Ibmulti+ND+EDS Part I T/M I.C
Revised: April 2013
AN. 01041/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Reo ERS inac, emulsion for injection for chickens
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.5 ml:
Active substance:
Inactivated Reovirus strain ERS inducing 6.7 log2 and ≤ 10.0 log2 antibody ELISA units
Adjuvant:
Light liquid paraffin, 215 mg
For the full list of excipients, see section 6.1
3.PHARMACEUTICAL FORM
Emulsion for injection, white to nearly white (after shaking)
4.CLINICAL PARTICULARS
4.1Target species
Chicken
4.2Indications for use, specifying the target species
Active immunisation of chickens as an aid in the protection of their progeny against weight gain losses due to enteric Reovirus (ERS) infection, and reduction of virus replication in target organs.
Onset of immunity: 4 weeks after two vaccinations
Duration of immunity: 47 weeks after two vaccinations
4.3Contraindications
None
4.4Special warnings
None
4.5Special precautions for use
Special precautions for use in animals
Vaccinate healthy birds only. For birds in lay please see section 4.7.
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/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 veterinary medicinal 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.
4.6Adverse reactions (frequency and seriousness)
A slight transient swelling (< 1 cm) may occur at the site of vaccination and may last up to three weeks.
4.7Use during pregnancy, lactation or lay
Do not use in birds in lay and within 4 weeks before the onset of the laying period.
4.8Interaction with other medicinal products and other forms of interaction
Safety and efficacy data are available which demonstrates that this vaccine can be administered the same day but not mixed with Intervet’s inactivated vaccines containing Reovirus strains 1733 and 2408.
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.
4.9Amounts to be administered and administration route
Each chicken should be intramuscularly vaccinated twice with 0.5 ml of vaccine in the thigh or breast muscle. Nobilis Reo ERS inac should be given to chickens from 7 weeks of age onwards but not later than 4 weeks before the expected onset of lay. The interval between the two vaccinations should be approximately 11 weeks.
Before using the vaccine allow it to reach ambient temperature (15 – 25°C).
Shake the bottle vigorously before use and periodically during use.
Make sure that vaccination equipment is clean and sterile before use.
4.10Overdose (symptoms, emergency procedures, antidotes), if necessary
No other effects than mentioned in section “Adverse reactions” were observed following the administration of a double dose of vaccine.
4.11Withdrawal period
Zero days.
5.IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated viral vaccines, ATCvet code: QI01AA04
Nobilis Reo ERS inac is an inactivated vaccine that contains the ERS strain of avian Reovirus. The antigen is suspended in the aqueous phase of a water-in-oil emulsion serving as adjuvant. The vaccine is intended to stimulate active immunity in chickens by transferring passive immunity to the progeny.
6.PHARMACEUTICAL PARTICULARS
6.1List of excipients
Light liquid paraffin
Polysorbate 80
Sorbitan oleate
Water for injection
6.2Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
2 years
Once broached, use within 3 hours.
6.4Special precautions for storage
Store in a refrigerator (2°C -8°C).
Do not freeze.
Protect from light.
6.5Nature and composition of immediate packaging
Bottle of polyethylene terephthalate (PET). The bottles are closed with a nitryl rubber stopper and sealed with a coded aluminium cap, containing 500 ml (1,000 doses) of vaccine. Presentations: 1 bottle of 500 ml (1000 ds) or 12 bottles of 500 ml (1000 ds).
Not all pack sizes may be marketed.
6.6Special 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
Intervet UK Ltd
Walton Manor
Walton
Milton Keynes
Buckinghamshire
MK7 7AJ
8.MARKETING AUTHORISATION NUMBER
Vm 01708/4540
9.DATE OF FIRST AUTHORISATION
6 June 2008
10.DATE OF REVISION OF THE TEXT
April 2013
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable
Approved: 22/04/2013
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