POM-V Prescription Required

Gudair Emulsion for Injection for Sheep and Goats

Active ingredient: Mycobacterium paratuberculosis

Form

Injection

Species

Goats Sheep

Manufacturer

CZ Vaccines S.A.U.

VMD MA No.

30824/4002

What it's used for

For the active immunisation of sheep and goats to stimulate cell-mediated and humoral immunity against M. avium subsp. paratuberculosis infection, as an ai...

Full indications, dosage and side effects ↓

View official SPC (PDF)

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Clinical information

Gudair Emulsion for Injection for Sheep and Goats — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.

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 is 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.

Revised: December 2023
AN: 02163/2023

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.

Revised: December 2023
AN: 02163/2023
Avoid administration in the areas of support and rubbing.

None

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.

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.
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 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
symptons occur seek medical advice immediately. Show the package leaflet or the

Revised: December 2023
AN: 02163/2023
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.

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.

Store and transport between +2 C and +8 C.
Protect from light.
Do not freeze.

Zero days
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated bacterial vaccines against paratuberculosis,
ATCvet code: QI04AB (sheep) and AI03AB01 (goats).
GUDAIR stimulates active immunization against in
sheep and goats.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.