FrancophonIA/ELRC3.0 huggingface dataset:
English: Since intradermal injection or intramuscular administration into the gluteal muscle could lead to a suboptimal response to the vaccine, these routes should be avoided.
Danish: Da intradermal injektion eller intramuskulær administration i glutealregionen kan føre til et suboptimalt respons over for vaccinen, skal disse administrationsveje undgås.
English: • They will take care that Ambirix is not given into a vein.
Danish: • De vil sørge for, at Ambirix ikke bliver givet i en blodåre.
English: If you are pregnant or breast-feeding, think that you might be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before having 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, sundhedspersonalet eller apotekspersonalet til råds, før du får denne vaccine.
English: • Do not use this vaccine after the expiry date which is stated on the carton.
Danish: • Brug ikke denne vaccine efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: • As with all vaccines, some people respond less well to a vaccine than others.
Danish: • Som det er tilfældet med alle vacciner, er der nogle personer der ikke får den fulde virkning af vaccinen, som andre gør.
English: Ambirix confers immunity against HAV and HBV infection by inducing specific anti-HAV and antiHBs antibodies.
Danish: Ambirix giver immunitet mod HAV- og HBV-infektion ved at inducere specifikke HAV- og HBsantistoffer.
English: • a temporary inflammation of the nerves, causing pain, weakness and paralysis in the arms and legs and often progressing to the chest and face (Guillain-Barré syndrome)
Danish: • midlertidig betændelsestilstand i nerverne, som medfører smerte, svaghed eller lammelse i arme eller ben, og som ofte breder sig til bryst og ansigt (Guillain-Barré syndrom)
English: Ambirix can be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.
Danish: Ambirix kan anvendes under graviditet når det tydeligvis er nødvendigt og de mulige fordele opvejer de potentielle risici for fosteret.
English: It is not yet fully established whether immunocompetent individuals who have responded to hepatitis A vaccination will require booster doses as protection in the absence of detectable antibodies may be ensured by immunological memory.
Danish: Det er endnu ikke fuldstændigt fastlagt, hvorvidt immunokompetente personer, som har responderet på hepatitis A-vaccination, behøver en boosterdosis, eftersom der ved fravær af påviselige antistoffer muligvis kan opnås beskyttelse ved hjælp af immunologisk hukommelse.
English: However, it is sometimes caught in other ways, such as by swimming in water that has sewage in it or from another infected person.
Danish: I nogle tilfælde kan virus dog også overføres på andre måder, f.eks. ved badning i vand forurenet med kloak- eller spildevand eller fra en smittet person.
English: The most commonly reported adverse reactions following Ambirix administration are pain and fatigue occurring in an approximated per dose frequency of 50% and 30% respectively.
Danish: De hyppigst rapporterede bivirkninger efter administration af Ambirix er smerter og træthed, som forekommer med en hyppighed på hhv. 50 % og 30 % pr. dosis.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Multiple sclerosis, encephalitis, encephalopathy, polyneuritis such as Guillain-Barré syndrome (with ascending paralysis), myelitis, convulsions, paralysis, facial palsy, neuritis, optic neuritis, neuropathy
Danish: Multipel sklerose, encefalitis, encefalopati, polyneuritis såsom Guillain-Barré syndrom (med ascenderende paralyse), myelitis, kramper, paralyse, facialisparese, neuritis, optikusneurit, neuropati
English: In situations where a booster dose of hepatitis A and/or hepatitis B is desired, a monovalent or combined vaccine can be given.
Danish: I situationer, hvor en boosterdosis af hepatitis A og/eller hepatitis B ønskes, kan der gives en monovalent eller kombineret vaccine.
English: What you need to know before you receive Ambirix
Danish: Det skal du vide, før du får Ambirix
English: A dose of 1.0 ml is recommended for subjects from 1 year up to and including 15 years of age.
Danish: En dosis på 1,0 ml anbefales til personer fra 1 år til og med 15 år.
English: It cannot protect against other infections that can affect the liver - even though these infections might have signs similar to those caused by the hepatitis A or B virus.
Danish: Den beskytter ikke mod andre infektioner, som kan påvirke leveren - selv om disse muligvis giver samme symptomer som hepatitis A- eller B-virus.
English: Infections and infestations Meningitis
Danish: Infektioner og parasitære sygdomme Meningitis
English: • Ambirix is a white, slightly milky liquid presented in a glass 1 ml pre-filled syringe.
Danish: • Ambirix er en hvid, næsten mælkeagtig væske i en 1 ml fyldt injektionssprøjte af glas.
English: • feeling tired or irritable
Danish: • træthed eller irritabilitet
English: Ambirix should not be given if:
Danish: Du må ikke få Ambirix hvis:
English: This is because, a higher proportion of subjects are protected in the interval between the second and third dose of the three dose combined vaccine, than after a single dose of Ambirix.
Danish: Dette skyldes, at en større andel af de vaccinerede er beskyttede i intervallet mellem 2. og 3. dosis i 3-dosisprogrammet med den kombinerede vaccine, i forhold til efter en enkelt dosis Ambirix.
English: - It is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.
Danish: - Ambirix gives under forhold, hvor fuldførelsen af vaccinationsforløbet på to doser kan sikres.
English: Clinical trials involved the administration of 2029 doses of Ambirix to 1027 subjects from 1 year up to and including 15 years of age.
Danish: De kliniske studier omfattede administration af 2.029 doser Ambirix til 1.027 personer i alderen fra 1 år til og med 15 år.
English: The standard primary course of vaccination consists of two doses, the first administered at the elected date and the second between 6 and 12 months after the first dose.
Danish: Standard-vaccinationsprogrammet for primær vaccination med Ambirix består af to doser, den første administreres på en udvalgt dato og den anden 6 til 12 måneder efter første dosis.
English: Ambirix is not recommended for postexposure prophylaxis (e.g. needle stick injury).
Danish: Ambirix anbefales ikke til post-ekspositionsprofylakse (f.eks. stikuheld med kanyle).
English: Gastrointestinal disorders Common: gastrointestinal symptoms
Danish: Mave-tarm-kanalen Almindelig: gastrointestinale symptomer
English: It is recommended that the two-dose regimen of Ambirix be completed prior to start of sexual activity.
Danish: Det anbefales, at 2-dosisprogrammet for Ambirix er fuldført forud for seksuel debut.
English: Symptoms may not be seen for 6 weeks to 6 months after infection.
Danish: Symptomerne vil muligvis først optræde 6 uger til 6 måneder efter smitte.
English: Ambirix should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Danish: Ambirix må kun anvendes under amning, når de mulige fordele opvejer de potentielle risici.
English: For the 289 subjects evaluable for immunogenicity, seroprotection rates (SP in the table below) against hepatitis B were significantly higher at months 2 and 6 with the three-dose vaccine than with Ambirix.
Danish: Hos de 289 personer, hvis immunisering blev undersøgt, var sero-beskyttelsesraten (SP i nedenstående tabel) for hepatitis B signifikant højere ved 2 og 6 måneder med 3-dosisvaccinen end med Ambirix.
English: Seropositivity rates for anti-HAV were 99.0% and seropositivity rates for anti-HBs were 99.0% at month 13 with seroprotection rates of 97.0%.
Danish: De sero-positive rater for anti-HAV var 99,0 %, og de sero-positive rater for anti-HBs var 99,0 % i måned 13 med sero-beskyttende rater på 97,0 %.
English: - The second injection - between 6 and 12 months after the first injection.
Danish: - Anden vaccination - mellem 6 og 12 måneder efter den første vaccination.
English: Skin and subcutaneous tissue disorders Erythema multiforme, lichen planus
Danish: Hud og subkutane væv Erythema multiforme, lichen planus
English: • In very small children, the injection may be given into the thigh muscle.
Danish: • Hos meget små børn kan vaccinen gives i lårmusklen.
English: The recommended schedule should be adhered to. Once initiated, the primary course of vaccination should be completed with the same vaccine.
Danish: Når først det primære vaccinationsprogram er påbegyndt, skal det afsluttes med den samme vaccine.
English: • severe headache with stiff neck and sensitivity to light (meningitis)
Danish: • kraftig hovedpine med nakkestivhed og øget følsomhed over for lys (meningitis)
English: • allergic and anaphylactic reactions - the signs can include a rash that may be itchy or blistering, swelling of the eyes and face, difficulty in breathing or swallowing, a sudden drop in blood pressure and loss of consciousness.
Danish: • Allergiske og anafylaktiske reaktioner - mulige tegn kan bl.a. være udslæt, som kan være kløende eller danne blærer, hævelse af øjne eller ansigt, vejrtræknings- eller synkebesvær, pludseligt blodtryksfald og bevidstløshed.
English: Adverse reactions reported following overdosage were similar to those reported with normal vaccine administration.
Danish: Bivirkningerne, som er rapporteret efter overdosering, er de samme, som er rapporteret efter normal vaccination.
English: General guidelines for booster vaccination can therefore be drawn from experience with the monovalent vaccines, as follows.
Danish: Erfaringerne fra de monovalente vacciner kan derfor overføres og anvendes som generelle retningslinjer i forbindelse med boostervaccination som følger.
English: However, this route of administration may result in suboptimal immune response to the vaccine.
Danish: Denne administrationsvej kan imidlertid medføre et suboptimalt immunrespons over for vaccinen (se pkt.
English: However, exceptionally Ambirix can be administered subcutaneously to subjects with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration to these subjects.
Danish: Undtagelsesvist kan Ambirix dog administreres subkutant hos personer med trombocytopeni eller blødningsforstyrrelser, da blødning kan forekomme efter en intramuskulær administration hos sådanne personer.
English: 4.2 Posology and method of administration
Danish: 4.2 Dosering og administation
English: • Ambirix can only help to protect you against infections with hepatitis A or B viruses.
Danish: • Ambirix kan kun beskytte dig mod infektioner med hepatitis A- eller B-virus.
English: Vaccine group
Danish: Vaccinegruppe
English: It is used to prevent two diseases: hepatitis A and hepatitis B.
Danish: Den beskytter mod to sygdomme: hepatitis A og hepatitis B.
English: • you have previously had an allergic reaction to any vaccine against hepatitis A or hepatitis B diseases
Danish: • du tidligere har haft en allergisk reaktion af vacciner mod hepatitis A- eller hepatitis B-infektion.
English: * refers to adverse reactions observed in clinical trials performed with the paediatric formulation
Danish: * bivirkning, som er rapporteret i kliniske studier med den pædiatriske formulering.
English: Concomitant immunoglobulin administration may result in lower antibody titres.
Danish: Samtidig administration af immunglobuliner kan resultere i et lavere antistoftiter.
English: However, when the monovalent hepatitis A and hepatitis B vaccines were administered concomitantly with specific immunoglobulins there was no effect on seroconversion rates.
Danish: I tilfælde, hvor de monovalente hepatitis A- og hepatitis B-vacciner blev administreret sammen med specifikke immunglobuliner, var der ingen påvirkning af serokonverteringsraterne.
English: • Ambirix is available in packs of 1 and 10 pre-filled syringes (with or without needles) and in pack sizes of 50 pre-filled syringes without needles.
Danish: • Ambirix findes i pakninger med 1 og 10 stk. fyldte injektionssprøjter (med eller uden nåle) og i pakninger med 50 stk. fyldte injektionssprøjter uden nåle.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ambirix, suspension for injection
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Ambirix, injektionsvæske, suspension
English: Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
Danish: Besvimelse kan opstå (overvejende hos unge) efter og endda før nålestik.
English: Seropositivity rates for anti-HBs antibodies were 74.2% one month after the first dose and 100% after the second dose given at month 6 (i.e. month 7).
Danish: Sero-positive rater for HBs-antistoffer var 74,2 % en måned efter første vaccination og 100 % efter den anden dosis givet i 6. måned (dvs. måned 7).
English: However, the vaccine may not work fully.
Danish: Virkningen af vaccinen kan dog være nedsat.
English: The safety and immunogenicity of Ambirix administered as a booster dose following a two dose primary course have not been evaluated.
Danish: Sikkerheden og immunogeniciteten af Ambirix givet som boosterdosis efter det primære 2-dosisprogram er ikke klarlagt.
English: Vascular disorders Rare: hypotension
Danish: Vaskulære sygdomme Sjælden: hypotension
English: Talk to your doctor, nurse or pharmacist before having Ambirix if:
Danish: Kontakt lægen, sundhedspersonalet eller apotekspersonalet, før du får Ambirix, hvis:
English: • Make sure you finish the complete course of two injections.
Danish: • Sørg for, at du får afsluttet hele vaccinationsprogrammet med to vaccinationer.
English: Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of your face or tongue
Danish: Tegn på en allergisk reaktion kan være kløende udslæt, åndenød og hævelse af ansigt eller tunge.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 1 PRE-FILLED SYRINGE WITHOUT NEEDLE 1 PRE-FILLED SYRINGE WITH 1 NEEDLE 10 PRE-FILLED SYRINGES WITHOUT NEEDLES 10 PRE-FILLED SYRINGES WITH 10 NEEDLES 50 PRE-FILLED SYRINGES WITHOUT NEEDLES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 1 FYLDT INJEKTIONSSPRØJTE UDEN KANYLE 1 FYLDT INJEKTIONSSPRØJTE MED 1 KANYLE 10 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER 10 FYLDTE INJEKTIONSSPRØJTER MED 10 KANYLER 50 FYLDTE INJEKTIONSSPRØJTER UDEN KANYLER
English: • reaction where the injection was given
Danish: • reaktioner hvor injektionen blev givet
English: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate response may not be achieved.
Danish: Hos patienter, som er i immunsuppressiv behandling eller som er immunkomprommiterede, kan tilstrækkeligt respons ikke altid forventes.
English: It is possible that subjects may be in the incubation period of a hepatitis A or hepatitis B infection at the time of vaccination.
Danish: Nogle personer kan være i inkubationsfasen af en hepatitis A- eller hepatitis B-infektion på tidspunktet for vaccination.
English: The anti-HBs seroprotection rates (titers ≥ 10 mlU/ml) at these time points were 37.4% and 98.2% respectively.
Danish: Anti-HBs sero-beskyttende rater (titre ≥ 10 mIE/ml) var henholdsvis 37,4 % og 98,2 %.
English: The anti-hepatitis B surface antigen (anti-HBs) and anti-hepatitis A virus (anti-HAV) antibody titres observed following a primary vaccination course with Ambirix are in the range of what is seen following vaccination with the monovalent hepatitis A and B vaccines.
Danish: Anti-hepatitis B-overfladeantigen (anti-HBs) og anti-hepatitis A-virus (anti-HAV) antistoftitrene, som påvises efter et primært vaccinationsforløb med Ambirix, ligger inden for samme område som det, der ses efter vaccination med de monovalente hepatitis A- og B-vacciner.
English: Other medicines and Ambirix
Danish: Brug af anden medicin sammen med Ambirix
English: In a clinical study, 102 subjects aged from 12 years up to and including 15 years received the second dose of Ambirix at month 12.
Danish: I et klinisk studie fik 102 børn i alderen fra 12 år til og med 15 den anden dosis Ambirix i måned 12.
English: Blood and lymphatic system disorders Thrombocytopenic purpura, thrombocytopenia
Danish: Blod og lymfesystem Trombocytopenisk purpura, trombocytopeni,
English: Cases of overdose with GlaxoSmithKline's combined hepatitis A and hepatitis B vaccine have been reported during post-marketing surveillance.
Danish: Tilfælde af overdosering med GlaxoSmithKlines kombinerede hepatitis A- og hepatitis B-vaccine er rapporteret i overvågningen efter markedsføring.
English: Psychiatric disorders Very common: irritability
Danish: Psykiske forstyrrelser Meget almindelig: irritabilitet
English: Nervous system disorders Syncope or vasovagal responses to injection, localised hypoaesthesia
Danish: Nervesystemet Synkope eller vasovagalt anfald i forbindelse med injektion, lokaliseret hypæstesi
English: Some people can feel sick, have a fever and aches and pains.
Danish: Nogle personer føler sig syge med kvalme, feber, ømhed og smerter.
English: No data on concomitant administration of Ambirix with specific hepatitis A immunoglobulin or hepatitis B immunoglobulin have been generated.
Danish: Der foreligger ikke data for samtidig administration af Ambirix med specifik hepatitis Aimmunglobulin eller hepatitis B-immunglobulin.
English: You may feel sleepy or dizzy after having Ambirix.
Danish: Du kan blive træt eller svimmel efter injektion med Ambirix.
English: • Keep this vaccine out of the sight and reach of children.
Danish: • Opbevar denne vaccine utilgængeligt for børn.
English: 6-11 yrs old
Danish: 6-11 år
English: Tell your doctor if you are taking, have recently taken or might take any other medicines or vaccines.
Danish: Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: Hypersensitivity after previous administration of hepatitis A and/or hepatitis B vaccines.
Danish: Overfølsomhed efter forudgående indgift af hepatitis A- og/eller hepatitis B-vacciner.
English: If any of the above apply (or you are not sure), talk to your doctor, nurse or pharmacist before having Ambirix.
Danish: Hvis noget af ovennævnte er gældende (eller du er i tvivl) skal du spørge lægen, sundhedspersonalet eller apotekspersonalet før du får Ambirix.
English: Following widespread use of either GlaxoSmithKline's combined hepatitis A and hepatitis B vaccines or the monovalent hepatitis A and/or hepatitis B vaccines, the following adverse reactions have additionally been reported.
Danish: Efter udbredt brug af enten GlaxoSmithKlines kombinerede hepatitis A- og hepatitis B-vacciner eller de monovalente hepatitis A- og/eller hepatitis B-vacciner er følgende bivirkninger yderligere rapporteret
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 30 August 2002
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: In clinical studies involving subjects from 1 year up to and including 15 years old, seropositivity rates for anti-HAV antibodies were 99.1% one month after the first dose and 100% after the second dose given at month 6 (i.e month 7).
Danish: I kliniske studier med personer fra 1 år til og med 15 år, var de sero-positive rater for HAV antistoffer 99,1 % en måned efter den første vaccination og 100 % efter den anden dosis givet i 6. måned (dvs. måned 7).
English: Side effects that occurred during routine use of Ambirix were as follows:
Danish: Bivirkninger, som er set ved rutinemæssig brug af Ambirix:
English: Immune system disorders Allergic reactions including anaphylactic and anaphylactoid reactions
Danish: Immunsystemet Allergiske reaktioner inklusive anafylaktiske og anafylaktoide reaktioner
English: In a comparative clinical trial conducted among subjects aged from 12 years up to and including 15 years of age, 142 received two doses of Ambirix and 147 received the standard three-dose combined vaccine.
Danish: I et sammenlignende studie udført blandt personer i alderen fra 12 år til og med 15 år, var der 142, som fik 2-dosis Ambirix, og 147, som fik standard-3-dosis kombineret vaccine.
English: The latter contained 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen.
Danish: Sidstnævnte indeholdt 360 ELISA-enheder formalininaktiveret hapatitis A-virus og 10 mikrogram rekombinant hepatitis Boverfladeantigen.
English: In subjects aged 12-15 years at primary vaccination the anti-HAV and anti-HBs antibody concentrations were comparable between groups that had received Ambirix or a 3-dose regimen of the combined vaccine (content as described above).
Danish: For børn i alderen 12-15 år for den primære vaccination var anti-HAV- og anti-HBs-antistofkoncentration sammenlignelig i de to grupper, som havde fået hhv. Ambirix eller et 3-dosisregime med kombinationsvaccinen (som beskrevet ovenfor).
English: If rapid protection against hepatitis B is required, the standard three dose regimen of the combined vaccine containing 360 ELISA Units of formalin inactivated hepatitis A virus and 10 micrograms of recombinant hepatitis B surface antigen is recommended.
Danish: Hvis der kræves hurtig beskyttelse mod hepatitis B anbefales standard 3-dosisprogrammet af den kombinerede vaccine, som indeholder 360 ELISA-enheder af formalininaktiveret hepatitis A-virus og 10 mikrogram rekombinant hepatitis B-overfladeantigen.
English: This difference is no longer present after the second dose of Ambirix (see section 5.1 for seroprotection rates).
Danish: Der er ikke længere nogen forskel efter den 2. dosis Ambirix (se pkt.
English: • Hepatitis B: Infection with the hepatitis B virus may cause the liver to become swollen (inflamed).
Danish: • Hepatitis B: Infektion med hepatitis B-virus kan medføre, at leveren svulmer op (en betændelsestilstand).
English: In 2 comparative trials in subjects aged 1-15 years, the incidences of local and general solicited symptoms after a two dose regimen of Ambirix was overall similar to that seen with the three dose combined vaccine containing 360 ELISA Units of HAV and 10 µg of HBsAg.
Danish: I to sammenlignende studier med personer i alderen 1-15 år var forekomsten af de undersøgte lokale og generelle bivirkninger efter et to-dosis vaccinationsprogram med Ambirix overordnet de samme, som blev set efter tre doser af en kombinationsvaccine indeholdende 360 ELISA-enheder HAV og 10 µg HBsAg.
English: 1 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl).
Danish: 1 ml suspension i fyldt injektionssprøjte (type I glas) med sprøjtestempel (butylgummi).
English: In haemodialysis patients and persons with an impaired immune system, adequate anti-HAV and anti-HBs antibody titers may not be obtained after the primary immunisation course.
Danish: Hos hæmodialysepatienter og personer med nedsat immunforsvar opnås ikke altid et tilstrækkeligt niveau af HAV- og HBantistoftitere efter det primære immuniseringsprogram.
English: The percentages with anti-HBs antibody ≥10 mIU/ml at this time point for subjects aged 1-11 years or 12-15 years at the time of the first dose were 77.3% and 85.9%, respectively.
Danish: Procentdelen af børn med anti-HBs-antistof ≥ 10 mIE/ml var på dette tidspunkt 77,3 % og 85,9 % for hhv. børn i alderen 1-11 år og 12-15 år på tidspunktet for den første vaccination.
English: • upper airway infections
Danish: • betændelse i øvre luftveje
English: • pain and redness where the injection was given
Danish: • smerte og rødme hvor injektionen blev givet
English: • fainting • loss of skin sensitivity to pain or touch (hypoaesthesia)
Danish: • besvimelse • nedsat følelse i huden over for smerter eller berøring