For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection.
FOR ANIMAL USE ONLY
Porcilis® PCV M Hyo
Reg. No. G4354 (Act 36/1947)
Emulsion for injection for pigs.
For the active immunisation of pigs to reduce viraemia, virus load in lungs and lymphoid tissues, virus shedding caused by porcine circovirus type 2 (PCV2) infection, and severity of lung lesions caused by Mycoplasma hyopneumoniae infection. To reduce the loss of daily weight gain during the finishing period in face of infections with M. hyopneumoniae and/or PCV2 (as observed in field studies).
Onset of immunity with single dose vaccination:
PCV2: 2 weeks after vaccination.
M. hyopneumoniae: 4 weeks after vaccination.
Onset of immunity with repeated dose vaccination:
PCV2: 18 days after first vaccination.
M. hyopneumoniae: 3 weeks after second vaccination.
Duration of immunity both vaccination schedules:
PCV2: 22 weeks after the last vaccination.
M. hyopneumoniae: 21 weeks after the last vaccination.
Each 2 mℓ dose of inactivated emulsion vaccine contains:
Porcine circovirus type 2 ORF2 subunit antigen ≥ 2,828 AU1
M. hyopneumoniae J strain inactivated ≥ 2,69 RPU2
Light mineral oil 0,268 mℓ
Aluminium (as hydroxide) 2,0 mg
1 Antigenic units as determined in the in vitro potency test (ELISA).
2 Relative potency units defined against a reference vaccine.
- Withdrawal period: Pigs – meat and offal, 21 days.
- Vaccinate healthy animals only.
- No information is available on the safety and efficacy of Porcilis® PCV M Hyo when used with any other veterinary medicinal product. A decision to use Porcilis® PCV M Hyo before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
- Do not mix Porcilis® PCV M Hyo with any other veterinary medicinal product.
- A transient increase in body temperature very commonly occurs on the day of vaccination (mean increase of + 1 °C, in individual pigs up to 2 °C). The animals return to normal from 1 to 2 days after the peak temperature is observed.
- 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.
- In very rare cases, anaphylactic-type reactions can occur, which may be life-threatening. In the event of such reactions, treatment may be needed.
- Use entire contents when container is first opened and do not store partially used containers for future use.
- 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).
DIRECTIONS FOR USE – USE ONLY AS DIRECTED
Before administering the vaccine, allow it to reach room temperature (15 °C to 25 °C).
Shake well before use.
Avoid introduction of contaminants.
Vaccinate pigs via intramuscular injection in the neck.
Single dose vaccination schedule
A single dose of 2 mℓ in pigs starting at 3 weeks of age.
Two dose vaccination schedule
Two 1 mℓ doses administered to pigs starting at 3 days of age, with a second dose at least 18 days later.
Needle length and diameter should be adapted to the age of the animal.
When PCV2 and/or M. hyopneumoniae infections occur early, the two-dose vaccination schedule is recommended.
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 ischaemic 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.
No data available.
A homogenous white to nearly white emulsion (after shaking) presented in polyethylene terephthalate (PET) vials of 20, 50, 100, 200 or 500 mℓ, closed with nitrile rubber stoppers and sealed with aluminium caps.
Not all pack sizes may necessarily be marketed.
Intervet South Africa (Pty) Ltd.
20 Spartan Road
Spartan, 1619, RSA
Tel: +27 (0) 11 923 9300
DATE OF PUBLICATION OF THIS PACKAGE INSERT
29 July 2019