VAXSAFE IB VACCINE (LIVING)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

INFECTIOUS BRONCHITIS VIRUS (INGHAM STRAIN) - LIVE

Available from:

BIOPROPERTIES PTY. LTD.

INN (International Name):

infectious bronchitis

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

INFECTIOUS BRONCHITIS VIRUS (INGHAM STRAIN) - LIVE VACCINE-VIRAL Active 0.0 P

Units in package:

!10000; !10mL vial; !5000 or; !doses; #10000; #20mL vial; #5000 or; #doses; +1000 or; +3mL vial; +5000; +doses

Class:

VM - Veterinary Medicine

Therapeutic group:

POULTRY | BREEDERS | BROILER | CHICKENS | CHICKS | CHOOKS | DAY OLD CHICKS | HATCHLINGS | LAYERS

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

INFECTIOUS BRONCHITIS | INFECTIOUS BRONCHITIS NEPHRITI

Product summary:

Poison schedule: 0; Withholding period: WHP: Nil.; Host/pest details: POULTRY: [INFECTIOUS BRONCHITIS]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY: [INFECTIOUS BRONCHITIS]; For the prevention of infectious bronchitis in poultry.Contraindicated for vaccinating unhealthy birds. See Precautions & Side-effects on leaflet also.

Authorization status:

Registered

Authorization date:

2022-07-01

Patient Information leaflet

_2011 _
_Robert Pottie _
_Page 1 of 1 _
_Vaxsafe IB RLP submission (55222-54296) Oct11 V1 _
_ _
RELEVANT LABEL PARTICULARS SUBMISSION
BIOPROPERTIES PTY LTD
PRODUCT: VAXSAFE
® IB VACCINE (LIVING), APVMA PRODUCT NUMBER: 55222
APVMA APPLICATION NUMBER: 54296
OCTOBER 2011
For all vial sizes (3 mL, 10 mL, 20 mL)
IMMEDIATE CONTAINER LABEL:
TEXT
FOR ANIMAL TREATMENT ONLY
VAXSAFE
® IB
IB VIRUS INGHAM STRAIN: > 10
3.0 EID
50
/DOSE
XXXXX DOSES
READ ACCOMPANYING LEAFLET
BPL LOGO
AVPMA NO. 55222/54296
STORE BELOW -18
O
C (DEEP FREEZE)
Protect from light
Batch:
Exp:
BIOPROPERTIES INTERNAL LABEL CODE
Abbreviation used above:
3 ML VIAL
10 ML VIAL
20 ML VIAL
XXXXX
1000 or 5000
5000 or 10000
5000 or 10000
PRODUCT LEAFLET
(Next two pages) RLP APPROVED
Infopest
Verified
Vaxsafe IB – V4
Page 1 of 2
FOR ANIMAL TREATMENT ONLY
VAXSAFE
® IB
VACCINE (LIVING)
ACTIVE CONSTITUENT: Each dose contains > 10
3.0
EID
50
*
living
Infectious Bronchitis Virus Ingham Strain.
*EID = Egg Infectious Dose
STATEMENT
OF
CLAIMS:
A
freeze-dried
vaccine
for
the
prevention of infectious bronchitis in poultry.
1000 / 5000 / 10,000 DOSES
CONTENTS
: The product consists of a freeze-dried pellet in a
3 mL glass vial containing 1000 or 5000 doses; a 10 mL glass
vial containing 5000 or 10,000 doses; or a 20 mL glass vial
containing 5000 or 10,000 doses.
READ DIRECTIONS CAREFULLY
DIRECTIONS FOR USE:
CONTRAINDICATIONS:
•
This product is contraindicated for vaccinating unhealthy
birds.
PRECAUTIONS:
•
Each bird must receive the full dose of living vaccine to be
fully protected.
•
The
living
vaccine
virus
must
not
be
exposed
to
disinfectants or heat.
•
Only
birds
in
good
health
should
be
vaccinated.
The
presence
of
mycoplasma
infection
(chronic
respiratory
disease; CRD) or other stress factors may cause severe
reaction.
•
Administer the vaccine early in the morning.
•
These
vaccines
should
be
used
immediately
upon
reconstitution.
SIDE-EFFECTS:
Occasionally a site reaction is encountered; usually in the form of
a
respiratory
“snicker”
best
heard
at
n

Summary of Product characteristics

MSDS
 - 
MATERIAL SAFETY DATA SHEET

VAXSAFE
®
 IB VACCINE (LIVING) 

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

MSDS-IB V5 

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 

NOT CLASSIFIED AS HAZARDOUS TO HEALTH ACCORDING TO CRITERIA
OF WORKSAFE AUSTRALIA 

PRODUCT IDENTIFICATION 

PRODUCT NAME: 
VAXSAFE
®
 IB VACCINE (LIVING) 
OTHER NAMES:  IB VACCINE, IB-I VACCINE, AVIAN INFECTIOUS
BRONCHITIS VACCINE (STRAIN 
I), IBV (INGHAM STRAIN), INGHAM STRAIN IB VACCINE. 
PRODUCT CODE:  0201 IBI. 
AVPMA NO:  55222 
UN NUMBER:  None allocated. 
DANGEROUS GOODS 
CLASS/SUBSIDIARY RISK:  None allocated. 
HAZCHEM CODE:  None allocated. 
POISONS SCHEDULE 
NUMBER:   Not scheduled. 
PRODUCT TYPE:  Poultry vaccine. 
CHEMICAL FAMILY:  Active ingredient consists of viable
avian Infectious Bronchitis Virus (IBV) 
that has been freeze-dried in a protective buffer. 
USE:  As a vaccine to prevent Infectious Bronchitis in
chickens. 
METHOD OF USE:  Administer by drinking water or eye-drop
to chickens aged one week or 
older, to infect all chickens in the vaccinated flock. 

PHYSICAL DESCRIPTION AND PROPERTIES 

APPEARANCE:  A pale pellet of freeze-dried vaccine in
a clear glass vial. The white label 
has an apple-green strip. The closure consists of a silver
tear-off 
aluminium crimp over a grey rubber stopper. Each vial has: 3 mL
capacity 
with a 1-1.5 mL vaccine pellet (containing 1000 or 5000 doses);
or 20 mL 
capacity with a 4-5 mL vaccine pellet (containing 5000 or
10,000 doses). 
FLASHPOINT:  Not relevant. 
FLAMMABILITY LIMITS:  Not relevant. 
SOLUBILITY IN WATER:  Fully miscible. 

INGREDIENTS 

Safety Data Sheet

PRODUCT NAME: VAXSAFE
® IB VACCINE (LIVING)
PAGE: 1 OF 5
VERSION 6, ISSUED: NOVEMBER, 2016
SAFETY DATA SHEET
Issued by: Bioproperties Pty Ltd
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 11 26 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)
SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER
BIOPROPERTIES PTY LTD
PHONE: [phone] (OFFICE HOURS)
36 CHARTER ST
FAX: [phone]
RINGWOOD, VIC 3134
EMERGENCY 0417 548 879 (ANY TIME)
CHEMICAL NATURE:
Active ingredient consists of viable avian Infectious Bronchitis Virus
(IBV) that has
been freeze-dried in a protective buffer.
TRADE NAME:
VAXSAFE
® IB VACCINE (LIVING)
APVMA CODE:
55222
PRODUCT USE:
A vaccine to control Infectious Bronchitis Virus (IBV) in chickens.
CREATION DATE:
JUNE, 2016
THIS VERSION ISSUED:
NOVEMBER, 2016
and is valid for 5 years from this date.
POISONS INFORMATION CENTRE: PHONE 13 11 26 FROM ANYWHERE IN AUSTRALIA
SECTION 2 - HAZARDS IDENTIFICATION
STATEMENT OF HAZARDOUS NATURE
This product is classified as:
Not classified as hazardous according to the criteria of SWA.
Not a Dangerous Good according to Australian Dangerous Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
SUSMP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good according to Australian Dangerous
Goods (ADG)
Code, IATA or IMDG/IMSBC criteria.
UN NUMBER:
None allocated.
GHS SIGNAL WORD: NONE. NOT HAZARDOUS.
PREVENTION
P102: Keep out of reach of children.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
RESPONSE
P353: Rinse skin or shower with water.
P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P370+P378: Not combustible. Use extinguishing media suited to burning
materials.
STORAGE
P411: Store below -18°C (deep freeze).
DISPOSAL
P501: Dispose of small quantities and empty containers by wrapping
with paper and putting in garbage. For
larger quantities, if recycling or reclaiming is not possible, use a
commercial waste disposal service.
E