AniMeloxan 1.5mg/ ml Oral Suspension

Main information

  • Trade name:
  • AniMeloxan 1.5mg/ ml Oral Suspension
  • Pharmaceutical form:
  • Suspension for injection
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AniMeloxan 1.5mg/ml Oral Suspension
    Slovenia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • meloxicam
  • Therapeutic area:
  • Dogs

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0267/001
  • Authorization date:
  • 22-10-2009
  • EU code:
  • UK/V/0267/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage, interactions, side effects

Revised:September2013

AN.01030/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Animeloxan1.5mg/mloralsuspensionfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlofsuspensioncontains:

Activesubstance:

Meloxicam1.5mg(equivalentto0.05mgperdrop)

Excipient:

Sodiumbenzoate1.5mg(equivalentto0.05mgperdrop)

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsuspension

Theproductisapaleyellowviscoussuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dog

4.2 Indicationsforuse,specifyingthetargetspecies

Alleviationofinflammationandpaininbothacuteandchronicmusculo-skeletal

disorders.

4.3 Contraindications

Donotuseinpregnantorlactatinganimals.

Donotuseinanimalssufferingfromgastrointestinaldisorderssuchasirritationand

haemorrhage,impairedhepatic,cardiacorrenalfunctionandhaemorrhagic

disorders.

Donotuseincaseofhypersensitivitytotheactivesubstanceortoanyofthe

excipients.

Donotuseindogslessthan6weeksofage.

4.4 Specialwarningsforeachtargetspecies

None

Revised:September2013

AN.01030/2012

Page2of6

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifadversereactionsoccur,treatmentshouldbediscontinuedandtheadviceofa

veterinarianshouldbesought.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal,asthereisa

potentialriskofincreasedrenaltoxicity.

Incaseofprolongeduse,monitoringduringtreatmentshouldbecarriedout.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

PeoplewithknownhypersensitivitytoNSAIDsshouldavoidcontactwiththe

veterinarymedicinalproduct.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

TypicaladversedrugreactionsofNSAIDssuchaslossofappetite,vomiting,

diarrhoea,faecaloccultbloodandapathyhaveoccasionallybeenreported.These

sideeffectsoccurgenerallywithinthefirsttreatmentweekandareinmostcases

transientanddisappearfollowingterminationofthetreatmentbutinveryrarecases

maybeseriousorfatal.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduring

pregnancyorlactation.

Pregnancy:

Donotuseduringpregnancy

Lactation:

Donotusefornursingbitches

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

OtherNSAIDs,diuretics,anticoagulants,aminoglycosideantibioticsandsubstances

withhighproteinbindingmaycompeteforbindingandthusleadtotoxiceffects.

MeloxicammustnotbeadministeredinconjunctionwithotherNSAIDsor

glucocorticosteroids.

Pre-treatmentwithanti-inflammatorysubstancesmayresultinadditionalorincreased

adverseeffectsandaccordinglyatreatment-freeperiodwithsuchdrugsshouldbe

observedforatleast24hoursbeforecommencementoftreatment.Thetreatment-

freeperiod,however,shouldtakeintoaccountthepharmacokineticpropertiesofthe

productsusedpreviously.

MeloxicammayantagonisetheantihypertensiveeffectsofACEinhibitors.

Revised:September2013

AN.01030/2012

Page3of6

4.9 Amountstobeadministeredandadministrationroute

Shakewellbeforeuse.

Tobeadministeredmixedwithfood.

Initialtreatmentisasingledoseof0.2mgmeloxicam/kgbodyweightonthefirstday.

Treatmentistobecontinuedoncedailybyoraladministration(at24-hourintervals)

atamaintenancedoseof0.1mgmeloxicam/kgbodyweight.

Particularcareshouldbetakenwithregardtotheaccuracyofdosing.

Thesuspensioncanbegivenusingeitherthedropdispenser(forverysmallbreeds)

orthemeasuringsyringeprovidedinthepackage.Thedispenserprovides0.05mg

meloxicamperdrop(i.e.adoseof0.1mgmeloxicam/kgbodyweightcorrespondsto

2drops/kgbodyweight).Thesyringefitsontothebottleandhasakg-bodyweight

scalewhichcorrespondstothemaintenancedose(i.e.0.1mgmeloxicam/kgbody

weight).Thusforthefirstday,twicethemaintenancevolumewillberequired.

Shakebottlewell.

Pushdownand

unscrewbottle

top.Attachthe

dosingsyringeto

thebottleby

gentlypushingthe

endontothetop

Turnthe

bottle/syringe

upsidedown.Pull

theplungerout

untiltheblackline

ontheplunger

correspondsto

yourdog’s

bodyweightin

Turnthebottleright

wayupandwitha

twistingmovement

separatethedosing

syringefromthe

bottle Emptythe

contentsofthe

syringeontothe

foodbypushing

theplungerin.

Revised:September2013

AN.01030/2012

Page4of6

Aclinicalresponseisnormallyseenwithin3-4days.Treatmentshouldbe

discontinuedafter10daysatthelatestifnoclinicalimprovementisapparent.

Forlongertermtreatment,onceclinicalresponsehasbeenobserved(after ≥4days),

thedoseoftheveterinarymedicinalproductcanbeadjustedtothelowesteffective

individualdosereflectingthatthedegreeofpainandinflammationassociatedwith

chronicmusculo-skeletaldisordersmayvaryovertime.

Avoidintroductionofcontaminationduringuse.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Inthecaseofoverdosagesymptomatictreatmentshouldbeinitiated.Pleasereferto

Section4.6(Adversereactions)fordetailsofsymptoms.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflammatoryandantirheumaticproducts,non-

steroids(oxicams)

ATCvetcode:QM01AC06

5.1 Pharmacodynamicproperties

Meloxicamisanon-steroidalanti-inflammatorydrug(NSAID)oftheoxicamclass

whichactsbyinhibitionofprostaglandinsynthesis,therebyexertinganti-

inflammatory,analgesic,anti-exudativeandantipyreticeffects.Itreducesleukocyte

infiltrationintotheinflamedtissue.Toaminorextentitalsoinhibitscollagen-induced

thrombocyteaggregation.Invitroandinvivostudiesdemonstratedthatmeloxicam

inhibitscyclooxygenase-2(COX-2)toagreaterextentthancyclooxygenase-1(COX-

1).

5.2 Pharmacokineticparticulars

Absorption

Meloxicamiscompletelyabsorbedfollowingoraladministrationandmaximalplasma

concentrationsareobtainedafterapproximately7.5hours.Whentheproductisused

accordingtotherecommendeddosageregime,steadystateconcentrationsof

meloxicaminplasmaarereachedontheseconddayoftreatment.

Distribution

Thereisalinearrelationshipbetweenthedoseadministeredandplasma

concentrationobservedinthetherapeuticdoserange.Approximately97%of

meloxicamisboundtoplasmaproteins.Thevolumeofdistributionis0.3l/kg.

Revised:September2013

AN.01030/2012

Page5of6

Metabolism

Meloxicamispredominantlyfoundinplasmaandisalsoamajorbiliaryexcretion

productwhereasurinecontainsonlytracesoftheparentcompound.Meloxicamis

metabolisedtoanalcohol,anacidderivativeandtoseveralpolarmetabolites.All

majormetaboliteshavebeenshowntobepharmacologicallyinactive.

Elimination

Meloxicamiseliminatedwithahalf-lifeof24hours.Approximately75%ofthe

administereddoseiseliminatedviafaecesandtheremainderviaurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Sodiumbenzoate

DispersibleCellulose

Sodiumcarmellose

Glycerol

Sorbitol,Liquid(non-crystallising)

Xylitol

Sodiumdihydrogenphosphatedihydrate

SaccharinSodium

HoneyFlavourIFFRS8008

Citricacidmonohydrate

PurifiedWater

6.2 Incompatibilities

Intheabsenceofcompatibilitystudies,thisveterinarymedicinalproductmustnotbe

mixedwithotherveterinarymedicinalproducts.

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years

Shelf-lifeafterfirstopeningtheimmediatepackaging:6months

6.4. Specialprecautionsforstorage

Donotstoreabove30ºC.

6.5 Natureandcompositionofimmediatepackaging

Highdensitypolyethylenebottlewithpolypropyleneinnercap,nozzleandoutercap.

Measuringdevice:Polypropylenesyringe

Packsize(s):Bottlesof10ml,32mland100ml

Notallpacksizesmaybemarketed.

Revised:September2013

AN.01030/2012

Page6of6

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

aniMedicaGmbH

ImSüdfeld9

48308Senden-Bösensell

Germany

8. MARKETINGAUTHORISATIONNUMBER

Vm24745/4001

9. DATEOFFIRSTAUTHORISATION

15August2008

10. DATEOFREVISIONOFTHETEXT

September2013

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

Notapplicable

APPROVED 13/09/13