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
None
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
Pharmacological particulars
Pharmacotherapeutic group: Inactivated bacterial vaccines against paratuberculosis, ATCvet code: QI04AB (sheep) and AI03AB01 (goats)
GUDAIR stimulates active immunization against Mycobacterium paratuberculosis in sheep and goats
Pharmaceutical particulars
Excipients
Marcol 52
Montanide 103
Montane 80
Polysorbate 80
Thiomersal.
Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections)
Incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale:
HDPE bottle: 2 years
Glass bottle: 3 years
Shelf life after first opening the immediate packaging: 35 days
Special precautions for storage
Store and transport between +2 °C and +8 °C.
Protect from light.
Do not freeze.
Immediate packaging
Type II Glass bottles of 30 ml with rubber-nitrile stopper and aluminium seal. High density polyethylene (HDPE) bottles with rubber-nitrile stopper and aluminium seal.
Package size:
Card box with 1 glass bottle containing 30 doses (30 ml).
Card box with 1 HDPE bottle containing 100 doses (100 ml)
Card box with 1 HDPE bottle containing 250 doses (250 ml)
Not all pack sizes may be marketed
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Shipping charges mainland GB zone1
| Value | Weight | Delivery Charge |
| Over £49.00 | Any Weight | FREE |
| Under £49.00 | No weight limit | £4.50 |
| Under £49.00 | Under 250 grams | £3.49 |
Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited options are available at extra cost - these usually arrive in 24-48hrs from dispatch but delays are possible during busy periods.
Postcodes outside of Zone 1 (including some areas within mainland UK) may incur extra carriage charges due to surcharges imposed by the couriers. These will be calculated on the website at the checkout.
NB: Orders placed with faster delivery must be placed before 13:00 to ensure same day dispatch (excluding weekends and bank holidays). Please also check on the product page that the items ordered show 'In Stock' otherwise your order will be delayed until the stock becomes available, which in most cases will only be 24hrs.
Estimated "Usually shipped in" information is shown against most products
Overseas orders
We no longer send goods outside of the UK.
Prescription Items
Prescription items will be sent on receipt of a valid signed and dated prescription.
Pick up
We offer a pickup service for orders placed over the phone.
Please ring us on 01833 641112 for more information.
Refrigerated Items
Refrigerated items will be sent by carrier or express delivery at a cost of £7.50, with coolpacks, unless you pay for a premium for a refrigerated delivery. We will contact you prior to despatch for your instructions.
We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email sales@hyperdrug.co.uk to obtain a returns number.
*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.
