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Date: Sunday, May 26, 2024 12:09

Release 2.156
Bovalto Respi Intranasal (NI)
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Bovalto Respi Intranasal, nasal spray, lyophilisate and solvent for suspension
Product index: Bovalto Respi Intranasal
Cattle - milk: See notes
Cattle - meat: Zero days
Withdrawal notes: Do not use during pregnancy and lactation
Incorporating:
Qualitative and quantitative composition
One dose (2 ml) contains:
Lyophilisate: Active substances:
Bovine parainfluenza 3 virus (PI3V), modified live virus, strain Bio 23/A, 105.0 – 107.5 TCID50
Bovine respiratory syncytial virus (BRSV), modified live virus, strain Bio 24/A, 104.0 – 106.0 TCID50
TCID50 – a 50% infectious dose for tissue cultures.
Excipients:
Qualitative composition of excipients and other constituents
Lyophilisate:
Trometamol
Edetic acid
Sucrose
Dextran 70
Solvent: (phosphate buffered saline)
Sodium chloride
Potassium chloride
Disodium hydrogen phosphate dodecahydrate
Potassium dihydrogen phosphate
Water for injection
Appearance before reconstitution:
The lyophilisate has a porous structure, off-white or yellowish colour.
The solvent is clear, colourless.
Pharmaceutical form
Nasal spray, lyophilisate and solvent for suspension.
Clinical particulars
Target species
Cattle.
Indications for use for each target species
For the active immunisation of calves from the age of 10 days against bovine respiratory syncytial virus (BRSV) and bovine parainfluenza 3 virus (PI3V), to reduce the quantity and duration of nasal excretion of both viruses.
Onset of immunity: 10 days after vaccination
Duration of immunity: 12 weeks after vaccination.
Contraindications
None.
Special warnings
The laboratory efficacy studies have demonstrated that the presence of maternally derived antibodies at the time of vaccination had no impact on vaccine efficacy in young animals.
Vaccinate healthy animals only.
Special precautions for use
Special precautions for safe use in the target species
Vaccinated calves can excrete the vaccine strains BRSV and PI3V for up to 6 days after vaccination. Therefore, the spread of the vaccine virus from vaccinated to unvaccinated calves cannot be excluded. Animals should be vaccinated at least 10 days before the critical period of stress or high risk of infection, such as rearrangement or transport of animals, or in early autumn. To achieve optimal results, it is recommended to vaccinate all calves of the herd.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Not applicable.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Very rare
(<1 animal / 10,000 animals treated, including isolated reports):
Hypersensitivity reaction*
*may require appropriate symptomatic treatment
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 its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Do not use during pregnancy and lactation.
Interactions with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal products. 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.
Administration routes and dosage
Nasal use.
Reconstitute the vaccine by aseptically adding the supplied solvent into the vial containing the lyophilised component. Mix well. Appearance after reconstitution: opalescent liquid of yellowish to pinkish colour.
Required volume of the reconstituted vaccine is either drawn up from the bottle by syringe with a needle, the needle is then replaced by the intranasal applicator provided and the vaccine is administered or left in the bottle and administered via a multi-dose applicator that can deliver each dose through the intranasal applicator. The intranasal applicator is used to spray the required volume of the vaccine into the animal´s nostrils. The applicator used should spray the vaccine in the form of 30 µm to 100 µm droplets.
Vaccination schedule:
Administer one dose (2 ml) of the reconstituted vaccine intranasally (1 ml of the vaccine into each nostril) to calves from 10 days of age using an intranasal applicator. It is recommended to use a new applicator for each animal, in order to prevent the transmission of infection.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
A slight and transient nasal discharge was observed the first three days after the administration of a 10-fold overdose without any adverse consequence for in-contact animals.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
Withdrawal periods
Zero days.
Pharmacological particulars
ATC vet code: QI02AD07
Immunologicals for bovidae; Cattle, live viral vaccines. To stimulate the active immunity against BRSV and PI3V.
Pharmaceutical particulars
Major incompatibilities
Do not mix with any other veterinary medicinal product, except solvent recommended for use with the veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years. Shelf-life of the solvent as packaged for sale: 4 years. Shelf life after reconstitution according to directions: 2 hours
Special precautions for storage
Lyophilisate and solvent: Store and transport refrigerated (2°C – 8°C). Do not freeze. Protect from direct sunlight.
Reconstituted vaccine: Store below 25°C. Do not freeze
Nature and composition of immediate packaging
Lyophilisate: type I glass bottle (1, 5 or 10 doses) with a rubber stopper and aluminium cap.
Solvent: 3 ml (1 dose) or 10-ml (5 doses) type I glass bottle or 20-ml (10 doses) type II glass bottle with a rubber stopper and an aluminium cap.
Pack size:
Cardboard box: 1 x 5 doses of lyophilised vaccine + 1x10 ml of solvent; 1 x 10 doses of lyophilised vaccine + 1 x 20 ml of solvent
Plastic box with a lid: 5 x 1 dose of lyophilised vaccine + 5 x 2 ml of solvent; 5 x 5 doses of lyophilised vaccine + 5x10 ml of solvent
Intranasal applicators are packaged separately. Applicators are distributed together with the vaccine.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such product
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
Vm 08327/3005
Significant changes
Date of the first authorisation or date of renewal
First authorisation:16 April 2018
Renewal: 25 June 2021
Date of revision of the text
December 2022
Any other information
Veterinary medicinal product subject to prescription.
Detailed information on this veterinary medicinal product is available in the Union Product Database
Legal category
Legal category: POM-V
GTIN
GTIN description:Bovalto Respi Intranasal 5 DOS X 1 GB/NI/IE
GTIN:3661103062295
GTIN description:Bovalto Respi Intranasal 10 DOS X 1 IE/NI
GTIN:4028691583318
GTIN description:Bovalto Respi Intranasal 1 DOS X 5 IE/NI
GTIN:4064951008542