natgillin/translations-raw huggingface dataset:
M- M- RVAXPRO er en vaccine.
M-M-RVAXPRO is a vaccine.
Vacciner virker ved at "lære" immunsystemet (organismens naturlige forsvar), hvordan det skal forsvare organismen mod sygdommen.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
M- M- RVAXPRO indeholder små mængder af en svækket form af de virus, der er årsag til mæslinger, fåresyge og røde hunde.
M-M-RVAXPRO contains small amounts of weakened forms of the viruses that cause measles, mumps, and rubella.
Når man får vaccinen, opfatter immunsystemet de svækkede virus som "fremmede" og producerer antistoffer mod dem.
When a person is given the vaccine, the immune system recognises the weakened viruses as ‘ foreign’ and makes antibodies against them.
Derefter vil immunsystemet fremover kunne producere antistoffer hurtigere, hvis det møder de samme virus igen.
In the future, the immune system will be able to produce antibodies quicker when it is again exposed to the viruses.
Antistofferne er med til at beskytte mod de sygdomme, der forårsages af disse virus.
The antibodies will help to protect against diseases caused by these viruses.
M- M - RVAXPRO fremstilles også med albumin, men dette albumin er fremstillet ved "rekombinant DNA - teknik" (en teknik, hvor en gærcelle har fået indsat et gen (DNA), som gør den i stand til at producere humant albumin).
M-M-RVAXPRO is very similar to another presentation of the measles, mumps and rubella vaccine already authorised (M-M-R II) but with a slight difference: where the existing presentation is manufactured with a protein, albumin, that is extracted from human serum (the liquid part of the blood); M-M-RVAXPRO is manufactured with the same protein, but made using ‘ recombinant DNA technology’ (a technique where a yeast is given a gene (DNA) that makes it able to produce human albumin).
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan er M- M- RVAXPRO blevet undersøgt?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int  EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has M-M-RVAXPRO been studied?
I undersøgelsen af M- M- RVAXPRO bliver dens virkning sammenlignet med virkningen af det tidligere vaccinepræparat mod mæslinger, fåresyge og røde hunde hos 1 279 børn.
The study for M-M-RVAXPRO compared its effectiveness to that of the previous presentation of the measles, mumps and rubella vaccine in 1,279 children.
I undersøgelsen har man registreret vaccinens evne til at få immunsystemet til at reagere mod virus.
The study measured the ability of the vaccine to make the immune system respond to the viruses.
Formålet var at finde ud af, om M- M- RVAXPRO giver tilstrækkelig beskyttelse mod sygdommen.
Another study in a further 1,997 children looked more specifically at one of the component of the vaccine (mumps) to show that the level used in M-M-RVAXPRO provides enough protection against the disease.
Hvilken fordel viser undersøgelserne, der er ved M- M- RVAXPRO?
What benefit has M-M-RVAXPRO shown during the studies?
M- M- RVAXPRO udløste en immunreaktion af samme styrke som den vaccine mod mæslinger, fåresyge og røde hunde, der indeholder serum albumin.
M-M-RVAXPRO provided the same level of immune response as the measles, mumps, and rubella vaccine containing serum albumin.
Der opnåedes følgende responsrater (et mål for, i hvilket omfang immunsystemet har reageret på virus):
The response rates (measuring how the immune system had responded to the viruses) were:
98, 3% for mæslinger, 99, 4% for fåresyge og 99, 6% for røde hunde.
98.3% for measles, 99.4% for mumps and 99.6% for rubella.
Hvilken risiko er der forbundet med M- M- RVAXPRO?
What is the risk associated with M-M-RVAXPRO?
Hos børn, der fik M- M- RVAXPRO, var de hyppigste bivirkninger feber (38, 5 °C eller derover) og reaktioner på indsprøjtningsstedet (rødme, smerte, hævelse).
The most common side effects in children who were given M-M-RVAXPRO were fever (38.5°C or higher), and injection site reactions (redness, pain, swelling).
Den fuldstændige liste over de indberettede bivirkninger ved M- M- RVAXPRO fremgår af indlægssedlen.
For the full list of all side effects reported with M-M-VAXPRO, please see the Package Leaflet.
M- M- RVAXPRO må ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for nogen vaccine mod mæslinger, fåresyge eller røde hunde, eller over for nogen af indholdsstofferne, herunder
M-M-RVAXPRO should not be used in people who may be hypersensitive (allergic) to any measles, mumps, or rubella vaccine, or to any of the ingredients, including neomycin (an antibiotic).
M- M- RVAXPRO må ikke gives under graviditet, ved feberfremkaldende sygdom (over 38, 5 °C), ved aktiv ubehandlet tuberkulose eller til patienter med sygdomme, der påvirker immunsystemet.
M-M-RVAXPRO should not be given during pregnancy, an illness with fever (over 38.5°C), active untreated tuberculosis (TB), or when the patient has any disease that affects their immune system.
Hvorfor er M- M- RVAXPRO blevet godkendt?
Why has M-M-RVAXPRO been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) har konkluderet, at fordelene ved M- M- RVAXPRO er større end risiciene ved anvendelse til kombineret vaccination mod mæslinger, fåresyge og røde hunde hos personer på 12 måneder eller derover.
The Committee for Medicinal products for Human Use (CHMP) decided that M-M-RVAXPRO’ s benefits are greater than its risks for the combined vaccination against measles, mumps, and rubella in individuals 12 months or older.
Udvalget har anbefalet udstedelse af markedsføringstilladelse for M- M- RVAXPRO.
They recommended that M-M-RVAXPRO be given marketing authorisation.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af M- M- RVAXPRO?
What measures are being taken to ensure the safe use of M-M-RVAXPRO?
Det firma, der fremstiller M- M- RVAXPRO, vil fortsætte overvågningen af bivirkninger for at fastslå, om brugen af rekombinant albumin i fremstillingsprocessen for M- M- RVAXPRO medfører bivirkninger som f. eks. allergiske reaktioner.
The Company that makes M-M-RVAXPRO will continue to monitor the side effects to see if using recombinant albumin in the manufacturing process of M-M-RVAXPRO leads to side effects such as allergic reactions.
Andre oplysninger om M- M- RVAXPRO:
Other information about M-M-RVAXPRO:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for M- M- RVAXPRO til Sanofi Pasteur MSD SNC den 5. maj 2006.
The European Commission granted a marketing authorisation valid throughout the European Union for M-M-RVAXPRO to Sanofi Pasteur MSD SNC on 5 May 2006.
Den Europæiske Offentlige Vurderingsrapport (EPAR) for M- M- RVAXPRO kan ses i sin helhed her.
The full EPAR for M-M-RVAXPRO is available here.
Dette sammendrag blev sidst opdateret i maj 2006.
This summary was last updated in 05-2006.
pulver: hætteglas; solvens: hætteglas
powder: vial (glass); solvent: vial (glass)
Fyldt injektionssprøjte
powder: vial (glass); solvent: pre-filled syringe (glass)
1 hætteglas + 1 fyldt injektionssprøjte med fastsiddende kanyle
1 vial + 1 pre-filled syringe with attached needle
10 hætteglas + 10 fyldte injektionssprøjter med fastsiddende kanyle
10 vials + 10 pre-filled syringes with attached needle
10 hætteglas + 10 fyldte injektionssprøjter uden kanyle
10 vials + 10 pre-filled syringes without needle
20 hætteglas + 20 fyldte injektionssprøjter uden kanyle
20 vials + 20 pre-filled syringes without needle
10 hætteglas + 10 fyldte injektionssprøjter + 10 kanyler
10 vials + 10 pre-filled syringes + 10 needles
20 hætteglas + 20 fyldte injektionssprøjter + 20 kanyler
20 vials + 20 pre-filled syringes + 20 needles
1/ 2 EU/ 1/ 06/ 337/ 013
EU/ 1/ 06/ 337/ 013
20 hætteglas + 20 fyldte injektionssprøjter + 40 kanyler
20 vials + 20 pre-filled syringes + 40 needles
M- M- RVAXPRO pulver og solvens til injektionsvæske, suspension.
M-M-RVAXPRO Powder and solvent for suspension for injection.
Mæslinge -, parotitis - og rubellavaccine (levende).
Measles, mumps, and rubella vaccine (live).
Efter rekonstitution indeholder 1 dosis (0, 5 ml):
After reconstitution, one dose (0.5 ml) contains:
Mæslingevirus1 Enders ’ Edmonston- stamme (levende, svækket) Parotitisvirus1 Jeryl Lynn™ stamme [niveau B]) (levende, svækket) Rubellavirus2 Wistar RA 27/ 3 stamme (levende, svækket)
Measles virus1 Enders’ Edmonston strain (live, attenuated)......... not less than 1x103 CCID50* Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated).... not less than 12.5x103 CCID50* Rubella virus2 Wistar RA 27/ 3 strain (live, attenuated)............... not less than 1x103 CCID50*
* Cellekultur infektiøs dosis 50%.
*50% cell culture infectious dose 1 produced in chick embryo cells.
1 fremstillet i kyllingeembryoceller.
2 produced in WI-38 human diploid lung fibroblasts.
4. 2).
M-M-RVAXPRO is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months or older (see section 4.2).
5. 1.
For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella, see section 5.1.
M- M- RVAXPRO skal anvendes på basis af officielle anbefalinger.
M-M-RVAXPRO is to be used on the basis of official recommendations.
Personer på 12 måneder eller derover
2 Individuals 12 months or older
Personer på 12 måneder eller derover bør gives én dosis på en given dato.
Individuals 12 months or older should receive one dose at an elected date.
Spædbørn fra 6 måneder til under 12 måneder
Infants between 6 months and less than 12 months
5. 1).
No data on the efficacy and safety of M-M-RVAXPRO for use in children below 12 months are currently available (see section 5.1).
Det kan forekomme, at spædbørn i alderen fra 6 til 12 måneder, som er vaccineret med en vaccine indeholdende mæslingevirus under et udbrud af mæslinger, eller som er vaccineret i den alder, der er i overensstemmelse med officielle anbefalinger, ikke responderer på vaccinen på grund af tilstedeværelse af cirkulerende antistoffer, som stammer fra moderen.
Infants between 6 months and less than 12 months vaccinated with a measles-containing vaccine during measles outbreak or vaccinated at that age in accordance with official recommendation may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin.
Sådanne spædbørn bør revaccineres i 12- 15 måneders alderen efterfulgt af en ekstra dosis indeholdende mæslingevaccine i overensstemmelse med officielle anbefalinger.
Such infants should be revaccinated at 12 to 15 months followed by an additional dose with a measles-containing vaccine according to the official recommendations.
Vaccinen skal injiceres intramuskulært (i. m.) eller subkutant (s. c.).
The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
6. 6 for klargøringsvejledning.
See section 6.6 for preparation instructions.
2, 4. 4 og 6. 1).
History of hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients, including neomycin (see sections 2, 4.4, and 6.1).
4. 4 og 4. 6).
Pregnancy (see also sections 4.4 and 4.6).
Vaccination skal udsættes under enhver sygdom med feber > 38, 5° C.
Vaccination should be postponed during any illness with fever > 38.5°C.
4. 4).
Active untreated tuberculosis (see section 4.4).
M- M- RVAXPRO er ikke kontraindiceret til personer, som får topiske eller lave doser parenterale kortikosteroider (f. eks. som astmaprofylakse eller substitutionsterapi).
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).
Humoral eller cellulær immundefekt (primær eller erhvervet), herunder hypogammaglobulinæmi og dysgammaglobulinæmi og AIDS, eller symptomgivende HIV- infektion, eller en aldersspecifik CD4+ T- lymfocytprocent på < 25% (se pkt.
In severely immunocompromised individuals
For svært immunkompromitterede personer, der ved en fejl er blevet vaccineret med mæslingeholdig vaccine, er der indberettet mæslingeencefalitis (MIBE), pneumonitis og fatal udgang som en direkte følge af udbredt infektion med mæslingevaccinevirus.
3 inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported.
Medicinsk behandling og overvågning skal altid være let tilgængeligt i tilfælde af en sjælden anafylaktisk reaktion efter indgivelse af vaccinen.
Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
3 Voksne og teenagere med kendt allergi kan have en øget risiko for at få en anafylaksislignende reaktion.
Adults and adolescents with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions.
Da levende mæslinge - og parotitisvaccine fremstilles ved dyrkning af kyllingeembryoceller, kan personer med anamnestiske anafylaktiske og anafylaksilignende reaktioner eller andre straks - reaktioner (f. eks. nældefeber, hævelse i munden eller halsen, besværet vejrtrækning, hypotension eller shock) efter indtagelse af æg have forhøjet risiko for overfølsomhedsreaktioner af straks- typen.
Since live measles vaccine and live mumps vaccine are produced in chick embryo cell culture, persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e. g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions.
Den potentielle risk/ benefit- ratio skal vurderes omhyggeligt, før vaccination overvejes i sådanne tilfælde.
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
Der skal udvises behørig forsigtighed ved administration af M- M- RVAXPRO til personer med egen anamnese eller familieanamnese med kramper eller hjernelæsion.
Due caution should be employed in administration of M-M-RVAXPRO to persons with individual or family history of convulsions, or a history of cerebral injury.
4. 8).
The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8).
Vaccinen indeholder 1, 9 mg sakkarose som et hjælpestof.
The vaccine contains 1.9 mg of sucrose as an excipient.
Denne mængde er for lille til at medføre uønskede hændelser hos patienter med sjældne hereditære problemer, såsom fruktoseintolerans, glukose- galaktosemalabsorption eller sukrase- isomaltaseinsufficiens.
This amount is too low to cause adverse events in patients with rare hereditary problems such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.
Vaccinen indeholder sporrester af rekombinant human albumin (rHA).
The vaccine contains residual traces of recombinant human albumin (rHA).
I en undersøgelse med børn der fik dosis nummer to af M- M- RVAXPRO, blev der ikke observeret sensibilisering over for rHA.
In a study with children receiving a second dose of M-M-RVAXPRO, sensitisation to rHA was not observed.
En teoretisk risiko for hypersensitivitet over for rHA med lav hyppighed kan ikke udelukkes.
A theoretical risk of hypersensitivity to rHA at a low frequency cannot be ruled out.
Derfor skal der udvises forsigtighed ved brug af produkter, der indeholder rHA, hos personer, som tidligere har vist tegn på hypersensitivitet over for rHA.
Therefore caution needs to be exercised when using any product containing rHA in individuals who previously showed signs of hypersensitivity to rHA.
4. 3 og 4. 6).
Pregnancy The vaccine should not be administered to pregnant females; furthermore, pregnancy should be avoided for 3 months following vaccination (see sections 4.3 and 4.6).
Trombocytopeni Denne vaccine skal gives subkutant hos personer med trombocytopeni eller enhver form for koagulationsforstyrrelse, da der kan opstå blødning efter intramuskulær indgivelse hos disse personer.
Thrombocytopenia 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.
Desuden kan personer, som reagerede med trombocytopeni efter den 1. dosis M- M- RVAXPRO (eller dens komponentvacciner) udvikle trombocytopeni ved yderligere doser.
In addition, individuals who experienced thrombocytopenia with the first dose of M-M-RVAXPRO (or its component vaccines) may develop thrombocytopenia with repeat doses.
Personens serologiske status kan evalueres for at afgøre, hvorvidt yderligere doser af vaccinen er påkrævet.
Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed.
4. 8).
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases (see section 4.8).
Øvrige Personer som vides at være smittet med HIV, men som ikke er immunkompromitterede, kan vaccineres.
4 Other Individuals who are known to be infected with human immunodeficiency viruses and are not immunocompromised may be vaccinated.
4. 3).
However, these vaccinees should be monitored closely for measles, mumps, and rubella because vaccination may be less effective in these patients than in persons not infected with human immunodeficiency viruses (see section 4.3).
4. 3).
Children under treatment for tuberculosis have not experienced exacerbation of the disease when vaccinated with live measles virus vaccine; no studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis (see section 4.3).
Som for enhver vaccine er det ikke sikkert, at vaccination med M- M- RVAXPRO resulterer i beskyttelse hos samtlige vaccinerede.
As for any vaccine, vaccination with M-M-RVAXPRO may not result in protection in all vaccinees.
Smitteoverførsel Udskillelse af små mængder levende svækket rubellavirus fra næsen eller halsen er forekommet hos flertallet af modtagelige personer 7 til 28 dage efter vaccination.
Transmission 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.
4. 6).
Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
4 Der er ikke rapporteret tilfælde af smitteoverførsel med den yderligere svækkede Enders ’ Edmonston - mæslingevirusstamme eller Jeryl Lynn™- parotitisvirusstammen fra de vaccinerede til modtagelige personer i kontakt med dem.
There are no reports of transmission of the more attenuated Enders’ Edmonston strain of measles virus or the Jeryl Lynn ™ strain of mumps virus from vaccinees to susceptible contacts.
Immunglobulin (IG) må ikke gives samtidigt med M- M- RVAXPRO.
Immune globulin (IG) is not to be given concomitantly with M-M-RVAXPRO.
Indgivelse af immunglobulin samtidigt med M- M- RVAXPRO kan påvirke det forventede immunrespons.
Administration of immune globulins concomitantly with M-M-RVAXPRO may interfere with the expected immune response.
Vaccination bør udsættes mindst 3 måneder efter blod - eller plasmatransfusioner eller indgivelse af humant serumimmunglobulin.
Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin.
Indgivelse af blodprodukter som indeholder mæslinge -, parotitis - eller rubellaantistoffer, herunder immunglobulinpræparater, bør undgås i 1 måned efter en dosis M- M- RVAXPRO, medmindre det er tvingende nødvendigt.
Administration of measles, mumps, or rubella antibody-containing blood products, including immune globulin preparations, should be avoided within 1 month after a dose of M-M-RVAXPRO unless considered to be essential.
Ved separat indgivelse af de enkelte levende svækkede mæslinge -, parotitis - og rubellavacciner er der rapporteret tilfælde, hvor huden kortvarigt har vist nedsat følsomhed over for tuberkulin.
It has been reported that live attenuated measles, mumps, and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
Hvis tuberkulintest skal udføres, bør den derfor administreres enten før, samtidigt med eller 4 til 6 uger efter vaccination med M- M- RVAXPRO.
Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or 4 to 6 weeks after vaccination with M-M-RVAXPRO.
Samtidig brug af andre vacciner Publicerede kliniske data støtter samtidig indgivelse af den tidligere formulering af mæslinge -, parotitis - og rubellavaccine fremstillet af Merck & Co., Inc. og andre børnevaccinationer, herunder DTaP (eller DTwP), IPV (eller OPV), HIB (Haemophilus influenzae type b med Hepatitis B- vaccine) og VAR (varicella).
Use with other vaccines Published clinical data support concomitant administration of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. with other childhood vaccinations, including DTaP (or DTwP), IPV (or OPV), HIB (Haemophilus influenzae type b), HIB-HBV (Haemophilus influenzae type b with Hepatitis B vaccine), and VAR (varicella).
På nuværende tidspunkt er der ikke foretaget specifikke undersøgelser af samtidig brug af M- M- RVAXPRO og andre vacciner.
Currently no specific studies have been conducted on the concomitant use of M-M-RVAXPRO and other vaccines.
Men da det er påvist, at M- M- RVAXPRO har samme sikkerheds - og immunogenicitetsprofil som den tidligere formulering af den kombinerede mæslinge -, parotitis - og rubellavaccine fremstillet af Merck & Co., Inc., kan erfaring med denne vaccine tages i betragtning.
5 and rubella vaccine manufactured by Merck & Co., Inc., experience with this vaccine can be considered.
M- M- RVAXPRO skal gives samtidig med, eller en måned før eller efter indgivelse af andre levende virus- vacciner, på separate injektionssteder.
M-M-RVAXPRO should be given concomitantly at separate injection sites, or one month before or after administration of other live virus vaccines.
Der er ikke udført undersøgelser med M- M- RVAXPRO til gravide.
Studies have not been conducted with M-M-RVAXPRO in pregnant women.
Det vides ikke, om M- M- RVAXPRO kan forårsage fosterskader, når den administreres til en gravid kvinde, eller om den kan påvirke reproduktionsevnen.
It is not known whether M-M-RVAXPRO can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity.
4. 3 og 4. 4).
Therefore, the vaccine should not be administered to pregnant females; furthermore, pregnancy should be avoided for 3 months following vaccination (see sections 4.3 and 4.4).
Ved rådgivning af kvinder som utilsigtet er vaccineret under graviditet, eller som er blevet gravide indenfor 3 måneder efter vaccination, bør lægen være opmærksom på følgende:
In order to advise women who are inadvertently vaccinated when pregnant or who become pregnant within 3 months of vaccination, the physician should be aware of the following:
(2) Parotitisinfektion under graviditetens første trimester kan forøge risikoen for spontan abort.
(1) In a 10 year survey involving over 700 pregnant women who received rubella vaccine within 3 months before or after conception (of whom 189 received the Wistar RA 27/ 3 strain), none of the newborns had abnormalities compatible with congenital rubella syndrome; (2) Mumps infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.