FrancophonIA/ELRC3.0 huggingface dataset:
English: The company informed the CHMP that there are no consequences on patients currently included in clinical trials, compassionate use programmes or named patient programmes with Vorinostat MSD.
Danish: Virksomheden har informeret CHMP om, at tilbagetrækningen ingen konsekvenser får for patienter, som nu deltager i kliniske undersøgelser, i programmer for anvendelse med særlig udleveringstilladelse eller i programmer for navngivne patienter med særlig udleveringstilladelse med Vorinostat MSD.
English: What was Vorinostat MSD expected to be used for?
Danish: Hvad forventedes Vorinostat MSD anvendt til?
English: How is Vorinostat MSD expected to work?
Danish: Hvordan forventes Vorinostat MSD at virke?
English: Because Vorinostat MSD was not compared with any other treatment, its safety and effectiveness could not be adequately assessed.
Danish: Sikkerheden og virkningen af Vorinostat MSD kunne ikke vurderes på behørig vis, fordi lægemidlet ikke var blevet sammenlignet med nogen anden behandling.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cervarix on 20 September 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Cervarix den 20. september 2007.
English: This compared with 56 of the more than 7,000 women who received the other vaccine.
Danish: Dette kan sammenholdes med 56 af de mere end 7 000 kvinder, der fik den anden vaccine.
English: This document is a summary of the European public assessment report (EPAR) for Cervarix.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cervarix.
English: This will help to protect against the diseases caused by these viruses.
Danish: Dette vil hjælpe til at beskytte mod de sygdomme, som disse vira forårsager.
English: The vaccine is given as an injection into the shoulder muscle.
Danish: Vaccinen gives som en injektion i skuldermusklen.
English: The full EPAR for Cervarix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Cervarix findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Cervarix is given according to official recommendations.
Danish: Cervarix gives i overensstemmelse med de officielle anbefalinger.
English: The women were followed up for up to four years after the first dose of the vaccines.
Danish: Kvinderne blev fulgt i op til fire år, efter de modtog den første dosis af vaccinen.
English: Cervarix is a vaccine.
Danish: Cervarix er en vaccine.
English: The antibodies help to destroy the virus.
Danish: Antistofferne er med til at ødelægge virussen.
English: Cervarix is given as two or three doses depending on age.
Danish: Cervarix gives som to eller tre doser afhængig af patientens alder.
English: For the prevention of anal lesions and cancer, four studies were carried out.
Danish: Hvad angår beskyttelse mod anale læsioner og kræft, blev der udført fire undersøgelser.
English: Other information about Cervarix
Danish: Andre oplysninger om Cervarix
English: There are more than 100 types of papillomavirus, some of which are associated with genital and anal cancers.
Danish: Der findes over 100 typer papillomavirus, hvoraf nogle typer er forbundet med genitale og anale cancerformer.
English: A similar study was carried out in girls aged 9 to 14 years of age.
Danish: En lignende undersøgelse blev udført hos piger i alderen 9-14 år.
English: It is recommended that individuals who receive the first dose of Cervarix should complete the course of vaccination.
Danish: Det anbefales, at personer, der får den første dosis Cervarix, gennemfører hele vaccinationsforløbet.
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Danish: Efter vaccinationen er immunsystemet hurtigere i stand til at producere antistoffer, når det udsættes for de virkelige virus.
English: What measures are being taken to ensure the safe and effective use of Cervarix?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cervarix?
English: For more information about treatment with Cervarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Cervarix, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: However, the second and third doses can be given after longer gaps if necessary.
Danish: Den anden og tredje dosis kan dog om nødvendigt gives efter længere tidsintervaller.
English: The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Danish: Proteinerne samles i "viruslignende partikler"(strukturer, der ligner HPV, så kroppen let kan genkende dem).
English: Papillomaviruses are viruses that cause warts and abnormal tissue growth.
Danish: Papillomavira er vira, der forårsager vorter og abnorm vævsvækst.
English: If necessary, the second dose can be given between 5 and 13 months after the first dose.
Danish: Den anden dosis kan om nødvendigt gives mellem 5 og 13 måneder efter den første dosis.
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 Cervarix.
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 Cervarix skal anvendes.
English: It is a suspension for injection that contains purified proteins for two types of the human papillomavirus (types 16 and 18).
Danish: Det er en injektionsvæske, suspension, som indeholder oprensede proteiner fra to typer af det humane papillomavirus (type 16 og 18).
English: When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Danish: Når en patient får vaccinen, danner immunsystemet antistoffer mod L1-proteinerne.
English: The studies looking at the levels of antibodies in males showed that their levels were similar to those in females.
Danish: De undersøgelser, der fokuserede på antistofniveauerne hos mænd viste, at deres niveauer svarede til kvindernes.
English: It is recommended that there is one month between the first and second doses, and five months between the second and third doses.
Danish: Der anbefales et tidsinterval på én måned mellem den første og anden dosis og et tidsinterval på fem måneder mellem den anden og tredje dosis.
English: Cervarix human papillomavirus vaccine [types 16, 18] (recombinant, adjuvanted, adsorbed)
Danish: Cervarix human papillomavirusvaccine [type 16, 18] (rekombinant, adjuveret, adsorberet)
English: The most common side effects with Cervarix (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection including pain, redness and swelling, and fatigue (tiredness).
Danish: De hyppigste bivirkninger ved Cervarix (som optræder hos flere end 1 ud af 10 patienter) er hovedpine, myalgi (muskelsmerter), reaktioner på injektionsstedet, herunder smerte, rødme og hævelse samt træthed.
English: All papillomaviruses have a shell or ‘capsid', which is made up of distinctive proteins called ‘L1 proteins'.
Danish: Alle papillomavira har en skal eller et "kapsid", der består af særlige proteiner kaldet "L1-proteiner".
English: The CHMP decided that Cervarix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Cervarix opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Cervarix.
English: People aged 9 to 14 years can be given two doses, six months apart.
Danish: Piger i alderen 9-14 år kan få to doser med seks måneders mellemrum.
English: Cervarix was more effective than the comparator vaccine in preventing abnormal cell growth in the cervix.
Danish: Cervarix var mere effektiv end sammenligningsvaccinen til at forebygge celleforandringer i livmoderhalsen.
English: Cervarix is used in males and females from the age of 9 years to protect against the following conditions caused by certain types of the human papillomavirus (HPV):
Danish: Cervarix anvendes til mænd/drenge og kvinder/piger på ni år og derover til beskyttelse mod følgende tilstande forårsaget af specifikke typer af human papillomavirus (HPV):
English: HPV types 16 and 18 cause approximately 70% of cervical cancers and 90% of anal cancers.
Danish: HPV type 16 og 18 er årsag til ca. 70 % af alle tilfælde af livmoderhalskræft og omkring 90% af alle tilfælde af analkræft.
English: The study also showed that Cervarix can provide protection against infection or lesions linked to some other HPV types.
Danish: Undersøgelsen viste desuden, at Cervarix kan yde beskyttelse mod infektioner eller læsioner med forbindelse til visse andre HPV-typer.
English: The vaccine is made using an ‘adjuvant system' that contains MPL, a purified lipid (a fat-like substance) extracted from bacteria, which enhances the response of the immune system to the vaccine.
Danish: Vaccinen fremstilles ved hjælp af et "adjuverende system", der indeholder MPL, en oprenset væske (en fedtlignende substans) udvundet af bakterier, som øger immunsystemets respons på vaccinen.
English: Taken together these results suggested that the vaccine would be effective at protecting from infection with these HPV types when given from 9 years of age, and that a two-dose vaccination is suitable in those aged 9 to
Danish: Set i sammenhæng indikerede disse resultater, at vaccinen ville være effektiv til at beskytte mod infektion med disse HPVtyper, når den blev givet fra niårsalderen, og at to-dosis vaccinationen er egnet til personer i alderen 9-14 år.
English: The vaccine is ‘adsorbed', which means that the virus-like particles and the MPL are fixed onto an aluminium compound, to stimulate a better immune response.
Danish: Vaccinen er »adsorberet«, hvilket betyder, at de viruslignende partikler og MPL er bundet til en aluminiumholdig forbindelse, hvorved immunresponsen forbedres.
English: To support the use in boys and men, two other studies compared the development of protective antibodies in males versus females.
Danish: For at støtte anvendelsen hos drenge og mænd blev deres udvikling af beskyttende antistoffer sammenlignet med pigers og kvinders i to undersøgelser.
English: What is the risk associated with Cervarix?
Danish: Hvilken risiko er der forbundet med Cervarix?
English: One study compared the level of protective antibodies developed in adult women after Cervarix use and compared it with those of another HPV vaccine already authorised for anal lesions and cancer.
Danish: I en undersøgelse blev niveauet af beskyttende antistoffer udviklet hos voksne kvinder efter at have anvendt Cervarix sammenlignet med niveauet hos en gruppe, der fik en anden HPV-vaccine, der allerede var godkendt til at behandle anale læsioner og kræft.
English: Why has Cervarix been approved?
Danish: Hvorfor blev Cervarix godkendt?
English: The additional five studies also showed that all of those aged 9 years and older who were given three doses of Cervarix developed high levels of antibodies against HPV types 16 and 18.
Danish: De supplerende fem undersøgelser viste endvidere, at alle personer på ni år og derover, som fik tre doser Cervarix, udviklede høje niveauer af antistoffer mod HPV-type 16 og 18.
English: For the full list of all side effects and restrictions with Cervarix, see the package leaflet
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cervarix fremgår af indlægssedlen.
English: Five additional studies also looked at the development of antibodies in girls and women from 9 to 25 years of age who were given three doses of Cervarix.
Danish: I fem supplerende undersøgelser blev udviklingen af antistoffer endvidere undersøgt hos piger og kvinder i alderen 9-25 år, som fik tre doser Cervarix.
English: Data on protection against precancerous vulvar and vaginal lesions indicated that Cervarix could be effective in protecting against these lesions.
Danish: Dataene om beskyttelse mod forstadier til kræft i de ydre kønsdele eller vagina viste, at Cervarix kunne være effektivt til at beskytte mod disse forstadier.
English: For the prevention of anal lesions and cancer, the studies that compared either 2 doses or 3 doses of Cervarix with another HPV vaccine authorised for anal cancer showed that antibody levels in women and girls were similar or better with Cervarix than with the other vaccine.
Danish: Som beskyttelse mod forstadier til analkræft og kræft viste undersøgelserne, der sammenlignede enten to eller tre doser Cervarix med en anden HPV-vaccine, der var godkendt til at behandle analkræft, at niveauet af antistoffer hos kvinder og piger var tilsvarende eller højere med Cervarix end med den anden vaccine.
English: These data indicate that Cervarix could be effective in protecting against anal lesions and cancer in males and females.
Danish: Disse data tyder på, at Cervarix kunne være effektivt til at beskytte mod forstadier til analkræft og kræft hos mænd og kvinder.
English: The main measure of effectiveness was the development of protective antibodies against HPV types 16 and 18 one month after the last dose in previously unvaccinated subjects.
Danish: Virkningen blev hovedsagelig målt på udviklingen af beskyttende antistoffer mod HPV-type 16 og 18 én måned efter indgivelsen af den sidste dosis hos ikke tidligere vaccinerede personer.
English: In the first main study, after an average of 39 months, four of the more than 7,000 women who received Cervarix and who had not been infected with HPV types 16 or 18 before, developed precancerous lesions in the cervix linked to these HPV types.
Danish: I den første hovedundersøgelse, efter gennemsnitligt 39 måneder, udviklede fire ud af de mere end 7 000 kvinder, som modtog Cervarix, og som ikke oprindeligt var smittet med HPV-type 16 eller 18, forstadier til livmoderhalskræft med forbindelse til disse HPV-typer.
English: People aged 15 and above are given three doses.
Danish: Piger og kvinder på 15 år og derover får tre doser.
English: The company also presented data on protection against precancerous vulvar and vaginal lesions in patients given Cervarix.
Danish: Virksomheden fremlagde desuden data om beskyttelse mod forstadier til kræft i de ydre kønsdele eller vagina hos patienter, der får Cervarix.
English: • precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva, vagina or anus).
Danish: • forstadier til kræft (abnorm cellevækst) i det genitale område (livmoderhals, ydre kønsdele, skeden eller endetarmsåbningen),
English: What is Cervarix?
Danish: Hvad er Cervarix?
English: Cervarix contains purified L1 proteins for HPV types 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by cells into which a gene (DNA) has been introduced that makes the cells able to produce the L1 proteins.
Danish: Cervarix indeholder oprensede L1-proteiner fra HPV-type 16 og 18, som er fremstillet ud fra en metode, der kaldes "rekombinant DNA-teknologi".
English: The study looked at how many women, who in the vast majority had no current infection with HPV types 16 or 18 at the start of the study, went on to develop precancerous lesions in the cervix linked to infection with these types of HPV.
Danish: I undersøgelsen blev der fokuseret på, hvor mange kvinder - hvoraf langt størstedelen ikke havde nogen infektion forårsaget af HPV-type 16 og 18 ved undersøgelses startudviklede forstadier til kræft i livmoderhalsen, som var forbundet med en infektion med disse HPVtyper.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cervarix have 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 sundhedspersonale og patienter skal følge for at sikre risikofri og effektiv anvendelse af Cervarix.
English: A second main study looked at the effect of two doses of Cervarix in girls aged 9 to 14 years compared with the effect of three doses in girls and women aged 15 to 25.
Danish: Virkningen af de to doser Cervarix hos piger i alderen 9-14 år blev sammenlignet med virkningen af tre doser hos piger og kvinder i alderen 15-25 år i en anden hovedundersøgelse.
English: How has Cervarix been studied?
Danish: Hvordan blev Cervarix undersøgt?
English: What is Cervarix used for?
Danish: Hvad anvendes Cervarix til?
English: What benefit has Cervarix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Cervarix?
English: How is Cervarix used?
Danish: Hvordan anvendes Cervarix?
English: The second main study showed that two doses of Cervarix given 5 to 13 months apart were no less effective in girls aged 9 to 14 than a standard three-dose vaccination was in older subjects: all previously unprotected subjects had developed high levels of protective antibodies against virus types 16 and 18 one month after their last dose.
Danish: Den anden hovedundersøgelse viste, at to doser Cervarix givet med 5-13 måneders mellemrum ikke var mindre effektiv hos piger i alderen 9-14 end en standard tre-dosis vaccination var hos ældre individer.
English: Cervarix was compared with another vaccine that is not active against HPV (in this case, a vaccine against hepatitis A virus).
Danish: Cervarix som beskyttelse mod forstadier til kræft eller livmoderhalskræft blev undersøgt i en hovedundersøgelse, der omfattede næsten 19 000 kvinder i alderen 15-25 år Cervarix blev sammenlignet med en anden vaccine, som ikke er aktiv mod HPV (i dette tilfælde en vaccine mod hepatitis A-virus).
English: How does Cervarix work?
Danish: Hvordan virker Cervarix?
English: • cancer of the cervix (neck of the womb) or anus;
Danish: • Livmoderhalskræft eller kræft i endetarmen
English: List of the names, pharmaceutical forms, strength of the medicinal product, route of administration, applicant in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelformer, styrke, indgivelsesvej, ansøgere i medlemsstaterne
English: Pharmaceutic al form
Danish: Lægemiddelform Indgivelsesvej
English: Mommox 0,05mg/dávku 50 microgram/dose nasal spray, suspension
Danish: Mommox 0,05mg/dávku 50 mikrogram/dosis næsespray, suspension nasal anvendelse
English: Luxembourg Sandoz B.V. Veluwezoom 22
Danish: Luxembourg Sandoz B.V.
English: United Kingdom Sandoz B.V. Veluwezoom 22
Danish: Storbritannien Sandoz B.V.
English: Belgium Sandoz B.V. Veluwezoom 22
Danish: Grækenland Sandoz B.V.
English: Mometasone Furoate/Sandoz 50 microgram/dose nasal spray, suspension
Danish: Mometasone Furoate/Sandoz 50 mikrogram/dosis næsespray, suspension nasal anvendelse
English: Mometasone furoate Sandoz 50 microgram/dose nasal spray, suspension
Danish: Mometasone furoate Sandoz 50 mikrogram/dosis næsespray, suspension nasal anvendelse
English: • Healthcare professionals have been informed in writing about these recommendations.
Danish: • Sundhedspersoner er informeret skriftligt om disse anbefalinger.
English: This inspection found that corrective measures previously agreed had not been appropriately implemented.
Danish: Ved inspektionen blev det konstateret, at tidligere aftalte korrigerende foranstaltninger ikke var blevet behørigt gennemført.
English: In particular, several manufacturing shortcomings had not been resolved.
Danish: Navnlig var adskillige mangler vedrørende fremstillingen ikke blevet udbedret.
English: * This document was revised on 14 October 2016 in line with an updated CHMP opinion clarifying recommendations concerning prohibition of supply.
Danish: * Dette dokument er revideret den 14. oktober 2016 i overensstemmelse med en ajourført udtalelse fra CHMP, hvori anbefalingerne vedrørende forbud mod udlevering præciseres.
English: The review of medicines manufactured by Pharmaceutics International Inc, US, was initiated on 23 June 2016 at the request of the European Commission under Article 31 of Directive 2001/83/EC.
Danish: Gennemgangen af lægemidler, der fremstilles af Pharmaceutics International Inc., USA, blev påbegyndt den 23. juni 2016 på anmodning af Europa-Kommissionen i medfør af artikel 31 i direktiv 2001/83/EF.
English: The CHMP's recommendation concerning these medicines were sent to the European Commission, which issued a legally binding decision valid throughout the EU.
Danish: CHMP's anbefalinger vedrørende disse lægemidler blev sendt til Europa-Kommissionen, der vedtog en juridisk bindende afgørelse med gyldighed i hele EU.
English: The medicines from these alternative sites therefore remain available in the EU.
Danish: Lægemidlerne fra disse andre fremstillingssteder er derfor fortsat tilgængelige i EU.
English: The manufacturing site had insufficient measures in place to reduce the risk that traces of one medicine could be transferred to another (cross-contamination).
Danish: På fremstillingsstedet var der ikke indført tilstrækkelige foranstaltninger til at mindske risikoen for, at spor af ét lægemiddel kunne overføres til et andet (krydskontaminering).
English: More information on Ammonaps can be found here.
Danish: Yderligere oplysninger kan findes her.
English: • There was no impact on the quality of the medicines produced at this site and corrective measures are currently being taken at the site to address these issues.
Danish: • Dette havde ingen indvirkning på kvaliteten af de lægemidler, der blev fremstillet på dette fremstillingssted, og der træffes nu korrigerende foranstaltninger på stedet for at løse disse problemer.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 29/11/2016 (Ammonaps) and 5/12/2016 (Dutasteride Actavis and associated names, Lutinus and associated names and SoliCol D3).
Danish: CHMP's udtalelser blev fremsendt til Europa-Kommissionen, som udstedte en endelig, retligt bindende beslutning, der finder anvendelse i alle EU's medlemsstater, den 29. november 2016 (Ammonaps) og den 5. december 2016 (Dutasteride Actavis og relaterede navne, Lutinus og relaterede navne, og SoliCol D3).
English: The Committee noted that recommendations on prohibitions of supply have been issued by the national supervisory authority.
Danish: Udvalget konstaterede, at de nationale tilsynsmyndigheder har udstedt anbefalinger om forbud mod udlevering.
English: The recommendation was the outcome of a review of good manufacturing practice (GMP) at Pharmaceutics International Inc.
Danish: Denne anbefaling var resultatet af en gennemgang af god fremstillingspraksis (GMP) hos Pharmaceutics International Inc.
English: Ammonaps is a medicine authorised in the EU through the centralised procedure, whereas the other medicines have been authorised through national procedures.
Danish: Lægemidlet Ammonaps er godkendt i EU ved den centrale procedure, mens de øvrige lægemidler er godkendt ved nationale procedurer.
English: For Lutigest/Lutinus, some batches produced at the US site were still available on the EU market and were to be recalled.
Danish: Med hensyn til Lutigest/Lutinus var nogle batcher, som var fremstillet på fremstillingsstedet i USA, stadig på markedet i EU og skulle tilbagekaldes.
English: In countries where alternatives are available, your doctor will consider putting you on another treatment.
Danish: I lande, hvor der er andre behandlingsmuligheder, vil lægen overveje at sætte dig i anden behandling.
English: The medicine is only to be marketed once evidence is provided that its manufacturing is compliant with GMP standards.
Danish: Lægemidlet vil først blive markedsført, når det er dokumenteret, at det fremstilles i overensstemmelse med GMP-standarderne.