Ecomectin 6 mg/g Premix for medicated feeding stuff for pigs

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:

6 milligram(s)/gram

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2008-05-02

Summary of Product characteristics

Health Products Regulatory Authority
23 August 2019
CRN008PR3
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ecomectin 6 mg/g Premix for medicated feeding stuff for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Ivermectin 6 mg/g
Excipient(s):
Propyl Gallate (E310) 0.3 mg/g
Butylhydroxyanisole (E320) 1.0 mg/g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feeding stuff.
Yellow-brown, free-flowing granules.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of nematode or arthropod infections due to:
GASTROINTESTINAL ROUNDWORMS
_Ascaris suum_ (adults and L4)
_Hyostrongylus rubidus_ (adults and L4)
_Oesophagostomum_ spp. (adults and L4)
_Strongyloides ransomi _(adults)*
LUNGWORMS
_Metastrongylus_ spp. (adults)
LICE
_Haematopinus suis_
MANGE MITES
_Sarcoptes scabiei_ var. _suis_
_ _
*Given to pregnant sows before farrowing, it effectively controls
transmission via milk of _S. ransomi _to piglets.
4.3 CONTRAINDICATIONS
Do not use for any other animal species as severe adverse reactions,
including fatalities in dogs may occur.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Exposure of treated pigs to infected animals, contaminated premises,
soil or pasture may result in re-infestation and
re-treatment may be necessary. Since the effect of ivermectin on mange
mites is not immediate, avoid direct contact between
Health Products Regulatory Authority
23 August 2019
CRN008PR3
Page 2 of 5
treated and untreated pigs for at least one week after completion of
treatment. Because louse eggs are unaffected by
ivermectin and may take up to three weeks to hatch, re-treatment may
be necessary.
Care should be taken to avoid the following practices because they
increase the risk of development of resistance and could
ultimately result in ineffective therapy:
- Too frequent and repe