Target species
Pigs.
Indications for use for each target species
Treatment and metaphylaxis of bacterial enteritis caused by micro-organisms susceptible to apramycin such as Escherichia coli.
The presence of the disease in the group must be established before the veterinary medicinal product is used.
Contraindications
Do not use in the cases of hypersensitivity to the active substance, to other aminoglycosides or to any of the excipients.
Do not use in animals suffering from kidney disorders.
Do not use in cats.
Special warnings
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 veterinary medicinal product should be combined with good management practices e.g. good hygiene, proper ventilation, no overstocking.
Special precautions for use
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level. Use of the veterinary medicinal product should be in accordance with official, national and regional antimicrobial policies.
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 veterinary medicinal product with caution.
During preparation and administration of the medicated feedingstuff, skin, eye and oral contact with the veterinary medicinal product, as well as inhalation of dust, should be avoided. Personal protective equipment consisting of 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) should be worn when handling the veterinary medicinal product.
Wash any contaminated skin. Wash hands carefully with soap and water after handling of the veterinary medicinal product. In the event of accidental ingestion, seek medical assistance immediately and show the package label.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Pigs: 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
Pregnancy and lactation:
Laboratory studies have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The use is not recommended in pregnant or lactating sows.
Interaction with other medicinal products and other forms of interaction
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.
Administration routes and dosage
In feed use.
The dosage is 4 000-8 000 IU apramycin/kg of bodyweight per day (equivalent to 4-8 g of the veterinary medicinal product per 100kg of bodyweight per day). Administer as the sole feeding stuff for at least 21 days. It is recommended to mix the required quantity of the veterinary medicinal product with a small amount of feed (20 – 50 kg) before mixing it in the total volume.
The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosing, the concentration of apramycin may need to be adjusted accordingly.
To adjust dosing properly the following calculation can be used:
...g product/kg b.w./day | x | average b.w. of pigs (kg) | | |
----------------------------------------------------- | = | g of the product/kg of feed |
average daily intake of feed (kg/animal) | | | |
Medicated feed may be pelleted using a pre-conditioning step for 5 minutes at a temperature not exceeding 85°C.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
A single 100 fold overdosing in 5 pigs did not result in any mortality.
A 25 to 50 fold overdosing during 28 days, did not provoke any toxic effect.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
This veterinary medicinal product is intended to be used for the preparation of medicated feed.
Withdrawal periods
Pigs:
Meat and offal: 1 day.