Suvaxyn PCV - summary of medicine characteristics

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose of 2 ml contains:

Inactivated recombinant Porcine Circovirus type 1 expressing the

Porcine Circovirus type 2 ORF2 protein

Sulfolipo-cyclodextrin (SLCD)

Squalane

Thiomersal

• * Relative Potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine.

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection

A milky white to pink opaque liquid, free from visible particles

4. CLINICAL PARTICULARS

Pigs (piglets) from 3 weeks of age.

• 4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

None.

• 4.4 Special warnings for each target species

Vaccinate healthy animals only.

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.

• 4.5 Special precautions for use

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 the label to the physician.

• 4.6 Adverse reactions (frequency and seriousness)

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)

• 4.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

Do not use during pregnancy and lactation.

4.8 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.

ounts to be administered and administration route

Intramuscular use.

Shake 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.

Administer one dose of 2 ml to piglets in the neck behind the ear.

Vaccination schedule:

One injection from 21 days of age.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No adverse reactions except those mentioned in section 4.6 were observed after the administration o double dose of vaccine.

• 4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for suidae, inactivated viral vaccine.

ATC Vet Code: QI09AA07

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.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Thiomersal

Minimum Essential Medium without phenol red

Sodium bicarbonate

Hepes acid

Water for injections

6.2 Major incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf life

Shelf life of the veterinary medicinal product as package for sale: 2 years.

Shelf life after first opening the immediate packaging: use immediately.

• ♦ 5

6.4 Special precautions for storage

Store and transport refrigerated (2 °C – 8 °C).

Do not freeze.

Protect from light.

• 6.5 Nature and composition of immediate packaging

Cardboard box containing polyethylene bottles with a chlorobutyl elastomer closure and sealed with an aluminium cap.

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).

Not all pack sizes may be marketed.

• 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products, if appropriate

7. MARKETING AUTHORISATION HOLDER

Zoetis Belgium SA

Rue Laid Burniat 1

1348 Louvain-la-Neuve

BELGIUM

8. MARKETING AUTHORISATION NUMBERS

EU/2/09/099/001–006

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency ).