Agri-Mectin Injection

ANADA 200-429,Approved by FDA

Injection for Cattle and Swine
1% Sterile Solution
A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Introduction

AGRI-MECTIN is an injectable parasiticide for cattle and swine. One low-volume dose effectively treats and controls the following internal and external parasites that may impair the health of cattle and swine: gastrointestinal roundworms (including inhibited Ostertagia ostertagi in cattle), lungworms, grubs, sucking lice, and mange mites of cattle; and gastrointestinal roundworms, lungworms, lice, and mange mites in swine.

Product DescriptIon

Ivermectin is derived from the avermectins, a family of potent, broad-spectrum antiparasitic agents isolated from fermentation of Streptomyces avermitilis.
Agri-Mectin Injection is a clear, ready-to-use, sterile solution containing 1% ivermectin, 40% glycerol formal, and propylene glycol, q.s. ad 100%. Agri-Mectin Injection is formulated to deliver the recommended dose level of 200 mcg ivermectin/kilogram of body weight in cattle when given subcutaneously at the rate of 1 mL/110 lb (50 kg). In Swine, Agri-Mectin Injection is formulated to deliver the recommended dose level of 300 mcg ivermectin/kilogram body weight when given subcutaneously in the neck at the rate of 1 mL/75 lbs (33 kg).

Cattle: Agri-Mectin Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, oungworms, grubs, sucking lice and mange mites in cattle:
Gastrointestinal Roundworms
(adults and fourth-stage larvae):
Ostertagia ostertagi
    (Including inhibitedO. ostertagi)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Oesophagostomum radiatum
Bunostomum phlebotomum
Nematodirus helvetianus
    (adults only)
N. spathiger (adults only)

Lungworms
(adults and fourth-stage larvae):
Dictyocaulus viviparus
Cattle Grubs(parasitic stages):
Hypoderma bovis
H. lineatum
Sucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mites Iscabies:
Psoroptes ovis
    (Syn.P. communisvar.bovis)
Sarcoptes scabieivar. bovis

Persistent Activity

Agri-Mectin Injection has been proved to effectively control infections and to protect cattle from reinfection withDictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment;Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment;Haemonchus placei and Cooperia oncophorafor 14 days after treatment.

Swine:  Agri-Mectin Injection is indicated for the effective treatment and control of the follwoing harmful species of gastrointestinal roundworms, lungworms, lice and mange mites in swine:

Gastrointestinal roundworms
Large roundworm,Ascaris suum
(adults and fourth-stage larvae)
Red stomach worm,Hyostrongylus rubidus
(adults and fourth-stage larvae)
Nodular worm,Oesophagostomum spp.
(adults and fourth-stage larvae)
Threadworm,Strongyloides ransomi (adults)
Somatic Roundworm Larvae:
Threadworm, Strongyloides ransomi (somtic larvae)
Sows must be treated at least seven days before farrowing to prevent infection in piglets.
Lungworm:
Metastrongylus spp. (adults)
Lice:
Haematopinus suis
Mange Mites:
Sarcoptes scabiei  var. suis

Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain water born organisms on which they feed. Do not permit water runoff from feedlots or production sites to enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.
As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insets that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and lifestyle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

50 mL, 200 mL, 500 mL

Store at 20-25oC.

Restricted Drug (California) - use only as directed.

AGRI-MECTIN  ivermectin injection

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:57561-468 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVERMECTIN (IVERMECTIN) IVERMECTIN 10 mg  in 1 mL

Packaging # Item Code Package Description 1 NDC:57561-468-02 50 mL in 1 VIAL 2 NDC:57561-468-07 200 mL in 1 VIAL 3 NDC:57561-468-06 500 mL in 1 VIAL

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200-429 12/29/2010

Labeler - Agri Laboratories, Ltd. (155594450)

Revised: 12/2010   Agri Laboratories, Ltd.