Excis

Main information

  • Trade name:
  • Excis Cutaneous Solution 10 g/l
  • Pharmaceutical form:
  • Cutaneous solution
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Excis Cutaneous Solution 10 g/l
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • cypermethrin
  • Therapeutic area:
  • Fish Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0134/001
  • Authorization date:
  • 03-07-2008
  • EU code:
  • UK/V/0134/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Revised:August2012

AN.01155/2010

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Excis10mg/mlconcentrateforsolutionforfishtreatment

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Cypermethrin(cis:trans/40:60)10mg/ml

Excipients:

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Concentrateforsolutionforfishtreatment.

Aclear,yellow-tintednon-aqueoussolutionwithanalcoholicodour.

4. CLINICALPARTICULARS

4.1Targetspecies

FarmedAtlanticsalmon(Salmosalar).

4.2Indicationsforuse,specifyingthetargetspecies

TheproductisindicatedforthetreatmentandcontrolofsealiceinfarmedAtlantic

salmon(Salmosalar).

TheproductwilltreatandcontrolallstagesofLepeophtheirussalmonis(copepodid,

chalimusI-IV,pre-adultandadult)andCaliguselongatus.

TreatmentofsealiceatthechalimusIVstage(i.e.beforetheymatureintogravid

females)shouldhelptoreducethenumberofinfectivestagesreleasednearthefish

cages,andisrecommended.

4.3Contraindications

Seesection4.7.

4.4Specialwarnings

IntensiveuseormisuseofExciscangiverisetoresistance.Toreducethisrisk

treatmentmethodsandprogrammesshouldbediscussedwithyourveterinary

Revised:August2012

AN.01155/2010

advisor.Efficacyofthisproductagainstsealiceisreducedifcypermethrinresistant

strainsarepresent.

4.5Specialprecautionsforuse

i) Specialprecautionsforuse

Donotexceedtherecommendeddosage.

ii) Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Wearprotectiveclothing,i.e.cottonoveralls,andnitrilerubberorneoprenegloves,

(0.3mmthick)andadisposablefacemaskwhenhandlingtheproductandtarpaulins

ornetsoftreatedcages.

Wearprotectiveclothing,gloves,eyeprotection,andadisposablefacemaskwhen

mixingandadministeringtheproduct.

Donotsmoke,drinkoreatwhilehandlingtheproduct.

Avoidcontactwiththeskin,eyes,noseandmouth.Ifclothingbecomes

contaminated,removewithoutdelayandwashskinthoroughlywithsoapandwater.

Changeoutofprotectiveclothingandwashhandsthoroughlyafterusingtheproduct.

Launderprotectiveclothingbeforere-use.

Theproductisoflowhazardbyoralanddermalroutes.Inhalationoftheproduct

maycauseirritationtothemucousmembranesandrespiratorytract.Skinexposure

maycausetransientsensations(tingling,numbness)whichdisappearafterafew

hours.Obtainmedicaladviceifsymptomspersist.

iii) Otherprecautions

EnvironmentalWarnings:Adischargeconsentmustbeobtainedfromtherelevant

waterauthoritybeforeuse.

Initsconcentratedform,theproductmaypresentadangertootheraquaticlife.

Preventanyunnecessaryreleaseoftheproductintothemarineenvironment.Donot

contaminatenaturalwaterwiththeproduct,thecontainer,ortherinsings,anddonot

re-usethecontainerforanypurpose.

4.6Adversereactions(frequencyandseriousness)

Mildtransientheadshaking/flashing/increasedjumpinghasbeenreportedinafew

fish(lessthan10%)inlessthan5%offieldtrials.Thecauseisunknown.There

havebeennopermanenteffects,nomortalitiesandallfisharenormalwithinhoursof

treatment.

Revised:August2012

AN.01155/2010

4.7Useduringpregnancy,lactationorlay

Therehavebeennosafetystudiescarriedoutonbroodstockandtheproductcannot,

therefore,berecommendedforuseinbreedingsalmon.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Theproductistobeadministeredbyadditiontoseawater:immediatelypriorto

administrationmixthecorrectvolumeofproductwithapproximately40litresof

seawaterbeforeaddingtotheseacageatseverallocationstoensuremaximum

dispersion.IntensiveuseormisuseofExciscangiverisetoresistance.Toreduce

thisrisktreatmentmethodsandprogrammesshouldbediscussedwithyour

veterinaryadvisor.Efficacyofthisproductagainstsealiceisreducedifcypermethrin

resistantstrainsarepresent.

Preparationoftheseacagetobetreated:Theseacagenetshouldberaisedtoa

depthof2-2.5metres,andthensurroundedbyimpervioustarpaulinstoisolatethe

cagetobetreated.Thedepthofenclosedwatershouldthenbe3metres.The

amountofproducttoachievethetreatmentdosecanbecalculatedusingthe

followingtable:

Cagesizein

metres Encloseddepthof

water

inmetres AmountofExcis

inml

12x12 3 216

15x15 3 338

16x16 3 384

Anoxygendiffusershouldbeusedduringtreatmenttomaintainanoxygenlevel

greaterthan7mg/lduringthetreatment.

TreatmentPeriod:1hourmaximum.

TreatmentDose:0.5mlExcis/m 3 seawater.Thisisequivalentto5.0µg

cypermethrin/litreseawater.

Treatmentmayberepeatedwhensignsofre-infestationoccur.

AstrategicapproachtosealicecontrolwithExcismayincreasetheintervalbetween

treatmentsandisrecommended.Treatmentofsealicebeforetheyreachthe

reproductivestage(e.g.atchalimusIV)shouldhelptoreducethenumberoffree-

swimminginfectivestagesreleasednearthefishcages.Thisshouldslowdownthe

rateofre-infestation.

Revised:August2012

AN.01155/2010

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Signsoftoxicityappeartobeheadshaking/flashing/increasedjumpinginafewfish.

Followingtreatment,thesesignsrapidlydisappear.

4.11Withdrawalperiod(s)

Meat:10degree-days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ectoparasiticidesfortopicaluse,incl.Insecticides

ATCVetCode:QP53AC08

5.1Pharmacodynamicproperties

Cypermethrinisaneuropoisonactingontheaxonsintheperipheralandcentral

nervoussystembyinteractingwithsodiumchannelsincrustaceans.

5.2Pharmacokineticproperties

Syntheticpyrethroidsaregenerallymetabolisedinmammalsthroughester

hydrolysis,oxidationandconjugationandthereisnotendencytoaccumulatein

tissues.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polysorbate20

Ethanol(Absolute)

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:6monthsfromthe

dateofmanufacture.

Revised:August2012

AN.01155/2010

6.4.Specialprecautionsforstorage

Donotstoreabove25°Candprotectfromlight

Storeintheoriginalcontainer.

Discardunusedproduct.

HIGHLYFLAMMABLE

6.5Natureandcompositionofimmediatepackaging

Highdensitypolyethylenebottles(250mlcapacity)withwhitescrewcaplidswhich

haveapolyethyleneliner.Thebottlescontain200mlproductandaredesignedto

floatshouldthesebedroppedaccidentally.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Thisformulatedproductisdesignedforthetreatmentoffish.However,atlevelsfar

greaterthanthetreatmentdose,theproductcouldbeharmfultofishandaquaticlife.

Donotcontaminatesurfacewatersorditcheswithproductorusedcontainers.

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewith

nationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalVaccinesLimited

4WarnerDrive

SpringwoodIndustrialEstate

Braintree

Essex,CM72YW

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBERS

UK: Vm18343/4010

Ireland:VPA10974/022/001

9. DATEOFFIRSTAUTHORISATION

07May1999

Revised:August2012

AN.01155/2010

10 DATEOFREVISIONOFTHETEXT

August2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

UK:

Tobesoldorsuppliedthroughveterinarysurgeonsonly.

LegalcategoryPOM-V

Ireland:

POM(E)Asanitemforsaleorsupplyonlyfromapharmacybyapharmacist,orbya

registeredveterinarysurgeonforthetreatmentofanimalsunderhis/hercare.

LegalcategoryPOM(E)

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Ceva SantE Animale)

Vectra 3D (Active substance: dinotefuran, pyriproxyfen, permethrin) - Centralised - Renewal - Commission Decision (2018)5783 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2555/R/9

Europe -DG Health and Food Safety