natgillin/translations-raw huggingface dataset:
(3) Rapporter har vist, at kvinder smittet med vildtypemæslinger under graviditeten har en forøget risiko for fostermisdannelser.
Although mumps vaccine virus has been shown to infect the placenta and foetus, there is no evidence that it causes congenital malformations in humans; and (3) Reports have indicated that contracting wild-type measles during pregnancy enhances foetal risk.
Forhøjede tal for spontan abort, dødfødsel, medfødte defekter og præmaturitet er observeret efter smitte med vildtypemæslinger under graviditeten.
Increased rates of spontaneous abortion, stillbirth, congenital defects, and prematurity have been observed subsequent to wild-type measles during pregnancy.
Der er ingen adækvate undersøgelser af den svækkede (vaccine) stamme af mæslingevirus under graviditet.
There are no adequate studies of the attenuated (vaccine) strain of measles virus in pregnancy.
Det vil dog være klogt at antage, at virusstammen fra en vaccine også kan medføre uønskede virkninger på fosteret.
However, it would be prudent to assume that the vaccine strain of virus is also capable of inducing adverse foetal effects.
5 NB!
Note:
Officielle anbefalinger kan variere med hensyn til, hvor længe graviditeten skal undgås efter vaccination.
Official recommendations may vary regarding the duration of the waiting period that is recommended for avoiding pregnancy following vaccination.
Post partum- kvinder I mange tilfælde har det været hensigtsmæssigt at lade kvinder modtagelige for rubella vaccinere i perioden umiddelbart efter fødslen.
Postpartum Women It has been found convenient in many instances to vaccinate rubella-susceptible women in the immediate postpartum period.
Undersøgelser har vist, at ammende post partum- kvinder vaccineret med levende svækkede rubellavacciner kan udskille virus i modermælken og overføre det til brysternærede spædbørn.
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.
Der skal derfor udvises forsigtighed, når M- M- RVAXPRO gives til en ammende kvinde.
It is not known whether measles or mumps vaccine virus is secreted in human milk; therefore, caution should be exercised when M-M-RVAXPRO is administered to a breast-feeding woman.
5. 1), og den generelle sikkerhedsprofil var sammenlignelig med den tidligere formulering af mæslinge -, parotitis - og rubellavaccine fremstillet af Merck & Co., Inc.
In clinical trials, M-M-RVAXPRO was administered to 1965 children (see section 5.1), and the general safety profile was comparable to the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
I et klinisk forsøg blev M- M- RVAXPRO givet til 752 børn, enten intramuskulært eller subkutant.
In a clinical trial, 752 children received M-M-RVAXPRO, either intramuscularly or subcutaneously.
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%).
6 although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
Blandt disse børn blev der observeret følgende vaccinerelaterede bivirkninger hos personer efter vaccination med M- M- RVAXPRO (bortset fra enkeltstående indberetninger med en hyppighed < 0, 2%).
Among these children, the following vaccine-related adverse reactions were observed in individuals following vaccination with M-M-RVAXPRO (excluding isolated reports with frequency < 0.2%).
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.
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.
Disse bivirkninger er opsummeret herunder (hyppighed ikke kendt).
Additionally, other adverse experiences reported with post-marketing use of M-M-RVAXPRO and/ or in clinical studies and post-marketing use of previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck & Co., Inc. without regard to causality or frequency are available and are summarised below (frequency not known).
[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)]
[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)]
Aseptisk meningitis (se nedenfor), atypiske mæslinger, epididymitis, orkitis, otitis media, parotitis, rinitis, subakut skleroserende panencefalitis (se nedenfor).
Infections and infestations Uncommon: nasopharyngitis, upper respiratory tract infection or viral infection Not known: aseptic meningitis (see below), atypical measles, epididymitis, orchitis, otitis media, parotitis, rhinitis, subacute sclerosing panencephalitis (see below)
Tilfælde af aseptisk meningitis er blevet indberettet efter mæslinge -, parotitis - og rubellavaccination.
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination.
Selv om der er påvist en kausal relation mellem andre stammer af parotitisvaccine og aseptisk meningitis, er der ikke påvist en sammenhæng mellem Jeryl Lynn™- parotitisvaccine og aseptisk meningitis.
Although a causal relationship between other strains of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis.
Regional lymfadenopati, trombocytopeni.
Blood and the lymphatic system disorders Not known: regional lymphadenopathy, thrombocytopenia
Anafylaksilignende reaktion, anafylaksi og relaterede fænomener såsom angioneurotisk ødem, ansigtsødem og perifert ødem.
Immune system disorders Not known: anaphylactoid reaction, anaphylaxis and related phenomenon such as angioneurotic oedema, facial oedema, and peripheral oedema
Irritabilitet.
Psychiatric disorders Not known: irritability
4. 3), øjenlammelser, neurit i nervus opticus, paræstesi, polyneuritis, polyneuropati, retrobulbær neuritis, synkope.
Nervous system disorders Not known: afebrile convulsions or seizures, ataxia, dizziness, encephalitis (see below), encephalopathy (see below), febrile convulsion (in children), Guillain-Barre syndrome, headache, measles inclusion body encephalitis (MIBE) (see section 4.3), ocular palsies, optic neuritis, paraesthesia, polyneuritis, polyneuropathy, retrobulbar neuritis, syncope
1 ud af hver 3 mio. doser vaccine med mæslingevirus fremstillet af Merck & Co., Inc.
Encephalitis and encephalopathy, excluding subacute sclerosing panencephalitis (SSPE), have been reported approximately once for every 3 million doses of the measles-containing vaccines manufactured by Merck & Co., Inc.
Overvågning efter markedsføring af de mere end 400 mio. doser, der er distribueret verden over gennem næsten 25 år (1978- 2003), indikerer, at alvorlige uønskede hændelser såsom encefalit og encefalopati fortsat rapporteres sjældent.
In
Dog antyder dataene muligheden for, at nogle af disse tilfælde kunne skyldes mæslingevacciner.
7 no case has it been shown conclusively that reactions were actually caused by vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines.
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.
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.
Øjne Ikke kendt: konjuktivit, retinitis.
Eye disorders Not known: conjunctivitis, retinitis
Nervedøvhed.
Ear and labyrinth disorders Not known: nerve deafness
4. 3), ondt i halsen.
Respiratory, thoracic, and mediastinal disorders Uncommon: rhinorrhoea Not known: bronchial spasm, cough, pneumonia, pneumonitis (see section 4.3), sore throat
Kvalme.
Gastrointestinal disorders Uncommon: diarrhoea or vomiting Not known: nausea
Pannikulitis, purpura, hudinduration, Steven- Johnsons syndrom, kløe.
Skin and subcutaneous tissue disorders Common: rash morbilliform or other rash Uncommon: urticaria Not known: panniculitis, purpura, skin induration, Stevens-Johnson syndrome, pruritus
Artritis og/ eller artralgi (som regel forbigående og sjældent kronisk [se nedenfor]), myalgi.
Musculoskeletal, connective tissue and bone disorders Not known: arthritis and/ or arthralgia (usually transient and rarely chronic [see below]), myalgia
7 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.
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.
Efter vaccination af børn er reaktionerne i led generelt usædvanlige (0- 3%) og af kort varighed.
Following vaccination in children, reactions in joints are generally uncommon (0-3%) and of brief duration.
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.
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.
Selv hos ældre kvinder (35- 45 år) tåles disse reaktioner generelt godt og påvirker sjældent normale aktiviteter.
Even in older women (35-45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Kronisk artritis er blevet associeret med infektion med vildtyperubella og er blevet relateret til persisterende virus og/ eller virusantigen isoleret fra kropsvæv.
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.
Kortvarig brænden og/ eller svie på indgivelsesstedet, feber (38, 5° C eller derover), utilpashed, papillit, perifert ødem, hævelse, ømhed, vesikler på indgivelsesstedet, blærer og diffus rødmen på indgivelsesstedet.
8 General disorders and administration site conditions Very common: fever (38.5°C or higher), injection site erythema, injection site pain, and injection site swelling Common: injection site bruising Uncommon: injection site rash Not known: burning and/ or stinging of short duration at the injection site, fever (38.5°C or higher), malaise, papillitis, peripheral oedema, swelling, tenderness, vesicles at the injection site, wheal and flare at the injection site
Vasculitis
Vascular disorders Not known: vasculitis
Overdosering er sjældent rapporteret og ikke forbundet med alvorlige bivirkninger.
Overdose has been reported rarely and was not associated with any serious adverse reactions.
Virusvaccine, ATC- kode J07BD52.
Viral vaccine, ATC code J07BD52
Vurdering af immunogenicitet og klinisk virkning En sammenlignende undersøgelse af 1 279 personer, som fik M- M- RVAXPRO eller den tidligere formulering af mæslinge -, parotitis - og rubellavaccine (fremstillet med humant serumalbumin) fremstillet af Merck & Co., Inc. påviste ens immunogenicitet og sikkerhed af de 2 produkter.
Evaluation of immunogenicity and clinical efficacy A comparative study in 1279 subjects who received M-M-RVAXPRO or the previous formulation (manufactured with human serum albumin) of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrated similar immunogenicity and safety between the 2 products.
Kliniske undersøgelser af 284 tredobbelt seronegative børn i alderen 11 måneder til 7 år viste, at den tidligere formulering af mæslinge -, parotitis - og rubellavaccine fremstillet af Merck & Co., Inc. er meget immunogen og sædvanligvis veltålt.
Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. is highly immunogenic and generally well tolerated.
I disse undersøgelser fremkaldte en enkelt injektion af vaccinen HI- antistoffer (hæmagglutinationinhibition) mod mæslinger hos 95% af modtagelige forsøgspersoner, parotitisneutraliserende antistoffer hos 96% og HI- antistoffer mod rubella hos 99%.
In these studies, a single injection of the vaccine induced measles hemagglutination-inhibition (HI) antibodies in 95%, mumps neutralising antibodies in 96%, and rubella HI antibodies in 99% of susceptible persons.
En sammenlignende undersøgelse af 752 forsøgspersoner, som modtog M- M- RVAXPRO enten ved intramuskulær eller subkutan injektion, påviste en tilsvarende immunogenicitetsprofil for begge indgivelsesveje.
A comparative study in 752 subjects who received M-M-RVAXPRO either by intramuscular route or subcutaneous route demonstrated a similar immunogenicity profile between both administration routes.
Virkningen af komponenterne i den tidligere formulering af mæslinge -, parotitis - og rubellavaccine fremstillet af Merck & Co., Inc. blev fastslået i en serie dobbeltblinde kontrollerede forsøg i marken, som viste en høj grad af beskyttende virkning fremkaldt af de enkelte vaccinekomponenter.
The efficacy of the components of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. was established in a series of double-blind controlled field trials, which demonstrated a high degree of protective efficacy afforded by the individual vaccine components.
Disse 8 undersøgelser fastslog desuden, at serokonversion som respons på vaccination mod mæslinger, parotitis og rubella var lig med beskyttelse mod disse sygdomme.
These studies also established that seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
Vaccination efter eksponering for smitte Vaccination af personer udsat for vildtypemæslinger kan give nogen beskyttelse, hvis vaccinen kan gives inden for 72 timer efter eksponering.
Post-exposure vaccination Vaccination of individuals exposed to wild-type measles may provide some protection if the vaccine can be administered within 72 hours after exposure.
Effektivitet Der er på verdensplan (1978- 2003) blevet distribueret over 400 mio. doser af den tidligere formulering af mæslinge -, parotitis - og rubellavaccine fremstillet af Merck & Co., Inc.
9 Effectiveness More than 400 million doses of the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2003).
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.
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.
Ikke- gravide teenagepiger og voksne kvinder Vaccination af modtagelige ikke- gravide teenagepiger og voksne kvinder i den fødedygtige alder med levende svækket rubellavirusvaccine er indiceret, hvis visse forsigtighedsregler overholdes (se pkt.
Non-pregnant adolescent and adult females Vaccination of susceptible non-pregnant adolescent and adult females of childbearing age with live attenuated rubella virus vaccine is indicated if certain precautions are observed (see sections 4.4 and 4.6).
M- M- RVAXPRO eller en monovalent rubellavaccine) for at nedsætte risikoen for eksponering af den gravide kvinde.
Previously unvaccinated children older than 12 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.
Personer, som sandsynligvis er modtagelige for parotitis og rubella M- M- RVAXPRO foretrækkes til vaccination af personer som sandsynligvis er modtagelige for parotitis og rubella.
Individuals likely to be susceptible to mumps and rubella M-M-RVAXPRO is preferred for vaccination of persons likely to be susceptible to mumps and rubella.
Personer, som har brug for vaccination mod mæslinger, kan få M- M- RVAXPRO uanset deres immunstatus mht. parotitis eller rubella, hvis en monovalent mæslingevaccine ikke er let tilgængelig.
Individuals who require vaccination against measles can receive M-M-RVAXPRO regardless of their immune status to mumps or rubella if a monovalent measles vaccine is not readily available.
Traditionelle ikke- kliniske undersøgelser er ikke udført, men der er ingen ikke- kliniske anliggender, som anses for relevante for klinisk sikkerhed ud over de data, som omfattes af produktresumeets øvrige punkter.
Traditional non-clinical studies were not performed, but there are no non-clinical concerns considered relevant to clinical safety beyond data included in other sections of the Summary of Product Characteristics.
Pulver Sorbitol Natriumphosphat Kaliumphosphat Saccarose Hydrolyseret gelatine Medium 199 med Hanks salte Minimum Essential Medium, Eagle (MEM) Mononatrium- L- glutamat 9 Neomycin Phenolrødt Natriumhydrogencarbonat Saltsyre (til justering af pH) Natriumhydroxid (til justering af pH)
Powder Sorbitol Sodium phosphate Potassium phosphate Sucrose Hydrolysed gelatin Medium 199 with Hanks’ salts Minimum Essential Medium, Eagle (MEM) Monosodium L-glutamate Neomycin
Det er dog fastslået, at vaccinen i brug er holdbar i 8 timer ved opbevaring i køleskab ved 2- 8° C.
After reconstitution, the vaccine should be used immediately; however, in-use stability has been demonstrated for 8 hours when refrigerated at2°C-8°C.
Opbevares i køleskab og transporteres nedkølet (2- 8° C).
Store and transport refrigerated (2°C – 8°C).
6. 3.
For storage conditions of the reconstituted medicinal product, see section 6.3
Pulver i hætteglas (type 1- glas) med en prop (butylgummi) og solvens i hætteglas (type 1- glas) med en prop (chlorbutyl) i pakningsstørrelser på 1 og 10 stk.
Powder in a vial (Type 1 glass) with a stopper (butyl rubber) and solvent in a vial (Type 1 glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10.
Før blanding med solvensen er pulveret en lysegul, kompakt, krystallinsk ” kage ”.
Before mixing with the solvent, the powder is a light yellow compact crystalline cake.
Hele mængden af solvens trækkes op i sprøjten, som skal bruges til rekonstitution.
Withdraw the entire volume of solvent into the syringe to be used for reconstitution.
Den rekonstituerede vaccine må ikke anvendes, hvis der observeres partikler eller hvis solvensens eller pulverets eller den rekonstituerede vaccinens udseende afviger fra den ovennævnte beskrivelse.
The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinier.
11 Any unused product or waste material should be disposed of in accordance with local requirements.
M- M- RVAXPRO pulver og solvens til injektionsvæske, suspension i fyldt sprøjte.
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe.
* Cellekultur infektiøs dosis 50% 1 fremstillet i kyllingeembryoceller.
*50% cell culture infectious dose 1 produced in chick embryo cells.
2 fremstillet i humane diploide WI- 38- lungefibroblaster.
2 produced in WI-38 human diploid lung fibroblasts.
Personer på 12 måneder eller derover
13 Individuals 12 months or older
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.
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.
14 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.
13 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.
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.
Øvrige Personer som vides at være smittet med HIV, men som ikke er immunkompromitterede, kan vaccineres.
15 Other Individuals who are known to be infected with human immunodeficiency viruses and are not immunocompromised may be vaccinated.
14 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.
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.
16 and rubella vaccine manufactured by Merck & Co., Inc., experience with this vaccine can be considered.
15 NB!
Note:
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%).
17 although injection-site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%).
1 ud af hver 3 mio. doser vaccine med mæslingevirusr fremstillet af Merck & Co., Inc.
Encephalitis and encephalopathy, excluding subacute sclerosing panencephalitis (SSPE), have been reported approximately once for every 3 million doses of the measles-containing vaccines manufactured by Merck & Co., Inc.
Overvågning efter markedsføring af de mere end 400 mio. doser, der er distribueret verden over gennem næsten 25 år (1978- 2003), indikerer, at alvorlige uønskede hændelser såsom encefalitis og encefalopati fortsat rapporteres sjældent.
In
Dog antyder dataene muligheden for, at nogle af disse tilfælde kunne skyldes mæslingevacciner.
18 no case has it been shown conclusively that reactions were actually caused by vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines.
Konjunktivit, retinitis.
Eye disorders Not known: conjunctivitis, retinitis