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APRACYN is used for treatment and metaphylaxis of colibacillosis in pigs and chickens (broilers), determined by strains of Escherichia coli sensitive to apramycin sulfate.
Apramycin sulfate (equivalent to 500 mg active apramycin) 1000 mg/g
Do not use in cases of known hypersensitivity to the active substance.
None known.
For oral administration in drinking water.
Pigs: 12,5 mg active substance/kg body weight/day, (equivalent to 25 mg Apracyn) for 7 consecutive days.
Broiler chickens: 25-50 mg active substance/kg body weight/day (equivalent to 50-100 mg Apracyn), for 5 consecutive days.
Medicated water should be the only source of drinking. The product must be well diluted in drinking water to disperse uniform as much as possible.
In order to obtain the correct dose, the weight of the animals should be determined as accurately as possible to avoid underdose.
The intake of medicated water depends on the clinical condition of the animals. In order to obtain the correct dose, the concentration of the veterinary medicinal product has to be adjusted accordingly. Medicated water must be renewed every 24 hours.
Meat and offal:
Pigs: zero days.
Broiler chickens: zero days.
Not for use in birds producing or intended to produce eggs for human consumption.
Keep out of the sight and reach of children. Do not store above 25 °C. Do not refrigerate or freeze. Store in the original package. Store in a dry place.
Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.
Shelf life after reconstitution into drinking water: 24 hours.
Special precautions for use in animals
Use of the veterinary medicinal 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. Use of the veterinary medicinal product deviating from the instructions given in the SPC may increase the prevalence of resistant bacteria and may decrease the effectiveness of treatment with other aminoglycosides due to the potential for cross-resistance.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
People with known hypersensitivity to apramycin should avoid contact with the product.
Handling a product of this nature can generate dust particles in the air. An overexposure to apramycin can cause irritation or sensitisation after skin or eye contact or inhalation.
Special precaution measures should be taken during reconstitution of the product in drinking water.
Use personal protective equipment consisting of gloves, mask, goggles and protective clothing while handling the product. In case of eye contact, rinse the affected area with plenty of water.
Do not smoke, eat or drink while handling this product.
If skin irritation occurs, seek medical advice and show your doctor the package leaflet.
In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Use during pregnancy, lactation or lay
Laboratory studies have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
The use of the product is not recommended in pregnant or lactating sows.
Do not use in birds producing eggs for human consumption.
Interaction with other medicinal products and other forms of interaction
None known.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Doses 3 times higher than the therapeutic dose did not produce clinical changes.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Medicines should not be disposed of via wastewater or household waste.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. The treated animals are kept in shelters throughout the treatment period, and the resulting manure will Not be used to fertilize the soil.
50 g, 100 g, 1 kg and 5 kg, bags made of polyethylene terephthalate laminate film / aluminum foil / low density polyethylene.
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