NOBILIS EDS INACTIVATED VACCINE FOR LAYING HENS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

EGG DROP SYDROME 76 VIRUS STRAIN BC 14; OIL ADJUVANT

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

vaccine - egg drop syndrome-

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

EGG DROP SYDROME 76 VIRUS STRAIN BC 14 VACCINE-VIRAL Active 0.0 P; OIL ADJUVANT OIL Other 0.0 P

Units in package:

500mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

POULTRY LAYERS (EGGS FOR HUMAN CONSUMP) | CAGED LAYERS | CHICKENS | CHOOKS | HEN

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

AVIAN HAEMAGGLUTINATING ADENOVIRUS | ADENOVIRUS | EGG DROP SYNDROME

Product summary:

Poison schedule: 0; Withholding period: WHP: Zero (0) days; Host/pest details: POULTRY LAYERS (EGGS FOR HUMAN CONSUMP): [AVIAN HAEMAGGLUTINATING ADENOVIRUS]; Poison schedule: 0; Withholding period: WHP: NIL; Host/pest details: POULTRY LAYERS (EGGS FOR HUMAN CONSUMP): [AVIAN HAEMAGGLUTINATING ADENOVIRUS]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY LAYERS (EGGS FOR HUMAN CONSUMP): [AVIAN HAEMAGGLUTINATING ADENOVIRUS]; Inactivated vaccine for the protection of laying hens against Egg Drop Syndrome' 76.Local tissue reactions may occur

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

NOBILIS EDS INACTIVATED VACCINE FOR LAYING HENS
50008/133831
Product Name:
APVMA Approval No:
Label Name:
NOBILIS EDS INACTIVATED VACCINE FOR LAYING HENS
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Inactivated EDS ’76 virus strain BC14 inducing ≥ 6.5 log2 HI units
per dose in an adjuvant
emulsion. Inactivated vaccine for the protection of laying hens
against Egg Drop Syndrome
’76.
Nobilis EDS contains one immunogenic strain of EDS ‘76 virus. The
virus is inactivated
with formalin. Subsequently it has been suspended in the aqueous phase
of an oil adjuvant
emulsion.
Claims:
Inactivated vaccine for the protection of laying hens against Egg Drop
Syndrome ‘76.
Net Contents:
500mL
Directions for Use:
Restraints:
Do not mix with other vaccines.
Contraindications:
Precautions:
Vaccinate healthy birds only.
Side Effects:
Vaccination reactions:
In healthy birds no clinical reaction to vaccination will be observed.
For some weeks after
vaccination a slight swelling may be felt at the site of vaccination.
Local tissue reactions
may occur.
Dosage and
Administration:
Shake the bottle well before use.
Broached vials should be used within 3 hours. RLP APPROVED
Allow to reach ambient temperature (15°C-25°C) before use. For IM or
SC injection in hens
0.5 mL/dose.
Before using vaccine allow it to reach ambient temperature
(15°C-25°C). Each bird should
be given 0.5 mL of vaccine intramuscularly in the thigh or chest
muscle or subcutaneously
into the lower part of the neck. Use the entire contents when first
opened. Use sterile
injection equipment.
Recommended vaccination program
Nobilis EDS should be given to birds approximately 16-20 weeks of age
but not less than 4
weeks before the expected onset of lay.
General Directions:
Immunity:
If vaccination has been carried out correctly the birds will develop
antibodies at a level
which provides protection against Egg Drop Syndrome ‘76.
Withholding Periods:
Zero (0) days.
Trade Advice:
Safety Directions:
First Aid Instructions:
If poisoning occurs, c

Summary of Product characteristics

PRODUCT NAME: NOBILIS® EDS INACTIVATED VACCINE FOR LAYING
HENS
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:
Inactivated virus in an oil/water emulsion.
TRADE NAME:
NOBILIS
® EDS INACTIVATED VACCINE FOR LAYING HENS
PRODUCT CODE:
RECOMMENDED USE:
Disease prevention by vaccination in laying and breeding poultry.
APVMA NO:
50008
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:
S25. 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:
White emulsion. Presented in 500mL bottle.
ODOUR:
No odour.
MAJOR HEALTH HAZARDS:
no significant risk factors have been found for this product.
The formaldehyde in this product is present at very low
concentrations. However, persons with known sensitisation to
formaldehyde should avoid contact with 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.
POTENTIAL HEALTH EFFECTS
EMERGENCY OVERVIEW
SECTION 2 - HAZARDS IDENTIFICATION
SECTION 1 - IDENTIFICATION OF CHEMICAL PRODUCT AND COMPANY
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 81