Bimectin Pour-On (Canada)

Company: Bimeda-MTC

(ivermectin)

POUR-ON FOR CATTLE

Veterinary Use Only

DIN 02283123

Introduction

Bimectin™ Pour-On contains ivermectin, a unique chemical entity. Its convenience, broad-spectrum efficacy and wide safety margin make it an excellent antiparasitic product for cattle.

One dose effectively controls a wide range of internal and external parasites that can impair the health and productivity of cattle.

Product Description

Bimectin™ Pour-On for cattle is a clear, blue coloured liquid containing 5 mg of ivermectin per mL (0.5% w/v). Bimectin™ Pour-On is formulated to deliver the recommended dose level of 500 µg of ivermectin per kg of body weight in cattle when applied along the top line from the withers to the tail head at the rate of 1 mL per 10 kg.

Active Ingredient

Ivermectin is an antiparasitic agent derived from the avermectin family of compounds. The avermectins are highly active, broad-spectrum antiparasitic agents isolated from fermentation of the soil organism Streptomyces avermitilis.

Bimectin Pour-On Indications

Bimectin™ Pour-On applied at the recommended dose level of 500 µg of ivermectin per kg of body weight is indicated for the treatment of parasitic infections and infestations due to gastrointestinal roundworms, eyeworms, lungworms, grubs, biting and sucking lice, mites and hornflies in cattle. In addition, due to its persistent effect, this product also controls certain parasitic infections and infestations as outlined in this document under PERSISTENT EFFECT. Following is a complete list of the parasites against which efficacy has been demonstrated:

Gastrointestinal Roundworms

Ostertagia ostertagi (adults and fourth stage larvae including inhibited O. ostertagi) *

Haemonchus placei (adults and fourth stage larvae) *

Trichostrongylus axei (adults and fourth stage larvae) *

T. colubriformis (adults and fourth stage larvae)

Cooperia surnabada (syn. mcmasteri) (adults) *

C. oncophora (adults) *

C. punctata (adults) *

Nematodirus helvetianus (fourth stage larvae)

Oesophagostomum radiatum (adults and fourth stage larvae) *

O. venulosum (adults)

Strongyloides papillosus (adults)

Trichuris ovis (adults)

Eyeworms

Thelazia gulosa (adults)

T. skrjabini (adults)

Lungworms

Dictyocaulus viviparus (adults and fourth stage larvae) *

Cattle Grubs (internal parasitic stages)

Hypoderma bovis

H. lineatum

Lice

Haematopinus eurysternus

Linognathus vituli*

Damalinia (syn. Bovicola) bovis*

Mites

Chorioptes bovis

Sarcoptes scabiei var. bovis

Note - If psoroptic mange is to be treated, Ivermectin Injection for Cattle is recommended.

Hornflies

Haematobia irritans*

(*) See PERSISTENT EFFECT

Persistent Effect

Endoparasites - Bimectin™ Pour-On given at the recommended dosage of 500 µg of ivermectin per kg of body weight effectively controls infections of Dictyocaulus viviparus and Oesophagostomum radiatum acquired up to 28 days after treatment; Trichostrongylus axei and Cooperia punctata acquired up to 21 days after treatment; and Haemonchus placei, Ostertagia ostertagi, Cooperia oncophora and Cooperia surnabada (syn. mcmasteri) acquired up to 14 days after treatment.

Ectoparasites - Bimectin™ Pour-On given at the recommended dosage of 500 µg of ivermectin per kg of body weight effectively controls infestations of Haematobia irritans acquired up to 35 days after treatment; Damalinia (syn. Bovicola) bovis and Linognathus vituli acquired up to 49 days after treatment.

For best results, Bimectin™ Pour-On should be part of a total parasite control program including internal and external parasites based on the epidemiology of these parasites. Consult your local veterinarian or entomologist for the most effective timing of applications.

Bimectin Pour-On Dosage And Administration

Bimectin™ Pour-On is formulated for external use only in cattle; it should not be used in other species. The formulation should be applied along the top-line in a narrow strip extending from the withers to the tail head at a dose rate of 1 mL per 10 kg of body weight.

5 L Bottles

Use dosing equipment compatible with Bimectin™ Pour-On.

Follow manufacturer’s directions for use and care of the equipment. Other dosing equipment may be incompatible, resulting in locking, incorrect dosage and leakage. Connect the dosing gun to the collapsible pack as follows: (1) Attach the open end of the draw-off tubing to the dosing gun and attach draw-off tubing to the self-venting cap with the stem. (2) Replace the shipping cap with the self-venting draw-off cap which has the stem and tighten this cap. (3) Invert the pack and gently prime the dosing gun, checking for leaks.

20 L Bottles

Use dosing equipment compatible with Bimectin™ Pour-On.

Follow manufacturer’s directions for use and care of the equipment. Other dosing equipment may be incompatible, resulting in locking, incorrect dosage and leakage. Connect the dosing gun to the bottle as follows: (1) Attach the open end of the draw-off tubing to the dosing gun and attach the draw-off tubing to the self-venting cap with the stem. (2) Replace the shipping cap with the self-venting draw-off cap which has the stem and tighten this cap. (3) Gently prime the dosing gun, checking for leaks.

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 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 channels and they do not readily cross the blood-brain barrier.

Note To User

The colour of Bimectin™ Pour-On for Cattle fades when exposed to light and, depending on the light intensity, fading may occur in less than 30 minutes. The rapid loss of colour does not reflect loss of potency of ivermectin. However, prolonged exposure (i.e., weeks) to light can also result in a gradual decline of ivermectin potency in the formulation.

Safety

Studies have demonstrated a wide safety margin. 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 has demonstrated an adequate safety margin in breeding animals.

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. Drug containers and any residual contents should be disposed of safely (e.g. by burying or incinerating) as free ivermectin may adversely affect fish or certain water-borne organisms.

WARNING

1. Treated cattle must not be slaughtered for use in human food for at least forty-nine (49) days after the latest treatment with this drug.

2. Because a withholding time for milk has not been established, do not use in dairy cows twenty (20) months of age or older.

3. 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 and contact a physician.

4. Use only in well-ventilated areas or outdoors. Close container when not in use.

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

CAUTIONS

1. For topical application only. Do not administer orally or parenterally.

2. This product is not for use in species other than cattle.

3. Cattle should not be treated when hair or hide is wet since reduced efficacy will be experienced. Rain falling on cattle in less than 2 hours after dosing may result in reduced efficacy.

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

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

Storage

Store at controlled room temperature, 15-25°C. Store bottle in carton to protect from light.

Flammable - keep away from heat, sparks, open flame or other sources of ignition.

Packaging

Bimectin™ Pour-On for Cattle is available in two ready to use sizes: 5 L and 20 L

Manufactured by: Bimeda-MTC Animal Health Inc., Cambridge, Ontario, Canada N3C 2W4

8BIM212-210

CPN: 1473010.0