FrancophonIA/ELRC3.0 huggingface dataset:
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Danish: Tabletovertræk: Lactosemonohydrat (mælkesukker), hypromellose (E464), triacetin (E1518), rød jernoxid (E172) og titandioxid (E171)
English: This may cause stomach upset or diarrhoea.
Danish: Iscover indeholder hydrogeneret ricinusolie Dette kan forårsage mavetilfælde eller diarré.
English: EU/1/98/070/008 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/009 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/010 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/012 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Danish: EU/1/98/070/008 4x 1 filmovertrukne tabletter i perforerede blisterkort af aluminium EU/1/98/070/009 30x1 filmovertrukne tabletter i perforerede blisterkort af aluminium EU/1/98/070/010 100x1 filmovertrukne tabletter i perforerede blisterkort af aluminium EU/1/98/070/012 10x1 filmovertrukne tabletter i perforerede blisterkort af aluminium
English: 5 How to store Iscover Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: EU/1/98/070/001 - Cartons of 28 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/002 - Cartons of 50x1 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/003 - Cartons of 84 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/004 - Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/005 - Cartons of 30 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/006 - Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/007 - Cartons of 14 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/011 - Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/013 - Cartons of 28 film-coated tablets in all aluminium blisters
Danish: EU/1/98/070/001 - Pakning med 28 filmovertrukne tabletter i blisterkort af PVC/PVDC/Aluminium EU/1/98/070/002 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af PVC/PVDC/Aluminium EU/1/98/070/003 - Pakning med 84 filmovertrukne tabletter i blisterkort af PVC/PVDC/Aluminium EU/1/98/070/004 - Pakning med 100 filmovertrukne tabletter i blisterkort af PVC/PVDC/Aluminium EU/1/98/070/005 - Pakning med 30 filmovertrukne tabletter i blisterkort af PVC/PVDC/Aluminium EU/1/98/070/006 - Pakning med 90 filmovertrukne tabletter i blisterkort af PVC/PVDC/Aluminium EU/1/98/070/007 - Pakning med 14 filmovertrukne tabletter i blisterkort af PVC/PVDC/Aluminium EU/1/98/070/011 - Pakning med 7 filmovertrukne tabletter i blisterkort af PVC/PVDC/Aluminium
English: EU/1/98/070/001 28 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/002 50x1 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/003 84 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/004 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/005 30 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/006 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/007 14 film-coated tablets in PVC/PVDC/Alu blisters
Danish: EU/1/98/070/001 28 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/070/002 50x1 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/070/003 84 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/070/004 100 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/070/005 30 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/070/006 90 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/98/070/007 14 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium
English: EU/1/98/070/014 - Cartons of 50x1 film-coated tablets in all aluminium blisters EU/1/98/070/015 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/98/070/016 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/98/070/017 - Cartons of 30 film-coated tablets in all aluminium blisters EU/1/98/070/018 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/98/070/019 - Cartons of 14 film-coated tablets in all aluminium blisters EU/1/98/070/020 - Cartons of 7 film-coated tablets in all aluminium blisters
Danish: EU/1/98/070/013 - Pakning med 28 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/014 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/015 - Pakning med 84 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/016 - Pakning med 100 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/017 - Pakning med 30 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/018 - Pakning med 90 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/019 - Pakning med 14 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/020 - Pakning med 7 filmovertrukne tabletter i blisterkort af aluminium
English: EU/1/98/070/011 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/98/070/013 28 film-coated tablets in all aluminium blisters EU/1/98/070/014 50x1 film-coated tablets in all aluminium blisters EU/1/98/070/015 84 film-coated tablets in all aluminium blisters EU/1/98/070/016 100 film-coated tablets in all aluminium blisters EU/1/98/070/017 30 film-coated tablets in all aluminium blisters EU/1/98/070/018 90 film-coated tablets in all aluminium blisters EU/1/98/070/019 14 film-coated tablets in all aluminium blisters EU/1/98/070/020 7 film-coated tablets in all aluminium blisters
Danish: EU/1/98/070/011 7 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/013 28 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/014 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/015 84 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/016 100 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/017 30 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/018 90 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/019 14 filmovertrukne tabletter i blisterkort af aluminium EU/1/98/070/020 7 filmovertrukne tabletter i blisterkort af aluminium
English: Each film-coated tablet contains 300 mg of clopidogrel (as hydrogen sulphate).
Danish: Iscover 300 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 300 mg clopidogrel (som hydrogensulfat).
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose, Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Danish: Tabletkerne: Mannitol (E421), hydrogeneret ricinusolie, mikrokrystallinsk cellulose, macrogol 6000, lavsubstitueret hydroxypropylcellulose
English: Batch:
Danish: Lot:
English: EU/1/98/070/008 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/009 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/010 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/98/070/012 - Cartons of 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Danish: EU/1/98/070/008- Pakning med 4x1 filmovertrukne tabletter i perforerede enkeltdosisblistere af aluminium EU/1/98/070/009 - Pakning med 30x1 filmovertrukne tabletter i perforerede enkeltdosisblistere af aluminium EU/1/98/070/010 - Pakning med 100x1 filmovertrukne tabletter i perforerede enkeltdosisblistere af aluminium
English: Ninety five patients (7%) in the guided de-escalation group and 118 patients (9%) in the control group (p non-inferiority=0.0004) had an event.
Danish: Det primære endepunkt (den kombinerede forekomst af CV-død, MI, slagtilfælde og BARC ≥2 blødning efter 12 måneder) blev mødt, hvilket viste non-inferioritet - 90 patienter (7%) i den guidede deeskaleringsgruppe og 118 patienter (9%) i kontrolgruppen (p non-inferioritet = 0,0004) havde en hændelse.
English: What Iscover is and what it is used for What you need to know before you take Iscover How to take Iscover
Danish: Det skal du vide, før du begynder at tage Iscover Sådan skal du tage Iscover Bivirkninger
English: What Iscover looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Content Package size
Danish: Emballage Indhold Pakningsstørrelse
English: EU Number
Danish: EU Nummer vej
English: 5 ml
Danish: Hætteglas (glas) 5 ml
English: • The active substances are:
Danish: • De aktive stoffer er:
English: The severity and type of symptoms can vary.
Danish: Sværhedsgraden og typen af symptomer kan variere.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En mindre infektion som f.eks. forkølelse bør ikke være et problem, men tal alligevel med din læge først.
English: Some people may need to go into hospital.
Danish: Nogle personer vil have behov for hospitalsindlæggelse.
English: In accordance with Article 114 of Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EC foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: This is usually into the upper arm.
Danish: Almindeligvis er det i overarmen.
English: Please talk to your doctor after this time period.
Danish: Kontakt derfor lægen efter denne tidsperiode.
English: The holder of marketing authorisation will continue to submit annual PSURs.
Danish: Indehaveren af markedsføringstilladelsen vil fortsætte med at insende årlige PSUR'er
English: If not, you may not be protected against the diseases.
Danish: Hvis ikke, er du muligvis ikke beskyttet.
English: Not always people who have been infected look or feel ill.
Danish: Det er ikke altid at personer, som er smittede ser syge ud eller føler sig syge.
English: • you have a severe infection with a high temperature.
Danish: • du har en alvorlig infektion med høj feber.
English: Most children recover completely but the illness is usually severe enough to make children ill for about a month.
Danish: De fleste børn kommer sig fuldstændigt, men sygdommen er normalt så alvorlig, at børn er syge i ca. en måned.
English: Most adults fully recover from the disease, but some people (particularly children) who may not have had symptoms can remain infected.
Danish: De fleste voksne kommer sig helt over sygdommen, men nogle personer (specielt børn), som ikke nødvendigvis har haft symptomer, kan forblive smittede.
English: Young children may not get all symptoms.
Danish: Små børn udvikler ikke altid alle symptomer.
English: This vaccine contains neomycin (an antibiotic).
Danish: Denne vaccine indeholder neomycin (et antibiotikum).
English: • You will normally have a total of two injections.
Danish: • Du vil normalt få i alt 2 vaccinationer.
English: The vaccine can be given after you have recovered.
Danish: Vaccinen kan gives når du er blevet rask igen.
English: This leaflet has been written assuming the person receiving the vaccine is reading it, but it can be given to adolescents and children so you may be reading it for your child.
Danish: Denne indlægsseddel er skrevet under antagelse af, at personen som modtager vaccinen læser den, men vaccinen kan gives til børn og unge, så det kan være nødvendigt, at du læser den for dit barn.
English: This medicinal product contains less than 1 mmol sodium (9 mg) per dose, i.e. essentially ‘sodiumfree'.
Danish: Denne medicin indeholder mindre end 1 mmol (9 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: If this happens, do not drive, cycle or use any tools or machines.
Danish: Hvis det sker, må du ikke føre motorkøretøj, cykle eller betjene værktøj eller maskiner.
English: Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
Danish: Da rapporteringen af disse bivirkninger er spontan, er det ikke muligt at estimere en pålidelig frekvens.
English: Each is given on a separate visit.
Danish: Hver vaccination bliver givet ved et separat lægebesøg.
English: They are called hepatitis B “carriers” and can still infect other people throughout their lives.
Danish: De kaldes hepatitis B ”smittebærere” og kan fortsat smitte andre personer igennem hele livet.
English: The virus is usually caught from food or drink that contains the virus.
Danish: Denne virus overføres oftest gennem mad eller drikke, der indeholder virus.
English: Concomitant vaccines should always be administered at separate injection sites and preferably into different limbs.
Danish: Samtidige vacciner skal altid administreres på separate injektionssteder og helst i forskellige legemsdele.
English: Date of latest renewal: 20 July 2012
Danish: Dato for første markedsføringstilladelse: 30. august 2002 Dato for seneste fornyelse: 20. juli 2012
English: The virus is usually caught from another infected person.
Danish: Denne virus overføres oftest fra andre smittede personer.
English: Adverse reactions reported are listed according to the following frequency: Very common:
Danish: De rapporterede bivirkninger er listet i overensstemmelse med følgende hyppigheder: Meget almindelig:
English: • you are allergic to Ambirix, or any of the other ingredients of this vaccine (listed in section 6).
Danish: • du er allergisk over for Ambirix eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6).
English: • you have fainted before or during a previous injection - in case this happens again.
Danish: • du tidligere er besvimet i forbindelse med nålestik - i tilfældet af, at det sker igen.
English: • Ambirix helps the body to produce its own protection (antibodies) against these diseases.
Danish: • Ambirix virker ved at hjælpe kroppen til selv at danne en beskyttelse (antistoffer) mod disse sygdomme.
English: • Store in a refrigerator (2°C to 8°C).
Danish: • Opbevares i køleskab (2 °C - 8 °C).
English: Guidelines for boosting are based on the assumption that antibodies are required for protection.
Danish: Vejledning vedrørende boostervaccination er baseret på antagelsen om, at antistoffer er nødvendige for beskyttelse.
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Kontakt straks lægen, hvis du oplever følgende alvorlige bivirkninger - du kan have behov for hurtig medicinsk behandling:
English: It is advised that Ambirix should not be administered at the same time as other vaccines unless absolutely necessary.
Danish: Det anbefales, at Ambirix ikke administreres samtidig med andre vacciner, medmindre det er absolut nødvendigt.
English: Your doctor will make sure that the vaccines are injected into different parts of your body.
Danish: Lægen vil sikre at forskellige vacciner gives på forskellige steder på kroppen.
English: Ambirix should not be given if you are allergic to neomycin.
Danish: Ambirix må ikke gives, hvis du er allergisk over for neomycin.
English: • If you miss the second injection, talk to your doctor and arrange another visit as soon as possible.
Danish: • Hvis du har glemt den anden vaccination, så kontakt lægen og få en ny tid så hurtigt som muligt.
English: • Post-marketing data
Danish: • Data efter markedsføring
English: • The doctor or nurse will give Ambirix as an injection into a muscle.
Danish: • Lægen eller sundhedspersonalet vil give Ambirix som en injektion i en muskel.
English: Symptoms begin 3 to 6 weeks after infection.
Danish: Symptomerne begynder 3 til 6 uger efter smitte.
English: Ambirix is for intramuscular injection, usually into the deltoid muscle.
Danish: Ambirix er til intramuskulær injektion, sædvanligvis i deltoidea musklen.
English: • The other ingredients in Ambirix are: sodium chloride and water for injections.
Danish: • De øvrige indholdsstoffer i Ambirix er: natriumchlorid og vand til injektionsvæsker.
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reactions following the administration of the vaccine.
Danish: Som ved alle injicérbare vacciner skal passende medicinsk behandling og overvågning altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion som følge af administrationen af vaccinen.
English: Ambirix contains neomycin and sodium
Danish: Ambirix indeholder neomycin og natrium
English: Ambirix is not usually given to women who are pregnant or breast-feeding.
Danish: Ambirix gives normalt ikke til kvinder, der er gravide eller ammer.
English: 6.4 Special precautions for storage Store in a refrigerator (2°C - 8°C).
Danish: 6.4 Særlige opbevaringsforhold Opbevares i køleskab (2 °C - 8 °C).
English: Please contact your doctor if you have similar side effects.
Danish: Kontakt lægen hvis du oplever lignende bivirkninger.
English: Ambirix is a turbid white suspension.
Danish: Ambirix er en uklar, hvid suspension.
English: Also shown are the results reported in the comparative study performed in 12-15 year-olds.
Danish: Her vises også resultaterne fra et sammenlignende studie med børn fra 12-15 år.
English: As with other vaccines, the administration of Ambirix should be postponed in subjects suffering from acute severe febrile illness.
Danish: Som ved andre vacciner skal administrationen af Ambirix udskydes hos personer, der lider af akut, alvorlig, febril sygdom.
English: • you have immune system problems (such as due to an illness, treatment or dialysis) - the vaccine may not work fully.
Danish: • du har et svækket immunsystem (f.eks. på grund af en sygdom, en behandling eller dialyse)virkningen af vaccinen vil muligvis være nedsat.
English: • you have a bleeding problem or bruise easily - the injection may be given just under the skin instead of into a muscle to reduce the amount of bleeding or bruising
Danish: • du har problemer med blødning, eller har let ved at få blå mærker - injektionen kan gives lige under huden i stedet for ind i en muskel for at mindske blødning eller blå mærker.
English: Your doctor will run blood tests to see whether more injections are needed to help you be better protected.
Danish: Lægen vil tage en blodprøve for at se, om du har behov for yderligere vaccinationer for at være bedre beskyttet.
English: Read all of this leaflet carefully before you/your child starts receiving this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn bliver vaccineret, da den indeholder vigtige oplysninger.
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or neomycin.
Danish: Overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpstofferne anført i punkt 6.1 eller neomycin.
English: Immune responses obtained one month after the full vaccination course (i.e at month 7) in a comparative clinical trial in children aged 1-11 years are presented in the following table.
Danish: Immunresponset opnået en måned efter hele vaccinationsprogammet (dvs. ved måned 7) i et sammenlignende klinisk studie med børn fra 1 år til 11 år vises i nedenstående skema.
English: • This vaccine has been prescribed for you/your child only.
Danish: • Lægen har ordineret denne vaccine til dig eller dit barn personligt.
English: Concomitant administration of Ambirix and other vaccines than those listed above has not been studied.
Danish: Samtidig administration af Ambirix og andre vacciner end dem, som er nævnt ovenfor, er ikke undersøgt.
English: • you need to be fully protected against hepatitis A and B infection within the next 6 monthsyour doctor may recommend a different vaccine
Danish: • du behøver fuld beskyttelse mod hepatitis A- og B-infektion inden for de næste 6 månederlægen kan vælge en anden vaccine.
English: The safety and efficacy of Ambirix in children aged less than 1 year have not been established.
Danish: Ambirix' sikkerhed og virkning hos børn under 1 år er ikke fastslået.
English: Pharmaco-therapeutic group: Vaccines, Hepatitis vaccines, ATC code J07BC20.
Danish: Farmakoterapeutisk klassifikation: Vacciner, Hepatitis-vacciner, ATC-kode: JO7BC20
English: EU/1/02/224/001 - pack of 1 without needle EU/1/02/224/002 - pack of 1 with 1 needle EU/1/02/224/003 - pack of 10 without needle EU/1/02/224/004 - pack of 10 with 10 needles EU/1/02/224/005 - pack of 50 without needle
Danish: EU/1/02/224/001 - pakning med 1 uden kanyle EU/1/02/224/002 - pakning med 1 med 1 kanyle EU/1/02/224/003 - pakning med 10 uden kanyler EU/1/02/224/004 - pakning med 10 med 10 kanyler EU/1/02/224/005 - pakning med 50 uden kanyler
English: AMBIRIX SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVASCULARLY.
Danish: AMBIRIX MÅ UNDER INGEN OMSTÆNDIGHEDER ADMINISTRERES INTRAVASKULÆRT.
English: The vaccine has not been tested in patients with an impaired immune system.
Danish: Vaccinen er ikke blevet testet hos patienter med nedsat immunforsvar.
English: Ambirix Combined HAB vaccine (360/10)
Danish: Kombineret HAB vaccine (360/10)
English: If you are taking medicines that affect your body's immune response, you can still have Ambirix if this is thought to be necessary.
Danish: Hvis du får medicin, som påvirker kroppens immunforsvar, kan du godt få Ambirix, hvis det skønnes nødvendigt.
English: Carriers are also at risk of serious liver problems, such as scarring (cirrhosis) or liver cancer.
Danish: Smittebærere har desuden risiko for at få alvorlige leversygdomme, f.eks. skrumpelever (cirrhose) eller leverkræft.
English: The vaccine will not prevent infection caused by other agents such as hepatitis C and hepatitis E and other pathogens known to infect the liver.
Danish: Vaccinen forhindrer ikke infektion forårsaget af andre vira så som hepatitis C og hepatitis E eller andre patogener, som er kendt for at inficere leveren.
English: Freezing destroys the vaccine.
Danish: Vaccinen må ikke fryses, da nedfrysning ødelægger vaccinen.
English: For some categories of subjects at risk of exposure to HBV (e.g. haemodialysis or immunocompromised patients) a precautionary attitude should be considered to ensure that a protective antibody level ≥ 10 mIU/ml is maintained.
Danish: For nogle personkategorier, som har øget risiko for HBV (f.eks hæmodialyse- eller immunkompromitterede patienter), skal sikkerhedsforanstaltninger overvejes for at sikre, at et beskyttende antistofniveau ≥ 10 mIE/ml opretholdes.
English: Ambirix is indicated in non-immune children and adolescents from 1 year up to and including 15 years of age for protection against hepatitis A and hepatitis B infection.
Danish: Ambirix er indiceret hos ikke-immune børn og unge fra 1 år til og med 15 år til beskyttelse mod hepatitis A- og hepatitis B-infektion.
English: Tell your doctor straight away if you notice any of the serious side effects listed above.
Danish: Kontakt straks lægen, hvis du oplever nogle af disse alvorlige bivirkninger, som er anført ovenfor.
English: It is not known whether Ambirix will prevent hepatitis A and hepatitis B in such cases.
Danish: Det er uvist, om Ambirix vil forhindre hepatitis A og hepatitis B i sådanne tilfælde.
English: Ambirix is a vaccine used in infants, children and young people from 1 year up to and including 15 years.
Danish: Ambirix er en vaccine, der gives til spædbørn, børn og unge fra 1 år til og med 15 år.
English: The vaccine does not contain live virus (see section 6 for the content of the vaccine) and therefore cannot cause hepatitis A or B infections.
Danish: Vaccinen indeholder ikke levende virus (se indholdsstofferne i denne vaccine i punkt 6) og kan derfor ikke forårsage hepatitis A- eller B-infektioner.
English: Local and general adverse reactions reported following primary vaccination with Ambirix were categorised by frequency.
Danish: Lokale og generelle bivirkninger indberettet efter primær vaccination med Ambirix blev kategoriseret efter frekvens.