VAXSAFE MG

Main information

  • Trade name:
  • VAXSAFE MG VACCINE (LIVING)
  • Pharmaceutical form:
  • MISC. VACCINES OR ANTI SERA
  • Units in package:
  • 30mL (2000 doses)
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VAXSAFE MG VACCINE (LIVING)
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • POULTRY LAYERS (EGGS FOR HUMAN CONSUMP) | CAGED LAYERS | CHICKENS | CHOOKS | HEN
  • Therapeutic area:
  • vaccine
  • Therapeutic indications:
  • CHRONIC RESPIRATORY DISEASE | MYCOPLASMA GALLISEPTICUM | VACCINE | CHRONIC RESPIRATORY DISEASE (C | EQUINE ROTAVIRUS | INFECTIOUS SINUSITIS
  • Product summary:
  • For the control of chronic respiratory disease (CRD) in layer chickens caused by M. gallisepticum (MG) in susceptible (MG free) chickens at risk of infection.This product is contraindicated for vaccinating unhealthy birds. This product is contraindicated for vaccination of birds undergoing medication with an antimicrobial known to inhibit M. gallisepticum multiplication, e.g. tetracycline, tiamulin, tylosin, …

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 35907/107711
  • Authorization date:
  • 19-05-2017
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Product Name:

APVMA Approval No:

VAXSAFE MG VACCINE (LIVING)

35907 / 107711

Label Name:

VAXSAFE MG VACCINE (LIVING)

Signal Headings:

FOR ANIMAL TREATMENT ONLY

Constituent

Statements:

Each dose contains >10 7.0 CCU* living, attenuated, temperature-sensitive Mycoplasma

gallisepticum vaccine Strain ts-11.

*Colour Changing Units

Claims:

Statement of Claims: An aid in the control of chronic respiratory disease (CRD) caused by

M. gallisepticum (MG) in susceptible (MG free) chickens at risk of infection.

Susceptible (MG free) layer flocks vaccinated with Vaxsafe® MG vaccine prior to MG

challenge exhibit less respiratory disease, require less anti-microbial medication and during

lay will produce more eggs than comparably challenged non-vaccinated flocks. Safety

testing has shown M. gallisepticum Strain ts-11 to be virtually non-pathogenic in chickens

and not readily transmitted between birds.

Net Contents:

30mL (2000 doses)

Directions for Use:

Direction for Use

Contraindications:

Contraindications:

This product is contraindicated for vaccinating unhealthy birds.

This product is contraindicated for vaccination of birds undergoing medication with an

antimicrobial known to inhibit M. gallisepticum multiplication, eg, Tetracycline, Tiamulin,

Tylosin, Enrofloxacin, Lincospectin, Gentamycin or macrolide antibiotics.

Precautions:

Precautions:

Vaxsafe® MG contains live organisms and correct storage and administration are

essential for successful use.

Do not refreeze Vaxsafe® MG after thawing.

Withdraw antibiotics from the flock for a period equivalent to the recommended

withholding period prior to vaccination and do not use after vaccination.

Where antibiotics must be used, preference should be given to agents with low

mycoplasma activity such as penicillin, amoxycillin or neomycin. They should not be given

within 4 weeks after vaccination.

Do not dilute. Thawed vaccine should be used as supplied.

RLP

APPROVED

Dosage and

Administration:

Dosage and Administration

Pullets are normally vaccinated between 6-14 weeks of age with the minimum age for

efficacious use being 4 weeks.

Application is by eye drop.

All birds in the flock should be vaccinated.

Vaccination need only be done once. Revaccination is not necessary and is not

recommended.

Method of Vaccination:

Thaw unopened vials rapidly in a large (5 – 10 L) volume of warm (35 oC) water and use

within 1 hour after thawing. Mix the contents of the vial by gentle agitation during thawing.

Invert the bottle repeatedly following thawing to ensure the contents have resuspended.

If held at room temperature, use the entire contents immediately.

Remove the aluminium seal and rubber stopper before inserting a plastic dropper tip

supplied with the vaccine. Each drop should be ~15 microlitres of vaccine.

Hold each bird with its head tilted to one side.

Invert the dropper bottle allowing a single drop to form at the tip and fall freely into the

open eye, gently flooding it. The drop (before release) and tip should NOT touch the eye

surface.

Allow the bird to blink before releasing it.

General Directions:

General Instructions:

Pullets should first be tested for MG infection. Testing for the presence of MG in the flock

is normally by way of the rapid serum agglutination test (RSAT) with blood samples being

tested within 24 hours of collection.

Operators should contact their laboratory service for advice on the collection and number

of blood samples to be taken.

Only flocks with no antibodies to MG should be vaccinated. Vaccination of infected birds

will not provide any economic benefit.

Vaccination should be carried out on MG free birds at least 3 weeks before exposure to

virulent MG is likely to occur.

Vaccination can be timed to coincide with other flock management practices (e.g. beak

trimming, Vaxsafe® MS (Mycoplasma synoviae) and fowl pox vaccination).

Withholding Periods:

Safety Directions:

USER SAFETY INFORMATION:

If vaccine is accidentally splashed into the operator’s eyes, the eyes and face should

be thoroughly washed with water to avoid any potential reaction to culture medium

constituents.

Additional information is available on the product Safety Data Sheet.

First Aid Instructions:

FIRST AID:

If poisoning occurs, contact a Doctor or Poisons Information Centre on 13 11 26.

First Aid Warnings:

Disposal:

Discard unused vaccine and empty vaccine bottles into a disinfectant solution (e.g. chlorine

based bleach). Dispose of any such inactivated, unused vaccine and empty containers by

wrapping in paper and putting in garbage.

In cases of spillage, soak up the liquid with an absorbent sponge or cloth and incinerate.

Treat the surface with a disinfectant solution (e.g. chlorine based bleach).

Storage:

STORAGE INSTRUCTIONS:

Vaxsafe® MG should always be protected from direct sunlight. For long term storage

Vaxsafe® MG should be stored at or below -70 oC. For short term storage (maximum of 4

weeks) Vaxsafe® MG can be stored in a domestic chest freezer (at or below -18 oC).

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