Raboral V-RG

Main information

  • Trade name:
  • Raboral V-RG
  • Pharmaceutical form:
  • Oral suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Raboral V-RG
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Live viral vaccines
  • Therapeutic area:
  • Other Other

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0018/001
  • Authorization date:
  • 30-05-2005
  • EU code:
  • FR/V/0018/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

RABORALV-RG

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

For1dose:

Activesubstance:

- Vacciniavirusexpressingtherabiesglycoprotein............................................................10 8

CCID50

Excipient(s):

- Gentamicin........................................................................................................................0.125mg

- Salinesolutionq.s..................................................................................................................2.5ml

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Bait(containingapolyethylenesachetfilledwithonedoseofvaccine).

4. CLINICALPARTICULARS

4.1 Targetspecies

Foxes(Vulpesvulpes).

4.2 Indicationsforuse,specifyingthetargetspecies

Activeimmunizationagainstrabiesinfoxes.

4.3 Contraindications

None

4.4 Specialwarningsforeachtargetspecies

Thebaitmatrixcontains0.6%oftetracyclinechlorhydrateastracer.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

-Vaccineshallonlybeusedbydulydesignatedcompetentadministrativeauthoritiesortheirauthorized

agents.

-Baitsshallbedistributedmanuallyorbylow-altitudeaerialdrops,atapproximately15vaccine-baits

persquarekilometer.

-Baitsshallnotbedistributedininhabitedareas,roads,riversorotherbodiesofwater.

-Thesachetandthebaitaremarkedwiththewording“VACCINEDONOTTOUCH”.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Nospecialprecautionistobetakenduringbaitdistributioncampaigns.Personsinvolvedinbaithandling

donotneedtobevaccinatedagainstrabies.

4.6 Adversereactions(frequencyandseriousness)

None

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Nodataavailable.

4.9 Amountstobeadministeredandadministrationroute

Onedoseofvaccine(onebait)perfox.

Baitsaredistributedatthedensityofapproximately15vaccine-baits/km 2 ,andaccordingtothe

legislationinforce.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theingestionofseveralbaitsdoesnotcauseanydisorder.

4.11Withdrawalperiod(s)

Notapplicable.

5. IMMUNOLOGICALPROPERTIES

Baitconsumptionisfollowedbytheimmunizationoffoxesagainstrabies,provenbytheprotection

againstchallengesorbytheonsetofrabies-specificantibodies.

ATCVetCode:QI07BD.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Gentamicin

Sodiumchloride

Disodiumphosphatedihydrate

Postassiumdihydrogenphosphate

Waterforinjections

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

12months

6.4.Specialprecautionsforstorage

Storebetween+2

Cand+8

C,protectedfromlight.

6.5 Natureandcompositionofimmediatepackaging

-Primarypackagingconsistsofapolyethylenesachetinsertedintoabait.

-Secondarypackagingconsistsof:

.polystyrenebox,packedincardbox,containing200baits;

.polyethylenebag,packedincardbox,containing200baits.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Vaccine-baitsshallbedestroyedbyMERIALorthedulydesignatedcompetentadministrative

authorities,byincineration.

7. MARKETINGAUTHORISATIONHOLDER

France

MERIAL

29avenueTonyGarnier

69007Lyon

FRANCE

BelgiumandLuxembourg

MERIALBelgium

243boulevardSylvainDupuis

1070Bruxelles

BELGIQUE

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10. DATEOFREVISIONOFTHETEXT

February2010.

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

29-5-2018

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Regeneron Ireland U.C.)

EU/3/18/2027 (Active substance: Three human monoclonal antibodies against the Ebola virus glycoprotein) - Orphan designation - Commission Decision (2018)3395 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/008/18

Europe -DG Health and Food Safety