Target species: Cattle (cows and heifers).
Indications for use for each target species
For active immunisation of healthy cows and heifers, in herds of dairy cattle with repeated occurrence of mastitis, to reduce the incidence and severity of clinical mastitis caused by Staphylococcus aureus and Escherichia. coli.
Onset of immunity: 4 weeks after completion of the primary vaccination course.
Duration of immunity: up to 6 months after completion of the primary vaccination course.
Contraindications: None.
Special warnings
The whole herd should be immunised.
Vaccination must be considered as one part of a comprehensive preventive mastitis control programme, which should address all factors important for the mammary gland health (e.g milking technique, drying-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other relevant management practices.
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species: Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: Seek medical advice if a local reaction occurs following accidental self-injection and show the package leaflet to the physician.
Special precautions for the protection of the environment: Not applicable.
Adverse events
Cattle (cows and heifers):
Common
(1 to 10 animals / 100 animals treated):
Injection site swelling1
Elevated temperature2
1 swelling (up to 5 cm2) for up to 2 weeks. 2 a slight and transient increase in body temperature up to 1.5 °C may occur and disappear spontaneously within the first 24 hours after the injection.
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
Pregnancy: Can be used during the last trimester of pregnancy.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Administration routes and dosage
Intramuscular use.
Allow the vaccine to reach a temperature of 15-25 °C and shake the vial slightly before administration. Administer one dose (2 ml) intramuscularly according to the following schedule:
- First dose: 45 days before expected parturition date.
- Second dose: 3 weeks after the first administration.
It is recommended to administer each dose on alternate sides. This full vaccination schedule must be repeated with each pregnancy.
Symptoms of overdose (and where applicable, emergency procedures and antidotes): Not applicable.
Withdrawal periods: Zero days.