VEPURED (Canada)

Escherichia coli Subunit Vaccine

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S):

Each dose of 1 ml contains:

Active substance:

Recombinant verotoxin 2e of E. coli RP* ≥ 1.50.

*RP - relative potency (ELISA).

Adjuvants: Aluminium hydroxide 2.117 mg (aluminium), DEAE-dextran.

Whitish suspension for injection.

INDICATION(S):

Active immunisation of piglets from 2 days of age to reduce the mortality and clinical signs of oedema disease (caused by verotoxin 2e produced by E. coli).

Onset of immunity: 21 days after vaccination.

Duration of immunity: 112 days after vaccination.

Contraindications

Do not use in cases of hypersensitivity to the active substance, to the adjuvants or to any of the excipients.

Adverse Reactions

Very common adverse reactions: Mild inflammation at the injection site (< 5 cm in diameter) that typically resolves within three days post-vaccination without treatment. Mild depression during the day of vaccination. Temperature rise of maximum 1.1 °C was observed. Temperatures returned to normal within 24 hrs. 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). If you notice any effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinarian.

TARGET SPECIES: Pigs.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION:

Intramuscular use. Administer a single intramuscular injection of 1 ml in the neck muscles.

ADVICE ON CORRECT ADMINISTRATION: Allow the vaccine to reach room temperature (15 - 25 °C) before administration. Shake well before use.

WITHDRAWAL PERIOD(S): 21 days.

SPECIAL STORAGE PRECAUTIONS:

Keep out of the sight and reach of children. Store and transport refrigerated (+2 to +8 °C). Do not freeze. Protect from light. Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Shelf life after first opening the container: 10 hours.

SPECIAL WARNINGS:

Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.

Major incompatibilities: Do not mix with any other veterinary medicinal product.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY:

Medicines should not be disposed of via wastewater or household waste. Ask your veterinarian or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

OTHER INFORMATION:

Pack sizes:

Cardboard box with 1 polyethylene (PET) vial of 10 doses (10 ml).

Cardboard box with 10 PET vials of 10 doses (10 ml).

Cardboard box with 1 PET vial of 50 doses (50 ml).

Cardboard box with 1 PET vial of 100 doses (100 ml).

Cardboard box with 1 PET vial of 250 doses (250 ml).

Not all pack sizes may be marketed.

FOR ANIMAL TREATMENT ONLY

Est. Lic. No.: 4.242-E

Distributed in Canada by: HIPRA ANIMAL HEALTH CANADA INC, 11 Holland Avenue, suite 605 - Ottawa, Ontario K1Y 4S1

Tel 613.422.7610

Manufactured by: LABORATORIOS HIPRA, S.A. Avda. la Selva, 135 . 17170 Amer (Girona) Spain

Tel. (34) 972 43 06 60. Fax (34) 972 43 06 61. hipra@hipra.com

716660-00.2

08-18

CPN: 1905005.1