Equimoxectin 18.92 mg/g, Oral Gel for Horses and Ponies
Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: VMD (Veterinary Medicines Directorate)
Valmisteyhteenveto
(SPC)
25-06-2015
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Aktiivinen ainesosa:
Moxidectin
Saatavilla:
Continental Farmaceutica
ATC-koodi:
QP54AB02
INN (Kansainvälinen yleisnimi):
Moxidectin
Lääkemuoto:
Oral gel
Prescription tyyppi:
POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
Terapeuttinen ryhmä:
Horses
Terapeuttinen alue:
Endectocide
Valtuutuksen tilan:
Authorized
Valtuutus päivämäärä:
2014-03-28
Valmisteyhteenveto
AN: 00398/2013
Issued: March 2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equimoxectin 18.92 mg/g, Oral Gel for Horses and Ponies
(Sweden and Finland: Equimoxectin vet 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)
Disodium Edetate
37.84 mg
0.24 mg
For a 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_._
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AN: 00398/2013
Issued: March 2014
_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 (hyp
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