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Date: Thursday, May 30, 2024 10:03

Release 2.251
Bovilis® INtranasal RSP™ Live, nasal spray, lyophilisate and solvent for suspension for cattle
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Bovilis® INtranasal RSP™ Live, nasal spray, lyophilisate and solvent for suspension for cattle
Product index: Bovilis® INtranasal RSP™
Cattle - meat: Zero days
Incorporating:
Qualitative and quantitative composition
Each dose of 2 ml contains:
Active substances:
Live bovine respiratory syncytial virus (BRSV), strain Jencine-2013: 5.0 – 7.0 log10 TCID50*
Live bovine parainfluenza virus type 3 (PI3), strain INT2-2013:4.8 – 7.3 log10 TCID50*
*50% tissue culture infective dose
For the full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Nasal spray, lyophilisate and solvent for suspension.
Lyophilisate: off-white or cream-coloured cake.
Solvent: clear colourless solution.
Clinical particulars
Target species
Cattle.
Indications for use
For active immunisation of calves from the day of birth onwards to reduce clinical signs of respiratory disease and viral shedding from infection with BRSV and PI3.
Onset of immunity: BRSV: 6 days (for calves vaccinated from the day of birth
onwards)
5 days (for calves vaccinated from the age of 1 week
onwards)
PI3: 1 week
Duration of immunity: 12 weeks
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Animals should be preferably vaccinated at least 5 – 7 days before a period of stress or increased infection pressure.
The efficacy against BRSV may be reduced by presence of maternally derived antibodies.
Special precautions for use
Vaccinated calves may excrete the vaccine strains up to 12 days following vaccination.
It is recommended to vaccinate all calves of the herd.
Operator warnings
Not applicable.
Adverse reactions
A mild and transient nasal discharge may very commonly occur during two days following vaccination. Mild and transient spontaneous coughing may commonly occur which normally resolves in three days. A mild and transient ocular discharge may commonly occur which normally resolves in two days. A transient rise in respiration rate may commonly occur which normally resolves within four days. A transient minor rise in body temperature may very commonly occur following vaccination (very rarely up to 41.1 °C) which normally resolves within four days.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy or lactation
Do not use during pregnancy and lactation.
Interaction 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 product. 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.
Calves can be vaccinated from the day of birth onwards.
Reconstitute lyophilisate with solvent as described below. Ensure that the lyophilisate is completely reconstituted before use. The reconstituted vaccine is an off-pink or pink coloured suspension.
Administer a single dose of 2 ml reconstituted vaccine per animal, 1 ml in each nostril.
Instructions for reconstitution:
1, 5 and 10 dose presentations For proper reconstitution of the lyophilisate, transfer the solvent to the vial with the lyophilisate (2 ml for the 1 dose, 10 ml for the 5 dose and 20 ml for the 10 dose; also see the table below) using a needle and syringe. The vacuum in the vaccine vial will allow quick emptying of the syringe. Then resuspend by shaking. The vaccine suspension can be drawn up in a syringe with a clean tip. The vaccine in the syringe is now ready for administration, directly from the tip of the syringe. A spraying device is not required.
20, 25 and 50 dose presentations
For proper reconstitution of the lyophilisate, transfer 20 ml of the solvent to the vial with the lyophilisate using a needle and syringe. The vacuum in the vaccine vial will allow quick emptying of the syringe. Then resuspend by shaking. Completely draw up the vaccine suspension and transfer it back to the solvent vial in order to get the correct dose/volume ratio for the respective presentation (40 ml for the 20 dose, 50 ml for the 25 dose and 100 ml for the 50 dose; also see the table below). The vaccine suspension can be drawn up in a syringe with a clean tip. The vaccine in the syringe is now ready for administration, directly from the tip of the syringe. A spraying device is not required.
When vaccinating animals, it is recommended to change syringes or tips of a multi-dose syringe 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
2ml
25
50 ml
2 ml
50
100 ml
2 ml
Overdose
At 10-fold overdose, no other signs than those described under section 4.6 have been observed. In individual calves exposed to very high vaccine dosages (150-fold maximum dose) signs of moderate to severe respiratory disease have been observed.
Withdrawal period(s)
Zero days.
Pharmacological particulars
ATC vet code: QI02AD07
Pharmacotherapeutic group
Immunologicals for bovidae, live viral vaccines.
The vaccine stimulates active immunity against bovine respiratory syncytial virus and bovine parainfluenza type 3 virus.
The vaccine stimulates receptors and cytokines involved in anti-viral innate immune responses.
Pharmaceutical particulars
Excipients
Lyophilisate:
Basal B8 medium
Hydrolysed gelatine
Pancreatic digest of casein
Sorbitol
Disodium hydrogen phosphate dihydrate
Solvent:
Disodium hydrogen 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 lyophilisate as packaged for sale: 2 years.
Shelf life of the solvent as packaged for sale (2 ml): 3 years.
Shelf life of the solvent as packaged for sale (10 ml, 20 ml, 40 ml, 50 ml, 100 ml): 5 years.
Shelf life after reconstitution according to directions: 6 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.
Immediate packaging
Lyophilisate:
Type I glass vial of 1, 5, 10, 20, 25 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Solvent:
Type I glass vial with 2 ml Unisolve and Type II glass vial with 10 ml, 20 ml, 40 ml, 50 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 of solvent
- 5 doses of lyophilisate + 10 ml of solvent
- 10 doses of lyophilisate + 20 ml of solvent
- 5 x 1 dose of lyophilisate + 5 x 2 ml of solvent
- 5 x 5 doses of lyophilisate + 5 x 10 ml of solvent
- 5 x 10 doses of lyophilisate + 5 x 20 ml of solvent
- Cardboard box with 20 doses of lyophilisate + cardboard box with 40 ml of solvent
- Cardboard box with 25 doses of lyophilisate + cardboard box with 50 ml of solvent
- Cardboard box with 50 doses of lyophilisate + cardboard box with 100 ml of solvent
Not all pack sizes 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)
Marketing Authorisation Number
UK: Vm 01708/4612
Significant changes
Date of the first authorisation or date of renewal
20 June 2019
Date of revision of the text
August 2022
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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