Animal NDC 58005-725-04 Sparmectin E
Ivermectin
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 58005-725-04 |
| Proprietary Name | Sparmectin E What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Ivermectin What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Sparhawk Laboratories, Inc. |
| Product Type | Prescription Animal Drug |
| Usage Information |
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| Active Ingredient(s) |
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| Marketing Category | ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | ANADA200341 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
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Sparmectin E Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Description
(ivermectin)
Liquid for Horses
10 mg per mL
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
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 Safety Data Sheet (SDS) contains more detailed occupational safety information.
Contact Information
To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Sparhawk Laboratories Inc at 1-800-255-6388 or 1-913-888-7500. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae
Precautions
SparMectin-E (ivermectin) 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.
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.