FrancophonIA/ELRC3.0 huggingface dataset:
English: • The CHMP considered that the efficacy of adrenaline in the treatment of anaphylaxis is wellsupported by anecdotal and retrospective evidence and that the safety of adrenaline is also well-established, and it has demonstrated a strong safety profile particularly with IM administration.
Danish: • CHMP fandt, at virkningen af adrenalin til behandling af anafylaksi er velunderbygget med anekdotisk og retrospektiv evidens, at sikkerheden af adrenalin ligeledes er veletableret, og at adrenalin har udvist en stærk sikkerhedsprofil, navnlig ved intramuskulær administration,
English: The CHMP has considered the totality of the available non-clinical and clinical evidence on the delivery of adrenaline from adrenaline auto-injectors and on whether the product information contains clear and detailed instructions for appropriate use.
Danish: CHMP har vurderet al den foreliggende prækliniske og kliniske evidens med henblik på afgivelsen af adrenalin fra adrenalin-autoinjektorer og på, om produktinformationen indeholder klare og detaljerede anvisninger for korrekt brug.
English: Variability in skin-to-muscle depth (STMD), gender, needle length and the device mechanism itself are important factors which determine whether the route of delivery is IM or SC.
Danish: Variation i afstanden fra hud til muskel (skin-to-muscle depth (STMD)), køn, nålelængden og selve anordningens mekanisme er vigtige bestemmende faktorer for, om administrationen sker intramuskulært eller subkutant.
English: The efficacy of adrenaline in the treatment of anaphylaxis is well-supported by anecdotal and retrospective evidence.
Danish: Virkningen af adrenalin til behandling af anafylaksi er velunderbygget med anekdotisk og retrospektiv evidens.
English: The CHMP sought the advice of experts on the feasibility of conducting imaging or PK studies or any other trials or tests that could be performed as well as the advice of the PRAC on potential databases or other data sources that might hold information on actual device usage.
Danish: CHMP søgte ekspertrådgivning om muligheden for at udføre billeddannelses- eller farmakokinetikundersøgelser eller eventuelle andre forsøg eller test samt rådgivning fra PRAC om potentielle kilder til oplysninger om den faktiske brug af anordningerne.
English: Published clinical data indicate that the rate of absorption is prolonged if the adrenaline is delivered subcutaneously (SC).
Danish: Publicerede kliniske data viser, at absorptionen forlænges ved subkutan administration af adrenalinet.
English: The CHMP also recommended further risk minimisation measures, including educational materials, to be submitted and agreed via risk management plans.
Danish: CHMP anbefalede desuden, at der blev forelagt yderligere risikominimeringsforanstaltninger, herunder informationsmateriale, som blev godkendt gennem risikohåndteringsplaner.
English: Some investigators are of the opinion that even when the needle length is shorter than the STMD, IM injection is still possible as the physical compression of subcutaneous tissue by the force of the device can help to overcome the deficit in needle length.
Danish: Nogle undersøgere er af den opfattelse, at intramuskulær injektion er mulig, uanset at nålen er kortere end STMD, da den fysiske sammentrykning ved påvirkning fra anordningen kan opveje nålens utilstrækkelige længde.
English: • The CHMP considered the totality of the available non-clinical and clinical data to inform whether adrenaline administered via an auto-injector is delivered intramuscularly or subcutaneously, including submissions by marketing authorisation holders, consultations with healthcare professionals, experts and the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: • CHMP tog i betragtning samtlige foreliggende prækliniske og kliniske data til afklaring af, om adrenalin, der administreres gennem en autoinjektor, bliver indgivet intramuskulært eller subkutant, herunder materiale fra markedsføringstilladelsesindehavere, drøftelser med sundhedspersoner, eksperter og Udvalget For Risikovurdering inden for Lægemiddelvurdering (PRAC),
English: The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) undertook a review of all authorised adrenaline auto-injectors to evaluate the most effective site for injection, the clarity of instructions for use as well as the most appropriate auto-injector needle length for ensuring intramuscular (IM) delivery of the adrenaline injection.
Danish: Det Forenede Kongeriges lægemiddelstyrelse (MHRA) foretog en gennemgang af alle godkendte adrenalin-autoinjektorer med henblik på at vurdere det mest effektive injektionssted, brugsanvisningens klarhed og den mest hensigtsmæssige længde af autoinjektorens nål til intramuskulær administration af adrenalin.
English: A key finding of the review was that there is no robust evidence that the administration devices deliver adrenaline intramuscularly in all patients.
Danish: Som et hovedresultat viste gennemgangen, at der ikke er holdbar evidens for, at adrenalinet afgives intramuskulært til alle patienter ved hjælp af disse administrationsanordninger.
English: • The CHMP considered that the preferred route of administration of adrenaline in an emergency situation has been established as IM, although intravenous administration may be indicated in severe cases.
Danish: • CHMP fandt, at den foretrukne administrationsvej i akutsituationer er fastlagt at være intramuskulær, skønt intravenøs administration kan være indiceret i svære tilfælde,
English: The CHMP concluded that the benefit-risk balance for adrenaline auto-injectors remains favourable subject to the agreed changes to the product information and the above-mentioned additional risk minimisation measures.
Danish: CHMP konkluderede, at benefit/risk-forholdet for adrenalin-autoinjektorer fortsat er positivt under forudsætning af de vedtagne ændringer i produktinformationen og ovenstående supplerende risikominimeringsforanstaltninger.
English: It is widely accepted that IM delivery is superior to SC delivery in achieving the rate of rise and levels of plasma adrenaline that are most effective to treat anaphylaxis.
Danish: Det er almindeligt accepteret, at intramuskulær administration er overlegen over subkutan administration med hensyn til at opnå den stigning i og maksimumværdi af plasmakoncentrationen af adrenalin, der har størst virkning til behandling af anafylaksi.
English: The CHMP therefore recommended amendments to the product information, in order to reflect the uncertainties in whether a single administration would suffice for any given episode and advise that patients are prescribed two pens which they should carry at all times, to include a recommendation for immediate associates of patients to be trained to use the AAI and to include information on the needle length.
Danish: CHMP anbefalede derfor ændringer af produktinformationen, så denne afspejler usikkerheden om, hvorvidt en enkelt administration er tilstrækkelig ved enhver given episode, tilråder, at der ordineres to penne, som patienten altid bærer på sig, og indeholder en anbefaling om, at patientens nærmeste pårørende oplæres i brug af adrenalin-autoinjektoren, samt oplysninger om nålelængde.
English: • The CHMP noted that the product information for the different auto-injectors would benefit from an update to include warnings and precautions on uncertainties in whether a single administration would suffice for any given episode and advise that patients are prescribed two pens which they should carry at all times, training of immediate associates of patients and inclusion of information on the needle length.
Danish: • CHMP bemærkede, at produktinformationen for de forskellige autoinjektorer med fordel kunne ajourføres med advarsler og forholdsregler vedrørende usikkerheden om, hvorvidt en enkelt administration er tilstrækkelig ved enhver given episode, anvisning om, at der ordineres to penne, som patienten altid skal har på sig, oplæring af patientens nærmeste pårørende og indsættelse af oplysninger om nålelængde,
English: The CHMP concluded that the benefit-risk balance for adrenaline auto-injectors remains favourable subject to the conditions to the marketing authorisations and taking into account the amendments to the product information and other risk minimisation measures recommended.
Danish: CHMP konkluderede, at benefit/risk-forholdet for adrenalin autoinjektorer er positivt under forudsætning af de anbefalede betingelser for markedsføringstilladelserne og ændringer af produktinformationen samt de øvrige anbefalede risikominimeringsforanstaltninger,
English: However, there is agreement that in general STMD is greater than the length of the needles of currently available adrenaline auto-injectors in many patients, both adult and child.
Danish: Der er dog enighed om, at det hos mange patienter, både voksne og børn, gælder, at STMD generelt er større end længden af nålen på de aktuelt tilgængelige adrenalin-autoinjektorer.
English: On the other hand, other investigators express an opinion that compression may preferentially involve muscle rather than subcutaneous tissue and therefore the needle deficit is not overcome by compression.
Danish: Andre undersøgere anfører, at det først og fremmest er muskelvævet, der sammentrykkes, og i mindre grad det subkutane væv, hvorfor den utilstrækkelige længde af nålen ikke opvejes ved sammentrykning.
English: Other factors such as the mechanism of action (spring loaded or not) and method of administration (swing and jab or place and press) of the device, the angle of placement on the skin and the force used to activate the device also play a part.
Danish: Også andre faktorer spiller en rolle, såsom anordningens virkemåde (fjederbelastet eller ikke), fremgangsmåden ved injektionen (om nålen svinges og stødes eller sættes og trykkes ind), nålens vinkel i forhold til huden og den kraft, enheden aktiveres med. CHMP bemærkede, at undersøgelserne ikke var overensstemmende med hensyn til, hvor stor betydning de tillægger sammentrykning af vævet.
English: • The CHMP considered that there are multiple factors that may affect whether adrenaline is delivered to the muscle or the subcutaneous tissue when an adrenaline auto-injector is used such as the needle length, the mechanism of action of the device, the angle of placement on the skin, the force used to activate the device and the patient/carer compliance.
Danish: • CHMP tog i betragtning, at en række faktorer kan have indflydelse på, hvorvidt adrenalin afgives til muskelvævet eller det subkutane væv ved anvendelse af en adrenalin-autoinjektor; dette gælder således nålens længde, anordningens virkemåde, dens vinkel i forhold til huden, den kraft, anordningen aktiveres med, og patientens/omsorgsgiverens compliance, Oplæring og oplysning af både patienter/omsorgsgivere og sundhedspersoner fandtes at være altafgørende,
English: However, the CHMP was of the view that PK and PD studies in healthy volunteers representing the broad range of phenotypes, or imaging studies in healthy volunteers to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device could be considered.
Danish: CHMP mente imidlertid, at man kunne overveje farmakokinetiske og farmakodynamiske undersøgelser hos raske forsøgspersoner, der repræsenterer et bredt udsnit af fænotyper, eller undersøgelser med billeddannelse hos raske forsøgspersoner, for at skaffe indsigt i forskellige faktorers betydning for adrenalins fordeling, eksponering og aktivitet ved administration med en adrenalin-autoinjektor.
English: While these non-clinical models have demonstrated that the adrenaline is projected beyond the tip of the needle to a greater or lesser extent the CHMP was of the view that it remains questionable how representative of the human tissue these models are.
Danish: Evidensen for penetration af adrenalin i vævet bygger hovedsagelig på prækliniske data, der er genereret med en gelatinemodel eller en svinemodel Disse prækliniske modeller har godtgjort, at adrenalinet i større eller mindre omfang transporteres videre fra spidsen af nålen, men CHMP fandt det tvivlsomt, om modellerne er repræsentative for humant væv.
English: The CHMP also concluded on the need for a PK/PD study to be conducted in order to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device.
Danish: CHMP konkluderede desuden, at der er behov for en farmakokinetisk/farmakodynamisk undersøgelse for at skaffe indsigt i betydningen af en række faktorer for adrenalinets fordeling, eksponering og aktivitet ved administration med en adrenalin-autoinjektor,
English: The CHMP agreed that there are many factors that may affect whether the adrenaline is delivered to the muscle or the subcutaneous tissue when an adrenaline auto-injector is used.
Danish: STMD er kun en af de faktorer, der har indflydelse på, om adrenalinen når frem til muskellaget eller ej. CHMP fandt, at der er mange faktorer, der kan have betydning for, om adrenalinen afgives i musklen eller i det subkutane væv ved anvendelse af en adrenalin-autoinjektor.
English: Journal of allergy and clinical immunology 108(5); 2001, 871-873
Danish: Journal of allergy and clinical immunology 108(5); 2001, 871-873 3 Song T, Nelson M, Chang J, et al. Adequacy of the epinephrine auto-injector needle length in delivering epinephrine to the intramuscular tissues.
English: Furthermore, the CHMP imposed a PK/PD study in order to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via an adrenaline auto-injector device and encouraged the possibility for a study to assess the effectiveness of the proposed risk minimisation measures and the conduct of an observational study to assess usage and incidence of lack of efficacy and device failure.
Danish: Udvalget opfordrede derudover til at udføre en undersøgelse til vurdering af effektiviteten af de foreslåede risikominimeringsforanstaltninger og foretage en observationsundersøgelse til vurdering af anvendelse, forekomst af manglende virkning og svigt af anordningerne.
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), ansøger(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne
English: The two new studies provided similar data.
Danish: De to nye undersøgelser udviser lignende data.
English: Acute severe febrile illness.
Danish: Akut alvorlig febril sygdom.
English: • if your child was born prematurely (before 37 weeks).
Danish: • hvis dit barn blev født for tidligt (før uge 37 i svangerskabet).
English: N= number of subjects with available results
Danish: N = antal børn med tilgængelige resultater
English: Strength *
Danish: Styrke *
English: At present, the potential implications of these observations for the duration of protection are not known.
Danish: På nuværende tidspunkt er de potentielle konsekvenser af disse observationer for varrigheden af beskyttelse ukendt.
English: Finally, the post-marketing surveillance data from the UK are reassuring.
Danish: Endelig er overvågningsdata indhentet efter markedsføringen i Storbritannien beroligende.
English: Vaccination is the best way to protect against diseases caused by these bacteria.
Danish: Vaccination er den bedste måde at beskytte sig mod sygdomme, som skyldes disse bakterier.
English: Immunisation with this vaccine does not substitute for routine tetanus immunisation.
Danish: Immunisering med denne vaccine erstatter ikke rutinemæssig immunisering med tetanus.
English: • Crying
Danish: • Gråd
English: Dispose of in accordance with local regulations.
Danish: Bortskaffes i overensstemmelse med nationale regler.
English: Do not use Menitorix after the expiry date which is stated on the carton.
Danish: Brug ikke Menitorix efter den udløbsdato, der står på pakningen.
English: Therefore the degree of protection that would be afforded is unknown.
Danish: Graden af den opnåelige beskyttelse er derfor ukendt.
English: Efficacy and Safety conclusions
Danish: Konklusioner med hensyn til effekt og sikkerhed
English: Evaluation of pharmacokinetic properties is not required for vaccines.
Danish: Evaluering af farmakokinetiske egenskaber er ikke påkrævet for vacciner.
English: The presence of a minor infection is not a contraindication for vaccination.
Danish: Forekomsten af en mindre infektion er dog ikke en kontraindikation for vaccination.
English: These issues were referred to the CHMP during the referral procedure under Article 29 of Directive 2001/83/EC, as amended, on 26 April
Danish: Disse spørgsmål blev henvist til CHMP under henvisningsproceduren i henhold til artikel 29 i direktiv 2001/83/EF, med senere ændringer, af 26. april 2007.
English: Remember, however, that no vaccine can provide complete, life-long protection in all people vaccinated.
Danish: Dog kan ingen vaccine give fuldstændig og livslang beskyttelse for alle de personer som vaccineres.
English: It is very important that your child has immediate medical treatment for any severe allergic reaction.
Danish: Det er meget vigtigt, at dit barn får hurtig lægebehandling mod alvorlige overfølsomhedsreaktioner.
English: The proportions reaching SBA titres of at least 1:8 are not affected.
Danish: Forholdene til opnåelse af SBA-titer på mindst 1:8 påvirkes ikke.
English: Adverse reactions occurring during these studies were mostly reported within 48 hours following vaccination.
Danish: Bivirkninger, som fremkom under disse forsøg, blev overvejende set inden for 48 timer efter vaccination.
English: The conditions of the Marketing Authorisation are set out in Annex IV.
Danish: Betingelserne for markedsføringstilladelsen findes i bilag IV.
English: • Post-marketing experience
Danish: • Post-marketing
English: In line with these conclusions, the CHMP regarded Menitorix (GSK Bio) as acceptable for registration.
Danish: I overensstemmelse med disse konklusioner vurderede CHMP, at Menitorix (GSK Bio) er acceptabelt til registrering.
English: 2-3-4 month schedule
Danish: 2-3-4-måneders program
English: Menitorix is not intended for use in adults.
Danish: Menitorix er ikke beregnet til brug for voksne.
English: • Other possible side effects:
Danish: • Andre mulige bivirkninger
English: PACKAGE LEAFLET: INFORMATION FOR THE USER
Danish: INDLÆGSSEDDEL INFORMATION TIL BRUGEREN
English: Menitorix-containing regimens were not more reactogenic than the comparative regimens in which the same total range of antigens was administered.
Danish: Regimer, som indeholder Menitorix, var ikke mere reaktogene end de sammenlignende regimer, hvor den samme totale række af antigener blev administreret.
English: Clinical alertness to the possibility of co-incidental meningitis should be maintained.
Danish: Klinisk opmærksomhed på risikoen for en tilfældig meningitis skal fastholdes.
English: Within one year of completion of the primary series, vaccine effectiveness in the infant cohort was estimated at 93% (95% confidence intervals 67-99%).
Danish: Inden for et år efter afslutningen af det primære program var vaccineeffektiviteten hos spædbørnskohorten estimeret til 93 % (95 % konfidensinterval 67-99 %).
English: The vaccine works by causing the body to produce its own protection (antibodies) against these bacteria.
Danish: Vaccinen virker ved, at kroppen danner sit eget forsvarssystem (antistoffer) mod disse bakterier.
English: Remember that the first dose of Menitorix should not be given before your child is 2 months of age.
Danish: Husk at første vaccination med Menitorix ikke bør gives, før dit barn er 2 måneder gammelt.
English: However, more than one year after completion of the primary series, there was clear evidence of waning protection.
Danish: Dog er der et år efter afslutningen af det primære program set klar evidens for faldende beskyttelse.
English: The most recent updates to the SPC serve to reflect the total data available thus far.
Danish: De seneste ajourføringer af produktresuméet afspejler de totale data, der indtil videre er tilgængelige.
English: Hypersensitivity reaction after previous administration of Menitorix.
Danish: Overfølsomhedsreaktioner efter tidligere administration af Menitorix.
English: The Applicant/MAH submitted an application for a Marketing Authorisation through the mutual recognition procedure for Menitorix on the basis of the marketing authorisation granted by the UK.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen indsendte en ansøgning om markedsføringstilladelse for Menitorix via proceduren for gensidig anerkendelse på baggrund af markedsføringstilladelsen udstedt af Storbritannien.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som for alle injicerbare vacciner skal passende medicinsk behandling og overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion efter administration.
English: If you are concerned about the dose or doses that have been given, please talk to your doctor or nurse.
Danish: Hvis du er bekymret for den dosis, der gives, skal du tale med lægen eller sygeplejersken.
English: Since Hib capsular polysaccharide antigen is excreted in the urine, a positive urine antigen test can be observed within 1-2 weeks following vaccination.
Danish: Da Hib-kapslet polysaccharid antigen udskilles i urinen, kan en positiv urin-antigen-test ses i 1-2 uger efter vaccination.
English: Pharmacotherapeutic group: bacterial vaccines ATC code: J07AG53
Danish: Farmakoterapeutisk klassifikation: bakteriel vaccine, ATC-kode: J07AG53
English: Severe allergic reactions can occur to any vaccine but they are very rare and are usually seen in less than 1 in 10,000 people who are vaccinated.
Danish: Alvorlige overfølsomhedsreaktioner (allergi) kan opstå ved alle vacciner, men er meget sjældne og ses normalt hos mindre en 1 ud af 10000 personer, som bliver vaccineret.
English: Menitorix should under no circumstances be administered intravascularly, intradermally or subcutaneously.
Danish: Menitorix må ikke under nogen omstændigheder administreres intravaskulært, intradermalt eller subkutant.
English: Like all medicines, Menitorix can cause side effects, although not everybody gets them.
Danish: Menitorix kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: They may also cause severe blood infections and spread throughout the body.
Danish: De kan også give alvorlige betændelse i blodet, som kan spredes rundt i kroppen.
English: The similarity of Menitorix to already licensed products and the fact that the available safety data do not indicate any unusual problems are both reasons to accept the database provided.
Danish: Menitorix' lighed med allerede godkendte produkter og det faktum, at de tilgængelige sikkerhedsdata ikke tyder på usædvanlige problemer, er begge årsager til at acceptere de udleverede databaser.
English: The CHMP adopted a List of Outstanding Issues for the Applicant/MAH to address and requested the Vaccine Working Party (VWP) to consider the same outstanding issues.
Danish: CHMP vedtog en liste over uafklarede spørgsmål, som ansøgeren/indehaveren af markedsføringstilladelsen skulle besvare, og bad arbejdsgruppen vedrørende vacciner (VWP) overveje de samme udestående spørgsmål.
English: Effectiveness in all other age groups (up to 18 years) primed with a single dose has so far remained around 90% or more within and more than one year after vaccination.
Danish: Effektiviteten i alle andre aldersgrupper (op til 18 år) eksponeret med en enkelt dosis, har indenfor 1 år eller mere efter vaccination indtil nu været på ca. 90 % eller derover.
English: Other diagnostic tests, not based on the detection of the capsular antigen in urine, should be used to confirm Hib disease during this period.
Danish: Andre diagnostiske test, som ikke baseres på måling af kapslet antigen i urinen, bør anvendes til bestemmelse af Hib-infektioner i denne periode.