Vetseal

Main information

  • Trade name:
  • Sureseal Intramammary Suspension for Cattle
  • Pharmaceutical form:
  • Intramammary suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Sureseal Intramammary Suspension for Cattle
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • VARIOUS PRODUCTS FOR TEATS AND UDDER
  • Therapeutic area:
  • Cattle Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0474/001
  • Authorization date:
  • 26-06-2013
  • EU code:
  • UK/V/0474/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:August2013

AN.00455/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Sureseal2.6gIntramammarySuspensionforCattle(CZ,DE,HU,IE,PL,SE,

SK,UK)

Noroseal2.6gIntramammarySuspensionforCattle(BE,IT,NL,PT,ES)

Intraseal2.6gIntramammarySuspensionforCattle(AT,DK)

SuresealIntramammarySuspensionforCattle(FR)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each4gIntramammarysyringecontains:

Activesubstance:

Bismuthsubnitrate,heavy 2.6g

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Intramammarysuspension

Lightbrownsuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle(dairycows)

4.2 Indicationsforuse,specifyingthetargetspecies

Preventionofascendingintramammaryinfectionsthroughoutthedryperiod.

Incowsconsideredlikelytobefreeofsub-clinicalmastitis,theproductmay

besuitableforuseonitsownindrycowmanagementformastitiscontrol.

Selectionofcowsfortreatmentwiththeproductshouldbebasedon

veterinaryclinicaljudgement.Selectioncriteriamaybebasedonthemastitis

andcellcounthistoryofindividualcows,orrecognisedtestsforthedetection

ofsub-clinicalmastitisorbacteriologicalsampling.

4.3 Contraindications

Donotusetheproductaloneincowswithclinicalorsub-clinicalmastitisat

dryingoffperiod.Seesection4.5

Donotuseduringlactation.

Issued:August2013

AN.00455/2012

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4.4 Specialwarnings

Inclinicalfieldtrials,useoftheproductwascombinedwithalong-acting

intramammaryantimicrobialatdrying-off.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Itisgoodpracticetoobservedrycowsregularlyforsignsofclinicalmastitis.

Ifasealedquarterdevelopsclinicalmastitis,theaffectedquartershouldbe

strippedoutmanuallybeforeappropriatetherapyisinstituted.

Toreducetheriskofcontamination,donotimmersethesyringeinwater.

Usethesyringeonlyonce.

Itisimportanttoobservestrictaseptictechniquefortheadministrationofthe

product,becausetheproductdoesnothaveantimicrobialactivity.

Donotadministeranyotherintramammaryproductfollowingadministrationof

theproduct.

Incowsthatmayhavesub-clinicalmastitis,theproductmaybeusedfollowing

administrationofasuitabledrycowantibiotictreatmenttotheinfected

quarter.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Avoidcontactwithskinoreyes.

Shouldskinoreyecontactoccur,washtheaffectedareathoroughlywith

water.

Ifirritationpersists,seekmedicaladviceandshowthislabeltothedoctor.

Ifyouknowthatyouareallergictobismuthsalts,avoidusingthisproduct.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Noneknown

4.7Useduringpregnancy,lactationorlay

Pregnancy:

Astheproductisnotsystemicallyabsorbedfollowingintramammaryinfusion,

theproductcanbeusedinpregnantanimals.Atcalving,thesealmaybe

ingestedbythecalf.Ingestionoftheproductbythecalfissafeandproduces

noadverseeffects.

Lactation:

Ifaccidentallyusedinalactatingcow,atransientriseinsomaticcellcount(up

to2-fold)maybeobserved.Insuchanevent,stripoutthesealmanually,no

additionalprecautionsarenecessary.

Issued:August2013

AN.00455/2012

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4.8 Interactionwithothermedicinalproductsandotherformsof

interaction

Inclinicaltrials,thecompatibilityoftheproducthasonlybeenshownwitha

cloxacillin-containingdrycowpreparation.

4.9 Amountstobeadministeredandadministrationroute

Intramammaryuse.

Infusethecontentofonesyringeoftheproductintoeachudderquarter

immediatelyafterthelastmilkingofthelactation(atdryingoff).Donot

massagetheteatorudderafterinfusionoftheproduct.

Caremustbetakennottointroducepathogensintotheteatinordertoreduce

theriskofpost-infusionmastitis(aseptictechnique).

Itisessentialthattheteatisthoroughlycleanedanddisinfected,withsurgical

spiritoralcohol-impregnatedwipes.Theteatsshouldbewipeduntilthewipes

arenolongervisiblydirty.Teatsshouldbeallowedtodrypriortoinfusion.

Infuseasepticallyandavoidcontaminationofthesyringenozzle.Following

infusionitisadvisabletouseanappropriateteatdiporspray.

4.10Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Twicetherecommendeddosehasbeenadministeredtocowswithoutany

clinicaladverseeffects.

4.11Withdrawalperiod(s)

Meat&offal:zerodays

Milk:zerohours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Variousproductsforteatsandudder

ATCvetcode:QG52X

5.1 Pharmacodynamicproperties

Infusionoftheproductintoeachudderquarterproducesaphysicalbarrier

againstthepenetrationofbacteriatherebyreducingtheincidenceof

ascendingintramammaryinfectionsduringthedryperiod.

5.2 Pharmacokineticparticulars

Bismuthsubnitrate,heavyisnotsystemicallyabsorbedfromthemammary

gland,butresidesasasealintheteatuntilphysicallyremoved(Shownin

cowswithadryperiodupto100days).

Issued:August2013

AN.00455/2012

Page4of5

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

AluminiumStearate

Povidone,iodinated

LiquidParaffin

6.2Incompatibilities

Noneknown

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

6.4.Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcompositionofimmediatepackaging

Lowdensitypolyethylenesyringewithasmoothtaperedhermeticallysealed

nozzle.

Packsizes:

24or60Intramammarysyringesinacarton

120Intramammarysyringesinabucket.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductshouldbedisposedofinaccordancewithlocal

requirements

7. MARKETINGAUTHORISATIONHOLDER

NorbrookLaboratoriesLimited

StationWorks

CamloughRoad

NEWRY,Co.Down

BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER

Vm02000/4362

Issued:August2013

AN.00455/2012

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9. DATEOFFIRSTAUTHORISATION

August2013

10. DATEOFREVISIONOFTHETEXT

August2013

APPROVED 5/08/13

There are no safety alerts related to this product.

21-11-2018

EU/3/18/2092 (Dr Regenold GmbH)

EU/3/18/2092 (Dr Regenold GmbH)

EU/3/18/2092 (Active substance: H-Arg-Pro-Lys-Pro-Gln-Gln-Phe-2Thi-Gly-Leu-Met(O2)-NH2-DOTA-213-bismuth) - Orphan designation - Commission Decision (2018)7802 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/145/18

Europe -DG Health and Food Safety