AmTech Phoenectin Liquid for Horses

Manufacturer: IVX Animal Health

(ivermectin)

10 Mg Per Ml

For Animal Use Only

ANADA 200-202, Approved by FDA

AmTech Phoenectin Liquid for Horses Caution

Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

Introduction

Phoenectin^® (ivermectin) Liquid for Horses has been formulated for professional administration by stomach tube or oral drench. One low-volume dose is effective against important internal parasites, including the arterial stages of Strongylus vulgaris, and bots.

Product Description

Ivermectin is derived from the avermectins, a family of potent, broad-spectrum antiparasitic agents, which are isolated from fermentation of Streptomyces avermitilis.

Phoenectin^® (ivermectin) Liquid is a clear, ready-to-use solution with each mL containing 1% ivermectin (10 mg), 0.2 mL propylene glycol, 80 mg polysorbate 80, 9 mg sodium phosphate monobasic monohydrate, 1.3 mg sodium phosphate dibasic anhydrous, 1 mg butylated hydroxytoluene, 0.1 mg disodium edetate, 3% benzyl alcohol and water for injection q.s. ad 100%.

AmTech Phoenectin Liquid for Horses Indications

Phoenectin^® (ivermectin) Liquid is indicated for the effective treatment and control of the following parasites in horses:

Large Strongyles (adults): strongylus Vulgaris (also Early Forms In Blood Vessels), s. Edentatus (also Tissue Stages), s. Equinus

triodontophorus spp. Including: t. Brevicauda, T. Serratus

craterostomum Acuticaudatum

small Strongyles (adults, Including Those Resistant To Some Benzimidazole Class Compounds): coronocyclus spp. Including: c. Coronatus, C. Labiatus, C. Labratus

cyathostomum spp. Including: c. Catinatum, C. Pateratum

cylicocyclus spp. Including: c. Insigne, C. Leptostomum, C. Nassatus, C. Brevicapsulatus

cylicodontophorus spp.

cylicostephanus spp. Including: c. Calicatus, C. Goldi, C. Longibursatus, C. Minutus

petrovinema Poculatum

small Strongyles

Fourth-stage larvae

Pinworms (adults and fourth-stage larvae) - Oxyuris equi

Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum

Hairworms (adults) - Trichostrongylus axei

Largemouth Stomach Worms (adults) - Habronema muscae

Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis

Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi

Intestinal threadworms (adults) - Strongyloides westeri

Summer sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

DOSAGE

Phoenectin^® (ivermectin) Liquid for Horses is formulated for administration by stomach tube (nasogastric intubation) or as an oral drench. The recommended dose is 91 mcg of ivermectin per lb (200 mcg/kg) of body weight. Each mL contains sufficient ivermectin to treat 110 lb (50 kg) of body weight: 10 mL will treat an 1100 lb (500 kg) horse.

Administration

Use a calibrated dosing syringe inserted into the bottle to measure the appropriate dose, or pour the Phoenectin^® (ivermectin) Liquid into a graduated cylinder for dose measurement. Use a clean syringe if accessing the bottle to avoid contaminating the remaining product.

Special consideration should be given to the effects or potential for injury from handling, restraint, and placement of the stomach tube during administration of Phoenectin^® Liquid. Phoenectin^® Liquid should be administered by drench if the risks associated with tubing are of concern. Due to the consequences of improper administration, Phoenectin^® Liquid is intended for use by a veterinarian only and is not recommended for dispensing.

Phoenectin^® Liquid in 1 to 20 and 1 to 40 dilutions with tap water has been shown to be stable for 72 hours under the conditions recommended for the product (i.e., at room temperature, in a tightly closed container, protected from light). The diluted product does not promote the growth of common organisms. However, prolonged storage of the diluted product cannot be recommended, as the effects of possible contaminants and interactions with untested materials are unknown.

Administration By Stomach Tube (gravity Or Positive Flow): The Recommended Dose Can Be Used Undiluted Or Diluted Up To 40 Times With Clean Tepid Water. Use Tepid Water To Flush Any Drug Remaining In The Tube Into The Horse's Stomach.

administration By Drench

For administration of Phoenectin^® Liquid by drench, an undiluted dose is recommended. Clear the horse's mouth of any food material, elevate the horse's head, and using a syringe, deposit the appropriate dose in the back of the mouth. In order to avoid unnecessary coughing or the potential for material to enter the trachea and lungs, do not use excessive pressure (squirting), do not use a large (diluted) dose volume, and do not deposit the dose in the laryngeal area. Increased dose rejection may occur if the dose is deposited in the buccal space. Keep horse's head elevated and observe the horse to insure the dose is retained.

PARASITE CONTROL PROGRAM

All horses should be included in a regular parasite control program with particular attention being paid to mares, foals and yearlings. Foals should be treated initially at 6 to 8 weeks of age, and routine treatment repeated as appropriate. Phoenectin^® (ivermectin) effectively controls gastrointestinal nematodes and bots in horses. Regular treatment will reduce the chances of verminous arteritis and colic caused by Strongylus vulgaris.

Product Advantages

Broad-spectrum Control - Phoenectin^® Liquid Kills Important Internal Parasites, Including Bots And The Arterial Stages Of s. Vulgaris, With A Single Dose. Phoenectin^® Liquid Is A Potent Antiparasitic Agent That Is Neither A Benzimidazole Nor An Organophosphate.

residue Warning Do not use in horses intended for human consumption.

HUMAN WARNINGS

Not for use in humans. Keep this and all drugs out of reach of children. Refrain from smoking and eating when handling. Wash hands after use. Avoid contact with eyes. The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, to obtain a MSDS or for assistance, contact IVX Animal Health, Inc. at 1-800-759-3664.

Precautions

Phoenectin^® Liquid has been formulated specifically for use in horses only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

Environmental Safety

Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of drug container in an approved landfill or by incineration.

Information For Horse Owners

Owners should be advised of the potential that swelling and itching reactions may occur after treatment with Phoenectin^® Liquid in horses carrying heavy infections of neck threadworm microfilariae, Onchocerca sp. These reactions are most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable.

Healing of summer sores involving extensive tissue changes may require other therapy in conjunction with Phoenectin^® Liquid. Reinfection, and measures for its prevention, should also be considered.

Owners should be advised to consult their veterinarian if these conditions do not improve.

Clinical Pharmacology

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 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.

Animal Safety

Phoenectin^® Liquid may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting their fertility.

Storage Information

Store in a tightly closed container at room temperature. Protect Phoenectin^® Liquid (undiluted or diluted) from light.

How Supplied

Phoenectin^® (ivermectin) Liquid for Horses is available in 100 mL or 200 mL plastic bottle. The 100 mL bottle contains sufficient ivermectin to treat 10-500kg (1100 lb) horses. The 200 mL bottle contains sufficient ivermectin to treat 20-500kg (1100 lb) horses. Contents may be poured into a graduated cylinder for dose measurement. Alternatively, a clean syringe may be inserted directly into the bottle to draw off the appropriate dose.

Manufactured by IVX Animal Health, Inc., St. Joseph, MO 64503

^® Registered trademark of IVX Animal Health, Inc.

NET CONTENTS:	NDC
100 mL	59130-680-01	500019-01 Rev0907
200 mL	59130-680-22	500019-22 Rev. 9-02

Nac No.

10740388