INGELVAC CircoFLEX 50ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac CircoFLEX suspension for injection for pigs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) contains:
Active substance:
Porcine circovirus type 2 ORF2 protein RP* 1.0–3.75
* Relative potency (ELISA test) by comparison with a reference vaccine
Adjuvant:
Carbomer 1 mg
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Suspension for injection.
Clear to slightly opalescent, colourless to yellowish suspension for injection.

4. CLINICAL PARTICULARS
4.1 Target species
Pigs
4.2 Indications for use, specifying the target species
For active immunisation of pigs from 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 disease (PCVD).
In addition, vaccination has been shown to reduce 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.
4.3 Contraindications
None.
4.4 Special warnings for each target species
None.
4.5 Special precautions for use
Special precautions for use in animals
Only healthy animals should be vaccinated.

Special precautions to be taken by the person administering the veterinary medicinal product to animals
None.
4.6 Adverse reactions (frequency and seriousness)
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.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
4.7 Use during pregnancy, lactation or lay
Can be used during pregnancy and lactation.
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 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.
4.9 Amounts to be administered and administration route
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.
 Cannot be administered in pregnant or lactating pigs.
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.
If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.

- After the 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. Any unused mixture or waste material should be disposed according to the instructions given in section 6.6.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Following the administration of a 4-fold overdose of vaccine no adverse reactions other than those described under section 4.6 have been observed.
4.11 Withdrawal period
Zero days.

5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines for pigs
ATCvet code: QI09AA07
This vaccine is designed to stimulate the development of an active immune response to porcine circovirus type 2.

6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carbomer
Sodium chloride
Water for injections
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product, except with Boehringer Ingelheim ́s Ingelvac MycoFLEX (not for use in pregnant or lactating pigs).
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: use immediately.
6.4 Special precautions for storage
Store and transport refrigerated (2 °C–8 °C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
Cardboard box with 1 or 12 high density polyethylene bottles of 10 ml, 50 ml, 100 ml or 250 ml with a chlorobutyl stopper and lacquered aluminium seal.
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
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.