FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-Marketing Observational Safety Surveillance Study Safety was evaluated in an observational study that included 69,237 children vaccinated with ProQuad 12 months to 12 years old and 69,237 matched children in a historical comparison group who were vaccinated concomitantly with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Danish: Sikkerheden blev evalueret i et observationsstudie, der omfattede 69.237 børn i alderen 12 måneder til 12 år, som blev vaccineret med ProQuad og 69.237 matchede børn i en historisk sammenligningsgruppe, som samtidigt blev vaccineret med mæslinge-, fåresyge- og rubellavaccinen fremstillet af Merck & Co., Inc., og den levende varicellavaccine (Oka/Merck).
English: The general safety profiles of the IM and SC administration routes were comparable; however, fewer subjects experienced injection-site adverse reactions in the IM group after each dose (see section 5.1 for study description).
Danish: Sikkerhedsprofilerne for de indgivne intramuskulære og subkutane vacciner var generelt sammenlignelige, men færre patienter fik bivirkninger omkring injektionsstedet i den intramuskulære gruppe efter hver dosis (se pkt.
English: ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age.
Danish: ProQuad er indiceret til samtidig vaccination mod mæslinger, fåresyge, røde hunde og skoldkopper hos personer, fra de er 12 måneder.
English: Cases of thrombocytopenia have been reported in postmarketing experience after primary vaccination with ProQuad.
Danish: Efter markedsføring er der indberettet tilfælde af trombocytopeni efter primær vaccination med ProQuad.
English: ‡, Erythema
Danish: eksem, erythem
English: 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).
Danish: 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).
English: 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).
Danish: I kliniske studier 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).
English: Withdraw the entire content of the reconstituted vaccine from the vial into the same syringe and inject the entire volume.
Danish: Hele hætteglassets indhold af rekonstitueret vaccine trækkes op i den samme injektionssprøjte og injiceres.
English: Anaphylactoid reaction, Anaphylaxis and related phenomenon such as Angioneurotic oedema, Facial oedema, and Peripheral oedema, Anaphylaxis in individuals with or without an allergic history
Danish: Anafylaktoid reaktion, anafylaksi og relaterede fænomener såsom angioneurotisk ødem, ansigtsødem og perifert ødem, anafylaksi hos personer med eller uden allergi i anamnesen
English: When completely mixed, the vaccine is a clear pale yellow to light pink liquid.
Danish: Efter opblandingen er vaccinen en klar lysegul til lyserød væske.
English: Varicella caused by vaccine strain was observed in post-marketing use with Varicella Vaccine live (Oka/Merck).
Danish: Varicella forårsaget af vaccinestamme er set ved brug af levende varicellavaccine (Oka/Merck) efter markedsføring.
English: Ear and labyrinth disorders Ear pain
Danish: Øre og labyrint Ørepine
English: • Newborn infants of mothers who have either not had chickenpox or have not been vaccinated against chickenpox.
Danish: • Nyfødte børn af mødre, som ikke har haft skoldkopper eller ikke er vaccineret mod sygdommen.
English: Vaccine recipients should avoid use of salicylates for 6 weeks after vaccination with ProQuad as Reye syndrome has been reported following the use of salicylates during wild-type varicella infection.
Danish: Personer, der vaccineres med ProQuad, bør undgå salicylater i 6 uger efter vaccination, da der er forekommet Reyes syndrom efter brug af salicylater under en naturligt forekommende skoldkoppeinfektion.
English: Studies have not been conducted with ProQuad in pregnant women.
Danish: Der foreligger ingen studier af ProQuad til gravide kvinder.
English: • Not known (frequency cannot be estimated from the available data): unusual bleeding or bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); inflammation of the brain (encephalitis); inflammation of the coverings of the brain and spinal cord not caused by bacterial infection (aseptic meningitis), severe skin disorders; stroke; seizures without a fever; joint pain and/or swelling (which could be transient or chronic); and inflammation of the lung (pneumonia/pneumonitis).
Danish: • Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): usædvanlig blødning eller blå mærker under huden; hævelse af testikler; prikken i huden, herpes zoster (helvedesild); hjernebetændelse (encephalitis); betændelse i de hinder, der omgiver hjernen og rygmarven, som ikke er forårsaget af en bakteriel infektion (aseptisk meningitis); svære hudreaktioner; slagtilfælde; kramper uden feber; ledsmerter og/eller hævelse (forbigående eller kronisk) og lungebetændelse (pneumoni/pneumonitis).
English: • immunocompromised individuals (see section 4.3),
Danish: Immunkompromitterede personer (se pkt.
English: • Pregnant women who have either not had chickenpox or have not been vaccinated against chickenpox.
Danish: • Gravide, som ikke har haft skoldkopper eller ikke er vaccineret mod sygdommen.
English: Ear infection, Gastroenteritis, Nasopharyngitis, Otitis media, Pharyngitis, Roseola, Viral infection, Viral rash
Danish: Øreinfektioner, gastroenteritis, nasopharyngitis, otitis media, pharyngitis, roseola, virusinfektion, virusudslæt
English: In addition, individuals who experienced thrombocytopenia following the first dose of a live measles, mumps, and rubella vaccine may develop thrombocytopenia with repeat doses.
Danish: Endvidere vil personer, som fik trombocytopeni efter første dosis af en levende MFR-vaccine, kunne få trombocytopeni ved efterfølgende doser.
English: At least one month must elapse between the first and second dose of any live viral attenuated vaccine.
Danish: Der skal forløbe mindst én måned mellem den første og den anden dosis af en levende, svækket virusvaccine inklusive ProQuad.
English: The immunogenicity and safety of ProQuad were evaluated in a clinical trial involving 799 subjects 4 through 6 years of age who had received Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. at least 1 month prior to study entry.
Danish: Immungenicitet og sikkerhed for ProQuad blev vurderet i et klinisk studie med 799 deltagere på 4-6 år, som havde fået levende skoldkoppevaccine (Oka/Merck) og MFR-vaccinen fremstillet af Merck & Co., Inc. mindst 1 måned, før de blev indlemmet i studiet.
English: Monosodium glutamate Sodium phosphate
Danish: Mononatriumglutamat Natriumphosphat
English: Ataxia, Convulsion, Headache, High-pitched crying, Hyperkinesia, Hypersomnia, Lethargy, Tremor
Danish: Ataksi, kramper, hovedpine, højlydt gråd, hyperkinesi, hypersomni, letargi, tremor
English: In a second long-term surveillance study, five cross-sectional surveys on varicella incidence, each from a random sample of approximately 8,000 children and adolescents 5 to 19 years of age, were conducted over 15 years, from 1995 (pre-vaccine) through 2009.
Danish: I et andet langvarigt overvågningsstudie blev der over 15 år udført fem krydssektionelle undersøgelser af forekomsten af varicella, hver fra en stikprøve på ca. 8.000 børn og unge mellem 5 og 19 år, fra
English: Varicella (titre ≥5 gp ELISA units/mL)
Danish: Skoldkop per (titer ≥5 gp ELISA enh./ml)
English: Consistent with clinical study data on the timing of fever and measles-like rash, a post-marketing observational study in children 12 to 60 months of age revealed an approximate two-fold increase (0.70 per 1000 vs. 0.32 per 1000 children) in the risk of febrile seizures in the 5- to 12-day timeframe after a first dose of ProQuad (N=31,298) compared with concomitant administration of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck) (N=31,298).These data suggest one additional case of febrile seizure per 2600 children vaccinated with ProQuad compared with separate administration of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., and the Varicella Vaccine live (Oka/Merck).
Danish: I overensstemmelse med data fra kliniske studier vedrørende tidspunktet for feber og mæslingelignende udslæt, har en analyse af et post-marketing sikkerhedsovervågningsstudie hos børn i alderen 12 til 60 måneder vist en omtrentlig fordobling (0,70 pr. 1000 vs. 0,32 pr. 1000 børn) af risikoen for at få feberkrampe i perioden 5 til 12 dage efter vaccination med den første dosis ProQuad (N=31.298), sammenlignet med samtidig vaccination af mæslinge-, fåresyge- og rubellavaccinen fremstillet af Merck & Co., Inc., og den levende varicellavaccine (Oka/Merck) (N=31.298).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG INDGIVELSESVEJ(E)
English: • A side effect after vaccination with measles, mumps, or rubella (in a single vaccine or combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or ProQuad) that involved easy bruising or bleeding for longer than usual.
Danish: • Har oplevet en bivirkning efter vaccination mod mæslinger, fåresyge eller røde hunde (som enkeltvacciner eller en kombineret vaccine såsom MFR-vaccinen fremstillet af Merck & Co., Inc. eller ProQuad), som bevirkede, at barnet let fik blå mærker eller blødte længere end sædvanligt.
English: Keep the vial of powder in the outer carton to protect from light.
Danish: Opbevar hætteglasset med pulver i den ydre karton for at beskytte mod lys.
English: It is preferred that the second dose be administered within three months following the first dose.
Danish: Den anden dosis af ProQuad eller en monovalent skoldkoppevaccine skal helst administreres inden for tre måneder efter den første dosis.
English: ProQuad may be used as the second dose in individuals who have previously received measles, mumps, and rubella vaccine and varicella vaccine.
Danish: ProQuad kan anvendes som anden dosis til personer, som tidligere er vaccineret mod mæslinger, fåresyge, røde hunde og skoldkopper.
English: In addition, cases of thrombocytopenia have been reported after primary vaccination or revaccination with measles vaccine; measles, mumps, and rubella vaccine; and varicella vaccine.
Danish: Endvidere er der indberettet tilfælde af trombocytopeni efter primær vaccination eller revaccination med vaccine mod mæslinger, med vaccine mod mæslinger, fåresyge og røde hunde samt med vaccine mod skoldkopper.
English: There is no evidence that varicella vaccine virus is excreted in breast milk.
Danish: Det er ikke påvist, at skoldkoppevirus fra vaccine udskilles i mælk.
English: After reconstitution, 1 dose (0.5 ml) contains (live, attenuated):
Danish: Efter rekonstitution indeholder 1 dosis (0,5 ml), (levende, svækket):
English: No clinical data are available for ProQuad administered after exposure to measles, mumps, rubella, or varicella.
Danish: Der foreligger ingen kliniske data om ProQuad administreret efter eksposition for mæslinger, fåresyge, røde hunde eller skoldkopper.
English: ProQuad powder for suspension for injection
Danish: ProQuad pulver til injektionsvæske, suspension
English: These patients should be monitored carefully for signs of measles, parotitis, rubella, and varicella.
Danish: Disse patienter skal monitoreres nøje for tegn på mæslinger, fåresyge, røde hunde og skoldkopper.
English: Other medicines and ProQuad
Danish: Brug af anden medicin sammen med ProQuad
English: The most common adverse events reported with the use of ProQuad were: injection-site reactions including pain/tenderness/soreness, redness, swelling or bruising; fever (≥39.4°C rectal equivalent); irritability; rash (including measles-like rash, varicella-like rash, and injection-site rash); upper respiratory infection; vomiting and diarrhoea.
Danish: De hyppigst rapporterede bivirkninger i forbindelse med brug af ProQuad var symptomer ved injektionsstedet inklusive smerte/ømhed, rødme, hævelse eller blå mærker; feber (≥39,4 C rektalt eller tilsvarende); irritabilitet; udslæt (inklusive mæslingelignende udslæt, skoldkoppelignende udslæt og udslæt ved injektionsstedet); øvre luftvejsinfektion, opkastninger samt diaré.
English: ProQuad is given to help protect your child against measles, mumps, rubella, and varicella (chickenpox).
Danish: ProQuad gives for at beskytte dit barn mod mæslinger, fåresyge, røde hunde og skoldkopper.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter rekonstitution af lægemidlet er anført under pkt.
English: 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.
Danish: Imidlertid er effekten af levende skoldkoppevaccine (Oka/Merck) og af MFR-vaccinen fremstillet af Merck & Co., Inc. påvist i en række studier.
English: Bronchiolitis, Candida nappy rash, Candidiasis, Cellulitis, Infectious croup, Viral gastroenteritis, Hand-foot-mouth disease, Influenza, Pseudocroup, Respiratory infection, Skin infection, Tonsillitis, Varicella
Danish: Bronchiolitis, candida bleudslæt, candidiasis, cellulitis, infektiøs strubehoste, viral gastroenteritis, hånd-fod-mund sygdom, influenza, falsk strubehoste, luftvejsinfektion, hudinfektion, tonsillitis, skoldkopper
English: Vaccine recipients should attempt to avoid, whenever possible, close association with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination.
Danish: Vaccinerecipienter skal i op til 6 uger efter vaccinationen så vidt muligt forsøge at undgå tæt omgang med modtagelige individer i højrisikogruppen.
English: Cases of aseptic meningitis have been reported following measles, mumps, and rubella vaccination.
Danish: Der er indberettet tilfælde af aseptisk meningitis efter MFR-vaccination.
English: ProQuad with Solvent for reconstitution supplied in a Pre-filled syringe:
Danish: ProQuad med solvens til rekonstitution leveret i forfyldt injektionssprøjte:
English: Atypical measles, Encephalitis*, Epididymitis, Herpes zoster*, Infection, Measles, Orchitis, Parotitis
Danish: Aseptisk meningitis*, atypisk mæslingeinfektion, encephalitis*, epididymitis, herpes zoster*, infektion, mæslinger, orchitis, fåresyge
English: Clinical studies have demonstrated that ProQuad can be given simultaneously (but at separate injection sites) with Prevenar and/or hepatitis A vaccine, or with monovalent or combination vaccines comprised of diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B antigen.
Danish: Kliniske studier har vist, at ProQuad kan gives samtidig (men på forskellige injektionssteder) med følgende vacciner: Prevenar og/eller hepatitis A vaccine eller med monovalent eller kombineret vacciner med indhold af antigen mod difteri, tetanus, kighoste (acellulær), Haemophilus influenzae type b, polio (inaktiveret) eller hepatitis B. I disse kliniske studier blev det påvist, at immunresponset var upåvirket.
English: Skin and subcutaneous tissue disorders Measles-like rash
Danish: Hud og subkutane væv Mæslingelignende udslæt
English: Post-marketing experience with live measles, mumps, and rubella vaccine indicates that individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination.
Danish: Efter markedsføring tyder erfaringer med levende vaccine mod mæslinger, fåresyge og røde hunde (MFR-vaccine) på, at personer, som lider af trombocytopeni, vil kunne opleve en forværring af denne lidelse efter vaccinationen.
English: Acne, Clammy skin, Exfoliative dermatitis, Drug eruption, Exanthema, Henoch-Schönlein purpura, Livedo reticularis, Papular rash, Pruritus, Skin discolouration, Skin lesion, Zosteriform rash
Danish: Akne, klam hud, exfoliativ dermatitis, drug eruption, exanthem, Henoch-Schönleins purpura, livedo reticularis, papulært udslæt, pruritus, misfarvning af hud, hudlæsion, zoster-lignende udslæt
English: ‡, Urticaria, Viral exanthema, Eczema, Erythema
Danish: ‡, urticaria, viralt exanthem,
English: Persistence of Immune Response
Danish: Vedvarende immunrespons
English: In addition to assessing the incidence of febrile seizures occurring within 30 days after the first dose (see section 4.8), the study also assessed the general safety of ProQuad in the 30-day period after the first or second dose.
Danish: 4.8), havde studiet også til formål at undersøge den generelle sikkerhed af ProQuad i perioden 30 dage efter første eller anden dosis.
English: Based on isolated case reports from post-marketing surveillance for Varicella Vaccine live (Oka/Merck), the possibility exists that varicella vaccine virus may rarely be transmitted to contacts of recipients of ProQuad who develop or do not develop a varicella-like rash (see section 4.4).
Danish: Baseret på enkeltstående rapporter fra post-marketing overvågningen af levende varicellavaccine (Oka/Merck), kan varicellavirus fra vaccinen sjældne gange overføres til personer i kontakt med modtagere af ProQuad, uanset om de fik skoldkoppelignende udslæt eller ej efter vaccination (se pkt.
English: b. Tabulated list of adverse reactions
Danish: b. Oversigt over bivirkninger i tabelform
English: The risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad in such cases (see section 4.8).
Danish: I sådanne tilfælde bør det potentielle risk/benefit-forhold vurderes nøje før eventuel vaccination med ProQuad (se pkt.
English: ProQuad can be given at the same time as other childhood vaccines such as Prevenar, and/or hepatitis A vaccine, or with vaccines containing diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B. A different place for the injection will be used for each vaccine.
Danish: ProQuad kan gives samtidigt med andre børnevacciner som Prevenar og/ eller hepatitis A vaccine, eller vacciner mod difteri, stivkrampe, kighoste (acellulær), Haemophilus influenzae type b, polio (inaktiveret) eller hepatitis B. Vaccinerne skal gives på forskellige injektionssteder.
English: Post-marketing experience with Varicella Vaccine live (Oka/Merck) suggests that transmission of varicella vaccine virus may rarely occur between healthy vaccine recipients (who develop or do not develop a varicella-like rash) and contacts susceptible to varicella, as well as high-risk individuals susceptible to varicella (see section 4.8).
Danish: Erfaringer med levende skoldkoppevaccine (Oka/Merck) efter markedsføring tyder på, at transmission af skoldkopper fra vaccine kan forekomme i sjældne tilfælde mellem raske vaccinemodtagere, (uanset om de udvikler skoldkoppelignende udslæt eller ej), og kontakter, der er modtagelige over for skoldkopper, samt individer i højrisikogruppen, som er modtagelige over for skoldkopper (se pkt.
English: What you need to know before you receive ProQuad
Danish: Det skal du vide, før du eller dit barn får ProQuad
English: Other side effects have been reported with the use of at least one of the following: ProQuad, previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck & Co., Inc., or Varicella Vaccine live (Oka/Merck).
Danish: Andre bivirkninger rapporteret med brug af mindst en af følgende: ProQuad, tidligere formuleringer af monovalent og af de kombinerede mæslinge-, fåresyge- og røde hundevacciner produceret af Merck & Co., Inc., eller levende skoldkoppevaccine (Oka/Merck).
English: The vaccine contains 16 mg of sorbitol.
Danish: Indholdsstoffer, som behandleren skal være opmærksom på Vaccinen indeholder 16 mg sorbitol.
English: CD4+ T-lymphocyte percentage in children below 12 months: CD4+ <25%, children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see sections 4.4 and 4.8).
Danish: Svær humoral eller cellulær (primær eller erhvervet) immundefekt, f.eks. svær kombineret immundefekt, agammaglobulinæmi og AIDS, eller symptomatisk hiv-infektion, eller en aldersspecifik CD4+ T-lymfocytprocent hos børn under 12 måneder: CD4+ <25 %; børn mellem 12-35 måneder: CD4+< 20 %; børn mellem 36-59 måneder: DC4+<15 % (se pkt.
English: The only vaccine-related systemic adverse reactions reported at a significantly greater rate in individuals who received the earlier formulation of ProQuad compared to individuals who received the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella Vaccine live (Oka/Merck) were fever (≥39.4°C rectal equivalent or abnormal) and measles-like rash.
Danish: De eneste vaccinerelaterede systemiske bivirkninger, som optrådte signifikant hyppigere hos personer, som fik den tidligere formulering af ProQuad, sammenlignet med personer som fik MFR-vaccinen fremstillet af Merck & Co., Inc. og Varicella Vaccine Live (Oka/Merck), var feber (≥39,4 C rektalt eller febril) og mæslingelignende udslæt.
English: 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.
Danish: Immungenicitet er undersøgt hos børn mellem 12-23 måneder uden anamnestiske mæslinger, fåresyge, røde hunde og skoldkopper, som deltog i 5 randomiserede kliniske studier.
English: Hydrolysed gelatin
Danish: Hydrolyseret gelatine Natriumchlorid
English: ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles; see sections 4.2, 4.4, and 5.1).
Danish: ProQuad kan gives til personer fra 9-måneders alderen under særlige omstændigheder (fx i overensstemmelse med nationale vaccinationsprogrammer, udbrudssituationer eller ved rejse til et område med høj forekomst af mæslinger, se pkt.
English: This leaflet was last revised in:
Danish: Denne indlægsseddel blev senest ændret {dato}
English: The only vaccine related injection-site adverse reaction that was more frequent among recipients of ProQuad than among recipients of Varicella Vaccine live (Oka/Merck) and the measles, mumps, and rubella vaccine manufactured by Merck & Co. Inc. was rash at the injection site.
Danish: Den eneste vaccinerelaterede bivirkning, som forekom hyppigere blandt recipienter af ProQuad end blandt recipienter af Varicella Vaccine live (Oka/Merck) og MFR-vaccinen fremstillet af Merck & Co., Inc., var udslæt ved injektionsstedet.
English: dpoc_belux@merck.com
Danish: malta_info@merck.com
English: • Common (may affect up to 1 in 10 people): injection site complaints including swelling or bruising; irritability; rash (including measles-like rash, varicella-like rash, and injection-site rash); upper respiratory infection; vomiting and diarrhoea.
Danish: • Almindelige (kan forekomme hos op til 1 ud af 10 personer): symptomer ved injektionsstedet inklusive hævelse eller blå mærker; irritabilitet; udslæt (inklusive mæslingelignende udslæt, skoldkoppelignende udslæt og udslæt ved injektionsstedet); øvre luftvejsinfektion, opkastninger samt diaré.