Rumenil fluke drench is an orally adminstered drench for the treatment and control of liver and Tapeworms in cattle. Rumenil's active ingredient, Oxyclozanide, has shown to have a high impact on rumen fluke that are present in the bile duct of the animal. Rumenil is appropriate for cattle all year round, although in housed animals the treatment should be re-administered 8 to 12 weeks later to control the threat of immature fluke that may have been present at the time of housing. Rumenil also boasts a very short withdrawal time for dairy cattle.

Active Ingredient: Oxyclozanide

Target Species: Cattle

Administration Method: Oral drench

Treats and Controls: Liver fluke, tapeworm

Withdrawal Time: 13 days for cattle intended for meat and offal, 108 hours for cattle producing milk for human consumption. Not permitted for sheep intended for meat and offal, not permitted for use on sheep producing milk for human consumption

Dosage for cattle: 15 ml per 50 kg of bodyweight

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

Key Features of Rumenil:

• Orally administered
• Helps treat and control of liver and Tapeworms in cattle. 
• Oxyclozanide, has a high impact on rumen fluke 
•  Can be used for cattle all year round,
•  a very short withdrawal time for dairy cattle.

Click here to Download Data Sheet

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Rumenil 34 mg/ml oral suspension for cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:
Oxyclozanide 34.0 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.
A smooth uniform off-white to yellow suspension.

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle.

4.2 Indications for use, specifying the target species

Treatment of chronic fascioliasis caused by the adult stage of Fasciola hepatica, sensitive to oxyclozanide. Elimination of gravid tapeworm segments (Moniezia spp).

4.3 Contraindications

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

4.4 Special warnings for each target species

At normal dose levels, oxyclozanide is not active against immature flukes present in liver tissue.
Milking cattle, particularly high yielders, may show a reduction in yield, occasionally of 5 % or more, for about 48 hours after handling.
The effect of this small loss may be minimised by spreading herd dosing over a period of about one week.

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.

To date no resistance to oxyclozanide has been reported. 

Use of the product should be based on local (regional, farm) epidemiological information about susceptibility of Fasciola spp. and recommendations on how to limit further selection for resistance to anthelmintics. 

4.5 Special precautions for use Special precautions for use in animals

When a dosing gun is used to administer the product, care must be taken to avoid damage to the pharyngeal region.

Adverse effects (see section 4.6) are occasionally enhanced in animals suffering from severe liver damage and/or dehydration at the time of dosing.

Due regard must always be given to the physical condition of animals undergoing treatment, particularly those inadvanced pregnancy and/or under stress from adverse weather conditions, poor nutrition, penning, handling etc. These effects are occasionally enhanced in animals suffering from severe liver damage and/or dehydration at the time of dosing.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Do not eat, drink or smoke when handling the product.
This veterinary medicinal product can cause irritation to skin, eyes and mucous membranes.
Wear impermeable gloves during use.
In case of contact with the product, rinse the affected area immediately with plenty of water.
Contaminated clothing should be removed immediately.
Wash hands after use.
People with known hypersensitivity to oxyclozanide or any of the excipients should avoid contact with the veterinary medicinal product.

Other precautions

Oxyclozanide is toxic to dung fauna and aquatic organisms. The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of oxyclozanide in cattle. The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for 5 days after treatment.

4.6 Adverse reactions (frequency and seriousness)

Cattle may show slight softening of the faeces with the occasional animal showing increased frequency of defaecation and transient inappetence.
Milking cattle, particularly high yielders, may show a reduction in yield, occasionally of 5 % or more, for about 48 hours after handling.
The effect of this small loss may be minimised by spreading herd dosing over a period of about one week.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy or lactation. See section 4.5. Target animals treated with oxyclozanide at the recommended therapeutic doses in several phases of reproduction showed no evidence of foetotoxicity, teratogenicity or effects on fertility

4.8 Interaction with other medicinal products and other forms of interactions

None known.

4.9 Amounts to be administered and administration route

Oral Use.
Shake well before use. 

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 overdosing. 
Dose according to bodyweight at the rate of 10 mg oxyclozanide per kg bodyweight (cattle)
Cattle : 3 ml per 10 kg bodyweight;
For example:- Bodyweight Dose
50 kg 15 ml
100 kg 30 ml
150 kg 45 ml
200 kg 60 ml
250 kg 75 ml
300 kg 90 ml
350 kg and over 105 ml 

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The effects of oxyclozanide overdosage are  possible diarrhoea, inappetence and loss of weight in cattle.
These effects are occasionally enhanced in animals with severe liver damage  and/or dehydration at the time of dosing.
At higher doses the severity of signs of toxicity increased and mortality occurred at 50 mg/kg bw and higher.

4.11 Withdrawal period(s)

Cattle:
Meat and offal: 13 days.
Milk: 108 hours (4.5 days).

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintics; Oxyclozanide
ATCvet code: QP52AG06.

5.1 Pharmacodynamic properties

Oxyclozanide is an anthelmintic of the salicylanilide group. The salicylanilides are proton ionophores, which act as specific uncouplers of mitochondrial oxidative phosphorylation, disrupting the metabolism of the parasite. The chemical structure of salicylanilides is characterised by the presence of an unstable proton. They are lipophilic molecules which allow the passage of protons across membranes, especially through the inner mitochondrial membrane.
Oxyclozanide has flukicidal activity against the adult stage of Fasciola hepatica. Its efficacy against cestodes is limited to the removal of segments of the tapeworm Moniezia.

5.2 Pharmacokinetic particulars

Oxyclozanide is slowly absorbed after oral administration with peak plasma levels approximately 11 hours after dosing. After oral administration of the product to cattle at a dose rate of 10 mg oxyclozanide per kg bodyweight the following parameters were observed: Cmax of 9.1 µg/ml, t½ of 11.3 hours and AUC of 231.0 µg.h/ml. Excretion is predominantly faecal, biliary excretion being the most important route of elimination (cattle studies only).

Environmental properties

Faeces containing oxyclozanide excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on dung degradation.
Oxyclozanide is toxic to aquatic organisms.
Oxyclozanide is persistent in soils

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Methyl Parahydroxybenzoate (E218)
Propyl Parahydroxybenzoate
Sodium laurilsulfate
Propylene Glycol \

Sodium Citrate
Disodium Edetate
Carmellose Sodium
AluminiumMagnesium Silicate
Simeticone
Purified Water

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: 1 year.

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 & 5L:White High Density Polyethylene HDPE flexi containers with a Polypropylene cap and a PVDC  seal
10 L: High Density Polyethylene (HDPE) container with a HDPE cap and an aluminium foil seal.
The product can be marketed with or without an 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 materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Do not contaminate ponds, waterways or ditches.
Treated animals (cattle) should not have access to surface water for 5 days after treatment to avoid adverse effects on aquatic organisms.

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

8 MARKETING AUTHORISATION NUMBER(S)
VPA10987/113/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19 February 2016
Date of last renewal: 19 February 2021

10 DATE OF REVISION OF THE TEXT
March 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 Weight – do not guess. Underestimating the weight of animal is a common cause of underdosing. Select and weigh the biggest animal 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.