Target species
Cattle, sheep and pigs.
Indications for use for each target species
•Prevention of infections of superficial traumatic or surgical wounds caused by micro-organisms sensitive to chlortetracycline.
•The veterinary medicinal product can be used as part of a treatment for superficial claw/hoof infections, in particular interdigital dermatitis (foot rot) in sheep and digital dermatitis in cattle.
Contraindications
Do not use in case of hypersensitivity to tetracyclines or to any of the excipients.
Special warnings
None
Special precautions for use
Special precautions for safe use in the target species:
Protect the eyes when spraying in the vicinity of the head. Clean the affected area thoroughly before spraying. Treatment of foot conditions should always be preceded by appropriate paring of the hoof, as this is critical for achieving an adequate response. After spraying the feet, the animal should be kept on dry ground for at least one hour.
The animal should be discouraged from licking the treated area, or treated areas on other animals.
Use of the veterinary medicinal product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level. Use of the product should be in accordance with official, national and regional antimicrobial policies.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions to chlortetracycline.
Wear appropriate impermeable gloves whilst handling the product.
Because of risk of eye irritation, contact with the eyes should be avoided. Protect the eyes and face.
Do not spray on an open flame or other ignition source. Do not pierce or burn, even after use.
Avoid inhaling vapours. Apply the veterinary medicinal product in open air or in sufficiently 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 label to the physician.
Special precautions for the protection of the environment
Not applicable
Adverse reactions
Cattle, sheep and pigs:
Rare (1 to 10 animals/10,000 animals treated): | Hypersensitivity reactions |
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
Lactation:
Following cutaneous administration of veterinary medicinal product, absorption of chlortetracycline is negligible and it is not detectable in the milk.
Interactions with other medicinal products and other forms of interaction
After cutaneous administration of chlortetracycline spray, absorption of chlortetracycline is negligible. No data on interactions with other local treatments are available.
Amounts to be administered and administration route
Cutaneous use:
Shake the container thoroughly before spraying. The container should be held at a distance of 15-20 cm from the area to be sprayed; spray for approximately 3 seconds (equivalent to approximately 3.9 g of product or 0.10 g chlortetracycline) until the treatment-area is evenly coloured. In case of claw/hoof infections this treatment should be repeated after 30 seconds.
- For prevention of infections after superficial traumatic or surgical wounds a single administration is recommended.
- For treatment of Dermatitis Digitalis, a double administration (with a 30 second interval) is recommended daily for three consecutive days.
- For treatment of other hoof infections (foot rot), a double administration (with a 30 second interval) is recommended. Dependent on the seriousness of the injury and the rate of improvement treatment should be repeated within 1 to 3 days
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Not applicable
Special restrictions for use and special conditions for use, including restriction on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
Withdrawal periods
Meat and offal : zero days
Milk : zero days
Do not use on the udder of lactating animals if milk is intended for human consumption.
Stained part of the pigskin must be removed prior to the rest of the animal being used for human consumption.