Adocam

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
    Ireland
  • 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

14-9-2018

Pending EC decision:  Inflacam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Inflacam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

14-9-2018

Pending EC decision:  Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Pending EC decision: Rheumocam, meloxicam, Opinion date: 13-Sep-2018

Europe - EMA - European Medicines Agency

29-11-2018

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Chanelle Pharmaceuticals Manufacturing Limited)

Inflacam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)8036 of Thu, 29 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2497/X/15

Europe -DG Health and Food Safety

21-11-2018

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Chanelle Pharmaceuticals Manufacturing Limited)

Rheumocam (Active substance: Meloxicam) - Centralised - Variation - Commission Decision (2018)7841 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/121/X/22

Europe -DG Health and Food Safety

19-10-2018

Recocam (Bimeda Animal Health Limited)

Recocam (Bimeda Animal Health Limited)

Recocam (Active substance: Meloxicam) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6954 of Fri, 19 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2247/T/10

Europe -DG Health and Food Safety

7-8-2018

Novem (Boehringer Ingelheim Vetmedica GmbH)

Novem (Boehringer Ingelheim Vetmedica GmbH)

Novem (Active substance: Meloxicam) - Centralised - Yearly update - Commission Decision (2018)5413 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

29-5-2018

Meloxivet (Eli Lilly and Company Limited)

Meloxivet (Eli Lilly and Company Limited)

Meloxivet (Active substance: Meloxicam) - Centralised - Withdrawal - Commission Decision (2018)3408 of Tue, 29 May 2018

Europe -DG Health and Food Safety

16-2-2018

Pending EC decision:  Metacam, meloxicam, Opinion date: 15-Feb-2018

Pending EC decision: Metacam, meloxicam, Opinion date: 15-Feb-2018

Europe - EMA - European Medicines Agency