ORNIVAC Coryza injection emulsion for chickens

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Composition:

One vaccination dose (0.5 ml) contains:

Active substances:

Avibacterium paragallinarum, sérotyp A, kmen 221, inaktivovaný	(≥5x107 CFU*) -	RP ³ 1*
Avibacterium paragallinarum, sérotyp B, kmen 222, inaktivovaný	(≥5x107 CFU*) -
Avibacterium paragallinarum, sérotyp C, kmen Modesto, inaktivovaný	(≥5x107 CFU*) -

* RP = Relative efficacy (ELISA test) of a mixed antigen of all three antigens compared to a reference serum obtained after vaccination of domestic chickens with a batch of vaccine that passed a challenge test on the target animal species.

Adjuvant:

Montanide ISA 70 VG                                                  0,365 ml          

Excipients:

Thiomersal                                                                   max. 0,05 mg

Formaldehyde                                                              max. 0,25 mg

Isotonic sodium chloride infusion solution             ad 0.5 ml

Pharmaceutical form

Injection emulsion

White oily liquid with a slightly shaky sediment.

Target species

Domestic fowl (layer hens).

Indications with specification for the target animal species

For active immunization of chickens and laying hens against Haemophilus influenzae (coryza) caused by Avibacterium paragallinarum serotypes A, B and C.

Onset of immunity: 3 weeks after completion of vaccination.

Duration of immunity: 63 weeks after completion of vaccination.

Contraindications

None.

Special warnings

Vaccinate only healthy animals.

Special precautions for use

Special precautions for safe use in target animal species:

Not applicable.

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

For users:

Tento veterinární léčivý přípravek obsahuje minerální olej. Náhodná injekce / náhodné sebepoškození injekčně podaným přípravkem může způsobit silné bolesti a otok, zvláště po injekčním podání do kloubu nebo prstu, a ve vzácných případech může vést k ztrátě postiženého prstu, pokud není poskytnuta rychlá lékařská péče. Pokud u vás došlo k náhodné injekci veterinárního léčivého přípravku, vyhledejte lékařskou pomoc, i když šlo jen o malé množství, a vezměte příbalovou informaci s sebou. Pokud bolest přetrvává více než 12 hodin po lékařské prohlídce, obraťte se na lékaře znovu.

For physicians:

This veterinary medicinal product contains mineral oil. Even if a small amount is injected, accidental injection of this veterinary medicinal product may cause intense swelling, which may result in ischemic necrosis and even amputation of a finger. Professional and RAPID surgical intervention is mandatory that may require timely surgical incision and thorough rinsing /irrigation of the injection site, especially where the finger pulp or tendon is involved.

Side effects

Not known.

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

Use during pregnancy, lactation or lay

Do not use in laying hens and within 4 weeks before the start of laying.

Interaction with other medicinal products and other forms of interaction

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

Routes of administration and dosage

Dose: 0.5 ml.

Method of administration:

The vaccine is administered subcutaneously in the upper third of the neck, or intramuscularly into the pectoral muscle.

Before use, bring the vaccine to room temperature (18-25°C) and shake very well.

Vaccination schedule:

First dose: no earlier than 5 weeks of age.

Second dose: no earlier than 4 weeks after the first dose and no later than 4 weeks before the start of laying.

Symptoms of overdose (and where relevant, first aid and antidote):

Not applicable.

Withdrawal period

None.

Major incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal product.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 10 hours.

Special precautions for storage

Store and transport refrigerated (2°C – 8°C).

Protect from freezing.

Protect from light.

Type and composition of the inner packaging

The vaccine is shipped in 250 ml HDPE plastic bottles containing 250 ml (500 doses) and 500 ml bottles containing 500 ml (1000 doses), closed with a chlorobutyl rubber stopper secured with a pull-off ring.

The vaccine bottles are placed in paper cartons. An approved package insert is attached to each package. Individual packages are packed in a cardboard box. For bulk packages, the vials are placed in a cardboard box with a grid.

Pack sizes:

1 x 500 doses, 1 x 1000 doses

10 x 500 doses, 10 x 1000 doses

Not all pack sizes may be marketed.