Patient leaflet - Circovac
B. PACKAGE LEAFLET
PACKAGE LEAFLET FOR:
Circovac emulsion and suspension for emulsion for injection for pigs
-
1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
CEVA-Phylaxia Veterinary Biologicals Co. Ltd., Szâllâs 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., Szâllâs u. 5., Budapest, 1107, Hungary
-
2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Circovac
Emulsion and suspension for emulsion for injection for pigs
-
3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Pale opalescent liquid prior to reconstitution
Each ml of reconstituted vaccine contains:
Active substance:
Inactivated porcine circovirus type 2 (PCV2)................................................. > 1.8 log10 ELISA Units
Excipient:
Thiomersal...................................................................................................................................0.10 mg
Adjuvant:
Light paraffin oil............................................................................................................ 247 to 250.5 mg
-
4. INDICATION(S)
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.
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.
-
5. CONTRAINDICATIONS
None.
-
6. ADVERSE REACTIONS
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.
-
7. TARGET SPECIES
Pigs (gilts, sows and piglets from 3 weeks of age).
-
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Reconstitute immediately after removal from the refrigerator (or other cold storage).
Piglets from 3 weeks of age : Administer one 0.5 ml dose by intramuscular injection.
Gilts and sows : 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.
-
9. ADVICE ON CORRECT ADMINISTRATION
When Circovac is used alone:
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 © 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.
-
10. WITHDRAWAL PERIOD
Zero days.
-
11. SPECIAL STORAGE PRECAUTIONS
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.
-
12. SPECIAL WARNING(S)
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..
-
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
-
14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this product is available on the website of the European Medicines Agency
-
15. OTHER INFORMATION