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Contra-indications, warnings, etc
Selection of cows for treatment with the veterinary medicinal product should be based on veterinary clinical judgement. Selection criteria may be based on the mastitis and cell count history of individual cows or recognised tests for the detection of subclinical mastitis or bacteriological sampling.
Since the veterinary medicinal product does not have antimicrobial activity, in order to minimize the risk of acute mastitis due to poor infusion technique and lack of hygiene, it is crucial to follow the aseptic technique of administration described in the Further Information section.
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Acute mastitis1
1 Primarily due to poor infusion technique and lack of hygiene. Please refer to the Further Information section regarding the importance of aseptic technique.
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.
Do not use the veterinary medicinal product alone in cows with subclinical mastitis at drying off. The compatibility of the veterinary medicinal product has only been shown with a cloxacillin-containing dry cow preparation.
Do not administer any other intramammary veterinary medicinal product following administration of the veterinary medicinal product. In cows that may have subclinical mastitis, the veterinary medicinal product may be used following administration of a suitable dry cow antibiotic treatment to the infected quarter.
Do not use in cows with clinical mastitis at drying off.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Twice the recommended dose has been administered to cows with no clinical adverse effects.
Do not use during lactation. If accidentally used in a lactating cow, a small (up to 2-fold) transient rise in somatic cell count may be observed. In such an event, strip out the seal manually. No additional precautions are necessary.
To reduce the risk of contamination, do not immerse the syringe in water.
Withdrawal periods
Meat and offal: Zero days
Milk: Zero days
Operator warnings
The veterinary medicinal product may cause skin and eye irritation. Avoid contact with skin or eyes.
Should skin or eye contact occur, wash the affected area thoroughly with water. If irritation persists, seek medical advice and show the label to the doctor.
People with known hypersensitivity to bismuth salts should avoid contact with the veterinary medicinal product.
Wash hands after use.