SUISENG (Canada)

Clostridium novyi - Clostridium perfringens type C - Escherichia coli

Bacterial Extract - Toxoid

STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS:

Composition per dose (2 ml):

F4ab fimbrial adhesin of E. coli ≥ 65% ER₆₀*

F4ac fimbrial adhesin of E. coli ≥ 78% ER₇₀*

F5 fimbrial adhesin of E. coli ≥ 79% ER₅₀*

F6 fimbrial adhesin of E. coli ≥ 80% ER₂₅*

LT Enterotoxoid of E. coli ≥ 55% ER₇₀*

Toxoid Clostridium perfringens, type C ≥ 35% ER₂₅*

Toxoid Clostridium novyi, type B ≥ 50% ER₁₂₀*

Hipramune G (Aluminium hydroxide and Ginseng).

Contains benzyl alcohol, polymyxin B and thimerosal as preservatives.

*% ERx: Percentage of immunized rabbits with a x serological EIA response.

SUISENG Indications

Piglets: For the passive protection of neonatal piglets by means of the active immunisation of breeding sows and gilts to reduce mortality and clinical signs of neonatal enterotoxicosis, such as diarrhoea, caused by enterotoxigenic Escherichia coli, expressing F4ab (K88ab), F4ac (K88ac), F5 (K99) or F6 (987P) adhesins.

For the passive immunisation of neonatal piglets against Necrotic Enteritis by means of the active immunisation of breeding sows and gilts to induce seroneutralizing antibodies against the β-toxin of Clostridium perfringens type C.

Sows and gilts: For active immunisation of breeding sows and gilts to induce seroneutralizing antibodies against α-toxin of Clostridium novyi. The relevance of the seroneutralizing antibodies was not experimentally determined.

Adverse Reactions

A small granuloma may occur in the muscle tissue at the injection site. The administration of the vaccine can cause the appearance of a small (less than 3 cm), local, transitory swelling (for 24-48 hours). In a few cases (up to 1% of the animals), temporary small nodules can be observed, which disappear within 2-3 weeks. The vaccination may cause a slight increase in body temperature for a transient period after vaccination (4-6 hours after injection). Rarely, an increase in rectal temperature higher than 1.5 °C, lasting less than 6 hours, may occur.

If you notice any serious effects or other effects not mentioned in the leaflet, please inform your veterinarian.

TARGET SPECIES:

Swine (sows and gilts).

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION:

Intramuscular, into the neck muscles.

Swine: 2 ml/animal.

The basic vaccination scheme consists of two doses: the first dose at approximately 6 weeks before farrowing and a second dose at approximately 3 weeks before farrowing. It is recommended that the first and second dose be given on opposite sides of the neck. Revaccination: On each subsequent gestation, administer one dose 3 weeks before the expected date of farrowing.

ADVICE ON CORRECT ADMINISTRATION:

It is advisable to administer the vaccine at a temperature between +15 °C and +25 °C. Shake before use.

WITHDRAWAL PERIOD:

21 days.

SPECIAL STORAGE PRECAUTIONS:

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

SPECIAL WARNINGS:

Can be used during pregnancy from 6 weeks before the expected farrowing date.

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 1 vial of 10 doses (20 ml).

- Cardboard box with 1 vial of 25 doses (50 ml).

- Cardboard box with 1 vial of 50 doses (100 ml).

- Cardboard box with 1 vial 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

708884-01.0

11-16

CPN: 1905000.1