IVERMECTIN: Product Information

IVERMECTIN- ivermectin injection
Durvet Inc.

Approve by FDA under ANADA # 200-429

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

Ivermectin 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.

IVERMECTIN Injection is a clear, ready-to-use, sterile solution containing 1% ivermectin, 40% glycerol formal, and propylene glycol, q.s. ad 100%. IVERMECTIN 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, IVERMECTIN 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).

Mode of Action

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA)

The margin of safety for compounds of this clas sis attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

Indications

Cattle : IVERMECTIN Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice and mange mites in cattle:
Gastrointestinal Roundworms (adults and fourth-stage larvae):
Ostertagia ostertagi (Including inhibited O. 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. lineatumSucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatusMites Iscabies:
Psoroptes ovis (Syn.P. communis var.bovis)
Sarcoptes scabiei var. bovis

´╗┐Persistent Activity

IVERMECTIN Injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus 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 oncophora for 14 days after treatment.

Swine: IVERMECTIN Injection is indicated for the effective treatment and control of the following 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

Dosage

Cattle : IVERMECTIN should be given only by subcutaneous injection under the loose skin in front of or behind the shoulder at the recommended dose level of 200 mcg ivermectin per kilogram of body weight. Each mL of IVERMECTIN contains 10 mg of ivermectin, sufficient to treat 110 lb (50 kg) of body weight (maximum 10 mL per injection site.).

Ivermectin-Cattle
(click image for full-size original)

Swine : IVERMECTIN should be given only by subcutaneous injection in the neck of swine at the recommended dose level of 300 mcg ivermectin per kilogram (2.2 lb) of body weight. Each mL of IVERMECTIN contains 10 mg of ivermectin, sufficient to treat 75 lb of body weight.

Ivermectin-Swine
(click image for full-size original)

Administration

Cattle: IVERMECTIN Injection is to be given subcutaneously only, to reduce risk of potentially fatal clostridial infection of the injection site. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16-gauge, 1/2 to 3/4″ needle is suggested. Inject under the loose skin in front of or behind the shoulder (see illustration). When using the 200 mL, 500 mL size, use only automatic syringe equipment. Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections. No special handling or protective clothing is necessary.

Ivermectin Injection Administration
(click image for full-size original)

Swine: IVERMECTIN Injection is to be given subcutaneously in the neck. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16- or 18-gauge needle is suggested for sows and boars, while an 18- or 20-gauge needle may be appropriate for young animals. Inject under the skin, immediately behind the ear (see illustration). When using the 200 mL, 500 mL size, use only automatic syringe equipment. As with any injection, sterile equipment should be used. The injection site should be cleaned and disinfected with alcohol before injection. The rubber stopper should also be disinfected with alcohol to prevent contamination of the contents. Mild and transient pain reactions may be seen in some swine following subcutaneous administration.

Recommended Treatment Program

SWINE : At the time of initiating any parasite control program, it is important to treat all breeding animals in the herd. After the initial treatment, use IVERMECTIN Injection regularly as follows:
BREEDING ANIMALS
Sows: Treat prior to farrowing, preferably 7-14 days before, to minimize infection of piglets.
Gilts: Treat 7-14 days prior to breeding.
Treat 7-14 days prior to farrowing.
Boars: Frequency and need for treatment are dependent upon exposure. Treat at least two times a year.
FEEDER PIGS
(Weaners/Growers/Finishers) All weaner/feeder pigs should be treated before placement in clean quarters.
Pigs exposed to contaminated soil or pasture may need retreatment if reinfections occurs.
NOTE:
(1) IVERMECTIN Injection has a persistent drug level sufficient to control mite infestations throughout the egg to adult life cycle. However, since the ivermectin effect is not immediate, care must be taken to prevent reinfestation from exposure to untreated animals or contaminated facilities. Generally, pigs should not be moved to clean quarters or exposed to uninfested pigs for approximately one week after treatment. Sows should be treated at least one week before farrowing to minimize transfer of mites to newborn baby pigs.
(2) Louse eggs are unaffected by IVERMECTIN Injection and may require up to three weeks to hatch. Louse infestations developing from hatching eggs may require retreatment.
(3) Consult a veterinarian for aid in the diagnosis and control of internal and external parasites of swine.
Special Minor Use
Reindeer : For the treatment and control of warbles (Oedemagena tarandi) in reindeer, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under ADMINISTRATION.
American Bison: For the treatment and control of grubs (Hypoderma bovis) in American bison, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under ADMINISTRATION.

>RESIDUE WARNING: Do not treat reindeer or American bison within 8 weeks (56 days) of slaughter. <

WARNING

Not for use in humans.

Keep this and all drugs out to reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain a MSDS or for assistance, contact Sparhawk Laboratories, Inc. at 1-800-255-6368.

RESIDUE WARNING: Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product n pre-ruminating calves. Do not use in calves to be processed for veal.
Do not treat swine within 18 days of slaughter.

Page 1 of 2 1 2

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2020. All Rights Reserved.