Animeloxan 20 mg/ ml solution for injection for cattle, pigs and horses

Main information

  • Trade name:
  • Animeloxan 20 mg/ ml solution for injection for cattle, pigs and horses
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Animeloxan 20 mg/ml solution for injection for cattle, pigs and horses
    Austria
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • meloxicam
  • Therapeutic area:
  • Cattle, Horses, Pigs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0377/002
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0377/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Issued:March2012

AN:00649/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Animeloxan,20mg/ml,solutionforinjectionforcattle,pigsandhorses

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlsolutionforinjectioncontains:

Activesubstance:

Meloxicam 20mg

Excipients:

Ethanol,anhydrous 158.00mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

SolutionforInjection

Clear,yellowsolution

4. CLINICALPARTICULARS

4.1Targetspecies

Cattle,pigandhorse

4.2Indicationsforuse,specifyingthetargetspecies

Cattle:

Foruseinacuterespiratoryinfectionwithappropriateantibiotictherapytoreduce

clinicalsignsincattle.

Foruseindiarrhoeaincombinationwithoralre-hydrationtherapytoreduceclinical

signsincalvesofoveroneweekofageandyoung,non-lactatingcattle.

Foradjunctivetherapyinthetreatmentofacutemastitis,incombinationwithantibiotic

therapy.

Pigs:

Foruseinnon-infectiouslocomotordisorderstoreducethesymptomsoflamenessand

inflammation.

Foradjunctivetherapyinthetreatmentofpuerperalsepticaemiaandtoxaemia(mastitis-

metritis-agalactiasyndrome)withappropriateantibiotictherapy

Horses:

Foruseinthealleviationofinflammationandreliefofpaininbothacuteandchronic

musculo-skeletaldisorders.

Forthereliefofpainassociatedwithequinecolic.

4.3Contraindications

Seealsosection4.7.

Donotuseinhorseslessthan6weeksofage.

Donotuseinanimalssufferingfromimpairedhepatic,cardiacorrenalfunctionand

haemorrhagicdisorders,orwherethereisevidenceofulcerogenicgastrointestinal

lesions.

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AN:00649/2010

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Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Forthetreatmentofdiarrhoeaincattle,donotuseinanimalsoflessthanoneweekof

age.

4.4Specialwarningsforeachtargetspecies

None.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifadversereactionsoccur,treatmentshouldbediscontinuedandtheadviceofa

veterinarianshouldbesought.

Avoiduseinveryseverelydehydrated,hypovolaemicorhypotensiveanimalswhich

requireparenteralrehydration,astheremaybeapotentialriskofrenaltoxicity.

Incaseofinadequatereliefofpainwhenusedinthetreatmentofequinecolic,careful

re-evaluationofthediagnosisshouldbemadeasthiscouldindicatetheneedfor

surgicalintervention.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Accidentalself-injectionmaygiverisetopain.Peoplewithknownhypersensitivityto

NSAIDsshouldavoidcontactwiththeveterinarymedicinalproduct.

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Ifaccidentalskincontactoccurs,washtheaffectedareathoroughly.

Washhandsafteruse.

4.6Adversereactions(frequencyandseriousness)

Incattle,asinglesubcutaneousinjectioncancauseanon-painfulswellingthatlastsupto

23days.Intravenousinjectionisgenerallywell-tolerated.

Inpigs,twoconsecutiveintramuscularinjectionshavealocalirritanteffectthatcanlast

upto9days.

Inhorses,atransientswellingattheinjectionsitecanoccurbutresolveswithout

intervention.

Inveryrarecasesanaphylactoidreactionsmayoccurandshouldbetreated

symptomatically.

4.7Useduringpregnancy,lactationorlay

Cattleandpigs:

Canbeusedduringpregnancyandlactation.

Horses:

Donotuseinpregnantorlactatingmares.

Donotuseinhorsesproducingmilkforhumanconsumption.

Seealsosection4.3.

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AN:00649/2010

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4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Donotadministerconcurrentlywithglucocorticosteroids,othernon-steroidalanti-

inflammatorydrugsorwithanti-coagulantagents.

4.9Amountstobeadministeredandadministrationroute

Cattle:

Singlesubcutaneousorintravenousinjectionatadosageof0.5mgmeloxicam/kgbody

weight(i.e.2.5ml/100kgbodyweight)incombinationwithantibiotictherapyorwithoral

re-hydrationtherapy,asappropriate.

Pigs:

Singleintramuscularinjectionatadosageof0.4mgmeloxicam/kgbodyweight(i.e.2.0

ml/100kgbodyweight)incombinationwithantibiotictherapy,asappropriate.If

required,asecondadministrationofmeloxicamcanbegivenafter24hours.

Horses:

Singleintravenousinjectionatadosageof0.6mgmeloxicam/kgbodyweight(i.e.3.0

ml/100kgbodyweight).

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inthecaseofoverdosagesymptomatictreatmentshouldbeinitiated.

4.11Withdrawalperiod(s)

Cattle:

Meatandoffal: 15days

Milk: 5days

Pigs:

Meatandoffal: 8days

Horses:

Meatandoffal: 5days

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflammatoryandantirheumaticproducts,non-steroids

(oxicams)

ATCvetcode: QM01AC06

5.1Pharmacodynamicproperties

Meloxicamisanon-steroidalanti-inflammatorydrug(NSAID)oftheoxicamclasswhich

actsbyinhibitionofprostaglandinsynthesis,therebyexertinganti-inflammatory,

analgesic,anti-exudativeandantipyreticeffects.Itreducesleukocyteinfiltrationintothe

inflamedtissue.Toaminorextentitalsoinhibitscollagen-inducedthrombocyte

aggregation.Meloxicamalsohasanti-endotoxicpropertiesbecauseithasbeenshown

toinhibitproductionofthromboxaneB

inducedbyE.coliendotoxinadministrationin

calves,lactatingcowsandpigs.

Issued:March2012

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5.2Pharmacokineticparticulars

Absorption

Inpigs,maximumplasmaconcentrationsofmeloxicamwerereachedat1.0hpost

administrationof singleintramuscularadministrationof Animeloxan20mg/ml atadose

of0.4mgmeloxicam/kgbodyweight.

Incattle,maximumplasmaconcentrationsofmeloxicamwerereachedat6.8hpost

singlesubcutaneousadministrationofAnimeloxan20mg/mlatadoseof0.5mg

meloxicam/kgbodyweight.

Distribution

Morethan98%ofmeloxicamisboundtoplasmaproteins.Thehighestmeloxicam

concentrationsaretobefoundinliverandkidney.Comparativelylowconcentrationsare

detectableinskeletalmuscleandfat.

Metabolism

Meloxicamispredominantlyfoundinplasma.Incattle,meloxicamisalsoamajor

excretionproductinmilkandbilewhereasurinecontainsonlytracesoftheparent

compound.Inpigs,bileandurinecontainonlytracesoftheparentcompound.

Meloxicamismetabolisedtoanalcohol,anacidderivativeandtoseveralpolar

metabolites.Allmajormetaboliteshavebeenshowntobepharmacologicallyinactive.

Themetabolisminhorseshasnotbeeninvestigated.

Elimination

Inpigs, themeanterminalhalf-lifewascalculatedtobeapproximately3.2hfor

meloxicamfollowingintramuscularadministration.

Incattle,themeanterminalhalf-lifefollowingsubcutaneousadministrationwas

calculatedtobeapproximately14.0hformeloxicam.

Inhorses,afterintravenousinjectionmeloxicamiseliminatedwithaterminalhalf-lifeof

8.5hours.

Approximately50%oftheadministereddoseiseliminatedviaurineandtheremainder

viafaeces.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

N-Methyl2-Pyrrolidone

Ethanol,anhydrous

Sodiumhydroxide

Hydrochloricacid,dilute

Waterforinjection

6.2Incompatibilities

Noneknown.

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6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging: 28days.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialtemperaturestorage

conditions.

6.5Natureandcompositionofimmediatepackaging

Clearglass(typeI)bottlesof50mland100ml,eachclosedwithbromobutylrubber

stoppersandfixedwithAluminium/PPflipcaps.

Availableincardboardboxescontaining:

1x50mlor12x50ml

1x100mlor12x100ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

aniMedicaGmbH

ImSuedfeld9

48308Senden-Boesensell

Germany

8. MARKETINGAUTHORISATIONNUMBER

Vm24745/4015

9. DATEOFFIRSTAUTHORISATION

28March2012

10.DATEOFREVISIONOFTHETEXT

March2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.