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Contra-indications, warnings, etc
Contra-indications: None
Special warnings for each target species; Vaccinate healthy animals only. The whole herd should be immunised. Immunisation has to be considered as one component in a complex intramammary infection 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 and health monitoring) and other management practices.
Special precautions to be taken by the person administering the veterinary medicinal product to the animals; This veterinary medicinal 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 veterinary medicinal product, seek prompt medical advice even if only a 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 veterinary medicinal 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.
Adverse reactions (frequency and seriousness)
Local swelling more than 5cm in diameter at the injection site is a very common reaction after administration of the vaccine. This swelling will have disappeared or be clearly reduced in size by 17 days post vaccination. However, in some cases, swelling may persist for up to 4 weeks.
A transient increase in rectal temperature (mean increase of 1 °C but may be up to 2 °C in individual animals) may very commonly occur in the first 24 hours after injection.
Anaphylactic-type reactions (eg. oedema) which might be life-threatening, may occur very rarely in some sensitive animals based on post-marketing safety experience. Under these circumstances, appropriate symptomatic treatment should be administered.
The frequency of adverse reactions is defined using the following convention:
-very common (more than 1 in 10 animals treated displaying adverse reaction(s))
-common (more than 1 but less than 10 in 100 animals treated)
-uncommon (more than 1 but less than 10 in 1000 animals treated)
- rare (more than 1 but less than 10 in 10,000 animals treated)
-very rare (less than 1 animal in 10,000 animals treated including isolated reports)
Use during pregnancy, lactation or lay; Can be used during pregnancy and lactation.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary: No information is available.
Withdrawal period(s); Zero days