MILBEMAX

Main information

  • Trade name:
  • MILBEMAX CHEWABLE TABLETS FOR SMALL DOGS AND PUPPIES
  • Pharmaceutical form:
  • Chewable tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MILBEMAX CHEWABLE TABLETS FOR SMALL DOGS AND PUPPIES
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Milbemycin, combinations
  • Therapeutic area:
  • Dogs

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0135/005
  • Authorization date:
  • 09-07-2011
  • EU code:
  • FR/V/0135/005
  • Last update:
  • 09-08-2016

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

SUMMARYOFPRODUCTCHARACTERISTICS

MILBEMAXchewabletabletsforsmalldogsandpuppies

SummaryofProductCharacteristics

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1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MILBEMAXchewabletabletsforsmalldogsandpuppies

SE:Milbemaxvet.chewabletabletsforsmalldogsandpuppies

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onechewabletabletcontains:

Activesubstances:

Milbemycinoxime 2.5mg

Praziquantel 25.0mg

Excipients:

Glycerol(E422) 92.12mg

Propyleneglycol(E1520) 0.91mg

Ironoxide,brown(E172) 0.66mg

Butylhydroxyanisole(E320) 0.26mg

Propylgallate(E310) 0.09mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Chewabletablet

Ovalshaped,darkbrown.

4. CLINICALPARTICULARS

4.1 Targetspecies

Dogs

4.2 Indicationsforuse,specifyingthetargetspecies

Indogs:treatmentofmixedinfectionsbyadultcestodesandnematodesofthefollowingspecies:

-Cestodes:

Dipylidiumcaninum

Taeniaspp.

Echinococcusspp.

Mesocestoidesspp.

-Nematodes:

Ancylostomacaninum

Toxocaracanis

Toxascarisleonina

Trichurisvulpis

Crenosomavulpis(Reductionofthelevelofinfection)

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Angiostrongylusvasorum(Reductionofthelevelofinfection)(seespecifictreatmentscheduleunder

section4.9“Amountstobeadministeredandadministrationroute”)

Theproductcanalsobeusedinthepreventionofheartwormdisease(Dirofilariaimmitis),if

concomitanttreatmentagainstcestodesisindicated.

4.3 Contraindications

Donotuseindogsweighinglessthan1kg.

Donotuseincaseofhypersensitivitytotheactivesubstancesortoanyofexcipients.

Seealsosection4.5"Specialprecautionsforuse".

4.4 Specialwarnings

StudieswithmilbemycinoximeindicatethatthemarginofsafetyincertaindogsofCollieorrelated

breedsislessthaninotherbreeds.Inthesedogs,therecommendeddoseshouldbestrictlyobserved.

Thetoleranceoftheproductinyoungpuppiesfromthesebreedshasnotbeeninvestigated.Clinical

signsinColliesaresimilartothoseseeninthegeneraldogpopulationwhenoverdosed(seesection

4.10“Overdose”).

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Treatmentofdogswithahighnumberofcirculatingmicrofilariaecansometimesleadtothe

appearanceofhypersensitivityreactions,suchaspalemucousmembranes,vomiting,trembling,

labouredbreathingorexcessivesalivation.Thesereactionsareassociatedwiththereleaseofproteins

fromdeadordyingmicrofilariaeandarenotadirecttoxiceffectoftheproduct.Theuseindogs

sufferingfrommicrofilaremiaisthusnotrecommended.

Inheartwormrisk-areas,orinthecaseitisknownthatadoghasbeentravellingtoandfrom

heartwormriskregions,beforeusingtheproduct,aveterinaryconsultationisadvisedtoexcludethe

presenceofanyconcurrentinfestationofDirofilariaimmitis.Inthecaseofapositivediagnosis,

adulticidaltherapyisindicatedbeforeadministeringtheproduct.

Echinococcosisrepresentsahazardforhumans.IncaseofEchinococcosis,specificguidelinesonthe

treatmentandfollowupandonthesafeguardofpersonshavetobefollowed.Expertsorinstitutesof

parasitologyshouldbeconsulted.

Nostudieshavebeenperformedwithseverelydebilitateddogsorindividualswithseriously

compromisedkidneyorliverfunction.Theproductisnotrecommendedforsuchanimalsoronly

accordingtoabenefit/riskassessmentbytheresponsibleveterinarian.

Indogslessthan4weeksold,tapeworminfectionisunusual.Treatmentofanimalslessthan4weeks

oldwithacombinationproductmaythereforenotbenecessary.

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowingfrequent,repeateduse

ofananthelminticofthatclass.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteruse.

Intheeventofaccidentalingestionofthetablets,particularlybyachild,seekmedicaladvice

immediatelyandshowthepackageleafletorthelabeltothedoctor.

4.6 Adversereactions(frequencyandseriousness)

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Inveryrareoccasions,systemicsigns(suchaslethargy),neurologicalsigns(suchasmuscletremors

andataxia)and/orgastrointestinalsigns(suchasemesis,drooling,diarrhoeaandanorexia)havebeen

observedindogsafteradministrationoftheveterinarymedicinalproduct.

4.7 Useduringpregnancy,lactationorlay

Thesafetyoftheveterinarymedicinalproducthasbeenestablishedduringpregnancyandlactation.

Canbeusedinpregnantandlactatingbitches.

Canbeusedinbreedinganimals.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcurrentuseoftheproductwithselamectiniswelltolerated.Nointeractionswereobserved

whentherecommendeddoseofthemacrocycliclactoneselamectinwasadministeredduringtreatment

withtheproductattherecommendeddose.Intheabsenceoffurtherstudies,cautionshouldbetaken

inthecaseofconcurrentuseoftheproductandothermacrocycliclactones.Also,nosuchstudieshave

beenperformedwithreproducinganimals.

4.9 Amountstobeadministeredandadministrationroute

Minimumrecommendeddoserate:0.5mgofmilbemycinoximeand5mgofpraziquantelperkgare

givenonceorally.Theproductshouldbeadministeredwithoraftersomefood.

Dependingonthebodyweightofthedog,thepracticaldosingisasfollows:

Weight NumberofTablet

1–5kg 1tablet

Incaseswhenheartwormdiseasepreventionisusedandatthesametimetreatmentagainsttapeworm

isrequired,theproductcanreplacethemonovalentproductforthepreventionofheartwormdisease.

ForAngiostrongylusvasoruminfections,milbemycinoximeshouldbegivenfourtimesatweekly

intervals.Itisrecommended,whereconcomitanttreatmentagainstcestodesisindicated,totreatonce

withtheproductandcontinuewiththemonovalentproductcontainingmilbemycinoximealone,forthe

remainingthreeweeklytreatments.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Theadversereactionsobservedarethesameasthoseobservedattherecommendeddose(seesection

4.6“Adversereactions(frequencyandseriousness)”)butmorepronounced.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiparasiticproducts,insecticidesandrepellants-endectocides

ATCvetCode: QP54AB51(Milbemycincombinations)

5.1 Pharmacodynamicproperties

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Milbemycinoximebelongstothegroupofmacrocycliclactones,isolatedfromthefermentationof

Streptomyceshygroscopicusvar.aureolacrimosus.Itisactiveagainstmites,againstlarvalandadult

stagesofnematodesaswellasagainstlarvaeofDirofilariaimmitis.

Theactivityofmilbemycinisrelatedtoitsactiononinvertebrateneurotransmission:Milbemycinoxime,

likeavermectinsandothermilbemycins,increasesnematodeandinsectmembranepermeabilityto

chlorideionsviaglutamate-gatedchlorideionchannels(relatedtovertebrateGABA

andglycine

receptors).Thisleadstohyperpolarisationoftheneuromuscularmembraneandflaccidparalysisand

deathoftheparasite.

Praziquantelisanacylatedpyrazino-isoquinolinederivative.Praziquantelisactiveagainstcestodesand

trematodes.Itmodifiesthepermeabilityforcalcium(influxofCa 2+ )inthemembranesoftheparasite

inducinganimbalanceinthemembranestructures,leadingtomembranedepolarisationandalmost

instantaneouscontractionofthemusculature(tetany),rapidvacuolizationofthesyncytialtegumentand

subsequenttegumentaldisintegration(blebbing),resultingineasierexpulsionfromthegastrointestinal

tractordeathoftheparasite.

5.2 Pharmacokineticparticulars

Afteroraladministrationofpraziquantelinthedog,peakserumlevelsofparentarerapidlyattained

(Tmaxapproximately0.5-4hours)anddeclinequickly(t

approximately1.5hours).Thereisa

substantialhepaticfirst-passeffect,withveryrapidandalmostcompletehepaticbiotransformation,

principallytomonohydroxylated(alsosomedi-andtri-hydroxylated)derivatives,whicharemostly

glucuronideand/orsulfateconjugatedbeforeexcretion.Plasmabindingisabout80%.Excretionisfast

andcomplete(about90%in2days);theprincipalrouteofeliminationisrenal.

Afteroraladministrationofmilbemycinoximeindogs,peakplasmalevelsoccuratabout2-4hours,and

declinewithahalf-lifeoftheunmetabolisedmilbemycinoximeof1-4days.Bioavailabilityisabout

80%.

Intherat,metabolismappearstobecompletealthoughslow,sinceunchangedmilbemycinoximehas

notbeenfoundinurineorfaeces.Mainmetabolitesintherataremonohydroxylatedderivatives,

attributabletohepaticbiotransformation.Inadditiontorelativelyhighliverconcentrations,thereissome

concentrationinfat,reflectingitslipophilicity.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Glycerol(E422)

Propyleneglycol(E1520)

Ironoxide,brown(E172)

Butylhydroxyanisole(E320)

Propylgallate(E310)

Starch,pregelatinised

Naturalchickenflavour

Confectioner’ssugarNF

Water,purified

Sodiumchloride

Citricacidmonohydrate

6.2 Incompatibilities

Notapplicable.

6.3 Shelflife

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Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:2years.

6.4.Specialprecautionsforstorage

Donotstoreabove25°C.

6.5 Natureandcompositionofimmediatepackaging

Aluminum/aluminumblister(OPA/Al/PE//Al/PE)oraluminumstrip(polyester/Al/PE)

Availablepacksizes:

1boxwith1blisterof2chewabletablets

1boxwith1blisterof4chewabletablets

1boxwith12blisters,eachblistercontains4chewabletablets

1boxwith1stripof2chewabletablets

1boxwith1stripof4chewabletablets

1boxwith12strips,eachstripcontains4chewabletablets

Notallpacksizesmaybemarketed.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinal

productshouldbedisposedofinaccordancewithlocalrequirements.

MILBEMAXchewabletabletsshouldnotenterwatercoursesasthismaybedangerousforfishand

otheraquaticorganisms.

7. MARKETINGAUTHORISATIONHOLDER

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{Address}

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<{fax}>

<{e-mail}>

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateofthefirstauthorisation:{nationallyapprovedonDD/MM/YYYYorDDmonthYYYY}

10 DATEOFREVISIONOFTHETEXT

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{MM/YYYY}or<monthYYYY>

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

FDA - U.S. Food and Drug Administration

20-9-2018

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump (IABP) For Interruption and/or Inability to Start Therapy at Altitudes above 3,200 Feet/975 Meters

Getinge is voluntarily initiating a Worldwide recall involving a field correction of approximately 5,223 Maquet/Getinge Cardiosave Intra-Aortic Balloon Pumps (IABP) sold by Datascope Corp., for a potential interruption and/or inability to start therapy to the patient regarding the use of certain Intra-Aortic Balloons (IABs) prior to or during the use with Cardiosave IABP for users who are at altitudes above 3200 feet/975 meters. This condition could potentially lead to patient hemodynamic instability.

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

6-8-2018

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

August 3, 2018: Northwest ENT Associates, P.C. to Pay Approximately $1.2 Million to Resolve False Claims Act Allegations

FDA - U.S. Food and Drug Administration

25-7-2018

Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers

Kraft Heinz Voluntarily Recalls Taco Bell Salsa Con Queso Mild Cheese Dip Distributed to Retailers

As a precaution, approximately 7,000 cases of Taco Bell Salsa Con Queso Mild Cheese Dip are being voluntarily recalled because the affected product is showing signs of product separation which can lead to a potential health hazard. This could create conditions that could allow for the growth of Clostridium botulinum (C. botulinum), a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.

FDA - U.S. Food and Drug Administration

18-7-2018

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

Hy-Vee Voluntarily Recalls Spring Pasta Salad Due to Reported Illnesses

WEST DES MOINES, Iowa (July 17, 2018) — Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling its Hy-Vee Spring Pasta Salad due to the potential that it may be contaminated with Salmonella. The potential for contamination was brought to Hy-Vee’s attention last night when approximately 20 illnesses in Minnesota, South Dakota, Nebraska and Iowa were potentially linked back to customers consuming the salad. The voluntary recall includes Hy-Vee Spring Pasta Salads in both 1 pound (16 oz.) an...

FDA - U.S. Food and Drug Administration

26-5-2018

Divvies, LLC  Conducts Voluntary Recall of Benjamint Crunch Chocolate Bars Due to Undeclared Milk In The Mint

Divvies, LLC Conducts Voluntary Recall of Benjamint Crunch Chocolate Bars Due to Undeclared Milk In The Mint

Divvies announced today a voluntary recall of its Benjamint Crunch Chocolate bars due to possible undeclared milk in the peppermint used in the bars. The recall is limited solely to the Benjamint Crunch Bars that were sold online through the Divvies website. This recall will impact approximately 140 consumers.

FDA - U.S. Food and Drug Administration

22-10-2018

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Merial)

NEXGARD SPECTRA (Active substance: Afoxolaner / milbemycin oxime) - Centralised - 2-Monthly update - Commission Decision (2018)6977 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/003842/WS1338/0015/G

Europe -DG Health and Food Safety

22-10-2018

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Roche Registration GmbH)

EU/3/05/264 (Active substance: Cholest-4-en-3-one, oxime) - Transfer of orphan designation - Commission Decision (2018)6995 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/081/04/T/02

Europe -DG Health and Food Safety

29-6-2018

BROADLINE (Merial)

BROADLINE (Merial)

BROADLINE (Active substance: Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel) - Centralised - Yearly update - Commission Decision (2018) 4164 of Fri, 29 Jun 2018

Europe -DG Health and Food Safety

14-6-2018

Evaluation Plan Estimators

Evaluation Plan Estimators

Before you lodge your pre-submission planning form (PPF) you can use the below evaluation plan estimators to approximate the dates of the milestones in the prescription medicine registration process. The estimators derive dates representing an example...

Therapeutic Goods Administration - Australia

29-5-2018

Profender (Bayer Animal Health GmbH)

Profender (Bayer Animal Health GmbH)

Profender (Active substance: Emodepside / Praziquantel) - Centralised - Yearly update - Commission Decision (2018)3405 of Tue, 29 May 2018

Europe -DG Health and Food Safety