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.
Special warnings for each target species
In field studies investigating the effect of the product on diarrhoea associated with cryptosporidiosis, 23% to 32% of calves in treated groups presented with diarrhoea, in comparison to 53% to 73% of calves in untreated groups, during the 7-day treatment period.
Special precautions for use in animals
The use of the product should be combined with good management practices e.g. good hygiene, proper ventilation and no overstocking. Repeated use of the product on farms should be avoided by improving management practices and through cleaning and disinfection.
Aminoglycosides are considered as critically important in human medicine. 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. The safety of the product has not been investigated in animals less than 3 days of age.
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.
People with known hypersensitivity (allergy) to paromomycin or any other aminoglycosides should avoid contact with the product.
Avoid contact with the skin and eyes.
Personal protective equipment consisting of protective clothing and impervious gloves should be worn when handling the veterinary medicinal product.
In the event of accidental contact with the skin or eyes, rinse with plenty of clean water.
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.
Do not eat, drink and smoke when handling the product.
Do not ingest. In case of accidental ingestion, seek medical advice immediately and show the label to the physician.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Aminoglycoside antibiotics such as paromomycin can cause oto- and nephrotoxicity.
Use during pregnancy, lactation or lay
Not applicable.
Overdose (symptoms, emergency procedures, antidotes)
Do not administer for more than 7 days since clinical signs associated with gastrointestinal lesions were observed after prolonged treatment duration. In 2 to 5 week old calves, overdoses in excess of 50 mg paromomycin sulphate/kg bodyweight may induce gastrointestinal lesions (ulceration, pustules, chronic hyperplastic inflammation) mostly in the rumen and reticulum. Bruxism and poor appetite have been reported. Repeated overdose may be associated with death.
Withdrawal Periods
Due to accumulation of paromomycin in the liver and kidneys, any repeated course of treatment during the withdrawal period must be avoided.
Meat and offal: 62 days.