NOAH Compendium

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Date: Tuesday, September 29, 2020 19:57

Release 11.129
Bovalto Respi 4 suspension for injection
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:Bovalto Respi 4 suspension for injection for cattle
Product index: Bovalto Respi 4
Cattle - milk: Zero days
Cattle - meat: Zero days
Qualitative and quantitative composition
One dose (2 ml) contains:
Active substances:
Inactivated bovine respiratory syncytial virus, strain BiO-24 RP* ≥ 1
Inactivated bovine parainfluenza 3 virus, strain Bio-23 RP* ≥ 1
Inactivated bovine viral diarrhoea virus, strain BiO-25 RP* ≥ 1
Inactivated Mannheimia haemolytica, serotype A1 strain DSM 5283 RP* ≥ 1
* Relative potency (RP) in comparison with the reference serum obtained after vaccination of guinea pigs with a vaccine batch that has successfully passed the challenge test in the target animals.
Adjuvants:
Aluminium hydroxide 8.0 mg
Quillaja saponin (Quil A) 0.4 mg
Excipients:
Thiomersal 0.2 mg
Formaldehyde 1.0 mg at most
For the full list of excipients, see Pharmaceutical Particulars.
Pharmaceutical form
Suspension for injection. Appearance: pinkish liquid with sediment.
Clinical particulars
Target species
Cattle.
Indications for use, specifying the target species
For active immunisation of cattle in the absence of maternally derived antibodies against:
- parainfluenza 3 virus, to reduce virus excretion due to infection
- bovine respiratory syncytial virus, to reduce virus excretion due to infection
- bovine viral diarrhoea virus, to reduce virus excretion due to infection
- Mannheimia haemolytica serotype A1, to reduce clinical signs and lung lesions.
Onset of immunity:
3 weeks
Duration of immunity:
6 months
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only
Special precautions for use in animals
Safety and efficacy studies were performed in sero-negative calves. The efficacy of the vaccination has not been demonstrated in presence of antibodies. The level of antibody response may be reduced by the presence of maternal antibodies. In the presence of maternal antibodies, timing of initial vaccination of calves should be planned accordingly.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental self- injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
A localised swelling may be very commonly observed at the injection site after vaccination. This swelling could reach up to 10cm or more in diameter and may be associated with pain and usually progressively reduces and disappears within 6 weeks after vaccination.
A transient slight increase in body temperature may commonly appear which is higher after the second injection (1.5°C at most) lasting up to 3 days after vaccination.
Anaphylactic-type reactions may very rarely occur after vaccination. In such cases, appropriate symptomatic treatment should be administered.
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, lactation or lay
Can be used 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
Subcutaneous use.
Dose: 2 ml administered subcutaneously.
Warm before use to a temperature of 15 °C to 25 °C and shake the contents of the bottle.
Primary vaccination
Calves from non-immune dams: two doses three weeks apart from 2 weeks of age
For calves from immune dams or where the immune status of the dam is unknown, the vaccination scheme should be adapted at the discretion of the veterinarian to take into account potential interference of maternally derived antibodies with the response to vaccination.
Revaccination
Administer one dose six months after completion of the primary vaccination scheme.
The efficacy of revaccination was demonstrated by measurement of the serological response and has not been assessed by challenge.
Overdose (symptoms, emergency procedures, antidotes), if necessary
No adverse effects other than those mentioned in the "Adverse Reactions" section were observed.
Withdrawal period(s)
Zero days.
Pharmacological particulars
Pharmacotherapeutic group: Immunologicals for Bovidae; inactivated viral and bacterial vaccines for cattle. The vaccine induces an active immunity against bovine respiratory syncytial virus, parainfluenza 3 virus, bovine viral diarrhoea virus and Mannheimia haemolytica.
Pharmaceutical particulars
List of excipients
Aluminium hydroxide, Thiomersal, Formaldehyde, Quillaja saponin (Quil A), Sodium chloride, Water for injections
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 10 hours.
Special precautions for storage
Store and transport refrigerated (2 °C – 8 °C).
Do not freeze. Protect from light.
Nature and composition of immediate packaging
Type I glass bottle of 10 ml with chlorobutyl elastomer closure (5 doses), Type II glass bottle of 50 or 100 ml with chlorobutyl elastomer closure (25 or 50 doses), Translucent HDPE plastic bottle of 10, 50 or 100 ml with chlorobutyl elastomer closure (5, 25 or 50 doses). Bottle is secured with an aluminium cap.
Cardboard box of 1 bottle of 5 doses (10 ml), Covered plastic box of 10 bottles of 5 doses (10 x 10 ml), Cardboard box of 1 bottle of 25 doses (50 ml), Cardboard box of 1 bottle of 50 doses (100 ml). 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 products
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
Vm 08327/4274
Significant changes
Date of the first authorisation or date of renewal
17 February 2016
Date of revision of the text
June 2020
Any other information
Legal category
Legal category: POM-V
GTIN
GTIN description:BOVALTO RESPI 4 5 dose
GTIN:03661103051206
GTIN description:BOVALTO RESPI 4 25 dose
GTIN:03661103051213