Animal NDC 86249-001-01 Ivermectin
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 86249-001-01 |
| Proprietary Name | Ivermectin 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 | Stellarnet Limited |
| Product Type | Otc 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 | ANADA200326 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. |
Ivermectin Images
Ivermectin 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
For Oral Use in Horses Only
IVERMECTIN
(ivermectin paste) 1.87%
Net Wt. 0.21 oz (6.08 g)
Contents treat up to 1,250 lb body weight
Approved by FDA under ANADA # 200-326
Apple Flavored
Removes worms and bots with a single dose.
Indications & Usage
INDICATIONS: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Ivermectin paste provides effective treatment and control of the following parasites in horses: large strongyles (adults), including Strongylus vulgaris (including early forms in blood vessels), S. edentatus (including tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; small strongyles (adults, including those resistant to some benzimidazole-class compounds), including Coronocyclus spp. (C. coronatus, C. labratus, and C. labiatus), Cyathostomum spp. (C. catinatum and C. pateratum), Cylicocyclus spp. (C. insignis, C. leptostomum, C. nassatus, and C. brevicapsulatus), Cylicodontophorus spp., Cylicostephanus spp. (C. calicatus, C. goldi, C. longibursatus, and C. minutus), and Poteriostomum spp.; 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; large-mouthed 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); and dermatitis caused by neck threadworm microfilariae (Onchocerca spp.).
Dosage & Administration
DOSAGE: This syringe contains sufficient paste to treat one 1,250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) of body weight. Each weight marking on the syringe plunger delivers sufficient paste to treat 250 lb of body weight. Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment and may encourage the development of parasite resistance.
PARASITE CONTROL PROGRAM:All horses should be included in a regular parasite control program, with particular attention given to mares, foals, and yearlings. Foals should be treated initially at 6 to 8 weeks of age, with routine treatments repeated as appropriate. Consult your veterinarian to develop a parasite control program that meets your specific needs. Ivermectin paste effectively controls gastrointestinal nematodes and bots of horses. Regular treatment reduces the likelihood of verminous arteritis caused by Strongylus vulgaris.
PRODUCT ADVANTAGES:Broad-spectrum control — ivermectin paste eliminates important internal parasites of horses, including bots and the arterial stages of Strongylus vulgaris, with a single dose. Ivermectin is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.
ADMINISTRATION:
- While holding the plunger, turn the knurled ring on the plunger one-quarter (1/4) turn to the left and slide it to the position corresponding to the prescribed weight, aligning the arrow on the ring with the line between the weight marking and “lb,” as shown in the pictogram.
- Lock the ring in place by making a one-quarter (1/4) turn to the right. Ensure that it is locked and no longer slides.
- Ensure that the horse’s mouth contains no feed.
- Remove the cover from the tip of the syringe.
- Insert the syringe tip into the horse’s mouth at the space between the teeth.
- Depress the plunger as far as it will go, depositing the paste on the back of the tongue.
- Immediately raise the horse’s head for a few seconds after dosing.
Warnings
ANIMAL SAFETY: Ivermectin paste may be used in horses of all ages, including mares at any stage of pregnancy. Stallions may be treated without adversely affecting fertility.
WARNING: Do not use in horses intended for human consumption. Not for use in humans. Keep this and all drugs out of the reach of children. Refrain from smoking or eating when handling this product. Wash hands after use. Avoid contact with eyes.
Storage And Handling
STORAGE INFORMATION: Store at 68°F to 77°F (20°C to 25°C). Excursions between 59°F and 86°F (15°C to 30°C) are permitted.
Precautions
PRECAUTIONS: Ivermectin paste 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.
OTHER WARNINGS: Parasite resistance may develop to any dewormer. Resistance has been reported for most classes of dewormers. Frequent treatment with a dewormer, used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated, may slow the development of parasite resistance. Clinical examinations, diagnostic tests, and parasite management history should be used to determine whether this product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, the effectiveness of treatment should be monitored (for example, through fecal egg count reduction tests or other appropriate methods). A decrease in a drug’s effectiveness over time, as determined by fecal egg count reduction tests, may indicate the development of resistance to the dewormer administered. Parasite management programs should be adjusted accordingly based on regular monitoring.
ENVIRONMENTAL SAFETY: Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.
INFORMATION FOR HORSE OWNERS: Swelling and itching reactions after treatment with ivermectin paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca spp.) microfilariae. These reactions are most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require additional appropriate therapy in conjunction with treatment with ivermectin paste. Reinfection and measures for its prevention should also be considered. Consult your veterinarian if the condition does not improve.
Other
Distributed by:
Y.L. Associates, Incorporated
9659 Limar Way
San Diego, CA 92129-3508
United States
Principal Display Panel - 0.21 Oz (6.08 G)
Keep out of the reach of children.
For Oral Use in Horses Only
NDC: 86249-001-01
IVERMECTIN
(ivermectin paste) 1.87%
Net Wt. 0.21 oz (6.08 g)
Contents treat up to 1,250 lb body weight
Approved by FDA under ANADA # 200-326
Apple-Flavored
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.
