Ivermectin for Cattle and Swine

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.

Ivermectin (ivermectin) Injection 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 of swine. Ivermectin's convenience, broad-spectrum efficacy and safety margin make Ivermectin Injection a unique product for parasite control of cattle and swine.

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 per 75 lb (33 kg).

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.

NOT FOR USE IN HUMANS.

Keep this and all drugs out of the reach of children.

The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance, or to obtain a copy of the SDS, contact Norbrook, Inc at 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1 -888-FDA-VETS or www.fda.gov/reportanimalae.

RESIDUE WARNINGS: 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 in pre-ruminating calves.
Do not use in calves to be processed for veal.
Do not treat swine within 18 days of slaughter.

Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment. For cattle, divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction.

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.

Observe cattle for injection site reactions. Reactions may be due to clostridial infection and should be aggressively treated with appropriate antibiotics. If injection site infections are suspected, consult your veterinarian.

This product is not for intravenous or intramuscular use.

Protect product from light.

Ivermectin Injection for Cattle and Swine has been developed specifically for use in cattle, swine, reindeer, and American bison only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

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 test 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.

Store at 59° to 86°F (15° to 30°C). Use within 60 days of first puncture and puncture a maximum of 25 times. If more than 25 punctures are anticipated, the use of multi-dosing equipment is recommended. When using a draw-off spike or needle with bore diameter larger than 16 gauge, discard any remaining product immediately after use. For 500 mL, and 1000 mL sizes: For use with automatic syringe equipment only. Discard any remaining product immediately after use.

Studies indicate that when ivermectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain aquatic organisms. Do not permit water runoff from feedlots to enter lakes, streams, or ponds. Do not contaminate water by direct application or by 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 insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

Ivermectin Injection for Cattle and Swine is available in five 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 or 100 head of 38 lb (17.3 kg) swine.

The 100 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 20 head of 550 lb (250 kg) cattle or 200 head of 38 lb (17.3 kg) swine.

The 250 mL pack is a multiple-dose, rubber-capped bottle. Each bottle contains sufficient solution to treat 50 head of 550 lb (250 kg) cattle or 500 head of 38 lb (17.3 kg) swine.

The 500 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 100 head of 550 lb (250 kg) cattle or 1000 head of 38 lb (17.3 kg) swine.

The 1000 mL pack is a multiple-dose, rubber-capped bottle designed for use with automatic syringe equipment. Each bottle contains sufficient solution to treat 200 head of 550 lb (250 kg) cattle or 2000 head of 38 lb (17.3 kg) swine.

Restricted Drug - California. Use Only as Directed.

Approved by FDA under ANADA # 200-437 Made in the UK.

Manufactured by:
Norbrook Laboratories Limited, Newry, BT35 6PU, Co. Down, Northem Ireland

Manufactured for:
Durvet, Inc., Blue Springs, MO 64014
www.durvet.com

Rev 10/20    004215I01

NDC 30798-243-17

durvet
Ivermectin
(ivermectin)
INJECTION FOR CATTLE
AND SWINE

1% Sterile Solution

A Parasiticide for the
Treatment and Control of
Internal and External Parasites
of Cattle and Swine.

Approved by FDA under ANADA # 200-437

500 mL (16.91 fl oz)

NDC 30798-243-17

durvet
Ivermectin
(ivermectin)
INJECTION FOR CATTLE
AND SWINE

1% Sterile Solution

500 mL (16.91 fl oz)

Approved by FDA
under ANADA # 200-437