Eprinex Pour-on for Beef and Dairy Cattle is used for the treatment of and control of gastro-intestinal worms (including inhibited Ostrtagia ostertagia and Cooperia spp.), lungworms, warbles, sucking and biting lice, chorioptic and sarcoptic mange mites in beef and dairy cattle. Eprinex Pour-on boasts a very short withdrawl time for beef cattle and no withdrawl time for dairy cattle.
Active Ingredient: Eprinomectin
Target Species: Cattle
Treats and Controls: Gastro-intestinal worm, lungworm, sucking and biting lice and mange mites
Administration Method: Pour-On
Withdrawal Time: 28 days for cattle intended for meat and offal, there is no withdrawal time for cattle producing milk for human consumption.
Dosage: 1 ml per 10 kg of bodyweight.
|Body Weight||Dose Volume||Number of full doses per pack:|
|250 ml||1 Litre||2.5 Litre||5 Litre|
Always read the label and all enclosed information for Eprinex Pour-on before administering to animals!
Trials demonstrate that treatment of lactating dairy cows with Epinex Pour-on can increase milk yield by up to 2 litres per cow per day.
• Treatment with EPRINEX increased milk production:
• Over the whole lactation treated cows produced:
– 63 L more milk
– 2.8 kg more protein
– 2.8 kg more milk fat.
• Treatment cost was recouped within 50 days of calving, with the
treatment investment trebled by the end of lactation.
"The Power To Produce Your Best"
This Product is only licensed for sale in the Republic of Ireland
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eprinex 0.5% w/v Pour-on Solution for Beef and Dairy Cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see Section 6.1
Eprinomectin 0.5% w/v
3 PHARMACEUTICAL FORM
Clear, slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 Target Species
Beef and dairy cattle.
Eprinomectin 0.5% w/v
4.2 Indications for use, specifying the target species
Eprinex Pour-on for Beef and Dairy Cattle is indicated for effective treatment and control of the following parasites:
Gastrointestinal roundworms (adults and fourth-stage larvae)
Ostertagia lyrata (adults only)
Ostertagia ostertagi (including inhibited L4)
Cooperia spp. (including inhibited L4)
Oesophagostomum spp. (adults only)
Trichuris spp (adults only)
Dictyocaulus viviparus (adults and L4)
Warbles (parasitic stages)
Sarcoptes scabiei var.bovis
Damalinia bovis (biting lice)
Linognathus vituli (sucking lice)
Haematopinus eurysternus (sucking lice)
Solenopotes capillatus (sucking lice)
Eprinex Pour-on for Beef and Dairy Cattle, applied as recommended, effectively controls reinfections with Ostertagia
spp. (including O. ostertagi and O. lyrata), Cooperia spp. (including C. oncophora, C. punctata and C. surnabada),
Nematodirus helvetianus, Oesophagostomum radiatum and Dictyocaulus viviparus for up to 28 days after treatment
and Haemonchus placei and Trichostrongylus spp. (including T.axei and T. colubriformis) for up to 21 days after
treatment. Eprinex Pour-On for Beef and Dairy Cattle controls Haematobia irritans (horn flies) for at least 7 days after
treatment. For the best results Eprinex Pour-On should be part of a programme to control both internal and external
parasites of cattle based on the epidemiology of these parasites.
This product is formulated only for topical application for beef and dairy cattle, including lactating dairy cattle.
Do not use in other animal species. Do not administer orally or by injection.
Do not apply to areas of the backline covered with mud or manure.
Do not use in animals with known hypersensitivity to the active ingredient.
4.4 Special warnings for each target species
4.5 Special precautions for use
Special precaution(s) for use in animals
The details provided in 4.10 apply.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure
occurs, flush eyes immediately with water.
Do not smoke or eat while handling the product.
Wash hands after use.
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
Eprinex Pour-On for Beef and Dairy Cattle may be used in dairy cattle during all stages of lactation.
Studies have demonstrated a wide safety margin.
Studies conducted at three times the recommended use level of 0.5 mg Eprinomectin/kg b.w. had no adverse effect on
breeding performance of cows or bulls.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
Administer only by topical application at the dose rate of 1ml of Eprinex Pour-On for Beef and Dairy Cattle per 10 kg
of body weight, corresponding to the recommended dose rate of 0.5 mg eprinomectin per kg b.w. The product should
be applied along the backline in a narrow strip extending from the withers to the tailhead. The following dosing packs
Squeeze-Measure-Pour System (250 ml and 1 litre bottles)
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. Tilt the bottle to deliver the dose. For the 1 litre bottle;
when a 100 kg (10 ml) or 150 kg (15 ml) dose is required, turn the pointer to "STOP" before delivering the dose.
The off (STOP) position will close the system between dosing.
Back-pack (2.5 and 5 litre packs)
Connect the dosing gun and draw-off tubing to the back-pack as follows.
Attach the open end of the draw-off tubing to an appropriate dosing gun.
Attach the draw-off tubing to the cap with the stem that is included in the pack. Replace shipping cap with the cap
having the draw-off tubing.
Tighten the draw-off cap.
Gently prime the dosing gun, checking for leaks.
Follow the dosing gun manufacturer's directions for adjusting the dose and proper use and maintenance of the dosing
gun and draw-off tubing.
Rainfall before or after treatment will not affect the efficacy of the product.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No signs of toxicity appeared when 8-week old calves were treated at up to 5x the therapeutic dose (2.5 mg
Eprinomectin/kg b.w.) 3 times at 7-day intervals.
One calf treated once at 10x the therapeutic dose (5 mg/kg b.w.) in the tolerance study showed transient mydriasis.
There were no other adverse reactions to treatment.
No antidote has been identified.
Meat and Offal: 15 days
Milk: Zero hours/days
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
ATCvet code: QP54AA04
5.1 Pharmacodynamic properties
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 or 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 gammaaminobutyric
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.
5.2 Pharmacokinetic properties
The bioavailability of topically applied eprinomectin in cattle is about 30% with most absorption occurring by about 10
days after treatment. Eprinomectin is not extensively metabolized in cattle following topical administration. In all
biological matrices, the B1a component of eprinomectin is the single most abundant residue.
The contribution of eprinomectin B1a to the total radioresidue level remained relatively constant between 7 days and 28
days after treatment - for example, between 84% and 90% in liver, the proposed principal target tissue.
Maximum plasma concentration
In beef cattle treated topically with radiolabelled eprinomectin at the recommended dose of 0.5 mg/kg bodyweight,
there was no distinct peak in the plasma radioactivity versus time curve, but a broad plateau occurred between 9 and 14
days after dosing. Highest concentrations of eprinomectin B1a were in the range of 7.33 - 19.74 ng/ml.
In lactating dairy cows treated topically with 0.75 mg radiolabelled eprinomectin/kg bodyweight, some animals showed
a distinct peak in plasma radioactivity levels, whereas others exhibited a broad plateau. Peak levels of eprinomectin
B1a were in the range of 42.7 - 134.4 ng/ml. The highest levels of plasma radioactivity occurred between one and 7
days after dosing.
The level of total residues in tissues of beef cattle and lactating dairy cows was of the same order with
The distribution of total residue in edible tissues differs from that seen with other macrocyclic lactones such as
abamectin and ivermectin. For these compounds, residue concentrations in fat were much closer to those in liver, and
fat contained significantly higher total residue concentrations than kidney, whereas the eprinomectin residue
concentrations in fat were much lower than those in liver and kidney.
The half-life for depletion of total residue was about 8 days for all 4 tissues in cattle. Eprinomectin B1a concentration
depleted at a similar rate to that of total residue.
Twenty dairy cows were treated with unlabelled eprinomectin at the recommended dose of 0.5 mg/kg of bodyweight.
The maximum concentration of eprinomectin B1a in milk ranged from < 2.3 ng/ml (the limit of quantitation) to 11.36
ng/ml, with the peak occurring 2-3 days after treatment in most of the animals.
Faeces was the major route of elimination of the drug in beef cattle and dairy cows.
In beef cattle, faeces and urine were collected from 2 steers, and the amount of drug excreted up to 28 days after dosing
was determined as 15 - 17% and 0.25 % in faeces and urine, respectively.
A further 53 - 56% of the dose was recovered from the skin at the application site collected from 3 animals sacrificed at
28 days after dosing.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Propylene glycol octanoate decanoate
Shelf life of the veterinary medicinal product as packaged for sale:
6.4 Special precautions for storage
Do not store above 30°C. Store bottle or pack in the original carton in order to protect from light.
6.5 Nature and composition of immediate packaging
Eprinex Pour-on for Beef and Dairy Cattle is available in four pack sizes - 250 ml, 1litre, 2.5 litre and 5 litre.
HPDE with HDPE lid.
The 250 ml bottle uses a 25 ml dispenser. Each bottle contains sufficient solution to treat 10 head of
250 kg cattle.
The 1 litre bottle uses a 50 ml dispenser. Each bottle contains sufficient solution to treat 40 head of
250 kg cattle.
The 2.5 litre pack is a back-pack designed for use with a suitable automatic dispensing gun. Each
pack contains sufficient solution to treat 100 head of 250 kg cattle.
The 5 litre pack is a back-pack designed for use with a suitable automatic dispensing gun. Each pack
contains sufficient solution to treat 200 head of 250 kg cattle.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Do not contaminate lakes or streams, as free eprinomectin may adversely affect fish and certain water-borne organisms.
Studies indicate that when eprinomectin comes in contact with the soil, it readily and tightly binds to the soil and
Any unused product or waste material should be disposed of in accordance with national requirements.
7 MARKETING AUTHORISATION HOLDER
Merial Animal Health Limited,
Harlow Business Park,
Essex, CM19 5TG,
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18th May 2007
10 DATE OF REVISION OF THE TEXT
15th February 2010
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