Summary of medicine characteristics - Nobilis OR Inac
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis OR inac emulsion for injection for chickens
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 0.25 ml:
Active substance
Inactivated whole cell suspension of Ornithobacterium rhinotracheale serotype A, strain B3263/91 1 × 107 cells
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inducing a mean titre in the chickens of the potency test of at least 11.2 (log2).
Adjuvant
Light liquid paraffin: 107.21 mg
Excipients
Traces of formaldehyde
For a list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Emulsion for injection
4. CLINICAL PARTICULARS4.1 Target species
Chickens
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4.2 Indications for use, specifying the target species
For passive immunisation of broilers induced by active immunisation of female broiler breeders to reduce infection with Ornithobacterium rhinotracheale serotype A when this agent is involved.
Under field conditions passive immunity is transferred during lay for 43 weeks after the last vaccination of broiler breeders, resulting in a duration of passive immunity in broilers of at least 14 days after hatching.
4.3 Contraindications
Do not use in birds in lay.
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4.4 Special warnings
None
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4.5 Special precautions for use
Special precautions for use in animals
Allow vaccine to reach room temperature (15–25°C) before using the vaccine.
Shake well before use.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
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.
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4.6 Adverse reactions (frequency and seriousness)
In laboratory studies, a local transient swelling was found at post mortem examination in up to 40% of the birds for at least 14 days after subcutaneous vaccination. Under field conditions, sporadic local and systemic clinical reactions have been reported.
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4.7 Use during pregnancy, lactation or lay
Do not use in birds in lay (see section 4.3).
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4.8 Interactions with other medicinal products and other forms of interaction
No information is available on the compatibility of this vaccine with any other. Therefore the safety and efficacy of this product when used with any other (either when used on the same day or at different times) has not been demonstrated.
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4.9 Amounts to be administered and administration route
The vaccination scheme consists of two injections with a dose of 0.25 ml, administered subcutaneously in the neck or intramuscularly in the breast. The first injection can be administered at an age of 6 – 12 weeks. The second injection has to be administered at least 6 weeks later at an age of 14 – 18 weeks.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No other undesirable effects have been observed after administration of a double dose when compared with a single dose of vaccine.
Occasionally hardened minor local swellings (0.5 – 2.0 cm) were observed which disappeared within 21 days after vaccination.
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4.11 Withdrawal period
Zero days.
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5. IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: Inactivated bacterial vaccine
ATCvet code: QI 01AB07
The vaccine is to stimulate active immunity in broiler breeders in order to provide passive immunity to the progeny against Ornithobacterium rhinotracheale serotype A.
6. PHARMACEUTICAL PARTICULARS6.1 List of excipients
Light liquid paraffin, Polysorbate 80, Sorbitan oleate, phosphate buffered aqueous solution
6.2 Incompatibilities
Do not mix with any other vaccine/immunological product.
6.3 Shelf life
15 months
Shelf life after first opening: Use immediately after opening
6.4 Special precautions for storage
Store and transport at 2 – 8°C.
Do not freeze.
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6.5 Nature and composition of immediate packaging
Carton box with one Polyethylene Terephthalate (PET) vial of 250 ml (1000 doses) or 500 ml (2000 doses), closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
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6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
7. MARKETING AUTHORISATION HOLDER
Intervet International
Wim de Korverstraat 35
NL-5831 AN Boxmeer
The Netherlands
8. MARKETING AUTHORISATION NUMBER(S)
EU/2/02/036/001–002
9.