Nobilis® ND Broiler

FOR ANIMAL USE ONLY

NOBILIS^® ND BROILER

Reg. No. G2469 (Act 36/1947)

Namibia Reg. No. V98/24.3/676 [NS0]

NAFDAC Reg. No. A6-100084

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^® ND Broiler is an inactivated vaccine intended for the active immunisation of 1-day-old broiler chicks against Newcastle Disease.

COMPOSITION

Each 0,1 mℓ dose of Nobilis^® ND Broiler contains ≥ 20 PD₅₀ units of inactivated Newcastle Disease virus (the Newcastle Disease virus antigen induces ≥ 4 log₂ HI units per ¹/₅₀ dose). The virus is inactivated with formalin and suspended in the aqueous phase of a water-in-oil emulsion.

STORAGE

• Store in the dark between 2 °C – 8 °C.
• Do not freeze.
• Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
• Protect from direct sunlight.
• After opening, the contents of the bottle should be used within 3 hours.

WARNINGS

• Withdrawal period: Do not market chickens for slaughter purposes for at least 6 weeks after vaccination.
• Do not inject intravenously.
• Ensure that chickens marketed do not have swellings at the vaccination site, as this may result in the condemnation of the chickens.
• Do not mix Nobilis^® ND Broiler with other vaccines, except when administered simultaneously with live Newcastle Disease vaccines.
• Vaccination of chickens in production may lead to a slight drop in egg production.
• Accidental self-injection may lead to a severe local allergic reaction. Consult a physician informing him/her that the vaccine contains a mineral oil.
• Do not store partially used bottles for future use and use the entire contents once the vaccine has been opened.
• 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.

Special precautions to be taken by the person administering NOBILIS^® ND BROILER to animals

To the user

NOBILIS^® ND BROILER contains mineral oil. If you are accidentally injected with this vaccine, seek prompt medical advice even if only a very small amount is injected and take the package insert with you to show to the physician. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician

NOBILIS^® ND BROILER contains mineral oil. Even if small amounts have been injected, this vaccine can cause intense vascular spasm which may, for example result in ischaemic necrosis and even the loss of a digit.

Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon sheaths.

PRECAUTIONS

• Vaccinate healthy chickens only.
• Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes, etc.) is clean and sterile prior to and during use.
• It is essential to adhere to the vaccination programme to maintain a satisfactory immune response.
• It is good vaccination practice to avoid contact with the eyes, hands and clothing when handling the vaccine.
• 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

Shake well before use and at regular intervals during the vaccination process.

 Recommended Vaccination Programme

Nobilis^® ND Broiler is administered by injection to 1-day-old chickens, in combination with a live Newcastle Disease vaccine (e.g. Nobilis^® ND Clone 30 (G2466)), according to the manufacturer’s instructions. The chickens vaccinated in this way will be protected against Newcastle Disease for up to 8 to 9 weeks of age.

Dosage and Administration

• Inject 0,1 mℓ per broiler chicken intramuscularly into the thigh, or subcutaneously into the back of the neck.
• Allow the vaccine to gradually reach room temperature (20 ºC – 25 ºC) prior to use.
• Remove the aluminium overseal and the vaccine is ready for use.
• Inject all the chickens in the flock.

VACCINATION REACTIONS

• In healthy chickens no clinical reaction to the vaccination will be observed. For some weeks after vaccination, a slight swelling may be felt at the site of injection. This does not constitute permanent damage of the tissue, provided the vaccination has been carried out aseptically.
• No interactions have been found when administered simultaneously with live Newcastle Disease vaccines.

PRESENTATION

200 mℓ, 250 mℓ or 500 mℓ PET flask closed with a nitryl rubber stopper containing

2 000, 2 500 or 5 000 doses respectively. Not all pack sizes may necessarily be marketed.

DATE OF PUBLICATION OF THIS PACKAGE INSERT

July 2003