Thursday, September 22, 2016

Zimecterin





Dosage Form: FOR ANIMAL USE ONLY
Zimecterin®

(ivermectin) 1.87% Paste

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.



Zimecterin Dosage and Administration


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. (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. (2) Lock the ring in place by making a 1/4 turn to the right. (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.



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® Paste kills important internal parasites, including bots and the arterial stages of S. vulgaris, with a single dose. Zimecterin® Paste is a potent antiparasitic agent that is neither a benzimidazole nor an organophosphate.



ANIMAL SAFETY


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



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 Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a MSDS, contact Merial 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.



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



Manufactured by: Merial Saúde Animal Ltda., Paulinia, São Paulo, CEP 13140-970, Brazil


Manufactured for: Merial Limited, Operational Headquarters, 3239 Satellite Blvd., Duluth, GA 30096-4640, U.S.A.



PRINCIPAL DISPLAY PANEL - 6.08 g label


Product 70961

For Oral Use in Horses Only


Zimecterin®

(ivermectin) 1.87% Paste


Anthelmintic and Boticide


For Treatment of Large Strongyles, Small Strongyles,

Pinworms, Roundworms (Ascarids), Hairworms,

Neck Threadworms, Large-mouth Stomach Worms,

Bots. See carton for complete indications and use

directions. Consult your veterinarian for assistance in

the diagnosis, treatment and control of parasitism.


NADA 134-314, Approved by the FDA

U.S. Pat. 4,199,569


Net Wt. 0.21 oz (6.08 g)


MERIAL




PRINCIPAL DISPLAY PANEL - 6.08 g box


Zimecterin®

(ivermectin) 1.87% Paste

ANTHELMINTIC AND BOTICIDE


MERIAL


CONTENTS WILL TREAT UP TO 1250 lb BODY WEIGHT.


Removes worms and bots

with a single dose.

For Oral Use in Horses Only

NADA 134-314, Approved by FDA


Net Wt. 0.21 oz (6.08 g)










Zimecterin 
ivermectin  paste










Product Information
Product TypeOTC ANIMAL DRUGNDC Product Code (Source)50604-7096
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ivermectin (ivermectin)ivermectin18.7 mg  in 1 g





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
150604-7096-16.08 g In 1 SYRINGE, PLASTICNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA13431406/15/1984


Labeler - Merial Limited (034393582)
Revised: 10/2009Merial Limited



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