Eprinex Pour-On (Canada)

Company: Boehringer Ingelheim Animal Health

(eprinomectin)

Pour-on

for Beef & Dairy Cattle

DIN 02237228

VETERINARY USE ONLY

For the treatment of parasitic infections due to gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, cattle grubs, and infestations due to sucking and biting lice, chorioptic and sarcoptic mange mites and horn flies in beef and dairy cattle; and for the treatment of parasitic infections due to gastrointestinal roundworms and lungworms in deer.

Active Ingredient

Each mL contains 5 mg of eprinomectin.

Note To User

Consult your veterinarian for the diagnosis, treatment and control of parasitism in cattle and deer. For best results, EPRINEX^® Pour-On should be used in a planned program to control both internal and external parasites.

Introduction

Eprinex^® Pour-On delivers highly effective internal and external parasite control in one low-volume application. EPRINEX^® Pour-On contains the active ingredient, eprinomectin, a unique chemical entity. Its convenience, broad-spectrum efficacy in a weatherproof formulation, wide margin of safety, zero meat withdrawal and zero milk discard make it an excellent product for parasite control in beef cattle, dairy cattle (including lactating dairy cows) and deer.

Product Description

Eprinex^® Pour-On for Beef and Dairy Cattle is a clear, colorless liquid, containing 5 mg of eprinomectin per mL. It is formulated to deliver the recommended dose level of 500 µg of eprinomectin per kg of body weight in target animals, when applied along the backline from the withers to the tail head, at the rate of 1 mL per 10 kg body weight.

Eprinomectin

The active ingredient, eprinomectin, is an antiparasitic agent from the macrocyclic lactone family of compounds.

Eprinex Pour-On Indications

1. BEEF and DAIRY CATTLE:

EPRINEX^® Pour-On is indicated for the treatment of parasitic infections and infestations due to the following gastrointestinal roundworms, lungworms, grubs, sucking and biting lice, mange mites and horn flies in beef and dairy cattle (including lactating dairy cattle):

Cattle Grubs (internal parasitic stages)

Hypoderma bovis

H. lineatum

Biting And Sucking Lice

Damalinia bovis

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

Mange Mites

Chorioptes bovis

Sarcoptes scabiei var bovis

Horn Flies

Haematobia irritans

EPRINEX^® Pour-On administered at the recommended dosage of 500 µg of eprinomectin per kg of body weight, effectively controls parasitic infestations with Haematobia irritans (horn flies) for up to 7 days after treatment. For optimal control of horn flies, EPRINEX^® Pour-On should be used as part of an integrated control program. Consult your veterinarian for the most effective timing of applications.

Persistent Activity

EPRINEX^® Pour-On administered at the recommended dosage of 500 µg of eprinomectin per kg of body weight, effectively controls parasitic infections with Ostertagia ostertagi, Nematodirus helvetianus, and Dictyocaulus viviparus for 28 days after treatment, Cooperia oncophora, C. punctata and C. surnabada (mcmasteri) for 21 days after treatment and Haemonchus placei, Trichostrongylus axei, T. colubriformis and Oesophagostomum radiatum for 14 days after treatment.

2. DEER:

EPRINEX^® Pour-on is indicated for the treatment of parasitic infections due to the following gastrointestinal roundworms and lungworms in deer:

*(Includes O. mossi/dikmansi, O. lyrata, O. leptospicularis, Spiculopteratia spiculoptera and S. asymmetrica.)

Administration

EPRINEX^® Pour-On is formulated for external use in beef cattle, dairy cattle and deer. The formulation should be applied along the backline, in a narrow strip extending from the withers to the tail head, at a dose volume of 1 mL per 10 kg of body weight, to achieve a dose level of 500 µg of eprinomectin per kg of body weight.

Squeeze-Measure-Pour System (250 mL and 1 L bottles)

1. Installation: Unscrew shipping cap from container top. Screw the Metering Cup onto container top, while leaving the “slotted end” of the dip tube exposed in the bottom of the container.

2. Measure: To select the correct dose rate, rotate the adjuster cap (top) in either direction to position the dose indicator to the weight of the animal you want to treat. When body weight is between markings, use the higher setting.

3. Squeeze the container gently to fill the Metering Cup to the required dose. By releasing the pressure, the dose automatically adjusts to the correct level.

4. Pour: Apply the full dose by tipping and pouring along the backline of the animal until the Metering Cup is empty.

Collapsible Packs (2.5 L And 5 L)

Connect the dosing applicator and draw-off tubing to the collapsible pack as follows: (1) Attach the open end of the draw-off tubing to an appropriate dosing applicator. (2) Attach the open end of the draw-off tubing to the dosing applicator and attach draw-off tubing to the self-venting cap with the stem. (3) Replace the shipping cap with the self-venting cap which has the stem and tighten this cap. (4) Invert the pack and gently prime the dosing applicator, checking for leaks. (5) Follow the dosing applicator manufacturer’s directions for adjusting the dose, proper use and maintenance of the dosing applicator and draw-off tubing.

Mode Of Action

Eprinomectin 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 margin of safety for compounds of this class 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.

Note To User

Rainfall anytime before or after treatment will not affect the efficacy of the product.

Safety

Studies have demonstrated a wide safety margin in target animals. Three times the recommended dose level had no adverse effect on breeding performance of cows or bulls. Treatment at five times the recommended therapeutic dose had no adverse effect on deer.

Environmental Safety

Studies indicate that when eprinomectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive. Drug containers and any residual contents should be disposed of safely, in accordance with local, provincial and national regulations. Free eprinomectin may adversely affect fish and certain water-borne organisms.

WARNINGS

1. Keep out of reach of children.

2. This product may be irritating to human skin and eyes. If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water.

Notes to user

(1) When used according to label directions, no meat withdrawal time is required following the use of EPRINEX^® Pour-On on beef cattle, dairy cattle and deer.

(2) When used according to label directions, no milk withholding time is required following the use of EPRINEX^® Pour-On on dairy cattle.

CAUTIONS

1. For topical application only: do not administer orally or by injection.

2. Do not apply to areas of the backline covered with mud or manure.

3. To prevent potential secondary reactions when treating infections with cattle grubs, consult your veterinarian on the correct timing of treatment.

4. No data are available on the effect of this product on the breeding performance of male and female deer.

Stability

Eprinex^® Pour-On is stable for 36 months when stored under normal conditions.

Storage

Store bottle or collapsible pack in carton to protect from light. For the 250 mL and the 1 L bottles, the Metering Cup should not remain attached to the container when not in use. Detach the Metering Cup after each use and replace the shipping cap to close the container top. Bottles should remain upright during storage.

Packaging

EPRINEX^® Pour-On for beef cattle and dairy cattle, is available in four ready to use sizes: 250 mL, 1 L, 2.5 L and 5 L. Not all pack sizes may be marketed.

250 mL - is supplied in a multiple-dose bottle with Metering Cup. Each bottle contains enough solution to treat 10 x 250 kg of body weight (one mL per 10 kg).

1 L - is supplied in a multiple-dose bottle with Metering Cup. Each bottle contains enough solution to treat 40 x 250 kg of body weight (one mL per 10 kg).

2.5 L - is supplied in a soft, collapsible pack including a self-venting draw-off assembly, designed for use with automatic dosing equipment. Each pack contains enough solution to treat 100 x 250 kg of body weight (one mL per 10 kg).

5 L - is supplied in a soft, collapsible pack including a self-venting draw-off assembly, designed for use with automatic dosing equipment. Each pack contains enough solution to treat 200 x 250 kg of body weight (one mL per 10 kg).

Boehringer Ingelheim Animal Health Canada Inc., 5180 South Service Road, Burlington ON L7L 5H4

EPRINEX^® and the Cattlehead logo are registered trademarks of Boehringer Ingelheim Vetmedica GmbH, used under license.

2050-2504-03

CPN: 1182037.6