SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Noromectin 0.08% w/v Drench Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance: Ivermectin 0.08% w/v Excipients:

Benzyl Alcohol 3.0% v/v

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Oral solution

A pale yellow clear liquid

4. CLINICAL PARTICULARS

4.1 Target species

Sheep

4.2 Indications for use, specifying the target species

The treatment and control of gastrointestinal nematodes, and lungworms and nasal bots of sheep

Gastrointestinal worms (adult and immature):

Haemonchus contortus, Ostertagia circumcincta, Trichostrongylus spp, Cooperia spp, Nematodirus spp including N. battus, Strongyloides papillosus, Oesophagostomum spp, and adult Chabertia ovina.

Inhibited larval stages and benzimidazole resistant strains of H. contortus and Ostertagia circumcincta are also controlled.

Lungworms(adult and immature):

Dictyocaulus filaria

Nasal bot (all larval stages): Oestrus ovis

4.3 Contra-indications

The product has been formulated specifically for use in sheep. It should not be used in other species, as adverse reactions, including fatalities in dogs, may occur.

The product is not for intravenous or intramuscular use.

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 dosing device (if any)

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to ivermectin (an avermectin) has been reported in Teladorsagia in sheep and goats within the EU and it is common in Haemonchus in sheep outside the EU. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

4.5 Special precautions for use

i. Special precautions for use in animals

None

ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals

Do not smoke, drink or eat while handling the product.

Avoid contact with skin and eyes. In case of accidental eye or skin contact, wash the affected area with clean running water immediately. Seek medical attention if irritation persists.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Some animals may cough slightly immediately after treatment. This is a temporary occurrence and is of no clinical consequence.

4.7 Use during pregnancy, lactation or lay

The product can be administered to ewes at any stage of pregnancy or lactation provided that the milk is not used for human consumption.

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

Ivermectin should be administered at a dosage rate of 200 µg per kg bodyweight (2.5 ml per 10 kg bodyweight). It should be administered orally. It is recommended that a suitably calibrated dosing gun is used to allow accurate dosing especially in young animals.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked. Do not mix with other products.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No antidote has been identified, however symptomatic treatment may be beneficial.

4.11 Withdrawal period

Sheep may not be slaughtered for human consumption until 14 days after the last treatment.

Do not use in sheep producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintic 3-AV

ATC Vet Code: QP54 AA 01

5.1 Pharmacodynamic properties

Ivermectin is a 22,23-dihydro derivative of an avermectin (which is a fermentation product produced by Streptomyces avermitilis) and consists of 2 homologues: B1a and B1b. It is a highly effective parasiticide with nematocidal, insecticidal and acaricidal activity documented in a wide range of domesticated animals.

Avermectins interact with glutamate-gated chloride ion channels, to increase membrane permeability to chloride ions, causing irreversible neuromuscular blockade in nematodes, followed by paralysis and death.

5.2 Pharmacokinetic properties

After administration orally to sheep at a dose of 200 µg/kg, the maximum plasma concentration of ivermectin was 5.99 µg/ml at 16.2 hours after administration and the elimination half-life was approximately 25 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl Alcohol

Polysorbate 80

Dimethylacetamide

Disodium Phosphate Dihydrate

Sodium Acid Phosphate Dihydrate

Water Purified

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 Years.

6.4 Special precautions for storage

Do not store above 25°C.

Protect from direct sunlight.

6.5 Nature and composition of immediate packaging

Supplied in 1.0L, 2.5L, 5.0L volumes, presented in high density polyethylene Jerry Cans or high density polyethylene back-packs both closed with white polypropylene, screw-fit caps summounting board faced, aluminium foil induction seals.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not

contaminate ponds, waterways or ditches with the product or used container. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4184

9. DATE OF FIRST AUTHORISATION

25^th May 2000

10. DATE OF REVISION OF THE TEXT

August 2010