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

Other information

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

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Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

2-10-2018

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Neurolixis SAS)

EU/3/14/1242 (Active substance: 3-Chloro-4-fluorophenyl-[4-fluoro-4-{[(5-methylpyrimidin-2-ylmethyl) amino]methyl}piperidin-1-yl]methanone) - Transfer of orphan designation - Commission Decision (2018)6436 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/163/13/T/01

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

FDA - U.S. Food and Drug Administration

14-9-2018

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here:  http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

FDA - U.S. Food and Drug Administration

12-9-2018

 Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 September 2018, European Medicines Agency, London, UK, From: 11-Sep-2018, To: 13-Sep-2018

The Committee for Medicinal Products for Veterinary Use (CVMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning veterinary medicines.

Europe - EMA - European Medicines Agency

11-9-2018

Agenda:  Agenda - COMP agenda of the 11-13 September 2018 meeting

Agenda: Agenda - COMP agenda of the 11-13 September 2018 meeting

Europe - EMA - European Medicines Agency

29-8-2018

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (GlaxoSmithKline Trading Services Limited)

Nucala (Active substance: mepolizumab) - Centralised - 2-Monthly update - Commission Decision (2018)5770 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3860/II/13/G

Europe -DG Health and Food Safety

13-8-2018

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Dystrogen Therapeutics S.A.)

EU/3/18/2045 (Active substance: Ex-vivo fused autologous human bone marrow-derived mesenchymal stem cell with allogenic human myoblast) - Orphan designation - Commission Decision (2018)5277 of Mon, 13 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/028/18

Europe -DG Health and Food Safety

31-7-2018

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children.  https://go.usa.gov/xUvBD  #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevicepic.twitter.com/ZP3ImzNw2T

Join us for the Pediatric Medical Device Development public meeting Aug 13-14 to identify ways to increase the availability of medical devices for children. https://go.usa.gov/xUvBD  #Pediatrics #medicaldevice pic.twitter.com/ZP3ImzNw2T

FDA - U.S. Food and Drug Administration

31-7-2018

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here:  https://go.usa.gov/xUvZm 

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm 

On Aug 13-14, the #FDA is hosting the Pediatric Medical Device Development public meeting at the White Oak campus. Join us and participate in discussions around increasing medical device development for children. More info here: https://go.usa.gov/xUvZm  #Pediatrics #medicaldevice pic.twitter.com/c0cuVYtTLK

FDA - U.S. Food and Drug Administration

30-7-2018

Apoquel (Zoetis Belgium S.A.)

Apoquel (Zoetis Belgium S.A.)

Apoquel (Active substance: Oclacitinib maleate) - Centralised - Renewal - Commission Decision (2018)5153 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2688/R/13

Europe -DG Health and Food Safety

27-7-2018

EU/3/14/1263 (bluebird bio (Germany) GmbH)

EU/3/14/1263 (bluebird bio (Germany) GmbH)

EU/3/14/1263 (Active substance: Autologous CD34+ haematopoietic stem cells transduced with lentiviral vector encoding the human beta A-T87Q-globin gene) - Transfer of orphan designation - Commission Decision (2018)5035 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/13/T/01

Europe -DG Health and Food Safety