HYORESP

Main information

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

Documents

Localization

  • Available in:
  • HYORESP
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0106/001
  • Authorization date:
  • 24-02-2012
  • EU code:
  • FR/V/0106/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

HYORESP

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Peronedoseof2ml:

Activesubstance:

.InactivatedwholecellMycoplasmahyopneumoniaeantigen,atleast......................3.0ELISA.U *

Adjuvant:

.Al +++

(ashydroxide).........................................................................................................4.2mg

Excipients:

.Thiomersal.......................................................................................................................0.2mg

* ELISA.U:Unitof RP(relativepotency) compared to referencevaccine.

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Suspensionforinjection.Milkycolor

4. CLINICALPARTICULARS

4.1 Targetspecies

-Sucklingpigletsfromtheageof5days

-Postweaningpiglets

-Fatteningpigs

4.2 Indicationsforuse,specifyingthetargetspecies

ForactiveimmunisationofpigstoreduceinfectionandlunglesionscausedbyMycoplasma

hyopneumoniae.

4.3 Contraindications

None.See4.7

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

. Applyusualproceduresforthehandlingoftheanimals.

. Vaccinateonlyhealthyanimals.

. Shakepriortouse.

. Applyusualasepticprocedures.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthepackageleafletor

thelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

. Administrationofthevaccinemaycausetransientoedemaandmuscularinflammationatthesite

ofinjection,notusuallyexceedingoneweekandrarelyuptofiveweeks.

. Thevaccinationmaycauseaslighttemperatureincrease(lessthan1°C)foratransientperiod

(lessthan24hoursafteradministration)withoutanyeffectontheanimal'shealthorzootechnical

performance.

. Inexceptionalcases,thevaccinemayrevealahypersensitivitystatus.Appropriatesymptomatic

treatmentshouldbeadministered.

4.7 Useduringpregnancy,lactationorlay

Intheabsenceofdata,theuseofthisvaccineisnotrecommendedinbreedinganimals.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Noinformationisavailableonthecompatibilityofthisvaccinewithanyother.Therefore,thesafety

andefficacyofthisproductwhenusedwithanyothervaccinehasnotbeendemonstrated.

4.9 Amountstobeadministeredandadministrationroute

Injectone2-mldoseofvaccinebyintramuscularroute,accordingtooneofthefollowingschedules:

- 2injectionsatanintervalof3-4weeksfrom5daysofage.

- or1injectionfromtenweeksofage.

Thechoiceofthevaccinationregimeshouldbebasedontheknowledgeoftherisks(timeof

occurrenceofinfection)intheherd.Vaccinationmustbeperformedpriortoanimalsbecoming

infected.Thesingleinjectionregimewillbelimitedtocaseswhereanimalinfectionoccursduringthe

midtolatefatteningperiod.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Nosideeffecthasbeenobservedaftertheadministrationofanoverdoseexceptthosementionedinthe

“AdversesReactions”section.

4.11Withdrawalperiod(s)

Zerodays.

5. IMMUNOLOGICALPROPERTIES

ATCvetcode:QI09AB13(Mycoplasmavaccine)

HYORESPisaninactivatedandadjuvantedvaccinewhichstimulatesactiveimmunityagainst

Mycoplasmahyopneumoniae.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Aluminiumhydroxide

Thiomersal

SalineSolution

6.2 Incompatibilities

Donotmixwithanyothervaccineorimmunologicalproduct.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:24hours.

6.4.Specialprecautionsforstorage

Storeandtransportrefrigerated(2

C–8

C),protectedfromlight.

6.5 Natureandcompositionofimmediatepackaging

Packagingintendedforsale:

CardboardboxwithoneTypeIglassbottleof10,20,50,or100mlwithabutylelastomerclosureand

aluminiumcap.

CardboardboxwithtenTypeIglassbottlesof10,20,50,or100mlwithabutylelastomerclosureand

aluminiumcap.

CardboardboxwithoneTypeIpolypropylenebottleof100or200mlwithabutylelastomerclosure

andaluminiumcap.

CardboardboxwithtenTypeIpolypropylenebottlesof100or200mlwithabutylelastomerclosure

andaluminiumcap.

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnational

requirements.

7. MARKETINGAUTHORISATIONHOLDER

AUSTRIA,FINLAND,FRANCE,GREECEandSWEDEN

MERIAL

29,avenueTonyGarnier,69007LYON

France

Tel:(33)472723000

BELGIUMandLUXEMBURG

MERIALBELGIUMS.A./N.V.

BdSylvainDupuislaan243,1070Brussel-Bruxelles-Brüssel

Belgium

Tel:(32)5294930

Fax:(32)5294911

DENMARK

MERIALNORDENA/S

Mileparken20E,2740Skovlunde

Denmark

Tel:(45)44540043

Fax:(45)44540045

GERMANY

MERIALGmbH

AmSöldnermoos6,85399HALLBERGMOOS

Germany

Tel:(49)81195930

Fax:(49)8119593101

ITALY

MERIALITALIASPA

CentroDirezionaleMilanofiori,Strada6,PalazzoE/5,20090Assago(MI)

Italy

Tel:(39)02577661

Fax:(39)0257766301

IRELANDandUNITED-KINGDOM

MERIALANIMALHEALTHLTD

POBox327,SandringhamHouse,HarlowBusinessPark,HARLOWEssexCM195TG

United-Kingdom

Tel:(44)1279775858

Fax:(44)1279775888

THENETHERLANDS

MERIALBV

Kleermakerstraat10,1991JLVelserbroek

TheNetherlands

Tel:(31) 235201080

Fax:(31) 235201088

SPAIN

MERIALLABORATORIOSSA

c/Tarragona,161-planta3a,08014BARCELONA

Spain

Tel:(34)932928383

Fax:(34)932928389

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

10 DATEOFREVISIONOFTHETEXT

April2007

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