NOBILIS FAV VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

LIVE FOWL ADENOVIRUS

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

vaccine - fowl adenovirus

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

LIVE FOWL ADENOVIRUS VACCINE-VIRAL Active 0.0 ml

Units in package:

#50x2000; #Dose/Vial; *50x1000; *Dose/Vial; 1-25 vials

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

POULTRY CHICKS - UP TO 28 DAYS OLD | CHICKS OF VACCINATED HENS

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

HOMOLOGOUS TYPES OF FOWL ADENOVIRUS INFE | INCLUSION BODY HEPATITUS

Product summary:

Poison schedule: 0; Withholding period: WHP: Nil.; Host/pest details: POULTRY CHICKS - UP TO 28 DAYS OLD: [HOMOLOGOUS TYPES OF FOWL ADENOVIRUS INFE]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY CHICKS - UP TO 28 DAYS OLD: [HOMOLOGOUS TYPES OF FOWL ADENOVIRUS INFE]; For the protection of chickens of vaccinated hens against homologous types of fowl adenovirus infection (inclusion body hepatitis) up to 28 days of age.Do not use for poultry in lay or that are in contact with birds in lay for which the serological status to FAV is either unknown or negative. DO NOT USE in laying birds where eggs or egg protein are to be used for human consumption or processing.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
INTERVET AUSTRALIA PTY LIMITED
PRODUCT NAME:
NOBILIS FAV VACCINE
ELABEL APPLICATION NO:
DC12-01835671E42
APVMA APPROVAL NO:
52390/100353
PRODUCT NO:
52390
VERSION NO:
6.0
APPLICATION STARTED:
2014-Sep-03 15:34:16
VERSION CREATED:
2015-Jan-07 11:34:06
STARTED BY:
Lyn Lavidis
PRINTED:
2015-Jan-07 11:46:16
LABEL NAME:
NOBILIS FAV VACCINE
SIGNAL HEADINGS:
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
[Vial]
Fowl Adenovirus, living (Esurient strain)
[Pack insert front and back]
ACTIVE CONSTITUENT:
Fowl Adenovirus, living (Esurient strain) 10^6.1 TCID50 per mL
CLAIMS:
For the protection of chickens of vaccinated hens against homologous
types of fowl
adenovirus infection (inclusion body hepatitis) up to 28 days of age.
NET CONTENTS:
[Vial]
Doses per vial – Refer to pack
[Pack Insert Front]
Contents: 1-25 [50] vials
[Tamperproof label]
Doses: 1000[2000] / vial
DIRECTIONS FOR USE:
READ PACK INSERT BEFORE USE- "Vial"
READ THE REVERSE SIDE OF THE PACK INSERT BEFORE USING THE PRODUCT -
"Pack Insert front"
RESTRAINTS:
Do not use for poultry in lay or that are in contact with birds in lay
for which the serological
status to FAV is either unknown or negative.
PRECAUTIONS:
[Pack Insert back]
Precautions:
1) Intervet Nobilis® FAV Vaccine should be administered to
replacement breeder stock
before they come into contact with flocks-in-lay for which the FAV
antibody status is
unknown or negative. If the vaccine were to spread from the flock
undergoing vaccination RLP APPROVED
For Official Use Only
to flocks in lay that are not already antibody-positive to FAV, a
disease associated with FAV
could occur in the progeny of antibody-negative layers as they become
infected and before
they develop immunity to FAV.
2) The product must be used immediately upon reconstitution and unused
vaccine must be
discarded after 2 hours.
DOSAGE AND
ADMINISTRATION:
[Pack Insert back]
DOSAGE AND ADMINISTRATION
Use entire contents within 2 hours of reconstitution.
Vaccination is recomme

Safety Data Sheet

PRODUCT NAME: NOBILIS
MATERIAL SAFETY DATA SHEET
THIS REVISION ISSUED: JULY, 2014
PAGE: 1 OF 6
MATERIAL SAFETY DATA SHEET
Issued by: Intervet Australia Pty Limited (trading as MSD Animal
Health) Phone: [phone] (Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Freeze-dried, live virus.
TRADE NAME:
NOBILIS FAV VACCINE
PRODUCT CODE:
3964
RECOMMENDED USE:
For the protection of chickens of vaccinated hens against homologous
types of Fowl
Adenovirus (FAV) infection (inclusion body hepatitis) up to 28 days of
age.
APVMA NO:
52390
THIS VERSION ISSUED:
Is valid for 5 years from this date.
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 the Australian Dangerous Goods (ADG)
Code.
RISK PHRASES:
Not Hazardous - No criteria found.
SAFETY PHRASES:
S22, S25. Do not breathe dust. Avoid contact with eyes.
SUSDP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
The vaccine is a freeze-dried, live virus vaccine, presented in 9mL
antibiotic vials
that have been sealed under vacuum and in which there is a 4mL plug of
dried vaccine.
ODOUR:
No distinctive odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
INHALATION:
SHORT TERM EXPOSURE:
Available data indicates that this product is not harmful. However
product may be mildly
irritating, although unlikely to cause anything more than mild
transient discomfort.
LONG TERM EXPOSURE:
No data for health effects associated with long term inhalation.
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
SECTION 2 - HAZARDS IDENTIFICATION
EMERGENCY OVERVIEW
POTENTIAL HEALTH EFFECTS
ISSUED BY: INTERVET AUSTRALIA PTY LIMITED
(TRADING AS MSD ANIMAL HEALTH)
91-105 HARPIN STREET
TEL: [phone] (BUSINESS HOURS)
BENDIGO EAST, VIC 3550, AUSTRALIA
FAX: 1 800