Summary of medicine characteristics - Porcilis PCV ID
SUMMARY OF PRODUCT CHARACTERISTICS
-
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PCV ID emulsion for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.2 ml contains:
Active substance:
Porcine circovirus type 2 ORF2 subunit antigen > 1436 AU1
Adjuvants:
dl-a-tocopheryl acetate 0.6 mg
Light liquid paraffin 8.3 mg
-
1 Antigenic units as determined in the in vitro potency test (antigenic mass assay).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection.
Homogenous, white to nearly white emulsion after shaking.
4. CLINICAL PARTICULARS4.1 Target species
Pigs for fattening.
-
4.2 Indications for use, specifying the target species
For the active immunisation of fattening pigs to reduce viraemia, virus load in lungs and lymphoid tissues and virus shedding caused by PCV2 infection. To reduce loss of daily weight gain and mortality associated with PCV2 infection.
Onset of immunity: 2 weeks after vaccination.
Duration of immunity: 23 weeks after vaccination.
4.3 Contraindications
None.
-
4.4 Special warnings for each target species
Vaccinate healthy animals only.
-
4.5 Special precautions for use
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
To the user:
This veterinary medicinal product 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 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:
This veterinary medicinal product 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.
-
4.6 Adverse reactions (frequency and seriousness)
Transient local reactions mostly consisting of hard non-painful swellings of up to 2 cm diameter were very commonly observed in laboratory studies and field trials. A biphasic pattern of the local reactions, consisting of an increase and decrease followed by another increase and decrease of the size, is commonly observed. In individual pigs the size may increase to 4 cm and redness may be observed. The local reactions disappear completely within approximately 5 weeks after vaccination.
The frequency of adverse reactions is defined using the following convention: – very common (more than 1 in 10 animals treated displaying adverse reaction(s)) – common (more than 1 but less than 10 animals in 100 animals treated) – uncommon (more than 1 but less than 10 animals in 1,000 animals treated) – rare (more than 1 but less than 10 animals in 10,000 animals treated)
-
– very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
-
4.7 Use during pregnancy, lactation or lay
Not applicable.
4.8 Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrate that this vaccine can be given with Porcilis M Hyo ID ONCE on the same day from 3 weeks of age, either at different sites (e.g. alternate sides of the neck), or at the same site providing that intradermal administration of each vaccine is separated by at least 3 cm.
The product literature of Porcilis M Hyo ID ONCE should be consulted. In case both vaccines are used on the same day the size of the local reactions may increase up to 6 cm in individual pigs, may last 7 weeks and are very commonly accompanied by redness and crusts. In the event that the crust is rubbed off, some small skin damage may be commonly observed. Moreover, a transient increase in body temperature on the day of vaccination of about 0.2 °C is common. In individual pigs this temperature may increase up to 2 °C. The animal’s temperature returns to normal within 1–2 days after the peak temperature is observed.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product 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.
-
4.9 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 multiple broaching.
Intradermal administration of 0.2 ml per animal, preferably at the sides of the neck, along the muscles of the back or in the hind leg 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 ID have been demonstrated using the device IDAL.
Vaccination scheme:
Vaccinate once from an age of 3 weeks onwards.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No data available.
-
4.11 Withdrawal period(s)
Zero days.
-
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: immunologicals for Suidae, inactivated viral vaccines for pigs.
ATCvet code: QI09AA07
The product stimulates the development of active immunity against porcine circovirus type 2 in pigs.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Polysorbate 80
Simethicone
Sodium chloride
Potassium chloride
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
dl-a-tocopheryl acetate
Light liquid paraffin
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 8 hours.
6.4. Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from direct sunlight.
-
6.5 Nature and composition of immediate packaging
Glass vial (type I) of 10 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
PET (polyethylene terephthalate) vial of 20 ml closed with a nitryl-based rubber stopper and sealed with an aluminium cap.
Pack size:
Cardboard box with 1 glass vial of 10 ml.
Cardboard box with 10 glass vials of 10 ml.
Cardboard box with 1 PET vial of 20 ml.
Cardboard box with 10 PET vials of 20 ml.
Not all pack sizes may be marketed.
-
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/015/187/001–004
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28/08/2015
Date of last renewal: DD/MM/YYYY