Animal NDC 57561-019-88 Agri-mectin

Ivermectin Pour-on

Animal NDC Product Code 57561-019-88

Field Name Field Value
Animal NDC Code 57561-019-88
Proprietary Name Agri-mectin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Ivermectin Pour-on What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Agri Laboratories Ltd.
Product Type Otc Animal Drug
Active Ingredient(s)
  • Ivermectin
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number ANADA200299 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Agri-mectin Animal Product Label Images

Agri-mectin Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

ANADA 200-299, Approved by the FDAContains 5 mg ivermectin/mLParasiticide Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.INTRODUCTIONIvermectin Pour-On delivers internal and external parasite control in one convenient low-volume application. Ivermectin Pour-On contains ivermectin, a unique chemical entity.

Mechanism Of Action

MODE OF ACTIONIvermectin is a member of the macrocylic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamategated 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.

Indications & Usage

INDICATIONSIvermectin Pour-On applied at the recommended dose level of 500 mcg/kg is indicated for the effective treatment and control of these parasites:Gastrointestinal RoundwormsOstertagia ostertagi  (including inhibited stage)             (adults and L4)Haemonchus placei                                                    (adults and L4)Trichostrongylus axei                                                 (adults and L4)T.  colubriformis                                                        (adults and L4)Cooperia  oncophora                                                  (adults and L4)Cooperia   punctata                                                   (adults and L4)Cooperia  surnabada                                                  (adults and L4)Strongyloides  papillosus                                           (adults)Oesophagostomum  radiatum                                    (adults and L4)Trichuris spp.                                                           (adults)Lungworms      Dictyocaulus  viviparus                    (adults and L4)Cattle Grubs   Hypoderma bovis, H.lineatum            (parasitic stages)Mites              Sarcoptes scabiei var. bovisLice                 Linognathus vituli, Haematopinus eurystemus,                        Damalinia bovis, Solenopotes capillatusHorn Flies       Haematobia  irritans    Persistent ActivityIvermectin Pour-On has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum  radiatum and Dictyocaulus  viviparous for 28 days after treatment; Cooperia  punctata and Trichostrongylus  axei  for 21 days after treatment; Ostertagia  ostertagi, Haemonchus  placei, Cooperia  oncophora and Cooperia  surnabada for 14 days after treatment; Damalinia  bovis for 56 days after treatment.Treatment of Cattle for Horn FliesIvermectin Pour-On controls horn flies (Haematobia irritans) for up to 28 days after dosing. For best results Ivermectin Pour-On should be part of a parasite control program for both internal and external parasites based on the epidemiology of these parasites. Consult your veterinarian or an entomologist for the most effective timing of applications.

Dosage & Administration

DOSAGEThe
dose rate is 1 mL for each 22 lb of body weight. The formulation should
be applied along the topline in a narrow strip extending from the
withers to the tailhead.ADMINISTRATIONSqueeze-Measure-Pour System(8.5 fl. oz/250 mL Bottle with 25 mL Measuring Cup)Measure
the amount of solution to be used, at the dose of 1 mL for each 22 lb
of body weight into a measuring cup. When body weight is between
markings use the higher setting.Tilt the measuring cup to deliver the dose.Squeeze-Measure-Pour System(33.8 fl. oz/1 L Bottle with 25 mL Measuring Cup)Measure
the amount of solution to be used, at the dose of 1 mL for each 22 lb
of body weight into a measuring cup. When body weight is between
markings use the higher setting.Tilt the measuring cup to deliver the dose.Collapsible Packs(84.5 fl. oz/2.5 L Pack and 169 fl. oz/5 L Pack)Connect
the applicator gun to the collapsible pack as follows: Attach the open
end of the draw-off tubing to dosing equipment.  Replace the shipping
cap with the draw-off cap and tighten down.  Attach draw-off tubing to
the draw-off cap.Gently prime the applicator gun, checking for leaks.Follow the manufacturer's directions for adjusting the dose.When
the interval between uses of the applicator gun is expected to exceed
12 hours, disconnect the gun and draw-off tubing from the product
container and empty the product from the gun and tubing back into the
product container.  To prevent removal of special lubricants from the
applicator gun, the gun and tubing must not be washed.

Animal Pharmacology & Or Toxicology

ANIMAL SAFETYStudies
conducted in the U.S.A. have demonstrated the safety margin for
ivermectin. Based on plasma levels, the topically applied formulation
is expected to be at least as well tolerated by breeding animals as is
the subcutaneous formulation which had no effect on breeding performance.

Warnings And Precautions

WARNING! DO NOT 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 Med-Pharmex, Inc. at (909) 593-7875.WARNING! FLAMMABLE!KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.This
product should not be applied to self or others because it may be
irritating to human skin and eyes and absorbed through the skin. To
minimize accidental skin contact, the user should wear a long-sleeved
shirt and rubber gloves. If accidental skin contact occurs, wash
immediately with soap and water. If accidental eye exposure occurs,
flush eyes immediately with water and seek medical attention.RESIDUE INFORMATION: Cattle must not be treated within 48 days of slaughter for human
consumption. 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.

Precautions

PRECAUTIONSStore away from excessive heat (104°F/40°C) and protect from light.•Use only in well-ventilated areas or outdoors.•Close container tightly when not in use.•Cattle should not be treated when hair or hide is wet since reduced efficacy may be experienced.•Do not use when rain is expected to wet cattle within six hours after treatment.•This product is for application to skin surface only. Do not give orally or parenterally.•Cloudiness
in the formulation may occur when Ivermectin Pour-On is stored at
temperatures below 32°F. Allowing to warm at room temperature will
restore the normal appearance without affecting efficacy.•Antiparasitic
activity of ivermectin will be impaired if the formulation is applied
to areas of the skin with mange, scabs or lesions, or with dermatoses
or adherent materials, e.g., caked mud or manure.•Ivermectin has
been associated with adverse reactions in sensitive dogs; therefore,
Ivermectin Pour-On is not recommended for use in species other than
cattle.

Information For Owners/Caregivers

When to Treat Cattle with GrubsIvermectin
Pour-On effectively controls all stages of cattle grubs. However,
proper timing of treatment is important. For the most effective
results, cattle should be treated as soon as possible after the end of
the heel fly (warble fly) season. While this is not peculiar to
ivermectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma  lineatum  when it is in the esophageal tissues may cause bloat; killing H. bovis
when it is in the vertebral canal may cause staggering or paralysis.
Cattle should be treated either before or after these stages of grub
development.  Cattle treated with Ivermectin Pour-On at the end of the
fly season may be re-treated with Ivermectin during the winter without
danger of grub-related reactions. For further information and advice on
a planned parasite control program, consult your veterinarian.

Environmental Warning

Environmental SafetyStudies
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 or certain water-borne
organisms on which they feed. Do not permit cattle to enter lakes,
streams or ponds for at least six hours after treatment. 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 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.

How Supplied

HOW SUPPLIEDIvermectin
Pour-On is available in an 8.5 fl. oz/250 mL bottle or 33.8 fl. oz/1 L
bottle with a squeeze-measure-pour system, or in an 84.5 fl. oz/2.5 L
or 169 oz/5 L collapsible pack container intended for use with
appropriate automatic dosing equipment.  Med-Pharmex, Inc., Pomona, CA 91767Rev. 12-06

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.

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