SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

HuveGuard NB suspension for ocular or oral use for chickens.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One dose of 0.025 ml contains:

Active substances:

Sporulated oocysts from two attenuated precocious lines of Eimeria species:

Eimeria necatrix, strain mednec3+8 100–310 oocysts*

Eimeria brunetti, strain roybru 3+28 50–155 oocysts*

* According to the in vitro counting procedure of the manufacturer at the time of blending and at release

Excipients

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for ocular or oral use.

Colourless to white to light beige suspension when shaken.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens (layers, breeders)

For the active immunisation of chickens from 14 days of age to reduce infection and clinical signs of coccidiosis caused byE. necatrix andE. brunetti.

Onset of immunity: 21 days post vaccination.

Duration of immunity: not demonstrated.

4.3 Contraindications

None.

4.4 Special warnings for each target species

The vaccine contains live coccidian oocysts and is dependent upon replication of the vaccine strains within the chickens for building up of immunity. It is common to find oocysts in the gastro-intestinal tract of vaccinated birds from 1–3 weeks or more after vaccination. These oocysts are most likely to be vaccinal oocysts which recycle in the birds via the litter. Recycling of oocysts is necessary for the development of immunity and for continued protection.

Since the protection against coccidial infection following vaccination is enhanced by natural challenge, access to any therapeutic agents having anti-coccidial activity at any time following vaccination can adversely affect the development of immunity. This is important throughout the life of the chicken.

4.5 Special precautions for use

Special precautions for use in animals

Vaccinate healthy birds only.

Chickens must be strictly floor reared on litter.

To reduce the chance of coccidial challenge before the onset of immunity, litter should be removed and chicken housing should be thoroughly cleaned between rearing cycles.

Special precautions to be taken by the person administering the veterinary medicinalproduct to animals

Wash and disinfect hands and equipment after use.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during lay

The safety of the veterinary medicinal product has not been established in laying birds. Do not use in birds in lay and within 4 weeks before the onset of the laying period.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer any anticoccidial agents, including sulphonamides, before or after vaccination, as doing so will have a negative impact on immunity which is dependent on the recycling of oocysts in the environment.

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.

4.9 Amounts to be administered and administration route

Oral (via drinking water) or ocular (eye drop) use.

Vaccination schedule: administer one dose of vaccine to each chicken from 14 days of age.

Once the 30 ml containing 1,000 or 5,000 doses vial is opened, the entire contents must be used.

Administration via drinking water

For the administration of the vaccine drinkers must be used.

Provide an adequate number of drinkers or drinking space so that all chicks have access to the vaccinal water and thus can receive the correct dose.

Place the drinkers evenly in the area where chicks are housed.

Water should be withheld for 2–4 hours before vaccination.

Preparation of the xanthan gum suspension:

Commercially available xanthan gum can be used.

For 1,000 doses put 3 litres of clean drinking water at room temperature in a suitable container and dissolve 5 g xanthan gum.

For 5,000 doses put 15 litres of clean drinking water at room temperature in a suitable container and dissolve 25 g xanthan gum.

Prepare the vaccine suspension as follows:

To re-suspend the oocysts, shake the vaccine vial vigorously. Open the vial and pour the whole contents into clean drinking water at room temperature: 2 litres for 1,000 doses and 10 litres for 5,000 doses. To ensure that all oocysts are removed from the vial, rinse it out 2–3 times with water. Shake the obtained 2 litres (1,000 doses) or 10 litres (5,000 doses) of vaccine suspension and transfer gradually into the prepared xanthan gum suspension, mixing thoroughly to ensure a homogeneous suspension.

Mixing the xanthan gum together with the vaccine suspension will result in a final quantity of 5 litre (for 1,000 doses) or 25 litre (for 5,000 doses) vaccine-xanthan gum suspension. Pour the vaccine suspension into the drinking equipment.

Eye-drop administration.

Use a standardised dropper for the eye-drop administration. The exact amount of tap water used depends on the drop size, specific to the dropper used.

For 1,000 doses and a drop size of 0.025 ml: use the vaccine undiluted.

For 5,000 doses and a drop size of 0.025 ml: add the entire contents of one vial to 100 ml water (total volume 125 ml).

Hold each bird with its head tilted to one side. Allow a singledrop (~0.025 ml) of vaccine suspension to fall freely into the open eye, gently flooding it. The drop (before release) and the dropper tip should not touch the eye surface. Allow the bird to blink before releasing it.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No side effects have been observed following administration of a 10-fold overdose.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: immunologicals for Aves, live parasitic vaccines for domestic fowl.

ATCvet code: QI01AN01.

To stimulate active specific immunity to wild strains of E. necatrix andE. brunettiwhen ingested by chickens. Vaccination is followed by continuous and lifelong recycling of vaccinal oocysts in birds via the litter. This recycling of oocysts results in the development of immunity and continued protection against wild strains of both Eimeriastrains.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride

Potassium chloride

Disodium hydrogen phosphate

Potassium dihydrogen phosphate

Polysorbate 80

Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 22 weeks.

Shelf life after first opening the immediate packaging: use immediately.

Shelf life after dilution according to directions: 4 hours.

6.4 Special precautions for storage

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

6.5 Nature and composition of immediate packaging

Low density polyethylene (LDPE) vial of 30 ml with a grey butyl rubber stopper and aluminium cap containing either 1,000 or 5,000 doses.

Pack sizes: cardboard box with 1, 5 or 10 vials of 1,000 or 5,000 doses.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerp

Belgium

8. MARKETING AUTHORISATION NUMBER

Vm 30282/4032

9. DATE OF FIRST AUTHORSATION

19 August 2016

10. DATE OF REVISION OF THE TEXT

August 2016

Approved: 19/08/2016