TOPVAC (Canada)

Escherichia coli - Staphylococcus aureus Bacterin

STATEMENT OF THE ACTIVE SUBSTANCE:

Escherichia coli (J5) inactivated > 50 RED₆₀*.

Staphylococcus aureus (CP8) strain SP 140 inactivated, expressing Slime Associated Antigenic Complex (SAAC) > 50 RED₈₀**.

Preservative: Benzyl alcohol.

* RED₆₀: Rabbit effective dose in 60% of the animals (serology).

** RED₈₀: Rabbit effective dose in 80% of the animals (serology).

INDICATION(S):

For herd immunisation of healthy cows and heifers, in dairy cattle herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis and the incidence and the severity of the clinical signs of clinical mastitis caused by Staphylococcus aureus, coliforms and coagulase-negative staphylococci.

The full immunisation scheme induces immunity from approximately day 13 after the first injection until approximately day 78 after the third injection (equivalent to 130 days post-parturition).

Adverse Reactions

Slight to moderate transient local swelling may occur after the administration of one dose of vaccine. A mean transient increase in body temperature of about 1 °C, in some cows up to 2 °C, may occur in the first 24 hours after injection. Animals immunised with an overdose did not show adverse reactions other than those observed after the administration of one dose of vaccine.

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

Intramuscular use. The injections should be preferably administered on the alternate sides of the neck.

Administer one dose (2 ml) by deep intramuscular injection in the neck muscles and according to the following schedule:

- First injection at 45 days before the expected parturition date.

- Second injection 35 days thereafter (corresponding to 10 days before the expected parturition date).

- Third injection 62 days after the second injection (equivalent to 52 days post-parturition).

The full immunisation program should be repeated with each gestation.

ADVICE ON CORRECT ADMINISTRATION:

Allow the vaccine to reach a temperature of +15 to +25 °C before administration. Shake before use.

WITHDRAWAL PERIOD:

Meat: Do not vaccinate within 21 days before slaughter. Milk: 0 days.

SPECIAL STORAGE PRECAUTIONS:

Store and transport refrigerated (+2 to +8 °C) and protected from light. Do not freeze.

SPECIAL WARNING(S):

The whole herd should be immunised. Immunisation has to be considered as one component in a complex mastitis control programme 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, health monitoring) and other management practices.

OTHER INFORMATION: Pack sizes:

- Cardboard box with 1, 10 and 20 vials of 1 dose.

- Cardboard box with 1 and 10 vials of 5 doses.

- Cardboard box with 1 and 10 vials of 25 doses.

- Cardboard box with 1 and 10 vials of 50 doses.

Not all pack sizes may be marketed.

FOR VETERINARY USE 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

Man.: 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

705469-03.0

11-16

CPN: 1905001.0