Target species
Sheep and Goats
Indications for use
For the active immunisation of sheep and goats to stimulate cell-mediated and humoral immunity against M. avium subsp. paratuberculosis infection, as an aid in the control of Johne’s disease in those species.
This is a Limited Marketing Authorisation. A full set of supporting efficacy data are not available for this product.
Further information on this product and its supporting data can be found on http://www.vmd.gov.uk/ProductInformationDatabase/
No information on onset of immunity or duration of immunity is available for this product.
Contraindications
None
Special warnings for each target species
Vaccination sensitises animals against johnin PPD, avian tuberculin PPD and, to a lesser extent, bovine tuberculin PPD. In vaccinated animals, the hypersensitivity reaction against avian tuberculin PPD is normally more intense than against bovine tuberculin PPD and clearly distinguishable. This will require careful interpretation of any tuberculin skin test that may be performed for tuberculosis diagnosis in animals vaccinated with this product.
Special precautions for use
Special precautions for use in animals
Gudair vaccine should be exclusively administered subcutaneously using a 6 mm (18 Gauge) needle on a 45º degree angle on the side of the neck midway between the ear and the front of the shoulder. Do not inject at any other site.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user
This 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 medical advice again.
To the physician
This 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.
In case of accidental self injection, persons who have been exposed to mycobacteria, either from a previous vaccination, or from environmental exposure may develop a reaction within the following hours. If a strong reaction or systemic symptoms occur seek medical advice immediately. Show the package leaflet or the label to the physician. TB interference test can be observed after accidental self-injection.
The use of personal protective equipment consisting of suitable protective clothing, gloves and footwear is recommended when handling the immunological veterinary medicinal product. All practicable measures of cleaning and disinfection of protective clothing, gloves, footwear, hands, and equipment (syringes, etc.) should be undertaken on entry and exit from the holding to minimise the risk of disease transfer.
Adverse reactions
The vaccine produces swelling at the injection site which gradually becomes a persistent, fibrous and cold nodule that does not affect the general health status of the animal. This event is very common. Nodule can be detected at 1-2 weeks post vaccination with medium size of approximately 2 cm in sheep and goats, reaching a mean maximum size of 3.5 cm in sheep and 4 cm in goats at 2 months post vaccination, decreasing until 1 year after vaccination. Occasionally, the diameter can reach values greater than 5 cm at 2 months after vaccination. Palpable lesions can be observed in the 20-25% of the sheep at 4 years post vaccination.
Nodules can rupture and discharge.
An average increase of body temperature in sheep can occasionally be observed varying between 0.5 and 1.0 °C. It lasted no longer than 48-96 hours.
Use during pregnancy, lactation or lay
The safety of the veterinary product has not been established during pregnancy or lactation.
Interactions
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.
Amounts to be administered and administration route
Subcutaneous route.
Shake well before use.
Sheep and goats: administer one dose of 1 ml subcutaneously.
Vaccination schedule
It is recommended that all replacement animals are vaccinated between 4 weeks and six months of age. In affected or at risk flocks and herds or groups of animals, the vaccination should be carried out on all individuals, including adult animals.
Avoid administration in the areas of support and rubbing.
Overdose
Overdose produces swelling at the injection site which gradually becomes a persistent, fibrous and cold nodule that does not affect the general health status of the animal. This event is very common.
Nodule can be detected at 1 week post vaccination with medium size of approximately 1.5 cm in sheep and 1.8 cm in goats, reaching a mean maximum size of 3 cm in sheep at 21 days and 4.9 cm in goats at 28 days post vaccination, which decrease quickly in the next days. Uncommonly, the diameter can reach values of 4 cm in sheep and 6 cm in goats.
Nodules can rupture and discharge.
An average increase of body temperature in sheep can occasionally be observed varying between 0.5 and 1.0°C. It lasts no longer than 24 hours.
Withdrawal period(s)
Zero days