GUMBOHATCH (Canada)

This treatment applies to the following species:

Chickens

Company: Hipra

Lyophilisate and diluent for suspension for injection for chickens

Bursal Disease Vaccine, Live Virus

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S): Each dose of reconstituted vaccine (0.05 ml for an in ovo dose or 0.2 ml for a subcutaneous dose) contains: Active substance: Live attenuated infectious bursal disease virus (IBDV), strain 1052 10^1.48 - 10^2.63 PU (Potency Units). Excipients: IBDV-specific antibody solution. Contains gentamicin, ampicillin and nystatin. Lyophilisate: brown reddish colour. Diluent: clear colourless solution.

INDICATION(S): For active immunization of 1-day-old broiler chicks and embryonated broiler chicken eggs to reduce clinical signs and lesions of the bursa of Fabricius caused by very virulent IBDV infection. The onset of immunity depends on the initial maternally derived antibodies (MDA) level of the batch of chickens and even then will be different for individual chickens. In practice, studies in commercial broiler chickens have shown an onset of immunity from between 24 days of age and 28 days of age. Onset of immunity: from 24 days of age. Duration of immunity: up to 43 days of age.

Contraindications

Do not use in flocks without MDAs against IBDV.

Adverse Reactions

In laboratory studies, lymphocyte depletion was very common after vaccine take, which was followed by a lymphocyte repopulation and regeneration of the bursa of Fabricius. This depletion does not cause immunosuppression in chickens. 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: Chickens and embryonated chicken eggs.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION: Posology: By the in ovo route: Administer one single injection of 0.05 ml of the reconstituted vaccine into each chicken egg at 18 days of embryonation. By the subcutaneous route: Administer one single injection of 0.2 ml of the reconstituted vaccine to each chick at 1 day of age. Method of administration: For in ovo administration: An automated egg injection machine can be used. The instructions for the calibration and use of the equipment should be strictly followed in order to deliver the appropriate dose. For the reconstitution and administration of the vaccine, use sterile equipment free from any residues of chemical disinfectants. Calculate and prepare the required volume of the vaccine as per the table below:

Dilutions for in ovo administration (0.05 ml per dose) :

Number and content of vaccine vials:	Diluent volume to be used
4 x 1 000 doses	200 ml
8 x 1 000 doses	400 ml
2 x 2 000 doses	200 ml
4 x 2 000 doses	400 ml
8 x 2 000 doses	800 ml
8 x 2 500 doses	1 000 ml
1 x 4 000 doses	200 ml
2 x 4 000 doses	400 ml
4 x 4 000 doses	800 ml
5 x 4 000 doses	1 000 ml
4 x 5 000 doses	1 000 ml

Reconstitution of the vaccine:

1. Withdraw 2 ml of the diluent and inject into the vial containing the lyophilisate. Mix the contents of the vial by gentle agitation until the contents are completely resuspended, then withdraw the suspension obtained and inject it into the diluent bag.

2. Rinse the vial with another 2 ml of the diluent/lyophilisate suspension obtained in step 1, and inject it back into the diluent bag.

3. Repeat step 2 to ensure that all the lyophilisate has been transferred into the diluent bag.

4. The reconstituted vaccine is a slightly reddish homogeneous suspension which should be used within 2 hours after reconstitution. The vaccine (0.05 ml dose) must be injected into the amniotic sac of 18-day-old embryonated broiler chicken eggs.

For subcutaneous administration: An automated syringe can be used. The instructions for the calibration and use of the equipment should be strictly followed in order to deliver the appropriate dose. For the reconstitution and administration of the vaccine, use sterile equipment free from any residues of chemical disinfectants. Calculate and prepare the required volume of the vaccine as per the table below:

Dilutions for subcutaneous administration (0.2 ml per dose):

Number and content of vaccine vials:	Diluent volume to be used
1 x 1 000 doses	200 ml
2 x 1 000 doses	400 ml
4 x 1 000 doses	800 ml
5 x 1 000 doses	1 000 ml
1 x 2 000 doses	400 ml
2 x 2 000 doses	800 ml
2 x 2 500 doses	1 000 ml
1 x 4 000 doses	800 ml
1 x 5 000 doses	1 000 ml

Reconstitution of the vaccine:

2. Rinse the vial with another 2 ml of the diluent/lyophilisate suspension obtained in step 1 and transfer it back into the diluent bag.

3. Repeat step 2 to ensure that all the lyophilisate has been transferred into the diluent bag.

4. The reconstituted vaccine is a slightly reddish homogeneous suspension which should be used within 2 hours after reconstitution. The vaccine (0.2 ml dose) must be injected under the skin of the neck of the 1-day-old broiler chicks.

WITHDRAWAL PERIOD(S): 21 days.

SPECIAL STORAGE PRECAUTIONS: Keep out of the sight and reach of children. Lyophilisate: Store and transport refrigerated (2 °C - 8 °C). Do not freeze. Protect from light. Diluent: Do not store above 25°C. Shelf life after reconstitution according to directions: 2 hours. Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the label.

SPECIAL WARNING(S): Special precautions for use in animals: This product should only be used in the areas where epidemiologically relevant very virulent IBDV strain is present. Vaccinate healthy animals only. It is recommended to vaccinate all chickens on a site at the same time. Vaccinated birds may excrete the vaccine strain up to 3 weeks following vaccine take. During this time, contact between the vaccinated chickens and any immunosuppressed or unvaccinated birds should be avoided. Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible wild and domestic birds. Special precautions to be taken by the person administering the veterinary medicinal product to animals: Wash and disinfect hands and equipment after use. Wash and disinfect hands after handling vaccinated birds or their litter because the virus is excreted by vaccinated birds for up to 3 weeks. In case of adverse reactions following accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. Lay: The safety of the veterinary medicinal product has not been established during lay. 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: After the administration of a 10-fold overdose mild exudate and slight congestion in the bursa of Fabricius were very commonly observed. Incompatibilities: Do not mix with any other veterinary medicinal product, except the diluent supplied for use with this 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 veterinarian or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

OTHER INFORMATION: Pack sizes: Cardboard box with 10 lyophilisate vials containing 1,000 doses. Cardboard box with 10 lyophilisate vials containing 2,000 doses. Cardboard box with 10 lyophilisate vials containing 2,500 doses. Cardboard box with 10 lyophilisate vials containing 4,000 doses. Cardboard box with 10 lyophilisate vials containing 5,000 doses. Cardboard box with 10 bags containing 200 ml diluent. Cardboard box with 10 bags containing 400 ml diluent. Cardboard box with 10 bags containing 800 ml diluent. Cardboard box with 10 bags containing 1,000 ml 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 VETERINARY USE ONLY

Est. Lic. No.: 4.242-E

Distributed in Canada: HIPRA ANIMAL HEALTH CANADA INC, 11 Holland Avenue, suite 605 - Ottawa, Ontario K1Y 4S1 - Tel 613.422.7610

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

727287-20.1

07-20

CPN: 1905013.0

HIPRA ANIMAL HEALTH CANADA INC.
11 HOLLAND AVENUE, SUITE 605, OTTAWA, ON, K1Y 4S1

Telephone:		613-422-7610
Fax:		613-422-7612
Website:		www.hipra.com
Email:		cservice.hforceca@hipra.com

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