FrancophonIA/ELRC3.0 huggingface dataset:
English: Accidental ingestion of the implant by the dog will not affect its health, since the oral bio-availability of GnRH agonists is very low.
Danish: Hvis implantatet ved et uheld spises af hunden vil dens helbred ikke påvirkes, da den orale biotilgængelighed af GnRH agonister er meget lav.
English: Initially, it stimulates pituitary function and secretion of the gonadotrophins LH (luteinising hormone) and FSH (follicle stimulating hormone).
Danish: Først stimulerer det hypofysens funktion og sekretion af gonadotropinerne LH (luteiniserende hormon) og FSH (follikel-stimulerende hormom).
English: In addition following a repeat treatment, the timing of a return to heat cannot be accurately predicted.
Danish: Yderligere, efterfulgt af gentagen behandling, kan tidspunktet for brunst ikke nøjagtigt forudsiges.
English: For a full list of excipients, see section 6.1.
Danish: Se en fuldstændig fortegnelse over hjælpestoffer i pkt.6.1.
English: Based on field data, the occurrence of oestrus after a single treatment was prevented for 12 months or more in 75% of treated adult bitches and  90 % of treated prepubertal bitches.
Danish: Feltdata viser, at forekomsten af østrus efter en enkel behandling blev udsat i 12 måneder eller mere hos 75 % af de behandlede voksne tæver og > 90 % af tæver, der blev behandlet præpuberalt.
English: Metabolism and excretion: The clearance of azagly-nafarelin following intravenous administration of the same dose is 0.46 l/h and the elimination half-life is 1.8 hours.
Danish: Metabolisering og udskillelse: Clearance af azagly-nafarelin efter intravenøs administration af samme dosis er 0,46 l/t og eliminationshalveringstiden er 1,8 timer.
English: The diluted solution for injection should be used immediately.
Danish: Injektionsopløsningen bør anvendes med det samme.
English: Inject intraperitoneally along the central line, 1/2 to 1 fin length in front of the pelvic fin base.
Danish: Injicer intraperitonelt langs midtlinjen, ½ til 1 finnelængde foran bugfinnen.
English: Locate the implant by gentle digital palpation of the administration site.
Danish: Lokaliser implantatet med palpation af administrationsstedet.
English: In the absence of clinical information, do not treat bitches less than 3 kg bodyweight and bitches of giant breeds over 45 kg bodyweight.
Danish: I tilfælde af manglende klinisk information, må tæver på under 3 kg og tæver på over 45 kg ikke behandles.
English: Azagly-nafarelin is a synthetic analogue of gonadotrophin-releasing hormone (GnRH).
Danish: Azagly-nafarelin er en syntetisk analog til gonadotropin-frigivende hormon (GnRH).
English: This retracts the needle and withdraws it, leaving the implant beneath the skin.
Danish: Derved tilbagetrækkes kanylen og efterlader implantatet under huden.
English: Chemical restraint (sedation and/or general anaesthesia) may be required for implant removal.
Danish: Sedation og/eller generel anæstesi kan være nødvendig for at fjerne implantatet.
English: In adult bitches, heat is commonly induced in the first month following the first administration of the implant.
Danish: Der kan ses brunst hos voksne tæver i den første måned efter første administration af implantatet.
English: Laboratory studies have shown that administration of the product during early pregnancy in the bitch is unlikely to affect that pregnancy (that is, pregnancy will be carried to full term with the birth of viable pups).
Danish: Laboratoriestudier har vist, at administration af produktet i den tidlige drægtighed hos tæven sandsynligvis ikke har effekt på drægtigheden (drægtigheden vil fortsætte til termin med fødsel af levedygtige hvalpe).
English: The distribution and metabolism of azagly-nafarelin have not been studied in the target species.
Danish: Distribution og metabolisme af azagly-nafarelin er ikke undersøgt i måldyret.
English: EXP {month/year}
Danish: ”Måned/År”
English: However, it should be noted that within the first month after treatment a proportion of treated bitches also experienced an induced heat (see section 4.5).
Danish: Det bør imidlertid bemærkes, at der inden for den første måned efter behandling forekom brunst hos nogle af de behandlede tæver (se pkt.
English: Pharmaceutical group: gonadotrophin-releasing hormone.
Danish: Farmakoterapeutisk gruppe: Gonadotropin-frigivende hormon.
English: Avoid self injection.
Danish: Undgå selvinjektion.
English: An empty sterile mixing vial is supplied separately.
Danish: Et tomt sterilt hætteglas til opblanding leveres separat.
English: Implant
Danish: Implantat
English: Following a single administration, return to ovarian activity after implant removal may take longer in bitches treated before puberty (average 255 days, range 36-429 days) than in adult bitches (average 68 days, range 12 to 264 days).
Danish: Efter en enkel behandling kan tiden indtil næste brunst, efter at implantatet er fjernet, vare længere hos tæver, der er behandlet før kønsmodning (i gennemsnit 255 dage, fra 36 til 429 dage) end i voksne tæver (gennemsnitligt 68 dage, fra 12 til 264 dage).
English: Therefore, if heat is observed, contact with male dogs should be prevented until all signs of heat (vulvar swelling, bleeding and attractiveness to male dogs) cease.
Danish: Hvis der opstår brunst, skal der undgås kontakt med hanhunde indtil alle tegn på brunst ophører (vulvaforstørrelse, blødning og tiltrækning af hanhunde).
English: The duration of prevention of gonadal function is obtained as detailed in the table below:
Danish: Varigheden af udsættelse af løbetid fremgår i detaljer af tabellen nedenfor:
English: 2 ml concentrate vials
Danish: 2 ml koncentrat hætteglas
English: Marketing authorisation holder and manufacturer
Danish: Markedsføringsindehaver og fremstiller
English: Intraperitoneal (IP) use
Danish: Intraperitoneal injektion (i.p.
English: It controls reproduction in fish by modulating the secretion of the pituitary gonadotrophins, luteinizing hormone (LH) and follicle stimulating hormone (FSH), also known in fish endocrinology as GtH-II and GtH-I, respectively.
Danish: Det kontrollerer reproduktionen hos fisk ved at styre udskillelsen af de overordnede kønshormoner; luteiniserende hormon (LH) og follikel-stimulerende hormon (FSH), der inden for fiskens endokrinologi også er kendt som henholdsvis GtH-II og GtH-I. GnRH analoger er peptider.
English: In adult bitches, the first treatment should be administered preferably in metoestrus.
Danish: Til voksne tæver bør første behandling helst administreres i metøstrus.
English: Gonazon should be injected subcutaneously, in the ventral anterior abdominal wall, in the region of the umbilicus, using aseptic technique.
Danish: Gonazon skal injiceres subkutant, foran i umbilicus regionen, under aseptiske forhold.
English: Remove the needle cap.
Danish: Fjern kanylens hætte.
English: The supplied solvent is used to dilute the concentrate to the correct dilution to allow for optimisation of injection volumes for fish of widely varying body weights.
Danish: Den medfølgende solvens bruges til at fortynde koncentratet til den fortynding, der muliggør en optimering af injektionsvolumenet for fisk med stor variation i legemsvægt.
English: Female salmonid fish such as Atlantic salmon (Salmo salar), rainbow trout (Oncorhynchus mykiss), brown trout (Salmo trutta) and Arctic charr (Salvelinus alpinus).
Danish: Laks af hunkøn som atlantisk laks (Salmo salar), regnbueørred (Oncorhynchus mykiss), søørred (Salmo trutta) og fjeldørred (Salvelinus alpinus).
English: After dilution, the product should be used immediately.
Danish: Efter opløsning bør produktet anvendes med det samme.
English: Instruct the owner to keep the administration site clean and dry for 24 hours.
Danish: Instruer dyrets ejer i at holde administrationsstedet rent og tørt i 24 timer.
English: Ensure that the administration site is clean and dry.
Danish: Sørg for at injektionsstedet er rent og tørt.
English: The table below provides the required volume of concentrate and the required volume of solvent to obtain the preferred injection volume of 0.1 ml/ kg fish, 0.2 ml/kg fish, 0.5 ml/kg fish or 1 ml/kg fish.
Danish: Tabellen nedenfor angiver mængden af koncentrat og solvens, der er nødvendig for at opnå det ønskede volumen på 0,1 ml/kg fisk, 0,2 ml/kg fisk, 0,5 ml/kg fisk eller 1,0 ml/kg fisk.
English: VIAL CONTAINING SOLVENT:
Danish: HÆTTEGLAS MED SOLVENS:
English: Sodium chloride / Hydrochloric acid 4N (for pH adjustment)
Danish: Natriumchlorid/Saltsyre 4N (for pH justering) Vand til injektionsvæsker
English: VIAL CONTAINING CONCENTRATE:
Danish: HÆTTEGLAS MED KONCENTRAT:
English: Azagly-nafarelin, a GnRH agonist, has biphasic effects on the pituitary gland when administered continuously.
Danish: Azagly-nafarelin, en GnRH-agonist, har bifasisk effekt på hypofysen, når det administreres vedvarende.
English: In the event of accidental self-administration of the implant, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvinjektion af implantatet ved uheld, søges omgående lægehjælp, og indlægsseddel eller etiket vises til lægen..
English: Dog (bitches)
Danish: Hund (tæve)
English: Store at 2 - 8C (in a refrigerator).
Danish: Opbevares og transporteres ved 2-8C (i køleskab).
English: Do not use in bitches (prepubertal and adult) intended for breeding (see section 4.7).
Danish: Må ikke bruges til tæver (præpuberal og voksne), der skal anvendes til avl.
English: Reductions in fecundity, egg quality and survival to the eyed-egg stage have been observed in fish treated with azagly-nafarelin.
Danish: En reduktion af frugtbarheden, ægkvaliteten og overlevelse til øjenæg-stadie er set hos fisk behandlet med azagly-nafarelin.
English: Therefore, the first treatment should preferably be administered in metoestrus.
Danish: Derfor bør første administration være i metøstrus.
English: Longterm administration results in pituitary desensitisation to the effects of GnRH resulting in a suppression of LH and FSH secretion by the pituitary.
Danish: Langtidsvirkningen resulterer i en desensibilisering af hypofysen over for effekten af GnRH, hvilket resulterer i en suppression af LH- og FSH-udskillelsen fra hypofysen.
English: Take care to avoid penetrating the abdominal wall musculature or fat tissue.
Danish: Undgå at injicere i bugmuskulatur eller fedtvæv.
English: Carton containing one vial with 2 ml of concentrate solution and 1 bottle with 100 ml of solvent.
Danish: Kartonæske indeholdende 1 hætteglas med 2 ml koncentrat og 1 hætteglas med 100 ml solvens.
English: Distribution: The apparent volume of distribution of azagly-nafarelin following intravenous bolus administration, at a dose equivalent to the content of one implant, is 0.12 l/kg.
Danish: Fordeling: Fordelingsvolumen med en intravenøs injektion af azagly-nafarelin, med en dosis der er ækvivalent til indholdet af et implantat, er 0,12 l/kg.
English: <Batch> <Lot> {number}
Danish: < Lot > < Batch.> {nummer}
English: Azagly-nafarelin, like other GnRH analogues, mimics the action of GnRH, through modulation of the secretion of LH and FSH in mammals and fish.
Danish: Som andre GnRH-analoger efterligner azagly-nafarelin GnRH's virkemåde gennem kontrollen med udskillelsen af LH og FSH i pattedyr og fisk.
English: Sodium acetate (tri-hydrate)
Danish: Benzylalkohol Natriumacetat (tri-hydrat)
English: High standards of biosecurity must be observed at the time of injection in order to prevent introduction and spread of infectious diseases between broodstock fish.
Danish: Der må udvises en høj grad af hygiejne ved injektionsbehandlingen for at undgå introduktion og spredning af infektiøse sygdomme mellem avlsfisk.
English: An individual carton box contains a single disposable injection device, preloaded inside a hypodermic needle covered with a protective cap.
Danish: Et enkelt karton med et injektionsapparat til engangsbrug, forberedt med hypodermisk kanyle beskyttet med en hætte.
English: Azagly-nafarelin is rapidly absorbed after intraperitoneal treatment in rainbow trout.
Danish: Azagly-nafarelin optages hurtigt efter intraperitonel behandling af regnbueørreder.
English: Marketing authorisation holder: Intervet International BV Wim de Körverstraat 35
Danish: Markedsføringsindehaver: Intervet International B.V.
English: The unit is sterile and comes in a sealed, light-proof, aluminium foil laminate pouch, packed in an individual carton box.
Danish: Enheden er steril og pakket i en forseglet lamineret pose af aluminiumsfolie, som beskytter mod lys.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Danish: A. FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Based on field trial data, it is evident that the implant may not be retained in a proportion (1.2%) of treated bitches.
Danish: Feltforsøg har vist, at implantatet ikke bibeholdes hos alle tæver (1,2 % af behandlede tæver).
English: The product when administered at the recommended treatment dose is ineffective in bitches aged 7 years or older.
Danish: Når produktet administreres i den anbefalede dosis er det uden effekt på tæver på 7 år eller ældre.
English: Prevention of gonadal function in bitches via long term blockade of gonadotrophin synthesis.
Danish: Udsættelse af løbetiden hos tæver via langtidsblokade af gonadotropin-syntesen.
English: "Month/Year" After dilution, the product should be used immediately.
Danish: ”måneder/år” Efter opløsning skal produktet bruges straks.
English: Excipient: Benzyl alcohol
Danish: Hjælpestof: Benzylalkohol
English: The product, when administered at the recommended treatment dose, is ineffective in bitches aged seven years or older.
Danish: Produktet er, når det administreres i den anbefalede dosis, uden effekt på tæver på 7 år eller ældre.
English: Solvent vial: 100 ml clear glass vial containing 100 ml of solution; rubber stopper and crimp cap.
Danish: Hætteglas med solvens: 100 ml klart hætteglas indeholdende 100 ml opløsning; gummiprop og krympehætte.
English: Azagly-nafarelin 1600 g/ml as azagly-nafarelin acetate.
Danish: Azagly-nafarelin 1600 g/ml som azagly-nafarelinacetat.
English: Dogs (bitches)
Danish: Hunde (tæver)
English: For subcutaneous administration.
Danish: Subkutan administration
English: In bitches where gonadal function has been successsfully prevented for a period of 12 months, then a second treatment may be administered at that time for continued prevention of oestrus.
Danish: I tæver, hvor brunsten er udeblevet i en periode på 12 måneder, kan der gives en anden behandling for at fortsætte udsættelsen af brunst.
English: Risk of overdose is negligible owing to the type of formulation and administration (single dose implant for subcutaneous administration).
Danish: På grund af lægemiddelform og administrationsvej (enkel dosis implantat til subkutan administration) kan der ses bort fra risiko for overdosering.
English: Prepare a small area (e.g. 4 cm²) of the ventral anterior abdominal/ umbilical region for an aseptic procedure.
Danish: Et område ca. 4 cm på den ventral foranliggende abdominal/umbilical region forberedes til aseptisk procedure.
English: If a bitch becomes pregnant following induced heat, embryonic resorption or abortion may occur.
Danish: Der kan forekomme embryonalresorption eller abort, hvis en tæve bliver drægtig efter induceret brunst.
English: Active substance: Azagly-nafarelin 18.5 mg per implant
Danish: Aktivt stof Azagly-nafarelin 18.5 mg pr. implantat.
English: This dose should be administered in the preferred volume for the particular body weight of fish.
Danish: Denne dosis bør gives i det bedst egnede volumen i forhold til de pågældende fisks legemsvægt.
English: Using aseptic technique, raise a small piece of skin in the region of the dog's umbilicus.
Danish: Under aseptisk teknik løftes et lille stykke skind i hundens umbilicus region og der injiceres subkutant.
English: 5831 AN Boxmeer The Netherlands
Danish: Win de Körverstraat 35 NL-5831 AN Boxmeer Holland
English: Avoid accidental self-injection.
Danish: Undgå selvinjektion ved uheld.
English: The dose should be administered in the preferred volume for the particular body weight of fish.
Danish: Dosis bør gives i det bedst egnede volumen i forhold til de pågældende fisks legemsvægt.
English: Carton: 1 concentrate vial and 1 solvent vial.
Danish: Kartonæske: 1 hætteglas med koncentrat og 1 hætteglas med solvens.
English: Concentrate vial: 3 ml brown glass vial containing 2 ml of solution; rubber stopper and crimp cap.
Danish: Hætteglas med koncentrat: 3 ml brunt hætteglas indeholdende 2 ml opløsning; gummiprop og krympehætte.
English: Gonazon concentrate for solution for injection of female salmonid fish
Danish: Gonazon, koncentrat til injektionsvæske, opløsning til laks af hunkøn
English: Sterile container: 50-ml empty
Danish: Steril beholder: 50 ml, tom.
English: Single disposable injection device, preloaded inside a hypodermic needle covered with a protective cap.
Danish: Engangsinjektionssprøjte, der er forberedt med en hypodermisk kanyle, som er beskyttet med en hætte.
English: The incidence of induced heat following administration of a repeat treatment to bitches that have not shown signs of oestrus following a previous administration of the product is low (estimated to be 8%).
Danish: Forekomsten af induceret brunst er lav (anslået til 8%) efter gentagen behandling af tæver, som ikke har vist tegn på østrus efter tidligere behandling.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
Danish: FREMSTILLER AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: Do not use in bitches (prepubertal and adult) intended for breeding.
Danish: Må ikke bruges i tæver (præpubental og voksne) påtænkt til avl.
English: Push the implant gently towards the stab incision.
Danish: Stemplet trykkes helt i bund.
English: A large proportion (68%) of the first heat after a single treatment in adult bitches were non-ovulatory.
Danish: Efter en enkelt behandling hos voksne tæver, sås der hos en stor andel (68%) ikke nogen ægløsning ved første brunst.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE
English: Solvent for solution for injection.
Danish: Solvens til injektionsvæske, opløsning.
English: Induced heat is not observed if treatment is started before puberty.
Danish: Når behandlingen starter før kønsmodning, er der ikke observeret induceret brunst.
English: Azagly-nafarelin is rapidly eliminated from plasma after IP treatment in rainbow trout.
Danish: Azagly-nafarelin elimineres hurtigt fra plasma efter i.p.
English: For animal treatment only- to be supplied only on veterinary prescription.
Danish: Må kun udleveres efter veterinærrecept.
English: Separate empty sterile containers
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE SEPARAT TOMT STERILT HÆTTEGLAS
English: After adequate (local) anaesthesia is present, apply gentle digital pressure to the far end of the implant.
Danish: Pres med fingrene på den fjerne ende af implantatet, efter der er udført passende (lokal) anæstesi.
English: Manufacturer responsible for the batch release: Intervet GesmbH
Danish: Fremstiller af batchfrigivelse Intervet GesmbH Siemensstrasse 107
English: Water for injection
Danish: Til subkutan injektion.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller
English: Concentrate for solution for injection.
Danish: Koncentrat til injektionsvæske, opløsning.
English: Batch < number >
Danish: < Lot> < Batch> (nummer)
English: EXP {month/year} After dilution, the product should be used immediately.
Danish: < Udløbsdato> <EXP> {MM/ÅÅÅÅ} Efter opløsning bør produktet anvendes med det samme.
English: Shelf life after dilution according to directions: the product should be used immediately.
Danish: Opbevaringstid efter fortynding eller rekonstituering ifølge anvisning: produktet bør anvendes med det samme.
English: However, the timing of return to heat cannot be predicted.
Danish: Ved gentagen behandling kan tidspunktet for brunst ikke nøjagtigt forudsiges.
English: If necessary, dissect away any fibrous tissue to free the implant.
Danish: Skub implantatet forsigtigt mod snittet og fjern det. Disseker fibrøst væv væk for at frigøre implantatet, hvis det er nødvendigt.
English: The elimination half-life (T1/2) and Mean Residence Time of azagly-nafarelin in trout after IP treatment of 32 µg/kg BW are 4.9 h and 6.8 h, respectively.
Danish: Eliminations halveringstiden (T½) og Mean Residence Time af azagly-nafarelin i ørreder efter i.p.
English: Open the foil pouch using the pre-cut incision to remove the sterile injection device.
Danish: Åbn folieposen ved at anvende det forskårne snit.
English: Carton Box
Danish: Karton
English: Vial containing solvent
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ 100 ML HÆTTEGLAS MED SOLVENS
English: 23 October 2000
Danish: 23. oktober 2000
English: See the Module “All authorised presentations”
Danish: Se ”All authorised presentations” modulet
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Danish: UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR)
English: These studies showed the protective efficacy of Hexavac against the above diseases in infants.
Danish: Disse undersøgelser viste, at Hexavac havde beskyttende effekt mod ovennævnte sygdomme hos spædbørn.
English: The CHMP, on the basis of quality, efficacy and safety data submitted, consideres that the overall benefit /risk ratio for Hexavac remains favourable in the approved indication.
Danish: CHMP var på grundlag af de forelagte oplysninger om kvalitet, sikkerhed og virkning af den opfattelse, at der forelå et tilfredsstillende risk/benefit-forhold til den godkendte indikation.
English: The most common adverse events were transient local reactions (pain, redness, swelling at the injection site) and systemic reactions (loss of appetite, fever, drowsiness, irritability).
Danish: De hyppigst forekommende bivirkninger var forbigående lokale reaktioner (smerte, rødme, hævelse på injektionsstedet) og systemiske reaktioner (appetitløshed, feber, døsighed, irritabilitet).
English: The following adverse effects were reported very rarely: allergic reaction, chills, fatigue, hypotonichyporesponsive episode, malaise, oedema, pallor, swelling or oedema of the entire limb(s), transient local lymph node swelling, convulsions (febrile and non febrile), encephalitis, encephalopathy with acute brain oedema, eyes rolling, Guillain Barré Syndrome, hypotonia, neuritis, abdominal pain, meteorism, nausea, petechiae, purpura, purpura thrombocytopenic, thrombocytopenia, agitation, sleep disorder, dyspnoea or Stridor inspiratory, angioedema, erythema, pruritus, rash, urticaria and flushing.
Danish: De følgende bivirkninger blev rapporteret meget sjældent: Allergiske reaktioner, kuldegysninger, træthed, hypotonisk-hyporesponsiv episode, utilpashed, ødem, bleghed, hævelse eller ødem på hele ekstremiteten(erne), forbigående lokal hævelse af lymfeknuderne, krampeanfald (med eller uden feber), hjernebetændelse, encefalopati med akut hjerneødem, rullende øjne, Guillain Barré syndrom, hypotoni, neuritis, kvalme, mavesmerter, meteorisme, petecchier, trombocytopenisk purpura, trombocytopeni, purpura, agitation, søvnforstyrrelser, dyspnø eller inspiratorisk stridor, angioødem, erythema, pruritus, udslæt, urticaria og rødmen.
English: The approval was based on results from clinical trials, which investigated the immunogenicity and reactogenicity of Hexavac when administered according to specific primary and booster vaccination schedules.
Danish: Godkendelsen var baseret på resultaterne af kliniske undersøgelser af den immunogene og reaktogene aktivitet af Hexavac, når stoffet indgives ifølge bestemte primære og booster vaccinationsprogrammer.