SUMMARY OF PRODUCT CHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Porceptal4 micrograms/mlsolution forinjection forpigs

DK, FI, IS, NO:PorceptalVet4 micrograms/mlinjection forpigs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Perml:

Activesubstance:

Buserelin acetate 4.2 µg

(correspondingto 4 µgbuserelin)

Excipients:

BenzylalcoholE1519 20.0 mg

Forafulllistofexcipients, seesection 6.1.

3. PHARMACEUTICALFORM

Solution forinjection

Aclear, colourlesssolution

4. CLINICALPARTICULARS

4.1 Targetspecies

Pigs(giltsand sows)

4.2 Indicationsforuse, specifying thetargetspecies

Inductionofovulationafteroestrussynchronisationbyweaning(sows)orbyadministrationofa progestin (gilts)to be used aspartofasinglefixed timeartificialinsemination program.

4.3 Contraindications

None

4.4 Specialwarnings

Buserelin isgiven afteroestrussynchronisation. In gilts, buserelin isgiven afterprogestin treatment. Provided thattheprogestin treatmentisended simultaneouslyin agroup ofgilts, itcausesa synchronisation ofoestrusin thetreated animals. In sows, oestrussynchronisation isachieved naturallybyweaning.

Insemination can bedoneat30-33 hoursafterbuserelin injection. When usingthisproduct,the animalsshould bechecked forsignsofoestrusatthetimeofartificialinsemination. Thereforethe presenceoftheboarisrecommended.

Itmayhappen thatnegativeenergybalanceduringlactation isassociated with mobilisation ofbody reserveswith alargedrop in backfatthickness(morethan approximately30 %). In such animals, oestrusand ovulation maybedelayed and theseanimalsshould bemanaged and bred on acaseby casebasis.

4.5 Specialprecautionsforuse

Specialprecautionsforusein animals

Iftherecommendedtimescheduleisnotcarefullyfollowed,fertilitymaybeimpaired.Progestinsand buserelin can onlybeused in healthyanimals.

Specialprecautionsto betaken by theperson administering theveterinary medicinalproductto animals

Becauseofthehormonaleffectsofbuserelin duringpregnancy, women who areorcould bepregnant should nothandletheproduct. Women ofchild-bearingageshould administertheproductwith caution.

Avoid contactwith skin and eyes. Wash handsafteruse.

Accidentalspillageon theskin should bewashed offimmediatelywith soap and water. Ifthe preparation should byaccidententertheeyes, rinseeyeswith waterand ifnecessarycontactadoctor. In caseofaccidentalself-injection, seekmedicaladviceimmediatelyand showthepackageleafletor thelabelto thephysician.

4.6 Adversereactions(frequency and seriousness)

Noneknown

4.7 Useduring pregnancy, lactation orlay

Theproductisnotindicated forusein pregnantand lactatingsows

4.8 Interaction with othermedicinalproductsand otherformsofinteraction

Noneknown.

4.9 Amountsto beadministered and administration route

Single2.5 ml(10 µgbuserelin)intramuscularorsubcutaneousinjection peranimal.

Do notpiercethestoppermorethan 12 times.

When treatinglargenumbersofanimals, useasuitabledraw-offneedleorautomaticdosingsyringeto avoid excessivepuncturingoftheclosure.

Theartificialinsemination schedulein pigsisasfollows:

Gilts:

Administer2.5 mlproductat115-120 hoursafterend ofthesynchronisation treatmentwith a progestin.

_{Asingleartificialinsemination should bedone30 -33 hoursafteradministration oftheproduct.}

Sows:

Administer2.5 mlproductat83-89 hoursafterweaning.

Asingleartificialinsemination should bedone30 -33 hoursafteradministration oftheproduct.

In individualcases, itmayhappen thatoestrusisnotexpressed at30 – 33 hoursafterPorceptal treatment. In thiscase, insemination can begiven later, atthemomentwhen oestrussignsarepresent.

4.10 Overdose(symptoms, emergency procedures, antidotes), ifnecessary

Thetoxicityofbuserelinislow.Evenwhentheadviseddoseisexceeded,theoccurrenceoftoxicity signsisunlikely.

4.11 Withdrawalperiod(s)

Meatand offal:zero days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeuticgroup:Gonadotropin-releasinghormones, ATCvetcode:QH01CA90

5.1 Pharmacodynamicproperties

Buserelinisasyntheticpeptidehormonewiththeactivity analoguetothenaturalgonadotrophin releasing hormone(GnRH).Itinducesintheanteriorpituitary thereleaseofluteinisinghormone(LH) and follicle stimulating hormone (FSH) into the blood. Higher amounts than the recommended clinicaldosesdo notfurtherstimulateLHand FSHsecretion.

5.2 Pharmacokineticparticulars

Afterparenteraladministration, buserelin israpidlyabsorbed and eliminated, mainlythrough urine. Metabolismoccursin theliver, kidneysand pituitary. Allmetabolitesaresmallinactivepeptides. The LHsurgeoccursrapidlyafterinjection.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

BenzylalcoholE1519

Sodiumchloride

Sodiumdihydrogen phosphatemonohydrate

Sodiumhydroxide(pHadjustment)

Concentrated hydrochloricacid (pHadjustment)

Waterforinjections

6.2 Incompatibilities

In theabsenceofcompatibilitystudies, thisveterinarymedicinalproductmustnotbemixed with otherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackaged forsale:2 years

Shelflifeafterfirstbroachingthevial:28 days

6.4 Specialprecautionsforstorage

Storein arefrigerator(2-8 °C)

Keep thevialin theoutercarton in orderto protectfromlight

6.5 Natureand composition ofimmediatepackaging

Cardboardboxcontaining colourlessglass(typeI)vialsof2.5ml,5 ml, 10 mlorcolourless glass(typeII)vialsof50ml,closedwithan ETFE laminatedbromobutylrubberstopper(typeI) (2.5 ml and 5 ml vials ) or a bromobutyl rubber stopper

(type I) (10 ml and 50 ml vials)and an aluminiumcrimp cap.

Packsizes:

• 10 vials of 2.5 ml

• ^{10 vials of 5 ml}

• ^{5 vials of 10 ml}

• ^{Single vial of 5 ml}

• ^{Single vial of 10ml}

• ^{Single vial of 50ml}

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunused veterinary medicinalproductorwaste materialsderived fromtheuseofsuch products

Anyunused veterinarymedicinalproductorwastematerialsderived fromsuch veterinarymedicinal productsshould bedisposed ofin accordancewith localrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm 01708/4604

9. DATEOFFIRSTAUTHORISATION

12 December 2013

10 DATEOFREVISIONOFTHETEXT

March 2016

Approved: 16 March 2016