HIPRABOVIS SOMNI/Lkt (Canada)

Company: Hipra

Emulsion for injection for cattle

Histophilus somni - Mannheimia haemolytica Bacterin - Toxoid

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S): One dose (2 ml) contains: Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid: ELISA > 2.8 (*)/dose; Inactivated Histophilus somni Bailie strain: MAT > 3.3 (**)/dose.

(*) A minimum of 80% of vaccinated rabbits show ELISA value of > 2.0; the mean ELISA is > 2.8.

(**) A minimum of 80% of vaccinated rabbits show a log₂ MAT value of ≥ 3.0; the mean log₂ MAT > 3.3.

Preservative: Thiomersal.

Adjuvant: Liquid paraffin.

INDICATION(S): To reduce the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in calves from 2 months of age. Onset of immunity: 3 weeks after completion of the basic vaccination scheme. Vaccination is recommended to be used before stress periods (shipping, allotments...). The vaccination scheme should be completed 3 weeks before such periods. Duration of immunity: has not been established.

Contraindications

Do not vaccinate unhealthy animals. Do not use in case of hypersensitivity to the active substances, to the adjuvant or to any of the excipients.

Adverse Reactions

Very common: A transient rise in temperature (up to 2 °C) after each vaccination can occur but this resolves after 4 days. Vaccinated animals might show a local swelling at the injection site of 1 to 7 cm after administration of the vaccine. This swelling will have disappeared or be clearly reduced in size by 14 days post vaccination however in some cases swelling may persist for up to 4 weeks after the second administration. Common: Mild apathy, anorexia and/or depression may be observed after each injection but these resolve within 4 days. Very rare: Anaphylactic-type reactions may occur in some sensitive animals. In such cases, appropriate symptomatic treatment such as antihistamines or cortisone or in more severe cases adrenaline should be given. The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment). - Common (more than 1 but less than 10 animals in 100 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 leaflet, please inform your veterinarian.

TARGET SPECIES: Cattle.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION: For subcutaneous use. Cattle from the age of 2 months onwards: 2 ml / animal. Recommended vaccination scheme: Administer one dose (2 ml) per calf, at 2 months of age. This 2 ml dose should be repeated after 21 days. Vaccinate calves by subcutaneous injection in the prescapular area. It is preferable to administer the second dose on alternate sides.

ADVICE ON CORRECT ADMINISTRATION: The vaccine should be allowed to warm to a temperature between 15 - 20 °C before administration. Shake before use. Avoid the introduction of contamination during use. Use only sterile needles and syringes for administration.

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 after the expiry date (EXP) stated on the carton and the label. Shelf life after first opening the immediate packaging: 10 hours.

SPECIAL WARNING(S): Special precautions for use in animals: Do not use in animals which are underweight for their age. Special precautions to be taken by the person administering the veterinary medicinal product to animals: If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again. Use during pregnancy, lactation or lay: Do not use during pregnancy. Do not use during lactation. Overdose: No effects other than those mentioned in “Adverse reactions” section were observed after administration of twice the recommended dose. Incompatibilities: Do not mix with any other veterinary medicinal product.

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 with one glass vial of 10 doses with a rubber stopper and aluminium cap. Cardboard box with one glass bottle of 50 doses with a rubber stopper and aluminium cap. 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

714948-00.1

04-18

CPN: 1905004.1