4.6

Adverse reactions (frequency and seriousness)

Vaccination can induce a very small (<0.5cm) local reaction (granuloma) at the site of injection that disappears about one week later. Rarely vaccination may induce a slight rise in body temperature (around 1^oC) that returns to normal within 1-2 days. These effects are without consequence to the health or reproductive performance of the animal

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

No information is available on the safety or efficacy of the concurrent use of Parvovax with any other vaccine. It is therefore recommended that no other vaccine be administered within 14 days before or after vaccination with Parvovax.

4.9

Amounts to be administered and administration route

Apply usual procedures for the handling of animals.

It is recommended to vaccinate all the breeders when implementing the vaccination programme.

Shake well before use.

Inject one 2-ml dose by deep intramuscular injection into the neck muscles behind the ear, according to the following schedule:

Basic Vaccination scheme

Sows:

One dose only during lactation and at the latest on weaning day.

Gilts and young boars over 6 months of age:

In the absence of porcine parvovirus antibodies:

1 dose two weeks before service mating.

In the presence of maternally derived antibodies to porcine parvovirus or where the status is unknown as regards maternally derived antibodies:

2 doses with a 15- or 21-day interval, the second dose being given at least 10 days before service mating.

Re-vaccination Scheme

Sows:

Annual 2 ml dose preferably during lactation and prior to weaning;

Boars:

Annual 2 ml dose.

4.10

Overdose (symptoms, emergency procedures, antidotes), if necessary

No undesirable effect (other than that described in Section 4.6) was observed after the administration of a double dose of vaccine.

4.11

Withdrawal periods

Zero days.

5.

PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Inactivated vaccine in adjuvant against porcine parvovirosis.

The vaccine stimulates active immunity against porcine parvovirus, shown by challenge or by the presence of haemagglutination inhibiting antibodies.

ATC Vet Code:

QI09AA02

5.1

Pharmacodynamic properties

5.2

Pharmacokinetic properties

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Benzyl alcohol

Ether of fatty alcohols and of polyols

Light paraffin oil

Polyoxyethylene fatty acids

Salts

Thiomersal

Trolamine

Water for injection

6.2

Major incompatibilities

Do not mix with any other product.

6.3

Shelf-life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time

Shelf-life: 24 months.

Use immediately after opening.

6.4

Special precautions for storage

Store and transport between +2^oC and +8^oC, protected from light.

6.5

Nature and composition of immediate packaging

Type 1 glass bottle; Nitrile elastomer closure; Aluminium cap;

1-dose bottle, 1-bottle package.

1-dose bottle, 10-bottle package.

5-dose bottle, 1-bottle package.

25-dose bottle, 1-bottle package.

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, if appropriate

Any unused product or waste material should be disposed of in accordance with national requirements.

7.

MARKETING AUTHORISATION HOLDER

Merial Animal Health Limited

PO Box 327

Sandringham House

Sandringham Avenue

Harlow Business Park

Harlow, Essex, CM19 5TG

United Kingdom

8.

MARKETING AUTHORISATION NUMBER(S)

Vm 08327/4221 (UK)

VPA 10857/45/1 (Ireland)

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17 October 2005 (UK)

6 November 2002 (Ireland)

10.

DATE OF REVISION OF THE TEXT

October 2007

11.

ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE

Not applicable.