Albex Gold (Albendazole)

Albex Gold is a highly effective and efficient fluke and worm single oral solution.
This treatment is in the form of a drench which is administered at the back of the throat via a drenching gun.

Albex Gold is designed to treat mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle.

Albex Gold is unique, it contains 20% w/v formulation of albendazole.
The only product to increase Albendazole to 20%

This means

• Smaller dose rate
• Less handling of animals
• Less labour at dosing times
• Less refilling of drenching guns

​Albex Gold's lower dose rate helps to reduce the likelihood of underdosing.
Underdosing increases the occurrence of anthelmintic resistance.

Increasing the concentration of Albendazole to 20%, reduces the dose rate, effectively reduces the likelihood of underdosing.

Albex Gold is also ovicidal against fluke and roundworm eggs.

Albex Gold is usually effective against inhibited larvae of
Lungworms:
Tapeworms:
Adult liver fluke:

Active Ingredient: 
Albendazole

Target Species: 
Cattle

Administration Method: 
For single oral use using a drenching gun

Treats and Controls: 
treatment of benzimidazole susceptible mature and developing immature forms of 
gastrointestinal roundworms,
lungworms,
tapeworms
and adult liver fluke in cattle.
It is also ovicidal against fluke and roundworm eggs.

Withdrawal Time: 
Meat and offal: 14 days.
Milk:                  72 hours

Dosage: 
The recommended dose is
7.5 mg albendazole per kg bodyweight 
5ml of the Albex Gold per 100 kg bodyweight.

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Key features of Albex Gold 

• Brand new, unique formulation
• Low-volume dose reduces labour and avoids under-dosing
• Short 72-hour milk withdrawal
• Kills worms and fluke in one treatment
• White drench, ideal for use at drying-off

Note: For the additional treatment of adult liver fluke (chronic fasciolosis).
The recommended dose is 10 mg albendazole per kg bodyweight corresponding to 5 ml of the product per 100 kg bodyweight.
A suitable graduated drenching gun should be used.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.
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 overdosing.

Click here to download Data Sheet

Health Products Regulatory Authority

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Albex Gold 200 mg/ml oral suspension for cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:

Active substance:
Albendazole 200.0 mg

Excipient:
Methyl Parahydroxybenzoate (E218) 2.0 mg
Propyl Parahydroxybenzoate 0.2 mg
For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Oral suspension
White to off white suspension

4 CLINICAL PARTICULARS

4.1 Target Species
Cattle

4.2 Indications for use, specifying the target species Indications:
For the treatment of benzimidazole susceptible mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle. 

The product is also ovicidal against fluke and roundworm eggs.

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

It is usually effective against inhibited larvae of Cooperia and Ostertagia.

Lungworms:  Dictyocaulusviviparus

Tapeworms:  Moniezia spp.

Adult liver fluke:  Fasciola hepatica.
The product is ovicidal and will kill fluke and roundworm eggs.

4.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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

Care must be taken not to damage the pharyngeal region when dosing.
Resistance to benzimidazoles (which includes albendazole) has been reported in Teladorsagia, Haemonchus, Cooperia and Trichostrongylus species in small ruminants in a number of countries, including the EU.
Resistance to albendazole has been reported in Cooperia and Teladorsagia species in cattle in developed countries such as New Zealand.
Therefore the 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.
Avoid the introduction of contamination during use.

4.5 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 dermal sensitisation.
Avoid contact with the eyes.
Wear protective glasses.
Direct contact with the skin should be kept to a minimum. 
Wear suitable protective clothing including impermeable rubber gloves. 
Wash hands after use. Laboratory studies in rats and rabbits have shown evidence of teratogenic effects.
Other precautions Albendazole is toxic to dung fauna and aquatic organisms.
Due to the risk to dung organisms, the product should not be used more than once per year.
Treated animals (cattle) should not have access to surface water for 7 days after treatment to avoid adverse effects on aquatic organisms.

4.6 Adverse reactions (frequency and seriousness)
None known.

4.7 Use during pregnancy, lactation or lay
Developmental studies in mice, rats, rabbits, and sheep showed albendazole to be teratogenic.
The malformations included visceral, craniofacial and bone defects.
Therefore, do not dose during the first trimester of pregnancy. Use only accordingly to the benefit/risk assessment by the responsible veterinarian during last two parts of pregnancy and during lactation.

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

4.9 Amounts to be administered and administration route
For single oral use.
Shake well before use.
Lungworms and gastro-intestinal roundworms:
The recommended dose is 7.5 mg albendazole per kg bodyweight corresponding to 3.75 ml of the product per 100 kg bodyweight.
For the additional treatment of adult liver fluke (chronic fasciolosis)
The recommended dose is 10 mg albendazole per kg bodyweight corresponding to 5 ml of the product per 100 kg bodyweight.
A suitable graduated drenching gun should be used.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible.
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 overdosing. 

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

4.11 Withdrawal period(s)
Cattle:
Meat and offal: 7 days.
Milk: 84 hours.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anthelmintics, benzimidazoles and related substances, Albendazole

ATCvet code:
QP52AC11.

5.1 Pharmacodynamic properties
The product 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. 
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.

5.2 Pharmacokinetic particulars
Albendazole is quickly metabolised to albendazole sulphoxide which persists at higher levels in bovine plasma for a longer duration after oral administration with peak plasma levels approximately 15 hours after dosing.
After oral administration of the product to cattle at a dose rate of 10 mg albendazole sulphoxide per kg bodyweight the following parameters were observed: Cmax of 1951.43 ng/ml, t½ of 2.4 hours and AUC of 32319.0 ng.h/ml.

Excretion is predominantly faecal, biliary excretion being the most important route of elimination (cattle studies only).


5.3   Environmental properties
Faeces containing albendazole excreted onto pasture by treated cattle reduce the abundance of dung fauna feeding organisms which may impact on dung degradation.
Albendazole is toxic to aquatic organisms from direct exposure and from drainage and/or run-off of albendazole from the soil.
The main metabolite of albendazole, albendazole sulfoxide have been shown to be very persistent.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate
Citric Acid Monohydrate
Sodium Citrate
Xanthan Gum
Povidone 90
Polysorbate 20
Propylene Glycol
Simethicone Emulsion

6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening the immediate packaging: 12 months.

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
1L, 2.5L, 3L & 5L:
Container and Closure: White HDPE flexi containers with a Polypropylene cap and an aluminium foil seal.
10 L: Container and Closure:
High Density Polyethylene (HDPE) white container with a HDPE cap and an aluminium foil seal.
Not all pack sizes may be marketed.

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. 
Dispose of used containers safely.
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 Pharmaceuticals Manufacturing Limited
Loughrea
Co. Galway
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA10987/123/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19 July 2019

10 DATE OF REVISION OF THE TEXT  
April 2021

 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.

​

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.

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.

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.