IVOMEC® EPRINEX®
(eprinomectin) Pour-On for Beef and Dairy CattleParasiticide-Topical
Parasiticide
NADA No.: 141-079
Active Ingredient(s): Contains 5 mg eprinomectin/mL.
Indications: IVOMEC® EPRINEX® (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, IVOMEC® EPRINEX® 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: IVOMEC® EPRINEX® (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.
Pharmacology: 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.
Dosage and Administration: Dosage: The product is formulated only for external
application to beef and dairy cattle. The dose rate is 1 mL/10 kg (22 lb) of body weight.
The product should be applied topically along the backline in a narrow strip extending
from the withers to the tailhead.
Administration:
Squeeze-Measure-Pour System (250 mL/8.5 fl oz Bottle with 25 mL Metering Cup):
Attach the metering cup to the bottle.
Set the dose by turning the top section of the cup to align the correct body weight
with the pointer on the knurled cap. When body weight is between markings, use the higher
setting.
Hold the bottle upright and 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. The off
(Stop) position will close the system between dosing. Tilt the bottle to deliver the dose.
Squeeze-Measure-Pour System (1 Liter/33.8 fl oz Bottle with 50 mL Metering Cup):
Attach the metering cup to the bottle.
Set the dose by turning the top section of the cup to align the correct body weight
with the pointer on the knurled cap. When body weight is between markings, use the higher
setting.
Hold the bottle upright and 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. When a
220 lb (10 mL) or 330 lb (15 mL) dose is required, turn the pointer to
"Stop" before delivering the dose. The off (Stop) position will close the system
between dosing. Tilt the bottle to deliver the dose.
Collapsible Pack (2.5 L/84.5 fl oz and 5 L/169 fl oz Packs):
Connect the dosing gun and draw-off tubing to the collapsible pack as follows:
Attach the open end of the draw-off tubing to an appropriate dosing applicator. Attach
the draw-off tubing to the cap with the stem that is included in the pack. Replace the
shipping cap with the cap having the draw-off tubing.
Gently prime the dosing applicator, checking for leaks. Follow the dosing applicator
manufacturer's directions for adjusting the dose and proper use and maintenance of the
dosing applicator and draw-off tubing.
Consult your veterinarian for assistance in the diagnosis, treatment and control of
parasitism.
Contraindication(s): IVOMEC® EPRINEX® (eprinomectin) 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.
Precaution(s): Store bottle or pack in the carton to protect from light and at
temperatures up to 86°F/30°C. Storage at temperatures up to 104°F/40°C is permitted
for a short period of time, however, such exposure should be minimized.
Environmental Safety: Studies indicate that when eprinomectin comes in contact with the
soil it readily and tightly binds to the soil and becomes inactive. Free eprinomectin may
adversely affect fish and certain aquatic organisms. 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.
Caution(s): 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.
Warning(s): Residue Information: 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 IVOMEC® EPRINEX® (eprinomectin)
Pour-On may be used for human consumption at any time following treatment.
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 Merial at 1-800-637-4251.
Adverse Reactions: No adverse reactions were observed during clinical trials.
Discussion: Use Conditions: Varying weather conditions, including rainfall, do
not affect the efficacy of IVOMEC® EPRINEX® Pour-On.
Management Considerations for Treatment of External Parasites: For best results
IVOMEC® EPRINEX® 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 IVOMEC® EPRINEX®
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 IVOMEC® EPRINEX® (eprinomectin)
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.
When to Treat Cattle with Grubs: IVOMEC® EPRINEX® Pour-On is highly 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 IVOMEC® EPRINEX® Pour-On at the end of the fly season may be
re-treated with IVOMEC® EPRINEX® 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.
Trial Data: 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.
Presentation: IVOMEC® EPRINEX® (eprinomectin) Pour-On for Beef and Dairy
Cattle is available in a 250 mL/8.5 fl oz or 1 L/33.8 fl oz bottle with a
squeeze-measure-pour system, or in a 2.5 L/84.5 fl oz or 5 L/169 fl oz
collapsible pack intended for use with appropriate automatic dosing equipment.
® IVOMEC and EPRINEX are registered trademarks of Merial.
U.S. Pat. 4427663 and 5602107
Disclaimer: Every effort has been made to ensure the accuracy of the
information published. However, it remains the responsibility of the readers to
familiarize themselves with the product information contained on the product label or
package insert. Compendium Code No.: 08491033
