Nobilis® Reo Inac

FOR ANIMAL USE ONLY

NOBILIS^® REO INAC

Reg. No. G2577 (Act 36/1947)

Namibia Reg. No. V05/24.3/187 [NS0]

INDICATIONS

Nobilis^® Reo Inac is an inactivated vaccine recommended for the booster vaccination of primed breeding stock against Avian Reo virus in order to protect the offspring of the vaccinated chickens against Avian Reo virus infections.

IMMUNITY

When priming and subsequent vaccination have been carried out correctly the offspring born at any stage of the laying period up to 50 weeks of age will, under normal field situations, have sufficient maternal antibodies to protect them against disease caused by Reo infections during the first weeks of life.

COMPOSITION

Nobilis^® Reo Inac is an inactivated vaccine containing 2 immunogenic strains of Reo virus.

Each dose of Nobilis^® Reo Inac contains Reo virus strains 1733 and 2408 inducing ≥ 7,4log₂ ELISA units. The viruses have been grown on CEF cell cultures and are inactivated with formalin and subsequently suspended in the aqueous phase of an oil adjuvant emulsion.

STORAGE INSTRUCTIONS

• Store between 2 °C and 8 °C in a refrigerator.
• Do not freeze.
• Protect from direct sunlight.
• Allow the vaccine to reach room temperature (20 °C and 25 °C) gradually before use.
• Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.

WARNINGS

• Withdrawal period: Do not market chickens for slaughter purposes for at least 6 weeks after vaccination.
• Vaccinate healthy chickens only.
• Ensure that chickens marketed do not have swellings at the site of vaccine administration, as this may result in the condemnation of the chickens.
• Vaccination of chickens in production may lead to a slight drop in egg production.
• Avoid intravenous injection.
• Do not mix Nobilis^® Reo Inac with other vaccines.
• Accidental self-vaccination may lead to severe local allergic reaction. Consult a physician informing him/her that the vaccine contains a mineral oil.
• Do not store partially used containers for future use and use the entire contents when 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.

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.
• Do not use disinfectants or antiseptics to sterilise any equipment.
• It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
• Adhere to the vaccination programme to obtain optimum results.
• Do not eat, drink or smoke whilst handling the product.
• 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).
• Do not contaminate rivers, dams or any water sources with containers or waste.

Special precautions to be taken by the person administering Nobilis^® Reo Inac to chickens

To the user

Nobilis® Reo Inac 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^® Reo Inac contains mineral oil. Even if small amounts have been self-injected, this vaccine can cause intense vascular spasm which may, for example result in ischemic 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.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Shake the bottle well prior to and at regular intervals during the vaccination process.

Dosage and administration

• Allow the vaccine to gradually reach room temperature (15 ºC to 25 ºC) prior to use.
• Remove the aluminium overseal and the vaccine is ready for use.
• Inject 0,5 mℓ per chicken subcutaneously into the lower part of the neck or intramuscularly into the thigh or chest muscle. (Intramuscular injection into the chest muscle: The needle should be pointed in the direction of the chicken’s head to prevent the needle from entering the body cavity).
• Inject all the chickens in the flock.
• Use a sterile syringe and needle.

VACCINATION PROGRAMME

• Nobilis^® Reo Inac should be given to chickens around 16 to 20 weeks of age, but not within 4 weeks prior to the onset of lay.
• For an optimal booster effect, the chickens must be primed with the live vaccine against Avian Reo virus.
• The best results will be obtained if vaccination with inactivated vaccine takes place 6 or more weeks after administration of the live primer but in no circumstances should it be done earlier than 4 weeks after priming.

ADVERSE 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 the vaccination. Local tissue reactions may occur.

PRESENTATION

Bottles containing 250 mℓ (sufficient for 500 doses) and 500 mℓ (sufficient for

1 000 doses). Each bottle is packed in a cardboard carton.

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

27 October 1998

Zimbabwe Reg. No. 96/80.23.17/9436 Pharmacological classification:  802317 Vaccines Other species Category for distribution: V.M.G.D.