Prevexxion RN - summary of medicine characteristics

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 0.2 ml dose of the vaccine suspension contains:

Active substance:

Cell-associated live recombinant Marek’s disease (MD) virus, serotype 1, strain RN1250:                                                        2­.9 to 3.9 log10 PFU*

• *PFU: plaque forming units.

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Concentrate and solvent for suspension for injection.

Concentrate: yellow to reddish pink opalescent homogeneous suspension.

Solvent: red-orange limpid solution.

4. CLINICAL PARTICULARS4.1 Target species

Chickens.

• 4.2 Indications for use, specifying the target species

For active immunisation of one-day-old chicks to prevent mortality and clinical signs and reduce lesions caused by MD virus (including very virulent MD virus).

Onset of immunity:      5 days after vaccination.

Duration of immunity: A single vaccination is sufficient to provide protection for the entire risk period.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

Vaccinate healthy animals only.

• 4.5 Special precautions for use

Special precautions for use in animals

Apply the usual aseptic precautions to all administration procedures.

As this is a live vaccine, the vaccine strain may be excreted from vaccinated birds, but it has not been shown to spread in experimental conditions.

Nevertheless, appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to unvaccinated chickens and other susceptible species.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Personal protective equipment consisting of gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, and during both the ampoule thawing and opening operations. Frozen glass ampoules may explode during sudden temperature changes. Store and use liquid nitrogen only in a dry and well-ventilated place. Inhalation of the liquid nitrogen is dangerous.

• 4.6 Adverse reactions (frequency and seriousness)

None.

• 4.7 Use during pregnancy, lactation or lay

This veterinary medicinal product is designed for one-day-old chicks and therefore the safety of the veterinary medicinal product has not been established during lay.

4.8 Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Vaxxitek HVT+IBD. Chickens with maternally derived antibodies against MD, when vaccinated with the mixed products, may have a delayed onset of immunity against infectious bursal disease (also known as Gumboro disease). The mixed vaccine suspension is not intended for the immunization of embryonated eggs.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.

• 4.9 Amounts to be administered and administration route

Subcutaneous use.

Preparation of the vaccine suspension:

• • Wear protective gloves, spectacles and boots during the ampoule thawing and opening operations. The handling of liquid nitrogen should take place in a well-ventilated area.
• • Preparation of the vaccine shall be planned before the ampoules are taken from the liquid nitrogen. The exact amount of vaccine ampoules and amount of solvent needed shall be calculated first according to the table below provided as example. When this product is mixed with Vaxxitek HVT+IBD, both should be diluted in the same solvent bag as indicated below.

Remove from the liquid nitrogen container only those ampoules, which are to be used immediately.

Thaw the contents of the ampoules rapidly by gentle agitation in water at 25 °C-30 °C. The thawing process should not exceed 90 seconds. Proceed immediately to the next step.

As soon as they are thawed, wipe the ampoules with a clean paper towel and then open them while holding them at arm’s length (in order to prevent injury if any ampoule breaks).

• • Select an appropriately sized sterile syringe to withdraw the vaccine from all the ampoules that are thawed, and fit it with a needle of 18 gauge or larger.
• • Tear the overpouch on the solvent bag, and then gently insert the syringe needle through the septum of one of the bag connecting tubes and withdraw 2 ml of solvent.
• • Then draw up the complete contents of all the thawed ampoules into the syringe. Do this by slowly drawing up the contents from each ampoule by gently tilting the ampoule forward and inserting the needle with the bevel edge facing downwards towards the bottom of the ampoule. Continue until all the vaccine is drawn out of the ampoule.
• • Transfer the syringe contents into the solvent bag (do not use the solvent if cloudy).
• • Gently mix the vaccine in the solvent bag by moving the bag back and forth.
• • It is important to rinse the ampoules and ampoule tips. To do this, draw up a small volume of the solvent containing the vaccine into the syringe. Then slowly fill the ampoule bodies and tips with it. Withdraw the content from the ampoule bodies and tips, and inject it back into the solvent bag.
• • Repeat this rinsing operation once.
• • Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be diluted in the solvent bag.
• • The vaccine is ready for use and should be mixed by gentle agitation and used immediately. During vaccination, gently swirl the bag frequently to ensure the vaccine remains homogenously mixed.
• • The vaccine is a clear, red-orange coloured suspension for injection to be used within two hours.

Do not freeze it under any circumstances. Do not re-use opened containers of vaccine.

Posology:

One single injection of 0.2 ml per one-day-old chick.

Method of administration:

The vaccine must be administered by subcutaneous injection in the neck.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

A limited and transient effect on growth was observed when 10-fold maximum release dose was administered to White Leghorn specified pathogen free chickens.

• 4.11 Withdrawal period(s)

Zero days.

• 5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for Aves, live viral vaccines.

ATCvet code: QI01AD03

The vaccine contains the recombinant virus RN1250 within chicken embryo cells.

The vaccine is an engineered MD virus composed of three serotype 1 strains. Its genome also contains long terminal repeats of reticuloendot­heliosis virus. The vaccine induces an active immunity against Marek’s disease in chickens.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Vaccine concentrate:

Dimethyl sulfoxide 199 Earle medium

Sodium hydrogen carbonate

Hydrochloric acid

Water for injections

Solvent:

Sucrose

Casein hydrolysate

Phenolsulfonphtha­lein (Phenol red)

Dipotassium phosphate

Potassium dihydrogen phosphate

Sodium hydroxide or hydrochloric acid

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product, except those mentioned in section 4.8 and the solvent supplied for use with the veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life of the solvent as packaged for sale: 2 years.

Shelf life after vaccine preparation according to directions: 2 hours at a temperature below 25°C.

6.4 Special precautions for storage

Vaccine concentrate:

Store and transport frozen in liquid nitrogen.

The liquid nitrogen containers must be checked regularly for liquid nitrogen level and must be refilled as needed.

Discard any ampoules that have been accidentally thawed.

Solvent:

Store below 30°C. Do not freeze. Protect from light.

• 6.5 Nature and composition of immediate packaging

Vaccine concentrate:

• – Type I glass ampoule of 1,000 doses of vaccine, 5-ampoule carrier.

• – Type I glass ampoule of 2,000 doses of vaccine, 5-ampoule carrier.

• – Type I glass ampoule of 4,000 doses of vaccine, 4-ampoule carrier.

The ampoule carriers are stored firstly in canisters, and these canisters are then stored latter in the liquid nitrogen containers

Solvent:

• – Polyvinylchloride bag containing 200 ml, 400 ml, 600 ml, 800 ml, 1,000 ml, 1,200 ml, 1,600 ml, 1,800 ml or 2,400 ml.

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

7. MARKETING AUTHORISATION HOLDER

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelhe­im/Rhein

GERMANY

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/20/254/001–003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 20/07/2020