Adocam 1.5mg/ml Oral Suspension

Main information

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

Documents

Localization

  • Available in:
  • Adocam 1.5mg/ml Oral Suspension
    Spain
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0268/001
  • Authorization date:
  • 30-04-2008
  • EU code:
  • UK/V/0268/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Adocam1.5mg/mloralsuspensionfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachmlofproductcontains:

Activesubstance(s):

Meloxicam1.5mg(equivalentto0.05mgperdrop)

Excipient(s):

Sodiumbenzoate1.5mg(equivalentto0.05mgperdrop)

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Oralsuspension

Theproductisapaleyellowviscoussuspension.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dog

4.2 Indicationsforuse,specifyingthetargetspecies

Alleviationofinflammationandpaininbothacuteandchronicmusculo-skeletaldisorders.

4.3 Contraindications

Donotuseinpregnantorlactatinganimals.

Donotuseinanimalssufferingfromgastrointestinaldisorderssuchasirritationandhaemorrhage,

impairedhepatic,cardiacorrenalfunctionandhaemorrhagicdisorders.

Donotuseincasesofknownhypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Donotuseindogslessthan6weeksofage.

4.4 Specialwarningsforeachtargetspecies

None

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifadversereactionsoccur,treatmentshouldbediscontinuedandtheadviceofaveterinarianshouldbe

sought.

Avoiduseinanydehydrated,hypovolaemicorhypotensiveanimal,asthereisapotentialriskof

increasedrenaltoxicity.

Incaseofprolongeduse,monitoringduringtreatmentshouldbecarriedout.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproductto

animals

PeoplewithknownhypersensitivitytoNSAIDsshouldavoidcontactwiththeveterinarymedicinal

product.

Incaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackageleafletorthe

labeltothephysician.

4.6 Adversereactions(frequencyandseriousness)

TypicaladversedrugreactionsofNSAIDssuchaslossofappetite,vomiting,diarrhoea,faecaloccult

bloodandapathyhaveoccasionallybeenreported.Thesesideeffectsoccurgenerallywithinthefirst

treatmentweekandareinmostcasestransientanddisappearfollowingterminationofthetreatment

butinveryrarecasesmaybeseriousorfatal.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasnotbeenestablishedduringpregnancyorlactation.

Pregnancy:

Donotuseduringpregnancy

Lactation:

Donotusefornursingbitches

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

OtherNSAIDs,diuretics,anticoagulants,aminoglycosideantibioticsandsubstanceswithhighprotein

bindingmaycompeteforbindingandthusleadtotoxiceffects.Meloxicammustnotbeadministered

inconjunctionwithotherNSAIDsorglucocorticosteroids.

Pre-treatmentwithanti-inflammatorysubstancesmayresultinadditionalorincreasedadverseeffects

andaccordinglyatreatment-freeperiodwithsuchdrugsshouldbeobservedforatleast24hours

beforecommencementoftreatment.Thetreatment-freeperiod,however,shouldtakeintoaccountthe

pharmacokineticpropertiesoftheproductsusedpreviously.

MeloxicammayantagonisetheantihypertensiveeffectsofACEinhibitors.

4.9 Amountstobeadministeredandadministrationroute

Tobeadministeredmixedwithfood.

Initialtreatmentisasingledoseof0.2mgmeloxicam/kgbodyweightonthefirstday.Treatmentisto

becontinuedoncedailybyoraladministration(at24-hourintervals)atamaintenancedoseof

0.1mgmeloxicam/kgbodyweight.

Particularcareshouldbetakenwithregardtotheaccuracyofdosing.

Thesuspensioncanbegivenusingeitherthedropdispenser(forverysmallbreeds)orthemeasuring

syringeprovidedinthepackage.Thedispenserprovides0.05mgmeloxicamperdrop(i.e.adoseof

0.1mgmeloxicam/kgbodyweightcorrespondsto2drops/kgbodyweight).Thesyringefitsontothe

bottleandhasakg-bodyweightscalewhichcorrespondstothemaintenancedose(i.e.0.1mg

meloxicam/kgbodyweight).Thusforthefirstday,twicethemaintenancevolumewillberequired.

Shakewellbeforeuse.

Aclinicalresponseisnormallyseenwithin3-4days.Treatmentshouldbediscontinuedafter10days

atthelatestifnoclinicalimprovementisapparent.

Forlongertermtreatment,onceclinicalresponsehasbeenobserved(after≥4days),thedoseofthe

veterinarymedicinalproductcanbeadjustedtothelowesteffectiveindividualdosereflectingthatthe

degreeofpainandinflammationassociatedwithchronicmusculo-skeletaldisordersmayvaryover

time.

4.10 Overdose(symptoms,emergency procedures,antidotes),ifnecessary

Inthecaseofoverdosagesymptomatictreatmentshouldbeinitiated.PleaserefertoSection4.6

(Adversereactions)fordetailsofsymptoms.

4.11 Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiinflammatoryandantirheumaticproducts,non-steroids(oxicams)

ATCvetcode:QM01AC06

5.1 Pharmacodynamicproperties

Meloxicamisanon-steroidalanti-inflammatorydrug(NSAID)oftheoxicamclasswhichactsby

inhibitionofprostaglandinsynthesis,therebyexertinganti-inflammatory,analgesic,anti-exudativeand

antipyreticeffects.Itreducesleukocyteinfiltrationintotheinflamedtissue.Toaminorextentitalso

inhibitscollagen-inducedthrombocyteaggregation.Invitroandinvivostudiesdemonstratedthat

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

5.2 Pharmacokineticparticulars

Absorption

Meloxicamiscompletelyabsorbedfollowingoraladministrationandmaximalplasmaconcentrations

areobtainedafterapproximately7.5hours.Whentheproductisusedaccordingtotherecommended

dosageregime,steadystateconcentrationsofmeloxicaminplasmaarereachedontheseconddayof

treatment.

Distribution

Thereisalinearrelationshipbetweenthedoseadministeredandplasmaconcentrationobservedinthe

therapeuticdoserange.Approximately97%ofmeloxicamisboundtoplasmaproteins.Thevolume

ofdistributionis0.3l/kg.

Metabolism

Meloxicamispredominantlyfoundinplasmaandisalsoamajorbiliaryexcretionproductwhereas

urinecontainsonlytracesoftheparentcompound.Meloxicamismetabolisedtoanalcohol,anacid

derivativeandtoseveralpolarmetabolites.Allmajormetaboliteshavebeenshowntobe

pharmacologicallyinactive.

Elimination

Meloxicamiseliminatedwithahalf-lifeof24hours.Approximately75%oftheadministereddoseis

eliminatedviafaecesandtheremainderviaurine.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

MicrocrystallineCellulose

Sodiumcarmellose

Glycerol

Sorbitol,liquid(non-crystallising)

Xylitol

SodiumBenzoate

Sodiumdihydrogendhosphatedihydrate

SaccharinSodium

HoneyFlavourIFFRS8008

Citricacidmonohydrate

PurifiedWater

6.2 Incompatibilities

Noneknown.

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.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

NicheGenericsLimited

1TheCamCentre

WilburyWay

Hitchin

Hertfordshire,SG40TW

UnitedKingdom

8. MARKETINGAUTHORISATIONNUMBER

Vm19611/4000

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

11 August2008

10 DATEOFREVISIONOFTHETEXT

April2008

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

NotApplicable

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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