FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data to support the use of PRIORIX with any other vaccines.
Danish: Der er ingen data, der understøtter anvendelse af PRIORIX samtidigt med andre vacciner.
English: Your doctor may delay vaccination for at least 3 months if you or your child has received a blood transfusion or human antibodies (immunoglobulins).
Danish: Lægen kan udsætte vaccinationen i mindst 3 måneder, hvis du eller dit barn har fået en blodtransfusion eller humane antistoffer (immunglobuliner).
English: A known contact dermatitis (skin rash when the skin is in direct contact with allergens such as neomycin) should not be a problem but talk to your doctor first;
Danish: Kontakteksem (udslæt, når huden kommer i direkte kontakt med allergener som neomycin) bør ikke være et problem, men tal med lægen først.
English: Contacts with disinfectants should be avoided (see section 4.4).
Danish: Kontakt med desinficerende midler skal undgås (se pkt.
English: • if you or your child has ever had a severe allergic reaction to egg protein.
Danish: • du eller dit barn nogen sinde har haft en alvorlig allergisk reaktion over for æggeprotein.
English: The risk of encephalitis following administration of the vaccine is far below the risk of encephalitis caused by natural diseases (measles: 1 in 1000 to 2000 cases; mumps: 2-4 in 1000 cases; rubella: approximately 1 in 6000 cases).
Danish: Risikoen for encefalitis efter vaccination er langt mindre end risikoen for encefalitis forårsaget af naturlige sygdomme (mæslinger: 1 ud af 1.000-2.000 tilfælde; fåresyge: 2-4 ud af 1.000 tilfælde; røde hunde: ca. 1 ud af 6.000 tilfælde).
English: Only in the event the child is confirmed or suspected to be immunodeficient, risks and benefits of vaccinating the mother should be evaluated (see section 4.3).
Danish: Kun hvis barnet har en dokumenteret eller mistænkt immundefekt, skal risici og fordele ved vaccination af moderen vurderes (se pkt.
English: Note: This SmPC, labelling and packages leaflet is the version valid at the time of Commission decision.
Danish: NB: Følgende produktresumé, etikettering og indlægsseddel er den gyldige version på det tidspunkt, hvor Kommissionen traf beslutningen.
English: • sudden life-threatening allergic reaction
Danish: • pludselig, livstruende allergisk reaktion
English: Individuals 12 months of age or older The dose is 0.5 ml.
Danish: Personer i alderen 12 måneder og derover Dosis er 0,5 ml.
English: However, some field studies report that the effectiveness against mumps may be lower than the observed seroconversion rates to mumps.
Danish: I nogle feltstudier er det imidlertid set, at effekten mod fåresyge kan være lavere end de observerede serokonverteringsrater for fåresyge.
English: Under no circumstances should the interval between doses be less than four weeks (see sections 4.4 and 5.1).
Danish: Intervallet mellem de to vaccinationer må under ingen omstændigheder være mindre end 4 uger (se pkt.
English: As with other vaccines, the administration of PRIORIX should be postponed in subjects suffering from acute severe febrile illness.
Danish: I lighed med andre vacciner skal vaccination med PRIORIX udsættes hos personer med akut alvorlig febril sygdom.
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 you are given this vaccine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apoteket til råds, før du får Priorix.
English: For hypersensitivity reactions to egg proteins, see section 4.4.
Danish: Ved overfølsomhed over for æggeproteiner, se pkt.
English: Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles.
Danish: Der kan opnås begrænset beskyttelse mod mæslinger ved vaccination inden for 72 timer efter eksponering for naturligt forekommende mæslingevirus.
English: Therefore, this SmPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Følgende produktresumé, etikettering og indlægsseddel repæsenterer derfor ikke nødvendigvis den gældende tekst.
English: Women who intend to become pregnant should be advised to delay for 1 month following PRIORIX vaccination.
Danish: Kvinder, der planlægger at blive gravide, skal tilrådes at udsætte graviditeten til 1 måned efter vaccination med PRIORIX.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION To be completed nationally
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Udfyldes nationalt]
English: When a person is vaccinated with Priorix, the immune system (the body's natural defence system) will make antibodies to protect the person from being infected by measles, mumps and rubella viruses.
Danish: Når en person vaccineres med Priorix, vil immunforsvaret (kroppens naturlige forsvarssystem) danne antistoffer for at beskytte personen mod at blive inficeret med mæslinge-, fåresyge- og røde hundevirus.
English: The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Danish: En lettere infektion, f.eks. forkølelse, bør ikke medføre udsættelse af vaccinationen.
English: Although women should be asked about the possibility of early pregnancy prior to vaccination, screening tests to exclude pregnancy are not required.
Danish: Selvom kvinder skal spørges om muligheden for tidlig graviditet før vaccination, er det ikke påkrævet at udføre en graviditetstest for at udelukke graviditet.
English: In case of high fever following vaccination please consult your doctor promptly;
Danish: Hvis der opstår høj feber efter vaccinationen, skal du straks kontakte lægen.
English: • if you or your child has a severe infection with a high temperature.
Danish: • hvis du eller dit barn har en alvorlig infektion med høj feber.
English: • bronchitis
Danish: • bronkitis
English: Post-marketing data
Danish: Data fra efter markedsføring
English: The vaccine should never be given into a vein.
Danish: Vaccinen må aldrig indsprøjtes i en blodåre.
English: Children below 12 months of age
Danish: Børn under 12 måneder
English: These patients should be vaccinated with caution and preferably using subcutaneous route.
Danish: Disse personer skal vaccineres med forsigtighed og fortrinsvis ved subkutan administration.
English: WITH 2 SEPARATE NEEDLES: PACK OF 1, 10, 25, 100 WITHOUT NEEDLE: PACK OF 1, 10, 20, 25, 40, 100
Danish: MED 2 SEPARATE KANYLER: PAKNINGER MED 1, 10, 25, 100 STK. UDEN KANYLER: PAKNINGER MED 1, 10, 20, 25, 40, 100 STK.
English: • allergic reactions
Danish: • allergiske reaktioner.
English: Other medicines and Priorix
Danish: Brug af anden medicin sammen med Priorix
English: After the addition of the solvent to the powder, the mixture should be well shaken until the powder is completely dissolved in the solvent.
Danish: Når solvens er tilsat pulveret, skal blandingen omrystes godt, indtil pulveret er fuldstændigt opløst.
English: The use of PRIORIX should be based on official recommendations.
Danish: Dosering PRIORIX skal anvendes på basis af officielle retningslinjer.
English: In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for three months or longer (up to 11 months) depending on the dose of human globulins administered because of the likelihood of vaccine failure due to passively acquired measles, mumps and rubella antibodies.
Danish: Vaccination af personer, som har fået humane gammaglobuliner eller blodtransfusioner, skal udsættes i 3 måneder eller mere (op til 11 måneder) afhængigt af dosis af humane globuliner, på grund af risikoen for vaccinesvigt som følge af passiv overførsel af mæslinge-, fåresyge- og rubella-antistoffer.
English: Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine.
Danish: Alkohol og andre desinficerende midler skal være fordampet fra huden, inden vaccinen injiceres, da disse kan inaktivere de svækkede virus i vaccinen.
English: • if you or your child is known to be allergic to neomycin (an antibiotic agent).
Danish: • hvis du eller dit barn er allergisk over for neomycin (et antibiotikum).
English: A minor infection such as a cold should not be a problem, but talk to your doctor first;
Danish: En lettere infektion som forkølelse er normalt ikke noget problem, men tal med lægen først.
English: - This vaccine has been prescribed for you only.
Danish: - Lægen har ordineret denne vaccine til dig personligt.
English: How Priorix is given
Danish: Sådan gives Priorix
English: Pharyngeal excretion of the rubella and measles virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day.
Danish: Faryngeal udskillelse af rubella- og mæslingevirus forekommer omkring 7 til 28 dage efter vaccination med maksimal udskillelse omkring dag 11.
English: During post-marketing surveillance, the following adverse reactions have been reported additionally following PRIORIX vaccination.
Danish: Ved overvågning efter markedsføring er der yderligere indberettet nedenstående bivirkninger efter vaccination med PRIORIX.
English: • if you or your child has any illness or takes any medicine that weakens the immune system such as Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
Danish: • hvis du eller dit barn har en sygdom eller tager medicin, der nedsætter immunforsvaret, f.eks. humant immundefektvirus (hiv) eller erhvervet immundefektsyndrom (aids).
English: The vaccine must be reconstituted by adding the entire contents of the supplied container of solvent to the vial containing the powder.
Danish: Vaccinen skal rekonstitueres ved at tilsætte al den medfølgende solvens til hætteglasset med pulver.
English: For instructions on reconstitution of the medicinal product before administration see section 6.6.
Danish: Instruktioner om rekonstitution af lægemidlet før administration, se pkt.
English: General disorders and administration site conditions: Kawasaki syndrome
Danish: Almene symptomer og reaktioner på administrationsstedet: Kawasakis syndrom
English: Skin and subcutaneous tissue disorders: Erythema multiforme
Danish: Hud og subkutane væv: Erythema multiforme
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Danish: Som ved anvendelse af alle injicerbare vacciner skal passende medicinsk behandling og overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion efter administration af vaccinen.
English: Due to minor variation of its pH, the reconstituted vaccine may vary in colour from clear peach to fuchsia pink without deterioration of the vaccine potency.
Danish: Som følge af små variationer i pH-værdien kan farven på den rekonstituerede vaccine variere fra klar ferskenfarvet til fuchsia-lyserød.
English: Priorix is injected under the skinor into the muscle.
Danish: Priorix indsprøjtes under huden eller i en muskel.
English: However there is no evidence of transmission of these excreted vaccine viruses to susceptible contacts.
Danish: Der er dog ingen evidens for overførsel af de udskilte vaccinevirus til modtagelige kontakter.
English: If tuberculin testing has to be done it should be carried out before or simultaneously with vaccination since it has been reported that combined measles, mumps and rubella vaccines may cause a temporary depression of tuberculin skin sensitivity.
Danish: Hvis der skal laves tuberkulintest, skal den udføres før eller samtidigt med vaccination, da det er blevet rapporteret, at kombineret mæslinge-fåresyge-røde hunde-vaccine kan forårsage en midlertidig nedsættelse af sensitiviteten for tuberkulin i huden.
English: Due caution should be employed in administration of PRIORIX to individuals with Central Nervous System (CNS) disorder, susceptibility to febrile convulsions or family history of convulsions.
Danish: Der skal udvises passende forsigtighed ved administration af PRIORIX til personer, som har forstyrrelser i centralnervesystemet (CNS-forstyrrelser), er disponeret for feberkramper eller har en familiær anamnese med kramper.
English: PRIORIX is for subcutaneous injection, although it can also be given by intramuscular injection.
Danish: PRIORIX gives normalt som subkutan injektion, men kan også gives som intramuskulær injektion (se pkt.
English: Side effects that occurred during clinical trials with Priorix were as follows:
Danish: Der er set følgende bivirkninger i kliniske studier med Priorix:
English: The vaccine should be injected promptly after reconstitution.
Danish: Denne vaccine skal injiceres straks efter rekonstitution.
English: Immune response in children aged 9 to 10 months
Danish: Immunrespons hos børn i alderen 9-10 måneder
English: The vaccine should preferably be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder (see section 4.4).
Danish: Vaccinen skal fortrinsvis administreres subkutant hos patienter med trombocytopeni eller andre koagulationsforstyrrelser (se pkt.
English: The injections should be given at separate injection sites.
Danish: Injektionerne skal gives forskellige steder på kroppen.
English: Seroconversion rates for measles, mumps and rubella were 92.6%, 91.5% and 100%, respectively.
Danish: Serokonverteringsraterne for mæslinger, fåresyge og røde hunde var henholdsvis 92,6 %, 91,5 % og 100 %.
English: If this is not possible, it must be stored in the refrigerator (2C - 8C) and used within 8 hours of reconstitution.
Danish: Hvis dette ikke er muligt, skal den opbevares i køleskab (2 C-8 C) og bruges inden for 8 timer efter rekonstitution.
English: Whether you or your child receives the vaccine will depend upon the level of your immune defenses.
Danish: Hvorvidt du eller dit barn kan vaccineres afhænger af, hvor godt dit eget eller dit barns immunforsvar er.
English: The safety profile presented below is based on a total of approximately 12,000 subjects administered PRIORIX in clinical trials.
Danish: Sikkerhedsprofilen, som er vist nedenfor, er baseret på data fra kliniske studier, hvor i alt ca. 12.000 personer er blevet vaccineret med PRIORIX.
English: • if you or your child has had a side effect after vaccination against measles, mumps or rubella that involved easy bruising or bleeding for longer than usual (see section 4).
Danish: • du eller dit barn har haft en bivirkning efter vaccination mod mæslinger, fåresyge eller røde hunde, som gav sig udslag i, at der hurtigt kom blå mærker, eller at du eller dit barn blødte i længere tid end normalt (se punkt 4).
English: Although Priorix contains live viruses, they are too weak to cause measles, mumps or rubella in healthy people.
Danish: Selvom Priorix indeholder levende virus, er de for svage til at give raske mennesker mæslinger, fåresyge eller røde hunde.
English: The most common adverse reactions following PRIORIX administration were injection site redness and fever 38°C (rectal) or 37.5°C (axillary/oral).
Danish: De hyppigste bivirkninger efter administration af PRIORIX var rødme på injektionsstedet og feber  38 °C (rektalt) eller  37,5 °C (aksillært/oralt).
English: Studies have shown that breastfeeding postpartum women vaccinated with live attenuated rubella vaccines may secrete the virus in breast milk and transmit it to breast-fed infants without evidence of any symptomatic disease.
Danish: Studier har vist, at ammende postpartum kvinder, som vaccineres med levende svækkede røde hunde-vacciner, kan udskille virus i mælken og overføre det til ammede spædbørn dog uden evidens for, at disse får symptomgivende sygdom.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue;
Danish: Symptomer på en allergisk reaktion kan være kløende udslæt, åndenød og hævet ansigt eller tunge.
English: In the event of either being observed, discard the solvent or reconstituted vaccine.
Danish: Hvis nogen af delene observeres, skal solvens eller den rekonstituerede vaccine kasseres.
English: Infants in their first year of life may not respond sufficiently to the components of the vaccine, due to the possible interference with maternal antibodies (see sections 4.2 and 5.1).
Danish: Spædbørn i deres første leveår responderer muligvis ikke tilstrækkeligt på vaccinernes komponenter på grund af den mulige interferens med antistoffer fra moderen (se pkt.
English: After the marketing of Priorix, the following additional side effects have been reported on a few occasions:
Danish: Efter markedsføring af Priorix er der yderligere set få tilfælde af følgende bivirkninger:
English: • if you or your child has a weakened immune defenses (e.g. because of an HIV infection.
Danish: • du eller dit barn har nedsat immunforsvar (f.eks. på grund af en hiv-infektion).
English: The seroconversion rates reported following the second dose given 3 months after the first dose were 100% for measles and 99.2% for mumps.
Danish: Serokonverteringsraterne rapporteret efter den anden dosis, som blev givet 3 måneder efter den første dosis, var 100 % for mæslinger og 99,2 % for fåresyge.
English: • if you or your child is allergic against any of the components of this vaccine (listed in section 6).
Danish: • hvis du eller dit barn er allergisk over for de aktive stoffer eller et af de øvrige indholdsstoffer i vaccinen (angivet i punkt 6).
English: If this is not possible, it must be stored at 2°C - 8°C and used within 8 hours of reconstitution.
Danish: Hvis dette ikke er muligt, skal den opbevares ved temperaturer på 2 °C-8 °C og bruges inden for 8 timer efter rekonstitution.
English: PRIORIX can be given simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), Meningococcal serotype C conjugated vaccine (MenC), varicella zoster vaccine (VZV), oral polio vaccine (OPV) and 10-valent pneumococcal conjugate vaccine in accordance with local recommendations.
Danish: PRIORIX kan gives samtidigt (men på forskellige injektionssteder) med følgende monovalente vacciner eller kombinationsvacciner (herunder hexavalente vacciner [DTPa-HBV-IPV/Hib]): difteritetanus-acellulær pertussis-vaccine (DTPa), Haemophilus influenzae type b-vaccine (Hib), inaktiveret poliovaccine (IPV), hepatitis B-vaccine (HBV), hepatitis A-vaccine (HAV), meningokok serotype Ckonjugeret vaccine (MenC), varicella zoster-vaccine (VZV), oral poliovaccine (OPV) og 10-valent pneumokok-konjugeret vaccine i overensstemmelse med de lokale retningslinjer.
English: (see sections 4.4 and 5.1).
Danish: 4.4 og 5.1).
English: As with all vaccines, Priorix may not fully protect all people who are vaccinated.
Danish: I lighed med andre vacciner giver Priorix ikke nødvendigvis alle vaccinerede personer fuld beskyttelse.
English: Vaccinees with a history of febrile convulsions should be closely followed-up.
Danish: Vaccinerede personer med feberkramper i anamnesen skal følges nøje.
English: INFORMATION IN BRAILLE To be completed nationally
Danish: INFORMATION I BRAILLE-SKRIFT [Udfyldes nationalt]
English: DATE OF REVISION OF THE TEXT To be completed nationally
Danish: DATO FOR ÆNDRING AF TEKSTEN [Udfyldes nationalt]
English: Individuals who have experienced anaphylaxis after egg ingestion should be vaccinated with extreme caution, with adequate treatment for anaphylaxis on hand should such a reaction occur.
Danish: Personer, der har udvist anafylaksi efter indtagelse af æg, skal vaccineres med yderste forsigtighed, og passende behandling af anafylaksi skal være let tilgængelig i tilfælde af, at en sådan reaktion skulle opstå.
English: Do not use this vaccine after the expiry date which is stated on the carton after EXP. After reconstitution, the vaccine should be administered promptly.
Danish: Brug ikke denne vaccine efter den udløbsdato, der står på pakningen efter EXP.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Danish: I lighed med andre vacciner fremkaldes der ikke nødvendigvis en beskyttende immunrespons hos alle vaccinerede personer.
English: This leaflet was last revised in {MM/YYYY} To be completed nationally
Danish: Denne indlægsseddel blev senest revideret {MM/ÅÅÅÅ} [Udfyldes nationalt]
English: Adverse reactions which might occur following the use of a combined mumps, measles, rubella vaccine correspond to those observed after administration of the monovalent vaccines alone or in combination.
Danish: De bivirkninger, der kan forekomme efter administration af mæslinge-fåresyge-røde hundekombinationsvaccine, svarer til de bivirkninger, der er observeret efter administration af de monovalente vacciner alene eller i kombination.
English: Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented.
Danish: Transmission af mæslinge- og fåresygevirus fra vaccinerede personer til modtagelige kontakter er aldrig blevet dokumenteret.
English: Transmission of the rubella vaccine virus to infants via breast milk as well as transplacental transmission has been documented without any evidence of clinical disease.
Danish: Overførsel af rubellavirus til spædbørn både via brystmælk og gennem placentabarrieren er blevet dokumenteret, dog uden tegn på klinisk sygdom.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose (0.5 ml) To be completed nationally
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 dosis (0,5 ml) [Udfyldes nationalt]
English: Humoral or cellular immune deficiency (primary or acquired), including hypogammaglobulinaemia, dysgammaglobulinaemia and AIDS or symptomatic HIV infection or an age-specific CD4+ Tlymphocyte percentage in children below 12 months: CD4+ <25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4).
Danish: Symptomgivende hiv-infektion eller en aldersspecifik CD4+ Tlymfocytprocent hos børn under 12 måneder på < 25 %, hos børn mellem 12-35 måneder på < 20 % og hos børn mellem 36-59 måneder på < 15 % (se pkt.
English: • redness at the injection site
Danish: • rødme på injektionsstedet
English: • Priorix must not be administered to pregnant women.
Danish: • Priorix må ikke anvendes under graviditet.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING VIAL + AMPOULE, PACK OF 1, 10, 20, 25, 40, 100
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE HÆTTEGLAS + AMPUL, PAKNINGER MED 1, 10, 20, 25, 40, 100 STK.
English: Infants less than 9 months of age The safety and efficacy of PRIORIX in infants under 9 months of age has not been established.
Danish: Spædbørn under 9 måneder PRIORIX' sikkerhed og virkning hos spædbørn under 9 måneder er ikke fastlagt.
English: Blood and lymphatic system disorders: Thrombocytopenia, thrombocytopenic purpura
Danish: Blod og lymfesystem: Trombocytopeni, trombocytopenisk purpura
English: Priorix may be given at the same time you or your child receives other recommended vaccinations such as diphtheria, tetanus, pertussis, Haemophilus influenzae type b, oral or inactivated polio, hepatitis A and B, meningococcal serogroup C conjugate vaccines, varicella as well as 10-valent pneumococcal conjugate vaccine.
Danish: Priorix kan gives samtidigt med, at du eller dit barn får andre anbefalede vacciner, f.eks. difteri-, stivkrampe (tetanus)-, kighoste (acellulær pertussis)-, Haemophilus influenzae type b-, oral eller inaktiveret polio-, hepatitis A- og B-, meningokok serotype C-konjugeret vaccine, skoldkoppe (varicella)- og 10-valent pneumokok-konjugeret vaccine.
English: Infants between 9 and 12 months of age
Danish: Spædbørn i alderen mellem 9 og 12 måneder
English: In clinical studies in children aged from 12 months to 2 years PRIORIX has been demonstrated to be highly immunogenic.
Danish: Immunrespons hos børn i alderen 12 måneder og derover Kliniske studier har vist, at PRIORIX har høj immunogenicitet hos børn i alderen fra 12 måneder til 2 år.