FOR ANIMAL USE ONLY

VECTORMUNE^® HVT-NDV

Reg. No. G4030 Act 36/1947

Live, frozen Vaccine

Newcastle Disease (NCD) is a controlled diseases according to the Animal Diseases Act, Act 35/1984. Any occurrence or suspected occurrence of Newcastle Disease must be reported immediately to the local state veterinarian.

A live frozen vaccine for the active immunisation of healthy day-old chicks and 18 to 19 day-old chicken embryos to aid in the prevention of Marek’s Disease (MD) and Newcastle Disease (NDV).  

Composition

This vaccine contains a genetically engineered, live Marek’s disease virus of serotype 3 (HVT, FC-126 strain) that has been genetically engineered to contain and express key protective Newcastle Disease virus (D-26 lentogenic strain) antigens. Minimum titre per dose is 3 420 PFUs (Plaque Forming Units) at release and 2 280 PFUs through expiration.

Storage

The vaccine must be stored frozen in liquid nitrogen.

The shelf-life of the unopened vaccine is 24 months.

Improper storage of the vaccine may cause potency losses.

The diluent must be stored at or below 25 °C, or preferably refridgerated between 2 – 7 °C.

Warnings

Do not slaughter chickens for human consumption within 21 days after vaccination.

Vaccinate healthy chickens only.

Do not vaccinate chicken embryos that are below 18 days of age.

Destroy any unused vaccine and all the vaccine containers when the vaccination is completed, in accordance with regulations on waste disposal.

Contains traces of gentamicin and amphotericin B as preservatives.

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.

Keep out of reach of children, uninformed persons animals.

Precautions

The person handling the vaccine must take all the necessary precautions when working with the liquid nitrogen and must wear gloves, a plastic face shield and protective goggles before removing vaccine ampoules from the liquid nitrogen.

All the fowls in the flock must be vaccinated at the same time.

Good management practices are recommended to reduce exposure to Newcastle Disease and Marek’s Disease for at least two weeks following vaccination.

Observe aseptic precautions. Ensure that all vaccination equipment is clean and sterile prior to use.

Do not contaminate with disinfectant or spirits.

Do not mix with other vaccines.

Use entire contents of ampoules immediately after reconstitution – do not store partially used ampoules for future use.

Do not overdose or over dilute the vaccine.

Do not use vaccine that has thawed in the liquid nitrogen container.

Do not use the contents of damaged ampoules.

Do not re-freeze the vaccine. Vaccine must be stored in liquid nitrogen.

It is good vaccination practice when handling the vaccine to avoid contact with the eyes or mucous membranes, hands and clothing.

Wash and disinfect hands with a disinfectant after vaccination.

DIRECTIONS FOR USE: Use ony as directed.

VECTORMUNE^® HVT-NDV is recommended for the active immunisation of healthy day-old chicks and 18 to 19 day-old chicken embryos against Marek’s Disease (MD) and Newcastle Disease (NDV).

VECTORMUNE^® HVT-NDV must be administered by in ovo vaccination to 18 to 19 day-old chicken embryos or by subcutaneous vaccination to day-old chicks.

Preparation of the vaccine

1. Check the container to confirm that a sufficient amount of liquid nitrogen is present to keep the vaccine frozen. If thawed, do not use the vaccine. The containers (Dewars) must be checked regularly for the liquid nitrogen level and must be refilled as needed.
2. After matching the dose size of the vaccine with the diluents size, quickly remove the exact number of ampoules needed.
3. A maximum of 4 ampoules should be thawed at one time. After inspecting the diluents and completing all preparations, the vaccine should be quickly removed from the Dewar and placed into a clean 26,5 °C thaw bath. This step can be repeated until the appropriate dosage has been reached. Gentle agitation during the thawing process promotes rapid, uniform thawing and evenly distributes the vaccine in the ampoule. Do not shake.
4. Immediately after thawing, mix the vaccine with the diluents at room temperature (about 25 °C).  Gently draw the vaccine from the ampoule with an 18 gauge, 1,5 inch needle and slowly mix with the diluents. To avoid damaging the vaccine, do not use excessive pressure to force the cells through the syringe into the diluent. Rinse the ampoule once with the diluted vaccine.
5. Use the vaccine immediately and mix the vaccine occasionally by gently agitating the ampoule (do not shake) to ensure uniform suspension of the cells.

Subcutaneous injection of day-old chicks

Satisfactory protection can only be obtained in healthy day-old chicks.

Mix 200 mℓ of diluent for each 1 000 doses of vaccine to administer 0,2 mℓ per day-old chick.

In healthy chicks no clinical reaction to vaccination is observed.

Use automatic or manual vaccination devices.

Sterilise the syringe, needles and other accessory equipment by autoclaving or boiling prior to vaccination.

Use a short (³/8 inch or ½ inch) 20 gauge needle for vaccination.

The preferred site is under the skin on the back of the neck midway between the head and the body and in a direction away from the head. Do not inject near the head. Do not inject into the muscle tissue or the neck vertebrae.

In ovo vaccination of 18 to 19 day-old fowl embryos:

Satisfactory protection can only be obtained in properly developed embryos. Eggs to be injected should be candled and dead embryos separated and discarded.

Devices used for the injection should be free from any disinfectant residues.

Prior to vaccination, check the right position of the eggs-vertical axis with air cell up.

Use only automatic injection devices dedicated to in ovo injection.

Read the egg injection system operator’s manual before initiating vaccination. Failure to follow instructions may result in personal injury, excessive embryonic mortality and low hatchability.

Sanitise the egg injection system before and after use following the procedures described in the operator’s manual.

Mix 100 mℓ of diluent for each 1 000 doses of vaccine to administer 0,1 mℓ per fowl embryo or mix 50 mℓ of diluent for each 1 000 doses of vaccine to administer 0,05 mℓ per fowl embryo.

Dilution guidelines:

Presentation

Fire-sealed glass ampoules containing 1 000, 2 000 or 4 000 doses of vaccine frozen in liquid nitrogen with the corresponding diluent.

Registration Holder

Ceva Animal Health (Pty) Ltd.

Reg No. 1973/016009/07

PO Box 7707

Halfway House

1685

Tel. 011 312 4088

Manufacturer

Biomune Co.

8906 Rosehill Road

Lenexa

Kansas 66215

USA

U.S. Vet Lic. No. 368

Patent Numbers US 6632664, US 5310678 and US 6866852