Cosecure Cattle Bolus

Main information

  • Trade name:
  • Cosecure Cattle Bolus
  • Pharmaceutical form:
  • Continuous-release intraruminal device
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Cosecure Cattle Bolus
    France
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Other mineral products, combinations
  • Therapeutic area:
  • Cattle

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0206/001
  • Authorization date:
  • 10-06-2010
  • EU code:
  • UK/V/0206/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:January2011

AN:01126/2009

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

CosecureCattleBolusContinuousReleaseIntraruminalDevice(UK,Ireland)

Cosecure VetContinuousReleaseIntraruminalDevice(Belgium,Denmark,France,

Luxembourg,Sweden)

RumifertContinuousReleaseIntraruminalDevice(Germany)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each100gboluscontainsthefollowingactivesubstances:

Copper: 13.4g

Cobalt: 0.5g

Selenium,assodiumselenate 0.3g

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Continuousreleaseintraruminaldevice.

Acylindrical,blueglasscontinualreleaseintraruminaldeviceapproximately82mmx

24mmandweighingapproximately100g,referredtothroughoutthetextasabolus.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle(over2monthsandweighingatleast100kgBW)

4.2Indicationsforuse,specifyingthetargetspecies

Forpreventionandtreatmentofcopperandseleniumdeficienciesandfor

improvementofcobaltsupply.

4.3Contraindications

Donotadministertonon-ruminatingcalvesortoanimalsweighinglessthan100kg

bodyweight.Donotadministertosheep.

SeealsoSection4.5,SpecialPrecautionsforUse

4.4Specialwarningsforeachtargetspecies

Theproductisnotintendedfortreatmentofacuteclinicalconditionssuchas

nutritionalmusculardystrophy.

Revised:January2011

AN:01126/2009

4.5Specialprecautionsforuse

(i) Specialprecautionsforuseinanimals

Priortosupplementationwithanyformofcopperorselenium,itshouldbe

demonstratedthatthereisaneedforextratraceelementstobegiventothe

animals.

Additionalcoppershouldnotbeadministeredorallyorbyinjection,or

seleniumbyinjection,withinsixmonthsafteradministrationoftheproductto

cattleatpastureorwithin4.5monthsincattlewherethedietissupplemented

withconcentratesunlesssubjectedtoarisk/benefitanalysisperformedbya

responsibleveterinarianineachcase.

Donotadministeranyaidstoalterdissolutionofthebolus.

Thebolusesaresensitivetosuddentemperaturechangessuchasthosethat

mayoccurwhenverycoldbolusesareswallowedbyananimal.Thereforeitis

importantthatthebolusisatroomtemperature(15-20°C)priorto

administrationtopreventthedevelopmentoffinecracksthatmaychangethe

activityofthebolus.

(ii) Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Inordertominimisetheriskofcontactallergy,weargloveswhenhandlingthis

product.

4.6Adversereactions(frequencyandseriousness)

Noneknown

4.7Useduringpregnancy,lactationorlay

Theproductmaybeadministeredtopregnantandlactatinganimals

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown

Revised:January2011

AN:01126/2009

4.9Amountstobeadministeredandadministrationroute

Ruminatingcattleovertwomonthsofageandweighingover100kgbodyweight:2

boluses.

Administerorallyusinganoesophagealballing-gun,whichdeliversthebolusdirectly

intothetopofthegullet.Greatcareshouldbetakennottocauseanyinjurybyrough

handlingorbyplacingtheguntoofarinsidethethroatoftheanimal.Ensurethat

eachanimalhasswallowedthebolusesbyholdingthemouthclosedandobserving

theanimalforashorttimeafterdosing.Gentlemassageofthethroatmayfacilitate

swallowingoftheboluses.

Thebolusesshouldnormallybeadministeredjustbeforeturnout,butadministration

maybecarriedoutatanytime,e.g.administertodairycowsatdryingofforat

calvingor30dayspost-calvingoratartificialinsemination.

Thebolusesaresensitivetosuddentemperaturechangessuchasthosethatmay

occurwhenverycoldbolusesareswallowedbyananimal.Therefore,itisimportant

thatthebolusisatroomtemperature(15-20°C)priortoadministrationtoprevent

thedevelopmentoffinecracksthatmaychangetheactivityofthebolus.

Tominimisetheriskofregurgitation,avoidroughhandlingofanimalsafterdosing.

Donotadministertherecommendeddosagetoanimalsmorefrequentlythanonce

every4.5monthstoanimalsreceivingconcentratesorevery6monthstocattleat

pasture.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noadverseeffectshavebeenobservedincattleadministeredthreetimesthe

recommendeddosageoveratwo-dayperiod.Clinicalsignsofcoppertoxicity,which

normallywillonlyoccurincasesofseverecopperoverdosageincludejaundice,

malaise,anacutedropinmildyieldand,later,haemoglobinuria.Signsofselenium

toxicityincludeCNSchanges,muscleweakness,vomiting,anorexia,depression,

incoordinationand,later,respiratoryproblems.Inthesecircumstances,intravenous

administrationofcopperand/orseleniumchelatingagentssuchasammonium

tetrathiomolybdateorEDTA(ethylendiaminetetraaceticacid)isrecommended.

Ammoniumtetrathiomolybdate(ATTP)isoftenquotedinveterinaryliteratureasan

antidotetocopperpoisoning.ATTPisnotanauthorisedveterinarymedicine.Any

pharmacologicallyactivesubstancesusedinaveterinarymedicinalproduct

administeredtoafood-producinganimalunderthecascademustbelistedinAnnex

I,IIorIIItoCouncilRegulation(EEC)No2377/90.AsATTPdoesnotappearinany

oftheseAnnexesitshouldnotbeadministeredtoananimalintendedforfood

production.

4.11Withdrawalperiod(s)

Cattle:Meatzerodays;milkzerohours.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:seleniumcombinations

ATCvetcode:QA12CE99

Revised:January2011

AN:01126/2009

5.1Pharmacodynamicproperties

Theactivesubstancesaretheessentialtraceelementscopper,cobaltandselenium.

Thebolusesaredesignedtodissolveslowlythroughoutthegrazingseason(upto6

months),releasingcopper,cobaltandselenium.

Copperisanintegralpartofseveralenzymeswithoxidasefunctione.g.

caeruloplasmin,monoamineoxidase,cytochromeoxidase,tyrosinase,lysyloxidase,

cytochromeCandsuperoxidedismutase.Thuscopperisessentialforavarietyof

bodyfunctionsincludinggrowth.Inaddition,extracoppersupplementationis

essentialincasesofinfertilityduetotheformationofthiomolybdateswith

molybdenum.

CobaltisanintegralpartinVitaminB12(cyanocobalamin),whichisimportantfor

severalmetabolicfunctions.Thisvitaminissynthesisedbymicro-organismsinthe

rumenandisabsorbedfromthereintothesystemiccirculation.VitaminB12actsas

aco-enzymeinseveralmetabolicpathwaysandinruminantsitsmainroleisinthe

metabolismofpropionate,whichisrequiredforsynthesisofglucoseviasuccinatein

theliver.

Seleniumisanintegralpartintheglutathioneperoxidase(GSHPx)enzymes,which

areinvolvedintheprotectionfromoxidantstress.Theseenzymeshaveasynergistic

rolewithvitaminEandotherantioxidantsinremovingtoxicperoxidesfromtissueand

preventingoxidativedamagetomembranes.Seleniumisrequiredinthethyroid

glandfortheconversionofT4toT3,theactivethyroxinemoleculeasseleniumis

requiredintheiodothyroninedeiodinaseenzymes.

5.2Pharmacokineticparticulars

Followingoraladministrationtheboluseslodgeinthereticulumwheretheydissolve

slowlyoveraperiodofapproximatelyfourandonehalftosixmonths.Theultimate

breakdownproductsarecopper,cobaltandseleniuminionicform.Theboluses

provideasourceofthesetraceelementsatlevelscompatiblewiththeanimals´daily

requirements.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Phosphorus(V)-oxide

Sodiumoxide

Magnesiumoxide

Otheroxides

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years.

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months.

Revised:January2011

AN:01126/2009

6.4.Specialprecautionsforstorage

Storeinadryplace.Donotfreeze.Protectfromfrost

Oncethepackagehasbeenopened,storeunusedbolusesintheplastictrayinthe

originalpackaginginanairtightcontainer.

6.5Natureandcompositionofimmediatepackaging

FivePCVtrays,eachcontainingfourbolusesandvacuumheatsealedina

polyester/aluminiumfoillaminatepouch,containedinaprintedcarton.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

TelsolLimited

23/24ColomendyIndustrialEstate

Denbigh

Denbighshire

LL165TA

8. MARKETINGAUTHORISATIONNUMBER

Vm18584/4000

9. DATEOFRENEWALOFTHEAUTHORISATION

27April2010

10 DATEOFREVISIONOFTHETEXT

January2011

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

None