NOBILIS EDS + ND COMBINED INACTIVATED VACCINE AGAINST EDS'76 AND NEWCASTLE DISEASE

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

EGG DROP SYDROME 76 VIRUS STRAIN BC 14; NEWCASTLE DISEASE VIRUS CLONE 30

Available from:

INTERVET AUSTRALIA PTY LIMITED

INN (International Name):

Newcastle disease virus (I)+vaccine - egg drop syndrome-

Pharmaceutical form:

MISC. VACCINES OR ANTI SERA

Composition:

EGG DROP SYDROME 76 VIRUS STRAIN BC 14 VACCINE-VIRAL Active 6.5 units; NEWCASTLE DISEASE VIRUS CLONE 30 VACCINE-VIRAL Active 50.0 units

Units in package:

*(1000; *doses); 500mL

Class:

VM - Veterinary Medicine

Manufactured by:

INTERVET AUSTRALIA

Therapeutic group:

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

Therapeutic area:

IMMUNOTHERAPY

Therapeutic indications:

AVIAN HAEMAGGLUTINATING ADENOVIRUS | NEWCASTLE DISEASE | ADENOVIRUS | EGG DROP SYNDROME

Product summary:

Poison schedule: 0; Withholding period: Zero (0) days.; Host/pest details: POULTRY: [AVIAN HAEMAGGLUTINATING ADENOVIRUS, NEWCASTLE DISEASE]; Poison schedule: 0; Withholding period: WHP: As per the label Zero (0) days.; Host/pest details: POULTRY: [AVIAN HAEMAGGLUTINATING ADENOVIRUS, NEWCASTLE DISEASE]; Poison schedule: 0; Withholding period: WHP: NIL; Host/pest details: POULTRY: [AVIAN HAEMAGGLUTINATING ADENOVIRUS, NEWCASTLE DISEASE]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY: [AVIAN HAEMAGGLUTINATING ADENOVIRUS, NEWCASTLE DISEASE]; For the vaccination of layers and breeders for the protection against sickness and death caused by Newcastle disease in early -mid lay and for the protection of layers and breeders against Egg Drop Syndrome '76.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

NOBILIS EDS + ND COMBINED INACTIVATED VACCINE AGAINST EDS'76 AND
NEWCASTLE DISEASE
58494/133830
Product Name:
APVMA Approval No:
Label Name:
NOBILIS EDS + ND COMBINED INACTIVATED VACCINE AGAINST EDS'76 AND
NEWCASTLE DISEASE
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
EDS’76 virus BC14: inducing ≥ 6.5 log2 HI units per dose; NDV
Clone 30: inducing ≥ 4 log2
HI units per 1/50th dose or containing ≥ 50 PD50 units per dose, in
oil adjuvant emulsion.
Nobilis EDS+ND contains one immunogenic strain of Newcastle Disease
virus and one
immunogenic strain of EDS’76 virus.
The viruses are inactivated with formalin. Subsequently they have been
suspended in the
aqueous phase of an oil adjuvant emulsion.
Claims:
The vaccine is recommended for the vaccination of layers and breeders
for the protection
against sickness and death caused by Newcastle disease in early-mid
lay and for the
protection of layers and breeders against Egg Drop Syndrome ’76.
Net Contents:
500mL (1000 doses)
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. RLP APPROVED
For Official Use Only
Dosage and
Administration:
Shake the bottle well before and during use. Broached vials should be
used within 3 hours.
Before using vaccine allow it to reach an ambient temperature (15°C
and 25°C). Use sterile
injection equipment.
Each bird should be given 0.5 mL of vaccine intramuscularly (IM) in
the thigh or chest
muscle or subcutaneously (SC) into the lower part of the neck.
Recommended vaccination program:
Nobilis EDS+ND should be given to birds around 14-18 weeks of age but
not less than 4
weeks before the expected onset of lay.
For an optimal booster effect, the birds must be primed with live
vaccine against Newcastle
Disease a

Summary of Product characteristics

PRODUCT NAME: NOBILIS EDS + ND COMBINED INACTIVATED VACCINE
AGAINST EDS 76 AND NEWCASTLE DISEASE
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 + ND COMBINED INACTIVATED VACCINE AGAINST EDS 76 AND
NEWCASTLE DISEASE
PRODUCT CODE:
27690
RECOMMENDED USE:
Disease prevention by vaccination in laying and breeding poultry.
APVMA NO:
58494
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: 1 80