Label: PROMECTIN B POUR-ON- ivermectin solution

ProMectin® B

Pour-On For Cattle

(ivermectin topical solution)

Approved by FDA under ANADA # 200-318

Contains 5 mg ivermectin/mL

Parasiticide

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

INTRODUCTION

ProMectin®  B (ivermectin topical solution) Pour-On delivers internal and external parasite control in one convenient low-volume application. ProMectin®  B (ivermectin topical solution) Pour-On contains ivermectin, a unique chemical entity.

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

INDICATIONS

ProMectin®  B (ivermectin  topical solution) Pour-On applied at the recommended dose level of 500 mcg/kg is indicated for the effective treatment and control of these parasites.

Gastrointestinal Roundworms

Ostertagia ostertagi                       (adults and L4)

(including inhibited stage)

Haemonchus placei                        (adults and L4)

Trichostrongylus axei                     (adults and L4)

T. colubriformis                              (adults and L4)

Cooperia oncophora                        (adults and L4)

Cooperia punctate                          (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                                 (parasitic stages)

Hypoderma bovis

H. lineatum

Mites

Sarcoptes scabiei var. bovis

Lice

Linognathus vituli

Haematopinus eurysternus

Damalinia bovis

Solenopotes capillatus

Horn Flies

Haematobia irritans

PERSISTENT ACTIVITY

Ivermectin topical solution has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum  radiatum  and Dictyocaulus  viviparus  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 FLIES

ProMectin®  B (ivermectin topical solution) Pour-On controls horn flies (Haematobia irritans) for up to

28 days after dosing. For best results ProMectin®  B (ivermectin topical solution) 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

The 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.

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing  may  result  in ineffective  treatment, and  encourage  the  development  of parasite resistance.

ADMINISTRATION BackPack (5 Liter Pack)

Connect the applicator gun to the backpack as follows:

• Attach the open end of the draw-off  tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Protector Drench Gun from Instrument Supplies Limited, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage).

• 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 Protector Drench Gun, the gun and tubing must not be washed.

ANIMAL SAFETY

Studies 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.

WARNING

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 Bimeda, Inc. at 1-888-524-6332.  For additional information about adverse drug experience reporting for animal drugs, contact  FDA at 1-888-FDA-VETS  or online at www.fda.gov/reportanimalae.

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 WARNING:

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

• Store at 20°C - 25°C (68°F - 77°F) and protect from light. Excursions permitted to 104°F (40°C).

• 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 ProMectin®  B 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, ProMectin® B (ivermectin topical solution) Pour-On is not recommended for use in species other than cattle.

• Restricted Drug (California)–Use only as directed.

OTHER WARNINGS

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 tests 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.

Environmental Safety

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 or  certain  aquatic organisms. Do not permit cattle to enter lakes, streams, or ponds for at least 6 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-dependant insects.

HOW SUPPLIED

ProMectin®  B (ivermectin topical solution) Pour-On is available in a 5 Liter Pack intended for use with appropriate automatic dosing equipment.