Equimax

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
    Ireland
  • 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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EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Dystrogen Therapeutics S.A.)

EU/3/18/2089 (Active substance: Ex vivo fused normal allogeneic human myoblast with autologous human myoblast derived from Duchenne muscular dystrophy affected donor) - Orphan designation - Commission Decision (2018)7798 of Wed, 21 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Dystrogen Therapeutics S.A.)

EU/3/18/2088 (Active substance: Ex vivo fused normal allogeneic human myoblast with another normal allogeneic human myoblast) - Orphan designation - Commission Decision (2018)7797 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/134/18

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

18-10-2018

Leflunomide Zentiva (Zentiva k.s.)

Leflunomide Zentiva (Zentiva k.s.)

Leflunomide Zentiva (Active substance: leflunomide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6923 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/001129/T/0032

Europe -DG Health and Food Safety

18-10-2018

Sutent (Pfizer Europe MA EEIG)

Sutent (Pfizer Europe MA EEIG)

Sutent (Active substance: sunitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6922 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/687/T/72

Europe -DG Health and Food Safety

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

Europe -DG Health and Food Safety

18-10-2018

Rapamune (Pfizer Europe MA EEIG)

Rapamune (Pfizer Europe MA EEIG)

Rapamune (Active substance: sirolimus) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6921 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/273/T/168

Europe -DG Health and Food Safety

26-9-2018

Comfortis (Elanco GmbH)

Comfortis (Elanco GmbH)

Comfortis (Active substance: Spinosad) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6323 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2233/T/18

Europe -DG Health and Food Safety

24-9-2018

Inhixa (Techdow Europe AB)

Inhixa (Techdow Europe AB)

Inhixa (Active substance: enoxaparin sodium) - Centralised - Variation - Commission Decision (2018)6101 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4264/X/18, 26

Europe -DG Health and Food Safety

24-9-2018

Cinqaero (Teva B.V.)

Cinqaero (Teva B.V.)

Cinqaero (Active substance: reslizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6218 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3912T/18

Europe -DG Health and Food Safety

19-9-2018

Reminder: #FDA site visit proposal solicitation period for the 2018  Experiential Learning Program is currently OPEN through Wednesday,  9/26/18 @ 12 pm EST. Click the link to find more about the  program & to submit your application  https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/x

Reminder: #FDA site visit proposal solicitation period for the 2018 Experiential Learning Program is currently OPEN through Wednesday, 9/26/18 @ 12 pm EST. Click the link to find more about the program & to submit your application https://go.usa.gov/xPrum  #MedicalDevice pic.twitter.com/FN1mNN65dD

FDA - U.S. Food and Drug Administration

18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

This third meeting between regulators and representatives of industry stakeholder organisations addresses all areas of product-development support, including scientific advice, specifics for paediatric and orphan medicines and support for innovation. The meeting focuses on the implementation of the orphan notice, ‘histology-independent indications’ in the context of orphan designations, the upcoming rollout of a new tool for orphan designation applications, digital technology proposals in medicine develo...

Europe - EMA - European Medicines Agency

18-9-2018

Agenda:  Agenda - PDCO agenda of the 18-21 September 2018 meeting

Agenda: Agenda - PDCO agenda of the 18-21 September 2018 meeting

Europe - EMA - European Medicines Agency