Cattle (cows and heifers)
Indications for use
For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.
The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection (equivalent to 130 days post-parturition).
Special warnings for each target species
The whole herd should be immunised.
Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality, health monitoring) and other management practices.
Special precautions for use
Special precautions for use in animals
Only healthy animals should be immunised.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Slight to moderate transient local reactions may occur after the administration of one dose of vaccine. They would mainly be: swelling (up to 5 cm2 on average), which disappears within 1 or 2 weeks at most. In some cases, there may also be pain at the inoculation site that spontaneously subsides in a maximum of 4 days.
A mean transient increase in body temperature of about 1°C, in some cows up to 2°C, may occur in the first 24 hours after injection.
Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation
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.
Amounts to be administered and administration route
Intramuscular use. The injections should be preferably administered on the alternate sides of the neck. Allow the vaccine to reach a temperature of +15 to + 25 °C before administration. Shake before use.
Administer one dose (2 ml) by deep intramuscular injection in the neck muscles and according to the following schedule:
-First injection at 45 days before the expected parturition date.
-Second injection 35 days thereafter (corresponding to 10 days before the expected parturition date).
-Third injection 62 days after the second injection (equivalent to 52 days post-parturition).
The full immunisation program should be repeated with each gestation.
No adverse reactions other than those mentioned in section 4.6. were observed after the administration of a double dose of vaccine.