Nobilis® MA5 + Clone 30
A live attenuated, freeze-dried vaccine, indicated for the immunisation of fowls against the Massachusetts type of serologically related types of Infectious Bronchitis and against Newcastle Disease.
FOR ANIMAL USE ONLY
Nobilis® MA5 + CLONE 30
Reg. No. G2301 (Act 36/1947)
Namibia Reg. No. V97/24.3/829 [NS0]
Newcastle disease is a controlled disease in terms of the Animal Diseases Act (Act 35/1984). The occurrence or suspicion of this disease must be reported to the responsible state veterinarian immediately.
INDICATIONS
Nobilis® Ma5 + Clone 30 is a live attenuated freeze-dried vaccine against Infectious Bronchitis (IB) and Newcastle Disease (ND) in chickens and is used for the immunisation of healthy chickens against the Massachusetts type of serologically related types of Infectious Bronchitis and against Newcastle Disease.
COMPOSITION
Each dose of vaccine contains at least 103,0 EID50 Infectious Bronchitis virus strain Ma5 (serotype Massachusetts) and 106 EID50 of the Newcastle Disease strain Clone 30. Traces of gentamicin, that was used during production, may be present in the final product.
IMMUNITY
An adequate immunity against ND and the Massachusetts type of IB, will last for approximately 6 weeks, provided that the vaccine is properly administered. In areas where ND is endemic, a second vaccination with Nobilis® Clone 30, should be given at an age of approximately 4 weeks.
STORAGE INSTRUCTIONS
- Store between 2 °C and 8 °C in a refrigerator.
- Do not freeze.
- Avoid prolonged or repetitive exposure to high ambient temperatures (20 °C to 25 °C).
- Protect from exposure to direct sunlight.
- After reconstitution: Use within 2 hours.
WARNINGS
- Withdrawal period: Do not vaccinate within 21 days of slaughter.
- Vaccinate healthy chickens only.
- In areas where ND is endemic, a second vaccination with Nobilis® ND Clone 30 (G2466), should be given at approximately 4 weeks.
- Ensure adequate hygiene and management in the post-vaccination period.
- Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.
- Each container should be used immediately after opening.
- 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
- 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.
- If the spray method is used for the administration of the vaccine, ensure that there is no chlorine, iron 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.
- In the case of Nobilis® Ma5 + Clone 30 presented as cups, 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.
- It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
- Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
DIRECTIONS FOR USE -USE ONLY AS DIRECTED
Administration
Nobilis® Ma5 + Clone 30 may be administered by coarse spray or eye drop application.
(For the eye drop application, the Intervet Diluent Oculo-Nasal may be used.)
Nobilis® Ma5 + Clone 30 may be delivered as a lyophilised pellet in a glass vial or as lyophilised spheres in cups. Each container should be used immediately and completely after opening.
- Spray Administration
- Nobilis® Ma5 + Clone 30 should be dissolved in cool, clean, non-chlorinated water which is free from iron.
- The vials of freeze-dried vaccine should be opened under water, or the content of the cup(s) should be poured into water. In both cases, mix the water containing the vaccine well before use. After reconstitution, the suspension should be clear.
- The volume of water for reconstitution should be sufficient to ensure an even distribution when sprayed onto the chickens. This will vary according to the age of the chickens being vaccinated and the management system.
- The vaccine medicated water should be spread evenly over the correct number of chickens, at a distance of 30 cm to 40 cm, preferably when the chickens are sitting together in dim light.
- For 1-day-old chickens, use 0,25 ℓ of water per 1 000 chickens and set nozzle to produce fine droplets, falling like a fine rain. For older chickens, dissolve 1 000 doses in 1 ℓ of water and set the nozzle to produce fine droplets falling like fine rain.
- The volume of water used for administration depends on the equipment used and the age of the chickens to be vaccinated. (Aerosol generators should be used only when this is known to be safe in chickens).
- If applicable, reduce or stop ventilation to prevent loss of spray.
- The spray apparatus should be free from sediments, corrosion and traces of disinfectants (preferably to be used for vaccination purposes only).
- Eye Drop Administration
- Dissolve the vaccine in physiological saline solution 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.
- Do not release the chicken until a swallowing motion is noticed.
- Intervet Diluent Oculo-Nasal is commercially available in South Africa and should be used instead of physiological saline solution.
- For numbers of chicken, between standard dosages, the next higher dosage should be chosen.
Note: Administration by coarse spray or eye drop route gives the best response. These should be the methods of choice, especially when vaccinating young chickens.
Vaccination Programme
The optimum time and method of administration depends largely upon local situation. The advice of a veterinarian should be sought. The vaccine is safe to use from 1-day-old onwards.
Guidelines
Type of Chicken | Age | Vaccine | Administration |
Broilers | 1-day-old | Nobilis® Ma5 + Clone 30 | Course spray or eye drop application |
Approx. 4 weeks (If ND endemic) | Nobilis® Clone 30 | Spray or eye drop application | |
Layers / Breeders | 1-day-old | Nobilis® Ma5 + Clone 30 | Course spray or eye drop application |
Approx. 4 weeks (If ND Endemic) | Nobilis® Clone 30 | Spray or eye drop application | |
Approx. 8 weeks | Nobilis® Ma5 + Clone 30 | Spray or eye drop application |
VACCINATION REACTION
The duration and intensity of the vaccination reaction (sneezing) 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.
PRESENTATION
Containers with sealed Type I glass vials containing 1 000, 2 500 or 5 000 doses of lyophilised pellet respectively.
Containers with sealed aluminium laminate cups containing 1 000, 2 500 or 5 000 doses of lyophilised sphereons.
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
18 February 2022
Zimbabwe Reg. No. E94/80.23.17/9385 Pharmacological classification: 802317 Distribution category: VMGD |