FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with Halaven (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), leucopenia (low white blood cell counts), anaemia (low red blood cell counts), reduced appetite, peripheral neuropathy (damage to the nerves in the extremities causing numbness, tingling and prickling sensations), headache, dyspnoea (difficulty breathing), cough, nausea (feeling sick), constipation, diarrhoea, vomiting, alopecia (hair loss), muscle and joint pain or pain in the back or limbs, fatigue (tiredness), pyrexia (fever) and weight loss.
Danish: De mest almindelige bivirkninger ved Halaven (som optræder hos flere end 1 ud af 10 patienter) er neutropeni (lavt antal neutrofiler, en type hvide blodlegemer, som bekæmper infektion), leukopeni (lavt antal hvide blodlegemer), anæmi (lavt antal røde blodlegemer), nedsat appetit, perifer neuropati (beskadigelse af nerverne i arme og ben, der medfører en snurrende og prikkende fornemmelse), hovedpine, dyspnø (vejrtrækningsbesvær), hoste, kvalme, forstoppelse, diarré, opkastning, alopecia (hårtab), muskel- og ledsmerter eller smerter i ryg og lemmer, træthed, pyreksi (feber) og vægttab.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Halaven.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Halaven skal anvendes.
English: It is used in patients who have already been treated with anthracyclines (unless this treatment was not suitable).
Danish: Det gives til patienter, der allerede har været i behandling med antracykliner (medmindre denne behandling ikke var egnet).
English: It attaches to a protein in cells called tubulin, which is important in the formation of the internal ‘skeleton' that cells need to assemble when they divide.
Danish: Det binder sig til et protein i cellerne kaldet "tubulin", som er vigtigt for dannelsen af det indre "skelet", som cellerne opbygger, når de deler sig.
English: The main measure of effectiveness was overall survival (how long the patients lived).
Danish: Det primære effektmål var samlet overlevelse (hvor længe patienterne levede).
English: In the second study, there was no significant difference in the average progression-free survival with Halaven (4.1 months) compared with capecitabine (4.2 months) or in the average overall survival with Halaven (15.9 months) compared with capecitabine (14.5 months).
Danish: I den anden undersøgelse var der ingen signifikant forskel i den gennemsnitlige progressionsfrie overlevelsestid med Halaven (4,1 måned) sammenlignet med capecitabin (4,2 måned) eller i den gennemsnitlige overlevelsestid med Halaven (15,9 måned) sammenlignet med capecitabin (14,5 måned).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Halaven, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Halaven, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: The active substance in Halaven, eribulin, is similar to an anticancer substance called halichondrin B, which is found in the marine sponge Halichondria okadai.
Danish: Det aktive stof i Halaven, eribulin, ligner et stof til behandling af kræft kaldet halichondrin B, som findes i den marine svamp Halichondria okadai.
English: The study compared Halaven with capecitabine (another cancer medicine).
Danish: Undersøgelsen sammenlignede Halaven med capecitabin (et andet lægemiddel mod kræft).
English: Halaven is given as intravenous (into a vein) injections over 21-day cycles.
Danish: Halaven gives som intravenøse indsprøjtninger i cyklusser af 21 dage.
English: For more information about treatment with Halaven, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Halaven, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Halaven treatment should be given under the supervision of a doctor experienced in the use of cancer medicines.
Danish: Behandling med Halaven bør gives under opsyn af en læge med erfaring i behandling med lægemidler mod kræft.
English: In breast cancer, Halaven was studied in two main studies involving a total of 1,864 patients.
Danish: Halaven blev vurderet i to hovedundersøgelser, som omfattede i alt 1 864 patienter.
English: Additionally, Halaven prolonged the length of time that liposarcoma patients lived, and this was considered important as these patients have limited treatment options.
Danish: Desuden forlængede Halaven overlevelsestiden for patienter med liposarkom, hvilket blev betragtet som vigtigt, da disse patienter har begrænsede behandlingsmuligheder.
English: Halaven is a cancer medicine that contains the active substance eribulin.
Danish: Halaven er et lægemiddel mod kræft, som indeholder det aktive stof eribulin.
English: The women were given either Halaven or another approved cancer medicine chosen by their doctor.
Danish: Kvinderne fik enten Halaven eller et andet middel til behandling af cancer, som blev valgt af deres læge.
English: For more details on the use of Halaven including recommendations on dose reduction, see the summary of product characteristics (also part of the EPAR).
Danish: Yderligere oplysninger om anvendelsen af Halaven, herunder anbefalinger om dosisreduktion, fremgår af produktresuméet (også en del af denne EPAR).
English: Doses may be delayed or reduced if patients have very low levels of neutrophils (a type of white blood cell) and platelets (components that help the blood to clot) in their blood or if liver or kidney function is impaired.
Danish: Doserne kan udsættes eller nedsættes, hvis patienten har et meget lavt antal neutrofiler (en type hvide blodlegemer) og blodplader (de blodlegemer, der medvirker ved blodets størkning) i blodet, eller hvis patienten har nedsat lever- eller nyrefunktion.
English: The third study showed that Halaven was effective at prolonging life in patients with liposarcoma: patients treated with Halaven lived for an average of 15.6 months, compared with 8.4 months for patients treated with dacarbazine.
Danish: Den tredje undersøgelse viste, at Halaven havde en livsforlængende effekt hos patienter med liposarkom: Patienter behandlet med Halaven levede i gennemsnit 15,6 måneder, sammenlignet med 8,4 måneder for patienter behandlet med dacarbazin.
English: The main measures of effectiveness were overall survival and progression-free survival (how long the patients lived without their disease getting worse).
Danish: Virkningen blev hovedsagelig målt på den samlede progressionsfri overlevelse (hvor lang tid patienterne levede, uden at deres sygdom forværredes).
English: Halaven was compared with dacarbazine (another cancer medicine), and the main measure of effectiveness was overall survival.
Danish: Halaven blev sammenlignet med dacarbazin (et andet lægemiddel mod kræft), og det primære effektmål var samlet overlevelse.
English: By attaching to tubulin in cancer cells, eribulin disrupts the formation of the skeleton, preventing the division and spread of the cancer cells.
Danish: Ved at binde sig til tubulinen i cancerceller standser eribulin skeletdannelsen og forhindrer derved cancercellerne i at dele og brede sig.
English: Halaven must not be used in women who are breastfeeding.
Danish: Halaven må ikke gives til ammende kvinder.
English: For the full list of all side effects reported with Halaven, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Halaven fremgår af indlægssedlen.
English: What is Halaven?
Danish: Hvad er Halaven?
English: Halaven is also used to treat adults with advanced or metastatic liposarcoma (a type of cancer of the soft tissues that develops from fat cells) that cannot be surgically removed.
Danish: Halaven bruges også til behandling af voksne med fremskreden eller metastatisk liposarkom (bløddelskræft, der opstår i fedtcellerne), som ikke kan fjernes kirurgisk.
English: Previous treatment should have included cancer medicines of the types known as anthracyclines and taxanes, unless these treatments were not suitable.
Danish: De tidligere behandlinger skal have omfattet et antracyklin- og et taxanpræparat, medmindre disse behandlinger ikke var egnet.
English: The second study involved 1,102 patients with advanced or metastatic breast cancer, with one or two previous treatments for advanced/metastatic cancer including an anthracycline and a taxane.
Danish: Den anden undersøgelse omfattede 1 102 patienter med fremskreden eller metastatisk brystcancer, som tidligere havde gennemgået en eller to behandlinger mod fremskreden eller metastatisk cancer, hvori der indgik et antracyklin- og et taxanpræparat.
English: The CHMP noted that, when Halaven was used as a third-line therapy for breast cancer (after at least two previous treatments with cancer medicines for advanced/metastatic disease), it prolonged the length of time that patients lived and the safety profile is within what is expected for chemotherapy medicines.
Danish: CHMP konstaterede, at når Halaven anvendes som tredjevalgsbehandling for brystkræft (efter mindst to tidligere behandlinger med lægemidler mod fremskreden eller metastatisk kræft), forlænger det patienternes overlevelsestid, og sikkerhedsprofilen holder sig inden for det, der kan forventes af kemoterapeutiske lægemidler.
English: How has Halaven been studied?
Danish: Hvordan blev Halaven undersøgt?
English: Halaven was also studied in 143 patients with liposarcoma who had previously undergone at least two other treatments, which included an anthracycline.
Danish: Halaven blev også undersøgt hos 143 patienter med liposarkom, som tidligere havde gennemgået mindst to andre behandlingsforløb med et antracyklinpræparat.
English: Halaven is used to treat locally advanced or metastatic breast cancer which has continued to spread after at least one previous treatment for advanced cancer.
Danish: Halaven anvendes til at behandle lokalt fremskreden eller metastatisk brystcancer med fortsat spredning efter mindst en anden behandling for fremskreden cancer.
English: In the first study, Halaven was compared with other treatments in 762 women with advanced or metastatic breast cancer, who had previously undergone at least two other treatments, which included an anthracycline and a taxane.
Danish: I den første undersøgelse blev Halaven sammenlignet med andre behandlinger hos 762 kvinder med fremskreden eller metastatisk brystcancer, som tidligere havde gennemgået mindst to andre behandlinger, der omfattede et antracyklin- og et taxanpræparat.
English: When Halaven was used as breast cancer second-line therapy (after at least one previous cancer treatment for advanced/metastatic disease), Halaven was a valuable treatment option similar to capecitabine and with an acceptable safety profile.
Danish: Når Halaven blev anvendt som andenvalgsbehandling for brystkræft (efter tidligere behandling med mindst ét lægemiddel mod fremskreden eller metastatisk kræft), var Halaven et godt behandlingsalternativ svarende til capecitabin og havde en tilfredsstillende sikkerhedsprofil.
English: What is Halaven used for?
Danish: Hvad anvendes Halaven til?
English: What benefit has Halaven shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Halaven?
English: How is Halaven used?
Danish: Hvordan anvendes Halaven?
English: In the first study, when comparing Halaven with all the other treatments grouped together, Halaven was shown to be more effective at prolonging life.
Danish: I den første undersøgelse viste Halaven sig at være mere effektivt til livsforlængelse, når det blev sammenlignet med alle andre behandlinger tilsammen.
English: It is available as a solution for injection.
Danish: Det fås som en injektionsvæske, opløsning.
English: Doctors should consider giving patients an antiemetic (a medicine that prevents nausea and vomiting) as Halaven may cause nausea or vomiting.
Danish: Halaven kan forårsage kvalme eller opkastning, og lægen bør overveje at give patienten et antiemetikum (et lægemiddel, som forebygger kvalme og opkastning).
English: How does Halaven work?
Danish: Hvordan virker Halaven?
English: 12 sachets l t o r
Danish: 12 breve t r
English: EMEA Procedure number
Danish: EMEA's procedurenr.
English: Sachet (alu)
Danish: Kutan anvendelse Brev (alu)
English: Invented name Strength Pharmaceutical Form Route of administration Packaging
Danish: Lægemiddelform Indgivelsesvej
English: • this is given once every 3 weeks
Danish: • dette indgives hver 3. uge
English: Preparation Date: ______________ Preparation Time: ______________ Prepared By: __________________
Danish: Tilberedningsdato: ______________ Tilberedningstidspunkt: _____________ Tilberedt af: __________________
English: This can happen straight away or later on in your treatment.
Danish: Dette kan ske straks eller senere i din behandling.
English: The use of gloves is required
Danish: Anvendelse af handsker er påkrævet.
English: Not Known: frequency cannot be estimated from the available data:
Danish: Ikke kendt: hyppigheden kan ikke estimeres ud fra forhåndenværende data:
English: • how well your body responds to the medicine.
Danish: • hvor godt din krop reagerer på medicinen.
English: Treatment usually lasts for about 3 to 6 months.
Danish: Behandlingen varer i reglen cirka 3 til 6 måneder.
English: Date of first authorisation: 13 July 2000 Date of latest renewal: 02 July 2010
Danish: Dato for første markedsføringstilladelse: 13. juli 2000 Dato for seneste fornyelse: 02. juli 2010
English: Your doctor will work out exactly how much you need.
Danish: Lægen vil udregne nøjagtigt, hvor meget du har brug for.
English: Median PFS (months)a
Danish: Median PFS (måneder)a
English: The number of times you have the drip depends on:
Danish: Antallet af gange, du skal have drop, afhænger af:
English: The doctor may give you a lower dose if they think you need it.
Danish: Lægen kan give dig en lavere dosis, hvis han/hun skønner, at du har behov for det.
English: Less than 25,000
Danish: Under 25.000
English: 4.5 Interactions with other medicinal products and other forms of interactions
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: These are signs of an allergic reaction and your drip (infusion) may have to be stopped:
Danish: Disse er tegn på en allergisk reaktion, og dit drop (infusion) skal måske stoppes:
English: Your doctor will do tests during your treatment to check that the medicine is working properly.
Danish: Din læge vil foretage undersøgelser under din behandling for at kontrollere, om medicinen virker korrekt.
English: How much you will be given
Danish: Så meget får du
English: 4 Less than 500
Danish: 4 Under 500
English: 4 Requires parenteral or enteral support
Danish: 4 Kræver parenteral eller enteral støttebehandling.
English: • reduced levels of certain blood cells - your doctor will regularly check your blood for this and decide if any treatment is required.
Danish: • nedsatte mængder af visse blodlegemer - din læge vil jævnligt kontrollere dit blod for dette og træffe beslutning om, hvorvidt der kræves nogen behandling.
English: You may get painful, red or dry skin.
Danish: Du kan få smertende, rød eller tør hud.
English: The following side effects may happen with this medicine.
Danish: Følgende bivirkninger kan forekomme med denne medicin.
English: • high blood glucose level (your doctor will see this in a blood test)
Danish: • højt blodsukkerniveau (din læge kan se dette i en blodprøve)
English: • Personnel should be trained to reconstitute the medicinal product.
Danish: • Personalet skal være uddannet i rekonstitution af lægemidlet.
English: Patients who suffer from this should avoid driving and operating machinery.
Danish: Patienter, der lider heraf, bør undgå at føre motorkøretøj og betjene maskiner.
English: Findings regarding response rate and progression-free survival are provided in Table 3.
Danish: Resultater vedrørende responsrate og progressionsfri overlevelse er givet i tabel 3.
English: This medicine is normally given by a doctor or nurse.
Danish: Dette lægemiddel bliver normalt indgivet af en læge eller sundhedspersonalet.
English: • the stage of your breast cancer
Danish: • stadiet af din brystkræft
English: Secondary endpoint
Danish: a Sekundært endpoint
English: • While heating proceed to step 4
Danish: • Mens det varmer fortsæt til trin 4
English: • you have ever had heart problems such as a heart attack, heart failure or you have had high blood pressure for a long time
Danish: • du nogensinde har haft problemer med hjertet som for eksempel hjerteanfald, hjertesvigt eller hvis du har haft højt blodtryk i lang tid
English: • you have liver problems.
Danish: • du har leverproblemer
English: Liquid waste may be flushed with large amounts of water.
Danish: Flydende affald kan skylles ud i afløbet med store mængder vand.
English: This is based on the size of your body (measured in “square metres” or “m2”).
Danish: Dette baseres på din kropsstørrelse (målt i ”kvadratmeter” eller ”m2”).
English: • the medicine “cyclophosphamide” is given on the same day.
Danish: • medicinen ”cyclophosphamid” indgives samme dag.
English: Three inserts, each with two 43.7mm openings per insert must be used.
Danish: Der skal anvendes tre indsatser med hver to 43,7 mm åbninger pr. indsats.
English: οC, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Danish: οC, medmindre rekonstituering og fortynding er sket under kontrollerede og godkendte aseptiske forhold.
English: These acute phenomena may be avoided by using a 1-hour infusion time.
Danish: Disse akutte fænomener kan undgås ved at anvende en infusionstid på 1 time.
English: If extravasation occurs, the infusion should be immediately terminated.
Danish: Dersom der forekommer ekstravasation, bør infusionen omgående seponeres.
English: • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Danish: • Utilsigtet kontakt med hud eller øjne skal omgående behandles med rigelige mængder vand.
English: The following information is intended for healthcare professionals only: PREPARATION GUIDE
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: KLARGØRINGSVEJLEDNING
English: 4.7 Effect on ability to drive and use machines
Danish: 4.7 Virkning på evnen til at føre motorkøretøj og betjene maskiner
English: These side effects may stop if the drip is given more slowly over a longer period of time.
Danish: Disse bivirkninger kan holde op, hvis droppet bliver indgivet langsommere over længere tid.
English: Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spain
Danish: Polígon Industrial Els Vinyets - Els Fogars, Sector 2, Carretera Comarcal C244, km 22 08777 Sant Quintí de Mediona (Barcelona) Spanien
English: If you feel dizzy or are not sure how you feel, do not drive or use any tools or machines.
Danish: Hvis du føler dig svimmel eller ikke er sikker på, hvordan du har det, så lad være med at føre motorkøretøj eller betjene værktøj eller maskiner.
English: If myelotoxicity delays treatment to greater than 35 days after the first dose of the previous cycle, then consideration should be given to stopping treatment.
Danish: Hvis myelotoksicitet forsinker behandlingen mere end 35 dage efter den første dosis af den foregående cyklus, bør det overvejes helt at ophøre med behandlingen.
English: • a change in how you walk, speech problems
Danish: • ændring i din gang, problemer med at tale
English: To ensure correct temperature control the use of a 35mm immersion thermometer is recommended.
Danish: For at sikre korrekt temperaturstyring anbefales det at anvende et 35 mm neddypningstermometer.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE /FORNYELSE AF TILLADELSEN
English: They will also look out for any side effects such as blood problems or heart problems.
Danish: Man vil også holde øje med eventuelle bivirkninger, som for eksempel problemer med blodet eller hjertet.
English: Pressure build-up may require venting.
Danish: Trykopbygning kan kræve udluftning.
English: It is important you read the entire contents of this guide prior to the preparation of this medicinal product.
Danish: Det er vigtigt, at du gennemlæser hele indholdet af denne vejledning, inden klargøringen af lægemidlet.
English: This type of medicine is called “chemotherapy”.
Danish: Denne type medicin kaldes kemoterapi.
English: • yellow skin or eyes.
Danish: • gul hud eller gule øjne.
English: Dosing subsequent to a dose reduction is left to the discretion of the physician in charge of the patient.
Danish: Dosering efter dosisreduktion overlades til den læge, der har ansvaret for patienten.
English: Ice may be applied to the affected area for approximately 30 minutes.
Danish: Der kan lægges is på det påvirkede område i cirka 30 minutter.
English: • warfarin - for thinning the blood
Danish: • warfarin - for at fortynde blodet
English: Verify the temperature set point by checking the thermometer.
Danish: Kontrollér temperaturindstillingspunktet ved at kontrollere termometeret.
English: 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 webportal
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er 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.
English: • All items for administration or cleaning, including gloves, should be placed in a high-risk, waste disposal bag for high-temperature incineration.
Danish: • Alle dele til indgivelse eller rengøring, herunder handsker, skal placeres i en særlig affaldspose til højrisikoaffald beregnet til forbrænding ved høje temperaturer.
English: RECOMMENDATIONS FOR SAFE HANDLING
Danish: ANBEFALINGER FOR SIKKER HÅNDTERING
English: • Personnel handling this medicinal product during reconstitution should wear protective clothing including masks, goggles and gloves.
Danish: • Personale, der håndterer dette lægemiddel, skal under rekonstitutionen bære beskyttelsestøj herunder masker, beskyttelsesbriller og -handsker.
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 hours at 2
Danish: Hvis det ikke anvendes øjeblikkeligt, er brugeren ansvarlig for opbevaringstid og -betingelser inden brug, der normalt ikke vil være mere end 24 timer ved 2
English: However, reduction of the QRS complex is considered more indicative of cardiac toxicity.
Danish: Reduktion af QRS-kompleks betragtes dog som værende mere indikativ for hjertetoksicitet.
English: If possible, Myocet liposomal should be avoided in patients with bilirubin > 50 μmol/l as the recommendation is based mainly on extrapolations.
Danish: Myocet liposomal skal om muligt undgås til patienter med bilirubin > 50 μmol/l, idet anbefalingen hovedsageligt er baseret på ekstrapolation.
English: The recommended dose is between 60 and 75 mg of the medicine for each square meter of your body:
Danish: Den anbefalede dosis er mellem 60 og 75 mg medicin for hver kvadratmeter af din krop:
English: Bilirubin < ULN and normal AST
Danish: Bilirubin < ULN og normal AST
English: These may be signs of a liver problem called jaundice.
Danish: Dette kan være tegn på et leverproblem kaldet gulsot