Nobilis Diluent Oculo Nasal
SUMMARY OF PRODUCT CHARACTERISTICS
1 Name of veterinary medicinal product
Nobilis Diluent Oculo Nasal
2 Qualitative and quantitative composition
Composition per ml
Monobasic potassium phosphate 0.37 mg
Disodium phosphate dihydrate 0.72 mg
Sodium chloride 7.65 mg
Disodium edetate 0.5 mg
Patent Blue V (E131) 0.17 mg
Water for injections ad 1.0 ml
3 Pharmaceutical form
Clear, blue, solution consisting of sterile phosphate buffered saline and EDTA.
4 Clinical particulars
4.1 Target species
Poultry
4.2 Indications for use specifying the target species
Diluent for reconstitution of Nobilis live vaccines licensed for Oculo/nasal administration to poultry.
4.3 Contra-indications and warnings in respect of other products used in the host immunological status of host and physiological status of host
Any contra-indications specified for the vaccine for which the diluent is used for reconstitution will apply.
4.4 Specific warnings for each target species
None
4.5 Special precautions for use
4.5.1 Special precautions for use in animals
No special precautions are required for handling the diluent however any recommendations specified for the vaccine for which Nobilis Diluent Oculo Nasal is used as a diluent will apply.
4.5.2 Special precautions to be taken by the person administering the product to animals
None
4.6 Adverse reactions (frequency and seriousness)
Any adverse effects specified for the vaccine for which Nobilis Diluent Oculo Nasal is used as the diluent will apply.
4.7 Use during pregnancy and lactation
Any recommendations specified for the vaccine for which Nobilis Diluent Oculo Nasal is used as the diluent will apply.
4.8 Interaction with other medicaments and other forms of interaction
None known.
4.9 Amounts to be administered and administration route
The instructions supplied with the vaccine should be read carefully before using the diluent.
For freeze dried vaccines the contents of the diluent vial should be transferred aseptically into the vial of freeze-dried vaccine immediately prior to use.
4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
No specific treatment or antidote recommended
4.11 Withdrawal periods
Zero days
5 Pharmacological properties
Not applicable. The diluent does not contain active ingredients.
6 Pharmaceutical particulars
6.1 List of excipients
No other ingredients than those listed under 2.
6.2 Incompatibilities
None known
6.3 Shelf life and in-use shelf life
Shelf life of the veterinary medicinal product as packaged for sale
48 months
Shelf life after dilution or reconstitution according to directions
In-use shelf life is that specified for the vaccine for which Nobilis Diluent Oculo Nasal is used as the diluent.
6.4 Special precautions for storage
Do not store above 25C.
Keep the container in the outer carton
6.5 Nature and composition of immediate packaging
The product is supplied in cartons with 10 PET vials containing 31.5 or 79 ml closed with a halogenated butylrubber stopper and an aluminium crimp cap.
Not all presentations may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from such veterinary medicinal products
Any unused product or waste material should be disposed of in accordance with national requirements.
7. MARKETING AUTHORISATION HOLDER
Intervet UK Ltd
Walton Manor
Walton
Milton Keynes
Bucks MK7 7AJ
MARKETING AUTHORISATION NUMBER(S)
Vm 01708/4502
DATE OF FIRST AUTHORISATION
09/11/2005
DATE OF REVISION OF THE TEXT
April 2010