PORCILIS® EPL

An inactivated virus vaccine for the active immunisation of pigs (sows and gilts).

FOR ANIMAL USE ONLY

Porcilis® EPL

Reg. No. G4372 (Act 36/1947)

Swine erysipelas is a notifiable disease in terms of the Animal Diseases Act, 1984 (Act 35 of 1984) and any incidence or suspected incidence of the disease must be reported to the state veterinarian.

An inactivated virus vaccine for the active immunisation of pigs (sows and gilts).

INDICATIONS

For the active immunisation of pigs against reproductive problems associated with parvovirus, erysipelas and Leptospira serovars:

  • To reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotypes 1 and 2.
  • To reduce transplacental infection, viral load and foetal mortality caused by porcine parvovirus.
  • To reduce clinical signs (increase of body temperature and reduction in feed intake or activity), infection and bacterial excretion caused by Leptospira interrogans serogroup Canicola serovar Canicola.
  • To reduce clinical signs (increase of body temperature and reduction in feed intake or activity), severity of infection and foetal mortality caused by L. interrogans serogroup Pomona serovar Pomona.
  • To reduce infection caused by L. interrogans serogroup Icterohaemorrhagiae serovars Copenhageni and Icterohaemorrhagiae, L. interrogans serogroup Australis serovar Bratislava, L. kirschneri serogroup Grippotyphosa serovars Grippotyphosa and Bananal/ Liangguang, L. weilii serogroup Tarassovi serovar Vughia and L. borgpetersenii serogroup Tarassovi serovar Tarassovi.

IMMUNITY

Onset of Immunity:

E. rhusiopathiae: 3 weeks.

Porcine parvovirus: 10 weeks.

Leptospira serogroups: 2 weeks.

Duration of Immunity:

E. rhusiopathiae: 6 months.

Porcine parvovirus: 12 months.

Leptospira serogroup Australis: 6 months.

Leptospira serogroups Canicola, Icterohaemorrhagiae, Grippotyphosa, Pomona and Tarassovi: 12 months.

COMPOSITION

Active ingredientQuantity per 2 mℓ dose
E. rhusiopathiae, serotype 2 (strain M2)≥ 1 ppd1
Porcine parvovirus (strain 014)≥ 130 U2
L. interrogans serogroup Canicola serovar Portland-Vere (strain Ca-12-000)≥ 2 816 U2
L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni (strain Ic-02-001)≥ 210 U2
L. interrogans serogroup Australis serovar Bratislava (strain As-05-073)≥ 1 310 U2
L. kirschneri serogroup Grippotyphosa serovar Dadas (strain Gr-01-005)≥ 648 U2
L. interrogans serogroup Pomona serovar Pomona (strain Po-01-000)≥ 166 U2
L. santarosai serogroup Tarassovi serovar Gatuni (strain S1148/02)≥ 276 U2

1 Pig protective dose as compared to a reference preparation known to be protective in pigs.

2 As determined in the in vitro antigenic mass ELISA potency test.

The vaccine contains 150 mg dl-α-tocopheryl acetate as an adjuvant.

STORAGE

  • Store in a refrigerator between 2 °C and 8 °C.
  • Do not freeze.
  • Protect from direct sunlight.
  • Shelf-life after first opening the container: 10 hours.

WARNINGS

  • Withdrawal period: 21 days.
  • For intramuscular injection only.
  • Vaccinate only healthy animals.
  • DO NOT mix Porcilis® EPL with any other vaccine, immunological product or medication.
  • No information is available on the compatibility of Porcilis® EPL with any other vaccine. A decision to use Porcilis® EPL before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
  • 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.

PRECAUTIONS

  • Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc.) are clean and sterile prior to use.
  • Transfer needle is sharp and may cause injury to self or animals if not handled properly or disposed of properly. In case of accidental self-injection seek medical advice immediately and show this package leaflet or the label to the physician.
  • It is good vaccination practice when handling vaccines to avoid contact with the eyes, hands and clothing.
  • Dispose of all unused vaccine, empty vaccine vials and disposable equipment in accordance with local waste disposal regulations.

USE DURING PREGNANCY AND LACTATION

Can be used during pregnancy and lactation.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • Before use allow the vaccine to reach room temperature.
  • Shake well before use.
  • Avoid introduction of contamination by multiple broaching.
  • Porcilis® EPL is administered intramuscularly.

DOSAGE AND ADMINISTRATION

Administer a single dose of 2 mℓ per pig via intramuscular injection.

Once broached, use within 10 hours.

Vaccination scheme

Basic vaccination scheme: Pigs which have not yet been vaccinated should be given a primary injection 6 to 8 weeks before the expected date of insemination and a booster injection 4 weeks later.

Revaccination: A single revaccination with Porcilis® EPL should be given once a year. Six months post each vaccination with Porcilis® EPL, a single revaccination with an Erysipelothrix rhusiopathiae containing product should be given to maintain immunity against Erysipelothrix rhusiopathiae.

In case of known infection pressure with L. interrogans serogroup Australis, a single revaccination with Porcilis® EPL should be given every 6 months, as it is unknown if or for how long the duration of immunity for this serogroup persists beyond 6 months.

ADVERSE REACTIONS

An increase in body temperature may occur very commonly up until 2 days after vaccination. The observed mean increase was 0,5 °C (in individual cases the maximum increase was 1,5 °C). Transient local reactions, mostly consisting of red, mild to hard, non-painful swellings are a very common observation. In general, local reactions may have a diameter of ≤ 5 cm, and in very rare cases local reactions in individual animals can be up to 20 cm in diameter. All local reactions disappear completely within approximately 2 weeks after vaccination. In individual animals, intermediate systemic reactions, such as vomiting, redness, rapid breathing and twitching, may rarely be observed, which resolve in a few minutes. In individual animals, a transient reduction in feed intake or activity may uncommonly occur. Feed intake and activity are completely restored within a week.

In post marketing experience:

A hypersensitivity reaction may occur in very rare cases.

PRESENTATION

A suspension for injection appearing homogenous white to nearly white after shaking. The injectable vaccine suspension is presented in polyethylene terephthalate (PET) vials, closed with rubber stoppers and sealed with aluminium caps, containing 20, 50, 100 or 250 mℓ, corresponding to 10, 25, 50 or 125 doses.

1 or 10 vials of 20 mℓ in a carton box.

1 or 10 vials of 50 mℓ in a carton box.

1 vial of 100 mℓ in a carton box.

1 vial of 250 mℓ in a carton box.

Not all pack sizes may necessarily be marketed.

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 01 March 2022