Ecomectin 18.7 mg/g Oral Paste for Horses

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Eco Animal Health Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

18.7 milligram(s)/gram

Pharmaceutical form:

Oral paste

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Horses

Therapeutic area:

ivermectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2007-01-05

Summary of Product characteristics

Health Products Regulatory Authority
13 April 2018
CRN000W14
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ecomectin 18.7 mg/g Oral Paste for Horses
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
​
​
Ivermectin
18.7
mg/g
​
​
​
EXCIPIENT(S):
​
​
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Paste
A white homogeneous paste
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of nematode or arthropod infections due to:
Large strongyles:
_Strongylus vulgaris_ (adults and L
4
stage larvae [arterial])
_Strongylus edentatus_ (adults and L
4
stage larvae [tissue])
_Strongylus equinus_ (adults)
Small strongyles (including benzimidazole resistant strains):
_Cyathostomum spp _(adults and luminal L
4
stage larvae)
_Cylicocyclus spp_. (adults and luminal L
4
stage larvae)
_Cylicodontophorus spp_. (adults and luminal L
4
stage larvae)
_Cylicostephanus spp_. (adults and luminal L
4
stage larvae)
_Gyalocephalus spp_. (adults and luminal L
4
stage larvae)
Ascarids:
_Parascaris equorum_ (luminal L5 larvae and adults)
Pinworms:
_Oxyuris equi_ (L
4
stage larvae and adults)
Health Products Regulatory Authority
13 April 2018
CRN000W14
Page 2 of 6
Neck threadworms:
_Onchocerca spp._ (microfilariae)
Stomach bots:
_Gasterophilus spp. _(oral and gastric stages)
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in dogs or cats as severe adverse reactions may occur.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Some horses with heavy infections of _Onchocerca_ spp. microfilariae
have experienced
oedema and pruritus following treatment, such reactions are assumed to
be the
result of death of large numbers of microfilariae. These signs resolve
within a few
days but symptomatic treatment may be advisable
Care shold be taken to avoid the following practices because they
increase the risk of
development of resistance and could ultimately result in