ivomec ® Plus (ivermectin and clorsulon) Injection for Cattle

NADA 140-833, Approved by the FDA       

67302, 67303, 67304, 67305

For the effective treatment and control of internal parasites, including adult liver flukes, and external parasites.

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

The ability of IVOMEC^® (ivermectin) to deliver internal and external parasite control has been proven in cattle markets around the world. Now, Merial combines ivermectin, the active ingredient of IVOMEC, with clorsulon, an effective adult flukicide. A single injection of IVOMEC Plus (ivermectin and clorsulon) offers all the benefits of IVOMEC plus control of adult Fasciola hepatica.

The dosage level of clorsulon supplied by IVOMEC Plus is effective only against adult liver flukes (Fasciola hepatica).

IVOMEC Plus is a ready-to-use sterile solution containing 1% w/v ivermectin, 10% clorsulon, 40% glycerol formal, and propylene glycol, q.s. ad 100%. It is formulated to deliver the recommended dose level of 200 mcg ivermectin/kg and 2 mg clorsulon/kg given subcutaneously behind the shoulder at the rate of 1 mL per 110 lb (50 kg) body weight.

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 class is 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. Clorsulon is rapidly absorbed into the circulating blood. Erythrocytes with bound drug as well as plasma are ingested by Fasciola hepatica. Adult Fasciola hepatica are killed by clorsulon because of inhibition of enzymes in the glycolytic pathway, which is their primary source of energy.

IVOMEC Plus Injection is indicated for the effective treatment and control of the following parasites of 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
Bunostomum phlebotomum
Nematodirus helvetianus (adults only)
N. spathiger (adults only)
Oesophagostomum radiatum
Lungworms (adults and fourth-stage larvae):
Dictyocaulus viviparus
Liver Flukes:
Fasciola hepatica (adults only)
Cattle Grubs (parasitic stages):
Hypoderma bovis
H. lineatum
Sucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mange Mites (cattle scab¹):
Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovis

IVOMEC Plus should be given only by subcutaneous injection at a dose volume of 1 mL per 110 lb (50 kg) body weight. This volume will deliver 10 mg ivermectin and 100 mg clorsulon. For example:

IVOMEC Plus (ivermectin and clorsulon) Injection is to be given subcutaneously only. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16-gauge, 1/2" to 3/4" sterile needle is recommended. Inject the solution subcutaneously (under the skin) behind the shoulder (see illustration).

Any single-dose syringe or standard automatic syringe equipment may be used with the 50 mL pack size. When using the 200 mL, 500 mL or 1000 mL pack 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.

The viscosity of the product increases in cool temperatures.

Administering IVOMEC^® Plus at temperatures of 5°C (41°F) or below may be difficult. Users can make dosing easier by warming both the product and injection equipment to about 15°C (59°F).

In breeding animals (bulls and cows), ivermectin and clorsulon used at the recommended level had no effect on breeding performance.

NOT FOR USE IN HUMANS.
Keep this and all drugs out of the reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact Merial at 1-888-637-4251.

Do not treat cattle within 21 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 in pre-ruminating calves. Do not use in calves to be processed for veal.

Transitory discomfort has been observed in some cattle following subcutaneous administration. Soft-tissue swelling at the injection site has also been observed. These reactions have disappeared without treatment. Divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction. Different injection sites should be used for other parenteral products.

IVOMEC Plus Injection has been developed specifically for use in cattle only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

For subcutaneous injection in cattle only.

This product is not for intravenous or intramuscular use.

Restricted Drug (California) - use only as directed.

IVOMEC Plus Injection is available in four ready-to-use pack sizes:

The 50 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 10 head of 550 lb (250 kg) cattle.

The 200 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 40 head of 550 lb (250 kg) cattle.

The 500 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle.

The 1000 mL pack is a soft, collapsible pack designed for use with automatic syringe equipment. Each pack contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle.

IVOMEC and Cattle Head Logo are registered trademarks of Merial.

Copyright © 2016 Merial. All Rights Reserved.

Distributed by:
Merial, Inc.
Duluth, GA 30096 USA

Made in Brazil

Rev. 01/2016

603003858

NADA 140-833, Approved by the FDA
Product 67305

ivomec^® Plus
(ivermectin and clorsulon)

Injection for Cattle

Treats 200–550 lb Cattle

For the treatment and control of internal
parasites, including adult liver flukes, and
external parasites.

1000 mL
MERIAL