IVOMEC 1% Injection for Swine

(ivermectin)

1% Sterile Solution

NADA 128-409, Approved by the FDA

412886, 412896

A Parasiticide For The Treatment And Control Of Internal And External Parasites Of Swine.

Consult Your Veterinarian For Assistance In The Diagnosis, Treatment And Control Of Parasitism.

Introduction

IVOMEC (ivermectin) is an injectable parasiticide for swine. A low volume dose effectively kills gastrointestinal roundworms, lungworms, lice, and mange mites that may impair the health of swine.

Discovered and developed by scientists from Merck Research Laboratories, ivermectin is a novel chemical entity. Its convenience, broad-spectrum efficacy and safety margin make IVOMEC Injection a unique product for parasite control in swine.

Product Description

Ivermectin is derived from the avermectins, a family of potent, broad-spectrum antiparasitic agents isolated from fermentation of Streptomyces avermitilis.

IVOMEC Injection is a clear, ready-to-use, sterile solution containing 1% ivermectin, 40% glycerol formal, and propylene glycol, q.s. ad 100%. IVOMEC Injection is formulated to deliver the recommended dose level of 300 mcg/kg given subcutaneously in the neck at the rate of 1 mL per 75 lb (33 kg).

Mode Of Action

Ivermectin kills certain parasitic roundworms and ectoparasites, such as mites and lice. Its action is unique and not shared by other antiparasitic agents. This action involves a chemical that serves as a signal from one nerve cell to another, or from a nerve cell to a muscle cell. This chemical, a neurotransmitter, is called gamma-aminobutyric acid or GABA.

In roundworms, ivermectin stimulates the release of GABA from nerve endings and enhances binding of GABA to special receptors at nerve junctions, thus interrupting nerve impulses-thereby paralyzing and killing the parasite.

The enhancement of the GABA effect in arthropods such as mites and lice resembles that in roundworms except that nerve impulses are interrupted between the nerve ending and the muscle cell. Again, this leads to paralysis and death.

The principal peripheral neurotransmitter in mammals, acetylcholine, is unaffected by ivermectin. Ivermectin does not readily penetrate the central nervous system of mammals where GABA functions as a neurotransmitter.

IVOMEC 1% Injection for Swine Indications

IVOMEC Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine.

Gastrointestinal Roundworms

Large roundworm, Ascaris suum (adults and fourth-stage larvae), Red stomach worm, Hyostrongylus rubidus (adults and fourth-stage larvae), Nodular worm, Oesophagostomum spp (adults and fourth-stage larvae) and Threadworm, Strongyloides ransomi (adults).

Somatic Roundworm Larvae

Threadworm, Strongyloides ransomi (somatic larvae). Sows must be treated at least seven days before farrowing to prevent infection in piglets.

Lungworms

Metastrongylus spp (adults)

Lice

Haematopinus suis

Mange Mites

Sarcoptes scabiei var. suis

Dosage

IVOMEC Injection should be given only by subcutaneous injection in the neck of swine at the recommended dose level of 300 mcg ivermectin per kilogram (2.2 lb) of body weight. Each mL of IVOMEC Injection contains 10 mg of ivermectin, sufficient to treat 75 lb (33 kg) of body weight.

The table below indicates the dose volume of IVOMEC Injection for swine by animal body weight:

Administration

Ivomec Injection (ivermectin) Is To Be Given Subcutaneously Only In The Neck. Animals Should Be Appropriately Restrained To Achieve The Proper Route Of Administration. Use Of A 16- Or 18-gauge Needle Is Suggested For Sows And Boars, While An 18- Or 20-gauge Needle May Be Appropriate For Young Animals. Inject Under The Skin, Immediately Behind The Ear (see Illustration).

use only automatic Syringe Equipment When Using The 200 Ml Or 500 Ml Pack Size. As With Any Injection, Sterile Equipment Should Be Used. The Injection Site Should Be Cleaned And Disinfected With Alcohol Before Injection. The Rubber Stopper Should Also Be Disinfected With Alcohol To Prevent Contamination Of The Contents. Mild And Transient Pain Reactions May Be Seen In Some Swine Following Subcutaneous Administration.

recommended Treatment Program

At the time of initiating any parasite control program, it is important to treat all the animals in the herd. After the initial treatment, use IVOMEC Injection regularly as follows:

Breeding Animals

Sows

Gilts

Boars

Feeder Pigs

(weaners/growers/finishers)

All weaner/feeder pigs should be treated before placement in clean quarters. Pigs exposed to contaminated soil or pasture may need retreatment if reinfection occurs.

Note

(2) Louse eggs are unaffected by IVOMEC Injection and may require up to three weeks to hatch. Louse infestations developing from hatching eggs may require retreatment.

(3) Consult a veterinarian for aid in the diagnosis and control of internal and external parasites of swine.

Warning

Not For Human Use.

Keep This And All Drugs Out Of The Reach Of Children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects in users, to obtain an MSDS, or for assistance, call 1-888-637-4251.

Residue Information Do not treat swine within 18 days of slaughter.

Precautions

This Product Is For Subcutaneous Injection In The Neck.

Protect product from light. IVOMEC Injection for Swine has been developed specifically for use in swine only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Environmental Safety

Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain waterborne organisms on which they feed. Do not permit water runoff from feedlots or production sites to enter lakes, streams, or ponds. Do not contaminate water by direct application, or by the improper disposal of drug containers. Dispose of drug containers in an approved landfill or by incineration.

As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such affects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse on populations of dung-dependant insects.

How Supplied

IVOMEC Injection for Swine is available in two ready-to-use pack sizes:

The 200 mL pack (Product 412886) is a soft, collapsible pack designed to use with automatic syringe equipment. Each pack contains sufficient solution to treat 400 head of 38 lb (17.3 kg) swine.

The 500 mL pack (Product 412896) is a soft, collapsible pack designed to use with automatic syringe equipment. Each pack contains sufficient solution to treat 1000 head of 38 lb (17.3 kg) swine.

IVOMEC and Pig Head Logo are registered trademarks of Merial.

Merial Limited, a company limited by shares registered in England and Wales (registered number 3332751) with a registered office at PO Box 327, Sandringham House, Sandringham Avenue, Harlow Business Park, Harlow, Essex CM19 5TG, England and domesticated in Delaware, USA as Merial LLC.

H41288(US)

H41289(US)

U.S. Pat. 4,199,569 & 4,853,372

Copyright © 2004 Merial Limited.

All Rights Reserved.

1050-1891-00

Rev. 10-2004

Merial Limited, 3239 Satellite Blvd., Duluth, Georgia 30096-4640, U.S.A.

Nac No.