_{SUMMARY OF PRODUCTCHARACTERISTICS}

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

WINVIL^®3 micro

Emulsionfor InjectionforAtlantic salmon

2. QUALITATIVEAND QUANTITATIVE COMPOSITION

Perdose(0.05ml)vaccine

_{Active substances:}

InactivatedAeromonassalmonicidasubspeciessalmonicida RPS₆₀≥80%

InactivatedMoritella viscosa RPS_end≥83%

Infectiouspancreatic necrosisvirus(IPNV) Serotype A₂ RP ≥2.0

RPS =RelativePercentSurvival.

RP =RelativePotencycomparedtoareferencevaccine

_Adjuvants:

Mineral oil 43.62%

_Excipients:

Formaldehyde (residual inactivant) <0.025%(w/v) See section 6.1foracompletelist ofexcipients

3. PHARMACEUTICALFORM

Emulsionforinjection.

Pale yellowemulsion.

A separation oftheemulsion can occurovertime, leading to atriphasicappearance where the upperlayerappearsas aclearoilyphase, themiddle layerasa pale yellowcreamy emulsion andthe bottom layerappearsas adarkbrown aqueousphase.

4. CLINICAL PARTICULARS

4.1 Targetspecies

Atlanticsalmon(Salmo salar)

4.2 Indicationsforuse,specifying thetarget species

For the active immunisation of Atlantic salmon (Salmo salar) to reduce mortality due to infection with Aeromonas salmonicida (furunculosis). The onset of immunity to A. salmonicidaoccurs at 446 degree days (mean water temperature °C multiplied by the number of holding days) following vaccination.

For the active immunisation of Atlantic salmon to reduce mortality due to infection with Infectious Pancreatic Necrosis Virus (IPNV). The onset of immunity to IPNV occurs at 625 degree days following vaccination.

For the active immunisation of Atlantic salmon to reduce mortality due to infection with M. viscosa (winter ulcer disease). The onset of immunity to M. viscosaoccurs at 286 degree days following vaccination.

The duration of immunity to A. salmonicida, M. viscosa and IPNV is not known.

This is a Provisional Marketing Authorisation. A full set of supporting efficacy data is not available for this product. In particular, protection against specific clinical signs such as ulceration associated with M. viscosahas not been demonstrated. Furthermore, limited information is available on long-term safety in terms of the frequency and severity of adhesions and lesions within the peritoneal cavity beyond 4 months post vaccination.

4.3 Contraindications

Do notuse ifthere are anysigns ofdiseaseinthefish.Seesection 4.7.

4.4 Specialwarnings

It isrecommendedthatall fishwithin the stockpopulation are vaccinatedin order toreduce infection spread.

Fish should bestarvedforaperiod of24hourspriorto vaccination andpreferablyatleast

24hourspost vaccination. Feed shouldgraduallybe re-introducedtofishpost vaccination overseveral daysuntilfull appetite isresumed.

4.5 Specialprecautionsforuse

Specialprecautionsforusein animals

Notapplicable.

Specialprecautionstobe takenbythe personadministeringtheveterinarymedicinal product to animals

Ensurethat themethodofrestraint, handling andadministration,e.g.bythe use of guarded needles,minimisestheriskofaccidentalinjection/self-injection.

Totheuser:

Thisproductcontainsmineral oil. Accidental injection/self-injectionmayresultin severepain and swelling, particularly ifinjectedintoajointor finger,andin rarecasescould result in the loss oftheaffectedfingerifpromptmedical attention isnotgiven.

Ifyou areaccidentallyinjectedwith thisproduct, seekprompt medical advice even ifonlya verysmall amountisinjected andtakethe packageleafletwith you.

Ifpain persistsfor morethan 12hoursafter medical examination,seekmedical advice again. Personal protectionlikegloves andguarded needles should beused when handling the veterinaryproduct.

Tothephysician:

Thisproductcontainsmineral oil. Even ifsmall amountshave been injected,accidental injection with thisproductcancauseintenseswelling, which may, forexample,resultin ischaemic necrosisandeven the loss ofadigit. Expert,PROMPT, surgical attention is required andmaynecessitateearlyincision and irrigation of the injected area, especially where there isinvolvementof fingerpulportendon.

4.6 Adversereactions(frequencyand seriousness)

Fishmay takeupto 11 daysto returntonormalfeeding.Side effects following intra-peritoneal administration of oil-adjuvanted vaccines may occur within several months following seawater transfer. Limited information is available on long-term safety in terms of the frequency and severity of adhesions and lesions within the peritoneal cavity beyond 4 months post vaccination.

Fish vaccinated with this product may present visceral adhesions within the peritoneal cavity, melanin pigmentation in parietal abdominal muscle or in rare cases granulomas among the viscera. Adhesions may be minor, connect various organs to the abdominal wall and leave an opaque peritoneum after being removed in up to 22% of vaccinated fish. Parietal melanin pigmentation may occur in <1 % of vaccinated fish and be moderately extensive yet readily removed and contain small areas that penetrate beyond the muscle surface. Visceral granulomas may occur in <1 % of vaccinated fish.

4.7 Use duringpregnancy,lactationorlay

Do notuse infish selectedforbroodstock.

4.8 Interactionwith othermedicinal productsand otherformsofinteraction

No information isavailable onthesafetyand efficacyofthisvaccine when used with any other veterinarymedicinal product. A decision tousethisvaccine beforeorafteranyother veterinarymedicinal product thereforeneedstobe madeon acasebycase basis.

4.9 Amountsto beadministered andadministration route

Administrationofthevaccine mustbeperformedusinganinjection system that prevents back-flushofthevaccine in tothevaccine tube/container.

Thevaccine should beat 15-20°Cbefore use.Oil based vaccinesare best injected at15 - 20°C tofacilitatevaccine deliveryand to avoid damage andstresstothefish.

Each 500ml ofvaccine issufficient tovaccinate10,000fish.Touse,fishareanaesthetiseduntilimmobilisedand administered0.05mlbyintraperitonealinjection onthemidline,one pelvicfin lengthahead of thepelvicgirdle. Theneedle should beatright anglestotheskin surface. It isrecommended that fish beatleast43.7gin sizeforinjectionadministration. A minimumwater temperatureof2°Cforvaccination is recommended.

4.10 Overdose(symptoms,emergencyprocedures,antidotes), if necessary

No adversereactionsotherthanthose described in section4.6areobserved.

4.11 Withdrawalperiod(s)

Zero degreedays.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Inactivatedvaccinesfor fish, ATC vet code:QI10AL0

Thevaccinestimulates the developmentofactiveimmunityagainstAeromonas salmonicida subspeciessalmonicida(furunculosis), Moritella viscosa(winterulcers) andIPNV(infectious pancreaticnecrosisvirus)in Atlanticsalmon.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Mineral oil

Polyoxyethylene sorbitanmonooleate

Sorbitan sesquioleate

Phosphatebuffered saline

Residual formaldehyde

6.2 Incompatibilities

Do not mixwith anyotherveterinarymedicinal product.

6.3 Shelf life

Shelf-lifeoftheveterinarymedicinal productas packagedfor sale: 12 months.

Shelf-lifeafterfirst opening theimmediatepackaging: Use within 10 hours of opening,remaining vaccine should bediscardedatend of use.

6.4 Specialprecautionsforstorage

Storeandtransport refrigerated(2°C - 8°C)

Do not freeze.

Keep in theoriginal containertoprotectagainstlight.

6.5 Natureandcomposition of immediatepackaging

Theproductissupplied in asingletube intravenousbagwith aplasticscrewcap closure and a plastic clamp off device together with afluidtransfertubing.

Packsize:500ml(10,000 doses)

6.6 Specialprecautionsforthedisposalofunused veterinary medicinal productor wastematerialsderived fromthe useofsuchproducts

Anyunused productorwastematerial should bedisposed ofin accordance with national requirements.

7. MARKETINGAUTHORISATION HOLDER

Elanco Europe Ltd

Lilly House

Priestley Road

Basingstoke

Hampshire

RG24 9NL

8. MARKETINGAUTHORISATION NUMBER

Vm00879/4080

9. DATE OF FIRSTAUTHORISATION

10 July 2014

10. DATE OF REVISIONOFTHE TEXT

S eptember 2016

Approved: 30 September 2016