Circovac emulsion and suspension for emulsion for injection for pigs
Company name: Merial Animal Health Ltd
Address: PO Box 327
Sandringham House
Harlow Business Park
Harlow
Essex CM19 5TG
Telephone: Companion Animals 0870 6000123
Production Animals 0800 592699
Fax: 01279 775888
Email: ukenquiry@merial.com
Website: www.merial.com
Emulsion and suspension for emulsion for injection containing inactivated porcine circovirus type 2 (PCV2) ≥1.8 log10 ELISA Units per ml of reconstituted vaccine.
Sows and gilts: Passive immunisation of piglets via the colostrum, after active immunisation of sows and gilts, to reduce lesions in lymphoid tissues associated with PCV2 infection and as an aid to reduce PCV2-linked mortality. Duration of immunity: up to 5 weeks after transfer of passive antibodies through colostrum intake. Can be used during pregnancy.
Piglets: Active immunisation of piglets to reduce faecal excretion of PCV2 and virus load in blood, and as an aid to reduce PCV2-linked clinical signs, including wasting, weight loss and mortality as well as to reduce virus load and lesions in lymphoid tissues associated with PCV2 infection.
Onset of immunity: 2 weeks. Duration of immunity: at least 14 weeks after vaccination.
Reconstitute immediately after removal from the refrigerator (or other cold storage).
To use the vaccine, shake vigorously the vial of antigen suspension and inject its contents into the vial of emulsion containing adjuvant. Gently mix before use. The reconstituted vaccine is a homogeneous white emulsion. Use within 3 hours after mixing.
Sows and gilts:
Administer one 2 ml dose by deep intramuscular injection in accordance with the following vaccination scheme:
Basic vaccination:
Gilts: One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before mating.
One further injection must be given, at least 2 weeks before farrowing.
Sows: One injection, followed 3 to 4 weeks later by a second injection, at least 2 weeks before farrowing.
Revaccination:
One injection at each gestation, at least 2 to 4 weeks before farrowing.
Piglets from 3 weeks of age:
Administer one 0.5 ml dose by deep intramuscular injection.
The efficacy of the vaccine in the face of intermediate to high levels of maternally derived antibodies has been demonstrated.
Contra-indications, warnings, etc
Keep out of the reach and sight of children.
Vaccinate only healthy animals.
Apply usual procedures for the handling of animals.
Apply usual aseptic procedures.
For animal treatment only.
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.
Vaccination may exceptionally cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be provided.
Slight and transient local reactions normally occur after the administration of one dose of vaccine, mainly swelling (up to 2 cm2 on average) and redness (up to 3 cm2 on average), and in some cases oedema (up to 17 cm2 on average). These reactions resolve spontaneously within 4 days on average without any consequence on the health or performance of vaccinated pigs.
In clinical studies, the post-mortem examination of the injection sites performed in sows at most 50 days after the vaccination revealed limited lesions such as a discoloration and a granuloma in the majority of animals, as well as necrosis or fibrosis in approximately half of the animals. In piglets, due to the smaller dose volume used, less extended lesions were observed in the laboratory trials whereas only limited fibrosis has uncommonly been observed at time of slaughter.
Within the 2 days following the injection, an average increase in rectal temperature of up to 1.4OC can occur. Rarely, an increase in rectal temperature of higher than 2.5OC, lasting less than 24 hours, may occur.
In rare cases, slight apathy or reduction in appetite may be observed, which should resolve spontaneously.
Exceptionally abortion may occur after vaccination.
No other adverse reactions except those mentioned above were observed after the administration of a double dose of vaccine.
Operator safety
To the user:
This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a join 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 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 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.
Withdrawal Periods
Zero days.
Do not mix with any other veterinary medicinal product. Store and transport refrigerated (2OC - 8OC). Do not freeze.
Store in the original package in order to protect from light. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
25 dose size for sows and gilts, 100 dose size for piglets: 1 vial of suspension (25 dose size for sows and gilts, 100 dose size for piglets) + 1 vial of emulsion (25 dose size for sows and gilts, 100 dose size for piglets).
The reconstituted vaccine contains an inactivated porcine circovirus type 2 (PCV2) in an oily adjuvant (o/w). It is intended to stimulate active immunity in gilts and sows to provide passive immunity in piglets, through colostrum intake. When used in piglets, it stimulates active immunity against porcine circovirus type 2.