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Clinical particulars
Target species
Indications for use
Treatment and metaphylaxis of bacterial enteritis caused by micro-organisms susceptible to apramycin such as Escherichia coli.
Do not use in the cases of hypersensitivity to apramycin or any of the excipients.
Do not use in animals suffering from kidney disorders.
Do not use in cats.
Special warnings for each target species
The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of feed animals should be treated parenterally.
The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation, no overstocking.
Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Use of the veterinary medicinal product deviating from the instructions given in the Summary of Product Characteristics may increase the prevalence of bacteria resistant to the apramycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to apramycin should administer the product with care.
During preparation and administration of the medicated feeding stuff, skin, eye and oral contact with the product, as well as inhalation of dust, should be avoided. Wear a protective suit, gloves and an appropriate dust mask (either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN140 with a filter to EN 143) when mixing and handling the product. Wash any contaminated skin. Wash hands carefully with soap and water after handling of the product. In the event of accidental ingestion, seek medical assistance immediately and show the package label.
Adverse Reactions
None known.
Use during pregnancy, lactation or lay
Laboratory studies have not produced evidence of teratogenic, foetotoxic or maternotoxic effects.
The use is not recommended in pregnant or lactating sows.
In certain conditions with a high degree of humidity there might be an apparent interaction with lectins. Aminoglycosides may have a negative influence on the kidney function. The administration of these agents to animals suffering from renal impairment or in combination with agents that also affect renal function may therefore present a risk of intoxication.
Do not administer with other aminoglycosides due to their nephrotoxic potential. Aminoglycosides may cause neuromuscular blockade. It is therefore recommended to take such an effect into account when anaesthetising treated animals.
Amounts to be administered and administration route
The dosage is 4000-8000 IU/kg of bodyweight per day (equivalent to 4-8 g of the product per 100kg of body weight per day).
Administer as the sole feeding stuff for at least 21 days.
It is recommended to mix the required quantity of the product with a small amount of feed (20 – 50 kg) before mixing it in the total volume.
The consumption of the medicated feed may depend of the clinical condition of the animals. In order to guarantee a correct dosing, the concentration of the product in the feed should be adjusted accordingly.
To adjust dosing properly following calculation can be used:
....g product/kg b.w./day x average b.w. of pigs (kg)
Average daily intake of feed (kg/animal)
= ...g of the product/kg of feed
Medicated feed may be pelleted using a pre-conditioning step for 5 minutes at a temperature not exceeding 85°C.
A single 100 fold overdosing in 5 pigs did not result in any mortality.
A 25 to 50 fold overdosing for 28 days, did not provoke any toxic effect.
Withdrawal periods
Meat and offal: 1 day