Target species
Cattle and sheep.
Indications for use for each target species
The veterinary medicinal product is indicated for intramammary use in the treatment of bovine mastitis caused by Gram-positive organisms. For the best results it should be used at the earliest signs of infection.
The product is also indicated as an intramammary infusion in ewes at weaning for the treatment and prevention of mastitis. The veterinary medicinal product is effective against Streptococcus agalactiae and other streptococcal species, penicillin-resistant and sensitive staphylococci and Actinomyces pyogenes.
In staphylococcal and certain forms of streptococcal mastitis, an adequate duration of treatment is important in achieving both clinical and bacteriological cures. The veterinary medicinal product with its slow release characteristics is designed to meet these requirements.
Contraindications
None.
Special warnings
None.
Special precautions for use
Special precautions for safe use in the target species:
Individual syringes must only be used once.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reaction to these substances may occasionally be serious.
People with known hypersensitivity should avoid contact with the veterinary medicinal product.
Handle this product with great care to avoid exposure, taking all recommended precautions.
In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Lactation:
The veterinary medicinal product is indicated for use in the lactating cow and for use in ewes at weaning.
Interaction with other medicinal products and other forms of interaction
None known.
Administration routes and dosage
Cows
Dosage
The recommended dose is three infusions per infected quarter - one syringe administered every 48 hours.
Administration
Clean and disinfect the teat with surgical spirit after milking; insert nozzle into the teat and apply gentle and continuous pressure until the suspension is expressed. The treated quarter(s) may be milked out at the next normal milking time.
Ewes
Dosage
A single infusion should be made into each udder half at weaning.
Administration
It is important that a simple hygienic procedure is followed. One operator should turn up and hold each ewe whilst a second person carries out the infusion technique. Clean and disinfect each teat end thoroughly with surgical spirit. Appose the syringe nozzle to the teat orifice and apply gentle, continuous pressure to express the suspension in the udder. Actual cannulation of the teat orifice is neither necessary nor desirable. Use a fresh syringe for each udder half to avoid the possibility of cross contamination during infusion.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
The veterinary medicinal product is non-irritant to the udder tissues and well tolerated in the target species. No adverse effects are to be expected from an accidental overdose.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Cattle (milk): 96 hours.
Sheep (milk): Not for use in ewes producing milk for human consumption.
Cattle and sheep (meat and offal): 7 days.