Target species
Cattle (over 2 months and weighing at least 100 kg bodyweight).
Indications for use
For prevention and treatment of copper and selenium deficiencies and for improvement of cobalt supply.
Contra-indications
Do not administer to non-ruminating calves or to animals weighing less than 100kg body weight. Do not administer to sheep. See also special precautions for use. Do not use in cases of hypersensitivity to the active substance(s), or to any of the excipients.
Special warnings
The veterinary medicinal product is not intended for treatment of acute clinical conditions such as nutritional muscular dystrophy.
Special precautions for use
Special precautions for safe use in the target species
Prior to supplementation with any form of copper or selenium, it should be demonstrated that there is a need for extra trace elements to be given to the animals. Additional copper should not be administered orally or by injection, or selenium by injection, within six months after administration of the veterinary medicinal product to cattle at pasture or within 4.5 months in cattle where the diet is supplemented with concentrates unless subjected to a risk/benefit analysis performed by a responsible veterinarian in each case.
Do not administer any aids to alter dissolution of the bolus.
The boluses are sensitive to sudden temperature changes such as those that may occur when very cold boluses are swallowed by an animal. Therefore it is important that the bolus is at room temperature (15 – 20oC) prior to administration to prevent the development of fine cracks that may change the activity of the bolus
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In order to minimise the risk of contact allergy, wear gloves when handling this veterinary medicinal product.
Special precautions for the protection of the environment
Not applicable
Adverse reactions
None known. Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details..
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
Interactions
None known.
Amounts to be administered and administration route
Intraruminal use.
Ruminating cattle over two months of age and weighing over 100 kg body weight: 2 boluses. Administer orally using an oesophageal balling-gun, which delivers the bolus directly into the top of the gullet. Great care should be taken not to cause any injury by rough handling or by placing the gun too far inside the throat of the animal. Ensure that each animal has swallowed the boluses by holding the mouth closed and observing the animal for a short time after dosing. Gentle massage of the throat may facilitate swallowing of the boluses.
The boluses should normally be administered just before turnout, but administration may be carried out at any time, e.g. administer to dairy cows at drying off or at calving or 30 days post-calving or at artificial insemination.
The boluses are sensitive to sudden temperature changes such as those that may occur when very cold boluses are swallowed by an animal. Therefore, it is important that the bolus is at room temperature (15 – 20oC) prior to administration to prevent the development of fine cracks that may change the activity of the bolus.
To minimise the risk of regurgitation, avoid rough handling of animals after dosing.
Do not administer the recommended dosage to animals more frequently than once every 4.5 months to animals receiving concentrates or every 6 months to cattle at pasture
Overdose
No adverse effects have been observed in cattle administered three times the recommended dosage over a two-day period. Clinical signs of copper toxicity, which normally will occur in cases of severe copper overdosage including jaundice, malaise, an acute drop in milk yield and, later, haemoglobinuria. Signs of selenium toxicity include CNS changes, muscle weakness, vomiting, anorexia, depression, incoordination and, later, respiratory problems. In these circumstances, intravenous administration of copper and/or selenium chelating agents such as ammonium tetrathiomolybdate or EDTA (ethylendiaminetetraacetic acid) is recommended.
Ammonium tetrathiomolybdate (ATTP) is often quoted in veterinary literature as an antidote to copper poisoning. ATTP is not an authorised veterinary medicine. Any pharmacologically active substances used in a veterinary medicinal product administered to a food-producing animal under the cascade must be allowed substances in accordance with Regulation (EU) No 470/2009 i.e. listed in Table 1 of the Annex to Regulation (EU) No 37/2010. As ATTP does not appear in this Annex it should not be administered to an animal intended for food production
Withdrawal periods
Cattle: Meat zero days; milk zero hours.