Boviseal Dry Cow Intramammary Suspension

Main information

  • Trade name:
  • Boviseal Dry Cow Intramammary Suspension
  • Pharmaceutical form:
  • Intramammary suspension
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Boviseal Dry Cow Intramammary Suspension
    Portugal
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0410/001
  • Authorization date:
  • 25-07-2012
  • EU code:
  • UK/V/0410/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

AN:00369/2013

Revised:August2013

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Boviseal2.6gintramammarysuspensionforcattle(dairycows).

Austria,DenmarkandGermany-TEATSEAL2.6gintramammarysuspension

forcattle(dairycows).

Belgium-UBROXEAL2.6gintramammarysuspensionforcattle(dairycows)

Italy,Luxembourg,Netherlands,Portugal,Spain-EASISEAL2.6g

intramammarysuspensionforcattle(dairycows).

France-MAMISEAL2.6gintramammarysuspensionforcattle(dairycows)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Each4gintramammarysyringecontains:

Activesubstance:Bismuthsubnitrate,heavy 2.6g

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Intramammarysuspension

Greyishwhite,smooth,unctuouscream.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle(dairycows).

4.2 Indicationsforuse,specifyingthetargetspecies

Preventionofnewintramammaryinfectionsthroughoutthedryperiod.

Incowsconsideredlikelytobefreeofsub-clinicalmastitis,theproductcanbe

usedonitsownindrycowmanagementandmastitiscontrol.

Selectionofcowsfortreatmentwiththeproductshouldbebasedonveterinary

clinicaljudgement.Selectioncriteriamaybebasedonthemastitisandcell

counthistoryofindividualcows,orrecognisedtestsforthedetectionofsub-

clinicalmastitisorbacteriologicalsampling.

AN:00369/2013

Revised:August2013

4.3 Contraindications

Seesection4.7.Donotusetheproductaloneincowswithsub-clinicalmastitis

atdryingoff.Donotuseincowswithclinicalmastitisatdryingoff.

4.4 Specialwarnings

None.

4.5 Specialprecautionsforuse

(i) Specialprecautionsforuseinanimals

Itisgoodpracticetoobservedrycowsregularlyforsignsofclinicalmastitis.If

asealedquarterdevelopsclinicalmastitis,theaffectedquartershouldbe

strippedoutmanuallybeforeappropriatetherapyisinstituted.

Toreducetheriskofcontamination,donotimmersethesyringeinwater.

Usethesyringeonlyonce.

Itisimportanttoobservestrictaseptictechniquefortheadministrationofthe

product,becausetheproductdoesnothaveantimicrobialactivity.

Donotadministeranyotherintramammaryproductfollowingadministrationof

theproduct.

Incowsthatmayhavesub-clinicalmastitis,theproductmaybeusedfollowing

administrationofasuitabledrycowantibiotictreatmenttotheinfectedquarter.

(ii) Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

NoneKnown

4.7 Useduringpregnancy,lactationorlay

Pregnancy:

Astheproductisnotabsorbedfollowingintramammaryinfusion,theproduct

canbeusedinpregnantanimals.Atcalving,thesealmaybeingestedbythe

calf.Ingestionoftheproductbythecalfissafeandproducesnoadverse

effects.

Lactation:

Theproductiscontra-indicatedforuseduringlactation.Ifaccidentallyusedin

alactatingcow,asmall(upto2-fold)transientriseinsomaticcellcountmaybe

observed.Insuchanevent,stripoutthesealmanually,noadditional

precautionsarenecessary.

AN:00369/2013

Revised:August2013

4.8 Interactionwithothermedicinalproductsandotherformsof

interaction

Inclinicaltrials,thecompatibilityoftheproducthasonlybeenshownwitha

cloxacillin-containingdrycowpreparation.

4.9 Amountstobeadministeredandadministrationroute

Forintramammaryuseonly.

Infusethecontentsofonesyringeoftheproductintoeachudderquarter

immediatelyafterthelastmilkingofthelactation(atdryingoff.).Donot

massagetheteatorudderafterinfusionoftheproduct.

Caremustbetakennottointroducepathogensintotheteatinordertoreduce

theriskofpost-infusionmastitis.

Itisessentialthattheteatisthoroughlycleanedanddisinfected,withsurgical

spiritoralcohol-impregnatedwipes.Theteatsshouldbewipeduntilthewipes

arenolongervisiblydirty.Teatsshouldbeallowedtodrypriortoinfusion.

Infuseasepticallyandtakecaretoavoidcontaminationofthesyringenozzle.

Followinginfusionitisadvisabletouseanappropriateteatdiporspray.

4.10 Overdose(symptoms,emergencyprocedures,antidotes),if

necessary

Twicetherecommendeddosehasbeenadministeredtocowswithnoclinical

adverseeffects.

4.11 Withdrawalperiods

Meat:Zerodays.

Milk:Zerodays.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Variousproductsforteatsandudder

ATCvetcode:QG52X

5.1 Pharmacodynamicproperties

Infusionoftheproductintoeachudderquarterproducesaphysicalbarrier

againsttheentryofbacteriatherebyreducingtheincidenceofnew

intramammaryinfectionsduringthedryperiod.

AN:00369/2013

Revised:August2013

5.2 Pharmacokineticparticulars

Bismuthsubnitrateisnotabsorbedfromthemammarygland,butresidesasa

sealintheteatuntilphysicallyremoved(Shownincowswithadryperiodup

to100da

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Liquidparaffin

AluminiumDiTriStearate

Silica,ColloidalAnhydrous

6.2 Incompatibilities

Noneknown.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:5years

6.4. Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5 Natureandcompositionofimmediatepackaging

Low-densitypolyethylenesyringewithasmooth,taperedhermeticallysealed

nozzle.

Marketingpresentations:boxesof24,60and120syringes.

Notallpacksizesmaybemarketed

6.6 Specialprecautionsforthedisposalofunusedveterinary

medicinalproductorwastematerialsderivedfromtheuseofsuch

products

Anyunusedproduct,sealstrippedfromananimalatcalvingorwaste

materialsshouldbedisposedofinaccordancewithnationalrequirements.

AN:00369/2013

Revised:August2013

7. MARKETINGAUTHORISATIONHOLDER

ContinentalFarmaceutica,

RueLaidBurniat,1

1348Louvain-la-Neuve

Belgium

8.MARKETINGAUTHORISATIONNUMBER

41966/4001

9. DATEOFFIRSTAUTHORISATIONOFTHEAUTHORISATION

23Jaunuary2013

10 DATEOFREVISIONOFTHETEXT

August2013

Approved:08/08/2013