Contraindications: None
Special warnings for each target species; Vaccinate healthy animals only. 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, animal comfort, air and water quality, health monitoring) and other management practices.
Special precautions to be taken by the person administering the veterinary medicinal product to 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 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 product can cause intense swelling, which may 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) Detail for GB only:
Very common adverse reactions - slight swelling at the injection site of less than 2 cm in diameter which disappears within 12 days at most
Common adverse reactions - Swelling at the injection site higher than 5cm in diameter which resolves within 3 days at most. Transient increase in body temperature of up to 1.80C between the first 4 hours and 3 days after injection during clinical studies, which spontaneously resolves within some days without compromising health status.
Post Authorisation Pharmacovigilance Reporting
Anaphylactic-type reactions which might be life-threatening and/or cause abortion occurred very rarely. Under these circumstances, appropriate and rapid symptomatic treatment should be administered.
Mild apathy, anorexia and/or recumbency occurred very rarely after administration of the vaccine.
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 animals in every 100 treated)
-uncommon (more than 1 but less than 10 animals in every 1,000 treated)
-rare (more than 1 but less than 10 animals in every 10,000 treated)
-very rare (less than 1 animal in every 10,000 animals treated, including isolated reports)
Adverse Events (Detail for Northern Ireland only): Ewes and adult female goats
Very common (>1 animal/10 animals treated): Injection site swelling of less than 2cm in diameter which disappears within 12 days at most.
Common (1 to 10 animals/100 animals treated): Injection site swelling higher than 5cm in diameter which resolves within 3 days at most. Elevated temperature: Transient reaction of up to 1.8°C occurred between the first 4 hours and 3 days after injection, which spontaneously resolves within some days without compromising animal health status.
Very rare: (<1 animal/10,000 animals treated, including isolated reports): Anaphylactic type reaction might be life-threatening and/or cause abortion. In such cases, appropriate and rapid symptomatic treatment should be administered. Mild apathy, anorexia or recumbency:
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 MA holder (or its local representative) or the national competent authority via the national reporting system.
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; Transient increase in body temperature of about 10C in some animals up to 1.80C may occur in the first 24-48 hours after injection of a 2-fold dose. Hard spots up to 5cm in diameter which disappear within 7-9 days may be observed after injection of a 2-fold dose.
Withdrawal Period - Zero days