SteroVet; Solution for Infusion for cattle, horse, sheep, goat, dog and cat

Main information

  • Trade name:
  • SteroVet; Solution for Infusion for cattle, horse, sheep, goat, dog and cat
  • Pharmaceutical form:
  • Solution for infusion
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • SteroVet; Solution for Infusion for cattle, horse, sheep, goat, dog and cat
    Spain
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • electrolytes with carbohydrates
  • Therapeutic area:
  • Cats, Cattle, Dogs, Goats, Horses, Sheep

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • ES/V/0193/001
  • Authorization date:
  • 26-11-2008
  • EU code:
  • ES/V/0193/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

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SteroVet

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

SteroVet;SolutionforInfusionforcattle,horse,sheep,goat,dogandcat

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1000mlsolutionforinfusioncontain:

Activesubstances:

SodiumChloride 1.25g

PotassiumChloride 1.80g

SodiumDihydrogenPhosphateDihydrate 1.14g

MagnesiumChlorideHexahydrate 0.51g

Sodium(S)-lactate 2.80g

(as50%m/msodium(s)-lactatesolution,5.60g)

Glucose 50.00g

(asglucosemonohydrate,55.0g)

Electrolyteconcentrations:

Sodium 53.7mmol/l

Potassium 24.1mmol/l

Magnesium 2.5mmol/l

Chloride 53.5mmol/l

Lactate 25.0mmol/l

Phosphate 7.3mmol/l

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinfusion

(Aclear,colourlessoralmostcolourlessaqueoussolution)

Freefrombacterialendotoxins.

Caloricvalue: 835kJ/l=200kcal/l

Theoreticalosmolarity: 444mOsm/l

Titrationacidity(topH7.4): <10mmol/l

pH: 4.0–5.5

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle,horse,sheep,goat,dogandcat

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SteroVet

4.2 Indicationsforuse,specifyingthetargetspecies

SteroVetisusedinalltargetanimalspecieswithoutmarkedelectrolytedisturbancesandacid/base

imbalance:

- Fortherapyofhypertonicdehydration;

- Forcoverageofmaintenancerequirementsoffluidandelectrolytes;

- Forpartialcoverageofenergyrequirements.

4.3 Contraindications

Donotuseinanimalswith:

- Hyperhydration;

- Hypotonicdehydration;

- Hyponatraemia;

- Hypochloraemia;

- Hyperkalaemia;

- Hyperglycaemia;

- Addison’sdisease(hypoadrenocorticism)insmallanimals;

- Glucoseintolerance;

- Impairmentoflactateutilisation;

- Alkalosis;

- severeliverimpairment.

4.4 Specialwarnings

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

SteroVetshouldonlybeadministeredwithparticularcautioninthefollowingconditions:

Horses

- Inhorsestotalplasmaproteinlevelsshouldbedeterminedbeforestartingandformaintainingfluid

regimen.

- Quarterhorsesorhorseswithquarterhorsesgenesmightbeatriskofdevelopingfasciculations

whentreatedwithSteroVetstartingthetreatmentatserumpotassiumlevelsof4–6mmol/Ldue

tothefactthatabout0.4%oftheQuarterHorsebreedareaffectedbyequinehyperkalaemic

periodicparalysis(HyPP)aheritabledisease.

AstherearenodataavailableconcerningtreatmentofHyPPgenebearinghorseswithSteroVet,

SteroVetshouldnotbeadministeredtohorsesknowntobeartheHyPPgene.

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SteroVet

Alltargetspecies

Inallspecies–Lactateoverdosesincaseswithheartdiseasemayprovokearrhytmiasandheart

failure.

Monitoringofserumelectrolytelevels,serumglucoselevels,waterbalance,acid-basebalanceandof

theclinicalconditionoftheanimalmayaccompanythetreatmenttopreventoverdosing,particularlyin

casesofrenalimpairmentwithtendencytowardshyperkalaemiaorincaseofmetabolicalterations.

Sodiumoverloadmayoccurwithmyocardialandrenaldamage.

Itshouldbeappreciatedthatintheperiodfollowingsurgicalinterferenceorseveretraumatheremay

beaninabilitytoexcreteexcessivesodium.

Whentreatinganimalsyoungerthan16weeks,apossiblelimitedlactatemetabolismshouldbe

considered.

Comparedtometabolicallyhealthyanimalsglucosetolerancemaybecompromisedinanimalswith

renalinsufficiencyandinthepost-operative/post-traumaticphase(post-aggressionmetabolism).The

oldertheanimalandthemoreseveretheunderlyingdisease,operationorinjury,themorefrequently

metabolicdisordersmaydevelopasapartofthepost-aggressionmetabolismthataresimilartodia-

betes.Serum/Plasmaglucoseconcentrationshouldbemonitoredinsuchpatientsalongwithinfusion

therapy.

Maintenancetherapywiththissolutionalonemayprovokedisordersoffluidandelectrolytebalance,

dependentonkidneyfunction.

Thrombosisofachosenveinisalwaysapossibilitywithintravenousinfusion.

Ifinfusionisprotractedthenanotherveinshouldbeselectedafter12-24hours.Thegivingsetshould

bechangedevery24hours.

SteroVetshouldbeusedwithcareonlyincaseofdecompensatedheartfailureandlungedema.

Thesolutionshouldbeprewarmedtobodytemperaturepriortousetoavoidhypothermia.

Donotadministertogetherwithbloodorthroughinfusionsetsthathavebeenusedormaybeusedfor

administrationofblood,sincethepossibilityofdevelopingagglutinationandhaemolysisexists.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

None

4.6 Adversereactions

Adversereactionsrelatedtocrystalloidsolutionsincludedilutionaleffectsoncoagulationfactorsand

albumin,andthepotentialforthedevelopmentofgeneralisedoedema.

4.7 Useduringpregnancy,lactation

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyandlactation.

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SteroVet

Useonlyaccordingtothebenefit/riskassessmentbytheresponsibleveterinarian.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Suxamethoniumandpotassiummayactsynergisticallyintermsofadverseeffectsoncardiacrhythm,

assuxamethonium,whenadministeredtogetherwithpotassium,mayprovokemarkedhyperkalaemia.

Incaseofco-administrationofMagnesiumsulphateapossibleadditiveeffectwithSteroVetleadingto

magnesiumtoxicosis(e.g.neuromuscularblockadewiththeriskofparalysisofrespiratorymuscles

and/orcardiacarrest)cannotbeexcluded.

4.9 Amountstobeadministeredandadministrationroute

Administrationbyintravenousroute.

Thevolumeandtimeofadministrationdependsontheindividualrequirementsoffluid,electrolytesand

glucosedeterminedbyveterinaryobservation,toavoidanypossibleeffectsduetooverdose.

Maintainasepticprecautionsduringadministration.

Donotuseifcontainerorclosureisdamaged.

Forsingleuseonly.Donotreconnectpartiallyusedcontainers.

Cloudysolutionsorsolutionscontainingvisiblesolidparticlesshouldnotbeadministered.

Generalguidelinesonfluidandelectrolyteintake:

Thequantityoffluidandelectrolyteforadministrationwillconsiderexistingdeficits,maintenance

requirementsandcontinuinglosses.

Theexistingdeficitisthatwhichhasbeenlostpriortoexamination.Itcanbeestimatedbythe

followingformula:mloffluiddeficit=dehydration(%)xkgb.w.x10.

Maintenancerequirementisproportionaltothebodysurfaceormetabolicbody(kg 0,75 ).Thusit

decreaseswithincreasingbodymass,i.e.maintenancerequirementsperkgbwishigherthesmaller

theanimal.Duringfeveranincreaseddemandofabout10%ofthemaintenanceneedofananimalis

requiredforeachcentigradeofbodytemperatureabovephysiologicallimit.

Ongoingfluidlossesthroughvomiting,diarrhoea,thethirdbodyfluidspace,andpolyuriamustalsobe

estimatedandreplaced.Inlargeanimals,however,SteroVetisnotintendedtocompensatethose

additionalfluidandelectrolytelossesduringmaintenancetherapy.Fluidandelectrolytelosses

exceedingmaintenancerequirementshavetobetreated/supplementedaccordingtoveterinarian’sbest

judgementandadaptedtotheanimalsclinicalsituation/condition.

Thevolumeadministeredforfluidreplacementmayneedtobeincreasedintheelderly.

Lactatinganimalshaveahigherneedwithregardtomaintenancerequirements.

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SteroVet

Undernormalconditionstherearethefollowingrecommendationsformaintenancerequirementsin

adultanimals:

Bodymass(kg) ml/kg/day

<5 120-80

5-20 80-50

20-100 50-30

>100 30-10

incats:

1-8 80-50

Inhorsesadditionalfluidmaintenancerequirementsof20–40 ml/kgbw/d haveto beinfused witha

non-energeticsolution, ifnecessary.

Maximuminfusionrates:

Generally,itisrecommendedthattheinfusionrateshouldbeadaptedaccordingtotheexistingfluid

deficit.Forglucosecontaininginfusionsolutionsamaximuminfusionrateof10ml/kgbw/hshouldnot

beexceeded.

Duringintravenousfluidadministrationtheanimalsshouldbemonitoredforsignsoffluidoverload

(principallypulmonaryoedema).

Generalguidelineoncarbohydrateintake:

ThefollowingmaximumdailydosesforglucoseinSteroVetshouldnotbeexceeded:

Bodyweight(kg) Maximumdailydose

(g/kgb.w./d) Maximumdailydose

(ml/kgb.w./d)

<2 5 100

2-5 4 80

5-20 3 60

20-100 2 40

>100 1.5 30

4.10Overdose

Overdoseoffluidandelectrolytes:

Symptoms

Overdosemayresultinhyperhydrationwithincreasedskintension,venouscongestion,oedema–

possiblyalsolungoedema-,hyperkalaemiaandacidbaseimbalances.

Fluidoverloadismanifestbyrestlessness,agitation,shivering,tachycardia,seriousnasaldischarge,

hypersalivation,tachypnoe,moistrales,coughing,polyuria,protrusionoftheeyesfromtheorbit,

vomitinganddiarrhoea.

Treatment

SteroVetinfusionmustbefinishedimmediatelyincaseofovertsignsofoverdose.

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Treatmentofoverdosage:Injectionofadiuretic.

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Overdoseofglucose:

Symptoms

Prolongedtreatmentwithglucosebytheparenteralroutemayreducetheproductionofinsulinand

provokeglucoseintolerance,producinghyperglycaemiaandglucosuria,dehydration,serumhyper-

osmolarity,hyperglycaemicorhyperosmolarcoma.

Treatment

Immediatestopofinfusion,rehydration,cautiousadministrationofinsulinwithfrequentchecksofblood

glucose,substitutionoflostelectrolytes,monitoringoftheacid-basebalance.

4.11Withdrawalperiod(s)

Cattle,horse,sheepandgoat:meatandoffal:Zerodays

milk:Zerodays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:electrolytesolutionswithcarbohydrates

ATCvetcode:QB05BB02

5.1 Pharmacodynamicproperties

SteroVetisa“ 1 /

-strenghelectrolytesolution”containingmetabolisableanionsandglucose,whichis

characterisedbyasodiumcontentoflessthan60mmol/l.SteroVetisintendedtocompensatesensible

(i.e.lossesbyurineandfaeces)andinsensiblelosses(i.e.lossesduringpantingandsweating)incase

oftemporaryexogenousinsufficientfluidandelectrolytesupply.Inadditiontothis,SteroVetcoversthe

basalglucoserequirementsofobligatoryglucoseutilisingorgans.

5.2 Pharmacokineticparticulars

Infusedpotassium,magnesiumandphosphorusareactivelytransportedintocell.Sodiumandchloride

mainlydistributeintheextracellularspace.Thekidneysarethemainrouteofexcretionforsodium,

potassium,magnesium,phosphorusandchloride.Lactateisoxidisedandexertsamildalkalinising

effect.

Duringinfusion,glucoseisfirstdistributedintheintravascularspaceandthentakenupinthe

intracellularspace.Duringglycolysis,glucoseismetabolisedtopyruvateorlactate.Lactatecanbe

partiallytakenupagainbytheglucosemetabolism(Cori’scycle).Underaerobicconditionspyruvateis

completelyoxidisedtocarbondioxideandwater.Aftercompleteoxidationofglucose,theendproducts

areeliminatedviathelung(carbondioxide)andthekidneys(water).Inhealthyanimalsonlyaminor

amountsofglucoseareeliminatedviathekidneys.Inpathologicalmetabolismconditions(e.g.diabetes

mellitus,post-aggressionsyndrome)withhyperglycaemia,glucoseiseliminatedviathekidneys

(glucosuria)whenthemaximumtubulartransportcapacityhasbeenexceeded.

Environmentalproperties

Notapplicable.

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SPC017v08_12_2007/SaM

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Hydrochloricacid(forpHadjustment)

Waterforinjections

6.2 Incompatibilities

Thesolutionshouldnotbeadministeredthroughthesameinfusionequipmentsimultaneously,beforeor

afteranadministrationofbloodbecauseofthepossibilityofpseudoagglutination.

SteroVetshouldnotbemixedwithadditivesandotherdrugs.Medicamentscontainingcalciummay

causeprecipitationifmixedwithSteroVet.

6.3 Shelflife

3years.

Useimmediatelyafteropeningthepackage.Disposeofanyunusedproduct.

6.4.Specialprecautionsforstorage

Donotrefrigerateorfreeze.

Keepthebottlesintheoutercartoninordertoprotectfromlight.

6.5 Natureandcompositionofimmediatepackaging

Lowdensitiypolyethylene-containers(Ecoflacplusbottles)

Cardboardboxescontaining

10bottleswith500mlsolutionforinfusion

10bottleswith1000mlsolutionforinfusion

Closure:thecontainerishermeticallyclosedbeforetheclosuresystemisapplied.

Theadditionalclosurecapontopofthesealedpolyethylenecontainerismadefrompoly-

ethylene.Betweenthecontainerandtheclosurecapanelastomericdiskisplaced.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialsshouldbedisposedofinaccordancewithnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

B.BraunVetCareGmbH

AmAesculap-Platz

78532Tuttlingen

Germany

+49/7461952953

+49/746171512

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SteroVet

SPC017v08_12_2007/SaM

8. MARKETINGAUTHORISATIONNUMBER(S)

XXXX

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

<{DD/MM/YYYY}><{DDmonthYYYY}>…

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.