Ovilis Toxovax

Main information

  • Trade name:
  • OVILIS TOXOVAX
  • Pharmaceutical form:
  • Powder and solvent for suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • OVILIS TOXOVAX
    Netherlands
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Toxoplasma vaccine
  • Therapeutic area:
  • Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0119/001
  • Authorization date:
  • 09-10-2010
  • EU code:
  • FR/V/0119/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

OvilisToxovaxRenewal –Productliterature(FR/V/0119/001/R/002)day90final

SUMMARYOFPRODUCTCHARACTERISTICS

OvilisToxovaxRenewal –Productliterature(FR/V/0119/001/R/002)day90final

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

OvilisToxovax

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

liveToxoplasmagondiitachyzoϊtesstrainS48perdose.

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Concentrateanddiluentforsuspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Sheep

4.2 Indicationsforuse,specifyingthetargetspecies

Activeimmunizationofnonpregnantewesofatleast4monthsold,toreduceabortionandperinatal

lambmortalitycausedbyToxoplasmagondii.

4.3 Contraindications

Donotvaccinateanimalsinthe3weeksbeforemating.

Donotvaccinatepregnantanimals.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Onlyhealthyanimalsshouldbevaccinated.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproduct

toanimals

Operatorsshouldpreferablywearglovesandprotecttheirfacesbyamask.

OvilisToxovaxRenewal –Productliterature(FR/V/0119/001/R/002)day90final

Theproductshouldnotbehandledbypregnantwomenasthevaccinemayinterferewithnormalfoetal

developmentandshouldnotbehandledbypersonswhoareimmuno-deficient(e.q.AIDSsufferers;

personsundergoingchemotherapyortakingimmuno-suppressivedrugs).

Livingtachyzoϊtescancausediseaseinman.Careshouldbetakentoavoidself-injectionandtoavoid

vaccinegettingintothemouthortheeyes.Incaseofself-injection,immediatemedicaladviceshouldbe

soughtandthedoctorshouldbeinformedthatself-injectionwithalivingtachyzoϊteToxoplasma

vaccinehasoccurred.

4.6 Adversereactions(frequencyandseriousness)

Hyperthermia(peaktemperature<41°C)beginningafewdaysaftervaccinationmaybeseen.The

temperaturereturnstonormalwithinatmost10daysaftervaccination.

4.7 Useduringpregnancy,lactationorlay

Donotuseduringpregnancy.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproduct. Adecisiontousethisvaccinebeforeorafteranyotherveterinary

medicinalproductthereforeneedstobemadeonacasebycasebasis.

4.9 Amountstobeadministeredandadministrationroute

Femalesheep(minimumage:4months):

Onedoseof0.1mlvaccineconcentratein2mldiluentperanimalbyintramuscularinjection,atleast3

weeksbeforemating,accordingtothefollowingscheme:

Inthefirstyear,vaccinatetheentireflock,andinthefollowingyearsonlythereplacementlambs.

Incertaincases(highvalueflocks,flockswithoutpreviousexposuretotoxoplasmosis),itmaybe

advisabletorevaccinateeverytwoyears.

Methodofadministration

Thevaccineconcentrateissuppliedinvialsof20or50doses.Immediatelybeforeusethisisdiluted

with2mlperdoseofthediluentUnisolve.

Thetransferofvaccineconcentratemaybedoneusingasterile10mlsyringefittedwithasterile

needle(16or18g):withdrawsomeairbeforeremovingthesyringefromthesolventvial,tomaintain

thevialundernegativepressureandavoidspillage.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noundesirableeffect,otherthanthosementionedunder'Adversereactions",wasobservedafter

injectionoftwentytimesthedose.

OvilisToxovaxRenewal –Productliterature(FR/V/0119/001/R/002)day90final

4.11Withdrawalperiod(s)

Meatandoffal:42days

Milk:Zerodays

5. IMMUNOLOGICALPROPERTIES

TheactiveingredientisliveToxoplasmagondiitachyzoϊtes,strainS48.TheS48strainhaslostthe

abilitytoformtissuecysts.Thetachyzoϊtesthereforeinduceactiveimmunityagainstfieldinfectionwith

T.gondii,butcannotcausedisease.

Pharmacotherapeuticgroup:Liveparasiticvaccines,Toxoplasma

ATCvetcode:QI04AN01

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

DMSO

Bovineserum

Sucrose

Tryptose

Disodiumhydrogenphosphatedihydrate

Potassiumdihydrogenphosphate

Sodiumchloride

Waterforinjections

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct,exceptdiluentrecommendedforusewiththe

product.

6.3 Shelflife

Vaccine:21monthsat

-140°C;afterthawing,10daysat2°C-8°C.

Diluent:5years

Afterdilution,keepthevaccinerefrigerated(2°C-8°C)anduseitassoonaspossible(within2

hours).

6.4.Specialprecautionsforstorage

Vaccine:Afterthawing,storeandtransportrefrigerated(2°C-8°C).Donotfreeze.Protectfrom

light.

Diluent:Storebelow25°Cifstoredseparatelyfromthevaccine.Donotfreeze.

6.5 Natureandcompositionofimmediatepackaging

OvilisToxovaxRenewal –Productliterature(FR/V/0119/001/R/002)day90final

Glassvial,hydrolyticalclassTypeI,closedwithahalogenobutylrubberstopperandsealedwitha

codedaluminiumcap,containing2or5ml(20or50dosesrespectively)ofvaccineconcentrate.

Glassvial,hydrolyticalclassTypeII,closedwithahalogenobutylrubberstopperandsealedwithan

aluminiumcap,containing40or100mldiluent.

Packsize:

Cartonboxwith1vialof20or50dosesofvaccineand1vialof40or100mldiluents

Cartonboxwith1vialof20or50dosesofvaccine

Cartonboxwith1vialof40or100mldiluents

Thediluentmaybepackedtogetherwiththevaccineorseparately,suchas:

1box:1vial20dosesofvaccine+1vialof40mlofdiluent

1box:1vial50dosesofvaccine+1vialof100mlofdiluent

1box:1vial20dosesofvaccine

1box:1vial50dosesofvaccine

1box:1vialof40mlofdiluent

1box:1vialof100mlofdiluent

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Disposalofwastematerialbyboiling,incinerationorimmersioninanappropriatedisinfectantapproved

forusebythecompetentauthorities.

7. MARKETINGAUTHORISATIONHOLDER

IntervetInternationalB.V.

WimdeKörverstraat35

NL5831ANBoxmeer

representedbythenationalcompaniesintheconcernedMemberStates

8. MARKETINGAUTHORISATIONNUMBER(S)

FR:67626xx

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

19.11.1997/19.10.2005–19.10.2010

10 DATEOFREVISIONOFTHETEXT

September2010

OvilisToxovaxRenewal –Productliterature(FR/V/0119/001/R/002)day90final

13-12-2018

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