MS 222 Pharmaq

Main information

  • Trade name:
  • MS 222 Pharmaq
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MS 222 Pharmaq
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Tricaine mesilate
  • Therapeutic area:
  • Fish

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0405/001
  • Authorization date:
  • 21-11-2012
  • EU code:
  • UK/V/0405/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

IssuedFebruary2013

AN:01919/2011

Page1of7

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

TricainePharmaq1000mg/gPowderforSolutionforFishTreatment

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance:

Qualitativecomposition Quantitativecomposition

TricaineMethaneSulphonate 1000mg/g

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Powderforsolutionforfishtreatment.

Whitetooff-whitepowder.

4. CLINICALPARTICULARS

4.1Targetspecies

1)Ornamentalfish,ortheirdevelopmentstages,and

2)Breedingandjuvenilestagesoffish.

4.2Indicationsforuse,specifyingthetargetspecies

Foruseinanimmersionbathforsedation,immobilisationandanaesthesiaoffishfor:

vaccination,transportation,weighing,tagging,clipping,strippingofbreedstock,

blood-samplingandsurgicalprocedures.

4.3Contraindications

Theproductshouldnotbeusedinthefollowingtropicalfishspecies:

Apistogramma(Mikrogeophagus)ramirez,Balantiocheilosmelanopterus,Etroplus

suratensis,Melanotaeniamaccullochi,Monodactylusargenteus,Phenacogrammus

interruptusandScatophagusargus

4.4Specialwarningsforeachtargetspecies

None

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Donotexceedthedoserecommendedforeachcategoryoffish.

Broodstockanaesthetisedforstrippingshouldbeimmersedin

unmedicatedwaterimmediatelybeforecollectionofeggsormilttoavoid

significantdirectcontactofeitherwiththeproduct.

Assolutionsoftheveterinarymedicinalproductareslightlyacidic,theuse

ofphosphateorimidazolbufferhasbeenproposedtoreducestress.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Ifyouknowyouarehypersensitive(allergic)toanaestheticssuchas

Tricainemesilate(Tricainemethanesulphonate),donothandlethe

product.

Donotcreatedustwhenhandlingthepowderorpreparingtheanaesthetic

solution.Incaseofaccidentalinhalationofdust,movetofreshairandif

breathingisaffected,seekmedicaladviceimmediatelyandshowthe

doctortheproductlabel.Insituationswheredustiscreatedwhenhandling

thepowder,wearadisposablehalfmaskrespiratorconformingto

EuropeanStandardEN149oranon-disposablerespiratortoEuropean

StandardEN140withafiltertoEN143.

Wearimpermeablerubbergloveswhenhandlingtheproductorsolution.

Avoidcontactwithskinandeyes.Incaseofaccidentalcontact,

immediatelywashtheaffectedareawithplentyofcleanrunningwater.If

irritationpersists,seekmedicaladvice.

Donoteat,drinkorsmokewhilsthandlingthisproduct.

Washhandsafteruse.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyand

showthepackageleafletorthelabeltothephysician.

Otherprecautions

Inordertoprotecttheenvironment,usedsolutionmusteitherbefiltered

usingactivatedcharcoalfilterspriortodilutionintheeffluenttobe

dischargedfromthefarmoritmustbetransferredtoaholdingtank

filledwithwaterwithsubsequentcontrolledreleasefordilutioninthe

effluenttobedischargedfromthefarm.Seesection6.6.

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4.6Adversereactions(frequencyandseriousness)

Noneknown.

4.7Useduringpregnancy,lactationorlay

Notapplicable.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

TricaineMethaneSulphonatehasbeenusedsuccessfullyatlowerconcentrationsin

conjunctionwithseveralotheranaesthetics.Noadverseinteractionwithother

pharmaceuticalshasbeenestablished.

4.9Amountstobeadministeredandadministrationroute

Anaqueoussolutionoftheproductisusedinanimmersionbathforsedation,

immobilisationandanaesthesiaoffish,bothornamentalandthoseintendedfor

humanconsumption.

Anumberoffactorsinfluencetheefficacyandsafetyoftheproduct,including

concentrationofthedruginwater,durationofexposure,temperature,oxygencontent

anddensityofbiomass.Becauseofthesevariablefactorsitisstronglyrecommended

thatatestoftheselecteddrugconcentrationandexposuretimeisconductedwitha

smallgroupofrepresentativefishbeforelargenumbersaremedicated.Thisis

especiallyimportantwhenwatertemperatureisattheupperorlowerendsofthe

normaltemperaturerangesforthespeciesbeingtreated.Theproductshouldbe

dissolvedinwaterofthesamecompositionandcharacteristicsasthattowhichthe

fishareaccustomed.Astheproducthasgoodaqueoussolubility,itmaybeadded

directlytothecontainer.Effectsonthefishshouldbemonitoredastheproductis

graduallyintroduced.

Beforeanaesthesia,orprolongedsedation,fishshouldbefastedfor12to24hours.

Duringtreatmenttheyshouldbestockedatadensitynotexceeding80g/litre.To

minimisedamageandlosswhenmedicatedforlongperiodsfortransportetc.the

levelofsedationshouldallowfishtomaintaintheirequilibriumandswimming

position.Aerationshouldbeprovidedunlesssedation,oranaesthesia,isofshort

duration.Inanaesthesialossofreflexestakesplaceinonetofifteenminutesafter

immersiondependinguponconcentrationemployed.Narcotisedfishshouldbe

removedfrommedicatedwaterandreturnedtotheirnormalenvironmentassoonas

possible,whenrecoverywilltakebetweenoneandthirtyminutes.

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Thefollowingexamplesofdoseratesandexposuretimesarebasedonlaboratory

andfieldexperience:

Concentration

mg/litreof

water Immersion

time(mins)

Troutspecies(7-

17ºC)

Sedation 10-30 Upto480

Anaesthesia Light

Deeper 30-80

80-180 Upto30

Upto10

Salmonspecies

Sedation 7-30 Upto240

Anaesthesia Light

Deeper 30-80

80-100 Upto10

Upto5

Bassspecies

Sedation 8-30 Upto480

Anaesthesia Light

Deeper 30-70

70-100 Upto20

Upto4

Carpspecies

Sedation 20-30 Upto1440

Anaesthesia 30-200 Upto8

Freshwatertropicalfish

Sedation 30-50 Upto1440

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Removefishimmediatelytoaeratedwaterofthesamecompositionandtemperature

thatisfreefromanaesthetic.Overdoseorprolongedexposuretotheproductmay

causerespiratoryfailureanddeath.

4.11Withdrawalperiod(s)

Fishmustnotbeslaughteredforhumanconsumptionduringtreatment.

Fishcanonlybeharvestedforhumanconsumption70degreedaysafterthe

lasttreatment.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anaesthetics,general,othergeneralanaesthetics

ATCvetcode:QN01AX93

5.1Pharmacodynamicproperties

Tricainemethanesulphonatehaspropertiesslightlydifferentfrom,butsimilarto,both

esterandamideanaesthetics,actingasageneralanaestheticornarcotic.Itismore

water-solublethanBenzocaine,lendingittofishapplication.Fisharenormally

IssuedFebruary2013

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immersedinsolutionsandbothabsorptionandexcretionoccurthroughthegill

epithelium.

Thedrugcausesreducedbloodflowthroughthegillsandreducedoxygen

consumption.Therateatwhichnarcosisisinduceddependsupontheconcentration

oftheproductinwaterandalsouponthewatertemperature.Athighertemperatures

onsetornarcosisismorerapid;howeverthesafetymarginisless.Immersionoffish

inunmedicatedwaterreversesnarcoticeffects.

5.2Pharmacokineticparticulars

Tricainemethanesulphonateissolubleinlipids,whichprobablyaccountsforitsrapid

diffusionacrossgillsinbothdirections,withrapidanaesthesiaandrapidrecovery.

Thedrugisdistributedthroughoutthebody.

Excretionoccursmainlyacrossthegillepithelium.Non-polarethylmeta-

aminobenzoateanditsN-acetylderivativearebothexcretedacrossthegills,

whereasthepolarmeta-aminobenzoicacidanditsN-acetylderivativeareexcreted

viathekidneys.Allspeciestestedappeartoproduceanacetylatedderivative,tothe

extentnormallyoflessthan20%oftheoriginalanaesthetic.Thehydrolysisto

producethefreeacidalsovarieswithspecies,sokidneyexcretionwillvarybetween

species.However,theeffectivenessvarieslessbetweenspeciesowingtothefree

movementofthedrugacrossthegills.

Theconcentrationinsalmonidmuscle,whilstthefishisunderanaesthetic,ranges

from9.4to72.0mg/kg.Thehalflifeoftheanaestheticinmuscleonwithdrawalis

approximately70minutes.Thus24hoursgives20halflives.Thehighest

concentrationsfoundinsalmonidmuscleafter24hourshavebeen2.6to3.2mg/kg

(theoralLDina30kgdogis30,000x4mgoftheanaesthetic).

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

None.

6.2Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelflifeafterdilutionorreconstitutionaccordingtodirections:24hours.

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6.4.Specialprecautionsforstorage

Storeintheoriginalcontainer.

Storeinadryplace.

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

Protectsolutionfromdirectsunlight.

6.5Natureandcompositionofimmediatepackaging

HighDensityPolyethylene(HDPE)tamperresistanttubsclosedwithandintegral,

tamperevident,lowdensitypolyethylenecap(snapon)containingeither25g,100g,

250gor1000g.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Usedsolutionmusteitherbefilteredusingactivatedcharcoalfilterspriorto

dilutionintheeffluenttobedischargedfromthefarmoritmustbetransferredtoa

holdingtankfilledwithwaterwithsubsequentcontrolledreleasefordilutionin

theeffluenttobedischargedfromthefarm.

Filtration

Filtrationofusedsolutionthroughanactivatedcharcoalfilterwillensurethatthe

concentrationofspenttricainemethanesulphonateindischargewaterdoesnot

exceed1µg/L.Spentcarbonfiltersshouldbedisposedofinaccordancewithlocal

requirements

Holdingtank

Transferofusedsolutiontoaholdingtankfilledwithwaterandcontrolledreleasefor

dilutionintheeffluentwillensurethattheconcentrationofspenttricainemethane

sulphonateindischargewaterdoesnotexceed1µg/Lwhenreleasingthesolution

fromtheholdingtankatflowratescalculatedinthetablebelow(1000Land50000L

holdingtanks).Dischargeflowsfordifferentsizedholdingtankscanbecalculatedas

showninthe50000Lcolumn.

Farmflowrate(L/min) Dischargeflow(L/h)fromholdingtank

1000Lholdingtank 50000Lholdingtank

10000-14999 15 (50*15) 750

15000-19999 22 (50*22)1100

20000-24999 30 (50*30)1500

25000-29999 37 (50*37)1850

30000-35000 45 (50*45)2250

Anyunusedveterinarymedicinalproductshouldbedisposedofinaccordancewith

nationalrequirements.

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7. MARKETINGAUTHORISATIONHOLDER

PharmaqLimited

Unit15

SandleheathIndustrialEstate

Fordingbridge

HampshireSP61PA

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm11003/4014

9. DATEOFFIRSTAUTHORISATION

07February2013

10.DATEOFREVISIONOFTHETEXT

February2013

Approved: 07/02/2013