natgillin/translations-raw huggingface dataset:
Der er rapporteret om tilfælde af aseptisk meningitis efter MFR- vaccination.
Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination.
Selv om der er påvist kausalitet mellem andre stammer af fåresygevaccine og aseptisk meningitis, er der ikke dokumenteret en forbindelse mellem Jeryl Lynn- vaccine mod fåresyge 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.
Blod - og lymfesystem Sjælden: leukocytose, lymfadenopati.
Blood and the lymphatic system disorders Rare: leukocytosis, lymphadenopathy.
Lymfadenitis, regional lymfadenopati, trombocytopeni.
Not known: lymphadenitis, regional lymphadenopathy, thrombocytopenia.
Ikke kendt:
Immune system disorders Rare: hypersensitivity.
Anafylaktoid reaktion, anafylaksi og relaterede fænomener såsom angioneurotisk ødem, ansigtsødem og perifert ødem, anafylaksi hos person med eller uden allergi i anamnesen.
Not known: anaphylactoid reaction, anaphylaxis and related phenomenon such as angioneurotic oedema, facial oedema, and peripheral oedema, anaphylaxis in individuals with or without an allergic history.
Metabolisme og ernæring Ikke almindelig: spisevægring, appetitløshed.
Metabolism and nutrition disorders Uncommon: anorexia, decreased appetite.
Sjælden: dehydrering.
Rare: dehydration.
Psykiske forstyrrelser Almindelig: irritabilitet.
Psychiatric disorders Common: irritability.
Ikke almindelig: grådlabilitet, insomni, søvnforstyrrelser.
Uncommon: crying, insomnia, sleep disorder.
Sjælden: agitation, apati, pylrethed, emotionel labilitet, nervøsitet, rastløshed.
Rare: agitation, apathy, clinging, emotional changes, nervousness, restlessness.
Nervesystemet Ikke almindelig: feberkramper, somnolens.
Nervous system disorders Uncommon: febrile seizure, somnolence.
Sjælden: ataksi, kramper, hovedpine, højlydt gråd, hyperkinesi, hypersomni, lethargi, tremor.
Rare: ataxia, convulsion, headache, high pitched crying, hyperkinesia, hypersomnia, lethargy, tremor.
4. 3), øjenlammelse, paræstesi, polyneuritis, polyneuropati, subakut skleroserende panencefalitis (se nedenfor), synkoper, myelitis transversa, tremor.
Not known: afebrile convulsions or seizures, Bell’ s palsy, cerebrovascular accident, dizziness, dream abnormality, encephalitis (see below), encephalopathy (see below), Guillain-Barré syndrome, measles inclusion body encephalitis (see section 4.3), ocular palsies, paraesthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis (see below), syncope, transverse myelitis, tremor.
1000 børn) til den, der
Consistent with clinical study data on the timing of fever and measles-like rash, an analysis of a post-marketing observational safety study in children (N=31,298, 99% in their second year of life) receiving their first dose of vaccine has shown that febrile seizures occurred more frequently 5-12 days following vaccination with ProQuad (n=22; 0.7 per 1000 children) when compared with data from children in a historical, age- and gender- matched, control group vaccinated with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/ Merck) concomitantly (N=31,298) before ProQuad was available (n=10; 0.3 per 1000 children).
1000 børn).
In the 0-30 day time period following vaccination, the incidence of febrile seizures with ProQuad (n=44; 1.4 per 1000 children) was similar to that observed in children receiving the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/ Merck) concomitantly (n=40; 1.3 per 1000 children).
Encefalitis og encefalopati (med undtagelse af subakut skleroserende panencefalitis [SSPE]) er indberettet for cirka 1 ud af hver 3 millioner doser vaccine med mæslingevirus fremstillet af Merck & Co., Inc.
7 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.
Efter påbegyndt markedsføring tyder overvågning af de over 428 millioner doser distribueret på verdensplan (1978 - 2005) på, at der fortsat kun foreligger sjældne rapporter om alvorlige bivirkninger såsom encefalitis og encefalopati.
Post-marketing surveillance of the more than 428 million doses that have been distributed worldwide (1978 to 2005) indicates that serious adverse events such as encephalitis and encephalopathy continue to be rarely reported.
Der foreligger ingen tilfælde, hvor det er fastlagt med sikkerhed, at reaktionerne faktisk skyldtes vaccinen, men oplysningerne tyder på, at nogle af tilfældene kunne have være udløst af mæslingevacciner.
In no case has it been shown conclusively that reactions were actually caused by the vaccine; however, the data suggest the possibility that some of these cases may have been caused by measles vaccines.
Nogle af disse tilfælde kan skyldes ikke- diagnosticerede mæslinger i barnets første leveår eller eventuelt mæslingevaccinationen.
Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination.
Resultaterne af en case- kontrol undersøgelse udført af US Centers for Disease Control and Prevention viser, at mæslingevaccinen generelt har beskyttet mod SSPE ved at forebygge mæslinger og den dermed forbundne risiko for SSPE.
The results of a retrospective case-controlled study conducted by the US Centers for Disease Control and Prevention show that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent risk of SSPE.
Øjne Sjælden: conjunctivitis, øjenflåd, øjenlågsbetændelse, øjenirritation, øjenhævelser, okulær hyperæmi, tåreflåd visuelt ubehag.
Eye disorders Rare: conjunctivitis, eye discharge, eyelid inflammation, eye irritation, eye swelling, ocular hyperaemia, tearing, visual discomfort.
Øjenlågsødem, irritation, neuritis nervi optici, retinitis, neuritis retrobulbaris.
Not known: oedema of the eyelid, irritation, optic neuritis, retinitis, retrobulbar neuritis.
Øre og labyrint Sjælden: ørepine.
Ear and labyrinth disorders Rare: ear pain.
Nervedøvhed.
Not known: nerve deafness.
Vaskulære sygdomme Sjælden: rødmen, bleghed.
Vascular disorders Rare: flushing, pallor.
Ekstravasation.
Not known: extravasation.
Luftveje, thorax og mediastinum Ikke almindelig: hoste, næsekongestion, åndedrætskongestion, rinoré.
Respiratory, thoracic, and mediastinal disorders Uncommon: cough, nasal congestion, respiratory congestion, rhinorrhoea.
Sjælden: astma, lungekongestion, sinuitis, nysen, hiven efter vejret.
Rare: asthma, pulmonary congestion, sinus disorder, sneezing, wheezing.
4. 3), pneumoni, lungekongestion, rhinitis, sinuitis, ondt i halsen.
Not known: bronchial spasm, bronchitis, epistaxis, pneumonitis (see section 4.3), pneumonia, pulmonary congestion, rhinitis, sinusitis, sore throat.
Mave- tarmkanalen Almindelig: diaré, opkastninger Sjælden: smerter i øvre abdomen, unormal fæces, obstipation, flatulens, kvalme, øget spytsekretion, stomatitis, tandgennembrud.
Rare: abdominal pain upper, abnormal faeces, constipation, flatulence, nausea, salivation increase, stomatitis, teething.
Abdominalsmerter, hæmatokeksi, mundsår.
Not known: abdominal pain, haematochezia, mouth ulcer.
Hud og subkutane væv Almindelig: mæslingelignende udslæt ‡, udslæt, skoldkoppelignende udslæt ‡.
Skin and subcutaneous tissue disorders Common: measles-like rash ‡, rash, varicella-like rash ‡,.
Ikke almindelig: dermatitis (inklusive kontaktdermatitis, atopisk dermatitis og bleudslæt), varmeknopper, røde hundelignende udslæt ‡, urticaria, viralt exanthem, eksem, erythema.
Uncommon: dermatitis (including contact, atopic, and diaper rash), heat rash, rubella-like rash ‡, urticaria, viral exanthema, eczema, erythema.
Ikke kendt:
Rare: acne, clammy skin, exfoliative dermatitis, drug eruption, exanthema, livedo reticularis, papular rash, pruritus, skin discoloration, skin lesion, zosteriform rash.
Erythema multiforme, Henoch- Schönleins purpura, herpes simplex, impetigo, pannikulitis, purpura, induration af huden, Stevens- Johnsons syndrom, solskoldethed.
Not known: erythema multiforme, Henoch-Schönlein purpura, herpes simplex, impetigo, panniculitis, purpura, skin induration, Stevens-Johnson syndrome, sunburn.
Ikke kendt:
Musculoskeletal, connective tissue and bone disorders Rare: arm pain, musculoskeletal stiffness.
Artritis og/ eller artralgi (sædvanligvis forbigående og sjældent kronisk [se nedenfor]), smerter i skeletmuskulaturen, myalgi, smerter i hofter, ben eller hals, hævelse.
Not known: arthritis and/ or arthralgia (usually transient and rarely chronic [see below]), musculoskeletal pain, myalgia, pain of the hip, leg, or neck, swelling.
8 Artralgi og/ eller artritis (sædvanligvis forbigående og sjældent kronisk) samt polyneuritis forekommer ved naturligt forekommende røde hunde, og hyppighed og sværhedsgrad varierer med alder og køn, idet de især berører voksne kvinder, mens præpubertetsbørn berøres mindst.
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 gender, being
Efter vaccination af børn er ledreaktioner generelt usædvanlige (0- 3%) og kortvarige.
8 greatest in adult females and least in prepubertal children.
Hos kvinder er incidensen af artritis og artralgi generelt højere end hos børn (12- 20%), og reaktionerne synes at være mere markante og vare længere.
Following vaccination in children, reactions in joints are generally uncommon (0 to 3%) and of brief duration.
Generelt tåler selv ældre kvinder (35- 45 år) reaktionerne godt, og de påvirker sjældent det normale aktivitetsniveau.
Even in older women (35 to 45 years), these reactions are generally well tolerated and rarely interfere with normal activities.
Kronisk artritis er sat i forbindelse med naturligt forekommende røde hunde og er relateret til vedvarende virus og/ eller viralt antigen 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.
Almene symptomer og reaktioner på administrationsstedet Meget almindelig: feber ≥38, 9°C (svarende til oral temperatur eller febril) ‡, erythema ‡ eller smerte/ ømhed ‡ ved injektionsstedet.
General disorders and administration site conditions Very common: fever ≥ 38.9°C (oral equivalent or abnormal )‡, erythema‡ or pain/ tenderness/ soreness‡ at the injection site.
Almindelig: ekkymose eller hævelser ‡ ved injektionsstedet, udslæt ved injektionsstedet ‡.
Common: ecchymosis or swelling ‡ at the injection site, injection-site rash‡.
Ikke almindelig: asteni/ træthed, blødning ved injektionsstedet, fortykkelse eller varme ved injektionsstedet, knude ved injektionsstedet, utilpashed.
Uncommon: asthenia/ fatigue, injection-site haemorrhage, injection-site induration or warmth, injection-site mass, malaise.
Sjælden: influenzalignende sygdom, afskalning ved injektionsstedet, misfarvning ved injektionsstedet, pruritus ved injektionsstedet, uspecificeret udslæt ved injektionsstedet, reaktion ved injektionsstedet, ardannelse ved injektionsstedet, hypertermi, smerte/ ømhed.
Rare: influenza-like illness, injection-site desquamation, injection-site discoloration, injection-site pruritus, injection-site rash non-specific, injection-site reaction, injection-site scar, hyperthermia, pain, pain/ tenderness/ soreness.
Komplikationer ved injektionsstedet (kortvarig brænden/ svien, eksem, ødem/ hævelse, urticaria- lignende udslæt, hæmatom, induration, knude, vesikler, vabler og opblussen), inflammation, læbeanomalier, papillitis, ruhed/ tørhed, stivhed, traume, skoldkoppelignende udslæt, blødning på venepunkturstedet, varmefornemmelse, varmt ved berøring.
Not known: injection site complaints (burning and/ or stinging of short duration, eczema, oedema/ swelling, hive-like rash, hematoma, induration, lump, vesicles, wheal and flare), inflammation, lip abnormality, papillitis, roughness/ dryness, stiffness, trauma, varicella-like rash, venipuncture site haemorrhage, warm sensation, warm to touch.
Undersøgelser Sjælden: vægttab.
Investigations Rare: weight loss.
Traumer, forgiftninger og behandlingskomplikationer Sjælden: kontusion, ikke- giftigt bid/ stik.
Injury and poisoning, and procedural complications Rare: contusion, non-venomous bite/ sting.
Sociale forhold Sjælden: påvirkning af dagligdagens aktiviteter.
Social circumstances Rare: activities of daily living impaired.
• Tilfælde af herpes zoster i kliniske forsøg Fra et klinisk forsøg rapporteredes 2 tilfælde af herpes zoster blandt 2108 raske forsøgspersoner i aldersgruppen 12- 23 måneder, som blev vaccineret med 1 dosis ProQuad og fulgt i 1 år.
Cases of herpes zoster in clinical studies In a clinical trial, 2 cases of herpes zoster were reported in 2108 healthy subjects 12 through 23 months of age who were vaccinated with one dose of ProQuad and followed for 1 year.
Data fra overvågningen af personer efter vaccination for skoldkopper i op til ni år tyder ikke på en hyppigere forekomst af herpes zoster hos denne population.
Surveillance data on varicella vaccinated individuals for up to nine years suggest no increase in the frequency of herpes zoster in this population.
Imidlertid kendes langtidsvirkningen af skoldkoppevaccination på incidensen af herpes zoster endnu ikke.
However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at present.
Der foreligger aktuelt ingen langtidsdata for ProQuad.
There are no long term data currently available for ProQuad.
4. 4).
Transmission The varicella vaccine virus may rarely be transmitted to contacts of recipients of Varicella Vaccine live (Oka/ Merck) who develop a varicella-like rash (see section 4.4).
Her skal det fremhæves, at denne type transmission er dokumenteret i 3 tilfælde ud af over 40 millioner doser levende skoldkoppevaccine (Oka/ Merck) anvendt til vaccination.
In particular, this kind of transmission has been documented 3 times out of more than 40 million doses of Varicella Vaccine live (Oka/ Merck) that have been distributed.
Transmission af skoldkoppevirus fra recipienter af levende skoldkoppevaccine (Oka/ Merck) uden skoldkoppelignende udslæt er rapporteret, men ikke bekræftet.
Transmission of varicella vaccine virus from recipients of Varicella Vaccine live (Oka/ Merck) without a varicella-like rash has been reported but has not been confirmed.
Terapeutisk klassifikation:
Pharmacotherapeutic group:
ATC- kode:
Viral Vaccine; ATC code:
Effekt Der er ikke udført formelle undersøgelser af ProQuads effekt.
Efficacy Formal studies to evaluate the efficacy of ProQuad have not been performed.
Imidlertid er effekten af levende skoldkoppevaccine (Oka/ Merck) og af MFR- vaccinen fremstillet af Merck & Co., Inc. påvist i en række undersøgelser.
However, the efficacy of Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. has been demonstrated in numerous studies.
Effekten af mæslinge -, fåresyge - og røde hundekomponenterne i ProQuad er tidligere påvist i en række dobbeltblinde kontrollerede feltundersøgelser med de monovalente vacciner fremstillet af Merck & Co., Inc., og de dokumenterede en høj beskyttelsesgrad.
Efficacy of the measles, mumps, and rubella components of ProQuad was previously established in a series of double-blind controlled field trials with the monovalent vaccines manufactured by Merck & Co., Inc., which demonstrated a high degree of protective efficacy.
I disse undersøgelser svarede serokonverteringen som reaktion på vaccination mod mæslinger, fåresyge og røde hunde til beskyttelse mod disse sygdomme.
In these studies seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
ProQuad opnår antistofreaktioner mod mæslinger, fåresyge og røde hunde svarende til reaktionerne efter vaccination med MFR- vaccinen fremstillet af Merck & Co., Inc.
ProQuad elicits rates of antibody responses against measles, mumps, and rubella similar to those observed after vaccination with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
Over 428 millioner doser af MFR- vaccinen fremstillet af Merck & Co., Inc. er distribueret på verdensplan (1978- 2005).
More than 428 million doses of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2005).
Udbredelsen af et totrins vaccinationsprogram i USA og lande såsom Finland og Sverige har reduceret incidensen af hver af de tre målsygdomme med > 99%.
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.
I de samlede kliniske forsøg med en enkelt dosis levende skoldkoppevaccine (Oka/ Merck) til raske børn lå vaccinens beskyttende effekt mod skoldkopper i alle sværhedsgrader mellem 81% og 100%.
In combined clinical trials of a single dose of Varicella Vaccine live (Oka/ Merck) in healthy children, the protective efficacy of the vaccine against all severities of varicella disease ranged from 81% to 100%.
I en stor case- kontrol undersøgelse vurderedes vaccinen til at have en effekt på 85% mod alle former for skoldkopper og 97% mod moderat til svær sygdom.
In a large case-control study, the vaccine was estimated to be 85% effective against all forms of varicella and 97% effective against moderately severe and severe disease.
I en undersøgelse til sammenligning af 1 dosis (N=1114) med 2 doser (N=1102) levende skoldkoppevaccine (Oka/ Merck) vurderedes vaccinens effekt mod skoldkopper i alle sværhedsgrader over en tiårig observationsperiode til at være 94% for 1 dosis og 98% for 2 doser (p < 0, 001).
In a study comparing 1 dose (N=1114) to 2 doses (N=1102) of Varicella Vaccine live (Oka/ Merck), the estimated vaccine efficacy against all severities of varicella disease for the 10-year observation period was 94% for 1 dose and 98% for 2 doses (p < 0.001).
I løbet af den tiårige observationsperiode var den kumulative forekomst af skoldkopper 7, 5% efter 1 dosis og 2, 2% efter 2 doser.
Over the 10-year observation period, the cumulative rate of varicella was 7.5% after 1 dose and 2.2% after 2 doses.
I en ELISA- enzymimmunanalyse baseret på glycoprotein (gpELISA er et meget følsomt målesystem, der ikke fås i handelen) har antistofreaktioner mod skoldkoppevirus ≥5 gpELISA enheder/ ml vist sig i høj grad at være korreleret med langtidsbeskyttelse.
Antibody responses against varicella virus ≥ 5 gpELISA Units/ ml in the glycoprotein enzyme-linked immunosorbent assay (gpELISA, a highly sensitive assay which is not commercially available) have been shown to be highly correlated with long-term protection.
I kliniske forsøg er det påvist, at immunisering med ProQuad opnår antistofreaktioner mod skoldkoppevirus på ≥5 gpELISA enheder/ ml, hvilket svarer til de reaktioner, der opnås efter vaccination med levende skoldkoppevaccine (Oka/ Merck).
Clinical studies have shown that immunization with ProQuad elicits rates of antibody responses against varicella virus ≥ 5 gpELISA Units/ ml similar to those observed after vaccination with Varicella Vaccine live (Oka/ Merck).
Immungeniciteten af den nuværende køleskabs- stabile formulering viste sig at være den samme som immungeniciteten af den tidligere formulering af ProQuad seks uger efter en enkelt dosis af vaccinen.
Immunogenicity Immunogenicity was studied in children 12 through 23 months of age with a negative clinical history of measles, mumps, rubella, and varicella who participated in 5 randomized clinical trials. The immunogenicity of the current refrigerator-stable formulation was shown to be similar to the immunogenicity of the earlier formulation of ProQuad six weeks after a single dose of the vaccine.
Immungeniciteten af en enkelt dosis af en tidligere formulering af ProQuad, var sammenlignelig med immungeniciteten af en enkelt dosis af de individuelle vacciner, der indgik (levende skoldkoppevaccine (Oka/ Merck) og MFR- vaccinen fremstillet af Merck Co., Inc.), som aktuelt anvendes rutinemæssigt til vaccination i nogle lande.
The immunogenicity of a single dose of an earlier formulation of ProQuad was comparable to the immunogenicity of a single dose of its individual component vaccines (Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.), currently used in routine vaccination in some countries.
Kliniske forsøg med 6897 forsøgspersoner, som fik ProQuad, har dokumenteret påviseligt immun - respons mod mæslinger, fåresyge, røde hunde og skoldkopper hos en stor andel af deltagerne.
Clinical trials involving 6987 subjects who received ProQuad demonstrated detectable immune responses to measles, mumps, rubella, and varicella in a high proportion of individuals.
Forekomsten af påviseligt antistof blev bestemt ved hjælp af en ELISA- enzymimmunanalyse, der var tilstrækkeligt følsom til at analysere mæslinger, fåresyge (stammer fra såvel naturligt forekommende fåresyge og fra vacciner) og røde hunde, og en gpELISA- test til skoldkopper.
The presence of detectable antibody was assessed by an appropriately sensitive enzyme-linked immunosorbent assay (ELISA) for measles, mumps (wild-type and vaccine-type strains), and rubella, and by gpELISA for varicella.
Efter en enkelt dosis 10 ProQuad var responsraterne over for vaccinen 97, 7% for mæslinger, mellem 96, 3% og 98, 8% for fåresyge og 98, 8% for røde hunde.
Following a single dose of ProQuad, the vaccine response rates were 97.7% for measles, 10 96.3% to 98.8% for mumps, and 98.8% for rubella.
Mens serokonverteringsraten for skoldkopper var lige høj i alle forsøgene (97, 9% til 99, 8%), er det ikke vist at serokonvertering korrelerer godt til beskyttelse.
While the seroconversion rate for varicella was uniformly high (97.9% to 99.8% across all studies), seroconversion has not been shown to correlate well with protection.
Vaccinens responsrate var 90, 9% (interval 80, 8% - 94, 5%) for skoldkopper baseret på en antistofreaktion på ≥5 gpELISA enheder/ ml (en responsrate, der er påvist at have en stærk korrelation til langtidsbeskyttelse).
The vaccine response rate was 90.9% (range 80.8% to 94.5%) for varicella based on a post-vaccination antibody titer ≥ 5 gpELISA units/ ml (an antibody titer that has been shown to be highly correlated with long-term protection).
Disse resultater svarede til de immunresponsrater, som blev induceret ved samtidig administration af en enkelt dosis levende skoldkoppevaccine (Oka/ Merck) og MFR- vaccinen fremstillet af Merck & Co., Inc. på forskellige injektionssteder.
These results were similar to the immune response rates induced by concomitant administration of a single dose of Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at separate injection sites.
3 måneder efter første dosis.
Children who received a second dose of ProQuad In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 3 months after the first dose.
Vaccinens responsrater var 99, 4% for mæslinger, 99, 9% for fåresyge, 98, 3% for røde hunde og 99, 4% for skoldkopper (≥5 gpELISA enheder/ ml).
The vaccine response rates were 99.4% for measles, 99.9% for mumps, 98.3% for rubella, and 99.4% for varicella (≥ 5 gpELISA Units/ ml).
4. 8).
The geometric mean titers (GMTs) following the second dose of ProQuad increased approximately 2 fold each for measles, mumps, and rubella, and approximately 41 fold for varicella (for safety information, see section 4.8).
Børn, som fik ProQuad i alderen 4- 6 år efter første vaccination med levende skoldkoppevaccine (Oka/ Merck) og MFR- vaccinen fremstillet af Merck & Co., Inc.
Children who received ProQuad at 4 through 6 years of age after primary vaccination with Varicella Vaccine live (Oka/ Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.