VETIVEX 1 (9 mg/ml) solution for infusion for cattle, horses dogs and cats

Main information

  • Trade name:
  • VETIVEX 1 (9 mg/ml) solution for infusion for cattle, horses dogs and cats
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VETIVEX 1 (9 mg/ml) solution for infusion for cattle, horses dogs and cats
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0457/001
  • Authorization date:
  • 24-04-2013
  • EU code:
  • UK/V/0457/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:June2013

AN:00148/2012

Page1of4

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

VETIVEX1(9mg/ml)solutionforinfusionforcattle,horsesdogsandcats[UK,IE]

VETIVEX9mg/mlsolutionforinfusionforcattle,horsesdogsandcats[BE,FR,NL]

AQUALEC9mg/mlsolutionforinfusionforcattle,horsesdogsandcats[DE,DK,SE]

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlcontains:

Activesubstance:

SodiumChloride 9mg

Sodium:150mmol/litre

Chloride:150mmol/litre

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinfusion.

Clear,colourlesssolution.

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle,horses,dogsandcats.

4.2Indicationsforuse,specifyingthetargetspecies

Thisproductisadministeredbyintravenousinfusionforthetreatmentofdehydrationin

cattle,horses,dogsandcats.Itmaybeusedtocorrecthypovolaemiaresultingfrom

shockorgastrointestinaldisease(especiallywheremetabolicalkalosisispresent,e.g.

incasesofsustainedvomitingorabomasaldisordersincattle).Itmaybeadministered

tomeetnormalfluidandelectrolyterequirementswhenfluidscannotbegivenorally.

4.3Contraindications

None

4.4Specialwarningsforeachtargetspecies

None.

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals:

Donotuseunlessthesolutionisclear,freefromvisibleparticlesandthecontaineris

undamaged.

Sodiumoverloadmayoccurinanimalswithcardiacorrenalimpairment.Itshouldbe

notedthatsodiumexcretionmaybeimpairedpost-surgery/trauma.

Ariskofthrombosiswithintravenousinfusionshouldbeconsidered.

Theproductshouldbewarmedtoapproximately37 °

Cpriortotheadministrationoflarge

volumes,oriftheadministrationrateishigh,inordertoavoidhypothermia.

Thisproductshouldnotbeusedforlongerthanisnecessarytocorrectandsustain

circulatingvolume.Inappropriate/excessiveusemayworsenorcreateametabolic

acidosis.

Maintainasepticprecautions.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals:

None.

4.6Adversereactions(frequencyandseriousness)

Excessiveinfusionratescancauserestlessness,moistlungsounds,tachycardia,

tachypnoea,nasaldischarge,coughing,vomitinganddiarrhoea.

4.7Useduringpregnancy,lactationorlay

Useunderveterinarysupervision.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.9Amountstobeadministeredandadministrationroute

Intravenoususe.

Thevolumeandrateofinfusionwilldependupontheclinicalcondition,existingdeficits

oftheanimal,maintenanceneedsandcontinuinglosses.

Generallyaimtocorrecthypovolaemiaby50%initially(ideallyover6hoursbutfasterif

necessary)andreassessbyclinicalexamination.

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

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

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

shouldnotbecontinuedforlongerthan1hourunlessurineoutputisrestored.The

maximuminfusionrateshouldbedecreasedinthepresenceofcardiac,renaland

pulmonarydisease.

4.10Overdose(symptoms,emergencyprocedures,antidotes)

Monitorfluidoutput.Theadministrationofadiureticmaybenecessary.

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AN:00148/2012

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4.11Withdrawalperiod

Cattleandhorses:Meatandoffal/milk –zerodays/hours.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Electrolytes,ATCvetcode:QB05BB01

5.1Pharmacodynamicproperties

Theintravenousinfusionisusedtoreplacedepletedwaterandelectrolyteswhenfluids

cannotbegivenorally.Itwillrestoreextracellularvolume(includingplasmavolume)and,

wheremetabolicalkalosisispresent,itwillhelptocorrectit.

5.2Pharmacokineticparticulars

Intravenousinfusionensuresrapiddistribution.Theconstituentsoftheinfusionsolution

willbemetabolisedandexcretedthroughthesamepathwaysasthosesubstances

derivedfromnormaldietarysources.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Waterforinjections.

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months

Theproductshouldbeusedimmediatelyandnotstoredafteropening.

6.4.Specialprecautionsforstorage

Donotstoreabove25

C.

Donotfreeze.

6.5Natureandcompositionofimmediatepackaging

Polyvinylchlorideinfusionbagoverwrappedwithpolypropylene.

Packsizes:100ml,500ml,1000mland2000ml.

Notallpacksizesmaybemarketed.

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6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm10434/4079

9. DATEOFFIRSTAUTHORISATION

20June2013

10.DATEOFREVISIONOFTHETEXT

June2013

Approved:20/06/2013

26-11-2018

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

The U.S. Food and Drug Administration today announced an open period for applications for grants to support the development of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys and chickens) or to treat minor species.

FDA - U.S. Food and Drug Administration

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