Summary of medicine characteristics - Nobilis IB Primo QX
SUMMARY OF PRODUCT CHARACTERISTICS
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1. 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
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
Active substance:
Live attenuated avian infectious bronchitis virus, strain D388: 104.0– 105.5 EID501
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1 50% egg infective dose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for oculonasal suspension
Lyophilisate for oculonasal suspension.
Lyophilisate: Off white, predominantly sphere shaped. Solvent (Solvent Oculo/Nasal): blue-coloured solution.
4. CLINICAL PARTICULARS4.1 Target species
Chickens.
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4.2 Indications for use, specifying the target species
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.
4.3 Contraindications
None.
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4.4 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 vaccine virus into premises in which the wild type strain is not present. The IB D388 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.
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4.5 Special precautions for use
Special precautions for use in animals
All chickens on the site should be vaccinated at the same time.
Vaccinated chickens may excrete the vaccine strain up to 20 days following vaccination. During this time, the contact of immunosuppressed and unvaccinated chickens with vaccinated chickens should be avoided.
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.
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4.6 Adverse reactions (frequency and seriousness)
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)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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4.7 Use during pregnancy, lactation or 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.
4.8 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 product information 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.
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4.9 Amounts to be administered and administration route
Administer 1 dose of reconstituted vaccine by coarse spray or by oculonasal route 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.
Reconstitute the lyophilisate immediately and entirely after opening of the cup.
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.
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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).
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2) Add the contents of the correct number of cups while stirring.
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3) Mix thoroughly with a clean stirrer, ensuring that all vaccine is dissolved. After reconstitution the suspension looks clear.
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4) Offer to birds immediately.
Oculonasal use:
Solvent Oculo/Nasal should be used for oculonasal application.
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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.
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2) Shake the vaccine suspension. After reconstitution the suspension looks clear.
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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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Very mild inflammatory changes have occasionally been found in the kidneys of specific pathogen free (SPF) chickens after administration of a 10-fold overdose.
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4.11 Withdrawal period(s)
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for aves, domestic fowl, live viral vaccine.
ATCvet code: QI01AD07.
To stimulate active immunity against the D388/QX type of avian infectious bronchitis virus.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Lyophilisate:
Sorbitol
Hydrolysed gelatine
Pancreatic digest of casein
Disodium phosphate dihydrate
Solvent:
Patent Blue V (E131)
Potassium dihydrogen phosphate
Disodium phosphate dihydrate
Disodium edetate dihydrate
Sodium chloride
Sodium hydroxide or hydrochloric acid (for pH adjustment)
Water for injections
6.2 Major 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.
6.3 Shelf life
Shelf life of the lyophilisate as packaged for sale: 24 months.
Shelf life of the solvent as packaged for sale: 4 years.
Shelf life after reconstitution according to directions: 2 hours.
6.4 Special precautions for storage
Lyophilisate:
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Solvent:
Store below 25 °C.
Do not freeze.
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6.5 Nature and composition of immediate packaging
Lyophilisate:
Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer containing 1,000; 2,500; 5,000 or 10,000 doses.
Solvent (Solvent Oculo/Nasal):
Low density polyethylene (LDPE) vial of 35 ml with a halogenobutyl rubber stopper and aluminium cap.
Packaging:
Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3–100 spheres)).
Cardboard box with 10 cups of lyophilisate (2,500 doses per 42 mm diameter cup (3–100 spheres)).
Cardboard box with 10 cups of lyophilisate (5,000 doses per 42 mm diameter cup (3–100 spheres)).
Cardboard box with 10 cups of lyophilisate (10,000 doses per 61 mm diameter cup (3–400 spheres)). Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3–100 spheres)) + cardboard box with 10 × 35 ml vial of solvent supplemented with dropper and adapter.
PET plastic box with 12 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3–100 spheres))
PET plastic box with 12 cups of lyophilisate (2,500 doses per 42 mm diameter cup (3–100 spheres))
PET plastic box with 12 cups of lyophilisate (5,000 doses per 42 mm diameter cup (3–100 spheres))
PET plastic box with 6 cups of lyophilisate (10,000 doses per 61 mm diameter cup (3–400 spheres)).
Not all pack sizes may be marketed.
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6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/14/174/001–009
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 04/09/2014.
Date of last renewal: 13/06/2019.