Bovalto Respi 4 Suspension for Injection

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Bovine viral diarrhoea virus, Mannheimia haemolytica

Saatavilla:

Boehringer Ingelheim Animal Health UK Ltd

ATC-koodi:

QI02AL

INN (Kansainvälinen yleisnimi):

Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Bovine viral diarrhoea virus, Mannheimia haemolytica

Lääkemuoto:

Suspension for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cattle

Terapeuttinen alue:

Inactivated Viral and Bacterial Vaccine

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2016-02-17

Valmisteyhteenveto

Revised: August 2023
AN: 03123/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BOVALTO Respi 4 suspension for injection
2.
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 section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Appearance: pinkish liquid with sediment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
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
Revised: August 2023
AN: 03123/2022
Page 2 of 5
-
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
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals:
Safety and effic