Hyogen (Canada)

Company: Ceva Animal Health

MYCOPLASMA HYOPNEUMONIAE BACTERIN

FOR VETERINARY USE ONLY

Storage

Keep out of the sight and reach of children.

Store and transport refrigerated (2°C - 8°C). Do not freeze. Protect from light.

Description

For the active immunization of fattening pigs from 3 weeks of age to reduce the occurrence and severity of lung lesions caused by Mycoplasma hyopneumoniae infection.

Onset of immunity: 3 weeks after the vaccination. Duration of immunity: 26 weeks after vaccination.

Precautions

1. Vaccinate only healthy animals.

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

3. 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.

4. 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 and 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.

5. Do not mix with any other veterinary medicinal product except Circovac^®.

6. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Directions For Use

1. Shake well before use.

2. Use sterile syringe and needle, respect aseptic conditions of vaccination.

3. For intramuscular use. Vaccinate pigs in the side of their neck.

4. When Hyogen^® is used alone: Administer a single dose of 2 ml from 3 weeks of age.

5. When Hyogen^® is mixed with Circovac^®:

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

Piglets from 3 weeks of age:

Hyogen^®

100 doses (200 mL of vaccine) in 250 mL bottle

Circovac^®

100 doses for piglets (50 mL of reconstituted suspension + emulsion)

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 200 mL of Hyogen^® and 50 mL of Circovac^® 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.

Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Circovac^® and administered to piglets at one injection site.

Vaccinate piglets from 3 weeks of age.

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

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

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

6. Do not use this veterinary medicinal product after the expiry date which is stated on the label.

7. Shelf life after first opening the container: 10 hours

Hyogen Caution

On the day of vaccination a transient mean increase in body temperature of about 1.3°C is very common. In an individual pig this increase might reach 2°C, but in all cases body temperature is back to normal the next day. A local reaction at the site of injection in the form of a swelling of a diameter up to 5 cm can be very common, which can last for three days. These reactions are of transient nature and do not need further treatment. Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting. These clinical signs normally resolve without treatment. The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals)

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

The data available are not sufficient to exclude the interaction of maternally derived antibodies 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 at the age of 3 weeks. In case of mixing with Circovac^®, 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 in 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.

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

Do not vaccinate within 21 days before slaughter.

Active Ingredient

Mycoplasma hyopneumoniae 2940 strain

Adjuvants: Light liquid paraffin, Escherichia coli J5 LPS

Excipient: Thiomersal

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

DISTRIBUTED BY: Ceva Animal Health Inc. 150 Research Lane, Suite 225, Guelph, ON N1G 4T2 - Toll-Free: 1-800-510-8864

A1009-01

CPN: 1221137.1