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Contra-indications, warnings, etc
Do not administer in case of hypersensitivity to apramycin.
Do not use in calves with functional rumen.
Do not use in animals suffering from kidney disorders.
Special warnings for each target species
Special precautions for use
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.
Where a diagnosis of Salmonella Dublin is made on the farm, then control measures including on-going monitoring of disease status, vaccination, biosecurity and movement controls should be considered. National control programmes should be followed where available.
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.
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 medicinal product to animals:
People with known hypersensitivity to apramycin or any other aminoglycoside should avoid contact with the product.
This product may cause irritation or sensitisation after skin or eye contact or inhalation.
Avoid contact with the eyes, skin and mucous membranes and inhalation of dust while preparing the medicated water/milk.
Use personal protective equipment consisting of gloves, mask, goggles and protective clothing while handling the product.
Wash hands after use.
In case of eye contact, rinse the affected area with plenty of water. In case of skin contact, wash thoroughly with soap and water. If irritation persists, seek medical advice.
In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
In case of onset of symptoms after exposure such as skin rash, seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips and eyes or difficult breathing are more serious symptoms and require urgent medical assistance.
Adverse reactions (frequency and seriousness): None known.
Use during pregnancy, lactation or lay
Pigs: The safety of the veterinary medicinal product has not been established during pregnancy and lactation in sows. Use only accordingly to the benefit-risk assessment by the responsible veterinarian.
Cattle: The use is not intended during pregnancy or lactation.
Rabbits: Oral doses of apramycin administered from 6th to the 18th day of pregnancy (including doses below the therapeutic doses), have shown evidence of foetotoxic effects. Do not use during pregnancy.
Chickens: Do not use in laying hens and within 4 weeks before the onset of the laying period.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Pigs: Pigs have been given up to nine times the recommended use level in their drinking water for 28 days with no untoward reaction.
Calves: Calves were given apramycin in milk replacer daily for five days, at doses up to 120 mg/kg of bodyweight. There was no toxic effect.
Chicken: There was no mortality when chickens were given a single oral dose of 1,000 mg/kg of bodyweight. Chickens were given up to 5 times the recommended level for 15 days with no untoward reaction.
Possible intoxications can be recognised by the following symptoms: soft faeces, diarrhoea, vomiting (weight loss, anorexia, and similar), renal impairment and effects on the central nervous system (reduced activity, loss of reflexes, convulsions, etc.).
Do not exceed the recommended dose.