NOBILIS® CORYZA

FOR ANIMAL USE ONLY

INDICATIONS

Nobilis^® Coryza is a trivalent inactivated vaccine for the protection of chickens from 5 weeks of age and onwards against Infectious Coryza infection caused by Avibacterium paragallinarum.

COMPOSITION

Each 0,5 mℓ dose of Nobilis^® Coryza contains at least 3 x 10⁸ bacteria of the serotypes A, B and C of Avibacterium paragallinarum inactivated with thiomersal and suspended in the aqueous phase of a water-in-oil emulsion.

STORAGE INSTRUCTIONS

• Store in the dark between 2 °C and 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.
• Use opened bottles within 3 hours.

WARNINGS

• Withdrawal period: Do not market chickens for slaughter purposes for at least 6 weeks after vaccination.
• Vaccinate healthy chickens only.
• Vaccination of chickens in production may lead to a slight drop in egg production.
• Avoid intravenous injection.
• Accidental self-injection may lead to severe local allergic reaction. Consult a physician informing him/her that the vaccine contains a mineral oil.
• Do not mix Nobilis^® Coryza with other veterinary medicinal products.
• Do not over- or under-dose the vaccine.
• Ensure that the chickens do not have local reactions (swellings) at the site of vaccine administration, or elevated temperature reactions (fever), as this may result in the condemnation of the carcasses.
• 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 etc.) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
• Do not store partially used containers for future use. Use the entire contents once opened.
• Adhere to the vaccination programme to obtain optimum results.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
• Do not eat, drink, or smoke whilst handling Nobilis^® Coryza.
• Destroy any unused vaccine and dispose of all the 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 the user:

Nobilis^® Coryza contains mineral oil. Accidental self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with Nobilis^® Coryza, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.

To the physician:

Nobilis^® Coryza contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, 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.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Recommended vaccination programme

Nobilis^® Coryza should be administered to chickens from 5 weeks of age onwards. To achieve a protection in layers and breeders up to 60 weeks of age, revaccination a few weeks before the onset of egg production is required.

Dosage and administration

• Each chicken should be administered 0,5 mℓ of Nobilis^® Coryza subcutaneously, into the lower part of the back of the neck.
• Allow the vaccine to gradually reach room temperature (20 ºC to 25 ºC) prior to use.
• Shake well before use and at regular intervals during the vaccination process.
• Once the aluminium overseal is removed, 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 the vaccination. This does not constitute permanent damage of tissues provided that the vaccination has been carried out subcutaneously and aseptically. If you notice any serious effects not mentioned in this leaflet, please inform your veterinarian.

PRESENTATION

500 mℓ Type II glass vial or a PET- flask closed with a halogenbutyl rubber stopper and sealed with a coded aluminium cap. Each vial is packed in a cardboard box.

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

04 October 2012

Zimbabwe Reg. no: E94/80.23.10/9383 Pharmacological classification: 802310 Distribution category: VMGD