Target Species
Pigs.
Indications for use
For the active immunisation of pigs:
- to reduce viremia, virus load in lungs and lymphoid tissues, and faecal virus shedding caused by porcine circovirus type 2 (PCV2) infection and severity of lung lesions caused by Mycoplasma hyopneumoniae infection and
- to reduce the loss of daily weight gain during the finishing period in face of infections with PCV2 and/or M. hyopneumoniae.
Onset of immunity:
PCV2: 2 weeks after vaccination,
M. hyopneumoniae: 4 weeks after vaccination.
Duration of immunity:
PCV2: 26 weeks after vaccination,
M. hyopneumoniae: 18 weeks after vaccination.
Contraindications
None.
Special warnings for each target species
Use of the vaccine in boars has not been evaluated and is therefore not recommended.
Special precautions for use
Vaccinate healthy animals only.
Operator warnings
None.
Adverse Reactions
Pigs:
Very common (>1 animal / 10 animals treated): | Elevated temperature1; Injection site swelling2; Injection site scabs3 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Hypersensitivity reaction |
1 Mean increase of 1 °C, up to 1.8 °C in individual piglets, and up to 2.6 °C in individual breeding pigs. The animals return to normal within 1 to 2 days after peak temperature.
2 Hard non-painful with a mean diameter of up to 3 cm in piglets and 5 cm in breeding pigs. The size may increase up to 6 cm in individual piglets and up to 12 cm in individual breeding pigs. A biphasic pattern, consisting of an increase and decrease followed by another increase and decrease of the size may be observed. Disappears within approximately 8 weeks after vaccination.
3 Scabs of round or elongated shape may be observed and can last at least until 9 weeks post vaccination.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Pregnancy and lactation:
Can be used during pregnancy and lactation.
Interactions
Safety and efficacy data in pigs from 3 weeks of age onwards are available which, demonstrate that this vaccine can be mixed and administered with Porcilis Lawsonia ID (see section Amounts to be administered and administration route below) and/or administered on the same day but not mixed with Porcilis PRRS. The administration site of non-mixed vaccines should be separated by approximately 3 cm. The product literature of Porcilis Lawsonia ID and/or Porcilis PRRS should be consulted before administration.
Adverse events are as described in adverse events, except for injection site swellings with a maximum diameter of up to 15 cm in individual breeding pigs. Injection site may show other signs of inflammation (pain, reddening, warmth and crusts).
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts to be administered and administration route
For intradermal use.
Before using the vaccine allow it to reach room temperature (15 °C – 25 °C) and shake well before use.
Avoid introduction of a contamination by multiple broaching.
Intradermal administration in the neck of 0.2 ml per animal using a multi-dose needle-free injection device for intradermal application of liquids suitable to deliver a “jet-stream” volume of vaccine (0.2 ml ± 10 %) through the epidermal layers of the skin.
Safety and efficacy of Porcilis PCV M Hyo ID have been demonstrated using the device IDAL.
Vaccination scheme:
A single dose is given to pigs from 3 weeks of age onwards.
Mixed use with Porcilis Lawsonia ID
Porcilis PCV M Hyo ID may be used to reconstitute Porcilis Lawsonia ID lyophilisate shortly before vaccination in pigs from 3 weeks of age onwards as follows:
Porcilis Lawsonia ID lyophilisate | Porcilis PCV M Hyo ID |
50 doses | 10 ml |
100 doses | 20 ml |
200 doses | 40 ml |
For proper reconstitution and correct administration, use the following procedure:
1. Allow Porcilis PCV M Hyo ID to reach room temperature and shake well before use.
2. Add approximately 5 - 10 ml of Porcilis PCV M Hyo ID to the Porcilis Lawsonia ID lyophilisate and mix briefly.
3. Withdraw the reconstituted concentrate from the vial and transfer it back into the vial with the Porcilis PCV M Hyo ID. Shake briefly to mix.
4. Use the vaccine suspension within 6 hours of reconstitution. Any vaccine remaining at the end of this time should be discarded.
Dosage:
A single dose (0.2 ml) of Porcilis Lawsonia ID lyophilisate reconstituted in Porcilis PCV M Hyo ID is given intradermally in the neck.
Visual appearance after reconstitution: homogenous white to nearly white emulsion after shaking.
Overdose
Not applicable.
Withdrawal periods
Zero days.