Ecomectin 5 mg/ml Pour-on Solution for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

ECO Animal Health Europe Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

5 milligram(s)/millilitre

Pharmaceutical form:

Pour-on solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2000-12-14

Summary of Product characteristics

1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ecomectin 5 mg/ml Pour-on Solution for Cattle
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE(S):
Ivermectin 5 mg
EXCIPIENT(S):
Benzyl alcohol (E1519) 10 mg
N-methyl pyrrolidone 35.5 mg
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Pour-on solution.
A clear, colourless solution
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle: For the treatment of infections with the following
parasites
Gastro-intestinal worms -
_Haemonchus placei _
(adult andL4)
_Ostertagia ostertagi _
(adult and L4, including inhibited larvae)
_Trichostrongylus axei _
(adult and L4)
_Trichostrongylus colubriformis _
(adult and L4)
_Cooperia punctata _
(adult only)
_Cooperia oncophora _
(adult only)
_Strongyloides papillosus _
(adult only)
_Oesophagostomum radiatum, _
(adult and L4)
Lungworm (adult and L4) –
_Dictyocaulus viviparus_
.
Warbles (parasitic stages) –
_Hypoderma bovis_
,
_Hypoderma lineatum_
.
Mange mites –
_Sarcoptes scabiei var. bovis_
.
The product may also be used to reduce infection of the mange mite
_Chorioptes bovis, _
but complete
elimination may not occur.
Sucking and biting lice –
_Linognathus vituli_
,
_Haematopinus eurysternus_
,
_Bovicola (Damalinia) bovis. _
The product has persistent activity against infections acquired with
_Trichostrongylus axei _
and
_Cooperia spp. _
up to 14 days after treatment, but only in the case of group
treatment;
_Ostertagia ostertagi _
and
_Oesophagostomum radiatum _
up to 21 days after treatment;
_Dictyocaulus viviparus _
up to 28 days after
treatment. It also has persistent activity against horn flies (
_Haematobia irritans_
) for up to 28 days after
treatment; partial efficacy against
_Haematobia irritans _
may last for up to 35 days post application.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
ingredient.
The product has been formulated for topical application specifically
for cattle. I