NOBILIS NEWCAVAC VACCINE AGAINST NEWCASTLE DISEASE IN POULTRY

Krajina: Austrália

Jazyk: angličtina

Zdroj: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktívna zložka:

INACTIVATED NEWCASTLE DISEASE VIRUS ANTIGEN

Dostupné z:

INTERVET AUSTRALIA PTY LIMITED

INN (Medzinárodný Name):

Newcastle disease virus (I)

Forma lieku:

MISC. VACCINES OR ANTI SERA

Zloženie:

INACTIVATED NEWCASTLE DISEASE VIRUS ANTIGEN VACCINE-VIRAL Active 0.0 P

Počet v balení:

*1000Doses; *500mL; @250mL; @500 Doses

Trieda:

VM - Veterinary Medicine

Výrobca:

INTERVET AUSTRALIA

Terapeutické skupiny:

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

Terapeutické oblasti:

IMMUNOTHERAPY

Terapeutické indikácie:

NEWCASTLE DISEASE | VACCINE | EQUINE ROTAVIRUS

Prehľad produktov:

Poison schedule: 0; Withholding period: Zero (0) days; Host/pest details: POULTRY: [NEWCASTLE DISEASE, VACCINE]; Poison schedule: 0; Withholding period: WHP: Nil.; Host/pest details: POULTRY: [NEWCASTLE DISEASE, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY: [NEWCASTLE DISEASE, VACCINE]; Inactivated vaccine against Newcastle disease in oil adjuvant emulsion.

Stav Autorizácia:

Registered

Dátum Autorizácia:

2023-07-01

Príbalový leták

NOBILIS NEWCAVAC VACCINE AGAINST NEWCASTLE DISEASE IN POULTRY
53811/132608
Product Name:
APVMA Approval No:
Label Name:
NOBILIS NEWCAVAC VACCINE AGAINST NEWCASTLE DISEASE IN POULTRY
Signal Headings:
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
Inactivated Newcastle Disease Virus inducing at least 4 log2 HI units
per 1/50 dose or at
least 50 PD50 units per dose. Virus is ND clone 30 (Beaudette’s La
Sota strain).
Nobilis NEWCAVAC contains one immunogenic strain of Newcastle disease
virus.
The virus has been grown on embryonated eggs and is inactivated with
formaldehyde.
Subsequently it has been suspended in the aqueous phase of an oil
adjuvant emulsion.
Claims:
The vaccine is recommended for the vaccination of layers and breeders
for protection
against sickness and death caused by Newcastle disease in early –
mid lay.
Net Contents:
250 mL (500 Doses)
500 mL (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
Dosage and
Administration:
Shake the bottle well before use.
Broached vials should be used within 3 hours.
Before using vaccine allow it to reach ambient temperature (between
15°C and 25°C).
Use sterile injection equipment only and use the entire contents when
first opened within
3 hours. 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.
Recommended Vaccination Program
Nobilis NEWCAVAC 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 effect, the
birds must be primed
with live vaccine against Newcastle disease.
General Directions:
Withholding Periods:
Zero (0) days
Trade Advice:
Safety Directions:
First Aid In

Súhrn charakteristických

PRODUCT NAME: NOBILIS NEWCAVAC® VACCINE AGAINST NEWCASTLE
DISEASE IN POULTRY
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 NEWCAVAC
® VACCINE
PRODUCT CODE:
20777
RECOMMENDED USE:
Disease prevention by vaccination in laying and breeding poultry.
APVMA NO:
53811
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
THIS PRODUCT MAY ONLY BE SUPPLIED TO THOSE PERSONS - OR THEIR
NOMINATED VETERINARIAN - WHO HAVE BEEN AUTHORISED
TO USE IT BY THEIR STATE CHIEF VETERINARY OFFICER OR CHIEF INSPECTOR
OF STOCK (OR THEIR NOMINATED DELEGATE).
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 - IDENTI