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Eprizero Pour-On (Eprinomectin)

Eprizero Pour-On (Eprinomectin)

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Eprizero Pour-on for cattle is a ready to use pour-on solution that is used in the treatment and gastrointestinal roundworms, lungworms, warbles, mange mites and lice. Eprizero Boasts a zero hour withdrawal time for dairy cattle and a reduced withdrawal time of 10 days for beef cattle.

Active Ingredient: Eprinomectin

Target Species: Beef Cattle, Dairy Cattle

Treats and Controls: Gastrointestinal roundworm, lungworm, warbles, lice, mange mites

Administration Method: Pour-On

Withdrawal Time:10 days for cattle intended for meat and offal, zero hours for cattle producing milk for human consumption

Dosage for cattle: 1 ml per 10 kg of bodyweight.

Body WeightDose VolumeNumber of full doses per pack:
2.5 Litre5 Litre
50kg5 ml5001000
100kg10 ml250500
150kg15 ml166333
200kg20 ml125250
250kg25 ml100200
300kg30 ml83166
350kg35 ml71142
400kg40 ml62125
450kg45 ml55111
500kg50 ml50100
550kg55 ml4590
600kg60 ml4183

Always read the label and all enclosed information for Eprizero before administering to animals!

Advantages of usingEprizeroPour-on

Increase on milk production: Studies have shown that cattle treated withEprizerocan have an increase in their milk yield of up to 2 litres per animal per day.

Increased weight gain: Cattle treated with Eprizero  have also been shown to graze for up to an hour longer every day. This leads to improved weight gain as well as improved milk yields.

Improved body conditions: The increase in grazing times leads also to an increase in the nutrients consumed by cattle. This increase in nutrients leads to healthier cattle with increased body conditions.

Improved fertility rates: The elimination of parasites and the improved overall health of the cattle will lead to increased fertility rates. Herds treated with Eprizero have shown increases of up to 20% in conception rates in the first year alone.

This product is only licensed for sale within the Republic of Ireland

Data Sheet

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eprizero 5 mg/ml Pour-On Solution for Beef and Dairy Cattle.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains:
Active Substance:
Eprinomectin 5 mg
Excipients:
Butylated Hydroxytoluene (E321) 0.1 mg
For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Pour-on solution.
A clear to very light yellow solution.
4 CLINICAL PARTICULARS
4.1 Target Species
Beef and dairy cattle.
1 ml of solution contains:
Active Substance:
Eprinomectin 5 mg
Excipients:
Butylated Hydroxytoluene (E321) 0.1 mg
For a full list of excipients, see section 6.1.

4.2 Indications for use, specifying the target species
Indicated for the treatment and prevention of the following parasites:
Gastrointestinal Roundworms (adults and fourth stage larvae):
Ostertagia spp., Ostertagia lyrata (adult), Ostertagia ostertagi (including inhibited O. ostertagi), Cooperia spp.
(including inhibited Cooperia spp.), Cooperia oncophora, Cooperia pectinata, Cooperia punctata, Cooperia
surnabada, Haemonchus placei, Trichostrongylus spp., Trichostrongylus axei, Trichostrongylus colubriformis,
Bunostomum phlebotomum, Nematodirus helvetianus, Oesophagostomum spp. (adult), Oesophagostomum radiatum,
Trichuris spp. (adult).
Lungworms (adults and fourth stage larvae):
Dictyocaulus viviparus
Warbles (parasitic stages):
Hypoderma bovis, H. lineatum
Mange Mites:
Chorioptes bovis, Sarcoptes scabiei var bovis
Lice:
Damalinia bovis (biting lice), Linognathus vituli (sucking lice), Haematopinus eurysternus (sucking lice),
Solenopotes capillatus (sucking lice).
Horn Flies:
Haematobia irritans.
Prolonged Activity
Applied as recommended, the product prevents reinfections with:
Parasite * Prolonged Activity
Dictyocaulus viviparus up to 28 days
Ostertagia spp up to 28 days
Oesophagostomum radiatum up to 28 days
Cooperia spp up to 21 days
Trichostrongylus spp up to 21 days
Haemonchus placei up to 14 days
Nematodirus helvetianus up to 14 days
*The following parasite species are included within each of the relevant genera: Ostertagia ostertagi, O. lyrata,
Cooperia oncophora, C. punctata, C. surnabada, Trichostronglus axei, T. colubroformis.

4.3 Contraindications
This product is formulated only for topical application to beef and dairy cattle, including lactating dairy cattle. Do not
use in other animal species. Do not administer orally or by injection.
Do not use in animals with known hypersensitivity to the active ingredient or any of the excipients.

4.4 Special warnings for each target species
The details provided in section 4.10 apply.
If there is a risk for re-infestation, the advice of a veterinarian should be sought regarding the need for and frequency of
repeat administration.
Care should be taken to avoid the following practices because they increase the risk of development of resistance and
could ultimately result in ineffective therapy:
- Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
- Underdosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of
calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal
Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an
anthelmintic belonging to another pharmacological class and having a different mode of action should be used.
To date no resistance to eprinomectin (a macrocyclic lactone) has been reported within the EU. However resistance to
other macrocyclic lactones has been reported in parasite species in cattle within the EU. Therefore, use of this product
should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and
recommendations on how to limit further selection for resistance to anthelmintics.
While mite and louse numbers decline rapidly following treatment, due to the feeding habits of the parasites, in some
cases several weeks may be required for complete eradication.
For effective use, the product should not be applied to areas of the backline covered with mud or manure.

4.5 Special precautions for use
i. Special precautions for use in animals
Not to be used in other species; avermectins can cause fatalities in dogs.
The product should be applied only to healthy skin.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to
animals
This product may be irritating to human skin and eyes and may cause hypersensitivity.
Avoid skin and eye contact with the product during treatment and when handling recently treated animals.
Users should wear rubber gloves, boots and a waterproof coat when applying the product.
Should clothing become contaminated, remove as soon as possible and launder before re-use.
If accidental skin contact occurs, wash the affected area immediately with soap and water.
If accidental eye exposure occurs, flush eyes immediately with water.
This product may be toxic after accidental ingestion.
Avoid accidental ingestion of the product by hand to mouth contact.
Do not smoke, eat or drink while handling the product.
In the event of ingestion, wash out mouth with water and seek medical advice.
Wash hands after use.
This product is flammable. Keep away from sources of ignition.
Inhalation of the product may cause irritation.
Use only in well ventilated areas or outdoors.
iii. Other precautions
Eprinomectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.
The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of
eprinomectin (and products of the same anthelmintic class) in cattle.
The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to four
weeks after treatment.

4.6 Adverse reactions (frequency and seriousness)
No undesirable effects have been identified when the product is used at the recommended dose rate.

4.7 Use during pregnancy, lactation or lay
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
None known.

4.9 Amounts to be administered and administration route
Administer only by topical application at the dose rate of 1 ml 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 topically by pouring along
the backline in a narrow strip extending from the withers to the tailhead.
Rainfall at anytime before or after treatment will not affect the efficacy of the product.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the
dosing device (dosing cup or dosing gun delivery system) should be checked.
For best results use as part of a program to control both internal and external parasites of cattle based on the
epidemiology of these parasites.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In adult cattle, after administration of 5 times the recommended dose (2.5 mg eprinomectin/kg body weight), mild hair
loss was observed. No other signs of toxicity were seen.
No antidote has been identified.

4.11 Withdrawal Period(s)
Meat & offal: 10 days
Milk: zero hours.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Avermectins.
ATC Vet Code: QP54AA04

5.1 Pharmacodynamic properties
Mode of action
Eprinomectin is a member of the macrocyclic lactone class of endectocides. 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 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.

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.
Eprinomectin consists of the components B1a ( 90 %) and B1b ( 10 %) which differ by a methylene unit and is not
extensively metabolized in cattle. Metabolites amount to approximately 10% of the total residues in plasma, milk,
edible tissues and faeces.
The metabolism profile is nearly identical, qualitatively and quantitatively, in the above biological matrices and does
not change significantly with time after administration of eprinomectin. The percent contribution of B1a and B1b to the
overall metabolite profile remains constant. The ratio of the two drug components in the biological matrices is identical
to that in the formulation demonstrating that the two eprinomectin components are metabolized with nearly equal rate
constants. Since the metabolism and the tissue distribution of the two components are quite similar, the
pharmacokinetics of the two components would be also similar.
Eprinomectin is strongly linked to plasma proteins (99 %). Faeces is the major route of elimination.

5.3 Environmental properties
Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms. Following
treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks. Faeces
containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms
which may impact on the dung degradation.
Eprinomectin is very toxic to aquatic organisms and may accumulate in sediments.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Butylated Hydroxytoluene (E321)
Cetearyl Ethylhexanoate and Isopropyl Myristate
Propylene Glycol Dicaprylocaprate
Denatonium Benzoate
Isopropyl Alcohol

6.2 Incompatibilities
No major incompatibility has been identified.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.
Shelf-life after first opening the immediate packaging: 3 months
6.4 Special precautions for storage
Do not store above 30°C. Keep container in the outer carton. Protect from light.

6.5 Nature and composition of immediate packaging
Translucent 250 mL and 1 L HDPE containers with integral squeeze measure pour system and white HDPE screw caps.
White 1 L, 2.5 L and 5 L HDPE backpacks and white polypropylene screw caps.
Not all packs sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be
disposed of in accordance with local requirements.
Extremely dangerous to fish and aquatic life. Do not contaminate ponds, waterways or ditches with the product or
empty container.

7 MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Station Works
Newry
Co. Down
BT35 6JP
Northern Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA: 10999/142/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
1st March 2013

10 DATE OF REVISION OF THE TEXT
October 2013
 

Delivery

 

Delivery Information

Here at Agridirect we have joined forces with DPD to ensure all packages are delivered promptly and safely to you. We ship to all mainland countries within the EU. Deliveries take place Monday to Friday excluding bank holidays. Once your order has been dispatched from our warehouse you will be notified by email. If there is a delay with your order for any reason you will be contacted immediately. 

Delivery Times
Ireland (ROI & NI)United Kingdom (Mainland Only)EU (Mainland Only)
1-3 Working Days2-4 Working Days4-6 Working Days

Some product have an extended delivery time, this is noted on the products.

Delivery Rates

Delivery Rates
CountryOrders Under €70Orders Over €70
Ireland (ROI & NI)€4.99€0.00
Austria€17.99€13.00
Belgium€14.99€10.00
Czech Republic€17.99€13.00
Denmark€17.99€13.00
Finland€29.99€25.00
France€14.99€10.00
Germany€14.99€10.00
Hungary€21.99€17.00
Italy€27.99€23.00
Luxenburg€14.99€10.00
Netherlands€14.99€10.00
Poland€14.99€13.00
Portugal€29.99€25.00
Slovakia€21.99€17.00
Slovenia€21.99€17.00
Spain€27.99€23.00
Sweden€27.99€23.00
United Kingdom (Mainland Only)€14.99€10.00

 

 

A selection of the products we sell are only licensed for sale within the Republic Of Ireland and can not be shipped outside of the country. These products are noted as only being available within the Republic of Ireland on the individual product pages

There may be an addition charge on certain bulky items. This charge will be clearly marked on an applicable products and will be explained on the checkout page before payment has been made.

 

Returns

Returns Policy

We’re sorry your purchase didn’t work out. But don’t worry; we have a great returns policy to help you out.
 

All purchases can be returned to us within 14 days of delivery and returned goods must be received within 14 days from the date you informed us of the return.
 

Purchases may be opened for inspection but must not be used and must be repackaged securely in the original packaging if you wish to return it.
 

If we discover goods have been used or there has been a loss in value of the goods due to damage to the goods, while in your care or whilst being returned to us, we will reduce the amount refunded, which may amount to the full cost of the product, to cover loss of value of goods.
 

We accept no responsibility for goods damaged or lost while in transit to us. 
 

The cost of the return, including all packaging and freight, lies solely with the consumer.
 

I have received a damaged product from you, what should I do?

First off, if you have received a damaged electrical product from us, do not plug it in. Any electrical products that are plugged in are deemed ‘as used and accepted’ and are not accepted as returns. All damages must be reported to us via phone or email within 24hours of receipt of goods. Please ensure you check your items upon delivery.

How do I begin the returns process?

If you wish to begin the return process, please email us at sales@agridirect.ie and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.

Once you have sent us all required information a member of our team will assess your claim and will contact you as soon as possible. Please hold off on returning products until a member of our team has called you to confirm.

 

Packaging

All returns must be the complete product which includes boxes, manuals and accessories that may have been include with the order.

All returns must be packaged appropriately for shipping, we will not accept responsibility for damages or loss which occur during shipping of a return product.
 

Address: Please ship the product to the following address: Agridirect, Drumrahan Retail, Church Street, Ballyconnell, Co Cavan
 

Refunds

Once the returned product has been returned to us and fully inspected a refund will be issued.

Please Note: A typical timeline for a refund to show in your account is up to 10 working days from the date processed, depending on your bank.

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