Noromectin 1.87% Oral Paste for Horses

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:

1.87 percent weight/weight

Pharmaceutical form:

Oral paste

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2001-04-06

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin 1.87% Oral Paste for Horses (AT, BE, FR, IE, IS, LU, NL,
PT, UK)
Noromectin 18.7 mg/g Oral Paste for Horses (DE, ES, FI)
Noromectin vet., oral paste for horses (DK, SE)
F. Mectin Pasta Orale 1.87% per cavalli (IT)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Ivermectin 1.87% w/w (18.7 mg/g)
Excipient(s)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Paste
A white homogenous paste.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of the following parasites of horses:
Roundworms in the stomach and intestines
Large strongyles
Strongylus vulgaris adults and 4th larval (arterial) stages
Strongylus edentatus adults and 4th larval (tissue) stages
Strongylus equinus adults
Small strongyles,adults
Cyathostomum catinatum
Cyathostomum peteratum
Cylicocyclus ashworthi
Cylicocyclus elongatus
Cylicocyclus insigne
Cylicocyclus leptostomum
Cylicocyclus nassatus
Cylicocyclus radiatus
Cylicostephanus asymetricus
Cylicostephanus bidentatus
Cylicostephanus calicatus
Cylicostephanus goldi
Cylicostephanus longibursatus
Cylicostephanus minutus
Cylicodontophorus
Bicornatus
Gyalocephalus capitatus
Hairworms
Trichostrongylus axei
adult
Pinworms
Oxyuris equi
adult and immature
Ascarids
Parascaris equorum
adult and 3rd and 4th
stage
Intestinal threadworms
Strongyloides westeri
adult
Neck threadworms
Onchocerca spp (microfilariae)
Lungworms
Dictyocaulus arnfieldi
adult and immature
Stomach bots
Gasterophilus spp
oral and gastric larval
stages
Ivermectin is not effective against encysted larval stages of the
small strongyles.
4.3 CONTRAINDICATIONS
Do not use in horses known to be hypersensitive to the active
ingredient or to any other
ingredients.
Do not use in dogs or cats as severe adverse reactions may occur.
See also 4.11
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The veterinary medicinal product has been formulated specifically for
us