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Health Products Regulatory Authority 

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Endospec 2.5% SC

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Albendazole 25 mg

Excipients:
Selenium (as sodium selenite) 0.27 mg
Cobalt (as cobalt sulphate) 0.624 mg
Chlorophyll WSI (E141) 3 mg (as colour)
Methyl Parahydroxybenzoate (E218) 2 mg (as preservative)
Propyl Parahydroxybenzoate (E216) 0.2 mg (as preservative)
For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Oral suspension.

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle, sheep.

4.2 Indications for use, specifying the target species
Endospec 2.5% SC is a broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep.
The product is also ovicidal against fluke and roundworm eggs.

In sheep it is active against benzimidazole-susceptible strains of the following species:

Roundworms:
Ostertagia,
Haemonchus,
Trichostrongylus,
Nematodirus (including N. battus),
Chabertia and Oesophagostomum.
It is usually effective against inhibited larvae of Ostertagia.

Lungworms:
Dictyocaulus filaria.

Tapeworms:
Moniezia spp.

Adult liver fluke:
asciola hepatica

In cattle it is active against the following species:

Roundworms:
Ostertagia,
Haemonchus,
Trichostrongylus,
Nematodirus,
Oesophagostomum,
Bunostomum,
Cooperia and Strongyloides spp.

It is usually effective against inhibited larvae of Cooperia and Ostertagia.
Lungworms:
Dictyocaulus viviparus.

Tapeworms:
Moniezia spp.

Adult liver fluke:
Fasciola hepatica.

Endospec 2.5% SC is ovicidal and will kill fluke and roundworm eggs, thus reducing pasture contamination.
The selenium and cobalt in this product are trace elements of use as nutritional supplements.

4.3 Contraindications
Do not use in sheep producing milk for human consumption.
o not use in animals with known hypersensitivity to the active ingredients.
Do not administer other cobalt and selenium supplements concurrently with this product unless specifically advised by your Veterinary Practitioner.

4.4 Special warnings for each target species
Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after treatment.

4.5 Special precautions for use
Special precautions for use in animals
Not to be diluted or mixed with other products.
Avoid the introduction of contamination during use.
The product should only be used in areas where deficiencies of cobalt and selenium are likely to occur.
If in any doubt seek the advice of your Veterinary Practitioner.
Intensive use of misuse of anthelmintics can give rise to resistance.
To reduce this risk, dosing programmes should be discussed with your Veterinary Practitioner.
Care must be taken not to damage the pharyngeal region when dosing particularly in sheep.

Special precautions to be taken by the person administering the product to animals
Direct contact with the skin should be kept to a minimum. Wear suitable protective clothing including impermeable rubber gloves.
Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)
None known.

4.7 Use during pregnancy, lactation or lay
Do not dose ewes at the ‘fluke and worm’ dose rate, (7.5 mg/kg), during tupping or for 1 month after removing the rams.
The use of Endospec 2.5% SC in breeding bulls or pregnant cattle is not expected to interfere with their reproductive performance.

4.8 Interaction with other medicinal products and other forms of interactions
Administration of ionophores to lambs has been shown to enhance selenium bioavailability.
Concurrent administration of ionophores and Endospec 2.5% SC may therefore lead to an increased risk of selenium toxicity.

4.9 Amounts to be administered and administration route
For oral administration only using properly calibrated dosing equipment.
Estimate bodyweight accurately.
One ml of Endospec 2.5% SC contains 25 mg Albendazole, 0.27 mg elemental selenium and 0.624 mg elemental cobalt.
Shake the container before use.

Cattle: Worm dose: 
For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs.
Dosage:
Approximately 7.5 mg albendazole per kg bodyweight.
Fluke and worm dose:
For the additional treatment of adult liver fluke (chronic fascioliasis) in cattle.
Dosage:
Approximately 10 mg albendazole per kg bodyweight.

Sheep: Worm dose:
For the control of roundworms, lungworms, tapeworms, fluke and roundworm eggs.
Dosage: Approximately 5 mg albendazole per kg bodyweight.

Fluke and Worm Dose: For the additional treatment of adult liver fluke (chronic fasioliasis) in sheep.
Dosage: Approximately 7.5 mg albendazole per kg bodyweight.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.

4.11 Withdrawal period(s)

Cattle Meat: 14 days.
Animals intended for human consumption may be slaughtered after 14 days following treatment.
Milk: 60 hours.
Milk intended for human consumption may be taken from animals after 60 hours following treatment.

Sheep Meat: 4 days.
Animals intended for human consumption may be slaughtered after 4 days following treatment.
Milk: Not for use in sheep producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Albendazole belongs to the benzimidazole class of anthelmintics.
Benzimidazoles bind to nematode tubulin, a protein necessary for the formation and viability of microtubules.
This occurs primarily in absorptive intestinal cells resulting in the absence of microtubules in the intestinal cells of the nematode, with the result that these cells cannot absorb nutrients, thus causing a consequent reduction in glycogen and effective starvation of the parasites.
Structural differences have been shown to exist between tubulin from mammalian and helminth sources, resulting in the preferential toxicity of albendazole to the helminth and not to the host.
Benzimidazoles have also been shown to inhibit the fumarate reductase system of helminths and impair energy production.
The selenium and cobalt are trace elements of use as nutritional supplements and are not intended to be used therapeutically.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Selenium (as Sodium Selenite)
Cobalt (as Cobalt Sulphate)
Chlorophyll WSI (E141)
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate (E216)
Citric Acid Monohydrate
Sodium Citrate
Xanthan Gum
Povidone K90
Polysorbate 20
Propylene Glycol
Simethicone emulsion
Purified Water

6.2 Major incompatibilities
Not to be diluted or mixed with other products.

6.3 Shelf-life
Shelf life of veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage
Do not store above 25 °C. 6.5

Nature and composition of immediate packaging 2.5 litre, 5 litre and 10 litre high density polyethylene containers and high density polyethylene closures with expanded polyethylene liners.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Do not contaminate ponds, waterways or ditches with the product or used containers.
Unused product and waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.


7 MARKETING AUTHORISATION HOLDER
Bimeda Animal Health Limited
2, 3 & 4 Airton Close
Airton Road
Tallaght
Dublin 24
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA22033/017/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23 September 1996
Date of last renewal: 22 September 2006

10 DATE OF REVISION OF THE TEXT
May 2019

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 Weight – 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.

 Cattle Oral drenches
Oral drenching guns are designed to deliver the treatment towards the back of the mouth over the tongue, so the entire dose is swallowed at once to optimise efficacy.
• Make sure animals are properly restrained, with their head held up
• Slide the nozzle of the dosing gun in the side of the mouth and over the tongue so that the entire dose is swallowed immediately
• Drenching equipment must be correctly calibrated and in good working order
• Calibrate the gun using the product just before treatment starts by delivering two or more doses into a graduated measuring cylinder.
Faulty equipment, or attempting to dose too quickly, may mean that the barrel of the gun does not fill properly or that the liquid is full of bubbles.

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.