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Date: Saturday, May 3, 2025 4:37

Release 2.134
HatchPak IB H120 Neo effervescent tablet for nebuliser suspension for chickens
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For chickens
Active ingredient: Vaccine Antigens
Product:HatchPak IB H120 Neo effervescent tablet for nebuliser suspension for chickens
Product index: HatchPak IB H120 Neo
Withdrawal notes: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose contains:
Active substance: Live Infectious Bronchitis virus, H120 strain 3.7 to 4.7 log10 EID50(*)
(*) EID50: 50 per cent egg infective doses
Excipient(s): For the full list of excipients, see section Pharmaceutical particulars.
Pharmaceutical form
Effervescent tablet for nebuliser suspension. Orange mottled, round tablet.
Clinical particulars
Target Species
One day old chickens.
Indications for use
In one day-old chickens: active immunisation against Infectious Bronchitis in order to reduce infection with Massachusetts serotype of Infectious Bronchitis virus.
Onset of immunity: 21 days
Duration of immunity: 6 weeks after a single administration.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy birds only.
Special precautions for use in animals
Vaccine viruses can spread to unvaccinated birds. Infection of unvaccinated chickens with the vaccine virus from vaccinated birds does not cause any signs of disease. Reversion to virulence trials carried out in the laboratory have shown that the vaccine viruses do not acquire any pathogenic characteristics after at least 5 passages in chickens.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Wash and disinfect hands and equipment after vaccinating. For more information, contact the manufacturer.
Adverse reactions:
Bronchial rales, not associated with respiratory distress or any general sign, are very common between 5 and 14 days after vaccination.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment).
- common (more than 1 but less than 10 animals in 100 animals).
- uncommon (more than 1 but less than 10 animals in 1,000 animals).
- rare (more than 1 but less than 10 animals in 10,000 animals).
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy, lactation or lay
The vaccine is only intended for use in newly hatched chicks and is not appropriate after the age of one day. The data available on the properties of the strain are not indicative of a detrimental effect on the reproductive tract.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with a Boehringer Ingelheim’s frozen live vaccine against Newcastle disease containing VG/GA-Avinew strain, and can be administered on the same day but not mixed with a Boehringer Ingelheim’s recombinant HVT vaccine expressing the protective antigen of the Infectious Bursal disease virus.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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.
Amounts to be administered and administration route
Route: Respiratory route (spray application).
Reconstitution of the vaccine:
1. Prepare a container filled with the appropriate quantity of clean non-chlorinated drinking water (7 to 30 ml per box of 100 chicks according to the type of sprayer used in the hatchery).
2. Dissolve a number of tablets corresponding to the number of doses to be administered in a container holding the appropriate quantity of clean non-chlorinated water prepared at step 1.
3. Wait until complete dissolution of the tablets before using the vaccine solution. The reconstituted vaccine is a yellow solution, and a foam layer may form over the surface.
4. Where HatchPak Avinew frozen suspension (ampoules carried by a green cane) is to be used concurrently, transfer the content of one ampoule prepared according to the leaflet’s instructions into the container which has previously been used to prepare Hatchpak IB H120 Neo.
5. The reconstituted vaccine prepared according to the instructions is ready for use. It should be used immediately after preparation and therefore the tablets should only be removed from blisters when needed.
Posology: One administration from day-old, via the respiratory route (spray application).
Method of administration:
- The vaccine is intended for mass vaccination of chicks in the hatchery, the vaccine solution should be applied as a coarse spray whilst the chicks are in their chick boxes.
- Spray the vaccine solution above the birds using a sprayer that enables production of drops of 100 µm or more that cover the chicks with the vaccine, so the vaccine is administered directly to their eye and the droplets pearls that shine on the down will encourage them to pick them off of each other and from the surface of the box.
- For effective vaccine distribution, make sure that birds are closely confined together during spraying. During and after vaccination ventilation should be switched off in order to avoid turbulences.
Overdose
No side effects other than those listed in “Adverse reactions” have been observed following the administration of more than 10 times the recommended dose of vaccine.
Withdrawal periods
Zero days.
Pharmacological particulars
ATCVet Code: QI01AD07. Pharmacotherapeutic group: Immunologicals, immunologicals for aves, domestic fowl, live viral vaccines, Avian Infectious bronchitis virus.
The vaccine contains live Infectious Bronchitis virus, H120 strain (Massachusetts serotype). The vaccine stimulates active immunity against Infectious Bronchitis.
Pharmaceutical particulars
Excipients
Citric acid, anhydrous, Sodium hydrogen carbonate, Magnesium stearate, Sunset Yellow FCF (E 110), Casein hydrolysate, D-Mannitol, Sodium hydroxide.
Major incompatibilities
The presence of disinfectant and/or antiseptic in water and material used for the preparation of the vaccine solution is not compatible with effective vaccination.
Do not mix with any other medicinal product, except live frozen vaccine against Newcastle disease containing VG/GA-Avinew strain.
Shelf life
Shelf life of the veterinary medicinal product as package for sale: 18 months.
Shelf life after opening the blister: use immediately. Shelf life after reconstitution according to directions: 2 hours.
Special precautions for storage
Do not keep unused tablets that have been removed from the blister. Keep the blisters in the outer carton. Store and transport refrigerated (2 °C – 8 °C). Keep the reconstituted vaccine below 25°C.
Immediate packaging
Box of 1 blister of 10 tablets of 1,000 doses; Box of 1 blister of 10 tablets of 2,000 doses; Box of 10 blisters of 10 tablets of 1,000 doses; Box of 10 blisters of 10 tablets of 2,000 doses.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm 08327/4280
Significant changes
Date of the first authorisation or date of renewal
June 2021
Date of revision of the text
June 2021
Any other information
N/A
Legal category
Legal category: POM-V
GTIN
GTIN description:Hatchpak IB H120 Neo 1000 doses x 10
GTIN:3661103058656
GTIN description:Hatchpak IB H120 Neo 2000 doses x 10
GTIN:3661103058663