NOBILIS IB VACCINE
Country: Australia
Language: English
Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)
Patient Information leaflet
(PIL)
19-06-2017
Summary of Product characteristics
(SPC)
19-06-2017
Active ingredient:
INFECTIOUS BRONCHITIS VIRUS (POULTRY)
Available from:
INTERVET AUSTRALIA PTY LIMITED
INN (International Name):
infectious bronchitis
Pharmaceutical form:
MISC. VACCINES OR ANTI SERA
Composition:
INFECTIOUS BRONCHITIS VIRUS (POULTRY) VACCINE-VIRAL Active 0.0 P
Units in package:
#4.5mL; #per vial; #vaccine; *50x5000; *doses; ^50x10000; ^doses; 1-25 vials
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:
INFECTIOUS BRONCHITIS | VACCINE | EQUINE ROTAVIRUS | INFECTIOUS BRONCHITIS NEPHRITI
Product summary:
Poison schedule: 0; Withholding period: WHP: Nil TRADE ADVICE: EXPORT SLAUGH TER INTERVAL (ESI): ESI is not required .; Host/pest details: POULTRY: [INFECTIOUS BRONCHITIS, VACCINE]; Poison schedule: 0; Withholding period: ; Host/pest details: POULTRY: [INFECTIOUS BRONCHITIS, VACCINE]; For the prevention of infectious Bronchitis disease in chickens, by administration at day-old to chickens hatched from parent stock which have been vaccinated against Infectious Bronchitis.
Authorization status:
Registered
Authorization date:
2023-07-01
Patient Information leaflet
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS) _(VETERINARY PRODUCTS)
_
_ _
APVMA NO:
35759
DATE: 1
ST NOVEMBER 2012_ _
PRODUCT NAME:
NOBILIS
® IB VACCINE
_Select appropriate: _
New Product (include all applicable RLPs) OR
Variation (highlight instructions that are being varied). Approval no.
of label being
varied: 35759/52971
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
® IB VACCINE
Vial, Carton front and inner lid
panel
Active constituent/s:
VIAL: Infectious Bronchitis virus living, attenuated
CARTON FRONT AND INNER LID PANEL: Active Constituent:
Infectious Bronchitis Virus, living, attenuated (Ref. 1/197/A).
Minimum titre at end of shelf life 10
3.0
EID
50
/ per dose.
Preservatives: Nil
As specified.
Statement of claims:
For the prevention of Infectious Bronchitis disease in chickens, by
administration at
day-old to chickens hatched from parent stock which have been
vaccinated against
Infectious Bronchitis.
Carton front and inner lid panel
Net contents:
VIAL: Doses per 4.5mL vial – Refer to pack
CARTON: Contents: 1 to 25, 50 vials x 5000 or 10000 dose vials
No. of vials
As specified.
Directions for Use
Heading:
Vial: READ INFORMATION INSIDE PACK BEFORE USE.
As specified. RLP APPROVED
LABEL PARTICULAR
TEXT
LABEL COMPONENTS
Carton Front Panel: READ THE INFORMATION PRINTED ON THE INSIDE OF
THE PACK BEFORE USING THIS PRODUCT.
Carton Inner Lid Panel: DIRECTIONS FOR USE:
Restraints:
Not required.
Contraindications:
Not required.
Precautions:
PRECAUTIONS:
_* It is recommended that the vaccine be diluted in 1.5-2.5% w/v
non-fat skim milk _
_powder in water, in order to neutralise any residual chlorine in the
tap water. Any _
_chlorine present could be harmful to the vaccine virus. Higher
concentrations of _
_powder will not affect the vaccine but could cause difficulties with
administration._
Carton Inner Lid Panel
Side effects:
Not required.
Dosage
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Summary of Product characteristics
PRODUCT NAME: NOBILIS IB 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: 1 800 033 461 (Business Hours)
Poisons Information Centre: 13 11 26 from anywhere in Australia, (0800
764 766 in New Zealand)
SUBSTANCE:
Freeze-dried, live virus vaccine, presented in 9mL glass vials that
have been sealed under
vacuum and in which there is a 4.5mL plug of dried vaccine.
TRADE NAME:
NOBILIS IB VACCINE
PRODUCT CODE:
3955
RECOMMENDED USE:
For use to protect poultry against Infectious Bronchitis.
APVMA NO:
35759
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:
White to off-white plug.
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.
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: 1 800 033 461 (BUSINESS HOURS)
BENDIGO EAST, VIC 3550, AUSTRALIA
FAX: 1 800 817 414
COMPANY ABN: 79 008 467 034
PRODUCT NAME: NOBILIS IB VACCINE
MATERIAL SAFETY DATA SHEET
THIS REVISION I
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