Target species
Cattle.
Indications for use for each target species
For active immunisation of cattle to reduce lesions and respiratory disease caused by Mannheimia haemolytica biotype A, serotype 1.
Onset of immunity: 7 days.
Duration of immunity: 17 weeks.
Contraindications
None.
Special warnings
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species:
Calves should be vaccinated at least 7 days before transport, mixing of animals of different origins, housing or any other event which may cause the animals to be stressed or exposed to new infections. Calves are usually most susceptible during early autumn. The vaccine will protect animals for at least 17 weeks, which will cover the period of risk from pasteurellosis.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Ensure that the method of restraint, handling, and administration, e.g. by the use of guarded needles, minimises the risk of accidental injection/self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
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 swelling1 Elevated temperature2 |
Rare (1 to 10 animals / 10,000 animals treated): | Hypersensitivity reactions3 |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Muscle tremor |
1 Mild, transient, and usually disappearing within 2 weeks or up to 52 days on rare
occasions. Observed within 24 to 48 hours post vaccination and up to 14 cm in
diameter.
2 Transient. Observed 1 to 4 hours post vaccination, up to a maximum of 40.9 °C. Resolving within 4 days without treatment.
3 Appropriate treatment, e.g. adrenaline and/or antihistamine, should be given without delay.
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:
Do not use during the whole pregnancy.
Fertility:
Do not use in breeding animals.
Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Rispoval RS.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.
Reconstitute the vaccine by first shaking the vial containing the emulsion, and then aseptically withdraw and add all the emulsion to the vial containing the lyophilisate. Shake well and aseptically administer 2 ml intramuscularly.
Do not use chemically sterilised syringes or needles.
Vaccination programme
A single two ml dose of reconstituted vaccine to be given to healthy cattle over the age of 3 months.
Should cattle be at risk from pasteurellosis at a subsequent time, a single vaccination is recommended at least 7 days prior to the period of expected disease challenge.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
None.
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
Not applicable.
Withdrawal periods
Zero days.