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Date: Sunday, May 26, 2024 11:45

Release 2.34
Bovilis Nasalgen®-C nasal spray, lyophilisate and solvent for suspension for cattle (GB)
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Bovilis Nasalgen®-C nasal spray, lyophilisate and solvent for suspension for cattle (GB)
Product index: Bovilis Nasalgen®-C nasal spray (GB)
Cattle - milk: Zero hours
Cattle - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose (2 ml) of reconstituted vaccine contains:
Active substance:
Live attenuated bovine coronavirus, strain CA25: 5.4 – 7.8 log10 TCID50*
*Tissue culture infectious dose 50%
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Lyophilisate: white or off-white colour.
Solvent: clear colourless solution.
Clinical particulars
Target Species
Cattle.
Indications for use
For the active immunisation of cattle from the day of birth onwards to reduce clinical signs of upper respiratory tract disease and nasal viral shedding from infection with bovine coronavirus.
Onset of immunity: 5 days.
Duration of immunity: 12 weeks.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Animals should preferably be vaccinated at least 5–7 days before a period of stress or increased infection pressure.
Special precautions for use
Vaccinated cattle may excrete the vaccine strain nasally or orally following vaccination. Excretion has been observed for up to 9 days following vaccination but may persist longer. The vaccine strain can spread to other cattle. Spread to other species has not been investigated and cannot be excluded.
It is recommended to vaccinate all calves of the herd.
Appropriate biosecurity procedures to limit the risk of introduction and spread of bovine coronavirus infection in premises should be part of management tools.
Operator warnings
Not applicable.
Adverse Reactions
Cattle:
Very Common
(> 1 animal /10 animals treated):
Nasal discharge, Increased respiratory rate,
Cough
Elevated temperature1
Common
(1 to 10 animals /100 animals treated):
Ocular discharge
1Elevated temperature up to 40.7 °C which normally resolves within three 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 the national competent authority via the national reporting system. See also section “Contact details” of the package leaflet.
Use during pregnancy or lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Interactions
Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Bovilis INtranasal RSP Live. The vaccines should be given into different nostrils. The product information of that veterinary medicinal product should be consulted before administration.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product 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.
Amounts to be administered and administration route
Nasal use.
Administer a single dose of 2 ml reconstituted vaccine to the calf from the day of birth onwards in one nostril.
Reconstitute the lyophilisate with the solvent (Unisolve) supplied as described below. Ensure that the lyophilisate is completely reconstituted before use.
The reconstituted product is a colourless or off-yellow suspension.
Instructions for reconstitution:
For proper reconstitution of the lyophilisate, transfer the solvent to the vial with the lyophilisate using a transfer needle or using a needle and syringe.
The 10-, 20-, and 50-dose presentations require a two-step reconstitution of the solvent to the vial with the lyophilisate and back to the solvent vial.
See the table below for the appropriate volumes. The vacuum in the vaccine vial will allow quick insertion of the solvent into the lyophilisate vial. Ensure complete resuspension by shaking the vial. The vaccine suspension can be drawn up in a syringe with a clean tip. Alternatively, the vial with reconstituted vaccine can be put in a multi-dose applicator.
The vaccine is now ready for administration into the nostril, directly from the tip of the syringe or applicator. A spraying device is not required.
When vaccinating animals, it is recommended to change syringes or tips of a multi-dose applicator between animals to avoid transmission of pathogens.
Doses per vial
Solvent volume required
Dose volume
1
2 ml
2 ml
5
10 ml
2 ml
10
20 ml
2 ml
20
40 ml
2 ml
50
100 ml
2 ml
Overdose
No adverse events other than those mentioned in Adverse reactions were observed after administration of a 10-fold overdose of the vaccine.
Withdrawal periods
Zero days.
Pharmacological particulars
ATCvet code: QI02AD10
Pharmacotherapeutic group
Immunologicals for Bovidae, live viral vaccines for cattle.
The vaccine stimulates active immunity against bovine coronavirus.
The vaccine stimulates gene expression for receptors and cytokines in anti-viral innate immune responses.
Pharmaceutical particulars
Excipients
Lyophilisate:
Veggie medium
Hydrolysed gelatin
Pancreatic digest of casein
Sorbitol
Disodium phosphate dihydrate
Solvent (Unisolve):
Disodium phosphate dihydrate
Potassium dihydrogen phosphate
Sodium chloride
Sucrose
Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale:
Lyophilisate: 2 years.
Solvent (2 ml): 3 years.
Solvent (10, 20, 40, 100 ml): 5 years.
Shelf life after reconstitution according to directions: 24 hours.
Special precautions for storage
Lyophilisate:
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Protect from light.
Solvent:
Store below 25 °C if stored independently from the lyophilisate.
Do not freeze.
Reconstituted vaccine:
Store at room temperature.
Immediate packaging
Lyophilisate:
Type I glass vial with 1, 5, 10, 20 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Solvent:
Type I glass vial with 2 ml Unisolve closed with a halogenobutyl rubber stopper and aluminium cap.
Type II glass vial with 10 ml, 20 ml, 40 ml or 100 ml Unisolve closed with a halogenobutyl rubber stopper and aluminium cap.
Pack sizes:
Cardboard box with:
- 1 dose of lyophilisate + 2 ml solvent
- 5 doses of lyophilisate + 10 ml solvent
- 10 doses of lyophilisate + 20 ml solvent
- 5 x 1 dose of lyophilisate + 5 x 2 ml solvent
- 5 x 5 doses of lyophilisate + 5 x 10 ml solvent
- 5 x 10 doses of lyophilisate + 5 x 20 ml solvent
- Cardboard box with 20 doses of lyophilisate + cardboard box with 40 ml solvent
- Cardboard box with 50 doses of lyophilisate + cardboard box with 100 ml solvent
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK(GB): Vm 01708/5066
Significant changes
Date of the first authorisation or date of renewal
30 August 2023.
Date of revision of the text
August 2023.
Any other information
For animal treatment only. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
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