FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no conclusive evidence that vaccination of individuals recently exposed to wild-type mumps or wild-type rubella will provide protection.
Danish: Der findes ingen afgørende beviser for, at vaccination af personer, som for nylig har været udsat for vildtypemæslinger eller vildtyperubella, giver beskyttelse.
English: Pregnancy should be avoided for 1 month following vaccination.
Danish: Graviditet bør undgås i 1 måned efter vaccination.
English: In comparison to the first dose, a second dose of M-M-RVAXPRO is not associated with an increase in the incidence and severity of clinical symptoms including those suggestive of hypersensitivity reaction.
Danish: Sammenlignet med første dosis associeres en anden dosis af M-M-RVAXPRO ikke med en stigning i incidensen og sværhedsgraden af kliniske symptomer, herunder symptomer, der tyder på overfølsomhedsreaktioner.
English: PostDose 1 PostDose 2
Danish: Postdosis 1 Postdosis 2
English: Although a theoretical risk cannot be excluded, no cases of congenital rubella syndrome have been reported in more than 3500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with a rubella-containing vaccine.
Danish: Selvom det ikke kan udelukkes, at der er en teoretisk risiko, er der ikke rapporteret om nogen tilfælde af kongenit rubellasyndrom hos børn af flere end 3.500 disponerede kvinder, der ikke vidste, at de var tidligt gravide, da de blev vaccineret med en rubellaholdig vaccine.
English: No data on the efficacy and safety of M-M-RVAXPRO for use in children below 9 months of age are currently available.
Danish: Der foreligger på nuværende tidspunkt ingen data vedrørende sikkerhed og virkning af M-M-RVAXPRO hos børn under 9 måneder.
English: The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8).
Danish: Lægen skal være på vagt over for den temperaturstigning, som kan opstå efter vaccination (se pkt.
English: You or your child should be monitored closely for measles, mumps, and rubella because vaccination may be less effective than for uninfected persons (see section Do not use M-M-RVAXPRO).
Danish: De eller Deres barn skal overvåges tæt for mæslinger, fåresyge og røde hunde, da vaccinationen kan være mindre effektiv end hos ikke-smittede personer (se afsnittet De bør ikke anvende M-M-RVAXPRO).
English: This vaccine contains 14.5 mg of sorbitol as an excipient.
Danish: Denne vaccine indeholder 14,5 mg sorbitol som hjælpestof.
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
Danish: Fremstiller ansvarlig for batchfrigivelse: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, Holland.
English: As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8).
Danish: Som ved alle injicérbare vacciner skal der altid være egnet nødhjælpsbehandling til øjeblikkelig rådighed i tilfælde af sjældne anafylaktiske reaktioner efter administration af vaccinen (se pkt.
English: M-M-RVAXPRO may be given with Prevenar and/or hepatitis A vaccine at the same visit at a separate injection site (e.g. the other arm or leg).
Danish: M-M-RVAXPRO kan gives sammen med Prevenar og/eller en hepatitis-A-vaccine ved samme besøg på separate injektionssteder (f.eks. den anden arm eller det andet ben).
English: Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).
Danish: Fortæl altid lægen eller på apoteket, hvis De eller Deres barn tager anden medicin (eller andre vacciner) eller har gjort det for nylig.
English: In these clinical studies, it was demonstrated that the immune responses were unaffected and that the overall safety profiles of the administered vaccines were similar.
Danish: I disse kliniske studier blev påvist, at immunresponsene ikke blev påvirket derved og at de generelle bivirkningsprofiler for de indgivne vacciner var lignende.
English: Among these children, the vaccine-related adverse reactions, summarised in section b, were observed in individuals following vaccination with M-M-RVAXPRO (excluding isolated reports with frequency <0.2%).
Danish: Blandt disse børn blev de vaccinerelaterede bivirkninger, der er opsummeret under punkt b., observeret hos personer efter vaccination med M-MRVAXPRO (bortset fra enkeltstående indberetninger med en hyppighed <0,2 %).
English: Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems.
Danish: Bloddyskrasier, leukæmi, lymfomer af enhver type eller andre maligne neoplasmer, der påvirker det hæmatopoietiske system og lymfesystemet.
English: Psychiatric disorders Crying
Danish: Psykiske forstyrrelser Gråd
English: The following side effects were reported with the use of M-M-RVAXPRO:
Danish: Følgende bivirkninger er indberettet i forbindelse med anvendelse af M-M-RVAXPRO:
English: Medium 199 with Hanks' salts Minimum Essential Medium, Eagle (MEM) Monosodium L-glutamate Neomycin
Danish: Medium 199 med Hanks salte Minimum Essential Medium, Eagle (MEM) Mononatrium-L-glutamat Neomycin
English: There have been reports of SSPE in children who did not have a history of infection with wild-type measles but did receive measles vaccine.
Danish: Der har været indberetninger af SSPE hos børn, som ikke havde en infektionsanamnese med vildtypemæslinger, men som havde fået mæslingevaccine.
English: After vaccination with M-M-RVAXPRO, IG should not be given for 1 month, unless your doctor tells you otherwise.
Danish: Efter vaccination med M-M-RVAXPRO, bør IG ikke gives i 1 måned, med mindre lægen siger noget andet.
English: M-M-RVAXPRO is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).
Danish: M-M-RVAXPRO er ikke kontraindiceret til personer, som får topiske eller lave doser parenterale kortikosteroider (f.eks. som astmaprofylakse eller substitutionsterapi).
English: Pharmacotherapeutic group: Viral vaccine, ATC code J07BD52
Danish: Farmakoterapeutisk klassifikation: Virusvaccine, ATC-kode J07BD52.
English: Currently no specific studies have been conducted on the concomitant use of M-M-RVAXPRO and other vaccines.
Danish: På nuværende tidspunkt er der ikke foretaget specifikke undersøgelser af samtidig brug af M-M-RVAXPRO og andre vacciner.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2.of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues.
Danish: Kronisk artritis er blevet associeret med infektion med vildtyperubella og er blevet relateret til persisterende virus og/eller virusantigen isoleret fra kropsvæv.
English: M-M-RVAXPRO can be given to persons who have been in recent (within 3 days) contact with a case of measles and may be incubating the disease.
Danish: M-M-RVAXPRO kan anvendes til personer som for nylig (indenfor de sidste 3 dage) har været i kontakt med et mæslingetilfælde og derfor muligvis er i inkubationsperioden.
English: Valence (seropro tection level)
Danish: Valens (serobeskyttelsesniveau)
English: In addition and as previously underlined from the first of June 2010 until the fifth of February 2016, the Dutch Pharmacovigilance Center (Lareb) received 327 reports of MedDRA® Preferred Term (PT) ‘Crying' (preferred term) following immunization with the MMR vaccine.
Danish: I tillæg hertil og som tidligere fremhævet modtog det hollandske Pharmacovigilance Center (Lareb) 327 rapporter fra 1. juni 2010 til 5. februar 2016 om MedDRA® standardtermen ”Gråd” efter immunisering med MFR-vaccine.
English: Immunogenicity and safety data show that M-M-RVAXPRO can be administered to infants between 9 and 12 months of age, in accordance with official recommendations or when an early protection is considered necessary (e.g., day-care, outbreak situations, or travel to a region with high prevalence of measles).
Danish: Immunogenicitets- og sikkerhedsdata viser, at M-M-RVAXPRO kan gives til spædbørn mellem 9 og 12 måneder i overensstemmelse med officielle anbefalinger, eller når tidlig beskyttelse anses for at være nødvendig (f.eks. daginstitution, ved udbrud eller ved rejse til et område med en høj forekomst af mæslinger).
English: When completely reconstituted, the vaccine is a clear yellow liquid.
Danish: Efter fuldstændig rekonstitution er vaccinen en klar gul væske.
English: There is no evidence that measles vaccine can cause SSPE.
Danish: Det er ikke påvist, at mæslingevaccine kan forårsage SSPE.
English: Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH)
Danish: Natriumhydrogencarbonat Saltsyre (til justering af pH) Natriumhydroxid (til justering af pH)
English: The MAH concluded that the review of both clinical trial and post-marketing data (including the EudraVigilance Data Analysis System (EVDAS)) for MMR, as well as a review of the literature, has not provided evidence to suggest a causal relationship for MMR and crying and therefore, a label update is not warranted at this time.
Danish: Indehaveren af markedsføringstilladelsen konkluderede, at gennemgangen af data fra både kliniske studier og efter markedsføring (herunder EudraVigilance Data Analysis System (EVDAS)) for MFR, tillige med gennemgang af litteraturen, ikke har givet evidens for, at der skulle være årsagssammenhæng mellem MFR og gråd, og derfor er en opdatering af produktinformationen ikke indiceret på nuværende tidspunkt.
English: These studies also established that seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
Danish: Disse undersøgelser fastslog desuden, at serokonversion som respons på vaccination mod mæslinger, parotitis og rubella var lig med beskyttelse mod disse sygdomme.
English: However, M-M-RVAXPRO may not always be able to prevent measles developing in these cases.
Danish: M-M-RVAXPRO kan dog ikke altid forhindre et mæslingeudbrud i sådanne tilfælde.
English: Only rarely have vaccine recipients developed chronic joint symptoms.
Danish: Vaccinemodtagere har kun sjældent udviklet kroniske ledsymptomer.
English: Previously unvaccinated individuals older than 9 months who are in contact with susceptible pregnant women should receive live attenuated rubella-containing vaccine (such as M-M-RVAXPRO or a monovalent rubella vaccine) to reduce the risk of exposure of the pregnant woman.
Danish: Ikke tidligere vaccinerede personer over 9 måneder, som er i kontakt med modtagelige gravide kvinder, bør have levende svækket vaccine indeholdende rubella (som f.eks. M-M-RVAXPRO eller en monovalent rubellavaccine) for at nedsætte risikoen for eksponering af den gravide kvinde.
English: The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or immune globulin (known as IG).
Danish: Lægen kan udsætte vaccinationen i mindst 3 måneder efter blod- eller plasma-transfusion eller efter indgivelse af immunglobulin (kendt som IG).
English: Females of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month, or according to doctor's recommendation, after they have been given the vaccine.
Danish: Kvinder i den fødedygtige alder skal tage de nødvendige forholdsregler for at undgå graviditet i 1 måned efter vaccination, eller efter lægens anvisning.
English: If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated.
Danish: Der kan være vedlagt to separate nåle: brug en nål til at rekonstituere vaccinen og en anden nål til indgivelse af vaccinen til den person, der skal vaccineres.
English: Adults and adolescents with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions.
Danish: Voksne og teenagere med kendt allergi kan have en øget risiko for at få en anafylaktisk eller anafylaktoid reaktion.
English: Panniculitis, Pruritus, Purpura, Skin induration, Stevens-Johnson syndrome
Danish: Pannikulit, pruritus, purpura, hudinduration, StevensJohnsons syndrom
English: Infants below 9 months of age:
Danish: Spædbørn under 9 måneder
English: Very common (may affect more than 1 in 10 vaccinees)
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10 vaccinerede)
English: Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccines may secrete the virus in breast milk and transmit it to breast-fed infants.
Danish: Undersøgelser har vist, at ammende post partum-kvinder vaccineret med levende svækkede rubellavacciner kan udskille virus i modermælken og overføre det til brysternærede spædbørn.
English: For precautions to be taken before handling or administering the medicinal product, and for instructions on reconstitution of the medicinal product before administration, see section 6.6.
Danish: For forholdsregler, der skal træffes, før håndtering eller administration af lægemidlet og for anvisninger omkring rekonstitution af lægemidlet før administration: Se pkt.
English: Administration of a higher than recommended dose of M-M-RVAXPRO was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of M-M-RVAXPRO.
Danish: Administration af en højere dosis end anbefalet af M-M-RVAXPRO er indberettet i sjældne tilfælde, og bivirkningsprofilen var sammenlignelig med den, der observeredes ved den anbefalede dosis af MM-RVAXPRO.
English: M-M-RVAXPRO contains sorbitol.
Danish: M-M-RVAXPRO indeholder sorbitol
English: Blood and the lymphatic system disorders Regional lymphadenopathy, Thrombocytopenia
Danish: Blod og lymfesystem Regional lymfadenopati, trombocytopeni
English: The seroprotection rates to measles, mumps, and rubella for the Full Analysis Set are given in Table 1.
Danish: Serobeskyttelsesraterne over for mæslinger, parotitis og rubella for det fulde analysesæt fremgår af Tabel 1.
English: Chronic arthritis
Danish: Kronisk artritis
English: Ask your pharmacist how to throw away vaccines you no longer use.
Danish: Spørg på apoteket, hvordan De skal bortskaffe vacciner.
English: Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within 8 hours.
Danish: Efter vaccinen er blandet med den medfølgende solvens, skal den enten anvendes straks eller opbevares i køleskabet og anvendes inden for 8 timer.
English: Discard if reconstituted vaccine is not used within 8 hours.
Danish: Rekonstitueret vaccine skal kasseres, hvis den ikke anvendes inden for 8 timer.
English: It is recommended that the vaccine be administered immediately after reconstitution or stored in the refrigerator and used within 8 hours to minimize loss of potency.
Danish: Det anbefales, at vaccinen gives straks efter rekonstitution eller opbevares i køleskab og anvendes inden for 8 timer for at minimere tab af styrke.
English: Therefore, based on the aforementioned information the PRAC recommends a variation in section 4.8 to add “Crying” with the frequency “uncommon”.
Danish: 4.8 for tilføjelse af ”Gråd” med hyppigheden ”Ikke almindelig”.
English: Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and sex, being greatest in adult females and least in prepubertal children.
Danish: Artralgi og/eller artritis (i reglen forbigående og sjældent kronisk) samt polyneuritis er karakteristiske træk ved infektion med vildtyperubella, og hyppighed og sværhedsgrad varierer med alder og køn, idet de især berører voksne kvinder og mindst hos præpubertetsbørn.
English: M-M-RVAXPRO is expected to have no or negligible influence on ability to drive and use machines.
Danish: M-M-RVAXPRO forventes ikke at have nogen eller kun ubetydelig indvirkning på evnen til føre motorkøretøj eller betjene maskiner.
English: Do not freeze the reconstituted vaccine.
Danish: Rekonstitueret vaccine må ikke nedfryses.
English: • Joint pain and/or swelling (usually transient and rarely chronic); muscle pain.
Danish: • Ledsmerter og/eller hævde led (normalt forbigående og sjælden kronisk); muskelsmerter.
English: Do not freeze the vaccine.
Danish: Vaccinen må ikke nedfryses.
English: Administration of immune globulins concomitantly with M-M-RVAXPRO may interfere with the expected immune response.
Danish: Indgivelse af immunglobulin samtidigt med M-M-RVAXPRO kan påvirke det forventede immunrespons.
English: This vaccine should be given subcutaneously to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Danish: Denne vaccine skal gives subkutant til personer med trombocytopeni eller enhver form for koagulationsforstyrrelse, da der kan opstå blødning efter intramuskulær indgivelse til disse personer.
English: An additional dose with a measles-containing vaccine should be considered according to official recommendations (see sections 4.4 and 5.1).
Danish: En ekstra dosis af en vaccine, der indeholder mæslingevirus, bør overvejes i overensstemmelse med officielle anbefalinger (se pkt.
English: Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Danish: Indehaver af markedsføringstilladelsen: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Frankrig.
English: The vaccine may be administered to persons 12 months of age or older.
Danish: Vaccinen kan gives til personer på 12 måneder eller derover.
English: Arthralgia and/or arthritis
Danish: † og/eller artralgi
English: Rubella (titre ≥10 IU/mL)
Danish: Rubella (titer ≥10 IU/mL)
English: Do not use this vaccine after the expiry date which is stated on the outer carton after EXP.
Danish: Brug ikke denne vaccine efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In the Full Analysis Set (vaccinated subjects regardless of their antibody titre at baseline), high seroprotection rates of >99% were elicited to mumps and rubella post-dose 2, regardless of the age of the vaccinee at the first dose.
Danish: I det fulde analysesæt (vaccinerede forsøgspersoner uanset deres antistof-titer ved baseline) sås høje serobeskyttelsesrater på >99 % over for parotitis og rubella efter dosis 2, uafhængigt af det vaccinerede barns alder ved første dosis.
English: For vaccines that cannot be given at the same time, M-M-RVAXPRO should be given 1 month before or after administration of those vaccines.
Danish: For vacciner, der ikke kan gives samtidigt, bør M-M-RVAXPRO gives 1 måned før eller efter anvendelse af de pågældende vacciner.
English: Therefore, inadvertent vaccination of unknowingly pregnant women with measles-, mumps-, or rubella-containing vaccines should not be a reason for termination of pregnancy.
Danish: Derfor bør utilsigtet vaccination af kvinder med ukendt graviditet med mæslinge-, parotitis- eller rubellaholdige vacciner ikke foranledige afbrydelse af graviditeten.
English: Keep the vial of powder in the outer carton in order to protect from light.
Danish: Hætteglasset med pulver opbevares i den ydre karton for at beskytte mod lys.
English: No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis.
Danish: Der er til dato ikke indberettet undersøgelser om virkningen af mæslingevirusvaccine hos børn med ubehandlet tuberkulose.
English: In addition, individuals who experienced thrombocytopenia with the first dose of M-M-RVAXPRO (or its component vaccines) may develop thrombocytopenia with repeat doses.
Danish: Desuden kan personer, som udviklede trombocytopeni efter den 1. dosis M-M-RVAXPRO (eller dens komponentvacciner) udvikle trombocytopeni ved yderligere doser.
English: Also, if the person who is to be vaccinated has already been exposed to the measles, mumps, or rubella virus but is not yet ill, M-M-RVAXPRO may not be able to prevent the illness from appearing.
Danish: Hvis personen som skal vaccineres desuden allerede er udsat for mæslinge-, fåresyge eller røde hunde-virus, men endnu ikke syg, er det muligt, at M-M-RVAXPRO ikke er i stand til at forhindre sygdommens udbrud.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for measles / mumps / rubella vaccines (live, attenuated), the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for vaccinerne mod mæslinger / fåresyge / røde hunde (levende, svækket) er CHMP nået frem til følgende videnskabelige konklusioner:
English: When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, and rubella viruses.
Danish: Når en person får vaccinen, danner immunsystemet (kroppens naturlige forsvar) antistoffer mod mæslinge-, fåresyge- og røde hunde-vira.
English: The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
Danish: Vaccinen skal indgives subkutant hos patienter med trombocytopeni eller enhver form for koagulationsforstyrrelse.
English: Post-exposure vaccination
Danish: Vaccination efter eksponering for smitte
English: DO NOT INJECT INTRAVASCULARLY.
Danish: MÅ IKKE INJICERES INTRAVASKULÆRT.
English: Encephalitis and Encephalopathy
Danish: Encefalitis og encefalopati
English: Fertility M-M-RVAXPRO has not been evaluated in fertility studies.
Danish: Fertilitet M-M-R-VAXPRO er ikke blevet evalueret i fertilitetsundersøgelser.
English: Withdraw the entire volume of solvent into a syringe to be used for reconstitution and injection.
Danish: Hele mængden af solvens trækkes op i en sprøjte, som skal bruges til både rekonstitution og injektion.
English: Mumps (titre ≥10 ELISA Ab units/mL)
Danish: Parotitis (titer ≥10 ELISA Ab units/mL)
English: There is no information to suggest that M-M-RVAXPRO affects the ability to drive or operate machinery.
Danish: Der er ingen oplysninger, der tyder på, at anvendelse af M-M-RVAXPRO påvirker evnen til at køre bil eller betjene maskiner.
English: Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Danish: Familieanamnese med medfødt eller arvelig immundefekt, med mindre det kan påvises, at den potentielle modtager af vaccinen er immunkompetent.
English: • Inflammation of blood vessels.
Danish: • Betændelse i blodkar.
English: • Whenever the risk management system is modified , especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur 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: • Diarrhoea, vomiting.
Danish: • Diaré, opkastning.
English: • Headache; fainting; nerve disorders which can cause weakness, tingling, or numbness; eye nerve disturbances.
Danish: • Hovedpine; besvimelse; nervelidelser, som kan forårsage svaghed, prikkende fornemmelse eller følelsesløshed; forstyrrelser af synsnerven.