Animec Oral Drench (Ivermectin)

Animec oral drench is an ivermectin based wormer for sheep. Animec is used for the treatment and control of gastro-intestinal worms, lungworms and nasal bots.

Active Ingredient: Ivermectin

Target Species: Sheep

Treats and Controls: Gastro-intestinal worms, lungworms, nasal bots

Administration Method: Oral drench

Withdrawal Time: 10 days for sheep intended for meat and offal. Not permitted for use on sheep producing milk for human consumption

Dosage for sheep: 2.5 ml per 10 kg of bodyweight.

Always read the label and all enclosed information for Animec Oral Suspension before administering to animals!

Commonly asked questions about Animec Drench

Q. Will Animec  kill worms that are resistant to control by white drenches?

A. Yes. Animec is routinely used in wormer rotation programmes. Also, it is often used to treat sheep that are brought in from market and neighbouring farms where the worming history is either not known or may be in doubt. It makes sense to treat all sheep with Animec and keep them isolated, preferably on hard standing, for 48 hours before mixing them with the main flock.

Q. Will Animec control inhibited time-bomb worms and help prevent the spring rise?

A. Yes. Treat the ewes just before you house the sheep or just prior to lambing. This will kill the dormant worms in the sheep that would emerge in the spring and contaminate pasture at the time when lambs are beginning to graze.

How sheep contract worms:

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

Click here to Download Data Sheet

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Animec 0.8 mg/ml Oral Solution for Sheep.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each ml contains:
Ivermectin 0.8mg

Excipient(s):
Benzyl Alcohol (E1519) 28.6mg
Butylhydroxyanisole (E320) 0.10 mg
Propyl Gallate (E310) 0.10 mg
For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Oral Solution.
A transparent, yellow coloured solution.

4 CLINICAL PARTICULARS
4.1 Target Species
Sheep.

4.2 Indications for use, specifying the target species
For the treatment of infections with the following parasites:
Nematodes

Gastrointestinal roundworms (adult and fourth larval stage)
Haemonchus contortus
Teladorsagia circumcincta
Trichostrongylus spp.
Cooperia spp.
Nematodirus spp.
Including N. battus
Strongyloides papillosus
Chabertia ovina

Lungworms(adult and fourth larval stage)
Dictyocaulus filaria
Arthropods

Nasal bot (all larval stages)
Oestrus ovis

4.3 Contraindications
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
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 body weight or misadministration of the product.
Resistance to ivermectin (an avermectin) has been reported in Teladorsagia in sheep and goats within the EU and it is common in Haemonchus in sheep outside the EU.
Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematode and recommendations on how to limit further selection for resistance to anthelmintics.

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.
There is cross-resistance with other avermectins and with milbemycins.


4.5 Special precautions for use
(i) Special precautions for use in animals
The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing programme should be established by the veterinary surgeon.
Veterinary advice should be sought on appropriate dosing programmes and stock management to achieve adequate parasite control, and to reduce the likelihood of anthelmintic resistance developing.
Veterinary advice should also be sought if the product does not achieve the desired clinical effect, as other diseases, nutritional disturbances or anthelmintic resistance might be involved.

Avermectins may not be well tolerated in non-target species. Cases of intolerance resulting in fatalities have been reported in dogs, especially Collies, Old English Sheep Dogs and related breeds or crosses, and also in turtles/tortoises.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after use.
Avoid contact with skin and eyes.
Do not eat, drink or smoke while handling the product.
Wear impervious gloves when handling or administering the product.
As absorption through skin can occur, in the event of accidental skin contact, wash the affected area immediately with soap and water.
If accidental eye exposure occurs, flush the eyes immediately with water.

(iii) Other precautions
None known.

4.6 Adverse reactions (frequency and seriousness)
Some sheep may cough immediately after treatment.
This passing response is of no consequence.

4.7 Use during pregnancy, lactation or lay
The veterinary medicinal product can be administered to ewes at any stage of pregnancy or lactation. See Section 4.11

4.8 Interaction with other medicinal products and other forms of interaction
None known. 

4.9 Amounts to be administered and administration route
For oral administration only.
The recommended dose rate is 0.2 mg ivermectin per kg bodyweight (corresponding to 2.5 ml per 10 kg bodyweight) To ensure administration of a correct dose, body weight should be determined as accurately as possible.
Accuracy of the dosing device should be checked.
If animals are to be treated collectively rather than individually they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or over- dosing.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
At doses up to 4 mg ivermectin per kg administered by stomach tube (20x the recommended dose level) undesirable toxic reactions occurred.
Acute symptoms (ataxia, staggering gait, incoordination, depression) were observed at the dose rate of 8 mg/kg (40x the recommended dose level) during a study carried out on 4 animals.
Twenty-four hours later, the animals showed only mild incoordination and depression.
Three days post dose all the animals were nearly normal.
It is possible that the signs of toxaemia were due to the propylene glycol. No antidote has been identified. Symptomatic treatment may be beneficial.

4.11 Withdrawal Period(s)

Meat and offal: 10 days.
Milk: Do not use in lactating sheep producing milk for human consumption.
Sheep must not be treated within 60 days prior to the commencement of lactation, if milk is to be used for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group:
Endectocides, avermectins

ATCvet code:
QP54AA01.

5.1 Pharmacodynamic properties
Ivermectin belongs to the avermectin family, which are a macrocyclic lactone group of endectocides.
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 grated by the neurotransmitter gammaaminobutyric 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 maximum plasma concentration is reached in 12 hours after oral administration and ranges from 6.3 to 17.9 ng/ml at the dose rate of 0.2 mg ivermectin per kg bodyweight.
This concentration gradually decreases to range from 1.31 to 10.55 ng/ml 2 days post dose with a terminal half-life of 42.4 hours.
Ivermectin binds extensively to plasma proteins.
Due to its high lipophilic nature, Ivermectin is extensively distributed. It tends to accumulate in fat tissue, which acts as a drug reservoir and the highest levels of Ivermectin are found in liver and fat. Ivermectin is only partially metabolized.
Ivermectin is mainly eliminated in the faeces as unaltered drug and faecal excretion accounts for 90% of the dose administered with <2% of the dose excreted in urine. Ivermectin is also excreted by the mammary gland.

Environmental Properties
None known.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Butylhydroxyanisole (E320)
Propyl Gallate (E310)
Benzyl Alcohol (E1519)
Propylene Glycol
Disodium Edetate
Polysorbate 80
Disodium Hydrogen Phosphate Dihydrate
Sodium Dihydrogen Phosphate Monohydrate
Purified Water

6.2 Incompatibilities
None known.

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the container: 18 months.

6.4 Special precautions for storage
Do not store above 30ºC.

6.5 Nature and composition of immediate packaging
White flat-bottomed flexi packs (1L, 2.5L, 5L and 6L (5L + 1L)) composed of high density polyethylene container, with a 38 mm tamper evident polypropylene cap.
Standard containers (jerri-cans) (1L, 2.5L, 5 L and 10L ) composed of high density polyethylene container, with tamper evident polyethylene cap.
Pack sizes (flexi pack): 1, 2.5 , 5L and 6L (5L+1L) Pack sizes (jerri-cans): 1, 2.5, 5L and 10 Litre Not all pack sizes may be marketed. 

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate surface waters or ditches with product or used container.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER
Chanelle Pharmaceutical Manufacturing Limited,
Loughrea,
Co. Galway,
Ireland.

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10987/070/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 29th May 2009
Date of last renewal: 3rd November 2014

10 DATE OF REVISION OF THE TEXT

Drench correctly
Sheep Oral Drench
The drenching technique is a vital part of ensuring that the wormer does its job effectively.
Make sure the sheep are properly restrained and cannot leap around when they are being drenched so they swallow the whole amount.
Sheep can also suffer serious injury, or even death, if they are unrestrained and the gun penetrates the tissues at the back of the mouth.
Place a hand under the head and tilt slightly to the side.
Slot the nozzle in the gap between molar and incisor teeth and then over the back of the tongue.
If the wormer is just put into the mouth, it will bypass the rumen as it escapes down the oesophageal groove and will be less effective.
This is particularly important for white (BZ) drenches.

Dosing Weigh – do not guess Underestimating the weight of sheep is a common cause of underdosing. Select and weigh the biggest sheep in the group to determine the correct dose. If there is a wide range of weights, consider splitting the group, then weigh the heaviest in each section. Do not forget to check that the weigh crate is accurate before starting!

Calibrate and maintain the drench gun
Always check the gun is delivering the right amount before you drench. Remove the plunger from a 10 ml syringe, put a thumb over the end and squirt the dose into it, making sure there are no air bubbles left. Adjust the gun until the dose delivered is correct. Drenching guns should also be well maintained and replaced regularly. Clean with warm soapy water after use and check springs and tubes to make sure there are no kinks that will form air bubbles.

Withholding food
Research has shown that the efficacy of the white (BZ) and clear (AV) drenches can be improved by withholding food for 12–24 hours before treatment. It is not advised to deprive heavily pregnant ewes of food, so if you treat this class of stock with anthelmintics, you may wish to use yellow drenches (LV) because their efficacy is less dependent on rumen fill.

Storage
Wormers should be stored securely, away from direct sunlight at 4–25°C. Check the use-by date and, once open, use within the time shown on the packaging. Shake white (BZ) products well before use.

Ivermectin is a semi-synthetic antiparasitic medication derived from avermectins, a class of highly active broad-spectrum antiparasitic agents isolated from the fermentation products of Streptomyces avermitilis. 
Ivermectin itself is a mixture of two avermectins, comprising roughly 90% 5-O-demethyl-22,23-dihydroavermectin A1a (22,23-dihydroavermectin B1a) and 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro­-25-(1-methylethyl) avermectin A1a (22,23-dihydroavermectin B1b).

Delivery Information

Delivery Service

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. 

Due to Brexit we are temporarily unable to ship to the UK. Shipping to Northern Ireland will remain in place.

Delivery Times

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

Delivery Rates

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.

Agridirect 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.

All returns should be complete which includes boxes, manuals and accessories that may have been included 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.

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

How do I return a product?

We have partnered with DPD to make your returns process easy and secure. simply follow the steps below and bring your package to an official DPD pickup point.

1) All returns must be accompanied with a fully filled out returns form which can be downloaded here.

2) To print off your return label click here or visit www.dpd.ie/returns and follow the on-screen instructions. Make sure and use your order number as your reference.

• Select “Continue as Guest”
• Select “Agridirect” from the drop-down menu
• Select your reason for returning
• Select the size of the package you wish to return
• Accept DPD’s terms and conditions
• Fill in your payment details
• Fill in your own details
• Follow the instructions to print off your label

3) Bring your package to a DPD pickup point. To find your nearest drop off point here.

Once the returned product has been received into our warehouse and been fully inspected a refund will be issued.

If you choose not to use the DPD returns service we recommend that you use a method that can be tracked.

For the return of bulk products please contact us at sales@agridirect.ie

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.

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.