IB VACCINE

Main information

  • Trade name:
  • NOBILIS IB VACCINE
  • Pharmaceutical form:
  • MISC. VACCINES OR ANTI SERA
  • Units in package:
  • 1-25x5000Ds, 50x5000Ds, 1-25x10000Ds, 50x10000Ds
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • INTERVET AUSTRALIA

Documents

Localization

  • Available in:
  • NOBILIS IB VACCINE
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • POULTRY | BREEDERS | BROILER | CHICKENS | CHICKS | CHOOKS | DAY OLD CHICKS | HATCHLINGS | LAYERS
  • Therapeutic area:
  • vaccine
  • Therapeutic indications:
  • INFECTIOUS BRONCHITIS | VACCINE | EQUINE ROTAVIRUS | INFECTIOUS BRONCHITIS NEPHRITI
  • Product summary:
  • 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.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 35759/56482
  • Authorization date:
  • 20-11-2012
  • Last update:
  • 15-06-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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

/ 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 &

administration:

Reconstitution of Vaccine:

1) Contains 4.5 mL of lyophilised vaccine per vial – equivalent to doses indicated

on the front of this pack.

2) For each vial of vaccine, prepare a sterile 5 mL syringe with one 18G x 35 mm

needle attached.

3) The vaccine is rehydrated and diluted with a 1.5-2.5% w/v solution of non-fat

skim milk powder in water.

4) Wipe vial dry and remove cap and plug.

5) Using the syringe, draw up 4.5 mL of the skim milk solution and transfer it

immediately into the vaccine vial. Gently agitate the fluid in the vial until the entire

pellet is fully dissolved and the vaccine is a uniform suspension.

6) The vaccine may now be administered in either of two ways (Spray or Drinking

Water).

Dosage and Administration:

USE ALL PRODUCT WITHIN 30 MINUTES OF RECONSTITUTION.

Do not attempt to refreeze or reuse unused vaccine at a later time. Keep

Carton Inner Lid Panel

Label Particular

Text

Label components

reconstituted product out of direct sunlight. Do not heat in any way.

A)

Spray Vaccination (Recommended):

NB: All utensils should be clean and free of toxic agents such as petroleum

products etc.

1) Transfer all the reconstituted vaccine to the spray bottle cabinet. For

each 5000 doses of vaccine, dilute to 250 mL with the skim milk solution

and gently mix.

2) Spray the vaccine onto day-old chickens in chick boxes.

3) Continue to spray until all the vaccine is used.

B)

Drinking Water Vaccination

1) Remove the birds’ drinking water about 30 minutes prior to vaccination.

2) Tehn pour the reconstituted vaccine (5, above) into the birds’ drinking

water.

The aim is to supply at least thirty minutes drinking (but no more than two

hours) to all birds. This is dependent upon climate but, as a guide, 5 litres of

prepared vaccine per 5000 day-old chickens per hour at 36°C.

General directions:

Not required.

Withholding

Period/s:

WITHHOLDING PERIOD: Zero (0) days

Vial, Carton front and Inner Lid

Panel

Trade Advice:

TRADE ADVICE:

EXPORT SLAUGHTER INTERVAL(ESI): ESI not required

Carton Inner Lid Panel

Safety Directions:

SAFETY DIRECTIONS:

Wear chemical goggles, plastic gloves and a mist spray filter if administering by

spray vaccination if an enclosed spray cabinet is not used. Additional information is

contained in the Material Safety Data Sheet.

Carton Inner Lid Panel

First Aid:

FIRST AID:

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone

Australia 131126.

Carton Inner Lid Panel

Label Particular

Text

Label components

Additional user

safety:

Not required.

Environmental

statements:

Not required.

Disposal:

DISPOSAL:

Dispose of empty containers by wrapping in paper and putting in garbage. Unused

product should be disposed of into an effluent handling system (e.g. septic tank).

Discarded needles/sharps should immediately be placed in a designated and

appropriately labelled ‘sharps’ container.

Carton Inner Lid Panel

Storage:

Vial and Carton Front Panel: Store below -18

C (deep freeze).

Carton Inner Lid Panel:

STORAGE:

Protect from light. Store below -18°C (deep freeze). Correct storage of this vaccine

is essential to ensure it is potent at the time of use. Store the vaccine vials in a

deep freeze or the freezing compartment of the refrigerator. Place the vaccine in a

cool box with ice on removal from the deep freeze until ready to reconstitute for

use.

As specified.

APVMA Approval

No.:

APVMA Approval No.: 35759/56482

Vial and Carton front panel

Batch and Expiry

Exp.

Vial and Carton side Panel 1

Name & address:

MSD Animal Health

Intervet Australia Pty Limited

91 – 105 Harpin Street

Bendigo East VIC 3550

Customer Service: Ph: 1800 033 461

Fax: 1800 817 414

Carton Front and Inner Lid

Panel

The following is for APVMA use only:

APVMA approval no.

APVMA No:

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