Adrenacaine

Main information

  • Trade name:
  • Adrenacaine Injection
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Adrenacaine Injection
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • lidocaine, combinations
  • Therapeutic area:
  • Cattle

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0332/001
  • Authorization date:
  • 25-02-2009
  • EU code:
  • UK/V/0332/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

AdrenacaineSolutionforInjectionforCattle

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveSubstance:

ProcaineHydrochloride 50mg/ml

Adrenaline(Epinephrine)(asAdrenalineAcidTartrate) 0.02mg/ml

Excipients:

Chlorocresol(aspreservative) 1.0mg/ml

SodiumMetabisulphiteE223(asantioxidant) 1.0mg/ml

Forafulllistofexcipients,seesection6.1

3. PHARMACEUTICALFORM

Solutionforinjection.

Aclearcolourlesssolution.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cattle

4.2 Indicationsforuse, specifyingthetargetspecies

Theproductisindicatedforuseinminorsurgicalproceduresparticularlydehorning

anddisbuddingincattle

4.3 Contraindications

Donotadministerbyintravenous,intra-articularorepiduralinjection.

Procainemayinhibittheactionofsulfonamidesandtheirconcurrentadministration

shouldbeavoided.

4.4 SpecialWarningsforeachtargetspecies

Noneknown.

4.5 Specialprecautionsforuse

i Specialprecautionsforuseinanimals

Careshouldbetakennottoinjecttheproductintravascularly.

ii Specialprecautionsto betakenby thepersonadministeringthe

veterinarymedicinalproductto animals

Careshouldbetakento avoidaccidentalself-injection.

Intheeventofself-injection,seekmedicalattentionandshowthelabeltothe

physician.Immediatelywashoffanysplashestotheeyesorskinwithcopious

amountsofwater.

Seek medicalattentionifirritationoccurs.

Washhandsafteruse.

4.6 Adversereactions(frequencyandseriousness)

Noneknown.

4.7 Useduringpregnancy,lactationorlay

Theproductcanbeadministeredatanystageofpregnancyorlactation.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Procainemayinhibittheactionofsulfonamidesandtheirconcurrentadministration

shouldbeavoided.

4.9 Amountstobeadministeredandadministrationroute

Theproductshouldbeadministeredbysubcutaneousinjectionasfollows:

Cattle:2-5 ml

Avoidexcessivebroaching.

Donotexceedtherecommendeddose.

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

Theproductiswelltoleratedatdosesupto3 timestherecommendeddoseforcattle.

LocalanaestheticsusedinexcesscancausesystemictoxicitycharacterisedbyCNS

effects.Ifsystemictoxicityoccurs,asaresultofinadvertentintra-vascularinjection,

theadministrationofoxygentotreatcardio-respiratorydepressionanddiazepamto

controlconvulsionsshouldbeconsidered

4.11Withdrawalperiod

Meat:zerodays

Milk:zerohours

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Anaesthetic

ATCVetCode:QN01BA52

5.1 Pharmacodynamicproperties

Procaine(p-aminobenzoyl-diethylaminoethanol)isanaminoester.Procaine,alocal

anaestheticshareswithotherchemicalfamiliestheabilitytoactasamembrane

stabiliser,byinterferingwiththeabilityofexcitablecellstogenerateortransmit

impulses.Procaineblocksconductionbydecreasingorpreventingthelargetransient

increaseinthepermeabilityofexcitablemembranestoNa+thatisproducedbya

slightdepolarisation.Theactionoflocalanaestheticsisduetotheirdirectinteraction

withvoltagesensitiveNa+ channels.

Adrenalineiscomposedoftwomajorconstituents,thearomaticportionofthe

moleculeconsistsof1,2-dihydroxybenzene(catechol),thealiphaticportionconsists

ofethanol-amine.

Thedurationoftheactionoflocalanaestheticsisproportionaltothetimewhichthey

areinactualcontactwithnervoustissue.Consequentlyprocedureswhichlocalisethe

drugatthenervegreatlyprolongtheperiodofanaesthesia.Ithasbeendemonstrated

thattheadditionofepinephrinetolocalanaestheticsolutionsgreatlyprolongsand

intensifiestheiraction.Epinephrineperformsadualservice.Bydecreasingtherate

ofabsorptionitnotonlylocalisestheanaestheticagentatthedesiredsitebutalso

allowstherateatwhichtheanaestheticisdestroyedinthebodytokeeppacewiththe

rateatwhichitentersthecirculation.Thisgreatlyreducessystemictoxicity.

5.2 Pharmacokineticparticulars

ProcaineHydrochlorideisalocalanaesthetic.Thein-vitrohalf-lifeofinplasmais

lessthan1 minute.Itisonlyslightlyboundto plasmaprotein(5.8%)andhasa

durationofanaestheticeffectofabout50 minutesinman.Adrenalineisadded to

localanaestheticssuchasProcaineHydrochloridetoslowdiffusionandlimit

absorptionasitconstrictsarteriolesandcapillaries,so prolongingthedurationofthe

effectandlesseningthedangeroftoxicity.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

SodiumChloride

SodiumMetabisulphite(E223)

Chlorocresol

SodiumHydroxide(pHadjuster)

HydrochloricAcid(pHadjuster)

WaterforInjections

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2 years

Shelf-lifeafterfirstopeningtheimmediatepackaging:28days

6.4Specialprecautionsforstorage

Donotstoreabove25

C.

Protectfromlight.

6.5Natureandcompositionofimmediatepackaging

Theproductwillbesuppliedin100mlambertypeIglassvialswithbromobutyl

bungsandaluminiumcaps.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

Norbrook LaboratoriesLimited

StationWorks

CamloughRoad

Newry

Co. Down

BT356JP

8. MARKETINGAUTHORISATIONNUMBER(S)

Vm02000/4243 (UK)

VPA10999/123/001(IE)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

7 July2004

10. DATEOFREVISIONOFTHETEXT

1-8-2018

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