DITEBOOSTER

Main information

  • Trade name:
  • DITEBOOSTER Suspension for Injection
  • Pharmaceutical form:
  • Suspension for Injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DITEBOOSTER Suspension for Injection
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0798/003/001
  • Authorization date:
  • 11-03-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

diTeBooster,suspensionforinjection.

Diphtheriaandtetanusvaccine(absorbed,reducedantigencontent).

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Perdose =0.5ml:

DiphtheriaToxoid,purified 6.25Lf/>2I.U.

TetanusToxoid,purified 6.25Lf/>20I.U.

Aluminiumhydroxide,hydrated,

corr.toaluminiumcontent 0.5mg

Thediphtheriaandtetanustoxins,obtainedfromculturesofCorynebacteriumdiphtheriaeandClostridiumtetani,are

purifiedanddetoxified.

Thetwotoxoidsareadsorbedtoaluminiumhydroxide.

Nosubstancesofhumanoriginareusedduringthevaccinemanufacture.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Suspensionforinjectioninsingle-dosevials.

Colourlesssuspensionofwhite/greyparticles.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Re-vaccinationofchildren(5yearsofage)andadultswhohavepreviouslyreceivedprimaryimmunisationofatleast

3dosesofdiphtheriaandtetanusvaccine.

diTeBoosterisnotintendedforprimaryimmunisationagainstdiphtheriaandtetanus.

TheuseofdiTeBoostershouldbeinaccordancewithofficialnationalrecommendations.

4.2Posologyandmethodofadministration

IncomparisonwithavaccineforprimaryimmunisationdiTeBoostercontainsreducedamountsofdiphtheriaand

tetanusantigens,andthevaccineshouldbeadministeredinaccordancewithnationalofficialrecommendations

regardingtheuseofsuchvaccines.

Thenecessaryprecautionsfortreatmentofanaphylacticreactionsshouldalwaysbetaken.

Shakebeforeuse.

diTeBoostershouldbeadministeredintramuscularlyasasingledoseof0.5ml.

Atcertainindications(forexamplehaemorrhagicdiathesis)diTeboostercanbeadministereddeepsubcutaneously.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/03/2011 CRN 2096751 page number: 1

Adultsandchildren( ≥5years)receivethesamedosage.

Repeatvaccinationagainstdiphtheriaandtetanusshouldbeperformedatintervalsperofficialrecommendations

(generally10years).

4.3Contraindications

Seriousadversereactionsfollowingpreviousvaccinationwiththevaccineorknownallergyagainstanyofthevaccine

componentsorconstituents.

4.4Specialwarningsandprecautionsforuse

diTeBoosterisnotintendedforprimaryimmunisationagainstdiphtheriaandtetanus.

Vaccinationshouldbepostponedincaseofacuteillnesswithfever.

Inchildrenandadultswithcompromisedimmuneresponse,theserologicalresponsemaybeimpaired.

Vaccinationofchildrenandadultsreceivingimmunosuppressivetreatmentcantakeplace,butmayresultinareduced

immunologicalresponse.

Formaldehydeisusedduringthemanufacturingprocessandtraceamountsmaybepresentinthefinalproduct.Caution

shouldbetakeninsubjectswithknownhypersensitivitytoformaldehyde.

diTeBoostercontainslessthan1mmolsodium(23mg)perdoseandisessentially"sodiumfree".

Toofrequentboostervaccinationwillincreasetheriskofadversereactions(refertosection4.2,Posologyandmethod

ofadministrationforrecommendationsonrepeatedvaccination).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Donotmixwithothervaccinesinthesamevialorsyringe.

ConcomitantuseofdiTeBoosterwithotherinactivatedvaccineshasnotbeenstudied.Itisunlikelythatco-

administrationwillresultininterferencewiththeimmuneresponses.Whenconsiderednecessary,diTeBoostercanbe

administeredsimultaneouslywithothervaccines,atadifferentinjectionsite.

4.6Fertility,pregnancyandlactation

Norelevantanimaldataareavailable.Inhumansthedataareinadequatetoassessteratogenicorfetotoxicriskduring

pregnancy.Duringpregnancythepossibleriskofclinicalinfectionfollowingexposureshouldbeweighedagainstthe

theoreticalrisksofvaccination.

ThereisnoevidencethatvaccinationofthebreastfeedingmotherwithdiTeBoosterisharmfultotheinfant.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/03/2011 CRN 2096751 page number: 2

4.8Undesirableeffects

InrelationtotheadministrationofdiTeBooster,themostcommonadversereactionsarerednessandswellingatthe

injectionsiteandfever.Thereactionsmostcommonlystartwithin48hoursfromthedayofvaccination.

4.9Overdose

Nocaseofoverdosehasbeenreported.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Tetanustoxoid,combinationswithdiphtheriatoxoid.

ATC-codeJ07AM51.

Shortlyafterre-vaccination,antibodiesareproducedagainstbothvaccineantigens.Protectionagainstdiphtheriaand

tetanuscanbeexpectedtolastforatleast10years.

5.2Pharmacokineticproperties

Noexperience.

5.3Preclinicalsafetydata

Thesubacuteandacutetoxicityofthevaccinecomponentshavebeeninvestigatedinanimaltests.Noclinical

Frequencyof

ADR

OrganClass Common

(>1/100and

<1/10) Uncommon

(>1/1,000and

<1/100) Rare

(>1/10,000and

<1/1,000) Veryrare

(<1/10,000)

Nervoussystem

disorder Vasovagal

syncope

Skinand

subcutaneous

tissuedisorders Eczemaand

dermatitis Urticarial

reactions

General

disordersand

administration

siteconditions Malaise

Fever ≥38 o

Redness/swelling

attheinjection

site Redness/swelling

≥6cmatthe

injectionsite. Highfever>

40ºC

Granulomaor

sterileabscessat

theinjectionsite.

ImmuneSystem

disorders Hypersensitivity

including

anaphylactic

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/03/2011 CRN 2096751 page number: 3

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Perdose=0.5ml:

SodiumHydroxidetopH=7

SodiumChloride

Waterforinjections

ThepHofthevaccineisapproximately7.

Foradsorbents,seesection2.

6.2Incompatibilities

Thevaccinemustnotbemixedwithothervaccinesormedicinalproducts.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Storeinarefrigerator(2 o

C-8 o

Donotfreeze

Discardifvaccinehasbeenfrozen.

6.5Natureandcontentsofcontainer

Single-dosevials(typeIglass)containing0.5ml(1dose).

Packsize:1x0.5ml,5x0.5mland10x0.5ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Shakebeforeuse.

Afterthoroughre-suspensionthevaccineshouldappearasacolourlesssuspensionofwhiteorgreyparticles.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

StatensSerumInstitut

5Artillerivej

DK-2300CopenhagenS

Denmark.

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/03/2011 CRN 2096751 page number: 4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11March2005

Dateoflastrenewal:9September2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/03/2011 CRN 2096751 page number: 5