natgillin/translations-raw huggingface dataset:
Der er ikke udført konventionelle ikke-kliniske studier, men der foreligger ingen ikke-kliniske spørgsmål af relevans for den kliniske sikkerhed ud over de data, der er medtaget i produktresuméets øvrige afsnit. 
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 (SmPC).
Den langvarige virkning af varicella-vaccinen på incidensen af herpes zoster kendes imidlertid ikke på nuværende tidspunkt. 
However, the long term effect of varicella vaccination on the incidence of herpes zoster is unknown at present.
Der er rapporteret andre bivirkninger efter indgivelse af ProQuad, og nogle af disse var alvorlige. 
Other side effects have been reported following administration of ProQuad and some of these were serious.
Vejledning i rekonstitution af vaccinen beregnet for læger og sundhedspersonale er anført sidst i indlægssedlen 
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet
• Spædbørn mellem 9 og 12 måneder: ProQuad kan indgives fra 9-måneders alderen. 
• Infants between 9 and 12 months of age: ProQuad may be administered from 9 months of age.
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.
Observationelle studier af varicella-vaccinens langvarige virkning Overvågningsdata fra to amerikanske observationelle effektivitetsstudier bekræftede, at udbredt varicellavaccination reducerer risikoen for varicella med ca. 90 %, og at beskyttelsen opretholdes i mindst 15 år hos både vaccinerede og ikke-vaccinerede personer. 
Observational studies of long-term effectiveness of varicella vaccine Surveillance data from two U.S. observational effectiveness studies confirmed that widespread varicella vaccination reduces the risk of varicella by approximately 90% and that protection is maintained over at least 15 years both in vaccinated and unvaccinated individuals.
Til rekonstitution af vaccinen må kun anvendes den medfølgende solvens, idet den er uden konserveringsmidler eller andre antivirale stoffer, som kunne inaktivere vaccinen. 
To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other antiviral substances, which might inactivate the vaccine.
Fortæl din læge, hvis dit barn er vaccineret for nylig, eller hvis der er planer om vaccination i den nærmeste fremtid. 
Tell the doctor if your child has recently received a vaccine or if one is scheduled to be given in the near future.
Hvis du glemmer at få ProQuad 
If you forget to take ProQuad
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. 
In women, incidence rates for arthritis and arthralgia are generally higher than those seen in children (12 to 20%), and the reactions tend to be more marked and of longer duration.
Resultaterne viste et gradvist samlet fald i hyppigheden af varicella på 90 % til 95 % (ca. 10 til 20 gange lavere) fra 1995 til 2009 i alle aldersgrupper, både hos vaccinerede og uvaccinerede børn og unge. 
Results showed a gradual decline of varicella rates by an overall 90% to 95% (approximately 10- to 20-fold) from 1995 to 2009 in all age groups, both in vaccinated and unvaccinated children and adolescents.
Bortset fra stigningen i feberkramper efter første dosis, blev der ikke identificeret sikkerhedsmæssige risici efter indgivelse af første eller anden dosis. 
Other than the increase in febrile seizure after the first dose, no safety concerns after the first or second dose were identified.
Det forventes, at ProQuad har ingen eller ubetydelig indflydelse på evnen til at føre motorkøretøj eller betjene maskiner. 
ProQuad is expected to have no or negligible influence on the ability to drive and use machines.
Post dosis 1 Post dosis 2 
Postdose 1 Postdose 2
Aktuel immunsuppressiv behandling (inklusive høje doser af kortikosteroider) (se pkt. 
Current immunosuppressive therapy (including high doses of corticosteroids) (see section 4.8).
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.
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. 
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.
• Er hiv-positiv (hiv = human immundefektvirus) uden symptomer på hiv-infektion. 
• An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease.
Disse data tyder også på, at varicellavaccination kan reducere risikoen for herpes zoster hos vaccinerede personer. 
These data also suggest that varicella vaccination may reduce the risk of herpes zoster in vaccinated individuals.
• Hvis personen, der skal vaccineres, er allergisk over for de aktive stoffer eller et af de øvrige indholdsstoffer i denne vaccine (inklusive neomycin eller et af de øvrige indholdsstoffer angivet i afsnit 6). 
• If the person to be vaccinated is allergic to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6).
Vaccination kan overvejes hos patienter med udvalgte immundefekter, når fordelene opvejer risiciene (asymptomatiske hiv-patienter, IgG-subklasse-defekt, kongenit neutropeni, kronisk granulomatøs sygdom og komplementdefekter). 
Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymptomatic HIV patients, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease, and complement deficiency diseases).
Sikkerheden af de to forskellige formuleringer var sammenlignelig efter en enkelt dosis. 
The safety profiles were comparable for the two different formulations after a single dose.
De foretrukne injektionssteder er regio femoralis anterior hos yngre børn og regio deltoidea hos ældre børn, unge og voksne. 
The preferred injection sites are the anterolateral area of the thigh in younger children and the deltoid area in older children, adolescents, and adults.
Der foreligger ikke tilstrækkelige data til at understøtte brug af ProQuad sammen med andre vacciner. 
There are insufficient data to support the use of ProQuad with any other vaccines.
Børn, som fik anden dosis ProQuad 
Children who received a second dose of ProQuad
Hvis du eller dit barn får en allergisk reaktion, skal du omgående søge læge. 
If you or your child have an allergic reaction, call your doctor right away.
ProQuad er ikke blevet evalueret med hensyn til potentiel forringelse af fertiliteten. 
ProQuad has not been evaluated for potential to impair fertility.
A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE 
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
I perioden 30 dage efter vaccination observeredes der ingen øget risiko for feberkramper (se pkt. 
In the 30-day timeframe following vaccination, no increased risk of febrile seizures was observed (see section 5.1).
Saltsyre (til justering af pH) Natriumhydroxid (til justering af pH) Urinstof 
Hydrochloric acid (to adjust pH) Sodium hydroxide (to adjust pH) Urea
Artralgi og/eller artritis 
Arthralgia and/or arthritis
Der foreligger p.t. ingen langtidsdata for ProQuad (se pkt. 
There are no long-term data currently available with ProQuad (see section 5.1).
Den rekonstituerede vaccine bortskaffes, hvis den ikke kan anvendes i løbet af 30 minutter. 
Discard if reconstituted vaccine is not used within 30 minutes.
I et stort case-kontrolstudie 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.
Indgivelsesmåde Vaccinen gives intramuskulært (IM) eller subkutant (SC). 
Method of administration The vaccine is to be injected intramuscularly (IM) or subcutaneously (SC).
• Hvis personen, der skal vaccineres, er i behandling eller får medicin, der kan svække immunsystemet (undtagen lave doser af kortikosteroider mod astma eller som substitutionsterapi). 
• If the person to be vaccinated is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
Hvis personen, der skal vaccineres, har været udsat for følgende problemer, skal du tale med lægen eller apoteket før vaccination med ProQuad: 
If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before ProQuad is given:
Over 518 millioner doser af MFR-vaccinen fremstillet af Merck & Co., Inc. er distribueret på verdensplan (1978-2007). 
More than 518 million doses of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. have been distributed worldwide (1978 to 2007).
Når personen er blevet vaccineret, bør vedkommende så vidt muligt i op til 6 uger efter vaccinationen undgå tæt kontakt med følgende personer: 
Once vaccinated, the person vaccinated should attempt to avoid for up to 6 weeks following vaccination, whenever possible, close association with the following individuals:
I så fald kan vaccinationen beskytte mindre effektivt end hos personer uden hiv (se under ProQuad må ikke anvendes). 
However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).
I det første studie, et langvarigt prospektivt kohortestudie, blev ca. 7.600 børn i 1995 vaccineret med varicellavaccine i deres andet leveår og fulgt aktivt i 14 år for at estimere forekomsten af varicella og herpes zoster. 
In the first study, a long-term prospective cohort study, approximately 7,600 children vaccinated in 1995 with varicella vaccine in their second year of life were actively followed for 14 years in order to estimate the occurrence of varicella and herpes zoster.
Mens serokonverteringsraten for skoldkopper var lige høj i alle studierne (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.
Efter vaccination med ProQuad bør Ig eller VZIG ikke gives i mindst 1 måned, medmindre lægen siger noget andet. 
After vaccination with ProQuad, IG or VZIG should not be given for 1 month, unless your doctor tells you otherwise.
Det er ikke dokumenteret, at mæslingevaccine kan føre til SSPE. 
There is no evidence that measles vaccine can cause SSPE.
Følgende andre bivirkninger er rapporteret i forbindelse med brug af ProQuad: 
The following other side effects reported with the use of ProQuad were:
• Hvis personen, der skal vaccineres, har en blodsygdom eller en kræftsygdom, der påvirker immunsystemet. 
• If the person to be vaccinated has a blood disorder or any type of cancer that affects the immune system.
• hvis personen, der skal vaccineres, er gravid (graviditet bør desuden undgås i 1 måned efter vaccinationen, se Graviditet og amning). 
• If the person to be vaccinated is pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breast-feeding).
Fortæl altid lægen eller apotekspersonalet, hvis du eller dit barn bruger anden medicin (eller vacciner) eller har gjort det for nylig. 
Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).
ProQuad bør ikke gives til gravide kvinder. 
ProQuad should not be given to pregnant women.
I sådanne tilfælde bør det potentielle risk/benefitforhold vurderes nøje, før vaccinationen gives. 
The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
I hele kontrolperioden var forekomsten af varicella ca. 10 gange lavere blandt de vaccinerede børn end blandt børn på samme alder i prævaccinationsperioden (den estimerede vaccineeffektivitet i studieperioden var mellem 73 % og 90 %). 
Over the entire follow-up, the incidence of varicella was approximately 10-fold lower among vaccinees than among children of the same age in the pre-vaccine era (estimated vaccine effectiveness over the study period was between 73% and 90%).
Børn, som fik 2 doser ProQuad intramuskulært eller subkutant I et klinisk studie fik 405 børn 2 doser ProQuad enten intramuskulært eller subkutant. 
Children who received 2 doses of ProQuad intramuscularly or subcutaneously In a clinical trial, 405 children received 2 doses of ProQuad, either by the intramuscular or subcutaneous route of administration.
Der kan forekomme allergiske reaktioner (nældefeber). 
Allergic reactions (hives) may occur.
Sikkerhedsprofilerne for de indgivne vacciner var sammenlignelige (se pkt. 
The safety profiles of the administered vaccines were comparable (see section 4.8).
Såvel feber som mæslingelignende udslæt indtraf sædvanligvis inden for 5-12 dage efter vaccinationen, varede i kort tid og forsvandt uden varige følger. 
Both fever and measles-like rash usually occurred within 5 to 12 days following the vaccination, were of short duration and resolved with no long-term sequelae.
Samtidig administration af immunglobuliner og ProQuad kan påvirke det forventede immunrespons. 
Administration of immune globulins concomitantly with ProQuad may interfere with the expected immune response.
I 5 kliniske studier blev ProQuad administreret uden andre vacciner til 6.038 børn i alderen 12-23 måneder. 
In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 through 23 months of age.
Graviditet Gravide kvinder bør ikke blive vaccineret med ProQuad 
Pregnancy Pregnant women should not be vaccinated with ProQuad.
Kun i sjældne tilfælde har vaccinemodtagere udviklet kroniske ledsymptomer. 
Only rarely have vaccine recipients developed chronic joint symptoms.
Ikke anvendt lægemiddel eller affald herfra bortskaffes i overensstemmelse med lokale regler. 
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Der er ikke foretaget studier af indflydelsen på evnen til at føre motorkøretøj eller betjene maskiner. 
No studies on the effects on the ability to drive or use machinery have been performed.
Brug af salicylater (for eksempel acetylsalicylsyre, som indgår i en række midler til smertelindring og febersænkning) bør undgås i 6 uger efter vaccination med ProQuad. 
The use of salicylates (for example, acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever) should be avoided for 6 weeks following vaccination with ProQuad.
Lægen vil så tage stilling til, om ProQuad bør anvendes. 
The doctor will decide if ProQuad should be given.
Der bør gå mindst 1 måned mellem vaccination med en levende virus og ProQuad. 
At least 1 month should elapse between receipt of a live virus vaccine and ProQuad.
Graviditet bør undgås i 1 måned efter vaccinationen. 
Pregnancy should be avoided for 1 month following vaccination.
Immunogenicitets- og sikkerhedsdata viser, at ProQuad kan gives til personer mellem 9 og 12 måneder under særlige omstændigheder (fx i overensstemmelse med de officielle anbefalinger, eller når tidlig beskyttelse anses for nødvendig). 
• Individuals between 9 and 12 months of age Immunogenicity and safety data show that ProQuad can be administered to individuals between 9 and 12 months of age, under special circumstances (e.g., in accordance with official recommendations or when early protection is considered necessary).
Solvens til ProQuad 
Solvent for ProQuad
Holdbarhed efter åbning er påvist i 30 minutter ved opbevaring mellem 20 C og 25 C. 
However, in-use stability has been demonstrated for 30 minutes when stored between 20C and 25C.
Encefalitis og encefalopati 
Encephalitis and encephalopathy
ProQuad skal indsprøjtes i en muskel eller under huden enten på yderlåret eller på overarmen. 
ProQuad should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm.
Der er ikke udført reproduktionsstudier i dyr med ProQuad. 
Animal reproduction studies have not been conducted with ProQuad.
Denne vaccine indeholder 16 mg sorbitol som hjælpestof. 
This vaccine contains 16 mg of sorbitol as an excipient.
Der har været indberetninger om feberkramper hos børn, der fik ProQuad. 
Febrile seizures have been reported in children receiving ProQuad.
I alle 8 studier var forekomsten af feber lavere efter anden dosis end efter første dosis. 
The fever rate in all eight studies was lower after the second dose than after the first dose.
Medfødt eller arvelig immundefekt i familien, med mindre der påvises immunkompetence hos den potentielle recipient af vaccinen. 
Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Administration af blodprodukter, der indeholder varicel-zoster virusantistoffer, inklusive VZIG og andre immunglobulinpræparater, inden for 1 måned efter en dosis ProQuad kan nedsætte immunresponset på vaccinen og dermed nedsætte vaccinens beskyttende effekt. 
Administration of varicella zoster virus antibody-containing blood products, including VZIG or other immune globulin preparations, within 1 month following a dose of ProQuad may reduce the immune response to the vaccine and hence reduce its protective efficacy.
Kvinder, der ammer eller har til hensigt at amme, bør fortælle det til deres læge. 
Persons who are breast-feeding or who intend to breast-feed should tell the doctor.
Børn i behandling for tuberkulose har ikke oplevet forværring af sygdommen efter vaccination med levende mæslingevirus vaccine. 
Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunized with live measles virus vaccine.
Det er ikke dokumenteret, at denne type virus overføres til modtagelige individer i kontakt med vaccinemodtagere. 
There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Vaccinationen bør udsættes i mindst 3 måneder efter blod- eller plasmatransfusion eller administration af immunglobuliner (Ig). 
Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).
Smerter og ømhed omkring injektionsstedet forekom med en statistisk lavere hyppighed hos personer, som fik ProQuad. 
Pain/tenderness/soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad.
Resultaterne af et case-kontrolstudie 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.
Hvis den, der skal vaccineres, allerede har været udsat for mæslinger, fåresyge, røde hunde eller skoldkopper, men endnu ikke er syg, vil ProQuad muligvis ikke være i stand til at forhindre sygdommen i at bryde ud. 
Also, if the person to be vaccinated has already been exposed to the measles, mumps, rubella, or varicella virus but is not yet ill, ProQuad may not be able to prevent the illness from appearing.
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.
Den rekonstituerede vaccine skal anvendes med det samme. 
After reconstitution, the vaccine should be used immediately.
For herpes zoster var der færre tilfælde af herpes zoster blandt de varicellavaccinerede børn i kontrolperioden, end det forventedes ud fra hyppigheden hos børn på samme alder med tidligere vildtype-varicella i prævaccinationsperioden (relativ risiko = 0,61, 95 % KI 0,43-0,89). 
Regarding herpes zoster, there were fewer herpes zoster cases among varicella vaccinees during the follow-up period than expected from rates in children of the same age with prior wild-type varicella during the pre-vaccine era (relative risk = 0.61, 95% CI 0.43 - 0.89).
Indehaver af markedsføringstilladelse: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Frankrig 
Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Antistoffernes persistens blev bestemt 1 år efter vaccinationen hos en delgruppe på 2108 deltagere i et klinisk studie. 
The persistence of antibody at 1 year after vaccination was evaluated in a subset of 2108 subjects who were involved in 1 clinical trial.
Hvad ProQuad indeholder 
What ProQuad contains
Børn, som fik ProQuad intramuskulært 
Children who received ProQuad intramuscularly
Data fra aktiv overvågning af børn, der blev vaccineret med levende varicella-vaccine (Oka/Merck) og fulgt i 14 år efter vaccinationen, viste ingen øget forekomst af herpes zoster sammenlignet med børn med tidligere vildtype varicella i prævaccinationsperioden. 
Active surveillance data in children vaccinated with Varicella Vaccine live (Oka/Merck) and followed for 14 years after vaccination showed no increase in the frequency of herpes zoster compared to children with prior wild-type varicella during the pre-vaccine era.
Lige som andre vacciner vil ProQuad muligvis ikke give alle modtagere af vaccinen fuld beskyttelse. 
As with other vaccines, ProQuad may not completely protect all persons who are vaccinated.
I 2 kliniske studier fik 1035 forsøgspersoner anden dosis ProQuad ca. 3 måneder efter første dosis. 
In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 3 months after the first dose.
Individer i højrisikogruppen, der er modtagelige over for skoldkopper, omfatter: 
High-risk individuals susceptible to varicella include:
Hvis du er gravid eller ammer, har mistanke om at du er gravid eller planlægger at blive gravid, skal du spørge din læge eller apoteket til råds, før du tager denne vaccine. 
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Almene symptomer og reaktioner på administrationsstedet Feber 
General disorders and administration site conditions Fever
Fremstillet i human diploid lungefibroblast (WI-38). ) 
2) Produced in human diploid lung (WI-38) fibroblasts.
Endvidere fremstilles levende mæslingevaccine og levende fåresygevaccine i cellekultur fra kyllingefostre. 
Additionally, live measles vaccine and live mumps vaccine are produced in chick embryo cell culture.
Immunglobulin (Ig) og varicel-zoster immunglobulin (VZIG) må ikke gives samtidig med ProQuad. 
Do not give immunoglobulin (IG) or Varicella Zoster Immune Globulin (VZIG) concomitantly with ProQuad.
ProQuad er ikke kontraindiceret til personer, der får lokaliserede eller lave doser af parenterale kortikosteroider (fx til astmaprofylakse eller substitutionsterapi). 
ProQuad is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).