Animeloxan 5 mg/ml solution for injection for dogs and cats

Main information

  • Trade name:
  • Animeloxan 2mg/ml
  • Pharmaceutical form:
  • Solution for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Animeloxan 2mg/ml
    Germany
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0377/001
  • Authorization date:
  • 26-10-2011
  • EU code:
  • UK/V/0377/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:March2012

AN:00648/2010

Page1of5

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Animeloxan,5mg/ml,solutionforinjectionfordogsandcats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1mlsolutionforinjectioncontains

Activesubstance:

Meloxicam 5mg

Excipients:

Ethanol,anhydrous 110.60mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

SolutionforInjection

Clear,yellowsolution

4. CLINICALPARTICULARS

4.1Targetspecies

Dogandcat

4.2Indicationsforuse,specifyingthetargetspecies

Dogs:

Alleviationofinflammationandpaininbothacuteandchronicmusculo-skeletal

disorders.Reductionofpost-operativepainandinflammationfollowingorthopaedicand

softtissuesurgery.

Cats:

Reductionofpost-operativepainafterovariohysterectomyandminorsofttissuesurgery.

4.3Contraindications

Donotuseinpregnantorlactatinganimals.

Donotuseinanimalssufferingfromgastrointestinaldisorderssuchasirritationand

haemorrhage,impairedhepatic,cardiacorrenalfunctionandhaemorrhagicdisorders.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseinanimalslessthan6weeksofagenorincatsoflessthan2kg.

4.4Specialwarningsforeachtargetspecies

Forpost-operativepainreliefincats,safetyhasonlybeendocumentedafter

thiopental/halothaneanaesthesia.

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Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifadversereactionsoccur,treatmentshouldbediscontinuedandtheadviceofa

veterinarianshouldbesought.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal,asthereisa

potentialriskofrenaltoxicity.

Anyoralfollow-uptherapyusingmeloxicamorotherNSAIDsshouldnotbeadministered

incats,asappropriatedosageregimensforsuchfollow-uptreatmentshavenotbeen

established.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Accidentalself-injectionmaygiverisetopain.Peoplewithknownhypersensitivityto

NSAIDsshouldavoidcontactwiththeveterinarymedicinalproduct.

Incaseofaccidentalself-injection,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

4.6Adversereactions(frequencyandseriousness)

TypicaladversedrugreactionsofNSAIDssuchaslossofappetite,vomiting,diarrhoea,

faecaloccultblood,apathyandrenalfailurehaveoccasionallybeenreported.Indogs,

thesesideeffectsoccurgenerallywithinthefirsttreatmentweekandareinmostcases

transientanddisappearfollowingterminationofthetreatmentbutinveryrarecasesmay

beseriousorfatal.Inveryrarecasesanaphylactoidreactionsmayoccurandshouldbe

treatedsymptomatically.

4.7Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyandlactation(See4.3).

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

OtherNSAIDs,diuretics,anticoagulants,aminoglycosideantibioticsandsubstances

withhighproteinbindingmaycompeteforbindingandthusleadtotoxiceffects.

AnimeloxanmustnotbeadministeredinconjunctionwithotherNSAIDsor

glucocorticosteroids.Concurrentadministrationofpotentialnephrotoxicdrugsshouldbe

avoided.Inanimalsatanaestheticrisk(e.g.agedanimals)intravenousorsubcutaneous

fluidtherapyduringanaesthesiashouldbetakenintoconsideration.Whenanaesthesia

andNSAIDareconcomitantlyadministered,ariskforrenalfunctioncannotbeexcluded.

Pre-treatmentwithanti-inflammatorysubstancesmayresultinadditionalorincreased

adverseeffectsandaccordinglyatreatment-freeperiodwithsuchdrugsshouldbe

observedforatleast24hoursbeforecommencementoftreatment.Thetreatment-free

period,however,shouldtakeintoaccountthepharmacologicalpropertiesofthe

productsusedpreviously.

4.9Amountstobeadministeredandadministrationroute

Dogs:

Musculo-skeletaldisorders:

Singlesubcutaneousinjectionatadosageof0.2mgmeloxicam/kgbodyweight(i.e.0.4

ml/10kgbodyweight).

Animeloxan1.5mg/mloralsuspensionfordogsmaybeusedforcontinuationof

treatmentatadosageof0.1mgmeloxicam/kgbodyweight,24hoursafter

administrationoftheinjection.

Issued:March2012

AN:00648/2010

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Reductionofpost-operativepain(overaperiodof24hours):

Singleintravenousorsubcutaneousinjectionatadosageof0.2mgmeloxicam/kgbody

weight(i.e.0.4ml/10kgbodyweight)beforesurgery,forexampleatthetimeof

inductionofanaesthesia.

Cats:

Reductionofpost-operativepain:

Singlesubcutaneousinjectionatadosageof0.3mgmeloxicam/kgbodyweight(i.e.

0.06ml/kgbodyweight)beforesurgery,forexampleatthetimeofinductionof

anaesthesia.

Particularcareshouldbetakenwithregardtotheaccuracyofdosing.

Avoidintroductionofcontaminationduringuse.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inthecaseofoverdosagesymptomatictreatmentshouldbeinitiated.

4.11Withdrawalperiod(s)

Notapplicable.

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.Invitroandinvivostudiesdemonstratedthatmeloxicaminhibits

cyclooxygenase-2(COX-2)toagreaterextentthancyclooxygenase-1(COX-1).

5.2Pharmacokineticparticulars

Absorption

Incats, maximumplasmaconcentrationsofmeloxicamwerereachedat3.2hpost

singlesubcutaneousinjectionofAnimeloxan5mg/mlatadoseof0.3mg

meloxicam/kgbodyweight.

Indogs,maximumplasmaconcentrationsofmeloxicamwerereachedat3.1hpost

singlesubeutaneousadministrationofAnimeloxan5mg/mlatadoseof0.2mg

meloxieam/kgbodyweight.

Distribution

Thereisalinearrelationshipbetweenthedoseadministeredandplasmaconcentration

observedinthetherapeuticdoserangeindogs.Morethan97%ofmeloxicamisbound

toplasmaproteins.Thevolumeofdistributionis0.3l/kgindogsand0.09l/kgincats.

Metabolism

Indogs,meloxicamispredominantlyfoundinplasmaandisalsoamajorbiliary

excretionproductwhereasurinecontainsonlytracesoftheparentcompound.

Issued:March2012

AN:00648/2010

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Meloxicamismetabolisedtoanalcohol,anacidderivativeandtoseveralpolar

metabolites.Allmajormetaboliteshavebeenshowntobepharmacologicallyinactive.

Elimination

Incats,themeanterminalhalf-lifewascalculatedtobe18.8h.

Indogs,themeanterminalhalf-lifewascalculatedtobe20.0h.

Approximately75%oftheadministereddoseiseliminatedviafaecesandthe

remainderviaurine.

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

N-Methyl2-Pyrrolidone

Ethanol,anhydrous

Sodiumhydroxide

Hydrochloricacid,dilute

Waterforinjection

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

Shelf-lifeafterfirstopeningtheimmediatepackaging: 28days.

6.4.Specialprecautionsforstorage

Thisveterinarymedicinalproductdoesnotrequireanyspecialtemperaturestorage

conditions.

6.5Natureandcompositionofimmediatepackaging

Clearglass(typeI)bottlesof10ml,20mland25ml,eachclosedwithbromobutyl

rubberstoppersandfixedwithAluminium/PPflipcaps.

Availableincardboardcartonscontaining:

1x10mlor5x10ml

1x20mlor5x20ml

1x25mlor5x25ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

aniMedicaGmbH

ImSuedfeld9

48308Senden-Boesensell

Germany

Issued:March2012

AN:00648/2010

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8. MARKETINGAUTHORISATIONNUMBER

Vm24745/4014

9. DATEOFFIRSTAUTHORISATION

28March2012

10.DATEOFREVISIONOFTHETEXT

March2012

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable.

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