Gudair Emulsion for Injection for Sheep and Goats

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Mycobacterium paratuberculosis

Tilgjengelig fra:

CZ Veterinaria S.A.

ATC-kode:

QI04AB

INN (International Name):

Mycobacterium paratuberculosis

Legemiddelform:

Emulsion for injection

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Goats, Sheep

Terapeutisk område:

Inactivated Bacterial Vaccine

Autorisasjon status:

Authorized

Autorisasjon dato:

2013-04-15

Preparatomtale

Revised: December 2023
AN: 02163/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
GUDAIR emulsion for injection for sheep and goats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1ml) of the vaccine contains:
ACTIVE SUBSTANCE:
_Mycobacterium paratuberculosis_ inactivated, strain 316F: ≥ 2 mm
ITT avian PPD*
(2.5 mg)
ADJUVANT(S):
Mineral oil adjuvant.............................q.s.
EXCIPIENTS:
Thiomersal ................................... 0.1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Milky-white emulsion for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep and goats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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
Page 2 of 6
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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
vacci