FrancophonIA/ELRC3.0 huggingface dataset:
English: However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).
Danish: I så fald kan vaccinationen beskytte mindre effektivt end hos personer uden hiv (se under ProQuad må ikke anvendes).
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: After vaccination with ProQuad, IG or VZIG should not be given for 1 month, unless your doctor tells you otherwise.
Danish: Efter vaccination med ProQuad bør Ig eller VZIG ikke gives i mindst 1 måned, medmindre lægen siger noget andet.
English: There is no evidence that measles vaccine can cause SSPE.
Danish: Det er ikke dokumenteret, at mæslingevaccine kan føre til SSPE.
English: The following other side effects reported with the use of ProQuad were:
Danish: Følgende andre bivirkninger er rapporteret i forbindelse med brug af ProQuad:
English: • If the person to be vaccinated has a blood disorder or any type of cancer that affects the immune system.
Danish: • Hvis personen, der skal vaccineres, har en blodsygdom eller en kræftsygdom, der påvirker immunsystemet.
English: • If the person to be vaccinated is pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breast-feeding).
Danish: • hvis personen, der skal vaccineres, er gravid (graviditet bør desuden undgås i 1 måned efter vaccinationen, se Graviditet og amning).
English: Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du eller dit barn bruger anden medicin (eller vacciner) eller har gjort det for nylig.
English: ProQuad should not be given to pregnant women.
Danish: ProQuad bør ikke gives til gravide kvinder.
English: The potential risk-to-benefit ratio should be carefully evaluated before considering vaccination in such cases.
Danish: I sådanne tilfælde bør det potentielle risk/benefitforhold vurderes nøje, før vaccinationen gives.
English: 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%).
Danish: 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 %).
English: 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.
Danish: Børn, som fik 2 doser ProQuad intramuskulært eller subkutant I et klinisk studie fik 405 børn 2 doser ProQuad enten intramuskulært eller subkutant.
English: Allergic reactions (hives) may occur.
Danish: Der kan forekomme allergiske reaktioner (nældefeber).
English: The safety profiles of the administered vaccines were comparable (see section 4.8).
Danish: Sikkerhedsprofilerne for de indgivne vacciner var sammenlignelige (se pkt.
English: 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.
Danish: Såvel feber som mæslingelignende udslæt indtraf sædvanligvis inden for 5-12 dage efter vaccinationen, varede i kort tid og forsvandt uden varige følger.
English: Administration of immune globulins concomitantly with ProQuad may interfere with the expected immune response.
Danish: Samtidig administration af immunglobuliner og ProQuad kan påvirke det forventede immunrespons.
English: In 5 clinical trials, ProQuad was administered without concomitant vaccines to 6038 children 12 through 23 months of age.
Danish: I 5 kliniske studier blev ProQuad administreret uden andre vacciner til 6.038 børn i alderen 12-23 måneder.
English: Pregnancy Pregnant women should not be vaccinated with ProQuad.
Danish: Graviditet Gravide kvinder bør ikke blive vaccineret med ProQuad
English: Only rarely have vaccine recipients developed chronic joint symptoms.
Danish: Kun i sjældne tilfælde har vaccinemodtagere udviklet kroniske ledsymptomer.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel eller affald herfra bortskaffes i overensstemmelse med lokale regler.
English: No studies on the effects on the ability to drive or use machinery have been performed.
Danish: Der er ikke foretaget studier af indflydelsen på evnen til at føre motorkøretøj eller betjene maskiner.
English: 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.
Danish: 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.
English: The doctor will decide if ProQuad should be given.
Danish: Lægen vil så tage stilling til, om ProQuad bør anvendes.
English: At least 1 month should elapse between receipt of a live virus vaccine and ProQuad.
Danish: Der bør gå mindst 1 måned mellem vaccination med en levende virus og ProQuad.
English: Pregnancy should be avoided for 1 month following vaccination.
Danish: Graviditet bør undgås i 1 måned efter vaccinationen.
English: • 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).
Danish: 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).
English: Solvent for ProQuad
Danish: Solvens til ProQuad
English: However, in-use stability has been demonstrated for 30 minutes when stored between 20C and 25C.
Danish: Holdbarhed efter åbning er påvist i 30 minutter ved opbevaring mellem 20 C og 25 C.
English: Encephalitis and encephalopathy
Danish: Encefalitis og encefalopati
English: ProQuad should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm.
Danish: ProQuad skal indsprøjtes i en muskel eller under huden enten på yderlåret eller på overarmen.
English: Animal reproduction studies have not been conducted with ProQuad.
Danish: Der er ikke udført reproduktionsstudier i dyr med ProQuad.
English: This vaccine contains 16 mg of sorbitol as an excipient.
Danish: Denne vaccine indeholder 16 mg sorbitol som hjælpestof.
English: Febrile seizures have been reported in children receiving ProQuad.
Danish: Der har været indberetninger om feberkramper hos børn, der fik ProQuad.
English: The fever rate in all eight studies was lower after the second dose than after the first dose.
Danish: I alle 8 studier var forekomsten af feber lavere efter anden dosis end efter første dosis.
English: Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.
Danish: Medfødt eller arvelig immundefekt i familien, med mindre der påvises immunkompetence hos den potentielle recipient af vaccinen.
English: 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.
Danish: 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.
English: Persons who are breast-feeding or who intend to breast-feed should tell the doctor.
Danish: Kvinder, der ammer eller har til hensigt at amme, bør fortælle det til deres læge.
English: Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunized with live measles virus vaccine.
Danish: Børn i behandling for tuberkulose har ikke oplevet forværring af sygdommen efter vaccination med levende mæslingevirus vaccine.
English: There is no confirmed evidence to indicate that such virus is transmitted to susceptible persons who are in contact with the vaccinated individuals.
Danish: Det er ikke dokumenteret, at denne type virus overføres til modtagelige individer i kontakt med vaccinemodtagere.
English: Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of immune globulins (IG).
Danish: Vaccinationen bør udsættes i mindst 3 måneder efter blod- eller plasmatransfusion eller administration af immunglobuliner (Ig).
English: Pain/tenderness/soreness at the injection site was reported at a statistically lower rate in individuals who received ProQuad.
Danish: Smerter og ømhed omkring injektionsstedet forekom med en statistisk lavere hyppighed hos personer, som fik ProQuad.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Chronic arthritis has been associated with wild-type rubella infection and has been related to persistent virus and/or viral antigen isolated from body tissues.
Danish: Kronisk artritis er sat i forbindelse med naturligt forekommende røde hunde og er relateret til vedvarende virus og/eller viralt antigen isoleret fra kropsvæv.
English: After reconstitution, the vaccine should be used immediately.
Danish: Den rekonstituerede vaccine skal anvendes med det samme.
English: 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).
Danish: 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).
English: Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Danish: Indehaver af markedsføringstilladelse: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, Frankrig
English: The persistence of antibody at 1 year after vaccination was evaluated in a subset of 2108 subjects who were involved in 1 clinical trial.
Danish: Antistoffernes persistens blev bestemt 1 år efter vaccinationen hos en delgruppe på 2108 deltagere i et klinisk studie.
English: What ProQuad contains
Danish: Hvad ProQuad indeholder
English: Children who received ProQuad intramuscularly
Danish: Børn, som fik ProQuad intramuskulært
English: 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.
Danish: 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.
English: As with other vaccines, ProQuad may not completely protect all persons who are vaccinated.
Danish: Lige som andre vacciner vil ProQuad muligvis ikke give alle modtagere af vaccinen fuld beskyttelse.
English: In 2 clinical trials, 1035 subjects were administered a second dose of ProQuad approximately 3 months after the first dose.
Danish: I 2 kliniske studier fik 1035 forsøgspersoner anden dosis ProQuad ca. 3 måneder efter første dosis.
English: High-risk individuals susceptible to varicella include:
Danish: Individer i højrisikogruppen, der er modtagelige over for skoldkopper, omfatter:
English: 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.
Danish: 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.
English: General disorders and administration site conditions Fever
Danish: Almene symptomer og reaktioner på administrationsstedet Feber
English: 2) Produced in human diploid lung (WI-38) fibroblasts.
Danish: Fremstillet i human diploid lungefibroblast (WI-38). )
English: Additionally, live measles vaccine and live mumps vaccine are produced in chick embryo cell culture.
Danish: Endvidere fremstilles levende mæslingevaccine og levende fåresygevaccine i cellekultur fra kyllingefostre.
English: Do not give immunoglobulin (IG) or Varicella Zoster Immune Globulin (VZIG) concomitantly with ProQuad.
Danish: Immunglobulin (Ig) og varicel-zoster immunglobulin (VZIG) må ikke gives samtidig med ProQuad.
English: ProQuad is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g. for asthma prophylaxis or replacement therapy).
Danish: ProQuad er ikke kontraindiceret til personer, der får lokaliserede eller lave doser af parenterale kortikosteroider (fx til astmaprofylakse eller substitutionsterapi).
English: In addition, a decrease by approximately 90% (approximately 10-fold) in varicella hospitalization rates was observed in all age groups.
Danish: Derudover blev der observeret et fald på ca. 90 % (ca. 10 gange lavere) i hyppigheden af indlæggelse pga. varicella hos alle aldersgrupper.
English: 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).
Danish: I et studie 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).
English: These surveillance data actually suggest that varicella-vaccinated children may have a lower risk of herpes zoster.
Danish: Dataene fra overvågningen tyder faktisk på, at børn, der er vaccineret mod varicella, kan have en lavere risiko for at få herpes zoster.
English: However, the appropriate suggested interval between transfusion or IG administration and vaccination will vary with the type of transfusion or indication for, and dose of, IG (e.g. 5 months for VZIG).
Danish: Hvor langt intervallet bør være mellem transfusion eller Ig-administration og vaccination vil dog afhænge af transfusionstypen eller indikationen for og doseringen af Ig (fx 5 måneder for VZIG).
English: Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system.
Danish: Bloddyskrasi, leukæmi, alle former for lymfomer og andre maligne neoplasmer, der påvirker det hæmatopoietiske og lymfatiske system.
English: If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.
Danish: Hvis du lider af en blodkoagulationssygdom eller har et lavt niveau trombocytter i dit blod, vil indsprøjtningen blive givet under huden.
English: ProQuad contains sorbitol.
Danish: ProQuad indeholder sorbitol
English: • Individuals 12 months of age and older: To ensure optimal protection against chickenpox, two doses of ProQuad should be given at least one month apart.
Danish: • Personer fra 12 måneder og ældre: For at sikre optimal beskyttelse mod skoldkopper skal der gives to doser ProQuad med mindst en måneds mellemrum.
English: Sodium bicarbonate
Danish: Natriumbicarbonat
English: The doctor will determine when ProQuad may be given.
Danish: Lægen vil så tage stilling til, hvornår ProQuad kan anvendes.
English: No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis.
Danish: Hidtil er det ikke undersøgt, om mæslingevacciner påvirker børn med ubehandlet tuberkulose.
English: ProQuad may also be administered to infants from 9 months of age under special circumstances (to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles).
Danish: ProQuad kan også gives til spædbørn fra 9-måneders alderen under særlige omstændigheder (i overensstemmelse med nationale vaccinationsprogrammer, i forbindelse med sygdomsudbrud eller ved rejse til et område med høj forekomst af mæslinger).
English: Store and transport refrigerated (2°C-8°C).
Danish: Opbevares og transporteres nedkølet (2° C - 8° C).
English: Therefore, caution should be exercised when considering whether to administer ProQuad to a breast-feeding woman.
Danish: Det bør derfor overvejes nøje, før ProQuad administreres til en kvinde, der ammer.
English: In the Full Analysis Set (vaccinated subjects regardless of their antibody titre at baseline), high seroprotection rates of >99% were elicited to mumps, rubella, and varicella post-dose 2, regardless of the age of the vaccinees at the first dose.
Danish: I det fulde analysesæt (vaccinerede personer uanset deres antistoftiter ved baseline) var der høje seroprotektionsrater på >99 % mod fåresyge, røde hunde og skoldkopper efter dosis 2, uanset barnets alder ved første dosis.
English: Both cases were unremarkable and no sequelae were reported.
Danish: Begge tilfælde var ubemærkelsesværdige og uden indberetning af følgesygdomme.
English: • Rare (may affect up to 1 in 1,000 people): bronchiolitis (difficulty breathing with or without cough); unsteadiness with walking.
Danish: • Sjældne (kan forekomme hos op til 1 ud af 1000 personer): bronkiolitis (åndedrætsbesvær med eller uden hoste) og usikker gang.
English: The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8).
Danish: Lægen bør holde øje med eventuelle temperaturstigninger efter vaccinationen (se pkt.
English: In three of these studies, the rates of injection-site erythema and swelling were statistically significantly higher after the second dose than after the first dose; however, in the remaining five studies, the rates of each of these reactions were similar after the first and second dose.
Danish: I tre af disse studier var forekomsten af erytem og hævelse på injektionsstedet efter anden dosis statistisk signifikant hyppigere end efter første dosis, mens hyppigheden af hver af disse bivirkninger var den samme efter første og anden dosis i de andre 5 studier.
English: Arthralgia and/or arthritis (usually transient and rarely chronic), and polyneuritis are features of infection with wild-type rubella and vary in frequency and severity with age and gender, being greatest in adult females and least in prepubertal children.
Danish: 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.
English: Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Danish: Fremstiller ansvarlig for batchfrigivelse: Merck Sharp and Dohme, B.V., Waarderweg, 39, NL- 2031 BN Haarlem, Holland
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Danish: Inden administration skal den rekonstituerede vaccine undersøges visuelt for fremmede partikler og/eller usædvanligt udseende.
English: 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.
Danish: Fra et klinisk studie 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.
English: The following adverse reactions were reported as vaccine related by the investigator in individuals after a single dose of ProQuad.
Danish: Følgende bivirkninger rapporteredes af investigator at kunne relateres til vaccinen hos personer efter en enkelt dosis ProQuad.
English: The seroprotection rates to measles, mumps, rubella, and varicella 6 weeks post-dose 1 and 6 weeks post-dose 2, for the Full Analysis Set are given in the following table.
Danish: Seroprotektionsraterne mod mæslinger, fåresyge, røde hunde og skoldkopper 6 uger efter dosis 1 og 6 uger efter dosis 2 for det fulde analysesæt fremgår af nedenstående tabel.
English: Individuals less than 12 months of age who are vaccinated with a measles-containing vaccine during measles outbreaks or for other reasons may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin and/or immaturity of the immune system (see sections 4.2 and 5.1).
Danish: Personer yngre end 12 måneder, der bliver vaccineret med en vaccine indeholdende mæslingevirus under udbrud af mæslinger eller af andre grunde, kan udvise manglende respons på vaccinen på grund af cirkulerende antistoffer fra moderen og/eller immunsystemets umodenhed (se pkt.
English: In clinical trials, no cases were reported regarding the development or worsening of thrombocytopenia in individuals vaccinated with ProQuad.
Danish: Der foreligger ingen kliniske data om udvikling eller forværring af trombocytopeni hos personer vaccineret med ProQuad.
English: In circumstances where contact with high-risk individuals susceptible to varicella is unavoidable, the potential risk of transmission of the varicella vaccine virus should be weighed against the risk of acquiring and transmitting wild-type varicella virus.
Danish: Under omstændigheder, hvor det er umuligt at undgå kontakt med individer i højrisikogruppen, som er modtagelige over for skoldkopper, skal den potentielle risiko for transmission af virus fra skoldkoppevaccinen afvejes mod risikoen for at få og overføre naturligt forekommende skoldkoppevirus.