Tuberculin

Main information

  • Trade name:
  • Tuberculin PPD Kit
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tuberculin PPD Kit
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Avian tuberculin PPD
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0342/001
  • Authorization date:
  • 24-01-2012
  • EU code:
  • UK/V/0342/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:November2012

AN:00636/2012

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SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEIMMUNOLOGICALVETERINARYMEDICINALPROCUCT

TuberculinPPDKit

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

BovineTuberculinPPD3000:

Per0.1ml(1dose):

Activesubstance:

BovineTuberculinpurifiedproteinderivativefromcultureofMycobacterium

bovis,strainAN53000IU*

Otherexcipients:

Phenol: 0.4 –0.5mg

Forafulllistofexcipients,seesection6.1

AvianTuberculinPPD2500:

Per0.1ml(1dose):

Activesubstance:

AvianTuberculinpurifiedproteinderivativefromcultureofMycobacterium

aviumsubspeciesavium,strainD4ER 2500IU*

Otherexcipients:

Phenol: 0.4 –0.5mg

Ponceau4R(E124): 5microgram

Forafulllistofexcipients,seesection6.1

(*IU:InternationalUnitsaccordingtoPh.Eur.)

3. PHARMACEUTICALFORM

Solutionforinjection

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle.

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4.2 Indicationsforuse,specifyingthetargetspecies

Tobeusedforthein-vivoidentificationofcattlewhichhavebeenexposedto

Mycobacterium species causing bovine tuberculosis. Simultaneous

administrationofBovineTuberculinPPD3000andAvianTuberculinPPD

2500andcomparingthedegreeofskinswellingofthetwoinjectionsites

enablesdifferentiationbetweenthespecificreactionintargetspeciesexposed

toMycobacteriumspeciescausingbovinetuberculosisandthenon-specific

reactionintargetspecies,whichhavebeenexposedtootherspeciesof

Mycobacteriaorrelatedgenera,causingcrosssensitisationtoBovine

TuberculinPPD3000.

4.3 Contra-indications

None

4.4 Specialwarnings

ForareliableresultoftheSingleIntradermalComparativeCervicalTuberculin

(SICCT)testtheuseoftheTuberculinPPDKitincattleshouldbeavoided

within42daysfollowingapreviousadministrationoftuberculinPPDs.In

specificcircumstances,atimeintervalshorterthan42daysmaynotbe

avoidede.g.whenaherdundergoingtestmayincluderecentlyacquired(and

tested)animals.However,ithasbeenobservedthatashortertimeinterval

betweentestsresultsinapotentiallossofskinresponsivenessandis

thereforenotrecommended.

Thereliabilityofthetestdependsupontheproperintradermalinjectionofthe

tuberculinPPDs(BovineandAvianTuberculinPPDs)togetherwiththe

accuratemeasurement,characterisation,andcomparisonoftheskinreactions

72hourslater.Subcutaneousinsteadofintradermalinjectionoftuberculin

PPDsmaygiverisetoafalseresultandisalsolikelytoleadtodesensitisation

oftheanimalforavariableperiod.

Thereliabilityofthetestisalsoinfluencedbythesiteofinjectionofthe

tuberculinPPD(see4.9)andbytheamountoftuberculinPPDadministered;

doseslessthantheprescribedamountof0.1mlarelikelytoleadtoafalse

resultoftheSICCTtest.

Thesensitivityofthetestcanbeinfluencedbyconcurrentinfectionwith

Mycobacteriumspeciesthatdonotcausebovinetuberculosis.Theinterval

sinceinfectionwithMycobacteriumspeciescausingbovinetuberculosis,either

whereanimmuneresponsehasnothadsufficienttimetodevelop,orwhere

theimmuneresponseperiodhasbeensuperseded,mightalsocontributetoa

lowersensitivity.Noticemustbetakenthattheresponseisordinarily

somewhatdepressedintheperi-parturientperiod.

Intheeventofafulminatinginfectionaresponsetotheintradermaltestcan

evenbeabsent.

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4.5 Specialprecautionsforuse,includingspecialprecautionstobetakenby

thepersonadministeringtheimmunologicalveterinarymedicinal

product

i. Specialprecautionsforuseinanimals

None

ii. Specialprecautionstobetakenbythepersonadministeringthe

immunologicalveterinarymedicinalproduct

Incaseofaccidentalself-injectionpersonswhohavebeenexposedto

tuberculinprotein,eitherfromaprevioustuberculosisvaccination,or

fromenvironmentalexposuremayexpectareaction.Over48to72

hoursthiswillcauseaskinreactionofahard,densewheal.Mild

itching,swelling,orirritationatthesiteoftheinjectionarefrequent

reactions.Ifastrongreactionorsystemicsymptomsoccurseekmedical

adviceimmediately.Showthepackageleafletorthelabeltothe

physician.

iii. Otherprecautions

Diseasespreadprecautions

Personalprotectiveequipmentconsistingofsuitableprotectiveclothing

andfootwearshouldbewornwhenconductingtuberculintests.All

practicablemeasuresofcleaninganddisinfectionofprotectiveclothing,

footwear,handsandequipment(syringes,etc.)shouldbeundertaken

onentryandexitfromtheholdingtominimisetheriskofdisease

transfer.

4.6 Adversereactions

Aswellingoftheskinisverycommonattheinjectionsitesshortlyafterthe

administration,inparticularincattleinfectedwithMycobacteriumbovis.In

uninfectedanimalsthisswellingwillgreatlydecreaseinsizewithin24hours

andcompletelydisappearwithin3to4days,unlesstheanimalhasbecome

sensitisedtootherspeciesofMycobacteriacapableofcausinganon-specific

reaction.Ininfectedcattleand/orincattlesensitisedwithnon-specific

mycobacteriatheinitialswelling,inuncommoncasesupto65mm,willalso

decreaseinsizewithin24hoursbutitwilltakeupto4weeksbeforethe

swellinghascompletelydisappeared.Ininfectedcattleasmallriseinbody

temperature,whichwillreturntonormalwithin24hours,canoccurbutis

uncommon.

4.7 Useduringpregnancy,lactationorlay

Althoughnospecificlaboratorysafetytestsweredoneinpregnantorlactating

cattle,experiencefromfielduseindicatethattheadministrationofBovine

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and/orAvianTuberculinPPDdoesnothaveanegativeeffectonreproductive

performanceorlactation.

4.8 Interactionwithotherveterinarymedicinalproductsandotherformsof

interaction

InjectionofotherproductsatoradjacenttothesiteoftuberculinPPDinjection

shouldbeavoidedduringtheperiodimmediatelypriortotuberculinPPD

injectionanduntilthecompletionofthereadingofthetuberculintest.Possible

reactionsduetosuchotherproductscouldbeconfusedwith,orotherwise

affect,thedelayedtypehypersensitivityreactionduetotheadministrationof

tuberculinPPDs.

Whereadministrationofamedicinalproductisnecessarysuchproductshould

notbeadministeredneartotheinjectionsitesoftheTuberculinPPDKitand

preferablynotonthesamesideoftheneck.

Ingeneralitisrecommendedthatnootherveterinarymedicinalproductshould

beadministeredbeforeandafteradministrationoftheTuberculinPPDKit.

Inparticular,theTuberculinPPDKitshouldnotbeusedincattlewhich

recentlyhavebeentreatedwithimmunosuppressivemedicinessuchas

glucocorticosteroidssincesuchatreatmentmayinfluencetheresultsofthe

tuberculintest.

Amoresevereinterpretationofthetuberculinskintestmayberequiredin

animalsvaccinatedagainstJohne’sDisease(paratuberculosis),asvaccination

couldgiverisetofalsenegativeSICCTtestresultsinsuchanimals.

N.B.Vaccinationofcattleagainstbovinetuberculosisiscurrentlyforbiddenin

theEuropeanUnion.

4.9 Amountstobeadministeredandadministrationroute

Selectionofsitesofinjection:

Theapprovedinjectionsitesaresituatedattheborderoftheanteriorand

middlethirdsofeithersideoftheneck.Inadultanimalstheuppersiteisabout

fourinches(10cm)belowthecrest.Thelowersiteshouldbeaboutfiveinches

(12.5cm)fromtheuppersite,onalinedrawnparallelwiththelineofthe

shoulder.Inyounganimalswherethereisinsufficientspacetoinjectboth

tuberculinPPDsintothesamesideoftheneck,thetuberculinPPDsshouldbe

injected,oneoneachsideoftheneck,atcorrespondingsitesinthecentreof

themiddlethirdoftheneck.Inanimals,whichhavenon-associatedlumpsor

swellingsproximaltotheinjectionsite(s)thetuberculinPPDshouldbeinjected

intotheoppositesideoftheneck.

Preparationofsitesofinjection:

Theselectedsitesofinjectionshouldbeclipped(anadequatelysizedareafor

identificationoftheinjectionsites),cleansed(withwateralone)ifobviously

dirty,anddebrisshouldberemovedpriortoinjection.Thepresenceofany

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abnormalitiesneartotheinjectionsite(s)shouldberecorded.Thepresenceof

skintuberculosisshouldalsoberecorded.

Measurementofskinthicknesspriorinjection:

Beforeinjection,afoldofskinateachoftheintendedinjectionsitesandwithin

theclippedareamustbetakenbetweentheforefingerandthumband

accuratelymeasuredtothenearestmillimetreusingcallipers.

Intradermalinjection:

Acorrectintradermalinjectiontechniqueandthedeliveryoftheprescribed

dosevolumeof0.1mlperinjectionareimportantforareliabletestresult.A

correctinjectionisconfirmedbypalpatingasmallpea-likeswellingateach

injectionsite.Ifthereisanydoubtabouteitheroftheinjectionsbeingdelivered

intradermally,afurtherinjectionshouldbemade,preferablyata

correspondingsiteontheothersideoftheneck.

Readingofthetuberculintestafterinjection:

Theinjectionsitesshouldbepalpatedcarefullytodetectreactions72hours

(+/-4hours)afterintradermalinjectionandtheskin-foldthicknessofeach

injectionsitere-measured.Thesamepersonshouldmeasuretheskinbefore

theinjectionandwhenthetestisread.

Measurementsoftheinjectionsitemustbetakencarefullybyplacingthe

callipers,wherearesponse(swelling)hasbeendetected,acrossthebroadest

widthoftheswelling,withoutapplyingunduepressure.

Clinicalsignscompatiblewithbovinetuberculosismustberecordedatthe

timeofreadingtoassistintheidentificationofanimalsthatmaybeexposed

butwhichhavenotbeenidentifiedasreactorsintheSICCTtest(i.e.false

negatives).

Thepresenceofclinicalsigns,suchasdiffuseorextensiveoedema,

exudation,necrosis,painatthesiteoftestorswellingoftherelatedpre-

scapularlymphnode,isalwaysindicativeoflikelyexposuretoMycobacterium

speciescausingbovinetuberculosis.Animalsshowingsuchreactionsmust

alwaysbedeemedasreactors,irrespectiveoftheskin-foldmeasurements

recorded.

InterpretationoftheSingleIntradermalComparativeCervicalTuberculin

(SICCT)test:

Fortheestablishmentandmaintenanceofofficiallytuberculosis-freeherd

statusforthepurposeofinternalEUtradinginbovines,theinterpretationof

theskinreactionsinducedbythebovineandaviantuberculinPPDinjections

shouldbemadeaccordingtothefollowinginstructions(asdescribedinsection

2.2.5.3.2ofAnnexBofCouncilDirective64/432/EEC).

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Interpretationof

skinreactionsof

theSICCTtest Clinicalobservationsandtherecordedincreasesinskin-

foldthicknessatthesitesofinjection72hoursafter

injectionoftheTuberculinPPDs.

Positivereaction

AreactiontobovinetuberculinPPDwhichismorethan4mm

greaterthanthereactiontoaviantuberculinPPD,orthe

presenceofclinicalsigns.

Inconclusive

reaction

AreactiontobovinetuberculinPPD(ofatleast2mm)which

isfrom1to4mmgreaterthanthereactiontoaviantuberculin

PPD,andtheabsenceofclinicalsigns.

Negativereaction

AreactiontobovinetuberculinPPDwhichisequaltoorless

thanthereactiontoaviantuberculinPPD,andtheabsenceof

clinicalsigns.

AnimalsinconclusivetotheSICCTtestthatarenotremoved,eithervoluntarily

bytheanimalownerorbythecompetentauthority,shallbesubjectedto

anothertestafteraminimumof42days.Animals,whicharenotnegativeto

thissecondtest,shallbedeemedpositivetothetest.

Nationalrequirementsforamoresevereinterpretationoftheskinreactions

mayapply.

4.10Overdose(signs,emergencyprocedure,antidotes),ifnecessary

Thereactionsseenafteradministrationofanoverdosearethesameasthose

describedunder4.6.

4.11Withdrawalperiods

Zerodays

5. IMMUNOLOGICALPROPERTIES

ATCvetcode(s):

BovineTuberculinPPD3000:QI02AR01

AvianTuberculinPPD2500:QI02AR02

Theseproductsareinvivodiagnosticsubstancestodiagnosethestateof

immunityofcattleagainstbovinetuberculosis.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Phenol

Glucoseanhydrous

Disodiumphosphatedihydrate

Potassiumdihydrogenphosphate

Waterforinjections

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Ponceau4R(E124)*

*ThecolouringagentPonceau4R(E124)isonlypresentinAvianTuberculin

PPD2500.

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

6.3 Shelf-life

Shelf-lifeoftheimmunologicalveterinarymedicinalproductaspacked

forsale:

TheTuberculinPPDKitcomprisestwocomponentseachwithadifferentshelf-

life.

Shelf-lifeofthe20-dosespresentation:

BovineTuberculinPPD3000:2½years

AvianTuberculinPPD2500:2years

Shelf-lifeofthe50-dosespresentation:

BovineTuberculinPPD3000:1½years

AvianTuberculinPPD2500:1½years

Theshelf-lifeoftheTuberculinPPDKitisspecifiedastheshelf-lifeofthe

componentwiththeearliestexpirydate.

Shelf-lifeafterfirstopeningofthecontainer:

Shouldbeusedimmediatelyafterfirstopening.

6.4 Specialprecautionsforstorage

Storeinarefrigerator(+2°C-+8°C).Donotfreeze.

Keepthevialsinthepolystyrenebox,closedwithcartonsleeve,inorderto

protectfromlight.

Transportation:

Maybetransportedat+2°C-+37°Cforaperiodnotlongerthan14days.Do

notfreeze.

Keepthevialsinthepolystyrenebox,closedwithcartonsleeve,inorderto

protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

The20-dosespresentationoftheTuberculinPPDKit:

Polystyreneboxwith20vials(hydrolyticTypeI)ofBovineTuberculinPPD

3000and20vials(hydrolyticTypeI)ofAvianTuberculinPPD2500.Eachvial

contains20dosesof0.1ml.

The50-dosespresentationoftheTuberculinPPDKit:

Polystyreneboxwith10vials(hydrolyticTypeI)ofBovineTuberculinPPD

3000and10vials(hydrolyticTypeI)ofAvianTuberculinPPD2500.Eachvial

contains50dosesof0.1ml.

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Thevialsareclosedwitharubber-butylstopperandsealedwithanaluminium

cap(blankcapforBovineTuberculinPPD3000andredcapforAvian

TuberculinPPD2500).Theboxisclosedwithalabelledcartonsleeve.A

packageleafletisincluded.

6.6 Specialprecautionsforthedisposalofunusedimmunologicalveterinary

medicinalproductsorwastematerialsderivedfromtheuseofsuch

products

Anyunusedproductorwastematerialderivedfromsuchproductsshouldbe

disposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

PrionicsLelystadBV

Platinastraat33

8211ARLelystad

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm 36410/4000

9. DATEOFTHEFIRSTAUTHORISATION

Date:24November2010

10. DATEOFREVISIONOFTHETEXT

Date:November2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Theimport,sale,supplyand/oruseoftheTuberculinPPDKitmaybeprohibitedin

certainMemberStatesonthewholeorpartoftheirterritorypursuanttoNational

AnimalHealthpolicy.Anypersonintendingtoimport,sell,supplyand/orusethe

TuberculinPPDKit hastoconsulttherelevantMemberStates’Competent

Authoritiesonthecurrentpoliciespriortoimport,sale,supplyand/oruse.

Approvedby: 20/11/12