Fatromectin 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:

2004-04-23

Summary of Product characteristics

Health Products Regulatory Authority
21 March 2019
CRN008Y3V
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fatromectin 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
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 and L4)
_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.
Health Products Regulatory Authority
21 March 2019
CRN008Y3V
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not use in