Energaid

Main information

Documents

Localization

  • Available in:
  • Energaid
    Portugal
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Oral rehydration formulations for veterinary use
  • Therapeutic area:
  • Cattle Food, Cattle Young

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0105/001
  • Authorization date:
  • 13-12-2007
  • EU code:
  • UK/V/0105/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

ENERGAIDpowderfororalsolutionforcalves.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance:

Each165 gsachetcontains:

Sodiumcitratedihydrate 9.73 g

Sodiumacetateanhydrous 5.41 g

Sodiumpropionateanhydrous 1.91 g

Sodiumchloride 4.65 g

Potassiumchloride 2.96 g

Glucoseanhydrous 135.3 g

Onreconstitutionin2litresofwatertheavailableionconcentrationsareas

follows:

Sodium 133 mmol/l

Potassium 20 mmol/l

Chloride 60 mmol/l

Propionate 10 mmol/l

Acetate 33 mmol/l

Citrate 16.54 mmol/l

Dextrose 375 mmol/l

Thepropionate,acetateandcitrateionstogetheryield93 mmol/lbicarbonate.

Excipients:

SunsetYellowDye(E110) 0.1 g

Silica,colloidalanhydrous 4.97 g

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Powderfororalsolution.

Apinkpowder

4. CLINICALPARTICULARS

4.1 Targetspecies

Calves

4.2 Indicationsforuse, specifyingthetargetspecies

Theveterinarymedicinalproductisacalorificoralrehydrationproduct

indicatedforthereversaloftheprocessesofdehydration,electrolyteloss,

metabolicacidosisandweightlossassociatedwithscourincalves.Efficacy

hasbeendemonstratedinE. coliinfectedcalves.

4.3 Contraindications

None.

4.4 SpecialWarningsforeachtargetspecies

Milkormilkreplacermaycontinuetobeadministeredattheonsetofthe

veterinarymedicinalproductadministrationifdeemedappropriatebya

veterinarysurgeon.

Inseverecasessomecalvesmayrequireadditionalintravenoustherapy.In

suchcasesconsultaveterinarysurgeon.

Ifsignsofdiseasepersistorappeartheveterinarysurgeonorveterinary

practitionershouldre-evaluatethesituation.

Anipplebottleortubefeedermaybeusedifconsideredappropriate.On

reconstitutionthesilicondioxidedoesnotgointosolutionbutremainsasa

finepowderinthemixingvessel.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

None.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproductto animals

None

4.6 Adversereactions(frequencyandseriousness)

None

4.7 Useduringpregnancy,lactationorlay

Notapplicable.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Notinvestigated.

4.9 Amountstobeadministeredandadministrationroute

Dosage: Asolutionfororaladministration,ispreparedas

follows:dissolvethecontentsofonesachetin2litres

ofclean,warmwater.Keep feedingutensilsclean.

Administration: Twolitresofthesolution,freshlypreparedasdirected,

isofferedtwicedailyfor2days.Forthenexttwodays,

1litreofsolutionand1litreofmilkormilkreplacer

(either mixed together or fed separately) are

administeredmorningandevening.Thereafternormal

dietisresumed.Ifsymptomsaresevere,thesolution

maybefed3or4timesdaily.Thesolutionmaybe

givenforamaximumof4daysonly,when

administeredonitsown.Normalfeedingshouldbe

resumedafterthecourseoftreatment.

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Theproducthasbeendemonstratedtobewelltoleratedinthetargetspecies.

Giventheosmoticcharacteroftheproduct,overdosemayleadinsomecases

tosofteningofthefaeces.Therefore,careshouldbetakeninthecorrect

preparationoftheresultingoralrehydrationsolution.

4.11 Withdrawalperiod

Zerodays

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Oralelectrolytesandcarbohydrates

ATCVetCode:QA07CQ02

5.1 Pharmacodynamicproperties

Theproductprovidesanadequatesourceofnutrientsandelectrolytesto

correctthesymptomsassociatedwithdiarrhoea.Inparticular,itprovides

potassiumto counteractdecreasingintracellularpotassiumlevels.

Theintestinalabsorptionofwaterisdependantlargelyonsodiumabsorption.

Theconcentrationofsodiumatalevelof133mmol/loptimisesthebasic

rehydratingabilityoftheproduct.Certaincompoundsincludingglucoseand

thebicarbonateprecursors,citrate,propionateandacetateareabletoassist

entericsodiumuptake.

Absorptionandmetabolismofthebicarbonateprecursorsprovidesapotential

93mmol/lofbicarbonatewhichhasanimportantroletoplayincorrecting

acidosis,andterminallyareanadditionalsourceofenergyfortheweakened

calf.Thefinalreconstitutedsolutionalsoprovides375mmol/lofglucose

providingahighcalorificcontent.Glucose,citrateandpropionateallenterthe

TricarboxylicAcid(Krebs)Cycleleadingtotheformationofenergy,whilst

acetatealthoughutilisedbyadifferentroutestillyieldsenergy.

5.2 Pharmacokineticproperties

-

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

SunsetYellowDye(E110)

Silica,colloidalanhydrous

6.2 Incompatibilities

None.

6.3 Shelflife

Unopenedsachets: 24 months

Reconstitutedsolution: 24 hours.

6.4 Specialprecautionsforstorage

Donotstoreabove25ºC.

Storeinadryplace.

6.5 Natureandcompositionofimmediatepackaging

Eachsachetcontains165gandiscomposedofpaper/lowdensity

polyethylene/aluminium.24sachetsarecontainedineachcarton.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordance

withnationalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

Norbrook LaboratoriesLimited

StationWorks

CamloughRoad

NEWRY

Co. Down,BT356JP

NorthernIreland

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm02000/4127

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

18thSeptember2002

10. DATEOFREVISIONOFTHETEXT

July2007

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

21-11-2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

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