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, mature and immature fluke
Administration Method: Oral drench
Withdrawal Time: 60 days for animals intended for meat and offal, Not permitted for use on animals producing milk for human consumption.
Dosage: 5.6 ml per 50 kg of bodyweight
|Body Weight||Dose Volume||Number of full doses per pack:|
|1 Litre||2.5 Litre|
Always read the label and all enclosed information for Curafluke 10% Oral Suspension before administering to animals!
How Livestock Contracts Liver Fluke
Animals are infected by ingesting encapsulated larvae (metacercariae) on contaminated grass. Typically,individual farms will have wet “flukey areas” that should not be used or grazed at times of the year whenmetacercariae are likely to be present, i.e. late summer to winter (depending on climatic conditions). However,cattle and sheep often graze on such areas. Therefore, it cannot be assumed that liver fluke infection is absentfrom any area of Ireland.
This product is only licensed for sale within the Republic of Ireland
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:
Fenbendazole 100 mg
Rafoxanide 100 mg
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
4 CLINICAL PARTICULARS
4.1 Target Species
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.
Fasciola sp.(mature and immature over 8 weeks of age)
The product has a good therapeutic effect against type II Ostertagiasis
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)
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
4.8 Interaction with other medicinal products and other forms of interaction
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
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)
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Curafluke 10%Oral Drench is well tolerated in cattle at three times the recommended dosage.
Animals must not be slaughtered for human consumption during treatment or for 60 days thereafter.
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 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.
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
Quinoline Yellow (E104)
Propyl Parahydroxybenzoate (E216)
Methyl Parahydroxybenzoate (E218)
Citric Acid Monohydrate
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
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
8 MARKETING AUTHORISATION NUMBER(S)
9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
14th September 2005
10 DATE OF REVISION OF THE TEXT
12th February 2010
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