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Poulvac Hitchner B1, Lyophilisate for reconstitution for eye drops solution, nasal drops solution, oral

Description

Active IngredientsPer dose
Live Newcastle Disease Virus, strain B1105.5 – 107.2EID50

INDICATIONS

For the active immunisation of chickens to reduce clinical signs due to infection with Newcastle disease virus.
The onset of immunity is from three weeks after vaccination. Immunity has been shown to last for at least 6 weeks.

CONTRAINDICATIONS

Do not vaccinate unhealthy birds.

ADVERSE REACTIONS

Reactions to vaccination occur seldom after intranasal, intraocular or drinking water administration. Mild respiratory distress is observed in up to 4% of birds vaccinated by the spray route. These symptoms typically appear within 4 to 9 days of the administration of the vaccine and may last several days.

TARGET SPECIES

Chickens.

DOSAGE, ROUTE AND METHOD OF ADMINISTRATION

For drinking water, spray, intranasal or eye drop administration.
Drinking Water:
For birds 2 weeks of age or older.

Never use less than one dose per bird. Discontinue any drinking water medication 24 hours before vaccination.

N.B. Check that the birds are never left without water after vaccine treatment.
Spray:
For birds 4 weeks of age or older

Hitchner B1 vaccine, has been successfully used in most types of spray equipment, the droplet sizes varying from coarse (Knapsack) to very fine (aerosol).
The vaccine should be dissolved as described under drinking water administration. The vaccine concentrate should then be added to the water in the sprayer tank and thoroughly mixed.
Intranasal:
For use in birds from one day of age.

Reconstitute the vaccine as directed below.
Fit the drop dispenser on the bottle.
Place finger over one nostril of the bird, allow one drop of the vaccine to fall into the other nostril.
Vaccination is completed when the vaccine is inhaled into nasal cavity. Do not release the bird until this occurs.
Eye drop:
For use in birds from one day of age.

Reconstitute the vaccine as directed below.
Fit the drop dispenser on the bottle.
Hold the bird so that one eye is pointed upwards and allow one drop of vaccine to fall into the eye.
Reconstitution for intranasal and eye drop routes:
Remove the aluminium foil and rubber stopper from the vaccine vial and add sterile diluent to half fill the vial.
Replace the rubber stopper and shake so that all the vaccine material is completely dissolved.

WITHDRAWAL PERIOD

Zero days.

SHELF LIFE

Shelf-life of the veterinary medicinal product as packaged for sale: 30 months.
Shelf-life after reconstitution according to directions: use immediately.

SPECIAL STORAGE PRECAUTIONS

Store and transport at +2°C to +8°C.
Protect from light.
Do not freeze

SPECIAL WARNINGS

Special precautions for use in animals
It is accepted that spray administration offers benefits over water administration in terms of ease of application and percentage of birds vaccinated. Nevertheless, greater secondary problems can result under certain management conditions. Spray vaccination should not be used if inter-current infection is suspected.
Do not use in birds in lay.
When administered by eye drop at day of age, no information is available on the safety and efficacy from the use of this vaccine with any other except Poulvac IBMM and Poulvac MDVac (frozen wet) administered concurrently by eye drop and by injection, respectively, or Poulvac Bursine 2 administered by eye drop within 7 days.
When administered by eye drop at 4 weeks of age, no information is available on the safety and efficacy from the use of this vaccine with any other except Poulvac ILT, Poulvac AE and Poulvac Bursine 2 by eye drop.
No information is available on the compatibility of this vaccine with any other except in the situations and with the products described above.
Do not mix with any other vaccine/immunological product except Poulvac IBMM, Poulvac ILT, Poulvac AE and Poulvac Bursine 2 when administering by eye drop. No information is available on the safety and efficacy of mixing this vaccine with any other for any other route of administration.
No adverse reactions exceeding those reported in section were recorded following administration of a tenfold overdose by the oral, intranasal or eye drop routes. The administration of a tenfold overdose by the spray route results in an increased incidence of respiratory distress and may result in mortality rates of up to 8 %.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Live Newcastle disease virus may cause conjunctivitis in man. When administering vaccine by the spray method operators must protect eyes and nose by wearing standard goggles and mask or a full face mask that comply with BS EN 166:2002 and BS EN 149:2001.
Dispose of waste material by boiling, incineration or immersion in appropriate disinfectant in accordance with national requirements.

OTHER INFORMATION

ATCVet Code: QI01AD06
Nature and composition of immediate packaging
The lyophilised vaccine is bottled in Type 1 Borosilicate Glass bottles with aluminium seals and rubber stoppers.
Fill volume for the 1,000, 2,500 or 5,000 dose presentation is 3.4 to 3.7 ml, 7.8 to 8.2 ml for the 10,000 dose presentation and 20.0 to 23.0 ml the 25,000 dose presentation.
Not all pack sizes may be marketed.
National label conditions must be observed by country.

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