INGELVAC MYCOFLEX

Main information

  • Trade name:
  • INGELVAC MYCOFLEX
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • INGELVAC MYCOFLEX
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Mycoplasma
  • Therapeutic area:
  • Pigs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0203/001
  • Authorization date:
  • 10-11-2011
  • EU code:
  • FR/V/0203/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

IngelvacMycoFLEXsuspensionforinjectionforpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

InactivatedMycoplasmahyopneumoniae,JStrainIsolateB-3745.

Eachdoseof1mlofinactivatedvaccinecontains:

Activesubstance:

Mycoplasmahyopneumoniae: >1RP*

*RelativePotency(ELISAtest)bycomparisonwithareference

vaccine.

Adjuvant: Carbomer:1mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection.

Cleartoslightlyopalescent,pinktobrownsuspensionforinjection.

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(fatteningpigsorfuturebreedersuntilfirstreproductiveservice).

4.2 Indicationsforuse,specifyingthetargetspecies

Foractiveimmunisationofpigsfrom3weeksofagetoreducelunglesionsfollowinginfectionwith

Mycoplasmahyopneumoniae.

Onsetofprotectionoccursby2weekspostvaccinationandlastsforatleast26weeks.

4.3 Contraindications

None.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Onlyhealthyanimalsshouldbevaccinated.

Incaseofanaphylacticreactions,theadministrationofepinephrineisrecommended.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

None.

4.6 Adversereactions(frequencyandseriousness)

Adversereactionsareuncommon:transientswellinguptofourcentimetresindiameter,sometimes

associatedwithrednessoftheskin,maybeobservedattheinjectionsite.Theseswellingsmaylastup

tofivedays.

Atransientmeanincreaseinrectalbodytemperatureofabout0.8°Clastingupto20hoursafter

vaccinationmaybeobserved.

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Safetyandefficacydataareavailablewhichdemonstratethatthisvaccinecanbemixedwith

BoehringerIngelheim’sIngelvacCircoFLEXandadministeredatoneinjectionsite.

Noinformationisavailableonthesafetyandefficacyofthisvaccinewhenusedwithanyother

veterinarymedicinalproductexcepttheproductmentionedabove.Adecisiontousethisvaccine

beforeorafteranyotherveterinarymedicinalproductthereforeneedstobemadeonacasebycase

basis.

4.9 Amountstobeadministeredandadministrationroute

Shakewellbeforeuse.

Singleintramuscularinjectionofonedose(1ml),preferablyintheneckofpigsfrom3weeksofage.

Avoidintroductionofcontaminationduringuse.

Avoidmultiplebroaching.

Vaccinedevicesshouldbeusedinaccordancewiththedeviceinstructionsprovidedbythe

manufacturer.

Useequipmentthatpreventsflushbackoftheveterinarymedicinalproduct.

WhenmixedwithIngelvacCircoFLEX:

Vaccinateonlypigsfrom3weeksofage.

WhenmixedwithIngelvacCircoFLEXthefollowingequipmentshouldbeused:

UsethesamepacksizesofIngelvacCircoFLEXandIngelvacMycoFLEX.

Usetheappropriatepacksizesforthenumberofpigstobevaccinated.

Usetwoseparatepre-sterilizedtransferneedles.

Useapre-sterilizedtransfercontainer(HDPEorEVAplasticcontainer,TypeIorTypeIIglass

containersclosedwithnaturallatex,polybutene-1rubberorsiliconisedchlorobutylstoppers)ofat

leastthedoublevolumeofanindividualbottlesize.

Pre-sterilizedtransfercontainersandtransferneedles(CEcertified)arecommonlyavailablevia

medicalequipmentsuppliers.

Toensurecorrectmixingfollowthestepsasdescribedbelow:

1. ConnectoneendofthefirsttransferneedletothevaccinebottleofIngelvacCircoFLEX.

2. - Connecttheoppositeendofthetransferneedletothetransfercontainer.

- AsepticallytransfertheIngelvacCircoFLEXvaccinetothetransfercontainerbyinverting

thevaccinebottle.Ifneeded,gentlypressthevaccinebottletofacilitatethetransfer.

- Aftertransferofthefullcontent,disconnectanddiscardthetransferneedleandtheempty

vaccinebottlefromthetransfercontainer.

3. ConnectoneendofthesecondtransferneedletothevaccinebottleofIngelvacMycoFLEX.

4. TotransfertheIngelvacMycoFLEXvaccineintothetransfercontaineralreadyfilledwith

IngelvacCircoFLEX,repeatstep2.

5. Toensureappropriatemixingofthevaccines,shakethetransfercontainerwelluntilthemixture

isofuniformorangetoreddishcolour.Duringvaccinationtheuniformityofthecolouredmixture

shouldbemonitoredandmaintainedbycontinuousagitation.

6. Administeronesingleinjectiondose(2ml)ofthemixtureintramuscularlyperpig,irrespectiveof

bodyweight.Foradministration,vaccinedevicesshouldbeusedinaccordancewiththedevice

instructionsprovidedbythemanufacturer.

Usetheentirecontentofthetransfercontainerimmediatelyaftermixing.Anyunusedmixtureorwaste

materialshouldbedisposedofinaccordancewithlocalrequirements.

ThepackageleafletofIngelvacCircoFLEXshouldalsobeconsultedbeforetheadministrationofthe

mixedproduct.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Followingtheadministrationofa4-foldoverdoseofvaccinenoadversereactionsotherthanthose

describedundersection4.6havebeenobserved.

4.11Withdrawalperiod

Zerodays.

5. IMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup: Mycoplasmavaccine

ATCvetcode: QI09AB13

ThisvaccineisdesignedtostimulatethedevelopmentofanactiveimmuneresponsetoMycoplasma

hyopneumoniae.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumchloride

Waterforinjection

6.2 Incompatibilities

Donotmixwithanyotherveterinarymedicinalproduct,exceptwithBoehringerIngelheim´sIngelvac

CircoFLEX.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale: 21months

Useimmediatelyafteropening.

6.4 Specialprecautionsforstorage

Storeandtransportrefrigerated(2°C–8°C).

Donotfreeze.

Protectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Cardboardboxwith1or12highdensitypolyethylenebottlesof10ml,50ml,100mlor250mlwitha

chlorobutylstopperandlacqueredaluminiumseal.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

BoehringerIngelheimVetmedicaGmbH

55216Ingelheim/Rhein

Germany

8. MARKETINGAUTHORISATIONNUMBER(S)

<Tobecompletednationally.>

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<Tobecompletednationally.>

10. DATEOFREVISIONOFTHETEXT

<Tobecompletednationally.>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

1-10-2018

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