A vaccine for the active immunisation of weaner pigs as an aid in the control of pleuropneumonia caused by Actinobacillus pleuropneumoniae.
FOR ANIMAL USE ONLY
Reg. No. G2295 (Act 36/1947)
Namibia Reg. No. V97/24.5/832 NS0
This vaccine may only be used by or under the supervision of persons registered in terms of or authorised in terms of section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982).
Porcilis® APP is indicated for the active immunisation of weaner pigs as an aid in the control of pleuropneumonia caused by Actinobacillus pleuropneumoniae.
The vaccine is based on an outer membrane protein (OMP) and three toxoids (detoxified APX I, APX II and APX III) produced by Actinobacillus pleuropneumoniae strains. Each dose of vaccine contains 50 units APX I, 50 units APX II, 50 units APX III and 50 units OMP as the active ingredients. The antigens are suspended in an aqueous adjuvant. Porcilis® APP contains 0,02 % formaldehyde as a preservative.
- Store in the dark between 2 °C and 8 °C.
- Protect from direct sunlight.
- Do not freeze.
- Avoid prolonged and repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
- Shelf life after first opening the bottle: Use within 10 hours of opening.
- Withdrawal period: None.
- Vaccinate healthy animals only.
- Avoid intravenous injection.
- Do not mix Porcilis® APP with other vaccines. No information is available on the compatibility of this vaccine with any other vaccine or medication.
- Do not over- or under-dose the vaccine.
- After vaccination, pigs may show a mild reaction with fever, dullness and anorexia. If they have a full stomach at the time of vaccination, vomiting may sometimes occur. Temporary mild swelling at the injection site may occur in some pigs. These reactions disappear 24 hours post vaccination.
- Accidental self-injection may lead to severe allergic reaction. Seek medical advice immediately and show the package leaflet or the label to the physician.
- 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.
- Observe aseptic precautions. Ensure that the vaccination equipment (needles, syringes, etc.) are 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.
- Wear protective clothing, masks, gloves etc. according to hazard standards.
- Avoid contact of the product with skin, eyes and mouth.
- Do not eat, drink or smoke whilst handling the product.
- Use entire contents when container is first opened and do not store partially used containers for future use.
- Adhere to the vaccination programme to obtain optimum results.
- Destroy any unused vaccine and dispose of all the 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.
If you notice any serious effects not mentioned in this leaflet, please inform your veterinarian.
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Shake well before use.
Allow the vaccine to reach room temperature (20 °C to 25 °C) gradually before use.
Maximum protection should be achieved before the start of the fattening period. Pigs can be vaccinated from an age of 6 weeks. Two vaccinations at a minimum interval of 4 weeks are required. It is advisable to vaccinate pigs at 6 and 10 weeks of age.
Dosage and Administration
Porcilis® APP must be administered by deep intramuscular injection behind the ear, at a dose of 2 mℓ.
After vaccination, pigs show a mild systemic reaction with fever, dullness and anorexia. If they have a full stomach at the time of vaccination, vomiting may sometimes occur. Temporary mild swelling at the injection site may occur. These reactions disappear within 24 hours post vaccination.
Glass and polyethylene terephthalate (PET) bottles containing 25 doses (50 mℓ).
Intervet South Africa (Pty) Ltd.
20 Spartan Road
Spartan, 1619, RSA
Tel: +27 (0) 11 923 9300
Intervet International B.V.
Wim de Körverstraat 35
DATE OF PUBLICATION OF THIS PACKAGE INSERT
30 August 2000