IVOMEC 0.27% Injection for Grower and Feeder Pigs

Manufacturer: Merial

NADA 128-409, Approved by the FDA

412576

(ivermectin)

0.27% Sterile Solution

A Parasiticide For The Treatment And Control Of Internal And External Parasites Of Grower And Feeder Pigs

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

Introduction

IVOMEC (ivermectin) Injection for Grower and Feeder Pigs is a dilute parasiticide for young pigs. A conveniently measured dose kills gastrointestinal roundworms, lungworms, lice, and mange mites that may impair the health of young pigs.

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 young pigs.

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 0.27% ivermectin, 40% glycerol formal, and propylene glycol, q.s. ad 100%. IVOMEC Injection is formulated to deliver the recommended dose level of 300 mcg ivermectin/kilogram body weight when given subcutaneously in the neck at the rate of 1 mL per 20 lb (8.8 kg).

Mode Of Action

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).

The wide margin of safety is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

IVOMEC 0.27% Injection for Grower and Feeder Pigs Indications

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

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).

Lungworms

Metastrongylus spp. (adults).

Lice

Haematopinus suis.

Mange Mites

Sarcoptes scabiei var. suis.

Dosage

IVOMEC Injection should be given only by subcutaneous injection (under the skin), in the neck at the recommended dose level of 300 mcg ivermectin per kilogram (2.2 lb) of body weight. Each mL of IVOMEC contains 2.7 mg of ivermectin, sufficient to treat 20 lb (8.8 kg) of body weight.

The table below indicates the dose volume of IVOMEC Injection for growing pigs body weight:

Body Weight (lb)	Dose Volume (ml)	Doses Per Pack
10	0.5	400
20	1.0	200
30	1.5	133
40	2.0	100
50	2.5	80
60	3.0	66
70	3.5	57

Administration

Ivomec Injection (ivermectin) Is To Be Given Subcutaneously (under The Skin) Immediately Behind The Ear (see Illustration). Animals Should Be Appropriately Restrained To Achieve The Proper Route Of Administration. An 18- Or 20-gauge Needle May Be Appropriate For Young Animals.

use only automatic Syringe Equipment. 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

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

For pigs over 70 lbs body weight, use IVOMEC Injection for Swine 1% Sterile solution.

Note

(1) IVOMEC Injection has a persistent drug level sufficient to control mite infestations throughout the egg to adult life cycle. However, since the ivermectin effect is not immediate, care must be taken to prevent reinfestation from exposure to untreated animals or contaminated facilities. Generally, pigs should not be moved to clean quarters or exposed to uninfested pigs for approximately one week after treatment.

(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.

Special Minor Use

Ranch-raised Foxes

For the treatment and control of ear mites (Otodectes cynotis) in ranch-raised foxes. Inject 200 mcg ivermectin per kilogram (2.2 lb) of body weight, subcutaneously between the shoulder blades. Repeat treatment in 3 weeks.

Body Weight (lb)	Dose Volume (ml)
6.5	0.25
13	0.50
20	0.75

Warning

Not For Use In Humans.

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.

Resricted Drug - use only as directed (California).

IVOMEC Injection for Grower and Feeder Pigs has been developed specifically for use in swine and foxes 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 ding 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 effects are species and life-cycle specific. When used according to label directions, the product is not expected to have a adverse impact on populations of dung-dependant insects.

How Supplied

IVOMEC Injection for Grower and Feeder Pigs is available in ready-to-use 200 mL soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 100 head of 40 lb (18 kg) pigs.

Merial Limited, a company limited by shares registered in England and Wales (registered number 3332571) with a registered office at PO Box 327, Sandringham House, Sandringham Avenue, Harlow Business Park, Harlow, Essex CM19 5QA, England and domesticated in Delaware, USA as Merial LLC.

IVOMEC and Pig Head Logo are registered trademarks of Merial Limited.

H60006(US)

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

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

Copyright © 2006 Merial Limited.

All Rights Reserved.

Rev. 08-2006

1050-1894-01

Nac No.

11110302