during follow-up in 12 patients out of the 83 patients with peripheral sensory neuropathy at the end of the chemotherapy.
Danish: Perifer sensorisk neuropati fortsatte under opfølgning hos 12 patienter ud af 83 patienter med perifer sensorisk neuropati ved slutningen af kemoterapien.
English: 4.1.5 Allow the reconstituted vial to stand for 5 minutes at room temperature (below 25ºC) and then check that the solution is homogenous and clear.
Danish: 4.1.5 Lad det rekonstituerede hætteglas stå i 5 minutter ved stuetemperatur (under 25 ºC), og kontroller så, at opløsningen er homogen og klar.
English: TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed (see table below):
Danish: Undergrupper af TAC-behandlede patienter efter prospektivt definerede betydningsfulde prognostiske faktorer blev analyseret (se tabel nedenfor):
English: Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Danish: Immunsystemet: Der er rapporter om tilfælde af anafylaktisk chok, nogle gange fatale.
English: You will be given Docefrez by a healthcare professional in the hospital.
Danish: Sundhedspersonalet vil give dig Docefrez på hospitalet.
English: It is important that you read the entire contents of this procedure prior to the preparation of either the Docefrez reconstituted solution or the Docefrez solution for infusion.
Danish: Det er vigtigt at læse hele indholdet af denne vejledning inden fremstilling af enten Docefrez-præmixopløsningen eller Docefrez-infusionsvæske
English: The required number of Docefrez powder vials should be allowed to reach room temperature (between 15°C - 25°C) for 5 minutes.
Danish: Det nødvendige antal Docefrez-pulverhætteglas skal opnå stuetemperatur (mellem 15 °C - 25 °C) i 5 minutter.
English: There are no studies on the effects of Docefrez on the ability to drive and use machines.
Danish: Der foreligger ingen undersøgelser af Docefrez's indvirkning på evnen til at køre bil og betjene maskiner.
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized to one of two arms.
Danish: I dette studie blev 501 patienter med lokalt fremskredent SCCHN og en WHO funktionsstatus på 0 eller 1, randomiseret i en af to arme.
English: 4.2.1 More than one vial of reconstituted solution may be necessary to obtain the required dose for the patient.
Danish: 4.2.1 Det kan være nødvendigt at bruge mere end ét hætteglas med rekonstitueret opløsning for at opnå den nødvendige dosis til patienten.
English: In combination with cisplatin and 5-fluorouracil
Danish: I kombination med cisplatin og 5-fluorouracil
English: Both the reconstituted concentrate and the solution for infusion should be visually inspected prior to use.
Danish: Både det rekonstituerede koncentrat og infusionsvæsken skal inspiceres visuelt inden brug.
English: Side effects may occur with certain frequencies, which are defined as follows: - very common: affects more than 1 user in 10 - common: affects 1 to 10 users in 100 - uncommon: affects 1 to 10 users in 1,000 - rare: affects 1 to 10 users in 10,000 - very rare: affects less than 1 user in 10,000 - not known: frequency cannot be estimated from the available data.
Danish: Bivirkninger kan optræde med bestemte hyppigheder, der er defineret som følger: - meget almindelig berører mere end 1 bruger ud af 10 - almindelig: berører 1 til 10 brugere ud af 100 - ikke almindelig: berører 1 til 10 brugere ud af 1.000 - sjælden: berører 1 til 10 brugere ud af 10.000 - meget sjælden berører færre end 1 bruger ud af 10.000 - ikke kendt: hyppighed kan ikke estimeres ud fra forhåndenværende data.
English: Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly.
Danish: Ældre: Baseret på de farmakokinetiske studier findes der ingen særlige retningslinjer for ældre.
English: Tell your doctor or nurse immediately during or shortly after the infusion, you notice any of the following symptoms of allergic reactions (very common): - flushing, skin reactions, itching - chest tightness, difficulty in breathing - fever or chills - back pain - low blood pressure.
Danish: Fortæl det til din læge eller sygeplejerske straks eller kort tid efter infusionen, hvis du bemærker et af følgende symptomer eller allergiske reaktioner (meget almindelige): - rødmen, hudreaktioner, kløe - tæthed for brystet, besvær med at trække vejret - feber eller kuldegysninger - rygsmerter - lavt blodtryk.
English: • dizziness, hearing impaired
Danish: • svimmelhed, nedsat hørelse
English: • dripping or running nose; inflammation of the throat and nose*
Danish: • dryppende eller løbende næse; betændelse i hals og næse*
English: • decrease in blood pressure (hypotension), heart failure; irregular heart beat (arrhythmia)
Danish: • fald i blodtryk (hypotension), hjertesvigt; uregelmæssigt hjerteslag (arytmi)
English: Detailed information on this medicine is available on the European Medicines Agency web site: ://www.ema.europa.eu
Danish: Du kan finde yderligere information om Docefrez på Det europæiske Lægemiddelagenturs (EMA) hjemmeside: ://www.ema.europa.eu
English: In the pivotal study the initial docetaxel infusion was started the day following the first dose of trastuzumab.
Danish: I pivotalforsøget blev den initiale docetaxel-infusion givet dagen efter den første dosis trastuzumab.
English: Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume from the appropriate number of reconstituted solutions using graduated syringes fitted with a needle.
Danish: I henhold til den nødvendige dosis til patienten, udtrykt i mg, udtages den tilsvarende volumen under aseptiske forhold fra det relevante antal rekonstituerede opløsninger med en gradueret sprøjte med påsat kanyle.
English: Cardiac toxicity
Danish: Hjerte toksicitet
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglasset i den originale pakning for at beskytte mod lys.
English: Hypersensitivity to the active substance or to any of the excipients.
Danish: Overfølsomhedsreaktioner forårsaget af det aktive stof eller et af hjælpestofferne.
English: Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Danish: Ud af 333 patienter behandlet med docetaxel hver tredje uge i et prostatakræftforsøg, var 209 patienter 65 år eller derover og 68 patienter var ældre end 75 år.
English: There is no relevant use of docetaxel 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: There is no relevant use of docetaxel in the paediatric population in the indications breast cancer, nonsmall cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma.
English: In particular, tell your doctor if you are using medicines containing any of the following active substances: - ritonavir and other protease inhibitors, used to treat HIV infection/AIDS - ketoconazole and itraconazole, used to treat fungal infections - ciclosporin, used to suppress your immune system (e.g. after transplants) - erythromycin, antibiotic used for bacterial infections
Danish: Fortæl det især til din læge, hvis du bruger medicin, der indeholder ét af følgende stoffer: - ritonavir og andre proteasehæmmere til behandling af HIV-infektion/AIDS - ketoconazol og itraconazol til behandling af svampeinfektioner - ciclosporin til bekæmpelse af immunsystemet (f.eks. efter transplantationer) - erythromycin, antibiotika mod bakterielle infektioner.
English: Fluid retention (severe/lifethreatening: 1%).
Danish: Væskeretention (alvorlig/livstruende: 1 %)
English: Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Danish: Der blev vist signifikant længere sygdomsfri overlevelse i TAC-armen sammenlignet med FAC-armen.
English: Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/4 thrombocytopenia
Danish: Blod og lymfesystem: Sjældent: blødningsepisoder associeret med grad 3/4 trombocytopeni.
English: Alopecia was observed to be ongoing during follow-up in 25 patients out of the 736 patients with alopecia at the end of the chemotherapy.
Danish: Alopeci fortsatte under opfølgning hos 25 patienter ud af de 736 patienter med alopeci ved slutningen af kemoterapien.
English: The solvent contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Danish: Solvensen indeholder små mængder ethanol (alkohol), mindre end 100 mg pr. dosis.