NASYM (Canada)

Company: Hipra

Bovine respiratory syncytial virus vaccine, modified live virus

Lyophilisate and diluent for suspension for vaccination of cattle

STATEMENT OF THE ACTIVE SUBSTANCE(S):

One dose (2 ml) contains:

Live attenuated bovine respiratory syncytial virus, strain Lym-56 10^4.7 - 6.5 CCID₅₀*.

*Cell culture infectious dose 50%.

INDICATION(S): Active immunisation of cattle to reduce virus shedding and respiratory clinical signs caused by bovine respiratory syncytial virus infection.

Onset of immunity: 21 days after administration of one dose by the nasal route. Reduction of respiratory clinical signs (but not a reduction of virus shedding) is observed 5 days after nasal vaccination. 21 days after the second dose of the two dose intramuscular vaccination schedule.

Duration of immunity: 2 months after nasal vaccination or 6 months after intramuscular vaccination.

Contraindications

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

Adverse Reactions

Slight alteration of faecal consistency may be commonly observed post-vaccination. Calves may uncommonly display a peak in temperature of at least 1.7 °C two days after vaccination that resolves the next day without treatment. Vaccination might exceptionally cause hypersensitivity reactions. In such cases, an appropriate systematic treatment should be administered. If you notice any serious effects or other effects not mentioned in the leaflet, please inform your veterinarian.

TARGET SPECIES: Cattle from 9 days of age.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION: Nasal use or intramuscular use. One dose is 2 ml. Cattle from 9 days of age: Primary vaccination (nasal use): Spray 1 ml into each nostril (so the total volume administered is 2 ml). Revaccination: One intramuscular injection of 2 ml should be given 2 months after the primary vaccination, and then every 6 months after the last revaccination. Cattle from 10 weeks of age: Primary vaccination (intramuscular injection): One intramuscular injection of 2 ml should be given, followed by a second intramuscular injection of 2 ml given 4 weeks later. Revaccination: One intramuscular injection of 2 ml should be given 6 months after completion of the primary vaccination scheme and then every 6 months after the last revaccination.

ADVICE ON CORRECT ADMINISTRATION: Reconstitute the vaccine with the corresponding volume of diluent:

1. Peel the top off the aluminium cap on the vial containing the diluent, and withdraw 10 ml.

2. Inject the 10 ml of diluent into the vial containing the lyophilisate (freeze-dried powder).

3. Shake until the freeze-dried powder is in suspension. The 5 doses vial is now ready to use.

4. For the 25 doses vial, once the freeze-dried powder is in suspension, withdraw all the suspension obtained from the vaccine vial and inject it into the vial containing the remaining diluent.

5. Shake well before use. The reconstituted vaccine is a slightly yellowish homogeneous suspension. Avoid contamination during reconstitution and use. Use only sterile needles and syringes for administration. For nasal use, spray the required volume of the vaccine into the animal’s nostrils (1 ml in each nostril) using an intranasal applicator (droplet size: 25-220 μm). It is recommended to use a new applicator for each animal.

WITHDRAWAL PERIOD: 21 days.

SPECIAL STORAGE PRECAUTIONS: Keep out of the reach and sight 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. Use immediately after reconstitution.

SPECIAL WARNING(S): Special precautions for use in animals: Vaccinate healthy animals only. Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Use during pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Overdose: No adverse reactions occurred following the administration of an overdose. Incompatibilities: Do not mix with any other veterinary medicinal product, except with the diluent supplied for use with the 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. Inactivate unused contents before disposal.

OTHER INFORMATION: Pack sizes: Cardboard box with 1 lyophilisate vial of 5 doses and 1 vial of 10 ml of diluent. Cardboard box with 1 lyophilisate vial of 25 doses and 1 vial of 50 ml of diluent. Cardboard box with 10 lyophilisate vials of 5 doses. Cardboard box with 10 vials of 10 ml of diluent. Cardboard box with 10 lyophilisate vials of 25 doses. Cardboard box with 10 vials of 50 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

726532-20.1

03-20

CPN: 1905006.0