Category: R
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| Category | POM-V |
| Temperature | Refrigerated |
| MA/VM/EU No: | 42058/4128 |
| Species |
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| VMD Link | https://www.vmd.defra.gov.uk/productinformationdatabase/files/SPC_Documents/SPC_138859.PDF |
| NOAH Link | |
| Dosage | Reconstitute the vaccine by first shaking the vial containing the emulsion, and then aseptically withdraw and add all of 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 2 ml dose of reconstituted vaccine to be given to healthy cattle over the age of 3 months. A single dose of vaccine will protect animals for at least 17 weeks. 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. |
| Withdrawals | s or heifers at the time of breeding. 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. Do not mix with any other veterinary medicinal product except the emulsion supplied with the product. A transient local swelling at the injection site is very commonly observed within 24 to 48 hours post vaccination. The swellings are up to 14 cm in diameter and usually disappear within 2 weeks post vaccination, with no need for treatment. On rare occasions, the local reaction may take longer to resolve (up to 52 days). A transient increase in rectal temperature (up to a maximum of 40.9°C) is very commonly observed within 1 to 4 hours post vaccination. Temperatures return to normal within 4 days without treatment. Rarely, hypersensitivity reactions may occur. In such cases, appropriate treatment e.g. adrenaline and/or antihistamine should be given without delay. Muscular trembling has also been noted very rarely.” 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 100 animals treated) -uncommon (more than 1 but less than 10 animals in 1,000 animals treated) -rare (more than 1 but less than 10 animals in 10,000 animals treated) -very rare (less than 1 animal in 10,000 animals treated, including isolated reports) User warnings Ensure that the method of restraint, handling and administration, e.g. by the use of guarded needles, minimizes the risk of accidental injection/self-injection. 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 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 further medical advice. To the doctor: 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. Withdrawal period Zero days. |
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