HIPRABOVIS IBR MARKER LIVE (Canada)

Company: Hipra

Lyophilisate and Diluent for suspension for injection for cattle

Bovine rhinotracheitis vaccine, modified live virus

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S): Lyophilisate: Each dose of 2 ml contains: Live gE-tk- double-gene deleted Infectious Bovine Rhinotracheitis Virus (IBR) (Bovine Herpes Virus type 1, strain CEDDEL): 10^6.3 - 10^7.3 CCID₅₀. Abbreviations: gE-: deleted glycoprotein E; tk-: deleted thymidine kinase; CCID: cell culture infectious dose. Diluent: Phosphate buffer solution. Contains ampicillin, gentamicin and nystatin as preservatives.

HIPRABOVIS IBR MARKER LIVE Indications

For the active immunisation of cattle from 3 months of age against Bovine Herpes Virus type 1 (BoHV-1) to reduce the clinical signs of Infectious bovine rhinotracheitis (IBR) and field virus excretion. Vaccinated animals can be differentiated from field virus infected animals due to the marker deletion (gE-) by means of commercial diagnostic kits, unless the animals were previously vaccinated with a conventional vaccine. Onset of immunity: 21 days after completion of the basic vaccination scheme. Duration of immunity: 6 months after completion of the basic vaccination.

Contraindications

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

Adverse Reactions

A slight increase in body temperature up to 1 °C is common within 4 days following vaccination. Occasionally, an increase in rectal temperature up to 1.5 °C in adult cows and up to 2 °C in calves may be observed. This transient rise in temperature is spontaneously resolved within 48 hours without treatment. A transient inflammation at the inoculation site is common in cattle within 72 hours post- vaccination. This slight swelling lasts for less than 24 hours in most cases. Vaccination might exceptionally cause hypersensitivity reactions. In such cases, an appropriate symptomatic treatment should be administered. If you notice any serious effects or other effects not mentioned in the leaflet, please inform your veterinary surgeon.

TARGET SPECIES: Cattle (calves and adult cows).

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION: Cattle from the age of 3 months onwards: 2 ml/animal. Intramuscular use, in the neck muscles. The recommended initial dose is 1 injection of 2 ml of the reconstituted vaccine per animal. The animal should be revaccinated 3 weeks later with the same dose. Thereafter a single booster dose of 2 ml should be administered every six months. The method of administration is by intramuscular route, in the neck muscles. The injections should be preferably administered on the alternate sides of the neck. The diluent should be allowed to warm to a temperature between 15 to 20 °C before reconstitution of the lyophilised tablet. Shake well before use. Avoid the introduction of contamination during reconstitution and use. Use only sterile needles and syringes for administration.

ADVICE ON CORRECT ADMINISTRATION: Reconstitute the lyophilised tablet with the entire contents of the supplied diluent to obtain a suspension for injection.

WITHDRAWAL PERIOD: 21 days.

SPECIAL STORAGE PRECAUTIONS: Keep out of the reach and sight of children. 5, 25 and 30 doses lyophilisate: Store and transport refrigerated (2 °C - 8 °C). 5 and 25 doses diluent: Store and transport refrigerated (2 °C - 8 °C). 30 doses solvent: Store and transport at room temperature (25 ± 5 °C). Do not freeze. Keep the bottles in the outer carton in order to protect from light. Do not use after the expiry date (EXP) stated on the carton and the label. Shelf-life after reconstitution according to directions: 6 hours.

SPECIAL WARNINGS: Can be used during pregnancy and lactation. Vaccinate healthy animals only. Apply the usual procedures for the handling of animals. Apply the usual aseptic procedures. 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. No adverse reactions except those mentioned in the Adverse Reactions section were observed after the administration of a 10-fold vaccine dose. Do not mix with any other veterinary medicinal product, except the diluent supplied for use with the veterinary medicinal product. Fetal health risks associated with vaccination of pregnant animals with HIPRABOVIS IBR MARKER LIVE were not observed in clinical trials conducted for licensure, but cannot be unequivocally excluded. Management strategies based on vaccination of pregnant animals with modified live vaccines should be discussed with a veterinarian.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

OTHER INFORMATION: Pack sizes: Cardboard box containing 1 bottle with 5 doses of lyophilised tablet and 1 bottle with 10 ml of diluent. Cardboard box containing 1 bottle with 25 doses lyophilised tablet and 1 bottle with 50 ml of diluent. Cardboard box containing 1 bottle with 30 doses of lyophilised tablet. Cardboard box containing 1 bottle with 60 ml of diluent. Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

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

712923-00.2

11-16

CPN: 1905010.0