Target species
Cattle (pre-ruminant calves), pig.
Indications for use
Treatment of gastro-intestinal infections caused by Escherichia coli susceptible to paromomycin.
Contra-indications
Do not use in animals with known hypersensitivity to paromomycin, other aminoglycosides or any of the excipients.
Do not use in cases with impaired function of the kidneys or liver.
Do not use in ruminating animals.
Do not use in turkeys due to the risk of selection for antimicrobial resistance in intestinal bacteria.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of water/milk animals should be treated parenterally using a suitable injectable product following the advice of the veterinarian.
The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation, no overstocking.
Since the product is potentially ototoxic and nephrotoxic, it is recommended to assess kidney function.
Special care should be taken when considering administration of the product to newborn animals due to the known higher gastrointestinal absorption of paromomycin in neonates. This higher absorption could lead to an increased risk of oto- and nephrotoxicity. The use of the product in neonates should be based on benefit-risk assessment by the responsible veterinarian. Prolonged or repeated use of the product should be avoided by improving management practices and through cleansing and disinfection.
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 product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to paromomycin and may decrease the effectiveness of treatment with aminoglycosides due to the potential for cross resistance.
Aminoglycosides are considered as critical in human medicine. Consequently, they should not be used as a first intention treatment in veterinary medicine.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product contains paromomycin, which can cause allergic reactions in some people. Anyone with known hypersensitivity (allergy) to aminoglycosides should avoid contact with the veterinary medicinal product. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Personal protective equipment consisting of protective clothing and impervious gloves should be worn when handling the veterinary medicinal product.
Do not eat, drink and smoke when handling the product. Wash hands after use. In case of accidental ingestion, seek medical advice immediately and show the label to the physician.
When handling this product, inhalation of the dust must be avoided by wearing a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator to European Standard EN 140 with a filter to EN 143.
Use in a well-ventilated area. Avoid inhaling the powder while preparing the medicated water or milk replacer. Avoid contact with the skin and eyes. In the event of accidental contact with the skin or eyes, rinse with plenty of water and seek medical attention if irritation persists.
Adverse reactions
Aminoglycoside antibiotics such as paromomycin can cause oto- and nephrotoxicity.
On rare occasions soft faeces has been observed.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
Laboratory studies in rat and rabbit have not produced any evidence of teratogenic, foetoxic, maternotoxic effects. The use is not recommended during the whole pregnancy.
Interactions
General anaesthetics and muscle relaxing products increases the neuro-blocking effect of aminoglycosides. This may cause paralysis and apnoea.
Do not use concurrently with loop diuretics and potentially oto- or nephrotoxic substances.
Amounts to be administered and administration route
Oral use.
Pre-ruminant cattle: administration in milk/milk replacer.
Pigs: administration in drinking water.
Duration of treatment: 3-5 days
Pre-ruminant cattle:17500 - 35000 IU per kg BW/day (equivalent to 2.5-5 g of product/10 kg BW/day)
Pigs: 17500 - 28000 IU per kg BW/day (equivalent to 2.5-4 g of product/10 kg BW/day)
For the administration through the drinking water milk or milk replacer, the exact daily amount of product should be calculated, based on the recommended dose, and the number and weight of the animals to be treated, according to the following formula:
To ensure a correct dosage body weight should be determined as accurately as possible.
The uptake of medicated water/milk /milk replacer depends on several factors including clinical conditions of the animals and the local conditions such as ambient temperature and humidity. In order to obtain the correct dosage, drinking water/milk/milk replacer uptake has to be monitored and the concentration of paromomycin has to be adjusted accordingly.
Medicated drinking water/milk/milk replacer and any stock solutions should be freshly prepared every 6 hours (in milk/milk replacer) or every 24 hours (in water).
To assure administration of the exact daily amount of product suitably calibrated weighing equipment should be used.
For the administration of the product commercially available dosing pumps can be used. The solubility of the product has been tested at the maximum concentration of 95 g/L.
Overdose
Paromomycin when administered orally is hardly absorbed systemically. Harmful effects due to accidental overdosing are highly unlikely.
Withdrawal periods
Pre-ruminant cattle: Meat and offal: 20 days
Pig: Meat and offal: 3 days