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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Albex 2.5% Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
Active Substance:
Albendazole 2.5 % w/v
Excipients:
Chlorophyll WS1, E141 0.3 % w/v
Methyl parahydroxybenzoate E218 0.2 % w/v
Propyl parahydroxybenzoate E216 0.02 % w/v

3 PHARMACEUTICAL FORM
Oral suspension.
A pale green, free flowing suspension.

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle and sheep
Active Substance:
Albendazole 2.5 % w/v
Excipients:
Chlorophyll WS1, E141 0.3 % w/v
Methyl parahydroxybenzoate E218 0.2 % w/v
Propyl parahydroxybenzoate E216 0.02 % w/v

4.2 Indications for use, specifying the target species
Albex 2.5% 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 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
Tapeworm: Moniezia spp.
Adult liver fluke: Fasciola hepatica
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: Fasciola hepatica
Albex 2.5% is ovicidal and will kill fluke and roundworm eggs, thus reducing pasture contamination.

4.3 Contraindications
Do not use in cases of known hypersensitivity to the active ingredient.

4.4 Special warnings for each target species
Not for use in sheep producing milk for human consumption.
Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks
after infection. Intensive use or misuse of anthelmitics can give rise to resistance. To reduce this risk, dosing
programmes should be discussed with your veterinary surgeon. Care must be taken not to damage the pharyngeal
region when dosing, particularly in sheep.

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.
Special precautions to be taken by the person administering the veterinary medicinal 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. Albex 2.5% can be safely used during lactation.
The use of Albex 2.5% 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 interaction
None known.

4.9 Amounts to be administered and administration route
For oral administration only using properly calibrated dosing equipment. Estimate bodyweight accurately. One ml of
Albex 2.5% contains 25 mg Albendazole. 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 albendzole 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, and 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 fascioliasis) in sheep.
Dosage: Approximately 7.5 mg albendazole per kg bodyweight.

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

4.11Withdrawal Period(s)
Animals intended for human consumption should not be slaughtered during treatment. Cattle must not be slaughtered
for human consumption until after 14 days after last treatment. Sheep must not be slaughtered for human consumption
until after 4 days after last treatment.
Milk intended for human consumption may be taken from cows only after 60 hours after the last treatment.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Albex 2.5% 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.
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.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methyl Parahydroxybenzoate
Propyl Parahydroxybenzoate
Citric Acid Monohydrate
Sodium Citrate
Chlorophyll WS 1 (E141)
Xanthan Gum
Povidone 90
Polysorbate 20
Propylene Glycol
Simethicone Emulsion
Purified Water

6.2 Incompatibilities
None known.

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

6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging
1.0 L, 2.5 L, 5.0 L and 10 L white standard containers or 1 L, 2.5 L and 5 L flexi-packs.
Standard Pack
Container: HDPE
Closure: HDPE
Cap liner: Expanded polyethylene
Tamper evidence: Closure is tamper evident
Flexi pack (vaccine pack)
Container: HDPE
Closure: Homo polymer polypropylene
Cap liner: Polyfaced steran wad
Tamper evidence: Aluminium foil seal
Flexi pack (flat bottomed stand alone)
Container: HDPE
Closure: Copolymer polypropylene
Cap liner: Polyfaced steran wad
Tamper evidence: Closure is tamper evident
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 ponds, waterways or ditches with the product or used containers.
Dispose of used containers safely.
Unused product should be disposed of in accordance with current practice for pharmaceutical waste under national waste
disposal regulations.

7 MARKETING AUTHORISATION HOLDER
Chanelle Animal Health Limited,
7 Rodney Street,
Liverpool, L1 9HZ,
United Kingdom.

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10879/5/1

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
22nd April 2001

10 DATE OF REVISION OF THE TEXT
4th April 2008

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.

Pharmacodynamics

Albendazole is a broad-spectrum anthelmintic. The principal mode of action for albendazole is by its inhibitory effect on tubulin polymerization which results in the loss of cytoplasmic microtubules.

Mechanism of action

Albendazole causes degenerative alterations in the tegument and intestinal cells of the worm by diminishing its energy production, ultimately leading to immobilization and death of the parasite. It works by binding to the colchicine-sensitive site of tubulin, thus inhibiting its polymerization or assembly into microtubules. As cytoplasmic microtubules are critical in promoting glucose uptake in larval and adult stages of the susceptible parasites, the glycogen stores of the parasites are depleted. Degenerative changes in the endoplasmic reticulum, the mitochondria of the germinal layer, and the subsequent release of lysosomes result in decreased production of adenosine triphosphate (ATP), which is the energy required for the survival of the helminth.

Albex 2.5% oral solution is a broad spectrum multi-purpose anthelmintic for sheep and cattle. Albex 2.5% is used for the treatment and control of mature and developing immature forms of gastro-intestinal roundworms, lungworms, tapeworms and adult liver fluke in sheep and beef cattle.

Active Ingredient: Albendazole

Target Species: Cattle, sheep

Treats and Controls: Gastro-intestinal roundworms, lungworms, tapeworms and adult liver fluke

Withdrawal Time: 14 days for cattle intended for meat and offal, 60 hours for cattle producing milk for human consumption. 4 days for sheep intended for meat and offal, not permitted for use on sheep producing milk for human consumption

Legal Status: POM

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 the loss of value of the 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 that occurs 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 returns form PDF.

2) To print off your return label click DPD Returns page 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 DPD pickup shops.

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.