Nobilis IB Primo QX - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release : Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens

Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each dose of reconstituted vaccine contains:

Live attenuated avian infectious bronchitis virus, strain D388: 104.0– 105.5 EID501

1 50% egg infective dose.

Lyophilisate: Off white, predominantly sphere shaped. Solvent (Solvent Oculo/Nasal): blue-coloured solution.

• 4. INDICATION(S)

For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus (IBV).

Onset of immunity: 3 weeks.

Duration of immunity: 8 weeks.

• 5. CONTRAINDI­CATIONS

None.

• 6. ADVERSE REACTIONS

A mild transient respiratory reaction (including nasal exudates) may very rarely occur for at least 10 days after vaccination.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Chickens.

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

After reconstitution, administer 1 dose of vaccine by coarse spray or by the oculonasal route of administration to chickens from 1 day of age or older. Cups may contain 3 spheres to up to 400 spheres depending on the required dosages and production yields. Do not use the product if the contents are brownish and stick to the container as this indicates that the integrity of the container has been breached.

• 9. ADVICE ON CORRECT ADMINISTRATION

Reconstitute the lyophilisate immediately and entirely after opening of the cup.

Administration routes:

Coarse spray:

When spray devices are used it is advisable to consult the technical staff of the distributors before using this technique. Apply coarse spray >250 microns. All containers used for reconstitution should be clean and free from any traces of detergent or disinfectant.

• 1) Reconstitute the lyophilisate using water of good quality (e.g. free from chlorine and/or disinfectants). Measure the correct volume of water for the number of birds to be vaccinated (depends on devices used).

• 2) Add the contents of the correct number of cups while stirring.

• 3) Mix thoroughly with a clean stirrer, ensuring that all vaccine is dissolved. After reconstitution the suspension looks clear.

• 4) Offer to birds immediately.

  
  
  
  

Oculonasal use:

Solvent Oculo/Nasal is available as solvent for oculonasal application.

• 1) The contents of a cup (1,000 doses only) can be added to Solvent Oculo/Nasal using the included adapter and administered after connecting the included dropper.

• 2) Shake the vaccine suspension. After reconstitution the suspension looks clear.

• 3) One drop containing one dose should be applied into one nostril or one eye. Ensure that the

nasal drop is inhaled before freeing the bird.

• 10. WITHDRAWAL PERIOD(S)

Zero days.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Lyophilisate: Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.

Solvent: Store below 25 °C. Do not freeze.

Do not use this veterinary medicinal product after the expiry date which is stated on the label.

Shelf life after reconstitution according to directions: 2 hours.

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Vaccinate healthy animals only.

The vaccine virus is capable of spreading to in contact birds for a minimum of 20 days after vaccination and appropriate care should be taken to separate vaccinated from non-vaccinated chickens. Precautionary measures should be taken to prevent spreading to wildlife. The premises must be cleaned and disinfected after each production round.

This vaccine should only be used after it has been established that the QX-like IBV variant strain is epidemiologically relevant. It is important to avoid introduction of the IB D388/QX vaccine virus into premises in which the wild type strain is not present. The IB D388/QX vaccine should only be applied in hatcheries to chickens from 1 day of age or older if adequate controls are in place to avoid the spread of the vaccine virus to birds that will be transported to non-IB QX exposed flocks.

The vaccine has been demonstrated to provide protection against QX-like variant. The protection against other circulating IB strains has not been investigated.

Special precautions for use in animals :

All chickens on the site should be vaccinated at the same time.

Special precautions to be taken by the person administering the veterinary medicinal product to animals :

In case of coarse spray, personal protective equipment consisting of masks with eye protection should be worn when handling the veterinary medicinal product. Wash and disinfect hands and equipment after vaccination to avoid the spread of the virus.

Lay :

The safety of Nobilis IB Primo QX has been demonstrated when administered during lay. The efficacy of Nobilis IB Primo QX has not been demonstrated when administered during lay.

A decision to use this vaccine during lay should be made on a case by case basis.

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 for spray or oculonasal application. Simultaneous use of both vaccines increases the risk of recombination of viruses and potential emergence of new variants. However, the chance of a hazard occurring has been estimated very low. For the mixed products the onset of immunity is 3 weeks and the duration of immunity is 8 weeks for the claimed protection against Massachusetts and QX-like strains of IBV. The safety parameters of the mixed vaccines are not different from those described for the vaccines administered separately. Read the package leaflet of Nobilis IB Ma5 before use.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Overdose (symptoms, emergency procedures, antidotes):

Very mild inflammatory changes have occasionally been found in the kidneys of specific pathogen free (SPF) chickens after administration of a 10-fold overdose.

Incompatibilities :

Do not mix with any other veterinary medicinal product, except Nobilis IB Ma5 or Solvent Oculo/Nasal recommended for use with the veterinary medicinal product.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {DD/MM/YYYY}