Suvaxyn PCV
adjuvanted inactivated vaccine against porcine circovirus type 2 in piglets
16
Medicinal product no longer authorised
authorised
Marketing authorisation holder: Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve BELGIUM
Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L. Ctra. Camprodón s/n "la Riba"
17813 Vall de Bianya Girona
SPAIN
Suvaxyn PCV suspension for injection for pigs
no
One dose of 2 ml contains:
Inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein
1.6 ≤ RP* ≤ 5.3
Sulfolipo-cyclodextrin (SLCD) 4 mg
Squalane 64 mg
Thiomersal 0.1 mg
Medicinal
* Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.
A milky white to pink opaque liquid, free from visible particles
Active immunisation of pigs over the age of 3 weeks against Porcine Circovirus Type 2 (PCV2) to reduce viral load in blood and lymphoid tissues, and the lesions in lymphoid tissues associated with PCV2 infection, as well as to reduce clinical signs - including loss of daily weight gain, and mortality associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Onset of immunity: from 3 weeks post-vaccination. Duration of immunity: 19 weeks post-vaccination
None.
authorised
A transient increase in body temperature (up to 1.7 °C) is very common during the first 24 hours after vaccination. This resolves spontaneously within 48 hours without treatment.
Local tissue reactions in the form of swelling at the injection site are very common and may last for up
to 26 days. The area of local tissue reactions is in general below 5 cm in diameter, but in some cases a larger swelling may occur. In clinical studies, a post-mortem examination of the injection site, performed 8 weeks after the administration of a single dose of the vaccine, revealed a mild to moderate granulomatous inflammation of the muscular fibres at the injection site.
Immediate mild hypersensitivity-like reactions may occur commonly after vaccination, resulting in transient clinical signs such as vomiting. These clinical signs normally resolve without treatment.
Exceptionally, a large proportion of animals may react in some specific herds after vaccination.Severe
anaphylactic reactions are uncommon but may be lethal. In case of such reactions, appropriate treatment is recommended.
The frequency of adverse reactions 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)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
no
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.
Pigs (piglets) from 3 weeks of age.
Medicinal
Single intramuscular injection in the neck behind the ear of one dose (2 ml) to pigs from 21 days of age.
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.
Zero days
Keep out of the sight and reach of children. Store and transport refrigerated (2 °C – 8 °C).
authorised
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
bottle.
Special warnings for each target species: Vaccinate only healthy animals.
Do not use in breeding boars.
The benefit of the vaccination of pigs with very high levels of maternally-derived antibodies, e.g. due to vaccination of their mothers, has not been demonstrated.
Special precautions for use in animals:
Avoid stress in the animals before and after the time of vaccination.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or
no
the label to the physician.
Pregnancy and lactation:
Do not use during pregnancy and lactation.
Interactions 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.
Medicinal
Overdose (symptoms, emergency procedures, antidotes):
No adverse reactions except those mentioned in section 6 were observed after the administration of a double dose of vaccine.
Major incompatibilities:
Do not mix with any other veterinary medicinal product.
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.
authorised
The vaccine strain is an inactivated recombinant Porcine Circovirus type 1 expressing the Porcine Circovirus type 2 ORF2 protein. It is intended to stimulate active immunity against PCV2 in piglets.
Cardboard box of 1 bottle of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Cardboard box of 10 bottles of 10 doses (20 ml), 50 doses (100 ml) or 125 doses (250 ml).
Medicinal
no
Not all pack sizes may be marketed.