Nobilis RT+IBMulti+ND+EDS vet.
Active substance
ATC code
Species
Chickens (breeders and layers).
Indications
Active immunisation of breeder and layer chickens for:
- Reduction of infection and prevention of egg drop caused by the Massachusetts serotype of infectious bronchitis virus (IBV);
- Reduction of egg drop and eggshell 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 eggshell defects related to avian rhinotracheitis (ART) virus (avian pneumovirus);
- Reduction of egg drop and eggshell defects related to EDS’76 virus.
Onset of immunity: 4 weeks after vaccination.
Duration of immunity: one laying period.
Dose to be administered and administration route
The vaccine should be given to chickens around 14 - 20 weeks of age but not later than 4 weeks before the expected onset of lay.
If live vaccines were used to prime chickens against infectious bronchitis, rhinotracheitis and Newcastle disease, the vaccine should be given at least 4 weeks after the administration of the live vaccines.
Each chicken should be given 0.5 ml of vaccine intramuscularly in the thigh or chest muscle.
Before using the vaccine allow it to reach ambient temperature (15 °C - 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.
Adverse reactions
Chickens:
|
Very common (>1 animal / 10 animals treated): |
Injection site swelling1 |
1 A transient diffuse swelling which persists for 14 days.
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 its local representative or the national competent authority via the national reporting system. See section “Contact details” of the package leaflet.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis RT+IBmulti+ND+EDS emulsion for injection for chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.5 ml:
Active substances:
Inactivated viral antigens of:
IBV strain M41 inducing ≥ 5.5 log2 VN units*
IBV strain 249g inducing ≥ 4.0 log2 VN units*
ART strain But1#8544 inducing ≥ 9.5 log2 ELISA units*
EDS’76 strain BC14 inducing ≥ 6.5 log2 HI units*
NDV strain Clone 30 inducing ≥ 4.0 log2 HI units per 1/50th of a dose* or containing ≥ 50 PD50 units
* serological response in chickens
Adjuvant:
Liquid paraffin: 215 mg.
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Emulsion for injection.
White to nearly white oily emulsion.
4. CLINICAL PARTICULARS
4.1 Target species
Chickens (breeders and layers).
4.2 Indications for use, specifying the target species
Active immunisation of breeder and layer chickens for:
- Reduction of infection and prevention of egg drop caused by the
Massachusetts serotype of infectious bronchitis virus (IBV);
- Reduction of egg drop and eggshell 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 eggshell defects
related to avian rhinotracheitis (ART) virus (avian pneumovirus);
- Reduction of egg drop and eggshell defects related to EDS’76 virus.
Onset of immunity: 4 weeks after vaccination. Duration of immunity: one laying period.
4.3 Contraindications
None.
4.4 Special warnings for each target species
Vaccinate healthy animals only.
4.5 Special precautions for use
Special precautions for use in animals: Not applicable.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
To the user:
This veterinary medicinal product contains mineral oil. Accidental injection/selfinjection 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.
Special precautions for the protection of the environment: Not applicable.
4.6 Adverse reactions (frequency and seriousness) Chickens:
|
Very common (>1 animal / 10 animals treated): |
Injection site swelling[1] |
competent authority via the national reporting system. See section “Contact details” of the package leaflet.
4.7 Use during pregnancy, lactation or lay
Laying birds:
Do not use in birds in lay and within 4 weeks before the start of the laying period.
4.8 Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy use 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 Amount(s) to be administered and administration route
The vaccine should be given to chickens around 14 - 20 weeks of age but not later than 4 weeks before the expected onset of lay.
If live vaccines were used to prime chickens against infectious bronchitis, rhinotracheitis and Newcastle disease, the vaccine should be given at least 4 weeks after the administration of the live vaccines.
Each chicken should be given 0.5 ml of vaccine intramuscularly in the thigh or chest muscle.
Before using the vaccine allow it to reach ambient temperature (15 °C - 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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
After administration of a double dose the reactions are not different from those observed after a single dose.
4.11 Withdrawal period(s)
Zero days.
5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Immunologicals for Aves, inactivated vial vaccines for domestic fowl.
ATCvet code: QI01AA18.
The antigens are inactivated with formalin or β-propiolactone and suspended in the aqueous phase of a 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 egg drop syndrome '76 virus.
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 and Newcastle disease virus. Priming with egg drop syndrome live vaccine is not necessary. The best results will be obtained if vaccination with the inactivated vaccine takes place at least 4 weeks after administration of the live primer.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Polysorbate 80
Sorbitan mono-oleate
Glycine
Water for injections
6.2 Major incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 3 hours.
6.4 Special precautions for storage
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
6.5 Nature and composition of immediate packaging
Bottle 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.
Pack sizes:
Cardboard box with 1 bottle of 250 ml (500 doses) or 500 ml (1000 doses).
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal product 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
MSD Animal Health UK Limited
Walton Manor, Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8. MARKETING AUTHORISATION NUMBER
Vm 01708/5083
9. DATE OF FIRST AUTHORISATION
22 October 2004
10. DATE OF REVISION OF THE TEXT
July 2023
11. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Approved: 07 July 2023
[1] A transient diffuse swelling which persists for 14 days.
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 its local representative or the national
| Art. Nr. | 01708/5083 |
|---|---|
| EAN | 8713184033505 |
