MILBEMAX CHEWABLE TABLETS FOR DOGS

Main information

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

Documents

Localization

  • Available in:
  • MILBEMAX CHEWABLE TABLETS FOR DOGS
    Netherlands
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • FR/V/0135/006
  • Authorization date:
  • 09-07-2011
  • EU code:
  • FR/V/0135/006
  • Last update:
  • 09-08-2016

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

SUMMARYOFPRODUCTCHARACTERISTICS

MILBEMAXchewabletabletsfordogs

SummaryofProductCharacteristics September2012

NovartisAnimalHealthInc. Confidential Page2of6

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MILBEMAXchewabletabletsfordogs

SE:Milbemaxvet.chewabletabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Onechewabletabletcontains:

Activesubstances:

Milbemycinoxime 12.5mg

Praziquantel 125.0mg

Excipients:

Glycerol(E422) 460.46mg

Propyleneglycol(E1520) 4.54mg

Ironoxide,brown(E172) 3.29mg

Butylhydroxyanisole(E320) 1.32mg

Propylgallate(E310) 0.46mg

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)

MILBEMAXchewabletabletsfordogs

SummaryofProductCharacteristics September2012

NovartisAnimalHealthInc. Confidential Page3of6

Angiostrongylusvasorum(Reductionofthelevelofinfection)(seespecifictreatmentscheduleunder

section4.9“Amountstobeadministeredandadministrationroute”)

Theproductcanalsobeusedinthepreventionofheartwormdisease(Dirofilariaimmitis),if

concomitanttreatmentagainstcestodesisindicated.

4.3 Contraindications

Donotuseindogsweighinglessthan5kg.

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)

MILBEMAXchewabletabletsfordogs

SummaryofProductCharacteristics September2012

NovartisAnimalHealthInc. Confidential Page4of6

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

5–25kg 1tablet

>25-50kg 2tablets

>50-75kg 3tablets

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

MILBEMAXchewabletabletsfordogs

SummaryofProductCharacteristics September2012

NovartisAnimalHealthInc. Confidential Page5of6

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

approximately0.5 - 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.

MILBEMAXchewabletabletsfordogs

SummaryofProductCharacteristics September2012

NovartisAnimalHealthInc. Confidential Page6of6

6.3 Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale: 3 2 years.

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

{Name}

{Address}

<{tel}>

<{fax}>

<{e-mail}>

8. MARKETINGAUTHORISATIONNUMBER(S)

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateofthefirstauthorisation:{nationallyapprovedonDD/MM/YYYYorDDmonthYYYY}

10 DATEOFREVISIONOFTHETEXT

{MM/YYYY}or<monthYYYY>

4-12-2018

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

Mylan Expands Its Voluntary Nationwide Recall of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, to all Lots Within Expiry Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylam

– Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochloroth...

FDA - U.S. Food and Drug Administration

4-12-2018

FDA Approves Pexion for Treating Noise Aversion in Dogs

FDA Approves Pexion for Treating Noise Aversion in Dogs

The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots.

FDA - U.S. Food and Drug Administration

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

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

18-7-2018

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA Approves NexGard for prevention of infections that cause Lyme disease in dogs

FDA has approved NexGard (afoxolaner), a chewable tablet administered once monthly to dogs, for the prevention of Borrelia burgdorferi (B. burgdorferi) infections by killing Black-legged ticks (Ixodes scapularis), which carry the bacterium.

FDA - U.S. Food and Drug Administration

13-7-2018

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan and Valsartan HCTZ Tablets Due to Detection of a Trace Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA) in The Products

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- that is used in the manufacture of the subject product ...

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