Nobilis® IB Primo QX

For the active immunisation of chickens from 1 day of age or older to reduce clinical signs of disease caused by infection with Infectious Bronchitis Virus serotype D388/QX.

FOR ANIMAL USE ONLY

NOBILIS® IB PRIMO QX

Reg. No. G4211 (Act 36/1947)

Only for use by or under the supervision of persons registered in terms of or authorised in terms of section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).

INDICATIONS

For the active immunisation of chickens from 1 day of age or older to reduce clinical signs of disease caused by infection with Infectious Bronchitis Virus serotype D388/QX.

COMPOSITION

Each dose of reconstituted vaccine contains:

Live Avian Infectious Bronchitis Virus strain D388: > 104,0 EID501

1EID50 = 50 % Egg Infective Dose

IMMUNITY

Onset of immunity: 3 weeks.

Duration of immunity: 8 weeks

STORAGE

Vaccine

  • Store between 2 °C and 8 °C.
  •  Do not freeze.
  •  Protect from light.

Solvent

  • Store between 2 °C and 25 °C.
  •  Do not freeze.

WARNINGS

  • Withdrawal period: Meat – Do not slaughter animals for human consumption for at least 21 days after vaccination. Eggs – Not to be used in chickens that lay eggs for human consumption.
  • Vaccinate healthy chickens only.
  • Nobilis® IB Primo QX if the spheres are brownish and stick to the container, as this indicates that the integrity of the container has been breached.
  • Do not use Nobilis® IB Primo QX if the spheres remain floating in the water and don’t dissolve, or if spheres have shrunk and/or appear dehydrated.
  • Destroy any unused vaccine and dispose of all the vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • If you notice any serious effects or other effects not mentioned in this package insert, please inform your veterinarian.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

  • In case of spray administration, personal protective equipment consisting of masks with eye protector should be worn when handling Nobilis® IB Primo QX.
  • Observe aseptic precautions.
  • Ensure that the vaccination equipment (spray apparatus, droppers) is clean prior to use.
  • Each cup should be used immediately after opening.
  • Nobilis® IB Primo QX should be dissolved in cool, clean, non-chlorinated water which is free from iron.
  • The spray apparatus should be free from sediments, corrosion and traces of disinfectants.
  • The spray apparatus should be used for vaccination purposes only.
  • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
  • Wash hands after vaccination.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Dosage and Administration

After reconstitution administer at least 1 dose of the Nobilis® IB Primo QX per chicken by coarse spray or via intranasal/ocular administration (eye drop) to chickens from 1 day of age or older (for the eye or nose drop application, the Intervet Diluent Oculo-Nasal may be used).

A. Spray Administration

  • Measure the correct volume of water for the number of chickens to be vaccinated and add the contents of the correct number of cups while stirring. Mix thoroughly with a clean stirrer, ensuring that all vaccine is dissolved.
  • Offer to the chickens immediately after reconstitution.
  • When spray devices are used it is advisable to consult the technical staff of Intervet South Africa before using this technique.
  • If applicable, reduce or stop ventilation to prevent loss of spray.

B. Intranasal/Eye drop Administration

  • Reconstitute Nobilis® IB Primo QX with the appropriate amount of a suitable solvent and administer by means of the standardised dropper.
  • One drop should be applied into one nostril or one eye. Ensure that the nasal drop is inhaled before freeing the chicken. The eye drop should be allowed to spread across the surface of the eye and do not release the chicken until a swallowing motion is noticed.
  • Nobilis® Diluent Oculo-Nasal is available as solvent.

ADVERSE REACTIONS

Vaccination may induce a mild transient respiratory reaction lasting a few days, which may

depend on the health and condition of the birds.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis® IB Ma5. No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except for the product mentioned above. A decision to use Nobilis® IB Primo QX before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.

PRESENTATION

Spheres (lyophilisate)

Sealed aluminium laminated cups containing 1 000, 2 500, 5 000 or 10 000 doses.

Solvent (oculo-nasal administration)

Blue coloured 35 mℓ plastic vial with a rubber stopper and aluminium cap.

Packaging

Cardboard box with ten cups of lyophilisate containing the same dosage.

Ten vials of solvent (only supplied with 1 000 doses of vaccine).

PET plastic box with 12 cups of lyophilisate of 1 000, 2 500 or 5 000 doses.

PET plastic box with 6 cups of lyophilisate of 10 000 doses.

Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road

Spartan, 1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

22 July 2021

Zimbabwe Reg No. 2023/80.23.17/9828
Pharmacological classification: 802317
Categories for distribution: VMGD