TOP-UBAC (Canada)

Company: Hipra

Streptococcus uberis Subunit Vaccine

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S): Each dose (2 ml) contains:

Active substances: Lipoteichoic acid (LTA) from Biofilm Adhesion Component (BAC) of Streptococcus uberis, strain 5616 ≥ 1 RPU*.

*Relative Potency Units (ELISA).

Adjuvant: Montanide ISA 907.1 mg, Monophosphoryl Lipid A (MPLA).

Emulsion for injection. White homogeneous emulsion.

INDICATION(S): For active immunization of healthy cows and heifers to reduce clinical signs of mastitis caused by Streptococcus uberis. Onset of immunity: approximately 36 days after the second dose.

Contraindications

None.

Adverse Reactions

Local swelling more than 5 cm in diameter at the injection site is a very common reaction after administration of the vaccine. This swelling will have disappeared or be clearly reduced in size by 17 days post vaccination. However, in some cases, swelling may persist for up to 4 weeks. A transient increase in rectal temperature (mean increase of 1 °C but may be up to 2 °C in individual animals) may very commonly occur in the first 24 hours after injection. The frequency of adverse reactions is defined using the following convention: Very common (more than 1 in 10 animals treated displaying adverse reaction(s)). Common (more than 1 but less than 10 animals in 100 animals treated). Uncommon (more than 1 but less than 10 animals in 1,000 animals treated). Rare (more than 1 but less than 10 animals in 10,000 animals treated). Very rare (less than 1 animal in 10,000 animals treated, including isolated re ports). Vaccination might exceptionally cause hypersensitivity reactions. In such cases, an appropriate systematic treatment should be administered. If you notice any side 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: Cattle.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION: Intramuscular use. Administer one dose (2 ml) by deep intramuscular injection in the neck muscles according to the following immunisation program: First dose approximately 60-days before the expected parturition date. Second dose approximately 21 days before the expected parturition date. Third dose about 15 days after calving. Protection of animals not vaccinated following this program has not been demonstrated. This should be considered in case of herd vaccination. The full immunisation program should be repeated with each gestation.

ADVICE ON CORRECT ADMINISTRATION: The injections should be preferably administered on the alternate sides of the neck. Allow the vaccine to reach room temperature +15 to +25 °C before administration. Shake before use.

WITHDRAWAL PERIOD: Milk: 0 days. Meat: 60 days.

SPECIAL STORAGE PRECAUTIONS: Keep out of the sight and reach of children. Store and transport refrigerated (+2 to +8 °C). Protect from light. Do not freeze. Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: use immediately.

SPECIAL WARNING(S): Special warnings for each target species: Only healthy animals should be immunised. The whole herd should be immunised. Immunisation has to be considered as one component in a complex mastitis intramammary infection control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, cow comfort, air and water quality and health monitoring) and other management practices. Special precautions to be taken by the person administering the veterinary medicinal product to animals: To the user: This veterinary medicinal product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. 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. To the physician: This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon. Pregnancy and Lactation: Can be used 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. Overdose (symptoms, emergency procedures, antidotes): No information is available. 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 veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

OTHER INFORMATION:

Pack sizes: Cardboard box with 20 glass vials of 1 dose (2 ml). Cardboard box with 1 PET vial of 5 doses (10 ml). Cardboard box with 1 PET vial of 25 doses (50 ml). Cardboard box with 1 PET vial of 50 doses (100 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

726480-00.0

06-20

CPN: 1905007.0