NOBILIS AEV VACCINE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

AVIAN ENCEPHALOMYELITIS VIRUS (LIVE)

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

vaccine - avian encephalomye

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

AVIAN ENCEPHALOMYELITIS VIRUS (LIVE) VACCINE-VIRAL Active 0.0 U

Units in package:

!1-25vials; !1000doses; #1000doses; #50x; %1-25vials; %500 doses; *2000doses; *50x; @500 Doses; @50x; ^1-25vials; ^2000doses

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

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

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

AVIAN ENCEPHALOMYELITIS

Product summary:

Poison schedule: 0; Withholding period: WHP:Nil; Host/pest details: CAGE BIRDS: [AVIAN ENCEPHALOMYELITIS]; POULTRY: [AVIAN ENCEPHALOMYELITIS]; Poison schedule: 0; Withholding period: ; Host/pest details: CAGE BIRDS: [AVIAN ENCEPHALOMYELITIS]; POULTRY: [AVIAN ENCEPHALOMYELITIS]; Chicks hatched from vaccinated parents are protected from clinical signs of AEV infection for the first 28 days of life.See Precautions on label

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
APVMA NO:
PRODUCT NAME:
51877
NOBI
LIS®
AEV VACCINE
DATE:
31ST
OCTOBER
2012
A~
•
Select appropriate:
D
New
Product (include all applicable RLPs)
OR
RLP
r&IVariation (highlight instructions that are being varied). Approval
no.
of
label being
varied:
50922
Approved
Label Components include
in
product label: Vial and Carton
LABEL
PARTICULAR
TEXT
LABEL COMPONENTS
Signal heading:
FOR ANIMAL TREATMENT ONLY
Vial, Carton front
and inner lid
panel
Product name:
NOBILIS® AEV VACCINE
Vial,
Carton front and
inner lid
panel
Active constituent!
s:
VIAL:
Avian Encephalomyelitis Virus, (living)
As
specified.
CARTON (FRONT AND INNER LID):
Avian Encephalomyelitis Virus, (living)
2:10
5
EID
50
per
mL
Statement of claims:
Chicks hatched from vaccinated parents are protected from clinical
signs
of
AEV
Vial,
Carton front and
inner l
id
infection
for
the first 28 days
of
life.
panel
Net contents:
VIAL:
Doses per 5
mL
vial -
Refer to pack.
As specified.
CARTON:
1 to 25, 50 vials of 500 Doses, 1000 Doses
or
2000 Doses
0
No.
of
vials
Directions for
Us
e
As
specified.
Heading:
Vial:
READ INFORMATION INSIDE PACK BEFORE USE.
Carton Front Panel:
READ THE INFORMATION PRINTED ON THE INSIDE OF
THE
PACK BEFORE USING THIS PRODUCT.
Carton Inner Lid Panel:
DIRECTIONS FOR USE:
-
--
-
-
--
--
- -
------
-
---
LABEL
PARTICULAR
TEXT
LABEL COMPONENTS
Restraints
:
Not required.
Contraindications:
Not required.
Precautions:
Carton Inner Lid Panel
PRECAUTIONS:
Vaccine
may
be
less likely to spread among birds held
in
cages with perforated
floors.
In
such flocks it
is
recommended that sera from a group
of
20 birds within
the shed be tested for
AEV
antibody at approximately 16 weeks of age. If the
reactor rate
is
less than 80%, veterinary advice should be sought as "to the need to
revaccinate.
Side
effects
:
Not required.
Dosage
&
DOSAGE AND ADMINISTRATION:
Carton Inner Lid Panel
administration:
The vaccine should be administered at least 6 weeks before the
breeders to be
vaccinated comme

Summary of Product characteristics

PRODUCT NAME: NOBILIS AEV VACCINE
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:
Solution of ingredients and suspension of live Avian Encephalomyelitis
Virus (AEV).
TRADE NAME:
NOBILIS AEV VACCINE
PRODUCT CODE:
3985
RECOMMENDED USE:
Chicks hatched from vaccinated parents are protected from clinical
signs of AEV infection
for the first 28 days of life. Refer to product label for application
details.
APVMA NO:
51877
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:
S37, S24/25. Wear suitable gloves. Avoid contact with skin and eyes.
SUSDP CLASSIFICATION:
None allocated.
ADG CLASSIFICATION:
None allocated. Not a Dangerous Good under the ADG Code.
UN NUMBER:
None allocated
PHYSICAL DESCRIPTION & COLOUR:
White turbid liquid.
ODOUR:
No 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: [phone]
COMPANY ABN: 79 008 467 034
PRODUCT NAME: NOBILIS AEV VACCIN