ZIMECTERIN- ivermectin paste

ZIMECTERIN by

Drug Labeling and Warnings

ZIMECTERIN by is a Animal medication manufactured, distributed, or labeled by Boehringer Ingelheim Animal Health USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS:

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. ZIMECTERIN® (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) – 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:

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. ZIMECTERIN® (ivermectin paste) effectively controls gastrointestinal nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.

PRODUCT ADVANTAGES:

Broad-spectrum Control – ZIMECTERIN® kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. ZIMECTERIN® is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.

STORAGE INFORMATION:

Store at 68° F - 77° F (20-25° C). Excursions between 59° F - 86° F (15-30° C) are permitted.

ADMINISTRATION:

1) While holding plunger, turn the knurled ring on the plunger ¼ turn to the left and slide it so the side nearest the barrel is at the prescribed weight marking, aligning the arrows on the ring and plunger with the notch on the ring, as shown in the pictogram. 2) Lock the ring in place by making ¼ 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.

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 adverse reactions in users, to obtain more information, or to obtain an SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.

PRECAUTIONS:

ZIMECTERIN® (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, 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 ZIMECTERIN® (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 ZIMECTERIN®. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

SPL UNCLASSIFIED SECTION

Product 7096101

® ZIMECTERIN is a registered trademark of the Boehringer Ingelheim Group.
© 2019 Boehringer Ingelheim Animal Health USA Inc.
All Rights Reserved.

Approved by FDA under NADA # 134-314

Marketed by: Boehringer Ingelheim Animal Health USA Inc. Duluth, GA, 30096

Made in Brazil

SEALED FOR SECURITY.
IF BROKEN, DO NOT ACCEPT

PRINCIPAL DISPLAY PANEL - 6.08 g Syringe Carton

ZIMECTERIN®
(ivermectin paste) 1.87%
ANTHELMINTIC AND BOTICIDE

CONTENTS WILL TREAT UP TO 1250 lb BODY WEIGHT.

Removes worms and bots with a single dose.

For Oral Use in Horses Only

Approved by FDA under NADA # 134-314

Net Wt. 0.21 oz (6.08 g)

Make every does count.
See New Instructions.

INGREDIENTS AND APPEARANCE

ZIMECTERIN 
ivermectin paste

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 0010-7096
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: 0010-7096-01	6.08 g in 1 SYRINGE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA134314	04/23/2021

Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)