VETIVEX 11 solution for infusion for cattle, horses, dogs and cats

Main information

  • Trade name:
  • Vetivex 11
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Vetivex 11
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • electrolytes
  • Therapeutic area:
  • Cats, Cattle, Cattle Young, Dogs, Horses

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0458/001
  • Authorization date:
  • 24-04-2013
  • EU code:
  • UK/V/0458/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:June2013

AN:00149/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VETIVEX11solutionforinfusionforcattle,horses,dogsandcats[UK,IE]

VETIVEXRingerLactateSolutionforinfusionforcattle,horses,dogsandcats[BE,FR,

NL]

INFUSOLECsolutionforinfusionforcattle,horses,dogsandcats[DE,DK,SE]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains:

Activesubstances:

SodiumLactate 3.17mg

SodiumChloride 6.00mg

PotassiumChloride 0.40mg

CalciumChloride 0.20mg

(equivalenttoCalciumChlorideDihydrate:0.27mg)

Sodium:131mmol/litre

Potassium:5mmol/litre

Calcium:2mmol/litre

Bicarbonate(aslactate):29mmol/litre

Chloride:111mmol/litre

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinfusion.

Clear,colourlesssolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle,horses,dogsandcats.

4.2Indicationsforuse,specifyingthetargetspecies

Thisproductisadministeredbyintravenousinfusionforthetreatmentofdehydrationand

metabolicacidosisincattle,horses,dogsandcats.Itmaybeusedtocorrectvolume

depletion(hypovolaemia)resultingfromgastrointestinaldiseaseorshock.

4.3Contraindications

Lactate-containingsolutionswillnotbeutilisedeffectivelyinanimalswithhepatic

impairmentanditisundesirabletousethisproductinanimalswithmetabolicalkalosis.

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4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals:

Donotuseunlessthesolutionisclear,freefromvisibleparticles,andthecontaineris

undamaged.

Ariskofthrombosiswithintravenousinfusionshouldbeconsidered.

Maintainasepticprecautions.

Thisproductshouldbewarmedtoapproximately37 o

Cpriortotheadministrationof

largevolumes,oriftheadministrationrateishigh,inordertoavoidhypothermia.

Donotuseunlessthesolutionisclear,freefromvisibleparticles,andthecontaineris

undamaged.

Thisproductdoesnotcontainanantimicrobialpreservative.Itisintendedforsingleuse

onlyandanyunusedcontentsshouldbediscarded.

Thisproductshouldbeusedwithcautioninanimalswithcardiacorrenalimpairmentas

sodiumoverloadmayoccur.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals:

None.

4.6Adversereactions(frequencyandseriousness)

Excessiveinfusionratescancauserestlessness,moistlungsounds,tachycardia,

tachypnoea,nasaldischarge,coughing,vomitinganddiarrhoea.

4.7Useduringpregnancy,lactationorlay

Useunderveterinarysupervision.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Thisproductisincompatiblewithmethylprednisolone,andsodiumlactateorsodium

bicarbonateintravenousinfusions.

4.9Amountstobeadministeredandadministrationroute

Intravenoususe.

Theinfusionshouldideallybewarmedtoapproximately37 o Cpriortoadministration.

Thevolumeandrateofinfusionwilldependupontheclinicalcondition,existingdeficits

oftheanimal,maintenanceneedsandcontinuinglosses.

Generallyaimtocorrecthypovolaemiaby50%initially(ideallyover6hoursbutfasterif

necessary)andreassessbyclinicalexamination.

Deficitsaregenerallyintherangeof50ml/kg(mild)to150ml/kg(severe).Aninfusion

rateof15ml/kg/hourisrecommendedintheabsenceofshock(range5-75ml/kg/hour).

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AN:00149/2012

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Inshock,highinitialinfusionrates,upto90ml/kg/hour,areneeded.Highinfusionrates

shouldnotbecontinuedforlongerthan1hourunlessrenalfunctionandurineoutputare

restored.Themaximuminfusionrateshouldbedecreasedinthepresenceofcardiac,

renalandpulmonarydisease.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Monitorfluidoutput.

4.11Withdrawalperiods

Cattleandhorses:Meatandoffal/milk –zerodays/hours.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Electrolytes, ATCvetcode:QB05BB01

5.1Pharmacodynamicproperties

Thisproductreplacesdepletedwaterandelectrolyteswhenadministeredviathe

intravenousroute,tocorrectwaterimbalanceindehydration,andrestoreelectrolyteand

acid-basebalance.Itwillrestoreplasmavolumeandcorrectmetabolicacidosis,asthe

hepaticmetabolismoflactateyieldsbicarbonateslowlyenoughtopreventacounter-

imbalanceofalkalosis.

5.2Pharmacokineticparticulars

Intravenousinfusionensuresrapiddistribution.Theconstituentsoftheinfusionsolution

willbemetabolisedandexcretedthroughthesamepathwaysasthosesubstances

derivedfromnormaldietarysources.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections

Hydrochloricacid,dilute(forpH-adjustment)

6.2Incompatibilities

Thisproductisincompatiblewithmethylprednisolone,andsodiumlactateorsodium

bicarbonateintravenousinfusions.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months

Theproductshouldbeusedimmediatelyandnotstoredafteropening.

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AN:00149/2012

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6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

Polyvinylchlorideinfusionbagsoverwrappedwithpolypropylene.

Allpacksizeshavetwoports.Inplaceoftheadditiveportonthe5000mlcombipackis

acombiport.Thisenablestwosuchbagstobeconnectedinsequenceandvolumes

greaterthan5000mltobeadministeredduringoneinfusion.

Packsizes:250ml,500ml,1000ml,3000ml,5000mland5000mlcombi.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchmedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm10434/4080

9. DATEOFFIRSTAUTHORISATION

20June2013

10.DATEOFREVISIONOFTHETEXT

June2013

Issued:June2013

AN:00149/2012

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Approved: 20/06/2013