Circovac
adjuvanted inactivated vaccine against porcine circovirus type 2
Marketing authorisation holder:
CEVA-Phylaxia Veterinary Biologicals Co. Ltd., Szállás u. 5., Budapest, 1107, Hungary Manufacturer for batch release:
MERIAL, Laboratoire Porte des Alpes, Rue de l'Aviation, F-69800 Saint Priest, France CEVA-Phylaxia Veterinary Biologicals Co. Ltd., Szállás u. 5., Budapest, 1107, Hungary
Circovac
Emulsion and suspension for emulsion for injection for pigs
Pale opalescent liquid prior to reconstitution Each ml of reconstituted vaccine contains:
Inactivated porcine circovirus type 2 (PCV2) ................................................. 1.8 log10 ELISA Units
Thiomersal ................................................................................................................................... 0.10 mg
Light paraffin oil ............................................................................................................ 247 to 250.5 mg
Onset of immunity: 2 weeks.
Duration of immunity: at least 14 weeks after vaccination.
Duration of immunity: up to 5 weeks after transfer of passive antibodies through colostrum intake.
None.
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 in average) and redness (up to 3 cm2 in average), and in some cases oedema (up to 17 cm2 in average). These reactions resolve spontaneously, in a maximum of 4 days on average, without any consequence on the health and the zootechnical performance.
In clinical studies, 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 up to 1.4 °C can occur. Rarely, an increase in rectal temperature of higher than 2.5 °C, 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.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals displaying adverse reaction(s) 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).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Pigs (gilts, sows and piglets from 3 weeks of age).
Reconstitute immediately after removal from the refrigerator (or other cold storage).
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.
To use the vaccine, shake vigorously the vial of antigen suspension and inject its content into the vial of emulsion containing adjuvant. Gently mix before use. The reconstituted vaccine is a homogeneous
white emulsion.
When Circovac is mixed with Hyogen / Hyogen J5 / Mhyogen vet.: Piglets from 3 weeks of age:
Circovac | Hyogen | / Hyogen J5 / Mhyogen vet. | |
100 doses for piglets (50 ml of reconstituted suspension + emulsion) | 100 doses (200 ml of vaccine) in 250 ml bottle | ||
Vaccine devices should be used under aseptic conditions and in accordance with the device instructions provided by the manufacturer.
step 1.-3. Prepare Circovac (C) by shaking vigorously the vial of antigen suspension and injecting its content into the vial of emulsion containing adjuvant.
step 4.-6. Mix 50 ml of Circovac and 200 ml of Hyogen / Hyogen J5 / Mhyogen vet. (H) and shake gently until a homogeneous white emulsion is obtained.
step 7. 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. Read also the product information of
Hyogen / Hyogen J5 / Mhyogen vet. before use.
Zero days.
Keep out of the sight and reach of children. Store and transport refrigerated (2 °C-8 °C).
Store in the original package in order to protect from light.
Use within 3 hours after mixing.
Do not use after the expiry date stated on the label after EXP.
Special warnings for each target species
The efficacy of the vaccine in the face of intermediate to high levels of maternally derived antibodies in piglets has been demonstrated.
Special precautions for use in animals Vaccinate only healthy animals.
Apply usual procedures for the handling of animals. Apply usual aseptic procedures.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
To the user:
This 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 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.
Pregnancy
Can be used during pregnancy.
Interactions with other medicinal products and other forms of interactions:
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Hyogen / Hyogen J5 / Mhyogen vet. and administered to piglets at one injection site. When mixed with Hyogen
/ Hyogen J5 / Mhyogen vet., vaccinate only piglets from 3 weeks of age.
The product literature of Hyogen / Hyogen J5 / Mhyogen vet. should be consulted before mixed administration.
Onset of immunity: 3 weeks after vaccination when mixed with Hyogen / Hyogen J5 / Mhyogen vet. Duration of immunity: 23 weeks when mixed with Hyogen / Hyogen J5 / Mhyogen vet..
In case of mixing with Hyogen / Hyogen J5 / Mhyogen vet., 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.
When Circovac is used mixed with Hyogen / Hyogen J5 / Mhyogen vet. 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.
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 / Hyogen J5 / Mhyogen vet.. 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.
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions, except those mentioned in the section “Adverse Reactions” were observed after the administration of a double dose of vaccine.
Incompatibilities:
Do not mix with any other veterinary medicinal product, except emulsion supplied for use with the product and Hyogen / Hyogen J5 / Mhyogen vet..
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Detailed information on this product is available on the website of the European Medicines Agency
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.
1 vial of suspension + 1 vial of emulsion: 5 dose size for gilts and sows, 20 dose size for piglets
10 vials of suspension + 10 vials of emulsion: 10 x 5 dose size for gilts and sows, 10 x 20 dose size for piglets
1 vial of suspension + 1 vial of emulsion: 25 dose size for gilts and sows, 100 dose size for piglets
10 vials of suspension + 10 vials of emulsion: 10 x 25 dose size for gilts and sows, 10 x 100 dose size for piglets
1 vial of suspension + 1 vial of emulsion: 50 dose size for gilts and sows, 200 dose size for piglets
10 vials of suspension + 10 vials of emulsion: 10 x 50 dose size for gilts and sows, 10 x 200 dose size for piglets.
Not all pack sizes may be marketed.
Hyogen / Hyogen J5 / Mhyogen vet. may be not authorised to use in certain Member States.