Ingelvac CircoFLEX Suspension for Injection for Pigs.
Each dose of 1 ml contains : Porcine circovirus type 2 ORF2 protein: minimum RP* 1.0, maximum RP* 3.75 (*Relative Potency - ELISA test - by comparison with a reference vaccine, Adjuvant : carbomer.
Clear to slightly opalescent, colourless to yellowish suspension for injection.
For active immunisation of pigs over the age of 2 weeks against Porcine Circovirus Type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related diseases (PCVD). In addition, vaccination has been shown to reduced PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.
Onset of protection: 2 weeks post vaccination
Duration of protection: at least 17 weeks.
Dosage and administration
Single intramuscular injection of one dose (1 ml), irrespective of body weight. Shake well before use. Avoid introduction of contamination during use. Vaccines devices should be used in accordance with the device instructions provided by the manufacturer. Avoid multiple broaching.
When mixed with Ingelvac MycoFLEX:
•Vaccinate only pigs as from 3 weeks of age.
When mixed with Ingelvac MycoFLEX the following equipment should be used:
•Use the same volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
•Use a pre-sterilised transfer needle. Pre-sterilised transfer needles (CE certified) are commonly available via medical equipment suppliers.
To ensure correct mixing follow the steps as described below:
1.Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
2.- Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX.
-Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX.
-After transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.
3.To ensure appropriate mixing of the vaccines, gently shake the vaccine bottle of Ingelvac MycoFLEX until the mixture is of uniform orange to reddish colour. During vaccination the uniformity of the coloured mixture should be monitored and maintained by continuous agitation.
4.Administer one single injection dose (2 ml) of the mixture intramuscularly per pig, irrespective of body weight. For administration, vaccine devices should be used in accordance with the device instructions provided by the manufacturer.
Use the entire vaccine mixture immediately after mixing.
Contra-indications, warnings, etc
Withdrawal period : Zero days
A mild and transient hyperthermia very commonly occurs on the day of vaccination. On very rare occasions anaphylactic reactions may occur and should be treated symptomatically. Only healthy animals should be vaccinated. The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
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.
Disposal Advice : Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Store and transport refrigerated (2°C-8°C). Do not freeze. Protect from light. Use immediately after opening. Avoid introduction of contamination during use.
High density polyethylene bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses) with a chlorobutyl stopper and lacquered aluminium seal. Each bottled is packed individually in a cardboard box. Not all pack sizes may be marketed.