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Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Curafluke 10% w/v Oral Drench

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substances
Fenbendazole 100 mg
Rafoxanide 100 mg
Excipients
Propyl Parahydroxybenzoate 0.1 mg
Methyl Parahydroxybenzoate 1 mg
Quinoline yellow E104 0.09 mg
For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Oral suspension

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle

4.2 Indications for use, specifying the target species
Curafluke 10% w/v Oral Drench permits a three way activity against Fluke, Lungworms and Stomach Worms in
Cattle. It is a broad spectrum anthelmintic for the treatment of benzimidazole susceptible mature and immature stages of nematodes and cestodes of the gastrointestinal and respiratory tracts of cattle. Rafoxanide is active against immature and mature Fasciola sp.
CATTLE:
Haemonshus sp.
Ostertagia sp.
Trichostrongylus sp.
Cooperia sp.
Nematodirus sp.
Bunostomum sp.
Trichuris sp.
Strongyloides sp.
Oesophagostomum sp.
Dictyocaulus sp.
Moniezia sp.
Fasciola sp.(mature and immature over 8 weeks of age)
The product has a good therapeutic effect against type II Ostertagiasis

4.3 Contraindications
Not for use against Benzimidazole resistant nematodes.

4.4 Special warnings for each target species
Where a dosing gun is used to administer the product, care should be taken to avoid causing injury to the mouth and
pharynx of animals.

4.5 Special precautions for use
Estimate bodyweight carefully.
Use only properly calibrated dosing equipment.

4.6 Adverse reactions (frequency and seriousness)
None known.

4.7 Use during pregnancy, lactation or lay
Fenbendazole and rafoxanide are safe for use during pregnancy. However, the product is not permitted for use in
animals producing milk for human consumption, including pregnant animals intended to produce milk for human
consumption.

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

4.9 Amounts to be administered and administration route
The recommended therapeutic dose of fenbendazole and rafoxanide is 11.25 mg/kg bodyweight of each active for
cattle.
For oral administration in cattle.
Shake well before use.
Practical dosage recommendations are as follows:
Cattle: 11.25 ml per 100 kg bodyweight

Bodyweight (kg)         Dose (ml)
CATTLE
50                                5.60
100                            11.25
300                            33.75
500                            56.25

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Curafluke 10%Oral Drench is well tolerated in cattle at three times the recommended dosage.

4.11 Withdrawal Period(s)
Animals must not be slaughtered for human consumption during treatment or for 60 days thereafter.
Milk:
Not permitted for use in animals producing milk for human consumption, including pregnant animals intended to
produce milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Summary presentation of the active ingredients
Fenbendazole (QP52AC13) is an anthelmintic belonging to the benzimidazole group which acts by blocking fumarate
reductase which results in the inhibition of the formation of adenosine triphosphate (involved in mitochondrial energy).
Rafoxanide (QP52AG05) is a salicylanilide anthelmintic and these are known to be potent uncouplers of oxidative
phosphorylation in animal tissues.

5.1 Pharmacodynamic properties
Fenbendazole, like many benzimidazoles, blocks fumarate reductase which results in the inhibition of the formation of
adenosine triphosphate (involved in mitochondrial energy).
There is also evidence that it inhibits glucose uptake and therefore increases glycogen utilization and depletes the worm’s glycogen reserves.
The overall effect of this action is to effectively starve the parasite to death.
Furthermore this action results in the detachment of the parasites but in the case of intestinal helminths this detachment does not result in loss of contact with the drug whereas in the case of the liver fluke such detachment would reduce such contact.
This probably explains its limited effect on the liver fluke and the good effect on intestinal helminths.
In vitro experiments indicate that salicylanilides, including the commercially used flukicides, oxyclozanide and
rafoxanide, uncouple oxidative phosphorylation in Fasciola hepatica and other parasites.

5.2 Pharmacokinetic properties
Fenbendazole
Fenbendazole is absorbed poorly from the gastro-intestinal tract leading to with low plasma levels of fenbendazole,
oxfendazole and sulphone. It is mainly excreted in the faeces though some of the metabolites that have been identified are excreted in the urine and bile. The active and its metabolites are mainly found in the plasma.
Rafoxanide
Kinetic studies of rafoxanide in cattle have shown that it is absorbed into the blood with a mean peak concentration of
circa 23 μg.ml-1 achieved in 2 to 3 days. Plasma are considerably higher than those in tissues. Only one metabolite
has been identified (3, 5-di-iodosalicylic acid) and this was found in blood tissues and milk. There is little known or
reported on the excretion of rafoxanide though apparently it is excreted in the bile.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Xanthan Gum
Quinoline Yellow (E104)
Simethicone Emulsion
Propyl Parahydroxybenzoate (E216)
Methyl Parahydroxybenzoate (E218)
Polysorbate 80
Sodium Citrate
Sodium Metabisulphite
Citric Acid Monohydrate
Purified Water

6.2 Incompatibilities
None known

6.3 Shelf-life
Shelf life of the veterinary medicinal product packaged in white HDPE containers: 3 years
Shelf life of the veterinary medicinal product packaged in clear HDPE containers: 2 years

6.4 Special precautions for storage
Do not store above 25°C.
Protect from light and frost.
Irish Medicines Board

6.5 Nature and composition of immediate packaging
A. 1 L, 2.5 L, 5 L HDPE clear/white rigid containers closed with a 38 mm HDPP screw cap with a wood pulp PVDC
liner.
B. 1 L, 2.5 L, 5 L white LDPE vaccine packs closed with a 31 mm HDPE screw cap with a wood pulp PVDC liner.


6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations

7 MARKETING AUTHORISATION HOLDER
Univet Ltd.
Tullyvin
Cootehill
County Cavan

8 MARKETING AUTHORISATION NUMBER(S)
VPA: 10990/032/002


9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14th September 2005

10 DATE OF REVISION OF THE TEXT
12th February 2010
 

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 an 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.

 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.

Curafluke 10% oral solution is a broad spectrum flukicide and wormer for cattle. It is used for the treatment and control of stomach worms, lungworms, mature and immature fluke, in beef cattle.

Active Ingredient: Rafoxanide, Fenbendazole

Target Species: Cattle

Treats and Controls: Stomach worms, lungworms, tapeworms, mature and immature fluke

Withdrawal Time: 60 days for animals intended for meat and offal, Not permitted for use on animals 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.