Equimoxectin 18.92 mg/g, oral gel for horses and ponies

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Moxidectin

Available from:

Zoetis Belgium S.A.

ATC code:

QP54AB02

INN (International Name):

Moxidectin

Dosage:

18.92 milligram(s)/gram

Pharmaceutical form:

Oral gel

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Horses

Therapeutic area:

moxidectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2014-03-28

Summary of Product characteristics

Health Products Regulatory Authority
13 May 2019
CRN008M2H
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equimoxectin 18.92 mg/g, oral gel for horses and ponies
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Moxidectin 18.92 mg
EXCIPIENTS:
Benzyl Alcohol (E1519) 37.84 mg
Disodium Edetate 0.24 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral gel.
Yellow gel.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses and ponies.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The veterinary medicinal product is indicated for treatment of
infections caused by moxidectin sensitive strains of:
- Large strongyles:
_. Strongylus vulgaris_ (adults and arterial stages)
_. Strongylus edentatus_ (adults and visceral stages)
_. Triodontophorus brevicauda_ (adults)
_. Triodontophorus serratus_ (adults)
_. Triodontophorus tenuicollis _ (adults)
- Small strongyles (adults and intraluminal larval stages):
_. Cyathostomum _spp.
_. Cylicocyclus _spp_._
_. Cylicostephanus _spp_._
_. Cylicodontophorus_ spp.
_. Gyalocephalus _spp.
Health Products Regulatory Authority
13 May 2019
CRN008M2H
Page 2 of 6
- Ascarids:
_. Parascaris equorum _(adult and larval stages)
- Other species:
_. Oxyuris equi _(adult and larval stages)
_. Habronema muscae _(adults)
_. Gasterophilus intestinalis _(L2, L3)
_. Gasterophilus nasalis _(L2, L3)
_. Strongyloides westeri _(adults)
_. Trichostrongylus axei_
The veterinary medicinal product has a persistent efficacy of two
weeks against small strongyles. The excretion of small
strongyles eggs is suppressed for 90 days.
The veterinary medicinal product is effective against (developing)
intramucosal L4 stages of small strongyles. At 8 weeks after
treatment, early (hypobiotic) EL3 stages of small strongyles are
eliminated.
4.3 CONTRAINDICATIONS
Do not administer to young foals less than 4 months.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR