NOAH Compendium

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Date: Thursday, May 30, 2024 6:30

Release 7.268
Suvaxyn Circo Emulsion for injection for pigs
 
Species: Pigs
Therapeutic indication: Immunological veterinary medical products: For pigs
Active ingredient: Vaccine Antigens
Product:Suvaxyn® Circo Emulsion for injection for pigs
Product index: Suvaxyn Circo
Pig - meat: Zero days
Incorporating:
Presentation
White homogenous emulsion.
Qualitative Composition
Quantitative Composition (2 ml dose)
Active Substances:
Inactivated recombinant chimeric porcine circovirus type 1 containing the porcine circovirus type 2 ORF2 protein
2.3 - 12.4 RP*
Adjuvants:
Squalane
0.4% (v/v)
Poloxamer 401
0.2% (v/v)
Polysorbate 80
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.
Uses
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 faecal shedding caused by infection with PCV2.
Onset of immunity
from 3 weeks after vaccination.
Duration of immunity
23 weeks after vaccination.
Dosage and administration
One dose of 2 ml per animal should be administered intramuscularly in the neck behind the ear to pigs from 3 weeks of age.
Advice on correct administration
Shake vaccine well before administration and intermittently during the process of vaccination.
The use of a multi-dosing syringe is recommended. Use vaccination devices according to the manufacturer’s instructions. The vaccine is to be administered aseptically. During storage, a slight black deposit may appear and the emulsion may separate into two distinct phases. Upon shaking, the black deposit disappears and the emulsion becomes homogenous again.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Contra-indications, warnings, etc
No information is available on the safety of this vaccine in breeding boars. Do not use in breeding boars.
The safety of the veterinary medicinal product has not been established during pregnancy or lactation. Do not use during pregnancy and lactation.
Vaccinate only healthy animals.
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.
Do not mix with any other veterinary medicinal product.
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, diarrhoea 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 post-mortem 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 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)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
A transient increase in body temperature (on average 0.8°C) was observed 4 hours after administration of a 2-fold 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.
Withdrawal period
Zero days.
Pharmaceutical precautions
Store and transport refrigerated (2°C - 8°C).
Do not freeze. Protect from light.
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.
Do not use after the expiry date stated on the label.
Shelf-life after first opening: use immediately.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Cardboard box containing 1 vial of 50 ml (25 doses), 100 ml (50 doses) or 250 ml (125 doses).
Cardboard box containing 10 vials of 50 ml (25 doses) or 100 ml (50 doses).
Cardboard box containing 4 vials of 250 ml (125 doses).
Not all pack sizes may be marketed.
Marketing Authorisation Holder (if different from distributor)
Not applicable.
Further information
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Marketing Authorisation Number
UK(GB): Vm 42058/5073
UK(NI): EU/2/17/223/001-006
Significant changes
GTIN
GTIN description:1 vial of 100 ml (50 doses)
GTIN:05414736041995