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Date: Sunday, June 15, 2025 13:39

Description: MSD-AH
Release 2.31
Nobilis® Diluent Oculo Nasal
 
Species: Poultry
Therapeutic indication: Immunological veterinary medical products: For poultry
Product:Nobilis® Diluent Oculo Nasal (UK)
Product index: Nobilis® Diluent Oculo Nasal (UK)
Poultry - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Active ingredient
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
For the full list of excipients, see section “Pharmaceutical Particulars”.
Pharmaceutical form
Clear, blue, solution consisting of sterile phosphate buffered saline and EDTA.
Clinical particulars
Target Species:
Poultry
Indications for use:
Diluent for reconstitution of Nobilis live vaccines licensed for Oculo/nasal administration to poultry.
Contraindications:
Any contra-indications specified for the vaccine for which the diluent is used for reconstitution will apply.
Special warnings for each target species:
None
Special precautions for use:
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.
Operator warnings:
None
Adverse Reactions:
Any adverse effects specified for the vaccine for which Nobilis Diluent Oculo Nasal is used as the diluent will apply.
Use during pregnancy or lactation:
Any recommendations specified for the vaccine for which Nobilis Diluent Oculo Nasal is used as the diluent will apply.
Interactions:
None known.
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.
Administration:
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.
Overdose:
No specific treatment or antidote recommended
Withdrawal periods:
Zero days.
Pharmacological particulars
Not applicable. The diluent does not contain active ingredients.
Pharmaceutical particulars
Excipients:
No other ingredients than those listed under 2.
Major incompatibilities:
None known
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.
Special precautions for storage:
Do not store above 25 °C.
Keep the container in the outer carton.
Immediate packaging:
The product is supplied in cartons with 10 PET vials containing 31.5 or 79 ml closed with a halogenated butyl rubber stopper and an aluminium crimp cap.
Not all presentations may be marketed.
Disposal:
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Intervet International B.V., represented by MSD Animal Health UK Limited.
Marketing Authorisation Number
Vm 06376/4131
Significant changes
Date of the first authorisation or date of renewal
09 November 2005
Date of revision of the text
January 2025
Any other information
Legal category
Legal category: POM-V
GTIN
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