SPARMECTIN E- ivermectin liquid

SPARMECTIN by

Drug Labeling and Warnings

SPARMECTIN by is a Animal medication manufactured, distributed, or labeled by Sparhawk Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

(ivermectin)

Liquid for Horses
10 mg per mL

FOR ANIMAL USE ONLY

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

INTRODUCTION

SparMectin-E (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 anti-parasitic agents, which are isolated from fermentation of Streptomyces avermitilis.

SparMectin-E 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, 0.54% w/v methyl paraben, 0.06% w/v propyl paraben and purified water q.s. ad 100%.

INDICATIONS

SparMectin-E (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)
Strongylus edentatus (also tissue stages)
Strongylus equinus
Triodontophorus spp. including:
   Triodontophorus brevicauda
   Triodontophorus serratus
Craterostomum acuticaudatum
Small Strongyles (adults, including those resistant to some benzimidazole class compounds):
Coronocyclus spp. including:
   Coronocyclus coronatus
   Coronocyclus labiatus
   Coronocyclus labratus
Cyathostomum spp. including:
   Cyathostomum catinatum
   Cyathostomum pateratum
Cylicocyclus spp. including:
   Cylicocyclus insigne
   Cylicocyclus leptostomum
   Cylicocyclus nassatus
   Cylicocyclus brevicapsulatus
   Cylicodontophorus spp.
Cylicostephanus spp. including:
   Cylicostephanus calicatus
   Cylicostephanus goldi
   Cylicostephanus longibursatus
   Cylicostephanus minutus
Petrovinema poculatum
Small Strongyles: Fourth-stage larvae
Pinworms (adults and fourth-stage larvae) - Oxyuris equi
Roundworms or ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum
Hairworms (adults) - Trichostrongylus axei
Large-mouth 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 & ADMINISTRATION

DOSAGE

SparMectin-E 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 of measure the appropriate dose, or pour the SparMectin-E 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 effects of potential for injury from handling, restraint, and placement of the stomach tube during administration of SparMectin-E Liquid. SparMectin-E Liquid should be administered by drench if the risks associated with tubing are of concern. Due to the potential consequences of improper administration, SparMectin-E Liquid is intended for use by a veterinarian only and is not recommended for dispensing.

SparMectin-E 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 contaminations 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 SparMectin-E 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 appropriated 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.

INSTRUCTIONS FOR USE

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. SparMectin-E (ivermectin) Liquid 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

SparMectin-E Liquid kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. SparMectin-E Liquid is a potent anti-parasitic agent that is neither a benzimidazole nor a organophosphate.

WARNINGS AND PRECAUTIONS

WARNINGS

Not for use in humans. Keep this and all drugs out of the reach of children. Do not use in horses intended for human consumption. 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 Sparhawk Laboratories, Inc. at 1-800-255-6368.

PRECAUTIONS

SparMectin-E 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 SparMectin-E Liquid in horses carrying heavy infections of neck threadworm microfilarie, Onchocerca sp. These reactions are most likely the result of microfilarie dying in large numbers. Symptomatic treatment may be advisable.

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

Owners should be advised to consult their veterinarian if these conditions do no 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 never 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 lactions have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

ANIMAL SAFETY

SparMectin-E 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 refrigerated between 2oC and 8oC (36oF and 46oF) with excursions up to 25oC (77oF) allowed. Protect SparMectin-E Liquid (undiluted or diluted) from light.

HOW SUPPLIED

SparMectin-E Liquid for Horses is available in a 100 mL plastic bottle. Each bottle contains sufficient ivermectin to treat 10-500 kg (1100 lb) horses. Contents may be poured into a graduated cylinder for dose measurements. Alternatively, a clean syringe may be inserted directly into the bottle to draw off the appropriate dose.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPARMECTIN  E
ivermectin liquid

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 58005-725
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IVERMECTIN (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D)	IVERMECTIN	10 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58005-725-04	100 mL in 1 BOTTLE, PLASTIC
2	NDC: 58005-725-05	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200341	05/01/2014

Labeler - Sparhawk Laboratories, Inc. (147979082)