Porcilis® PCV

For the active immunisation of pigs, to reduce the virus load in blood and lymphoid tissues and to reduce the weight loss associated with PCV2 infection occurring during the fattening period.

PORCILIS® PCV

Reg. No. G3936 (Act 36/1947)

INDICATIONS

Porcilis® PCV is indicated for the active immunisation of pigs, to reduce the virus load in blood and lymphoid tissues and to reduce the weight loss associated with PCV-2 infection occurring during the fattening period.

IMMUNITY

Onset of immunity:  2 weeks.

Duration of immunity: 22 weeks.

COMPOSITION

Porcine Circovirus type 2, ORF2 subunit antigen: ≥ 3720 AU per 2 mℓ.

The vaccine may contain traces of gentamycin which is used during manufacturing.

STORAGE

  • Store between 2 °C and 8 °C in a refrigerator.
  • Do not freeze.
  • Protect from direct sunlight.
  • Shelf-life after first opening the container: 8 hours.

WARNINGS

  • Withdrawal period: Do not slaughter pigs for human consumption within 21 days after vaccination.
  • Vaccinate healthy pigs only.
  • Do not vaccinate pregnant or lactating sows.
  • Do NOT mix with any other vaccine or immunological product.
  • No information is available on the compatibility of Porcilis® PCV with any other vaccine. Therefore, the safety and efficacy of Porcilis® PCV when used with any other product (either when used on the same day or at different times) has not been demonstrated.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons.  If this is suspected, seek veterinary advice and notify the registration holder.

Special warnings

To the user:

  • Porcilis® PCV contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or a 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 vaccine, seek prompt medical advice even if only a very small amount is injected and take the package insert with you to show to the physician.
  • If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician:

Porcilis® PCV contains mineral oil. Even if small amounts have been accidentally injected, this vaccine can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of the affected finger. 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.

ADVERSE EFFECTS (FREQUENCY AND SERIOUSNESS)

A transient rise in body temperature may occur after vaccination. Some piglets may be depressed and show a reduced feed intake for a few days. A transient local reaction at the injection site may be observed in the form of a hard and sometimes warm swelling, diminishing within a few weeks.

In very rare cases (less than 1 animal in 10 000 animals), anaphylactic-type reactions can occur, which may be life-threatening. In the event of such reactions, treatment may be needed.

PREGNANCY AND LACTATION

The safety of Porcilis® PCV has not been established during pregnancy or lactation.

Do not vaccinate pregnant or lactating sows.

PRECAUTIONS

  • Only healthy pigs should be vaccinated.
  • Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes, needles etc.) is clean and sterile prior to and during use.
  • Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Do not contaminate waste sources.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • The vaccine is a liquid and a ready to use product.
  • Before using the vaccine allow it to reach room temperature (15 °C to 25 °C) and shake well before use.
  • Use sterile syringes and needles.
  • Avoid introduction of contamination.
  • Avoid use of vaccination equipment with rubber parts.

Vaccination Scheme

  1. In the case of low levels of maternal antibody against PCV-2, or when PCVD occurring at a later age, a single vaccination is advised:

Administer (one dose of 2 mℓ), by intramuscular injection in the neck in the area behind the ear, to pigs from an age of 3 weeks onwards.

  • In the case when it is expected that higher levels of maternal antibody against PCV-2 are present, the following schedule of 2 vaccinations is advised:

Administer (one dose of 2 mℓ), by intramuscular injection in the neck in the area behind the ear, according to the following schedule:

– The first injection (2 mℓ) can be given from an age of 3 to 5 days, second injection (2 mℓ) 2 to 3 weeks later.

Consult your veterinarian for vaccination schedules to suit the disease situation and immune status currently present on the farm.

PRESENTATION

Polyethylene terephthalate (PET) vials of 20, 50, 100, 200 or 500 mℓ.  Vials are closed with a rubber stopper and sealed with a coded aluminium cap.

REGISTRATION HOLDER     

Intervet South Africa (Pty) Ltd.

20 Spartan Road,

Spartan, 1619,

RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT

08 July 2015