Cirbloc M Hyo (Canada)

Company: Ceva Animal Health

Porcine Circovirus Vaccine, Type 2d, Killed Baculovirus Vector, Mycoplasma hyopneumoniae Bacterin

For Veterinary Use Only

Cirbloc M Hyo Indications

For the active immunisation of pigs to reduce:

● viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection,

● severity of lung lesions caused by Mycoplasma hyopneumoniae infection,

● the loss in body weight gain.

Onset of immunity:

PCV2: 2 weeks after vaccination

M. hyopneumoniae: 3 weeks after vaccination

Duration of immunity:

PCV2: 23 weeks after vaccination

M. hyopneumoniae: 23 weeks after vaccination

The product stimulates the development of active immunity against porcine circovirus type 2 and Mycoplasma hyopneumoniae in pigs.

The efficacy studies have shown that the vaccine was effective against PCV2a, 2b and 2d.

The recombinant porcine circovirus type 2d antigen (ORF2 capsid protein) auto-assembles into virus-like-particles (VLPs).

The vaccine is able to reduce the loss in body weight gain in those farms where the level of PCV2 infection is high and the duration is long.

Description

Off-white emulsion. Greyish creaming and sedimentation may occur. Homogeneous emulsion after shaking.

Active Ingredients

Each 2 mL dose contains:

*AU: Antigen units as measured in potency test (ELISA)

ADJUVANT:

EXCIPIENTS:

Sorbitan trioleate, Polysorbate 80, Sodium chloride, Potassium chloride, Disodium phosphate dihydrate, Potassium dihydrogen phosphate, Water for injection.

Directions For Use

Intramuscular use. Vaccinate pigs in the neck.

A single dose of 2 mL is given to pigs from 3 weeks of age onwards.

Allow it to reach room temperature (15°C - 25°C).

Shake well before use. Apply usual aseptic procedures.

CAUTIONS:

1. Vaccinate healthy animals only.

2. In farms where PCV2 and M. hyopneumoniae vaccination of sows and gilts is performed during their late pregnancy and the high levels of MDA can be expected, the use of CIRBLOC^® M HYO may be delayed.

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

4. 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.

Warnings

1. Do not vaccinate within 21 days before slaughter.

2. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

To the user:

This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:

This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Adverse Reactions

Pigs (for fattening)

¹ Swellings of 0.2 cm to 2 cm diameter might occur when administration is performed with mass injector; they disappear spontaneously within nine days.

² Lethargy and increase in body temperature can occur four hours after vaccination, with a maximum of 1.7°C at individual level and 0.5 - 0.78°C as an average, resolving spontaneously by the next day.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinarian.

Storage

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

Do not freeze.

Store in the original container.

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

PRESENTATION:

CIRBLOC^® M HYO is available in 50, 100, 250 and 500 mL bottles.

Not all pack sizes may be marketed.

MANUFACTURED BY:

Ceva-Phylaxia Co. Ltd. 1107 Budapest Szállás u. 5. Hungary

IMPORTED BY:

Ceva Animal Health Inc. 150 Research Lane, Suite 225, Guelph, ON N1G 4T2

Toll-Free: 1-800-510-8864

A6192

CPN: 1221172.0