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
    Austria
  • Language:
  • English

Therapeutic information

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

Other information

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

20-7-2016

Marketing authorisation for medicine for cows suspended in the EU/EEA

Marketing authorisation for medicine for cows suspended in the EU/EEA

On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.

Danish Medicines Agency

21-6-2016

Use of medicine for cows suspended

Use of medicine for cows suspended

Today, the Danish Medicines Agency has decided to suspend the use of the veterinary medicine Velactis, which is used to reduce milk production (drying-off) in dairy cows.

Danish Medicines Agency

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