Target Species
Cattle, sheep and pigs
Indications for use
For the treatment of the following infections caused by, or associated with, organisms sensitive to oxytetracycline in cattle, sheep and pigs:
Treatment of foot infections caused in particular by: Dichelobacter nodosus, Fusobacterium necrophorum and other Fusobacterium spp., and Bacteroides spp.
Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions.
Contraindications
Do not use for treatment of teats in order to prevent the veterinary medicinal product from getting into milk.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
The animals should be treated in a well ventilated area.
Do not spray in or near the eyes.
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.
Operator warnings
Because of the risk of sensitisation and contact dermatitis, the user should avoid skin contact. Wear appropriate impermeable gloves whilst handling the veterinary medicinal product.
Because of risk of eye irritation, contact with the eyes should be avoided.
Protect the eyes and face.
Do not spray on a naked flame or any incandescent material.
Do not pierce or burn the container, even after use.
Avoid inhaling vapours.
Apply the veterinary medicinal product in the open air or in a well ventilated area.
Wash hands after use.
Do not eat or smoke whilst administering the veterinary medicinal product.
In case of accidental ingestion or in case of contact with eyes, seek medical advice immediately and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse Reactions
None known.
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 or lactation
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interactions
None known.
Amounts to be administered and administration route
For cutaneous use.
Shake well before use. The spray container is suitable to be used in upright and inverted positions. Before application properly clean the surface to be treated, spray the veterinary medicinal product for 1-2 seconds, at a distance of 15-20 cm, until the area has a homogeneous colour. Repeat the treatment every 12 hours for 1 to 3 days, depending on the healing process.
To achieve the best results in case of pedal lesions the following instructions are recommended:
•fully clean the foot area, completely removing foreign material, exudates and necrotic tissue
•keep the animal on dry ground for 12 hours after each application.
Overdose
None known.
Withdrawal periods
Cattle, sheep:
Meat and offal: Zero days
Milk: Zero hours
Pigs:
Meat and offal: Zero days
Stained part of the pig skin must be removed prior to the rest of the animal being used for human consumption.