FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution, use immediately or within 30 minutes if stored between 20°C and 25°C.
Danish: Efter rekonstitution skal vaccinen anvendes omgående eller i løbet af 30 minutter ved opbevaring mellem 20° C og 25° C.
English: If you have been told by your doctor that you or your child has an intolerance to some sugars, inform your doctor before you or your child receive this vaccine.
Danish: Hvis din læge har fortalt dig, at du eller dit barn ikke tåler visse sukkerarter, skal du kontakte din læge, før du eller dit barn får vaccinen.
English: Evaluation of immunogenicity in children from 9 to 12 months of age at the time of first dose A clinical study was conducted with ProQuad administered with a 2-dose schedule, the doses being given 3 months apart in 1,620 healthy subjects from 9 to 12 months of age at the time of first dose.
Danish: Evaluering af immunogenicitet hos børn i alderen 9-12 måneder ved første dosis Der blev udført et klinisk studie med ProQuad administreret i et 2-dosis-program, hvor dosis blev givet med 3 måneders interval til 1.620 raske forsøgspersoner i aldersgruppen 9 til 12 måneder ved første dosis.
English: 3) Produced in human diploid cells (MRC-5).
Danish: Fremstillet i humane diploide celler (MRC-5).
English: Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline cake.
Danish: Før opblanding med solvens er vaccinens pulver en hvid til lysegul kompakt krystallinsk kage.
English: The vaccine should be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.
Danish: Vaccinen skal gives subkutant hos patienter med trombocytopeni eller andre koagulationsforstyrrelser.
English: 3) Produced in human diploid (MRC-5) cells.
Danish: Fremstillet i humane diploide (MRC-5) celler.
English: Injury and poisoning, and procedural complications Contusion, Non-venomous bite/sting
Danish: Traumer, forgiftninger og behandlingskomplikationer Kontusion, ikke-giftigt bid/stik
English: Due caution should be employed in the administration of ProQuad to persons with individual or family history of convulsions, or a history of cerebral injury.
Danish: Der bør udvises forsigtighed ved administration af ProQuad i tilfælde af krampeanfald i den personlige eller familiære anamnese eller tidligere tilfælde af hjerneskade.
English: If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, or 4 to 6 weeks after vaccination with ProQuad.
Danish: Hvis der skal foretages tuberkulintest, skal den udføres enten før, samtidig med eller mindst 4-6 uger efter vaccination med ProQuad.
English: Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or at least 4 to 6 weeks after immunization with ProQuad.
Danish: Hvis der skal foretages tuberkulintest, skal den administreres enten på et tidspunkt før, samtidig med eller mindst 4-6 uger efter vaccination med ProQuad.
English: • Uncommon (may affect up to 1 in 100 people): cough.
Danish: • Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer): hoste.
English: ‡ or Pain/Tenderness/Soreness at the injection site
Danish: ‡, erythem ‡ eller smerte/ømhed ved injektionsstedet
English: These adverse events include:
Danish: Disse bivirkninger omfatter:
English: Usually for injections into the muscle the thigh area is preferred in young children, whereas for older individuals the upper arm area is the preferred injection site.
Danish: Normalt foretrækkes indsprøjtninger i yderlåret hos små børn, mens det foretrukne indsprøjtningssted for ældre patienter er i overarmen.
English: See also section 3 How to use ProQuad.
Danish: Se også afsnit 3 Sådan får du ProQuad
English: In comparison, following ProQuad given concomitantly with Prevenar and/or hepatitis A vaccine in 3 clinical trials, the observed rates of reported fever (≥39.4°C rectal equivalent) ranged from 15.2% to 27.2%.
Danish: Til sammenligning: Efter indgivelse af ProQuad sammen med Prevenar og/eller hepatitis A-vaccine i 3 kliniske studier varierede den indberettede hyppighed af feber (≥39,4 C rektalt eller tilsvarende) mellem 15,2 % og 27,2 %.
English: Before reconstitution, the powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless liquid.
Danish: Før rekonstitution er pulveret en hvid til lysegul kompakt krystallinsk masse og solvensen er en klar farveløs væske.
English: 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).
Danish: 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).
English: Crying, Insomnia, Sleep disorder
Danish: Grådlabilitet, insomnia, søvnforstyrrelser
English: Tell your doctor if there is anyone who falls into one of the categories above and is expected to be in contact with the person vaccinated after vaccination.
Danish: Fortæl det til din læge, hvis du kender nogen, som falder ind under en af disse kategorier, og som du tror vil komme i kontakt med personen, der skal vaccineres.
English: Complications of varicella from vaccine strain including herpes zoster and disseminated disesase such as aseptic meningitis and encephalitis have been reported in immunocompromised or immunocompetent individuals.
Danish: Der har været indberetninger om komplikationer med varicella forårsaget af vaccinestamme, herunder herpes zoster og dissemineret sygdom såsom aseptisk meningitis og encephalitis hos immunkompromitterede eller immunkompetente personer.
English: To ensure optimal protection against chickenpox and measles, two doses of ProQuad should be given at least three months apart.
Danish: For at sikre optimal beskyttelse mod skoldkopper og mæslinger skal der gives to doser ProQuad med mindst 3 måneders mellemrum.
English: ProQuad must not be mixed in a syringe with other vaccines.
Danish: ProQuad må ikke blandes med andre vacciner i en injektionssprøjte.
English: No specific studies have been conducted in individuals from 2 years of age who had not previously received measles, mumps, rubella, and varicella vaccines.
Danish: Der er ikke udført specifikke studier med personer fra og med 2 år, som ikke tidligere var vaccineret mod mæslinger, fåresyge, røde hunde og skoldkopper.
English: Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad (see section 4.4).
Danish: Vaccinerecipienter bør undgå brug af salicylater i 6 uger efter vaccination med ProQuad (se pkt.
English: Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants.
Danish: Studier har vist, at kvinder, der ammer efter fødslen, og som er vaccineret med levende, svækket røde hundevirus, kan udskille virus i mælken og overføre den til barnet.
English: The overall safety profile of ProQuad was comparable whether it was administered concomitantly or alone.
Danish: Den overordnede sikkerhedsprofil for ProQuad var den samme, uanset om ProQuad blev indgivet sammen med andre vacciner eller alene.
English: 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.
Danish: 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.
English: Following ProQuad given alone in 7 clinical trials, the observed rates of fever (≥39.4°C rectal equivalent) ranged from 10.1% to 39.4%.
Danish: Efter indgivelse af ProQuad alene i 7 kliniske studier varierede hyppigheden af feber (≥39,4 C rektalt eller tilsvarende) mellem 10,1 % og 39,4 %.
English: Vaccination with ProQuad may not result in protection in all vaccine recipients.
Danish: Det er muligt, at vaccination med ProQuad ikke beskytter alle vaccinemodtagere.
English: In eight clinical studies, the overall rates of adverse reactions after a second dose of ProQuad were generally similar to, or lower than, those seen with the first dose.
Danish: I 8 kliniske studier var den generelle forekomst af bivirkninger efter anden dosis ProQuad stort set tilsvarende eller lavere end forekomsten efter første dosis.
English: There have been reports of SSPE in children who did not have a history of infection with wild-type measles but did receive measles vaccine.
Danish: Der foreligger rapporter om SSPE hos børn, som ikke havde haft naturligt forekommende mæslinger, men var blevet vaccineret med mæslingevaccine.
English: It is not known whether measles or mumps vaccine virus is secreted in human milk.
Danish: Det vides ikke, om mæslinge- eller fåresygevirus fra vaccine udskilles i human mælk.
English: In these studies seroconversion in response to vaccination against measles, mumps, and rubella paralleled protection from these diseases.
Danish: I disse studier svarede serokonverteringen som reaktion på vaccination mod mæslinger, fåresyge og røde hunde til beskyttelse mod disse sygdomme.
English: Arthritis and/or arthralgia (usually transient and rarely chronic)* , Musculoskeletal pain, Myalgia, Pain of the hip, leg, or neck, Swelling
Danish: Artritis og/eller artralgi (sædvanligvis forbigående og sjældent kronisk)*, smerter i skeletmuskulaturen, myalgi, smerter i hofter, ben eller hals, hævelse
English: In the infants with serological evidence of rubella infection, none had symptomatic disease.
Danish: Hos spædbørn med røde hunde påvist i serum var der ingen tilfælde af symptomatisk sygdom.
English: Immunocompromised individuals (see section 4.3) Necrotizing retinitis has been reported post-marketing in immunocompromised individuals.
Danish: 4.3) Nekrotiserende retinitis er blevet rapporteret post-marketing hos immunkompromitterede personer.
English: ProQuad is not to be injected directly into any blood vessel.
Danish: ProQuad må ikke gives direkte i et blodkar.
English: 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%.
Danish: I de samlede kliniske studier med en enkelt dosis levende skoldkoppevaccine (Oka/Merck) til raske børn lå vaccinens beskyttende effekt mod skoldkopper i alle sværhedsgrader mellem 81 % og 100 %.
English: After reconstitution, one dose (0.5 ml) contains: The active substances are:
Danish: Efter rekonstitution indeholder 1 dosis (0,5 ml): De aktive indholdsstoffer er:
English: Erythema multiforme, Herpes simplex, Impetigo, Panniculitis, Purpura, Skin induration, StevensJohnson syndrome, Sunburn
Danish: Erythema multiforme, herpes simplex, impetigo, pannikulitis, purpura, induration af huden, StevensJohnsons syndrom, solskoldethed
English: If you or your child get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du eller dit barn oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apotek.
English: The post-dose 2 geometric mean titres (GMTs) against mumps, rubella, and varicella were comparable across all age categories, while the GMTs against measles were lower in subjects who received the first dose at 9 months of age as compared to subjects who received the first dose at 11 or 12 months of age.
Danish: De geometriske middelværdier (GMT'er) efter dosis 2 mod fåresyge, røde hunde og skoldkopper var sammenlignelige på tværs af alle aldersgrupper, mens GMT'erne mod mæslinger var lavere hos børn, der fik den første dosis i 9-måneders alderen, sammenlignet med børn, der fik den første dosis i 11eller 12-måneders alderen.
English: Valence (seropro tection level)
Danish: Valens (seropro tektionsni veau)
English: Store in the original package in order to protect from light.
Danish: Opbevares i den originale ydrepakning for at beskytte mod lys.
English: It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
Danish: Der foreligger rapporter om, at levende svækkede vacciner mod mæslinger, fåresyge og røde hunde indgivet separat kan medføre midlertidig undertrykkelse af hudens følsomhed over for tuberkulin.
English: 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 vaccine recipients to susceptible contacts.
Danish: Der foreligger ingen rapporter om den mere svækkede Enders Edmonston mæslingevirusstamme eller Jeryl Lynn-stammen af fåresygevirus fra vaccinerecipienter til modtagelige kontakter.
English: In such cases, individuals should receive a second dose of ProQuad, given a minimum of 3 months apart, to ensure optimal protection against measles and varicella (see sections 4.4 and 5.1).
Danish: I sådanne tilfælde bør personen have endnu en dosis ProQuad efter mindst tre måneder for at sikre optimal beskyttelse mod mæslinger og skoldkopper (se pkt.
English: • Uncommon (may affect up to 1 in 100 people): seizures with a fever.
Danish: • Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer): krampeanfald med feber.
English: Psychiatric disorders Irritability
Danish: Psykiske forstyrrelser Irritabilitet
English: The antibody persistence rates 1 year postvaccination in recipients of a single dose of ProQuad were 98.9% (1722/1741) for measles, 96.7% (1676/1733) for mumps, 99.6% (1796/1804) for rubella, and 97.5% (1512/1550) for varicella (≥5 gpELISA Units/ml).
Danish: Hos recipienter af en enkelt dosis ProQuad var antistoftitrenes persistens 1 år efter vaccinationen 98,9 % (1722/1741) for mæslinger, 96,7 % (1676/1733) for fåresyge, 99,6 % (1796/1804) for røde hunde og 97,5 % (1512/1550) for skoldkopper (≥5 gpELISA enheder/ml).
English: Following a single dose of ProQuad, the vaccine response rates were 97.7% for measles, 96.3% to 98.8% for mumps, and 98.8% for rubella.
Danish: Efter en enkelt dosis ProQuad var responsraterne over for vaccinen 97,7 % for mæslinger, mellem 96,3 % og 98,8 % for fåresyge og 98,8 % for røde hunde.
English: Most cases of varicella reported in recipients of 1 dose or 2 doses of vaccine were mild.
Danish: I de fleste tilfælde var skoldkopperne milde hos recipienter af 1 eller 2 doser vaccine.
English: Dose 1 at 9 months / Dose 2 at 12 months N = 527
Danish: Dosis 1 v. 9 måneder/ Dosis 2 v. 12 måneder N = 527
English: If the person to be vaccinated has a blood clotting disorder or low levels of platelets, the vaccine should be given under the skin because bleeding may occur following administration into the muscle.
Danish: Hvis den person, der skal vaccineres, lider af en blodkoagulationssygdom eller har et lavt niveau trombocytter, skal vaccinen gives under huden, fordi der kan opstå blødning efter indsprøjtning i en muskel.
English: Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
Danish: Hos de fleste vaccinemodtagere er der udskilt små mængder af den levende, svækkede røde hundevirus fra næse eller hals 7-28 dage efter vaccinationen.
English: Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions.
Danish: Personer med anafylaktiske, anafylaktoide eller andre akutte reaktioner (fx urticaria, hævelser i mund og hals, åndedrætsbesvær, hypotension eller chock) efter indtagelse af æg kan have en øget risiko for akutte overfølsomhedsreaktioner.
English: After 2 doses, the seroprotection rates against measles were 98.1% when the first dose was given at 11 months, compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective met).
Danish: Efter 2 doser var seroprotektionsraterne mod mæslinger 98,1 %, når den første dosis blev givet ved 11 måneder, sammenlignet med 98,9 %, når den første dosis blev givet ved 12 måneder (non-inferioritet opfyldt).
English: • Very common (may affect more than 1 in 10 people): injection site complaints including pain/tenderness/soreness, redness, fever (38.9°C or higher);
Danish: • Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer): symptomer ved injektionsstedet inklusive smerte/ømhed, rødmen, feber (38,9°C eller højere).
English: Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or varicella (chickenpox) in healthy people.
Danish: Selv om ProQuad indeholder levende virus, er disse for svage til at udløse mæslinger, fåresyge, røde hunde eller skoldkopper hos raske mennesker.
English: Precautions to be taken before handling or administering the medicinal product: see section 6.6.
Danish: Sikkerhedsforanstaltninger før håndtering og administration af lægemidlet, se pkt.
English: ProQuad, when reconstituted, is clear pale yellow to light pink liquid.
Danish: Efter rekonstitution er ProQuad en klar, lysegul til lyserød væske.
English: Experience with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. demonstrates that antibodies to measles, mumps, and rubella viruses are still detectable in most individuals 11 to 13 years after primary vaccination.
Danish: Erfaringer med MFR-vaccinen fremstillet af Merck & Co., Inc. viser, at antistoffer mod mæslinger, fåresyge og røde hunde stadig kan påvises hos de fleste 11-13 år efter den første vaccination.
English: After two doses, the seroprotection rates against measles were 94.6% when the first dose was given at 9 months, compared to 98.9% when the first dose was given at 12 months (non-inferiority study objective not met).
Danish: Efter to doser var seroprotektionsraterne mod mæslinger 94,6 %, når første dosis blev givet ved 9 måneder, sammenlignet med 98,9 %, når første dosis blev givet ved 12 måneder (non-inferioritet ikke opfyldt).
English: In the 5- to 12-day timeframe after the administration of the first dose of quadrivalent measles, mumps, rubella and varicella vaccines in children, an increased risk of febrile seizure was observed compared to concomitant administration of measles, mumps, rubella and varicella vaccines (see sections 4.8 and 5.1).
Danish: I perioden 5 til 12 dage efter vaccination af den første dosis af den firvalente mæslinge-, fåresyge-, rubella- og varicellavaccine hos børn, blev der observeret en øget risiko for feberkramper sammenlignet med samtidig vaccination af mæslinge-, fåresyge-, rubella- og varicellavaccine (se pkt.
English: Formal studies to evaluate the efficacy of ProQuad have not been performed.
Danish: Der er ikke udført formelle studier af ProQuads effekt.
English: Oedema of the eyelid, Irritation, Optic neuritis, Retinitis, Retrobulbar neuritis
Danish: Øjenlågsødem, irritation, neuritis nervi optici, retinitis, retrobulbær neuritis
English: Agitation, Apathy, Clinging, Emotional changes, Nervousness, Restlessness
Danish: Agitation, apati, pylrethed, emotionel labilitet, nervøsitet, rastløshed
English: This vaccine should be given subcutaneously to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals.
Danish: Denne vaccine skal gives subkutant til patienter med thrombocytopeni eller koagulationsforstyrrelser, da der kan opstå blødning efter en intramuskulær indgivelse hos disse patienter.
English: Blood and the lymphatic system disorders Leukocytosis, Lymphadenopathy
Danish: Blod- og lymfesystem Leukocytose, lymfadenopati
English: Post-exposure prophylaxis
Danish: Profylakse efter eksposition
English: In clinical studies involving healthy subjects who received 1 dose of Varicella Vaccine live (Oka/Merck), detectable varicella antibodies were present in most individuals tested for up to 10 years postvaccination.
Danish: I kliniske studie med raske forsøgspersoner, som fik 1 dosis levende skoldkoppevaccine (Oka/Merck), kunne skoldkoppeantistoffer påvises hos de fleste i op til 10 år efter vaccinationen.
English: 1) Produced in chick embryo cells.
Danish: ) Fremstillet i kyllingefosterceller. )
English: Women of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month following vaccination.
Danish: Kvinder i den fødedygtige alder skal sikre sig mod graviditet i 1 måned efter vaccinationen.
English: The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulin (IG), or varicella zoster immune globulin (VZIG).
Danish: Lægen kan udsætte din vaccination i mindst 3 måneder efter en blod- eller plasmatransfusion eller indgift af immunglobulin (Ig) eller varicel-zoster-immunglobulin (VZIG).
English: Nervous system disorders Febrile seizure*, Somnolence
Danish: Nervesystemet Feberkramper*, døsighed
English: Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6).
Danish: Endvidere bør graviditet undgås i 1 måned efter vaccination (se pkt.
English: ProQuad with Solvent for reconstitution supplied in a Vial:
Danish: ProQuad med solvens til rekonstitution leveret i hætteglas:
English: ProQuad powder for suspension for injection IM/SC
Danish: ProQuad pulver til injektionsvæske, suspension IM/SC
English: Dose 1 at 12 months / Dose 2 at 15 months N = 466
Danish: Dosis 1 v. 12 måneder/ Dosis 2 v. 15 måneder N = 466
English: Dose 1 at 11 months / Dose 2 at 14 months N = 480
Danish: Dosis 1 v. 11 måneder/ Dosis 2 v. 14 måneder N = 480
English: Clinical trials involving 6987 subjects who received ProQuad demonstrated detectable immune responses to measles, mumps, rubella, and varicella in a high proportion of individuals.
Danish: Kliniske studier med 6897 forsøgspersoner, som fik ProQuad, har dokumenteret påviseligt immunrespons mod mæslinger, fåresyge, røde hunde og skoldkopper hos en stor andel af deltagerne.
English: Reconstitution instructions
Danish: Vejledning i rekonstitution
English: 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.
Danish: Effekten af mæslinge-, fåresyge- og røde hundekomponenterne i ProQuad er tidligere påvist i en række dobbeltblinde kontrollerede feltstudier med de monovalente vacciner fremstillet af Merck & Co., Inc., og de dokumenterede en høj beskyttelsesgrad.
English: When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, rubella, and varicella viruses.
Danish: Når en person vaccineres med ProQuad, danner immunsystemet (kroppens naturlige forsvar) antistoffer mod mæslinge-, fåresyge-, røde hunde- og skoldkoppevirus.
English: Metabolism and nutrition disorders Anorexia, Decreased appetite
Danish: Metabolisme og ernæring Spisevægring, appetitløshed
English: Measles (titre ≥255 mIU/mL)
Danish: (titer ≥255 mIE/ml)
English: The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided with the vial of powder.
Danish: Vaccinen fås som pulver til injektionsvæske i et hætteglas med en enkelt dosis, og pulveret skal opblandes med den solvens, som leveres sammen med hætteglasset med pulver.