FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Nobivac Myxo-RHD Plus, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Nobivac Myxo-RHD Plus, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The European Medicines Agency decided that Nobivac Myxo-RHD Plus's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Nobivac Myxo-RHD Plus opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: The most common side effects with Nobivac Myxo-RHD Plus (which may affect up to 1 in 10 animals) are a short-lived temperature increase of 1 to 2 °C and a small, non-painful swelling (maximum 2 cm diameter) at the injection site within the first two weeks after vaccination.
Danish: De hyppigste bivirkninger ved Nobivac Myxo-RHD Plus (som kan forekomme hos op til 1 ud af 10 dyr) er en stigning i temperaturen på 1 til 2 °C og en lille, ikke-smertefuld hævelse (maks.
English: In addition, the company also presented field studies with the already authorised vaccine Nobivac Myxo-RHD which contains live myxoma vectored RHD virus strain 009 only.
Danish: Desuden har virksomheden også fremlagt feltstudier med den allerede godkendte vaccine, Nobivac Myxo-RHD, som indeholder levende myxoma, som fremstilles med vektoren RHD-virus, dog kun stamme 009.
English: Nobivac Myxo-RHD Plus contains small amounts of weakened forms of the myxoma virus that causes myxomatosis.
Danish: Nobivac Myxo-RHD Plus indeholder små mængder af en svækket form af myxomavirus, der forårsager myxomatose.
English: Nobivac Myxo-RHD Plus received a marketing authorisation valid throughout the EU on 19 November
Danish: Nobivac Myxo-RHD Plus fik en markedsføringstilladelse med gyldighed i hele EU den 19/11/2019.
English: Nobivac Myxo-RHD Plus is available as a freeze dried powder (lyophilisate) and solvent for suspension for injection and can only be obtained with a prescription.
Danish: Nobivac Myxo-RHD Plus fås som frysetørret pulver (lyofilisat) og solvens til injektionsvæske, opløsning, og udleveres kun på recept.
English: Nobivac Myxo-RHD Plus is a vaccine used in rabbits to reduce death and clinical signs due to myxomatosis and rabbit haemorrhagic disease (RHD).
Danish: Nobivac Myxo-RHD Plus er en vaccine, der anvendes til kaniner for at mindske dødeligheden og de kliniske symptomer på myxomatose og hæmoragisk sygdom hos kaniner (RHD).
English: For the full list of side effects and restrictions for Nobivac Myxo-RHD Plus, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger med Nobivac Myxo-RHD Plus fremgår af indlægssedlen.
English: An overview of Nobivac Myxo-RHD Plus and why it is authorised in the EU
Danish: En oversigt over Nobivac Myxo-RHD Plus, og hvorfor det er godkendt i EU
English: Nobivac Myxo-RHD Plus contains live myxoma vectored RHD virus strains 009 and MK1899.
Danish: Nobivac Myxo-RHD Plus indeholder levende myxoma, som fremstilles med vektoren RHD-virus, stamme 009 og stamme MK1899
English: Other information about Nobivac Myxo-RHD Plus
Danish: Andre oplysninger om Nobivac Myxo-RHD Plus
English: Why is Nobivac Myxo-RHD Plus authorised in the EU?
Danish: Hvorfor er Nobivac Myxo-RHD Plus godkendt i EU?
English: What is Nobivac Myxo-RHD Plus and what is it used for?
Danish: Hvad er Nobivac Myxo-RHD Plus, og hvad anvendes det til?
English: What are the risks associated with Nobivac Myxo-RHD Plus?
Danish: Hvilke risici er der forbundet med Nobivac Myxo-RHD Plus?
English: How does Nobivac Myxo-RHD Plus work?
Danish: Hvordan virker Nobivac Myxo-RHD Plus?
English: How is Nobivac Myxo-RHD Plus used?
Danish: Hvordan anvendes Nobivac Myxo-RHD Plus?
English: What benefits of Nobivac Myxo-RHD Plus have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nobivac Myxo-RHD Plus?
English: Date of first authorisation: 15 February 2016
Danish: Dato for første markedsføringstilladelse: 15. februar 2016
English: N=89 subjects from a separate study
Danish: N=89 deltagere fra et separat studie
English: Stability data indicate that the vaccine is stable at temperatures up to 25°C for 150 hours.
Danish: Stabilitetsdata viser, at vaccinen er stabil ved temperaturer på op til 25 °C i 150 timer.
English: If not, your child may not be fully protected against the diseases.
Danish: I modsat fald vil dit barn muligvis ikke være helt beskyttet mod sygdommene.
English: Pack of 1 or 10.
Danish: Pakning med 1 eller 10.
English: Component of a multipack, cannot be sold separately
Danish: Del af en multipakning; kan ikke sælges separat
English: Results obtained for each component of the vaccine are summarised in Table 2 and Table 3.
Danish: De resultater, der er indsamlet for hver komponent i vaccinen, er opsummeret i tabel 2 og tabel 3.
English: Your doctor will tell you when this dose should be given.
Danish: Lægen vil fortælle dig, hvornår denne dosis skal gives.
English: No cases of overdose have been reported.
Danish: Der er ikke indberettet tilfælde af overdosering.
English: The coughing often has a “whooping” sound.
Danish: Hosten har ofte en “pibende” lyd.
English: Serious allergic reactions are a very rare possibility (may affect up to 1 in 10,000 people) after receiving any vaccine.
Danish: Alvorlige allergiske reaktioner er en meget sjælden mulighed (kan ramme op til 1 ud af 10.000), efter at man har fået en vaccine.
English: However, a lower immune response may be observed and the level of clinical protection is unknown.
Danish: Et lavere immunrespons kan dog observeres, og det kliniske beskyttelsesniveau er ukendt.
English: The following convention has been used for the classification of adverse reactions: Very common (1/10)
Danish: Følgende konvention er blevet anvendt i klassifikationen af bivirkninger: Meget almindelig (1/10)
English: • Temperature of 40.5°C within 48 hours, not attributable to another identifiable cause
Danish: • En temperatur på  40,5 °C inden for 48 timer, der ikke kan tilskrives anden identificerbar årsag
English: No pharmacokinetic studies have been performed.
Danish: Der er ikke udført farmakokinetiske studier.
English: Fimbriae Types 2 and 3 (FIM)
Danish: Fimbriae type 2 og 3 (FIM)
English: The recommended dose is as follows:
Danish: Den anbefalede dosis er:
English: Other tests should be performed in order to confirm Hib infection during this period.
Danish: Andre test bør udføres for at bekræfte Hib infektion i dette tidsrum.
English: Immunocompromised children
Danish: Immunkompromitterede børn
English: Very Common Crying, irritability
Danish: Gråd, irritabilitet
English: 4.8 Undesirable effects a- Summary of the safety profile
Danish: 4.8 Bivirkninger a- Resumé af sikkerhedsprofilen
English: Read all of this leaflet carefully before your child is vaccinated with this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden dit barn vaccineres med dette lægemiddel, da den indeholder vigtige oplysninger.
English: There may be some circumstances, such as high incidence of pertussis, when the potential benefits outweigh possible risks.
Danish: Der kan være omstændigheder, for eksempel ved høj forekomst af pertussis, hvor de potentielle fordele opvejer de mulige risici.
English: This vaccine is not intended for administration to women of child-bearing age.
Danish: Denne vaccine er ikke beregnet til administration til kvinder i den fertile alder.
English: Important information about the protection provided
Danish: Vigtige oplysninger om beskyttelsen
English: Interference with laboratory testing
Danish: Interferens med laboratorieundersøgelser
English: Do not use Vaxelis if your child:
Danish: Brug ikke Vaxelis, hvis dit barn:
English: • Hepatitis B: caused by the hepatitis B virus.
Danish: • Hepatitis B: Forårsages af hepatitis B-virussen.
English: • The vaccine does not contain any live bacteria or viruses and it cannot cause any of the infectious diseases against which it protects.
Danish: • Vaccinen indeholder ikke levende bakterier eller virusser, og den kan ikke give nogen af de smitsomme sygdomme, som den beskytter imod.
English: Non-clinical data reveal no special hazard for humans based on conventional studies.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier.
English: These data are intended to guide healthcare professionals in case of a temporary temperature excursion only.
Danish: Disse oplysninger er kun beregnet som en vejledning til sundhedspersonalet i tilfælde af midlertidige temperaturudsving.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Danish: Da fordelen ved vaccination er stor hos denne gruppe spædbørn, bør vaccination ikke undlades eller udsættes.
English: It is important to follow the instructions from the doctor or nurse so that your child completes the course of injections.
Danish: Det er vigtigt, at lægens eller sygeplejerskens anvisninger følges, så dit barn fuldfører injektionsforløbet.
English: 40/8/32 DU
Danish: 40/8/32 DE
English: Prior to immunisation
Danish: Før immunisering
English: Limited data from 111 pre-term newborn infants in clinical trials indicate that Vaxelis can be given to premature infants.
Danish: Begrænsede data fra 111 for tidligt fødte børn i kliniske studier indikerer, at Vaxelis kan gives til præmature spædbørn.
English: When these signs or symptoms occur they usually develop quickly after the injection is given and while the child is still in the clinic or doctor's surgery.
Danish: Hvis disse tegn eller symptomer opstår, udvikler de sig normalt hurtigt, efter at injektionen er givet, og mens barnet endnu er på klinikken eller hos lægen.
English: These reactions start within 24 to 72 hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the injection site and resolve spontaneously within 3 to 5 days.
Danish: Disse reaktioner begynder inden for 24-72 timer efter vaccination, kan være forbundet med erythem, varme, ømhed eller smerter på injektionsstedet og forsvinder spontant inden for 3-5 dage.
English: As a minimum, a dose of Hib vaccine must be administered.
Danish: Der skal som et minimum administreres en dosis Hib-vaccine.
English: Your doctor or nurse will give these injections at different sites and will use different syringes and needles for each injection.
Danish: Lægen eller sygeplejersken vil give disse injektioner på forskellige steder og vil bruge forskellige injektionssprøjter og kanyler til hver injektion.
English: Uncontrolled neurologic disorder or uncontrolled epilepsy: pertussis vaccination should not be administered until treatment for the condition has been established, the condition has stabilised and the benefit clearly outweighs the risk.
Danish: Ukontrolleret, neurologisk forstyrrelse eller ukontrolleret epilepsi: Pertussis-vaccinationen må ikke administreres, før en behandling af tilstanden er fastlagt, tilstanden er stabiliseret, og fordelen klart opvejer risikoen.
English: Booster dose should be given in accordance with the official recommendations.
Danish: Booster-dosen skal gives i overensstemmelse med de officielle anbefalinger.
English: The cough may last for one to two months or longer.
Danish: Hosten kan vare i 1-2 måneder eller længere.
English: Other paediatric population
Danish: Anden pædiatrisk population
English: Vaccination with Vaxelis may need to be delayed until your child is better.
Danish: Vaccinationen med Vaxelis skal måske udsættes, indtil barnet får det bedre.
English: • low blood pressure causing dizziness or collapse.
Danish: • lavt blodtryk, der giver svimmelhed eller kollaps
English: Genetic Polymorphism Immune responses to the vaccine have not been studied in the context of genetic polymorphism.
Danish: Genetisk polymorfi Immunresponset på vaccinen er ikke undersøgt i sammenhæng med genetisk polymorfi.
English: Poliovirus (Inactivated) Type 1 (Mahoney)
Danish: Poliovirus (inaktiveret) Type 1 (Mahoney)
English: The immune responses to Vaxelis in these infants were generally similar to those of the overall study population.
Danish: Immunresponserne på Vaxelis hos disse spædbørn var generelt de samme som hos den samlede studiepopulation.
English: Poliovirus (Inactivated) Types 1/2/3
Danish: Poliovirus (inaktiveret) type 1/2/3
English: Pack of 10 (without blue box).
Danish: Pakning med 10 (uden blå boks).
English: It can lead to paralysis or muscle weakness most commonly of the legs.
Danish: Den kan føre til lammelse eller muskelsvaghed, normalt i benene.
English: In some people, the virus can stay in the body for a long time, and can eventually lead to serious liver problems, including liver cancer.
Danish: I nogle tilfælde kan virussen blive i kroppen i lang tid og efterhånden føre til alvorlige leverproblemer, herunder kræft i leveren.
English: • allergic reaction, serious allergic reaction (anaphylactic reaction)
Danish: • allergisk reaktion, alvorlig allergisk reaktion (anafylaktisk reaktion)
English: The vaccine works by causing the body to produce its own protection (antibodies) against the bacteria and viruses that cause the following diseases:
Danish: Vaccinen virker ved at få kroppen til at producere sin egen beskyttelse (antistoffer) mod de bakterier og virusser, der er årsag til følgende sygdomme:
English: It causes the liver to become swollen (inflamed).
Danish: Den får leveren til at blive hævet (betændt).
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Danish: Den potentielle risiko for apnø og behovet for respiratorisk overvågning i 48-72 timer skal tages i betragtning, når den primære immuniseringsserie administreres til meget præmature børn (født efter ≤ 28 ugers svangerskab), og især til børn med respiratorisk immaturitet i anamnesen.
English: • As with any vaccine, Vaxelis may not protect 100% of children who receive the vaccine.
Danish: • Som det er tilfældet med alle vacciner kan Vaxelis muligvis ikke give 100% beskyttelse af de børn, der får vaccinen.
English: The presence of a minor illness and /or low grade fever does not constitute a contraindication.
Danish: Forekomst af let sygdom og/eller let feber udgør ikke en kontraindikation.
English: First course of vaccination (primary vaccination)
Danish: Første vaccinationsforløb (primær vaccination)
English: Adjuvants are included to improve the immune response of vaccines.
Danish: Adjuvanser tilsættes for at forbedre vacciners immunrespons.
English: Keep the container in the outer carton in order to protect from light.
Danish: Opbevares i den ydre karton for at beskytte mod lys.
English: However,children with long standing problems with their immune system such as HIV infection (AIDS) may still be given Vaxelis but the protection may not be as good as in children with ahealthyimmune system.
Danish: Børn med langvarige problemer med deres immunsystem, for eksempel hiv-infektion (aids), kan imidlertid stadig få Vaxelis, men beskyttelsen vil muligvis ikke være så god som hos børn med et sundt immunsystem.
English: In the absence of compatibility studies, this vaccine must not be mixed with other vaccines or medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må denne vaccine ikke blandes med andre vacciner eller lægemidler.
English: To make sure that Vaxelis is suitable for your child, it is important to talk to your doctor or nurse if any of the points below apply to your child.
Danish: For at sikre, at Vaxelis er egnet til dit barn, er det vigtigt at tale med lægen eller sundhedspersonalet, hvis et eller flere af punkterne herunder gør sig gældende for dit barn.
English: Anti-FIM (vaccine response)
Danish: Anti-FIM (vaccinerespons)
English: It causes severe coughing that may lead to problems with breathing.
Danish: Den forårsager kraftig hoste, der kan føre til problemer med vejrtrækningen.
English: Talk to your doctor, pharmacist or nurse before vaccination if your child:
Danish: Kontakt lægen, apoteket eller sundhedspersonalet før vaccinationen, hvis dit barn:
English: • blueness of the tongue or lips
Danish: • blåfarvning af tunge eller læber
English: Your doctoror nurse will assess the potential benefit offered by vaccination, once the condition is stabilized.
Danish: Lægen eller sygeplejersken vil vurdere den potentielle fordel, der kan opnås ved vaccination, når tilstanden er stabiliseret.
English: Multipack of 50 (with blue box).
Danish: Multipakning med 50 (med blå boks).
English: • difficulty in breathing
Danish: • åndedrætsbesvær
English: Vaxelis should not be mixed with any other vaccine or other parenterally administered medicinal products.
Danish: Vaxelis må ikke blandes med andre vacciner eller andre parenteralt administrerede lægemidler.
English: Pharmaco-therapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC code: J07CA09
Danish: Farmakoterapeutisk klassifikation: Vacciner, kombinerede bakterielle og virale vacciner, ATC- kode: J07CA09
English: As with other vaccines, administration of Vaxelis should be postponed in children suffering from moderate to severe acute disease, with or without fever.
Danish: Som det er tilfældet med andre vacciner, skal administration af Vaxelis udsættes hos børn, der lider af moderat til svær akut sygdom med eller uden feber.
English: Paralysis of the muscles that control breathing and swallowing can be fatal.
Danish: Lammelse af de muskler, der styrer åndedræt og synkning, kan være dødelig.
English: Apnoea in very premature infants (≤28 weeks of gestation).
Danish: Apnø hos meget præmature spædbørn (≤ 28 ugers svangerskab).
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours of vaccination
Danish: • Kollaps eller shock-lignende tilstand (hypotonisk-hyporesponsiv episode [HHE]) inden for 48
English: Do not administer by intravascular, intradermal or subcutaneous injection.
Danish: Må ikke administreres ved intravaskulær, intradermal eller subkutan injektion.
English: The use of Vaxelis should be in accordance with official recommendations.
Danish: Vaxelis skal anvendes i overensstemmelse med de officielle anbefalinger.
English: Immunogenicity after primary series and booster doses
Danish: Immunogenicitet efter primær vaccinationsserie og booster-dosis
English: If your child misses a scheduled injection, it is important that you discuss with your doctor or nurse who will decide when to give the missed dose.
Danish: Hvis barnet ikke får en planlagt injektion, er det vigtigt, at du taler med lægen eller sygeplejersken, der vil beslutte, hvornår den glemte dosis skal gives.
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed using sensitive tests, for at least 30 days following vaccination.
Danish: Da kapsel-polysaccharid-antigenet i Hib udskilles i urin, kan der observeres en positiv urinprøve i følsomme test i mindst 30 dage efter vaccination.
English: Your child will receive two or three injections given at least one month apart.
Danish: Barnet vil få to eller tre injektioner, der gives med mindst 1 måneds mellemrum.
English: • was born very prematurely (at or before 28 weeks of gestation).
Danish: • Barnet blev født meget for tidligt (i eller inden 28. svangerskabsuge).
English: In these infants, longer gaps than normal between breaths may occur for 2 to 3 days after vaccination.
Danish: Hos disse børn kan der opstå længere mellemrum mellem åndedragene end normalt i 2-3 dage efter vaccination.
English: Vaxelis can be used for a mixed hexavalent/pentavalent/hexavalent combined vaccine immunisation schedule.
Danish: Vaxelis kan bruges til en blandet heksavalent/pentavalent/heksavalent kombineret vaccineimmuniseringsplan.
English: As with all injectable vaccines, the vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
Danish: Som det er tilfældet med alle injektionsvacciner, skal vaccinen administreres med forsigtighed til personer med thrombocytopeni eller en blødningsforstyrrelse, da der kan opstå blødning efter intramuskulær administration.
English: Considerable study data suggest that individuals who have ever had a seroprotective response to hepatitis B vaccination will have a memory response that is protective against clinical disease if exposed to the hepatitis B virus.
Danish: Omfattende studiedata tyder på, at personer, som nogensinde har haft serobeskyttende respons på hepatitis B-vaccination, har en hukommelsesrespons, som beskytter mod klinisk sygdom ved eksponering for hepatitis B-virus.
English: Your doctor or nurse will tell you when your child should come back for their next injection as per the local vaccination program.
Danish: Lægen eller sygeplejersken vil fortælle dig, hvornår barnet skal have sin næste injektion, alt efter det lokale vaccinationsprogram.
English: The normal appearance of the vaccine is a uniform, cloudy, white to off-white suspension, which may settle down during storage.
Danish: Vaccinen er normalt en ensartet, uklar, hvid til offwhite suspension, der kan bundfælde under opbevaring.
English: If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including Vaxelis, should be based on careful consideration of the potential benefits and possible risks.
Danish: Hvis Guillain-Barrés syndrom er opstået inden for 6 uger efter den primære vaccine, der indeholdt tetanustoksoid, skal beslutningen om at give vacciner med tetanustoksoid, herunder Vaxelis, baseres på en nøje overvejelse af de potentielle fordele og risici.
English: d- Premature infants
Danish: d- Præmature spædbørn
English: Vaccination should be preceded by a review of the individual's medical history (in particular, previous vaccinations and possible adverse reactions).
Danish: Før vaccination skal patientens anamnese gennemgås (specielt tidligere vaccinationer og eventuelle bivirkninger).
English: If any of these symptoms occur after leaving the place where your child received his/her injection, you must consult a doctor IMMEDIATELY:
Danish: Hvis et eller flere af disse symptomer optræder, efter at du har forladt stedet, hvor barnet fik sin injektion, skal du STRAKS kontakte en læge:
English: Do not use this vaccine after the expiry date which is stated on the carton and the label after EXP.
Danish: Brug ikke denne vaccine efter den udløbsdato, der står på pakningen og etiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: oC), decreased appetite,
Danish: oC), nedsat appetit og opkastning.
English: LLOQ = 4EU/mL are for anti-PT, anti-PRN and anti-FIM; and LLOQ = 3EU/mL for anti-FHA
Danish: LLOQ = 4EU/ml er for anti-PT, anti-PRN og anti-FIM; og LLOQ = 3EU/ml for anti-FHA
English: The immunogenicity of the vaccine may be reduced by immunosuppressive treatment or immunodeficiency.
Danish: Vaccinens immunogenicitet kan være nedsat i forbindelse med immunsupprimerende behandling eller immundefekter.
English: The primary vaccination schedule consists of two or three doses, with an interval of at least 1 month between doses, and may be given from 6 weeks of age, in accordance with the official recommendations.
Danish: Den primære vaccinationsplan består af to eller tre doser med et interval på mindst 1 måned imellem doserne og kan gives fra 6-ugers-alderen i overensstemmelse med de officielle anbefalinger.
English: Bordetella pertussis antigens (Pertussis Toxoid/Filamentous Haemagglutinin/ Fimbriae types 2 and 3/Pertactin)
Danish: Bordetella pertussis-antigener (pertussistoksoid/filamentøs hæmagglutinin/fimbriae type 2 og 3/pertactin)