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
    United Kingdom
  • Language:
  • English

Therapeutic information

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

Other information

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

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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

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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

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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

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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

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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

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

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