Milbemax tablets for Dogs

Main information

  • Trade name:
  • Milbemax tablets for Dogs
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Milbemax 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/0135/002
  • Authorization date:
  • 17-04-2011
  • EU code:
  • FR/V/0135/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

MILBEMAXdogsFinalRENEWALSPCJuly2007

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

MILBEMAX ®

Tabletsfordogs

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstances:

Milbemycinoxime 12.5mg

Praziquantel 125.0mg

Excipients:

QSPonetabletof625mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Tablet

Roundshaped,white.Onesidebearstheimprint“CCA”,theotherside“NA”.

4. CLINICALPARTICULARS

4.1Targetspecies

Dogs

4.2Indicationsforuse,specifyingthetargetspecies

Indogs:treatmentofmixedinfectionsbyadultcestodesandnematodesofthe

followingspecies:

-Cestodes:

Dipylidiumcaninum

Taeniaspp.

Echinococcusspp.

Mesocestoidesspp.

-Nematodes:

Ancylostomacaninum

MILBEMAXdogsFinalRENEWALSPCJuly2007

Toxocaracanis

Toxascarisleonina

Trichurisvulpis

Crenosomavulpis(Reductionofthelevelofinfection)

Angiostrongylusvasorum(Reductionofthelevelofinfection;seespecifictreatment

scheduleunderSPCpoint“4.9Amountstobeadministeredandadministrationroute”)

Theproductcanalsobeusedinthepreventionofheartwormdisease(Dirofilaria

immitis),ifconcomitanttreatmentagainstcestodesisindicated.

4.3Contraindications

Donotuseindogsweighinglessthan5kg

Seealsopoint"Specialprecautionsforuse"

4.4Specialwarnings

Studieswithmilbemycinoximeindicatethatthemarginofsafetyincertaindogsof

Collieorrelatedbreedsislessthaninotherbreeds.Inthesedogs,therecommended

doseshouldbestrictlyobserved.

ThetoleranceofMILBEMAXinyoungpuppiesfromthesebreedshasnotbeen

investigated.

ClinicalsignsinColliesaresimilartothoseseeninthegeneraldogpopulationwhen

overdosed(seeinpoint4.10).

4.5Specialprecautionsforuse,includingspecialprecautionstobetakenbythe

personadministeringthemedicinalproducttoanimals

Specialprecautionsforuseinanimals

Aspergoodveterinarypractice,animalsshouldbeweighedtoensureaccurate

dosing

Treatmentofdogswithahighnumberofcirculatingmicrofilariaecansometimeslead

totheappearanceofhypersensitivityreactions,suchaspalemucousmembranes,

vomiting,trembling,labouredbreathingorexcessivesalivation.Thesereactionsare

associatedwiththereleaseofproteinsfromdeadordyingmicrofilariaeandarenota

directtoxiceffectoftheproduct.Theuseindogssufferingfrommicrofilaremiaisthus

notrecommended.

Inheartwormrisk-areas,orinthecaseitisknownthatadoghasbeentravellingtoand

fromheartwormriskregions,beforeusingMILBEMAX,aveterinaryconsultationis

advisedtoexcludethepresenceofanyconcurrentinfestationofDirofilariaimmitis.In

thecaseofapositivediagnosis,adulticidaltherapyisindicatedbeforeadministering

MILBEMAX.

Echinococcosisrepresentsahazardforhumans.IncaseofEchinococcosis,specific

guidelinesonthetreatmentandfollowupandonthesafeguardofpersonshavetobe

followed.Expertsorinstitutesofparasitologyshouldbeconsulted.

MILBEMAXdogsFinalRENEWALSPCJuly2007

Nostudieshavebeenperformedwithseverelydebilitateddogsorindividualswith

seriouslycompromisedkidneyorliverfunction.Theproductisnotrecommendedfor

suchanimalsoronlyaccordingtoabenefit/riskassessmentbytheresponsible

veterinarian.

Indogslessthan4weeksold,tapeworminfectionisunusual.Treatmentofanimals

lessthan4weeksoldwithacombinationproductmaythereforenotbenecessary.

Parasiteresistancetoanyparticularclassofanthelminticmaydevelopfollowing

frequent,repeateduseofananthelminticofthatclass

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Intheeventofaccidentalingestionofthetablets,particularlybyachild,seekmedical

adviceimmediatelyandshowthepackageleafletorthelabeltothedoctor.

4..6Adversereactions(frequencyandseriousness)

“Inveryrareoccasions,systemicsigns(suchaslethargy),neurologicalsigns(suchas

muscletremorsandataxia)and/orgastrointestinalsigns(suchasemesis,diarrhea,anorexia

anddrooling)havebeenobservedindogsafteradministrationoftheveterinarymedicinal

product.

4.7Useduringpregnancy,lactationorlay

Theproductmaybeusedinbreedingdogsincludingpregnantandlactatingbitches.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

TheconcurrentuseofMILBEMAXwithselamectiniswelltolerated.Nointeractions

wereobservedwhentherecommendeddoseofthemacrocycliclactoneselamectin

wasadministeredduringtreatmentwithMILBEMAXattherecommendeddose.Inthe

absenceoffurtherstudies,cautionshouldbetakeninthecaseofconcurrentuseof

MILBEMAXandothermacrocycliclactones.Also,nosuchstudieshavebeen

performedwithreproducinganimals.

4.9Amountstobeadministeredandadministrationroute

Minimumrecommendeddoserate:0.5mgofmilbemycinoximeand5mgof

praziquantelperkgaregivenonceorally.

Theproductshouldbeadministeredwithoraftersomefood.

Dependingonthebodyweightofthedog,thepracticaldosingisasfollows:

Weight Tablets

5 –25kg 1tablet

>25 –50kg 2tablets

MILBEMAXdogsFinalRENEWALSPCJuly2007

>50 –75kg 3tablets

Incaseswhenheartwormdiseasepreventionisusedandatthesametimetreatment

againsttapewormisrequired,MILBEMAXcanreplacethemonovalentproductforthe

preventionofheartwormdisease.

ForAngiostrongylusvasoruminfections,milbemycinoximeshouldbegivenfourtimes

atweeklyintervals.Itisrecommended,whereconcomitanttreatmentagainstcestodes

isindicated,totreatoncewithMILBEMAXandcontinuewiththemonovalentproduct

containingmilbemycinoximealone,fortheremainingthreeweeklytreatments.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Noothersignsthanthoseobservedattherecommendeddosehavebeenobserved

(see4.6)

4.11Withdrawalperiod(s)

Notapplicable

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:Antiparasiticproducts,insecticidesandrepellants-

Endectocides

ATCvetCode:QP54AB51(Milbemycincombinations)

5.1Pharmacodynamicproperties

Milbemycinoximebelongstothegroupofmacrocycliclactones,isolatedfromthe

fermentationofStreptomyceshygroscopicusvar.aureolacrimosus.Itisactiveagainst

mites,againstlarvalandadultstagesofnematodesaswellasagainstlarvaeof

Dirofilariaimmitis.

Theactivityofmilbemycinisrelatedtoitsactiononinvertebrateneurotransmission:

Milbemycinoxime,likeavermectinsandothermilbemycins,increasesnematodeand

insectmembranepermeabilitytochlorideionsviaglutamate-gatedchlorideion

channels(relatedtovertebrateGABA

andglycinereceptors).Thisleadsto

hyperpolarisationoftheneuromuscularmembraneandflaccidparalysisanddeathof

theparasite.

Praziquantelisanacylatedpyrazino-isoquinolinederivative.Praziquantelisactive

againstcestodesandtrematodes.Itmodifiesthepermeabilityforcalcium(influxof

Ca2+)inthemembranesoftheparasiteinducinganimbalanceinthemembrane

structures,leadingtomembranedepolarisationandalmostinstantaneouscontraction

ofthemusculature(tetany),rapidvacuolizationofthesyncytialtegumentand

subsequenttegumentaldisintegration(blebbing),resultingineasierexpulsionfromthe

gastrointestinaltractordeathoftheparasite

5.2Pharmacokineticparticulars

MILBEMAXdogsFinalRENEWALSPCJuly2007

Afteroraladministrationofpraziquantelinthedog,peakserumlevelsofparentare

rapidlyattained(T

approximately0.5-4hours)anddeclinequickly(t

approximately

1.5hours);thereisasubstantialhepaticfirst-passeffect,withveryrapidandalmost

completehepaticbiotransformation,principallytomonohydroxylated(alsosomedi-and

tri-hydroxylated)derivatives,whicharemostlyglucuronideand/orsulfateconjugated

beforeexcretion.Plasmabindingisabout80%.Excretionisfastandcomplete(about

90%in2days);theprincipalrouteofeliminationisrenal.

Afteroraladministrationofmilbemycinoximeindogs,peakplasmalevelsoccurat

about2-4hours,anddeclinewithahalf-lifeoftheunmetabolisedmilbemycinoximeof

1-4days.Bioavailabilityisabout80%.

Intherat,metabolismappearstobecompletealthoughslow,sinceunchanged

milbemycinoximehasnotbeenfoundinurineorfeces.Mainmetabolitesintheratare

monohydroxylatedderivatives,attributabletohepaticbiotransformation.Inadditionto

relativelyhighliverconcentrations,thereissomeconcentrationinfat,reflectingits

lipophilicity

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Cellulose,microcristalline

Croscarmellosesodium

Povidone

Lactosemonohydrate

Silica,colloidalanhydrous

Magnesiumstearate

6.2Incompatibilities

Notapplicable

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:

2years

6.4.Specialprecautionsforstorage

Donotstoreabove30°C

Keepblisterintheoutercartontoprotectfromlight

6.5Natureandcompositionofimmediatepackaging

PVC/PE/PVdC/aluminiumblister

MILBEMAXdogsFinalRENEWALSPCJuly2007

Availablepacksizes:

Boxwith2tabletsinblister

Boxwith4tabletsinblister

Boxwith10tabletsinblister

Boxwith20tabletsinblister

Boxwith50tabletsinblister

Boxwith100tabletsinblister

Notallpacksizesmaybemarketed

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductor

wastematerialsderivedfromtheuseofsuchproducts

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithnational

requirements.

Theproductshouldnotcomeintocontactwith(IE'sproposal)watercoursesasthismay

bedangerousforfishandotheraquaticorganisms.

7. MARKETINGAUTHORISATIONHOLDER

NovartisAnimalHealthInc.

8. MARKETINGAUTHORISATIONNUMBER(S)

{NationalMANumber(s)}

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

{DDMMMYYYY}

10.DATEOFREVISIONOFTHETEXT

{MMMYYYY}

PROHIBITIONOFSALE,SUPPLYAND/ORUSE

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

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