Porcilis® PORCOLI DF

Porcilis® Porcoli DF is an inactivated vaccine recommended for the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs, such as diarrhoea due to neonatal enterotoxicosis during the first days of life.

Reg. No. G 3164 Act 36/1947
Nambia Reg. No. V05/24.5/458 [NSO]

INDICATIONS

Porcilis® Porcoli DF is an inactivated vaccine recommended for the passive immunisation of piglets by active immunisation of sows/gilts to reduce mortality and clinical signs, such as diarrhoea due to neonatal enterotoxicosis during the first days of life, caused by those Escherichia coli strains, which express the fimbrial adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P).

COMPOSITION

Each dose of 2 mℓ contains the F4ab (K88ab) fimbrial adhesin, the F4ac (K88ac) fimbrial adhesin, the F5 (K99) fimbrial adhesin, the F6 (987P) fimbrial adhesin and LT toxoid, which induce a mean antibody titre of respectively ≥ 9,0 log2 Ab titre, ≥ 5,4 log2 Ab titre, ≥ 6,8 log2 Ab titre, ≥ 7,1 log2 Ab titre and ≥ 6,8 log2 Ab titre after vaccination of mice 1/20 dose.

The antigens are adjuvanted with 150 mg dl-α-tocopheryl acetate per dose.

STORAGE

  • Store between 2 °C and 8 °C in a refrigerator.
  • Do not freeze.
  • Do not use Porcilis® Porcoli DF after the expiry date which is stated on the container label.
  • Shelf life after first opening: 3 hours.
  • Do not store partially used containers for future use.

WARNINGS

  • Withdrawal period: Zero days.
  • Vaccinate healthy animals only.
  • Do not mix this vaccine with any other vaccine or medication.
  • Do not over- or under-dose the vaccine.
  • Do not inject intravenously.
  • A mean transient increase in body temperature of about 1 °C (in some pigs up to

3 °C), may occur in the first 24 hours after vaccination.

  • Reduced feed intake and listlessness may occur in approximately 10 % of the animals on the day of vaccination but returns to normal within 1 to 3 days.
  • A transient swelling and redness at the injection site may be observed in approximately 5 % of the animals. The diameter of the swelling is in general below 5 cm, but in some cases a larger swelling may occur.
  • The swelling and redness at the injection site may occasionally last for at least 14 days.
  • 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 advise and notify the registration holder.

PRECAUTIONS

  • Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
  • Adhere to the vaccination programme to obtain optimum results.
  • Do not eat, drink or smoke whilst handling the product.
  • 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 rivers, dams or any water sources with containers or waste.
  • Due to the adjuvant used local reactions may occur in some animals at the injection site. It will disappear after a few days.

SPECIAL WARNINGS

To the user

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

To the physician

Porcilis® PCV M Hyo contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischemic necrosis and even the loss of a digit. 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.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • Shake well before use.
  • Before using the vaccine allow it to reach room temperature 15 °C to 25 °C.

DOSAGE AND ADMINISTRATION

Intramuscular injection in sows and gilts of 2mℓ of the vaccine per animal in the neck, in the area behind the ear.

Vaccination scheme

Basic vaccination: Sows/gilts which have not yet been vaccinated with Porcilis® Porcoli DF should receive a vaccination preferably 6 to 8 weeks before the expected date of farrowing and a booster injection 4 weeks later.

Revaccination: A single revaccination shall be carried out during the second half of next pregnancies, preferably 2 to 4 weeks before the expected date of farrowing.

PRESENTATION

Glass or polyethylene terephthalate (PET) vials of 20 mℓ, 50 mℓ and 100 mℓ, individually packed in a cardboard box.

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 THIS PACKAGE INSERT 12 August 2003