PORCILIS® COLICLOS

An inactivated bacterial vaccine for the active immunisation against neonatal enterotoxicosis and neonatal enteritis in pigs.

FOR ANIMAL USE ONLY

PORCILIS® COLICLOS

Reg. No. G4374 (Act 36/1947)

Suspension for injection for pigs

INDICATIONS

Porcilis® ColiClos is an inactivated bacterial vaccine for the active immunisation against neonatal enterotoxicosis and neonatal enteritis in pigs.

Porcilis® ColiClos is used for the passive immunisation of progeny by active immunisation of sows and gilts, to reduce mortality and clinical signs during the first days of life, caused by Escherichia coli strains which produce LT and express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) and Clostridium perfringens type C.

COMPOSITION

Active ingredientQuantity per 2 mℓ dose
E. coli components: 
F4ab fimbrial adhesin≥ 9,7 log2 Ab titre¹
F4ac fimbrial adhesin≥ 8,1 log2 Ab titre¹
F5 fimbrial adhesin≥ 8,4 log2 Ab titre¹
F6 fimbrial adhesin≥ 7,8 log2 Ab titre¹
LT toxoid≥ 10,9 log2 Ab titre¹
C. perfringens component: 
Type C (strain 578) β-toxoid≥ 20 IU2

¹Mean Antibody titre (Ab) obtained after vaccination of mice with a 1/20 or 1/40 sow dose.

2 International units of beta antitoxin according to Ph. Eur.

Adjuvant per 2 mℓ dose: 150 mg dl-α-tocopheryl acetate.

STORAGE INSTRUCTIONS

  • Store between 2 °C and 8 °C in a refrigerator.
  • Do not freeze.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator.
  • Protect from direct sunlight.
  • Shelf-life after first opening the vial: 10 hours.

WARNINGS

  • Withdrawal period: Do not slaughter pigs for human consumption within 21 days after vaccination.
  • Vaccinate healthy pigs only.
  • For intramuscular injection only.
  • After vaccination, a transient rise in body temperature may occur and a transient swelling may arise at the site of injection.
  • A slight redness and/or roughness may transiently occur after a double dose vaccination.
  • Do not mix Porcilis® ColiClos with any other vaccine, immunological product or medication.
  • No information is available on the safety and efficacy of Porcilis® ColiClos when used with any other veterinary medicinal product. The decision to use Porcilis® ColiClos 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

  • Protection of piglets is achieved by colostrum intake. Therefore, care should be taken to ensure that each piglet ingests a sufficient quantity of colostrum.
  • Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc.) is clean and sterile prior to and during use.
  • In case of accidental self-injection, seek medical advice immediately and show this package leaflet to the physician.
  • It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
  • 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).

USE DURING PREGNANCY AND LACTATION

Can be used during pregnancy.

DIRECTIONS FOR USE -USE ONLY AS DIRECTED

  • Allow the vaccine to gradually reach room temperature (20 °C to 25 °C) prior to use.
  • Shake well before use and at regular intervals during use.
  • Porcilis® ColiClos is administered intramuscularly.
  • Once the vial is broached, use within 10 hours.

DOSAGE AND ADMINISTRATION

Administer a single dose of 2 mℓ per pig, via intramuscular injection in the neck region behind the ear.

Vaccination scheme

Primary vaccination: Sows/gilts which have not yet been vaccinated with Porcilis® ColiClos, are given a primary injection 6 to 8 weeks before the expected date of farrowing and a booster injection 4 weeks later.

Revaccination: A single revaccination is carried out 2 to 4 weeks before the expected date of farrowing.

SIDE EFFECTS

An increase in body temperature, up to 2 °C may be observed on the day of vaccination.

Reduced activity and lack of appetite on the day of vaccination occurs commonly. At the injection site, a hard swelling, up to 10 cm in diameter, that can be painful sometimes, may be observed for up to 25 days at the injection site.

IDENTIFICATION

White to nearly white aqueous suspension.

PRESENTATION

Type 1 glass vials or polyethylene terephthalate (PET) vials containing 20, 50, 100, 200 or 250 mℓ, packed in a cardboard box. Vials are closed with halogenobutyl rubber stoppers and sealed with aluminium caps.

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 THIS PACKAGE INSERT

07 October 2019