FrancophonIA/ELRC3.0 huggingface dataset:
English: • Symptoms, in particular of POTS, may overlap with other conditions such as chronic fatigue syndrome, and patients may have a diagnosis of both chronic fatigue syndrome and POTS.
Danish: • Symptomerne, navnlig ved POTS, kan overlappe med andre sygdomme såsom kronisk træthedssyndrom, og patienterne kan have en diagnose på både kronisk træthedssyndrom og POTS.
English: Symptoms often overlap with other conditions such as chronic fatigue syndrome.
Danish: Symptomerne overlapper ofte andre sygdomme såsom kronisk træthedssyndrom.
English: It therefore did not recommend any changes to the terms of licensing or the product information for these medicines.
Danish: Udvalget anbefalede derfor ikke ændringer af betingelserne for markedsføringstilladelserne eller produktinformationen for disse lægemidler.
English: The review noted that some symptoms of CRPS and POTS may overlap with chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis or ME).
Danish: Ved gennemgangen blev det bemærket, at nogle af symptomerne på disse syndromer kan ligne symptomerne ved kronisk træthedssyndrom (CFS, der også kendes som myalgisk encephalomyelitis eller ME).
English: • The review found no evidence that the overall occurrence of these syndromes in vaccinated girls was different from that expected in these age groups, even taking into account a variety of possible scenarios for underreporting and reports that did not fully meet diagnostic criteria for these syndromes.
Danish: • Ved gennemgangen fandtes ingen evidens for, at den samlede forekomst af disse syndromer hos vaccinerede piger er forskellig fra den forventede i aldersgruppen, også ved forskellige mulige scenarier for underindberetning og indberetninger, der ikke fuldt ud opfylder de diagnostiske kriterier for disse syndromer.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: • HPV (human papillomavirus) is a major cause of cancer of the cervix (neck of the womb) and some other cancers, as well as other conditions such as genital warts.
Danish: • HPV (vortevirus eller humant papillomavirus) er en vigtig årsag til livmoderhalskræft og visse andre kræfttyper såsom kønsvorter.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Danish: Gennemgangen blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC), som har ansvar for vurdering af sikkerhedsspørgsmål vedrørende lægemidler til mennesker, og som fremsatte et sæt anbefalinger.
English: Therefore there is no reason to change the way the vaccines are used or amend the current product information.
Danish: Der er derfor ingen grund til at ændre den måde, vaccinerne anvendes på, eller ændre den nuværende produktinformation.
English: • CRPS (chronic regional pain syndrome) is defined as continuing pain that is disproportionate to the inciting event (typically an episode of trauma or limb immobilisation), and is associated with sensory, sudomotor, motor and dystrophic changes.
Danish: • CRPS (refleksdystrofi) defineres som vedholdende smerter, som er ude af proportioner med den udløsende hændelse (typisk et traume eller immobilisering af en ekstremitet), og som er forbundet med sensoriske, sudomotoriske, motoriske og dystrofiske ændringer.
English: Given that many reports have features of chronic fatigue syndrome, evidence including a large published study1 that showed no link between chronic fatigue syndrome and HPV vaccines was also considered relevant.
Danish: Eftersom mange af indberetningerne har kendetegn svarende til kronisk træthedssyndrom, blev evidens bestående i en stor offentliggjort undersøgelse1, der ikke viste nogen sammenhæng mellem kronisk træthedssyndrom og HPV-vacciner, også anset for relevant.
English: Use of these vaccines is expected to prevent many cases of cervical cancer (cancer of the neck of the womb, which is responsible for over 20,000 deaths in Europe each year) and various other cancers and conditions caused by HPV.
Danish: Anvendelsen af disse vacciner forventes at forebygge mange tilfælde af livmoderhalskræft (som er ansvarlig for over 20 000 dødsfald om året i Europa) og en række andre kræftformer og andre lidelser, der forårsages af HPV.
English: On 19 November EMA completed its review of the evidence surrounding reports of two syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women given human papillomavirus (HPV) vaccines.
Danish: Den 19. november afsluttede EMA sin gennemgang af rapporterne med dokumentationen for to syndromer hos unge kvinder, der vaccineres mod humant papillomavirus (HPV): refleksdystrofi, der også kaldes komplekst regionalt smertesyndrom (CRPS), og postural ortostatisk takykardisyndrom (POTS).
English: • There are therefore no recommendations to amend the product information or to change the way HPV vaccines are used.
Danish: • Der er derfor ingen anbefalinger om at ændre produktinformationen eller den måde, HPV-vacciner anvendes på.
English: The CHMP concurred that the available evidence does not support that CRPS and POTS are caused by HPV vaccines.
Danish: CHMP var enig i, at den foreliggende dokumentation ikke støtter, at HPV-vacciner er årsag til CRPS og POTS.
English: Results of a large published study that showed no link between HPV vaccine and CFS were therefore particularly relevant.
Danish: Resultaterne af en stor offentliggjort undersøgelse viste ingen sammenhæng mellem HPV-vaccine og CFS.
English: Cervarix has been approved since September 2007 for use in women and girls to protect against precancerous growths and cancer in the cervix and genital area.
Danish: Cervarix har været godkendt siden september 2007 til anvendelse hos kvinder og piger til beskyttelse mod forstadier til kræft, livmoderhalskræft og kræft omkring kønsdelene.
English: These vaccines are given to protect them from cervical cancer and other HPV-related cancers and pre-cancerous conditions.
Danish: Disse vacciner anvendes til at beskytte mod livmoderhalskræft og andre HPV-relaterede kræftformer og forstadier til kræft.
English: However, available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year, and at least 150 girls and young women per million may develop POTS each year.
Danish: I de foreliggende skøn anslås det imidlertid, at CRPS årligt udvikles hos omkring 150 piger og unge kvinder pr. million i alderen 10-19 i den almindelige befolkning, og at mindst 150 piger og unge kvinder om året udvikler POTS.
English: Use of these vaccines is expected to prevent many cases of cervical cancer as well as various other cancers and conditions caused by HPV.
Danish: Brug af disse vacciner forventes at forebygge mange tilfælde af livmoderhalskræft og en række andre kræftformer og lidelser forårsaget af HPV.
English: Gardasil has been authorised since September 2006, and is approved for use in males and females for preventing precancerous growths and cancer in the cervix and anus, and genital warts.
Danish: Gardasil har været godkendt siden september 2006 og er godkendt til anvendelse hos mænd og kvinder til forebyggelse af forstadier til kræft, livmoderhalskræft og kræft i endetarmsåbningen
English: In reaching its recommendations, it also consulted a group of leading experts in the field, and took into
Danish: Udvalget baserede også sine anbefalinger på rådføring med en
English: • Available estimates suggest that in the general population around 150 girls and young women per million aged 10 to 19 years may develop CRPS each year and at least 150 girls and young women per million may develop POTS each year.
Danish: • I de foreliggende skøn anslås der at forekomme 150 CRPS-tilfælde om året pr. million piger og unge kvinder i alderen 10-19 år i den almindelige befolkning, mens 150 piger og unge kvinder pr. million årligt kan udvikle POTS.
English: CRPS produces long-lasting pain affecting a limb, and POTS is associated with an increase in heart rate on standing up, together with various symptoms including dizziness, weakness, pain, feeling sick, and fatigue.
Danish: CRPS bevirker langvarige smerter i en arm eller et ben, og POTS er forbundet med en stigning i puls, når man rejser sig op, foruden andre symptomer såsom svimmelhed, svaghed, smerter, kvalme og træthed.
English: CRPS is a chronic pain syndrome affecting a limb, while POTS is a condition where the heart rate increases abnormally on sitting or standing up, together with symptoms such as dizziness, fainting and weakness, as well as headache, aches and pains, nausea and fatigue.
Danish: Refleksdystrofi (CRPS) er et kronisk smertesyndrom, der rammer et ben eller en arm, mens POTS er en sygdom, hvor pulsen stiger abnormt, når man sætter sig op eller rejser sig, og er ledsaget af symptomer såsom svimmelhed, besvimelsesanfald og svaghed foruden hovedpine, smerter, kvalme og træthed.
English: The Agency's Pharmacovigilance Risk Assessment Committee (PRAC) was responsible for the initial review.
Danish: Den indledende gennemgang blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: • There are therefore no recommendations to change the way in which the vaccines are used and no changes have been made to the prescribing information for these vaccines.
Danish: • Der er derfor ingen anbefalinger om at ændre den måde, vaccinerne bruges på, og produktinformationen for vaccinerne er ikke ændret.
English: Symptoms of CRPS and POTS may overlap with other conditions, making diagnosis difficult in both the general population and vaccinated individuals.
Danish: Diagnosen er derfor vanskelig, både i den almindelige befolkning og hos vaccinerede.
English: These data were reported based on more than 400 million doses distributed worldwide.
Danish: Disse data er blevet indberettet på basis af over 400 mio. doser distribueret på verdensplan.
English: Exposure was estimated at 171,000 infants per year.
Danish: Eksponeringen blev estimeret til 171.000 spædbørn pr. år.
English: Date of first authorisation: 11 May 2006 Date of latest renewal: 11 May 2011
Danish: Dato for første markedsføringstilladelse: 11. maj 2006 Dato for seneste fornyelse: 11. maj 2011
English: • Crying.
Danish: • Gråd.
English: The interval between 2 doses should be at least 4 weeks.
Danish: Intervallet mellem 2 doser bør være mindst 4 uger.
English: Non-pregnant adolescent and adult females
Danish: Ikke-gravide teenagepiger og voksne kvinder
English: In 297 reports a clear time to onset could be determined.
Danish: I 297 rapporter kunne et klart tidspunkt for indtræden fastsættes.
English: Symptoms may persist for a matter of months or on rare occasions for years.
Danish: Symptomerne kan varer ved i månedsvis eller i sjældne tilfælde årevis.
English: 71% of the reports (212 of 297) concerned crying with a time to onset of more than 24 hours.
Danish: 71% af rapporterne (212 af 297) omhandlede gråd, hvor tiden til indtræden var mere end 24 timer.
English: Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Danish: Selv hos ældre kvinder (35-45 år) tåles disse reaktioner generelt godt og påvirker sjældent normale aktiviteter.
English: Active untreated tuberculosis.
Danish: Aktiv ubehandlet tuberkulose.
English: All adverse reactions were evaluated in 1940 children.
Danish: Alle bivirkninger blev vurderet hos 1940 børn.
English: A second dose may be administered at least 4 weeks after the first dose in accordance with official recommendation.
Danish: Anden dosis kan gives mindst 4 uger efter den første dosis i overensstemmelse med officielle anbefalinger.
English: The vaccine may contain traces of recombinant human albumin (rHA).
Danish: Vaccinen kan indeholde spor af rekombinant humant albumin (rHA).
English: Vaccination should be postponed during any illness with fever >38.5°C.
Danish: Vaccination skal udsættes under enhver sygdom med feber > 38,5° C.
English: The majority of the crying occurred 6 to 10 days after vaccination.
Danish: De fleste tilfælde af gråd forekom 6 til 10 dage efter vaccinationen.
English: Not known (Frequency cannot be estimated from the available data)*
Danish: Ukendt (hyppigheden kan ikke vurderes ud fra de tilgængelige data)*
English: The safety profile post-dose 1 and 2 was generally comparable for all age cohorts.
Danish: Sikkerhedsprofilen efter dosis 1 og 2 var generelt sammenlignelig for alle aldersgrupper.
English: The second dose is intended for individuals who did not respond to the first dose for any reason.
Danish: Den anden dosis er beregnet til personer, som af ukendt årsag ikke responderede på den første dosis.
English: Widespread use of a 2-dose vaccination schedule in the United States and countries such as Finland and Sweden has led to a >99% reduction in the incidence of each of the 3 targeted diseases.
Danish: Udbredt anvendelse af et vaccinationsprogram med 2 doser i USA og lande såsom Finland og Sverige har resulteret i en reduktion af incidensen på >99 % for hver af de 3 målsygdomme.
English: Individuals 12 months or older should receive one dose at an elected date.
Danish: Personer på 12 måneder eller ældre bør gives én dosis på en given dato.
English: Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
Danish: Personens serologiske status kan evalueres for at afgøre, hvorvidt yderligere doser af vaccinen er nødvendigt.
English: Such infants should be revaccinated at 12 to 15 months of age.
Danish: Sådanne spædbørn bør revaccineres i 12-15-måneders alderen.
English: Non-clinical studies have not been conducted.
Danish: Der er ikke gennemført nogen ikke-kliniske undersøgelser.
English: M-M-RVAXPRO is to be used on the basis of official recommendations.
Danish: M-M-RVAXPRO skal anvendes på basis af officielle anbefalinger.
English: Seroprotection rates [95% CI]
Danish: Serobeskyttelsesrater [95% CI]
English: Current immunosuppressive therapy (including high doses of corticosteroids).
Danish: Aktuel immunsuppresiv behandling (herunder høje doser kortikosteroider).
English: The antibodies help protect against infections caused by these viruses.
Danish: Antistofferne medvirker til at beskytte mod infektioner forårsaget af disse vira.
English: After reconstitution, one dose (0.5 ml) contains:
Danish: Efter rekonstitution indeholder 1 dosis (0,5 ml):
English: Women who intend to become pregnant should be advised to delay.
Danish: Kvinder, der planlægger graviditet, bør rådes til at vente.
English: Effectiveness
Danish: Effektivitet
English: Reconstitution instructions intended for medical and healthcare professionals are included at the end of the package leaflet.
Danish: Rekonstitutionsvejledning tiltænkt læger og sundhedspersonale er medtaget sidst i indlægssedlen.
English: This vaccine contains a trace amount of neomycin.
Danish: Denne vaccine indeholder en spormængde af neomycin.
English: This latency period appears to correspond with the time to onset of general malaise that often occurs after the MMR vaccination.
Danish: Denne latensperiode synes at korrespondere med tiden for indtræden af generel utilpashed, som ofte forekommer efter MFR-vaccination.
English: If, however, the vaccine is given a few days before exposure, substantial protection may be afforded.
Danish: Hvis vaccinen derimod gives få dage inden udsættelse for smitte, kan den give betydelig beskyttelse.
English: • Irritability.
Danish: • Irritabilitet.
English: • Fever (38.5°C or higher).
Danish: • Feber (38,5 °C eller derover).
English: In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and adult women.
Danish: Hos unge piger synes reaktionerne at ligge midt imellem incidensen hos børn og voksne kvinder.
English: Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration.
Danish: Efter vaccination af børn er reaktionerne i led generelt usædvanlige (0-3 %) og af kort varighed.
English: Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination.
Danish: Nogle af disse tilfælde kan være en følge af ikke erkendte mæslinger i det første leveår eller eventuelt af mæslingevaccinationen.
English: Interference with laboratory tests: see section 4.5.
Danish: Interaktion med laboratorieprøver: Se pkt.
English: Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours after exposure.
Danish: Vaccination af personer udsat for vildtypemæslinger kan give nogen beskyttelse, hvis vaccinen kan gives inden for 72 timer efter eksponering.
English: Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De eller Deres barn vaccineres, da den indeholder vigtige oplysninger.
English: Use with other vaccines
Danish: Samtidig brug af andre vacciner
English: • Bruising or bleeding more easily than normal.
Danish: • Patienter får blå mærker eller bløder lettere end normalt.
English: • Inflammation of the retina (in the eye) with changes in sight.
Danish: • Betændelse i retina (øjets nethinde) med ændringer af synet.
English: The general safety profile of either administration routes were comparable, although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Danish: Den generelle sikkerhedsprofil var sammenlignelig for de to administrationsveje, selv om reaktioner på injektionsstedet var mindre hyppige i i.m.-gruppen (15,8 %) end i s.c.-gruppen (25,8 %).
English: Adverse reactions are ranked under headings of frequency using the following convention: [Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to ≤1/100); Not known (cannot be estimated from the available data)]
Danish: [Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til ≤ 1/100), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)]
English: Intramuscular or subcutaneous use.
Danish: Intramuskulær eller subkutan anvendelse.
English: Under special circumstances, it can be given from 9 months of age.
Danish: Under særlige omstændigheder kan vaccinen gives fra 9-måneders alderen.
English: There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Danish: Der er ingen sikre beviser for, at sådanne virus overføres til modtagelige personer, som er i kontakt med de vaccinerede.
English: In the absence of compatibility studies, the vaccine must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør vaccinen ikke blandes med andre lægemidler.
English: It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
Danish: Det er vigtigt at bruge en separat steril sprøjte og kanyle til hver patient for at hindre overførsel af smitstoffer fra en person til en anden.
English: MSD VACCINS Tel:+ 33 (0)1 80 46 40 40
Danish: MSD VACCINS Tél: + 33 (0)1 80 46 40 40
English: The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.
Danish: De foretrukne injektionssteder er den anterolaterale region af låret hos små børn og deltoidearegionen hos større børn, teenagere og voksne.
English: In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12-20%), and the reactions tend to be more marked and of longer duration.
Danish: Hos kvinder er incidensen af artritis og artralgi generelt højere end hos børn (12-20 %), og reaktionerne tenderer mod at være markante og af længere varighed.
English: Individuals 12 months of age or older:
Danish: Personer på 12 måneder eller ældre
English: Further doses should be administered according to your doctor's recommendation.
Danish: Yderligere doser skal gives efter lægens anvisning.
English: In the infants with serological evidence of rubella infection, none had symptomatic disease.
Danish: Hos spædbørn med serologiske tegn på rubellainfektion var der ingen, der havde symptomgivende sygdom.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apoteket til råds, før De får denne vaccine.
English: M-M-RVAXPRO may be given with some routine childhood vaccines that may be due to be given at the same time.
Danish: M-M-RVAXPRO kan gives sammen med rutinemæssige børnevaccinationer, som skal gives på samme tid.
English: These patients should be monitored carefully for signs of measles, parotitis, and rubella.
Danish: Disse patienter skal monitoreres nøje for tegn på mæslinger, parotitis og rubella.
English: It is not known whether M-M-RVAXPRO can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
Danish: Det vides ikke, om M-M-RVAXPRO kan forårsage fosterskader, når den administreres til en gravid kvinde, eller om den kan påvirke reproduktionsevnen.
English: The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
Danish: Risk/benefit-ratioen skal vurderes omhyggeligt, før vaccination overvejes i sådanne tilfælde.
English: Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Danish: Vaccination kan overvejes hos patienter med udvalgte immundefekter, når fordelene opvejer risiciene (asymptomatiske hiv-patienter, IgG-subklasse-defekt, kongenit neutropeni, kronisk granulomatøs sygdom eller komplementmangelsygdomme).
English: Hydrolysed gelatin
Danish: Hydrolyseret gelatine
English: The results of a retrospective case-controlled study conducted by the US Centers for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent risk of SSPE.
Danish: Resultaterne af en retrospektiv case-kontrolleret undersøgelse udført af det amerikanske center for sygdomskontrol og forebyggelse (US Centers for Disease Control and Prevention) tyder på, at den generelle effekt af mæslingevaccine har været beskyttelse mod SSPE ved at forebygge mæslinger med sygdommens naturlige risiko for SSPE.
English: Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
Danish: Udskillelse af små mængder levende svækket rubellavirus fra næsen eller halsen er forekommet hos flertallet af modtagelige personer 7 til 28 dage efter vaccination.
English: • Cough; lung infection with or without fever.
Danish: • Hoste; lungebetændelse med eller uden feber.
English: Infants between 9 and 12 months of age:
Danish: Spædbørn mellem 9 og 12 måneder:
English: produced in WI-38 human diploid lung fibroblasts.
Danish: fremstillet i humane diploide WI-38-lungefibroblaster.