Ingelvac PCV FLEX - summary of medicine characteristics

Summary of medicine characteristics - Ingelvac PCV FLEX

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Ingelvac PCV FLEX 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 suspensi

ection.

CLINICAL PARTICULARS

4.1

Target species

Pigs

4.2

Indications for use, specifying the target species

For active immunisation of pigs with no PCV2 maternally derived antibodies from the age of 2 weeks against porcine circovirus type 2 (PCV2).

Under experimental challenge conditions in which only seronegative animals were included, it was demonstrated that vaccination reduces mortality, clinical signs 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 immunity: 2 weeks post vaccination

Duration of immunity: at least 17 weeks.

4.3

None.

Contraindications

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

Not applicable.

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 treated displaying adverse reactions)
– 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

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 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 Shake well before use.

Avoid introduction of contamination Vaccines devices should be used in a manufacturer.

Avoid multiple broaching.

dose (1 ml), irrespective of body weight.

ring use.

ordance with the device instructions provided by the

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 recommendation should be followed:

Use the same volumes of Ingelvac PCV FLEX 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 PCV

FLEX.

– Transfer the Ingelvac PCV FLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX. If needed, gently press the vaccine bottle of Ingelvac PCV FLEX to facilitate the transfer.
– After the transfer of the full content of Ingelvac PCV FLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac PCV FLEX.

3.

4.

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.

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 materi 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 described under section 4.6 have been observed.

ose

4.11 Withdrawal period

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Immunologicals for suidae, ina ATCvet code: QI09AA07

iral vaccines for pigs

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 Major incompatibiliti

Do not mix with any other veterinary medicinal product, except with 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

Pack sizes of 1 or 12 high density polyethylene bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses).

Each vial is closed 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 product should be disposed of in accordance with local requirements.

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