FrancophonIA/ELRC3.0 huggingface dataset:
English: if your child has fever or other illness, particularly a cough, cold or flu (vaccination should be delayed).
Danish: - Hvis dit barn har feber eller anden sygdom, især hoste, forkølelse eller influenza (vaccination bør udsættes).
English: In rare instances, these cases were associated with swelling of the entire limb.
Danish: I sjældne tilfælde blev det forbundet med opsvulmning af hele ekstremiteten.
English: Rare (>1/10,000 and <1/1,000) Body as a whole - General disorders: Prolonged or abnormal crying.
Danish: Sjældne (>1/10.000 og <1/1000) Hele kroppen - generelle reaktioner: Langvarig eller unormal gråd.
English: These signs and symptoms usually occurred within 48 hours following the vaccination.
Danish: Disse tegn og symptomer indtraf sædvanligvis indenfor 2 døgn efter vaccinationen.
English: in case of newborns, adolescents or adults.
Danish: - Til nyfødte, unge og voksne.
English: Except in the case of immunosuppressive therapy (see 4.4 Special warnings and special precautions for use), no significant clinical interaction with other treatments or biological products has been documented.
Danish: Med undtagelse af immunosuppressiv behandling (se 4.4 "Særlige advarsler og forsigtighedsregler vedrørende brugen"), er der ikke dokumenteret klinisk signifikant interaktion med andre behandlinger eller biologiske produkter.
English: In these circumstances the vaccination course should be continued with vaccine not containing a pertussis component.
Danish: I så fald skulle vaccinationsprogrammet fortsættes med en vaccine, som ikke indeholder en pertussiskomponent.
English: METHOD AND, IF NECESSARY, ROUTE(S) OF ADMINISTRATION Shake well before use.
Danish: ANVENDELSESMÅDE OG OM NØDVENDIGT INDGIVELSESVEJ(E) Omrystes grundigt før brug.
English: Psychiatric disorders: Agitation / Sleep disorder.
Danish: Psykiatriske lidelser: Agitation / søvnforstyrrelser.
English: Adjuvanted on aluminium hydroxide (0.3 mg)
Danish: Adjuveret til aluminiumhydroxid (0,3 mg)
English: Name and address of the manufacturer of the biological active substances
Danish: Navn og adresse på fremstillerne af de biologisk aktive stoffer
English: There should be an interval of at least 1 month between doses : such as 2 , 3, 4 months; 2, 4, 6 months; 3, 5 months.
Danish: Der skal være et interval på minimum 1 måned imellem doserne: f.eks. 2,3,4 måneder, 2,4,6 måneder eller 3,5 måneder.
English: In such cases it is recommended to postpone the vaccination until the end of the disease or treatment.
Danish: Det anbefales at vaccinationen udskydes indtil sådan sygdom eller behandling er afsluttet.
English: HEXAVAC has been generally well tolerated in clinical trials.
Danish: Generelt set tolereredes HEXAVAC godt i kliniske forsøg.
English: This vaccine should not be used in newborns, adolescents or adults.
Danish: Denne vaccine bør ikke anvendes til nyfødte, unge og voksne.
English: They were mostly mild, generally lasting for up to 72 hours and resolved spontaneously.
Danish: De var i de fleste tilfælde milde, generelt varede op til 3 døgn og forsvandt spontant.
English: Febrile convulsion and high-pitched crying have been reported rarely.
Danish: Feberkramper og højrøstet gråd er sjældent rapporteret.
English: • Post marketing experience
Danish: • Erfaringer efter markedsføring
English: The FHA is not detoxified.
Danish: FHA er ikke inaktiveret.
English: When administered alone PRP induces a serological response, but it is weakly immunogenic in infants.
Danish: Når PRP administreres alene induceres et serologisk svar men dette er svagt immunogent hos spædbørn.
English: MANUFACTURER'S BATCH NUMBER Batch
Danish: FREMSTILLERENS BATCHNUMMER Batch
English: HEXAVAC should under no circumstances be administered intravascularly.
Danish: HEXAVAC må under ingen omstændigheder administreres intravaskulært.
English: The immunogenicity of HEXAVAC could be reduced by immunosuppressive treatment or immunodeficiency.
Danish: Vaccinens immunogenicitet kan reduceres af immunosuppressiv behandling eller af immuninsufficiens.
English: WHAT IS HEXAVAC AND WHAT IT IS USED FOR
Danish: HVAD ER HEXAVAC OG HVAD BRUGES DEN TIL
English: In addition, other undesirable effects have been reported with the marketed use of vaccines closely related to HEXAVAC.
Danish: Desuden har andre bivirkninger været rapporteret ved brug af markedsførte vacciner nært beslægtet til HEXAVAC.
English: Storing HEXAVAC 6.
Danish: Opbevaring af HEXAVAC 6.
English: Pharmacotherapeutic group: Bacterial and viral vaccines, combined, ATC code : J07CA
Danish: Terapeutisk klassifikation: kombineret bakteria- og virusvaccine, ATC kode: J07CA
English: A mean 20.5-fold rise in antibody titres to HBs was observed after the booster dose.
Danish: En gennemsnitlig 20,5-foldig øgning i antistoftitre mod HBs blev observeret efter boosterdosis.
English: Immune response after booster injection
Danish: Immunsvar efter boosterinjektion
English: HEXAVAC is available in packs of 1, 10, 25 and 50 with or without neddles.
Danish: HEXAVAC fås i pakningsstørrelser på 1, 10, 25 og 50 stk. med eller uden nål.
English: because as with other similar vaccines, cases of Haemophilus b disease may occur in the week after vaccination prior to the onset of the protective effects of the vaccine.
Danish: - Fordi der som ved lignende vacciner kan opstå tilfælde af Haemophilus b infektion i ugen efter vaccination, inden vaccinens beskyttelse indtræder.
English: Primary vaccination :
Danish: Primærimmunisering:
English: What HEXAVAC is and what it is used for 2.
Danish: Hvad er HEXAVAC og hvad bruges den til 2.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
English: A single bilateral oedematous reaction of the lower limbs and a single, hypotonic hyporesponsive episode have been reported.
Danish: Et enkelt tilfælde med dobbeltsidig ødem i de nedre ekstremiteter og et enkelt tilfælde af hypotonisk-hyporesponsiv episode har været rapporteret.
English: Active substances:
Danish: Aktive stoffer
English: POSSIBLE SIDE EFFECTS
Danish: Mulige bivirkninger
English: EXPIRY DATE EXP:
Danish: UDLØBSDATO EXP :
English: 6.6 Instructions for use and handling
Danish: 6.6 Eventuelle instruktioner vedrørende anvendelse og håndtering
English: As with other hepatitis B vaccines, in many instances, the causal relationship to the vaccine has not been established.
Danish: Som for andre hepatit B vacciner er årsagssammenhængen i mange tilfælde ikke blevet påvist.
English: These reactions were mostly moderate (less than or equal to 39° C) and transient.
Danish: Disse reaktioner var for størstedelens vedkommende moderate (≤ 39°C) og forbigående.
English: The primary vaccination schedule consists of two or three doses of 0.5 ml administered within the first year of life according to the official recommendations.
Danish: Grundvaccinationsprogrammet består af to eller tre doser på 0,5 ml der administreres i løbet af det første leveår i henhold til myndighedernes anbefalinger.
English: For needle free syringes, the needle should be pushed firmly on to the end of the prefilled syringe and rotated through 90 degrees.
Danish: Ved injektionssprøjter uden nål skal nålen trykkes fast på enden af den fyldte sprøjte og drejes 90 grader.
English: After booster, GMTs increased to 16.7 µg/ml and 23.0 µg/ml in each group respectively, indicating a strong anamnestic response.
Danish: Efter boosterinjektionen steg GMTs til henholdsvis 16,7 µg/ml og 23,0 µg/ml i de to grupper, hvilket viser et stærkt anamnestisk respons.
English: The vaccine may not prevent hepatitis B infection in such cases.
Danish: Vaccinen vil muligvis ikke forebygge hepatitis B i sådanne tilfælde.
English: The covalent binding of PRP to tetanus toxoid makes it a T-cell dependent antigen which induces a specific IgG anti-PRP response in infants and which elicits immune memory.
Danish: Den kovalente binding af PRP til tetanustoksoid gør konjugatet til et T-celle afhængigt antigen, som inducerer et specifikt IgG anti-PRP svar hos spædbørn og frembringer immunologisk hukommelse.
English: if your child has an hypersensitivity to neomycin, streptomycin and polymyxin B, due to the use of these substances during production.
Danish: - Hvis dit barn er overfølsom overfor neomycin, streptomycin eller polymyxin B, grundet anvendelsen af disse substanser under fremstillingen.
English: ** Surface antigen of hepatitis B virus produced from recombinant strain 2150-2-3 of the yeast
Danish: ** Overflade-antigen af hepatitis B virus fremstillet i rekombinante gærceller, stamme 2150-2-3
English: The acellular pertussis components (pertussis toxin: PT and filamentous haemagglutinin: FHA) are extracted from Bordetella pertussis cultures then separately purified.
Danish: De acellulære pertussis komponenter (pertussistoksin: PT og filamentøst haemagglutinin: FHA) ekstraheres fra Bordetella pertussis kulturer og renses derefter separat.
English: In subjects who have a history of a severe reaction within 48 hours of a previous injection with a vaccine containing similar components, the course of vaccination should be carefully considered.
Danish: Hos børn som tidligere har vist en alvorlig reaktion indenfor 2 døgn efter en injektion med en vaccine, der indeholder lignende komponenter, skal vaccinationsprogrammet overvejes omhyggeligt.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Redness and/or induration > 7 cm at the injection site increased after booster immunisation but remained < 1 %.
Danish: Rødme og/eller induration > 7 cm på injektionsstedet steg efter boosterimmuniseringen men forblev < 1 %.
English: Respiratory system disorders: Dyspnoea or Stridor inspiratory.
Danish: Lidelser i åndedrætssystemet: Dyspnø eller inspiratorisk stridor
English: • Clinical trials experience
Danish: • Erfaringer fra kliniske studier
English: The pertussis toxin (PT) is detoxified separately with glutaraldehyde to create the toxoid (PTxd).
Danish: Pertussistoksinet (PT) inaktiveres separat med glutaraldehyd til fremstilling af et toksoid (PTxd).
English: The following additional undesirable effects have been reported following the widespread use of HEXAVAC.
Danish: Følgende yderligere bivirkninger har været rapporteret efter udbredt brug af HEXAVAC.
English: However, when HEXAVAC was co-administered in clinical studies the rate of febrile reactions was higher compared to that occurring following administration of hexavalent vaccines alone.
Danish: Når Hexavac i de kliniske studier blev co-administreret, var antallet af febrile reaktioner imidlertid højere end ved administration af hexavalente vacciner alene.
English: Common (>1/100 and <1/10) Application site disorders (reactions at the injection site): Oedema / Pruritus / Urticaria.
Danish: Almindelige (>1/100 og <1/10) Reaktioner på applikationsstedet (reaktioner på injektionsstedet): ødem, pruritus, urticaria.
English: In addition, tell your doctor if your child experiences any symptoms that suggest an allergic reaction such as rash, redness, itching, pallor or oedema after any dose in the vaccination series.
Danish: Du bedes også informere lægen om dit barn har symptomer der tyder på en allergisk reaktion såsom udslæt, rødme, kløe, bleghed eller ødem, uanset hvilken dosis vaccine i vaccinationsprogrammet barnet har fået.
English: Other side effects included irritability, sleepiness, fever, sleeplessness, diarrhoea, vomiting, loss of appetite and prolonged crying where the child cannot be consoled.
Danish: Øvrige bivirkninger omfattede irritabilitet, døsighed, feber, søvnløshed, diaré, opkastning, nedsat appetit og langvarig gråd hvor barnet ikke lader sig trøste.
English: The rate of fever equal to or greater than 40 °C increased after booster immunisation but remained < 1 %.
Danish: Hyppigheden af feber på 40 °C eller højere steg efter boosterimmuniseringen men forblev < 1 %.
English: HEXAVAC does not protect against invasive diseases due to serotypes other than Haemophilus influenzae type b or against meningitis of other origins.
Danish: HEXAVAC beskytter ikke mod invasive sygdomme forårsaget af andre serotyper end Haemophilus influenzae type b eller mod meningitis af anden oprindelse.
English: HEXAVAC is an injectable vaccine in a 0.5 ml single dose syringe.
Danish: HEXAVAC er en injicerbar vaccine i en 0,5 ml enkeltdosissprøjte.
English: As each dose may contain undetectable traces of neomycin, streptomycin and polymyxin B, caution should be exercised when the vaccine is administered to subjects with hypersensitivity to these antibiotics.
Danish: Eftersom hver dosis kan indeholde upåviselige spor af neomycin, streptomycin og polymyxin B bør forsigtighed udvises når vaccinen gives til børn som er overfølsomme overfor disse antibiotika.
English: As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of vaccine.
Danish: Som ved enhver vaccine skal fornødne behandlingsfaciliteter og medicin være let tilgængelige til øjeblikkelig anvendelse i tilfælde af en anafylaktisk reaktion efter injektion.
English: Very rarely there may be allergic reaction; chills; fatigue; malaise; oedema; swelling of the entire limb(s); Guillain Barré Syndrome; hypotonic hyporesponsive episode; pallor; convulsions (with or without fever); brain inflammation, acute brain swelling; eyes rolling; decrease in muscle tone; neuritis; nausea; abdominal gas and/or pain; low platelet count; purple or red brown spots visible through the skin; agitation; difficulty sleeping; breathing difficulty ; wheezing ; swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing; rash; skin redness; generalized hives; generalized itching; flushing; temporary swelling of local lymph nodes.
Danish: Meget sjældent kan der forekomme allergiske reaktioner, kuldegysninger, træthed, utilpashed, ødem, hævelse på hele ekstremiteten(erne), Guillain Barré syndrom, hypotonisk-hyporesponsiv episode, bleghed, krampeanfald (med eller uden feber), hjernebetændelse, akut hævelse af hjernen, rullende øjne, nedsat muskeltonicitet, neuritis, kvalme, luft og/eller smerter i maven, lavt trombocyttal, lilla eller rødbrune pletter synlige gennem huden, agitation, søvnforstyrrelser, åndedrætsbesvær, hvæsende åndedræt, hævelser i ansigtet, læberne, tungen eller halsen, der kan medføre problemer med at synke eller trække vejret, udslæt, rødlig hud, generel nældefeber, generel kløe, rødmen, forbigående lokal hævelse af lymfeknuderne.
English: No increase in the number of undesirable reactions was noted between first, second and third doses of the primary series except for an increase in the rate of fever equal to or greater than 38 °C after the second dose in the primary series.
Danish: Der blev ikke konstateret nogen forhøjelse i antallet af rapporterede bivirkninger mellem 1., 2. og 3. dosis under primærimmuniseringen bortset fra en lille forhøjelse i hyppigheden af feber på 38 °C eller højere efter 2. dosis i primærimmuniseringen.
English: This vaccine induces specific humoral antibodies against HBsAg (anti-HBs) and against diphtheria and tetanus toxoids (anti-D and anti-T).
Danish: Denne vaccine inducerer specifikke humorale antistoffer mod HBsAG (anti-HBs) og mod difteri- og tetanustoksoider (anti-D og anti-T).
English: If any of the following events are known to have occurred in temporal relation to receipt of the vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:
Danish: Er det kendt at nogen af de følgende reaktioner er indtruffet i tidsmæssig sammenhæng med vaccinationen, bør man nøje overveje beslutningen om at administrere yderligere doser af vacciner som indeholder pertussis:
English: For pertussis, 91.8 % and 90.5 % of infants achieved a four-fold rise in PT and FHA antibody titres respectively.
Danish: Med hensyn til pertussis udviklede 91,8 % respektive 90,5 % af spædbørnene en firefoldig øgning af PT og FHA antistoffer.
English: For excipients, see 6.1
Danish: Hjælpestoffer, se 6.1
English: Before you use HEXAVAC 3.
Danish: Inden du anvender HEXAVAC 3.
English: Just before the booster injection anti-PRP GMTs were 0.40 µg/ml and 0.64 µg/ml for HEXAVAC and for the control group respectively.
Danish: Umiddelbart inden boosterinjektionen var anti-PRP GMTs på 0,40 µg/ml og 0,64 µg/ml for henholdsvis HEXAVAC og kontrolgruppen.
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN OG, OM NØDVENDIGT, STYRKE OG/ELLER INDGIVELSESVEJ(E)
English: The 4-fold increase in post immunisation titres is considered a sign of seroconversion of which the clinical significance is unknown in the absence of a serological correlate of protection.
Danish: Den firedobbelte øgning i titre efter vaccination, hvis kliniske signifikans er ukendt i mangel af et serologisk beskyttelsesniveau, anses som tegn på serumkonversion.
English: Take special care with HEXAVAC:
Danish: Særlig forsigtighed med HEXAVAC kræves:
English: HEXAVAC must not be mixed in the same syringe with other vaccines or other parenterally administered drugs.
Danish: HEXAVAC må ikke blandes i samme sprøjte med andre vacciner eller andre parenterale lægemidler.
English: A mean 7.4 and 4.3-fold rise in antibody titres to PT and FHA respectively was achieved and all toddlers developed protective antibody titres against poliovirus types 1, 2 and 3.
Danish: Der blev opnået en gennemsnitlig 7,4- respektive 4,3-foldig øgning i antistoftitre mod PT og FHA, og alle udviklede beskyttende antistoftitre mod poliovirus type 1, 2 and 3.
English: Known hypersensitivity to any component of the vaccine or severe reaction after previous administration of the vaccine.
Danish: Kendt overfølsomhed overfor en eller flere af de i vaccinen indgående komponenter eller tidligere alvorlig reaktion på vaccinen.
English: Immune response after primary vaccination
Danish: Immunsvar efter primærimmunisering
English: HEXAVAC should not be used as the birth dose or subsequent doses during the first year of life for children born to HbsAg-positive mothers .
Danish: HEXAVAC bør ikke anvendes ved fødslen eller efterfølgende vaccinationer i løbet af det første leveår til børn født af HBsAg-positive mødre.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 dose = 0.5 ml
Danish: INDHOLDSMÆNGDE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER En dosis = 0,5 ml
English: HEXAVAC will not prevent hepatitis infection caused by other agents such as hepatitis A, hepatitis C and hepatitis E or by other liver pathogens.
Danish: HEXAVAC forebygger ikke hepatitis infektion forårsaget af hepatitis A, hepatitis C, hepatitis E eller af andre leverpatogener.
English: if your child has a thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
Danish: - Hvis dit barn har trombocytopeni eller blødningsforstyrrelser, idet blødning kan forekomme efter intramuskulær administration hos sådanne patienter.
English: The poliomyelitis vaccine is obtained from the propagation of poliomyelitis viruses types 1, 2 and 3 on Vero cells, purified, then inactivated by formaldehyde.
Danish: Poliovaccinen fremstilles ved dyrkning af poliovirus typer 1, 2 og 3 på Vero celler, som renses og derefter inaktiveres med formaldehyd.
English: BEFORE YOU USE HEXAVAC
Danish: INDEN DU ANVENDER HEXAVAC
English: In clinical trials, more than 3,900 infants and 4,400 toddlers (from 12 to 20 months of age) have received HEXAVAC.
Danish: I kliniske studier blev HEXAVAC givet til flere end 3900 spædbørn og 4400 småbørn (i alderen 12 til 20 måneder).
English: After primary vaccination, 93.7 % of infants had an anti-PRP titre equal to or greater than 0.15 µg/ml; the GMTs were diminished compared to the control group (2.06 µg/ml versus 3.69 µg/ml).
Danish: Efter primærimmuniseringen udviste 93,7 % af børnene anti-PRP titre på 0,15 µg/ml eller højere; GMT's var nedsat i sammenligning med kontrolgruppen (2,06 µg/ml kontra 3,69 µg/ml) .
English: The surface antigen of hepatitis B virus is produced by culture of a recombinant strain of yeast cells (Saccharomyces cerevisiae).
Danish: Overfladeantigener fra hepatitis B virus fremstilles ved dyrkning af en rekombinant stamme af gærceller (Saccharomyces cerevisiae).
English: Less commonly, fever equal to or greater than 40 °C, tenderness at the injection site, prolonged inconsolable crying and redness and/or induration > 7 cm at the injection site or swelling of the entire limb have been reported.
Danish: Mindre hyppigt blev feber på 40 °C eller højere, ømhed på injektionsstedet, langvarig utrøstelig gråd og rødme og/eller induration > 7 cm på injektionsstedet eller hævelse af hele ekstremiteten rapporteret.
English: After a 3, 5, 12 months schedule, immune responses were compatible with the sought clinical protection and of the same magnitude as those reported previously for HEXAVAC or other licensed combination vaccines during the second year of life
Danish: Efter 3,5,12 måneders immunuseringsskemaet er immuneresponse i løbet af andet leveår sammenligneligt og af samme intensitet som den eftertragtede kliniske beskyttelse tidligere rapporteret for HEXAVAC og andre godkendte kombinationsvacciner.
English: PHARMACEUTICAL FORM Suspension for injection in pre-filled syringe HEXAVAC is a slightly opaque white suspension
Danish: LÆGEMIDDELFORM Injektionsvæske, suspension i fyldt injektionssprøjte HEXAVAC er en svagt uklar, hvid suspension.
English: The diphtheria and tetanus toxoids are prepared from the toxins of cultures of Corynebacterium diphtheriae and Clostridium tetani by formaldehyde detoxification followed by purification.
Danish: Difteri- og tetanustoksoiderne fremstilles af toksinerne fra kulturer af Corynebacterium diphteriae og Clostridium tetani som er inaktiveret med formaldehyd og derefter renset.
English: Very rare reactions following the use of Sanofi Pasteur MSD hepatitis B (recombinant) vaccine include alopecia, hypotension, optic neuritis, facial paralysis, erythema multiforme, and anaphylaxis.
Danish: Meget sjældne reaktioner efter anvendelse af Sanofi Pasteur MSD hepatitis B (rekombinant) vaccine omfatter alopecia, hypotension, betændelse af synsnerven, ansigtslammelse, erythema multiforme, og anafylaksi.
English: Platelets, bleeding & clotting disorders: Petechiae / Purpura / Purpura thrombocytopenic / Thrombocytopenia.
Danish: Nedsat funktion af trombocytter, blødning & koagulaton: Petecchiae / trombocytopenisk purpura / trombocytopeni / purpura.
English: Central and peripheral nervous system disorders: Convulsions (febrile and non febrile) / Encephalitis / Encephalopathy with acute brain oedema / Eyes rolling / Guillain Barré Syndrome / Hypotonia / Neuritis.
Danish: Forstyrrelser i centralnervesystemet og det perifere nervesystem: Krampeanfald (med eller uden feber) / hjernebetændelse/ encefalopati med akut hjerneødem/ rullende øjne / Guillain Barré syndrom / hypotoni / neuritis.
English: Store at 2 °C - 8 °C (in a refrigerator).
Danish: Opbevares ved 2 °C - 8 °C (i køleskab).
English: Before use, the vaccine should be well shaken in order to obtain a homogeneous slightly opaque white suspension.
Danish: Omrystes grundigt før brug for at få en homogen og svagt uigennemsigtig, hvid suspension.
English: Following the booster dose, 96.6 % of toddlers developed anti-HBs titres equal to or greater than 10 mIU/ml.
Danish: Efter boosterdosis udviklede 96,6 % af småbørnene anti-HBs titre på 10 mIE/ml eller højere.
English: Development of anti-HBs titre equal to or greater than 10 mIU/ml and of anti-D and anti-T equal to or greater than 0.01 IU/ml measured 1-2 months after the third injection correlates with protection against hepatitis B infection and against diphtheria and tetanus respectively.
Danish: Udvikling af anti-HBs-titer på 10 mIE/ml eller højere og af anti-D og anti-T på 0,01 IE/ml eller højere, målt 1-2 måneder efter den tredje injektion anses for beskyttende mod HBV-infektion henholdsvis difteri og tetanus.