Bovalto Respi 4 Suspension for Injection

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

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

Disponibil de la:

Boehringer Ingelheim Animal Health UK Ltd

Codul ATC:

QI02AL

INN (nume internaţional):

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

Forma farmaceutică:

Suspension for injection

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Cattle

Zonă Terapeutică:

Inactivated Viral and Bacterial Vaccine

Statutul autorizaţiei:

Authorized

Data de autorizare:

2016-02-17

Caracteristicilor produsului

Revised: June 2020
AN: 01560/2019
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
- bovine viral diarrhoea virus, to reduce virus excretion due to
infection
Revised: June 2020
AN: 01560/2019
Page 2 of 5
- _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 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 o