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IVERMECTIN

Sparhawk Laboratories, Inc.

IVERMECTIN INJECTION for Cattle and Swine 1% Sterile Solution


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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
Ostertagia ostertagi

Product Description

Streptomyces avermitilis.

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 class is 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.

Indications


Cattle
Gastrointestinal Roundworms

Ostertagia ostertagi
O. ostertagi
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Oesophagostomum radiatum
Bunostomum phlebotomum
Nematodirus helvetianus
   

N. spathiger


Lungworms

Dictyocaulus viviparus
Cattle Grubs
Hypoderma bovis
H. lineatum
Sucking Lice
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mites
Psoroptes ovis
P. communisbovis
Sarcoptes scabiei 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
Ascaris suum

Hyostrongylus rubidus

Oesophagostomum spp.

Strongyloides ransomi
Somatic Roundworm Larvae:
Strongyloides ransomi

Lungworm:
Metastrongylus spp
Lice:
Haematopinus suis
Mange Mites:
Sarcoptes scabiei  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

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

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

Swine


Recommended Treatment Program


SWINE

BREEDING ANIMALS
Sows
Gilts

Boars:

FEEDER PIGS
(Weaners/Growers/Finishers)



NOTE




Special Minor Use

ReindeerOedemagena tarandiADMINISTRATION.

American Bison
Hypoderma bovisADMINISTRATION.

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

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.

Environmental Safety

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-borne 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 insects 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.

How Supplied

50 mL, 200 mL, 500 mL


Store at 20-25oC.

Restricted Drug (California) - use only as directed.






IVERMECTIN
IVERMECTIN

IVERMECTIN

IVERMECTIN INJECTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:58005-346
Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
IVERMECTIN Ivermectin 10 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58005-346-02 50 in 1 VIAL
2 NDC:58005-346-07 200 in 1 VIAL
3 NDC:58005-346-06 500 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200429 2010-07-05


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