Contraindications
None.
Special warnings
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:
To the user:
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 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 veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal 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.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cattle:
Very common (≥1 animal / 10 animals treated): Injection site inflammation1, elevated temperature2
Uncommon (1 to 10 animals / 1,000 animals treated): Anaphylactic-type reaction3
1 A slight to moderate transient injection site inflammation (up to 14 cm of diameter) may be observed, which rapidly decreases in diameter within 2 days and subsides within 2 weeks without treatment.
2 An elevated temperature (mean increase 1.7 ºC, in individual animals up to 2.4 ºC) may occur after vaccination. This increase subsides spontaneously within 3 days.
3 In cases of anaphylactic-type reactions, an appropriate symptomatic treatment should be administered.
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. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse events other than those described above were observed .
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
Any person intending to manufacture, import, possess, distribute, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Official control authority batch release may be required for this product according to national requirements.
Withdrawal periods
Zero days.