Equimax Oral Gel for Horses

Main information

  • Trade name:
  • Equimax Oral Gel for Horses
  • Pharmaceutical form:
  • Oral gel
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Equimax Oral Gel for Horses
    Hungary
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • ivermectin, combinations
  • Therapeutic area:
  • Horses Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0156/001
  • Authorization date:
  • 20-01-2011
  • EU code:
  • UK/V/0156/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1.Nameoftheveterinarymedicinal product

Equimaxoral gel forHorses

2.Qualitative andquantitative composition

Eachgram of Equimaxcontains

Activesubstances

Ivermectin 18.7 mg

Praziquantel 140.3 mg

Excipients

Titaniumdioxide (E171) 20 mg

Propyleneglycol 731 mg

Forafull list of excipients, seesection 6.1

3.Pharmaceutical form

Oral Gel.

4.Clinical particulars

4.1 Target species

Horses.

4.2 Indicationsforuse, specifying thetarget species

Forthe treatment of mixed cestode and nematodeorarthropod infestations, dueto adult and

immatureroundworms, lungworms, botsand tapeworms in horses:

-Nematodes

Large-strongyle:

Strongylus vulgaris(adultand arterial larvae)

Strongylus edentatus(adultandL4 tissue larval stages)

Strongylus equinus(adult)

Triodontophorusspp.(adult)

Small-strongyle:

Cyathostomum: Cylicocyclusspp., Cylicostephanusspp.,Cylicodontophorusspp.,

Gyalocephalusspp. (adultand non-inhibited mucosal larvae).

Parascaris:Parascarisequorum(adultand larvae).

Oxyuris:Oxyurisequi(larvae).

Trichostrongylus:Trichostrongylus axei(adult).

Strongyloides:Strongyloides westeri(adult).

Habronema:Habronemaspp. (adult),

Onchocerca:Onchocercaspp.microfilariaei.e. cutaneous onchocerciasis

Lungworm:Dictyocaulus arnfieldi(adultand larvae).

Cestodes(Tapeworm):Anoplocephala perfoliata, Anoplocephalamagna, Paranoplocephala

mamillana.

Dipteraninsects:Gasterophilusspp. (larvae)

As tapeworm infestation is unlikelyto occurin horses beforetwo months of age, treatment of

foals below this ageis not considered necessary.

4.3 Contraindications

Do not usein foals under2 weeks ofage.Do not usein mares from whichmilk is taken for

human consumption.

Do not usein horses known to behypersensitive to activeingredinet or to anyotehringredients

4.4 Specialwarningsforeachtarget species

Theproduct can beusedsafelyin stallions.

4.5 Specialprecautionsforuse

i) Specialprecautionsforuseinanimals

Avermectins maynot bewelltolerated in allnon target species. Cases of intoleranceare

reported in dogs, especiallyCollies, Old English Sheepdogs andrelated breeds or crosses,

and also in turtles andtortoises.

Dogsand cats should notbeallowed toingest spilled paste oraccess to used syringes dueto

the potential foradverseeffects related to ivermectin toxicity.

As ivermectin is extremelydangerous to fish andaquaticlifetreated animals should nothave

direct access to surfacewaterand ditches duringtreatment.

Parasiteresistanceto a particularclass ofanthelmintic maydevelop followingfrequent,

repeated useofan anthelminticof that class.

ii) Specialprecautionsto betakenby thepersonadministering themedicinal products

to animals

Wash hands after use(tobesurethat eyecontamination can not occur).

Avoid contact with the eyes.In the caseofaccidental contact, rinse with abundant quantities

ofwater.In caseof eyeirritation, seek medical attention.

Do not eat, drinkorsmokewhile handlingthis product.

In theevent ofaccidentalingestion, seek medicaladviceand show thedoctorthe leaflet so

that heknows whatyouhavetaken.

iii) Otherprecautions

4.6 Adverses reactions(frequency andseriousness)

Horses carryingheavyinfection ofOnchocerca microfilariaehaveexperienced such reactions

as swellingand itchingaftertreatment.It is assumed that thesereactions arethe resultof the

destruction oflargenumbers of microfilariae.In caseof veryhigh levels ofinfestation,

destruction ofthe parasites maycauseamild transient colicand loosefaeces in thetreated

horse.

Colic, diarrheaand anorexia havebeen reported inveryrareoccasionsopsttreatment, in

particulat when thereis heavyworm burden.

In veryrareoccasions, allergicreactions such as hypersalivation, lingual oedema and urticaria,

tachycardia, congested mucus membranes,and subcutaneous oedema havebeen reported

followingtreatment with teh product.

A veterinarian should beconsulted ifthesesigns persist.

4.7 Useduring pregnancy, lactationorlay

Theproduct can beusedsafelyin mares duringthewholepregnancyperiod and lactation

period.

4.8 Interaction with othermedicinal products andotherforms ofinteraction

Noneknown.

4.9 Amount(s) to beadministeredandadministrationroute

PosologySingle administration.200 µgofIvermectin and 1.5 mgof praziquantel perkgof

bodyweightcorrespondingto 1.07gof paste per 100 kgbodyweight.Bodyweightand dosage

should beaccuratelydetermined priorto treatmentas underdosingmight lead toan increased

risk ofdevelopment of reistanceto anthelminthic drugs.

Weight Dosage Weight Dosage

Up to 100 kg 1.070 g 351-400 kg 4.280 g

101-150 kg 1.605 g 401-450 kg 4.815 g

151-200 kg 2.140 g 451-500 kg 5.350 g

201-250 kg 2.675 g 501-550 kg 5.885 g

251-300 kg 3.210 g 551-600 kg 6.420 g

301-350 kg 3.745 g

*Concerns the7.49gsyringeonly

Thefirst division delivers enough paste to treat 100 kg.Each subsequent syringedivision

delivers enough paste to treat 50 kgof bodyweight. Thesyringeshould beadjusted to the

calculated dosagebysettingthe ringon theappropriateplaceon the plunger.

Thesyringecontaining6.42 gof paste delivers sufficient paste to treat 600 kgof bodyweight at

the recommended doserate.

Thesyringecontaining7.49 gof paste delivers sufficient paste to treat 700 kgof bodyweight at

the recommended doserate.

Directions foruse

Oral use.

Beforeadministration, adjustthe syringeto thecalculated dosagebysetting theringon the

plunger.Thepaste isadministered orallybyinsertingthe nozzle ofthe syringethrough the

interdental spaceand depositingthe required amount of paste on thebackofthe tongue. The

animal's mouth should befreeof anyfood.Immediatelyafteradministration, elevate thehead

ofthe horsefor afew seconds to ensurethe doseis swallowed.Theveterinarysurgeon should

giveadviceregardingappropriate dosingprogrammes andstock management to achieve

adequate parasitecontrolforboth tapeworm and roundworm infestations.

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

A tolerancestudyperformed in foals from 2 weeks of agewith doses up to 5 times the

recommended dosageshowed no adversereactions.

Safetystudiesconductedwith theveterinarymedicinal product administered to mares at 3

times the recommendeddosageat 14 dayintervals duringthe wholegestation and lactation did

not show anyabortions,anyadverseeffects onthe gestation, parturition and on the mares

general health, noranyabnormalities on thefoals.

Safetystudiesconductedwith theveterinarymedicinal product administered to stallions at 3

times the recommendeddosagedid notshow anyadverseeffects in particularon the

reproductiveperformances.

4.11 Withdrawalperiods

Meat and Offal:35 days.

Not permitted foruse inhorses producingmilk for human consumption.

5.Pharmacological properties

Pharmacotherapeuticgroup: Anthelminthics

ATCvet code: QP54AA51

5.1 Pharmacodynamicproperties

Ivermectin is a macrocyclic-lactone derivativewhich has a broad antiparasitic activityagainst

nematodes andarthropods.It acts byinhibitingnerveimpulses.Its modeofaction includes the

glutamate-gatedchlorideion channels.Ivermectinbindsselectivelyand with high affinityto

glutamate-gatedchlorideion channels which occurin invertebrate nerveandmusclecells. This

leads to an increasein thepermeabilityof thecellmembraneto chlorideionswith

hyperpolarization ofthenerveor musclecell,resultingin paralysisand death of the relevant

parasites. Compoundsofthis class mayalso interact with otherligand-gated chloridechannels,

suchas thosegated bytheneurotransmitter gamma-aminobutyric acid (GABA). Themargin of

safetyforcompoundsofthis class is attributableto thefact that mammalsdo not have

glutamate-gatedchloridechannels.Praziquantel is a pyrazinoisoquinolinederivativewhich

exerts its anthelmintic activityagainstmanyspecies of cestodesand trematodes.It primarily

actsbyimpairingboth motilityandfunction ofthesuckers ofcestodes.Itsmode ofaction

includes the impairingofneuromuscularco-ordination but also influencing thepermeabilityof

the integument oftheworms, which leads to excessivecalcium andglucoseloss. This induces

spastic paralysisof theparasitemusculature.

5.2 Pharmacokineticparticulars

Afteradministration oftherecommended dosageto horses, the ivermectin plasma peak was

reached within 24 hours.Theivermectin concentration was still over2 ng/ml 14 daysafter

administration. Theelimination half-lifeof ivermectin was 90h. With regard to praziquantel,

the plasma peak was reached within 1 hour. Thepraziquantel was rapidlyeliminated and was

not detected after 8 hpost treatment. Theelimination half-lifeof praziquantel was 40 min.

Environnmental properties

6.Pharmaceutical particulars

6.1 List ofexcipients

Hydrogenatedcastor oil

Hydroxypropylcellulose

Titaniumdioxide (E171)

Propyleneglycol

6.2 Incompatibilities

Not applicable.

6.3 Shelf-life

Shelf lifeof theveterinarymedicinal product as packaged forsale: 2years.

Shelf lifeof theveterinarymedicinal product afterfirst openingthecontainer: 6 months.

6.4 Specialprecautionsforstorage

Do not storeabove30

C.Storeopened syringes below 25°C.

6.5 Natureandcontentsofimmediatepackaging

An adjustable multidose syringeconsistingof high densitypolyethylene(white)and low

densitypolyethylene(white). Thesyringecontains 6.42 grams of productand isfitted with

variable dosecapacity.

Product presentations:

Boxof 1,12 or48 syringes.

Blisterof onesyringe.

6.6 Specialprecautionsforthedisposalofunusedproduct orwastematerials derived

fromtheuseofsuchproducts, ifappropriate

Unused product andcontainers should bedisposed of in accordancewith national requirements.

EXTREMELY DANGEROUSTO FISH AND AQUATICLIFE. Do not contaminatesurface

waters or ditches withthe product or used container.

7. Marketing authorisationholder

VIRBAC DE PORTUGALLABORATORIOSLDA

RuaDionísio Saraiva,Lote 1, 1° Andar, Porta2

2080-104 Almeirim-PORTUGAL

8. Marketing authorisationnumber

Marketingauthorisationnumber:

Date offirstauthorisation/renewal of theauthorisation

Date ofrevision ofthe text:21June2004

9. Dateofthefirstauthorisationordateofrenewal oftheauthorisation

10. Dateofrevisionofthetext

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