Label: IVERMECTIN paste
- NDC Code(s): 86010-100-01
- Packager: JEFFERS
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated April 19, 2022
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INDICATIONS & USAGE
INDICATIONS: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. IVERMECTIN (ivermectin paste) provides 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 and T. serratus and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)-Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and 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)-Trichostrogylus 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 Sorescaused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
DOSAGE & ADMINISTRATION
DOSAGE: This syringe contains sufficient paste to treat one 1250 lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) body weight. Each weight marking on the syringe plunger delivers enough paste to treat 250 lb 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 encourage the development of parasite resistance.
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. Consult your veterinarian for a control program to meet your specific needs. IVERMECTIN (ivermectin paste) effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.
- OTHER SAFETY INFORMATION
- STORAGE AND HANDLING
DOSAGE & ADMINISTRATION
(1) While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking, aligning the arrow on the ring to the line between the weight and lbs, as shown in the pictogram.
(2) Lock the ring in place by making a 1/4 turn to the right. Ensure it is locked (it should no longer slide).
(3) Make sure that the horse's mouth contains no feed.
(4) Remove the cover from the tip of the syringe.
(5) Insert the syringe tip into the horse's mouth at the space between the teeth.
(6) Depress the plunger as far as it will go, depositing paste on the back of the tongue.
(7) Immediately raise the horse's head for a few seconds after dosing.
WARNINGS AND PRECAUTIONS
WARNING: Do not use in horses intended for human consumption.
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 Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance, or to obtain a copy of the SDS contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at
1-888-FDA-VETS or www.fda.gov/reportanimalae.
PRECAUTIONS: IVERMECTIN (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.
USER SAFETY WARNINGS
OTHER WARNINGS: Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.
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.
Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).
A decrease in a drug's effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan 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 (ivermectin paste) have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp.) microfilariae. These reactions were 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 other appropriate therapy in conjunction with treatment with IVERMECTIN. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86010-100 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ivermectin (UNII: 8883YP2R6D) (IVERMECTIN - UNII:8883YP2R6D) Ivermectin 18.7 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86010-100-01 6.08 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200326 12/12/2013 Labeler - JEFFERS (094385218) Registrant - Bimeda, Inc. (060492923) Establishment Name Address ID/FEI Business Operations Bimeda-MTC Animal Health 256232216 manufacture