Atipam (5.0 mg/ ml solution for injection for Cats and Dogs - atipamezole hydrochloride

Main information

  • Trade name:
  • Atipam (5.0 mg/ ml solution for injection for Cats and Dogs - atipamezole hydrochloride
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Atipam (5.0 mg/ml solution for injection for Cats and Dogs - atipamezole hydrochloride
    Greece
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • atipamezole
  • Therapeutic area:
  • Cats, Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0263/001
  • Authorization date:
  • 02-12-2008
  • EU code:
  • UK/V/0263/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:June2013

AN.00690/2012

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Atipam,5.0mg/ml,solutionforinjectionforcatsanddogs.

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlcontains:

Activeingredients

Atipamezolehydrochloride 5.0mg

(equivalentto4.27mgatipamezolebase)

Excipients

Methylparahydroxybenzoate(E218) 1.0mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Solutionforinjection.

Clearandcolourlesssterileaqueoussolution.

4. CLINICALPARTICULARS

4.1. Targetspecies

Catsanddogs.

4.2. Indicationsforuse,specifyingthetargetspecies

Atipamezolehydrochlorideisaselectiveα2-antagonistandisindicatedforreversalof

thesedativeeffectsofmedetomidineanddexmedetomidineincatsanddogs.

4.3. Contraindications

Theproductshouldnotbeusedin:

-Breedinganimals

-Animalssufferingfromliver-orrenaldiseases

Seealsosection4.7.

4.4. Specialwarningsforeachtargetspecies

Makesuretheanimalhasregainedanormalswallowingreflexbeforeanyfoodordrink

isoffered.

4.5. Specialprecautionsforuse

Specialprecautionsforuseinanimals

Afteradministrationoftheproduct,theanimalsshouldbeallowedtorestinaquiet

place.Duringrecoverytimeanimalsshouldnotbeleftunattended.

Duetodifferentdosingrecommendationscautionshouldbetakenifusingtheproduct

off-labelinanimalsotherthanthetargetspecies.

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Ifsedativesotherthan(dex)medetomidinearegiven,itmustbekeptinmindthatthe

effectsofthoseotheragentsmaypersistafterreversalof(dex)medetomidine.

Atipamezoledoesnotreversetheeffectofketamine,whichmaycauseseizuresindogs

andelicitcrampsincatswhenusedalone.Donotadministeratipamezolewithin30 –

40minutesofprioradministrationofketamine.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Duetothepotentpharmacologicalactivityofatipamezole,skin –,eye-andmucous

membrane-contactwiththisproductshouldbeavoided.Incaseofaccidentalcontactof

theproductwithskinoreyesrinseabundantlywithfreshwater.Seekmedicalattentionif

irritationpersists.Removecontaminatedclothesthatareindirectcontactwiththeskin.

Careshouldbetakentoavoidaccidentalingestionorself-injection.Incaseof

accidentalingestionorself-injection,seekmedicaladviceimmediatelyandshowthe

packageleaflettothephysician.

4.6. Adversereactions(frequencyandseriousness)

Atransienthypotensiveeffecthasbeenobservedduringthefirst10minutespost-

injectionofatipamezolehydrochloride.Inrarecaseshyperactivity,tachycardia,

salivation,atypicalvocalisation,muscletremor,vomiting,increasedrespiratoryrate,

uncontrolledurinationanduncontrolleddefecationmayoccur.Inveryrarecases

recurrenceofsedationmayoccurortherecoverytimemaynotbeshortenedafter

administrationofatipamezole.

Incats,whenusinglowdosestopartiallyreversetheeffectsofmedetomidineor

dexmedetomidine,thepossibilityofhypothermia(evenwhenarousedfromsedation)

shouldbeguardedagainst.

4.7. Useduringpregnancyorlactation.

Thesafetyoftheproducthasnotbeendocumentedadequatelyduringpregnancyand

lactation.Thereforetheuseisnotrecommendedduringpregnancyandlactation.

4.8. Interactionswithotherveterinarymedicinalproductsandotherformsof

interaction

Asimultaneousadministrationofatipamezolewithothercentrallyactingmedicinal

productsasdiazepam,acepromazineoropiatesisnotrecommended.

4.9. Amountstobeadministeredandadministrationroute

Forsingleintramuscularinjectionincatsanddogs.Useofanappropriatelygraduated

syringeisrecommendedtoensureaccuratedosingwhenadministeringsmallvolumes.

Atipamezoleisgenerallyadministered15-60minutesafterthemedetomidineor

dexmedetomidineinjection.

Dogs:Theatipamezolehydrochloridedose(inµg)isfivetimesthatoftheprevious

medetomidinehydrochloridedoseortentimesthatofthedexmedetomidine

hydrochloridedose.Duetothe5-foldhigherconcentrationoftheactiveingredient

(atipamezolehydrochloride)inthisproductcomparedtothatofpreparationscontaining

1mgmedetomidinehydrochloridepermlandthe10-foldhigherconcentration

Revised:June2013

AN.00690/2012

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comparedtothatofpreparationscontaining0.5mgdexmedetomidinehydrochloride,an

equalvolumeofeachpreparationisrequired.

Dosageexampledogs:

Medetomidine1.0mg/mlsolutionfor

injectiondosage Atipam5.0mg/mlsolutionfor

injectiondosage

0,04ml/kgbodyweight(bw),

i.e.40μg/kgbw 0,04ml/kgbodyweight(bw),

i.e.200μg/kgbw

Dexmedetomidine0.5mg/mlsolution

forinjectiondosage Atipam5.0mg/mlsolutionfor

injectiondosage

0,04ml/kgbodyweight(bw),

i.e.20μg/kgbw 0,04ml/kgbodyweight(bw),

i.e.2 00μg/kgbw

Cats:Theatipamezolehydrochloridedose(inµg)istwo-and-a-halftimesthatofthe

previousmedetomidinehydrochloridedoseorfivetimesthatofthedexmedetomidine

hydrochloridedose.Duetothe5-foldhigherconcentrationoftheactiveingredient

(atipamezolehydrochloride)inthisproductcomparedtothatofpreparationscontaining

1mgmedetomidinehydrochloridepermlandthe10-foldhigherconcentration

comparedtothatofpreparationscontaining0.5mgdexmedetomidinehydrochloride,

halfthevolumeoftheproducttothatofthepreviouslyadministeredmedetomidineor

dexmedetomidineshouldbegiven.

Dosageexamplecats:

Medetomidine1.0mg/mlsolutionfor

injectiondosage Atipam5.0mg/mlsolutionfor

injectiondosage

0,08ml/kgbodyweight(bw),

i.e.80μg/kgbw 0,04ml/kgbodyweight(bw),

i.e.200μg/kgbw

Dexmedetomidine0.5mg/mlsolution

forinjectiondosage Atipam5.0mg/mlsolutionfor

injectiondosage

0,08ml/kgbodyweight(bw),

i.e.40μg/kgbw 0,04ml/kgbodyweight(bw),,

i.e.200μg/kgbw

Therecoverytimeisshortenedtoapproximately5minutes.Theanimalsbecomemobile

afterapproximately10minutesafteradministrationoftheproduct.

4.10.Overdose(symptoms,emergencyprocedures,antidotes)ifnecessary

Overdoseofatipamezolehydrochloridemayresultintransienttachycardiaandover-

alertness(hyperactivity,muscletremor).Ifnecessary,thesesymptomsmaybereversed

byamedetomidinehydrochloridedosewhichislowerthantheusuallyusedclinical

dose.

Ifatipamezolehydrochlorideisinadvertentlyadministeredtoananimalnotpreviously

treatedwith(dex)medetomidinehydrochloride,hyperactivityandmuscletremormay

occur.Theseeffectsmaypersistforabout15minutes.

4.11.Withdrawalperiods

Notapplicable

Revised:June2013

AN.00690/2012

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5. PHARMACOLOGICALPROPERTIES

ATCvetcode:QV03AB90

Pharmacotherapeuticgroup:α2-receptorantagonist(Antidote)

5.1. Pharmacodynamicproperties

Atipamezoleisapotentandselectiveα2-receptorblockingagent(α2-antagonist),which

promotesthereleaseoftheneurotransmitternoradrenalineinthecentralaswellasin

theperipheralnervoussystems.Thisleadstoactivationofthecentralnervoussystem

duetosympatheticactivation.Otherpharmacodynamiceffectssuchasimpactonthe

cardiovascularsystem,aremild,althoughatransientdecreaseinbloodpressuremay

occurwithinthefirst10minutesfollowingadministrationofatipamezolehydrochlodride.

Asaα2-antagonist,atipamezoleiscapableofeliminating(orinhibiting)theeffectsof

theα2-receptoragonist,medetomidineordexmedetomidine.Thusatipamezole

reversesthesedativeeffectsof(dex)medetomidinehydrochlorideincatsanddogsto

normalandmayleadtoatransientincreaseinheartrate.

5.2. Pharmacokineticparticulars

Atipamezolehydrochlorideisrapidlyabsorbedafterintramuscularinjection.The

maximalconcentrationinthecentralnervoussystemisreachedin10-15minutes.

Volumeofdistribution(Vd)isabout1–2.5l/kg.Thehalf-life(t

)ofatipamezole

hydrochlorideisreportedtobeapproximately1hour.Atipamezolehydrochlorideis

rapidlyandcompletelymetabolised.Themetabolitesaremainlyexcretedinurinewitha

smallamountexcretedinfaeces.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Methylparahydroxybenzoate(E218),

Sodiumchloride,

Sodiumhydroxide(forpHadjustment),

Hydrochloricacid(forpHadjustment),

Waterforinjections

6.2. Incompatibilities

Intheabsenceofcompatibilitystudiesthisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproductsinthesamesyringe.

Seealsosection4.8.

6.3. Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:3years

Shelf-lifeafterfirstopeningtheimmediatepackaging: 28days

6.4. Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialstorageconditions.

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6.5. Natureandcompositionofimmediatepackaging

Cardboardboxwith1clearglasstypeIvialof5,10or20ml,withatefloncoated

halogenatedrubberstopperandaluminiumcap.Notallpacksizesmaybemarketed.

6.6. Specialprecautionsforthedisposalofunusedveterinarymedicinal

productsorwastematerials

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

EurovetAnimalHealthB.V.,

Handelsweg25,

5531AEBladel,

TheNetherlands.

8. MARKETINGAUTHORISATIONNUMBER

Vm16849/4011

9. DATEOFFIRSTAUTHORISATION

04March2008

10. DATEOFREVISIONOFTHETEXT

June2013

Approved: 05/06/2013