Noromectin Premix 6 mg/g Premix for Medicated Feeding Stuff for Swine

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Norbrook Laboratories (Ireland) 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:

2001-11-16

Summary of Product characteristics

Health Products Regulatory Authority
07 February 2019
CRN008TK5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin Premix 6 mg/g Premix for Medicated Feeding Stuff for Swine
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCE_
Ivermectin 6 mg/g
_EXCIPIENTS_
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Premix for medicated feedingstuff. Free flowing yellow to light brown
meal.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of the following
gastrointestinal
roundworms, lungworms, lice and mange in adult and growing pigs:
Gastrointestinal worms:
_Ascaris suum _(adults and fourth-stage larvae)
_Hyostrongylus rubidus _(adults and fourth-stage larvae)
_Oesophagostomum_ spp (adults and fourth-stage larvae)
_Strongyloides ransomi_ (adults)
Lungworms
_Metastrongylus_ spp (adults)
Lice:
_Haematopinus suis_
Mange mites:
_Sarcoptes scabiei_ var_ suis_
Health Products Regulatory Authority
07 February 2019
CRN008TK5
Page 2 of 7
The product given to pregnant sows before farrowing effectively
controls
transmission via the milk of _S. ransomi_ to piglets.
4.3 CONTRAINDICATIONS
Avermectins may not be well tolerated in all non-target species (cases
of intolerance
with fatal
outcome are reported in dogs – especially Collies, Old English
Sheepdogs and
related breeds or crosses, and also in turtle / tortoises).
Do not use in animals known to be hypersensitive to the active
substance, or to any
of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 repeated use of anthelmintics from the same class,
over an
extended period of time.
- Underdosing, which may be due to underestimation of body weight,
misadministration of the product, or lack of calibration of the dosin