VAXSAFE MS VACCINE (LIVING)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MYCOPLASMA SYNOVIAE STRAIN MS-H VACCINE, LIVING

Available from:

BIOPROPERTIES PTY. LTD.

INN (International Name):

Mycoplasma synoviae

Pharmaceutical form:

MISC. AURAL, OPHTHALMIC, ORO/NASO PHARYNGEAL

Composition:

MYCOPLASMA SYNOVIAE STRAIN MS-H VACCINE, LIVING VACCINE-GENERAL Active 105.7 ccu/dose

Units in package:

30 mL (1000 doses); 30 mL (2000 doses)

Class:

VM - Veterinary Medicine

Therapeutic group:

POULTRY BROILERS (MEAT FOR HUMAN CONSUM) | POULTRY LAYERS (EGGS FOR HUMAN CONSUMP) | POULTRY PULLETS (GROWING CHOOK) | BREEDING

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

AIRSACCULITIS | CHRONIC RESPIRATORY DISEASE | INFECTIOUS SYNOVITIS | VACCINE | EQUINE ROTAVIRUS | MS

Product summary:

Poison schedule: 0; Withholding period: WHP:Nil; Host/pest details: POULTRY BROILERS (MEAT FOR HUMAN CONSUM): [AIRSACCULITIS, CHRONIC RESPIRATORY DISEASE, INFECTIOUS SYNOVITIS, VACCINE]; POULTRY LAYERS (EGGS FOR HUMAN CONSUMP): [AIRSACCULITIS, CHRONIC RESPIRATORY DISEASE, INFECTIOUS SYNOVITIS, VACCINE]; POULTRY PULLETS (GROWING CHOOK): [AIRSACCULITIS, CHRONIC RESPIRATORY DISEASE, INFECTIOUS SYNOVITIS, VACCINE]; An aid in the control of chronic respiratory disease (CRD), air sacculitis and synovitis caused by M. synoviae in susceptible (MS free) chickens.This product is contraindicated for vaccinating unhealthy birds. This product is contraindicated for vaccinating birds undergoing medication with a antimicrobial known to inhibit M.synoviae multiplication. eg tetracycline, tiamulin, tylosin, enrofloxacin,

Authorization status:

Registered

Authorization date:

2022-07-01

Patient Information leaflet

Product Name:
APVMA Approval No:
VAXSAFE MS VACCINE (LIVING)
47985/112251
Label Name:
VAXSAFE MS VACCINE (LIVING)
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Active constituent: Each dose contains ≥10
5.7
CCU* living, attenuated,
temperature-sensitive Mycoplasma synoviae Strain MS-H.
* Colour Changing Units
Claims:
Statement of Claims: An aid in the control of chronic respiratory
disease (CRD),
airsacculitis and synovitis caused by M. synoviae (MS) in susceptible
(MS free) chickens.
Susceptible (MS free) layer and broiler breeder flocks vaccinated with
Vaxsafe® MS prior
to MS challenge exhibit less respiratory and synovial disease,
improved performance
and have decreased susceptibility to opportunistic bacterial diseases.
These include
such diseases as colibacillosis, staphylococcus, and fowl cholera
during production when
compared with comparable challenged non-vaccinated flocks. Progeny of
vaccinated
breeders show decreased susceptibility to serositis, synovitis and
secondary E. coli
infections.
Vaxsafe® MS can also assist in the control of transmission (including
vertical transmission)
of wild type MS in challenged breeder flocks and form an integral part
of MS eradication
programs in multi-age sites.
Net Contents:
Contents: 30 mL sufficient for 1000 or 2000 doses by eye drop
application.
Directions for Use:
Directions for Use
Contraindications:
• This product is contraindicated for vaccinating unhealthy birds.
• This product is contraindicated for vaccinating birds undergoing
medication with an
antimicrobial known to inhibit M. synoviae multiplication, eg,
Tetracycline, Tiamulin, Tylosin,
Enrofloxacin, Lincospectin, Gentamycin or macrolide antibiotics.
Precautions:
• Vaxsafe® MS contains live organisms and correct storage and
administration are
essential for successful use.
• Do not refreeze Vaxsafe® MS 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.

Summary of Product characteristics

MSDS
 - 
MATERIAL SAFETY DATA SHEET

VAXSAFE
®
 MS VACCINE (LIVING)

BIOPROPERTIES Pty Ltd 
Page 1 of 4 
Date of Issue: December 2011 

MSDS-MS V6 

BIOPROPERTIES PTY. LTD. 

ACN  007  303  728 

36 CHARTER STREET 
TELEPHONE: 
03 9876 0567 
RINGWOOD  VIC   3134 
FACSIMILE: 
03 9876 0556 
AUSTRALIA 
EMERGENCY: 
0417 548 879 

WORK HAZARD ASSESSMENT 

THE VACCINE IS NOT CLASSIFIED AS HAZARDOUS
TO HEALTH ACCORDING TO CRITERIA OF WORKSAFE AUSTRALIA 

PRODUCT IDENTIFICATION 

PRODUCT NAME:  VAXSAFE
® 
MS  VACCINE (LIVING) 
OTHER NAMES:  MS-H VACCINE, MS VACCINE. 
PRODUCT CODE:  9501 MSH 
APVMA NO:  47985 
UN NUMBER:  None allocated.

DANGEROUS GOODS 
CLASS/SUBSIDIARY RISK:  None allocated. 
HAZCHEM CODE:  None allocated. 
POISONS SCHEDULE NO:   None allocated. 
PRODUCT TYPE:  Poultry vaccine. 
CHEMICAL
FAMILY:  Active  ingredient  consists  of  viable  _Mycoplasma_  _synoviae_  (MS) 
suspended in a protective buffer. 
USE:  As  an  aid  in  the  control  of  chronic  respiratory  disease, air  sacculitis  and 
synovitis in broiler breeder and layer chickens,
as caused by MS  
METHOD OF USE:  Administered  by  eyedrop  to  chickens  preferably  between  4-12  weeks  of 
age. 

PHYSICAL DESCRIPTION AND PROPERTIES 

APPEARANCE:  Frozen liquid of a pale colour in a 30 mL
plastic bottle containing sufficient 
vaccine for 1000 doses by eye drop application. 
MELTING POINT:  Not relevant 
BOILING POINT:  Not relevant 
VAPOUR PRESSURE:  Not relevant 
VOLATILE MATERIALS:  Not available 
SPECIFIC GRAVITY:  Not relevant. 
FLASHPOINT:  Not relevant 
FLAMMABILITY LIMITS:  Not relevant 
SOLUBILITY IN WATER:  Fully miscible 
PH:  Not available 

INGREDIENTS 

Worksafe Exposure Limits 
CHEMICAL NAME 
CAS # 
PROPORTION 
BY VOLUME 
ES-TWA 

Safety Data Sheet

Vaxsafe MS 1000 doses – V7
Page 1 of 1
FOR ANIMAL TREATMENT ONLY
VAXSAFE
® MS
VACCINE (LIVING)
ACTIVE
CONSTITUENT
:
Each
dose
contains
>10
5.7
CCU
*
living,
attenuated, temperature-sensitive _Mycoplasma synoviae _Strain MS-H.
*
Colour Changing Units
STATEMENT OF CLAIMS:
An aid in the control of chronic respiratory
disease (CRD), airsacculitis and synovitis caused by _M._ _synoviae_
(MS)
in susceptible (MS free) chickens.
Susceptible (MS free) layer and broiler breeder flocks vaccinated with
Vaxsafe
®
MS
prior
to
MS
challenge
exhibit
less
respiratory
and
synovial
disease,
improved
performance
and
have
decreased
susceptibility to opportunistic bacterial diseases. These include such
diseases as colibacillosis, staphylococcus, and fowl cholera during
production
when
compared
with
comparable
challenged
non-
vaccinated flocks. Progeny of vaccinated breeders show decreased
susceptibility to serositis, synovitis and secondary _E. coli_
infections.
Vaxsafe
®
MS can also assist in the control of transmission (including
vertical transmission) of wild type MS in challenged breeder flocks
and
form an integral part of MS eradication programs in multi-age sites.
Safety testing has shown the MS-H vaccine strain to be virtually non-
pathogenic in birds and not vertically transmitted, or not readily
laterally
transmitted between birds. Lateral transmission will occur more often
between birds penned or caged together than separated flocks.
1000 DOSES
CONTENTS:
Vaxsafe
®
MS is supplied frozen in a plastic peel-top eye-
dropper vial containing 30 mL sufficient for 1000 doses by eye drop
application.
READ DIRECTIONS CAREFULLY
DIRECTIONS FOR USE:
CONTRAINDICATIONS:

This product is contraindicated for vaccinating unhealthy birds.

This product is contraindicated for vaccinating birds undergoing
medication with an antimicrobial known to inhibit _ M. synoviae_
multiplication, eg, Tetracycline, Tiamulin, Tylosin, Enrofloxacin,
Lincospectin, Gentamycin or macrolide antibiotics.
PRECAUTIONS:

Vaxsafe
®
MS contains live organ