Label: ZIMECTERIN GOLD- ivermectin and praziquantel paste
- NDC Code(s): 0010-6001-03, 0010-6001-04
- Packager: Boehringer Ingelheim Animal Health USA Inc.
- Category: OTC ANIMAL DRUG LABEL
Drug Label Information
Updated October 27, 2023
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INDICATIONS:
Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. ZIMECTERIN® GOLD (ivermectin/praziquantel) Paste provides effective treatment and control of the following parasites in horses. Tapeworms – Anoplocephala perfoliata, 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.
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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 and 454 mcg praziquantel per lb (1 mg/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.
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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 2 months of age, and routine treatment repeated as appropriate. Consult your veterinarian for a control program to meet your specific needs.
ZIMECTERIN® GOLD Paste effectively controls gastrointestinal cestodes, nematodes and bots of horses. Regular treatment will reduce the chances of verminous arteritis caused by Strongylus vulgaris.
- PRODUCT ADVANTAGES: Broad-spectrum Control
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ANIMAL SAFETY:
ZIMECTERIN® GOLD Paste may be used in horses two months of age or older. ZIMECTERIN® GOLD Paste has not been tested in foals younger than two months of age, mares at or near the time of breeding, pregnant or lactating mares, and breeding stallions. ZIMECTERIN® GOLD Paste, when tested at 1, 3 and 5-times the maximum recommended dose every two weeks in 5-month old foals, and at 10-times the maximum recommended dose in a separate study, did not elicit any adverse clinical signs of toxicity. In a foal safety study in younger animals, ZIMECTERIN® GOLD Paste was found safe at up to 3-times the maximum recommended dose in 2-month old foals.
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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 arrow on the 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).
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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 a SDS, contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251.
- PRECAUTIONS:
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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/flock, 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.
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Post-Approval Experience:
Although not all adverse reactions are reported, the following reactions are based on voluntary post-approval drug experience reporting. There have been rare reports of swelling and irritation of the mouth, lips, and tongue following administration of ZIMECTERIN® GOLD. These reactions have been transitory in nature
- Environmental Safety:
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Information For Horse Owners:
Swelling and itching reactions after treatment with ivermectin 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® GOLD Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.
- STORAGE:
- SPL UNCLASSIFIED SECTION
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Principal Display Panel – 7.35 g Paste Syringe Carton
Approved by FDA under NADA # 141-214
ZIMECTERIN®GOLD
(ivermectin 1.55% / praziquantel 7.75%) PasteREMOVES ROUNDWORMS, TAPEWORMS AND BOTS WITH A SINGLE DOSE.
FOR ORAL USE IN HORSES ONLYMake every dose count.
See New Instructions.CONTENTS WILL TREAT UP TO 1250 lb BODY WEIGHT.
Net Wt. 0.26 oz (7.35g)
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INGREDIENTS AND APPEARANCE
ZIMECTERIN GOLD
ivermectin and praziquantel pasteProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:0010-6001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D) ivermectin 15.5 mg in 1 g praziquantel (UNII: 6490C9U457) (praziquantel - UNII:6490C9U457) praziquantel 77.5 mg in 1 g Product Characteristics Color ORANGE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0010-6001-04 1 in 1 CARTON 1 7.35 g in 1 SYRINGE, PLASTIC 2 NDC:0010-6001-03 6 in 1 CARTON 2 7.35 g in 1 SYRINGE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141214 11/25/2020 Labeler - Boehringer Ingelheim Animal Health USA Inc. (007134091)