Nobilis® Rismavac + CA126

Nobilis® Rismavac + CA126 is a combined live, cell-associated Marek’s Disease vaccine recommended for the immunisation of healthy chicks against Marek’s Disease.

FOR ANIMAL USE ONLY

NOBILIS® RISMAVAC + CA126

Reg. No. G2632 (Act 36/1947)
Namibia Reg. No. V05/24.3/659 [NS0]

This vaccine may only be used by persons registered in terms of or authorised in terms of section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act No. 19 of 1982).

INDICATIONS
Nobilis® Rismavac + CA126 is a combined live, cell-associated Marek’s Disease vaccine recommended for the immunisation of healthy chicks against Marek’s Disease.

COMPOSITION
Nobilis® Rismavac + CA126 is a combined live vaccine containing FC-126 (serotype 3) strain of Turkey Herpes Virus and CVI-988 (serotype 1) strain of Fowl Herpes Virus.
Each dose of Nobilis® Rismavac + CA126 contains at least 3,0 log10 PFU of live Turkey Herpes Virus strain FC-126 (serotype 3) and at least 3,0 log10 PFU of live Fowl Herpes Virus strain CVI-988 (serotype 1) in the cell-associated form, as a suspension of virus containing SPF chicken embryo fibroblasts.

STORAGE

  • The vaccine containing ampoules (inserted in metal canes) are stored in liquid nitrogen (-100 °C or below).
  • Only 1 ampoule should be removed at any one 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 in water at room temperature (20 °C to 25 °C).
  • After dilution, the vaccine must be used 2 within 2 hours when stored at 2 hours at 2 ° to 8 °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 below 30 °C.

WARNINGS

  • Withdrawal period: Do not slaughter for human consumption within 21 days of vaccination.
  • Keep the frozen vaccine ampoule in liquid nitrogen until ready to vaccinate.
  • When removing an ampoule from the cane, hold the palm of the gloved hand away from the body and face.
  • The contents of the ampoule should be thawed by immersing in water at room temperature. Do not thaw in hot or ice-cold water. Ampoules have been known to explode on sudden temperature changes.
  • Do not use vaccine that has been thawed other than immediately before use.
  • 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.
  • It is good vaccination practice when handling vaccines to avoid contact with the eyes, hands and clothing.
  • The bag of mixed vaccine should be kept in an ice bath and swirled frequently.
  • Solvent: The solvent must be at room temperature between 20 °C and 25 °C at the time of mixing.
  • Good management practice is important to reduce the exposure to Marek’s Disease during the first weeks following vaccination.
  • The operator should protect the hands with gloves, wear long sleeves and use a face mask or goggles.
  • Accidental self-injection may lead to severe local allergic reactions. Consult a physician informing him/her that the Nobilis® Rismavac + CA126 is a live vaccine and that it contains a small amount of dimethyl sulphoxide (DMSO).
  • Do not mix Nobilis® Rismavac + CA126 with other vaccines.
  • The entire contents of the bag must be used within 2 hours of mixing.
  • Do not store partially used containers for future use.
  • Do not inject intravenously.
  • 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

  • Vaccinate healthy day-old chicks only.
  • Observe aseptic precautions. Ensure that vaccination equipment (needles, syringes, etc.) are clean and sterile prior to and during use.
  • Sterilise vaccination equipment by boiling in water for 20 minutes or by autoclaving for 15 minutes at 121 °C.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • 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.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Preparation of the Vaccine

  • Sterilise vaccination equipment by boiling in water for 20 minutes or by autoclaving for 15 minutes at 121 °C. Do not use chemical disinfectants.
  • Use contents of 1 ampoule of the vaccine per bag of sterile solvent for 1 000 chicks. For every 1 000 doses of vaccine, 200 mℓ of the solvent must be used.
  • Before withdrawing the vaccine 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.
  • 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.
  • The contents of the ampoule is rapidly thawed by immersing the water at room temperature between 20 °C and 25 °C. Do not thaw in hot or ice-cold water. Dry the ampoule and shake 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 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 syringe slowly with a portion of the solvent. (Note: The solvent should be at room temperature between 20 °C to 25 °C at the time of mixing).
  • The contents of the filled syringe are then added to the remaining solvent. It is important that this be 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.

Dosage and administration

  • The vaccine is injected subcutaneously in the neck.
  • Inject 0,2 mℓ per chick.
  • The bag of vaccine should be kept in an ice bath and swirled frequently.
  • The entire contents of the bag must be used within 2 hours of mixing.
  • Any remaining vaccine should be discarded according to local waste disposal regulations.

PRESENTATION
The vaccine is presented in Type I hydrolytical glass ampoules containing 1 000 or 2 000 doses of vaccine.

The Solvent for Cell Associated Poultry Vaccines is presented in multilayer plastic bags of 200, 400 and 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

17 March 2022