Target species
Cattle (pre-ruminant).
Indications for use, specifying the target species
Reduction in the occurrence of diarrhoea due to diagnosed Cryptosporidium parvum.
Calves should only receive the veterinary medicinal product upon confirmation of cryptosporidial oocysts in their faeces and before the onset of diarrhoea.
Paromomycin reduces faecal oocyst shedding.
Contraindications
Do not use in cases of hypersensitivity to the active substance, to other aminoglycosides or to 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 veterinary medicinal 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
Special precautions for use in animals
The use of the veterinary medicinal product should be combined with good management practices e.g. good hygiene, proper ventilation and no overstocking. Repeated use of the veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal product has not been investigated in animals less than 3 days of age.
Special precautions to be take by the person administering the veterinary medicinal product to animals
This veterinary medicinal product contains paromomycin, which can cause allergic reactions in some people.
People with known hypersensitivity to paromomycin or any other aminoglycoside should avoid contact with the veterinary medicinal product.
Avoid contact with the skin and eyes. 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 package leaflet or the label to the physician.
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 veterinary medicinal product.
Do not ingest. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment
Not applicable.
Other precautions:
Not applicable.
Adverse reactions (frequency and seriousness)
Undetermined frequency (cannot be estimated from available data) | Nephropathy (nephrotoxicity) (1) Internal ear disorder (ototoxicity) (1) |
1 - can be caused by aminoglycoside antibiotics such as paromomycin
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Not applicable.
Interaction with other medicinal products and other forms of interaction
General anaesthetics and muscle relaxing products increase the neuro-blocking effect of aminoglycosides. This may cause paralysis and apnoea.
Amount(s) to be administered and administration route
For oral use.
Dose rate: 35 000 IU of paromomycin/kg BW/day for 7 consecutive days, i.e. 2.5 ml of veterinary medicinal product / 10 kg BW/day for 7 consecutive days.
To ensure a correct dosage, the use of either a syringe or an appropriate device for oral administration is necessary and the veterinary medicinal product should be administered directly in the mouth of the animal.
To ensure a correct dosage, bodyweight should be determined as accurately as possible.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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 35 000 IU paromomycin/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