Circovac (Canada)

Company: Ceva Animal Health

Porcine Circovirus Vaccine, Type 2, Killed Virus

Contains 50 mL / 25 doses for sows and gilts, 100 doses for piglets.

Description

Circovac^® vaccine is an injectable emulsion made from combining a suspension containing a killed porcine circovirus type 2 (PCV2), and an oily emulsion.

Circovac Indications

Sows and gilts:

Circovac^® vaccine is indicated for the passive immunisation of piglets via the colostrum following vaccination of sows and gilts and as an aid in the control of PCV2 infection. Efficacy of the vaccine was evaluated by challenging piglets at up to 5 weeks of age.

Piglets:

Circovac^® is indicated for the vaccination of piglets 3 weeks of age or older to reduce viremia, virus in lymphoid tissue and fecal excretion of PCV2 and to aid in the reduction of clinical signs associated with porcine circovirus-associated disease. Efficacy was determined through piglet vaccination-challenge studies. The onset of protection is 2 weeks post-vaccination and the duration of immunity for reduction of viremia and fecal excretion of virus is at least 14 weeks. The efficacy of the vaccine in the face of intermediate to high levels of maternal antibodies has been demonstrated.

For optimal results, vaccination should be part of a comprehensive health management program.

Dosage

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Hyogen^® and administered to piglets at one injection site. When mixed with Hyogen^®, vaccinate only piglets from 3 weeks of age.

Onset of immunity: 3 weeks after vaccination when mixed with Hyogen^®.

Duration of immunity: 23 weeks when mixed with Hyogen^®.

Aseptically inject the content of the suspension vial into the emulsion vial and mix gently.

After reconstitution, use within 3 hours.

When Circovac^® is used alone:

Sows and gilts:

Administer 2 mL (1 dose) by deep intramuscular route according to the following vaccination scheme:

● Primary vaccination:
2 injections before farrowing, 3 weeks apart, with the second injection 3 weeks before farrowing.

● Revaccination:
One injection at each gestation, at least 2 to 4 weeks before farrowing.

Piglets from 3 weeks of age:

Administer 0.5 mL (1 dose) by deep intramuscular route.

General directions for reconstitution of vaccine:

Shake the vial containing the antigen suspension vigorously (3 times) before using. Aseptically reconstitute the antigen suspension with the accompanying emulsion as described below:

- Draw up the content of the antigen suspension vial into a sterile syringe.

- Inject the content of the syringe into the vial of emulsion with the needle positioned above the level of liquid to allow pressure equilibration.

- Remove the syringe and discard.

- Gently blend the 2 components by inverting the vial manually 5 - 10 times. Do not shake.

When Circovac^® is mixed with Hyogen^®:

The mixed use is restricted to the 100 doses (200 mL) presentations of Hyogen^® and to the 100 doses presentations (50 mL of reconstituted vaccine) of Circovac^®.

Piglets from 3 weeks of age:

Vaccine devices should be used under aseptic conditions and in accordance with the device instructions provided by the manufacturer.

Prepare Circovac^® by vigorously shaking the vial of antigen suspension and injecting its content into the vial of emulsion containing adjuvant.

Mix 50 ml of Circovac^® and 200 ml of Hyogen^® and shake gently until a homogeneous white emulsion is obtained.

Administer one 2.5 ml dose of the mixture by intramuscular injection, in the side of the neck.

Use the entire vaccine mixture immediately after mixing.

The product literature of Hyogen^® should be consulted before mixed administration.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, except when mixed with Hyogen^®. 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.

Precautions

Store at 2-7°C. Do not freeze. Do not expose to heat or direct light. Use entire contents when first opened. Discard empty containers and all unused contents according to local regulations. Do not vaccinate within 21 days prior to slaughter. In sows and gilts, vaccination may induce a transient oedema and a small local reaction without any effect on the health and the reproductive performance of the animals. In piglets, vaccination may induce at the injection site a transient redness and swelling. Vaccination may exceptionally cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be provided. Contains thimerosal and gentamicin as preservatives.

In case of mixing with Hyogen^®, slight and transient local reactions may occur very commonly after the administration, mainly swelling (0.5 cm - 5 cm), mild pain and redness as well as in some cases oedema. These reactions resolve spontaneously within maximum 4 days. Transient lethargy may occur very commonly on the day of vaccination which resolves spontaneously within one day. An increase in individual rectal temperature of up to 2.5°C may occur commonly lasting less than 24 hours. The above adverse reactions were observed in clinical studies.

When Circovac^® is used mixed with Hyogen^® the data available are not sufficient to exclude the interaction of maternally derived antibodies against Mycoplasma hyopneumoniae with vaccine uptake. Interaction with maternally derived antibodies is known and should be taken into consideration. It is recommended to delay vaccination in piglets with residual MDA against Mycoplasma hyopneumoniae at the age of 3 weeks.

Warning

Humans injected with this vaccine should consult a physician immediately.

Advise medical personnel that the vaccine is an oil emulsion type.

SALE OF THIS PRODUCT IS RESTRICTED TO VETERINARIANS

Manufactured by: Ceva-Phylaxia Co. Ltd., Szállás u. 5. - 1107 Budapest - Hungary

Distributed in Canada by: Ceva Animal Health Inc. - 150 Research Lane, Suite 225, Guelph, ON N1G 4T2

A4645

CPN: 1221132.1