Patient leaflet - Suvaxyn Circo
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Suvaxyn Circo emulsion for injection for pigs
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorization holder and manufacturer responsible for batch release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Suvaxyn Circo emulsion for injection for pigs
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
One dose (2 ml) contains:
Active substances:
Inactivated recombinant chimeric porcine circovirus type Icontaining the porcine 2.3 – 12.4 RP* circovirus type 2 ORF2 protein
Adjuvant:
Squalane 8 pl (0.4% v/v)
Poloxamer 401 4 pl (0.2% v/v)
Polysorbate 80 0.64 pl (0.032%
v/v)
Excipients:
Thiomersal 0.2 mg
*
Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
White homogenous emulsion.
4.
INDICATION(S)
For active immunisation of pigs from 3 weeks of age against Porcine Circovirus type 2 (PCV2) to reduce viral load in blood and lymphoid tissues and fecal shedding caused by infection with PCV2.
Onset of immunity: from 3 weeks after vaccination.
Duration of immunity: 23weeks after vaccination
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
A transient increase in body temperature (on average 1 °C) is very common during the first 24 hours after vaccination. In individual pigs the temperature increase compared to pre-treatment may commonly exceed 2 °C. This resolves spontaneously within 48 hours without treatment. Immediate mild hypersensitivity-like reactions may occur uncommonly after vaccination, resulting in transient clinical signs such as vomiting, diarrhea or depression. These clinical signs normally resolve without treatment. Anaphylaxis may occur in very rare cases. In case of such reactions, appropriate treatment is recommended.
Local tissue reactions in the form of swelling at the injection site, which may be associated with local heat, redness and pain at palpation, are very common and may last for up to 2 days (based on laboratory safety studies). The area of local tissue reactions is in general below 2 cm in diameter. In a laboratory study, a postmortem examination of the injection site, performed 4 weeks after the administration of a single dose of the vaccine, revealed a mild inflammatory response, as evidenced by the absence of tissue necrosis and little fibrosis.
The frequency of possible adverse effects is defined using the following convention: – very common (more than 1 in 10 animals treated displaying adverse reaction(s)) – common (more than 1 but less than 10 animals in 100 animals treated) – uncommon (more than 1 but less than 10 animals in 1,000 animals treated) – rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
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7. TARGET SPECIES
Pigs (for fattening).
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular use.
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 3 weeks of age.
9.
ADVICE ON CORRECT ADMINISTRATION
Shake well before administration and intermittently during the process of vaccination. The vaccine is to be administered aseptically.
The use of a multi-dosing syringe is recommended. Use vaccination devices according to the manufacturer’s instructions.
A slight black deposit may appear and the emulsion may separate into two distinct phases during storage. Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.
10.
WITHDRAWAL PERIOD(S)
Zero days
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the vial after EXP.
Once broached use immediately.
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12. SPECIAL WARNING(S)
Special warnings for use in animals:
Vaccinate only healthy animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
Not applicable.
Pregnancy and lactation :
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Do not use during pregnancy and lactation.
Fertility:
No information is available on the safety of this vaccine in breeding boars. Do not use in breeding boars.
Interaction with other medicinal products and other forms of interaction:
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.
Overdose (symptoms, emergency procedures, antidotes):
A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2fold overdose. This resolved spontaneously within 24 hours without treatment.
Local tissue reaction in the form of swelling (below 2 cm in diameter) at the injection site was commonly observed and resolved within 2 days.
Major incompatibilities :
Do not mix with any other vaccine or immunological product.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency
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15. OTHER INFORMATION