Hypermune

Main information

  • Trade name:
  • Hypermune-Re Equine Plasma Immunological Intravenous Infusion Solution
  • Pharmaceutical form:
  • Solution for infusion
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hypermune-Re Equine Plasma Immunological Intravenous Infusion Solution
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • BEE
  • Therapeutic area:
  • Horses Young

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0298/001
  • Authorization date:
  • 28-05-2008
  • EU code:
  • UK/V/0298/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

RevisedMay2012

AN:01006/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

HYPERMUNE-REEquinePlasma

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

QualitativeCompositionFrozenEquinePlasma

QuantitativeComposition

Activesubstances:

EquineIg G≥24g/l

EquineTotalProtein≥50g/l

AntibodiestoRhodococcusequi≥40%VILstandard

Excipient:

AcidCitrateDextrose-Atoensurecitratecontent10-20mmols/l

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Plasmaforintravenousinfusion,afterthawing.

4. CLINICALPARTICULARS

4.1 Targetspecies

Foalsfrom24hourstosixdaysofage.

4.2 Indicationsforuse,specifyingthetargetspecies

ForfoalswithFailureofPassiveTransfer

ToraisethelevelofcirculatingIgGinneonatalfoalswhichhavebeenshowntohavelow

levels(lessthan4g/l).Theraisedlevelhasbeendemonstratedapproximately24hours

afteradministrationbutthedurationoftheeffectisnotknown.

ForfoalswithNormalpassiveTransfer

ToraisethelevelofRhodococcusequiantibodies.Theraisedlevelhasbeen

demonstratedapproximately24hoursafteradministrationandraisedlevelsthough

declininggenerallylastforupto21days.

4.3 Contraindications

None

RevisedMay2012

AN:01006/2011

Page2of6

4.4 Specialwarnings<foreachtargetspecies>

ItisrecommendedthatappropriateRhodococcuscontrolmeasuresshouldbe

implementedtocontroldisease.Suchmeasuresincludeavoidanceofovercrowding,

controllingpaddockdustlevels,provisionofshadefortheanimals,removaloffaecesfrom

pasturesandclosemonitoringoffoalhealth.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotadministermorethan2dosestoananimal.

Ifaseconddoseisrequireddonotadministerthisbefore24hours.

Toreduceriskofadversereactions:

TransfusionReactions.Carefulmonitoring,especiallyatthestartandthroughoutthe

transfusionisessential.Distinctionmustbemadebetweenreactiontorestraintand

catheterisation and signs attributable to transfusion reaction. If tachycardia,

hyperventilatingortremblingoccurs,thetransfusionshouldbesloweddownorstopped

altogether.Ifsignsabatewithinfiveminutes,astheyshould,thenthetransfusionshould

becontinued.Iftheyrecuragain,thetransfusionshouldbestoppedentirely.

Anaphylaxis.Carefulmonitoring,especiallyatthestartandthroughoutthetransfusion,is

essential.Iftachycardia,hyperventilatingortremblingoccurs,thetransfusionshouldbe

sloweddownorstoppedaltogether.Ifsignsabatewithinfiveminutes,astheyshould,then

thetransfusionshouldbecontinued.Iftheyrecuragain,thetransfusionshouldbestopped

entirely.Ifsevere,orothersignsoccursuchascolic,pyrexia,cardiacarrhythmias,urticaria

andcollapse,thetransfusionshouldbestoppedandifnecessaryepinephrine(0.01mg/kg),

corticosteroidsandintravenoussalineadministered.Theseemergencydrugsshould

alwaysbeonhand.Flunixinmeglumineat0.25mg/kgmaybeusedprophylacticallyto

reducetheincidenceofsideeffects.

VolumeOverload.Volumeoverloadisapossiblehazardofplasmatransfusionespeciallyif

theadministrationiscarriedoutinfoalscompromisedinanywayortooquickly.Everyfoal

shouldbefullyclinicallyexaminedpriortotransfusionandinthecaseofcompromised

foalsthetransfusionshouldbemaintainedataslowrate,1litrefora50kgfoalorprorata

in1hour.Carefulmonitoringthroughoutthetransfusionisessential.Ifhyperventilating,

respiratorydistressortremblingoccurs,thetransfusionshouldbesloweddownorstopped

altogether.Diureticsmaybeusedinseverecases.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Administeronlyusingabloodgivingsettominimiseriskofself-injection.Incaseof

accidentalcontactwithskin,washaffectedareasthoroughlywithwarmsoapywater.

4.6Adversereactions(frequencyandseriousness)

ItshouldbenotedthatACD-Aisanexcipientandthatexcesscitratemaycauseareaction

intherecipientfoal.Thismaybeseenasmusclefasciculations,weaknessandcardiac

abnormalities.

RevisedMay2012

AN:01006/2011

Page3of6

TransfusionReactionsareveryrare;signsincludetachycardia,hyperventilatingand

trembling.

Anaphylaxisisveryrare,butcanoccurwithproductsofthisnature.Signsinclude

tachycardia,hyperventilatingandtrembling,orothersignssuchascolic,pyrexia,cardiac

arrhythmias,urticariaandcollapse.

VolumeOverloadisararehazardofplasmatransfusionespeciallyiftheadministrationis

carriedoutinfoalscompromisedinanywayortooquickly.Signsincluderespiratory

distress,hyperventilation,staggeringandcollapsewheninstandingrestraint.Additionally,

ifthefoalisinlateralrecumbencyfrothmaybeseenatthenostril.

Measurestoavoidtheseadversereactionsaredetailedinsection4.5

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantorlactatinghorses.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

SafetyandefficacydataareavailablewhichdemonstratethatHypermune-REcanbe

administeredonthesamedaybutnotmixedwithtetanusantitoxin.

NoinformationisavailableonthesafetyandefficacyofHypermune-REwhenusedwith

anyotherveterinarymedicinalproductexcepttheproductmentionedabove.Adecisionto

usethisproductbeforeorafteranyotherveterinarymedicinalproductthereforeneedsto

bemadeonacasebycasebasis.

Aswithcolostrumderivedpassiveimmunity,thepassiveimmunitytransferredby

Hypermune-REmayinterferewithresponsetovaccine.Itisrecommendedthatthisis

consideredwhenstartingavaccineprogrammewithdueadherencetothevaccine

manufacturer’sinstructions.

4.9 Amountstobeadministeredandadministrationroute

ForfoalswithFailureofPassiveTransfer

Hypermune-REmaybeadministeredtofoalsfrom24hoursto6daysofagewhereithas

beenshownaftertestingthattheyhavelowlevelsofserumIgG(lessthan4g/l).The

doserequiredisonelitrefora50kgfoal(andprorata,i.e.20mlperkg).

Abloodsampleshouldbecollectedfromthefoalapproximately24hourslaterandre-

testedforthelevelofserumIgG.Ifthisisstilllow,afurtherdosemaybeadministered.

Thisshouldbegivenwithin24 –48hoursofthefirstadministrationandbegiveninthe

samemannerasthefirst(intravenously,viaabloodgivingset,over15-20minutes).

ForfoalswithNormalPassiveTransfer

Thedoserequiredisonelitrefora50kgfoal(andprorata,i.e.20mlperkg).Tosustain

raisedlevelsofcirculatingRhodococcusequiantibodiesaseconddosemaybegivenat

approximately21dayslater.Thisshouldbegiveninthesamemannerasthefirst

(intravenously,viaabloodgivingset,over15-20minutes).

Methodofadministration

RevisedMay2012

AN:01006/2011

Page4of6

Therequireddoseisadministeredviaacatheterplacedinthejugularveinusingablood

givingsetequippedwithameshfilter.Theproductshouldbeadministeredslowly,

particularlyatthestart,andadministrationshouldtake15 –20minutes.Throughoutthe

administration,thefoalshouldbemonitoredforsignsofadversereactions.

Thawingshouldnottakeplaceinamicrowaveoven.Thelitrebagofplasmashouldbe

immersedonlyinwarmwateratnotmorethan40ºC.Awaterbathsuchasasinkfullof

domesticwarmwaterisideal.Astheplasmathawsandthewatercools,morewarmwater

maybeaddedasrequiredbuthotwater(notgreaterthanhandhot)mustbeavoidedasit

willdamagetheproteins.Theentirelitreofplasmashouldbebroughtslowlytobody

temperaturebeforeusetoensureallthecryoprecipitateisdissolved.Underoptimum

conditionsthiswholeprocessmaytake2-2½hours.Occasionallysmallamountsoffibrin

maystillbeseenfloatingintheplasma.Itisnotsignificantbutmustbefilteredoutbythe

filterinthebloodadministrationset.

Inspectforleakageandifapparentonthawingtheentirecontentsmustbediscarded.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noinformationisavailableontheeffectsofadministeringanoverdose

Volumeoverloadinfoals

Volumeoverloadisararehazardofplasmatransfusionespeciallyiftheadministrationis

carriedoutinfoalscompromisedinanywayortooquickly.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Tomodulatetheimmunesystembyprovidingequineimmunoglobulins,andspecific

antibodiestoRhodococcusequi.Fromlimitedfieldstudiesthereisatrendofreduced

severityofR.equidiseaseandareducedrequirementforintensiveantibiotictreatment

withtheuseofHypermuneREbytherecommendedschedule

ATCvetcode:QI05AM.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

AcidCitrateDextrose-A

6.2Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct.

RevisedMay2012

AN:01006/2011

Page5of6

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeoncethawed:24hours

6.4.Specialprecautionsforstorage

Storeinafreezer(-30°Cto-20°C)

HYPERMUNE-REshouldbehandledcarefullywhenbeingunpackedandstoredinthe

freezer.Thebubble-wrapshouldnotberemovedasitprotectsthebrittlefrozenplasticwhich

issusceptibletodamagefromcarelesshandlingsuchasbeingdroppedorknockedinthe

freezer.Whenthaweditshouldbestoredinarefrigerator.

6.5Natureandcompositionofimmediatepackaging

ThecontainerisaPVCwithDEHPone-litrehumanplasmasteriletransferbagwithtwo

protectivesterileports.Thewholebagisoverwrappedwithprotectivebubblewrapfor

storageandtransport.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

VeterinaryImmunogenicsLtd

CarletonHill

Penrith

Cumbria

CA118TZ

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBERS

Vm18513/4001 VPA10662/001/001

9. DATEOFFIRSTAUTHORISATION

03/04/2007(UK) 22/08/2008(IE)

10 DATEOFREVISIONOFTHETEXT

May2012

RevisedMay2012

AN:01006/2011

Page6of6

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable