Ivermectin Injection

Name: Ivermectin Injection

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 macrcyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

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.).

Swine: IVERMECTIN should be given only by subcutaneous injection in the neck of swine at the reocmmended 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.



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.


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 teh 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.


Precautions

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 infection.

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.

When to Treat Cattle with Grubs
IVERMECTIN effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities. Killing Hypoderma lineatum when it is in the tissue surrounding the esophagus (gullet) may cause salivation and bloat.: Killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. These reactions are not specific to treatment with a IVERMECTIN, but can occur with any successful treatment of grubs. Cattle should be treated either before or after these stages of grub development. Consult your veterinarian concerning the proper time for treatment. Cattle treated with IVERMECTIN after the end of the heel fly season may be retreated with IVERMECTIN during the winter for internal parasites, mange mites, or sucking lice without danger of grub-related reactions. A planned parasite control program is recommended.

How Supplied

50 mL, 200 mL, 500 mL


Store at 20-25oC.

Restricted Drug (California) - use only as directed.





IVERMECTIN 
Ivermectin Injection
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58005-346
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:58005-346-02 50 mL in 1 VIAL
2 NDC:58005-346-07 200 mL in 1 VIAL
3 NDC:58005-346-06 500 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200-429 07/05/2010
Labeler - Sparhawk Laboratories, Inc. (958829558)
Revised: 06/2010   Sparhawk Laboratories, Inc.
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