Target Species
Chickens
Indications for use
For the active immunisation of chickens for:
•reduction of egg drop caused by avian metapneumovirus (AMPV)
•reduction of respiratory signs and egg drop caused by infectious bronchitis virus (IBV) strains Massachusetts (GI-1 genotype) and 4/91-793B (GI-13 genotype)
•reduction of mortality and clinical signs caused by Newcastle disease virus (NDV)
•passive immunisation of the progeny of the vaccinated chickens to
- reduce mortality and clinical signs of disease caused by very virulent (CS89) and classical (STC) variants of infectious bursal disease virus (IBDV).
- reduce viraemia and clinical signs of disease caused by avian reovirus (ARV) (genotypes 1 and 4).
Onset of immunity:
•IBV, NDV, IBDV and ARV: 4 weeks post-vaccination
•AMPV: 5 weeks post-vaccination
•IBDV and ARV in progeny: 1 day of age
Duration of immunity:
•AMPV, IBV, NDV, IBDV and ARV: 80 weeks post-vaccination
•IBDV and ARV in progeny: 3 weeks of age
Cross-protection has been established for IBV strains QX-D388 (GI-19 genotype), Var2 (GI-23 genotype) and Q1 (GI-16 genotype).
Cross-protection has been established for IBDV antigenic variant strains (variant E and GLS).
Cross protection has been established for ARV genotypes 2, 3 and 5.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Special precautions for use
Not applicable.
Operator warnings
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this veterinary medicinal product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse Reactions
Uncommon (1 to 10 animals / 1 000 animals treated): | Injection site lump1 |
1 Generally disappearing within 3 weeks.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation
Do not use in birds in lay and within 3 weeks before the start of the laying period.
Interactions
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.
Amounts to be administered and administration route
This vaccine is intended for use as a booster vaccination following priming with either live or inactivated vaccines in the vaccination schedule. Primary vaccinations should be performed with live or inactivated vaccines against infectious bronchitis virus (e.g. Nobilis IB 4-91, Nobilis IB Ma5), infectious bursal disease virus (e.g. Nobilis Gumboro D78, Innovax-ND-IBD) and avian reovirus (e.g. Nobilis Reo 1133, Nobilis Multriva REOm). The vaccine should be given at least 4 weeks after administration of the primary vaccination.
For intramuscular use.
Administer a single dose of 0.3 ml in the breast or thigh region from 8 weeks of age onwards, but no later than 3 weeks before the onset of lay.
Before use, allow the vaccine to reach room temperature.
Shake well before use.
Syringes and needles must be sterile before use.
Follow standard aseptic procedures.
When primary vaccinations were performed against avian metapneumovirus (e.g. Nobilis Rhino CV) and/or Newcastle disease virus (e.g. Nobilis ND C2, Nobilis ND Clone 30, Innovax-ND-IBD), the vaccine should be given at least 4 weeks after administration of the primary vaccination.
Overdose
No adverse reactions other than those mentioned in section 3.6 were observed after the
administration of a double dose of vaccine.
Withdrawal periods
Zero days.