Equip Rotavirus Emulsion for Injection for Horses

Main information

  • Trade name:
  • Equip Rotavirus Emulsion for Injection for Horses
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Equip Rotavirus Emulsion for Injection for Horses
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Equine rotavirus vaccine
  • Therapeutic area:
  • Horses Females

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0241/001
  • Authorization date:
  • 21-12-2011
  • EU code:
  • UK/V/0241/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:April2012

AN:01961/2011

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

EquipRotavirusemulsionforinjectionforhorses

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Qualitativecomposition

EquineRotavirusvaccine(inactivated).

Quantitativecomposition

ActiveSubstances: Per1mldose

InactivatedEquineRotavirusH2strainRP>1.0*

(7.4x10 6

to7.4x10 7

FAID

*Productisblendedbasedonpre-inactivationtitrebuttheblendedand

finishedproductmusthavearelativepotencyofatleast1.0.

Adjuvants: Per1mldose

SPOilAdjuvant:

PluronicL121 1mg

Squalane 2mg

Tween80(Polysorbate80) 0.16mg

PhosphateBufferedSaline to0.05ml

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Emulsionforinjection

4. CLINICALPARTICULARS

4.1 TargetSpecies

Horses(pregnantmares)

4.2 Indicationsforusespecifyingthetargetspecies

Forvaccinationofpregnantmarestoprovidepassivetransferof

antibodiestofoalstoreducetheriskofdiarrhoeacausedby

EquineRotavirusH2serotype.

Maresareabletotransferthepassiveimmunitytothefoals4

weeksafterthethirdvaccination.Foalsofthevaccinatedmares

showanincreaseinantibodiesagainstEquineRotavirusfor

approximatelysixtydays.

Revised:April2012

AN:01961/2011

4.3 Contraindications

Donotuseinunhealthyanimals.

4.4 Specialwarnings

Useofthisvaccineinamarecanonlyaidthecontrolofdiarrhoea

associatedwithrotavirusinitsfoalwhenthefoalreceivesan

adequatequantityofcolostrum,shortlyafterbirth.Boththemare’s

abilitytorespondbytheproductionofantibodiesincolostrumand

theabilityofthefoaltoingestandabsorbthatcolostrumis

requiredforthevaccinetohaveaneffect.

4.5 Specialprecautionsforuse

i. Specialprecautionsforuseinanimals

None.

ii. Specialprecautionstobetakenbythepersonadministering

theveterinarymedicinalproducttoanimals

Incaseofaccidentalself-injection/ingestion/spillageonto

skin,seekmedicaladviceimmediatelyandshowthe

packageinsertorlabeltothephysician.

iii. Otherprecautions

EquipRotavirusdoesnothaveanyimpactonthe

environment.

4.6 Adversereactions(frequencyandseriousness)

Maresmaydevelopasmallvisiblesofttofirmswelling(<3.5x

<2.5cm)lastingforgenerallyonlytwodays.Theswellingmaybe

painfulfor1-2days.Somemaresmayalsodevelopa1ºC

transienttemperaturerise,whichmaylastforupto2days.

4.7 Inmostcasesthesesmallandtransientinjectionsite

reactionsresolvewithnoneedfortreatment.Useduring

pregnancy,lactationorlay

Tobeusedduringpregnancy.

4.8 Interactionswithothermedicinalproductsandotherformsof

interaction

Noinformationisavailableonthecompatibilityofthisvaccinewith

anyother.

Revised:April2012

AN:01961/2011

Thereforethesafetyandefficacyofthisproductwhenusedwith

anyother(eitherwhenusedonthesamedayoratdifferenttimes)

hasnotbeendemonstrated.

4.9 Amountstobeadministeredandadministrationroute

1.0mldosepermaretobeadministeredbydeepintramuscular

injection.

VaccinationSchedule

Pregnantmaresshouldbegiventhreedosesofvaccineconsisting

ofasingle1mldoseadministeredatthe8th,9thand10thmonth

ofeachpregnancy.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Adverseeventsobservedafteradministrationofadoubledoseare

similartothosefollowingadministrationofasingledoseaslisted

inSection4.6.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Tostimulateactiveimmunityinpregnantmaresinordertoprovide

passiveimmunitytotheirfoalsasanaidinthecontrolofdiarrhoea

associatedwithequinerotavirusinfection

ATCVetCode:QI05AA09

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

HEPESDiluent:

Eagle’sEarle’sMEMgrowthmedium

HEPESacid

Sodiumhydrogencarbonate

Waterforinjection

Hydrochloricacid

Sodiumhydroxide

6.2 Incompatibilities

Donotmixwithanyothervaccine/immunologicalproduct.

Revised:April2012

AN:01961/2011

6.3 Shelflife

12months.

6.4 Specialprecautionsforstorage

Storeandtransportrefrigerated(2°C-8°C).

Protectfromlight.

Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

Container:Sterilesingle-usepolypropylenesyringes(Ph.Eur.

3.2.8)containingonedoseeach,andclosedwithrubbertips(Ph.

Eur.3.2.9).

Syringesaresuppliedinpacksof3,10,20and40units.Notall

packsizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinary

medicinalproductorwastematerialsderivedfromtheuseof

suchproducts

Anyunusedveterinarymedicinalproductorwastematerials

derivedfromsuchveterinarymedicinalproductsshouldbe

disposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

PfizerLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

8. MARKETINGAUTHORISATIONNUMBERS

Vm 00057/4310

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHE

AUTHORISATION

Date:05September2008

10. DATEOFREVISIONOFTHETEXT

Date:April2012