FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose to be given depends on the patient's bodyweight and the infusion is repeated every 3 weeks.
Danish: Dosis afhænger af patientens legemsvægt, og infusionen gentages hver 3. uge.
English: Other information about Kadcyla
Danish: Andre oplysninger om Kadcyla
English: Patients may remain on treatment unless the disease gets worse or unless they no longer tolerate treatment.
Danish: Patienterne kan fortsætte på behandlingen, indtil sygdommen bliver værre, eller til behandlingen ikke længere tåles.
English: A risk management plan has been developed to ensure that Kadcyla is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Kadcyla anvendes så risikofrit som muligt.
English: In patients who develop allergic reactions or side effects, the treating doctor may have to reduce the dose or stop treatment with Kadcyla.
Danish: Hos patienter, der får allergiske reaktioner eller bivirkninger, kan lægen være nødt til at nedsætte dosis eller standse behandlingen med Kadcyla.
English: Patients should be observed during and after the infusion for any infusion-related reactions such as flushing, shivering fits and fever.
Danish: Patienterne bør observeres under og efter infusionen for eventuelle reaktioner på infusionen såsom rødme, kulderystelser og feber.
English: What measures are being taken to ensure the safe and effective use of Kadcyla?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kadcyla?
English: Kadcyla trastuzumab emtansine
Danish: Kadcyla trastuzumabemtansin
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Kadcyla's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Kadcyla opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In one main study, which involved 991 such patients, those treated with Kadcyla lived on average for 9.6 months without their disease getting worse compared with 6.4 months for patients who were treated with two other anti-cancer medicines, capecitabine and lapatanib.
Danish: I én hovedundersøgelse med deltagelse af 991 sådanne patienter levede de, der blev behandlet med Kadcyla, i gennemsnit i 9,6 måneder uden forværring af sygdommen, sammenlignet med 6,4 måneder for dem, der blev behandlet med de to andre kræftlægemidler capecitabin og lapatinib.
English: The most common side effects with Kadcyla (which may affect more than 25% of patients) are nausea (feeling sick), fatigue (tiredness) and headache.
Danish: De hyppigste bivirkninger ved Kadcyla (som kan forekomme hos mere end 25 % af patienterne) er kvalme, træthed og hovedpine.
English: Why is Kadcyla approved?
Danish: Hvorfor er Kadcyla blevet godkendt?
English: Patients treated with Kadcyla also survived for 31 months compared with 25 months for patients treated with capecitabine and lapatinib.
Danish: De patienter, der blev behandlet med Kadcyla, overlevede desuden i 31 måneder, sammenholdt med 25 måneder for dem, der blev behandlet med capecitabin og lapatinib.
English: Regarding Kadcyla's safety, overall side effects were considered to be manageable and the overall safety profile was considered favorable compared with other currently available medicines.
Danish: Vedrørende sikkerheden af Kadcyla fandtes bivirkningerne overvejende at kunne behandles, og den overordnede sikkerhedsprofil blev anset for fordelagtig i forhold til andre tilgængelige lægemidler.
English: What is Kadcyla and what is it used for?
Danish: Hvad er Kadcyla, og hvad anvendes det til?
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 bindes i cellerne til proteinet tubulin, der er vigtigt for dannelsen af cellernes indvendige "skelet", som cellerne skal samle for at kunne dele sig.
English: What are the risks associated with Kadcyla?
Danish: Hvilke risici er der forbundet med Kadcyla?
English: Kadcyla can only be obtained with a prescription and treatment should be prescribed by a doctor and given under the supervision of a healthcare professional who is experienced in the treatment of cancer patients.
Danish: Kadcyla fås kun på recept, og behandlingen bør iværksættes af en læge og gives under opsyn af en sundhedsperson med erfaring i behandling af kræftpatienter.
English: It is not intended to provide practical advice on how to use Kadcyla.
Danish: Det er ikke en praktisk vejledning i, hvordan Kadcyla bør anvendes.
English: The active substance in Kadcyla, trastuzumab emtansine, is made up of two active components which are linked together:
Danish: Det aktive stof i Kadcyla, trastuzumabemtansin, består af to aktive komponenter, der er koblet sammen:
English: It is used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in adults who previously received trastuzumab and a taxane (type of cancer medicine).
Danish: Det anvendes til behandling af fremskreden brystkræft, der har bredt sig til andre dele af kroppen (er metastatisk) hos voksne, der tidligere er blevet behandlet med trastuzumab og et taxan (en type kræftmedicin).
English: Kadcyla can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer cell produces on its surface large quantities of a protein which stimulates the growth of the cancer cell and is called HER2 (human epidermal growth factor).
Danish: Kadcyla kan kun anvendes, når kræftsygdommen er påvist at have "overekspression af HER2": Det vil sige, at kræftcellerne på deres overflade producerer store mængder af proteinet HER2 (human epidermal vækstfaktor), som stimulerer kræftcellers vækst.
English: For more information about treatment with Kadcyla, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Kadcyla, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: DM1 becomes active once Kadcyla enters the cancer cell.
Danish: DM1 bliver aktivt, når Kadcyla trænger ind i kræftcellen.
English: The most common serious side effects are haemorrhage (bleeding), pyrexia (fever), dyspnoea (difficulty breathing), musculoskeletal pain (pain in muscles and bones), thrombocytopenia (low blood platelet counts), abdominal pain (stomach ache), and vomiting.
Danish: De hyppigste alvorlige bivirkninger er blødning, feber, vejrtrækningsbesvær (dyspnø), muskel- og ledsmerter, for lavt antal blodplader (trombocytopeni), mavesmerter og opkastning.
English: Kadcyla has been shown to significantly delay disease getting worse and to prolong survival in patients with advanced and metastatic breast cancer that expressed HER2 and who were previously treated with trastuzumab and a taxane.
Danish: Kadcyla er påvist at bremse sygdommens forværring væsentligt og at forlænge overlevelsen hos patienter, der havde fremskreden metastatisk brystkræft med ekspression af HER2 og tidligere var blevet behandlet med trastuzumab og et taxan.
English: Kadcyla is a cancer medicine that contains the active substance trastuzumab emtansine.
Danish: Kadcyla er et lægemiddel mod kræft og indeholder det aktive stof trastuzumabemtansin.
English: • Trastuzumab, a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the protein HER2, which is found in large quantities on the surface of some cancer cells.
Danish: • Trastuzumab er et protein af typen monoklonalt antistof, som er opbygget, så det genkender og bindes til proteinet HER2, der findes i store mængder på overfladen af visse kræftceller.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the cancer cells.
Danish: Ved at bindes til HER2 aktiverer trastuzumab immunsystemets celler, som derefter dræber kræftcellerne.
English: Trastuzumab also stops HER2 from stimulating the growth of the cancer cells.
Danish: Trastuzumab forhindrer desuden HER2 i at stimulere kræftcellernes vækst.
English: By attaching to tubulin in cancer cells, DM1 stops the formation of this skeleton, preventing the division and growth of the cancer cells.
Danish: Ved at bindes til tubulin i kræftcellerne blokerer DM1 opbygningen af dette skelet og forhindrer derved kræftcellerne i at dele sig og vokse.
English: About a quarter of breast cancers overexpress HER2.
Danish: Overekspression af HER2 findes i omkring en fjerdedel af alle brystkræfttilfælde.
English: The CHMP considered that in patients treated with Kadcyla, there was a significant improvement in survival compared with standard therapy.
Danish: CHMP fandt, at behandling med Kadcyla resulterede i væsentligt bedre overlevelse end standardbehandling.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kadcyla, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: I produktresuméet og indlægssedlen for Kadcyla er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter.
English: For the full list of all side effects reported with Kadcyla, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Kadcyla fremgår af indlægssedlen.
English: For practical information about using Kadcyla, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Kadcyla, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Kadcyla is available as a powder that is made up into a solution for infusion (drip) into a vein.
Danish: Kadcyla leveres som et pulver, der efter opløsning indgives med drop (ved infusion i en vene).
English: What benefits of Kadcyla have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Kadcyla?
English: How is Kadcyla used?
Danish: Hvordan anvendes Kadcyla?
English: How does Kadcyla work?
Danish: Hvordan virker Kadcyla?
English: Because of a potential risk of confusion between Kadcyla and Herceptin due to their similar sounding active substances (trastuzumab emtansine and trastuzumab) the company will provide educational material to all healthcare professionals expected to use Kadcyla or Herceptin to alert them not to use these medicines interchangeably and to inform them of measures they should take to avoid medication errors.
Danish: Virksomheden skal derfor udlevere informationsmateriale til alle sundhedspersoner, der forventes at anvende Kadcyla eller Herceptin, med henblik på at de ikke anvender det ene af disse lægemidler i stedet for det andet, og for at informere dem om forholdsregler, de bør træffe for at undgå fejlmedicinering.
English: The recommended dose is two tablets taken once a day with food for 8, 12 or 24 weeks.
Danish: Den anbefalede dosis er to tabletter én gang dagligt, der tages sammen med mad i 8, 12 eller 24 uger.
English: Viekirax received a marketing authorisation valid throughout the EU on 15 January 2015.
Danish: Viekirax fik en markedsføringstilladelse med gyldighed i hele EU den 15. januar 2015.
English: Further information on Viekirax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Viekirax findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This slows the removal of paritaprevir from the body, allowing paritaprevir to act against the virus for longer.
Danish: Derved bremses udskillelsen af paritaprevir fra kroppen, så paritaprevir kan virke i længere tid mod virusset.
English: As for all medicines, data on the use of Viekirax are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Viekirax løbende overvåget.
English: Other information about Viekirax
Danish: Andre oplysninger om Viekirax
English: It contains 3 active substances: ombitasvir, paritaprevir and ritonavir.
Danish: Det indeholder 3 aktive stoffer: ombitasvir, paritaprevir og ritonavir.
English: Almost all the patients with these genotypes treated in studies had the virus cleared from their blood.
Danish: Næsten alle patienter med disse genotyper, der var omfattet af studierne, fik elimineret virus fra blodet.
English: For more information about using Viekirax, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Viekirax, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Viekirax is available as tablets containing 12.5 mg ombitasvir, 75 mg paritaprevir and 50 mg ritonavir.
Danish: Viekirax fås som tabletter, der indeholder 12,5 mg ombitasvir, 75 mg paritaprevir og 50 mg ritonavir.
English: The Agency therefore decided that Viekirax's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Agenturet konkluderede derfor, at fordelene ved Viekirax opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: By blocking these proteins, the medicine prevents the hepatitis C virus from multiplying and infecting new cells.
Danish: Ved at blokere disse proteiner forhindrer lægemidlet hepatitis C-virusset i at formere sig og inficere nye celler.
English: What measures are being taken to ensure the safe and effective use of Viekirax?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Viekirax?
English: The clearance rate was particularly high in patients infected with genotypes 1b and 4.
Danish: Eliminationsraten var særligt høj hos patienter, der var smittet med genotype 1b og 4.
English: Side effects reported with Viekirax are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Viekirax vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What is Viekirax and what is it used for?
Danish: Hvad er Viekirax, og hvad anvendes det til?
English: It must also not be used together with medicines that can raise or lower the levels of Viekirax's active substances in the blood.
Danish: Viekirax må heller ikke anvendes sammen med lægemidler, der kan øge eller sænke indholdet af Viekirax' aktive stoffer i blodet.
English: This study is being carried out in light of data suggesting that patients treated with these medicines who have had liver cancer could be at risk of their cancer returning early.
Danish: Studiet gennemføres på baggrund af data, der indikerer, at patienter, der har haft leverkræft, og som behandles med disse lægemidler, kan være i risiko for, at kræften vender hurtigt tilbage.
English: An overview of Viekirax and why it is authorised in the EU
Danish: En oversigt over Viekirax, og hvorfor det er godkendt i EU
English: The third active substance, ritonavir, does not act directly against hepatitis C virus but it blocks the action of an enzyme called CYP3A that breaks down paritaprevir.
Danish: Det tredje aktive stof, ritonavir, virker ikke direkte på hepatitis C-virus, men blokerer virkningen af enzymet CYP3A, der nedbryder paritaprevir.
English: Why is Viekirax authorised in the EU?
Danish: Hvorfor blev Viekirax godkendt i EU?
English: The combination of medicines used and the duration of treatment will depend on the genotype of hepatitis C virus infecting the patient, the nature of the patient's liver problems, for example if they have liver cirrhosis (scarring) or their liver is not working properly, and whether they have received previous treatment.
Danish: Kombinationen af lægemidler og behandlingens varighed afhænger af, hvilken genotype af hepatitis C-virus patienten er smittet med, hvilken type leverproblemer patienten har, dvs. om patienten f.eks. har skrumpelever (levercirrose (ardannelse i leveren)) eller utilstrækkelig leverfunktion, og om patienten er blevet behandlet tidligere.
English: When Viekirax was given with dasabuvir, the virus was cleared from the blood in 91% of the patients.
Danish: Når Viekirax blev givet sammen med dasabuvir, blev virus elimineret fra blodet hos 91 % af patienterne.
English: Several varieties (genotypes) of hepatitis C virus exist, and Viekirax is recommended for patients with virus of genotypes 1a, 1b and 4.
Danish: Der findes flere genotyper (varianter) af hepatitis C-virus, og Viekirax anbefales til patienter med virus af genotype 1a, 1b og 4.
English: The company that markets Viekirax will carry out a study in patients who have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as Viekirax.
Danish: Den virksomhed, der markedsfører Viekirax, skal gennemføre et studie med patienter, der tidligere har haft leverkræft, for at vurdere risikoen for, at kræften vender tilbage efter behandling med direkte virkende antivirale lægemidler som Viekirax.
English: Viekirax is always used in combination with other medicines for chronic hepatitis C, such as dasabuvir and ribavirin.
Danish: Viekirax anvendes altid i kombination med andre lægemidler mod kronisk hepatitis C, f.eks. dasabuvir og ribavirin.
English: The European Medicines Agency noted that Viekirax in combination with other medicines is effective in clearing the hepatitis C virus genotypes 1a, 1b and 4, including in patients with liver scarring.
Danish: Det Europæiske Lægemiddelagentur bemærkede, at Viekirax i kombination med andre lægemidler er effektivt til at eliminere hepatitis C-virus genotype 1a, 1b og 4, herunder hos patienter med skrumpelever.
English: Viekirax can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in managing patients with chronic hepatitis C.
Danish: Viekirax udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af kronisk hepatitis C.
English: The most common side effects with Viekirax in combination with dasabuvir and ribavirin (which may affect more than 1 in 5 people) are tiredness and nausea (feeling sick).
Danish: De hyppigste bivirkninger ved Viekirax i kombination med dasabuvir og ribavirin (der kan forekomme hos mere end 1 ud af 5 patienter) er træthed og kvalme.
English: What are the risks associated with Viekirax?
Danish: Hvilke risici er der forbundet med Viekirax?
English: In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.
Danish: I et syvende studie blev patienter, der havde skrumpelever, men stabil leverfunktion (kompenseret cirrose), og som var smittet med genotype 1b, behandlet med Exviera og Viekirax uden ribavirin, og virus blev elimineret fra blodet hos 100 % af patienterne (60 ud af 60).
English: An additional study showed Viekirax to be effective against genotype 4: when given with ribavirin, Viekirax cleared this genotype from the blood of all the 91 patients infected with it after 12 weeks.
Danish: Et yderligere studie viste, at Viekirax var effektivt mod genotype 4: Når Viekirax blev givet sammen med ribavirin, var genotype 4 efter 12 uger elimineret fra blodet hos alle 91 patienter, der var smittet med denne genotype.
English: For the full list of side effects and restrictions of Viekirax, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Viekirax fremgår af indlægssedlen.
English: Viekirax must not be used in patients with moderate to severe liver impairment and in women taking ethinylestradiol, an oestrogen found in hormonal contraceptives.
Danish: Viekirax må ikke anvendes hos patienter med moderat til svært nedsat leverfunktion eller hos kvinder, der får østrogenet ethinylestradiol, der findes i hormonale præventionsmidler.
English: Although there were some cases of raised liver enzymes in patients treated with Viekirax in combination with dasabuvir and ribavirin, side effects with this combination were generally well tolerated.
Danish: Selvom der sås forhøjede leverenzymer hos nogle af de patienter, der blev behandlet med Viekirax i kombination med dasabuvir og ribavirin, var bivirkningerne ved denne kombinationsbehandling generelt håndterbare.
English: Viekirax is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Danish: Viekirax er et antiviralt (virusbekæmpende) lægemiddel, der bruges i kombination med andre lægemidler til behandling af kronisk hepatitis C (smitsom leverbetændelse forårsaget af hepatitis Cvirus).
English: How is Viekirax used?
Danish: Hvordan anvendes Viekirax?
English: What benefits of Viekirax have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Viekirax?
English: The 3 active substances in Viekirax work in different ways: ombitasvir blocks the action of a protein in the hepatitis C virus called ‘NS5A' and paritaprevir blocks the action of another protein called ‘NS3/4A', both of which the virus needs to multiply.
Danish: Ombitasvir blokerer virkningen af hepatitis Cvirussets protein (NS5A), mens paritaprevir blokerer virkningen af et andet protein (NS3/4A).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Viekirax have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Viekirax.
English: How does Viekirax work?
Danish: Hvordan virker Viekirax?
English: In patients with liver scarring, Viekirax treatment in combination with dasabuvir and ribavirin resulted in a clearance rate of between 93% and 100% after 24 weeks of treatment.
Danish: Patienter med skrumpelever opnåede en elimination af virus på mellem 93 % og 100 % efter 24 ugers behandling med Viekirax kombineret med dasabuvir og ribavirin.
English: In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Viekirax in combination with dasabuvir was effective in clearing the virus from the blood.
Danish: Viekirax i kombination med dasabuvir var effektivt til at eliminere virus fra blodet i 6 hovedstudier med ca. 2 300 patienter med hepatitis C-virus genotype 1a eller 1b. Mellem 96 % og 100 % af patienterne uden skrumpelever fik elimineret virus fra blodet efter 12 ugers behandling (med eller uden ribavirin).
English: • less able to remember things
Danish: • dårligere til at huske ting
English: There must be at least 3 hours between each dose.
Danish: Der skal være mindst 3 timer mellem hver dosis.
English: In small children, this may be 4 to 6 times a day.
Danish: For små børn kan dette være 4 til 6 gange om dagen.
English: Date of first authorisation: 27 November 2015
Danish: Dato for første markedsføringstilladelse: 27. november 2015
English: • There are no other ingredients.
Danish: • Der er ingen andre indholdsstoffer.
English: Final study report expected end of July 2030.
Danish: Den endelige studierapport forventes i udgangen af juli
English: Forty-four patients were evaluated in this analysis.
Danish: 44 patienter blev evalueret i denne analyse.
English: 1 (6.3%) each
Danish: 1 (6,3%) af hver
English: The conversion is as follows:
Danish: Omregningen er følgende:
English: If you take these medicines, you may need regular blood tests:
Danish: Hvis du tager disse lægemidler, skal du muligvis have taget regelmæssige blodprøver:
English: Oral or gastroenteral use.
Danish: Oral eller gastroenteral anvendelse.
English: continued according to feeding schedule for 4-8 hours.
Danish: fortsættes i henhold til ernæringsregimet i 4-8 timer