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Date: Saturday, May 18, 2024 12:53

Description: MSD-AH
Release 2.61
Nobilis® RT+IBmulti+G+ND
 
Species: Chickens
Therapeutic indication: Immunological veterinary medical products: For poultry, For chickens
Active ingredient: Vaccine Antigens
Product:Nobilis® RT+IBmulti+G+ND
Product index: Nobilis® RT+IBmulti+G+ND
Poultry - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Per dose of 0.5 ml:
Active substance(s):
ART strain But1#8544 : inducing ≥ 9.5 log2 ELISA units*
IBV strain M41(Massachusetts): inducing ≥ 5.5 log2 VN units*
IBV strain 249g (D274/D207): inducing ≥ 4.0 log2 VN units*
IBDV strain D78: inducing ≥ 14.5 log2 VN units*
NDV strain Clone 30: inducing ≥ 4.0 log2 HI units per 1/50th dose*
or containing ≥ 50 PD50 units
* serological response in chickens
Adjuvant:
Liquid paraffin: 215 mg
Excipients:
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Emulsion for injection (water-in-oil).
White to nearly white oily emulsion.
Clinical particulars
Target Species
Chickens (future breeders).
Indications for use
Active immunisation of breeder chickens for:
- reduction of infection and prevention of egg drop caused by the Massachusetts serotype of Infectious Bronchitis virus;
- reduction of egg drop and egg shell defects caused by the D274/D207 serotype of Infectious Bronchitis virus;
- reduction of infection caused by Newcastle Disease virus;
- prevention of respiratory signs and reduction of egg drop and egg shell defects related to Avian Rhinotracheitis virus;
- passive immunisation of the progeny of the vaccinated birds against Infectious Bursal Disease for at least the first four weeks of life.
Contraindications
None.
Special warnings for each target species
None.
Special precautions for use
Vaccinate only healthy animals.
Vaccination with inactivated vaccine will not completely prevent shedding of wild type virus after infection. Therefore this vaccine is only meant to reduce the clinical signs and not as a tool for eradication of the diseases.
Operator warnings
To the user:
This 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 product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.
If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician:
This product contains mineral oil. Even if small amounts have been injected, accidental injection with this 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
A mild transient swelling may be observed at the injection site for 2 weeks.
Use during pregnancy or lactation
Not to be used during lay or within 4 weeks before the onset 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 needs to be made on a case by case basis.
Amounts to be administered and administration route
Nobilis RT+IBmulti+G+ND should be given to birds around 14 - 20 weeks of age but not later than 4 weeks before the expected onset of lay.
In the event that live vaccines were used to prime birds against Infectious Bronchitis, Rhinotracheitis, Newcastle Disease and Infectious Bursal Disease, Nobilis RT+IBmulti+G+ND should be given at least 4 weeks after the administration of the live vaccines.
Administer one dose of 0.5 ml vaccine per bird via intramuscular injection in the thigh or chest muscle.
Before using the vaccine allow it to reach ambient temperature (15 - 25 °C).
Shake the bottle vigorously before use and periodically during use.
Ensure that vaccination equipment is clean and sterile before use.
Do not use vaccination equipment with rubber parts as the excipient may damage certain types of rubber.
Overdose
After administration of a double dose the reactions are not different from those observed after a single dose.
Withdrawal period
Zero days
Pharmacological particulars
ATC Vet Code: QI01AA06
Pharmacotherapeutic group
Inactivated viral vaccine
The antigens are inactivated with formalin or β-propiolactone and suspended in the aqueous phase of an water in oil adjuvant emulsion, in order to enhance a prolonged stimulation of immunity.
The vaccine is intended to stimulate active immunity against Avian Rhinotracheitis virus, against the Massachusetts and D274/D207 serotypes of Infectious Bronchitis virus and against Newcastle disease; and to stimulate active immunity against Infectious Bursal (Gumboro) Disease in order to provide passive immunity to the progeny.
An enhanced immune response is obtained when the product is used for booster immunisation after priming the birds with live vaccines, if available, against Infectious Bronchitis, Rhinotracheitis, Newcastle Disease and Infectious Bursal Disease. The best results will be obtained if vaccination with the inactivated vaccine takes place at least 4 weeks after administration of the live primer.
Pharmaceutical particulars
Excipients
Polysorbate 80
Sorbitan monooleate
Glycine
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Once broached, use within 3 hours.
Special precautions for storage
Store in a refrigerator (2°C - 8°C). Protect from light. Do not freeze.
Immediate packaging
Vial of polyethylene terephthalate (PET), closed with a nitryl rubber stopper and sealed with a colour coded aluminium cap, containing 250 ml (500 doses) or 500 ml (1000 doses) of vaccine.
Not all pack sizes may be marketed.
Disposal
Any unused product or waste material should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4627
Significant changes
Date of the first authorisation or date of renewal
Date of revision of the text
17th November 2020.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:Nobilis® RT+IBmulti+G+ND 1x500ml:
GTIN:08713184024763