Patient leaflet - Prevexxion RN
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release
Boehringer Ingelheim Animal Health France SCS
Laboratoire Porte des Alpes
Rue de l’Aviation,
69800 Saint-Priest
FRANCE
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
PREVEXXION RN concentrate and solvent for suspension for injection
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
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.
Concentrate and solvent for suspension for injection.
Concentrate: yellow to reddish pink opalescent homogeneous suspension.
Solvent: red-orange limpid solution.
4. INDICATION(S)
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.
5. CONTRAINDICATIONS
None
6. ADVERSE REACTIONS
None.
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
7. TARGET SPECIES
Chickens.
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
One single injection of 0.2 ml per one-day-old chick.
The vaccine must be administered by subcutaneous injection in the neck
9. ADVICE ON CORRECT ADMINISTRATION
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.
| Solvent bag | Number of Prevexxion RN ampoules | Number of Vaxxitek HVT+IBD ampoules |
| 1 x 200 ml | 1 x 1,000 doses | 1 x 1,000 doses |
| 1 x 400 ml | 2 x 1,000 doses or 1 x 2,000 doses | 2 x 1,000 doses or 1 x 2,000 doses |
| 1 x 800 ml | 4 x 1,000 doses or 2 x 2,000 doses or 1 x 4,000 doses | 4 x 1,000 doses or 2 x 2,000 doses |
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 the vaccine under any circumstances. Do not re-use opened containers of vaccine.
10. WITHDRAWAL PERIOD(S)
Zero days.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
The vaccine concentrate must be stored and transported frozen in liquid nitrogen.
The liquid nitrogen containers must be checked regularly for liquid nitrogen level and must be refilled as needed.
Solvent must be stored at a temperature below 30°C.
Do not freeze.
Protect from light.
Shelf life after vaccine preparation according to directions: 2 hours at a temperature below 25°C.
Do not use the vaccine after the expiry date which is stated on the ampoule after EXP.
12. SPECIAL WARNING(S)
Special warnings for each target species:
Vaccinate healthy animals only.
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.
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.
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.
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.
Major incompatibilities:
Do not mix with any other veterinary medicinal product, except those mentioned in section “Interactions” and the solvent supplied for use with the veterinary medicinal product.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Discard any ampoules that have been accidentally thawed. Do not re-freeze under any circumstances. Do not re-use opened containers of vaccine.
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
15. OTHER INFORMATION
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.
Package sizes:
Frozen 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 of 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.
17