FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Zalviso.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zalviso.
English: The full EPAR and risk management plan summary for Zalviso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Zalviso findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Zalviso
Danish: Andre oplysninger om Zalviso
English: What is Zalviso and what is it used for?
Danish: Hvad er Zalviso, og hvad anvendes det til?
English: Why is Zalviso approved?
Danish: Hvorfor blev Zalviso godkendt?
English: The device locks for 20 minutes after the patient has taken a tablet and does not allow the patient to take more than 3 doses in one hour.
Danish: Anordningen er låst i 20 minutter efter, at patienten har taget en tablet, og tillader ikke patienten at tage mere end 3 doser i løbet af en time.
English: Zalviso is a ‘hybrid medicine'.
Danish: Zalviso er et "hybridt lægemiddel".
English: A risk management plan has been developed to ensure that Zalviso is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zalviso anvendes så sikkert som muligt.
English: Because Zalviso is a hybrid generic, the applicant presented data on the reference medicine in addition to results from its own studies.
Danish: Da Zalviso er et hybridt generisk lægemiddel, fremlagde ansøgeren oplysninger om referencelægemidlet foruden resultaterne af sine egne undersøgelser.
English: The tablets must be allowed to dissolve under the tongue and must not be chewed or swallowed.
Danish: Tabletterne skal opløses under tungen og må ikke tygges eller synkes.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but Zalviso is available in a different form.
Danish: Det vil sige, at det svarer til et "referencelægemiddel", der indeholder samme aktive stof, men Zalviso fås i en anden form.
English: The most serious side effect is respiratory depression (impaired breathing) which could potentially lead to the patient stopping breathing altogether.
Danish: Den alvorligste bivirkning er nedsat vejrtrækning (respirationsdepression), som kan føre til, at patienten helt holder op med at trække vejret.
English: Zalviso must not be used in patients who already have significant impaired breathing.
Danish: Zalviso må ikke anvendes hos patienter, der i forvejen har væsentligt nedsat vejrtrækning.
English: The most common side effects with Zalviso (which may affect more than 1 in 10 people) are nausea (feeling sick) and vomiting.
Danish: De hyppigste bivirkninger ved Zalviso (som kan forekomme hos mere end 1 ud af 10 personer) er kvalme og opkastning.
English: Of 177 patients using Zalviso, 139 rated their pain control as excellent or good (79%), compared with 118 of 180 (66%) using morphine.
Danish: Af 177 patienter, der anvendte Zalviso, bedømte de 139 deres smertekontrol som glimrende eller god (79 %), sammenholdt med 118 af 180 (66 %) af dem, der anvendte morfin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zalviso'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 Zalviso opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Regarding safety, the side effects were those expected of opioids, and were considered manageable.
Danish: Hvad sikkerheden angår, var bivirkningerne dem, man forventer af opioider, og blev anset for at kunne behandles.
English: What measures are being taken to ensure the safe and effective use of Zalviso?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zalviso?
English: The main measure of effectiveness was based on a patient score that measured the decrease in intensity of pain over 48 hours of treatment.
Danish: Det vigtigste mål for virkningen var baseret på en patientscore, der målte faldet i smerteintensiteten i løbet af 48 timers behandling.
English: In both cases Zalviso was compared with placebo (a dummy treatment).
Danish: I begge tilfælde blev Zalviso sammenlignet med virkningsløs behandling (placebo).
English: What are the risks associated with Zalviso?
Danish: Hvilke risici er der forbundet med Zalviso?
English: The Committee considered that an additional option for patient-controlled pain relief immediately after surgery, when the pain is worst, was beneficial, especially since it did not need to be given into a vein.
Danish: Udvalget fandt, at det var nyttigt med en supplerende mulighed for patientstyret smertelindring straks efter en operation, når smerterne er værst, navnlig fordi det ikke behøvede at indgives i en vene.
English: Zalviso is an opioid (a strong painkiller) that is used to treat pain occurring in adults after an operation.
Danish: Zalviso er et opioid (et stærkt smertestillende middel), der anvendes til behandling af smerter hos voksne efter en operation.
English: The tablets are only for use in hospital and can only be obtained with a prescription from a doctor experienced in treating patients with opioids.
Danish: Resoribletterne er kun til hospitalsbrug og fås kun på recept fra en læge med erfaring i at behandle patienter ved hjælp af opioider.
English: When the patient places a Zalviso tablet under the tongue, a dose of sufentanil is rapidly absorbed into the blood stream through the blood vessels in the lining of the mouth.
Danish: Når patienten anbringer en tablet af Zalviso under tungen, optages en dosis af sufentanil hurtigt i blodet ved blodets gennemstrømning af karrene i mundslimhinden.
English: It is not intended to provide practical advice on how to use Zalviso.
Danish: Det er ikke en praktisk vejledning i, hvordan Zalviso bør anvendes.
English: The device also uses an identifier so that only the patient who has been given a special thumb tag can release tablets.
Danish: Anordningen har desuden en identifikator, så kun den patient, der har fået en særlig elektronisk kode, kan udløse tabletterne.
English: For abdominal surgery, the average decrease in pain intensity was 50 points greater with Zalviso than with placebo (106 versus 56).
Danish: Ved abdominalkirurgi var det gennemsnitlige fald i smerteintensiteten 50 point større med Zalviso end med placebo (106 mod 56).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zalviso, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zalviso, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: This allows the medicine to be transported to receptors in the brain and spinal cord where sufentanil acts to relieve pain.
Danish: Derved bliver lægemidlet transporteret til receptorerne i hjernen og rygraden, hvor sufentanil lindrer smerterne.
English: For more information about treatment with Zalviso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zalviso, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For the full list of side effects and restrictions with Zalviso, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Zalviso fremgår af indlægssedlen.
English: The active substance in Zalviso, sufentanil, is an opioid.
Danish: Det aktive stof i Zalviso er sufentanil, der er et opioid.
English: For knee and hip surgery the decrease in pain intensity was around 88 points greater with Zalviso (76 versus -11) than with placebo.
Danish: Ved knæ- og hofteoperation var faldet i smerteintensitet ca. 88 point større med Zalviso (76 mod -11) end med placebo.
English: The reference medicine for Zalviso is called Sufenta Forte, and is available as a solution for injection, whereas Zalviso is available as sublingual tablets (tablets to be dissolved under the tongue).
Danish: Referencelægemidlet for Zalviso er Sufenta Forte, der fås som injektionsvæske, hvorimod Zalviso fås som tabletter, der opløses under tungen (sublinguale resoribletter).
English: The patient places the Zalviso tablets under their tongue when needed using a special device.
Danish: Patienten anbringer efter behov Zalviso-resoribletterne under tungen ved hjælp af en særlig anordning.
English: It contains the active substance sufentanil.
Danish: Zalviso indeholder det aktive stof sufentanil.
English: Zalviso is available as sublingual tablets containing 15 micrograms of sufentanil.
Danish: Zalviso fås som sublinguale resoribletter med 15 µg sufentanil.
English: How does Zalviso work?
Danish: Hvordan virker Zalviso?
English: For practical information about using Zalviso, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Zalviso, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What benefits of Zalviso have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Zalviso?
English: How is Zalviso used?
Danish: Hvordan anvendes Zalviso?
English: However, considering the fact that post-operative pain improves by itself over time as well as the potential for addiction or the body becoming used to the opioid and requiring larger doses, the medicine and its administration device should only be used in a hospital setting, and restricted to use for a maximum duration of 72 hours.
Danish: Smerterne efter operationer aftager imidlertid af sig selv med tiden, og der er mulighed for afhængighed eller for, at kroppen vænner sig til opioider og kræver større doser.
English: A third main study compared Zalviso with a patient-controlled pain relief system using morphine, another opioid, and involved 359 patients who had undergone major abdominal, knee or hip surgery.
Danish: I den tredje hovedundersøgelse blev Zalviso sammenlignet med et patientstyret smertelindringssystem, hvor der blev anvendt et andet opioid (morfin).
English: One main study involved 178 patients who had abdominal surgery (surgery on the belly) and another involved 426 patients who had surgery on the knee or hip.
Danish: En anden havde deltagelse af 426 patienter, der fik foretaget operation af knæet eller hoften.
English: These side effects were normally mild or moderate.
Danish: Disse bivirkninger var sædvanligvis lette eller moderate.
English: This will help to protect against the diseases caused by these viruses.
Danish: Dette beskytter mod den sygdom, som disse virus forårsager.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil 9 on 10 June 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Gardasil 9 den 10. juni 2015.
English: These virus-like particles are not capable of causing infection or disease.
Danish: Disse viruslignende partikler kan ikke bevirke smitte eller sygdom.
English: This is a summary of the European public assessment report (EPAR) for Gardasil 9.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Gardasil 9.
English: The full EPAR and risk management plan summary for Gardasil 9 can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Gardasil 9 findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The women were followed up for around three and a half years after the third dose of the vaccine.
Danish: Kvinderne blev fulgt op i ca. tre et halvt år efter den tredje dosis vaccine.
English: Human papillomaviruses are viruses that cause warts and abnormal tissue growth.
Danish: Human papillomavirus er virus, der forårsager vorter og abnorm vækst af væv.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Gardasil 9'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 Gardasil 9 opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: There are more than 100 types of papillomavirus, some of which are associated with anogenital cancers in both men and women.
Danish: Der findes mere end 100 typer papillomavirus, hvoraf nogle er knyttet til kræft omkring kønsdelene og anus hos både mænd og kvinder.
English: Gardasil 9 is given according to official recommendations.
Danish: Gardasil 9 anvendes i henhold til officielle anbefalinger.
English: human papillomavirus 9-valent vaccine (recombinant, adsorbed)
Danish: human papillomavirusvaccine, 9-valent (rekombinant, adsorberet)
English: A risk management plan has been developed to ensure that Gardasil 9 is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Gardasil 9 anvendes så sikkert som muligt.
English: There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Danish: Der skal altid gå mindst en måned mellem første og anden dosis, og mindst tre måneder mellem den anden og den tredje dosis, og alle doserne bør gives i løbet af et år.
English: Nearly 100% of cervical cancers are caused by HPV infection.
Danish: Næsten 100 % af alle tilfælde af livmoderhalskræft skyldes HPV-infektion.
English: Patients who show signs of an allergy after a dose of Gardasil 9 (or of its precursor vaccines Gardasil or Silgard) should stop the vaccination course or should not receive Gardasil 9 at all.
Danish: Patienter, der viser tegn på allergi efter en dosis af Gardasil 9 (eller en af vaccinens forløbere, Gardasil eller Silgard) bør stoppe vaccinationsforløbet eller bør slet ikke modtage Gardasil 9.
English: In Europe, approximately 90% of anal cancers, 15% of vulvar cancers, 70% of vaginal cancers, and 30 to 40% of penile cancers are estimated to be caused by HPV infection.
Danish: I Europa skønnes cirka 90 % af alle tilfælde af analkræft, 15 % af vulvakræft, 70 % af vaginalkræft og 30-40 % af peniskræft at være forårsaget af HPV-infektion.
English: In studies, the most common side effects with Gardasil 9 (seen in more than 1 patient in 10) were reactions at the site of the injection (redness, pain and swelling) and headache.
Danish: I undersøgelserne var de hyppigste bivirkninger ved Gardasil 9 (som optræder hos mere end 1 ud af 10 patienter) reaktioner på injektionsstedet (rødme, smerter og hævelse) og hovedpine.
English: Other information about Gardasil 9
Danish: Andre oplysninger om Gardasil 9
English: It contains purified proteins from the nine types of HPV listed above.
Danish: Det indeholder rensede proteiner fra de ni typer HPV, der er nævnt ovenfor.
English: This study also showed that antibody levels against types 6, 11, 16 and 18 were adequate to protect against these four types of HPV infection.
Danish: Undersøgelsen viste også, at indholdet af antistoffer mod type 6, 11, 16 og 18 var tilstrækkeligt til at beskytte mod disse fire typer HPV-infektion.
English: The vaccine also contains an ‘adjuvant', a compound containing aluminium to stimulate a better response.
Danish: Vaccinen indeholder desuden en aluminiumholdig forbindelse (et "adjuvans"), der forstærker immunreaktionen.
English: HPV types 16 and 18 cause a large majority of cervical and anal cancers, while HPV types 6 and 11 cause most of genital warts.
Danish: HPV type 16 og 18 er årsag til langt de fleste tilfælde af livmoderhalskræft og analkræft, mens HPV type 6 og 11 er årsag til størstedelen af kønsvorter.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil 9, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Gardasil 9, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Regarding side effects, although a large proportion of subjects develop injection site reactions, these are only slightly more than for Gardasil.
Danish: Hvad bivirkninger angår, opstod der reaktioner på injektionsstedet hos en stor del af de vaccinerede, dog kun i lidt større omfang end ved Gardasil.
English: • precancerous lesions (growths) and cancers in the cervix, vulva or vagina and anus;
Danish: • kræftforstadier (prækankrøse forandringer) og kræft i livmoderhalsen (cervix), kvindens ydre kønsdele (vulva), skeden (vagina) og endetarmsåbningen (anus),
English: A further 5 HPV types (31, 33, 45, 52, and 58) also carry a high risk for developing cancer (they cause around 20% of cervical cancers).
Danish: Der er fem andre HPV-typer (31, 33, 45, 52 og 58), som også medfører høj kræftrisiko (de er årsag til ca. 20 % af alle tilfælde af livmoderhalskræft).
English: All papillomaviruses have a shell, or ‘capsid', that is made up of proteins called ‘L1 proteins'.
Danish: Alle papillomavirus har en skal (et capsid) bestående af L1-proteiner.
English: What measures are being taken to ensure the safe and effective use of Gardasil 9?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Gardasil 9?
English: The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Danish: Det er strukturer, der ligner HPV, så kroppen let kan genkende dem.
English: It is not intended to provide practical advice on how to use Gardasil 9.
Danish: Det er ikke en praktisk vejledning i, hvordan Gardasil 9 bør anvendes.
English: For more information about treatment with Gardasil 9, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Gardasil 9, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Why is Gardasil 9 approved?
Danish: Hvorfor blev Gardasil 9 godkendt?
English: What are the risks associated with Gardasil 9?
Danish: Hvilke risici er der forbundet med Gardasil 9?
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 one month after the third dose.
Danish: Det vigtigste mål for virkningen var dannelsen af antistoffer mod HPV type 6, 11, 16, 18, 31, 33, 45, 52 og 58 en måned efter den tredje dosis.
English: For a three-dose schedule, the second dose should be given two months after the first and the third given four months after the second.
Danish: Når den gives som tre doser, skal den anden dosis gives to måneder efter den første, og den tredje gives fire måneder efter den anden.
English: What is Gardasil 9 and what is it used for?
Danish: Hvad er Gardasil 9, og hvad anvendes det til?
English: This study found that Gardasil 9 stimulates similar levels of protection against all nine virus types in young men and women.
Danish: Undersøgelsen viste, at Gardasil 9 gav samme niveau af beskyttelse mod alle ni virustyper hos unge mænd og kvinder.
English: The fifth main study involving 1,518 subjects compared the effect of a two-dose schedule of Gardasil 9 with a three-dose schedule.
Danish: Den femte undersøgelse omfattede 1 518 personer og sammenlignede virkningen af 2 doser af Gardasil 9 med virkningen af tre doser.
English: For a twodose schedule, the second dose should be given between five and thirteen months after the first dose.
Danish: Når den gives som to doser, skal den anden dosis gives mellem 5 og 13 måneder efter den første dosis.
English: This study looked at the development of antibodies one month after the last dose, and it showed that boys and girls given two doses of Gardasil 9 have similar levels of protection against all nine virus types to girls and women given three doses of Gardasil 9.
Danish: Undersøgelsen så på udviklingen af antistoffer en måned efter den sidste dosis og viste, at piger og drenge, der fik 2 doser af Gardasil 9, havde samme niveau af beskyttelse mod alle 9 virustyper som piger og kvinder, der fik tre doser Gardasil 9.
English: The third study compared the effect of Gardasil 9 with the effect of Gardasil in 600 girls aged 9 to 15 years.
Danish: I den tredje undersøgelse sammenlignedes virkningen af Gardasil 9 med Gardasil hos 600 piger i alderen 9-15 år.
English: The fourth main study compared the levels of antibodies against all nine HPV types one month after the third dose in around 1,419 young men aged 16 to 26 with those in 1,101 women aged 16 to 26.
Danish: I den fjerde hovedundersøgelse blev antistofindholdet mod alle ni HPV-typer målt en måned efter den tredje dosis hos ca. 1 419 unge mænd i alderen 16-26 år og sammenlignet med antistofindholdet hos 1 101 kvinder i alderen 16-26 år.
English: Thus Gardasil 9 is expected to prevent the majority of cervical, vaginal and vulvar cancers and premalignant lesions, as well as genital warts associated with HPV.
Danish: Gardasil 9 forventes derfor at forebygge størstedelen af kræfttilfælde i livmoderhalsen, skeden og kvindens ydre kønsdele samt forstadier til kræft og kønsvorter knyttet til HPV.
English: For the full list of all side effects reported with Gardasil 9, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Gardasil 9 fremgår af indlægssedlen.
English: For practical information about using Gardasil 9, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Gardasil 9, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The study showed that the vaccine stimulates the production of adequate levels of antibodies against HPV of all nine types in girls and boys aged between nine and 15 years when compared with women 16-26 years of age, for whom protection against disease was demonstrated in the first study.
Danish: Undersøgelsen viste, at vaccinen bevirkede dannelse af tilstrækkelige mængder antistoffer mod alle ni typer HPV hos piger og drenge i alderen 9-15 år ligesom hos de kvinder i alderen 16-26 år, der blev beskyttet mod sygdom i den første undersøgelse.
English: The first study looked at the effectiveness of Gardasil 9 in over 14,000 women aged between 16 and 26 years.
Danish: Den første undersøgelse omhandlede effektiviteten af Gardasil 9 hos over 14 000 kvinder i alderen 1626 år.
English: Gardasil 9 is normally given according to a either a two-dose schedule or a three-dose schedule for males and females from 9 to 14 years old and a three-dose schedule for males and females 15 years old and over.
Danish: Gardasil 9 gives normalt enten som to eller tre doser til begge køn fra 9-14 år, og som tre doser til begge køn fra 15 år og derover.
English: Gardasil 9 is a vaccine used in males and females from the age of nine years to protect against the following conditions caused by nine types of the human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58):
Danish: Gardasil 9 er en vaccine, der anvendes hos begge køn fra niårsalderen til beskyttelse mod følgende sygdomme forårsaget af ni typer human papillomavirus (HPV-type 6, 11, 16, 18, 31, 33, 45, 52 og
English: The second study in 3066 subjects compared the effect of Gardasil 9 in girls and boys aged nine to 15 years with the effect of Gardasil 9 in young women aged 16 to 26 years.
Danish: I den anden undersøgelse hos 3 066 personer sammenlignedes virkningen af Gardasil 9 hos piger og drenge i alderen 9-15 år med virkningen af Gardasil 9 hos unge kvinder i alderen 16-26 år.