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:

Continental Farmaceutica

ATC code:

QP54AB02

INN (International Name):

MOXIDECTIN

Dosage:

18.92 mg/g

Pharmaceutical form:

Oral Gel

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Equine - Food

Therapeutic area:

Moxidectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2014-03-28

Summary of Product characteristics

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
3 PHARMACEUTICAL FORM
Oral gel.
Yellow gel.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses and ponies.
Each g contains:
ACTIVE SUBSTANCE:
Moxidectin
18.92 mg
EXCIPIENTS:
Benzyl Alcohol (E1519)
37.84 mg
Disodium Edetate
0.24 mg
For a full list of excipients, see section 6.1
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/03/2014_
_CRN 7015190_
_page number: 1_
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.
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 CONTR