Nobilis® Rismavac

NOBILIS^® RISMAVAC

Reg. No. G2444 (Act 36/1947)

Namibia Reg. No. V98/24.3/674 [NS0]

NAFDAC Reg. No. A6-100088, A-6-100089

Only for use by or under the supervision of persons registered in terms of, or authorised in terms of, Section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).

INDICATIONS

Nobilis^® Rismavac is a live vaccine recommended for the immunisation of healthy day-old chicks against Marek’s Disease and is also indicated where virulent strains of Marek’s Disease are prevalent.

COMPOSITION

Nobilis^® Rismavac is a live vaccine containing Marek’s Disease virus serotype 1, strain

CVI-988. Each dose of Nobilis^® Rismavac contains at least 3,0 log₁₀ TCID₅₀ serotype 1, strain CVI-988, in the cell associated form, as a suspension of virus containing SPF chicken embryo fibroblasts. The vaccine contains stabilisers and antibiotics.

STORAGE INSTRUCTIONS

• The vaccine containing ampoules (which are inserted in metal canes) are stored in liquid nitrogen (-196 °C or below).
• Only 1 ampoule should be removed at a time.
• The cane holding the remaining ampoules should be replaced immediately in the canister of the liquid nitrogen container.
• The contents of the removed ampoule should rapidly be thawed by immersing it in water at room temperature (20 °C – 25 °C).
• The liquid nitrogen container must be stored in an upright position in a dry, well-ventilated area away from incubator intakes and chicken boxes.
• The solvent is stored at or below 25 °C.
• Use within 2 hours after opening of the ampoule.

WARNINGS

• Withdrawal period: Do not slaughter chickens for human consumption within 21 days of vaccination.
• Vaccinate healthy day-old chicks only.
• Avoid intravenous injection.
• Do not mix Nobilis^® Rismavac with other vaccines.
• Keep the frozen vaccine ampoule in liquid nitrogen until ready to vaccinate.
• Do not use Nobilis^® Rismavac that has been previously thawed other than immediately before use.
• The contents of the ampoule should be thawed by immersing it in water at room temperature.
• Do not thaw in hot or ice cold water. Ampoules have been known to explode on sudden temperature changes.
• The temperature of the solvent must be at room temperature (20 °C to 25 °C) at the time of mixing.
• Liquid nitrogen containers and the vaccine should be handled by properly trained personnel only, taking into consideration the safety precautions for handling liquid nitrogen and materials at very low temperatures.
• When removing an ampoule from the cane, hold the palm of the gloved hand away from the body and face.
• Good management practice is important to reduce the exposure to Marek’s Disease during the first weeks following vaccination.
• 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.
• The operator should protect the hands with gloves, wear long sleeves and use a face mask or goggles.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
• Accidental self-injection may lead to severe local allergic reactions. Consult and inform the physician that the vaccine is a live vaccine and that it contains a small amount of dimethyl sulphoxide (DMSO).
• Dispose of any containers, disposable equipment and any other waste after use, in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008) and do not reuse for any other purpose.
• Do not contaminate rivers, dams or any water sources with container or waste.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

• After dilution, administer a single 0,2 mℓ dose of vaccine per chicken by subcutaneous injection in the neck or intramuscularly in the leg.
• Use within 2 hours after opening of the ampoule.

Preparation of the vaccine

Disinfect vaccinating equipment by boiling it in water for 20 minutes or by autoclaving

(15 minutes at 121 °C). Do not use chemical disinfectants. The handling of liquid nitrogen should take place in a well-ventilated area.

1. Use contents of 1 ampoule per bag of sterile solvent for 1 000 chicks. For every 1 000 doses of vaccine, 200 mℓ of the solvent must be used.
2. Before withdrawing Nobilis^® Rismavac from the liquid nitrogen container, protect the hands with gloves, wear long sleeves and use a face mask or goggles. An accident might occur with either the liquid nitrogen or the vaccine ampoules. When removing an ampoule from the cane, hold palm of the gloved hand away from the body and face.
3. When withdrawing a cane of ampoules from the canister in the liquid nitrogen container, expose only the ampoule to be used immediately. It is recommended only to handle 1 ampoule at a time. After removing the ampoule, the cane holding the remaining ampoules should be replaced immediately in the canister of the liquid nitrogen container.
4. The content of the ampoule is rapidly thawed by immersing it in water at room temperature (20 °C to 25 °C). Do not thaw in hot or ice-cold water. Dry the ampoule and gently rotate it to disperse the contents. Then break the ampoule at its neck and immediately proceed as below.

(Caution: Ampoules have been known to explode on sudden temperature changes).

• Draw the contents of the ampoule into a sterile 5 mℓ or 10 mℓ syringe fitted with a 1 mm (18 gauge) needle.
• Insert the needle through the insertion point of the solvent bag and dilute immediately by filling the syringe slowly with a portion of the solvent.

(Note: The solvent should be at room temperature (20 °C to 25°C) at the time of mixing).

• The content of the filled syringe is then added back to the remaining solvent. It is important that this is done slowly, allowing the vaccine to run down the side of the bag. Gently shake the bag as the vaccine is being mixed. Withdraw a portion of the solvent with the syringe to flush the ampoule. Inject the washings back into the solvent bag. Remove the syringe.
• Fill the previously sterilised automatic syringe according to the manufacturer’s recommendations and set the dose for 0,2 mℓ.
• The vaccine is now ready for use.

PRESENTATION

Nobilis^® Rismavac is presented in Type I hydrolytical glass ampoules containing 1 000 doses or 2 000 doses of vaccine. The solvent is a clear red solution in plastic bags of 200 mℓ, 400 mℓ or 800 mℓ. 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

05 January 1998

Zimbabwe Reg. No. E94/80.23.10/9362 Veterinary Classification: 802310 Distribution Category: VMGD