Moxodex is a fast acting oral drench wormer for sheep that is aimed at controlling roundworm and lungworm. It has a persistent effect that will prevent reinfection for up to 5 weeks after use, leaving you with an 8 week dosing interval.  Moxodex has been shown to be effective against certain benzimidazole resistant strains of worms. Moxodex uses the same active ingredient as Cydectin sheep drench which many users will be familiar with.

Active Ingredient:  Moxidectin

Target Species: Sheep

Treats and Controls: Gastro-intestinal (round) worms, lungworms

Administration Method: Oral drench

Withdrawal Time: 14 days for sheep intended for meat and offal. 5 days for sheep producing milk for human consumption

Dosage for sheep: 1 ml per 5 kg of bodyweight.

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

Precautions when using Animal Medications

Care should be taken to avoid the following when treating your livestock:

• Too frequent or repeated use of the same class of Anthelmintics over an extended period
• Underdosing by under estimating weights or failing to calibrate dosing gun
• Failing to test faecal samples to determine if any resistance to the Anthelmintics you are using is already present.

How sheep contract worms:

Features of Moxodex for sheep

• Moxidectin Based drench
• Treats Roundworms and Lungworms
• Fast acting
• Protect your flock from infestations for 4 to 5 weeks after application
• 8 Week dosing interval

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

Click here to Download Data Sheet

Health Products Regulatory Authority

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Moxodex 1 mg/ml oral solution for sheep

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Active substance:
Moxidectin  1.00 mg
Excipient:
Benzyl Alcohol (E1519)  40.0 mg
For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Oral solution
Clear colourless to yellowish solution

4 CLINICAL PARTICULARS
4.1 Target Species
Sheep.

4.2 Indications for use, specifying the target species
For the treatment and prevention of mixed infections of sheep with parasites sensitive to moxidectin  

Adult and/or immature gastro-intestinal nematodes:
- Haemonchus contortus (including inhibited larvae)
- Teladorsagiacircumcincta (including inhibited larvae)
- Teladorsagiatrifurcata
- Trichostrongylus axei (including inhibited larvae)
- Trichostrongylus colubriformis
- Trichostrongylus vitrinus
- Nematodirus battus
- Nematodirus spathiger
- Nematodirus filicolis (adults only)
- Strongyloides papillosus (larval stages only)
- Cooperia curticei (adults only)
- Cooperia oncophora
- Oesophagostomum columbianum
- Oesophagostomum venulosum (adults only)
- Chabertia ovina
- Trichuris ovis (adults only)

Adult respiratory tract nematode:
- Dictyocaulus filaria
The product has a persistent effect in preventing reinfection:
for 5 weeks by Teladorsagiacircumcincta and Haemonchus contortus
for 4 weeks by Oesophagostomum columbianum

Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole resistant strains of:
Haemonchus contortus
Teladorsagiacircumcincta
Trichostrongylus colubriformis
Cooperia curticei

4.3 Contraindications
Do not use in cases of known hypersensitivity to the active substance or to 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, 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.
Resistance to macrocyclic lactones has been reported in Teladorsagia in sheep in a number of countries.
In 2018, throughout Europe, multiple resistance of Teladorsagiacircumcincta to moxidectin, levamisole, benzimidazole and ivermectin were reported.
Moxidectin resistant Haemonchuscontortus and Trichostrongyluscolubriformis were also described.

Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of parasites, local history of treatments and recommendations on how to use the product under sustainable conditions to limit further selection for resistance to antiparasitic compounds.

4.5 Special precautions for use
Special precautions for use in animals
None known.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
- Avoid direct contact with skin and eyes.
- Wear impermeable rubber gloves during use.
- In the event of eye contact, flush the eye with copious amounts of clean water and seek medical advice.
- Wash hands or any exposed area after use.
- Do not smoke, eat or drink when handling this product.

Other precautions regarding impact on the environment Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible.
Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.

Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:

 Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms.
Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of 4 days and may decrease dung fly abundance during that period.
It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, studies with incurred residues indicate no long-term effects.
Nevertheless, in case of repeated treatments with moxidectin (as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.

 Moxidectin is inherently toxic to aquatic organisms including fish.
The product should be used only according to the label instructions.
Based on the excretion profile of moxidectin when administered as the oral formulation to sheep, treated animals should not have access to watercourses during the first 3 days after treatment.

4.6 Adverse reactions (frequency and seriousness)
None known. 

4.7 Use during pregnancy, lactation or lay
Moxidectin has been shown to be safe for use in pregnant, lactating and breeding animals.
Can be used during pregnancy and lactation.
Can be used in breeding animals.

4.8 Interaction with other medicinal products and other forms of interactions
The effects of GABA agonists are increased by moxidectin.

4.9 Amounts to be administered and administration route
Should be given as a single oral drench of 1 ml/5 kg live bodyweight, equivalent to 200 μg moxidectin/kg live bodyweight, using any standard drenching equipment.
To ensure administration of a correct dosage, body weight should be determined as accurately as possible; accuracy of the dosing equipment should be checked.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Symptoms have not been observed at less than 5 times the recommended dose.
They are manifested as transient salivation, depression, drowsiness and ataxia 8 to 12 hours post-treatment. Treatment is not generally necessary and recovery is generally complete within 24 to 48 hours. 
There is no specific antidote.

4.11 Withdrawal period(s)
Meat and offal: 14 days.
Milk: 5 days.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group:
Endectocides, macrocyclic lactones, milbemycins

ATC Vet code:
QP 54 AB 02

5.1 Pharmacodynamic properties
Moxidectin is a parasiticide active against a wide range of economically important internal and external parasites and is a second generation macrocyclic lactone of the milbemycin family.
Its principal mode of action is interfering with neuromuscular transmission of the GABA (gamma amino butyric acid)-gated or glutamate-gated chloride channels. 
Moxidectin stimulates the release of GABA and increases its binding to the postsynaptic receptors.
The net effect is to open the chloride channels on the postsynaptic junction to allow the inflow of chloride ions and induce an irreversible resting state.
This results in flaccid paralysis and eventual death of parasites exposed to the drug.

5.2 Pharmacokinetic particulars
Moxidectin is absorbed after oral administration with peak plasma levels around 13 hours after dosing and is eliminated slowly with a t ½ of approximately 7 days..
The drug is distributed throughout the body tissues but due to its lipophilicity the target tissue is fat where concentrations are 10 to 20 times higher than those found in other tissues.
Moxidectin undergoes limited biotransformation by hydroxylation.
The only significant route of excretion is the faeces.

Environmental properties
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance.
In particular, in acute and chronic toxicity studies with algae, crustaceans and fish, moxidectin showed toxicity to these organisms, yielding the following endpoints:

  
 
 EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.
NOEC: the concentration in the study at which no effects are observed.
This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life.
To mitigate this risk, all precautions for use and disposal must be adhered to.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Benzyl Alcohol (E1519) 
Propylene Glycol  
Polysorbate 20  
Disodium Phosphate Dodecahydrate
Sodium Dihydrogen Phosphate Dihydrate 
Water, purified

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: 18 months.
Shelf life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage
Keep the container in the outer carton in order to protect from light. 
Do not store above 25°C.

6.5 Nature and composition of immediate packaging
White HDPE flexi containers containing 1L, 2.5 L, 3 L and 5 L of product. 
The containers are closed with an aluminium foil seal and polypropylene tamper-evident caps.
The product is marketed in a cardboard outer carton. 
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
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Do not contaminate watercourses with the product.

7 MARKETING AUTHORISATION HOLDER
Chanelle Pharmaceuticals Manufacturing Limited
Ida Industrial Estate
Dublin Road
Loughrea
Co. Galway
Galway
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA10987/111/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 25 August 2017

10 DATE OF REVISION OF THE TEXT
February 2022

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.

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.