Ivomec Sterile Injection for Cattle, Sheep and Swine (Canada)

Company: Boehringer Ingelheim Animal Health

(ivermectin)

FOR VETERINARY USE ONLY

For the treatment of infections and infestations due to internal and external parasites in cattle and swine, and parasitic infections due to internal parasites in sheep.

Introduction

Ivomec^® Sterile injection for Cattle, Sheep and Swine contains ivermectin, a unique chemical entity. Its convenience, broad-spectrum efficacy and wide safety margin make it an excellent antiparasitic product for cattle, sheep and swine.

One low-volume dose effectively controls internal and external parasites of cattle and swine and internal parasites of sheep that can impair health and productivity.

Product Description

Ivomec^® is a ready-to-use sterile solution containing the following ingredients per mL: 10 mg ivermectin, 0.40 mL glycerol formal and propylene glycol q.s. ad 1 mL. Ivomec^® is formulated to deliver the recommended dose level of 200 µg ivermectin per kg of body weight in cattle and sheep when given subcutaneously at the rate of 1 mL per 50 kg. In swine, Ivomec^® is formulated to deliver the recommended dose level of 300 µg ivermectin per kg body weight given subcutaneously at the rate of 1 mL per 33 kg.

Active Ingredient

Ivermectin is the first in a series of antiparasitic agents derived from the avermectin family of compounds. The avermectins are highly active, broadspectrum antiparasitic agents isolated from fermentation of the soil organism Streptomyces avermitilis.

Ivomec Sterile Injection for Cattle, Sheep and Swine Indications

Cattle

Ivomec^® is indicated for the treatment of infections and infestations due to gastrointestinal roundworms, lungworms, grubs, sucking lice and mange mites in cattle:

Gastrointestinal roundworms: *Ostertagia ostertagi (adults and fourth stage larvae including inhibited O. ostertagi); O. lyrata (adults); Haemonchus placei (adults and fourth stage larvae); Trichostrongylus axei (adults and fourth stage larvae); T. colubriformis (adults); Cooperia oncophora (adults and fourth stage larvae); C. punctata (adults); Oesophagostomum radiatum (adults and fourth stage larvae); Strongyloides papillosus (adults)

Eye worms: Thelazia spp.

Lungworms: *Dictyocaulus viviparus (adults and fourth stage larvae)

Cattle grubs (internal parasitic stages): Hypoderma bovis; H. lineatum

Sucking lice: Linognathus vituli; Haematopinus eurysternus; Solenopotes capillatus

Mites: Sarcoptes scabiei var. bovis; Psoroptes ovis (syn. P. communis var. bovis)

*Ivomec^® given at the recommended dosage controls infections of Dictyocaulus viviparus, Ostertagia ostertagi and Oesophagostomum radiatum for 21 days after treatment; Haemonchus placei, Trichostrongylus axei, Cooperia punctata and Cooperia oncophora for 14 days after treatment.

Sheep

Ivomec^® is indicated for the treatment of infections due to gastrointestinal roundworms, lungworms, and larval stages of the nasal bot in sheep:

Gastrointestinal roundworms: Adults and immatures: Haemonchus contortus; Ostertagia circumcincta; Trichostrongylus colubriformis; Cooperia curticei; Oesophagostomum columbianum; Chabertia ovina

Adults: Trichostrongylus axei; Oesophagostomum venulosum; Trichuris ovis

Lungworms: Dictyocaulus filaria (adults and immatures)

Nasal bot: Oestrus ovis (all larval stages)

Swine

Ivomec^® is indicated for the treatment of the following parasitic infections and infestations in swine:

Gastrointestinal roundworms: Large roundworms, Ascaris suum (adults and L4); Red stomach worm, Hyostrongylus rubidus (adults and L4); Nodular worm, Oesophagostomum spp. (adults and L4); Threadworm, Strongyloides ransomi (adults and somatic larvae)

Somatic Threadworm Larvae (Strongyloides ransomi). Sows must be treated at least seven days before farrowing to prevent infection of piglets.

Lungworm: Metastrongylus spp. (adults)

Lice: Haematopinus suis

Mites: Sarcoptes scabiei var. suis

Ivomec Sterile Injection for Cattle, Sheep and Swine Dosage And Administration

Cattle

Ivomec^® should be given only by subcutaneous injection at the recommended dosage level of 200 µg of ivermectin per kg of body weight. Each mL contains 10 mg of ivermectin, sufficient to treat 50 kg of body weight (maximum 10 mL per injection site).

Ivomec^® should be given subcutaneously only. Inject under the loose skin in front of or behind the shoulder. Use of a 16 gauge, 15 to 20 mm (3/4 inch) needle is suggested. Use sterile equipment.

Sheep

The recommended dose level is 1 mL of Ivomec^® per 50 kg of body weight (200 µg of ivermectin per kg). The recommended route of administration is by subcutaneous injection. the solution may be given with any standard automatic or single-dose equipment. use sterile equipment.

The loose skin behind the shoulder is an acceptable site. In woolly sheep, be certain that the needle has penetrated the wool and skin before delivering the dose.

Swine

The recommended dose level is 1 mL of Ivomec^® per 33 kg of body weight (300 µg of ivermectin per kg of body weight). The recommended route of administration is by subcutaneous injection in the neck. The solution may be given with any standard automatic or single-dose equipment. In young pigs, especially those below 16 kg for which less than 0.5 mL of Ivomec^® Injection is indicated, dosing accuracy is important. The use of a syringe that can accurately deliver as little as 0.1 mL is recommended. Use aseptic technique.

Recommended Treatment Program For Swine

I. Breeding Animals:

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

Sows

Treat prior to farrowing, preferably 7-14 days before, to minimize infection of piglets.

Gilts

Treat 7-14 days prior to breeding. Treat 7-14 days prior to farrowing.

Boars

Frequency and need for treatments are dependent upon exposure. Treat at least two times per year.

II. Feeder pigs:

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

Note:

1. Ivomec^® 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. Sows should be treated at least one week before farrowing to minimize transfer of mites to newborn baby pigs.

2. Louse eggs are unaffected by Ivomec^® 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.

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.

Clinical Advantages

Injectable Convenience

Ivomec^® is the first injectable antiparasitic agent highly effective against both internal and external parasites of cattle and swine and internal parasites of sheep in Canada. It can be administered quickly and easily.

Broad-spectrum

Ivomec^® provides broad-spectrum efficacy against gastrointestinal roundworms, lungworms, cattle grubs, sheep nasal bot, and sucking lice and mange mites of cattle and swine with one easy to give injection (see complete list of parasites).

Unique Chemical Compound

Ivomec^® provides contains ivermectin, a unique antiparasitic compound.

Safety

Ivomec^® has demonstrated a wide safety margin at the recommended dose level in cattle, swine and sheep. Ivomec^® may be used in breeding animals.

WARNING

1. Treated cattle and sheep must not be slaughtered for use in food for at least thirty-five (35) days after the latest treatment with this drug; treated swine must not be slaughtered for use in food for at least twenty-eight (28) days after the latest treatment with this drug.

2. Non-lactating dairy cattle must not be treated with this drug for at least two (2) months prior to calving.

3. Not for use in lactating dairy cattle.

4. Not for use in ewes where milk is to be used for human consumption.

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

Ivomec Sterile Injection for Cattle, Sheep and Swine Caution

1. Do not administer intravenously or intramuscularly.

2. Transitory discomfort has been observed in some animals following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment. Divide doses greater than 10 mL between injection sites to reduce occasional discomfort to site reaction. Different sites should be used for other parenteral products.

3. Sheep: Following subcutaneous injections activity suggesting pain, sometimes intense but usually transient, has been seen in some sheep.

Adequate vaccination against clostridial infections in sheep is recommended.

Consult your veterinarian for advice on a vaccination program.

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

Environmental Safety

Studies indicate that when ivermectin 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 ivermectin may adversely affect fish and certain waterborne organisms.

Storage

Store bottle in carton to protect from light.

Packaging

Ivomec^® for Cattle, Sheep and Swine is available in four ready to use sizes:

50 mL, 200 mL, 500 mL and 1000 mL.

50 mL: Product 41330 CA, DIN 00630470, is supplied in a multiple-dose, rubber-capped bottle.

200 mL: Product 41331 CA, DIN 00630470, is contained in a soft, collapsible pack designed for use with automatic injection equipment.

500 mL: Product 41332 CA, DIN 00630470, is also contained in a collapsible pack designed for use with automatic injection equipment.

1000 mL: Product 41333 CA, DIN 00630470, is also contained in a collapsible pack designed for use with automatic injection equipment.

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

Ivomec^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

147536-002

CPN: 1182038.3