ORNIVAC FC emulsion for injection

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Composition

One dose (0,5 ml) contains:

Pasteurella multocida, serotype A1, stain X-73, inactivated*

Pasteurella multocida, serotype A3, strain P-1059, inactivated*

Pasteurella multocida, serotype A4, strain P-1662, inactivated*

Pasteurella multocida, serotype A3x4, strain CU, inactivated *

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

Adjuvants:

Montanide ISA 70 VG                                                0.36 ml

Excipient:                                                      

Thiomersal                                                                 max. 0.05 mg

Pharmaceutical form

Emulsion for injection

White or brownish-white oily liquid with a sediment homogenizable after shaking

Target species:

Domestic fowl and turkey

Indications

For active immunization of domestic fowl and turkey to reduce clinical signs of poultry pasteurellosis caused by Pasteurella multocida serotypes A1, A3, A4, A3x4. 

Onset of immunity 14 days after the application of the second dose 4-6 weeks after the first vaccination.

Immunity lasts for a minimum of 16 weeks.

Contra indications

None.

Special warnings for each target species

Vaccinate only healthy animals.

Special precautions for use

Not applicable.

Special precautions for the person administering the veterinary medicinal product to animals:

To users:

This veterinary medicinal product contains mineral oil. Accidental injection/self-injury by the injected product may cause severe pain and swelling, especially after injection into a joint or finger, which in rare cases may lead to amputation of the affected finger if prompt medical attention is not given. If accidental self-injection happens seek medical advice, even if only a small amount, and take the package leaflet with you. If the pain persists more than 12 hours after medical examination, consult physician.

To physicians/doctors:

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. Expert, RAPID surgical care is required that may require early surgical incision and irrigation of the injection site, especially where the pulp of the digit or tendon is involved.

Adverse reactions (frequency and seriousness)

Domestic fowl (layers), turkey.  

Frequent (1 to 10 animal/ 100 vaccinated

Injection site swelling*

* Diameter of max. 25 mm, disappears progressively in 8 days

Use during pregnancy, lactation or lay

Layers:

Do not use during lay and in pullets within 4 weeks before the onset of lay.

Interaction with other medicinal products and other forms of interaction

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 should be made on a case by case basis.

Amounts to be administered and administration route

Do not use the vaccine if there is visible signs of damage and/or defect on the vial and its content. 

Dose: 0.5 ml

Route of administration

The vaccine is administered subcutaneously into the upper dorsal region of the neck or intramuscularly into the pectoral muscle.
It is recommended to temper the vaccine to room temperature (20–22°C) and shake it well before administration.
The vaccination schedule includes two doses of the vaccine.

Vaccination schedule:

Domestic fowl

The first dose of the vaccine is administered no earlier than the 6th week of age, the second dose is administered 4 weeks after the first dose and no later than 4 weeks before the start of laying.

Turkey

The first dose of the vaccine is administered no earlier than the 6th week of age, the second dose is administered 4 weeks after the first dose and no later than 4 weeks before onset of lay.

Overdosing (symptoms, first aid and/or antidotes) if necessary

Not applicable

Withdrawal period (s)

Zero days.

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 storageStorage and transportation temperature: (2 °C – 8 °C).

Protect from light and freeing.

Type and composition of inner packaging

The vaccine is shipped:

In plastic 250 ml HDPE bottles (500 doses) and in plastic 500 ml HDPE bottles (1000 doses) closed with rubber puncture-proof stoppers, fitted with aluminium caps or a pull-off ring (aluminium flip-off cap) and placed in a cardboard box or a cardboard box with a grid.
Approved package insert included in each package.

Packaging:

1 x 250 ml (500 doses)

1 x 500 ml (1000 doses)

10 x 250 ml (10 x 500 doses)

10 x 500 ml (10 x 1000 doses)

Not all pack sizes may be marketed.