Active substance

Mareks disease / Turkey herpes virus (MD) (serotype 1) (strain CVI 988) (cellassociated)

ATC code

QI01AD03 Avian herpes virus (Mareks disease / MD)

QI01AD Live viral vaccines

QI01A Immunologicals for domestic fowl

QI01 Immunologicals for aves

QI Immunologicals

Species

Chickens

Indications

For active immunisation of one-day-old future layer chicks to reduce mortality, clinical signs and lesions caused by very virulent strains of Marek’s disease virus.

Onset of immunity: 9 days after vaccination.

Duration of immunity: A single vaccination is sufficient to provide protection during the risk period of infection with Marek’s disease virus.

Dose to be administered and administration route

Subcutaneous use (preferably under the skin of the neck):

One single injection of 0.2 ml per chick is applied at one day of age.

The vaccine may be injected by automatic syringe. Overview table for recommended dilution possibilities of different presentations:

Cevac MD Rispens No. of ampoules x doses (D)	Solvent presentation (ml)	Volume of one dose (ml)
1 x 1,000 D	200	0.20
1 x 2,000 D	400
2 x 2,000 D	800
1 x 4,000 D	800
4000 + 1000 D	1000
3 x 2000 D	1200
2 x 4000 D	1600

Overview table for recommended dilution possibilities of different presentations in case of associated use:

No. of ampoules x doses (D)		Solvent presentation (ml)	Volume of one dose (ml)
Cevac MD Rispens	Vectormune ND	Solvent presentation (ml)	Volume of one dose (ml)
1 x 1,000 D	1 x 1,000 D	200	0.20
1 x 2,000 D	1 x 2,000 D	400
2 x 2,000 D	2 x 2,000 D	800
1 x 4,000 D	1 x 4,000 D	800
4000 + 1000 D	4000 + 1000 D	1000
3 x 2000 D	3 x 2000 D	1200
2 x 4000 D	2 x 4000 D	1600

The usual aseptic precautions should be applied to all administration procedures. Be familiar with all safety and precautionary measures for handling liquid nitrogen in order to prevent personal injury.

Reconstitution of the vaccine:

1. Use Cevac Solvent Poultry for reconstitution. After matching the dose size of the ampoules with the solvent size, quickly remove the exact number of ampoules needed from the liquid nitrogen container.

2. Draw up 2 ml of solvent into a 5 ml syringe. Use minimum 18 gauge needle. In case of associated use different syringe should be used for each vaccine.

3. Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39°C.

4. As soon as they are completely thawed, open ampoules holding them at arm length in order to prevent any risk of injury should the ampoule break.

5. Once the ampoule is open, slowly draw up the content into the 5-ml sterile syringe prepared as in point 2.

6. Transfer the thawed suspension into the solvent bag. The reconstituted vaccine prepared as described is mixed by gentle agitation.

7. Withdraw a portion of the diluted vaccine from the solvent bag into the syringe and use it to rinse the ampoule. Inject it gently back into the solvent bag. Repeat once or twice.

8. The reconstituted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.

Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.

Use the reconstituted vaccine immediately, slowly mix regularly to ensure uniform suspension of cells and use within a period not exceeding 2 hours.

It should be ensured that the diluted vaccine is mixed regularly in a gentle way during the vaccination session to guarantee that the vaccine remains homogenous and that the correct virus titer is administered during vaccination session.

Discard any ampoules that have been accidentally thawed. Do not re-freeze under any circumstances.

Do not re-use opened containers of diluted vaccine.

Adverse reactions

Chicken: None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Dispensing

POM-V - Prescription Only Medicine – Veterinarian

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cevac MD Rispens concentrate and solvent for suspension for injection for chickens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 0.2 ml dose contains:

Active substance:

Cell-associated live Marek’s disease virus (MDV)

serotype 1, strain CVI-988 800-5000 PFU^*

^*PFU: plaque forming unit Excipients:

Qualitative composition of excipients and other constituents

Concentrate:

EMEM

L-glutamine

Sodium bicarbonate

Hepes

Bovine serum

Dimethyl sulfoxide

Water for injections

Solvent:

Sucrose

Casein hydrolysate

Sorbitol

Dipotassium hydrogen phosphate

Potassium dihydrogen phosphate

Phenol red

Water for injections

Concentrate: yellow to reddish brown, dense, frozen virus suspension. Solvent: clear, orange to red solution.

3. CLINICAL INFORMATION

3.1 Target species

Chickens

3.2 Indications for use for each target species

For active immunisation of one-day-old future layer chicks to reduce mortality, clinical signs and lesions caused by very virulent strains of Marek’s disease virus.

Onset of immunity: 9 days after vaccination.

Duration of immunity:A single vaccination is sufficient to provide protection during the risk period of infection with Marek’s disease virus.

3.3 Contraindications None.

3.4 Special warnings

Vaccinate healthy animals only.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Spread of the vaccine strain was demonstrated between chickens and may occur from 14 days after vaccination. Vaccinated chickens may excrete the vaccine strain for at least 112 days following vaccination. During this time, the contact of immunosuppressed and unvaccinated chickens with vaccinated chickens should be avoided.

The excreted vaccine strain is safe in non-vaccinated chickens.

Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species. Special precautions should be taken to avoid spreading of the vaccine strain to quails and pheasants.

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

Liquid nitrogen containers and vaccine ampoules should be handled by properly trained personnel only.

Personal protective equipment consisting of protective gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, during the ampoule thawing and opening operations. Frozen glass ampoules may explode during sudden temperature changes.

Store and use liquid nitrogen in a dry and well-ventilated place only. Inhalation of the liquid nitrogen vapour is dangerous.

Personnel attending vaccinated birds should follow hygiene principles and take particular care in handling litter from vaccinated chickens.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

Chicken: None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national

competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Laying birds: Do not use in birds in lay.

3.8 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 Vectormune ND by subcutaneous application.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above. 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.

3.9 Administration routes and dosage