FrancophonIA/ELRC3.0 huggingface dataset:
English: Two primary immunisation schedules can be recommended:
Danish: To programmer til primærvaccination kan anbefales:
English: The following information is intended for medical or health care professionals only:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: The concomitant administration of pneumococcal conjugate vaccine (PREVENAR) given with hepatitis B vaccine using the 0, 1 and 6 and 0, 1, 2 and 12 month schedules has not been sufficiently studied.
Danish: Samtidig administration af pneumokok-konjugatvaccine (PREVENAR) og hepatitis B-vaccine ved hjælp af 0, 1 og 6 og 0, 1, 2 og 12 måneders programmet er ikke blevet tilstrækkeligt undersøgt.
English: Additional doses may need to be considered for persons who do not respond or have a sub-optimal response to a course of vaccinations.
Danish: Der kan være behov for at overveje yderligere doser hos personer, som ikke responderer eller responderer suboptimalt på en vaccinationsserie.
English: For any information about this vaccine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker yderligere oplysninger om denne vaccine, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: The doctor or nurse will give the vaccine as an injection into muscle.
Danish: Lægen eller sygeplejersken giver vaccinen som en intramuskulær injektion.
English: Immunocompromised vaccinees (e.g. dialysis patients, transplant patients, AIDS Patients)
Danish: Immunkompromitterede personer (f.eks. dialysepatienter, transplanterede patienter, aids-patienter)
English: This vaccine should never be given into a blood vessel.
Danish: Denne vaccine må aldrig injiceres i et blodkar.
English: Revaccination should be considered for high-risk individuals, after weighing the benefits of vaccination against the potential risk of experiencing increased local or systemic adverse reactions.
Danish: Revaccination bør overvejes for højrisikopersoner efter vurdering af vaccinationens fordele mod den potentielle risiko for øgede lokale eller systemiske bivirkninger.
English: Instructions
Danish: Instruktioner
English: Special dosage recommendations:
Danish: Særlige doseringsanbefalinger:
English: Do not use this vaccine after the expiry date which is stated on the label.
Danish: Brug ikke vaccinen efter den udløbsdato, der står på pakningen.
English: The vaccine should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Danish: Vaccinen bør kun anvendes under graviditet, hvis den potentielle fordel opvejer den potentielle risiko for fosteret.
English: However, some local vaccination schedules currently include a recommendation for a booster dose and these should be respected.
Danish: For tiden omfatter nogle lokale vaccinationsprogrammer dog en anbefaling om en boosterdosis, og disse bør overholdes.
English: A number of factors have been observed to reduce the immune response to hepatitis B vaccines.
Danish: Et antal faktorer er blevet observeret, som kan reducere immunsvaret på hepatitis B-vacciner.
English: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Danish: Hos meget præmature spædbørn (født i eller før 28. svangerskabsuge) kan der ses respirationspauser, der er længere end normalt, i 2 til 3 dage efter vaccination.
English: HBVAXPRO can be administered provided total (cumulative multiple excursion) time out of refrigeration (at temperatures between 8°C and 25°C) does not exceed 72 hours.
Danish: HBVAXPRO kan administreres, forudsat den samlede tid uden for køleskab (ved temperaturer mellem 8 °C og 25 °C) ikke overstiger 72 timer.
English: Read all of this leaflet carefully before you are vaccinated because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du bliver vaccineret, da den indeholder vigtige oplysninger.
English: However, because data are insufficient concerning the safety of hepatitis B vaccine when additional doses in excess of the recommended series are administered, revaccination following completion of the primary series is not routinely recommended.
Danish: Idet der dog findes utilstrækkelige data angående hepatitis B-vaccinens sikkerhed, når yderligere doser administreres udover det anbefalede 3-dosis program, anbefales revaccination ikke rutinemæssigt efter primærimmuniseringen er fuldført.
English: Reduced risk of Hepatocellular Carcinoma
Danish: Nedsat risiko for hepatocellulært carcinom
English: As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8).
Danish: Som for alle vacciner til injektion skal hensigtsmæssig medicinsk behandling altid være let tilgængelig i tilfælde af en sjælden anafylaktisk reaktion efter vaccinationen (se pkt.
English: Latex rubber may cause severe allergic reactions.
Danish: Latexgummi kan forårsage alvorlige allergiske reaktioner.
English: Read all of this leaflet carefully before you or your child is vaccinated because it contains important information.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn bliver vaccineret, da den indeholder vigtige oplysninger.
English: - In the case of unvaccinated or incompletely vaccinated individuals, additional doses should be given as in the recommended immunisation schedule.
Danish: - I tilfælde af uvaccinerede eller utilstrækkeligt vaccinerede personer skal yderligere doser gives som i det anbefalede vaccinationsprogram.
English: The potential risk of apnoea and the need for respiratory monitoring for 48 to 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 (see section 4.8).
Danish: Der skal tages højde for den potentielle risiko for apnø og behovet for overvågning af respirationen i 48 til 72 timer ved administration af den primære vaccinationsserie til præmature spædbørn (født ≤ 28. gestationsuge) og særligt hos personer med respiratorisk immaturitet i anamnesen (se pkt.
English: Among 130 vaccinated infants, the estimated efficacy in prevention of chronic hepatitis B infection was 95 % as compared to the infection rate in untreated historical controls.
Danish: Blandt 130 vaccinerede spædbørn var den estimerede beskyttende effekt overfor kronisk hepatitis B-infektion 95 % sammenlignet med infektionsraten i ubehandlede historiske kontrolgrupper.
English: Consideration should be given to serological testing of those subjects who may be at risk of not achieving seroprotection following a complete course of HBVAXPRO.
Danish: Serologiske undersøgelser af de personer, som kan have risiko for ikke at opnå serobeskyttelse efter en komplet HBVAXPRO-serie, skal overvejes.
English: It is recommended that the vaccine be administered in the schedules indicated.
Danish: Det anbefales, at vaccinen gives i overensstemmelse med de anførte programmer.
English: The requirements for submission of PSURs 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 PSUR'er 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 Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: In accordance with standard medical practice for hepatitis B vaccine administration, regular antibody testing should be done in hemodialysis patients.
Danish: I overensstemmelse med standard medicinsk praksis for administration af hepatitis B-vaccine, skal der udføres regelmæssige antistofundersøgelser på hæmodialysepatienter.
English: The need for a booster dose in healthy individuals who have received a full primary vaccination course has not been established.
Danish: Behovet for en boosterdosis hos raske personer som har fået hele det primære vaccinationsprogram er ikke fastlagt.
English: - Subsequent doses of vaccine should be given according to the locally recommended vaccination schedule.
Danish: - Efterfølgende vaccinedoser bør gives som anbefalet i det lokale vaccinationsprogram.
English: In two infant trials using different dosing schedules and concomitant vaccines, the proportion of infants with protective levels of antibodies were 97.5 % and 97.2 % with geometric mean titres of 214 and 297 IU/l, respectively.
Danish: I to studier med spædbørn, hvor der anvendtes forskellige doseringsprogrammer og samtidige vacciner, var andelen af spædbørn med beskyttende antistofniveauer 97,5 % og 97,2 % med geometriske middeltitre på henholdsvis 214 og 297 IE/l.
English: The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.
Danish: De specifikke grupper med erkendt risiko der skal vaccineres, skal fastsættes på basis af de officielle anbefalinger.
English: Amorphous aluminium hydroxyphosphate sulfate is included in this vaccine as an adsorbant.
Danish: Amorf aluminiumhydroxyphosphatsulfat er tilsat denne vaccine som et adsorberende stof.
English: Your doctor or nurse will decide when to give the missed dose.
Danish: Lægen eller sygeplejersken bestemmer, hvornår den manglende dosis skal gives.
English: Some local vaccination schedules currently include recommendations for a booster dose.
Danish: For tiden omfatter nogle lokale vaccinationsprogrammer en anbefaling om en boosterdosis.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: In subjects in whom insufficient antibody titres are achieved after boosting, the use of alternative hepatitis B vaccines should be considered.
Danish: Hos personer, hvor der opnås utilstrækkelige antistoftitre efter revaccination, skal brugen af alternative hepatitis B-vacciner overvejes.
English: This product contains natural rubber latex which may cause allergic reactions.
Danish: Produktet indeholder naturgummi-latex, som kan give allergiske reaktioner.
English: Therefore, hypersensitivity reactions may occur (see sections 2 and 4.8).
Danish: Derfor kan overfølsomhedsreaktioner forekomme (se pkt.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger, kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Your doctor, pharmacist or nurse will inform you if a booster dose should be given.
Danish: Din læge, apotekspersonalet eller sygeplejersken vil informere om, hvorvidt en boosterdosis skal gives.
English: This vaccine should be administered intramuscularly.
Danish: Denne vaccine bør administreres intramuskulært.
English: Fatigue, Fever, Malaise, Influenza-like symptoms
Danish: Træthed, feber, utilpashed, influenza-lignende symptomer
English: The appropriate strength for administration to individuals from birth to 15 years of age is HBVAXPRO 5 micrograms.
Danish: Den passende styrke for administration til børn fra fødslen og op til 15 år er HBVAXPRO 5 mikrogram.
English: Caution should be exercised when prescribing the vaccine to pregnant or breast-feeding women.
Danish: Der skal udvises forsigtighed ved ordination af vaccinen til gravide eller ammende kvinder.
English: Pharmacotherapeutic group: anti-infectious, ATC code: J07BC01
Danish: Farmakoterapeutisk klassifikation: infektionssygdomme, systemiske midler, ATC-kode: J07BC01
English: c. Other special population
Danish: Meget sjælden c. Anden særlig population
English: Fertility: HBVAXPRO has not been evaluated in fertility studies.
Danish: Fertilitet HBVAXPRO er ikke blevet evalueret i fertilitetsstudier.
English: There have been reports of administration of higher than recommended doses of HBVAXPRO.
Danish: Der har været indberetninger om administration af højere doser HBVAXPRO end de anbefalede.
English: Hepatocellular carcinoma is a serious complication of hepatitis B virus infection.
Danish: Hepatocellulært carcinom er en alvorlig komplikation af hepatitis B-virusinfektion.
English: This vaccine may contain traces of formaldehyde and potassium thiocyanate, which are used during the manufacturing process.
Danish: Denne vaccine kan indeholde spor af formaldehyd og kaliumthiocyanat, som anvendes under fremstillingen.
English: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon France
Danish: MSD VACCINS 162 avenue Jean Jaurès 69007 Lyon Frankrig
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: - Hepatitis B immunoglobulin should be given as soon as possible after exposure (within 24 hours).
Danish: - Hepatitis B immunglobulin bør gives snarest muligt efter eksponering (indenfor 24 timer).
English: Date of first authorisation: 27/04/2001 Date of last renewal: 17/03/2011
Danish: Dato for første markedsføringstilladelse: 27. april 2001 Dato for seneste fornyelse: 17. marts 2011
English: Do not inject intravascularly.
Danish: Må ikke injiceres intravaskulært.
English: As with other hepatitis B vaccines, the duration of the protective effect in healthy vaccinees is unknown at present.
Danish: Som ved andre hepatitis B-vacciner er varigheden af den beskyttende effekt hos raske, vaccinerede personer ikke kendt på nuværende tidspunkt.
English: Immune system disorders Serum sickness, Anaphylaxis, Polyarteritis nodosa
Danish: Immunsystemet Serumsyge, anafylaksi, polyarteritis nodosa
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af indflydelsen på evnen til at føre bil eller betjene maskiner.
English: Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see section 4.4).
Danish: Apnø hos meget præmature spædbørn (født i ≤ 28. gestationsuge) (se pkt.
English: For clinical or laboratory monitoring regarding immunocompromised individuals or individuals with known or presumed exposure to hepatitis B virus, see section 4.2.
Danish: For klinisk eller laboratoriemæssig overvågning vedrørende immunkompromitterede personer eller personer med kendt eller formodet eksponering for hepatitis B-virus, se pkt.
English: The other ingredients are sodium chloride, borax and water for injections.
Danish: Øvrige indholdsstoffer: natriumchlorid, natriumborat og vand til injektionsvæsker.
English: Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia or bleeding disorders.
Danish: Undtagelsesvist kan vaccinen injiceres subkutant hos patienter med trombocytopeni eller blødningsforstyrrelser.
English: * produced in Saccharomyces cerevisiae (strain 2150-2-3) yeast by recombinant DNA technology.
Danish: * fremstillet i Saccharomyces cerevisiae (stamme 2150-2-3) gærceller ved hjælp af rekombinant DNA-teknologi.
English: Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Danish: Spørg din læge, apotekspersonalet eller sygeplejersken til råds, før du tager nogen form for medicin.
English: Exceptionally, the vaccine may be administered subcutaneously in patients with thrombocytopaenia (diminution of blood platelets) or to persons at risk of haemorrhage.
Danish: Undtagelsesvist kan vaccinen injiceres subkutant hos patienter med trombocytopeni (nedsat antal blodplader) eller risiko for blødning.
English: The vaccine will not prevent infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E and other pathogens known to infect the liver.
Danish: Vaccinen beskytter ikke mod infektion forårsaget af hepatitis A, hepatitis C og hepatitis E eller andre patogener, der inficerer leveren.
English: Although the duration of the protective effect of a previous formulation of Merck's recombinant hepatitis B vaccine in healthy vaccinees is unknown, follow-up over 5-9 years of approximately 3,000 high-risk subjects given a similar plasma-derived vaccine has revealed no cases of clinically apparent hepatitis B infection.
Danish: Skønt varigheden af den beskyttende effekt af en tidligere formulering af Mercks rekombinante hepatitis B-vaccine hos raske vaccinerede er ukendt, viser en opfølgning over 5-9 år af ca. 3000 personer i højrisikogruppe, som har fået en tilsvarende vaccine fremstillet ud fra plasma, at der ikke er udviklet kliniske tegn på en hepatitis B-infektion.
English: The protective efficacy of a dose of hepatitis B immunoglobulin at birth followed by 3 doses of a previous formulation of Merck's recombinant hepatitis B vaccine has been demonstrated for neonates born to mothers positive for both hepatitis B virus surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg).
Danish: Den beskyttende effekt af en dosis hepatitis B immunglobulin ved fødslen efterfulgt af 3 doser af en tidligere formulering af Mercks rekombinante hepatitis B-vaccine er vist hos spædbørn, som er født af mødre, der var positive for både hepatitis B-virus overflade-antigen (HBsAg) og hepatitis B-virus eantigen (HBeAg).
English: Respiratory, thoracic and mediastinal disorders Bronchospasm-like symptoms
Danish: Luftveje, thorax og mediastinum Bronkospasmelignende symptomer
English: The accelerated schedule including the 12 month booster dose can be proposed.
Danish: Det fremskyndede vaccinationsprogram, herunder revaccination ved 12 måneder, er en mulighed.
English: Vascular disorders Hypotension, Vasculitis
Danish: Vaskulære sygdomme Hypotension, vaskulit
English: Dosage recommendations for neonates born to mothers who are hepatitis B virus carriers
Danish: Doseringsanbefalinger til nyfødte født af mødre, der er bærere af hepatitis B-virus
English: The active substance is:
Danish: Aktivt stof :
English: - concomitantly with other vaccines, using separate sites and syringes.
Danish: - samtidigt med andre vacciner, idet der dog skal anvendes separate sprøjter på forskellige injektionssteder.
English: The recommended dose for each injection (1 ml) is 40 micrograms for predialysis and dialysis adult patients
Danish: Den anbefalede dosis pr. injektion (1 ml) er 40 mikrogram til voksne prædialyse- og dialysepatienter.
English: General disorders and administration site conditions Local reactions (injection site): Transient soreness, Erythema, Induration
Danish: Almene symptomer og reaktioner på administrationsstedet Lokale reaktioner (injektionsstedet): forbigående ømhed, erytem, induration
English: Blood and the lymphatic system disorders Thrombocytopaenia, Lymphadenopathy
Danish: Blod- og lymfesystem Trombocytopeni, lymfadenopati
English: The recommended dose for each injection (0.5 ml) is 5 micrograms for individuals from birth through 15 years of age.
Danish: Den anbefalede dosis pr. injektion (0,5 ml) er 5 mikrogram til børn fra fødslen til og med 15 år.
English: 1 single dose 0.5 ml pre-filled syringe without needle 10 single dose 0.5 ml pre-filled syringes without needle 20 single dose 0.5 ml pre-filled syringes without needle 50 single dose 0.5 ml pre-filled syringes without needle 1 single dose 0.5 ml pre-filled syringe with 1 separate needle 10 single dose 0.5 ml pre-filled syringes with 1 separate needle (for each syringe) 1 single dose 0.5 ml pre-filled syringe with 2 separate needles 10 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) 20 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) 50 single dose 0.5 ml pre-filled syringes with 2 separate needles (for each syringe)
Danish: 1 endosis fyldt injektionssprøjte a 0,5 ml uden nål 10 endosis fyldte injektionssprøjter a 0,5 ml uden nål 20 endosis fyldte injektionssprøjter a 0,5 ml uden nål 50 endosis fyldte injektionssprøjter a 0,5 ml uden nål 1 endosis fyldt injektionssprøjte a 0,5 ml med 1 separat nål 10 endosis fyldte injektionssprøjter a 0,5 ml med 1 separat nål (til hver injektionssprøjte) 1 endosis fyldt injektionssprøjte a 0,5 ml med 2 separate nåle 10 endosis fyldte injektionssprøjter a 0,5 ml med 2 separate nåle (til hver injektionssprøjte) 20 endosis fyldte injektionssprøjter a 0,5 ml med 2 separate nåle (til hver injektionssprøjte) 50 endosis fyldte injektionssprøjter a 0,5 ml med 2 separate nåle (til hver injektionssprøjte)
English: The vaccine induces specific humoral antibodies against hepatitis B virus surface antigen (anti-HBsAg).
Danish: Vaccinen inducerer specifikke humorale antistoffer mod hepatitis B virus overflade-antigen (antiHBsAg).
English: Sodium chloride, borax and water for injections.
Danish: Natriumchlorid, natriumborat og vand til injektionsvæsker.
English: However, HBVAXPRO is expected to have no or negligible influence on the ability to drive and use machines.
Danish: Det forventes, at HBVAXPRO har ingen eller kun ubetydelig indflydelse på evnen til at føre motorkøretøj og betjene maskiner.
English: Revaccination of nonresponders
Danish: Revaccination af personer som ikke udvikler antistofsvar
English: - At birth, one dose of hepatitis B immunoglobulin (within 24 hours).
Danish: - Ved fødslen gives en dosis hepatitis B immunglobulin (inden for 24 timer).
English: If you or your child forget one dose of HBVAXPRO 5 micrograms
Danish: Hvis du eller dit barn har glemt en dosis HBVAXPRO 5 mikrogram
English: A booster dose should be given when antibody levels decline below 10 IU/l.
Danish: En boosterdosis skal gives, når antistofniveauet falder til under 10 IE/l.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Danish: Yderligere oplysninger om denne vaccine findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Once the vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Danish: Når hætteglassets forsegling er blevet brudt, skal den udtrukne vaccine anvendes med det samme, og hætteglasset smides ud.
English: In general, the adverse event profile reported with overdose was comparable to that observed with the recommended dose of HBVAXPRO.
Danish: Generelt var bivirkningsprofilen ved overdosering sammenlignelig med den, der ses ved administration af den anbefalede dosis HBVAXPRO.
English: Infants receiving the compressed regimen (0, 1, 2 months dosing schedule) must receive the 12 month booster to induce higher antibody titres.
Danish: Spædbørn som behandles efter det komprimerede program (0, 1, 2 måneders dosisplan) skal revaccineres ved 12 måneder for at inducere højere anstistoftitre.
English: The needle is attached by twisting in clockwise direction, until the needle fits securely on the syringe.
Danish: Nålen fastgøres ved at dreje med uret, indtil nålen sidder sikkert på sprøjten.
English: The most common side effects seen are injection-site reactions: soreness, redness and hardening.
Danish: De bivirkninger, som hyppigst ses, er reaktioner på injektionsstedet: ømhed, rødme og hårdhed.
English: HBVAXPRO 10 micrograms is not indicated in this subset of paediatric population.
Danish: Dosering hos personer under 16 år HBVAXPRO 10 mikrogram er ikke indiceret til denne undergruppe i den pædiatriske population.
English: The recommended dose for each injection (1 ml) is 10 micrograms for individuals 16 years of age or more.
Danish: Den anbefalede dosis pr. injektion (1 ml) er: 10 mikrogram til personer fra 16 år og ældre.