UBAC Inactivated Subunit Vaccine against Streptococcus uberis for Cattle

Pays: Australie

Langue: anglais

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Ingrédients actifs:

STREPTOCOCCUS UBERIS ANTIGEN; MONTANIDE ISA 201 VG; MONOPHOSPHORYL LIPID A (MPLA)

Disponible depuis:

LABORATORIOS HIPRA S.A.

forme pharmaceutique:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

STREPTOCOCCUS UBERIS ANTIGEN VACCINE-ANTIGEN Active 0.0 P; MONTANIDE ISA 201 VG Other 0.0 P; MONOPHOSPHORYL LIPID A (MPLA) Other 0.0 P

Unités en paquet:

10 mL; 100 mL; 20 x 2 mL; 50 mL

classe:

VM - Veterinary Medicine

Domaine thérapeutique:

IMMUNOTHERAPY

Descriptif du produit:

Poison schedule: 0; Withholding period: Zero (0) days. EXPORT SLAUGHTER INTERVA L (ESI): Zero (0) days. Before using thi s product, confirm the current ESI from the distributor on 02 8088 0720 or the A PVMA website (apvma.gov.au/residues).; Host/pest details: CATTLE: [CLINICAL INTRAMAMMARY INFECTIONS, STREPTOCOCCUS UBERIS]

Statut de autorisation:

Registered

Date de l'autorisation:

2024-02-06

Notice patient

One dose (2 mL) contains:
Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of
Streptococcus uberis,
strain 5616 ≥ 1 Relative Potency Units (ELISA)
Also contains:
Montanide ISA (adjuvant)
Monophosphoryl Lipid A (adjuvant)
Constituent
Statements:
For active immunisation of healthy cows and heifers to reduce the
incidence of clinical
intramammary infections caused by Streptococcus uberis, to reduce the
somatic cell count
in Streptococcus uberis positive quarter milk samples and to reduce
milk production losses
caused by Streptococcus uberis intramammary infections.
Onset of immunity: approximately 36 days after the second dose.
Duration of immunity: approximately the first 5 months of lactation.
Claims:
20 x 2 mL, 10 mL, 50 mL, 100 mL
Net Contents:
Directions for Use:
Restraints:
READ SAFETY DIRECTIONS
FOR ANIMAL TREATMENT ONLY
Signal Headings:
UBAC Inactivated Subunit Vaccine against Streptococcus uberis for
Cattle
Label Name:
Contraindications:
Precautions:
Only healthy animals should be immunised.
The whole herd should be immunised.
Protection of animals not vaccinated according to this program has not
been demonstrated.
UBAC Inactivated Subunit Vaccine against Streptococcus uberis for
Cattle
92734/136470
Product Name:
APVMA Approval No: RLP APPROVED
Local swelling more than 5 cm in diameter at the injection site is a
very common reaction
after administration of the vaccine. This swelling will have
disappeared or be clearly
reduced in size by 17 days post vaccination. However, in some cases,
swelling may persist
for up to 4 weeks.
A transient increase in rectal temperature (mean increase of 1°C but
may be up to 2°C in
individual animals) commonly occur in the first 24 hours after
injection.
Anaphylactic-type reactions (e.g. oedema) which might be
life-threatening, may occur very
rarely in some sensitive animals based on post-marketing safety
experience. Under these
circumstances, appropriate symptomatic treatment should be
administered.
The frequency of adverse reaction is defined using the follo