VAXSAFE SBH VACCINE (LIVING)

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

MAREK'S DISEASE VIRUS STRAIN SB-1 (SEROTYPE 2); HERPES VIRUS OF TURKEYS STRAIN FC126 (SEROTYPE 3)LIVING,

Available from:

BIOPROPERTIES PTY. LTD.

INN (International Name):

MDV (SB-1)(1428PFU/Ds)+MDV (HVT-FC 126)(1466PFU/Ds)

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

MAREK'S DISEASE VIRUS STRAIN SB-1 (SEROTYPE 2) VACCINE-VIRAL Active 0.0 PFU/dose; HERPES VIRUS OF TURKEYS STRAIN FC126 (SEROTYPE 3)LIVING, VACCINE-VIRAL Active 0.0 PFU/dose

Units in package:

2000 doses; 3000 doses; 4000 doses

Class:

VM - Veterinary Medicine

Therapeutic group:

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

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

MAREK'S DISEASE | HERPES VIRUS OF TURKEYS (HVT)

Product summary:

Poison schedule: 0; Withholding period: WHP: N/A; Host/pest details: POULTRY: [MAREK'S DISEASE]; Poison schedule: ; Withholding period: WHP: N/A; Host/pest details: POULTRY: [MAREK'S DISEASE]; Poison schedule: ; Withholding period: ; Host/pest details: POULTRY: [MAREK'S DISEASE]; For the prevention of clinical Marek's disease in chickens.DO NOT USE in chickens if the parent flock has been vaccinated with this vaccine or another bivalent Marek's Disease vaccine. CONTRAINDICATIONS, PRECAUTIONS, sections: See Label.

Authorization status:

Registered

Authorization date:

2020-07-01

Patient Information leaflet

22/03/10
H:\Reg Affairs Shared\Labels All Countries\Future
Labels\SBH\63411_45612_2000dose_Immediate_MPL_V01.doc
VAXSAFE SBH VACCINE (LIVING) 2ML AMPOULE (IMMEDIATE CONTAINER) LABEL
2000 DOSE
SUBMISSION 22 MARCH 2010
2.5cm h x 3.3 cm w
FOR ANIMAL TREATMENT ONLY
VAXSAFE
® SBH
VACCINE
MDV STRAIN SB-1 (≥ 1428 PFU/DOSE)
& HVT STRAIN FC126 (≥1466
PFU/DOSE)
MIN.
2000 DOSES
READ ACCOMPANYING
LEAFLET
BIOPROPERTIES Pty Ltd
APVMA No. 63411/2/0909
Store in Liquid Nitrogen
Batch:
Exp:
LBL-SBH/2 V1
TEXT:
FOR ANIMAL TREATMENT ONLY
VAXSAFE
® SBH VACCINE
MDV STRAIN SB-1 (≥ 1428 PFU/DOSE) & HVT STRAIN
FC126 (≥ 1466 PFU/DOSE)
MIN. 2000 DOSES
READ ACCOMPANYING LEAFLET
BIOPROPERTIES PTY LTD
APVMA:63411/2/0909
Store in Liquid Nitrogen
Batch:
Exp:
LBL-SBH/2 V1
APPROVED
LABEL
Info
PEST


Verified
22/03/10
H:\Reg Affairs Shared\Labels All Countries\Future
Labels\SBH\63411_45612_2000dose_Immediate_MPL_V01.doc
LABEL SPECIFICATIONS - TEXT:
FOR ANIMAL TREATMENT ONLY
Caps, Arial, Bold, 4pt
VAXSAFE
® SBH VACCINE
Arial, Bold, 9pt, “SBH” Caps
MDV STRAIN SB-1 (≥ 1428 PFU/DOSE) & HVT STRAIN
FC126 (≥ 1466 PFU/DOSE)
Arial, Bold, 5pt
MIN.
Arial, Bold, 5pt
2000 DOSES
Caps, Arial, Bold 9pt
READ ACCOMPANYING LEAFLET
Arial, Bold, 5pt
BIOPROPERTIES PTY LTD
Arial, 4pt
APVMA: 63411/2/0909
Arial, 3.5pt
STORE IN LIQUID NITROGEN
Arial, 4pt
Batch:
Arial, 4pt
Exp:
Arial, 4pt
LBL-SBH/2 V1
Arial, 3pt
DETAILS:
Text Colour:
Black
Label Material:
Clear Printable Polyester
Label Measurements:
2.5cm h x 3.3 cm w
22/03/10
H:\Reg Affairs Shared\Labels All Countries\Future
Labels\SBH\63411_45612_3000dose_Immediate_MPL_V01.doc
VAXSAFE SBH VACCINE (LIVING) 2ML AMPOULE (IMMEDIATE CONTAINER) LABEL
3000 DOSE
SUBMISSION 22 MARCH 2010
2.5cm h x 3.3 cm w
FOR ANIMAL TREATMENT ONLY
VAXSAFE
® SBH
VACCINE
MDV STRAIN SB-1 (≥ 1428 PFU/DOSE)
& HVT STRAIN FC126 (≥1466
PFU/DOSE)
MIN.
3000 DOSES
READ ACCOMPANYING
LEAFLET
BIOPROPERTIES Pty Ltd
APVMA No. 63411/3/0909
Store in Liquid Nitrogen
Batch:
Exp:
LBL-SBH/3 V1
TEXT:
FOR ANIMAL TREATMENT ONLY
VAXSAFE
® SBH VACC

Summary of Product characteristics

MSDS
 - 
MATERIAL SAFETY DATA SHEET

VAXSAFE
®
 SBH VACCINE (LIVING)

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

MSDS-SBH 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 

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

Note: This product is stored in liquid nitrogen which can cause
frostbite and remove air from enclosed spaces. 
Before working with the vaccine it is important to become
fully familiar with the safe use and handling of liquid 
nitrogen 
– see AS 1894-1976 _Code of practice for the safe handling of
Cryogenic Fluids_, and study its MSDS. 

PRODUCT IDENTIFICATION 

PRODUCT NAME:  VAXSAFE
®  
SBH VACCINE (LIVING) 
OTHER NAMES:  HVT & SB1 VACCINE 
PRODUCT CODE:  9801 SBH 
AVPMA NO.  63411 
UN NO:  None allocated 
DANGEROUS GOODS 
CLASS/SUBSIDIARY RISK: 
None allocated 
HAZCHEM CODE:  None allocated 
POISONS SCHEDULE NO:   None allocated. 
PRODUCT TYPE:  Poultry vaccine 
CHEMICAL FAMILY:  The active ingredients consist of a mixture
of 2 avian herpesviruses in a 
protective buffer. 
USE:  As a vaccine to control Marek’s Disease in chickens. 
METHOD OF USE:  Given by injection to day-old chicks or to
18-day embryos prior to hatch. 

PHYSICAL DESCRIPTION AND PROPERTIES 

APPEARANCE:  Frozen, pale pink or straw-coloured liquid in
a labelled, sealed clear-glass 
ampoule - stored in liquid nitrogen. 
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.�