Orafluke 10%
Orafluke 10% permits a three-way activity against fluke, lungworms and stomach worms in cattle and sheep. 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.
5% w/v oral suspension of fenbendazole and rafoxanide
Available in 1L and 2.5L
Orafluke 10% is a concentrated dose of 5.6ml per 50 Kg body weight in cattle
Batch Expiry Date 08/2022
Summary of Product Characteristics
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Orafluke 10% w/v Oral Suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances
per ml
Fenbendazole
100 mg
Rafoxanide
Excipients
100 mg
Quinoline Yellow (E104)
0.09 mg
Propyl Parahydroxybenzoate (E216)
0.10 mg
Methyl Parahydroxybenzoate (E218)
1.00 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
A pale lemon, free flowing suspension.
4 CLINICAL PARTICULARS
4.1 Target Species
Cattle.
4.2 Indications for use, specifying the target species
Orafluke 10% w/v Oral Suspension 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.
Cattle:
Haemonchus sp.
Ostertagia sp.
Trichostrongylus sp.
Cooperia sp.
Nematodirus sp.
Bunostomum sp.
Trichuris sp.
Strongyloides sp.
Oesophagostomum sp.
Dictyocaulus sp.
Moniezia sp.
Rafoxanide is active against immature and mature Fasciola sp. over 8 weeks of age. The product has a good therapeutic effect against type II Ostertagiasis.
4.3 Contraindications
None.
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.
As with other anthelmintics, veterinary advice should be sought on appropriate dosing programmes and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing. If the product does not achieve the desired clinical effect, other diseases, nutritional disturbances or anthelmintic resistance may be involved. 4.5 Special precautions for use
Special precautions for use in animals
Estimate bodyweight accurately. Use properly calibrated equipment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash hands after use.
In case of splashes into the eyes, rinse immediately with water.
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. See section 4.11.
4.8 Interaction with other medicinal products and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
For oral administration in cattle.
The recommended therapeutic dose is 11.25mg fenbendazole and 11.25mg rafoxanide per kilogram bodyweight Shake well before use.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Orafluke 10 is well tolerated in cattle at three times the recommended dosage.
4.11 Withdrawal Period(s)
Meat: 60 days.
Milk:
Not authorised for use in animals producing milk for human consumption including during the dry period. Do not use during the last trimester of pregnancy in heifers which are intended to produce milk for human consumption.
5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
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 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 microgram.ml-1 achieved in 2 to 3 days. Plasma levels are considerably higher than those in tissues. Only one metabolite has been identified (3,5-di-iodosalicylic acid) and it 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 (E415)
Quinoline Yellow (E104)
Simeticone
Propyl Parahydroxybenzoate (E216)
Methyl Parahydroxybenzoate (E218)
Polysorbate 80
Sodium Citrate (E331)
Sodium Metabisulphite (E223) Citric Acid Monohydrate Purified Water
6.2 Incompatibilities
None known.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
6.4 Special precautions for storage
Do not store above 25oC.
Protect from freezing and light.
6.5 Nature and composition of immediate packaging
1 L (flat bottom flexi pack, jerrican), 2.5 L (flat bottom flexi pack, back pack), 5 L (jerrican) HDPE white rigid containers closed with a 38 mm HDPP screw cap with a wood pulp PVDC liner.
Not all pack sizes may be marketed.
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
Interchem (Ireland) Ltd.,
29 Cookstown Industrial Estate,
Dublin 24, Ireland.
MARKETING AUTHORISATION NUMBER(S)
VPA: 10555/003/002
DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
5th June 2006
10 DATE OF REVISION OF THE TEXT
May 2013
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