EPRIZERO- eprinomectin solution
Eprizero by
Drug Labeling and Warnings
Eprizero by is a Animal medication manufactured, distributed, or labeled by Norbrook Laboratories Limited. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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INTRODUCTION
Eprizero™ Pour-On delivers effective internal and external parasite control in one application. Eprizero Pour-On contains eprinomectin, a unique avermectin. Its broad-spectrum efficacy in a weatherproof formulation, margin of safety, zero slaughter withdrawal and zero milk discard, make it a convenient product for parasite control in beef and dairy cattle, including lactating dairy cattle.
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MODE OF ACTION
Eprinomectin 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.
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INDICATIONS
Eprizero (eprinomectin) Pour-On is indicated for the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) body weight, to achieve a dose level of 500 mcg eprinomectin/kg body weight, Eprizero Pour-On is indicated for the effective treatment and control of the following parasites.
Gastrointestinal Roundworms
Haemonchus placei (adults and L4) Ostertagia ostertagi (including inhibited L4) (adults and L4) Trichostrongylus axei (adults and L4) Trichostrongylus colubriformis (adults and L4) Trichostrongylus longispicularis (adults only) Cooperia oncophora (adults and L4) Cooperia punctata (adults and L4) Cooperia surnabada (adults and L4) Nematodirus helvetianus (adults and L4) Oesophagostomum radiatum (adults and L4) Bunostomum phlebotomum (adults and L4) Strongyloides papillosus (adults only) Trichuris spp. (adults only) Lungworms
Dictyocaulus viviparus (adults and L4) Cattle Grubs (all parasitic stages)
Hypoderma lineatum
Hypoderma bovis
Lice
Damalinia bovis
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mange Mites
Chorioptes bovis
Sarcoptes scabiei
Horn Flies
Haematobia irritans
Persistent Activity
Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle has been proved to effectively control infections and to protect cattle from re-infection with Dictyocaulus viviparus for 21 days after treatment and Haematobia irritans for 7 days after treatment.
Use Conditions
Varying weather conditions, including rainfall, do not affect the efficacy of Eprizero Pour-On.
Management Considerations for Treatment of External Parasites
For best results Eprizero Pour-On should be applied to all cattle in the herd. Cattle introduced to the herd later should be treated prior to introduction. Consult your veterinarian or an entomologist for the most effective timing of applications for the control of external parasites.
Chorioptic Mange: In clinical studies evaluating the efficacy of Eprizero Pour-On against chorioptic mange mites, mites were not recovered from skin scrapings taken 8 weeks after treatment; however, chronic skin lesions were still present on some animals.
Horn flies: For optimal control of horn flies, as Eprizero Pour-On provides 7 days of persistent activity against horn flies, the product should be used as part of an integrated control program utilizing other control methods to provide extended control.
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ADMINISTRATION
Squeeze-Measure-Pour System (33.8 fl oz/1 liter pack with dispensing cap)
The dispensing cap is graduated in 5 mL increments. Each 5 mL will treat 110 lbs body weight. When body weight is between markings, use the next higher increment. Attach the dispensing cap to the container. Select the correct dose rate by rotating the adjuster top in either direction to position the dose indicator to the appropriate level. Hold the container upright and gently squeeze it to deliver a slight excess of the required dose as indicated by the calibration lines. By releasing the pressure, the dose automatically adjusts to the correct level. Tilt the container to deliver the dose. The “closed-off-shut” position will close the system between dosing. If the animal being treated weighs more that 550 lbs (250 kg), refill the dispensing cap to the additional amount required to provide the total dose for that animal and apply as directed.
Container (84.5 fl oz/2.5 liter pack; 169 fl oz/5 liter pack)
The applicator gun from Simcro Tech, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage. Remove the shipping cap from the backpack container and replace with the vent cap provided. Attach the hose from the automatic dosing equipment to the outlet from the vent cap. Follow the applicator gun manufacturer's directions for priming the gun, adjusting the dose, and care of the applicator gun following use.
Container (676 fl oz/20 liter container with draw-off device)
The draw-off device and applicator gun from Simcro Tech, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage. Screw Feedlot pack cap and dip tube onto the 20 liter drum ensuring a tight fit. Connect the long 3m feed tube at one end to the spigot on the Feedlot pack cap and the other end to the applicator gun. Then follow the applicator gun manufacturer's directions for priming the gun, adjusting the dose, and care of the applicator gun following use.
When the interval between use of the applicator gun is expected to exceed 12 hours, disconnect the gun, draw off tubing and dip tub and cap from the product container, empty the product from the gun and tubing back into the container and replace the shipping cap.
Weight Dose 220 lb (100 kg) 10 mL 330 lb (150 kg) 15 mL 440 lb (200 kg) 20 mL 550 lb (250 kg) 25 mL 660 lb (300 kg) 30 mL 770 lb (350 kg) 35 mL 880 lb (400 kg) 40 mL 990 lb (450 kg) 45 mL 1100 lb (500 kg) 50 mL -
ANIMAL SAFETY
Tolerance and toxicity studies have demonstrated the margin of safety for eprinomectin in cattle. In toxicity studies, application of 3 times the recommended dose had no adverse effects on neonatal calves, and application of up to 5 times the recommended dose 3 times at 7 day intervals had no adverse effects on 8 week old calves. In the tolerance study, one of 6 cattle treated once at 10 times the recommended dose showed clinical signs of mydriasis. Application of 3 times the recommended dose had no adverse effect on breeding performance of cows or bulls.
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RESIDUE WARNINGS
When used according to label directions, neither a pre-slaughter drug withdrawal period nor a milk discard time is required, therefore, meat and milk from cattle treated with Eprizero (eprinomectin) Pour-On may be used for human consumption at any time following treatment. A withdrawal period has not been established for pre-ruminating calves. Do not use in calves to be processed for veal.
WARNING
Keep this and all drugs out of the reach of children.
NOT FOR USE IN HUMANS.
As with any topical medication intended for treatment of animals, skin contact should be avoided. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water. The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance, contact Norbrook at 1-866-591-5777.
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PRECAUTIONS
This product is for topical application only. Do not administer orally or by injection.
Do not apply to areas of the backline covered with mud or manure.
Eprizero Pour-On is not recommended for use in species other than cattle. Severe adverse reactions have been reported in other species treated with products containing compounds of this class.
When to Treat Cattle with Grubs
Eprizero Pour-On is effective against 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 eprinomectin, 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 Eprizero Pour-On at the end of the fly season may be re-treated with Eprizero Pour-On during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.
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ENVIRONMENTAL SAFETY
Studies indicate that when eprinomectin comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin/eprinomectin may adversely affect fish and 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, eprinomectin 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.
- ADVERSE REACTIONS
- STORAGE CONDITIONS
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HOW SUPPLIED
Eprizero (eprinomectin) Pour-On for Beef and Dairy Cattle is available in 1 L/33.8 fl oz container with a squeeze-measure-pour system, or in a 2.5 L/84.5 fl oz or 5 L/169 fl oz container or 20 L/676 fl oz container intended for use with appropriate automatic dosing equipment.
Restricted Drug (California) - Use Only as Directed.
Made in the UK.
Manufactured by:
Norbrook Laboratories Limited
Newry, BT35 6PU, Co. Down, Northern Ireland.
™ Eprizero is a trademark of Norbrook Laboratories Limited.
121670I01Norbrook®
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Principal Display Panel - Eprizero Pour-On Front Label
NDC: 55529-156-08
Eprizero™
(eprinomectin)
POUR-ON for Beef and Dairy Cattle
Parasiticide
Contains 5 mg eprinomectin/mL
For Treatment and Control of Internal and External Parasites
Residue Information:
Not for use in calves to be processed for veal.
Zero Slaughter Withdrawal
Zero Milk Discard
ANADA 200-563, Approved by FDA
5L (169 fl oz)
321670L01
Norbrook®
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Principal Display Panel - Eprizero Pour-On Carton Label
NDC: 55529-156-08
Eprizero™
(eprinomectin)
POUR-ON for Beef and Dairy Cattle
Parasiticide
Contains 5 mg eprinomectin/mL
For Treatment and Control of
Internal and External ParasitesResidue Information:
Not for use in calves to be processed for veal.
Zero Slaughter Withdrawal
Zero Milk Discard
ANADA 200-563, Approved by FDA
5L (169 fl oz)
Contains 200 Doses (550 lb)
Norbrook®
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INGREDIENTS AND APPEARANCE
EPRIZERO
eprinomectin solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC: 55529-156 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength eprinomectin (UNII: 75KP30FD8O) (eprinomectin - UNII:75KP30FD8O) eprinomectin 5 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 55529-156-06 1 in 1 CARTON 1 1000 mL in 1 BOTTLE, PLASTIC 2 NDC: 55529-156-07 1 in 1 CARTON 2 2500 mL in 1 BOTTLE, PLASTIC 3 NDC: 55529-156-08 1 in 1 CARTON 3 5000 mL in 1 BOTTLE, PLASTIC 4 NDC: 55529-156-09 20000 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200563 01/16/2017 Labeler - Norbrook Laboratories Limited (214580029) Establishment Name Address ID/FEI Business Operations Norbrook Laboratories Limited 232880554 MANUFACTURE, ANALYSIS
Trademark Results [Eprizero]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPRIZERO 86325674 5332327 Live/Registered |
Norbrook Laboratories Limited 2014-07-01 |
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