Name of the Immunological Veterinary Medicinal Product
Cevac NEW FLU H9 K

Inactivated oil-emulsion vaccine for the immunization of chickens against avian influenza and Newcastle disease.

Qualitative and Quantitative Composition of Active Ingredients and Components:

Cevac NEW FLU H9 K vaccine contains the Newcastle disease virus strain La Sota and avian influenza virus type A subtype H9N2 in an inactivated form, with a homogenized oil adjuvant and merthiolate as a preservative.

Each 0.2 ml dose contains:

Active substances:

Inactivated Newcastle disease virus (ND), strain NDV SZ LaSota, producing at least 32 (5 log2) HI titer

Inactivated avian influenza virus, strain H9N2, producing at least 256 (8 log2) HI titer

The immunogenic activity is measured by the hemagglutination inhibition (HI) test in the serum of vaccinated SPF chickens.

Pharmaceutical Form:

Inactivated oil adjuvant emulsion.

Target species:
Chicken.

Indications for use:
For active immunization of chickens against Newcastle disease and avian influenza virus type A subtype H9N2.

Contraindications:
None.

Special warnings:

Vaccination should be carried out only in healthy birds.
Protection is achieved only in well-developed healthy birds.

Use only sterile injection equipment.

Before use, the vaccine should be kept at room temperature (15–25°C) for 3–4 hours. Shake the bottle well before use.

After opening the vial, its contents should be used within 24 hours.

Special precautions for the operator:

In case of accidental self-injection, seek medical attention immediately.

Adverse reactions:

None reported.

Use in laying birds:

The vaccine is usually not used in laying hens or within 2 weeks before the onset of laying.

However, in case of epidemiological necessity, it may be used during the laying period.

A slight temporary decrease in egg production may occur after vaccination.

Interaction with other medicinal products:

There is no information available on the safety and efficacy of simultaneous use with other veterinary medicinal products.

Method of administration:

The vaccine is administered:

• Subcutaneously (in the neck area)

• Intramuscularly (in the breast or thigh muscle)

Vaccination program:

Broilers:
One vaccination from the first day of life.

Laying hens:
One vaccination in the first days of life.

Then two revaccinations during the growing period are recommended.

Dosage:

Chicks: 0.2 ml per bird

From 2 weeks of age: 0.5 ml per bird

Overdose:

Even a double dose is considered safe.

Immunological properties:

The vaccine stimulates active immunity against Newcastle disease and avian influenza subtype H9N2.

Excipients:

• Paraffin (light liquid)

• Polyol fatty acid esters

• Thiomersal (merthiolate)

• Water for injection

Shelf life:

Unopened container: 24 months

After opening the vial: 24 hours

Storage conditions:

Store at +2°C to +8°C, protected from light.
Do not freeze.

Packaging:

The vaccine is packaged in high-density polyethylene containers.

100 ml – 500 × 0.2 ml doses or 200 × 0.5 ml doses

500 ml – 2500 × 0.2 ml doses or 1000 × 0.5 ml doses

The vial is sealed with a rubber stopper and aluminum cap.

Manufacturer:

Ceva-Phylaxia Veterinary Biologicals Co.

1107 Budapest, Hungary
Tel: +36 1 262 9505