Nobilis® IB MA5

Reg. No. G2300 (Act 36/1947)

Namibia Reg. No. V97/24.3/822 [NS0]

INDICATIONS

Nobilis^® IB Ma5 is a live attenuated vaccine to prevent infectious bronchitis (Massachusetts type) in chickens.

COMPOSITION

Each dose of Nobilis^® IB Ma5 contains at least 10^3,0 EID₅₀ infectious bronchitis virus strain Ma5 (serotype Massachusetts). The vaccine contains stabilisers and gentamicin.

STORAGE INSTRUCTIONS

• Store between 2 °C – 8 °C in a refrigerator.
• Do not freeze.
• Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
• Protect from exposure to direct sunlight.
• The diluent may be stored at room temperature between 20 °C – 25 °C.
• In-use shelf life after reconstitution: 2 hours.

WARNINGS

• Withdrawal period: Do not slaughter animals for human consumption for at least 21 days after vaccination.
• Vaccinate healthy chickens only.

• It is advisable to vaccinate all the susceptible chickens on the farm at the same time. If this is not feasible, strict separation of vaccinated and unvaccinated chickens should be done to prevent the spread of the vaccine virus to the unvaccinated chickens.
• Use according to the number of doses as indicated on the label.
• Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.
• Do not mix Nobilis^® IB Ma5 with any other vaccine or medication other than Nobilis^® IB Primo QX (G4211) or Nobilis^® IB 4-91 (G4031).
• Do not administer simultaneously with any other live vaccines.
• Do not open and reconstitute until ready to start vaccination.
• Use the vaccine immediately after reconstitution.
• Do not store partially used containers for future use.
• Dispose of any unused vaccine, empty vaccine containers and disposable vaccination equipment according to the National Environmental Management Waste Act, 2008 (Act 59 of 2008), after vaccination.
• KEEP OUT OF REACH OF CHILDREN, ANIMALS AND UNINFORMED PERSONS.
• 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

• Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
• Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis^® IB Primo QX (G4211) or Nobilis^® IB 4-91 (G4031) for spray or intranasal/ocular administration from 1-day-old onwards. Read the product information of Nobilis^® IB Primo QX (G4211) or Nobilis^® IB 4-91 (G4031) before use.
• If the spray application is used for the administration of the vaccine, ensure that there is no iron, chlorine or disinfectants in the water.
• The spray apparatus should be free from sediments, corrosion and traces of disinfectants. It should preferably be used for vaccination purposes only.
• Do not use disinfectants and/or spirits prior to vaccination.
• Wash and disinfect hands and equipment before and after vaccination.
• Nobilis^® IB Ma5 may be administered as a lyophilised pellet in a glass vial or as lyophilised spheres in a cup. In the case of the aluminium cup presentation, the cups must contain at least 3 spheres. Do not use Nobilis^® IB Ma5 if the contents are brownish and stick to the containers as this indicates that the integrity of the container has been breached.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

1. Spray Application
2. Nobilis^® IB Ma5 should be dissolved in cool, clean, non-chlorinated water which is free from iron.
3. The vial of freeze-dried vaccine should be opened under water or the content of the cup(s) should be poured into the water. In both cases, mix the water containing the vaccine well before use. After reconstitution, the suspension looks clear.
4. The spray apparatus should be free from sediments, corrosion and traces of disinfectants. It should preferably be used for vaccination purposes only.
5. The vaccine-medicated water should be spread evenly over the correct number of chickens, at a distance of 30 to 40 cm, preferably when the chickens are sitting together in dim light.
6. For 1-day-old chicks, use 0,25 ℓ water per 1 000 chicks and set nozzle to produce fine droplets, falling like a fine rain. For older chickens, dissolve 1 000 doses per ℓ of water and set the nozzle to produce fine droplets (Aerosol generators should be used only when this is known to be safe to chickens).

• Intranasal/Eye-drop Application
• Dissolve Nobilis^® IB Ma5 in physiological saline or Intervet Diluent Oculo-Nasal and administer by means of a standardised dropper (usually 30 mℓ per 1 000 doses).
• One drop should be applied from a height of a few centimetres onto 1 eye. As an eye drop application, the drop should be allowed to spread evenly across the surface of the eye.
• The handler should ensure that the nasal drop is inhaled by the chick and a swallowing motion is noticed before the chicken is released.
• Intervet’s diluent, Diluent Oculo-Nasal, is commercially available in South Africa and should be used instead of physiological saline solution.

• Drinking water Application
• The vials should be opened under water or the content of the cup(s) should be poured into the water. In both cases, mix the water containing the vaccine well before use. After reconstitution the suspension looks clear.
• Nobilis^® IB Ma5 should be dissolved in cool, clean water which is free of iron and chlorine.
• Ensure uptake of all the vaccine-medicated water within 2 hours. Depending on the weather conditions, it may be advisable to deprive the birds of water prior to vaccination. It is essential to have enough water containers to provide adequate drinking space. These water containers should be clean and free from traces of detergents and disinfectants.
• Dissolve 1 000 doses in as many litres of water as the age of the chickens in days, to a maximum of 40 ℓ.
• The vaccine should be given in the early morning as this is the main period of drinking or the cool period on a hot day. When vaccinating larger flocks, it is advisable to start by dissolving only part of the vaccine.
• If vaccine is administered through a central water supply or a proportioner, great care should be taken.
• For numbers of birds between standard dosages, the next higher dosage should be chosen.

Note: Administration by coarse spray or the intranasal/eye-drop method gives the best response. These should be the methods of choice, especially when vaccinating young chicks. The vaccine can be administered through the drinking water. The vaccine should be dissolved in an amount of water which will be consumed by the chickens within approximately 2 hours.

VACCINATION PROGRAMME

The optimum time and method of administration depend largely upon local situation. The advice of a veterinary surgeon should be sought. The vaccine is safe to use in chicks from

1-day-old onwards.

Guidelines

Broilers:                             Vaccination at 1-day-old by coarse spray or intranasal/eye-drop method.

Layers and Breeders:   Vaccination at 1-day-old by coarse spray or intranasal/eye-drop method.

Revaccination:                At approximately 6 weeks of age by coarse spray, intranasal/eye-drop or drinking water administration.

Instructions on reconstitution when Nobilis^® IB Ma5 is used together with Nobilis^® IB Primo QX or Nobilis^® IB 4-91:

• Reconstitution and subsequent application of both lyophilisates are to be followed as outlined above for spray and intranasal/eye-drop administration.
• The same volumes of water (spray administration) or Intervet Diluent Oculo-Nasal (intranasal/eye-drop administration) should be used as required for the single product.
• The vaccines should be reconstituted individually into water (spray administration) or into Intervet Diluent Oculo-Nasal (intranasal/eye-drop administration) and subsequently mixed together before use.
• Do not open and reconstitute until ready to start vaccination.
• Each vial or cup should be used immediately after opening.

Note: Do not use Nobilis^® IB Ma5 simultaneouslytogether with Nobilis^® IB Primo QX (G4211) and Nobilis^® IB 4-91 (G4031). Nobilis^® IB Ma5 can be used with either Nobilis^® IB Primo QX (G4211) or Nobilis^® IB 4-91 (G4031).

IMMUNITY

After a first vaccination an adequate immunity against the Massachusetts type of IB will

last for approximately 6 weeks provided that the vaccine is properly administered.

VACCINATION REACTION

The duration and intensity of the vaccination reaction and the establishment of a solid immunity are generally dependent on the health and condition of the chickens. Hygiene and management are also important in the post-vaccination period to minimise vaccine reaction.

Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.

PRESENTATION

Type I hydrolytic glass vials closed with a halogenobutyl rubber bung and sealed with a coded aluminium cap containing freeze-dried pellet of 1 000, 2 500 or 10 000 doses.

Containers with 6 or 12 sealed aluminium laminate cups with a polypropylene cup and polypropylene/polyethylene lid contact layer containing 1 000, 2 500, 5 000 or 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

10 June 2021