FrancophonIA/ELRC3.0 huggingface dataset:
English: Varroosis is a disease of honey bees caused by infestation with a parasite called varroa mite (Varroa destructor).
Danish: Varroasyge er en sygdom hos honningbier, som er angrebet af en parasit, der kaldes en varroamide (Varroa destructor).
English: An overview of Dany's BienenWohl and why it is authorised in the EU
Danish: En oversigt over Dany's BienenWohl, og hvorfor det er godkendt i EU
English: The varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in harm and/or death of bees.
Danish: Varroamidens ernæring består af hæmolymfe (blod) fra voksne bier samt larver og pupper (honningbiens udviklingsstadier), hvilket resulterer i, at honningbierne skades og/eller dør.
English: Why is Dany's BienenWohl authorised in the EU?
Danish: Hvorfor blev Dany's BienenWohl godkendt i EU?
English: What is Dany's BienenWohl and what is it used for?
Danish: Hvad er Dany's BienenWohl, og hvad anvendes det til?
English: Dany's BienenWohl is available as a powder and solution to prepare a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Danish: Dany's BienenWohl fås som et pulver og opløsning til bistadedispersion (en væske, der bruges inde i bistadet) og udleveres uden recept.
English: What are the risks associated with Dany's BienenWohl?
Danish: Hvilke risici er der forbundet med Dany's BienenWohl?
English: If possible, the use of Dany's BienenWohl should be alternated with another medicine that kills mites in a different way to reduce the chance of the mites developing resistance.
Danish: For at forhindre udvikling af resistens hos miderne bør man om muligt skiftevis anvende Dany's BienenWohl og et andet middel, der slår miderne ihjel på en anden måde.
English: How is Dany's BienenWohl used?
Danish: Hvordan anvendes Dany's BienenWohl?
English: What benefits of Dany's BienenWohl have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Dany's BienenWohl?
English: How does Dany's BienenWohl work?
Danish: Hvordan virker Dany's BienenWohl?
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/14/955/001 Lymphoseek
Danish: Styrke Lægemiddelform Administration
English: The European Commission granted a marketing authorisation valid throughout the European Union for Silgard on 20 September 2006.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Silgard den 20. september 2006.
English: This document is a summary of the European public assessment report (EPAR) for Silgard.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Silgard.
English: The full EPAR for Silgard can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Silgard findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Silgard is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Silgard anvendes så sikkert som muligt.
English: Silgard is given according to official recommendations.
Danish: Silgard administreres i henhold til de officielle anbefalinger.
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
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,
English: Other information about Silgard:
Danish: Andre oplysninger om Silgard
English: What is the risk associated with Silgard?
Danish: Hvilken risiko er der forbundet med Silgard?
English: Patients who show signs of an allergy after a dose of Silgard should not receive further doses of the vaccine.
Danish: Patienter, som viser tegn på en allergisk reaktion efter dosering med Silgard, må ikke administreres yderligere doser af lægemidlet.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better
Danish: Vaccinen indeholder desuden en »adjuvans« (en aluminiumholdig forbindelse), som giver en bedre
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Silgard, 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 Silgard, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: In studies, the most common side effects with Silgard (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
Danish: I undersøgelserne var de hyppigste bivirkninger ved Silgard (som optrådte hos flere end 1 ud af 10 patienter) hovedpine og reaktioner på injektionsstedet (rødmen, smerter og hævelse).
English: Silgard is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Danish: Silgard 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: It is recommended that individuals who receive the first dose of Silgard should complete the dosing regimen with Silgard.
Danish: Det anbefales, at personer, der får den første dosis Silgard, gennemfører hele Silgarddoseringsregimet.
English: What measures are being taken to ensure the safe and effective use of
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Silgard?
English: In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
Danish: I modsætning hertil udviklede 85 af de over 8 000 kvinder, som fik en placebovaccine, læsioner forårsaget af disse to HPVtyper.
English: A similar effect of Silgard was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Danish: En tilsvarende virkning af Silgard sås, når analysen også omfattede læsioner i livmoderhalsen, som skyldes de andre to HPV-typer (type 6 og 11).
English: For more information about treatment with Silgard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Silgard, kan du læse indlægssedlen (også en del af denne EPAR) eller
English: human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Danish: human papillomavirusvaccine [type 6, 11, 16 og 18] (rekombinant,
English: In four main studies of Silgard given as three doses, Silgard was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Danish: I fire hovedundersøgelser af Silgard givet som tre doser, blev Silgard sammenlignet med placebo (en virkningsløs vaccine) hos næsten 21 000 kvinder i alderen 16-26 år.
English: The CHMP decided that Silgard's benefits are greater than its risks and recommended that it be given
Danish: CHMP besluttede, at fordelene ved Silgard opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Silgard.
English: For people aged nine to thirteen years, Silgard can be given as two doses six months apart.
Danish: Hos personer i alderen 9-13 år kan Silgard gives som to doser med seks måneders mellemrum.
English: There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate
Danish: Der var ingen tilfælde af analkræft i undersøgelsen, men beskyttelsen mod præcancerøse anallæsioner forventes at give en tilsvarende beskyttelse mod analkræft.
English: In addition, the results confirmed the ability of Silgard to protect against lesions and HPV infection in 24- to 45-year-old women.
Danish: Resultaterne bekræftede endvidere Silgards evne til at beskytte mod læsioner og HPV-forårsagede infektioner hos kvinder i alderen 24-45 år.
English: For people aged fourteen or above, Silgard is normally given according to a three-dose schedule with the second dose given two months after the first and the third given four months after the second..
Danish: Hos personer på 14 år og derover gives Silgard normalt ifølge et tredosisprogram, hvor den anden dosis gives to måneder efter den første, og den tredje dosis gives fire måneder efter den anden.
English: In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Silgard who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Danish: De fire undersøgelser hos 21 000 kvinder viste, at ud af de over 8 000 kvinder, der var vaccineret med Silgard og aldrig havde været inficeret med HPV-type 6, 11, 16 og 18, var der én kvinde, der udviklede en præcancerøs læsion i livmoderhalsen, som kunne skyldes HPV 16 eller 18.
English: In the three studies on genital lesions 2 women out of almost 8,000 in the Silgard group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Danish: I de tre undersøgelser vedrørende genitale læsioner udviklede to kvinder ud af næsten 8 000 i Silgardgruppen kønsvorter, og der var ingen tilfælde af præcancerøse læsioner i de ydre kønsdele og i vagina.
English: Another study in around 800 girls and women compared the effect of two doses of Silgard in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years.
Danish: I en anden undersøgelse, der omfattede ca. 800 piger og kvinder, blev virkningen af to doser Silgard hos piger i alderen 9-13 år sammenlignet med virkningen af tre doser hos piger og unge kvinder i alderen 16-24 år.
English: The studies also showed that Silgard provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.
Danish: Undersøgelserne viste desuden, at Silgard ydede en vis beskyttelse mod læsioner i livmoderhalsen, som skyldes to andre HPV-typer, herunder type 31.
English: For the full list of all side effects reported with Silgard, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Silgard fremgår af indlægssedlen.
English: Three studies of Silgard given as three doses looked at the ability of Silgard to prevent infection with HPV types 6, 11, 16 and 18 and genital lesions caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
Danish: Tre undersøgelser af Silgard givet som tre doser omhandlede Silgards evne til at forebygge infektion med HPV-type 6, 11, 16 og 18 samt genitale læsioner forårsaget af disse HPV-typer hos knap 4 000 kvinder i alderen 24-45 år samt dannelsen af antistoffer mod disse HPV-typer hos ca. 1 700 piger og
English: What benefit has Silgard shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der ved Silgard?
English: Silgard contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Danish: Silgard indeholder oprensede L1-proteiner fra HPV-type 6, 11, 16 og 18, som er fremstillet ved hjælp af en metode, der kaldes »rekombinant DNA-teknologi«.
English: Finally, a main study in around 4,000 boys and men from 16 to 26 years of age compared the vaccine against placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
Danish: Endelig blev vaccinen sammenlignet med placebo i en hovedundersøgelse, der omfattede ca. 4 000 drenge og mænd i alderen 16-26 år, med henblik på at undersøge vaccinens virkning i forbindelse med forebyggelse af kønsvorter, præcancerøse anallæsioner og analkræft.
English: The study testing Silgard given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.
Danish: Undersøgelsen af Silgard givet som to doser hos piger i alderen 9-13 år viste, at de to doser givet med seks måneders mellemrum ikke var mindre effektive end tredosisvaccinationen.
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18
Danish: Virkningen blev hovedsagelig målt på dannelsen af antistoffer mod HPV-type 6, 11, 16 og 18 en måned efter den sidste dosis.
English: It is available in vials or prefilled syringes.
Danish: Det fås i hætteglas eller fyldte
English: If this applies to you, the vaccination will not be given until you are feeling better.
Danish: Hvis dette gælder for dig, vil vaccinationen ikke blive givet, før du har det bedre.
English: These must be mixed together before use.
Danish: Disse skal blandes sammen inden brug.
English: These infections are passed easily from person to person and can cause death if not treated.
Danish: Disse infektioner overføres let fra person til person, og kan medføre dødsfald, hvis de ikke behandles.
English: • decreased feeling or sensitivity, especially in the skin
Danish: • nedsat følelse eller følsomhed, især i huden
English: Make sure you or your child finishes the complete vaccination course.
Danish: Sørg for, at du eller dit barn afslutter hele vaccinationsforløbet.
English: Date of first authorisation: 20 April 2012 Date of latest renewal: 16 February 2017
Danish: Dato for første markedsføringstilladelse: 20. april 2012 Dato for seneste fornyelse: 16. februar 2017
English: Nimenrix should be used in accordance with available official recommendations.
Danish: Nimenrix skal anvendes i overensstemmelse med tilgængelige, officielle anbefalinger.
English: • difficulty sleeping
Danish: • problemer med at sove
English: • pain in the arms or legs
Danish: • smerter i arme eller ben
English: • you have an infection with a high temperature (over 38°C).
Danish: • du har en infektion og høj feber (over 38 °C).
English: These antibodies help protect you against the diseases.
Danish: Disse antistoffer er med til at beskytte dig mod sygdommene.
English: However, do not drive or use any machines if you are feeling unwell.
Danish: Du må dog ikke køre i trafikken eller arbejde med maskiner, hvis du føler dig utilpas.
English: VR: vaccine response defined as the proportion of subjects with:
Danish: VR: vaccinerespons defineret som andelen af personer med:
English: No data are available beyond the age of 2 years.
Danish: Der foreligger ingen data for personer over 2 år.
English: The powder or cake is white.
Danish: Pulver eller pulverkage er hvidt.
English: • you are allergic to the active substances or any of the other ingredients in this vaccine (listed in section 6).
Danish: • hvis du er allergisk over for de aktive stoffer eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6).
English: If not used within 8 hours, do not administer the vaccine.
Danish: Er vaccinen ikke anvendt inden for 8 timer, må den ikke administreres.
English: • Do not use this medicine after the expiry date which is stated on the carton.
Danish: • Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP.
English: It is unknown whether Nimenrix is excreted in human milk.
Danish: Det vides ikke, om Nimenrix udskilles i human mælk.
English: Although delay is not recommended, stability has been demonstrated for 8 hours at 30°C after reconstitution.
Danish: Selvom det ikke anbefales at udskyde administrationen, er der vist stabilitet efter rekonstitution i 8 timer ved 30 °C.
English: 44 micrograms
Danish: 44 mikrogram
English: Your doctor will tell you if and when you need an additional dose of Nimenrix, especially if you or your child:
Danish: Lægen vil fortælle dig om og hvornår, du har behov for en yderligere dosis Nimenrix, især hvis du eller dit barn:
English: You will be informed when you or your child should come back for the next injection.
Danish: Du vil få at vide, hvornår du eller dit barn skal komme igen for at få den næste indsprøjtning.
English: • A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix.
Danish: • En poolet analyse af data fra 9.621 personer, som fik administreret en enkelt dosis Nimenrix.
English: Children (2-17 years) with anatomical or functional asplenia
Danish: Børn (2-17 år) med anatomisk eller funktionel aspleni
English: Adverse reactions reported are listed according to the following frequency categories:
Danish: De rapporterede bivirkninger er opstillet efter følgende hyppigheder:
English: • you have a bleeding problem or you bruise easily.
Danish: • du har blødningsproblemer eller let får blå mærker.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change in the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Adverse reactions reported in subjects aged >55 years were similar to those observed in younger adults.
Danish: Bivirkninger, som blev rapporteret hos forsøgspersoner i alderen > 55 år, var de samme som dem, der blev observeret hos yngre voksne.
English: Nimenrix helps your body to produce its own protection (antibodies) against the bacteria.
Danish: Nimenrix hjælper kroppen med at danne sin egen beskyttelse (antistoffer) mod bakterierne.
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Relevant medicinsk behandling og overvågning skal altid være let tilgængelig i tilfælde af, at der opstår en sjælden anafylaktisk reaktion efter administration af vaccinen.
English: Table 1 Tabulated summary of adverse reactions by system organ class System Organ Class
Danish: Skema 1 Liste over bivirkninger efter systemorganklasse Systemorganklasse
English: Pregnancy There is limited experience with use of Nimenrix in pregnant women.
Danish: Der er en begrænset erfaring med anvendelse af Nimenrix til gravide kvinder.
English: After reconstitution, the vaccine should be used promptly.
Danish: Efter rekonstitution skal vaccinen bruges straks.
English: An additional primary dose of Nimenrix may be considered appropriate for some individuals (see section 4.4).
Danish: En yderligere primærdosis Nimenrix kan være hensigtsmæssig for nogle personer (se pkt.
English: Nimenrix should not be mixed with other vaccines.
Danish: Nimenrix må ikke blandes med andre vacciner.
English: The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows:
Danish: Nimenrix' sikkerhed, som er angivet i nedenstående skema, er baseret på datasæt fra to kliniske studier:
English: A new needle should be used to administer the vaccine.
Danish: Der skal bruges en ny kanyle til administration af vaccinen.
English: Vaccination with Nimenrix should be postponed in subjects suffering from an acute severe febrile illness.
Danish: Vaccination med Nimenrix skal udsættes hos personer, der har en akut alvorlig febril sygdom.
English: Name and address of the manufacturers of the biological active substance GlaxoSmithKline Biologicals S.A.
Danish: Navn og adresse på fremstillerne af det biologisk aktive stof GlaxoSmithKline Biologicals S.A.
English: Table 1 shows the adverse reactions reported from the studies in subjects aged from 6 weeks up to 55 years of age and post-marketing experience.
Danish: Skema 1 viser de bivirkninger, som blev rapporteret fra studierne med forsøgspersoner i alderen 6 uger op til 55 år samt erfaringer efter markedsføring.
English: Protection against meningococcal disease
Danish: Beskyttelse mod meningokoksygdom
English: Pharmacotherapeutic group: vaccines, meningococcal vaccines, ATC code: J07AH08
Danish: Farmakoterapeutisk klassifikation: Vacciner, meningokokvacciner, ATC-kode: J07AH08
English: Nimenrix may be given to adults, adolescents, children and infants over the age of 6 weeks.
Danish: Nimenrix kan gives til voksne, unge, børn og spædbørn over 6 uger.
English: If you have a weak immune system (such as due to HIV infection or medicines that affect the immune system) you may not get a full benefit from Nimenrix.
Danish: Hvis du har nedsat immunforsvar (f.eks. på grund af hiv-infektion eller medicin, der påvirker immunforsvaret), får du muligvis ikke fuld gavn af Nimenrix.
English: Nimenrix is always injected into a muscle, usually in the upper arm or thigh.
Danish: Nimenrix bliver altid indsprøjtet i en muskel, normalt i overarmen eller låret.
English: More than 98% of subjects had anti-PT, FHA or PRN concentrations above the assay cut-off thresholds.
Danish: Mere end 98 % af forsøgspersonerne havde anti-PT-, FHA- eller PRN-koncentrationer over den fastsatte grænseværdi (cut-off).
English: • septicaemia - an infection of the blood.
Danish: • blodforgiftning - en infektion i blodet.
English: If you are pregnant, think you may be pregnant, plan to become pregnant or are breast-feeding, you must tell your doctor before receiving Nimenrix.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du fortælle det til lægen, inden du får Nimenrix.
English: A minor infection such as a cold should not be a problem.
Danish: En mindre infektion som forkølelse er normalt ikke noget problem.
English: Add the solvent to the powder.
Danish: Tilsæt solvensen til pulveret.
English: Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement mediated bactericidal activity.
Danish: Antistoffer mod meningokok-kapslen beskytter mod meningokoksygdomme via komplementmedieret baktericid aktivitet.
English: The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Danish: Tilstedeværelse af en let infektion, f.eks. forkølelse, bør ikke medføre en udsættelse af vaccinationen.
English: Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was administered to 274 individuals aged 56 years and older.
Danish: Sikkerheden er desuden vurderet i et separat studie, hvor en enkelt dosis Nimenrix blev administreret til 274 personer i alderen 56 år og derover.
English: Non-clinical data reveal no special hazard for humans based on local tolerance, acute toxicity, repeated dose toxicity, developmental/reproductive toxicity and fertility studies.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af lokal tolerance, akut toksicitet, toksicitet efter gentagne doser, udviklings- og reproduktionstoksicitet samt fertilitet.
English: • received your dose more than approximately one year ago and could be at risk of infection caused by Neisseria meningitidis type A
Danish: • fik dosen for mere end ca. et år siden og kan have risko for infektion forårsaget af Neisseria meningitidis type A
English: The following side effects may happen with this medicine:
Danish: Dette lægemiddel kan have følgende bivirkninger:
English: However, talk to your doctor or nurse first.
Danish: Du skal dog fortælle det til lægen eller sygeplejersken først.
English: Very common Irritability Uncommon
Danish: Meget almindelig Irritabilitet Ikke almindelig Insomni