Ivermax PPOUR-ON

Aspen Veterinary Resources
Bimeda Inc., Division of Cross Vetpharm Group

FULL PRESCRIBING INFORMATION

Ivermax^®
(ivermectin)
POUR-ON for Cattle
Contains 5 MG ivermectin/mL

PARASITICIDE

Kills: Roundworms ( including Brown Stomach Worm), Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites, Horn Files

                                                                             WARNING! FLAMMABLE!

                                                           KEEP AWAY FROM HEAT,SPARKS,OPEN FLAME,

                                                                    AND OTHER SOURCES OF IGNITION

WARNING! NOT FOR USE IN HUMANS

Restricted Drug (California) - Use Only as Directed

ANADA 200-318, Approved by FDA

NET CONTENTS: 84.5 fl oz (2.5 Liter)

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

Introduction: lvermax^® (ivermectin) Pour-On delivers internal and external parasite control in one

convenient low-volume application. lvermax^® Pour-On contains ivermectin, a unique chemical

entity.

Uses

Indications: lvermax^® (ivermectin) Pour-On applied at the recommended dose level of 500 mcg/kg is indicated for the effective treatment and control of these parasites.

Gastrointestinal Roundworms

Ostertagia ostertagi                                                 (adult and L₄)

     (including inhibited state)

Haemonchus placei                                                  (adult and L₄)

Trichostrongylus axel                                               (adult and L₄)

T. colubriformis                                                       (adult and L₄)

Cooperia oncophora                                                 (adult and L₄)

Cooperia punctata                                                   (adult and L₄ )

Cooperia sumabada                                                 (adult and L₄)

Strongyloides papillosus                                           (adult)

Oesophagostomum radiatum                                    (adult and L₄)

Trichuris spp.                                                          (adult)

Lungworm

Dictyocaulus viviparus                                              (adult and L₄)

Cattle Grubs                                                            (parasitic stages)

Hypoderma bovis

H.lineatum

Mites

Sarcoptes scabiei var. bovis

Lice

Linognathus vituli

Haematopinus euryStemus

Damalinia bovis

Solenopotes capillatus

Hom Flies

Haematobia irritans

Persistent Activity: lvermax^®(ivermectin) Pour-On has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparous for 28 days after treatment; Cooperia punctata and Trichostrongytus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia sumabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.

Treatment of Cattle for Horn Flies: lvermax^®(ivermectin) Pour-On controls horn flies (Haematobia irritans) for up to 28 days after dosing. For best results lvermax^®(ivermectin) Pour-On should be part of a parasite control program for both internal and external parasites based on the epidemiology of these parasites. Consult your veterinarian or an entomologist for the most effective timing of applications.

Dosage: The dose rate is 1 ml for each 22 lb of body weight. The formulation should be applied along the topline in a narrow strip extending from the withers to the tail head.

Administration: Squeeze-Measure-Pour System (33.8 fl oz 1 Liter Bottle with 25 mL Measuring Cap)

Attach metering cap to the bottle.
Select the correct dose rate by rotating the adjuster cap in either direction to position the dose indicator to the appropriate dose.
Gently squeeze the bottle to fill to level (any excess will return to the bottle) and then tip and apply to animal along topline.

BackPack (84.5 fl oz/2.5 Liter Pack and 169 fl. oz/5 Liter Pack).

Connect the applicator gun to the backpack as follows: Attach the open end of the draw-off tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Protector Drench Gun from Instrument Supplies Limited, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage).

Replace the shipping cap with the draw-off cap and tighten down.

Attach draw-off tubing to the draw-off cap.

Gently prime the applicator gun, checking for leaks.

Follow the manufacturer's directions for adjusting the dose.

When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and tubing back into the product container. To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed.

Free standing (338 fl oz/10 Liter Bottle and 676 fl oz/20 Liter Bottle)

Connect the applicator gun to the Bottle as follows: Attach the open end of the draw-off tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Protector Drench Gun from instrument Supply Limited, or equivalent is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage).

Replace the shipping cap with the draw-off cap and tighten down.

Attach draw-off tubing to the draw-off cap.

Gently prime the applicator gun, checking for leaks.

Follow the manufacturer's directions for adjusting the dose.

When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and the tubing back into the product container. Replace the draw-off cap with the shipping cap. To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed. If the shipping cap is to be used with the faucet spigot installed (which can be used for refilling the 33.8 fl oz/1 Liter Bottle, 84.5 fl oz/2.5 Liter Pack or 169 fl oz/5 Liter Pack), pop the plastic seal out of the center of the shipping cap, screw in the threaded spigot, and tighten down. Store the bottle upright, with the spigot in the off position between uses.

Mode of Action: lvermectin is a member of the macrocylic 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 ligandgated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have the glutamate-gated chloride channel, the macrocyclic lactones have a low affinity for other mammalian ligandgated chloride channel and they do not readily cross the blood-brain barrier.

Animal Safety: Studies conducted in the U.S.A. have demonstrated the safety margin for ivermectin. Based on plasma levels, the topically applied formulation is expected to be at least as well tolerated by breeding animals as is the subcutaneous formulation which had no effect on breeding performance.

RESIDUE WARNING: Cattle must not be treated within 48 days of slaughter for human consumption. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

                                                                   WARNING! NOT FOR USE IN HUMANS.

This product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water and seek medical attention.

Keep this and all drugs out of the reach of children.

Restricted Drug (California) - Use Only as Directed.

The Material Safety Data Sheets (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or lor assistance contact Aspen Veterinary Resources ^® , Ltd. at (800) 378-8551.

                                                                             WARNING! FLAMMABLE!

                           KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.

PRECAUTIONS

Store at 20°C - 25°C (68°F-77°F), excursions permitted between 15°C and 30°C (between 59°F - 86°F). Brief exposure to temperature up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25"C (77°F); however such exposure should be minimized and protect from light.

Use only in well-ventilated areas or outdoors.

Close container tightly when not in use.

Cattle should not be treated when hair or hide is wet since reduced efficacy may be experienced.

Do not use when rain is expected to wet cattle within six hours after treatment.

This product is for application to skin surface only. Do not give orally or parenterally.

Cloudiness in the formulation may occur when lvermax^® (ivermectin) Pour-On is stored at temperatures below 32°F. Allowing to warm at room temperature will restore the normal appearance without affecting efficacy.

Antiparasitic activity of ivermectin will be impaired if the formulation is applied to areas of the skin with mange scabs or lesions, or with dermatoses or adherent materials, e.g., caked mud or manure.

lvermectin has been associated with adverse reactions in sensitive dogs; therefore, lvermax® (ivermectin) Pour-On is not recommended for use in species other than cattle.

When to Treat Cattle with Grubs: lvermax^® (ivermectin) Pour-On effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to ivermectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.

Cattle treated with lvermax^®(ivermectin) Pour-On at the end of the fly season may be re-treated with lvermax^®(ivermectin) Pour-On during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

Environmental Safety: Studies indicate that when ivermectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish or certain aquatic organisms. Do not permit cattle to enter lakes, streams, or ponds for at least 6 hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of 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 effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependant insects.

Package lnformation: lvermax^® (ivermectin) Pour-on is available in a 33.8 II oz/1 Liter Bottle with a measure-pour system, an 84.5 fl. oz/2.5 Liter Pack, a 169 fl. oz/5 Liter Pack, a 338 fl oz/10 Liter Bottle and a 676 fl oz/20 Liter Bottle intended for use with appropriate automatic dosing equipment.