ERYSENG PARVO (Canada)

Company: Hipra

Parvovirus Vaccine, Killed Virus, Erysipelothrix Rhusiopathiae Bacterin

STATEMENT OF THE ACTIVE SUBSTANCE(S): One dose (2 ml) contains: Inactivated porcine parvovirus, strain NADL-2, RP* > 1.15. Inactivated Erysipelothrix rhusiopathiae, strain R32E11, ELISA > 3.34 log₂ IE_50%**. * RP - relative potency (ELISA). ** IE_50% - Inhibition ELISA 50%.

ERYSENG PARVO Indications

For the active immunisation of female pigs for the protection of progeny against transplacental infection caused by porcine parvovirus. For the active immunisation of male and female pigs to reduce clinical signs (skin lesions and fever) of swine erysipelas caused by Erysipelothrix rhusiopathiae, serotype 1 and serotype 2. Onset of immunity: Porcine parvovirus: from the beginning of the gestation period. E. rhusiopathiae: three weeks after completion of the basic vaccination scheme. Duration of immunity: Porcine parvovirus: vaccination provides foetal protection for the duration of gestation. Revaccination should be performed prior to each gestation, refer to section “Dosage for each species, route(s) and method of administration”. E. rhusiopathiae: vaccination protects against swine erysipelas until the time of the recommended revaccination (approximately six months after the basic vaccination scheme), refer to section “Dosage for each species, route(s) and method of administration”.

Contraindications

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Adverse Reactions

Very common adverse reactions: Mild to moderate inflammation at the injection site that typically resolves within four days but in some cases may persist for up to 12 days post-vaccination. Common adverse reactions: A transient increase in body temperature within the first 6 hours after vaccination, which spontaneously resolves within 24 hours. Vaccination might exceptionally cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be administered. 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 serious effects or other effects not mentioned in the package leaflet, please inform your veterinarian.

TARGET SPECIES: Pigs.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION: Administer one dose of 2 ml by intramuscular injection in the neck muscles according to the following schedule: Basic vaccination: Pigs from 6 months of age which have not been previously vaccinated with the product should be given two injections with an interval of 3-4 weeks. The second injection should be administered 3-4 weeks before mating. Revaccination: A single injection should be given 2-3 weeks prior to each subsequent mating (approximately every 6 months).

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

WITHDRAWAL PERIOD: 21 days.

SPECIAL STORAGE PRECAUTIONS: Keep out of the sight and reach of children. Store and transport refrigerated (2 °C - 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: use immediately.

SPECIAL WARNINGS: Special precautions for use in animals: Vaccinate healthy animals only. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Pregnancy and lactation: Can be used during pregnancy and lactation. 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. Overdose (symptoms, emergency procedures, antidotes): No adverse reactions other than already mentioned under section “Adverse reactions” can be expected after the administration of a 2-fold vaccine dose. 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 glass vial of 10 doses (20 ml). Cardboard box with 1 glass vial of 25 doses (50 ml). Cardboard box with 1 glass vial of 50 doses (100 ml). Cardboard box with 1 PET bottle of 10 doses (20 ml). Cardboard box with 1 PET bottle of 25 doses (50 ml). Cardboard box with 1 PET bottle of 50 doses (100 ml). Cardboard box with 1 PET bottle of 125 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

713575-00.3

09-17

CPN: 1905003.1