FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine works by helping the body to make antibodies (the body's natural defences) which protect you or your child against this disease.
Danish: Vaccinen virker ved at hjælpe kroppen med at danne antistoffer (kroppens naturlige forsvar), som beskytter dig eller dit barn mod denne sygdom.
English: Do not use the vaccine if it cannot be re-suspended.
Danish: Vaccinen må ikke anvendes, hvis den ikke kan re-suspenderes.
English: Results from Groups 2 and 3 are not presented, as only 2 representative strains were evaluated.
Danish: Resultater fra gruppe 2 og 3 er ikke medtaget, da kun 2 repræsentative stammer blev evalueret.
English: Not known (cannot be estimated from available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: The vaccine contains two important components from the surface of the bacteria.
Danish: Vaccinen indeholder to vigtige bestanddele fra bakteriens overflade.
English: Individuals 10 years and older
Danish: Personer på 10 år og derover
English: • have had any problems after any dose of Trumenba such as an allergic reaction or problems with breathing.
Danish: • har haft problemer efter en dosis Trumenba, f.eks. en allergisk reaktion eller vejrtrækningsproblemer.
English: Serum was obtained approximately 1 month after vaccination.
Danish: Serum blev udtaget ca. 1 måned efter vaccination.
English: Trumenba should not be given: - if you or your child are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Danish: Trumenba må ikke gives: - hvis du eller dit barn er allergisk over for det aktive stof eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Danish: I tilfælde af overdosering anbefales det at overvåge vitale funktioner og muligvis give symptomatisk behandling.
English: Experience of overdose is limited.
Danish: Der er begrænset erfaring med overdosering.
English: Because this reaction was derived from spontaneous reports, the frequency could not be determined and is thus considered as not known.
Danish: Eftersom bivirkningen er indberettet spontant, kan hyppigheden ikke fastsættes og anses derfor som ikke kendt.
English: Fever ≥ 38 °C (Pyrexia)
Danish: Feber ≥ 38 °C (pyreksi)
English: Very common (≥ 1/10)
Danish: Meget almindelig (≥1/10)
English: Persistence of immunity and response to booster vaccination
Danish: Persistens af immunitet og respons på booster-vaccination
English: Of the 1,713 subjects randomised, 427 were in Group 1, 430 were in Group 2, 427 were in Group 3, 286 were in Group 4, and 143 were in Group 5.
Danish: Ud af de 1.713 randomiserede forsøgspersoner, var 427 i gruppe 1, 430 var i gruppe 2, 427 var i gruppe 3, 286 var i gruppe 4, og 143 var i gruppe 5.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Trumenba is given.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får Trumenba.
English: Fainting, feeling faint, or other stress-related reactions can occur as a response to any needle injection.
Danish: Besvimelse, mathed eller andre stressrelaterede reaktioner kan forekomme som reaktion på enhver indsprøjtning.
English: Your doctor may still recommend that you receive Trumenba if you are at risk of meningococcal disease.
Danish: Din læge vil måske stadig anbefale, at du får Trumenba, hvis du er i risiko for at få meningokoksygdom.
English: Nevertheless, vaccination should not be withheld when there is a clear risk of exposure to meningococcal infection.
Danish: Alligevel bør vaccination ikke undlades, hvis der er klar risiko for eksponering for meningokokinfektion.
English: Adverse reactions reported in clinical studies are listed in decreasing order of frequency and seriousness according to the following frequency categories:
Danish: Bivirkninger rapporteret i kliniske studier er anført efter faldende hyppighed og sværhedsgrad i henhold til følgende hyppighedsgrupper:
English: Not known (cannot be estimated from available data) - Allergic reactions
Danish: Hyppighed ikke kendt (kan ikke vurderes ud fra tilgængelige data) - Allergiske reaktioner
English: 60 micrograms
Danish: 60 mikrogram
English: The requirements for submission of periodic safety update repots for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
Danish: Denne vaccine kan som alle andre vacciner give bivirkninger, men ikke alle får bivirkninger.
English: Pharmacotherapeutic group: vaccines; ATC code: J07AH09
Danish: Farmakoterapeutisk klassifikation: vacciner, ATC-kode: J07AH09
English: Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Danish: Relevant medicinsk behandling og overvågning skal altid være umiddelbart tilgængelig i tilfælde af en anafylaktisk reaktion efter administration af vaccinen.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of repeated dose toxicity and reproduction and developmental toxicity.
Danish: Prækliniske data viste ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser samt reproduktions- og udviklingstoksicitet.
English: * The following is considered an adverse reaction for Trumenba and was reported in the postmarketing experience.
Danish: * Anses som bivirkning ved Trumenba og er rapporteret efter markedsføringen.
English: These additional hSBAs support and extend the breadth of vaccine coverage demonstrated by the 4 representative primary strains (Tables 3 and 4).
Danish: Disse yderligere hSBA'er understøtter og udvider bredden af vaccinens dækning, påvist af de 4 repræsentative primære stammer (Skema 3 og 4).
English: Trumenba should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Danish: Trumenba bør kun anvendes under amning, hvis de mulige fordele opvejer de potentielle risici.
English: 60 micrograms each
Danish: 60 mikrogram af hver
English: BATCH NUMBER<, DONATION AND PRODUCT CODES>
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER
English: In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Danish: For at forbedre sporbarheden af biologiske lægemidler skal navnet på det administrerede præparat og batchnummeret tydeligt noteres i patientjournalen.
English: When Trumenba is given to your or your child, the following side effects may occur:
Danish: Når du eller dit barn får Trumenba, kan følgende bivirkninger forekomme:
English: Do not inject intravenously, intradermally, or subcutaneously.
Danish: Må ikke injiceres intravenøst, intradermalt eller subkutant.
English: For the second and third doses, serum was obtained approximately 1 month after the second or third vaccination dose.
Danish: For anden og tredje dosis blev serum udtaget ca. 1 måned efter den anden eller tredje vaccinedosis.
English: Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000)
Danish: Ikke almindelig (≥1/1.000 til <1/100) Sjælden (≥1/10.000 til <1/1.000) Meget sjælden (<1/10.000)
English: Study B1971033 is an open-label, follow-up study of subjects previously enrolled in a primary study, including Study B1971012.
Danish: Studie B1971033 er et åbent opfølgende studie hos forsøgspersoner, der tidligere har været inkluderet i et primært studie, herunder studie B1971012.
English: If you receive more than 1 vaccination at the same time it is important that different injection sites are used.
Danish: Hvis du får mere end 1 vaccination på samme tidspunkt, er det vigtigt, at vaccinationerne gives forskellige steder.
English: For instructions on the handling of the vaccine before administration, see section 6.6.
Danish: For instruktioner om håndtering af vaccinen før administration, se pkt.
English: • have a bleeding problem or bruise easily.
Danish: • har problemer med blødninger eller let får blå mærker.
English: The safety profile presented is based on analysis of over 15,000 subjects (aged 10 years and older) who have been vaccinated with at least 1 dose of Trumenba in 11 completed clinical studies.
Danish: Sikkerhedsprofilen er baseret på analyse af over 15.000 personer (≥ 10 år), der er vaccineret med mindst 1 dosis Trumenba i 11 afsluttede kliniske studier.
English: Trumenba should not be given to individuals with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, unless the potential benefit clearly outweighs the risk of administration.
Danish: Trumenba bør ikke gives til personer med trombocytopeni eller andre koagulationsforstyrrelser, som kontraindicerer intramuskulær injektion, medmindre den potentielle fordel klart opvejer risikoen ved administration.
English: Procedures should be in place to avoid injury from fainting.
Danish: Der skal træffes forholdsregler for at undgå tilskadekomst som følge af besvimelse.
English: Common (these may affect up to 1 in 10 people) - Vomiting - Fever ≥ 38 °C
Danish: Almindelige bivirkninger (disse kan påvirke op til 1 ud af 10 personer) - Opkastning - Feber over 38 °C
English: Similar results were observed in Groups 2 and 3 as observed in Group 1.
Danish: Der sås lignende resultater i gruppe 2 og 3 som i gruppe 1.
English: Vaccination should be postponed in individuals suffering from an acute severe febrile illness.
Danish: Vaccination med Trumenba skal udsættes hos personer, der har en akut alvorlig febril sygdom.
English: It is unknown whether Trumenba is excreted in human milk.
Danish: Det er ukendt, om Trumenba udskilles i human mælk.
English: During storage, a white deposit and clear supernatant may be observed.
Danish: Under opbevaring kan der ses en hvid udfældning og en klar supernatant.
English: If you take medicines that affect your immune system (such as radiation therapy, corticosteroids, or some types of cancer chemotherapies), you may not get the full benefit of Trumenba.
Danish: Hvis du får en behandling, som påvirker dit immunsystem (f.eks. strålebehandling, medicin med binyrebarkhormon eller visse typer kemoterapi mod kræft), vil du muligvis ikke få den fulde gavn af Trumenba.
English: However, some of the side effects mentioned under section 4 ‘Possible side effects' may temporarily affect you.
Danish: Nogle af bivirkningerne i afsnit 4 kan måske påvirke dig midlertidigt.
English: White liquid suspension.
Danish: Hvid, flydende suspension.
English: 1 Month after booster Dose
Danish: 1 måned efter booster-dosis
English: - This vaccine has been prescribed for you or your child only.
Danish: - Lægen har ordineret denne vaccine til dig eller dit barn personligt.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility in females (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår fertilitet hos hundyr (se pkt.
English: If this occurs, wait until the effects wear off before driving or using machines.
Danish: Hvis dette sker, skal du vente, med at føre motorkøretøj eller betjene maskiner, indtil virkningen har fortaget sig.
English: In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.
Danish: Hvis der ses fremmedlegemer/partikler og/eller ændring af det fysiske udseende, må vaccinen ikke administreres.
English: Talk to your doctor, pharmacist or nurse before vaccination with Trumenba.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet inden vaccination med Trumenba.
English: Safety and efficacy of Trumenba in children below 10 years of age have not been established.
Danish: Pædiatrisk population Trumenbas sikkerhed og virkning hos børn under 10 år er ikke klarlagt.
English: As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients.
Danish: I lighed med andre vacciner vil vaccination med Trumenba muligvis ikke beskytte alle, der bliver vaccineret.
English: Limitations of clinical trials
Danish: Begrænsninger i de kliniske studier
English: A survey of over 2,150 different invasive meningococcal serogroup B isolates collected from 2000-2014 in 7 European countries, the US and Canada demonstrated that over 91% of all meningococcal serogroup B isolates expressed sufficient levels of fHbp to be susceptible to bactericidal killing by vaccine-induced antibodies.
Danish: En undersøgelse af over 2.150 forskellige invasive meningokok serogruppe B-stammer indsamlet i 2000-2014 i 7 europæiske lande, USA og Canada viste, at over 91 % af alle meningokok serogruppe B-stammer udtrykte tilstrækkeligt høje niveauer af fHbp til at være følsomme for den baktericide effekt af vaccineinducerede antistoffer.
English: There are no data available on the interchangeability of Trumenba with other meningococcal group B vaccines to complete the vaccination series.
Danish: Der foreligger ingen data, hvor Trumenba udskiftes med andre meningokok gruppe B-vacciner til færdiggørelse af vaccinationsserien.
English: Immunocompromised individuals, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Trumenba.
Danish: Immunkompromitterede personer, herunder personer, der får immunsupprimerende behandling, kan have utilstrækkeligt immunrespons på Trumenba.
English: Read all of this leaflet carefully before you or your child receives this vaccine because it contains important information for you or your child
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn får dette lægemiddel, da den indeholder vigtige oplysninger
English: The efficacy of Trumenba has not been evaluated through clinical trials.
Danish: Trumenbas virkning er ikke blevet evalueret i kliniske studier.
English: Booster dose
Danish: Booster-dosis
English: It is important to follow the instructions from the doctor, pharmacist or nurse so that you or your child completes the course of injections.
Danish: Det er vigtigt at følge lægens, farmaceutens eller sygeplejerskens anvisninger, så du eller dit barn får alle indsprøjtninger.
English: Group 1 received Trumenba at months 0, 2, and 6.
Danish: Gruppe 1 fik Trumenba ved måned 0, 2 og 6.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: You or your child will receive 2 injections of the vaccine given at least 1 month apart and a third injection at least 4 months after the second injection.
Danish: Du eller dit barn vil få 2 indsprøjtninger med vaccinen, som gives med mindst 1 måneds mellemrum, og derefter en tredje indsprøjtning mindst 4 måneder efter den anden indsprøjtning.
English: Persons with familial complement deficiencies (for example, C5 or C3 deficiencies) and persons receiving treatments that inhibit terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroup B, even if they develop antibodies following vaccination with Trumenba.
Danish: Personer med arvelige komplementdefekter (f.eks. C5 eller C3 defekter) samt personer, som får en behandling, der hæmmer terminal komplementaktivering (f.eks. eculizumab), har en øget risiko for invasiv sygdom forårsaget af Neisseria meningitidis serogroup B, selvom de udvikler antistoffer efter vaccination med Trumenba.
English: 1 dose (0.5 ml)
Danish: 1 dosis (0,5 ml)
English: The vaccine should be visually inspected for particulate matter and discoloration prior to administration.
Danish: Vaccinen skal undersøges visuelt for eventuelle partikler og misfarvning inden administration.
English: Trumenba has no or negligible influence on the ability to drive and use machines.
Danish: Trumenba påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Administration of Trumenba with vaccines other than those mentioned above, has not been studied.
Danish: Vaccination med andre vacciner end de ovenfor nævnte sammen med Trumenba, er ikke blevet undersøgt.
English: HAV/saline
Danish: HAV/saltvand
English: A composite response was defined as a response for all 4 hSBA strains combined.
Danish: Et sammensat respons blev defineret som et samlet respons for alle 4 hSBA-stammer.
English: As with other injectable vaccines, syncope (fainting) can occur in association with administration of Trumenba.
Danish: I lighed med andre injicerbare vacciner kan der forekomme synkope (besvimelse) i forbindelse med administration af Trumenba.
English: Polysorbate 80 (E433) Water for injections For adsorbent, see section 2.
Danish: Polysorbat 80 (E433) Vand til injektionsvæske Adsorberende stof, se pkt.
English: (2) For subjects with a baseline hSBA titre ≥ 1:4, a 4-fold response was defined as an hSBA titre ≥ 4 times the lower limit of quantitation or ≥ 4 times the baseline titre, whichever was higher.
Danish: (2) For forsøgspersoner med baseline hSBA-titer ≥ 1:4 blev et 4-dobbelt respons defineret som hSBA-titer ≥ 4 gange den nedre kvantificeringsgrænse eller ≥ 4 gange baseline-titeren, afhængigt af hvad der var højest.
English: Nervous system disorders Very Common: Headache
Danish: Nervesystemet Meget almindelig: Hovedpine
English: In the immunogenicity analysis for Trumenba, a response was defined as an hSBA titre of at least 1:8 or 1:16 depending on the hSBA strain.
Danish: I immunogenicitetsanalysen for Trumenba blev respons defineret som en hSBA-titer på mindst 1:8 eller 1:16, afhængigt af hSBA-stammen.
English: There are no data from the use of Trumenba in pregnant women.
Danish: Der er ingen data fra anvendelse af Trumenba til gravide kvinder.
English: Before use, the pre-filled syringe should be shaken vigorously to ensure that a homogeneous white suspension is obtained.
Danish: Inden brug skal den fyldte injektionssprøjte rystes kraftigt for at sikre, at der opnås en ensartet, hvid suspension.
English: The study assessed the safety, tolerability, immunogenicity, and demonstration of manufacturability of 3 lots of Trumenba administered on a 0-, 2-, and 6-month schedule.
Danish: Studiet vurderede sikkerheden, tolerabiliteten, immunogeniciteten og fremstillingsegnetheden af 3 lot Trumenba givet i henhold til en 0, 2 og 6 måneders plan.
English: Trumenba is for intramuscular use only.
Danish: Trumenba er kun til intramuskulær anvendelse.
English: The preferred site for injection is the deltoid muscle of the upper arm.
Danish: Det foretrukne injektionssted er musculus deltoideus.
English: 3 doses: 2 doses (0.5 ml each) administered at least 1 month apart, followed by a third dose at least 4 months after the second dose (see section 5.1).
Danish: 3 doser: 2 doser (a 0,5 ml) administreret med mindst 1 måneds mellemrum, efterfulgt af en tredje dosis mindst 4 måneder efter den anden dosis (se pkt.
English: Sodium Chloride Histidine
Danish: Natriumchlorid Histidin
English: fHbp is found on the surface of meningococcal bacteria and is essential for bacteria to avoid host immune defenses.
Danish: fHbp findes på overfladen af meningokokker og er essentielt for bakterier for at omgå værtens immunforsvar.
English: Tell your doctor, pharmacist or nurse if you or your child:
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis du eller dit barn:
English: A total of 2,693 subjects received at least 1 dose of Trumenba and 897 received at least 1 dose of HAV vaccine/saline.
Danish: I alt 2.693 forsøgspersoner fik mindst 1 dosis Trumenba, og 897 fik mindst 1 dosis HAV-vaccine/natriumchlorid-injektionsvæske.
English: However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination.
Danish: En lettere infektion, såsom en forkølelse, bør dog ikke medføre, at vaccinationen udskydes.
English: Recombinant lipidated fHbp (factor H binding protein) Produced in Escherichia coli cells by recombinant DNA technology Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose)
Danish: Rekombinant lipideret fHbp (faktor H-bindingsprotein) Produceret i Escherichia coli-celler vha. rekombinant DNA-teknologi Adsorberet til aluminiumphosphat (0,25 milligram aluminium pr. dosis)
English: The most common adverse reactions observed were injection site pain, redness and swelling at the vaccination site, headache, fatigue, chills, diarrhoea, muscle pain, joint pain, and nausea.
Danish: De hyppigst observerede bivirkninger var smerter, rødme og hævelse på vaccinationsstedet, hovedpine, træthed, kulderystelser, diarré, muskelsmerter, ledsmerter og kvalme.
English: The 4 test strains express fHbP variants representing the 2 subfamilies (A and B) and, when taken together, are representative of meningococcal serogroup B strains causing invasive disease.
Danish: De 4 teststammer udtrykker fHbp-varianter, der repræsenterer de to subfamilier (A og B), og tilsammen er repræsentative for de meningokok serogruppe B-stammer, som forårsager invasiv sygdom.
English: Immunisation with Trumenba, which contains one fHbp variant each from subfamily A and B, is intended to stimulate the production of bactericidal antibodies that recognize fHbP expressed by meningococci.
Danish: Immunisering med Trumenba, som indeholder én fHbp-variant fra hver af subfamilierne A og B, er beregnet til at stimulere produktionen af baktericide antistoffer, der genkender fHbp udtrykt af meningokokker.
English: Adverse reactions following booster vaccination in 268 subjects aged 15 to 23 years were similar to adverse reactions during the primary Trumenba vaccination series approximately 4 years earlier.
Danish: Bivirkningerne af booster-vaccination hos 268 personer i alderen 15-23 år var sammenlignelige med bivirkningerne under den primære vaccinationsserie 4 år tidligere.
English: 6 PHARMACEUTICAL PARTICULARS
Danish: 6 FARMACEUTISKE OPLYSNINGER
English: Suspension for injection
Danish: Suspension til injektion
English: The tip cap and rubber plunger of the pre-filled syringe are not made with natural rubber latex.
Danish: Sprøjtespidshætten og gummistemplet i den fyldte injektionssprøjte er fremstillet uden naturgummilatex.
English: 2D barcode carrying the unique identifier included.
Danish: <Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: There are no data on the use of Trumenba in subjects above 65 years of age.
Danish: Der foreligger ingen data for brug af Trumenba hos personer over 65 år.
English: A booster response in hSBA responses at 1 month following a dose of Trumenba approximately 4 years after a primary series of 2 doses (Group 3) or 3 doses (Groups 1 and 2) was observed.
Danish: Der sås et booster hSBA respons 1 måned efter en dosis Trumenba ca. 4 år efter den primære serie på 2 doser (gruppe 3) eller 3 doser (gruppe 1 og 2).
English: However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
Danish: 4.8 kan dog midlertidigt påvirke evnen til at føre motorkøretøj eller betjene maskiner.
English: What you need to know before you or your child receives Trumenba 3.
Danish: Det skal du vide, før du eller dit barn får Trumenba 3.
English: Trumenba is a vaccine composed of 2 recombinant lipidated factor H binding protein (fHbp) variants.
Danish: Trumenba er en vaccine, der er sammensat af 2 varianter af rekombinant, lipideret faktor H-bindende protein (fHbp).