DERCUNIMIX

Main information

  • Trade name:
  • DERCUNIMIX
  • Pharmaceutical form:
  • Lyophilisate and Solvent
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DERCUNIMIX
    Italy
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • live myxomatosis virus + inactivated rabbit haemorrhagic disease virus
  • Therapeutic area:
  • Rabbit

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0121/001
  • Authorization date:
  • 24-02-2012
  • EU code:
  • FR/V/0121/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

DERCUNIMIX

Lyophilisateandsuspensionforsuspensionforinjectionforrabbits

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Foronedoseofvaccine(0.2ml):

Lyophilisate

Attenuatedmyxomatosisvirus,SG33strain,atleast..............................................2.7log

10 CCID50*

* CellCultureInfectiveDose50%

Suspension

InactivatedViralHaemorrhagicDisease(VHD)virus,AG88strain.....................................5PD90*

Adjuvant:

ions(intheformofaluminiumhydroxide)...................................................................0.350mg

Excipient:

Thiomersal.......................................................................................................................0.010mg

* PD90:q.s. to obtain theprotection of atleast9 animalsoutof 10 vaccinated with 1/5 th of dose.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Lyophilisateandsuspensionforsuspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Rabbits.

4.2 Indicationsforuse,specifyingthetargetspecies

Infuturebreedersfromtheageof10weeksandinbreeders:

- ForprimaryandboosterimmunisationtoreducemortalitycausedbyViralHaemorrhagicDisease

ofrabbits.

- Forboosterimmunisationtopreventmortalitycausedbymyxomatosis.

ImmunityagainstVHDhasbeendemonstrated1weekaftervaccinationandpersistsduringoneyear.

Immunityagainstmyxomatosispersistsduring4months.

4.3 Contraindications

None

4.4 Specialwarnings<foreachtargetspecies>

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Vaccinatehealthyanimalsonly.

Applytheusualasepticprocedures.

Onlysterileanddisinfectant-freeand/orantiseptic-freeequipmentshouldbeusedfortheinjectionof

thevaccine.

Asnosafetyandefficacystudieswereperformedindwarfrabbits,thevaccinationofthiscategoryof

rabbitsisnotrecommended.

Inhighlycontaminatedarea,itcouldbeadvisabletovaccinaterabbitsagainstVHDasof4weeksof

age.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Inthecaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackageleaflet

orthelabeltothephysician.

4..6Adversereactions(frequencyandseriousness)

Thevaccinationbyintradermalrouteisfollowedbyalimitedlocalreaction(3-4mmnodule),regressing

within3weeks.

Inalatentlymyxomatosis-infectedenvironment,vaccinationwithalivemyxomatosisvaccinecan

triggerthedevelopmentofattenuatedmyxoma-likelesions,disappearingwithin15days.

4.7 Useduringpregnancy,lactationorlay

Canbeusedduringpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproduct.Adecisiontousethisvaccinebeforeorafteranyotherveterinary

medicinalproductthereforeneedstobemadeonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

One0.2-mldoseperanimalbyintradermalrouteintheear,accordingtothefollowingvaccination

schedule:

- "myxomatosis"priming:atweaning,usingtheattenuatedSG33strainofmyxomatosisvirus.

- vaccinationwiththeproduct:6weeksafterthe"myxomatosis"priming(i.e.at10to11weeksof

age).

- boosterswiththeproduct:yearly.

Withintheone-yearintervalsbetweentwoinjectionsoftheproduct,aboostervaccinationusinga

vaccinecontainingtheSG33myxomatosisstrainisrequiredevery4months.

Methodofadministration:

ShakewellthebottleofVHDcomponentuntilresuspensionofthedeposit.

ThedarkcolourandthedepositobservedinthebottomofVHDcomponentbottle,beforeshaking,are

usual.

Pushtheneedleofa5-mlsyringethroughthebottleclosureoftheVHDcomponent.Suckuparound2

mlofproduct.

Pushtheneedleofthefilledsyringethroughthebottleclosureofthemyxomatosiscomponent.Inject

thevolumeofVHDcomponent.

Shakewellthebottleofmyxomatosiscomponentforafewsecondstoreconstitutethelyophilisate

entirely.

SuckupthereconstitutedvaccinewiththesyringeandinjectitintothebottleofVHDcomponent.

Whenusinganintradermicinoculationapplicator,theheadoftheapplicatorshouldbebuiltinsucha

waythattheoutletforthevaccinedoesnothavedirectcontactwiththeskin.Iftheapparatusis

designedtodeliver0.1ml,twoinjectionsatdifferentsitesintothesameeararerequired(oneinjection

intoeachearmaybepossibleifthesizeoftheearisnotsufficient).

Inanycase,refertotheinstructionsforuseoftheapplicatormanufacturer.Thecorrectadministration

ofthevaccinecanbecheckedbythepresenceofpapulesimmediatelyaftertheinjection.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noundesirableeffectotherthanthosereportedinsection"Adversereactions"wasobservedafterthe

administrationoftwodosesofvaccine.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

ATCvetcode:QI08AH01.

TheSG33strainofmyxomatosisvirusisliveandattenuated.TheAG88strainofVHDvirusis

inactivatedandaluminiumhydroxide-adjuvanted.Afteradministrationtoanimals,thevaccineinducesa

specificprotectionagainstmyxomatosisandagainstViralHaemorrhagicDiseaseofrabbits(VHD),as

demonstratedbychallenge.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Thiomersal(declaredinproductliterature)

Sucrose

BovinealbuminfractionV

Salts

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproducts.

6.3 Shelflife

Shelflifeoftheveterinaryproductaspackagedforsale:24months.

Shelf-lifeafterreconstitution:2hours.

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(2°C-8ºC).Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Type-Iglassbottle.

Butyl-derivedelastomerclosure(freeze-driedpellet).

Nitrileelastomerclosure(diluent).

Aluminiumcap.

Boxofone10-dosebottleoflyophilisateandone10-dosebottleofsuspension.

Boxofone20-dosebottleoflyophilisateandone20-dosebottleofsuspension.

Boxofone40-dosebottleoflyophilisateandone40-dosebottleofsuspension.

Boxoften10-dosebottlesoflyophilisateandten10-dosebottlesofsuspension.

Boxoften20-dosebottlesoflyophilisateandten20-dosebottlesofsuspension.

Boxoften40-dosebottlesoflyophilisateandten40-dosebottlesofsuspension.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewiththelocalrequirements.

7. MARKETINGAUTHORISATIONHOLDERS

BELGIUM

MERIALBELGIUM

BdSylvainDupuis243,1070BRUXELLES

Belgium

FRANCE

MERIAL

29,avenueTonyGarnier,69007LYON

France

GERMANY

MERIALGmbH

AmSöldnermoos6,85399HALLBERGMOOS

Germany

ITALY

MERIALITALIAS.P.A.

Strada6-PalazzoE-53°piano,Milanofiori,20090ASSAGO(MI)

Italy

THENETHERLANDS

MERIALBV

Kleermakerstraat,10,1991JLVELSERBROEK

TheNetherlands

PORTUGAL

MERIALPORTUGUESALDA

Av.MariaLamas,Lote19–BL.Apiso2,SerraDasMinas,2635-432RIODEMOURO

Portugal

SPAIN

MERIALLABORATORIOSSA

c/Tarragona,161-planta3a,08014BARCELONA

Spain

8. MARKETINGAUTHORISATIONNUMBER(S)

Belgium: BE-V277351

France: FR/V/15628493/1998

Germany: PEI.V.01945.01.1

Italy: 10dosesx1 103169013

10dosesx10 103169049

20dosesx1 103169025

20dosesx10 103169052

40dosesx1 103169037

40dosesx10 103169064

TheNetherlands: REGNL09873

Portugal: 684/00DGV

Spain: 1386ESP

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Firstauthorisation:22/02/2001

Lastrenewaloftheauthorisation:12/02/2006

10 DATEOFREVISIONOFTHETEXT

10/12/2010

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety