PORCILIS® COLICLOS
An inactivated bacterial vaccine for the active immunisation against neonatal enterotoxicosis and neonatal enteritis in pigs.
FOR ANIMAL USE ONLY
Reg. No. G4374 (Act 36/1947)
An inactivated bacterial vaccine for the active immunisation against neonatal enterotoxicosis and neonatal enteritis in pigs.
INDICATIONS
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 those Escherichia coli strains, which express the adhesins F4ab (K88ab), F4ac (K88ac), F5 (K99), F6 (987P) and/or produce LT and caused by Clostridium perfringens type C.
COMPOSITION
| Active ingredient | Quantity per 2 mℓ dose |
| E. coli components: | |
| F4ab fimbrial adhesin | ≥ 9,7 log2 Ab titre¹ |
| F4ac fimbrial adhesin | ≥ 7,8 log2 Ab titre¹ |
| F5 fimbrial adhesin | ≥ 7,4 log2 Ab titre¹ |
| F6 fimbrial adhesin | ≥ 7,6 log2 Ab titre¹ |
| LT toxoid | ≥ 12,0 log2 Ab titre¹ |
| C. perfringens component: | |
| Type C (strain 578) β-toxoid | ≥ 20 IU2 |
¹ Mean 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
- Store in the dark between 2 °C and 8 °C.
- Do not freeze.
- Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator.
- Protect from direct sunlight.
WARNINGS
- Withdrawal period: Do not slaughter animals for human consumption within 21 days after vaccination.
- For intramuscular injection only.
- Vaccinate healthy animals 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. A 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.) are clean and sterile prior to use.
- 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 the vaccine 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.
DIRECTIONS FOR USE -USE ONLY AS DIRECTED
- Porcilis® ColiClos is administered intramuscularly.
- Once broached, use within 10 hours.
DOSAGE AND ADMINISTRATION
Administer a single dose of 2 mℓ per animal 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 commonly occurs and/or a sometimes painful and hard swelling up to 10 cm in diameter may be observed for up to 25 days at the injection site.
IDENTIFICATION
White to nearly white aqueous suspension.
PRESENTATION
Cardboard box with polyethylene terephthalate (PET) or glass vials (type I) of 20, 50, 100, 200 or 250 mℓ. 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